Materials Molecular

1 Poly(p-phenylene-2,6 benzo[1,2-d:45-d'] bisoxazole (PBO)

2 Poly(p-phenylene-2,6 benzo[1,2-d:45-d'] bisthiazole (PBZT)

**material life cycle** 

Fig. 7. Waste Generation and Exergy Loss (Dewulf et al., 2008, Lem et al., 2009, 2010)

#### **9. Flow of Ag and AgNPs as a food metabolism process in material life cycle**

Using a material flow analysis (MFA), Johnson et al. (2006) in their "anthropogenic cycling of silver in 1997" study have found that North America and Europe have the biggest share of use of silver products on a per capita basis. They found that global silver discards are approximately 57% of the silver mined and only 57% of the silver entering waste management globally is recycled. The amount of silver entering landfills globally is comparable to the amount found in silver mining tailings. Eckelman and Graedel (2007) reported that more than 13 Gg of silver are emitted annually to the environment globally. The tailings and landfills make up almost three-fourths of the total emission.

Figure 8 gives an overview of a silver/nanosilver product's life cycle as food and waste in industrial metabolism. The metabolization of resources should be optimized with respect to exergy. Dewulfn and Van Langenhove (2002, 2004) have previously applied exergy analysis as a quantitative tool in the thermodynamic optimization of the life cycle of plastics.

Waste Minimization for the Safe Use of Nanosilver

mentioned the size of nanosilver in 2010.

exhibit size dependent magnetic memory properties (Sun, 2007).

Fig. 9. Patents Describing Size of Nanosilver (Adopted from Lem et al., 2012)

As seen in Table 2, much effort has been employed to refine the type of stabilizers depending on the size of the nanosilver. For the larger diameters up to 400 nm, polyethylene glycol, poly (styrenesulfonate), cetyltrimethylammonium bromide have been used. For the medium diameters up to 100 nm, proteins, peptides, polyvinylpyrrolidone, human serum albumin and transferring have been reported in the IP publication to stabilize the nanosilver. For the very small diameter up to 15 nm, polyvinylpyrrolidone, (1-vinyl pyrrolidone)-acrylic acid copolymer, polyoxyethylene stearate, and 1-vinylpyrrolidonevinyl acetic acid copolymer were used. Since most AgNPs require to be capped by stabilizers for dispersion, the cytotoxic effect from NP size may be mixed with that from stabilizers. A study employed physically produced AgNPs for examination of the size effect

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 233

size dependent material properties which are substantially different from their counterparts in bulk. The extent of valence electron delocalization can vary with the size of the particle or domain. Quantum effects become relevant for sizes less than 10 nm. Material properties become tunable by size (Sun, 2007); notably, coordination number imperfection, surface relaxation behavior, nanosolidification in physical properties, superplasticity in mechanical properties, melting and thermal diffusivity in thermal properties, acoustic phonon hardening and optical phonon softening behavior, quantum confinement effects in optical properties, work function and dielectric suppression in electrical properties, and magnetic modulation in magnetic properties. For example, the bandgap of semiconductors such as ZnO, CdS, and Si, changes with size. Magnetic materials such as Fe, Co, Ni, Fe3O4, etc.,

In spite of the significance in the size of nanosilver, patenting directly addressing size effects only started in 2006 as seen in Figure 9. It is growing every year and 19 patent publications

Fig. 8. A Silver/Nanosilver Product's Life Cycle as **Food** and **Waste** in Industrial Metabolism (Adopted from Lem et al., 2010)

Once again as in Figure 6, a mass balance of each step in the life cycle in Figure 8 is equal to the food resource (in blue color arrows) available in each step minus the wastes (in red color arrows) at each step. Therefore, a summation of all the steps gives rise to the total value generated. Eqn 4 can be found

$$\text{Total Value Performance} = \sum \text{(Food Resistance in Each Step)} - \sum \text{(waste)}\_{\text{all sources}} \tag{4}$$

For the continuous process we have the generalized Eqn. 3 (above)

$$P(\mathbf{x}) = \int \mathcal{J}\_j V(\mathbf{x}\_j) d\mathbf{x}\_j - \int a \rho\_j \mathcal{W}(\mathbf{x}\_j) d\mathbf{x} \tag{5}$$

Therefore, the main thrust in the waste minimization is to minimize the waste generation function W (xj) at any step j.

#### **10. Effect of size on functional materials (silver)**

It is well established that the size of nanomaterials affects its properties (Sun, 2007). There is no exception in AgNPs, particularly as an antibacterial and anti-biofouling agent (Chaloupka et al., 2010; Liu H-L et al., 2010; Liu JG et al., 2010; Sotiriou & Pratsinis, 2010). Fundamental morphology, surface area, and property changes with smaller size have led to

Fig. 8. A Silver/Nanosilver Product's Life Cycle as **Food** and **Waste** in Industrial

= − λ

Therefore, the main thrust in the waste minimization is to minimize the waste generation

It is well established that the size of nanomaterials affects its properties (Sun, 2007). There is no exception in AgNPs, particularly as an antibacterial and anti-biofouling agent (Chaloupka et al., 2010; Liu H-L et al., 2010; Liu JG et al., 2010; Sotiriou & Pratsinis, 2010). Fundamental morphology, surface area, and property changes with smaller size have led to

For the continuous process we have the generalized Eqn. 3 (above)

**10. Effect of size on functional materials (silver)** 

Once again as in Figure 6, a mass balance of each step in the life cycle in Figure 8 is equal to the food resource (in blue color arrows) available in each step minus the wastes (in red color arrows) at each step. Therefore, a summation of all the steps gives rise to the total value

= − ( ) ( ) *all sources Total Value Performance Food Resource in Each Step wastes* (4)

 ω

() ( ) ( ) *P x V x dx W x dx j jj j j* (5)

Metabolism (Adopted from Lem et al., 2010)

generated. Eqn 4 can be found

function W (xj) at any step j.

size dependent material properties which are substantially different from their counterparts in bulk. The extent of valence electron delocalization can vary with the size of the particle or domain. Quantum effects become relevant for sizes less than 10 nm. Material properties become tunable by size (Sun, 2007); notably, coordination number imperfection, surface relaxation behavior, nanosolidification in physical properties, superplasticity in mechanical properties, melting and thermal diffusivity in thermal properties, acoustic phonon hardening and optical phonon softening behavior, quantum confinement effects in optical properties, work function and dielectric suppression in electrical properties, and magnetic modulation in magnetic properties. For example, the bandgap of semiconductors such as ZnO, CdS, and Si, changes with size. Magnetic materials such as Fe, Co, Ni, Fe3O4, etc., exhibit size dependent magnetic memory properties (Sun, 2007).

In spite of the significance in the size of nanosilver, patenting directly addressing size effects only started in 2006 as seen in Figure 9. It is growing every year and 19 patent publications mentioned the size of nanosilver in 2010.

Fig. 9. Patents Describing Size of Nanosilver (Adopted from Lem et al., 2012)

As seen in Table 2, much effort has been employed to refine the type of stabilizers depending on the size of the nanosilver. For the larger diameters up to 400 nm, polyethylene glycol, poly (styrenesulfonate), cetyltrimethylammonium bromide have been used. For the medium diameters up to 100 nm, proteins, peptides, polyvinylpyrrolidone, human serum albumin and transferring have been reported in the IP publication to stabilize the nanosilver. For the very small diameter up to 15 nm, polyvinylpyrrolidone, (1-vinyl pyrrolidone)-acrylic acid copolymer, polyoxyethylene stearate, and 1-vinylpyrrolidonevinyl acetic acid copolymer were used. Since most AgNPs require to be capped by stabilizers for dispersion, the cytotoxic effect from NP size may be mixed with that from stabilizers. A study employed physically produced AgNPs for examination of the size effect

Waste Minimization for the Safe Use of Nanosilver

pad as an example as illustrated as in Figure 10.

Fig. 10. Shoe Pads (Adopted from Lem et al., 2012)

AgNPs can be controlled release at least seven in ways:

(i.e., the Lotus Leaf Effect).

3. Oxidant availability, 4. Media composition,

6. Release device structure,

2. Particle surface modification,

1. Particle size,

7. Locality.

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 235

We have started to answer the first question by examining each step of the material flow in a metabolism during the life cycle as discuss earlier. The value generated is equal to the food resource available in each step minus the wastes at each step (Lem et al., 2009). In the material flow model, we need to include probabilistic method as suggested by Gottschalk et al. (2010) that is commonly being used in Design for Six Sigma (DFSS, Curran et al., 2006). To answer the second and third question, we need to understand how the use of nanosilver can be minimized based on specific needs in release and apply the DFLSS and TRIZ to generate innovative ideas for the eco-products design. As an exercise, we will use a shoe

The amount of AgNPs release depends on the mechanics of the release. To prevent and control these occurrences, it is necessary to use "right amount" of suitable biocides to control fowl and kill microbes. Using a TRIZ approach (Terninko et al., 1998; Rantanen & Dom., 2002) in Figure.11, such a concept is proposed to use water activity as a means to control the water content of AgNO3 in the nanofibers where these nanofibers have a shell and core structure. In addition to the controlled release of AgNPs, the use of the nanofibers is to produce a very high contact angle surface to prevent water absorption on the surface

5. Structured release materials (such as multilayer shell and core structured nanofibers),

(Liu H-L et al., 2010). Results revealed that AgNPs of smaller average size (among 3 nm, 6 nm or > 10 nm) had greater antibacterial activity as well as cytotoxicity. This study pointed out the critical role of NP size in their effect on human health and environment.

### **11. Waste minimization in eco-product design for public health**

We have recommended earlier to use Design for Lean Six Sigma - Green (DFLSS-G) and TRIZ to design eco-products (Lem et al., 2009). Kobayashi (2005) has used a product life planning methodology based on a quality function deployment (QFD) and a software tool to establish an *eco*-design concept of a product and its life cycle in multigenerational ecoproducts development. Serban et al., (2004) have used a TRIZ approach to design for environment for over a product life cycle. We need to answer the following three hard questions in this design:




We have started to answer the first question by examining each step of the material flow in a metabolism during the life cycle as discuss earlier. The value generated is equal to the food resource available in each step minus the wastes at each step (Lem et al., 2009). In the material flow model, we need to include probabilistic method as suggested by Gottschalk et al. (2010) that is commonly being used in Design for Six Sigma (DFSS, Curran et al., 2006). To answer the second and third question, we need to understand how the use of nanosilver can be minimized based on specific needs in release and apply the DFLSS and TRIZ to generate innovative ideas for the eco-products design. As an exercise, we will use a shoe pad as an example as illustrated as in Figure 10.

Fig. 10. Shoe Pads (Adopted from Lem et al., 2012)

The amount of AgNPs release depends on the mechanics of the release. To prevent and control these occurrences, it is necessary to use "right amount" of suitable biocides to control fowl and kill microbes. Using a TRIZ approach (Terninko et al., 1998; Rantanen & Dom., 2002) in Figure.11, such a concept is proposed to use water activity as a means to control the water content of AgNO3 in the nanofibers where these nanofibers have a shell and core structure. In addition to the controlled release of AgNPs, the use of the nanofibers is to produce a very high contact angle surface to prevent water absorption on the surface (i.e., the Lotus Leaf Effect).

AgNPs can be controlled release at least seven in ways:

1. Particle size,

234 Public Health – Methodology, Environmental and Systems Issues

(Liu H-L et al., 2010). Results revealed that AgNPs of smaller average size (among 3 nm, 6 nm or > 10 nm) had greater antibacterial activity as well as cytotoxicity. This study pointed

We have recommended earlier to use Design for Lean Six Sigma - Green (DFLSS-G) and TRIZ to design eco-products (Lem et al., 2009). Kobayashi (2005) has used a product life planning methodology based on a quality function deployment (QFD) and a software tool to establish an *eco*-design concept of a product and its life cycle in multigenerational ecoproducts development. Serban et al., (2004) have used a TRIZ approach to design for environment for over a product life cycle. We need to answer the following three hard

Poly(Styrenesulfonate), Cetyltrimethylammonium Bromide; 1-400 nm

or Transferrin 1-100 nm.

**Product Nanosilver Size** 

 1-100 nm in diameter

1-15 nm

Cosmetics And Personal Care / Hair Care

Medical - Implant

Biomedical Device -

Lense

out the critical role of NP size in their effect on human health and environment.

**11. Waste minimization in eco-product design for public health** 

1. Do we have a complete understanding of AgNPs product life cycle?

**Publication Number Stabilizers/Important Components Application Area/ End** 

Stabilizer : Agarose, Hydrogel, Paa (Poly Acrylic Acid), Pva (Poly Vinyl Alcohol), Chitosan, Pnipam (Poly-N-Isopropyl Acrylamide), Substituted Pnipam (Including Pnipam-Aa (Poly-N-Isopropyl Acrylamide-Acrylic Acid), Pnipam-Allylamine (Poly-N-Isopropyl Acrylamide-Allylamine), And Pnipam-Sh), Pamam (Polyamidoamine), Peg (Polyethylene Glycol), Alginic

3. What can we do to minimize use of AgNPs with optimal effects?

Stabilizers: Proteins And/Or Peptides And/Or Polyvinylpyrrolidone: Human Serum Albumin And

Acid and/or Hpc (Hydroxyl Propyl Cellulose)

US20090011046A1 Stabilizer: Proteins And/Or Peptides: Human Serum Albumin

US20080181931A1 Stabilizer: Acrylic Acid, Polyacrylic Acid, Poly(Ethyleneimine),

Pigment, Or A Beneficial Agent.

Polyvinylpyrrolidone

CN101402757A Stabilizer: Amine Light Stabilizer. Packaging

Stabilizer : Hydroquinone, Hydroquinone Monomethyl Ether, T-Butyl Paracresol And Hydroxy Methoxybenzophenone, A

Stabilizer: Polyvinylpyrrolidone, (1-Vinyl Pyrrolidone)-Acrylic Acid Copolymer, Polyoxyethylene Stearate, And 1- Vinylpyrrolidone-Vinyl Acetic Acid Copolymer.

Stabilizer: Glycerin, Polyethylene Glycol, Ethanol, Ethylene Glycol, Propylene Glycol, Sorbitan Fatty Acid Alkylester And

Stabilizer: Polyacrylic Acid (PAA), A Poly(Ethyleneimine) (PEI), A Poly(Vinylpyrrolidone) (PVP), A Copolymer of Acrylic Acid

Transferrin;

US20090326614A1 Stabilizer : Polyethylene Glycol (Peg),

Table 2. Type of Stabilizers Used (Adopted from Lem et al., 2012)

Its Ethylene Oxide, Hydrogenated Caster Oil

(AA) with a Vinylic Monomer, Acrylic Acid

2. Do we have a clear understanding on the unmet needs?

questions in this design:

WO2010091529A1

US20100172997A1

US20080248086A1

KR2008083499A

KR2006026362A

US20050013842A1


Waste Minimization for the Safe Use of Nanosilver

Define Environment System (Function Model)

> Identify Ideal Final Result

Compare/Contrast Existing Environment System with Ideal Final Result

Establish Ideality Equation (ΣUseful/ΣHarmful)

> Identify system level contradictions

Substance-Field (Su-Field) Algorithm

> **1. Conflict Resolution, 2. Ideal Final Result, 3. Development of Measurement Systems.**

> **1. Conflict Resolution, 2. Trimming, 3. Subversion Analysis, 4. Problem Solving**

**1. Conflict Resolution, 2. Trimming, 3. Problem Solving**

**DFSS** 

**Voice of the Customer**

**Concept Development All** 

**Detailed Design All** 

**Optimize**

**Validate/ Implement**

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 237

(Adopted from Terninko et al, 1998)

Use 39 Parameters

Physical Contradiction Technical Contradiction

**Convert**

Separation 40 Principles Contradiction Matrix

Solutions

Problem Solved?

No Yes

Compare Solution Ideality (1) with Existing Environmental System (2) with Ideal Final Result

Implement

**Cycle**

1. Example - Friends of Earth/USEPA vs. Silver

4. Search for Previously Well-Solved Problems a. Examine 39 engineering parameters/40

Step 3: Review toxicity data for environmentally relevant silver compounds. Optimize wherever possible. Review earlier search for previously

Step 1: Voice of the Environment (VOE) 1. Safety of AgNP Products. 2. Define Ideality Based QFD

Step 2: Conflict resolution

3. Use of Resources

well-solved problems

resolution/Ideality Revisit

principles. b. IP Landscaping

Validate potential solution Step 4: Gap Closing - Conflict

Nanotechnology Work Group 2. Define Functionality/ Requirements

Fig. 12. Flow Chart for DFLSS-G with TRIZ (Adopted from Lem et al., 2010)

Identify the Problem

be Changed

be Changed,

Identify contradictions at sub- or super-system level

**Phase TRIZ Tools Approach Application to AgNP Product Life** 

1. Find The Principle that Needs to

2. Then Find the Principle that is an Undesired Secondary Effect.

1. Find the Principle that Needs to

2. Then Find the Principle that is an Undesired Secondary Effect.

1. Look for Analogous Solutions 2. Adapt to the Potential Solution 3. Optimize – Ideality

Create System Model

Table 3. TRIZ Approach in DFLSS-G for AgNPs Products Life Cycle (Adopted from Lem et al.,

2010)

The release can be by one, combination of several, or a combination of all. The first four have been demonstrated by Liu JG et al. (2010) experimentally that the release of AgNPs can be tuned. To understand better the mechanic of the release, we will extend the work by Schiesser (1992, 2011) to describe the release control (desorption and diffusion) in our model.

**Using Water Activity to Control the Water Content of** 

Fig. 11. The Proposed TRIZ Concept (Adopted from Lem et al., 2011)

#### **11.1 DFLSS and TRIZ**

A flow chart of the procedure to be used in our study is given in Figure 12 and a TRIZ approach in Design for Lean Six Sigma – Green for AgNPs products life cycle is given in Table 3. We are using the following four steps iterative approach:

**First:** determine the Voice of the Environment regarding the safety of the AgNPs products using two extreme sides of the debate between Friends of Earth/USEPA and Silver Nanotechnology Work Group (SNWG) to obtain a resolution regarding "Conflict". We try to answer the question - could improving one technical characteristic to solve a problem cause other technical characteristics to worsen? Once the problem is defined, we need to define the system boundaries, quantify mass flows of AgNPs, and define several emission scenarios.

**Second:** search for previously well-solved problems by looking at the 39 engineering parameters/40 principles (Terninko et al., 1998; Rantanen & Dom., 2002). Antimicrobial nanoscale silver is typically embedded within substrates, mainly a a matrix such as a polymer, where any antimicrobial functionality is achieved via release of silver ions (Ag+).

The behavior of silver in environment will be reviewed, and a mass balance model applied to calculate predicted environmental concentrations. The uncertainty of the results is assessed and predicted concentrations are compared to experimental and empirical data (examine an example such as "Nanoparticle Silver Released into Water from Commercially Available Sock Fabrics" by Benn and Westerhoff, 2008).

The release can be by one, combination of several, or a combination of all. The first four have been demonstrated by Liu JG et al. (2010) experimentally that the release of AgNPs can be tuned. To understand better the mechanic of the release, we will extend the work by Schiesser

> **Using Water Activity to Control the Water Content of AgNO3 in Nanofibers with a Core and Shell Structure**

> > **TRIZ (AgNP)** Tool Object

> > > Contradictions

Kill Germs vs. Kill Human Cells

**Effects Standard**

A flow chart of the procedure to be used in our study is given in Figure 12 and a TRIZ approach in Design for Lean Six Sigma – Green for AgNPs products life cycle is given in

**First:** determine the Voice of the Environment regarding the safety of the AgNPs products using two extreme sides of the debate between Friends of Earth/USEPA and Silver Nanotechnology Work Group (SNWG) to obtain a resolution regarding "Conflict". We try to answer the question - could improving one technical characteristic to solve a problem cause other technical characteristics to worsen? Once the problem is defined, we need to define the system boundaries, quantify mass flows of AgNPs, and define several emission scenarios.

**Second:** search for previously well-solved problems by looking at the 39 engineering parameters/40 principles (Terninko et al., 1998; Rantanen & Dom., 2002). Antimicrobial nanoscale silver is typically embedded within substrates, mainly a a matrix such as a polymer, where any antimicrobial functionality is achieved via release of silver ions (Ag+). The behavior of silver in environment will be reviewed, and a mass balance model applied to calculate predicted environmental concentrations. The uncertainty of the results is assessed and predicted concentrations are compared to experimental and empirical data (examine an example such as "Nanoparticle Silver Released into Water from Commercially

Release Ag+NP

Resources

Pros vs. Cons

**Other TRIZ Based Tools**

Ideal Final Result

Information available to be used to solve the contractions

Solution that resolves the contradictions without compromise

> **40 Principles**

(1992, 2011) to describe the release control (desorption and diffusion) in our model.

**AgNO3 in Nanofibers**

Fig. 11. The Proposed TRIZ Concept (Adopted from Lem et al., 2011)

Table 3. We are using the following four steps iterative approach:

Available Sock Fabrics" by Benn and Westerhoff, 2008).

Ag+ NO3 -

**11.1 DFLSS and TRIZ** 

**Water Activity Affected by Temp at Constant Water Content**

(Adopted from Terninko et al, 1998)

Fig. 12. Flow Chart for DFLSS-G with TRIZ (Adopted from Lem et al., 2010)


Table 3. TRIZ Approach in DFLSS-G for AgNPs Products Life Cycle (Adopted from Lem et al., 2010)

Waste Minimization for the Safe Use of Nanosilver

Fig. 14. Water Droplets on a Leaf

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 239

Fig. 13. The Proposed Structural Release Medium (Adopted from Lem et al., 2011)

**Third:** compile and predict the toxicity data for environmentally relevant silver compounds for no effect concentrations. This material flow will be optimized based on a review of our earlier search for previously well-solved problems.

**Fourth:** evaluate and determine the potential for risk caused by the release of silver into environment using all available experimental data and literature data.

#### **11.2 Release mechanics of AgNPs**

As discussed earlier, the release of AgNPs can be controlled seven ways: (1) particle size, (2) particle surface modification, (3) oxidant availability, (4) media composition, (5) structured release materials, (6) structure of release device, and (7) locality. The release can be by one, combination of several, or a combination of all. The first four have been demonstrated by Liu JG et al. (2010) that the release of AgNPs can be tuned. The readers are referred to their excellent paper for details. In this section, we will focus our discussion on the last three methods.

#### **11.2.1 Structured release material**

One way to control the release of AgNPs is the control of the presence of water. Water activity (aw) is defined as aw=p/po (where p and po are the partial pressures of water above a medium such as a food and a pure solution under identical conditions It is a measure of how efficiently the "free" water vs. the "bound" water present can take part in a chemical and/or physical reaction. Water content as a function of water activity has played a critical role in the understanding of food processing science and technology (Cassini et al., 2009). Nadia et al. (2011) have suggested further use of the glass transition temperature (Tg) of the material together with water activity in the material. This combination is a powerful tool for understanding the quantification of water mobility in foods and controlling the shelf-life of products. They reported that Tg, moisture content, and aw are useful tools to quantify the water migration pattern in food precisely (Nadia et al., 2011).

The design of the structured release material must have an appropriate Tg, and the desired concentration of total water content present in a medium strongly bound to specific sites. These sites can be the hydroxyl groups of polysaccharides, the carbonyl, amino groups of proteins or synthetic polymers like nylon, polyurethanes, and other polar polymers containing hydrogen bonds and ion-dipole bonds. The preferred structure of the release material can be either bilayer such as shell/core or multilayered where the availability of free water in the material containing AgNO3 can be controlled as needed (see Figure 13).

#### **11.2.2 Structure of the release device**

It has been known for many centuries that water forms spherical droplets on a leaf as seen in Figure 14, and it is more pronounced in the lotus leaf (Luzinov et al., 2006; Ramaratnam et al., 2008; Schilthuizen, 2009; Eichhoff, 2011). Lotus leaves are unusually water-repellent and keep themselves spotless, because on their surface there are countless miniature protrusions, coated with a water-repellant hydrophobic substance. Water cannot spread out on the leaves; so it acts as droplets, removing grime and soil as it moves. The rough surface inhibits wettability and reduces the contact area for dirt particles. Lotus effect has found many interesting applications in consumer products, surface coatings, electronic materials, and smart textile (Luzinov et al., 2006; Ramaratnam et al., 2008; Schilthuizen, 2009).

**Third:** compile and predict the toxicity data for environmentally relevant silver compounds for no effect concentrations. This material flow will be optimized based on a review of our

**Fourth:** evaluate and determine the potential for risk caused by the release of silver into

As discussed earlier, the release of AgNPs can be controlled seven ways: (1) particle size, (2) particle surface modification, (3) oxidant availability, (4) media composition, (5) structured release materials, (6) structure of release device, and (7) locality. The release can be by one, combination of several, or a combination of all. The first four have been demonstrated by Liu JG et al. (2010) that the release of AgNPs can be tuned. The readers are referred to their excellent

One way to control the release of AgNPs is the control of the presence of water. Water activity (aw) is defined as aw=p/po (where p and po are the partial pressures of water above a medium such as a food and a pure solution under identical conditions It is a measure of how efficiently the "free" water vs. the "bound" water present can take part in a chemical and/or physical reaction. Water content as a function of water activity has played a critical role in the understanding of food processing science and technology (Cassini et al., 2009). Nadia et al. (2011) have suggested further use of the glass transition temperature (Tg) of the material together with water activity in the material. This combination is a powerful tool for understanding the quantification of water mobility in foods and controlling the shelf-life of products. They reported that Tg, moisture content, and aw are useful tools to quantify the

The design of the structured release material must have an appropriate Tg, and the desired concentration of total water content present in a medium strongly bound to specific sites. These sites can be the hydroxyl groups of polysaccharides, the carbonyl, amino groups of proteins or synthetic polymers like nylon, polyurethanes, and other polar polymers containing hydrogen bonds and ion-dipole bonds. The preferred structure of the release material can be either bilayer such as shell/core or multilayered where the availability of free water in the material containing AgNO3 can be controlled as needed (see Figure 13).

It has been known for many centuries that water forms spherical droplets on a leaf as seen in Figure 14, and it is more pronounced in the lotus leaf (Luzinov et al., 2006; Ramaratnam et al., 2008; Schilthuizen, 2009; Eichhoff, 2011). Lotus leaves are unusually water-repellent and keep themselves spotless, because on their surface there are countless miniature protrusions, coated with a water-repellant hydrophobic substance. Water cannot spread out on the leaves; so it acts as droplets, removing grime and soil as it moves. The rough surface inhibits wettability and reduces the contact area for dirt particles. Lotus effect has found many interesting applications in consumer products, surface coatings, electronic materials, and

smart textile (Luzinov et al., 2006; Ramaratnam et al., 2008; Schilthuizen, 2009).

paper for details. In this section, we will focus our discussion on the last three methods.

earlier search for previously well-solved problems.

**11.2 Release mechanics of AgNPs** 

**11.2.1 Structured release material** 

**11.2.2 Structure of the release device** 

environment using all available experimental data and literature data.

water migration pattern in food precisely (Nadia et al., 2011).

Fig. 13. The Proposed Structural Release Medium (Adopted from Lem et al., 2011)

Fig. 14. Water Droplets on a Leaf

Waste Minimization for the Safe Use of Nanosilver

**12. Future study** 

from Lem et al., 2011)

**13. References** 

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 241

In our Design for Lean Six Sigma based Waste Minimization research program, we have begun our journey to study the life cycle assessment of nanosilver starting with the use of product life cycle process mapping and Design for Lean Six Sigma with TRIZ. We are planning to have a more multidisciplinary and international interaction to the characterization of AgNPs products and their transformations in relevant biological and environmental media. A rigorous material flow analysis is needed to quantitatively assess the environmental impact of AgNPs emission. We have continued our study on waste minimization for the safe use of nanosilver in consumer products with particular attention paid to the eco-product design for public health. The data that have been generated from an IP search study help us design eco-products using Design for Lean Six Sigma - Green (DFLSS - G) and TRIZ (Curran et al., 2006; Lem et al., 2006; Terninko et al., 1998) as seen in Figure 17. In addition we need to verify the concept illustrated in Figure 17 experimentally. We will use Monte Carlo (Curran et al., 2006), artificial neural network modeling (Chayjan et al., 2011), and generic programming (Langdon, 2008) approach in the front-end of the innovative concept generation process to search for the best new generation design. To have a better understanding the mechanic of the release control, we will extend the work by Schiesser and his coworkers (Silebi & Schiesser, 1992; 2011) to describe the desorption and

diffusion in a pore with Monte Carlo simulations (Gottschalk et al., 2010).

Fig. 17. Proposed Structure of an Eco-Product Required Biocides for a Shoe Pad (Adopted

Ahamed, M., Karns, M., Goodson, M., Rowe, J., Hussain, S. M., Schlager, J. J., & Hong, Y.L.,

(2008), "DNA Damage Response to Different Surface Chemistry of Silver Nanoparticles in Mammalian Cells," Toxicology and Applied Pharmacology, 233, pp. 404–410.

Our goal is to control the wetting of water on the release device by using the concept advanced by Nano-Tex, LLC. Nano-Tex improves the water-repellent property of fabric using the so-called "Lotus Effect" by creating hydrocarbon nano-whiskers that are of 1/1000 of the size of a typical cotton fiber. The distance between the whiskers on the fabric is smaller than a typical drop of water and water thus remains on the top of the whiskers and above the surface of the fabric. (Eichhoff, 2011; Schneider, 2008; Wong et al., 2006; Lo, 2006).

A pictorial diagram of our proposed structure of the release device is shown in Figure 15. The materials used to make the release device have been suggested by KnollTextile (2010) and Wong et al. (2006).

Fig. 15. Proposed Structure of Release Device (Adopted from Lem et al., 2011)

#### **11.2.3 Locality**

Bacterial fouling by humans has become a serious environmental and health issue. The existence of bacteria and its fouling in shoes and socks used/worn by human can lead to problems such as biofouling accumulation which leads to health problems. However, as seen in Figure 16, only certain areas in a shoe pad may require suitable biocides such as AgNPs for antifouling. Most sweat and frictional force occur in these areas indicated by the changing of the color of the pad.

Fig. 16. Locality of Required Biocides for a Foot and a Shoe (Adopted from Yang et al., 2010)

### **12. Future study**

240 Public Health – Methodology, Environmental and Systems Issues

Our goal is to control the wetting of water on the release device by using the concept advanced by Nano-Tex, LLC. Nano-Tex improves the water-repellent property of fabric using the so-called "Lotus Effect" by creating hydrocarbon nano-whiskers that are of 1/1000 of the size of a typical cotton fiber. The distance between the whiskers on the fabric is smaller than a typical drop of water and water thus remains on the top of the whiskers and above the surface of the fabric. (Eichhoff, 2011; Schneider, 2008; Wong et al., 2006; Lo, 2006). A pictorial diagram of our proposed structure of the release device is shown in Figure 15. The materials used to make the release device have been suggested by KnollTextile (2010)

Fig. 15. Proposed Structure of Release Device (Adopted from Lem et al., 2011)

Bacterial fouling by humans has become a serious environmental and health issue. The existence of bacteria and its fouling in shoes and socks used/worn by human can lead to problems such as biofouling accumulation which leads to health problems. However, as seen in Figure 16, only certain areas in a shoe pad may require suitable biocides such as AgNPs for antifouling. Most sweat and frictional force occur in these areas indicated by the

Fig. 16. Locality of Required Biocides for a Foot and a Shoe (Adopted from Yang et al., 2010)

and Wong et al. (2006).

**11.2.3 Locality** 

changing of the color of the pad.

In our Design for Lean Six Sigma based Waste Minimization research program, we have begun our journey to study the life cycle assessment of nanosilver starting with the use of product life cycle process mapping and Design for Lean Six Sigma with TRIZ. We are planning to have a more multidisciplinary and international interaction to the characterization of AgNPs products and their transformations in relevant biological and environmental media. A rigorous material flow analysis is needed to quantitatively assess the environmental impact of AgNPs emission. We have continued our study on waste minimization for the safe use of nanosilver in consumer products with particular attention paid to the eco-product design for public health. The data that have been generated from an IP search study help us design eco-products using Design for Lean Six Sigma - Green (DFLSS - G) and TRIZ (Curran et al., 2006; Lem et al., 2006; Terninko et al., 1998) as seen in Figure 17. In addition we need to verify the concept illustrated in Figure 17 experimentally. We will use Monte Carlo (Curran et al., 2006), artificial neural network modeling (Chayjan et al., 2011), and generic programming (Langdon, 2008) approach in the front-end of the innovative concept generation process to search for the best new generation design. To have a better understanding the mechanic of the release control, we will extend the work by Schiesser and his coworkers (Silebi & Schiesser, 1992; 2011) to describe the desorption and diffusion in a pore with Monte Carlo simulations (Gottschalk et al., 2010).

Fig. 17. Proposed Structure of an Eco-Product Required Biocides for a Shoe Pad (Adopted from Lem et al., 2011)

#### **13. References**

Ahamed, M., Karns, M., Goodson, M., Rowe, J., Hussain, S. M., Schlager, J. J., & Hong, Y.L., (2008), "DNA Damage Response to Different Surface Chemistry of Silver Nanoparticles in Mammalian Cells," Toxicology and Applied Pharmacology, 233, pp. 404–410.

Waste Minimization for the Safe Use of Nanosilver

Arch Occup Environ Health, 82, pp. 1043–1055.

Surfaces", Histochem Cell Biol., 133, pp. 359–366.

pp. 137-148.

CN1433776A, 2003.

Pollut Res., 9 (4), pp. 267-273

Protection Agency, July 15, 2010.

December 20, 2005

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 243

Cochrane, T., & Smith, J. A., (2001), "Designing Processes and Products to Minimize Wastes

Consumer Demand Beneficiaries in Korea - Cosmetics Market, July 2008. Available At Http://Www.Invescogreatwall.Com/Data/20080821090357MI-Korea-Jul08-E.Pdf Crosera, M., Bovenzi, M., Maina, G., Adami, G., Zanette, C., Florio, C., & Larese, F. F., (2009),

Curran, S.A., Lem, K. W., Sund, S., & Gabriel,G., (2006), "Six Sigma Design: An Overview of

Danscher, G., Locht, L. J., (2010), "In Vivo Liberation of Silver Ions from Metallic Silver

De Meester, B., Dewulf, J., Verbeke,S., Janssens, A., & Van Langenhovea, H., (2009),

Deng K.E, & Jin M. Z., (2003), "Process For Preparing Colloidal Silver Solution",

Dewulf, J., & Van Langenhove, H., (2002), "Assessment of the Sustainability of Technology

Dewulf, J., & Van Langenhove, H., (2004), "Thermodynamic Optimization of the Life Cycle

Dewulf, J., Van Langenhove, H., Muys, B., Bruers, S., Bakshi, B. R., Grubb, G. F., Paulus, D.

Eckelman, M. J., & Graedel, T.E., (2007), "Silver Emissions and their Environmental Impacts:

Edgar, T. F., & Huang, Y. L., (1994), "Artificial Intelligence Approach To Synthesis Of A

EI-Badawy A, Feldhake D, & Venkatapathy R., (2010) "State of the Science Literature

Eichhoff, J. (2011), "Smart Textiles Creating Added Value For Textile Products,"

Evans, S., Bergendahl, M. N., Gregory, M., & Ryan, C., (2009), "Towards a sustainable

Feder, B., (2005) "Old Curative Gets New Life at Tiny Scale." The New York Times,

policy," University of Cambridge Institute for Manufacturing, 2009. Faunce T., & Watal A., (2010), "Nanosilver and Global Public Health: International

DOI: 10.1081/E-ECHP-120016185, Marcel Dekker, pp. 2719-2733

the Built Environment", Building and Environment, 44, pp. 11–17.

of Plastics by Exergy Analysis", Int. J. Energy Res. 28, pp. 969–976

for Resource Accounting", Environ. Sci. Technol., 41, 8477–8483

Management IV, ACS Symposium Series. 554, pp. 96-113.

Wassets/Daten/Rahmenprogramm/Pdf/Smart-Textiles.Pdf

Regulatory Issues", Nanomedicine 5(4), pp. 617-632.

A Multilevel Assessment", Environ. Sci. Technol., 41, pp 6283-6289

Produced", Meche Conference Transactions; Engineering For Profit from Waste, 9,

"Nanoparticle Dermal Absorption and Toxicity: A Review of the Literature", Int

Design for Six Sigma (DFSS)", Encyclopedia of Chemical Processing (Lee, S., Ed.),

"Exergetic Life-Cycle Assessment (ELCA) for Resource Consumption Evaluation in

by Means of a Thermodynamically Based Life Cycle Analysis", Environ Sci &

M., & Sciubba. E., (2008), "Exergy: Its Potential and Limitations in Environmental Science and Technology", Environmental Science & Technology, 42(7), 2221-2232 Dewulf, J., Bössh, J.M.E., Demeester, B., Van Dervorst , G., H. Van Langenhove, H., Hellweg,

S., & Huijbregts, M. A. J., (2007), "Cumulative Exergy Extraction from the Natural Environment (CEENE): a Comprehensive Life Cycle Impact Assessment Method

Process For Waste Minimization", In Emerging Technologies In Hazardous Waste

Review: Everything Nanosilver and More", Scientific, Technical, Research, Engineering and Modelling Support Final Report, United States Environmental

Friedrichshafen, 16 July 2011 Available At Http://Www.Outdoor-Show.De/Od-

industrial system - With recommendations for education, research, industry and


 Http://Www.Bfr.Bund.De/Cm/216/Bfr\_Raet\_Von\_Nanosilber\_In\_Lebensmitteln \_Und\_Produkten\_Des\_Taeglichen\_Bedarfs\_Ab.Pdf


Atiyeh, B. S., Costagliola, M., Hayek, S. N., & Dibo, S. A., (2007), "Effect of Silver on Burn

Barry D., (2002), "How to Win Face in the Korean Cosmetics Market, EXPORT AMERICA",

Bartels K., (2010), BfR Opinion Nr. 024/2010. "Status of Regulation for Nanomaterials

Http://Www.Bfr.Bund.De/Cm/216/Bfr\_Raet\_Von\_Nanosilber\_In\_Lebensmitteln

Benn, T.M., & Westerhoff, P., (2008), "Nanoparticle Silver Released into Water from Commercially Available Sock Fabrics", Environ. Sci. Technol., 42 (11), pp. 4133–4139 Berglund, R. L. & Snyder, G. E., (1990), "Minimize Waste during Design", Hydrocarbon

Brauer S., Lem K.W., & Haw J.R., (2009), "The Markets for Soft Nanomaterials: Cosmetics

Brumlik, C. J., Lem, K. W., Choudhury, A., Lakhani, A. A., Kuyate, P., Pathak, P. P., Vaidya,

Cassini, A.S., Marczak, L.D.F., & Noreña, C.P.Z., (2009), "Comparison between the

Chaloupka K., Malam Y.K., & Seifalian A.M., (2010), "Nanosilver as a New Generation of

Chao J.B., Liu J.F., Yu S.J., Feng Y.D., Tan Z.Q., Liu R, & Yin Y.G., (2011), "Speciation

Chayjan, R. A. & Esna –Ashar, M., (2011), "Effect of Moisture Content on Thermodynamic

Chen, X., & Schluesener, H. J. , (2008), "Nanosilver: A Nanoproduct in Medical

Chih, Y-W., & Cheng, W-T., (2007), "Supercritical Carbon Dioxide-Assisted Synthesis of

Ciantar, C., Hadfield, M. & Howarth, G., (2001), "Case Studies to Assist Integrating Waste

and Pharmaceuticals", Nano and Green Technology Conference. New York City,

M., Iqbal, Z., & Careil, J-M., (2011), "Overview of 2010-2011 technology trends in nano-engineered energy generation and storage for large commercial markets," To be Presented at Nanotechnology 2011 Conference, Nanomaterials and Nanochemistry, Nano-Enabled Energy Systems, Nanomedicine and Nano-Bio Convergence - Emphasizing Emerging Science and Technologies, Applications, Commercialization and Business Opportunities, Javits Convention Center, New

Isotherms of Two Commercial Types of Textured Soy Protein", Latin American

Nanoproduct in Biomedical Applications", Trends in Biotechnology, 28(11), pp.

Analysis of Silver Nanoparticles and Silver Ions in Antibacterial Products and Environmental Waters Via Cloud Point Extraction-Based Separation", Anal.Chem.,

Characteristics of Grape: Mathematical and Artificial Neural Network Modeling",

Silver Nano-Particles in Polyol Process", Materials Science and Engineering B 145,

Prevention in Product Design", Meche Conference Transactions; Engineering for

\_Und\_Produkten\_Des\_Taeglichen\_Bedarfs\_Ab.Pdf

Processing, International Edition. 69(4), pp. 39-42.

139–148.

December 2002, pp. 6-7.

November 18, 2009.

580-588.

pp. 67–75.

83, pp. 6875-6882.

York, NY, November 1-3, 2011.

Applied Research, 39, pp. 91-97.

Czech J. Food Sci., 29 (3) pp. 250–259.

Profit from Waste, 9, pp. 201-210.

Application", Toxicology Letters, 176, pp. 1–12.

December 2009; Available at

Wound Infection Control and Healing: Review of the Literature", Burns, 33, pp.

including Nanosilver in the EU in General and for Use as Biocides and in Novel Foods," IPINTECH LLC, November 30, 2010, Private Report to Nanobiz LLC. 28


Waste Minimization for the Safe Use of Nanosilver

Korea, November 26, 2009.

6,214,908, April, 10, 2001.

6,414,066, July 2, 2002.

Korea, December 2, 2010.

University, November 2006.

NSTI-Nanotech 2011, 3(7), pp. 557 - 560.

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 245

Lem K.W., Haw J.R., Lee D.S., Iqbal Z., Salama A., Semthil Kurmaran, R., Sund, S., Curran,

Lem K.W., Haw J.R., Sund S., Curran S.A., Brumlik C., Smith P., Brauer, S., Schmidt, D., &

Lem, K. W., Curran, S.A., Sund, S., & Gabriel, G., (2006) "Thermosets: Materials, Processes,

Lem, K. W., Letton, A., Izod, T. P. J., Lupton, F. S., & Bedwell, W. B., (2001), "Composition

Lem, K. W., Letton, A., Izod, T. P. J., Lupton, F. S., & Bedwell, W. B., (2002), "Composition

Lem, K.W., Haw, J. R., Lee, D.S., Iqbal, Z., A. Salama, Kurmaran, S., Sund, S., Curran, S.,

Lem, K.W., Haw, J. R., Lee, D.S., Iqbal, Z., A. Salama, Kurmaran, S., Sund, S., Curran, S.,

Lem, K.W., Haw, J. R., Lee, D.S., Brumlik, C., Sund, S., Curran, S., Smith, P., Brauer, S.,

Lem, K.W., Haw, J. R., Lee, D.S., Brumlik, C., Sund, S., Curran, S., Smith, P., Brauer, S.,

Nanoparticle Synthesis & Applications, NSTI-Nanotech 2010, 1 (3), pp. 391 Lem, K.W., Haw, J. R., Lee, D.S., Brumlik, C., Sund, S., Curran, S., Smith, P., Brauer, S.,

Liu J.G., Sonshine D.A., Shervani S., & Hurt R.H., (2010), "Controlled Release of Biologically Active Silver from Nanosilver Surfaces," ACS Nano, 4(11), pp. 6903-69013. Liu, H-L., Dai, S. H. A., Fu, K-Y & Hsu, S-H., (2010), "Antibacterial Properties of Silver

Liu, X., Lee, P.Y., Ho, C.M., Lui, V.C., Chen, Y., Che, C.M., Tam, P.K., Wong, K. K., (2010),

Environment, Health & Safety, NSTI-Nanotech 2011, 3(7), pp. 557

Nanotechnology (Proceeding), NSTI-Nanotech 2010, 1(6), pp. 889

Waterborne Polyurethane", Int. J. Nanomedicine, 5, pp 1017-2028.

Jeollabuk-do, South Korea, November 26, 2009.

Marcel Dekker, pp. 3031-3047, DOI: 10.1081/E-ECHP-120007991

S., Brumlik, C., & Choudhury, A., (2011), " Nanosilver – Why It Is Still So Hot?",

Iqbal, Z., (2009), "Waste Minimization in Commercialization of Nanotechnology", Seminar Presented Chonbuk National University, Jeonju, Jeollabuk-Do, South

and Waste Minimization", Encyclopedia of Chemical Processing (Lee, S., Ed.),

Containing Caprolactam-Free Residue from Depolymerization of Nylon 6 Carpet and Use Thereof In Paving Asphalt, Plastic Lumber and Crack Sealants", US Patent

Containing Caprolactam-Free Residue from Depolymerization of Nylon 6 Carpet and Use Thereof In Paving Asphalt, Plastic Lumber and Crack Sealants", USP

Brumlik, C., & Choudhury, A., (2010), "Waste Minimization in Consumer Products Containing Nanosilver" Seminar presented Chonbuk National University, Jeonju,

Brumlik, C., & Choudhury, A., (2011) "Nano Silver-Why It is still so Hot Now?",

Schmidt, D., & Iqbal, Z., (2009), "Waste Minimization in Commercialization of Nanotechnology" Seminar presented Chonbuk National University, Jeonju,

Schmidt, D., & Iqbal, Z., (2010) "Nano Silver - Why It is so Hot Now?",

Schmidt, D., & Iqbal, Z., (2010), "Effect of Size on Properties of Nano-Structured Polymers - Transition from Macroscaling to Nanoscaling", Polymer

Nanoparticles in three Different Sizes and Their Nanocomposites with a New

"Silver Nanoparticles Mediate Differential Responses in Keratinocytes and Fibroblasts during Skin Wound Healing". Chem. Med. Chem., 5(3), pp.468-475 Lo, L. Y., (2006), "Wrinkle-Resistant Finishes On Cotton Fabric Using Nanotechnology,"

Ph.D. Thesis, Institute of Textiles and Clothing, The Hong Kong Polytechnic


Available at http://www.cs.ucl.ac.uk/staff/ucacbbl/WBL\_papers.html


Gottschalk, F., Scholz, R. W., & Nowack, B., "Probabilistic Material Flow Modeling for

Gutowski, T. G., (2002), "Environmentally Benign Manufacturing and Ecomaterials; Product Induced Material Flows", Materials Transactions. 43(3), pp. 359-363. Hansen, S. F., (2009) "Regulation and Risk Assessment of Nanomaterials – Too Little, Too

Height M.J., (2009), "Evaluation Of Hazard And Exposure Associated With Nanosilver And

Johnson, J. J., Jirikowic, J., Bertram, M., van Beers, D., Gordon, R. B., Henderson, K., Klee, R.

Johnson, J., Bertram, M., Henderson, K., Jirikowic. J., & Graedel, T.E., (2005), "The

Johnson, J., Gordon, R., & Graedel, T.E., (2006), "Silver Cycles: The Stocks and Flows Project,

Jun, E-H, Lim, K-M, Kim, K. Y., Bae, O-N, Noh, J-Y., Chung, K-H., & Chung, J-H., (2009),

Karthik Ramaratnam, K., Iyer, S. K., Kinnan, M. K., Chumanov, G., Brown, P. J., & Luzinov,

Kim, S-J., Kim, M. N., Jang, M.H., & Hwang, Y. Y., (2010), 'Kim Chi Containers Containing

Knolltextile, (2010), "Nano-Tex® With Bioam Antimicrobial", January 2010 Available At

Kobayashi, H., (2005), "Strategic Evolution of Eco-Products: A Product Life Cycle Planning

Koecher J., Eiden, S., Mayer-Bartschmid, A., & Knezevic, I., (2009), "Medical Devices with an

Available at http://www.cs.ucl.ac.uk/staff/ucacbbl/WBL\_papers.html Lansdown, A. B. G., (2010), "A Pharmacological and Toxicological Profile of Silver as an

Lem K.W., Choudhury A., Lakhani A.A., Kuyate P., Haw J.R., Lee D.S., Iqbal Z., &

http://www.jeffjournal.org/papers/Volume3/3.4.1\_Brown.pdf

Chemistry and Engineering, Konkuk University, Seoul, Korea.

Methodology", Research in Engineering Design, 16 (1-2), pp. 1-16

Antibacterial Polyurethaneurea Coating", US20090252804A1, 2009. Langdon, W. B., (2008), "Genetic Programming for Drug Discovery", Technical Report CES-

Http://Www.Knoll.Com/Techdoc/KT\_Tech\_Bioam.Pdf

Software, 25, 320, 2010

University of Denmark

Year Meeting, March 11, 2009

Technology, 39, pp. 4655-4665.

Part 3", JOM, 2006 February, pp. 34-38

481 ISSN: 1744-8050, 26 February 2008.

Volume 2010, Article ID 910686, 16 pages

On Nanotechnology, 6 (In Press)

Manag., 7, pp. 93–103

University, Seoul, 18.

Assessing the Environmental Exposure to Compounds: Methodology and an Application to Engineered Nano-Tio2 Particles", Environmental Modelling &

Late?", PhD Thesis, Department of Environmental Engineering, Technical

Other Nanometal Oxide Pesticide Products," FIFRA Scientific Advisory Panel (SAP) Open Consultation Meeting. Arlington, Virginia, November 3 – 6, 2009. Housenger, J. E., (2009) "Status of Regulating Nanoscale Particles and Prions," CPDA Mid-

J., Lanzano, T., Lifset, R., Oetjen, L., & Graedel, T. E., (2005), "Contemporary anthropogenic silver cycle: A multilevel Analysis", Environmental Science &

Contemporary Asian Silver Cycle: 1-year Stocks and Flows", J Mater Cycles Waste

"Silver nanoparticles enhance thrombus formation through increased platelet aggregation and procoagulant activity." College of Pharmacy, Seoul National

I., (2008), "Ultrahydrophobic Textiles Using Nanoparticles: Lotus Approach", Journal Of Engineered Fibers And Fabrics, 3(4), pp. 1-14 Available at

Nanosilvers," Fall 2010 Senior Course (KU 3176) Project, Department of Materials

Antimicrobial Agent in Medical Devices,", Advances in Pharmacological Sciences,

Brumlik, C. J., (2012), "Use of Nanosilver in Consumer Products," Recent Patents


Waste Minimization for the Safe Use of Nanosilver

Technology", SCINT, October 2009 Available At http://Www.Scint.Nl/Docs/Smarttextilesscint.Pdf

MIT Sloan Management Review, Winter, 2001, pp. 24-38.

States, December 5 , 2008 Available At

Health?" Friends Of Earth. Available At:

1999. US Patent 5,932,724, August 3, 1999.

Particles ", Environ. Sci. Technol., 44 (14), pp. 5649–5654.

(Theory of Inventive Problem Solving)", Russia, CRC Press.

Progress in Solid State Chemistry, 35, pp. 1-159

Report.Pdf

report.pdf

US6548264B1, 2003.

2011. Available at

content/Eg\_Hk\_039451.Pdf

1006.

in Consumer Products – Its Impact on the Eco-Product Design for Public Health 247

Schilthuizen, S., (2009), "Smart Textiles Enabled by Nanotechnology, RFID and Sensor

Schneider R, (2008), Textile International Enterprises, Presented At Marketing In The United

 http://Export.Textiles.Org.Tw/Doc/(1)Marketing%20in%20the%20US%202011.Pdf Sciubba, E., & Göran Wall, G., (2007), "A brief Commented History of Exergy from the Beginnings to 2004", Int. J. of Thermodynamics, 10 (1), pp. 1-26, ISSN 1301-9724 Senge, P.M. & Carstedt, G., (2001), "Innovating Our Way to the Next Industrial Revolution,"

Senjen R., & Illuminato I., (2007), "Nanosilver – A Threat To Soil, Water and Human

Senjen, R., & Illuminato, I., (2009), "Nano & Biocidal Silver – Extreme Germ Killers Present a

Serban, D., Man, E., Ionescu N., & Roche, T., (2004) "A TRIZ Approach to Design for Environment," (D. Talab and T. Roche eds.), Product Engineering, pp. 89–100. Shin, N-M., (2008), "Obesity in South Korea", School Of Nursing, Korea University, Available At Http://U21health.Mty.Itesm.Mx/Sites/Default/Files/27\_0.Pdf Sifniades, S., Levy, A. B., & Hendrix, J. A. J., (1999) "Processes For Depolymerization Nylon-

Silebi, C. A., & Schiesser, W. E., (1992; 2011), "Dynamic Modeling of Transport Process Systems", (ISBN: 0126434204 / 0-12-643420-4/0126434204), Elsevier Ltd., NY. Sotiriou G.A., & Pratsinis S.E., (2010), "Antibacterial Activity of Nanosilver Ions and

Stensberg M.C., Wei Q.S., Mclamore E.S., Porterfield D.M., Wei A., & Sepúlveda M.S., (2011),

Tan W., Santra S., Zhang P., Tapec R., & Dobson J., (2003), Coated Nanoparticles,

Terninko J., Zusman A., & Zlotin B., (1998), "Systematic Innovation – Introduction to TRIZ

Tolaymat T.M., El Badawy A.M., Genaidy A., Scheckel K.G., Luxton T.P., & Suidan M., (2010),

U.S. Commercial Service, Asia-Pacific Cosmetics and Toiletries Market Overview March 11,

http://Export.Gov/Hongkong/Build/Groups/Public/@Eg\_Hk/Documents/Web

Assessment, Monitoring And Imaging", Nanomedicine, 6(5), pp. 879-89. Sun, C.Q., (2007) "Size dependence of nanostructures: Impact of bond order deficiency",

Growing Threat to Public Health," Friends of Earth, June 2009.Available at: www.foeeurope.org/activities/nanotechnology/Documents/FoE\_Nanosilver\_

Containing Whole Carpet To Form Caprolactam", US Patent 5,929,234, July 27,

"Toxicological Studies On Silver Nanoparticles: Challenges And Opportunities In

"An Evidence-Based Environmental Perspective Of Manufactured Silver Nanoparticle In Syntheses And Applications: A Systematic Review And Critical Appraisal Of Peer-Reviewed Scientific Papers", Sci. Total Environ., 408(5), pp. 999-

www.Foeeurope.Org/Activities/Nanotechnology/Documents/Foe\_Nanosilver\_

	- All\_Or\_Toxic\_Heavy\_Metal.Pdf

Luoma, S. N., (2008), "Silver Nanotechnologies and the Environment Old Problems or New

Mamikunian, V., (2007), "Investor Enthusiasm for Nanotech Opportunities in Electronics,

Mousa S.A., & Linhardt, R., (2010), "Silver Nanoparticles as Anti-Microbial",

Mueller, N., & Nowack, B., (2008), "Exposure Modeling of Engineered Nanoparticles in the

Nadia, D. M., Catherine, B., Francis, C., BOUDHRIOUA Nourhène, B., Nabil, K., (2011)

NANO-CARE® Fabric Protection Named As One of TIME Magazine's Coolest Inventions of

Nischala, K., Rao, T. N., & Hebalkar, N., (2011), "Silica–Silver Core–Shell Particles for

Nowack B., Krug H.F., & Height M.J., (2011), "120 Years of Nanosilver History: Implications

Nowack, B., Krug, H. F., & Height, M., (2011), "120 Years of Nanosilver History: Implications for Policy Makers", Environ. Sci. Technol. 45, pp. 1177-1183. Oh S.G., (2002), "Technology Using Sulfur Compounds for Increasing Antibacterial Property/Sterilizing Power of Silver Nano Particle", KR2002043499A, 2002. Panyala, N. R., Pena-Mendez, E. M., & Havel., "Silver or Silver Nanoparticles: A Hazardous Threat to the Environment and Human Health?", (2008), J. Appl. Biomed., 6, pp. 117-129 Powell M.., (2011), "Silver: Miraculous Cure-All or Toxic Heavy Metal? A Historical Review

Powers C. M., (2010), "Developmental Neurotoxicity of Silver And Silver Nanoparticles

Rebitzera, G., Ekvallb,T., Frischknechtc, R., Hunkelerd, D., Norrise, G., Rydbergf, T.,

Ross, S., Evans, D., & Michael Webber, M., (2002), "How LCA Studies Deal with

Samuel, R., Almedom, A.M., Hagos, G., Albin, S., Mutungi, A., (2005), "Promotion of

SchäFer B., Tentschert J., & Luch A,. (2011), "Nanosilver in Consumer Products and Human Health: More Information Required!", Environ. Sci. Technol. 45, pp. 7589-7590.

Modeled in Vitro and in Vivo", Ph.D. Dissertation, Department Of Pharmacology

Schmidtg, W.-P., Suhh, S., Weidemai, B.P., & Pennington, D.W., (2004), "Life Cycle Assessment Part 1: Framework, Goal and Scope Definition, Inventory Analysis, and

Handwashing as a Measure of Quality of Care and Prevention of Hospital-Acquired Infections in Eritrea: The Keren Study", Afr Health Sci., 5(1), pp. 4–13.

European Drying Conference –Eurodrying 2011, pp. 1-4 Available At

Woodrow Wilson International Center for Scholars.

Environment", Environ. Sci. Technol., 42, pp. 4447–4453

http://www.uibcongres.org/imgdb/archivo\_dpo11056.pdf

Http://Www.Bopuniforms.Com/Images/Nanocare.Pdf

the Year, Greensboro, NC, November 18, 2002 Available At

for Policy Makers", Environ. Sci. Technol. 45, pp. 1177 –1183. Nowack, B., (2010), "Nanosilver Revisited Downstream", Science, 330, pp. 1054-1055.

of Silver's Harmful Effects on Humans," Available At:

& Cancer Biology, Duke University, Durham, North Carolina. Rantanen, K. L., & Domb, E., (2002), "Simplified TRIZ," St. Lucie Press, New York

Applications", Environment International 30, 701– 720 .

Uncertainty", Int J LCA., 7 (1), pp. 47 – 52

PMCID: PMC1831903

Http://Www.Nanoceo.Net/Files/Silver\_Magic\_Cure-

All\_Or\_Toxic\_Heavy\_Metal.Pdf

"Lux Research Inc. 3-15

US200100317617A1, 2010.

203–208

Challenges?", PEN 15. Washington, DC: Project on Emerging Nanotechnologies,

"Moisture Desorption Isotherms, Isosteric Heats of Desorption and Glass Transition of Fresh Pear and Apple: Experimental and Mathematical Investigation,

Antibacterial Textile Application", Colloids and Surfaces B: Biointerfaces, 82, pp.


http://Export.Textiles.Org.Tw/Doc/(1)Marketing%20in%20the%20US%202011.Pdf


 http://Export.Gov/Hongkong/Build/Groups/Public/@Eg\_Hk/Documents/Web content/Eg\_Hk\_039451.Pdf

**Section 3** 

**Health Systems** 

United States Environmental Protection Agency, www.epa.gov/lean, August 2009, EPA-100-K-09-006,

http://www.epa.gov/lean/environment/toolkits/professional/resources/Enviro-Prof-Guide-Six-Sigma.pdf


http://Www.Freewebs.Com/Jayaram-

Co/Doc/Selected\_Appz\_Of\_Nanotechnology\_In\_Textiles.Pdf


## **Section 3**

**Health Systems** 

248 Public Health – Methodology, Environmental and Systems Issues

United States Environmental Protection Agency, www.epa.gov/lean, August 2009, EPA-

Uznanski, P., & Bryszewska, E., (2010), "Synthesis of Silver Nanoparticles from Carboxylate Precursors under Hydrogen Pressure", J Mater Sci., 45, pp. 1547–1552 Vaidyanathan, R., Gopalram, S., Kalishwaralal, K., V. Deepak, V., Pandian, S. R. K., &

Volpe, R., (2010), "Letter to EPA Regarding the EPA Nanosilver Scientific Advisory Panel Report," Silver Nanotechnology Working Group (SNWG), February 2010

Wijnhoven S.W.P., Peijnenburg W.J.G.M., Herberts C.A., Werner I. Hagens, W. I., Oomen, A.

Winslow, C.-E. A., (1920), "The Untilled Fields of Public Health," Science, n.s. 51, pp. 23 Wong Y.W.H., Yuen C. W. M., Leung M. Y. S., Ku S.K.A., & Lam, H.L.I., (2006), "Selected

Yang, J. H., Park, S. E., Chung, I. J., & Kwon, T. Y., (2010), 'The Silver City," Fall 2010 Senior

Yang, W. D., (2006), "Nano Silver Container For Keeping Disinfectants Including Gauze, Alcohol, Hydrogen Peroxide And The Like", KR2006102451A, 2006. Yu, I. J., (2008), "Subchronic Inhalation Toxicity Evaluation of Silver Nanoparticles," KEMTI,

Zhang, J. J., Gurkanb, Z., & Jargensen, S. E., (2010), "Application of Eco-Exergy for

Zhang, Q-Y., (2002), "Multiple Objectives Application Approach to Waste Minimization",

Zhao W., Li L H., & Danzeng LB., (2010), "Study Of Size Effect on the Conductivity of Nano-

Zhu H., & Zhu L., (2004), "Anti-Coagulation Nano Silver Antibiotic Dressing",

Zhu H., Zhu L., (2002), "Method For Preparing Micro Powder Containing Anti-

Co/Doc/Selected\_Appz\_Of\_Nanotechnology\_In\_Textiles.Pdf

Wall, G., (1988), "Exergy Flows in Industrial Processes", Energy, 13(2), pp. 197-208.

http://www.epa.gov/lean/environment/toolkits/professional/resources/Enviro-

Gurunathan, S., (2010), "Enhanced Silver Nanoparticle Synthesis by Optimization of Nitrate Reductase Activity," Colloids and Surfaces B: Biointerfaces 75, pp. 335–

G., Heugens, E. H. W., Roszek, B., Bisschops, J., Gosens, I., Van De Meent, D., Dekkers, S., De Jong, W. H., Van Zijverden, M., Sips, A. J. A. M., & Robert E. Geertsma, R. E., (2009) "Nano-Silver – A Review Of Available Data And Knowledge Gaps In Human And Environmental Risk Assessment

Applications of Nanotechnology in Textiles," AUTEX Research Journal, 6 (1), pp. 1-

Course (KU 3176) Project, Department of Materials Chemistry and Engineering,

Assessment of Ecosystem Health and, Development of Structurally Dynamic

Silver Colloids," Microwave and Millimeter Wave Technology ICMMT

Agglomerated Nanometer Silver, Micro Powder Produced By The Method And Its

100-K-09-006,

8 Available at

341

Prof-Guide-Six-Sigma.pdf

Nanotoxicology", 3(2), pp. 109-138.

http://Www.Freewebs.Com/Jayaram-

5th Korea-US Nano Forum, April 17-19, 2008.

Models", Ecological Modelling 221, pp 693–702

Proceedings. Chengdu, May 8-11, 2010.

Application", WO2002090025A1, 2002.

CN1473553A, 2004.

Journal of Zhejiang University, Science. 3(4), pp. 405-411.

Konkuk University, Seoul, Korea.

**11** 

Nathan Grills

*Australia* 

*University of Melbourne* 

**New Challenges in Public** 

**Health Practice: The Ethics of Industry** 

**Alliance with Health Promoting Charities** 

In an increasingly market driven society, characterised by neoliberal economic policies and promotion of free trade, powerful multinationals have become significant actors, for good and bad, in global public health. These powerful multinational companies are using increasingly sophisticated marketing strategies not only to promote products - some of which are deleterious to health – but also to lobby against public health initiatives that threaten their profit. Should public health practitioners cooperate with, or even attempt to coopt, these powerful organisations in an endeavour to promote health? Although this seems to be an increasing trend one must remain cogniscent that these companies will promote profit at the expense of health and often they are more effective at coopting health causes for their profit driven purposes than health causes are at coopting them for public health ends (Wright 2010). In particular, this chapter explores how sponsorship of charities by corporates is actually a form of advertising that, when unhealthy products are promoted, can damage public health. The favoured approach by industry to minimise negative impacts of such advertising is via self regulatory codes. However, in Australia and elsewhere, these have by and large failed (Handsley E, Nehmy C et al. 2007; Ofcom 2008; National Preventative Health Taskforce 2009, p151; World Advertising Research Centre 2009). For example, in Australia the voluntary self regulatory policy to limit advertising of unhealthy products to children, called the Quick Service Restaurant Industry (QSRI), has resulted in no meaningful change since being introduced in 2009. The New South Wales Cancer Council concluded that "Children's exposure to unhealthy fast-food advertising has not changed following the introduction of self-regulation" (Chapman, Hebden et al. 2011). Is it time for policy makers to impose limits on

the promotion of unhealthy products in order to protect the health of the public.

definitely not in the interests of the shareholders!

It is not so surprising that self regulation initiatives fail as it is counter intuitive, and against shareholder interests, for a profit seeking industry to minimise profit through self regulation. For example, arround 50% of profit from gambling comes from those who are being harmed by the product: "problem gamblers" (The Public Health Association of Australia 2008). Therefore limiting advertising of unhealthy products in order to remove damage to health would threaten the viability of such industries and that outcome is

**1. Introduction** 

### **New Challenges in Public Health Practice: The Ethics of Industry Alliance with Health Promoting Charities**

Nathan Grills *University of Melbourne Australia* 

#### **1. Introduction**

In an increasingly market driven society, characterised by neoliberal economic policies and promotion of free trade, powerful multinationals have become significant actors, for good and bad, in global public health. These powerful multinational companies are using increasingly sophisticated marketing strategies not only to promote products - some of which are deleterious to health – but also to lobby against public health initiatives that threaten their profit. Should public health practitioners cooperate with, or even attempt to coopt, these powerful organisations in an endeavour to promote health? Although this seems to be an increasing trend one must remain cogniscent that these companies will promote profit at the expense of health and often they are more effective at coopting health causes for their profit driven purposes than health causes are at coopting them for public health ends (Wright 2010).

In particular, this chapter explores how sponsorship of charities by corporates is actually a form of advertising that, when unhealthy products are promoted, can damage public health. The favoured approach by industry to minimise negative impacts of such advertising is via self regulatory codes. However, in Australia and elsewhere, these have by and large failed (Handsley E, Nehmy C et al. 2007; Ofcom 2008; National Preventative Health Taskforce 2009, p151; World Advertising Research Centre 2009). For example, in Australia the voluntary self regulatory policy to limit advertising of unhealthy products to children, called the Quick Service Restaurant Industry (QSRI), has resulted in no meaningful change since being introduced in 2009. The New South Wales Cancer Council concluded that "Children's exposure to unhealthy fast-food advertising has not changed following the introduction of self-regulation" (Chapman, Hebden et al. 2011). Is it time for policy makers to impose limits on the promotion of unhealthy products in order to protect the health of the public.

It is not so surprising that self regulation initiatives fail as it is counter intuitive, and against shareholder interests, for a profit seeking industry to minimise profit through self regulation. For example, arround 50% of profit from gambling comes from those who are being harmed by the product: "problem gamblers" (The Public Health Association of Australia 2008). Therefore limiting advertising of unhealthy products in order to remove damage to health would threaten the viability of such industries and that outcome is definitely not in the interests of the shareholders!

New Challenges in Public Health Practice:

the aim and the effect is mitigation.

any media (Handsley E, Nehmy C et al. 2007, p153).

away from a product that potentially harms children.

The Ethics of Industry Alliance with Health Promoting Charities 253

example from the health field is DrinkWise, a charity funded by the alcohol industry, aiming to shape "a healthier and safer drinking culture in Australia where drinking to excess, or drinking too young, is considered undesirable". Such recompense is desirable if

However, sponsorship is ethically tenuous when a company whose product potentially causes illhealth, assists victims, and in doing so advertises the very product that caused the illhealth. Libertarians would argue that companies should be entitled to pursue such strategies, as informed adults are capable of discernment and can decide accordingly.

However, there is a flaw in the assumption of consumers being fully informed or having the necessary agency to make such distinctions. For example, are people aware that DrinkWise is industry sponsored and have been accused of promoting the very products that caused the harm they are seeking to mitigate? The consumer may be unable to make a fully informed choice if the true identity of the organisation is unclear. If company X sponsors a charity Y which addresses the ill-health caused by the same company X, then consumers should surely be informed that charity Y is supported by Company X whose product causes the ill health.

However, it seems more ethically objectionable when a company whose product could harm children, then assists the children who might be harmed, to make these children consume more of their potentially harmful product. Not only is a potentially harmful product being advertised to children, but the immature target audience, unaware of the danger of the product being marketed, could be influenced to view it as harmless or even good. Acknowledging the effect of advertising unhealthy products to children, Australia's National Public Health Task Force (NPHTF) recommended phasing out of "premium offers, toys, competitions and the use of promotional characters, including celebrities and cartoon characters, to market EDNP food and drink to children across all media sources". Similar moves have been initiated in other countries (Handsley E, Nehmy C et al. 2007; Ofcom 2008; National preventative health taskforce 2009, p151; World Advertising Research Centre 2009) (World Health Organization 2003; Livingstone 2006): Sweden and Norway prohibit commercial advertising directed at children via television, and Quebec prohibits the use of

Perhaps even more insidious is where the funding of worthy charities creates an unhealthy alliance which allows a company to attain the moral high ground, and so limit their vulnerability to challenges regarding their unhealthy products and questionable practices. For example, if a policy-maker decided to limit a company's ability to inappropriately market their product to children, the company might then generate popular opinion against the politician with arguments like "this will undermine our ability to support children's charities such as the Ronald McDonald kids health truck!" (Prisk 2011). This supports a concept described in the literature where Corporate Social Responsibility, such as sponsoring a charity, is really about company credibility and positioning in order to benefit their bottom line (Wright 2010), or as Wright describes, limited to where it is profitable and often as a reaction to criticism of their product and practices. An example of ethically questionable practices might involve sponsoring a children's organisation to divert attention

I will outline four case studies which demonstrate that this practice might be more common than we perceive. Each case study may represent the intentional use of CSR to gain moral

In relation to corporate funding of health charities this seems to be entirely unchecked by either government or industry self regulation. At the very best this approach involves fundraising for a good cause that would otherwise be underfunded, and no doubt the charities themselves have no other motivation than to see their important cause supported. However, cynics of Corporate Social Responsibility (CSR) would argue that the ultimate goal for industry is profit, or at the very least trying to mitigate criticism of the organisation (Wright 2010). At its most sinister, might CSR involve an ethically questionable model whereby the charity is exploited to promote a company whose product is deleterious to health? This chapter describes how unethical behaviour increases along a spectrum when using charities to advertise by:


Although there are various international case studies one could cite (see www.cmaj.ca/cgi/content/full/cmaj.110085/DCI for a list) this chapter unpacks four examples demonstrating potentially unhealthy alliances where industry has seemingly coopted children's charities and public causes in order to sell a product that damages health. This discussion attempts to raise awareness about such subtle marketing and intends to help readers discern what might be appropriate and inappropriate use of charitable causes.

Ultimately, we would hope that reading this chapter leads the reader towards taking action to protect our most vulnerable consumers from powerful industry interests. The chapter finishes by exploring how those in public health can creatively engage with this issue and respond by even using many of the same tactics utilised by companies whose products damage health.

#### **2. What is an acceptable form of company sponsorship of health charities?**

Advertising and marketing is very effective at selling 'goods', but these goods are not necessarily good. In the area of marketing Energy Dense and Nutrient Poor Food and Beverages (EDMPFB) various international reviews have concluded that heavy marketing is likely to have deleterious effects on children by encouraging products high in salt, sugar and fat (World Health Organization 2003; Livingstone 2006; National Preventative Health Taskforce 2009). Accordingly, in many countries, various codes exist to regulate marketing. However, Australian restrictions have been largely voluntary self-regulated codes which have failed to prevent ethically questionable advertising, such as advertising to children (Hebden, King et al. 2011) (Chapman, Hebden et al. 2011).

On the surface it seems acceptable, or even desirable, that a company whose product causes damage should contribute to alleviation of the same damage. Such is the basis for carbon credits and taxes whereby companies contributing to carbon production may choose, or be required, to contribute towards mitigation of the problem to which they contribute. An

In relation to corporate funding of health charities this seems to be entirely unchecked by either government or industry self regulation. At the very best this approach involves fundraising for a good cause that would otherwise be underfunded, and no doubt the charities themselves have no other motivation than to see their important cause supported. However, cynics of Corporate Social Responsibility (CSR) would argue that the ultimate goal for industry is profit, or at the very least trying to mitigate criticism of the organisation (Wright 2010). At its most sinister, might CSR involve an ethically questionable model whereby the charity is exploited to promote a company whose product is deleterious to health? This chapter describes how unethical behaviour increases along a spectrum when

4. Funding a children's charity to promote a product that causes the very illness that the

5. Funding a children's charity to promote a product that causes the very illness that the charity seeks to respond to, and use this sponsorship to attain the high moral ground and lobby against public health approaches to address the public health problem Although there are various international case studies one could cite (see www.cmaj.ca/cgi/content/full/cmaj.110085/DCI for a list) this chapter unpacks four examples demonstrating potentially unhealthy alliances where industry has seemingly coopted children's charities and public causes in order to sell a product that damages health. This discussion attempts to raise awareness about such subtle marketing and intends to help readers discern what might be appropriate and inappropriate use of charitable causes.

Ultimately, we would hope that reading this chapter leads the reader towards taking action to protect our most vulnerable consumers from powerful industry interests. The chapter finishes by exploring how those in public health can creatively engage with this issue and respond by even using many of the same tactics utilised by companies whose products

Advertising and marketing is very effective at selling 'goods', but these goods are not necessarily good. In the area of marketing Energy Dense and Nutrient Poor Food and Beverages (EDMPFB) various international reviews have concluded that heavy marketing is likely to have deleterious effects on children by encouraging products high in salt, sugar and fat (World Health Organization 2003; Livingstone 2006; National Preventative Health Taskforce 2009). Accordingly, in many countries, various codes exist to regulate marketing. However, Australian restrictions have been largely voluntary self-regulated codes which have failed to prevent ethically questionable advertising, such as advertising to children

On the surface it seems acceptable, or even desirable, that a company whose product causes damage should contribute to alleviation of the same damage. Such is the basis for carbon credits and taxes whereby companies contributing to carbon production may choose, or be required, to contribute towards mitigation of the problem to which they contribute. An

**2. What is an acceptable form of company sponsorship of health charities?** 

(Hebden, King et al. 2011) (Chapman, Hebden et al. 2011).

using charities to advertise by:

charity seeks to respond to

damage health.

1. Funding a charitable cause in order to advertise a product 2. Funding a children's charity to advertise a product

3. Funding a children's charity to promote a product that causes harm

example from the health field is DrinkWise, a charity funded by the alcohol industry, aiming to shape "a healthier and safer drinking culture in Australia where drinking to excess, or drinking too young, is considered undesirable". Such recompense is desirable if the aim and the effect is mitigation.

However, sponsorship is ethically tenuous when a company whose product potentially causes illhealth, assists victims, and in doing so advertises the very product that caused the illhealth. Libertarians would argue that companies should be entitled to pursue such strategies, as informed adults are capable of discernment and can decide accordingly.

However, there is a flaw in the assumption of consumers being fully informed or having the necessary agency to make such distinctions. For example, are people aware that DrinkWise is industry sponsored and have been accused of promoting the very products that caused the harm they are seeking to mitigate? The consumer may be unable to make a fully informed choice if the true identity of the organisation is unclear. If company X sponsors a charity Y which addresses the ill-health caused by the same company X, then consumers should surely be informed that charity Y is supported by Company X whose product causes the ill health.

However, it seems more ethically objectionable when a company whose product could harm children, then assists the children who might be harmed, to make these children consume more of their potentially harmful product. Not only is a potentially harmful product being advertised to children, but the immature target audience, unaware of the danger of the product being marketed, could be influenced to view it as harmless or even good. Acknowledging the effect of advertising unhealthy products to children, Australia's National Public Health Task Force (NPHTF) recommended phasing out of "premium offers, toys, competitions and the use of promotional characters, including celebrities and cartoon characters, to market EDNP food and drink to children across all media sources". Similar moves have been initiated in other countries (Handsley E, Nehmy C et al. 2007; Ofcom 2008; National preventative health taskforce 2009, p151; World Advertising Research Centre 2009) (World Health Organization 2003; Livingstone 2006): Sweden and Norway prohibit commercial advertising directed at children via television, and Quebec prohibits the use of any media (Handsley E, Nehmy C et al. 2007, p153).

Perhaps even more insidious is where the funding of worthy charities creates an unhealthy alliance which allows a company to attain the moral high ground, and so limit their vulnerability to challenges regarding their unhealthy products and questionable practices. For example, if a policy-maker decided to limit a company's ability to inappropriately market their product to children, the company might then generate popular opinion against the politician with arguments like "this will undermine our ability to support children's charities such as the Ronald McDonald kids health truck!" (Prisk 2011). This supports a concept described in the literature where Corporate Social Responsibility, such as sponsoring a charity, is really about company credibility and positioning in order to benefit their bottom line (Wright 2010), or as Wright describes, limited to where it is profitable and often as a reaction to criticism of their product and practices. An example of ethically questionable practices might involve sponsoring a children's organisation to divert attention away from a product that potentially harms children.

I will outline four case studies which demonstrate that this practice might be more common than we perceive. Each case study may represent the intentional use of CSR to gain moral

New Challenges in Public Health Practice:

potentially benefit financially by the sponsorship.

medical publications of high repute'" (Judgement, p169).

(Royal Children's Hospital 2010).

The Ethics of Industry Alliance with Health Promoting Charities 255

Indeed, such sponsorship can divert attention away from the potential harms of this company's EDNPFB whilst also attaining a moral high ground. That is, any challenge to the Donut King's charitable sponsorship - probably including this challenge - will immediately draw a response such as "Get a heart! Are you saying we shouldn't support HeartKids"! Interestingly, a medical colleague originally forwarded me this advertisement and encouraged us to visit Donut King to support HeartKids. I couldn't easily express my disapproval to her given that her child suffered congenital heart disease and would

The objection was not that children with congenital heart disease are harmed by Donut King's product and, indeed, most children with congenital heart disease need a high calorie intake. However, looking beyond the individual level, is there a population effect of normalising such unhealthy products? Through such sponsorship the Donut King is promoted as a good citizen who cares about health, and its products might be widely associated with a health cause, both of which may potentially increase sales of unhealthy products population wide. Secondly, even if the population effect is small, is it ethically appropriate to promote unhealthy products using vulnerable children to convey a message

that this company cares about the very hearts that their product may damage?

**2.2 Case study 2: McDonalds' alliances with the Royal Children's Hospital (RCH)** 

McDonald's relationship with the RCH Melbourne permits them to have a fast-food franchise on the hospital's grounds (Royal Children's Hospital 2010). The EDNPFBs that McDonalds promote are linked with childhood obesity and ill-health. In the famous UK libel case McDonalds sued two individuals for disseminating brochures claiming that McDonalds, amongst other things, was bad for health. The UK court of appeal found that "there is a respectable (not cranky) body of medical opinion which links a junk food diet with a risk of cancer and heart disease' and 'this link was accepted both in the literature published by McDonalds themselves and by one or more of McDonald's own experts and in

Granted, McDonalds at RCH is much appreciated by parents and children alike, making the perfect sweetener for a child facing the trauma of visiting hospital. I also confess that as a father of a chronically unwell child, after leaving the ward at 10pm I have visited McDonalds to wind down in a friendly environment. However, I could have just as easily wound down in whatever cafe or restaurant was still open and accessible. Additionally, the government has stepped in to require the McDonalds at the new RCH to provide 80% healthy foods choices (green and amber) whilst restricting unhealthy food choices to 20%

Yet the concern around McDonalds in the RCH is more complex than the negligible health impact on individual parents or children visiting McDonalds on a few random occasions whilst receiving care. There are ethical concerns about this alliance. Firstly, McDonalds can use their sponsorship to promote their brand name and unhealthy products to children and the wider community. This normalisation of EDNPFB consumption in the wider community is hazardous given that childhood obesity is approaching 30% in Australia. Secondly, is it ethically acceptable to allow our most vulnerable children to be exploited for the marketing of potentially unhealthy and harmful products? We allow these companies to promote an

high ground and sell potentially harmful products, or may be merely coincidental. Either way these practises need to be challenged.

#### **2.1 Case study 1: The Donut King alliance HeartKids**

The Donut King has become a regular supporter of HeartKids which is a foundation to support children with heart diseases and their families. On a single day in 2011 they kindly offered to give 50 cents of every purchase of a coffee from their fast food chain to the HeartKids charity. Of course this was promoted widely through adverts and in store promotion that cobranded Donut King products with the HeartKids logo (HeartKids 2011). Many readers would not initially discern any problem with Donut King supporting such a worthy charity, but the partnership warrants closer scrutiny.

Doughnuts are Energy Dense and Nutrient Poor Food and Beverage (EDNPFB) foods and such foods are linked with childhood obesity and cardiovascular disease later in life (National preventative health taskforce 2009). Whilst adults might be aware that doughnuts are potentially damaging EDNPFB and that sponsorship of a charity might actually be advertising, children may not be (HeartKids 2011). Additionally, children may be incapable of disentangling the apparent contradiction of an advertisement that links a fast food chain selling unhealthy food that can ultimately damage hearts, with a charity promoting healthy hearts in children! Is such advertising ethical if it exploits our most vulnerable community members: children and their health?

high ground and sell potentially harmful products, or may be merely coincidental. Either

The Donut King has become a regular supporter of HeartKids which is a foundation to support children with heart diseases and their families. On a single day in 2011 they kindly offered to give 50 cents of every purchase of a coffee from their fast food chain to the HeartKids charity. Of course this was promoted widely through adverts and in store promotion that cobranded Donut King products with the HeartKids logo (HeartKids 2011). Many readers would not initially discern any problem with Donut King supporting such a

Doughnuts are Energy Dense and Nutrient Poor Food and Beverage (EDNPFB) foods and such foods are linked with childhood obesity and cardiovascular disease later in life (National preventative health taskforce 2009). Whilst adults might be aware that doughnuts are potentially damaging EDNPFB and that sponsorship of a charity might actually be advertising, children may not be (HeartKids 2011). Additionally, children may be incapable of disentangling the apparent contradiction of an advertisement that links a fast food chain selling unhealthy food that can ultimately damage hearts, with a charity promoting healthy hearts in children! Is such advertising ethical if it exploits our most vulnerable community

way these practises need to be challenged.

members: children and their health?

**2.1 Case study 1: The Donut King alliance HeartKids** 

worthy charity, but the partnership warrants closer scrutiny.

Indeed, such sponsorship can divert attention away from the potential harms of this company's EDNPFB whilst also attaining a moral high ground. That is, any challenge to the Donut King's charitable sponsorship - probably including this challenge - will immediately draw a response such as "Get a heart! Are you saying we shouldn't support HeartKids"! Interestingly, a medical colleague originally forwarded me this advertisement and encouraged us to visit Donut King to support HeartKids. I couldn't easily express my disapproval to her given that her child suffered congenital heart disease and would potentially benefit financially by the sponsorship.

The objection was not that children with congenital heart disease are harmed by Donut King's product and, indeed, most children with congenital heart disease need a high calorie intake. However, looking beyond the individual level, is there a population effect of normalising such unhealthy products? Through such sponsorship the Donut King is promoted as a good citizen who cares about health, and its products might be widely associated with a health cause, both of which may potentially increase sales of unhealthy products population wide. Secondly, even if the population effect is small, is it ethically appropriate to promote unhealthy products using vulnerable children to convey a message that this company cares about the very hearts that their product may damage?

#### **2.2 Case study 2: McDonalds' alliances with the Royal Children's Hospital (RCH)**

McDonald's relationship with the RCH Melbourne permits them to have a fast-food franchise on the hospital's grounds (Royal Children's Hospital 2010). The EDNPFBs that McDonalds promote are linked with childhood obesity and ill-health. In the famous UK libel case McDonalds sued two individuals for disseminating brochures claiming that McDonalds, amongst other things, was bad for health. The UK court of appeal found that "there is a respectable (not cranky) body of medical opinion which links a junk food diet with a risk of cancer and heart disease' and 'this link was accepted both in the literature published by McDonalds themselves and by one or more of McDonald's own experts and in medical publications of high repute'" (Judgement, p169).

Granted, McDonalds at RCH is much appreciated by parents and children alike, making the perfect sweetener for a child facing the trauma of visiting hospital. I also confess that as a father of a chronically unwell child, after leaving the ward at 10pm I have visited McDonalds to wind down in a friendly environment. However, I could have just as easily wound down in whatever cafe or restaurant was still open and accessible. Additionally, the government has stepped in to require the McDonalds at the new RCH to provide 80% healthy foods choices (green and amber) whilst restricting unhealthy food choices to 20% (Royal Children's Hospital 2010).

Yet the concern around McDonalds in the RCH is more complex than the negligible health impact on individual parents or children visiting McDonalds on a few random occasions whilst receiving care. There are ethical concerns about this alliance. Firstly, McDonalds can use their sponsorship to promote their brand name and unhealthy products to children and the wider community. This normalisation of EDNPFB consumption in the wider community is hazardous given that childhood obesity is approaching 30% in Australia. Secondly, is it ethically acceptable to allow our most vulnerable children to be exploited for the marketing of potentially unhealthy and harmful products? We allow these companies to promote an

New Challenges in Public Health Practice:

2010).

The Ethics of Industry Alliance with Health Promoting Charities 257

This outlines both the reasons for the link (\$8 million) and also demonstrates the moral high ground obtained in that every dollar from Tattersall's "represents both a personal sacrifice and affectionate regard". How can one question a donor who has an affectionate regard for an important institution like the RCH? Such organisations can use their moral high ground to influence policy as was shown in the recent senate committee investigation into gaming where Woolworths, the biggest owner of electronic gaming machines, threatened that they would have to decrease their investment in the community if profits from electronic gaming machines were limited by legislation (Needham 2011 (Feb 11)). Perhaps the new RCH,

The community needs to recognise that the products that Tattersall's promotes actually cause significant harm to the very society that it claims to be helping through its support of

However, despite Tattersall's association with such damage, it has represented itself by sponsoring the very society that it harms. Tattersall's do not only sponsor children's hospitals and hospital emergency departments in Australia but various sporting clubs in which our children participate. Many sporting clubs have become dependent on the revenue from sponsorship of Gambling agencies or from revenue from owning gaming machines. There is little doubt that allowing the gambling industry to operate in sports clubs exposes children to advertising and normalisation of such products. Do we need better protection? However, once again the gambling agencies have attained the moral high ground where clubs and supporters may well contest that the club depends on that revenue. If we ban the "Tattersals' sponsorship" then we risk accusations of compromising institutions that actually promote health. In Australia McDonalds has similarly inserted itself into the health DNA of our schools and youth clubs through sponsoring Auskick, kids sporting events and, at a higher level, sponsoring Australian international sporting teams such as the Australian Olympic Team. The Australian Olympic Team website allows McDonalds to boast "In Australia, we are very proud to be helping kids be active by supporting Little Athletics, Soccer, and Basketball in various

"The problems of pokie gambling are not trivial. They include financial distress and ruin, bankruptcy, fraud, embezzlement, and theft and misappropriation of the funds, property and income of family, friends, employers and others. Gambling problems are also strongly associated with crime generally, family breakdown, divorce, the neglect and abuse of children, mental and physical illness, depression and anxiety, and not infrequently include suicide. The children of regular and problem gamblers are themselves significantly more likely to have a gambling problem than those of nongamblers, and poker machine venues are most strongly concentrated in poorer

charities. One expert researcher in the field, Professor Charles Livingstone argues:

"completed in 2011", might reconsider this unhealthy association?

suburbs"(The Public Health Association of Australia 2008).

states" (http://corporate.olympics.com.au/sponsor/mcdonalds)

"The ongoing contribution of Tattersall's, one of the hospital's longest standing corporate partners, has reached a total of \$8 million. Each and every dollar that comes into the Foundation represents both personal sacrifice and the affectionate regard that Victorians have for the Royal Children's Hospital." (Royal Children's Hospital

image of a company which cares about the very children that their product may harm. Finally, is it acceptable to allow McDonalds or Donut King to attain the moral high ground by affiliating themselves with children's healthcare institutions and causes? It is very difficult to oppose unhealthy practices and products when these 'good corporate citizens' are seen to be promoting children's health.

So why do we allow an organisation whose product may damage children's health to sponsor our children's hospital? Are there other 'healthier' organisations which could support the RCH? I would like to reiterate Margaret Chan's challenge to such companies: "I would like to ask the food and beverage industries. Does it really serve your interests to produce, market, globally distribute, and aggressively advertise, especially to children, products that damage the health of your customers?"(Chan 2011). Again, such a case is difficult to sustain given outrage generated by threatening funds for children's healthcare (Prisk 2011). McDonalds are very safely on the moral high ground.

How can one argue against "supporting families" and "helping seriously ill children"?

#### **2.3 Case study 3: Tattersall's alliance with the RCH**

Would you allow the following company to speak to your kids when the company has a majority stake in an industry which:


Most responsible parents would not allow such companies to promote their product to their children, so why does RCH allow Tattersall's to do so in the Children's Hospital? A RCH Foundation report provides an answer:

image of a company which cares about the very children that their product may harm. Finally, is it acceptable to allow McDonalds or Donut King to attain the moral high ground by affiliating themselves with children's healthcare institutions and causes? It is very difficult to oppose unhealthy practices and products when these 'good corporate citizens'

So why do we allow an organisation whose product may damage children's health to sponsor our children's hospital? Are there other 'healthier' organisations which could support the RCH? I would like to reiterate Margaret Chan's challenge to such companies: "I would like to ask the food and beverage industries. Does it really serve your interests to produce, market, globally distribute, and aggressively advertise, especially to children, products that damage the health of your customers?"(Chan 2011). Again, such a case is difficult to sustain given outrage generated by threatening funds for children's healthcare

How can one argue against "supporting families" and "helping seriously ill children"?

Would you allow the following company to speak to your kids when the company has a

• Makes more than 50% of their profit by trapping powerless addicts (Hancock,

• Is associated with one in five suicide attempts in patients presenting to the Alfred

Most responsible parents would not allow such companies to promote their product to their children, so why does RCH allow Tattersall's to do so in the Children's Hospital? A RCH

• Increases crime rates in the area (study reported in the Age, July, 2010) • Impoverishes and breaks up thousands of families in Australia each year

are seen to be promoting children's health.

(Prisk 2011). McDonalds are very safely on the moral high ground.

**2.3 Case study 3: Tattersall's alliance with the RCH** 

• Profits from the most vulnerable and poorest

majority stake in an industry which:

Schellinck et al. 2008)

Hospital in Melbourne

Foundation report provides an answer:

"The ongoing contribution of Tattersall's, one of the hospital's longest standing corporate partners, has reached a total of \$8 million. Each and every dollar that comes into the Foundation represents both personal sacrifice and the affectionate regard that Victorians have for the Royal Children's Hospital." (Royal Children's Hospital 2010).

This outlines both the reasons for the link (\$8 million) and also demonstrates the moral high ground obtained in that every dollar from Tattersall's "represents both a personal sacrifice and affectionate regard". How can one question a donor who has an affectionate regard for an important institution like the RCH? Such organisations can use their moral high ground to influence policy as was shown in the recent senate committee investigation into gaming where Woolworths, the biggest owner of electronic gaming machines, threatened that they would have to decrease their investment in the community if profits from electronic gaming machines were limited by legislation (Needham 2011 (Feb 11)). Perhaps the new RCH, "completed in 2011", might reconsider this unhealthy association?

The community needs to recognise that the products that Tattersall's promotes actually cause significant harm to the very society that it claims to be helping through its support of charities. One expert researcher in the field, Professor Charles Livingstone argues:

"The problems of pokie gambling are not trivial. They include financial distress and ruin, bankruptcy, fraud, embezzlement, and theft and misappropriation of the funds, property and income of family, friends, employers and others. Gambling problems are also strongly associated with crime generally, family breakdown, divorce, the neglect and abuse of children, mental and physical illness, depression and anxiety, and not infrequently include suicide. The children of regular and problem gamblers are themselves significantly more likely to have a gambling problem than those of nongamblers, and poker machine venues are most strongly concentrated in poorer suburbs"(The Public Health Association of Australia 2008).

However, despite Tattersall's association with such damage, it has represented itself by sponsoring the very society that it harms. Tattersall's do not only sponsor children's hospitals and hospital emergency departments in Australia but various sporting clubs in which our children participate. Many sporting clubs have become dependent on the revenue from sponsorship of Gambling agencies or from revenue from owning gaming machines. There is little doubt that allowing the gambling industry to operate in sports clubs exposes children to advertising and normalisation of such products. Do we need better protection? However, once again the gambling agencies have attained the moral high ground where clubs and supporters may well contest that the club depends on that revenue. If we ban the "Tattersals' sponsorship" then we risk accusations of compromising institutions that actually promote health. In Australia McDonalds has similarly inserted itself into the health DNA of our schools and youth clubs through sponsoring Auskick, kids sporting events and, at a higher level, sponsoring Australian international sporting teams such as the Australian Olympic Team. The Australian Olympic Team website allows McDonalds to boast "In Australia, we are very proud to be helping kids be active by supporting Little Athletics, Soccer, and Basketball in various states" (http://corporate.olympics.com.au/sponsor/mcdonalds)

New Challenges in Public Health Practice:

Research in Cancer 2008).

**3. Why is it unethical?** 

sponsorship?

exploitation.

The Ethics of Industry Alliance with Health Promoting Charities 259

highlights the extent of the alcohol problem amongst youth with 13% of children aged 16 year olds having drunk at dangerous levels in the past week (Centre for Behavioural

As these statistics suggest, allowing companies to insert themselves into schools is self evidently unacceptable but the alcohol industry inserts itself more insidiously into children's health causes outside the school environment. The AMA documents how the increasingly sophisticated marketing of alcohol is aimed at attracting, influencing, and recruiting new generations of potential drinkers (Australian Medical Association 2009). One example is the targeting and supporting of not-for-profit Australian sporting clubs by alcohol companies. Children involved in these clubs grow up viewing alcohol advertisements and conceivably accepting the industry as an important part of their society and a promoter of good health. Nothing could be further from the truth given that alcohol is one of the greatest dangers faced by the young people of Australia! Furthermore, alcohol, from whatever perspective you look at it, is damaging to sporting performance so it is ironic, or maybe intentional, to link a health damaging product to health promoting activities. Instead such support of charities by the alcohol industry would seem to be another example of an industry injurious to children's health allying

To help determine if a sponsorship is ethical it is also worth referring to the stewardship model outlined in the report by the Nuffield Council on Ethics (2007). They concluded that in regards to the role of industry, the media and other parties, "businesses have obligations towards society. Many businesses already have social responsibility policies. Where industries fail to meet reasonable standards it is acceptable for the state to intervene through regulations (Paragraphs 2.47-2.50 and 3.41)". If the above case studies represent failure to meet acceptable standards, then should the state government intervene to limit this

Secondly, when promotion of unhealthy products involves children, through the use of children's health institutions and charities, the mandate for action is clearer. The stewardship model outlines "protecting and promoting the health of children and other vulnerable groups" as a high order principle that can justify limiting freedoms (Nuffield Council on Bioethics 2007). It would seem that allowing companies to exploit children's charities to promote harmful products would go against the stewardship model. In effect children represent a market failure due to imperfect information and information asymmetry as they are incapable of being fully informed consumers. We therefore have an ethical mandate to steward our most vulnerable by protecting them against

Permitting companies to exploit children's charities and children's health services to promote harmful products might qualify as "behaviour harming others". According to J.S. Mill, in his famous volume 'On liberty', intervention by the state is only justified when behaviour harms others, as such sponsorship might do if it causes more consumption of the harmful products (Mills 1909). Similarly a recent article in the Lancet argues "Liberty should be restricted, in a liberal society, only when there is a clear and direct threat of harm to

itself with children's charities in order to promote its product and image.

#### **2.4 Case study 4: Alcohol industry alliance with children's fundraising**

There is good evidence that exposure to alcohol advertising shapes young adolescents' attitudes toward alcohol, their intentions to drink, and underage drinking behaviour (Martin 2002). Additionally, studies show that alcohol advertisements are often shown during the shows that target teens such as sporting events (Martin 2002). In Australia, thankfully, alcohol advertisements are no longer shown during children's programs. However, alcohol advertisements do still target youngsters during shows watched by large numbers of children such as sporting events. In 2002, in the US, over a billion dollars was spent to advertise alcohol on TV and around 22% of these advertisements were seen more by youth than adults (Center on Alcohol Marketing and Youth 2004).

Similarly to Tattersall's and McDonalds, alcohol companies do not only advertise through traditional media platforms. The alcohol industry has been a regular sponsor of sporting and charity events held through our schools. This can achieve a similar end to more traditional forms of advertising. A recent report by the Australian National Council on Drugs found that alcohol was often the focus of various fundraisers which include supporting wine "drives" conducted via newsletters, liquor "tasting events" on school premises, and alcoholic bottles featuring school logos. Dr Herron from the Australian National Council on Drugs states:

"I think we all know subliminal messages have a huge impact on young people. Through attaching (fundraisers) to a school newsletter, we're legitimising them and saying it's all right for students to be transporting information about alcohol between the home and school." (Barry 2011)

Again it must be questioned if such charitable sponsorship is benevolent or little more than blatant advertising to adults and children by profit driven alcohol companies.

However, the involvement of charitable causes makes rational debates on this issue difficult to have. Few critics of advertising to children would doubt that well meaning parents and friends have the best intentions in raising funds for worthy causes. Indeed, the alcohol companies take advantage of this very fact to, once again, attain the moral high ground and an immunity to being challenged. Parents and friends become a powerful ally for the alcohol companies and might well defend the company by passing off the 'sponsorship' as harmless and merely for philanthropic purposes.

Similarly to the first three case studies, we again question if it is ethical to allow an alcohol company to link itself to a school when damage from youth alcohol usage is so prevalent and damaging throughout Australian society (Chikritzhs, Pascal et al. 2004). The list of damage caused to youth by alcohol is long and well established but can be best summarised by the fact that Alcohol accounts for 13 % of all deaths among people 14-17 years of age and in Australia, each week, one teenager dies and around 60 are hospitalized from alcoholrelated causes (Jones, Chikritzhs et al. 2004; Clark, Thatcher et al. 2008). Teenagers without the benefit of good judgement from experience, are particularly vulnerable to alcohol related harm in a way that older drinkers may not be (Australian Medical Association 2009). Among young Australians, the most common causes of death and injury due to risky or high-risk drinking are road injury, suicide, and violent assault (Chikritzhs, Pascal et al. 2004). The Australian School Students' Alcohol and Drug Survey (hereinafter ASSAD) highlights the extent of the alcohol problem amongst youth with 13% of children aged 16 year olds having drunk at dangerous levels in the past week (Centre for Behavioural Research in Cancer 2008).

As these statistics suggest, allowing companies to insert themselves into schools is self evidently unacceptable but the alcohol industry inserts itself more insidiously into children's health causes outside the school environment. The AMA documents how the increasingly sophisticated marketing of alcohol is aimed at attracting, influencing, and recruiting new generations of potential drinkers (Australian Medical Association 2009). One example is the targeting and supporting of not-for-profit Australian sporting clubs by alcohol companies. Children involved in these clubs grow up viewing alcohol advertisements and conceivably accepting the industry as an important part of their society and a promoter of good health. Nothing could be further from the truth given that alcohol is one of the greatest dangers faced by the young people of Australia! Furthermore, alcohol, from whatever perspective you look at it, is damaging to sporting performance so it is ironic, or maybe intentional, to link a health damaging product to health promoting activities. Instead such support of charities by the alcohol industry would seem to be another example of an industry injurious to children's health allying itself with children's charities in order to promote its product and image.

#### **3. Why is it unethical?**

258 Public Health – Methodology, Environmental and Systems Issues

There is good evidence that exposure to alcohol advertising shapes young adolescents' attitudes toward alcohol, their intentions to drink, and underage drinking behaviour (Martin 2002). Additionally, studies show that alcohol advertisements are often shown during the shows that target teens such as sporting events (Martin 2002). In Australia, thankfully, alcohol advertisements are no longer shown during children's programs. However, alcohol advertisements do still target youngsters during shows watched by large numbers of children such as sporting events. In 2002, in the US, over a billion dollars was spent to advertise alcohol on TV and around 22% of these advertisements were seen more

Similarly to Tattersall's and McDonalds, alcohol companies do not only advertise through traditional media platforms. The alcohol industry has been a regular sponsor of sporting and charity events held through our schools. This can achieve a similar end to more traditional forms of advertising. A recent report by the Australian National Council on Drugs found that alcohol was often the focus of various fundraisers which include supporting wine "drives" conducted via newsletters, liquor "tasting events" on school premises, and alcoholic bottles featuring school logos. Dr Herron from the Australian

"I think we all know subliminal messages have a huge impact on young people. Through attaching (fundraisers) to a school newsletter, we're legitimising them and saying it's all right for students to be transporting information about alcohol between

Again it must be questioned if such charitable sponsorship is benevolent or little more than

However, the involvement of charitable causes makes rational debates on this issue difficult to have. Few critics of advertising to children would doubt that well meaning parents and friends have the best intentions in raising funds for worthy causes. Indeed, the alcohol companies take advantage of this very fact to, once again, attain the moral high ground and an immunity to being challenged. Parents and friends become a powerful ally for the alcohol companies and might well defend the company by passing off the 'sponsorship' as

Similarly to the first three case studies, we again question if it is ethical to allow an alcohol company to link itself to a school when damage from youth alcohol usage is so prevalent and damaging throughout Australian society (Chikritzhs, Pascal et al. 2004). The list of damage caused to youth by alcohol is long and well established but can be best summarised by the fact that Alcohol accounts for 13 % of all deaths among people 14-17 years of age and in Australia, each week, one teenager dies and around 60 are hospitalized from alcoholrelated causes (Jones, Chikritzhs et al. 2004; Clark, Thatcher et al. 2008). Teenagers without the benefit of good judgement from experience, are particularly vulnerable to alcohol related harm in a way that older drinkers may not be (Australian Medical Association 2009). Among young Australians, the most common causes of death and injury due to risky or high-risk drinking are road injury, suicide, and violent assault (Chikritzhs, Pascal et al. 2004). The Australian School Students' Alcohol and Drug Survey (hereinafter ASSAD)

blatant advertising to adults and children by profit driven alcohol companies.

**2.4 Case study 4: Alcohol industry alliance with children's fundraising** 

by youth than adults (Center on Alcohol Marketing and Youth 2004).

National Council on Drugs states:

the home and school." (Barry 2011)

harmless and merely for philanthropic purposes.

To help determine if a sponsorship is ethical it is also worth referring to the stewardship model outlined in the report by the Nuffield Council on Ethics (2007). They concluded that in regards to the role of industry, the media and other parties, "businesses have obligations towards society. Many businesses already have social responsibility policies. Where industries fail to meet reasonable standards it is acceptable for the state to intervene through regulations (Paragraphs 2.47-2.50 and 3.41)". If the above case studies represent failure to meet acceptable standards, then should the state government intervene to limit this sponsorship?

Secondly, when promotion of unhealthy products involves children, through the use of children's health institutions and charities, the mandate for action is clearer. The stewardship model outlines "protecting and promoting the health of children and other vulnerable groups" as a high order principle that can justify limiting freedoms (Nuffield Council on Bioethics 2007). It would seem that allowing companies to exploit children's charities to promote harmful products would go against the stewardship model. In effect children represent a market failure due to imperfect information and information asymmetry as they are incapable of being fully informed consumers. We therefore have an ethical mandate to steward our most vulnerable by protecting them against exploitation.

Permitting companies to exploit children's charities and children's health services to promote harmful products might qualify as "behaviour harming others". According to J.S. Mill, in his famous volume 'On liberty', intervention by the state is only justified when behaviour harms others, as such sponsorship might do if it causes more consumption of the harmful products (Mills 1909). Similarly a recent article in the Lancet argues "Liberty should be restricted, in a liberal society, only when there is a clear and direct threat of harm to

New Challenges in Public Health Practice:

King's placement of its product in a children's hospital.

had raised for the hospital (Farquharson 2011, March 20).

defamation cases being brought against the group.

on such important issues are important.

unhealthy brands.

tobacco companies.

products.

The Ethics of Industry Alliance with Health Promoting Charities 261

concerted campaign, and effective when it is part of a multipronged approach. The use of the new media is also important. A website called unhealthyalliances is under development. A campaign in Canada drew on a Facebook group to undermine the Burger

In particular, health professionals should advocate for the banning of advertising of damaging products in children's hospitals and institutions where they work. After all, the problem is not primarily related to the companies, which are by nature profit driven. Instead the onus falls largely on the health organizations themselves where many of us work. We should be continually challenging our employers towards more ethical behaviour by dissuading them from accepting money from, and partnering with, companies whose products damage children's health. We should not accept ethical standards being compromised merely in order to finance health programs, buildings and services. In Toronto staff contributed to preventing the Burger King from continuing to operate at the Sick Kids Hospital. The group drew comments from physicians and health professionals to add pressure not to renew the Burger King's lease despite the \$2.5million the Burger King

Physicians who sit on boards and advise on hospital governance issues need to avoid being complicit by not taking action. They can advocate for regulations and clauses to limit the food industry exploiting children. An article in the CMJ advises that at the very least "partnerships should comprise unconditional arm's-length grants with clauses limiting how corporations use health organization brands" (Freedhoff Y and PC. 2011). They warn that if we do not act we risk compromising health promotion goals by helping to promote

Awareness could be raised through counter advertising campaigns aimed at unravelling the unhealthy alliance between health charities and a company which promotes unhealthy

https://www.getup.org.au/campaigns/pokies-reform/grandfinal-ad/get-this-ad-on-the-air The Get Up advocacy group has produced various counter advertising campaigns such as the one challenging the positioning of pokies in sporting clubs frequented by children. Such campaigns can be particularly effective but are often prohibitively expensive and risk

Given the significant power of the companies and their ability to scare journals, publishers and media formats, is it reasonable to revert to the type of tactics used in the Billboard Utilising Graffitists Against Unhealthy Promotions (BUGAUP) campaign? BUGAUP successfully countered tobacco advertising by adding counter slogans on the advertising by

A similar idea was utilised in a recent campaign to expose Tattersall's unhealthy alliance with RCH. Members of the public used the Tattersall's advertising sign to educate the public about the hazards of gambling. Over a three month period eight messages were written, before the message was successfully conveyed and the RCH finally removed the sign. Whilst not advocating illegal graffiti, other legal forms of public health advocacy and protest

innocent parties who cannot respond for themselves" (Finn and Savulescu 2011). There seems adequate evidence now that advertising of unhealthy products to children does cause harm to children who are incapable of responding.

The intervention ladder developed under the Nuffield Bioethics report holds that more intrusive interventions require stronger justification. Although the ethics of advertising to children is still being contested, we conclude that allowing companies promoting unhealthy products to link their product to health institutions or causes, is a justification for action.

Regulating advertising to children is gathering widespread support in Australia where consumers (or more accurately the parents of consumers) are tired of having to fight against blanket advertising to maintain healthy diets for their children. Key findings from a recent phone survey is South Australia were:


(Cancer Council SA 2011)

Along these lines of protecting minors, the Gambling Regulation Act 2003 (Vic) would seemingly be justified in seeking "to ensure that minors are neither encouraged to gamble nor allowed to do so" (section 1.1.iib) (Victorian Government 2003). This act therefore challenges Tattersall's promotion of their brand at the RCH.

#### **4. What action should be taken?**

If such behaviour is proceeding with little regulation in many countries then what can be done? I suggest a similar approach to what has worked in previous campaigns such as the one to limit tobacco companies' right to advertise their harmful product. It has taken a concerted, multipronged and sustained campaign to undermine the supposed right to advertise this dangerous product. This included advertising, mobilising physicians around the cause, raising public awareness, undertaking research and advocating to the policy makers and key stakeholders.

Firstly we believe that public health practitioners and doctors should raise awareness of potentially unethical approaches. Doctors and the health profession more generally are still widely respected by the community. As professionals concerned for the health of those in our community we must be making efforts to protect the health of our most vulnerable. At the very least, awareness can be raised in the public health arena by writing to media outlets, journals and other fora in order to expose, or at least question, apparent unhealthy alliances. Such lobbying has been shown to be an important part of a

innocent parties who cannot respond for themselves" (Finn and Savulescu 2011). There seems adequate evidence now that advertising of unhealthy products to children does cause

The intervention ladder developed under the Nuffield Bioethics report holds that more intrusive interventions require stronger justification. Although the ethics of advertising to children is still being contested, we conclude that allowing companies promoting unhealthy products to link their product to health institutions or causes, is a justification for action.

Regulating advertising to children is gathering widespread support in Australia where consumers (or more accurately the parents of consumers) are tired of having to fight against blanket advertising to maintain healthy diets for their children. Key findings from a recent

• 85% of consumers believe children should be protected from unhealthy food

• 93% of people were in favour of the government introducing stronger restrictions to reduce the amount of unhealthy food and drink advertising seen by children, with 79%

• 86% of grocery buyers are in favour of a ban on advertising of unhealthy foods at times

• When asked what most commonly negatively impacted their children's food purchase requests, grocery buyers reported television commercials (36%) or toys and giveaways

Along these lines of protecting minors, the Gambling Regulation Act 2003 (Vic) would seemingly be justified in seeking "to ensure that minors are neither encouraged to gamble nor allowed to do so" (section 1.1.iib) (Victorian Government 2003). This act therefore

If such behaviour is proceeding with little regulation in many countries then what can be done? I suggest a similar approach to what has worked in previous campaigns such as the one to limit tobacco companies' right to advertise their harmful product. It has taken a concerted, multipronged and sustained campaign to undermine the supposed right to advertise this dangerous product. This included advertising, mobilising physicians around the cause, raising public awareness, undertaking research and advocating to the policy

Firstly we believe that public health practitioners and doctors should raise awareness of potentially unethical approaches. Doctors and the health profession more generally are still widely respected by the community. As professionals concerned for the health of those in our community we must be making efforts to protect the health of our most vulnerable. At the very least, awareness can be raised in the public health arena by writing to media outlets, journals and other fora in order to expose, or at least question, apparent unhealthy alliances. Such lobbying has been shown to be an important part of a

when children watch TV, with 70% strongly in favour.

challenges Tattersall's promotion of their brand at the RCH.

harm to children who are incapable of responding.

phone survey is South Australia were:

advertising.

(24%).

strongly in favour.

(Cancer Council SA 2011)

**4. What action should be taken?** 

makers and key stakeholders.

concerted campaign, and effective when it is part of a multipronged approach. The use of the new media is also important. A website called unhealthyalliances is under development. A campaign in Canada drew on a Facebook group to undermine the Burger King's placement of its product in a children's hospital.

In particular, health professionals should advocate for the banning of advertising of damaging products in children's hospitals and institutions where they work. After all, the problem is not primarily related to the companies, which are by nature profit driven. Instead the onus falls largely on the health organizations themselves where many of us work. We should be continually challenging our employers towards more ethical behaviour by dissuading them from accepting money from, and partnering with, companies whose products damage children's health. We should not accept ethical standards being compromised merely in order to finance health programs, buildings and services. In Toronto staff contributed to preventing the Burger King from continuing to operate at the Sick Kids Hospital. The group drew comments from physicians and health professionals to add pressure not to renew the Burger King's lease despite the \$2.5million the Burger King had raised for the hospital (Farquharson 2011, March 20).

Physicians who sit on boards and advise on hospital governance issues need to avoid being complicit by not taking action. They can advocate for regulations and clauses to limit the food industry exploiting children. An article in the CMJ advises that at the very least "partnerships should comprise unconditional arm's-length grants with clauses limiting how corporations use health organization brands" (Freedhoff Y and PC. 2011). They warn that if we do not act we risk compromising health promotion goals by helping to promote unhealthy brands.

Awareness could be raised through counter advertising campaigns aimed at unravelling the unhealthy alliance between health charities and a company which promotes unhealthy products.

#### https://www.getup.org.au/campaigns/pokies-reform/grandfinal-ad/get-this-ad-on-the-air

The Get Up advocacy group has produced various counter advertising campaigns such as the one challenging the positioning of pokies in sporting clubs frequented by children. Such campaigns can be particularly effective but are often prohibitively expensive and risk defamation cases being brought against the group.

Given the significant power of the companies and their ability to scare journals, publishers and media formats, is it reasonable to revert to the type of tactics used in the Billboard Utilising Graffitists Against Unhealthy Promotions (BUGAUP) campaign? BUGAUP successfully countered tobacco advertising by adding counter slogans on the advertising by tobacco companies.

A similar idea was utilised in a recent campaign to expose Tattersall's unhealthy alliance with RCH. Members of the public used the Tattersall's advertising sign to educate the public about the hazards of gambling. Over a three month period eight messages were written, before the message was successfully conveyed and the RCH finally removed the sign. Whilst not advocating illegal graffiti, other legal forms of public health advocacy and protest on such important issues are important.

New Challenges in Public Health Practice:

concerned about the bottom line.

and PC. 2011).

consumption.

www.cmaj.ca/cgi/content/full/cmaj.110085/DCI ).

**5. The bigger picture** 

The Ethics of Industry Alliance with Health Promoting Charities 263

This chapter has focussed on relevant examples from Australia where youth alcohol, childhood obesity and social problems from gambling are some of our most significant public health problems. However, this is a global problem and there are numerous examples from different countries where companies, whose product is harmful, link themselves to health organisations and health causes in order to mitigate their poor image or even to leverage support policies from these health organisations. The Canadian Medical Journal published a list of health organizations whose messages and reputations have been tarnished by partnerships with food companies (available at

The common message from all these examples is that we need to be cogniscent of this tendency whereby charities are utilised, or subverted, to ultimately sell unhealthy products to our children and community. We need to question if corporate sponsorship of charities is altruistic philanthropy or merely exploitation of charities to sell what can be dangerous products? Companies may not always act so insidiously but it should be remembered that they are ultimately accountable not to public health but to their shareholders who are

Beyond just attaining the moral high ground there is very real danger that such companies can use their support to pressure health institutions and policy making bodies to avoid implementing healthy policies that might damage the image, and profit, of the sponsoring company. Such unhealthy alliances also help the company to lobby against important health initiatives. An editorial in the CMJ describes how the CEO of Coca-Cola, Sandy Douglas, leveraged the company's relationship with the American Academy of Family Physicians to help make the case that soda taxes were unnecessary (Freedhoff Y

More recently there has been concern about corporate lobby power being brought to bear on multilateral UN agencies. An example of an unhealthy alliance with a multilateral is where UNICEF Canada, which amongst other things undertakes nutritional programs in developing countries, allowed its name to be used to promote Cadbury chocolate bars (Lancet 2010). Such partnerships are of growing concern given that changes to WHO funding mechanisms could see it receive more funding from, and work more closely with, the private sector. One commentator on the recent WHO reforms being discussed stated: "fears about WHO's independence remain as a result of the repeated calls for an increase in the role of the private sector and the possibility of funding from them". In effect the WHO would be opening itself up to a conflict of interest where the world's largest independent health watchdog and peak advisory and normative body in health, could receive funds from vested interests. If the food and beverage industry is allowed to become involved in sponsoring the WHO would it compromise the WHO's power to promote normative guidelines on obesity prevention which may involve setting limits on advertising to kids, and advising limits on salt/sugar/fat in certain foods? There is already such a precedent where food and beverage industry applied lobby pressure on powerful member states to oppose an evidence based guidelines around limits on sugar

Graffiti on the sign week 2

No sign (week 9)

#### **5. The bigger picture**

262 Public Health – Methodology, Environmental and Systems Issues

Graffiti on the sign week 2

No sign (week 9)

This chapter has focussed on relevant examples from Australia where youth alcohol, childhood obesity and social problems from gambling are some of our most significant public health problems. However, this is a global problem and there are numerous examples from different countries where companies, whose product is harmful, link themselves to health organisations and health causes in order to mitigate their poor image or even to leverage support policies from these health organisations. The Canadian Medical Journal published a list of health organizations whose messages and reputations have been tarnished by partnerships with food companies (available at www.cmaj.ca/cgi/content/full/cmaj.110085/DCI ).

The common message from all these examples is that we need to be cogniscent of this tendency whereby charities are utilised, or subverted, to ultimately sell unhealthy products to our children and community. We need to question if corporate sponsorship of charities is altruistic philanthropy or merely exploitation of charities to sell what can be dangerous products? Companies may not always act so insidiously but it should be remembered that they are ultimately accountable not to public health but to their shareholders who are concerned about the bottom line.

Beyond just attaining the moral high ground there is very real danger that such companies can use their support to pressure health institutions and policy making bodies to avoid implementing healthy policies that might damage the image, and profit, of the sponsoring company. Such unhealthy alliances also help the company to lobby against important health initiatives. An editorial in the CMJ describes how the CEO of Coca-Cola, Sandy Douglas, leveraged the company's relationship with the American Academy of Family Physicians to help make the case that soda taxes were unnecessary (Freedhoff Y and PC. 2011).

More recently there has been concern about corporate lobby power being brought to bear on multilateral UN agencies. An example of an unhealthy alliance with a multilateral is where UNICEF Canada, which amongst other things undertakes nutritional programs in developing countries, allowed its name to be used to promote Cadbury chocolate bars (Lancet 2010). Such partnerships are of growing concern given that changes to WHO funding mechanisms could see it receive more funding from, and work more closely with, the private sector. One commentator on the recent WHO reforms being discussed stated: "fears about WHO's independence remain as a result of the repeated calls for an increase in the role of the private sector and the possibility of funding from them". In effect the WHO would be opening itself up to a conflict of interest where the world's largest independent health watchdog and peak advisory and normative body in health, could receive funds from vested interests. If the food and beverage industry is allowed to become involved in sponsoring the WHO would it compromise the WHO's power to promote normative guidelines on obesity prevention which may involve setting limits on advertising to kids, and advising limits on salt/sugar/fat in certain foods? There is already such a precedent where food and beverage industry applied lobby pressure on powerful member states to oppose an evidence based guidelines around limits on sugar consumption.

New Challenges in Public Health Practice:

Mail. Toronto.

The Ethics of Industry Alliance with Health Promoting Charities 265

Chikritzhs, T., P. Pascal, et al. (2004). "Under-Aged Drinking Among 14-17 Year Olds and

Clark, D., D. Thatcher, et al. (2008). "Alcohol, psychological dysregulation and adolescent

Farquharson, V. (2011, March 20). Burger King loses foothold at Sick Kids. The Globe and

Handsley E, Nehmy C, et al. (2007). "Media, public health and law: A lawyer's primer on the

HeartKids. (2011). "Donut King supporting heartkids on valentines day." from

Hebden, L., L. King, et al. (2011). "Advertising of fast food to children on Australian television: the impact of industry self-regulation." Med J Aust 195(1): 20-24. Jones, P., T. Chikritzhs, et al. (2004). "Under-Aged Drinking Among 14-17 Year Olds and

Livingstone (2006). New research on advertising foods to children - an updated view of the

Martin, S. (2002). "Alcohol Advertising and Youth." Alcoholism: Clinical and Experimental

National preventative health taskforce (2009). Australia: the healthiest country by 2020

Nuffield Council on Bioethics (2007). Public health: ethical issues. London, Nuffield Council

Ofcom (2008). Changes in the nature and balance of television food advertising to children: A review of HFSS advertising restrictions. London, Office of Communications.

The Public Health Association of Australia (2008). Gambling and Health policy. Australia.

food advertising debate. ." Media and Arts Law Review 12(1): 16.

Institute, Curtin University of Technology, Perth. Bulletin No.7.

Needham, K. (2011 (Feb 11)). Pokies 'just like burgers'. The Age. Melbourne.

Prisk, T. (2011). Truck drives access to health care. Centralwesterndaily.

http://www.newrch.vic.gov.au/Shopsservicesandamenities.

Victorian Government (2003). Gambling Regulation Act Australia

Lancet (2010). "Trick or treat or UNICEF Canada." Lancet 376: 1514.

Finn, A. and J. Savulescu (2011). "Is immunisation child protection?" Lancet 378(9790): 465 - 468. Freedhoff Y and H. PC. (2011). "Parnterships between health organisaitons and the food industry risk derailing public health nutrition (editorial) " CMAJ 183(3). Hancock, L., T. Schellinck, et al. (2008). "Gambling and corporate social responsibility (CSR):

Institute, Curtin University of Technology Bulletin No.7.

management." Policy and society 27: 55–68.

rting\_heartkids\_on\_valentines\_day/

Office of Communications.

Commonwealth of Australia.

Research 26( ): 900-906. Mills, J. (1909). On liberty P. F. Collier & Son.

on Bioethics.

Royal Children's Hospital. (2010). from

Related Harms in Australia, National Alcohol Indicators." National Drug Research

brain development." Alcoholism Clinical and Experimental Research 32(3): 375-385.

Re-defining industry and state roles on duty of care, host responsibility and risk

http://www.heartkidsvic.org.au/index.php/state/news\_item/donut\_king\_suppo

Related Harms in Australia, National Alcohol Indicators." National Drug Research

literature, in television advertising of food and drink products to children. London,

National Preventative Health Strategy – the roadmap for action. Canberra,

#### **6. Conclusion**

We believe that there is an ominous, and largely unquestioned, trend for unhealthy products to be co-advertised with children's health services and charities. Whilst not accusing companies of inappropriate behaviour, this viewpoint challenges regulators and health institutions themselves to reconsider unhealthy alliances. These alliances potentially advertise unhealthy products to children, give companies that produce harmful products a moral high ground of supporting children's health, and ultimately undermine important health promotion messages. We argue that such activities are ethically questionable, and using a public health framework for ethics, warrant more intrusive regulations on advertising through our children's health institutions and charities.

In the new era of public health this issue must be dealt with effectively if we are to maintain our health levels and challenge the increasing double burden of infectious and non infectious diseases in the developing world. This is the new frontline in public health and we are currently lagging behind in this conflict. This chapter, it is hoped, has helped expose potential opposition to public health and this might serve as a call to action for public health practitioners and advocates.

#### **7. Acknowledgments**

Dr Bruce Bolam for helping develop the concept and reviewing a number of iterations of this paper along the way.

Prof Rob Moodie for modelling a public health advocate and for the encouragement to write about such issues**.** 

#### **8. References**


We believe that there is an ominous, and largely unquestioned, trend for unhealthy products to be co-advertised with children's health services and charities. Whilst not accusing companies of inappropriate behaviour, this viewpoint challenges regulators and health institutions themselves to reconsider unhealthy alliances. These alliances potentially advertise unhealthy products to children, give companies that produce harmful products a moral high ground of supporting children's health, and ultimately undermine important health promotion messages. We argue that such activities are ethically questionable, and using a public health framework for ethics, warrant more intrusive regulations on advertising through our children's health institutions and

In the new era of public health this issue must be dealt with effectively if we are to maintain our health levels and challenge the increasing double burden of infectious and non infectious diseases in the developing world. This is the new frontline in public health and we are currently lagging behind in this conflict. This chapter, it is hoped, has helped expose potential opposition to public health and this might serve as a call to action for public health

Dr Bruce Bolam for helping develop the concept and reviewing a number of iterations of

Prof Rob Moodie for modelling a public health advocate and for the encouragement to write

Australian Medical Association (2009). Alcohol Use and Harms in Australia (2009)

Barry, E. (2011). "No place for booze in schools fundraisers, says Australian National

Cancer Council SA (2011). Public supports tougher regulation of unhealthy food

Center on Alcohol Marketing and Youth (2004). Youth Exposure to Alcohol Ads On TV

Centre for Behavioural Research in Cancer (2008). Australian School Students' Alcohol and

Chan, M. (2011). Tackling food-related diseases: voluntary measures or regulation - carrot or

Chapman, K., L. Hebden, et al. (2011). "Advertising of fast food to children on Australian

stick? . The World Health Organization's global forum: Addressing the challenge of

television: the impact of industry self-regulation." Medical Journal of Australia

**6. Conclusion** 

charities.

practitioners and advocates.

**7. Acknowledgments** 

this paper along the way.

http://ama.com.au/node/4762.

advertising. Adelaide.

Council on Drugs " The Herald Sun March 2.

Drug Survey (ASSAD) Cancer Council Victoria.

noncommunicable diseases, Moscow.

about such issues**.** 

2002.

195(1): 20-24.

**8. References** 


**12** 

*Poland* 

**Primary and Hospital Healthcare in Poland –** 

Spatial distribution and location of healthcare facilities have been long acknowledged as main interests of Polish medical geography, although most research done dates back to the late 1980s and early 1990s (Mazurkiewicz, 1994; Michalski, 1999). These include e.g. some renowned studies of health services in Warsaw (Grochowski, 1988; Malczewski, 1989). Unfortunately, healthcare accessibility and availability have not been widely explored by geographers in the 2000s; thus marginalized in spatial sciences, has been detained by other

In 1952 geography of health was officially recognized and incorporated into geographical sciences by Medical Geography Committee operating within the structures of International Geographical Union. At the time, geography of health endeavored to investigate geographical factors of causes and consequences related to changes in population health status and morbidity. Presently, this subdiscipline consists of two distinctive strands: the spatial distribution of disease and death, and the geographical complexities surrounding the provision, access to and inequality of health care (Kearns & Gesler, 2002; Parr, 2003). Hence, most researchers clearly distinguish geography of healthcare as a domain that focuses on spatial accessibility of health services through the lenses of their distribution, demand, supply, utilization and planning (Mayer, 1982; Moon et. al., 1998). Moreover, geography of health care has evolved to investigate how medical resources meet population needs in space (Rosenberg, 1998; Kearns & Moon, 2002). Irrespective of such collaborative approaches some spatiallyaware researchers frequently explore spatial and non-spatial factors underlying healthcare

The most important regulation of Polish healthcare system guarantees equal access for everyone, which is directly declared in the Polish Constitution, Article 68, Paragraph 2: "*Equal access to health care services, financed from public funds, shall be ensured by public authorities to citizens, irrespective of their material situation. The conditions for, and scope of, the provision of services shall be established by statute*". As suggested here, equal access refers to free utilization of health services. Although provided and financed by the state, health services should be congruent with other dimensions of accessibility. These are: affordability, accommodation, acceptability, availability and spatial accessibility (Penchansky & Thomas, 1981). First three dimensions can be viewed as non-spatial, however planning and fund distribution on healthcare in particular regions and counties should be based on potential

disciplines such as public health (see Chawla et. al, 2004).

accessibility (Haynes, 2003; Wang & Luo 2005; Unal et. al, 2007).

**1. Introduction** 

**Organization, Availability and Space** 

Paweł Kretowicz and Tomasz Chaberko

*Jagiellonian University* 

World Advertising Research Centre. (2009). "US government to scrutinise food marketing to children." Retrieved 1 May 2010, from

www.warc.com/news/topnews.asp?ID=24840. .


### **Primary and Hospital Healthcare in Poland – Organization, Availability and Space**

Paweł Kretowicz and Tomasz Chaberko *Jagiellonian University Poland* 

#### **1. Introduction**

266 Public Health – Methodology, Environmental and Systems Issues

World Advertising Research Centre. (2009). "US government to scrutinise food marketing to

World Health Organization (2003). Diet, nutrition and the prevention of chronic diseases.

Wright, K. (2010). "Corporate Social Responsibility: A Review of the Literature." The higher

Report of a joint WHO/FAO expert consultation. W. T. Series. Geneva, World

children." Retrieved 1 May 2010, from www.warc.com/news/topnews.asp?ID=24840. .

Health Organization. 916.

education academy 19(24).

Spatial distribution and location of healthcare facilities have been long acknowledged as main interests of Polish medical geography, although most research done dates back to the late 1980s and early 1990s (Mazurkiewicz, 1994; Michalski, 1999). These include e.g. some renowned studies of health services in Warsaw (Grochowski, 1988; Malczewski, 1989). Unfortunately, healthcare accessibility and availability have not been widely explored by geographers in the 2000s; thus marginalized in spatial sciences, has been detained by other disciplines such as public health (see Chawla et. al, 2004).

In 1952 geography of health was officially recognized and incorporated into geographical sciences by Medical Geography Committee operating within the structures of International Geographical Union. At the time, geography of health endeavored to investigate geographical factors of causes and consequences related to changes in population health status and morbidity. Presently, this subdiscipline consists of two distinctive strands: the spatial distribution of disease and death, and the geographical complexities surrounding the provision, access to and inequality of health care (Kearns & Gesler, 2002; Parr, 2003). Hence, most researchers clearly distinguish geography of healthcare as a domain that focuses on spatial accessibility of health services through the lenses of their distribution, demand, supply, utilization and planning (Mayer, 1982; Moon et. al., 1998). Moreover, geography of health care has evolved to investigate how medical resources meet population needs in space (Rosenberg, 1998; Kearns & Moon, 2002). Irrespective of such collaborative approaches some spatiallyaware researchers frequently explore spatial and non-spatial factors underlying healthcare accessibility (Haynes, 2003; Wang & Luo 2005; Unal et. al, 2007).

The most important regulation of Polish healthcare system guarantees equal access for everyone, which is directly declared in the Polish Constitution, Article 68, Paragraph 2: "*Equal access to health care services, financed from public funds, shall be ensured by public authorities to citizens, irrespective of their material situation. The conditions for, and scope of, the provision of services shall be established by statute*". As suggested here, equal access refers to free utilization of health services. Although provided and financed by the state, health services should be congruent with other dimensions of accessibility. These are: affordability, accommodation, acceptability, availability and spatial accessibility (Penchansky & Thomas, 1981). First three dimensions can be viewed as non-spatial, however planning and fund distribution on healthcare in particular regions and counties should be based on potential

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 269

Health Professionals (Centralny Rejestr Lekarzy, www.nil.org.pl). These sources are

Center of Health Information Systems operating within the Ministry of Health is the main body responsible for data capture and storage. Annual Survey Programs of Official Statistics include public health data, which obligates every healthcare institution to send the required information to the Center monthly or annually. The records collected facilitate accurate analyses of medical resources and their utilization (data available on a municipal level). For example, MZ-88 and MZ-89 forms are used to collect data about medical staff employed in each health care unit in the whole country. Similarly, forms MZ-11 to MZ-15 include the data about number of patients and consultations with physicians by date, patients' age and sex, type of ailment etc. Analogous information about hospital care can be derived from MZ-11Szp forms provided by every facility in the country (by both facility location and patient residence). Unfortunately, not all hospitals follow this regulation what would result in strong underestimations (no data for one hospital in an area) if any geographical analysis was conducted. All of the data sheets are also sent to Centers of Public Health located in 16 provincial seats. Until recently, these institutions operated as separate entities, but they have now been incorporated into Health Departments of Province Offices. Administrative division of Poland authors wish to refer to in this study is presented below (Figure 1). Poland is divided into 16 provinces (49 until 1999), 314 land and 65 urban counties, 2478

extremely useful in geographical analyses of such subjects as:

b. location of new facilities, changes of ownership (since 2004)

c. spatial accessibility and availability of health professionals by specialty d. number and structure of hospital beds with respect to potential health needs

a. location and organization of healthcare facilities

self-governed municipalities.

Source: authors' own work

Fig. 1. Administrative division of Poland since 1999.

and actual/expected population needs (Guagliardo, 2004). The notions of availability and accessibility describe the relationship between location of healthcare facilities and patient residence. Availability reflects an assessment of how the volume and type of existing services (and resources) reflect the clients (patients) volume and types of needs (Joseph & Phillips, 1984). Spatial accessibility refers to distance, travel time, cost and modes of transportation.

The most important barrier to egalitarian conditions of healthcare utilization includes much higher demand of medical services as compared to the supply. This demand increases along with economic growth and development of new technologies. The existing medical resources (especially in secondary – specialized care and tertiary – hospital care) can no longer meet the needs of all patients simultaneously, nor do the financial resources can be distributed across all in need. As a consequence, long lines to the specialist offices discourage the sick and make them shift from public to non-public healthcare facilities. Worse still, heath services offered in non-public facilities are not always refunded by the National Health Fund (Narodowy Fundusz Zdrowia – NFZ – the institution responsible for redistribution of insurance contributions); thus patients have to pay for services. Furthermore, annual budgetary limits to health services also constrain access to healthcare and contribute to long wait times. These restrictions result from new technologies in medicine and pharmacy, which provide more efficient, but expensive medical equipment, treatments and medicines. In 2009 only 5% of patients generated no fewer than 60% of the total expenditures on services guaranteed by the NFZ (Ruszkowski, 2010).

Commercialization in Polish healthcare system has progressed dynamically since the early 1990s. Presently, about 75% of general practitioner offices and 82% of specialist offices in Poland operate as non-public facilities. In case of hospitals this proportion in 2010 amounts to 35% with a total number of hospital beds in non-public facilities reaching 32.8 thousands (16% of all hospital beds in Poland). This indicates that the majority of commercialized hospitals comprise relatively small facilities whereas the largest ones remain either state or province-owned.

#### **2. Data sources and setting**

According to Kaczmarek (2007) the availability of medical services depends on the volume and structure of current resources (e.g. number of medical doctors, nurses, hospital beds, medical equipment). Unfortunately, under the socialist rule before 1989 access to data concerning material and personal resources in healthcare was very limited. Neither existing registers nor Central Statistical Office was capturing data for all of the medical specialties. Besides, official figures were often aggregated and presented as simple classifications (Dziubińska-Michalewicz, 1994). Presently, Central Statistical Office (Local Databank, www.stat.gov.pl) provides scarce information concerning healthcare facilities (total number), although most is available on a municipal level. This data is divided by the ownership (public and non-public), type of care (primary and hospital) and utilization (crude number of consultations with physicians). County-level data includes the number of public and non-public hospital beds and the number of hospitalized patients (until 2003). In order to assess the distribution, organization, ownership and medical staff in healthcare facilities across the country the best databases offer the Register of Health Care Units (Rejestr Zakładów Opieki Zdrowotnej, www.rejestrzoz.gov.pl) and Central Register of Health Professionals (Centralny Rejestr Lekarzy, www.nil.org.pl). These sources are extremely useful in geographical analyses of such subjects as:

a. location and organization of healthcare facilities

268 Public Health – Methodology, Environmental and Systems Issues

and actual/expected population needs (Guagliardo, 2004). The notions of availability and accessibility describe the relationship between location of healthcare facilities and patient residence. Availability reflects an assessment of how the volume and type of existing services (and resources) reflect the clients (patients) volume and types of needs (Joseph & Phillips, 1984). Spatial accessibility refers to distance, travel time, cost and modes of

The most important barrier to egalitarian conditions of healthcare utilization includes much higher demand of medical services as compared to the supply. This demand increases along with economic growth and development of new technologies. The existing medical resources (especially in secondary – specialized care and tertiary – hospital care) can no longer meet the needs of all patients simultaneously, nor do the financial resources can be distributed across all in need. As a consequence, long lines to the specialist offices discourage the sick and make them shift from public to non-public healthcare facilities. Worse still, heath services offered in non-public facilities are not always refunded by the National Health Fund (Narodowy Fundusz Zdrowia – NFZ – the institution responsible for redistribution of insurance contributions); thus patients have to pay for services. Furthermore, annual budgetary limits to health services also constrain access to healthcare and contribute to long wait times. These restrictions result from new technologies in medicine and pharmacy, which provide more efficient, but expensive medical equipment, treatments and medicines. In 2009 only 5% of patients generated no fewer than 60% of the

Commercialization in Polish healthcare system has progressed dynamically since the early 1990s. Presently, about 75% of general practitioner offices and 82% of specialist offices in Poland operate as non-public facilities. In case of hospitals this proportion in 2010 amounts to 35% with a total number of hospital beds in non-public facilities reaching 32.8 thousands (16% of all hospital beds in Poland). This indicates that the majority of commercialized hospitals comprise relatively small facilities whereas the largest ones remain either state or

According to Kaczmarek (2007) the availability of medical services depends on the volume and structure of current resources (e.g. number of medical doctors, nurses, hospital beds, medical equipment). Unfortunately, under the socialist rule before 1989 access to data concerning material and personal resources in healthcare was very limited. Neither existing registers nor Central Statistical Office was capturing data for all of the medical specialties. Besides, official figures were often aggregated and presented as simple classifications (Dziubińska-Michalewicz, 1994). Presently, Central Statistical Office (Local Databank, www.stat.gov.pl) provides scarce information concerning healthcare facilities (total number), although most is available on a municipal level. This data is divided by the ownership (public and non-public), type of care (primary and hospital) and utilization (crude number of consultations with physicians). County-level data includes the number of public and non-public hospital beds and the number of hospitalized patients (until 2003). In order to assess the distribution, organization, ownership and medical staff in healthcare facilities across the country the best databases offer the Register of Health Care Units (Rejestr Zakładów Opieki Zdrowotnej, www.rejestrzoz.gov.pl) and Central Register of

total expenditures on services guaranteed by the NFZ (Ruszkowski, 2010).

transportation.

province-owned.

**2. Data sources and setting** 


Center of Health Information Systems operating within the Ministry of Health is the main body responsible for data capture and storage. Annual Survey Programs of Official Statistics include public health data, which obligates every healthcare institution to send the required information to the Center monthly or annually. The records collected facilitate accurate analyses of medical resources and their utilization (data available on a municipal level). For example, MZ-88 and MZ-89 forms are used to collect data about medical staff employed in each health care unit in the whole country. Similarly, forms MZ-11 to MZ-15 include the data about number of patients and consultations with physicians by date, patients' age and sex, type of ailment etc. Analogous information about hospital care can be derived from MZ-11Szp forms provided by every facility in the country (by both facility location and patient residence). Unfortunately, not all hospitals follow this regulation what would result in strong underestimations (no data for one hospital in an area) if any geographical analysis was conducted. All of the data sheets are also sent to Centers of Public Health located in 16 provincial seats. Until recently, these institutions operated as separate entities, but they have now been incorporated into Health Departments of Province Offices. Administrative division of Poland authors wish to refer to in this study is presented below (Figure 1). Poland is divided into 16 provinces (49 until 1999), 314 land and 65 urban counties, 2478 self-governed municipalities.

Source: authors' own work

Fig. 1. Administrative division of Poland since 1999.

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 271

provincial budgets (institutions of a regional range). These expenditures were allocated without any regard to spatial distribution of population demand and healthcare utilization. All in all, fund distribution was organized by extrapolation of expenditures incurred in the previous year, providing their maximization with no rights to transfer any expenses for the next year (Curtis & Malczewski, 1990). Such management was ineffective, inadequate to the current social expectations and put numerous health care units in financial hardship. After the political transformation of 1989, this extensive policy led to shortages of personnel,

The aforementioned system of healthcare managed and financed by the state budget and based on the lack of private health care institutions is called the Semashko model. This model, criticized for the extensive allocation of funds, dominated Poland and other socialist countries in the second half of the 20th century. Healthcare institutions were utilized only by patients who resided in the preventive-therapeutic districts (embracing from 30 000 to 150 000 inhabitants). Nonetheless, the basic units were called micro-district and embraced from 3 000 to 6 000 inhabitants. These units had to possess at least one physician in service and cover at least one village or district (borough) (Kaser, 1976). Moreover, health services for certain social groups were organized by completely different public bodies e.g. enterprise health services, railroad health services, Ministry of the Interior Affairs and Ministry of Defense health services (Grochowski, 1988). In 1972, the integrated health care management units - ZOZ (Zespół Opieki Zdrowotnej) were established. These entities were responsible for management of hospitals, outpatient clinics, specialist and primary health care as well as some social services. In 1991 health care units replaced integrated health care managements units, but retained the same acronym (ZOZ – Zakład Opieki Zdrowotnej). The Semashko model operated until 1999, when, in the aftermath of reforms in the Polish healthcare, insurance contributions were introduced. By this means, a transition from budgetary to insurance model put healthcare system in Poland on different tracks leading to the Bismarck model (social insurance model). This model introduces mandatory insurances, free choice of service and insurance provider as well as contract-based organization of healthcare system. New model alters spatial patterns of

medical equipment, medicines and favored corruption (Millard 1995).

Source: googlemaps.com

Photo 1. Stanislaw Staszic's county hospital in Piła.

This study employs the data extracted from both Register of Health Care Units and Central Statistical Office. According to *The Act of 30th September 1991 on Health Care Units* (*Ustawa z dnia 30 września 1991 o zakladach opieki zdrowotnej*; Dz.U. 1991, Nr 220, Poz. 1600.) register entry is tantamount to official permission to run a medical office or health center (fines are levied upon those unregistered). Register of Health Care Units includes detailed information about facility address, location of its branches, legal foundations, organizational structure, type of medical specialty, number of beds in each ward (for hospitals and other inpatient clinics). Unfortunately, some information found in the Register turns out to be unreliable as not all specialist offices are included into the computer database (regardless of declared trustworthiness by the Center of Health Information Systems). For this reason, authors decide to take into consideration only primary and hospital healthcare. In spite of clear attempts to enhance data availability, a lack of necessary information provided by Polish statistical institutions is considered as a major limitation for health-related research and medical geography in particular. The main indicator of primary healthcare availability utilized this study includes practitioner's office to population ratio. In case of hospital care this measure comprises the number of hospital beds to population ratio.

#### **3. Organization of healthcare system in Poland after World War II**

Contemporary spatial organization of healthcare system in Poland has been shaped by historical determinants, healthcare model employed by the politicians as well as recent socio-economic processes. Under socialist rule, as in many other sectors of the national economy, management and planning in healthcare fell under central authorities. *The Act of 28th October 1948 on Collective Health Care Centers and Planned Economy in Healthcare* (Ustawa z dnia 28 października 1948 r. *o zakładach społecznych służby zdrowia i planowej gospodarce w służbie zdrowia*, Dz.U. 1948 Nr 55, Poz. 434.) virtually barred local governments and territorial health care centers from making consecutive decisions in healthcare organization and planning. Every resolution must have been first discussed and then approved by the district departments of national administration. Former healthcare system was organized in conjunction with the administrative division of the country. The provincial hospitals (socalled integrated provincial hospitals – Wojewódzki Szpital Zespolony) were most privileged as they offered the widest variety and highest quality of medical services. As a result, inequalities in spatial distribution of tertiary care increased significantly and favored these provinces with the largest district/regional facilities. Moreover, this gap widened after locations of some institutions in accordance with the political and military will of the Warsaw Pact (Ruszkowski 2008). Such locations were justified ideologically as communistic authorities were determined to arrange sufficient hospital infrastructure for the army in case of war (anticipated World War III). Hence, oversized and strategically-located institutions were being constructed across the entire country, but chiefly in the west of Poland. Consequently, large hospital facilities usually exceeded the needs of local population. A good example of such location could be Stanislaw Staszic's county hospital in Piła (Wielkopolskie Province), of which construction began in 1977 (Photo. 1.)

The number of beds in Stanislaw Staszic's Hospital in Piła peaked in 1992 when comprised as many as 726 beds. This number greatly exceeded local demand and was gradually reduced down to 601 beds in 2010; thus maladjustment of hospital size to the population needs was evident. The same problem concerned the spatial distribution of expenditures on healthcare financed both by the national (institutions of a nationwide range) and the provincial budgets (institutions of a regional range). These expenditures were allocated without any regard to spatial distribution of population demand and healthcare utilization. All in all, fund distribution was organized by extrapolation of expenditures incurred in the previous year, providing their maximization with no rights to transfer any expenses for the next year (Curtis & Malczewski, 1990). Such management was ineffective, inadequate to the current social expectations and put numerous health care units in financial hardship. After the political transformation of 1989, this extensive policy led to shortages of personnel, medical equipment, medicines and favored corruption (Millard 1995).

Source: googlemaps.com

270 Public Health – Methodology, Environmental and Systems Issues

This study employs the data extracted from both Register of Health Care Units and Central Statistical Office. According to *The Act of 30th September 1991 on Health Care Units* (*Ustawa z dnia 30 września 1991 o zakladach opieki zdrowotnej*; Dz.U. 1991, Nr 220, Poz. 1600.) register entry is tantamount to official permission to run a medical office or health center (fines are levied upon those unregistered). Register of Health Care Units includes detailed information about facility address, location of its branches, legal foundations, organizational structure, type of medical specialty, number of beds in each ward (for hospitals and other inpatient clinics). Unfortunately, some information found in the Register turns out to be unreliable as not all specialist offices are included into the computer database (regardless of declared trustworthiness by the Center of Health Information Systems). For this reason, authors decide to take into consideration only primary and hospital healthcare. In spite of clear attempts to enhance data availability, a lack of necessary information provided by Polish statistical institutions is considered as a major limitation for health-related research and medical geography in particular. The main indicator of primary healthcare availability utilized this study includes practitioner's office to population ratio. In case of hospital care

this measure comprises the number of hospital beds to population ratio.

(Wielkopolskie Province), of which construction began in 1977 (Photo. 1.)

The number of beds in Stanislaw Staszic's Hospital in Piła peaked in 1992 when comprised as many as 726 beds. This number greatly exceeded local demand and was gradually reduced down to 601 beds in 2010; thus maladjustment of hospital size to the population needs was evident. The same problem concerned the spatial distribution of expenditures on healthcare financed both by the national (institutions of a nationwide range) and the

**3. Organization of healthcare system in Poland after World War II** 

Contemporary spatial organization of healthcare system in Poland has been shaped by historical determinants, healthcare model employed by the politicians as well as recent socio-economic processes. Under socialist rule, as in many other sectors of the national economy, management and planning in healthcare fell under central authorities. *The Act of 28th October 1948 on Collective Health Care Centers and Planned Economy in Healthcare* (Ustawa z dnia 28 października 1948 r. *o zakładach społecznych służby zdrowia i planowej gospodarce w służbie zdrowia*, Dz.U. 1948 Nr 55, Poz. 434.) virtually barred local governments and territorial health care centers from making consecutive decisions in healthcare organization and planning. Every resolution must have been first discussed and then approved by the district departments of national administration. Former healthcare system was organized in conjunction with the administrative division of the country. The provincial hospitals (socalled integrated provincial hospitals – Wojewódzki Szpital Zespolony) were most privileged as they offered the widest variety and highest quality of medical services. As a result, inequalities in spatial distribution of tertiary care increased significantly and favored these provinces with the largest district/regional facilities. Moreover, this gap widened after locations of some institutions in accordance with the political and military will of the Warsaw Pact (Ruszkowski 2008). Such locations were justified ideologically as communistic authorities were determined to arrange sufficient hospital infrastructure for the army in case of war (anticipated World War III). Hence, oversized and strategically-located institutions were being constructed across the entire country, but chiefly in the west of Poland. Consequently, large hospital facilities usually exceeded the needs of local population. A good example of such location could be Stanislaw Staszic's county hospital in Piła

Photo 1. Stanislaw Staszic's county hospital in Piła.

The aforementioned system of healthcare managed and financed by the state budget and based on the lack of private health care institutions is called the Semashko model. This model, criticized for the extensive allocation of funds, dominated Poland and other socialist countries in the second half of the 20th century. Healthcare institutions were utilized only by patients who resided in the preventive-therapeutic districts (embracing from 30 000 to 150 000 inhabitants). Nonetheless, the basic units were called micro-district and embraced from 3 000 to 6 000 inhabitants. These units had to possess at least one physician in service and cover at least one village or district (borough) (Kaser, 1976). Moreover, health services for certain social groups were organized by completely different public bodies e.g. enterprise health services, railroad health services, Ministry of the Interior Affairs and Ministry of Defense health services (Grochowski, 1988). In 1972, the integrated health care management units - ZOZ (Zespół Opieki Zdrowotnej) were established. These entities were responsible for management of hospitals, outpatient clinics, specialist and primary health care as well as some social services. In 1991 health care units replaced integrated health care managements units, but retained the same acronym (ZOZ – Zakład Opieki Zdrowotnej). The Semashko model operated until 1999, when, in the aftermath of reforms in the Polish healthcare, insurance contributions were introduced. By this means, a transition from budgetary to insurance model put healthcare system in Poland on different tracks leading to the Bismarck model (social insurance model). This model introduces mandatory insurances, free choice of service and insurance provider as well as contract-based organization of healthcare system. New model alters spatial patterns of

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 273

well as make contracts with the National Health Fund. These novelties triggered a continuous increase in the number of health care units and health care centers across the country since 1991, but most intense spread was observed at the beginning of the 21th century. The data currently available allow for investigating these phenomena in a spatial dimension since 2004 (when a computer database – Register of Health Care Units was created). The number of health care units in 2004, 2007 and 2010 per 10 thousand inhabitants is presented in the Figure 2 irrespective of medical specialty and organizational forms. Higher number of health care units contributes to better availability and diversity of medical services. The changes in the number of health care units are inarguably connected with an increase of non-public entities. Because the range of influence for certain units often exceeds the municipal or regional borders (patients choose health professionals located nearby their places of residence) an average measure was calculated. This measure combines each municipality and all adjacent to them according to queen contiguity spatial weights

Most health care centers are located in the largest metropolitan areas both in cities and their vicinity as the suburban inhabitants often utilize health services provided by the institutions located in the inner city. More favorable healthcare availability in metropolitan areas results from large demographic potential, extensive financial resources, and excellent access to specialized medical services, the latter caused by high-rank education provided by medical universities that educate most qualified personnel. Thus, health professionals who obtained rare specializations usually practice in the largest cities. Furthermore, hospital wards with a catchment area encompassing several provinces (e.g. due to the uncommon specialization and rare disease treatment) are located in the largest cities too. Nevertheless, certain areas such as medium-sized towns, especially former province capitals (between 1975 and 1999 Poland was divided into 49 provinces; this period gave an economic boost to provincial capitals), are distinguished by a high-level and numerous medical services. The infrastructure inherited from the period of the People's Republic of Poland contributed to the concentration of health care units in these towns presently. Regional approach demonstrates Śląskie, Łódzkie, Zachodniopomorskie and Podlaskie Provinces as those of the best healthcare availability. Fast pace of changes can be observed in Zachodniopomorskie and Podlaskie Provinces whereas fewer health care units per 10 thousands inhabitants can be found in Kujawsko-Pomorskie, Pomorskie, and Warmińsko-

General practitioner is considered as a key element of primary healthcare in Poland. Individual GP practices were established quite recently – in 1991. These doctors are supposed to perform *gatekeeper's* role that is to provide entrance to the whole healthcare system as a first institution patients refer to. As follows, this role assumes that initial patient-doctor contact begins at general practitioner office (in Poland, these physicians are called family doctors). Theoretically, family doctors ought to possess enough knowledge and experience to cure (or at least assist) the majority of diseases; however they are granted a wide range of administrative competences. Aside from prescriptions, they can issue referrals to other specialists or hospitals and for numerous medical examinations.

frequently used in spatial statistics.

Mazurskie Provinces.

**4.1 Primary heathcare** 

healthcare utilization by the patients, who are now allowed to choose health professional and health care institution wherever they wish including locations outside their area of residence. Irrespectively, the system present in Poland is now criticized as the individual contributions remain involuntary, do not depend on individual decisions and the insured have no influence on the quality of service received (Siwińska et. al., 2008).

Presently, changes in Polish healthcare system to some extent follow principals of the Bismarck's model as gradual decentralization of management and financing have been implemented since the early 1990s. From economic and administrative viewpoints this decentralization is reflected by the liberalization of healthcare market, which results in gradual replacements of state health care units by municipal and non-public entities. Local governments (provinces, counties and municipalities) are now allowed to found and manage health care units what is permitted by the *Act of 30th September 1991 on Health Care Units*. Four forms of health care units are mentioned in this act with respect to their ownership and financial system: independent public health care centers (SPZOZ), budget entity, self-governmental budgetary establishment, and non-public health care unit (NZOZ). Decentralization of financial system and transformation of health care units into independent public health care centers began in 1998 and 1999 after sickness funds were established. This decentralization was reversed in 2003 as National Health Fund was founded, something that led to concentration of financial resources on a national level. The return to central healthcare financier and insurer was fiercely criticized by the politicians and scientific community; thus regional branches of NFZ were established, each responsible for healthcare financing and insurances in one province (but still operating under the Ministry of Health). Consequently, a lack of state-independent insurer and provider of healthcare limits patients' choice, which plainly contradicts the Bismarck's model principals. Contrarily to the healthcare financing and insuring, the responsibilities of management and planning in healthcare were imposed on local governments. Unfortunately, local communities were not able to cover increasing expenses and debts which health care units amassed over the years. These debts resulted from operation in accordance with constitutional principle of equal and free access to health services as well as life saving obligations. Moreover, the financial burdens are excavating prompted by the inability to declare bankruptcy by these health care units which are crucial for local population in order to retain overall health security intact.

#### **4. Spatial inequalities in the availability of primary and hospital care**

Legal and administrative characteristics concerning the organization of Polish healthcare system have a direct impact on spatial issues of the essence for researchers in medical geography. From an economic perspective, geographical sciences may lie beneath the premises for allocation of funds in particular regions (in accordance with spatially diverse needs) as well as the distribution of decisive and executive competences in health policy (spatial scale problem – consistency between administrative level and responsibility for health policy goals). From a social perspective, a key issue is to increase accessibility to and availability of medical services for all citizens, particularly the poorer friction of population who reside in peripheral areas.

Both spatial accessibility and availability of healthcare was radically improved by the enforcement of legal acts that gave non-public entities rights to run healthcare practices as well as make contracts with the National Health Fund. These novelties triggered a continuous increase in the number of health care units and health care centers across the country since 1991, but most intense spread was observed at the beginning of the 21th century. The data currently available allow for investigating these phenomena in a spatial dimension since 2004 (when a computer database – Register of Health Care Units was created). The number of health care units in 2004, 2007 and 2010 per 10 thousand inhabitants is presented in the Figure 2 irrespective of medical specialty and organizational forms. Higher number of health care units contributes to better availability and diversity of medical services. The changes in the number of health care units are inarguably connected with an increase of non-public entities. Because the range of influence for certain units often exceeds the municipal or regional borders (patients choose health professionals located nearby their places of residence) an average measure was calculated. This measure combines each municipality and all adjacent to them according to queen contiguity spatial weights frequently used in spatial statistics.

Most health care centers are located in the largest metropolitan areas both in cities and their vicinity as the suburban inhabitants often utilize health services provided by the institutions located in the inner city. More favorable healthcare availability in metropolitan areas results from large demographic potential, extensive financial resources, and excellent access to specialized medical services, the latter caused by high-rank education provided by medical universities that educate most qualified personnel. Thus, health professionals who obtained rare specializations usually practice in the largest cities. Furthermore, hospital wards with a catchment area encompassing several provinces (e.g. due to the uncommon specialization and rare disease treatment) are located in the largest cities too. Nevertheless, certain areas such as medium-sized towns, especially former province capitals (between 1975 and 1999 Poland was divided into 49 provinces; this period gave an economic boost to provincial capitals), are distinguished by a high-level and numerous medical services. The infrastructure inherited from the period of the People's Republic of Poland contributed to the concentration of health care units in these towns presently. Regional approach demonstrates Śląskie, Łódzkie, Zachodniopomorskie and Podlaskie Provinces as those of the best healthcare availability. Fast pace of changes can be observed in Zachodniopomorskie and Podlaskie Provinces whereas fewer health care units per 10 thousands inhabitants can be found in Kujawsko-Pomorskie, Pomorskie, and Warmińsko-Mazurskie Provinces.

#### **4.1 Primary heathcare**

272 Public Health – Methodology, Environmental and Systems Issues

healthcare utilization by the patients, who are now allowed to choose health professional and health care institution wherever they wish including locations outside their area of residence. Irrespectively, the system present in Poland is now criticized as the individual contributions remain involuntary, do not depend on individual decisions and the insured have no influence

Presently, changes in Polish healthcare system to some extent follow principals of the Bismarck's model as gradual decentralization of management and financing have been implemented since the early 1990s. From economic and administrative viewpoints this decentralization is reflected by the liberalization of healthcare market, which results in gradual replacements of state health care units by municipal and non-public entities. Local governments (provinces, counties and municipalities) are now allowed to found and manage health care units what is permitted by the *Act of 30th September 1991 on Health Care Units*. Four forms of health care units are mentioned in this act with respect to their ownership and financial system: independent public health care centers (SPZOZ), budget entity, self-governmental budgetary establishment, and non-public health care unit (NZOZ). Decentralization of financial system and transformation of health care units into independent public health care centers began in 1998 and 1999 after sickness funds were established. This decentralization was reversed in 2003 as National Health Fund was founded, something that led to concentration of financial resources on a national level. The return to central healthcare financier and insurer was fiercely criticized by the politicians and scientific community; thus regional branches of NFZ were established, each responsible for healthcare financing and insurances in one province (but still operating under the Ministry of Health). Consequently, a lack of state-independent insurer and provider of healthcare limits patients' choice, which plainly contradicts the Bismarck's model principals. Contrarily to the healthcare financing and insuring, the responsibilities of management and planning in healthcare were imposed on local governments. Unfortunately, local communities were not able to cover increasing expenses and debts which health care units amassed over the years. These debts resulted from operation in accordance with constitutional principle of equal and free access to health services as well as life saving obligations. Moreover, the financial burdens are excavating prompted by the inability to declare bankruptcy by these health care units which are crucial for local population in order

**4. Spatial inequalities in the availability of primary and hospital care** 

Legal and administrative characteristics concerning the organization of Polish healthcare system have a direct impact on spatial issues of the essence for researchers in medical geography. From an economic perspective, geographical sciences may lie beneath the premises for allocation of funds in particular regions (in accordance with spatially diverse needs) as well as the distribution of decisive and executive competences in health policy (spatial scale problem – consistency between administrative level and responsibility for health policy goals). From a social perspective, a key issue is to increase accessibility to and availability of medical services for all citizens, particularly the poorer friction of population

Both spatial accessibility and availability of healthcare was radically improved by the enforcement of legal acts that gave non-public entities rights to run healthcare practices as

on the quality of service received (Siwińska et. al., 2008).

to retain overall health security intact.

who reside in peripheral areas.

General practitioner is considered as a key element of primary healthcare in Poland. Individual GP practices were established quite recently – in 1991. These doctors are supposed to perform *gatekeeper's* role that is to provide entrance to the whole healthcare system as a first institution patients refer to. As follows, this role assumes that initial patient-doctor contact begins at general practitioner office (in Poland, these physicians are called family doctors). Theoretically, family doctors ought to possess enough knowledge and experience to cure (or at least assist) the majority of diseases; however they are granted a wide range of administrative competences. Aside from prescriptions, they can issue referrals to other specialists or hospitals and for numerous medical examinations.

Source: Authors' own work based on Central Statistical Office (www.stat.gov.pl).

Fig. 2. The number of medical facilities per 10 thousands inhabitants in Poland in 2004, 2007 and 2010.

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 275

By this means, their medical functions are limited to distribution of prescriptions (most common and easy-to-cure diseases) or a set of referrals when the case is difficult to diagnose. Moreover, appointments aimed at receiving sick leaves are also very common. Therefore, the contemporary general practitioner office can be dubbed as a generator of referrals/hospitalizations and in this way whole sets of these documents can free family doctors from the responsibility to assist in more difficult and atypical cases. The original idea of family doctor assumes long-term and permanent contact between patients and health professional. The family doctor should be acquainted with patients' medical record and earn his trust through the years. However, frequent rotation of health professionals working in health care centers (mainly these located in cities) abides these goals from being obtainable. In sparsely populated rural areas, health services are usually provided by one general practitioner and a nurse. Moreover, in certain localities only branches of public health care centers are located and services are provided only during a few hours

The foundation of healthcare model based on family doctor in Poland makes treatment more accessible and receivable everywhere, though the free-of-charge care can be obtained in both public and non-public health care unit, provided that the latter made a contract with the National Health Fund. The free choice of family doctor does not change the fact that the majority of patients are registered at general practitioner offices located in the vicinity of their places of residence. This solution is convenient for patients, especially when the change of residence in Poland does not require obligatory registration. Nevertheless, more changes of family doctor than twice a year requires from patient 80 PLN fee, unless this change is caused by a permanent migration to another place of residence, involuntary obligation, or results from other circumstantial conditions beyond patient's control. Patients who wish to change their primary care provider have to declare this will on a proper form. According to the National Health Fund a maximum number of patients registered to one general practitioner should not exceed 2750 (in other words: there should be at least 3.64 family doctors per 10 thousand inhabitants). However, the number of family doctors in Poland amounted to 10 206 in 2010, that is 2.67 family doctors per 10 thousand inhabitants (The Polish Chamber of Physicians and Dentists, www.nil.org.pl). This implies that there is rather

The distribution of primary health care units in Poland shows significant spatial diversity among provinces and counties (Figure 3). As for geographical factors of healthcare in different regions, this pattern does not directly refer to the level of socio-economic development, population distribution or historical background. Conversely, a noticeable diversity within certain regions can be observed. Among five provinces with the highest number of health care institutions per 10 thousand inhabitants there are regions of completely different background and socio-economic characteristics. Some diverse as far as primary healthcare availability is concerned counties are adjacent to each other. For example, they include counties located to the west of Poland (territories that used to be a part of Germany before World War II) in Zachodniopomorskie Province as well as less developed regions located to the east (so-called Eastern Wall) represented by Lubelskie Province. Similar diversity can be observed among provinces with the lowest availability of GP offices, e.g. Wielkopolskie and Podlaskie. Whereas the former can be considered as an area of economic prosperity, the latter is rather underdeveloped and experiences

a shortfall than excess of general practitioners in the country.

per day.

Source: Authors' own work based on Central Statistical Office (www.stat.gov.pl).

and 2010.

Fig. 2. The number of medical facilities per 10 thousands inhabitants in Poland in 2004, 2007

By this means, their medical functions are limited to distribution of prescriptions (most common and easy-to-cure diseases) or a set of referrals when the case is difficult to diagnose. Moreover, appointments aimed at receiving sick leaves are also very common. Therefore, the contemporary general practitioner office can be dubbed as a generator of referrals/hospitalizations and in this way whole sets of these documents can free family doctors from the responsibility to assist in more difficult and atypical cases. The original idea of family doctor assumes long-term and permanent contact between patients and health professional. The family doctor should be acquainted with patients' medical record and earn his trust through the years. However, frequent rotation of health professionals working in health care centers (mainly these located in cities) abides these goals from being obtainable. In sparsely populated rural areas, health services are usually provided by one general practitioner and a nurse. Moreover, in certain localities only branches of public health care centers are located and services are provided only during a few hours per day.

The foundation of healthcare model based on family doctor in Poland makes treatment more accessible and receivable everywhere, though the free-of-charge care can be obtained in both public and non-public health care unit, provided that the latter made a contract with the National Health Fund. The free choice of family doctor does not change the fact that the majority of patients are registered at general practitioner offices located in the vicinity of their places of residence. This solution is convenient for patients, especially when the change of residence in Poland does not require obligatory registration. Nevertheless, more changes of family doctor than twice a year requires from patient 80 PLN fee, unless this change is caused by a permanent migration to another place of residence, involuntary obligation, or results from other circumstantial conditions beyond patient's control. Patients who wish to change their primary care provider have to declare this will on a proper form. According to the National Health Fund a maximum number of patients registered to one general practitioner should not exceed 2750 (in other words: there should be at least 3.64 family doctors per 10 thousand inhabitants). However, the number of family doctors in Poland amounted to 10 206 in 2010, that is 2.67 family doctors per 10 thousand inhabitants (The Polish Chamber of Physicians and Dentists, www.nil.org.pl). This implies that there is rather a shortfall than excess of general practitioners in the country.

The distribution of primary health care units in Poland shows significant spatial diversity among provinces and counties (Figure 3). As for geographical factors of healthcare in different regions, this pattern does not directly refer to the level of socio-economic development, population distribution or historical background. Conversely, a noticeable diversity within certain regions can be observed. Among five provinces with the highest number of health care institutions per 10 thousand inhabitants there are regions of completely different background and socio-economic characteristics. Some diverse as far as primary healthcare availability is concerned counties are adjacent to each other. For example, they include counties located to the west of Poland (territories that used to be a part of Germany before World War II) in Zachodniopomorskie Province as well as less developed regions located to the east (so-called Eastern Wall) represented by Lubelskie Province. Similar diversity can be observed among provinces with the lowest availability of GP offices, e.g. Wielkopolskie and Podlaskie. Whereas the former can be considered as an area of economic prosperity, the latter is rather underdeveloped and experiences

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 277

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl) and

Fig. 4. The rural counties in I (low) and V (high) quintile in general practitioner availability as measured by offices per 10 thousand inhabitants or I (low) and V (high) quintile in population density in 2010 (encircled counties were selected for further local analyses).

a. Tucholski County (Kujawsko-Pomorskie Province – orange color) placed in the I

b. Górowski County (Dolnośląskie Province – green color) placed in the V quintile in GP

c. Olkuski County (Małopolskie province – red color)placed in I quintile of GP offices

d. Ropczycko-Sędziszowski County (Podkarpackie Province – blue color) placed in V quintile of GP offices availability and V quintile of population density (Figure 5). The example of Tucholski County shows that spatial accessibility to family doctors is constrained only in sparsely populated areas of the low GP offices availability. Within Tucholski County there are numerous small villages located further than 10 km from the nearest GP office, although most are located within the range of 3 km. Such areas are rather rare in Poland and can be found only in the northern part of the country and in some municipalities located in the Carpathians. Among the counties with high population density spatial accessibility is comparable for both the areas of low and high GP offices availability. Nonetheless, the high concentration of GP offices in towns elevates the indicator for the whole county (Ropczycko-Sędziszowski County). The areas characterized by high density of population and considerable number of GP offices are

quintile in GP offices availability and population density

offices availability and I quintile of population density

availability and V quintile of population density

Central Statistical Office data (www.stat.gov.pl).

The selected areas include:

located only in southern Poland.

depopulation processes. Such diversity results from different models of healthcare organization and strategies implemented by local governments, but also spatial inequalities inherited after the Communistic times. In the areas of worse availability of primary care, family practices are probably larger as measured by the number of physicians in service. For this reason, significant differences can be observed between cities with county status (the largest towns and cities) and land counties. The majority of land counties are characterized by favorable accessibility of GP offices, what stems from higher population density and concentration medical facilities as a part of larger health care centers*.* As for land counties more GP offices per 10 thousand inhabitants are present in those with the lowest population number and density. Despite theoretically lower demand for medical services in these areas the network of GP offices is left uninterrupted what minimizes the distance between patient residence and family doctor.

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl) and Central Statistical Office data (www.stat.gov.pl).

Fig. 3. The number of general practitioner offices per 10 thousand inhabitants in Polish counties and provinces in 2010.

Analyses of primary healthcare on a regional level hide local disparities in health care accessibility reflected by the distribution of population. In order to detect conditions that underlie the availability of primary healthcare four types of areas (counties) in the whole country are singled out. The prerequisite for this selection is a simple spatial typology created according to the number of GP offices per 10 thousand inhabitants and population density (Figure 4).

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl) and Central Statistical Office data (www.stat.gov.pl).

Fig. 4. The rural counties in I (low) and V (high) quintile in general practitioner availability as measured by offices per 10 thousand inhabitants or I (low) and V (high) quintile in population density in 2010 (encircled counties were selected for further local analyses).

The selected areas include:

276 Public Health – Methodology, Environmental and Systems Issues

depopulation processes. Such diversity results from different models of healthcare organization and strategies implemented by local governments, but also spatial inequalities inherited after the Communistic times. In the areas of worse availability of primary care, family practices are probably larger as measured by the number of physicians in service. For this reason, significant differences can be observed between cities with county status (the largest towns and cities) and land counties. The majority of land counties are characterized by favorable accessibility of GP offices, what stems from higher population density and concentration medical facilities as a part of larger health care centers*.* As for land counties more GP offices per 10 thousand inhabitants are present in those with the lowest population number and density. Despite theoretically lower demand for medical services in these areas the network of GP offices is left uninterrupted what minimizes the distance between patient

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl) and

Fig. 3. The number of general practitioner offices per 10 thousand inhabitants in Polish

Analyses of primary healthcare on a regional level hide local disparities in health care accessibility reflected by the distribution of population. In order to detect conditions that underlie the availability of primary healthcare four types of areas (counties) in the whole country are singled out. The prerequisite for this selection is a simple spatial typology created according to the number of GP offices per 10 thousand inhabitants and population

Central Statistical Office data (www.stat.gov.pl).

counties and provinces in 2010.

density (Figure 4).

residence and family doctor.


The example of Tucholski County shows that spatial accessibility to family doctors is constrained only in sparsely populated areas of the low GP offices availability. Within Tucholski County there are numerous small villages located further than 10 km from the nearest GP office, although most are located within the range of 3 km. Such areas are rather rare in Poland and can be found only in the northern part of the country and in some municipalities located in the Carpathians. Among the counties with high population density spatial accessibility is comparable for both the areas of low and high GP offices availability. Nonetheless, the high concentration of GP offices in towns elevates the indicator for the whole county (Ropczycko-Sędziszowski County). The areas characterized by high density of population and considerable number of GP offices are located only in southern Poland.

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 279

not in urban centers with a high concentration of healthcare resources, but in sparsely

These inequalities in access to hospitals could have been mitigated alongside with the implementation of legislative Act on Network of Hospitals. The project of this legislation propounded a set of criteria to decide which institutions should be incorporated into Polish hospital network (hospitals that do not fulfill the criteria were either to be shut down or privatized). Among other things, these conditions included the optimal number of hospital beds with a regard to geographical distribution of medical resources. So-called regional adjustment plans were supposed to take into account "*the directions of hospital infrastructure development, demographic and epidemiologic determinants and their changes in time, the structure and length of hospitalizations*". Besides, these plans had to include the provision of sufficient accessibility to high-quality health services. As follows, according to the guidelines provided by the Ministry of Health a hospital must have at least 150 beds and the minimal number of beds per 10 thousand inhabitants should not be less than 40 (*The projected Act on Network of Hospitals, 2007*). Aforementioned project was vetoed in January 2009 due to political reasons and strong criticism from local governments (particularly controversial was the issue of closing down small hospitals). Though turned down, this project showed a great importance of geographic aspects concerning hospital network and its organization. No sooner than 15 years after transformation did the decision makers notice a need to fix the

populated areas, where there is one large hospital (Ruszkowski, 2010).

unfavorable distribution of tertiary healthcare in Poland.

psychiatric hospitals and facilities located in health resorts).

Statistical Office data (www.stat.gov.pl).

Source: Authors' own work based on Healthcare Register (www.rejestrzoz.gov.pl) and Central

Fig. 6. The number of hospital beds per 10 thousands inhabitants in 2000 and 2010 (without

Currently, an increase in the number of hospital beds Poland is observed, what was not the issue shortly after socio-economic transformation in the 1990s. Figure 6 shows some mosaiclike disparities across Polish counties as measured by hospital beds per 10 thousand inhabitants. In many counties this indicator falls below the recommended 40 beds per 10 thousand inhabitants. The regions "abundant" with hospital beds include Dolnośląskie and Śląskie Provinces. Urban areas, especially these of the largest Polish cities, possess relatively high number of hospital beds, which rarely fall below 60 beds per 10 thousand patients. This

Source: Authors' own work.

Fig. 5. Primary healthcare in four counties of different population density and GP offices availability in 2010.

On the other hand, many sparsely populated counties have a high GP offices availability, what is particularly prominent in Zachodniopomorskie Province. The example of Górowski County demonstrates that, unless there are villages without family doctor offices in operation, the majority of such villages are located within 5 km distance from the nearest GP office. The opposite situation exists in Olkuski County, where larger villages are located relatively far from GP offices and some concentration of health care institutions is observed only in towns and adjoining villages. Interestingly, within the counties of low availability of GP offices and high population density fall some suburban areas of the biggest cities in Poland such as: Poznań, Warszawa, Gdańsk and Kraków. This proves that inhabitants of metropolitan areas utilize the healthcare services in the central city, what decreases the demand for GP offices in suburban areas.

#### **4.2 Hospital healthcare**

Inappropriate spatial and organizational structure of Independent Public Health Care Centers (SPZOZ) is believed to underpin the inequalities in Polish inpatient healthcare (Ruszkowski, 2008). Undoubtedly, higher actual net needs (in this case the number of hospitalized patients) concern large urban centers, what directly results from their demographic potential. However, healthcare needs are considered to be the best satisfied

Fig. 5. Primary healthcare in four counties of different population density and GP offices

On the other hand, many sparsely populated counties have a high GP offices availability, what is particularly prominent in Zachodniopomorskie Province. The example of Górowski County demonstrates that, unless there are villages without family doctor offices in operation, the majority of such villages are located within 5 km distance from the nearest GP office. The opposite situation exists in Olkuski County, where larger villages are located relatively far from GP offices and some concentration of health care institutions is observed only in towns and adjoining villages. Interestingly, within the counties of low availability of GP offices and high population density fall some suburban areas of the biggest cities in Poland such as: Poznań, Warszawa, Gdańsk and Kraków. This proves that inhabitants of metropolitan areas utilize the healthcare services in the central city, what decreases the

Inappropriate spatial and organizational structure of Independent Public Health Care Centers (SPZOZ) is believed to underpin the inequalities in Polish inpatient healthcare (Ruszkowski, 2008). Undoubtedly, higher actual net needs (in this case the number of hospitalized patients) concern large urban centers, what directly results from their demographic potential. However, healthcare needs are considered to be the best satisfied

Source: Authors' own work.

demand for GP offices in suburban areas.

**4.2 Hospital healthcare** 

availability in 2010.

not in urban centers with a high concentration of healthcare resources, but in sparsely populated areas, where there is one large hospital (Ruszkowski, 2010).

These inequalities in access to hospitals could have been mitigated alongside with the implementation of legislative Act on Network of Hospitals. The project of this legislation propounded a set of criteria to decide which institutions should be incorporated into Polish hospital network (hospitals that do not fulfill the criteria were either to be shut down or privatized). Among other things, these conditions included the optimal number of hospital beds with a regard to geographical distribution of medical resources. So-called regional adjustment plans were supposed to take into account "*the directions of hospital infrastructure development, demographic and epidemiologic determinants and their changes in time, the structure and length of hospitalizations*". Besides, these plans had to include the provision of sufficient accessibility to high-quality health services. As follows, according to the guidelines provided by the Ministry of Health a hospital must have at least 150 beds and the minimal number of beds per 10 thousand inhabitants should not be less than 40 (*The projected Act on Network of Hospitals, 2007*). Aforementioned project was vetoed in January 2009 due to political reasons and strong criticism from local governments (particularly controversial was the issue of closing down small hospitals). Though turned down, this project showed a great importance of geographic aspects concerning hospital network and its organization. No sooner than 15 years after transformation did the decision makers notice a need to fix the unfavorable distribution of tertiary healthcare in Poland.

Source: Authors' own work based on Healthcare Register (www.rejestrzoz.gov.pl) and Central Statistical Office data (www.stat.gov.pl).

Fig. 6. The number of hospital beds per 10 thousands inhabitants in 2000 and 2010 (without psychiatric hospitals and facilities located in health resorts).

Currently, an increase in the number of hospital beds Poland is observed, what was not the issue shortly after socio-economic transformation in the 1990s. Figure 6 shows some mosaiclike disparities across Polish counties as measured by hospital beds per 10 thousand inhabitants. In many counties this indicator falls below the recommended 40 beds per 10 thousand inhabitants. The regions "abundant" with hospital beds include Dolnośląskie and Śląskie Provinces. Urban areas, especially these of the largest Polish cities, possess relatively high number of hospital beds, which rarely fall below 60 beds per 10 thousand patients. This

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 281

uniformly throughout the country and across medical specialties. In 2009, about 75% general practitioner offices (max. Wielkopolskie 94%, min. Świętokrzyskie 48%), 82% specialist offices (Wielkopolskie 91%, Świętokrzyskie 70%) and 45% of general and specialized hospital facilities (Dolnośląskie 68%, Świętokrzyskie 24%) belonged to commercial entities. Changes in ownership structure are clearly reflected by *inverse care law* – a concept developed by Hart in 1971 (Hart, 1971). This law assumes that the availability of good medical care tends to vary inversely with the need of the population served. In other words, financial resources are not allocated in conjunction with the distribution of needs, but rather along with the distribution of resources. Location and quality of health services offered by non-public health care units become market-oriented and favor more affluent regions and social groups. The poorer patients are not as attractive customers as other inhabitants despite of higher needs reported by the former. Such situation is most characteristic for the USA – a country with a dominance of private healthcare financed by non-public insurance companies (except for the elderly and low-income groups). This organization of healthcare

Spatial aspects concerning privatization and directions of ownership changes are presented on the example of all medical facilities, general practitioner offices and hospitals. Figure 7 depicts transformations of public health care units into non-public entities for 2004, 2007 and 2010. According to the *Act of 30th September 1991 on Health Care Units* non-public health care units can be founded by: churches and religious groups, employers, foundations, trade unions, professional or other associations, other national or foreign legal or natural persons

Changes in health care unit ownership structure evidenced by an increase of non-public facilities progresses rapidly in the whole country. In small rural communities private entities get complete or partial hold of municipal health centers followed by a contract drew with the National Health Fund. As for primary care, almost all services remain refunded by the NFZ, but in case of specialist offices some services are paid. Thus, in many areas the spatial accessibility of healthcare increases as branch offices are more likely to be opened by commercialized health care units, but this happens selectively (usually in the largest villages). Private medical offices in large cities remain market-oriented and operate under great competition. Therefore, firms locate their offices is strategic locations usually in the vicinity of potential clients e.g. in large shopping centers. A good example of this is Enel-Med healthcare provider which possesses offices in the biggest shopping malls across the country: Arkadia and Blue City (Warsaw), Galeria Krakowska (Cracow), Arkady Wrocławskie (Wrocław), Manufaktura (Łódź) and Kupiec Poznański (Poznań). Some of the services offered by private healthcare firms are not refunded by the NFZ, so, in spite of improved spatial accessibility, their affordability is limited. In less populous urban areas and towns medical offices are often located in private houses what is rare in the bigger cities (except for dental offices). Unfortunately, in spite of rising market-oriented availability the possibilities to utilize health services are constrained by too high demand and annual limitations for certain services and their refund by the NFZ. As a consequence, long lines and wait times to the physicians are observed what discourages the patients and attracts them to utilize paid services (frequent in specialist offices). Free healthcare can be utilized without a need to wait after private (and paid) consultation – such practices are not

Whiteis (1997) calls "*corporate-sponsored medicine*".

or non-legal partnerships.

uncommon.

surplus is utilized by the population of counties located in suburban zones where there are either no hospitals or some small unspecialized institutions. Counties located along the province boundaries have considerably lower number of hospital beds. Importantly, one large hospital, even though located in a small county, may have a broad catchment area. As a consequence, adjoining counties have fewer hospital beds per 10 thousand inhabitants. This attests to the inequality in spatial distribution of tertiary care in Poland. This problem particularly concerns large institutions, sizes of which often exceed local demand. Simultaneously, such hospital catchment areas become large and attract patients residing in more distant areas with no at all or only small general hospitals. The concentration of hospital resources in one place is perceived as profitable and socially approvable when these institutions offer a wide variety of specialized health services and operate as centers of scientific research and new technologies (Ferguson et al., 1997). The selective concentration of specialized hospital infrastructure in 1960s and 1970s in Poland resulted in too many hospital beds which cannot be explained neither by local demand nor accessibility of qualified personnel.

In 2000, there were 49.9 hospital beds per 10 thousand inhabitants in Poland. During next ten years this proportion increased to 55.2. However, the observed number did not always increase in accordance with in the improvements in accessibility of stationary health care and across particular medical specializations. The research conducted by the Centre of Health Care Organization and Economics by the end of 1990s showed significant inequalities in spatial distribution of long-term care beds and the necessity to increase their number significantly (Kozierkiewicz, 2008). Results of the study conducted by the National Institute of Hygiene indicated that the greatest excess of hospital beds concerns such wards as: ophthalmology, otolaryngology, pediatric surgery, obstetrics and gynecology, and especially in the west of Poland. On the other hand, shortages of hospital beds can be found on rehabilitation, hematological and oncological wards (Goryński et al., 2006). Aforementioned study was questioned by Murkowski (2007), who argues that the largest surplus of hospital beds is observed in Śląskie, Łódzkie, Lubelskie and Podlaskie Provinces, so in the central and eastern Poland. This finding is more or less congruent with the results presented in the Figure 6. On the other hand, reflections presented by Krzanowski (2007) are somewhat controversial and reveal alleged influence of healthcare system on hospital morbidity. As pointed out by this author, regional differences in hospitalization rates for certain diseases are well explained by the available number of hospital beds. Medical geographers with a sufficient experience and skills in finding spatial relations between the needs and supplies in many socio-economic domains should be included into researchers exploring this phenomenon. The application of causative and consecutive analyzes would help find solutions for Krzanowski's concern that is to tell whether and in which regions the statement "*if there are spare beds, there will also be patients*" can be true.

#### **5. Commercialization and privatization in Polish healthcare**

Commercialization and privatization in Polish healthcare are considered as key determinants of spatial and non-spatial availability to primary and hospital care in the recent years. From a spatial perspective these processes lead to an increase in the number of medical facilities, however commercialized healthcare limit affordability for both insured and uninsured citizens as some services are paid. Commercialization does not occur

surplus is utilized by the population of counties located in suburban zones where there are either no hospitals or some small unspecialized institutions. Counties located along the province boundaries have considerably lower number of hospital beds. Importantly, one large hospital, even though located in a small county, may have a broad catchment area. As a consequence, adjoining counties have fewer hospital beds per 10 thousand inhabitants. This attests to the inequality in spatial distribution of tertiary care in Poland. This problem particularly concerns large institutions, sizes of which often exceed local demand. Simultaneously, such hospital catchment areas become large and attract patients residing in more distant areas with no at all or only small general hospitals. The concentration of hospital resources in one place is perceived as profitable and socially approvable when these institutions offer a wide variety of specialized health services and operate as centers of scientific research and new technologies (Ferguson et al., 1997). The selective concentration of specialized hospital infrastructure in 1960s and 1970s in Poland resulted in too many hospital beds which cannot be explained neither by local demand nor accessibility of

In 2000, there were 49.9 hospital beds per 10 thousand inhabitants in Poland. During next ten years this proportion increased to 55.2. However, the observed number did not always increase in accordance with in the improvements in accessibility of stationary health care and across particular medical specializations. The research conducted by the Centre of Health Care Organization and Economics by the end of 1990s showed significant inequalities in spatial distribution of long-term care beds and the necessity to increase their number significantly (Kozierkiewicz, 2008). Results of the study conducted by the National Institute of Hygiene indicated that the greatest excess of hospital beds concerns such wards as: ophthalmology, otolaryngology, pediatric surgery, obstetrics and gynecology, and especially in the west of Poland. On the other hand, shortages of hospital beds can be found on rehabilitation, hematological and oncological wards (Goryński et al., 2006). Aforementioned study was questioned by Murkowski (2007), who argues that the largest surplus of hospital beds is observed in Śląskie, Łódzkie, Lubelskie and Podlaskie Provinces, so in the central and eastern Poland. This finding is more or less congruent with the results presented in the Figure 6. On the other hand, reflections presented by Krzanowski (2007) are somewhat controversial and reveal alleged influence of healthcare system on hospital morbidity. As pointed out by this author, regional differences in hospitalization rates for certain diseases are well explained by the available number of hospital beds. Medical geographers with a sufficient experience and skills in finding spatial relations between the needs and supplies in many socio-economic domains should be included into researchers exploring this phenomenon. The application of causative and consecutive analyzes would help find solutions for Krzanowski's concern that is to tell whether and in which regions the

statement "*if there are spare beds, there will also be patients*" can be true.

**5. Commercialization and privatization in Polish healthcare** 

Commercialization and privatization in Polish healthcare are considered as key determinants of spatial and non-spatial availability to primary and hospital care in the recent years. From a spatial perspective these processes lead to an increase in the number of medical facilities, however commercialized healthcare limit affordability for both insured and uninsured citizens as some services are paid. Commercialization does not occur

qualified personnel.

uniformly throughout the country and across medical specialties. In 2009, about 75% general practitioner offices (max. Wielkopolskie 94%, min. Świętokrzyskie 48%), 82% specialist offices (Wielkopolskie 91%, Świętokrzyskie 70%) and 45% of general and specialized hospital facilities (Dolnośląskie 68%, Świętokrzyskie 24%) belonged to commercial entities. Changes in ownership structure are clearly reflected by *inverse care law* – a concept developed by Hart in 1971 (Hart, 1971). This law assumes that the availability of good medical care tends to vary inversely with the need of the population served. In other words, financial resources are not allocated in conjunction with the distribution of needs, but rather along with the distribution of resources. Location and quality of health services offered by non-public health care units become market-oriented and favor more affluent regions and social groups. The poorer patients are not as attractive customers as other inhabitants despite of higher needs reported by the former. Such situation is most characteristic for the USA – a country with a dominance of private healthcare financed by non-public insurance companies (except for the elderly and low-income groups). This organization of healthcare Whiteis (1997) calls "*corporate-sponsored medicine*".

Spatial aspects concerning privatization and directions of ownership changes are presented on the example of all medical facilities, general practitioner offices and hospitals. Figure 7 depicts transformations of public health care units into non-public entities for 2004, 2007 and 2010. According to the *Act of 30th September 1991 on Health Care Units* non-public health care units can be founded by: churches and religious groups, employers, foundations, trade unions, professional or other associations, other national or foreign legal or natural persons or non-legal partnerships.

Changes in health care unit ownership structure evidenced by an increase of non-public facilities progresses rapidly in the whole country. In small rural communities private entities get complete or partial hold of municipal health centers followed by a contract drew with the National Health Fund. As for primary care, almost all services remain refunded by the NFZ, but in case of specialist offices some services are paid. Thus, in many areas the spatial accessibility of healthcare increases as branch offices are more likely to be opened by commercialized health care units, but this happens selectively (usually in the largest villages). Private medical offices in large cities remain market-oriented and operate under great competition. Therefore, firms locate their offices is strategic locations usually in the vicinity of potential clients e.g. in large shopping centers. A good example of this is Enel-Med healthcare provider which possesses offices in the biggest shopping malls across the country: Arkadia and Blue City (Warsaw), Galeria Krakowska (Cracow), Arkady Wrocławskie (Wrocław), Manufaktura (Łódź) and Kupiec Poznański (Poznań). Some of the services offered by private healthcare firms are not refunded by the NFZ, so, in spite of improved spatial accessibility, their affordability is limited. In less populous urban areas and towns medical offices are often located in private houses what is rare in the bigger cities (except for dental offices). Unfortunately, in spite of rising market-oriented availability the possibilities to utilize health services are constrained by too high demand and annual limitations for certain services and their refund by the NFZ. As a consequence, long lines and wait times to the physicians are observed what discourages the patients and attracts them to utilize paid services (frequent in specialist offices). Free healthcare can be utilized without a need to wait after private (and paid) consultation – such practices are not uncommon.

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 283

In 2004, public healthcare units prevailed only in Świętokrzyskie and Kujawsko-Pomorskie Provinces, but in 2010 the majority of healthcare facilities in the whole country were nonpublic. Commercialization in the Polish healthcare first dominated Wielkopolskie Province, where liberal and entrepreneurial attitudes prevail among the local population. Conversely, in Świętokrzyskie and Mazowieckie Provinces left-wing political parties traditionally gain great popularity among traditionally pretentious communities. These parties strive to delay the privatization of healthcare in fear of paid services and undermined health security. Such social attitudes are clearly reflected in election results; therefore more conservative municipal authorities are not likely to foster quick changes in health care unit ownership. This selective commercialization depends on leading political fraction in local governments. Perhaps, low availability and quality of services in some areas make their residents press on local authorities for non-public care irrespective off political affiliations. This factor may be

In primary healthcare commercialization processes occur very fast (Figure 8). In 2004 most counties had more than a half of their general practitioner offices commercialized. In 2010 about 75% of all GP practices belonged to non-public entities. Three separate areas of sizeable prevalence in the proportion of non-public facilities can be demarcated: prosperous and liberal west (Lubuskie and Wielkopolskie Provinces), most industrialized south of population traditionally emigrating to the west, Germany in particular (Śląskie and Opolskie) as well as poor eastern borderland (Lubelskie). On the other hand, Świętokrzyskie Province, the south of Mazowieckie and Łódzkie Provinces are represented by a dominance of people's and left-wing political affiliations; thus comprise a majority of areas with public healthcare offices. In other regions decisions against commercialization depend on specific

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl).

According to some scientific views the most financial problems experienced by hospitals can be easily solved by changing their ownership to join stock or commercial companies (Masiakowski, 2005; Milczarek, 2005; Rój, 2006). This does not mean that the majority of independent public health care centers (mainly hospitals) need to be converted into private

Fig. 8. The share of non-public general practitioner offices in 2004 and 2010

of the essence in the eastern part of the country

local determinants.

Source: Author's own work based on Central Statistical Office (www.stat.gov.pl) Fig. 7. The share of public and commercial healthcare facilities in 2004, 2007 and 2010.

Source: Author's own work based on Central Statistical Office (www.stat.gov.pl)

Fig. 7. The share of public and commercial healthcare facilities in 2004, 2007 and 2010.

In 2004, public healthcare units prevailed only in Świętokrzyskie and Kujawsko-Pomorskie Provinces, but in 2010 the majority of healthcare facilities in the whole country were nonpublic. Commercialization in the Polish healthcare first dominated Wielkopolskie Province, where liberal and entrepreneurial attitudes prevail among the local population. Conversely, in Świętokrzyskie and Mazowieckie Provinces left-wing political parties traditionally gain great popularity among traditionally pretentious communities. These parties strive to delay the privatization of healthcare in fear of paid services and undermined health security. Such social attitudes are clearly reflected in election results; therefore more conservative municipal authorities are not likely to foster quick changes in health care unit ownership. This selective commercialization depends on leading political fraction in local governments. Perhaps, low availability and quality of services in some areas make their residents press on local authorities for non-public care irrespective off political affiliations. This factor may be of the essence in the eastern part of the country

In primary healthcare commercialization processes occur very fast (Figure 8). In 2004 most counties had more than a half of their general practitioner offices commercialized. In 2010 about 75% of all GP practices belonged to non-public entities. Three separate areas of sizeable prevalence in the proportion of non-public facilities can be demarcated: prosperous and liberal west (Lubuskie and Wielkopolskie Provinces), most industrialized south of population traditionally emigrating to the west, Germany in particular (Śląskie and Opolskie) as well as poor eastern borderland (Lubelskie). On the other hand, Świętokrzyskie Province, the south of Mazowieckie and Łódzkie Provinces are represented by a dominance of people's and left-wing political affiliations; thus comprise a majority of areas with public healthcare offices. In other regions decisions against commercialization depend on specific local determinants.

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl).

Fig. 8. The share of non-public general practitioner offices in 2004 and 2010

According to some scientific views the most financial problems experienced by hospitals can be easily solved by changing their ownership to join stock or commercial companies (Masiakowski, 2005; Milczarek, 2005; Rój, 2006). This does not mean that the majority of independent public health care centers (mainly hospitals) need to be converted into private

Primary and Hospital Healthcare in Poland – Organization, Availability and Space 285

The largest proportion of commercialized hospitals between 2004 and 2010 concerned Kujawsko-Pomorskie, Pomorskie and Dolnośląskie Provinces. Usually, one or largest facility was commercialized in one county, thus small disparities within counties contrast with large disparities between them. The latter, though, show a mosaic spatial configuration as a direct consequence of selective processes dependent on either undisputed and quick decisions or social protests and political unwillingness among the decision makers. Nevertheless, faster changed can be observed in western Poland what is comparable to the level of socio-

In this study Polish healthcare system is characterized from spatial and organizational viewpoints. The analyses conducted show considerable regional and local disparities in access to health services across the country. While existing inequalities are evident and allow for delineation of excess/shortage areas as far as health resources are concerned, the evolution of geographical studies should aim at seeking spatial relationships between healthcare resources and population needs. Such approach has been put into practice in the USA health policy. The main purpose of Health Professional Shortage Areas (HPSA) is to identify areas of greater need for health care services and redirect limited healthcare professional resources to people in those areas. This objective is congruent with the geography of healthcare principal that is matching healthcare resources to population needs in time and space. Consequently, some apparent scientific goals also come to the fore. These include more complex cross comparisons between volume and structure of health resources and volume and structure of population needs. Such multivariate analyses ought to be able to provide answers to simple questions i.e. how many hospital beds do we need?; What hospital wards need to be expanded or downsized?; What is the optimal number of general practitioners/ practitioner offices per 10 thousand inhabitants in an area including current

Limited geographic access to primary care in Poland concerns only areas of very low population density, which are not as common as in other European counties. For that reason non-spatial limitations (including financial and legal) should forge ahead when analyzing

This study introduces to the complexities of Polish healthcare legal and administrative foundations and spatial availability with a special regard to difficulties adversely affecting patients' access to healthcare facilities. To conclude, spatial and organizational availability of

a. ineffective and extensive management of healthcare resources during the communistic times, lack of regional and local health policies, system centralization (state

c. transition from budgetary to insurance healthcare model (similar to Bismarck model),

d. increasing number of health care units higher accessibility and availability (much

e. mosaic spatial distribution of hospital care (better availability explained by the

utilization of healthcare facilities (Jones & Moon, 1987; Powell, 1995).

organization, management, planning and financing) b. hospital locations in 1945-1989 unrelated to population needs

contract-based financing of healthcare

proximity to large general hospital)

better in metropolitan areas)

healthcare in Poland are shaped by the following phenomena and processes:

economic development.

health, demographic and economic situation?.

**6. Conclusions** 

properties because they operate with no regard to economic rationality (Jończyk, 2008). Unfortunately, considerable service overproduction and capital intensity (rising needs, new technologies in medicine and pharmacy) combined with simultaneous financial scarcities in municipal budgets led to large indebtedness. This is the main reason why commercialization processes are at issue and worry local and regional authorities as well as politicians. However, ownership changes do not result in a complete lack of control over hospitals as most shares are often hold by public bodies; thus, instead of privatization, the term commercialization better illustrates current transformation in the Polish healthcare (Misińska & Nawara, 2008). These processes are selective and connected with restructuring and reforms in healthcare system, but particularly with vigorous attempts to clear hospitals of liability for debts. The germ of these endeavors was to be *the Act of Regulations of Healthcare Legislations* (so-called healthcare legislation package), which proposed mandatory choice: to convert all public hospitals into commercial companies or pay their debts by public owners (local and regional governments). In 2009, this legislation was vetoed by President Lech Kaczyński, who refused to allow for paid services and put population health security in jeopardy as some unprofitable hospitals could have been shut down in the aftermath of the new code.

Nevertheless, commercialization of healthcare facilities continues, partially fueled by financial aid of so-called *Governmental B Plan*. This plan promises a donation for these governments which commercialize hospital, make over all assets, property and other resources (unless a new owner already possess the resources necessary to run a hospital), and designate the entity that would take over all of the debts amassed. Most frequently, commercialized independent health care centers are converted to limited liability companies with shares held by local or regional governments. In 2004, 6.4% of all hospital beds were owned by non-public entities. In 2010, this indicator increased to 15.5%, so 32.8 thousand hospital beds per 210.8 thousand in the whole Poland belonged to non-public bodies. The spatial depiction of these transformations is presented in the Figure 9.

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl).

Fig. 9. The share of hospital beds in non-public facilities in 2004 and 2010 (without psychiatric and facilities located in health resorts, urban counties are combined with rural except the largest cities).

The largest proportion of commercialized hospitals between 2004 and 2010 concerned Kujawsko-Pomorskie, Pomorskie and Dolnośląskie Provinces. Usually, one or largest facility was commercialized in one county, thus small disparities within counties contrast with large disparities between them. The latter, though, show a mosaic spatial configuration as a direct consequence of selective processes dependent on either undisputed and quick decisions or social protests and political unwillingness among the decision makers. Nevertheless, faster changed can be observed in western Poland what is comparable to the level of socioeconomic development.

### **6. Conclusions**

284 Public Health – Methodology, Environmental and Systems Issues

properties because they operate with no regard to economic rationality (Jończyk, 2008). Unfortunately, considerable service overproduction and capital intensity (rising needs, new technologies in medicine and pharmacy) combined with simultaneous financial scarcities in municipal budgets led to large indebtedness. This is the main reason why commercialization processes are at issue and worry local and regional authorities as well as politicians. However, ownership changes do not result in a complete lack of control over hospitals as most shares are often hold by public bodies; thus, instead of privatization, the term commercialization better illustrates current transformation in the Polish healthcare (Misińska & Nawara, 2008). These processes are selective and connected with restructuring and reforms in healthcare system, but particularly with vigorous attempts to clear hospitals of liability for debts. The germ of these endeavors was to be *the Act of Regulations of Healthcare Legislations* (so-called healthcare legislation package), which proposed mandatory choice: to convert all public hospitals into commercial companies or pay their debts by public owners (local and regional governments). In 2009, this legislation was vetoed by President Lech Kaczyński, who refused to allow for paid services and put population health security in jeopardy as some unprofitable hospitals could have been shut down in the

Nevertheless, commercialization of healthcare facilities continues, partially fueled by financial aid of so-called *Governmental B Plan*. This plan promises a donation for these governments which commercialize hospital, make over all assets, property and other resources (unless a new owner already possess the resources necessary to run a hospital), and designate the entity that would take over all of the debts amassed. Most frequently, commercialized independent health care centers are converted to limited liability companies with shares held by local or regional governments. In 2004, 6.4% of all hospital beds were owned by non-public entities. In 2010, this indicator increased to 15.5%, so 32.8 thousand hospital beds per 210.8 thousand in the whole Poland belonged to non-public bodies. The

spatial depiction of these transformations is presented in the Figure 9.

Source: Authors' own work based on Register of Health Care Units (www.rejestrzoz.gov.pl). Fig. 9. The share of hospital beds in non-public facilities in 2004 and 2010 (without

psychiatric and facilities located in health resorts, urban counties are combined with rural

aftermath of the new code.

except the largest cities).

In this study Polish healthcare system is characterized from spatial and organizational viewpoints. The analyses conducted show considerable regional and local disparities in access to health services across the country. While existing inequalities are evident and allow for delineation of excess/shortage areas as far as health resources are concerned, the evolution of geographical studies should aim at seeking spatial relationships between healthcare resources and population needs. Such approach has been put into practice in the USA health policy. The main purpose of Health Professional Shortage Areas (HPSA) is to identify areas of greater need for health care services and redirect limited healthcare professional resources to people in those areas. This objective is congruent with the geography of healthcare principal that is matching healthcare resources to population needs in time and space. Consequently, some apparent scientific goals also come to the fore. These include more complex cross comparisons between volume and structure of health resources and volume and structure of population needs. Such multivariate analyses ought to be able to provide answers to simple questions i.e. how many hospital beds do we need?; What hospital wards need to be expanded or downsized?; What is the optimal number of general practitioners/ practitioner offices per 10 thousand inhabitants in an area including current health, demographic and economic situation?.

Limited geographic access to primary care in Poland concerns only areas of very low population density, which are not as common as in other European counties. For that reason non-spatial limitations (including financial and legal) should forge ahead when analyzing utilization of healthcare facilities (Jones & Moon, 1987; Powell, 1995).

This study introduces to the complexities of Polish healthcare legal and administrative foundations and spatial availability with a special regard to difficulties adversely affecting patients' access to healthcare facilities. To conclude, spatial and organizational availability of healthcare in Poland are shaped by the following phenomena and processes:


Primary and Hospital Healthcare in Poland – Organization, Availability and Space 287

Kearns R. Moon G., 2002, *From medical to health geography: novelty, place and theory after a* 

Kozierkiewicz A., 2008, *Koło ratunkowe dla szpitali. Od doświadczeń do modelu restrukturyzacji*,

Malczewski J., 1989, *Optymalizacja obszarów obsługi placówek podstawowej ochrony zdrowia*,

Masiakowski A., 2005, *Prywatyzacja w ochronie zdrowia*, Zdrowie Publiczne 115, 2, pp. 252-

Mayer, J. D., 1982, *Relation between two traditions of medical geography: health system planning and geographical epidemiology*, Progress in Human Geography, 6, pp. 216-230. Mazurkiewicz L., 1994, *Czy geografia człowieka powinna zajmować się problematyką zdrowia*,

Michalski T., 1999, *Nowe nurty w światowej i polskiej geografii medycznej*, Kwartalnik

Milczarek M., 2006, *Warunki ekonomiczno-finansowe działalności i rozwoju szpitali*. *Perspektywy i* 

Millard F., 1995*, Changes in the health care system in post-communist Poland*, Health & Place 1,

Misińska B., Nawara P., 2008, *Publiczna i prywatna własność w systemie ochrony zdrowia w* 

Ministerstwo Zdrowia, 2006, *Wskaźniki do tworzenia projektu tworzenia sieci szpitali z* 

Parr, H., 2003, *Medical geography: Care and caring*, Progress in Human Geography, 27, 2, pp.

*The projected act of Network of Hospitals, (Projekt ustawy o krajowej sieci szpitali)*, Ministerstwo

Penchansky R., Thomas J.W., 1981, *The Concept of Access*, Medical Care 19, 2, pp. 127-140. Powell M., 1995, *On the outside looking in: medical geography, medical geographers, and access to* 

Rosenberg M. W., *Medical or health geography?: populations, peoples and places*, International

Portsmouth, UK. Social Science & Medicine 46, pp. 627–30. Murkowski M., 2007, *W sieci niekompetencji*, Menedżer Zdrowia, 4/2007, pp. 21-24.

Zdrowia, available on the Ministry of Health website

*health care*, Health&Place, Vol. 1, No. 1., pp. 41-50. Register of Healthcare Units official website – www.rejestrzoz.gov.pl.

Journal of Population Geography, 4, 1998, pp. 211-226

rm\_17052007.pdf, Access: 12/17/2010.

*niezbędne działania*, Polityka Zdrowotna, t. 3, Instytut Polityki Ochrony Zdrowia

*kontekście form organizacyjno-prawnych prowadzenia działalności medycznej*, [w:] Ryć K., Skrzypczak Z. (Ed.), *Ochrona zdrowia i gospodarka – mechanizmy rynkowe a regulacje publiczne*, Wydawnictwo Naukowe Wydziału Zarządzania Uniwersytetu

*elementami analizy sytuacji demograficznej i stanu zdrowia ludności*, Materiał przygotowany dla Ministra Zdrowia przez Państwowy Zakład Higieny na podstawie danych Centrum Informacyjnych Ochrony Zdrowia i Państwowego Zakładu Higieny dotyczących infrastruktury szpitali i ich działalności, Warszawa. Moon G., Gould M. and Jones K., 1998, *Seven up – refreshing medical geography: an introduction* 

*to selected papers from the Seventh International Symposium in Medical Geography*,

website:http://www.mz.gov.pl/wwwfiles/ma\_struktura/docs/u\_siec\_szpitali\_ke

*decade of change*, Progress of Human Geography, 26, 5, pp. 605-625.

Krzanowski M., 2007, *Są łóżka, będą i chorzy…*, Rynek Zdrowia 4/2007, pp. 48-49.

Przegląd Geograficzny, T. LXI, z. 1-2, pp. 23-31.

Przegląd Geograficzny, t. LXVI, z. 1-2, pp. 191-195.

Termedia, Warszawa.

Geograficzny, 4, 12, pp. 85–89.

3, pp. 179-188.

212-221.

przy Uniwersytecie Medycznym, pp. 7-9.

Warszawskiego, Warszawa, pp. 335-344.

253.


#### **7. References**


f. increasing needs along with advancements in medicine and pharmacy as well as better

g. various quality of hospital services linked to the following dilemma: does contemporary hospital heal or perform contracts? A quest for balance between money

h. the role of the general practitioner: limited in treatment, but major in administration (sick leaves, prescriptions, referrals); organizational and spatial access impeded in case

i. threats of hospital privatization and healthcare security of citizens, declining role of

j. faster ownership change in the west of Poland parallel to rising socio-economic

Chawla M., Berman P., Windak A., Kulis M., *Provision of ambulatory health services in Poland: a* 

Curtis S., Malczewski J., 1990, *Planowanie przestrzennej alokacji wydatków na ochronę zdrowia w* 

Dziubińska-Michalewicz M., 1994, *Sektor prywatny w opiece zdrowotnej, wyniki badań ankietowych*, Antidotum - Zarządzanie w Opiece Zdrowotnej, 12, pp. 27-34. Ferguson B., Sheldon T.A., Posnett J., (eds.), 1997, *Concentration and Choice in Healthcare*, FT

Jones D. R., Moon G., 1987, *Health, Disease and Society*, London, Routledge and Kegan Paul. Jończyk J., 2008, Aspekty *prywatyzacji szpitala*, Praca i Zabezpieczenie Społeczne, 7, pp. 2-7. Joseph, A.E., Phillips, D.R., *Accessibility and Utilization - Geographical Perspectives on Health* 

Haynes R., Lovett A., Sunnenberg G., 2003, *Potential accessibility, travel time and consumer* 

Goryński P., Wojtyniak B., Kuszewski K., 2006*, Ile potrzeba nam łóżek szpitalnych* – *załącznik do* 

Grochowski M., 1988, *Rejonizacja służby zdrowia a dostępność usług medycznych*, Rozwój

Guagliardo M.F., 2004, *Spatial accessibility of primary care: concepts, methods and Challenges*,

Kaczmarek T., Marcinkowski J. T., Zysnarska M., Maksymiuk T., Majewicz A., 2007,

Kaser M., 1976, *Health care in the Soviet Union and Western Europe*, Croom Helm Limited,

*choice: geographical variations in general medical practice registration in Eastern England*,

Regionalny, Rozwój Lokalny, Samorząd Terytorialny 15, Uniwersytet Warszawski,

*Nierówności społeczne w dostępie do zdrowia*, Problemy Higieny i Epidemiologii, 88, 3,

*Care Delivery*, Happer & Row Publishers, New York, 1984.

Environment and Planning A, Vol. 35, pp. 1733-1750.

*projektu ustawy o sieci szpitali*, Menedżer Zdrowia 9/2006.

Wydział Geografii i Studiów Regionalnych, Warszawa.

International Journal of Health Geographies 3, 3. pp. 1-13.

Hart, J., *The Inverse Care Law*, The Lancet, 297, 1971, pp. 405-412.

*Anglii i w Polsce - zarys badań porównawczych*, [w:] Smoleń M. (Ed.), *Teoria i praktyka organizacji ochrony zdrowia. Przestrzenne planowanie finansowe opieki zdrowotnej. Elementy teorii. Próba praktycznych rozwiązań*, Instytut Medycyny Pracy, Łódź, pp.

small hospitals, even though some may be important for peripheral areas

*case study from Krakow*, Social Science & Medicine, 58, pp. 227-235.

availability of healthcare facilities

of secondary healthcare

**7. References** 

63-81.

Healthcare, London.

pp. 259-266.

London.

saving, debt reduction and patient needs

development and liberal attitudes among the locals


**13** 

*Brazil* 

**Planning Incorporation** 

*Biomedical Engineering Institute,* 

Francisco de Assis S. Santos and Renato Garcia

*Federal University of Santa Catarina, Florianópolis,* 

**of Health Technology into Public Health Center** 

The incorporation process of Health Technology (HT), particularly, Medical Equipment(s) (ME) encompasses all activities ranging from purchasing, renting, leasing or exchanging, technology assessment, planning and identification of needs, installation, technical rehearsals, calibration, users' training etc. The incorporation process also includes prediction of technology use for ascertaining if what has been planned can be realized, and for aiding

According to Wang (2009), the incorporation process of ME can be divided into two phases: planning and acquisition. The planning phase includes assessment of needs and impacts, and costs and benefits of ME after auditing the existing resources. The data collected during auditing and assessment should be established and converted into a technology incorporation plan, which might guide future investments. The second phase relies on the selection and acquisition of products that are appropriate to a certain application and environment. Purchasing options, such as leasing, lending and the revenue sharing models,

Health systems must be built in blocks in order to inform the financing policies, human resources, information, service aid, management and health technology. The interrelations and interactions among these blocks constitute a system. If any of these is lacking, the health system cannot work on the level needed to improve public health. Each block has its own organizational and political challenges. This chapter will discuss the health technology block, considering ME as the essential tool to public health (WHO,

Technology in health service aid is indispensable, even in the most remote and low-resource areas. Drugs, implants, disposable products and medical equipment are the main items that contributed to the progress of health care in the last century, as compared with that during the preceding thousands years. Unfortunately, technology also adds significantly to the fast and ever-growing health costs. Within this context the ME stand for relevant costs to the health system and sometimes under low and limited resources, besides of many medical

future incorporations (World Health Organization [WHO], 2011a).

procedures being totally dependable of technological resources.

**1. Introduction**

should always be considered.

2007; WHO, 2009).


### **Planning Incorporation of Health Technology into Public Health Center**

Francisco de Assis S. Santos and Renato Garcia *Biomedical Engineering Institute, Federal University of Santa Catarina, Florianópolis,* 

*Brazil* 

#### **1. Introduction**

288 Public Health – Methodology, Environmental and Systems Issues

Rój J., 2006, *Forma organizacyjno-prawna a gospodarka finansowa szpitala*, [w:] Węgrzyn M.,

Ruszkowski J, 2008, *Polski system zdrowotny – socjalizm w rynkowym otoczeniu*, [w:] Ryć K.,

Ruszkowski J., 2010, *Zwiększenie bezpieczeństwa zdrowotnego*, ekspertyza finansowana ze

Siwińska V., Brożyniak J., Iłżecka I., Jarosz M. J., Orzeł Z., 2008*, Modele systemów opieki* 

*Świadczenia opieki zdrowotnej finansowane ze środków publicznych*, Vademecum issued by

Unal E., Chen S.E., Waldorf B.S., 2007, *Spatial accessibility of health care in Indiana*, Purdue

*The Act of 28th October 1948 on Collective Health Care Centers and Planned Economy in Healthcare* 

*The Act of 30th September 1991 on Health Care Units* as published in *Dziennik Ustaw* No. 220,

*The Act of 6 th November 2008 on Code Indroducing Healthcare Legislations, Presidential veto -* 

Wang, F. and Luo, W., 2005, *Assessing spatial and nonspatial factors for healthcare access: towards* 

Whiteis D. G., 1997, *Unhealthy cities: corporate medicine, community economic underdevelopment and public health*, International Journal of Health Services, 27, pp. 227-242.

*an integrated approach to defining health professional shortage areas*, Health & Place, 11,

 (http://orka.sejm.gov.pl/proc6.nsf/ustawy/294\_u.htm), Access: 03/14/2011. *The Act of Regulations of Healthcare Legislations, vetoed by President Lech Kaczyński in 2009. The Constitution Of The Republic Of Poland of 2nd April, 1997 as published in Dziennik Ustaw No.* 

The Polish Chamber of Physicians and Dentists official website - www.nil.org.pl

The Central Statistical Office Local Databank website - www.stat.gov.pl

National Health Fund, National Health Fund, Poland, 2011.

University Working Papers, West Lafayette, paper nr 07-07.

*wprowadzające ustawy z zakresu ochrony zdrowia),*

*sukcesu*, Prace naukowe AE Wrocław, pp. 53-58.

Warszawskiego, Warszawa, pp. 29-42.

Regionalnego.

pp. 358-367.

*1948 Nr 55, Poz. 434.)* 

Nr 220, Poz. 1600.).

*78, Item 483.* 

pp. 131-146.

Wasilewski D. (Ed.), *Komercjalizacja i prywatyzacja ZOZ - kluczowe warunki osiągnięcia* 

Skrzypczak Z. (Ed.), *Ochrona zdrowia i gospodarka – mechanizmy rynkowe a regulacje publiczne*, Wydawnictwo Naukowe Wydziału Zarządzania Uniwersytetu

środków projektu nr POPT.03.04.00-00-019/07 w ramach Programu Operacyjnego Pomoc Techniczna 2007-2013 wykonana na zlecenie Ministerstwa Rozwoju

*zdrowotnej w Polsce i wybranych państwach europejskich*, Zdrowie Publiczne, 118, 3,

*as published in Dziennik Ustaw No. 55, Item 434 (Ustawa z dnia 28 października 1948 r. o zakładach społecznych służby zdrowia i planowej gospodarce w służbie zdrowia, Dz.U.* 

Item 1600 (*Ustawa z dnia 30 września 1991 o zakladach opieki zdrowotnej*; Dz.U. 1991,

*legislation not passed by the parliament (Ustawa z dnia 6 listopada 2008 r. Przepisy* 

The incorporation process of Health Technology (HT), particularly, Medical Equipment(s) (ME) encompasses all activities ranging from purchasing, renting, leasing or exchanging, technology assessment, planning and identification of needs, installation, technical rehearsals, calibration, users' training etc. The incorporation process also includes prediction of technology use for ascertaining if what has been planned can be realized, and for aiding future incorporations (World Health Organization [WHO], 2011a).

According to Wang (2009), the incorporation process of ME can be divided into two phases: planning and acquisition. The planning phase includes assessment of needs and impacts, and costs and benefits of ME after auditing the existing resources. The data collected during auditing and assessment should be established and converted into a technology incorporation plan, which might guide future investments. The second phase relies on the selection and acquisition of products that are appropriate to a certain application and environment. Purchasing options, such as leasing, lending and the revenue sharing models, should always be considered.

Health systems must be built in blocks in order to inform the financing policies, human resources, information, service aid, management and health technology. The interrelations and interactions among these blocks constitute a system. If any of these is lacking, the health system cannot work on the level needed to improve public health. Each block has its own organizational and political challenges. This chapter will discuss the health technology block, considering ME as the essential tool to public health (WHO, 2007; WHO, 2009).

Technology in health service aid is indispensable, even in the most remote and low-resource areas. Drugs, implants, disposable products and medical equipment are the main items that contributed to the progress of health care in the last century, as compared with that during the preceding thousands years. Unfortunately, technology also adds significantly to the fast and ever-growing health costs. Within this context the ME stand for relevant costs to the health system and sometimes under low and limited resources, besides of many medical procedures being totally dependable of technological resources.

Planning Incorporation of Health Technology into Public Health Center 291

• Obtain balance between clinical needs, personal desire and available financial

• Introduce pro-active planning to meet long-term needs, and thereby reduce emergency

• Offer more learning opportunities to clinicians and students when they are

• Encourage the actors involved in the incorporation process to create conditions conducive to establishment of monitoring actions towards the long life cycle of ME, and

It is important to note that other objectives can be added to the foregoing list depending on the need of each ME or health care. The Clinical Engineer must help in identifying the key factors for achieving the objectives defined. These factors must consider aspects inherent to technology, infrastructure, human resources and costs. They thus have a wide scope for choosing the parameters that meet the challenge of ME incorporation by using Clinical

After identifying the parameters, it will be possible to develop a systematized methodology that is based on the decision making domain, health technology assessment (HTA) and health technology incorporation. The Clinical Engineer can, therefore, act as a facilitator and as an actor of a team or interdisciplinary commission that formulates recommendations and supports decision making for ME incorporation, based on the evidence available in literature, in such a way as to minimize or even eliminate

A conceptual approach is needed to understand health technology, especially ME, its role

Health care is a human right, according to the Universal Declaration of Human Rights. However, it does not give access to universal health care. The World Health Report commented on this issue, in the context of primary health care, thus: "*Primary care and social protection reforms depend on choosing health-systems policies, such as those related to essential drugs, technology, human resources and financing, which are supportive of the reforms and promote* 

• Maintain or increase standardization to improve efficiency and reduce risks.

• Observe the valid legal aspects in national and regional contexts.

and life cycle, and the actors involved in its incorporation process.

*equity and people-centred care*" (WHO, 2008; United Nations, 2011).

• Increase the access of patients to health care in equitable manner. • Enlarge the coverage of patients' population and geographic areas.

• Reduce risks to patients, clinicians and environment. • When suitable, keep or improve the ME market.

• Reduce the Total Cost of Ownership (TCO).

thus contribute to future planning.

• Increase transparency of the public lender process.

• Identify the cultural and social barriers and facilitators.

resources.

acquisitions.

academically affiliated.

Engineering methodology.

subjectivity in decision making.

**2.1.1 Medical equipment function** 

**2.1 Conceptual approach** 

Management and administration of this health system technology, which aims at improving the cost-benefit ratio, safety, and reliability, falls within the domain of Biomedical Engineering. Clinical Engineering, which forms part of this domain, incorporates the quality parameters in all phases of the technology life cycle (Raymond, 2004; Moraes & Garcia, 2007).

Therefore, the Clinical Engineer, through ME management and administration, must identify the needs, limitations and factors required to evolve a methodology that leads to appropriate planning of ME incorporation through a systematized and rational structure. Thus, the health system can recommend incorporating just safe and effective ME that has infrastructure, human resources and financial viability. Moreover, it has to observe the legal, social and ethical aspects of the context in which the ME is to be inserted (Centers for Medicare and Medicaid Services, 2000; Cutler & Mcclellan, 2001; Sônego, 2007; Santos & Garcia, 2010).

Inadequate planning of ME incorporation practices can lower the quality of service aid or of ME's performance. On the other hand, adequate planning can lead to safe, equitable and quality health care. Besides, it also helps in identifying the technology that is appropriate to the Health Care Center (HCC)— not just the cheapest one taken from proposal selection (public bidding)—in terms of well defined and satisfactory parameters, such as deliverance, installation, performance test , training, payment and guarantee. Also, the technology must be so chosen as to encourage the distributors and manufacturers come back with future offerings (Calil, 2007; WHO, 2011a).

These guidelines are to be followed not only in case of purchases, but also in case of the equipments received through donation, renting or borrowing, including the ones replacing the existing ones. Moreover, should be applied to the individual institutions and/or network systems composed of several hospitals in various levels, health centers and community clinics, although the complexity and deadlines are very different from one case to another (Wang, 2009).

This chapter deals with identifying and recommending the main factors that must be considered for ME incorporation. The Clinical Engineer can help the actors involved, as a process facilitator, in identifying these factors and in deciding if incorporation is a real necessity. Thus, the performance of the Clinical Engineer strengthens not just the ME incorporation, but the whole health system and thus the public health.

#### **2. Incorporation process of medical equipment**

The main target of ME incorporation process is to maximize the benefits–clinical or financial—and minimize the costs—investment or recurrent ones-- especially of the local low resource communities, thus helping them in controlling the health problems effectively. The objectives may vary from one HCC to the other, but they usually include some of the following (Kaur, 2005a; Wang, 2009; WHO, 2011a; Santos & Garcia, 2010):


Management and administration of this health system technology, which aims at improving the cost-benefit ratio, safety, and reliability, falls within the domain of Biomedical Engineering. Clinical Engineering, which forms part of this domain, incorporates the quality parameters in all phases of the technology life cycle (Raymond, 2004; Moraes & Garcia,

Therefore, the Clinical Engineer, through ME management and administration, must identify the needs, limitations and factors required to evolve a methodology that leads to appropriate planning of ME incorporation through a systematized and rational structure. Thus, the health system can recommend incorporating just safe and effective ME that has infrastructure, human resources and financial viability. Moreover, it has to observe the legal, social and ethical aspects of the context in which the ME is to be inserted (Centers for Medicare and Medicaid Services, 2000; Cutler & Mcclellan, 2001; Sônego, 2007; Santos &

Inadequate planning of ME incorporation practices can lower the quality of service aid or of ME's performance. On the other hand, adequate planning can lead to safe, equitable and quality health care. Besides, it also helps in identifying the technology that is appropriate to the Health Care Center (HCC)— not just the cheapest one taken from proposal selection (public bidding)—in terms of well defined and satisfactory parameters, such as deliverance, installation, performance test , training, payment and guarantee. Also, the technology must be so chosen as to encourage the distributors and manufacturers come back with future

These guidelines are to be followed not only in case of purchases, but also in case of the equipments received through donation, renting or borrowing, including the ones replacing the existing ones. Moreover, should be applied to the individual institutions and/or network systems composed of several hospitals in various levels, health centers and community clinics, although the complexity and deadlines are very different from one case

This chapter deals with identifying and recommending the main factors that must be considered for ME incorporation. The Clinical Engineer can help the actors involved, as a process facilitator, in identifying these factors and in deciding if incorporation is a real necessity. Thus, the performance of the Clinical Engineer strengthens not just the ME

The main target of ME incorporation process is to maximize the benefits–clinical or financial—and minimize the costs—investment or recurrent ones-- especially of the local low resource communities, thus helping them in controlling the health problems effectively. The objectives may vary from one HCC to the other, but they usually include some of the

incorporation, but the whole health system and thus the public health.

following (Kaur, 2005a; Wang, 2009; WHO, 2011a; Santos & Garcia, 2010):

• Decrease the time spent in investigation, treatment and rehabilitation.

**2. Incorporation process of medical equipment**

• Improve clinical results and patient satisfaction. • Guarantee better access, quality and use of ME.

• Increase patients' life expectancy.

2007).

Garcia, 2010).

offerings (Calil, 2007; WHO, 2011a).

to another (Wang, 2009).


It is important to note that other objectives can be added to the foregoing list depending on the need of each ME or health care. The Clinical Engineer must help in identifying the key factors for achieving the objectives defined. These factors must consider aspects inherent to technology, infrastructure, human resources and costs. They thus have a wide scope for choosing the parameters that meet the challenge of ME incorporation by using Clinical Engineering methodology.

After identifying the parameters, it will be possible to develop a systematized methodology that is based on the decision making domain, health technology assessment (HTA) and health technology incorporation. The Clinical Engineer can, therefore, act as a facilitator and as an actor of a team or interdisciplinary commission that formulates recommendations and supports decision making for ME incorporation, based on the evidence available in literature, in such a way as to minimize or even eliminate subjectivity in decision making.

#### **2.1 Conceptual approach**

A conceptual approach is needed to understand health technology, especially ME, its role and life cycle, and the actors involved in its incorporation process.

#### **2.1.1 Medical equipment function**

Health care is a human right, according to the Universal Declaration of Human Rights. However, it does not give access to universal health care. The World Health Report commented on this issue, in the context of primary health care, thus: "*Primary care and social protection reforms depend on choosing health-systems policies, such as those related to essential drugs, technology, human resources and financing, which are supportive of the reforms and promote equity and people-centred care*" (WHO, 2008; United Nations, 2011).

Planning Incorporation of Health Technology into Public Health Center 293

These phases are efficient as long as they are supported by the health policies which are supervised by trained personnel. While interdependence of these phases is important to achieve the desired results, the operation within each phase must also be planned and executed with protocols that correspond to the administrative level (national, regional and

In the R&D phase, the entry parameters depend on the national policy of health technology R & D and on the health needs of the population. Besides meeting these requirements, the national policy must concentrate on encouraging the industry, so that the industry can generate innovative health products and make them available to whoever needs them

The regulation phase consists in protecting the society by publishing rules, rehearsing protocols, pre-authorizing purchases, registering, post-sale vigilance and reporting on contra-indications. The focus in this phase is on guaranteeing the safety of patients and

In the HTA phase, it is possible to systematically evaluate the proprieties, effects and/or impacts of ME on the deliverance of health care by a well-designed and defined methodology. The main target of this phase is to educate the health policy formulators on related technology. Thus, it is possible to properly plan from incorporation of the ME to the removal of ME. Depending on the issues involved, time frame for decision making and availability of resources, the HTA can be tackled in different ways, such as by more detailed HTA reports, availing of reports produced elsewhere, fast review, and monitoring

The HTM phase encompasses a variety of attributions, which include, *inter alia*, the following: identification of needs, collection of reliable data about ME, incorporation process, a complete inventory of ME, maintenance program based on risk reduction and safe operation, aiming for safe tools and high quality health service, allotting sufficient resources to maintain the technology under use, monitoring the clinical effectiveness of ME, updating and deactivation or replacement of unsafe and obsolete equipment (Kaur, 2005b;

From the foregoing discussion, it follows that each phase has specific attributions. However, it is important to highlight that technology life cycle phases are not independent; that is, action taken in one phase may impact other phases. This underlines the need for adequate planning of ME incorporation, and thus for strengthening technology life cycle, the actors

The technology life cycle phases can operate at local, regional and national levels. The

characteristics, perspectives and impacts of each phase are described in Table 1.

technological reports (Velasco-Garrido & Busse, 2005; HTA GLOSSARY, 2010).

In general, ME life cycle presents four phases (WHO, 2011b):

• Research and Development (R & D).

• Health Technology Assessment (HTA). • Health Technology Management (HTM).

• Regulation.

local) (WHO, 2011b).

(WHO, 2011b).

technology users (WHO, 2011b).

Santos & Garcia, 2010; WHO, 2011b).

involved and the health system.

In this regard, it can be observed that health systems depend on health technology for the desired health results. It is important to plan ME programs according to the protocols and policies that can result in equitable, safe, appropriate and high technology access. ME requires adjustment, maintenance, repairing, user training and deactivation, which are usually performed by Clinical Engineers. ME is used for diagnostic purposes, treatment of certain diseases and rehabilitation with some kind of accessory input or other equipment. ME does not include implants and disposables (WHO, 2011b).

Technology1 by itself has low intrinsic value and its value depends on how it is used. It is through the ME that health-predicted needs and benefits are realized, considering its impact on the patients, users, infrastructure, maintenance, costs and valid legislation. If the incorporation is planned and properly guided, then the ME can help policy formulators, decision makers, Clinical Engineers and health professionals in fulfilling their objectives of treating the patients under a better cost-benefit relation. However, if the technology is inappropriately incorporated or used, it can harm people, and cause loss of value and resources (Wang, 2009; National Institute for Health Research [NHS], 2010).

In this context, efforts must be made to manage the ME in a rational way, so that some balance can be found between the desired needs and benefits on the one hand, and the positive or negative impacts on the other. The importance of Clinical Engineering structures is thus evident in offering mechanisms that enable efficient and transparent ME incorporation planning. Nonetheless, the actors involved in the process must be aware that the incorporation is directly linked to the necessity of treating or diagnosing some clinical condition. Consequently, the eligibility of the applicant ME for incorporation must be assessed.

The eligibility refers to justification in realizing the ME assessment in the incorporation. To help this, some issues must be addressed, considering different aspects of demographic density, complexity of the health problem, and the nonexistence of unused ME in the HCC. This could enable the manufacturer and the distributor to guarantee the supply of spare parts during servicing of the equipment.

#### **2.1.2 The medical equipment life cycle**

ME is vital to health care service in that it improves the public health system. From the innovation phase to the replacement one, the tools used in the system must have four essential characteristics: availability; accessibility; adjustment; and financial capacity2. These would help to enhance the life cycle of the ME in such a way that not all the efforts may not have to be centered on the innovation phase alone, but on the incorporation one too in an adequate and rational manner; this ensures their use in an efficient and equitable way (WHO, 2011b).

<sup>1</sup>The majority of dictionaries define technology as the application of knowledge to practical means.

<sup>2</sup>Relationship between prices of services according to the maintainer, the deposit required for the entry of customers and the ability to pay, or the existence of health insurance by the customer.

In general, ME life cycle presents four phases (WHO, 2011b):


292 Public Health – Methodology, Environmental and Systems Issues

In this regard, it can be observed that health systems depend on health technology for the desired health results. It is important to plan ME programs according to the protocols and policies that can result in equitable, safe, appropriate and high technology access. ME requires adjustment, maintenance, repairing, user training and deactivation, which are usually performed by Clinical Engineers. ME is used for diagnostic purposes, treatment of certain diseases and rehabilitation with some kind of accessory input or other equipment.

Technology1 by itself has low intrinsic value and its value depends on how it is used. It is through the ME that health-predicted needs and benefits are realized, considering its impact on the patients, users, infrastructure, maintenance, costs and valid legislation. If the incorporation is planned and properly guided, then the ME can help policy formulators, decision makers, Clinical Engineers and health professionals in fulfilling their objectives of treating the patients under a better cost-benefit relation. However, if the technology is inappropriately incorporated or used, it can harm people, and cause loss of value and resources (Wang, 2009; National Institute for Health Research [NHS],

In this context, efforts must be made to manage the ME in a rational way, so that some balance can be found between the desired needs and benefits on the one hand, and the positive or negative impacts on the other. The importance of Clinical Engineering structures is thus evident in offering mechanisms that enable efficient and transparent ME incorporation planning. Nonetheless, the actors involved in the process must be aware that the incorporation is directly linked to the necessity of treating or diagnosing some clinical condition. Consequently, the eligibility of the applicant ME for incorporation must be

The eligibility refers to justification in realizing the ME assessment in the incorporation. To help this, some issues must be addressed, considering different aspects of demographic density, complexity of the health problem, and the nonexistence of unused ME in the HCC. This could enable the manufacturer and the distributor to guarantee the supply of spare

ME is vital to health care service in that it improves the public health system. From the innovation phase to the replacement one, the tools used in the system must have four essential characteristics: availability; accessibility; adjustment; and financial capacity2. These would help to enhance the life cycle of the ME in such a way that not all the efforts may not have to be centered on the innovation phase alone, but on the incorporation one too in an adequate and rational manner; this ensures their use in an efficient and equitable way

1The majority of dictionaries define technology as the application of knowledge to practical

2Relationship between prices of services according to the maintainer, the deposit required for the entry

of customers and the ability to pay, or the existence of health insurance by the customer.

ME does not include implants and disposables (WHO, 2011b).

2010).

assessed.

(WHO, 2011b).

means.

parts during servicing of the equipment.

**2.1.2 The medical equipment life cycle** 


These phases are efficient as long as they are supported by the health policies which are supervised by trained personnel. While interdependence of these phases is important to achieve the desired results, the operation within each phase must also be planned and executed with protocols that correspond to the administrative level (national, regional and local) (WHO, 2011b).

In the R&D phase, the entry parameters depend on the national policy of health technology R & D and on the health needs of the population. Besides meeting these requirements, the national policy must concentrate on encouraging the industry, so that the industry can generate innovative health products and make them available to whoever needs them (WHO, 2011b).

The regulation phase consists in protecting the society by publishing rules, rehearsing protocols, pre-authorizing purchases, registering, post-sale vigilance and reporting on contra-indications. The focus in this phase is on guaranteeing the safety of patients and technology users (WHO, 2011b).

In the HTA phase, it is possible to systematically evaluate the proprieties, effects and/or impacts of ME on the deliverance of health care by a well-designed and defined methodology. The main target of this phase is to educate the health policy formulators on related technology. Thus, it is possible to properly plan from incorporation of the ME to the removal of ME. Depending on the issues involved, time frame for decision making and availability of resources, the HTA can be tackled in different ways, such as by more detailed HTA reports, availing of reports produced elsewhere, fast review, and monitoring technological reports (Velasco-Garrido & Busse, 2005; HTA GLOSSARY, 2010).

The HTM phase encompasses a variety of attributions, which include, *inter alia*, the following: identification of needs, collection of reliable data about ME, incorporation process, a complete inventory of ME, maintenance program based on risk reduction and safe operation, aiming for safe tools and high quality health service, allotting sufficient resources to maintain the technology under use, monitoring the clinical effectiveness of ME, updating and deactivation or replacement of unsafe and obsolete equipment (Kaur, 2005b; Santos & Garcia, 2010; WHO, 2011b).

From the foregoing discussion, it follows that each phase has specific attributions. However, it is important to highlight that technology life cycle phases are not independent; that is, action taken in one phase may impact other phases. This underlines the need for adequate planning of ME incorporation, and thus for strengthening technology life cycle, the actors involved and the health system.

The technology life cycle phases can operate at local, regional and national levels. The characteristics, perspectives and impacts of each phase are described in Table 1.

Planning Incorporation of Health Technology into Public Health Center 295

fundamental that those Engineers never forget that they are just members of a team and not

User's integration in the development and assessment of ME is explicitly recommended in literature. This perspective turns out to be beneficial to technology producers, besides highlighting the importance of users inside the incorporation process (Woodside et al, 1998; Kittel et al, 2002; Sarwar & Robinson, 2007). In addition, other approaches directly reflect on the potential impact of the user's integration into the assessment process. (Mcgregor &

Just as Clinical Engineers and users, all other actors in the incorporation process—interns, like patient groups, or externs like manufacturers, distributors or regulators—need to be

Regarding decision making in ME incorporation, the representation of multiple perspectives of the actors is a key element of justice (Singer et al., 2000). Similar approaches can be found

It is important to stress that, without necessary resources, adequate planning of ME is not possible, and consequently the incorporation process too. The progress of health technology with assured benefits to the patients and increased efficacy is rather slower within the health systems than in other health service economies. This can be ascribed to several barriers in

• Lack of formal mechanisms to disseminate recommendations and information about

• Insufficient sharing of information between buyers and sellers that can result in bad

• Lack of financial and technical support to the companies in turning innovative ideas

Fortunately, notwithstanding these barriers, the new ventures introduced by World Health Organization, along with recommendations towards ME, have been well accepted by the country members. These can be turned into better and more efficient health systems. Nowadays, in developing countries like Brazil, some attention is being given to preparation and dissemination of methodology guidelines for assessment and incorporation of ME. This contributes to the development of recommendations to deal with the challenge of ME

Even so, many barriers still remain to be broken down to achieve complete success in ME incorporation and usage. In this context, it is important to identify clearly the needs for adequate planning. One of the most critical necessities is undeniably the human resources. In general, the two common mistakes are excessive centralization of decision-making and

• Availability of adequate data on the cost and price of new health technology.

• The culture within the health systems is not sufficiently entrepreneurial.

• Need for training the health system teams in using the new ME.

the only ones responsible for ME incorporation (Harding & Epstein, 2004).

considered equally important, and treated accordingly(Gibson et al., 2004).

**2.2 Identification of resources for incorporation** 

this process, such as the following (Robert et al., 2009):

in Drummond et al. (2008), which presents the key principles to guide the HTA.

Brophy, 2005).

ME assessment.

incorporation process.

purchasing decisions.

into marketable products.

• Bureaucracy around purchasing procedures.


Table 1. Characteristics of ME life cycle phases (Source: WHO, 2011b).

#### **2.1.3 Actors involved in the incorporation process**

Past experience shows that ME incorporation process has not been well coordinated in most countries. In many cases, it led to undesirable results, such as increase in cost, abusive use of the facilities and frustrating managers, users and patients. However, by learning from these experiences, the application of knowledge has been so conditioned as to derive maximum advantage from each of the ME life cycle phases (David & Judd, 1993; Sprague, 1988).

The incorporation process, which involves clinical, technical, financial, infrastructural and human resource impacts, is a challenging task. Therefore, a multidisciplinary team is required to plan and execute the ME incorporation process effectively. The team can prevent recurrence of past errors, and identify the potential factors that may lead to dissatisfactory results. The team must be formed by including representatives from clinical, administrative, financial, clinical engineering, installations, information technology and material management areas. Besides, it needs to be strengthened with specialized knowledge and services of consultants and distributors (Coe & Banta, 1992; Wang, 2009).

The Clinical Engineers can be strong members of the team in that they ensure that the real clinical needs of the user are identified, treated and, when possible, attended to. They can serve as a communication link between professionals of different disciplines involved in the incorporation process, inside or outside the HCC. Besides, their experience and skills can be used to help the HCC in its systematic and safe incorporation of the technology process. It is

Table 1. Characteristics of ME life cycle phases (Source: WHO, 2011b).

services of consultants and distributors (Coe & Banta, 1992; Wang, 2009).

Past experience shows that ME incorporation process has not been well coordinated in most countries. In many cases, it led to undesirable results, such as increase in cost, abusive use of the facilities and frustrating managers, users and patients. However, by learning from these experiences, the application of knowledge has been so conditioned as to derive maximum advantage from each of the ME life cycle phases (David & Judd, 1993;

The incorporation process, which involves clinical, technical, financial, infrastructural and human resource impacts, is a challenging task. Therefore, a multidisciplinary team is required to plan and execute the ME incorporation process effectively. The team can prevent recurrence of past errors, and identify the potential factors that may lead to dissatisfactory results. The team must be formed by including representatives from clinical, administrative, financial, clinical engineering, installations, information technology and material management areas. Besides, it needs to be strengthened with specialized knowledge and

The Clinical Engineers can be strong members of the team in that they ensure that the real clinical needs of the user are identified, treated and, when possible, attended to. They can serve as a communication link between professionals of different disciplines involved in the incorporation process, inside or outside the HCC. Besides, their experience and skills can be used to help the HCC in its systematic and safe incorporation of the technology process. It is

**2.1.3 Actors involved in the incorporation process** 

Sprague, 1988).

fundamental that those Engineers never forget that they are just members of a team and not the only ones responsible for ME incorporation (Harding & Epstein, 2004).

User's integration in the development and assessment of ME is explicitly recommended in literature. This perspective turns out to be beneficial to technology producers, besides highlighting the importance of users inside the incorporation process (Woodside et al, 1998; Kittel et al, 2002; Sarwar & Robinson, 2007). In addition, other approaches directly reflect on the potential impact of the user's integration into the assessment process. (Mcgregor & Brophy, 2005).

Just as Clinical Engineers and users, all other actors in the incorporation process—interns, like patient groups, or externs like manufacturers, distributors or regulators—need to be considered equally important, and treated accordingly(Gibson et al., 2004).

Regarding decision making in ME incorporation, the representation of multiple perspectives of the actors is a key element of justice (Singer et al., 2000). Similar approaches can be found in Drummond et al. (2008), which presents the key principles to guide the HTA.

#### **2.2 Identification of resources for incorporation**

It is important to stress that, without necessary resources, adequate planning of ME is not possible, and consequently the incorporation process too. The progress of health technology with assured benefits to the patients and increased efficacy is rather slower within the health systems than in other health service economies. This can be ascribed to several barriers in this process, such as the following (Robert et al., 2009):


Fortunately, notwithstanding these barriers, the new ventures introduced by World Health Organization, along with recommendations towards ME, have been well accepted by the country members. These can be turned into better and more efficient health systems. Nowadays, in developing countries like Brazil, some attention is being given to preparation and dissemination of methodology guidelines for assessment and incorporation of ME. This contributes to the development of recommendations to deal with the challenge of ME incorporation process.

Even so, many barriers still remain to be broken down to achieve complete success in ME incorporation and usage. In this context, it is important to identify clearly the needs for adequate planning. One of the most critical necessities is undeniably the human resources. In general, the two common mistakes are excessive centralization of decision-making and

Planning Incorporation of Health Technology into Public Health Center 297

the clinical team on the diseases that need to be addressed and the health policies they

Besides, a survey must be undertaken to check if the HCC that is going to receive the technology has already some ME that meets the clinical needs under consideration, or if it has any unused equipment. Following are the other questions that must be taken into

• Does the demographic density of the HCC region that is going to use the ME justify the

account in this regard (Kaur, 2005a; WHO, 2011a; Robert et al., 2009; Wang, 2009):

• Does the ME have an entry in the register of competent regulating establishment?

• Does the complexity of the identified health problem justify ME incorporation?

justified, immediate disengagement of the incorporation process must be considered.

• Is there any personal preference from the clinical or administrative team of the HCC? • Will the ME incorporation and its results impact significantly on the

• Is there any guarantee that the manufacturer will offer spare parts during the projected

All these issues justify a detailed ME assessment, which needs time, human resources and financial investments. If the majority of the factors justify the need for ME incorporation, one can pass on to the next planning phase, which involves assessment of the impacts upon users, patients, infrastructure and immanent traits of technology. In case the need is not

Answers to the proposed questions can be found in international and national literature. Yet, the technological park of HCC may have to be covered to check if any unused ME exists. Data in respect of demographic density and demand can be taken from the Health Ministry sites. Interviews with clinical and administrative team, as well as with some manufacturers, are recommended to identify personal preferences and ascertain the capacity

When applicable, it might be necessary to assess the amount of ME needed, on the basis of epidemiological data, population to be assisted, geographic distances to be covered, status of the HCC that is recently in need of technology, including its capacity to utilize the equipment or the usage time per case. However, sometimes, it may not be possible to go beyond just the figures, because many variables are subjective or difficult to estimate. Besides, the available data might not be reliable enough to lead to correct indications. Nonetheless, some attempts can be made, assuming potential risks and making adjustments,

The impact of technology incorporation into health services, particularly of ME, can be viewed in both positive and negative ways. The determining point of the impact will be the way in which the planning is conducted. Therefore, before incorporating ME into the health systems, one must study the likely impact of this equipment on the service, both direct and indirect. One of the main reasons cited for the disuse of ME is sometimes the failure to predict ME's impact (World Health Assembly Health Technologies [WHA], 2007). These

recommend, and not the technology they want (Wang, 2009).

• Is there any demand in the health service offered by the ME?

treatment/diagnosis of patients by any other specialist?

so that they provide some basis for future assessments (Wang, 2009).

**2.4 Impact of medical equipment incorporation** 

incorporation?

life cycle of the ME?

to supply the spares, respectively.

reposing too much confidence in the specialists concerned. Centralizing decisions brings political problems related to favoritism, subjectivity, and lack of transparency. And, too much confidence in specialists needs credibility and general support, which sometimes get worse because of lack of a wider view (Wang, 2009).

Therefore, it is necessary to establish a transparent and efficient process that can identify and plan the actions pertinent to ME incorporation process. As has already been said, the engagement of many actors in this challenge can bring more transparency and a generalized approach, as well as all the relevant factors. So, it is recommended that a multidisciplinary team be formed and supported by representatives of every group of actors involved, where the Clinical Engineer can act as a task facilitator.

However, it is necessary to get information and evidence of internal and external sources of ME, which can enable the planning of ME incorporation. Following are some internal sources of information and evidence and the main factors to be considered for each source (Wang, 2009):


Following are the external sources of information and evidence, and the main factors to be considered (Wang, 2009):


The multidisciplinary teams at the local level can be considered as determined people to ME incorporation management in the health system as a whole. However, their attributions and actions must be tailored to the needs of the situation. The actions of the multidisciplinary team at local level need administrative and technical support. Systematic research of scientific literature and HTA reports by specialized technicians would be helpful for simultaneous execution of the planning tasks within the timeframe given for ME incorporation process (Kaur, 2005a; WHO, 2011a).

#### **2.3 Evaluation of the necessity for medical equipment incorporation**

Prior to ME incorporation, one must clearly understand the difference between desire and need. This is because many acquisitions were made more under the impulse of desire and for subjective reasons, than in the common interest of the majority of the actors, which must be the case. The need for ME incorporation must be assessed rationally by discussions with

reposing too much confidence in the specialists concerned. Centralizing decisions brings political problems related to favoritism, subjectivity, and lack of transparency. And, too much confidence in specialists needs credibility and general support, which sometimes get

Therefore, it is necessary to establish a transparent and efficient process that can identify and plan the actions pertinent to ME incorporation process. As has already been said, the engagement of many actors in this challenge can bring more transparency and a generalized approach, as well as all the relevant factors. So, it is recommended that a multidisciplinary team be formed and supported by representatives of every group of actors involved, where

However, it is necessary to get information and evidence of internal and external sources of ME, which can enable the planning of ME incorporation. Following are some internal sources of information and evidence and the main factors to be considered for each source

Following are the external sources of information and evidence, and the main factors to be

• Health Information Centers: epidemiological data, possible refund, rules and

• Manufacturers: product specifications, financial conditions, requisites to installation

• Regulating mediums, Civil Engineers and Architects: infrastructure requisites and

• Other distributors: aiding equipment and furniture, alternative supply and service

The multidisciplinary teams at the local level can be considered as determined people to ME incorporation management in the health system as a whole. However, their attributions and actions must be tailored to the needs of the situation. The actions of the multidisciplinary team at local level need administrative and technical support. Systematic research of scientific literature and HTA reports by specialized technicians would be helpful for simultaneous execution of the planning tasks within the timeframe given for ME

Prior to ME incorporation, one must clearly understand the difference between desire and need. This is because many acquisitions were made more under the impulse of desire and for subjective reasons, than in the common interest of the majority of the actors, which must be the case. The need for ME incorporation must be assessed rationally by discussions with

• Current users: efficacy, effectiveness, safety, easy training and usage. • Clinical Engineering: reliability, safety, maintenance and availability.

• Information Technology: network problems and software support. • Material management: input, accessories and alternative distributors.

regulations, marketing rivalry, financial problems and HTA reports.

and functioning, post-purchasing guarantee and support.

**2.3 Evaluation of the necessity for medical equipment incorporation** 

• Installation management: requirements of usefulness and environment impact.

worse because of lack of a wider view (Wang, 2009).

the Clinical Engineer can act as a task facilitator.

(Wang, 2009):

considered (Wang, 2009):

sources.

impacts, regulations and codes.

incorporation process (Kaur, 2005a; WHO, 2011a).

the clinical team on the diseases that need to be addressed and the health policies they recommend, and not the technology they want (Wang, 2009).

Besides, a survey must be undertaken to check if the HCC that is going to receive the technology has already some ME that meets the clinical needs under consideration, or if it has any unused equipment. Following are the other questions that must be taken into account in this regard (Kaur, 2005a; WHO, 2011a; Robert et al., 2009; Wang, 2009):


All these issues justify a detailed ME assessment, which needs time, human resources and financial investments. If the majority of the factors justify the need for ME incorporation, one can pass on to the next planning phase, which involves assessment of the impacts upon users, patients, infrastructure and immanent traits of technology. In case the need is not justified, immediate disengagement of the incorporation process must be considered.

Answers to the proposed questions can be found in international and national literature. Yet, the technological park of HCC may have to be covered to check if any unused ME exists. Data in respect of demographic density and demand can be taken from the Health Ministry sites. Interviews with clinical and administrative team, as well as with some manufacturers, are recommended to identify personal preferences and ascertain the capacity to supply the spares, respectively.

When applicable, it might be necessary to assess the amount of ME needed, on the basis of epidemiological data, population to be assisted, geographic distances to be covered, status of the HCC that is recently in need of technology, including its capacity to utilize the equipment or the usage time per case. However, sometimes, it may not be possible to go beyond just the figures, because many variables are subjective or difficult to estimate. Besides, the available data might not be reliable enough to lead to correct indications. Nonetheless, some attempts can be made, assuming potential risks and making adjustments, so that they provide some basis for future assessments (Wang, 2009).

#### **2.4 Impact of medical equipment incorporation**

The impact of technology incorporation into health services, particularly of ME, can be viewed in both positive and negative ways. The determining point of the impact will be the way in which the planning is conducted. Therefore, before incorporating ME into the health systems, one must study the likely impact of this equipment on the service, both direct and indirect. One of the main reasons cited for the disuse of ME is sometimes the failure to predict ME's impact (World Health Assembly Health Technologies [WHA], 2007). These

Planning Incorporation of Health Technology into Public Health Center 299

in the first periods of implementation (Dar-El, 2000). The tool also allows adequate allocation of tasks to the members of the workgroups so as to enable them complete their performance characteristics, besides the monitoring of costs related to the process

Figure 2 shows the relation of cost versus ME complexity, divided into two categories (A & B). The line 0b represents the cost or time spent to train a technician (beginner) in operating the equipment of category B and the line ba in operating the equipment of category A. From their comparison, it can be seen that the more complex the ME is, the more would be the

In terms of the magnitude of complexity, one can consider classifying the ME based on the

• Low complexity equipment: The ME of this category has complex electronic or mechanical circuits, but they pose no maintenance problem (e.g., thermal double boiler, sterilizer, sphygmomanometer, mechanical scales, etc.) Those who operate this

• High complexity equipment: The ME of this category demands qualified technicians with specialized training. In many cases, these technicians have higher education and some of them had foreign training. Following are some examples of this equipment: nuclear magnetic resonance, scanner, chemical analyzers (some types), gamma

Therefore, the degree of complexity of ME can help in estimating the costs and the training time required for each ME, because the more complex the ME is, the higher would be the cost and time needed. In other words, from the degree of complexity of the equipment, one can draw a qualitative estimate of the cost and time required to train a person in operating that equipment. For instance, the cost and time required to manage an ultrasound machine, which belongs to the high complexity category, would be much higher than the cost and time required to operate a cardiac monitor that belongs to the medium complexity category. With that information in mind, it is possible to properly hire specialized training services or even sign maintenance contracts for users' training. However, final cost estimates can be

chamber, linear accelerator, ultrasound machine (image diagnosis system), etc.

equipment need not be specialists, and the training they need is quite simple. • Medical equipment of medium complexity: The ME of this category requires personnel with basic education and training that can meet the repairing needs. Examples of the ME of this category are incubator, centrifuge, cardiac monitor, electrocardiograph,

time (or cost) required to train the professional (Souza et al, 2010; Cheng, 2006).

Fig. 2. Training curve based on ME complexity (Source: Cheng, 2004).

following definitions (Calil & Teixeira, 1998):

hemodialysis equipment, etc.

(Anzanello & Fogliatto, 2007).

impacts can be portrayed as three pillars: Human Resources, Technology and Infrastructure. Figure 1 shows the impact on health technology from Clinical Engineering view, particularly ME:

Fig. 1. Impact on health technology, particularly ME, from clinical engineering view must be considered to obtain safety, reliability and efficiency deliverance of health service by ME usage (Source: Santos, Souza & Garcia, 2010).

#### **2.4.1 Impact on human resources**

Health professionals are individually responsible for the transparency of their practices in certain aspects of health care offers. Therefore, they have the responsibility, as part of their continuous professional development, to acquire, maintain and disseminate knowledge and abilities in availing of ME. Before inducting health technology into HCC, the managers must ensure that the health professionals are adequately educated to guarantee safe usage of technology (NHS, 2005).

The users' training needs can cover educational services, as well as clinical users' training. Safety training aspects, such as those with laser equipment, must also be considered for inclusion in user training needs (Harding & Epstein, 2004).

Additionally, a training plan is necessary, considering the training material, manuals, trainers and other resources pertinent to the training, as also the need of the establishment of a schedule of personal training activities in order to regard the personal turnover and gradual loss of competence. This plan must take into account some fundamental aspects (NHS, 2005) listed below:


However, for conducting any program one incurs cost, which can be directly related to the learning curve of the user in relation to the ME which will be used.

The learning curve is a tool which can monitor the performance of workers assigned with certain tasks. Through the curves, it is possible to evaluate and plan for more productive tasks, and thereby, to reduce the loss arising out of the inability, which is checked, above all,

impacts can be portrayed as three pillars: Human Resources, Technology and Infrastructure. Figure 1 shows the impact on health technology from Clinical Engineering view,

Fig. 1. Impact on health technology, particularly ME, from clinical engineering view must be considered to obtain safety, reliability and efficiency deliverance of health service by ME

Health professionals are individually responsible for the transparency of their practices in certain aspects of health care offers. Therefore, they have the responsibility, as part of their continuous professional development, to acquire, maintain and disseminate knowledge and abilities in availing of ME. Before inducting health technology into HCC, the managers must ensure that the health professionals are adequately educated to guarantee safe usage of

The users' training needs can cover educational services, as well as clinical users' training. Safety training aspects, such as those with laser equipment, must also be considered for

Additionally, a training plan is necessary, considering the training material, manuals, trainers and other resources pertinent to the training, as also the need of the establishment of a schedule of personal training activities in order to regard the personal turnover and gradual loss of competence. This plan must take into account some fundamental aspects

• Constant information about the changes made in the legislation pertinent to ME.

learning curve of the user in relation to the ME which will be used.

However, for conducting any program one incurs cost, which can be directly related to the

The learning curve is a tool which can monitor the performance of workers assigned with certain tasks. Through the curves, it is possible to evaluate and plan for more productive tasks, and thereby, to reduce the loss arising out of the inability, which is checked, above all,

particularly ME:

usage (Source: Santos, Souza & Garcia, 2010).

inclusion in user training needs (Harding & Epstein, 2004).

• Degree of ME risk and, therefore, priority level. • The need for flexible approaches to learning.

**2.4.1 Impact on human resources** 

technology (NHS, 2005).

(NHS, 2005) listed below:

• Accessibility to all ME users.

in the first periods of implementation (Dar-El, 2000). The tool also allows adequate allocation of tasks to the members of the workgroups so as to enable them complete their performance characteristics, besides the monitoring of costs related to the process (Anzanello & Fogliatto, 2007).

Figure 2 shows the relation of cost versus ME complexity, divided into two categories (A & B). The line 0b represents the cost or time spent to train a technician (beginner) in operating the equipment of category B and the line ba in operating the equipment of category A. From their comparison, it can be seen that the more complex the ME is, the more would be the time (or cost) required to train the professional (Souza et al, 2010; Cheng, 2006).

Fig. 2. Training curve based on ME complexity (Source: Cheng, 2004).

In terms of the magnitude of complexity, one can consider classifying the ME based on the following definitions (Calil & Teixeira, 1998):


Therefore, the degree of complexity of ME can help in estimating the costs and the training time required for each ME, because the more complex the ME is, the higher would be the cost and time needed. In other words, from the degree of complexity of the equipment, one can draw a qualitative estimate of the cost and time required to train a person in operating that equipment. For instance, the cost and time required to manage an ultrasound machine, which belongs to the high complexity category, would be much higher than the cost and time required to operate a cardiac monitor that belongs to the medium complexity category.

With that information in mind, it is possible to properly hire specialized training services or even sign maintenance contracts for users' training. However, final cost estimates can be

Planning Incorporation of Health Technology into Public Health Center 301

Inspections of performance and safety verify the functionality and safe usage of a tool. Preventive Maintenance (PM) refers to the programmed activities to ensure that the ME endures its useful life through actions like calibrating, replacing dysfunctional parts, greasing, cleaning, etc. Under PM, the inspection can be done as an individual or group activity to guarantee ME's functionality. CM refers to activities carried out to restore the

Fig. 3. Categories and types of ME maintenance: Inspection and Preventive Maintenance;

Once the ME is incorporated into HCC, it is important to understand different aspects of the resulting impact on the infrastructure. Following are some of the advance actions to be

• The type of floor, and equipment weight and disposition in relation with other

• Check if the HCC has more than one floor, and if 'yes', identify the floor for installing

• Ascertain the availability of gas and water supply and their supply conditions, like

• Check the availability of power supply for electric connections; also, check if the HCC

• Check the need for weatherproofing such as air-conditioning, and quality control (air

These actions are particularly important to HCCs in rural areas and developing countries where stable sources of energy, adequate water supply and controlled environment in terms

carried out before acquiring the technology (Calil, 2007; Wang, 2009; WHO, 2011d):

and Corrective Maintenance (Source: WHO, 2011c).

technology equipment in adjacent rooms. • Type, size, and position of the place and building.

type, quality and quantity, and pressure.

of temperature and humidity are not always available.

• Other factors that may be specified as installation prerequisites.

**2.4.3 Impact on infrastructure** 

the ME.

• The space needed to install the ME.

has an emergency generator.

quality and humidity).

physical integrity, safety and/or performance of a failure ME (WHO, 2011c).

made only after a market survey and discussions with manufacturers, distributors, and companies specialized in ME training.

#### **2.4.2 Impact on technology**

The ME needs to be operated in an efficient and safe way. To achieve this, various factors that may interfere with each other will have to be considered. So, one must prepare a maintenance plan that covers not only preventive or remedial maintenance, but also detects potential and hidden errors that are not usually identified by users, but can cause injury or death to the patients (Kaur, 2005a; Wang, 2009).

For preparing a maintenance plan, one must consider the following actions (Kaur, 2005a):


It is important to note that the ME, which does not have adequate support of maintenance services, consumable goods, and replacement parts, it is probable that the ME may remain unused for long periods and might ultimately be replaced prematurely. Therefore, it is essential to any health establishment, no matter its size, to implement a ME maintenance program. The complexity of this program depends on the size and type of installation, its locale, and necessary resources. The need for a good maintenance program will be the same regardless of whether the ME is in a high income, urban environment or in a low or medium income, rural environment (Kaur, 2005a; WHO, 2011c).

The ME maintenance can be divided into two categories: Inspection and Preventive Maintenance (IPM), and Corrective Maintenance (CM) (see Figure 3). IPM includes all programmed activities that guarantee equipment functionality and prevention of failure3.

<sup>3</sup>The condition of not meeting intended performance or safety requirements, and/or a breach of physical integrity. A failure is corrected by repair and/or calibration (WHO, 2011b).

made only after a market survey and discussions with manufacturers, distributors, and

The ME needs to be operated in an efficient and safe way. To achieve this, various factors that may interfere with each other will have to be considered. So, one must prepare a maintenance plan that covers not only preventive or remedial maintenance, but also detects potential and hidden errors that are not usually identified by users, but can cause injury or

For preparing a maintenance plan, one must consider the following actions (Kaur, 2005a):

• Check the guarantee date and enquire if the distributor offers, during the guarantee period, the spares required, and if the guarantee period can be extended for an

• Check, in case of any breakage of ME, whether the manufacturer will replace or repair the broken part or even offer refund if the equipment has manufacturing or material defects. Will the offer cover all parts of the equipment? Does the manufacturer pay for

• Ensure availability of consumables, accessories, spare parts and maintenance materials. • Check if the maintenance requires the service of a qualified engineer, and if the answer is 'yes', identify the local distributor or representative who can help in case of

• If no distributor or representative is available locally, check if somebody is available at

• To increase the bargaining power for entering into a maintenance contract, check if there are companies, other than the authorized agent, who can offer maintenance

• Identify, from the options available, the maintenance contract that has the best costbenefit ratio for each ME. In most cases, purchasing ME by lending or leasing is advantageous, but it needs to be checked if the input and maintenance costs do not

It is important to note that the ME, which does not have adequate support of maintenance services, consumable goods, and replacement parts, it is probable that the ME may remain unused for long periods and might ultimately be replaced prematurely. Therefore, it is essential to any health establishment, no matter its size, to implement a ME maintenance program. The complexity of this program depends on the size and type of installation, its locale, and necessary resources. The need for a good maintenance program will be the same regardless of whether the ME is in a high income, urban environment or in a low or medium

The ME maintenance can be divided into two categories: Inspection and Preventive Maintenance (IPM), and Corrective Maintenance (CM) (see Figure 3). IPM includes all programmed activities that guarantee equipment functionality and prevention of failure3.

3The condition of not meeting intended performance or safety requirements, and/or a breach of

physical integrity. A failure is corrected by repair and/or calibration (WHO, 2011b).

companies specialized in ME training.

death to the patients (Kaur, 2005a; Wang, 2009).

**2.4.2 Impact on technology** 

acceptable cost.

the shipping expenses?

breakdown or glitch.

service.

regional or national level.

exceed the purchasing costs in a short time.

income, rural environment (Kaur, 2005a; WHO, 2011c).

Inspections of performance and safety verify the functionality and safe usage of a tool. Preventive Maintenance (PM) refers to the programmed activities to ensure that the ME endures its useful life through actions like calibrating, replacing dysfunctional parts, greasing, cleaning, etc. Under PM, the inspection can be done as an individual or group activity to guarantee ME's functionality. CM refers to activities carried out to restore the physical integrity, safety and/or performance of a failure ME (WHO, 2011c).

Fig. 3. Categories and types of ME maintenance: Inspection and Preventive Maintenance; and Corrective Maintenance (Source: WHO, 2011c).

#### **2.4.3 Impact on infrastructure**

Once the ME is incorporated into HCC, it is important to understand different aspects of the resulting impact on the infrastructure. Following are some of the advance actions to be carried out before acquiring the technology (Calil, 2007; Wang, 2009; WHO, 2011d):


These actions are particularly important to HCCs in rural areas and developing countries where stable sources of energy, adequate water supply and controlled environment in terms of temperature and humidity are not always available.

Planning Incorporation of Health Technology into Public Health Center 303

Fig. 5. Model depicting the process of health technology incorporation process, particularly ME. The proposal is based on decision making domains, technology assessment and HT incorporation. The domains establish interconnections, and there are multiple parameters

In the decision making domain, interconnections are made among the mind functions, decision making types and actions. The mind functions are made by analysis, synthesis and imagination, and evaluation. The analysis consists in separating a whole into its constituent parts, the synthesis and imagination is the reverse of analysis, that is, it presents or puts the things in groups to make a whole. Evaluation comes into action in mental activities, such as success criteria establishment, performance evaluation and judging people (Adair, 2007).

These functions can relate with those decision making types that can assume a reflective or deliberated form. The reflective one comes from the necessity of reflecting on how people make decisions based on their experiences, where they use the knowledge acquired by experience to identify and evaluate the situations and later make decisions (Fadok, Boyd & Warden, 1995; Zsambock, 1997). The deliberated form is based on reason, which supports the decision process, wherein the decision maker within his/her context will analyze, synthesize and evaluate to achieve the desired result (Klein, 1997; Joseph, 2007). So, from the interconnections between the mind functions and the decision making form, actions and

The decision analysis, which sets relevant technological alternatives, together with systematic review of studies about the effects of technology on health management, and the economic analysis that relates costs and effects, forms the main methodology used in HTA

Within the technology assessment domain, it is possible to choose and apply multi-criteria methodology to support decision making, and assessment methods of clinical evidences and

post results can be created with the decision maker as the actor.

and actors to be considered.

(Krauss-Silva, 2004).

Information about the likely impact on the infrastructure can be obtained from the manufacturers. They usually offer architectonic projects and support structuring layouts for installing robust ME, such as robotic surgery system and magnetic resonance instrument (Wang, 2009).

#### **2.5 Proposed model for medical equipment incorporation**

Clinical Engineering plays an important role, through Health Technology Management (HTM), in innovation, incorporation, usage/utilization and ME re-processing. Thus, the proposed model comes from HTM incorporation phase. It is important to highlight here that, in the last few years, the profile has been undergoing some changes in the incorporation process, which are not being released just in the HCC, but also in the entire health system. Therefore, the methodology aimed at helping this process must contemplate taking such actions that can be applied to the benefit of public health (Sônego, 2007; Santos & Garcia, 2010). Figure 4 depicts the conceptualization of the proposed model, with focus on ME incorporation phase.

Fig. 4. Conceptualization of the proposed model with focus on ME incorporation phase.

It is important to note that the phases of ME life cycle are not independent, i. e., the actions in any one phase can impact the other phases. Besides, each phase has specific stages, which must be appropriately planned and guided to obtain satisfactory results in respect of the patients. Thus, by monitoring the actions carried out in one phase of technology, and observing the consequent impact on other phases, one can plan in a better way the actions in other phases of the ME life cycle.

Against this background, a model was developed to support the ME incorporation process, as shown in Figure 5.

Information about the likely impact on the infrastructure can be obtained from the manufacturers. They usually offer architectonic projects and support structuring layouts for installing robust ME, such as robotic surgery system and magnetic resonance instrument

Clinical Engineering plays an important role, through Health Technology Management (HTM), in innovation, incorporation, usage/utilization and ME re-processing. Thus, the proposed model comes from HTM incorporation phase. It is important to highlight here that, in the last few years, the profile has been undergoing some changes in the incorporation process, which are not being released just in the HCC, but also in the entire health system. Therefore, the methodology aimed at helping this process must contemplate taking such actions that can be applied to the benefit of public health (Sônego, 2007; Santos & Garcia, 2010). Figure 4 depicts the conceptualization of the proposed model, with focus on

Fig. 4. Conceptualization of the proposed model with focus on ME incorporation phase.

It is important to note that the phases of ME life cycle are not independent, i. e., the actions in any one phase can impact the other phases. Besides, each phase has specific stages, which must be appropriately planned and guided to obtain satisfactory results in respect of the patients. Thus, by monitoring the actions carried out in one phase of technology, and observing the consequent impact on other phases, one can plan in a better way the actions in

Against this background, a model was developed to support the ME incorporation process,

**2.5 Proposed model for medical equipment incorporation** 

(Wang, 2009).

ME incorporation phase.

other phases of the ME life cycle.

as shown in Figure 5.

Fig. 5. Model depicting the process of health technology incorporation process, particularly ME. The proposal is based on decision making domains, technology assessment and HT incorporation. The domains establish interconnections, and there are multiple parameters and actors to be considered.

In the decision making domain, interconnections are made among the mind functions, decision making types and actions. The mind functions are made by analysis, synthesis and imagination, and evaluation. The analysis consists in separating a whole into its constituent parts, the synthesis and imagination is the reverse of analysis, that is, it presents or puts the things in groups to make a whole. Evaluation comes into action in mental activities, such as success criteria establishment, performance evaluation and judging people (Adair, 2007).

These functions can relate with those decision making types that can assume a reflective or deliberated form. The reflective one comes from the necessity of reflecting on how people make decisions based on their experiences, where they use the knowledge acquired by experience to identify and evaluate the situations and later make decisions (Fadok, Boyd & Warden, 1995; Zsambock, 1997). The deliberated form is based on reason, which supports the decision process, wherein the decision maker within his/her context will analyze, synthesize and evaluate to achieve the desired result (Klein, 1997; Joseph, 2007). So, from the interconnections between the mind functions and the decision making form, actions and post results can be created with the decision maker as the actor.

The decision analysis, which sets relevant technological alternatives, together with systematic review of studies about the effects of technology on health management, and the economic analysis that relates costs and effects, forms the main methodology used in HTA (Krauss-Silva, 2004).

Within the technology assessment domain, it is possible to choose and apply multi-criteria methodology to support decision making, and assessment methods of clinical evidences and

Planning Incorporation of Health Technology into Public Health Center 305

After assessing the eligibility and identifying the life cycle phase of the ME under consideration for incorporation, one must undertake a more detailed assessment of the technology. This assessment must satisfy all aspects of Classes I, II, III, IV considered in the

Classes I and II are essential in the evaluation process, because there must be evidences of safety and efficacy/effectiveness that satisfy at least the minimum conditions for using the technology without causing any harm to the patients and users. These parameters must be evaluated from the clinical data available in literature, systematic reviews or HTA approaches, such as the following: "*Methodological Guidelines: Health Technology Assessment Appraisals*" "(BRASIL, 2009a), "*Clinical Evidence for Medical Devices: Regulatory Processes Focusing on Europe and the United States of America* "(WHO, 2010) or "*Health Technology* 

In a rational sense, the ME incorporation team must satisfy itself about the quality of the available evidence and assess whether the criteria of safety and efficacy/effectiveness meet the minimum acceptable conditions required to proceed with the assessment of the ME

However, if the results obtained in Classes I and II are favorable, one must try evaluating Classes III and IV. Class III covers different aspects of infrastructure, human resources, maintenance and regulatory procedures. The investigators are encouraged to consider four

• Learning curve: This criterion refers to the time and effort required to train a user in effective use of the ME. For estimating these, the complexity of the ME must first be assessed, because the more complex the ME is, the more would be the time and effort required to train operators and technical team. For information relevant to this criterion, one must check with the distributors, manufacturers, similar ME inventories, and

• Installation ease: Installation ease is linked to infrastructure conditions, which may include alteration of physical space, adaptors, accessories, compatibility with other technologies, energy, water and gas supply nets, humidity and temperature controls, and input storage needs. Information relevant to these aspects can be obtained from

• Maintenance ease: This criterion covers all the conditions necessary for executing the maintenance plan. Foremost among them is the availability of professionals in the region, state or country, who can train the technicians and technology users in operating and maintaining the ME to be installed. Besides, one must also ensure a suitably worded guarantee, availability of spares, facilities for software updating, indigenous availability of authorized distributors, and possibility of finding a third party for maintenance through a contract that is linked to the purchasing of goods or even the renting of ME. The most important thing in meeting these requirements is to identify the best cost-benefit ratio that calls for no compromise in meeting the clinical needs, and the one that ensures optimum utilization of the useful

• Usability: As far as this criterion is concerned, no single technique can answer all the questions. Therefore, what is needed is a combination of techniques, considering the

applicant for incorporation. Failing this, it makes no sense to evaluate other aspects.

establishments that publish technical manuals about ME, such as ECRI.

regulatory establishments and sometimes manufacturer's manuals.

planning phase of incorporation, as shown in the model presented in Figure 5.

*Assessment Handbook*"(Jørgensen, 2007; Stenbæk &Jensen, 2007)*.* 

essential factors in this regard:

life time of the ME.

costs. The methodology that can be employed in the ME assessment includes, *inter alia,* the following approaches: calculation of Maintenance Expended Limits (MEL) value; economic analysis; Elimination and Choice Translation Reality (ELECTRE); Analytic Hierarchy Process (AHP); Multi-Attribute Failure Mode Analysis (MAFMA); Measuring Attractiveness by a Category Based Evaluation Technique (MACBETH); fuzzy logic; systematic review; Grading of Recommendations Assessment, Development and Evaluation (GRADE).

Lastly, the HT incorporation domain includes three stages: planning; proposal production; receiving and installation. These stages show multiple parameters to be evaluated. In the planning stage, four classes of parameters must be considered. These are Class I: Safety; Class II: Efficacy/Effectiveness; Class III: Infrastructure Impacts, Human Resources, Maintenance and Regulatory Aspects; and Class IV: TCO and Economic Analysis. The proposed production stage must enable technical specification of the technology to meet the clinical and technical needs. At the time of receiving the technology, one must check if the technology satisfies the technical specifications, and if it has all the essential accessories. Only after that, the equipment can be installed as planned and commissioned after performance and safety tests.

Thus, the architecture of the model depends on the inter-relations the domains, where the HT incorporation domain relates to the decision making one and the technology assessment one has multiple parameters and actors involved in the process (decision maker, health system and HCC).

#### **2.5.1 Surveying parameters to be evaluated**

Initially, the researcher must verify whether the foundation available for ME incorporation is strong enough to justify detailed assessment of health technology. This is because a thorough assessment of ME needs time, specialist professionals and consequently investments. If the foundation is found unfavorable, the assessment can be aborted with justifications based on the same questions raised for eligibility assessment, following the issues against item 2.3. However, depending on the context and technology under assessment, the incorporation team might ask additional questions during eligibility assessment for an initial map of the technology and thereby avoid wastage of time and investment over unjustified assessment or even unnecessary ME incorporation.

If the eligibility is found to be favorable to technology, one must identify the phase in which the ME is. This is important, because the ME in the adoption or incorporation phase will possibly have higher variation in clinical effect in comparison with that of the ME in usage phase. The ME in the obsolescence phase must be avoided, because of non-availability of spares and high maintenance costs.

It is important that this survey considers the life cycle phases of technology right from the acquisition phase. The ME identified as belonging to previous phases, such as 'under development' and 'pre-market', which are relevant to the health system, must be evaluated by the *Early awareness and alert systems* of EuroScan (Simpson et al., 2009). This is because the technology under the previous phases of incorporation has specific characteristics, mainly in relation to scientific safety evidence and efficacy/effectiveness, as the ME effect has not been observed in large scale.

costs. The methodology that can be employed in the ME assessment includes, *inter alia,* the following approaches: calculation of Maintenance Expended Limits (MEL) value; economic analysis; Elimination and Choice Translation Reality (ELECTRE); Analytic Hierarchy Process (AHP); Multi-Attribute Failure Mode Analysis (MAFMA); Measuring Attractiveness by a Category Based Evaluation Technique (MACBETH); fuzzy logic; systematic review;

Lastly, the HT incorporation domain includes three stages: planning; proposal production; receiving and installation. These stages show multiple parameters to be evaluated. In the planning stage, four classes of parameters must be considered. These are Class I: Safety; Class II: Efficacy/Effectiveness; Class III: Infrastructure Impacts, Human Resources, Maintenance and Regulatory Aspects; and Class IV: TCO and Economic Analysis. The proposed production stage must enable technical specification of the technology to meet the clinical and technical needs. At the time of receiving the technology, one must check if the technology satisfies the technical specifications, and if it has all the essential accessories. Only after that, the equipment can be installed as planned and commissioned after

Thus, the architecture of the model depends on the inter-relations the domains, where the HT incorporation domain relates to the decision making one and the technology assessment one has multiple parameters and actors involved in the process (decision maker, health

Initially, the researcher must verify whether the foundation available for ME incorporation is strong enough to justify detailed assessment of health technology. This is because a thorough assessment of ME needs time, specialist professionals and consequently investments. If the foundation is found unfavorable, the assessment can be aborted with justifications based on the same questions raised for eligibility assessment, following the issues against item 2.3. However, depending on the context and technology under assessment, the incorporation team might ask additional questions during eligibility assessment for an initial map of the technology and thereby avoid wastage of time and

If the eligibility is found to be favorable to technology, one must identify the phase in which the ME is. This is important, because the ME in the adoption or incorporation phase will possibly have higher variation in clinical effect in comparison with that of the ME in usage phase. The ME in the obsolescence phase must be avoided, because of non-availability of

It is important that this survey considers the life cycle phases of technology right from the acquisition phase. The ME identified as belonging to previous phases, such as 'under development' and 'pre-market', which are relevant to the health system, must be evaluated by the *Early awareness and alert systems* of EuroScan (Simpson et al., 2009). This is because the technology under the previous phases of incorporation has specific characteristics, mainly in relation to scientific safety evidence and efficacy/effectiveness, as the ME effect has not been

investment over unjustified assessment or even unnecessary ME incorporation.

Grading of Recommendations Assessment, Development and Evaluation (GRADE).

performance and safety tests.

**2.5.1 Surveying parameters to be evaluated** 

spares and high maintenance costs.

observed in large scale.

system and HCC).

After assessing the eligibility and identifying the life cycle phase of the ME under consideration for incorporation, one must undertake a more detailed assessment of the technology. This assessment must satisfy all aspects of Classes I, II, III, IV considered in the planning phase of incorporation, as shown in the model presented in Figure 5.

Classes I and II are essential in the evaluation process, because there must be evidences of safety and efficacy/effectiveness that satisfy at least the minimum conditions for using the technology without causing any harm to the patients and users. These parameters must be evaluated from the clinical data available in literature, systematic reviews or HTA approaches, such as the following: "*Methodological Guidelines: Health Technology Assessment Appraisals*" "(BRASIL, 2009a), "*Clinical Evidence for Medical Devices: Regulatory Processes Focusing on Europe and the United States of America* "(WHO, 2010) or "*Health Technology Assessment Handbook*"(Jørgensen, 2007; Stenbæk &Jensen, 2007)*.* 

In a rational sense, the ME incorporation team must satisfy itself about the quality of the available evidence and assess whether the criteria of safety and efficacy/effectiveness meet the minimum acceptable conditions required to proceed with the assessment of the ME applicant for incorporation. Failing this, it makes no sense to evaluate other aspects.

However, if the results obtained in Classes I and II are favorable, one must try evaluating Classes III and IV. Class III covers different aspects of infrastructure, human resources, maintenance and regulatory procedures. The investigators are encouraged to consider four essential factors in this regard:


Planning Incorporation of Health Technology into Public Health Center 307

creates poverty. Within the vicious circle of higher income is good health and good health is

The Clinical Engineering can contribute, through administration and management of ME, to the preparation, guidance and observation of the impact of methodologies aimed at ME incorporation planning in the HCC in the context of health systems. Additionally, adequate incorporation planning requires multidisciplinary knowledge; so, the Clinical Engineer, who has multidisciplinary education, can act as a facilitator by establishing an interface among the actors involved in ME incorporation and by promoting the culture of constant monitoring of the impact of technology on health, after its incorporation in the health system. The observation of the impacts and the lessons learnt from past and recent needs can contribute to planning future incorporation, (Moraes, 2007; Santos & Garcia, 2010;

Many times, technology management in health is seen as an independent task, but for a few links with other parts of the health service. In other words, in the past, the technical personnel were hardly ever involved in crucial activities such as investment plans, service quality evaluation or organizational issues. However, this scenario has been undergoing some change in the last few years. So, ME management can now be clearly defined as an integral part of the health system and its activity felt at all levels of the public health service

The ME cannot be managed in isolation, but only with other components of the health care, including the aims, procedures, finances, level of personnel and support systems at each health service level. To accomplish this, the creation of a multidisciplinary group of management of technology is recommended for each level (local, estate, and national). This group must have representatives of different disciplines: medical, clinical, clinical engineering, support service, purchasing sector, financial and maintenance team of ME

Within this context, the incorporated ME is fundamental to health care service, particularly to diagnosis and disease treatment. The available and accessible ME in health care environment is related to the equity and health service offer that is more relevant to the patients' needs. Any national health plan needs policies, strategies and plans of action to health technologies, especially the ME. A robust health system must guarantee access to safe, efficient and high quality ME, in order to prevent, diagnose and treat diseases and injuries, and help the patients in their rehabilitation, and to promote public health (WHO,

ME incorporation is an important element of the HTM. This is a complex and multidisciplinary process for developing the activities to support decision making, though some members of the health team and distributors believe that it is just the action of purchasing. For example, costs outside the budget for additional accessories may become necessary after the supply order for ME has already been placed. Or, some unexpected changes may become necessary in installation plans, because the dimensions and other specifications of the ME have not been properly worked out. This entails considerable costs and delays, besides impairing the quality of the public health system. Yet, the technology may remain completely unused, consequently its use can harm the patient or personnel, thus impacting the public health in a negative way (Harding & Epstein, 2006). It underlines

related with higher income and welfare (WHO, 2011b).

Signori & Garcia, 2010).

(KAUR, 2005a).

(KAUR, 2005a).

2011b).

medical environment limitations, and the human costs in terms of fatigue, stress, frustration, discomfort and satisfaction, learning talent, ME use tax, adaptability to the task and the user's needs, and user's characteristics. To achieve global usability, one must address the following measures:


The usage measures cited above (or their estimates) can be obtained by interviewing the clinical team or from similar ME inventories, and pre-market study reports submitted to the departments concerned by the registrar of commerce, for example, ANVISA4 and FDA5.

As regards Class IV costs, the criteria that must be considered are those, which might be covered by the TCO and economic analysis. The TCO corresponds to the sum of the costs of acquisition, operation, maintenance, training and replacement. Calculating these costs is sometimes challenging. Therefore, they might be estimated on the basis of information gathered from the distributors, manufacturers and HTA reports. The idea behind estimating the total property cost is to ensure that one does not go just by the acquisition cost, which can be attractive, but also other costs that might go against technology usage.

Through economic analysis, one can investigate the cost-benefit relation to ascertain if the results obtained from the technology under assessment justify the costs, and whether they compare favorably with other technological options that show good cost-benefit relations. Instructions on economic analysis with focus on health technologies can be obtained from the guide "*Methodological Guidelines: Economic Evaluation of Health Technologies*" (BRASIL, 2009b).

These guidelines would be helpful in undertaking the team activities of ME incorporation. However, with the help of the Clinical Engineer, one can add another criterion. The incorporation process will be a challenging one in the context of variations related to geographical regions, health policies, demand, human and financial resources, and cultural aspects, among other pertinent factors.

#### **3. Conclusions**

One of the factors that reaffirms the importance of ME incorporation is the improvement in people's health during the last decade, an achievement that could not reach the poor and other socially marginalized or excluded groups earlier. Increasing inequalities in health status are more evident in rural areas. This situation was created by the uneven distribution of money, power and other resources at global, national and local levels, which were in turn influenced by political equations. The health social determinant is mainly responsible for the inequalities in health. The available evidence points to a two-way relationship between poverty and health. Within this vicious circle, poverty creates poor health, and poor health

<sup>4</sup> http://portal.anvisa.gov.br

<sup>5</sup> http://www.fda.gov/

must address the following measures:

cost of task realization.

aspects, among other pertinent factors.

2009b).

**3. Conclusions** 

4 http://portal.anvisa.gov.br 5 http://www.fda.gov/

successfully, and the average of completed tasks.

• Satisfaction: Satisfaction scale and frequency of use and complaints.

can be attractive, but also other costs that might go against technology usage.

medical environment limitations, and the human costs in terms of fatigue, stress, frustration, discomfort and satisfaction, learning talent, ME use tax, adaptability to the task and the user's needs, and user's characteristics. To achieve global usability, one

• Efficacy: Percentage of aims realized, and of users who completed the task

• Efficiency: Time to complete a task, tasks completed per unit of time and monetary

The usage measures cited above (or their estimates) can be obtained by interviewing the clinical team or from similar ME inventories, and pre-market study reports submitted to the departments concerned by the registrar of commerce, for example, ANVISA4 and FDA5.

As regards Class IV costs, the criteria that must be considered are those, which might be covered by the TCO and economic analysis. The TCO corresponds to the sum of the costs of acquisition, operation, maintenance, training and replacement. Calculating these costs is sometimes challenging. Therefore, they might be estimated on the basis of information gathered from the distributors, manufacturers and HTA reports. The idea behind estimating the total property cost is to ensure that one does not go just by the acquisition cost, which

Through economic analysis, one can investigate the cost-benefit relation to ascertain if the results obtained from the technology under assessment justify the costs, and whether they compare favorably with other technological options that show good cost-benefit relations. Instructions on economic analysis with focus on health technologies can be obtained from the guide "*Methodological Guidelines: Economic Evaluation of Health Technologies*" (BRASIL,

These guidelines would be helpful in undertaking the team activities of ME incorporation. However, with the help of the Clinical Engineer, one can add another criterion. The incorporation process will be a challenging one in the context of variations related to geographical regions, health policies, demand, human and financial resources, and cultural

One of the factors that reaffirms the importance of ME incorporation is the improvement in people's health during the last decade, an achievement that could not reach the poor and other socially marginalized or excluded groups earlier. Increasing inequalities in health status are more evident in rural areas. This situation was created by the uneven distribution of money, power and other resources at global, national and local levels, which were in turn influenced by political equations. The health social determinant is mainly responsible for the inequalities in health. The available evidence points to a two-way relationship between poverty and health. Within this vicious circle, poverty creates poor health, and poor health creates poverty. Within the vicious circle of higher income is good health and good health is related with higher income and welfare (WHO, 2011b).

The Clinical Engineering can contribute, through administration and management of ME, to the preparation, guidance and observation of the impact of methodologies aimed at ME incorporation planning in the HCC in the context of health systems. Additionally, adequate incorporation planning requires multidisciplinary knowledge; so, the Clinical Engineer, who has multidisciplinary education, can act as a facilitator by establishing an interface among the actors involved in ME incorporation and by promoting the culture of constant monitoring of the impact of technology on health, after its incorporation in the health system. The observation of the impacts and the lessons learnt from past and recent needs can contribute to planning future incorporation, (Moraes, 2007; Santos & Garcia, 2010; Signori & Garcia, 2010).

Many times, technology management in health is seen as an independent task, but for a few links with other parts of the health service. In other words, in the past, the technical personnel were hardly ever involved in crucial activities such as investment plans, service quality evaluation or organizational issues. However, this scenario has been undergoing some change in the last few years. So, ME management can now be clearly defined as an integral part of the health system and its activity felt at all levels of the public health service (KAUR, 2005a).

The ME cannot be managed in isolation, but only with other components of the health care, including the aims, procedures, finances, level of personnel and support systems at each health service level. To accomplish this, the creation of a multidisciplinary group of management of technology is recommended for each level (local, estate, and national). This group must have representatives of different disciplines: medical, clinical, clinical engineering, support service, purchasing sector, financial and maintenance team of ME (KAUR, 2005a).

Within this context, the incorporated ME is fundamental to health care service, particularly to diagnosis and disease treatment. The available and accessible ME in health care environment is related to the equity and health service offer that is more relevant to the patients' needs. Any national health plan needs policies, strategies and plans of action to health technologies, especially the ME. A robust health system must guarantee access to safe, efficient and high quality ME, in order to prevent, diagnose and treat diseases and injuries, and help the patients in their rehabilitation, and to promote public health (WHO, 2011b).

ME incorporation is an important element of the HTM. This is a complex and multidisciplinary process for developing the activities to support decision making, though some members of the health team and distributors believe that it is just the action of purchasing. For example, costs outside the budget for additional accessories may become necessary after the supply order for ME has already been placed. Or, some unexpected changes may become necessary in installation plans, because the dimensions and other specifications of the ME have not been properly worked out. This entails considerable costs and delays, besides impairing the quality of the public health system. Yet, the technology may remain completely unused, consequently its use can harm the patient or personnel, thus impacting the public health in a negative way (Harding & Epstein, 2006). It underlines

Planning Incorporation of Health Technology into Public Health Center 309

Anzanello, M. J., & Fogliatto, F. S. (2007). Curvas de Aprendizado: Estado da Arte e

BRASIL. Ministério da Saúde. (2009a). Secretaria de Ciência, Tecnologia e Insumos

BRASIL. Ministério da Saúde. (2009b). Secretaria de Ciência, Tecnologia e Insumos

Calil, S. J. (2007). Caminhos para a Incorporação de Tecnologias em Saúde. *Debates GV* 

Calil, Saide J.; Teixeira, Marilda S. (1998). Gerenciamento de Manutenção de Equipamentos

Coe, G. & Banta, D. (1992). Health Care Technology Transfer in Latin America and the

Cheng, M. (2004). A Strategy to Maintain Essential Medical Equipment in Developing

from<http://www.elsevier.com/wps/find/bookdescription.cws\_home/702695/descriptio

Centers for Medicare and Medicaid Services. (2000). Review of Assumptions and Methods

Cutler, D. M., & Mcclellan, M. Is Technological Change in Medicine Worth it?. *Health Affairs*,

David, Y. & Judd, T.M. Medical Technology Management, Space Labs Medical (Medical Inc.

David, Y., & Jahnke, E. G. (2005). Medical Technology Management: From Planning to

Dar-El, E. (2000). *Human Learning: from Learning Curves to Learning Organizations* (1 edition),

Fadok, D. S., Boyd, J., & Warden, J. (1995). Air Power's Quest for Strategic Paralysis, In:

Gibson, J. L., Martin, D. K., & Singer, P. A. (2004). Setting Priorities in Health Care

Caribbean, *International Journal Technology Assessment Health Care*, Vol. 8, No. 2,

Countries, In: *Clinical Engineering Handbook,* Joseph Dyro, pp. (133-134), Academic

of the Medicare Trustees Financial Projections, In: *Technical Review Panel on the* 

<https://www.cms.gov/reportstrustfunds/downloads/TechnicalPanelReport2000.pdf>

Application. *Proceedings of the 2005 IEEE Engineering in Medicine and Biology 27th* 

*School of Advanced Air Power Studies*, 12 April 2011, Available from:

Organizations: Criteria, Processes and Parameters of Success. *BMC Health Services* 

*Saúde*, Vol. 3, (Primeiro Semestre de 2007), pp. (31-34)

Hospitalares. Série Saúde & Cidadania, v.11, pp. (8-47).

*Medicare Trustees Reports*, March 2011, Available from:

Biophysical Messurement Series), Redmond, WA, 1993

*Annual Conference,* Shanghai, China, September 1-4, 2005

Vol. 20, No. 5, (September 2001), pp. (11-29)

Springer, ISBN-10: 0792379438, New York

*Research*, Vol. 4, No. 1, pp. (17-25)

<http://dodreports.com/pdf/ada291621.pdf>

(109-123)

\_2009.pdf >

ude\_2009.pdf >

Press, Retrieved

n#description>

(March 1992), pp. (255-267)

03 September 2011, Available from:

Perspectivas de Pesquisa. *Gestão da Produção*, Vol. 14, No. 1, (jan.-abr. 2007), pp.

Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes Metodológicas: Elaboração de Pareceres Técnico-Científico, In: *Instituto Nacional do Cancer (INCA)*,

<http://www1.inca.gov.br/inca/Arquivos/publicacoes/diretrizes\_PTC\_2\_edicao

Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes Metodológicas: Estudos de Avaliação Econômica de Tecnologia em Saúde, In: *Biblioteca Virtual em Saúde. Ministério da Saúde*, 03 September 2011, Available from: < http://bvsms.saude.gov.br/bvs/publicacoes/avaliacao\_economica\_tecnologias\_sa

the need to systematize the ME incorporation process and thereby mitigate or eliminate some negative factors of the process that can affect the technology life cycle.

The model proposed here is based on constructing three domains: Decision Making; Technology Assessment and ME incorporation. It can help the incorporation team in identifying, predicting and guiding the realization of measures to minimize possible unfavorable impacts, as also to maximize the benefits obtained through ME incorporation. This is possible because the model has been built on scientific evidence and reliable information available in literature. Besides, the proposed model would be helpful to future researches in that it represents a consolidated methodology that deals with the multiple parameters involved in the ME incorporation process in a systematic and rational way. The Clinical Engineer, as a multidisciplinary education professional, can be a fundamental actor in methodology development and a facilitator of ME incorporation, which can ensure health service deliverance in a safe, effective, and equitable way, besides rational utilization of the resources in the developing countries.

One can observe that health technology, particularly ME, suffers from lack of clinical evidences in the innovation and incorporation phases of the life cycle. Besides, a higher variation is expected on the clinical effect as compared with the technology under wide usage. This is because the technology that belongs to the initial phases has not been monitored on a large enough scale. Therefore, at the time of incorporation, one must prioritize the ME that is in the usage phase. The Clinical Engineering can be helpful to the incorporation team in the identification phase of the life cycle, as well as in the search, selection and assessment of available evidences in literature so as to ensure that the technology to be incorporated is safe and effective. So, the deliverance of health system with quality and equality contributes to the promotion of public health (Sônego, 2007).

Additionally, it is important to highlight that the phases of technology life cycle are not independent, i. e., actions in any one phase can impact other phases. For example, an inadequate incorporation plan can lead to high costs of maintenance, unavailability of technology, risks to patients and users, and spilling of unsatisfactory clinical results into other phases of the ME life cycle (Moraes, 2007).

Lastly, one must note that, after ME incorporation, the Clinical Engineer retains the management of other phases of technology life cycle with him for future ME updating, improvement and replacement. The services of Clinical Engineering are more necessary at this stage to deal with the responsibility of ME management program within the framework of guidelines that range from the strategic phase to the replacement phase.

#### **4. Acknowledgment**

The authors are thankful to the CAPES (Coordination of Improvement of Higher Education Personnel) for financial support, and IEB-UFSC, for motivation and support to this research.

#### **5. References**

Adair, J. E. (2007). *Decision Making & Problem Solving Strategies* (2nd ed), Kogan Page, ISBN 10 0 7494 4918 7, Philadelphia, USA

the need to systematize the ME incorporation process and thereby mitigate or eliminate

The model proposed here is based on constructing three domains: Decision Making; Technology Assessment and ME incorporation. It can help the incorporation team in identifying, predicting and guiding the realization of measures to minimize possible unfavorable impacts, as also to maximize the benefits obtained through ME incorporation. This is possible because the model has been built on scientific evidence and reliable information available in literature. Besides, the proposed model would be helpful to future researches in that it represents a consolidated methodology that deals with the multiple parameters involved in the ME incorporation process in a systematic and rational way. The Clinical Engineer, as a multidisciplinary education professional, can be a fundamental actor in methodology development and a facilitator of ME incorporation, which can ensure health service deliverance in a safe, effective, and equitable way, besides rational utilization of the

One can observe that health technology, particularly ME, suffers from lack of clinical evidences in the innovation and incorporation phases of the life cycle. Besides, a higher variation is expected on the clinical effect as compared with the technology under wide usage. This is because the technology that belongs to the initial phases has not been monitored on a large enough scale. Therefore, at the time of incorporation, one must prioritize the ME that is in the usage phase. The Clinical Engineering can be helpful to the incorporation team in the identification phase of the life cycle, as well as in the search, selection and assessment of available evidences in literature so as to ensure that the technology to be incorporated is safe and effective. So, the deliverance of health system with

Additionally, it is important to highlight that the phases of technology life cycle are not independent, i. e., actions in any one phase can impact other phases. For example, an inadequate incorporation plan can lead to high costs of maintenance, unavailability of technology, risks to patients and users, and spilling of unsatisfactory clinical results into

Lastly, one must note that, after ME incorporation, the Clinical Engineer retains the management of other phases of technology life cycle with him for future ME updating, improvement and replacement. The services of Clinical Engineering are more necessary at this stage to deal with the responsibility of ME management program within the framework

The authors are thankful to the CAPES (Coordination of Improvement of Higher Education Personnel) for financial support, and IEB-UFSC, for motivation and support to this research.

Adair, J. E. (2007). *Decision Making & Problem Solving Strategies* (2nd ed), Kogan Page, ISBN

quality and equality contributes to the promotion of public health (Sônego, 2007).

of guidelines that range from the strategic phase to the replacement phase.

some negative factors of the process that can affect the technology life cycle.

resources in the developing countries.

other phases of the ME life cycle (Moraes, 2007).

10 0 7494 4918 7, Philadelphia, USA

**4. Acknowledgment** 

**5. References** 


<http://www1.inca.gov.br/inca/Arquivos/publicacoes/diretrizes\_PTC\_2\_edicao \_2009.pdf >


<https://www.cms.gov/reportstrustfunds/downloads/TechnicalPanelReport2000.pdf>


Planning Incorporation of Health Technology into Public Health Center 311

Robert, G., Greenhalgh, T. MacFarlane, & F., Peacock, R. Organisantional Factors

Santos, F. A. & Garcia, R. (2010). Decision Process Model to the Health Technology

Santos, R. Souza, R. E. H. & Garcia, R. Health Care Technology Management Applied to

Sarwar, S. G., & Robinson, I. (2007). Benefits of and Barriers to Involving Users in Medical

Simpson S., Hiller J., Gutierrez-Ibarluzea I., Kearney B., Norderhaug I., Fay AF., Packer C.,

*Assessment in Health Care*, Vol. 23, No 1 , (January 2007), pp. (131-137) Signori, M. R. & Garcia, R. Clinical Engineering and Risk Management in Healthcare

Buenos Aires, Argentina, August 31 - September 4, 2010

No. 7272, (November 2000), pp. (1316-1318)

*Executive*, Vol. 3, No. 6, (Nov./Dec. 1988), p.p (26-29)

<http://www.un.org/en/documents/udhr/index.shtml>

September 4, 2010

Retrieved from

08 August 2011, Available from:

*on Medical Devices*, Bangkok, Thailand, September 9-11, 2010

Influencing Technology Adoption and Assimilation in the NHS: A Systematic Literature Review, In: *National Institute for Health Research (NHS),* July 2011, Available from: < http://www.sdo.nihr.ac.uk/files/project/223-final-report.pdf >

Incorporation, *Proceedings of 32nd Annual International Conference of the IEEE EMBS*,

Public Hospitals in Santa Catarina – Brazil, *Proceedings of First WHO Global Forum* 

Device Technology Development and Evaluation. *International Journal of Technology* 

Technological Process Using Architecture Framework. *Proceedings of 32nd Annual International Conference of the IEEE EMBS*. Buenos Aires, Argentina, August 31 -

Asua J., Benguria G., Blanchard S., Blozik E., Bonnevie BM., Clifford T., Eckerlund I., Galnares L., Groeneveld K., Hae Lee Robin S., Hakak N., Husereau D., Ibargoyen N., Kaila M., Künzli C., Llanos A., Luengo S., Morrison A., Mundy L., Tal O., Wallgren L., & Wallin J. (June 2009). A Toolkit for the Identification and Assessment of New and Emerging Health Technologies, In *EuroScan International Network*, July 2009, Retrieved from <http://www.euroscan.org.uk/methods> Singer, P. A., Martin, D. K., Giacomini, M., & Pardy, L. (2000) Priority Setting for New

Technologies in Medicine: Qualitative Case Study. *British Medical Journal*, Vol. 321,

Equipamentos Eletromédicos, In: *Universidade Federal de Santa Catarina*, October

Finn Børlum Kristensen and Helga Sigmund, pp. (47-56), National Board of Health

<http://www.sst.dk/publ/Publ2008/MTV/Metode/HTA\_Handbook\_net\_final.pdf >

Objectives, Role of Evidence, and Structure in Europe. Copenhagen, In: *World Health Organization Regional Office for Europe*, 10 October 2011, Available from: <http://www.euro.who.int/\_\_data/assets/pdf\_file/0018/90432/E87866.pdf>

Souza, A. F., Heringer, C., H. T., Junior, J. S., & Moll, J. R. (2010). *Gestão de Manutenção em Serviços de Saúde* (First edition). Ed. Blucher, ISBN 9788521205630, São Paulo Sonego, F. (2007). Estudo de Métodos de Avaliação de Tecnologias em Saúde Aplicada a

2011, Available from < http://www.tede.ufsc.br/teses/PEEL1174-D.pdf > Sprague, G. R. (1988). Managing Technology Assessment and Acquisition. Healthcare

Stenbæk, D. E., & Jensen, M. F. (2007). Literature searches, In: *Health Technology Assessment,* 

United Nations. (1948). Universal Declaration of Human Rights. Geneva. In: *United Nations*,

Velasco-Garrido M. & Busse R. (2005). Health Technology Assessment: An Introduction to


<http://www.who.int/management/procure\_commission\_healthcare.pdf>

Kaur, M., Fagerli, T., Temple-Bird, C., Lenel, A., & Kawohl, W. (2005b). How to Organize a System of Healthcare Technology Management, In: *World Health Organization*, September 2011, Available from:

<http://www.who.int/management/organize\_system\_%20healthcare.pdf >


 <http://www.dominiopublico.gov.br/pesquisa/DetalheObraForm.do?select\_actio n=&co\_obra=199521>


ion#description

Harding, G., & Epstein, A. (2004). Technology Procurement, In: *Clinical Engineering* 

HTA GLOSSARY. International Network of Agencies for Health Technology Assessment

Kaur, M., Fagerli, T., Temple-Bird, C., Lenel, A., & Kawohl, W. (2005a). How to Procure and

<http://www.who.int/management/procure\_commission\_healthcare.pdf> Kaur, M., Fagerli, T., Temple-Bird, C., Lenel, A., & Kawohl, W. (2005b). How to Organize a

 <http://www.who.int/management/organize\_system\_%20healthcare.pdf > Krauss-Silva, L. (2004). Avaliação Tecnológica em Saúde: Questões Metodológicas e Operacionais. *Cadernos de Saúde Pública*, Vol. 2, No. 2, (January 2004), pp. (199-207) Klein, G. (1997). An Overview of Naturalistic Decision Making Applications, In: *Naturalistic* 

Associates, ISBN 0-8058-1873-1, Mahway, New Jersey

*Rehabilitation*, Vol. 24, No. 3, (February 15), pp. (106-114)

ion#description>

2011, Available from:

nal.pdf>

Available from:

n=&co\_obra=199521>

medical-devices.pdf>

ion#description

pp. (133-134), Academic Press, Retrieved from

<http://www.htaglossary.net>

September 2011, Available from:

*Handbook,* Joseph Dyro, pp. (118-122), Academic Press, Retrieved from < http://www.elsevier.com/wps/find/bookdescription.cws\_home/702695/descript

and Health Technology Assessment international, August 2010, Available from

Commission your Healthcare Technology, In: *World Health Organization*, September

System of Healthcare Technology Management, In: *World Health Organization*,

*Decision Making*. Gary Klein & Caroline Zsambock, pp. (49-57), Lawrence Erlbaum

Manual Wheelchairs for Three Individuals with Spinal Cord Injury. *Disability and* 

Kristensen and Helga Sigmund, pp. (57-67), National Board of Health, Retrieved from<http://www.sst.dk/publ/Publ2008/MTV/Metode/HTA\_Handbook\_net\_fi

Assessment (HTA) Development: A way to Increase Impact. *International Journal of Technology Assessment in Health Care*, Vol. 21, No. 2 , (April 2005), pp. (263-267) Moraes, L. (2007). Metodologia para Auxiliar na Definição de Indicadores de Desempenho

para a Gestão da Tecnologia Médico-Hospitalar, In: *Domínio Público*, 21 July 2011,

(2005), In: *National Institute for Health Research (NHS),* July 2011, Available from: <http://www.eastcheshire.nhs.uk/About-The-Trust/policies/T/Training-on-

Kittel, A., Marco, A. D., & Steward, H. (2002). Factors Influencing the Decision to Abandon

Joseph, A. (2007). Decision Management, *Proceedings of IEEE Military Communications Conference*, ISBN 978-1-4244-1513-7, Orlando, FL, USA, October 2007 Jørgensen, H. (2007) . Assessment of literature, In: *Health Technology Assessment,* Finn Børlum

Mcgregor, M., & Brophy, J. M. (2005) End-user Involvement in Health Technology

<http://www.dominiopublico.gov.br/pesquisa/DetalheObraForm.do?select\_actio

NHS - National Health Research. Policy for Training in the Safe Use of Medical Devices

Raymond, P. Z. (2004). Clinical Engineering, In: *Clinical Engineering Handbook,* Joseph Dyro,

http://www.elsevier.com/wps/find/bookdescription.cws\_home/702695/descript


<http://www.sst.dk/publ/Publ2008/MTV/Metode/HTA\_Handbook\_net\_final.pdf >

United Nations. (1948). Universal Declaration of Human Rights. Geneva. In: *United Nations*, 08 August 2011, Available from:

<http://www.un.org/en/documents/udhr/index.shtml>

Velasco-Garrido M. & Busse R. (2005). Health Technology Assessment: An Introduction to Objectives, Role of Evidence, and Structure in Europe. Copenhagen, In: *World Health Organization Regional Office for Europe*, 10 October 2011, Available from: <http://www.euro.who.int/\_\_data/assets/pdf\_file/0018/90432/E87866.pdf>

**14** 

*1Ministry of Health,* 

*1,2Republic of Benin 3The Netherlands* 

**Policy and Management of** 

**Health Care Sector in Benin** 

*2Polytechnic School, University of Abomey-Calavi, 3Athena Institute, Vrije Universiteit, Amsterdam,* 

**Medical Devices for the Public** 

P. Th. Houngbo1,3, G. J. v. d. Wilt3, D. Medenou2, L. Y. Dakpanon1,2, J. Bunders3 and J. Ruitenberg3

Health technology, according to WHO is the application of organized knowledge and skills in the form of devices, medicine, vaccines, procedures and systems development to solve a health problem and improve quality of lives4. When used in this paper, the term healthcare technology means the different types of devices or equipment used in health facilities. Its encompasses: medical equipment for clinical use; hospital furniture; vehicles; service Supplies; plant; communication equipment; fire fighting equipment; fixtures built into the building; office equipment; office furniture; training equipment, walking aids and workshop

Healthcare technologies offer many benefits and have greatly enhanced the ability of health professionals to prevent, diagnose and treat diseases11. They are one of the essential elements for the delivery of health services. The use of technology in health care systems in developing and transition countries faces a great number of difficulties. Since about 95% of the healthcare technology used in these countries is imported30; mismatches occur because the technology development process has not usually considered the needs and realities of the target environments. These mismatches in the technology transfer process to countries with financial and technical constraints are often of great significance. Thus, in Benin, medical devices and equipment represent a significant proportion of national health care expenditure. Each year, more than 10,600,000 US\$, (about 20%)20 of the national health budget, are spent on procurement of medical devices and equipment for healthcare facilities. Despite this great amount of money spent each year on an ever-increasing array of medical devices and equipment, not enough attention is paid to the equipment use and maintenance. Management of medical devices is not yet recognised as an integral part of public health policy. Planning, follow up and maintenance of the equipment are inefficient

**1. Introduction** 

equipment.

and ineffective 12, 13, 14, 15, 16, 17, 18, 19, 20, and 21.


<http://whqlibdoc.who.int/publications/2011/9789241501538\_eng.pdf >

WHO - World Health Organization. (2011d). Medical Device Technical Series. Needs Assessment for Medical Devices, In: *World Health Organization*, 23 July 2011, Available from:

<http://whqlibdoc.who.int/publications/2011/9789241501385\_eng.pdf >


### **Policy and Management of Medical Devices for the Public Health Care Sector in Benin**

P. Th. Houngbo1,3, G. J. v. d. Wilt3, D. Medenou2, L. Y. Dakpanon1,2, J. Bunders3 and J. Ruitenberg3 *1Ministry of Health, 2Polytechnic School, University of Abomey-Calavi, 3Athena Institute, Vrije Universiteit, Amsterdam, 1,2Republic of Benin 3The Netherlands* 

#### **1. Introduction**

312 Public Health – Methodology, Environmental and Systems Issues

Wang, B. (2009). Strategic Health Technology Incorporation, In: Synthesis Lectures on

<http://www.morganclaypool.com/doi/abs/10.2200/S00216ED1V01Y200908BM

WHA - World Health Assembly. (2007). Health Technologies, Sixtieth World Health

WHO - World Health Organization. (2007). Everybody's Business: Strengthening Health

WHO - World Health Organization. (2008). World Health Report 2008: Primary Health

WHO - World Health Organization. (2009). Systems Thinking for Health Systems

<http://whqlibdoc.who.int/publications/2009/9789241563895\_eng.pdf> WHO - World Health Organization. (2011a). Medical Device Technical Series. Procurement

<http://whqlibdoc.who.int/publications/2011/9789241501378\_eng.pdf> WHO - World Health Organization. (2011b). Medical Device Technical Series. Development

<http://whqlibdoc.who.int/publications/2011/9789241501538\_eng.pdf > WHO - World Health Organization. (2011d). Medical Device Technical Series. Needs

Woodside, A. G., Breaux, R., & Briguglio, E. (1998). Testing Care-Giver Acceptance of New

Zsambock, C. (1997). Naturalistic Decision Making Where Are We Now?, *In: Naturalistic* 

<http://whqlibdoc.who.int/publications/2011/9789241501385\_eng.pdf >

Associates, ISBN 0-8058-1874-X, Mahway, New Jersey

<http://apps.who.int/gb/ebwha/pdf\_files/WHASSA\_WHA60-Rec1/E/cover-

<http://www.who.int/healthsystems/strategy/everybodys\_business.pdf>

Publishers Series, Retrieved from

Sebtember 2011, Available from:

*Health Organization*, 12 July 2011, Available from:

from: <http://www.who.int/whr/2008/whr08\_en.pdf>

E032?journalCode=bme >

July 2011, Available from:

Available from:

3/4/5, pp (446-457)

intro-60-en.pdf>

Biomedical Engineering, John D. Enderle, pp. (5-61), Morgan & Claypool

Assembly Agenda item 12.19. WHA60.29. In: *World Health Organization*, 15

Systems to Improve Health Outcomes: WHO's Framework for Action, In: *World* 

Care–Now More than Ever. In: *World Health Organization*, 10 July 2011, Available

Strengthening, In: *World Health Organization*, 14 July 2011, Available from:

Process Resource Guide, In: *World Health Organization*, 16 July 2011, Available from:

of Medical Device Policies, In: *World Health Organization*, 16 July 2011, Available from: < http://whqlibdoc.who.int/publications/2011/9789241501637\_eng.pdf> WHO - World Health Organization. (2011c). Medical Device Technical Series. Medical

Equipment Maintenance Programme Overview, In: *World Health Organization*, 17

Assessment for Medical Devices, In: *World Health Organization*, 23 July 2011,

Syringe Technologies. *International Journal of Technology Management*, Vol. 15, No.

*Decision Making*, Gary Klein & Caroline Zsambock, pp (3-28), Lawrence Erlbaum

Health technology, according to WHO is the application of organized knowledge and skills in the form of devices, medicine, vaccines, procedures and systems development to solve a health problem and improve quality of lives4. When used in this paper, the term healthcare technology means the different types of devices or equipment used in health facilities. Its encompasses: medical equipment for clinical use; hospital furniture; vehicles; service Supplies; plant; communication equipment; fire fighting equipment; fixtures built into the building; office equipment; office furniture; training equipment, walking aids and workshop equipment.

Healthcare technologies offer many benefits and have greatly enhanced the ability of health professionals to prevent, diagnose and treat diseases11. They are one of the essential elements for the delivery of health services. The use of technology in health care systems in developing and transition countries faces a great number of difficulties. Since about 95% of the healthcare technology used in these countries is imported30; mismatches occur because the technology development process has not usually considered the needs and realities of the target environments. These mismatches in the technology transfer process to countries with financial and technical constraints are often of great significance. Thus, in Benin, medical devices and equipment represent a significant proportion of national health care expenditure. Each year, more than 10,600,000 US\$, (about 20%)20 of the national health budget, are spent on procurement of medical devices and equipment for healthcare facilities. Despite this great amount of money spent each year on an ever-increasing array of medical devices and equipment, not enough attention is paid to the equipment use and maintenance. Management of medical devices is not yet recognised as an integral part of public health policy. Planning, follow up and maintenance of the equipment are inefficient and ineffective 12, 13, 14, 15, 16, 17, 18, 19, 20, and 21.

Policy and Management of Medical Devices for the Public Health Care Sector in Benin 315

**Indicators** 

The public healthcare system of the country has been reorganized according to the decentralization policy and consists of three levels: **central** with the National Referral Hospital (> 600 beds), **intermediate** with five Province or Departmental Hospitals (>100 beds) and **peripheral** with thirty four Health Zones, twenty seven fairly functional Zone Hospitals (> 46 beds), seventy seven Communal Health Centers, four hundred eighty seven Arrondissement Health Centers and many Village Health Units and other private health facilities. Apart from that, the health system also has the following public hospitals: the Mother and Child Hospital, many detection and treatment centers for tuberculosis and leprosy, the National Hospital for Psychiatry, the National Hospital for Gerontology, two

Healthcare technology management and maintenance remains one of the main challenges of the developing countries healthcare systems in general and, of Benin particularly. Thus, although many financial resources are used for procurement of devices, not enough attention is paid to their future. While some of the equipment were donated, a significant portion was purchased with loans provided by bilateral and multilateral agencies and will have to be paid back with great sacrifice26. One of the root causes of the equipment idleness is the lack of effective management. It is important to point out that despite the several initiatives undertaken by the ministry of health to improve the *healthcare technology* 

Many facilities, especially Zone Hospitals, continue to lack the basic technologies they need to provide quality care to the patients, because equipment is unavailable, inoperative, misused or inappropriate. The situation is most severe in the Communal and Arrondissement health facilities far from the first referral hospitals. This has far-reaching implications for the prevention and treatment of disease and disability and often leads to a

 Population in 2006 7,839,914 Human Development Index 0.437 Country rank 163/177 GPD per capita (Purchasing Power Parity US\$) 1,141 Life expectancy at birth (years) 55.4 Public expenditure on health (% of GPD) in 2004 4.5 Health expenditure per capita (PPP US\$) in 2004 40 Infant mortality rate per 1,000 live births 67 Maternal mortality ratio per 100,000 live births 474 HIV/AIDS prevalence (%) 2.0 Adult literacy rate (% ages 15 and older) 34.7

*Sources:* 1. Human Development Reports: 2007/2008; 2. Benin Demographic and Health Survey 2006; 3. Benin Health Statistics Directory 2006.

Buruli Ulceration Treatment Centers12 etc…

**2.2 The health system** 

waste of scarce resources.

Table 1. Selected demographic and health indicators of Benin

**2.3 Healthcare technology management and maintenance** 

*management cycle* no significant changes have been noticed13, 14, 15, 16 and 17.

This study, supported by the *Netherlands Organisation for International Cooperation in Higher Education* (NUFFIC) from 2007 was conducted in Benin Ministry of Health (MoH) and at the University of Abomey-Calavi in collaboration with the Athena Institute, Vrije Universiteit Amsterdam from 2006-2008 aimed to identify factors appearing between 1998 and 2008 that adversely affected the healthcare technology management cycle i.e., planning, budgeting, selection, procurement, distribution, installation, training, operation, maintenance and disposal of medical devices. The results will allow to identify the key factors of mismanagement and critical maintenance system of medical devices in Benin and to formulate recommendations to improve the system. The first part of this paper gives background information on the country, its health system and an overview of its healthcare technology management state. The second part describes the methods and materials used and the third part presents the results, followed by discussion, comments and recommendations in the final section.

#### **2. Background information**

#### **2.1 Benin: The country**

Located on the West coast of Africa, the Republic of Benin is small (114,763 square kilometers), with a coastline on the Gulf of Guinea nestled between Nigeria, Niger, Burkina Faso, and Togo (Figure 1). The population, estimated at 7,839,914 in 2006, includes a multitude of ethnic and linguistic groups. Benin remains one of the world's least developed countries and has been ranked 163 of 177 on the United Nations Human Development Index (2005). Demographic and health indicators are given below (Table 1).

Fig. 1. Map of Benin (*Source:* USAID, 2006)


**Indicators** 

*Sources:* 1. Human Development Reports: 2007/2008;

2. Benin Demographic and Health Survey 2006;

3. Benin Health Statistics Directory 2006.

Table 1. Selected demographic and health indicators of Benin

#### **2.2 The health system**

314 Public Health – Methodology, Environmental and Systems Issues

This study, supported by the *Netherlands Organisation for International Cooperation in Higher Education* (NUFFIC) from 2007 was conducted in Benin Ministry of Health (MoH) and at the University of Abomey-Calavi in collaboration with the Athena Institute, Vrije Universiteit Amsterdam from 2006-2008 aimed to identify factors appearing between 1998 and 2008 that adversely affected the healthcare technology management cycle i.e., planning, budgeting, selection, procurement, distribution, installation, training, operation, maintenance and disposal of medical devices. The results will allow to identify the key factors of mismanagement and critical maintenance system of medical devices in Benin and to formulate recommendations to improve the system. The first part of this paper gives background information on the country, its health system and an overview of its healthcare technology management state. The second part describes the methods and materials used and the third part presents the results, followed by discussion, comments and

Located on the West coast of Africa, the Republic of Benin is small (114,763 square kilometers), with a coastline on the Gulf of Guinea nestled between Nigeria, Niger, Burkina Faso, and Togo (Figure 1). The population, estimated at 7,839,914 in 2006, includes a multitude of ethnic and linguistic groups. Benin remains one of the world's least developed countries and has been ranked 163 of 177 on the United Nations Human Development Index

(2005). Demographic and health indicators are given below (Table 1).

recommendations in the final section.

Fig. 1. Map of Benin (*Source:* USAID, 2006)

**2. Background information** 

**2.1 Benin: The country** 

The public healthcare system of the country has been reorganized according to the decentralization policy and consists of three levels: **central** with the National Referral Hospital (> 600 beds), **intermediate** with five Province or Departmental Hospitals (>100 beds) and **peripheral** with thirty four Health Zones, twenty seven fairly functional Zone Hospitals (> 46 beds), seventy seven Communal Health Centers, four hundred eighty seven Arrondissement Health Centers and many Village Health Units and other private health facilities. Apart from that, the health system also has the following public hospitals: the Mother and Child Hospital, many detection and treatment centers for tuberculosis and leprosy, the National Hospital for Psychiatry, the National Hospital for Gerontology, two Buruli Ulceration Treatment Centers12 etc…

#### **2.3 Healthcare technology management and maintenance**

Healthcare technology management and maintenance remains one of the main challenges of the developing countries healthcare systems in general and, of Benin particularly. Thus, although many financial resources are used for procurement of devices, not enough attention is paid to their future. While some of the equipment were donated, a significant portion was purchased with loans provided by bilateral and multilateral agencies and will have to be paid back with great sacrifice26. One of the root causes of the equipment idleness is the lack of effective management. It is important to point out that despite the several initiatives undertaken by the ministry of health to improve the *healthcare technology management cycle* no significant changes have been noticed13, 14, 15, 16 and 17.

Many facilities, especially Zone Hospitals, continue to lack the basic technologies they need to provide quality care to the patients, because equipment is unavailable, inoperative, misused or inappropriate. The situation is most severe in the Communal and Arrondissement health facilities far from the first referral hospitals. This has far-reaching implications for the prevention and treatment of disease and disability and often leads to a waste of scarce resources.

Policy and Management of Medical Devices for the Public Health Care Sector in Benin 317

was to identify weaknesses in the whole Benin healthcare technology management cycle. Data were collected through observational visits and reading reports, interviews, and questionnaires (inventory sheets). The steps were i) Equipment inventory was done at all the public healthcare facilities in southern Benin; ii) Healthcare equipment in these facilities were compared to the MoH available Essential Medical Device List of each health facility level iii) The needs assessment of each healthcare facility was done using a pilot asset assessment software. Finally, interviews were held with a range of stakeholders including policy makers of the MoH, healthcare facility managers, equipment users (physicians, nurses, midwives, lab technicians, X-ray machine technician ….) and,

The results of the study are summarised in tables 2 to 6 and figure2. Tables 2, 3 and 4 show the mean ad hoc reference selling prices of selected medical devices in comparison with the prices the same devices were sold to the Ministry of Health from 1998 to 1999, 2001 to 2004 and 2005 to 2008. Table 5 and figure 2 show the trends of [MoH device acquisition prices/Ad hoc device reference selling prices] ratio during the three periods of years. The ten equipment studied were: 1) blood pressure device 2) spectrophotometer 3) electric suction unit 4-) Electrocardio-graph 5) X-ray apparatus 6) hot air sterilizer 7) autoclave 8)

The letter X that may be a, b, c, d, e, f, g, h, i or j represents respectively the "ad hoc reference prices" (the private healthcare facilities device acquisition prices) of each device in local currency. The letter Y that may be A, B, C, D, E, F, G, H, I or J are respectively the MoH same device acquisition prices through public procurement. Table 6 presents the findings of the two surveys and shows the factors affecting the healthcare technology management cycle in 321 health centers and hospitals in southern Benin. The factors were grouped (but not ranked) in sixth categories which were respectively maintenance and repair; distribution; use; technology assessment; policy, planning and budgeting; and

The key factors that have been identified so far include the high acquisition costs; the lack of insight of the government on medical device market prices, the lack of capacity to monitor reasonable prices from suppliers, the lack of insight into the cost/performance ratio of various brands of medical devices, an unequal distribution of devices among health care facilities, an unbalanced allocation of resources to acquisition of devices compared to infrastructure, and maintenance. Other key factors identified included the insufficiency of human resources with appropriate capacity to manage equipment, the unavailability of spare parts, and the lack of an annual maintenance budget. In a nutshell, the lack of policy and management tools like "the up to date essential medical devices list and "the reference prices list for essential medical devices" to support the implementation of the existing policy. The latter allows health sector authorities to monitor financial diversions occurring in public procurement contract awards, while the former serves as a reference tool to assess availability of fully operational devices at different hierarchical

ventilator 9) anaesthesia system and 10) blood bank refrigerator.

maintenance technicians.

**4. Results** 

procurement.

levels of healthcare facilities.

#### **3. Materials and methods**

The study was carried out in the MoH, 321 healthcare facilities of the southern part of the country, the Ministry of Economy and Finance, some representatives of external support agencies in Benin and ten accredited suppliers of medical device companies. It consisted of surveys undertaken in 2006 and 2007 and of desk research (content analysis) based on 1998 to 2008 procurement collected data. It aimed to determine the factors that adversely affect the healthcare technology management cycle (planning, budgeting, selection, procurement, distribution, installation, training, operation, maintenance and disposal of medical devices) in Benin.

#### **3.1 Desk research and short survey**

This study focused on the procurement management of medical devices in the Republic of Benin and aimed to identify the main weak points in the procurement management system of medical devices from 1998 to 2008. It was based on data collected from documents (such as national procurement magazines and health equipment public procurement and bidding contracts from the Ministries of Health and Economy and Finances), and on interviews and informal discussions with ten local accredited suppliers of medical devices in Benin.

A comparative study was done concerning the selling prices of ten medical devices procured by Benin MoH further to international tenders. The steps were i) Ten medical devices were selected from the available essential medical device list. ii) Their mean reference selling prices (based on their specifications) were determined from 10 local medical device accredited suppliers based on the prices the devices were sold to the private health facilities. iii) The mean prices at which the same devices were sold to the Ministry of Health following open tenders public procurement were identified, in three periods: 1998 to 1999; 2001 to 2004 and 2005 to 2008 when the procurement evaluation process has been changed and improved. iv) The mean prices at which they were sold to the MoH were compared to the ad hoc mean reference selling prices provided by the private healthcare facilities and/or from the local suppliers' price list for private facilities.

#### **3.2 Surveys**

Two surveys were carried out in 321 healthcare facilities of the six southern departments (provinces). The first, entitled "management and maintenance of healthcare technology", was conducted in 2006 in 11 health centers and hospitals. It aimed to identify the weaknesses in the healthcare technology management and maintenance system in order to make recommendations for its improvement. Data were collected through observational visits, interviews and questionnaires. The second, entitled "healthcare technology assessment in the southern Benin public healthcare facilities" was carried out in 310 health centers and hospitals in 2006 and 2007. The first objective was to determine the extent of disparity between what medical devices/equipment were planned and what was actually available in each selected health facility to facilitate procurement for the poorly equipped health facilities of the essential medical devices. The second objective was to identify weaknesses in the whole Benin healthcare technology management cycle. Data were collected through observational visits and reading reports, interviews, and questionnaires (inventory sheets). The steps were i) Equipment inventory was done at all the public healthcare facilities in southern Benin; ii) Healthcare equipment in these facilities were compared to the MoH available Essential Medical Device List of each health facility level iii) The needs assessment of each healthcare facility was done using a pilot asset assessment software. Finally, interviews were held with a range of stakeholders including policy makers of the MoH, healthcare facility managers, equipment users (physicians, nurses, midwives, lab technicians, X-ray machine technician ….) and, maintenance technicians.

#### **4. Results**

316 Public Health – Methodology, Environmental and Systems Issues

The study was carried out in the MoH, 321 healthcare facilities of the southern part of the country, the Ministry of Economy and Finance, some representatives of external support agencies in Benin and ten accredited suppliers of medical device companies. It consisted of surveys undertaken in 2006 and 2007 and of desk research (content analysis) based on 1998 to 2008 procurement collected data. It aimed to determine the factors that adversely affect the healthcare technology management cycle (planning, budgeting, selection, procurement, distribution, installation, training, operation, maintenance and disposal of medical devices)

This study focused on the procurement management of medical devices in the Republic of Benin and aimed to identify the main weak points in the procurement management system of medical devices from 1998 to 2008. It was based on data collected from documents (such as national procurement magazines and health equipment public procurement and bidding contracts from the Ministries of Health and Economy and Finances), and on interviews and informal discussions with ten local accredited suppliers

A comparative study was done concerning the selling prices of ten medical devices procured by Benin MoH further to international tenders. The steps were i) Ten medical devices were selected from the available essential medical device list. ii) Their mean reference selling prices (based on their specifications) were determined from 10 local medical device accredited suppliers based on the prices the devices were sold to the private health facilities. iii) The mean prices at which the same devices were sold to the Ministry of Health following open tenders public procurement were identified, in three periods: 1998 to 1999; 2001 to 2004 and 2005 to 2008 when the procurement evaluation process has been changed and improved. iv) The mean prices at which they were sold to the MoH were compared to the ad hoc mean reference selling prices provided by the private healthcare facilities and/or from the local suppliers' price list for

Two surveys were carried out in 321 healthcare facilities of the six southern departments (provinces). The first, entitled "management and maintenance of healthcare technology", was conducted in 2006 in 11 health centers and hospitals. It aimed to identify the weaknesses in the healthcare technology management and maintenance system in order to make recommendations for its improvement. Data were collected through observational visits, interviews and questionnaires. The second, entitled "healthcare technology assessment in the southern Benin public healthcare facilities" was carried out in 310 health centers and hospitals in 2006 and 2007. The first objective was to determine the extent of disparity between what medical devices/equipment were planned and what was actually available in each selected health facility to facilitate procurement for the poorly equipped health facilities of the essential medical devices. The second objective

**3. Materials and methods** 

**3.1 Desk research and short survey** 

of medical devices in Benin.

private facilities.

**3.2 Surveys** 

in Benin.

The results of the study are summarised in tables 2 to 6 and figure2. Tables 2, 3 and 4 show the mean ad hoc reference selling prices of selected medical devices in comparison with the prices the same devices were sold to the Ministry of Health from 1998 to 1999, 2001 to 2004 and 2005 to 2008. Table 5 and figure 2 show the trends of [MoH device acquisition prices/Ad hoc device reference selling prices] ratio during the three periods of years. The ten equipment studied were: 1) blood pressure device 2) spectrophotometer 3) electric suction unit 4-) Electrocardio-graph 5) X-ray apparatus 6) hot air sterilizer 7) autoclave 8) ventilator 9) anaesthesia system and 10) blood bank refrigerator.

The letter X that may be a, b, c, d, e, f, g, h, i or j represents respectively the "ad hoc reference prices" (the private healthcare facilities device acquisition prices) of each device in local currency. The letter Y that may be A, B, C, D, E, F, G, H, I or J are respectively the MoH same device acquisition prices through public procurement. Table 6 presents the findings of the two surveys and shows the factors affecting the healthcare technology management cycle in 321 health centers and hospitals in southern Benin. The factors were grouped (but not ranked) in sixth categories which were respectively maintenance and repair; distribution; use; technology assessment; policy, planning and budgeting; and procurement.

The key factors that have been identified so far include the high acquisition costs; the lack of insight of the government on medical device market prices, the lack of capacity to monitor reasonable prices from suppliers, the lack of insight into the cost/performance ratio of various brands of medical devices, an unequal distribution of devices among health care facilities, an unbalanced allocation of resources to acquisition of devices compared to infrastructure, and maintenance. Other key factors identified included the insufficiency of human resources with appropriate capacity to manage equipment, the unavailability of spare parts, and the lack of an annual maintenance budget. In a nutshell, the lack of policy and management tools like "the up to date essential medical devices list and "the reference prices list for essential medical devices" to support the implementation of the existing policy. The latter allows health sector authorities to monitor financial diversions occurring in public procurement contract awards, while the former serves as a reference tool to assess availability of fully operational devices at different hierarchical levels of healthcare facilities.

Policy and Management of Medical Devices for the Public Health Care Sector in Benin 319

Table 5. Trend of the [MoH device acquisition price/Ad hoc device reference prices] ratio

7 1998-1999

2001-2004 2005-2008

Fig. 2. Comparative graphs of the MoH selected medical device acquisition prices

2. Healthcare technology assessment in the southern Benin public health facilities.

during the three periods of years:1998-1999; 2001-2004 and 2005-2008.

1. Management and maintenance of healthcare technology

**4.2 Finding of the surveys 1 and 2** 

during the three periods of years: 1998-1999; 2000-2004 and 2005-2008.


#### **4.1 Findings of the desk research and short survey**

Table 2. Comparison of the mean ad hoc reference prices of medical devices to the Ministry of Health same device acquisition prices, 1998 to 1999.


Table 3. Comparison of the mean ad hoc reference prices of medical devices to the Ministry of Health same device acquisition prices, 2001 to 2004.


Table 4. Comparison of the mean ad hoc reference prices of medical devices to the Ministry of Health same device acquisition prices, 2005 to 2008.

Table 2. Comparison of the mean ad hoc reference prices of medical devices to the Ministry

Table 3. Comparison of the mean ad hoc reference prices of medical devices to the Ministry

Table 4. Comparison of the mean ad hoc reference prices of medical devices to the Ministry

**4.1 Findings of the desk research and short survey** 

of Health same device acquisition prices, 1998 to 1999.

of Health same device acquisition prices, 2001 to 2004.

of Health same device acquisition prices, 2005 to 2008.


Table 5. Trend of the [MoH device acquisition price/Ad hoc device reference prices] ratio during the three periods of years: 1998-1999; 2000-2004 and 2005-2008.

Fig. 2. Comparative graphs of the MoH selected medical device acquisition prices during the three periods of years:1998-1999; 2001-2004 and 2005-2008.

#### **4.2 Finding of the surveys 1 and 2**


Policy and Management of Medical Devices for the Public Health Care Sector in Benin 321

to infirm or to confirm the present findings and also to understand the true reasons of the

The Ministry of Health still needs a national public procurement policy and management tool like a reference prices list of the most widely used devices to overcome and to master the increasing and unreasonable medical device prices. It is normal to have the device acquisition costs paid by the government a bit higher than the reference set prices because of financial and administrative fees involved when the suppliers submit tenders. It is acceptable and reasonable to have the average device selling prices comprised between **1.1 to 1.2 times** higher than the ad hoc reference prices. But, when the device selling prices offers by a supplier are more than that, they could be considered as *outbidding*. It is thus urgent for the Benin government especially the MoH to have an insight on that fact, to encourage the development of policies and laws regarding a reference price lists document of medical devices. The availability of the reference prices of the essential medical devices will allow the health sector authorities to monitor the usual financial diversion occurring during the procurement management activities. It is expected that once this document becomes available, the MoH could buy value-based pricing equipment each year and save a lot of money that can be used

The results of the two surveys: i) "management and maintenance of healthcare technology" and ii) "healthcare technology assessment in the southern Benin public healthcare facilities" have revealed many weaknesses in the Benin health system through its healthcare technology management cycle. The results show failures in each link of the cycle (planning, budgeting, selection, procurement, distribution, installation, training, operation, maintenance and disposal of medical devices) resulting in low overall community health effectiveness. It is necessary to point out that the findings of the two surveys, i.e. the factors affecting healthcare technology management were only grouped (but not ranked) in sixth categories. The ranking of the factor categories (I, II, III, IV, V and VI) in order to set up

As recommendations, twenty actions need to be taken by the government to overcome this situation in order to achieve its goal to improve the quality of/and access to health services that taking into account the poor and indigent. It is thus urgent to develop and implement a good medical device national policy which can include the following: i)An improved national list of essential medical devices and equipment based on evidence from the studies; ii) A national policy and plan for medical devices; iii) A national functional regulation authority in medical device empowered with legislation; iv) A document on assessment of medical device needs; v) National regulations based on ISO standards or WHO specifications; vi) National procurement procedure; vii) National policy for acceptance of donations; viii) Negotiated pricing list of each item of equipment; ix) National guide for management and use of medical devices; x) An inventory of suppliers and medical in use; xi) The cost of all the equipment of each level of Benin health facility related to the cost of infrastructure; xii) The service life span of each medical device or equipment in use in Benin health care facility or hospital in order to plan the replacement at a systematic time; xiii) The list of medical devices which have the highest risk; xiv) The spare parts which have the highest failure rate in order to plan their procurement; xv) The list of critical equipment and instrument affected by the electrical power outages and power anomalies in Benin hospitals; xvi) Good software based planning and management tools for management and

ineffective management of healthcare equipment in Benin.

to improve the health of Benin population through other investments.

priority actions will be discussed in the next paper.


Table 6. Factors affecting the healthcare technology management cycle in 321 health centers and hospitals in southern Benin.

#### **5. Discussion and recommendations**

Goods acquisition, especially healthcare technology, represents an important part of any health budget and need to be looked with close attention. Through the results shown in Tables 2, 3, 4, 5 and, figure 2, it is clearly seen that, independently of the procurement years, the device acquisition prices by the MoH remain higher than the private healthcare facilities same device acquisition prices. Although the Benin first Goods and Services Procurement Code was implemented during the years 2001 to 2004 and has also been amended in 2004 and be implemented from 2005 to 2008, no significant improvements were found regarding the higher prices of medical equipment paid by the MoH. One can notice that the MoH pays too much for medical devices acquisition through public procurement and this was at its worst in 2001-2004. When analysing year by year available data of this period it was found that the highest acquisition prices were critical in 2003 and 2004. It is important to deeply understand the real reasons that underlie this phenomenon. Many hypotheses could be drawn to explain this fact but, it will be more interesting to increase the sample size (>10 medical devices) of the study for more reliability. The internal and external validities of the findings could be improved if a quasi-experimental study was designed. Thus, widely surveys will be conducted in the next papers with more representative sample size and strong method as controlled interrupted time series based on segmented regression analysis

Table 6. Factors affecting the healthcare technology management cycle in 321 health

Goods acquisition, especially healthcare technology, represents an important part of any health budget and need to be looked with close attention. Through the results shown in Tables 2, 3, 4, 5 and, figure 2, it is clearly seen that, independently of the procurement years, the device acquisition prices by the MoH remain higher than the private healthcare facilities same device acquisition prices. Although the Benin first Goods and Services Procurement Code was implemented during the years 2001 to 2004 and has also been amended in 2004 and be implemented from 2005 to 2008, no significant improvements were found regarding the higher prices of medical equipment paid by the MoH. One can notice that the MoH pays too much for medical devices acquisition through public procurement and this was at its worst in 2001-2004. When analysing year by year available data of this period it was found that the highest acquisition prices were critical in 2003 and 2004. It is important to deeply understand the real reasons that underlie this phenomenon. Many hypotheses could be drawn to explain this fact but, it will be more interesting to increase the sample size (>10 medical devices) of the study for more reliability. The internal and external validities of the findings could be improved if a quasi-experimental study was designed. Thus, widely surveys will be conducted in the next papers with more representative sample size and strong method as controlled interrupted time series based on segmented regression analysis

centers and hospitals in southern Benin.

**5. Discussion and recommendations** 

to infirm or to confirm the present findings and also to understand the true reasons of the ineffective management of healthcare equipment in Benin.

The Ministry of Health still needs a national public procurement policy and management tool like a reference prices list of the most widely used devices to overcome and to master the increasing and unreasonable medical device prices. It is normal to have the device acquisition costs paid by the government a bit higher than the reference set prices because of financial and administrative fees involved when the suppliers submit tenders. It is acceptable and reasonable to have the average device selling prices comprised between **1.1 to 1.2 times** higher than the ad hoc reference prices. But, when the device selling prices offers by a supplier are more than that, they could be considered as *outbidding*. It is thus urgent for the Benin government especially the MoH to have an insight on that fact, to encourage the development of policies and laws regarding a reference price lists document of medical devices. The availability of the reference prices of the essential medical devices will allow the health sector authorities to monitor the usual financial diversion occurring during the procurement management activities. It is expected that once this document becomes available, the MoH could buy value-based pricing equipment each year and save a lot of money that can be used to improve the health of Benin population through other investments.

The results of the two surveys: i) "management and maintenance of healthcare technology" and ii) "healthcare technology assessment in the southern Benin public healthcare facilities" have revealed many weaknesses in the Benin health system through its healthcare technology management cycle. The results show failures in each link of the cycle (planning, budgeting, selection, procurement, distribution, installation, training, operation, maintenance and disposal of medical devices) resulting in low overall community health effectiveness. It is necessary to point out that the findings of the two surveys, i.e. the factors affecting healthcare technology management were only grouped (but not ranked) in sixth categories. The ranking of the factor categories (I, II, III, IV, V and VI) in order to set up priority actions will be discussed in the next paper.

As recommendations, twenty actions need to be taken by the government to overcome this situation in order to achieve its goal to improve the quality of/and access to health services that taking into account the poor and indigent. It is thus urgent to develop and implement a good medical device national policy which can include the following: i)An improved national list of essential medical devices and equipment based on evidence from the studies; ii) A national policy and plan for medical devices; iii) A national functional regulation authority in medical device empowered with legislation; iv) A document on assessment of medical device needs; v) National regulations based on ISO standards or WHO specifications; vi) National procurement procedure; vii) National policy for acceptance of donations; viii) Negotiated pricing list of each item of equipment; ix) National guide for management and use of medical devices; x) An inventory of suppliers and medical in use; xi) The cost of all the equipment of each level of Benin health facility related to the cost of infrastructure; xii) The service life span of each medical device or equipment in use in Benin health care facility or hospital in order to plan the replacement at a systematic time; xiii) The list of medical devices which have the highest risk; xiv) The spare parts which have the highest failure rate in order to plan their procurement; xv) The list of critical equipment and instrument affected by the electrical power outages and power anomalies in Benin hospitals; xvi) Good software based planning and management tools for management and

Policy and Management of Medical Devices for the Public Health Care Sector in Benin 323

We would like to thank very much The Netherlands Organization for International Cooperation in Higher Education (NUFFIC) that grants fellowship for the main investigator to undertake PhD research. Thanks are also due to the technical officers of the Ministry of Health for their collaboration. The authors are grateful to Prof E. P. Wright for her fruitful

[1] Bloom, G., Temple-Bird, C.: *Medical Equipment in Sub-Saharan Africa: A Framework for* 

[2] Benin Tourisme: *Benin; histoire [online]. 2007 Aug 25* Available from: URL:

[3] Department of Health, Republic of South Africa: *A Framework for Health Technology* 

[4] Fahlgren B.: *Access to effective medical technology in Developing Countries-what role for* 

[5] Goodman, C.S. and Ahn, R.: *Methodological Approaches Used in Health care Technology* 

[6] Gouvernement du Benin. *Développement économique* Available from: URL: www.gouv.bj. [7] Guinand C.: *Maintenance biomédicale. Zones sanitaires appuyées par le PBA-SSP. Evaluation et* 

[8] Heimann, P., Poluta, M.A.: *Health Technology Management in Sub-Saharan Region as a Pre-*

[9] Institut National pour les Statistique et L'analyse Economique : *Enquête Démographique et* 

[10] Issakovov, A.: *Service and Maintenance in Developing Countries, pp. 21-28 in:* Medical

[11] Keller J.P.JR., and Walker S.: *Best Practices for Medical Technology Management: A U.S. Air Force-ECRI Collaboration*: Advances in Patient Safety: Vol. 4. pp 45-55, USA, 2004. [12] Ministère de la Santé: *Annuaire des statistiques sanitaires de la République du Bénin. Edition* 

[13] Ministère de la Santé Publique: *Atelier National d'Orientation des Politiques et Stratégies* 

[14] Ministère de la Santé Publique de la République du Bénin : *Avant-projet de politique et* 

[15] Ministère de la Santé de la République du Bénin: *Etude d'évaluation de la situation* 

*requisite for Optimising the Donor Aid Intervention Process*. (In press) WHO, ARA,

Devices: International Perspectives on Health and Safety. Ed. Van Gruting C.W.D.

*Nationales de Maintenance Hospitalière en République du Bénin à Possotomè du 21 au 23* 

*stratégies de maintenance des infrastructures et équipements médicaux au Bénin, Février* 

*actualisée des plateaux techniques des formations sanitaires publiques par niveau de soin et vérification de leur conformité aux normes dans les six (06) départements du sud Bénin,*

*suivi des activités des techniciens.* Décembre 2000. Cotonou, 2000.

*Policy-Formulation*. IDS research Report No.19, WHO/SHS/NHP/90.6, WHO,

**7. Acknowledgement** 

comments.

**8. References** 

Geneva, 1990.

Geneva, 1997.

*2006.*

*de Santé,* Cotonou 2006.

Elsevier, Amsterdam, 1994.

*février 2000 . Possotomè* 2000.

*2000 . Possotomè* 2000.

Bénin 2006.

*Policies*.

www.benintourisme. com.

*WHO?* WHO Geneva 2004.

*Assessment*. NICHSR, USA 2004.

maintenance of medical devices; xvii) A post-market surveillance/vigilance system for alerts, notifications and recalls; xviii) A national budget for devices, using costing, budgeting and financing; xix) Standard operating procedures and best practices that cover every stage in the life span of medical devices; xx) Creation of an independent Direction of Healthcare Technology Management and maintenance within the Ministry of Health.

The following Healthcare Technology Management Cycle (Figure 3) could be used as a framework for health equipment management in developing country, providing a guideline for the necessary regulations and systems.

**The Healthcare Technology Management Cycle**11**:**An example of a framework for health equipment management in developing country.

Fig. 3. The Healthcare Technology Management Cycle

#### **6. Conclusion**

Management and maintenance of healthcare technology in developing countries especially in the poor sub-Saharan Africa countries, remain a challenge. From the planning to the disposal of the devices many actions need to be undertaken to improve the Healthcare Technology Management Cycle. The achievements in the public healthcare sector depend on the full involvement of each stakeholder, but the main responsibility is still that of the governments. They need the political willingness and commitment to recognize management and maintenance of devices as an integral part of public health policy in order improve the quality and access to healthcare in each country.

#### **7. Acknowledgement**

322 Public Health – Methodology, Environmental and Systems Issues

maintenance of medical devices; xvii) A post-market surveillance/vigilance system for alerts, notifications and recalls; xviii) A national budget for devices, using costing, budgeting and financing; xix) Standard operating procedures and best practices that cover every stage in the life span of medical devices; xx) Creation of an independent Direction of Healthcare Technology Management and maintenance within the Ministry of Health.

The following Healthcare Technology Management Cycle (Figure 3) could be used as a framework for health equipment management in developing country, providing a guideline

**The Healthcare Technology Management Cycle**11**:**An example of a framework for health

Decommissioning **Cancellation And Disposal**

9

**Planning And Assessment**

1

**Budgeting And Financing**

2

**Technology Assessment and Selection**

**Procurement And** 

3

**Installation Logistic**

4

**And Commissioning**

Management and maintenance of healthcare technology in developing countries especially in the poor sub-Saharan Africa countries, remain a challenge. From the planning to the disposal of the devices many actions need to be undertaken to improve the Healthcare Technology Management Cycle. The achievements in the public healthcare sector depend on the full involvement of each stakeholder, but the main responsibility is still that of the governments. They need the political willingness and commitment to recognize management and maintenance of devices as an integral part of public health policy in order

5

**. Create Awareness . Monitor and evaluate**

for the necessary regulations and systems.

equipment management in developing country.

**Maintenance And Repair**

**Operation and Safety**

> **Training and Skill Development**

Fig. 3. The Healthcare Technology Management Cycle

improve the quality and access to healthcare in each country.

**6. Conclusion** 

7

8

6

We would like to thank very much The Netherlands Organization for International Cooperation in Higher Education (NUFFIC) that grants fellowship for the main investigator to undertake PhD research. Thanks are also due to the technical officers of the Ministry of Health for their collaboration. The authors are grateful to Prof E. P. Wright for her fruitful comments.

#### **8. References**


**Section 4** 

**Global Health** 


## **Section 4**

**Global Health** 

324 Public Health – Methodology, Environmental and Systems Issues

[16] Ministère de la Santé Publique de la République du Bénin : *Etude sur l'élaboration d'un* 

[17] Ministère de la Santé de la République du Bénin : *Politique de maintenance des* 

[18] Ministère de la Santé Publique de la République du Bénin : *Politiques et stratégies nationales de développement du secteur santé (1997-2001) .* Cotonou 1998. [19] Ministère de la Santé Publique de la République du Bénin : *Politiques et Stratégies* 

[20] Ministère de la Santé de la République du Bénin : *Rapport de la mission d'expertise* 

[21] Ministère de la Santé de la République du Bénin: *Recueil d'informations de la Cellule de* 

[22] Projet Bénino-Allemand des Soins de Santé Primaire (PBA-SSP): *Guide d'entretien du* 

[23] South African Medical Research Council: *Executive Report of the Regional Workshop on* 

[26] Wang, B.: *A framework for Health Equipment Management in Developing Countries*. Hospital

[27] World Health Organization: *Medical Device Regulations: Global Overview and Regulating* 

[28] World Health Organization: *Regulation Challenges (Medical device regulation: a framework)*.

[29] World Health Organization: *Experts on Healthcare Technology in the Developing World* 

[30] World Health Organization: *Essential Health Technologies: Strategy 2004- 2007*. WHO.

[31] World Health Organization.: *Global Harmonization Task Force (Working Toward Harmonization in Medical Device Regulation Full Document)*. Geneva 2004.

*Meet at Savoy Place (Managing Health care Technology)* WHO. 2, 2002.

[24] USAID : Rapid assessment of the health system in Benin. Benin 2002 [25] USAID: *Country background*; Benin. Available from: URL: www.usaid.gov.

Engineering and Facilities Management 2003

WHO Drug Information Vol 17, No. 4, 2003.

Draft for comments by member States. 11, 2003.

*Principle.* WHO, ISBN 92 4 154618.

1995

2000.

2005

1994

Cotonou 1997

*Bénin.* Cotonou 2002

*Passa-tion des Marchés*, Cotonou, 2006.

*système décentralisé de maintenance hospitalière (30 mars au 15 avril 1995).* Cotonou

*infrastructures, des équipements médico-techniques et du parc automobile en République du* 

*Nationales de Maintenance Hospitalière en République du Bénin (2001-2005).* Cotonou

*thématique en gestion et maintenance des équipements et infrastructures de la santé*, Bénin

*Matériel des CSSP et CCS du Projet Bénino-Allemand des Soins de Santé Primaires .* 

*Health care Technology in Sub-Saharan Region*, Somerset West, South Africa. April

**15** 

*1,3USA 2Mexico* 

**Non-Communicable** 

*1Harvard School of Public Health, Boston, MA,* 

**Diseases in the Global Health Agenda** 

Julio Frenk1, Octavio Gómez-Dantés2 and Felicia M. Knaul3

*2Center for Health Systems Research, National Institute of Public Health,* 

*3Harvard Global Health Equity Initiative and Harvard Medical School, Boston, MA,* 

For a long time non-communicable diseases (NCDs) have been a major cause of death and disability worldwide. However, the profile of this health challenge is changing: Having dominated the epidemiologic contour of high-income countries in the 20th century, it is now increasingly affecting the developing regions of our planet. Unless we start implementing measures to reduce the burden of NCDs in low- and middle-income countries, the pressure on their health systems will be unbearable and will limit the prospects for economic development.1 In this chapter we discuss the need to confront this emerging challenge through a change in the orientation of global health. The central message is that it is necessary to incorporate NCDs into the global agenda and deploy comprehensive strategies in developing countries to address them. Such strategies should include both prevention services and cost-effective treatments.

In the first part of the chapter we discuss the present situation of NCDs in low- and middleincome countries, with emphasis on cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, along with a major risk related to most of them, obesity. Part two is devoted to the discussion of four myths that have hindered the incorporation of NCDs to the global health agenda and a set of proposals to strengthen the battle against them, using as an example several initiatives implemented in Mexico as part of a comprehensive health reform. The chapter concludes with a call to mobilize international collective action in the

During the past half-century the world witnessed a fundamental transformation in the field of health: a shift in the dominant patterns of disease and death towards higher age groups

Improvements in nutrition, access to water and sanitation, and expanded coverage of public health interventions such as immunizations and oral rehydration therapy reduced the burden of disease attributed to under-nutrition, common infections and reproductive

**1. Introduction** 

pursuit of shared goals around NCDs.

**2. The global burden of NCDs** 

and towards chronic conditions.

### **Non-Communicable Diseases in the Global Health Agenda**

Julio Frenk1, Octavio Gómez-Dantés2 and Felicia M. Knaul3 *1Harvard School of Public Health, Boston, MA, 2Center for Health Systems Research, National Institute of Public Health, 3Harvard Global Health Equity Initiative and Harvard Medical School, Boston, MA, 1,3USA 2Mexico* 

#### **1. Introduction**

For a long time non-communicable diseases (NCDs) have been a major cause of death and disability worldwide. However, the profile of this health challenge is changing: Having dominated the epidemiologic contour of high-income countries in the 20th century, it is now increasingly affecting the developing regions of our planet. Unless we start implementing measures to reduce the burden of NCDs in low- and middle-income countries, the pressure on their health systems will be unbearable and will limit the prospects for economic development.1

In this chapter we discuss the need to confront this emerging challenge through a change in the orientation of global health. The central message is that it is necessary to incorporate NCDs into the global agenda and deploy comprehensive strategies in developing countries to address them. Such strategies should include both prevention services and cost-effective treatments.

In the first part of the chapter we discuss the present situation of NCDs in low- and middleincome countries, with emphasis on cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, along with a major risk related to most of them, obesity. Part two is devoted to the discussion of four myths that have hindered the incorporation of NCDs to the global health agenda and a set of proposals to strengthen the battle against them, using as an example several initiatives implemented in Mexico as part of a comprehensive health reform. The chapter concludes with a call to mobilize international collective action in the pursuit of shared goals around NCDs.

#### **2. The global burden of NCDs**

During the past half-century the world witnessed a fundamental transformation in the field of health: a shift in the dominant patterns of disease and death towards higher age groups and towards chronic conditions.

Improvements in nutrition, access to water and sanitation, and expanded coverage of public health interventions such as immunizations and oral rehydration therapy reduced the burden of disease attributed to under-nutrition, common infections and reproductive

Non-Communicable Diseases in the Global Health Agenda 329

Diabetes is the fourth major non-communicable challenge. The number of adults with this disease has doubled in the past three decades, from 153 million in 1980 to 347 million in 2008.11 This disease produces 1.3 million deaths annually, more than 80% of them in developing regions.6 To this we should add its morbidity impacts, since diabetes is the leading cause of renal failure, limb amputation, and visual impairment and blindness. This imposes huge economic burdens on individuals, households, health care systems, and national economies. According to a report of the International Diabetes Federation, total expenditure on diabetes reached 376 billion dollars in 2010 and is projected to exceed 490

Obesity is closely related to the increasing prevalence of cardiovascular diseases, several forms of cancer, and diabetes. According to a paper recently published in *The Lancet*, there are 1.46 billion overweight adults globally; 495 million of them obese.13 Among other factors, this is the result of recent changes in the global food system which is producing increasing amounts of affordable processed food.14 Obesity levels range from 3% in Japan to around 80% in some of the islands of the South Pacific. Children are being increasingly affected. A report of the US Institute of Medicine indicates that 20% of American children between the ages of 2 years and 5 years are overweight or obese.15 Figures of the latest National Health and Nutrition Survey in Mexico indicate that the prevalence of obesity among children 5 to 12 years old increased from 6% to 10% between 1999 and 2006.16 In the developing world this epidemic first affected the affluent middle-aged adults in urban settings, but it is now spreading to rural areas and indigenous populations, affecting

If the present trends continue, by 2050 more than 50% of the world population could be clinically obese and national health systems would be overburdened by the demands associated to this health risk.17 Withrow and colleagues estimated that obese individuals

The shift of the burden of disease in developing countries towards chronic conditions is demanding the design and implementation of new local health strategies, but it is also calling for changes in the contents and orientation of the global health agenda. In the following section we will discuss four myths that have delayed the incorporation of NCDs to the global

During the 20th century international health was mostly involved in the control of communicable diseases, which were supposed to be characteristic of developing countries and mostly controlled in the developed world. NCDs, in contrast, had a low profile in the global health agenda, under the belief that they would be limited for quite a long time to high-income countries. In those days there was also a general consensus around the idea

Reality proved to be more complex. Infections never disappeared from the developed world. AIDS and antibiotic resistance have been strong remainders of the danger of lowering the guard against communicable diseases. As shown in the previous section, NCDs are increasingly dominating the health profile of the developing world. Finally, many ailments originally classified as non-communicable have now been found to have an

younger age groups, and rapidly turning obesity into a disease of the poor.

agenda and a set of proposals to successfully address these emerging challenges.

**3. Overcoming the barriers to incorporate NCDs to the global agenda** 

have medical costs 30% higher than those with normal weight.13

that infections and NCDs were biologically un-related.

billion dollars by 2030.12

problems, and produced major gains in child survival beyond age 5. Recently, the expansion of the global coverage of immunizations, for example, produced a 74% drop of measles deaths between 2000 and 2007.2 The number of global deaths due to malaria declined from almost one million in 2000 to 780 thousand in 2009.3 Annual maternal deaths also fell from more than a half a million in 1980 to less than 350 thousand in 2008.4

The gains made against infectious diseases and advances in child survival rendered huge improvements in life expectancy. In fact, during the 20th century the world as a whole experienced a larger gain in life expectancy than in all the previously accumulated history of humankind. Life expectancy was only 30 years in 1900. By 1985 it had more than doubled to 62 years. In 2010 the average estimate for the world reached 70 years, but with huge regional differences, ranging from 83 years in Japan to scarcely 47 years in Zimbabwe.5

Today growing proportions of the world population are living long enough to experience the effects of the exposure to health risks related to modern living such as lack of physical activity, consumption of unhealthy diets and products (tobacco, alcohol and illicit drugs), stress and social isolation, all of which increased the prevalence of NCDs to the point of turning them into the leading cause of death worldwide. According to a recent World Health Organization (WHO) report, two thirds (36 million) of the total annual deaths are attributed to these diseases and 80% of them occur in low- and middle-income countries.6

The most common NCDs are cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes. Heart diseases are the main cause of death worldwide. They produce 17 million deaths annually, 80% of which occur in low- and middle-income countries.6 In fact, deaths due to heart diseases today are more numerous in China and India than in all the developed world.

Cancer is another major challenge. According to WHO, there are 7.6 million cancer deaths annually worldwide, which represent around 21 percent of all NCD deaths.6 Two thirds of them occur in low- and middle income countries.

The most common cancers among women in developing nations are breast, cervical, stomach, lung, and colorectal cancer.7 Every year more than half a million new cases of breast cancer occur in this part of the world.8 In Latin America, Uruguay (83 per 100,000 women) and Argentina (75 per 100,000 million) have already reached breast cancer incidence rates similar to that of Canada (96 per 100,000 women), which is one of the highest in the world.9 Cervical cancer, which has become a rare disease in rich nations, produces more than 200,000 deaths annually in developing countries.10

Among men, the most common neoplasms in developing nations are lung, stomach, liver, esophageal, and colorectal cancer.7 While rich countries are witnessing a decline in new cases of lung cancer as a result of broad anti-smoking campaigns, many low- and middleincome nations are experiencing the opposite trend. Liver cancer is also increasing among men in poor countries. More than 80% of the new cases of this disease occur in developing nations, with Sub-Saharan Africa and Southeast Asia showing the highest rates worldwide. It comes as no surprise to find out that in these same regions hepatitis B virus infection is endemic.

The third major group of NCDs is formed by chronic respiratory diseases, including asthma and chronic obstructive pulmonary disease, which produce 4.2 million deaths annually.6

problems, and produced major gains in child survival beyond age 5. Recently, the expansion of the global coverage of immunizations, for example, produced a 74% drop of measles deaths between 2000 and 2007.2 The number of global deaths due to malaria declined from almost one million in 2000 to 780 thousand in 2009.3 Annual maternal deaths also fell from

The gains made against infectious diseases and advances in child survival rendered huge improvements in life expectancy. In fact, during the 20th century the world as a whole experienced a larger gain in life expectancy than in all the previously accumulated history of humankind. Life expectancy was only 30 years in 1900. By 1985 it had more than doubled to 62 years. In 2010 the average estimate for the world reached 70 years, but with huge regional

Today growing proportions of the world population are living long enough to experience the effects of the exposure to health risks related to modern living such as lack of physical activity, consumption of unhealthy diets and products (tobacco, alcohol and illicit drugs), stress and social isolation, all of which increased the prevalence of NCDs to the point of turning them into the leading cause of death worldwide. According to a recent World Health Organization (WHO) report, two thirds (36 million) of the total annual deaths are attributed to these diseases and 80% of them occur in low- and middle-income countries.6 The most common NCDs are cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes. Heart diseases are the main cause of death worldwide. They produce 17 million deaths annually, 80% of which occur in low- and middle-income countries.6 In fact, deaths due to heart diseases today are more numerous in China and India than in all the

Cancer is another major challenge. According to WHO, there are 7.6 million cancer deaths annually worldwide, which represent around 21 percent of all NCD deaths.6 Two thirds of

The most common cancers among women in developing nations are breast, cervical, stomach, lung, and colorectal cancer.7 Every year more than half a million new cases of breast cancer occur in this part of the world.8 In Latin America, Uruguay (83 per 100,000 women) and Argentina (75 per 100,000 million) have already reached breast cancer incidence rates similar to that of Canada (96 per 100,000 women), which is one of the highest in the world.9 Cervical cancer, which has become a rare disease in rich nations, produces

Among men, the most common neoplasms in developing nations are lung, stomach, liver, esophageal, and colorectal cancer.7 While rich countries are witnessing a decline in new cases of lung cancer as a result of broad anti-smoking campaigns, many low- and middleincome nations are experiencing the opposite trend. Liver cancer is also increasing among men in poor countries. More than 80% of the new cases of this disease occur in developing nations, with Sub-Saharan Africa and Southeast Asia showing the highest rates worldwide. It comes as no surprise to find out that in these same regions hepatitis B virus infection is

The third major group of NCDs is formed by chronic respiratory diseases, including asthma and chronic obstructive pulmonary disease, which produce 4.2 million deaths annually.6

more than a half a million in 1980 to less than 350 thousand in 2008.4

developed world.

endemic.

them occur in low- and middle income countries.

more than 200,000 deaths annually in developing countries.10

differences, ranging from 83 years in Japan to scarcely 47 years in Zimbabwe.5

Diabetes is the fourth major non-communicable challenge. The number of adults with this disease has doubled in the past three decades, from 153 million in 1980 to 347 million in 2008.11 This disease produces 1.3 million deaths annually, more than 80% of them in developing regions.6 To this we should add its morbidity impacts, since diabetes is the leading cause of renal failure, limb amputation, and visual impairment and blindness. This imposes huge economic burdens on individuals, households, health care systems, and national economies. According to a report of the International Diabetes Federation, total expenditure on diabetes reached 376 billion dollars in 2010 and is projected to exceed 490 billion dollars by 2030.12

Obesity is closely related to the increasing prevalence of cardiovascular diseases, several forms of cancer, and diabetes. According to a paper recently published in *The Lancet*, there are 1.46 billion overweight adults globally; 495 million of them obese.13 Among other factors, this is the result of recent changes in the global food system which is producing increasing amounts of affordable processed food.14 Obesity levels range from 3% in Japan to around 80% in some of the islands of the South Pacific. Children are being increasingly affected. A report of the US Institute of Medicine indicates that 20% of American children between the ages of 2 years and 5 years are overweight or obese.15 Figures of the latest National Health and Nutrition Survey in Mexico indicate that the prevalence of obesity among children 5 to 12 years old increased from 6% to 10% between 1999 and 2006.16 In the developing world this epidemic first affected the affluent middle-aged adults in urban settings, but it is now spreading to rural areas and indigenous populations, affecting younger age groups, and rapidly turning obesity into a disease of the poor.

If the present trends continue, by 2050 more than 50% of the world population could be clinically obese and national health systems would be overburdened by the demands associated to this health risk.17 Withrow and colleagues estimated that obese individuals have medical costs 30% higher than those with normal weight.13

The shift of the burden of disease in developing countries towards chronic conditions is demanding the design and implementation of new local health strategies, but it is also calling for changes in the contents and orientation of the global health agenda. In the following section we will discuss four myths that have delayed the incorporation of NCDs to the global agenda and a set of proposals to successfully address these emerging challenges.

#### **3. Overcoming the barriers to incorporate NCDs to the global agenda**

During the 20th century international health was mostly involved in the control of communicable diseases, which were supposed to be characteristic of developing countries and mostly controlled in the developed world. NCDs, in contrast, had a low profile in the global health agenda, under the belief that they would be limited for quite a long time to high-income countries. In those days there was also a general consensus around the idea that infections and NCDs were biologically un-related.

Reality proved to be more complex. Infections never disappeared from the developed world. AIDS and antibiotic resistance have been strong remainders of the danger of lowering the guard against communicable diseases. As shown in the previous section, NCDs are increasingly dominating the health profile of the developing world. Finally, many ailments originally classified as non-communicable have now been found to have an

Non-Communicable Diseases in the Global Health Agenda 331

This complexity can only be addressed through a comprehensive response to NCDs built on

• First, the design and application of a new generation of health promotion and disease

• Second, the achievement of universal social protection guaranteeing access to high-

• Third, the adoption of innovations in the delivery of health services that make use of

Many countries have made progress along these pillars. Mexico is a relevant example. In the following paragraphs, some of the most important lessons in the use of each of the pillars in

The first pillar was predicated on the notion that health systems will not be able to handle the growing burden of NCDs without a renewed emphasis on public health. Aware of this reality, a crucial component of the Mexican reform was the establishment of a new public health agency charged with protection of the population against health risks through food safety, definition of environmental and occupational standards, regulation of the pharmaceutical industry, and control of hazardous substances like alcohol and tobacco.

Along with other developments, this new agency has greatly strengthened the stewardship role of the Ministry of Health, which has become empowered to mobilize all instruments of

In addition, the financial re-engineering of the health system included a protected fund for community health services targeting health promotion and disease prevention

Important as promotion and prevention are, control efforts must also include access to health care. Indeed, even if we invest increasing amounts of resources in the prevention of NCDs, we will still need to deal with the consequences of exposures to risks that have already occurred. Those consequences include episodes of disease that require treatment, which all too often exposes families to the associated risk of financial catastrophe. For this reason, a comprehensive strategy must also include the second pillar: universal social protection.

Based on sound evidence about the extent of pernicious out-of-pocket payments, in 2003 the Mexican Congress approved a major legislative reform establishing a system of social protection in health. This system has substantially increased public funding for health in order to provide universal health insurance, including the half of the population, 50 million

The vast majority of these persons are now enrolled in a new public insurance scheme called *Seguro Popular*, which guarantees access to a comprehensive package of cost-effective services covering the prevention, early detection, diagnosis, treatment, and palliation of the major causes of ill health, including, of course, NCDs. The law stipulates that the package must be progressively expanded and updated annually on the basis of changes in the

The key to expand such resources has been to start with an explicit set of guaranteed benefits. This ties the reform to concrete deliverables, which is a main ingredient to gain public support. This approach tackles health system strengthening starting with the desired

three major pillars:

prevention strategies;

quality care without fear of financial catastrophe;

a reform recently implemented in this country are discussed.

public policy in the pursuit of health as a social objective.

interventions, including, of course, those targeted at NCDs.

persons, most of them poor, who had lacked protection until then.

epidemiologic profile, technological developments and resource availability.

the technological and managerial revolutions of our times.

infectious cause. According to WHO, one fifth of all cancers worldwide are caused by chronic infections produced by agents such as HIV, HPV, and hepatitis B virus.18 Bacterial, viral, and parasitic infections also underlie other NCDs, such as rheumatic heart disease, Chagas cardiomyopathy, and peptic ulcer.

To make matters more complex, many NCDs can literally be transmitted through genetic, epigenetic, and social networking mechanisms. The former Director General of WHO, Gro Harlem Brundtland, used to talk about "communicated diseases," which may be noncommunicable in the epidemiologic sense of the word, but are transmitted through advertising and sponsorship of unhealthy products such as tobacco, junk food, and soft drinks.19

If we are to successfully meet the NCD challenge, we must overcome the four following myths, which have been identified in the work of the Global Task Force on Expanding Access to Cancer Care.

*Myth #1: NCDs are not a major problem in developing countries.* As shown above, a solid body of evidence has documented the rising importance of NCDs. According to the WHO *Global Status Report on NCDs*, nearly 80% of NCD deaths occur in low- and middle-income countries, and even in African countries they will exceed communicable, maternal, perinatal, and nutritional diseases as the most common causes of death by 2030.6

*Myth #2*: *Even if the NCDs are important, there is very little that developing nations can do to address them.* Actually, we have at our disposal cost-effective interventions for the majority of NCDs common in developing regions, and we should deploy them alongside preventive strategies in what has been called the full cycle of care.20

*Myth #3: Even if there are effective interventions, developing countries cannot afford them.* Several experiences show that it is feasible to mobilize both global and national resources in a fiscally responsible way to greatly expand access to comprehensive services for NCDs.

*Myth #4: Responding to the challenge of NCDs would distract attention from other more urgent priorities, mainly the health-related Millennium Development Goals (MDGs).* This myth is especially pernicious because it tends to polarize the global health community in a zerosum, competitive mentality. Instead, we should look for synergies among disease-specific programs and strengthen health systems so that they can address the multiple, diverse, and complex needs of real people. A solid health system will be able to meet the needs related both to the unfinished agenda of common infections and to the emerging burden of NCDs.

These four myths sound very familiar because they were applied to AIDS over a decade ago. Back then, these same four misconceptions were put forward as justifications for inaction. Fortunately they were successfully eradicated and expanded access to prevention and care for HIV/AIDS is now considered one of the greatest achievements in the history of global health. The same success can now apply to NCDs if we develop the right evidencebased policies and if we continue to involve all relevant actors.

NCDs are the driving force behind a health picture that can be characterized by two words: change and complexity. Our common challenge is that most health systems simply have not kept up with the pressures derived from the epidemiologic transition. In particular, ministers of health throughout the world are facing unprecedented demands as they seek to become effective stewards to develop health systems that respond to the needs and expectations of the population with equity, quality, and financial protection for all.

infectious cause. According to WHO, one fifth of all cancers worldwide are caused by chronic infections produced by agents such as HIV, HPV, and hepatitis B virus.18 Bacterial, viral, and parasitic infections also underlie other NCDs, such as rheumatic heart disease,

To make matters more complex, many NCDs can literally be transmitted through genetic, epigenetic, and social networking mechanisms. The former Director General of WHO, Gro Harlem Brundtland, used to talk about "communicated diseases," which may be noncommunicable in the epidemiologic sense of the word, but are transmitted through advertising

If we are to successfully meet the NCD challenge, we must overcome the four following myths, which have been identified in the work of the Global Task Force on Expanding

*Myth #1: NCDs are not a major problem in developing countries.* As shown above, a solid body of evidence has documented the rising importance of NCDs. According to the WHO *Global Status Report on NCDs*, nearly 80% of NCD deaths occur in low- and middle-income countries, and even in African countries they will exceed communicable, maternal,

*Myth #2*: *Even if the NCDs are important, there is very little that developing nations can do to address them.* Actually, we have at our disposal cost-effective interventions for the majority of NCDs common in developing regions, and we should deploy them alongside preventive

*Myth #3: Even if there are effective interventions, developing countries cannot afford them.* Several experiences show that it is feasible to mobilize both global and national resources in a fiscally responsible way to greatly expand access to comprehensive services for NCDs.

*Myth #4: Responding to the challenge of NCDs would distract attention from other more urgent priorities, mainly the health-related Millennium Development Goals (MDGs).* This myth is especially pernicious because it tends to polarize the global health community in a zerosum, competitive mentality. Instead, we should look for synergies among disease-specific programs and strengthen health systems so that they can address the multiple, diverse, and complex needs of real people. A solid health system will be able to meet the needs related both to the unfinished agenda of common infections and to the emerging burden of

These four myths sound very familiar because they were applied to AIDS over a decade ago. Back then, these same four misconceptions were put forward as justifications for inaction. Fortunately they were successfully eradicated and expanded access to prevention and care for HIV/AIDS is now considered one of the greatest achievements in the history of global health. The same success can now apply to NCDs if we develop the right evidence-

NCDs are the driving force behind a health picture that can be characterized by two words: change and complexity. Our common challenge is that most health systems simply have not kept up with the pressures derived from the epidemiologic transition. In particular, ministers of health throughout the world are facing unprecedented demands as they seek to become effective stewards to develop health systems that respond to the needs and

expectations of the population with equity, quality, and financial protection for all.

and sponsorship of unhealthy products such as tobacco, junk food, and soft drinks.19

perinatal, and nutritional diseases as the most common causes of death by 2030.6

strategies in what has been called the full cycle of care.20

based policies and if we continue to involve all relevant actors.

Chagas cardiomyopathy, and peptic ulcer.

Access to Cancer Care.

NCDs.

This complexity can only be addressed through a comprehensive response to NCDs built on three major pillars:


Many countries have made progress along these pillars. Mexico is a relevant example. In the following paragraphs, some of the most important lessons in the use of each of the pillars in a reform recently implemented in this country are discussed.

The first pillar was predicated on the notion that health systems will not be able to handle the growing burden of NCDs without a renewed emphasis on public health. Aware of this reality, a crucial component of the Mexican reform was the establishment of a new public health agency charged with protection of the population against health risks through food safety, definition of environmental and occupational standards, regulation of the pharmaceutical industry, and control of hazardous substances like alcohol and tobacco.

Along with other developments, this new agency has greatly strengthened the stewardship role of the Ministry of Health, which has become empowered to mobilize all instruments of public policy in the pursuit of health as a social objective.

In addition, the financial re-engineering of the health system included a protected fund for community health services targeting health promotion and disease prevention interventions, including, of course, those targeted at NCDs.

Important as promotion and prevention are, control efforts must also include access to health care. Indeed, even if we invest increasing amounts of resources in the prevention of NCDs, we will still need to deal with the consequences of exposures to risks that have already occurred. Those consequences include episodes of disease that require treatment, which all too often exposes families to the associated risk of financial catastrophe. For this reason, a comprehensive strategy must also include the second pillar: universal social protection.

Based on sound evidence about the extent of pernicious out-of-pocket payments, in 2003 the Mexican Congress approved a major legislative reform establishing a system of social protection in health. This system has substantially increased public funding for health in order to provide universal health insurance, including the half of the population, 50 million persons, most of them poor, who had lacked protection until then.

The vast majority of these persons are now enrolled in a new public insurance scheme called *Seguro Popular*, which guarantees access to a comprehensive package of cost-effective services covering the prevention, early detection, diagnosis, treatment, and palliation of the major causes of ill health, including, of course, NCDs. The law stipulates that the package must be progressively expanded and updated annually on the basis of changes in the epidemiologic profile, technological developments and resource availability.

The key to expand such resources has been to start with an explicit set of guaranteed benefits. This ties the reform to concrete deliverables, which is a main ingredient to gain public support. This approach tackles health system strengthening starting with the desired

Non-Communicable Diseases in the Global Health Agenda 333

also *healthy* policies. This integration is particular relevant to the control of NCDs since

Finally, the health community should strive to create networks that guarantee the continuity of care, which is a crucial component of the treatment of most chronic diseases. A related transformation involves moving beyond health *centers*, which by definition concentrate human and technological resources, into health *spaces*, which extend the reach of comprehensive care into schools, workplaces, recreational areas, and the homes of those

We should recognize that the driving force to face the NCD challenge will be located in countries. However, no individual nation can respond on its own to the global challenges that underlie the risk factors for NCDs. To address them we require international collective action in the pursuit of shared goals. A major vehicle in this respect is the development of global policy instruments, like the Framework Convention on Tobacco Control. Another crucial element comes in the form of global public goods, like the evidence base that must be built by rigorously evaluating national innovations. In this way, it will be possible to fuel a

International action also requires the mobilization of global solidarity, as the fight against HIV/AIDS has so successfully exemplified. NCDs once again offer the world the chance to demonstrate that we are all committed to the universal value of health. Everyone has a role in this common endeavor: national governments, bilateral agencies, international organizations, global partnerships, private business, and the rich diversity of civil society, from professional

Giving NCDs their rightful place in the global health agenda will not be an easy task. Yet, if we act together to develop a prompt and comprehensive response, major improvements will

[1] Abegunde DO, Mathers CD, Adam T, Ortegon M, Strong K. The burden and costs of

chronic diseases in low-income and middle-income countries. Lancet

http://www.who.int/mediacentre/news/releases/2008/pr47/en/index.html.

[3] Centers for Disease Control and Prevention. World Malaria Day 2011. Achieving

http://www.cdc.gov/Features/WorldMalariaDay/. Accessed June 10, 2011 [4] IHME. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress

[5] UNDP. Human Development Report 2010. The real wealth of nations. Pathways to

http://www.healthmetricsandevaluation.org/research/publicationsummary/maternal-mortality-181-countries-1980-2008-systematic-analysis-

human development. New York: UNDP, 2010:143-47.

process of shared learning among countries about what works and in which context.

associations and advocacy groups to academic institutions and research centers.

be made in the health and wellbeing of the world population.

[2] WHO. Global measles deaths drop by 74%. Available at:

progress and impact. Available at:

towards MDG5. Available at:

progress. Accessed June 10, 2011.

many of the risk factors related to them fall beyond the limits of the health sector.

who live with a chronic condition.

**5. References** 

2007;370:1929-38.

Accessed June 10, 2011.

outcomes, rather than with the existing inputs, as is the usual practice. Once the package of guaranteed interventions has been defined, it is possible to work our way backwards to estimate the requirements for inputs, including financial resources, workforce development, facilities, drugs, and other technologies.

Thanks to this approach, there was ample support for increasing public investments in health, despite general economic difficulties. The recipe for success was very simple: the Ministry of Health didn't *ask* for money; rather it *offered* explicit benefits for all, including the health benefits but also the large economic benefits of reducing the burden of chronic diseases.

An explicit package of interventions is the key to develop a "diagonal" strategy, whereby specific disease priorities are used to strengthen the overall structure and function of the health system.2121

The true test of a reform, however, comes when benefits and resources make their way to the communities and facilities where actual delivery of services takes place. And this leads to the third and final pillar of health system strengthening: the deployment of innovations to assure that high-quality services reach all who need them. A particularly promising avenue is offered by the mobile phone revolution, with its enormous potential to expand access. Equally important are managerial innovations to improve efficiency, such as the delivery of NCD care in settings that require less intensity in the use of human resources and medical technology but still achieve good levels of quality.

#### **4. Conclusions**

In order to address the challenge of NCDs in the developing world we need to put in place a comprehensive strategy whose components have to be implemented both at the global and the local levels.

First of all, we need to overcome the lack of attention to this development challenge and integrate NCDs with communicable diseases in the global health agenda. The main objective in this regard should be to expand the MDGs to include health targets related to NCDs common in low- and middle-income countries, such as hypertension, diabetes, and cancer. WHO, in fact, has already proposed a 25% reduction of deaths attributed to NCDs by 2025 based on 2010 rates.

Second, it is necessary to mobilize local and global resources to finance the sustainable implementation of comprehensive strategies to address NCDs. Additional global resources will be crucial to implement these strategies in low-income countries.

Third, new health initiatives should consider the integration of prevention and treatment to control NCDs in a mutually reinforcing way. There are lessons to be learned in this respect from AIDS, where treatment has enormous impacts in preventing dissemination. Early detection and treatment of diabetes is also crucial to avoid the complications of this ailment, which require complex and costly interventions that impose pressures both on households and health systems. In reality there is no choice but to strengthen health systems so that they can offer comprehensive responses to the double burden of disease confronted by low- and middle-income countries.

The attention to the full cycle of care also implies the integration of all sectors whose activities are related to health in order to design and implement not only health policies but also *healthy* policies. This integration is particular relevant to the control of NCDs since many of the risk factors related to them fall beyond the limits of the health sector.

Finally, the health community should strive to create networks that guarantee the continuity of care, which is a crucial component of the treatment of most chronic diseases. A related transformation involves moving beyond health *centers*, which by definition concentrate human and technological resources, into health *spaces*, which extend the reach of comprehensive care into schools, workplaces, recreational areas, and the homes of those who live with a chronic condition.

We should recognize that the driving force to face the NCD challenge will be located in countries. However, no individual nation can respond on its own to the global challenges that underlie the risk factors for NCDs. To address them we require international collective action in the pursuit of shared goals. A major vehicle in this respect is the development of global policy instruments, like the Framework Convention on Tobacco Control. Another crucial element comes in the form of global public goods, like the evidence base that must be built by rigorously evaluating national innovations. In this way, it will be possible to fuel a process of shared learning among countries about what works and in which context.

International action also requires the mobilization of global solidarity, as the fight against HIV/AIDS has so successfully exemplified. NCDs once again offer the world the chance to demonstrate that we are all committed to the universal value of health. Everyone has a role in this common endeavor: national governments, bilateral agencies, international organizations, global partnerships, private business, and the rich diversity of civil society, from professional associations and advocacy groups to academic institutions and research centers.

Giving NCDs their rightful place in the global health agenda will not be an easy task. Yet, if we act together to develop a prompt and comprehensive response, major improvements will be made in the health and wellbeing of the world population.

#### **5. References**

332 Public Health – Methodology, Environmental and Systems Issues

outcomes, rather than with the existing inputs, as is the usual practice. Once the package of guaranteed interventions has been defined, it is possible to work our way backwards to estimate the requirements for inputs, including financial resources, workforce development,

Thanks to this approach, there was ample support for increasing public investments in health, despite general economic difficulties. The recipe for success was very simple: the Ministry of Health didn't *ask* for money; rather it *offered* explicit benefits for all, including the health benefits but also the large economic benefits of reducing the burden of chronic diseases.

An explicit package of interventions is the key to develop a "diagonal" strategy, whereby specific disease priorities are used to strengthen the overall structure and function of the

The true test of a reform, however, comes when benefits and resources make their way to the communities and facilities where actual delivery of services takes place. And this leads to the third and final pillar of health system strengthening: the deployment of innovations to assure that high-quality services reach all who need them. A particularly promising avenue is offered by the mobile phone revolution, with its enormous potential to expand access. Equally important are managerial innovations to improve efficiency, such as the delivery of NCD care in settings that require less intensity in the use of human resources and medical

In order to address the challenge of NCDs in the developing world we need to put in place a comprehensive strategy whose components have to be implemented both at the global and

First of all, we need to overcome the lack of attention to this development challenge and integrate NCDs with communicable diseases in the global health agenda. The main objective in this regard should be to expand the MDGs to include health targets related to NCDs common in low- and middle-income countries, such as hypertension, diabetes, and cancer. WHO, in fact, has already proposed a 25% reduction of deaths attributed to NCDs by 2025

Second, it is necessary to mobilize local and global resources to finance the sustainable implementation of comprehensive strategies to address NCDs. Additional global resources

Third, new health initiatives should consider the integration of prevention and treatment to control NCDs in a mutually reinforcing way. There are lessons to be learned in this respect from AIDS, where treatment has enormous impacts in preventing dissemination. Early detection and treatment of diabetes is also crucial to avoid the complications of this ailment, which require complex and costly interventions that impose pressures both on households and health systems. In reality there is no choice but to strengthen health systems so that they can offer comprehensive responses to the double burden of disease confronted by low- and

The attention to the full cycle of care also implies the integration of all sectors whose activities are related to health in order to design and implement not only health policies but

will be crucial to implement these strategies in low-income countries.

facilities, drugs, and other technologies.

technology but still achieve good levels of quality.

health system.2121

**4. Conclusions** 

the local levels.

based on 2010 rates.

middle-income countries.


http://www.cdc.gov/Features/WorldMalariaDay/. Accessed June 10, 2011

[4] IHME. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards MDG5. Available at:

http://www.healthmetricsandevaluation.org/research/publicationsummary/maternal-mortality-181-countries-1980-2008-systematic-analysisprogress. Accessed June 10, 2011.

[5] UNDP. Human Development Report 2010. The real wealth of nations. Pathways to human development. New York: UNDP, 2010:143-47.

**16** 

*Malaysia* 

**Diseases of Poverty:** 

*Monash University, Sunway Campus,* 

**The Science of the Neglected** 

Pascale Allotey, Daniel D. Reidpath and Shajahan Yasin *Global Public Health, School of Medicine and Health Sciences,* 

Diseases of poverty are those diseases identified as affecting the poorest and most disadvantaged populations in the world. Poverty is one of the main risk factors for the conditions, creating exposure to poor water and sanitation; poor nutrition, poor environmental conditions that favour the growth and spread of micro-organisms and vectors that cause and transmit disease; and lack of education and access to appropriate disease prevention, health promotion, treatment and rehabilitative services. Diseases of poverty include for instance, the neglected tropical (communicable) diseases (NTDs) which until relatively recently were considered low priority for both governments and pharmaceutical companies (1–4). Furthermore, diseases of poverty increasingly include the noncommunicable diseases (5–7); hypertension, cardiovascular diseases, diabetes and other metabolic diseases and cancers, previously considered diseases of affluence (8–11). While there is some variation in the specific drivers that cause and exacerbate the communicable and non-communicable diseases for the poor, invariably, the processes and context are similar, impeding choices for healthier lifestyles, access to and acceptability and affordability of regular and quality care for chronic conditions and strategies for prevention and health promotion. In turn, affliction with these diseases hinders economic opportunities and development and perpetuates poverty. The disease increases vulnerability and exposure to

poverty by increasing household expenditure and decreasing household income.

Through mechanisms provided by the Millennium Declaration and associated Millennium Development Goals, the World Economic Forum, the Global Fund, the Bill and Melinda Gates Foundation and the US President's Emergency Fund for AIDS Relief, the global health community has highlighted the plight of the poor and vulnerable, and gained support to address the major diseases. There is more funding available in global health now than there has ever been before (12–14). Major drug companies have committed to free donation of particular pharmaceuticals in an effort to achieve elimination of a number of diseases (15). The more recent UN Summit on NCDs employed this global advocacy process to elicit support from the highest levels of government to address the growing burden of specific chronic diseases. Critically however, programmes that result from these global health campaigns have historically been characterised largely by disease focused, vertical interventions that treat communities as a collective, providing a large scale clinical intervention. Much less attention is

**1. Introduction** 


### **Diseases of Poverty: The Science of the Neglected**

Pascale Allotey, Daniel D. Reidpath and Shajahan Yasin *Global Public Health, School of Medicine and Health Sciences, Monash University, Sunway Campus, Malaysia* 

#### **1. Introduction**

334 Public Health – Methodology, Environmental and Systems Issues

[6] World Health Organization. Global Status Report on Noncommunicable Diseases 2010.

[7] Economist Intelligence Unit. Breakaway: The global burden of cancer- challenges and

[8] García M, Jemal A, Ward EM, et al. Global cancer facts and figures 2007. Atlanta, GA:

[9] Lozano R, Gómez-Dantés H, Lewis S, Torres-Sánchez L, López-Carrillo L. Tendencias del

[11] Goodarz D, Finucane MM, Lu Y, Singh G, Cowan MJ, Pachiorek CJ et al. National,

[12] International Diabetes Federation. The economic impacts of diabetes. Available at:

[13] Withrow and colleagues quoted in Wang YC, McPherson K, Marsh T, Gortmaker S,

[14] Swinburn BA, Sacks, G, Hall KD, McPherson KI, Finegood DT, Moodie M, Gortmaker

[15] Institute of Medicine. Early Childhood Obesity Prevention Policies. Washington, DC:

[16] Instituto Nacional de Medicina. Encuesta Nacional de Salud y Nutrición 2006.

[18] World Health Organization. About two out of five cancers can be prevented. Available at:

[19] Brundtland GH. International Policy Conference on Children and Tobacco. Available at:

[20] Porter M. A strategy for health care reform. Toward a value-based system. New

[21] Sepúlveda J. Foreword. In: Jamison DT, Breman JG, Measham AR, et al, editors. Disease

Cuernavaca, Morelos: Instituto Nacional de Salud Pública, 2006.

[17] King D. The future challenge of obesity. Lancet 2011;378:743-44.

204/en/index.html. Accessed February 25, 2011.

England Journal of Medicine 2009; 361:109-112.

University Press for The World Bank, 2006: xiii-xv.

cáncer de mama en América Latina y el Caribe. Salud Pública de México

http://www.who.int/mediacentre/factsheets/fs297/en/index.html. Accessed

regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants. Lancet

http://www.idf.org/diabetesatlas/economic-impacts-diabetes. Accessed

Brown M. Health and economic burden of the projected obesity trends in the USA

SL. The global obesity pandemic: shaped by global drivers and local environments.

http://www.who.int/mediacentre/multimedia/podcasts/2010/cancer\_day\_20100

general/speeches/1999/english/19990318\_international\_policy\_conference.html.

control priorities in developing countries [2nd edition]. New York: Oxford

opportunities. London: The Economist Intelligence Unit, 2009.

Geneva: WHO, 2011:1.

September 6, 2011.

2011;378(9785):31-40.

September 6, 2011.

Lancet 2011;378:804-14.

http://www.who.int/director-

Accessed Febraury 27, 2011.

IOM, 2011.

American Cancer Society, 2007.

2009;51(supplement 2):S147-S156. [10] World Health Organization. Cancer. Available at:

and the UK. Lancet 2011;378:815-25.

Diseases of poverty are those diseases identified as affecting the poorest and most disadvantaged populations in the world. Poverty is one of the main risk factors for the conditions, creating exposure to poor water and sanitation; poor nutrition, poor environmental conditions that favour the growth and spread of micro-organisms and vectors that cause and transmit disease; and lack of education and access to appropriate disease prevention, health promotion, treatment and rehabilitative services. Diseases of poverty include for instance, the neglected tropical (communicable) diseases (NTDs) which until relatively recently were considered low priority for both governments and pharmaceutical companies (1–4). Furthermore, diseases of poverty increasingly include the noncommunicable diseases (5–7); hypertension, cardiovascular diseases, diabetes and other metabolic diseases and cancers, previously considered diseases of affluence (8–11). While there is some variation in the specific drivers that cause and exacerbate the communicable and non-communicable diseases for the poor, invariably, the processes and context are similar, impeding choices for healthier lifestyles, access to and acceptability and affordability of regular and quality care for chronic conditions and strategies for prevention and health promotion. In turn, affliction with these diseases hinders economic opportunities and development and perpetuates poverty. The disease increases vulnerability and exposure to poverty by increasing household expenditure and decreasing household income.

Through mechanisms provided by the Millennium Declaration and associated Millennium Development Goals, the World Economic Forum, the Global Fund, the Bill and Melinda Gates Foundation and the US President's Emergency Fund for AIDS Relief, the global health community has highlighted the plight of the poor and vulnerable, and gained support to address the major diseases. There is more funding available in global health now than there has ever been before (12–14). Major drug companies have committed to free donation of particular pharmaceuticals in an effort to achieve elimination of a number of diseases (15). The more recent UN Summit on NCDs employed this global advocacy process to elicit support from the highest levels of government to address the growing burden of specific chronic diseases. Critically however, programmes that result from these global health campaigns have historically been characterised largely by disease focused, vertical interventions that treat communities as a collective, providing a large scale clinical intervention. Much less attention is

Diseases of Poverty: The Science of the Neglected 337

A great deal has been made of stigmatization, disfigurement, persistent poverty, poor maternal and child health outcomes, poor health and education of children caused by infectious diseases (4,22–24). The choice of the word "neglect" is pointed and loaded, forcing us to reflect on our social obligations. Inherent in this campaign strategy is an appeal for the

These issues have been raised time and again by researchers working across the areas of health and human rights, the social determinants of health (26) anthropology and sociology (27–31) to mention a few. At the very least increasing standards of living, provision of the basic human rights of food, shelter, and clothing are definitive interventions towards the elimination of diseases of poverty. The body of evidence that supports the need for structural intervention is significant (32) and is obvious in the lack of these diseases in communities with an even marginally higher socio-economic status than "the bottom billion" (33). Tackling structural problems is harder because the interventions required are more complex; some have suggested too complex to consider (34). However not intervening at these levels increases the futility of current efforts. The re-emergence of diseases that were

Other vulnerabilities highlighted in diseases of poverty include stigmatisation, social isolation, and disfigurement. These are vulnerabilities that result from social and cultural norms of what is considered normal and who is an acceptable member of the community (28,36,37). The effects of these on health relate to values that are less tangible than disease;

The basic concern here is not new and to a significant degree, revisits the major, largely unresolved debates that raged almost 40 years ago between proponents and opponents of Primary Health Care (PHC) (38–40). The critical question is this: does one partition out individual, proximal, biological causes (i.e., the disease) and address them as independent context free problems, or is there a need for a different approach which attempts to address the multiple distal and proximal causes within the context in which they occur? The primary health care debates addressed this question in favour of a disease specific approach with the introduction of Selective Primary Health Care programmes (41), vertical programmes. This establishes the putative 'pro-poor' credentials of diseases of poverty, despite the focus on identifying unabashed medical and technological fixes – the "magical bullet" to combat

The contribution of the biomedical technologies cannot be underestimated. However, unless there are also significant interventions to address *health* and *poverty*, and the myriad marginalising factors in the social, cultural, economic, political and physical environments in which affected populations live, there will continue to be neglected people. Even in the research into the NTDs there is a distinct and patent disinterest in the social and contextual (42). Vaccines and drugs do not cure *neglect or poverty* and are not sufficient to rescue the

Even if it is decided that it would be safe to focus on the health side of the agenda rather than the poverty side, social and environmental (i.e., contextual) concerns cannot be

1 This section draw significantly on earlier work of the authors and re-presents a number of the ideas

recognition of human suffering and the need for social justice (25).

supposed to have been eradicated 40 years ago (35) is a case in point.

equity, opportunity, access - and require intervention at different levels.

disease (38).

neglected bottom billion from poverty (18).

without repeated citation, but also extends on some of those ideas(43).

**3. The Implementation gap1**

focused on the more persistent underlying contributors to diseases of poverty – poverty and its other contextual drivers that are intimately interlinked with the diseases and outcomes.

In this discussion paper, we argue that despite the importance of these contextual drivers, they are largely neglected in the science and evidence that contributes to solutions for addressing diseases of poverty. We begin with the premise that there are fundamental differences in the ways that different disciplines conceptualise health, illness and disease. From a biomedical and clinical sciences perspective, diseases of poverty represent 'slugs, bugs and drugs' and present an ideal opportunity for technical fixes. There is robust evidence on the efficacy of these fixes and a strategy based on this evidence presents good value for money(16–20). From the perspective of the social sciences however, there is less of a separation between the person, the human condition, the environment and the disease process. The interest, from a social science perspective is primarily in the social, cultural, environmental and economic drivers of poverty and disadvantage, societal norms that mitigate marginalisation and the ecological factors that determine who becomes ill, what they do about it, and the outcomes of the illness. This would therefore also encompass the contextual factors that would enhance or hinder the delivery of a given biomedical strategy that involves populations. While robust and theoretically grounded, evidence from social science research and solutions that arise from that research may not necessarily present the kinds of context free, quantifiable, linear solutions that are frequently desired under biomedical research models. Similarly, under social science models, a solution that removes proximal causes of suffering without addressing the more distal and complex contextual factors that continue to put populations at risk, may not appear to be a desirable end point for a strategy. In this paper therefore we explore:


To address these questions, this report consists of a critical review of the diseases of poverty with a focus on the social, cultural, environmental and other contextual factors that affect risk, exposure, treatment and sequelae. In this context, diseases of poverty refer to the neglected diseases defined as those diseases which (i) have a disproportionate effect on the most disadvantaged sections of the community (the poor and marginalised); and (ii) lack investment in research and development for solutions that are explicitly accessible to the disadvantaged. We then provide a critical analysis of the sciences required to explore the complex nature of neglect in diseases of poverty and offer some suggestions for a broader approach to achieving long term solutions.

#### **2. The context of diseases of poverty**

Most of the conditions identified as diseases of poverty are treatable with currently available drugs. That notwithstanding, prevalence of these conditions remains high and the conditions persist (21). The neglected tropical diseases campaign for instance has relentlessly highlighted the plight of the populations affected by the range of target diseases.

focused on the more persistent underlying contributors to diseases of poverty – poverty and its other contextual drivers that are intimately interlinked with the diseases and outcomes.

In this discussion paper, we argue that despite the importance of these contextual drivers, they are largely neglected in the science and evidence that contributes to solutions for addressing diseases of poverty. We begin with the premise that there are fundamental differences in the ways that different disciplines conceptualise health, illness and disease. From a biomedical and clinical sciences perspective, diseases of poverty represent 'slugs, bugs and drugs' and present an ideal opportunity for technical fixes. There is robust evidence on the efficacy of these fixes and a strategy based on this evidence presents good value for money(16–20). From the perspective of the social sciences however, there is less of a separation between the person, the human condition, the environment and the disease process. The interest, from a social science perspective is primarily in the social, cultural, environmental and economic drivers of poverty and disadvantage, societal norms that mitigate marginalisation and the ecological factors that determine who becomes ill, what they do about it, and the outcomes of the illness. This would therefore also encompass the contextual factors that would enhance or hinder the delivery of a given biomedical strategy that involves populations. While robust and theoretically grounded, evidence from social science research and solutions that arise from that research may not necessarily present the kinds of context free, quantifiable, linear solutions that are frequently desired under biomedical research models. Similarly, under social science models, a solution that removes proximal causes of suffering without addressing the more distal and complex contextual factors that continue to put populations at risk, may not appear to be a desirable end point

2. The challenges in conceptualising and operationalizing these factors for the purposes of

3. The barriers to the translation of social science generated evidence in global public

To address these questions, this report consists of a critical review of the diseases of poverty with a focus on the social, cultural, environmental and other contextual factors that affect risk, exposure, treatment and sequelae. In this context, diseases of poverty refer to the neglected diseases defined as those diseases which (i) have a disproportionate effect on the most disadvantaged sections of the community (the poor and marginalised); and (ii) lack investment in research and development for solutions that are explicitly accessible to the disadvantaged. We then provide a critical analysis of the sciences required to explore the complex nature of neglect in diseases of poverty and offer some suggestions for a broader

Most of the conditions identified as diseases of poverty are treatable with currently available drugs. That notwithstanding, prevalence of these conditions remains high and the conditions persist (21). The neglected tropical diseases campaign for instance has relentlessly highlighted the plight of the populations affected by the range of target diseases.

for a strategy. In this paper therefore we explore:

approach to achieving long term solutions.

**2. The context of diseases of poverty** 

generating evidence;

health; and

1. The contextual factors the define diseases of poverty;

4. Some solutions to rebalancing the scientific approaches to neglected.

A great deal has been made of stigmatization, disfigurement, persistent poverty, poor maternal and child health outcomes, poor health and education of children caused by infectious diseases (4,22–24). The choice of the word "neglect" is pointed and loaded, forcing us to reflect on our social obligations. Inherent in this campaign strategy is an appeal for the recognition of human suffering and the need for social justice (25).

These issues have been raised time and again by researchers working across the areas of health and human rights, the social determinants of health (26) anthropology and sociology (27–31) to mention a few. At the very least increasing standards of living, provision of the basic human rights of food, shelter, and clothing are definitive interventions towards the elimination of diseases of poverty. The body of evidence that supports the need for structural intervention is significant (32) and is obvious in the lack of these diseases in communities with an even marginally higher socio-economic status than "the bottom billion" (33). Tackling structural problems is harder because the interventions required are more complex; some have suggested too complex to consider (34). However not intervening at these levels increases the futility of current efforts. The re-emergence of diseases that were supposed to have been eradicated 40 years ago (35) is a case in point.

Other vulnerabilities highlighted in diseases of poverty include stigmatisation, social isolation, and disfigurement. These are vulnerabilities that result from social and cultural norms of what is considered normal and who is an acceptable member of the community (28,36,37). The effects of these on health relate to values that are less tangible than disease; equity, opportunity, access - and require intervention at different levels.

The basic concern here is not new and to a significant degree, revisits the major, largely unresolved debates that raged almost 40 years ago between proponents and opponents of Primary Health Care (PHC) (38–40). The critical question is this: does one partition out individual, proximal, biological causes (i.e., the disease) and address them as independent context free problems, or is there a need for a different approach which attempts to address the multiple distal and proximal causes within the context in which they occur? The primary health care debates addressed this question in favour of a disease specific approach with the introduction of Selective Primary Health Care programmes (41), vertical programmes. This establishes the putative 'pro-poor' credentials of diseases of poverty, despite the focus on identifying unabashed medical and technological fixes – the "magical bullet" to combat disease (38).

The contribution of the biomedical technologies cannot be underestimated. However, unless there are also significant interventions to address *health* and *poverty*, and the myriad marginalising factors in the social, cultural, economic, political and physical environments in which affected populations live, there will continue to be neglected people. Even in the research into the NTDs there is a distinct and patent disinterest in the social and contextual (42). Vaccines and drugs do not cure *neglect or poverty* and are not sufficient to rescue the neglected bottom billion from poverty (18).

#### **3. The Implementation gap1**

Even if it is decided that it would be safe to focus on the health side of the agenda rather than the poverty side, social and environmental (i.e., contextual) concerns cannot be

 1 This section draw significantly on earlier work of the authors and re-presents a number of the ideas without repeated citation, but also extends on some of those ideas(43).

Diseases of Poverty: The Science of the Neglected 339

theory that is free of contextual considerations. This means that a transistor works the same in New York, Bogotá, and Ouagadougou. When you start your laptop computer, which has millions of transistors, you do not first have to find out where to make contextual adjustments to the transistors. Superficially the science under-pinning the transistor looks to provide the

On reflection the context-free nature of the findings are superficial. It is not the case that the transistor works in all contexts; rather, industrial manufacturing processes have been developed which make sure that the context within the transistors' housings remain the same without regard to where the transistors are. In effect, manufacturers have learned to create miniature, identical, controlled environments, with a fixed context of operation that conforms to an idealised model. The quantum effects work reliably and consistently within the bounds of the miniature environment, but without the same certainty outside that environment.

The second example is of a leaf. Science and engineering has provided significant insights into aerodynamics. We have instrumentally valuable theories that predict airflow and lift. Empirical work in wind tunnels, computer simulation efforts and theoretical advances allow for very precise predictions to be made about how aircraft will behave under a range of plausible environmental conditions. Predicting the path, however, that a leaf will follow when blown down an alley is beyond us. The idealised understanding that we have of aerodynamics allows us to frame and control the context of the science that is done. Aircraft wings are crafted so that they maximise our predictive capacity, and conform to our understandings of the laws of aerodynamics. When we cannot control the context of the

These observations are not pedantry, and they do not belittle the science that allows us to fly aircraft and build computers. What they do suggest, however, is that our science works because we know and understand the context in which it is applied. With a change in context, the success of the science is less certain. When developing health interventions, we do not have the luxury of constructing the context to suit the kinds of interventions or designing the intervention to work in a single context. Rather, we need to engage in the type

At a recent scientific meeting on community directed ivermectin distribution program for the control of Onchocerciasis, a report was presented from Nigeria where the intervention was not achieving the results anticipated given known effectiveness and the reported high coverage of ivermectin. When the gap between coverage and results was investigated, the evaluation team found that the villagers were receiving the ivermectin; however, instead of taking the tablets themselves, they were distributing them among their cattle. The villagers had decided that the economic benefit of a healthy herd far out-weighted the health loss

The science had shown that ivermectin was a clinically effective approach to onchocerciasis control in one context. Community-based trials confirmed the effectiveness after scaling up the intervention in another context (44); and the economic analysis showed that it was costeffective (45,46). This was the 'truth' as revealed by the science of fixed contexts. The reality, however, was that the effectiveness of the intervention depended on a range of contextual factors – such as competing economic incentives. Having located the research in fixed (or well regulated) contexts, the likely variability of outcome that occurs in the wilds of real life,

very kinds of context-free insight that real science is all about.

science, however, what we actually know becomes far less impressive.

of science that embraces interventions that are contextually appropriate.

they faced by failing to treat their personal affliction with onchocerciasis.

did not enter into any decisions about effectiveness.

avoided. An almost exclusive focus on the biomedical overestimates the value of the current science, leaving unresolved issues with implementation; that is, embedding a putatively effective intervention in a community. It is, after all, not enough to have the perfect cure if no one in need is able to receive it. Whether an intervention to be implemented in neglected populations has the same benefit in that population as it does in another population is an empirical question.

The randomised control trial (RCT) is widely regarded as the "gold standard" form of scientific evidence for establishing the effectiveness of a treatment (i.e., the cause effect relationship between treatment and cure), with decreasing levels of evidence treated with increasing levels suspicion. The problem with the RCT (and the levels of evidence) is that, in a general sense, and contrary to the expectations of many researchers, an RCT does not show the effectiveness of a treatment. It shows the effectiveness of a treatment in a particular context. Conducting multi-site RCTs, or conducting meta-analyses of multiple RCTs supports the generality of the finding. However, the conclusions about effectiveness can never be made without acknowledging the very controlled nature of experimental studies on which the conclusions about effectiveness are based; and by extension, the limitations imposed on generalising the results into less controlled, more realistic, contexts.

The intention to treat (ITT) analysis of RCTs is a partial acknowledgement of the problems of context. In the simplest kind of RCT, patients are randomly allocated to a treatment or a control (non-treatment / "usual treatment") group. Imagine that some people who were allocated to the treatment group ended up receiving no treatment – just like the control group. Under the ITT analysis, one analyses the results of the intervention as if all the people allocated to the treatment group, even those who did not receive treatment, did end up receiving treatment. This can seem somewhat counter-intuitive. Why would one analyse data counter to the reality of what happened? The analysis, however, establishes the effectiveness of a policy, i.e., an intention to treat patients in a particular way. The biological efficacy of the treatment should have already been established in early stage trials, and not be in doubt. The ITT analysis established the effectiveness of a treatment policy in a particular clinical setting.2

The use of community-based trials, and 'less rigorous' forms of effectiveness study try to capture the likely context in which an intervention might actually be employed; and to some degree they support the generalisation of the findings. A caveat, however, always remains, because study sites are inevitably different from sites that do not fall under the scrutiny of researchers. The context of the research study is not the context in which most lives are lived. The generalisation of the conclusions from the research study site to the populations that do not live under those conditions goes beyond the science.

The philosopher of science Nancy Cartwright raised points relevant to this argument in other branches of science. The issue is about what one knows in a general sense from doing scientific research. One of her points was that what one knows, relates to the context in which the research was conducted. Two illustrative examples of hers relate to the electronic transistor and to a leaf blowing in an alley. Consider the first example of the electronic transistor; a device used to regulate the flow of electricity. The basis of the transistor is grounded in quantum physics – a

<sup>2</sup> Interestingly, DDR recently read a description of statistical techniques to avoid the ITT analysis, so that the "true" effect of the intervention could be estimated. This presupposes that the idea of a true effect devoid of a context in which a treatment is applied makes any sense – which seems very doubtful.

avoided. An almost exclusive focus on the biomedical overestimates the value of the current science, leaving unresolved issues with implementation; that is, embedding a putatively effective intervention in a community. It is, after all, not enough to have the perfect cure if no one in need is able to receive it. Whether an intervention to be implemented in neglected populations has the same benefit in that population as it does in another population is an

The randomised control trial (RCT) is widely regarded as the "gold standard" form of scientific evidence for establishing the effectiveness of a treatment (i.e., the cause effect relationship between treatment and cure), with decreasing levels of evidence treated with increasing levels suspicion. The problem with the RCT (and the levels of evidence) is that, in a general sense, and contrary to the expectations of many researchers, an RCT does not show the effectiveness of a treatment. It shows the effectiveness of a treatment in a particular context. Conducting multi-site RCTs, or conducting meta-analyses of multiple RCTs supports the generality of the finding. However, the conclusions about effectiveness can never be made without acknowledging the very controlled nature of experimental studies on which the conclusions about effectiveness are based; and by extension, the limitations imposed on generalising the results into less controlled, more realistic, contexts. The intention to treat (ITT) analysis of RCTs is a partial acknowledgement of the problems of context. In the simplest kind of RCT, patients are randomly allocated to a treatment or a control (non-treatment / "usual treatment") group. Imagine that some people who were allocated to the treatment group ended up receiving no treatment – just like the control group. Under the ITT analysis, one analyses the results of the intervention as if all the people allocated to the treatment group, even those who did not receive treatment, did end up receiving treatment. This can seem somewhat counter-intuitive. Why would one analyse data counter to the reality of what happened? The analysis, however, establishes the effectiveness of a policy, i.e., an intention to treat patients in a particular way. The biological efficacy of the treatment should have already been established in early stage trials, and not be in doubt. The ITT analysis established the effectiveness of a treatment policy in a particular clinical setting.2

The use of community-based trials, and 'less rigorous' forms of effectiveness study try to capture the likely context in which an intervention might actually be employed; and to some degree they support the generalisation of the findings. A caveat, however, always remains, because study sites are inevitably different from sites that do not fall under the scrutiny of researchers. The context of the research study is not the context in which most lives are lived. The generalisation of the conclusions from the research study site to the populations

The philosopher of science Nancy Cartwright raised points relevant to this argument in other branches of science. The issue is about what one knows in a general sense from doing scientific research. One of her points was that what one knows, relates to the context in which the research was conducted. Two illustrative examples of hers relate to the electronic transistor and to a leaf blowing in an alley. Consider the first example of the electronic transistor; a device used to regulate the flow of electricity. The basis of the transistor is grounded in quantum physics – a

2 Interestingly, DDR recently read a description of statistical techniques to avoid the ITT analysis, so that the "true" effect of the intervention could be estimated. This presupposes that the idea of a true effect devoid of a context in which a treatment is applied makes any sense – which seems very doubtful.

that do not live under those conditions goes beyond the science.

empirical question.

theory that is free of contextual considerations. This means that a transistor works the same in New York, Bogotá, and Ouagadougou. When you start your laptop computer, which has millions of transistors, you do not first have to find out where to make contextual adjustments to the transistors. Superficially the science under-pinning the transistor looks to provide the very kinds of context-free insight that real science is all about.

On reflection the context-free nature of the findings are superficial. It is not the case that the transistor works in all contexts; rather, industrial manufacturing processes have been developed which make sure that the context within the transistors' housings remain the same without regard to where the transistors are. In effect, manufacturers have learned to create miniature, identical, controlled environments, with a fixed context of operation that conforms to an idealised model. The quantum effects work reliably and consistently within the bounds of the miniature environment, but without the same certainty outside that environment.

The second example is of a leaf. Science and engineering has provided significant insights into aerodynamics. We have instrumentally valuable theories that predict airflow and lift. Empirical work in wind tunnels, computer simulation efforts and theoretical advances allow for very precise predictions to be made about how aircraft will behave under a range of plausible environmental conditions. Predicting the path, however, that a leaf will follow when blown down an alley is beyond us. The idealised understanding that we have of aerodynamics allows us to frame and control the context of the science that is done. Aircraft wings are crafted so that they maximise our predictive capacity, and conform to our understandings of the laws of aerodynamics. When we cannot control the context of the science, however, what we actually know becomes far less impressive.

These observations are not pedantry, and they do not belittle the science that allows us to fly aircraft and build computers. What they do suggest, however, is that our science works because we know and understand the context in which it is applied. With a change in context, the success of the science is less certain. When developing health interventions, we do not have the luxury of constructing the context to suit the kinds of interventions or designing the intervention to work in a single context. Rather, we need to engage in the type of science that embraces interventions that are contextually appropriate.

At a recent scientific meeting on community directed ivermectin distribution program for the control of Onchocerciasis, a report was presented from Nigeria where the intervention was not achieving the results anticipated given known effectiveness and the reported high coverage of ivermectin. When the gap between coverage and results was investigated, the evaluation team found that the villagers were receiving the ivermectin; however, instead of taking the tablets themselves, they were distributing them among their cattle. The villagers had decided that the economic benefit of a healthy herd far out-weighted the health loss they faced by failing to treat their personal affliction with onchocerciasis.

The science had shown that ivermectin was a clinically effective approach to onchocerciasis control in one context. Community-based trials confirmed the effectiveness after scaling up the intervention in another context (44); and the economic analysis showed that it was costeffective (45,46). This was the 'truth' as revealed by the science of fixed contexts. The reality, however, was that the effectiveness of the intervention depended on a range of contextual factors – such as competing economic incentives. Having located the research in fixed (or well regulated) contexts, the likely variability of outcome that occurs in the wilds of real life, did not enter into any decisions about effectiveness.

Diseases of Poverty: The Science of the Neglected 341

vulnerability of neglected populations to disease. The obvious place to look for this research is in the social sciences literature, or the intersection between the clinical, biomedical, and

In a bibliometric analysis of four diseases of poverty (chikungunya, dengue, leishmaniasis, and onchocerciasis) we found that social sciences contribute to less than 2% of the published research (42). That was a generous counting of the social sciences contribution. The research that was funded was generally insipid, because it was there to act as a hand-maiden for biomedical research, never intended to support a research agenda of implementation or distal intervention. And the lack of a social sciences research agenda has a negative impact on the value of the biomedical research that is conducted, and limits our options for

To say that the social sciences have been totally overlooked in the global health efforts would however be inaccurate. The value of the social sciences up until now, however, is qualified. In the area of NTDs, evidence from anthropological studies on stigmatization, the lived experiences of patients disfigured by diseases such as leprosy, yaws, onchocerciasis and filariasis, and the effects of these on health seeking, access to and quality of care, have been used particularly to support advocacy (4,18,28,53,24,54,55). The research that explores the reasons for the failures of programmes for instance is not insubstantial. Anthropological research has provided data on the importance of cultural and social constructions of illness and disease. We have some understanding of the different levels of practitioners, how and why they might be consulted and their role (or lack thereof) within a formal health system. There is evidence from the social sciences of the complexities and pathways to health seeking, the economic and social drivers, the effects of gender and other social determinants. Health economics has shed light on willingness of patients or clients to pay for different types of health services, interventions and pharmaceuticals; and the local market forces that hinder or enable distribution of and access to health services and pharmaceuticals. Health services and health systems research provides rigorous data on the socio-economic and political context in which local, national and global

In broad terms however, social science research in this area has to date focused largely on the evaluation of the implementation process and on factors that will enhance community participation in community based programs (56). Both the process and the outcome indicators therefore relate to the administration of treatment and where appropriate, a short term reduction in NCDs. In other words these approaches to 'deploying' the social sciences are rather utilitarian and often tokenistic (43). The consequences to this are the often questionable quality of the social science evidence generated. Implementation research for instance, if well designed and implemented has the potential to contribute significantly to disease control efforts – however it is an area of research that is poorly funded (43) The problem arises often because social scientists are invited onto teams to undertake specific research projects rather than being a conceptual part of the planning of the intervention (27) To obtain the higher objective of improving the health and reducing vulnerabilities, it is important for researchers, policy makers and funding agencies to broaden the perspective on the range of research that is needed to address neglected diseases of neglected populations, and to rethink the types of integrated interventions and the nature of evidence to show effectiveness. There is a need to refocus on the health of neglected populations -

health policy supports (or otherwise) disease control programs.

health as an enabling process (38) - and not merely removing disease.

social sciences literature.

intervention to proximal cures.

There are two important corollaries to this. The first: imagine two interventions both of which are significantly more effective than no treatment. Furthermore, in clinical trials researchers have established that intervention A is significantly more effective than intervention B (i.e., 0 *A B* > > ). When the context changes from the controlled research environment to point of implementation, the apparent magnitude of the effect of the interventions can reverse, with intervention B having a greater effect than intervention A (i.e., 0 *B A*> > or 0 *B A*> = ). This will occur if, at the stage of implementation, the more effective A cannot be embedded in the community.

The second corollary, which is an extension of the first, is that interventions that seem to be cost-ineffective in one context maybe the cost-effective interventions in another context, and the cost-effective intervention in another context will be the cost-ineffective intervention in this context. Continuing to use interventions A and B, following the effectiveness studies, the economic analysis established that A is more cost-effective than B. However, on implementation, when A fails to achieve any community up-take, B becomes the more costeffective of the interventions. The implications of this are hard to under-estimate.

Decision making based on effectiveness and cost-effectiveness, which is a rational approach to the optimal allocation of scarce resources, may fail dramatically if the information on which the decision is based comes from the partial science of fixed contexts.

As Allotey et al. observed (p.3), effectiveness is regarded as the appropriate end point for most intervention research. But knowing that a treatment is effective in routine clinical care is not enough, particularly in resource poor settings (i.e., the settings of the neglected). The goal must be the sustainable adoption of the intervention by the health systems and the target population, and not simply the establishment of effectiveness in a monitored clinical population. In other words, an intervention must become embedded; firmly integrated as part of the health system and the health culture of the disease endemic setting. It must be available, acceptable, accessible and affordable to those who need it; used appropriately, and become a part of the disease prevention, treatment seeking culture.

Biomedical research is neither intended to address nor capable of addressing questions about implementation. Thus, not only is the value of the biomedical research limited by our lack of research on the contextual effects associated with implementation, it is also outside the expertise of those scientists to address the issues.

#### **4. The science of the neglected**

To this point we have argued that the approach to the neglected diseases has leveraged the idea of the vulnerable and neglected population to advance an argument for providing additional resources to the biomedical scientists so that they can develop cures for neglected diseases – "vaccines against poverty". We then discuss the evidence about social vulnerability to disease, and the possibility of social interventions that address more distal causes of disease – intervening before the biomedical concerns arise. Finally we argued that the focus on proximal interventions is based on a flawed notion of the under-lying science and the generality of that science. In effect we argue for the development of contextually relevant science capable of accounting for social and environmental factors affecting the implementation of interventions.

What is missing from our discussion is (i) the research that supports the implementation of proximal cures, and (ii) the research that supports distal interventions that change the social

There are two important corollaries to this. The first: imagine two interventions both of which are significantly more effective than no treatment. Furthermore, in clinical trials researchers have established that intervention A is significantly more effective than intervention B (i.e., 0 *A B* > > ). When the context changes from the controlled research environment to point of implementation, the apparent magnitude of the effect of the interventions can reverse, with intervention B having a greater effect than intervention A (i.e., 0 *B A*> > or 0 *B A*> = ). This will occur if, at the stage of implementation, the more

The second corollary, which is an extension of the first, is that interventions that seem to be cost-ineffective in one context maybe the cost-effective interventions in another context, and the cost-effective intervention in another context will be the cost-ineffective intervention in this context. Continuing to use interventions A and B, following the effectiveness studies, the economic analysis established that A is more cost-effective than B. However, on implementation, when A fails to achieve any community up-take, B becomes the more cost-

Decision making based on effectiveness and cost-effectiveness, which is a rational approach to the optimal allocation of scarce resources, may fail dramatically if the information on

As Allotey et al. observed (p.3), effectiveness is regarded as the appropriate end point for most intervention research. But knowing that a treatment is effective in routine clinical care is not enough, particularly in resource poor settings (i.e., the settings of the neglected). The goal must be the sustainable adoption of the intervention by the health systems and the target population, and not simply the establishment of effectiveness in a monitored clinical population. In other words, an intervention must become embedded; firmly integrated as part of the health system and the health culture of the disease endemic setting. It must be available, acceptable, accessible and affordable to those who need it; used appropriately,

Biomedical research is neither intended to address nor capable of addressing questions about implementation. Thus, not only is the value of the biomedical research limited by our lack of research on the contextual effects associated with implementation, it is also outside

To this point we have argued that the approach to the neglected diseases has leveraged the idea of the vulnerable and neglected population to advance an argument for providing additional resources to the biomedical scientists so that they can develop cures for neglected diseases – "vaccines against poverty". We then discuss the evidence about social vulnerability to disease, and the possibility of social interventions that address more distal causes of disease – intervening before the biomedical concerns arise. Finally we argued that the focus on proximal interventions is based on a flawed notion of the under-lying science and the generality of that science. In effect we argue for the development of contextually relevant science capable of accounting for social and environmental factors affecting the

What is missing from our discussion is (i) the research that supports the implementation of proximal cures, and (ii) the research that supports distal interventions that change the social

effective of the interventions. The implications of this are hard to under-estimate.

which the decision is based comes from the partial science of fixed contexts.

and become a part of the disease prevention, treatment seeking culture.

the expertise of those scientists to address the issues.

**4. The science of the neglected** 

implementation of interventions.

effective A cannot be embedded in the community.

vulnerability of neglected populations to disease. The obvious place to look for this research is in the social sciences literature, or the intersection between the clinical, biomedical, and social sciences literature.

In a bibliometric analysis of four diseases of poverty (chikungunya, dengue, leishmaniasis, and onchocerciasis) we found that social sciences contribute to less than 2% of the published research (42). That was a generous counting of the social sciences contribution. The research that was funded was generally insipid, because it was there to act as a hand-maiden for biomedical research, never intended to support a research agenda of implementation or distal intervention. And the lack of a social sciences research agenda has a negative impact on the value of the biomedical research that is conducted, and limits our options for intervention to proximal cures.

To say that the social sciences have been totally overlooked in the global health efforts would however be inaccurate. The value of the social sciences up until now, however, is qualified. In the area of NTDs, evidence from anthropological studies on stigmatization, the lived experiences of patients disfigured by diseases such as leprosy, yaws, onchocerciasis and filariasis, and the effects of these on health seeking, access to and quality of care, have been used particularly to support advocacy (4,18,28,53,24,54,55). The research that explores the reasons for the failures of programmes for instance is not insubstantial. Anthropological research has provided data on the importance of cultural and social constructions of illness and disease. We have some understanding of the different levels of practitioners, how and why they might be consulted and their role (or lack thereof) within a formal health system. There is evidence from the social sciences of the complexities and pathways to health seeking, the economic and social drivers, the effects of gender and other social determinants. Health economics has shed light on willingness of patients or clients to pay for different types of health services, interventions and pharmaceuticals; and the local market forces that hinder or enable distribution of and access to health services and pharmaceuticals. Health services and health systems research provides rigorous data on the socio-economic and political context in which local, national and global health policy supports (or otherwise) disease control programs.

In broad terms however, social science research in this area has to date focused largely on the evaluation of the implementation process and on factors that will enhance community participation in community based programs (56). Both the process and the outcome indicators therefore relate to the administration of treatment and where appropriate, a short term reduction in NCDs. In other words these approaches to 'deploying' the social sciences are rather utilitarian and often tokenistic (43). The consequences to this are the often questionable quality of the social science evidence generated. Implementation research for instance, if well designed and implemented has the potential to contribute significantly to disease control efforts – however it is an area of research that is poorly funded (43) The problem arises often because social scientists are invited onto teams to undertake specific research projects rather than being a conceptual part of the planning of the intervention (27)

To obtain the higher objective of improving the health and reducing vulnerabilities, it is important for researchers, policy makers and funding agencies to broaden the perspective on the range of research that is needed to address neglected diseases of neglected populations, and to rethink the types of integrated interventions and the nature of evidence to show effectiveness. There is a need to refocus on the health of neglected populations health as an enabling process (38) - and not merely removing disease.

Diseases of Poverty: The Science of the Neglected 343

are also available on investments into other programmes designed to meet the other millennium development goals, which also address the vulnerabilities highlighted by the neglected disease advocates. A cost effectiveness analysis of these investments could technically provide an indication of what a dollar could purchase per intervention type. However the success of programmes still tends to be measured often by their coverage rather than by longer term outcomes, and in global health, seldom by improvements in the levels of poverty and broader development. Reasons for this include the time limited nature of programmes; the discipline focus of people involved in programmes, that is health sector and therefore the disease focus – lack of capacity to design the relevant research, monitoring

To focus on the addressing neglect and vulnerabilities from a health perspective would require a different way of conceptualising the link between poverty, health and disease, acknowledging the complexities and developing appropriate and realistic solutions. This would mean more than a simple combination of individual supplementary (vertical) programmes. It would also necessarily require a redefinition of outcomes and successes, working to a longer time frame than is currently adhered to in disease based vertical

Diseases of poverty represent a rich and dynamic interplay between the context of people's lives and the disease process. The interaction is complex and evolves within a social and cultural context as much as it does within a physical and biological context. Understanding this complex dynamic is crucial for the sustainable management of diseases of poverty. The evidence from the health literature, however, is that there is little investigator driven social science research to speak of in the diseases of poverty, and a similarly poor presence of interdisciplinary science. Without this, our understanding and management of diseases of poverty is inevitably reduced to a strategy that relies on a repetitive, reductionist flat-world

The research to address neglected diseases of poverty needs more sophisticated funders and priority setters. Pharmaceuticals (including vaccines) are critical, but they are not the only solutions, and their final application is not in flat worlds. Their application is in complex dynamic worlds in which pathologies evolve to exploits the social nature of humans. Our current understanding of the dynamic, and our understanding of how to develop sustainable approaches to disease management are poor. There are no research templates to overcome this, and the silos of current science into the diseases of poverty have discouraged

As a major recommendation there is a need to reconceptualise the outcomes for addressing vulnerability and the addressing the health needs of the neglected, poor, disenfranchised and dispossessed. Recognising that the challenges cannot be reduced to simplistic biomedical solutions is a first step. Global public health is ideally placed to bring together

[1] A New Era of Hope for the World's Most Neglected Diseases. PLoS Medicine. 2005 Sep

and evaluation tools that would allow a focus that were any broader.

programmes. A detailed discussion is beyond the scope of this paper.

science to overcome an acknowledged complex system.

the development of genuinely interdisciplinary research.

the different disciplines to engage in these developments.

**6. Conclusion** 

**7. References** 

1;2(9):e323 EP -.

Critical opportunities are missed through the lack of integration of data from the social science disciplines. Health and illness are social constructs and as such, the disciplines and theories that help us to make sense of these issues should be as much a part of the agenda as pharmaceutical developments. It is tragic, for instance that so much is made of the suffering of patients of neglected tropical diseases, but there is little if any evidence in the funded programmes that addresses how families and communities affected by these diseases could be supported to deal with the social and economic sequelae. Studies of outbreaks of infectious diseases in South East Asia also highlight the almost exclusive disease focus of public health interventions and the total neglect of the mental health and social and economic consequences of these interventions (described as social chaos) on the populations affected (57). To address these issues would require a more complex understanding of the community and its dynamics and the broader political context in which the affected populations live.

Studies in gender for instance have produced frameworks that facilitate the integration of gender across programmes. Similar approaches have been suggested for use with the social sciences (27,43,57,58)

#### **5. Alternative models**

There are essentially two issues that are conflated in the advocacy and the current approach to diseases of poverty. The first is the focus on neglect and vulnerabilities – as highlighted above, a significantly complex issue which we, as global health professionals, have an obligation to address (47). These issues cannot however, be fully addressed by vertical programmes. The second is the specific issue of disease which forms an important part of the factors which may be the cause of, but also exacerbate and sustain poverty and vulnerability. This issue is the focus of vertical programmes (41). Interventions to address these two issues should clearly not be mutually exclusive, but often are.

The question of which general approach is better does depend on the expected outcomes but may of course be empirical. Assuming that the expected goal, as most global health programs stipulate, is the improvement of the health of populations, how would a poverty reduction, empowerment, equity based development programme fare against a preventive chemotherapy programme for instance, or one that combined approaches. Studies that test this empirically are rarely designed, in part because the different interventions seek different outcomes. Vertical programmes measure success in terms of reductions in the occurrence of specific diseases. Contextually based, comprehensive programmes count some broader measure of well-being as the desirable outcome. However it is difficult to imagine that there would be no value added to ensuring that the pieces lock together seamlessly. Programmes that privilege longer term improvements in the living conditions over merely achieving significant coverage of mass drug administration have shown a greater impact in rescuing communities and tackling concerns about neglected diseases and neglected populations (48). These tend to be smaller programmes, with significant input from communities and do not operate under the pressures of reporting to funders. Furthermore, when the outcomes of such programmes are published, the robustness of the 'evidence' is often questioned because they were not designed as 'empirical' studies (4,49–51).

There are data that could arguably have the potential to provide a proxy indication of how the different approaches measure up. We know for instance that significant funds have been invested into global public health most of which have gone into vertical programmes dealing with the big three and more recently, the neglected tropical diseases (13,52). Data are also available on investments into other programmes designed to meet the other millennium development goals, which also address the vulnerabilities highlighted by the neglected disease advocates. A cost effectiveness analysis of these investments could technically provide an indication of what a dollar could purchase per intervention type. However the success of programmes still tends to be measured often by their coverage rather than by longer term outcomes, and in global health, seldom by improvements in the levels of poverty and broader development. Reasons for this include the time limited nature of programmes; the discipline focus of people involved in programmes, that is health sector and therefore the disease focus – lack of capacity to design the relevant research, monitoring and evaluation tools that would allow a focus that were any broader.

To focus on the addressing neglect and vulnerabilities from a health perspective would require a different way of conceptualising the link between poverty, health and disease, acknowledging the complexities and developing appropriate and realistic solutions. This would mean more than a simple combination of individual supplementary (vertical) programmes. It would also necessarily require a redefinition of outcomes and successes, working to a longer time frame than is currently adhered to in disease based vertical programmes. A detailed discussion is beyond the scope of this paper.

#### **6. Conclusion**

342 Public Health – Methodology, Environmental and Systems Issues

Critical opportunities are missed through the lack of integration of data from the social science disciplines. Health and illness are social constructs and as such, the disciplines and theories that help us to make sense of these issues should be as much a part of the agenda as pharmaceutical developments. It is tragic, for instance that so much is made of the suffering of patients of neglected tropical diseases, but there is little if any evidence in the funded programmes that addresses how families and communities affected by these diseases could be supported to deal with the social and economic sequelae. Studies of outbreaks of infectious diseases in South East Asia also highlight the almost exclusive disease focus of public health interventions and the total neglect of the mental health and social and economic consequences of these interventions (described as social chaos) on the populations affected (57). To address these issues would require a more complex understanding of the community and its dynamics and the broader political context in which the affected populations live.

Studies in gender for instance have produced frameworks that facilitate the integration of gender across programmes. Similar approaches have been suggested for use with the social

There are essentially two issues that are conflated in the advocacy and the current approach to diseases of poverty. The first is the focus on neglect and vulnerabilities – as highlighted above, a significantly complex issue which we, as global health professionals, have an obligation to address (47). These issues cannot however, be fully addressed by vertical programmes. The second is the specific issue of disease which forms an important part of the factors which may be the cause of, but also exacerbate and sustain poverty and vulnerability. This issue is the focus of vertical programmes (41). Interventions to address

The question of which general approach is better does depend on the expected outcomes but may of course be empirical. Assuming that the expected goal, as most global health programs stipulate, is the improvement of the health of populations, how would a poverty reduction, empowerment, equity based development programme fare against a preventive chemotherapy programme for instance, or one that combined approaches. Studies that test this empirically are rarely designed, in part because the different interventions seek different outcomes. Vertical programmes measure success in terms of reductions in the occurrence of specific diseases. Contextually based, comprehensive programmes count some broader measure of well-being as the desirable outcome. However it is difficult to imagine that there would be no value added to ensuring that the pieces lock together seamlessly. Programmes that privilege longer term improvements in the living conditions over merely achieving significant coverage of mass drug administration have shown a greater impact in rescuing communities and tackling concerns about neglected diseases and neglected populations (48). These tend to be smaller programmes, with significant input from communities and do not operate under the pressures of reporting to funders. Furthermore, when the outcomes of such programmes are published, the robustness of the 'evidence' is often questioned

There are data that could arguably have the potential to provide a proxy indication of how the different approaches measure up. We know for instance that significant funds have been invested into global public health most of which have gone into vertical programmes dealing with the big three and more recently, the neglected tropical diseases (13,52). Data

these two issues should clearly not be mutually exclusive, but often are.

because they were not designed as 'empirical' studies (4,49–51).

sciences (27,43,57,58)

**5. Alternative models** 

Diseases of poverty represent a rich and dynamic interplay between the context of people's lives and the disease process. The interaction is complex and evolves within a social and cultural context as much as it does within a physical and biological context. Understanding this complex dynamic is crucial for the sustainable management of diseases of poverty. The evidence from the health literature, however, is that there is little investigator driven social science research to speak of in the diseases of poverty, and a similarly poor presence of interdisciplinary science. Without this, our understanding and management of diseases of poverty is inevitably reduced to a strategy that relies on a repetitive, reductionist flat-world science to overcome an acknowledged complex system.

The research to address neglected diseases of poverty needs more sophisticated funders and priority setters. Pharmaceuticals (including vaccines) are critical, but they are not the only solutions, and their final application is not in flat worlds. Their application is in complex dynamic worlds in which pathologies evolve to exploits the social nature of humans. Our current understanding of the dynamic, and our understanding of how to develop sustainable approaches to disease management are poor. There are no research templates to overcome this, and the silos of current science into the diseases of poverty have discouraged the development of genuinely interdisciplinary research.

As a major recommendation there is a need to reconceptualise the outcomes for addressing vulnerability and the addressing the health needs of the neglected, poor, disenfranchised and dispossessed. Recognising that the challenges cannot be reduced to simplistic biomedical solutions is a first step. Global public health is ideally placed to bring together the different disciplines to engage in these developments.

#### **7. References**

[1] A New Era of Hope for the World's Most Neglected Diseases. PLoS Medicine. 2005 Sep 1;2(9):e323 EP -.

Diseases of Poverty: The Science of the Neglected 345

[22] Conteh L, Engels T, Molyneux DH. Socioeconomic aspects of neglected tropical

[23] Hotez PJ. Empowering Women and Improving Female Reproductive Health through

[25] Allotey P, Reidpath DD, Pokhrel S. Social sciences research in neglected tropical

[26] Marmot M, Friel S, Bell R, Houweling T, Taylor S. Closing the gap in a generation:

[27] Manderson L, Aagaard-Hansen J, Allotey P, Gyapong M, Sommerfeld J. Social research

[28] Perera M, Whitehead M, Molyneux D, Weerasooriya M, Gunatilleke G. Neglected

[29] Dunn FL. Role of human behavior in control of parasitic diseases. Bulletin of the World

[30] Dunn FL. Behavioural aspects of the control of parasitic diseases. Bulletin of the World

[31] Manderson L, Jenkins J, Tanner M. Women and tropical diseases : Introduction. Social

[32] Lynch JW. Income inequality and mortality: importance to health of individual income,

[33] Smith GD, Lynch J. Commentary: Social capital, social epidemiology and disease

[34] Meyers W, Portaels F. Mycobacterium ulcerans infection (buruli ulcer). In: Guerrant RL,

and Practice. Philadelphia: Churchill Livingstone Elsevier; 2006. p. 429–35. [35] Asiedu K. Yaws eradication: past efforts and future perspectives. Bull World Health

[36] Reidpath DD, Chen K, Gifford S, Allotey P. He hath the french pox: stigma, social value and social exclusion. Sociology of Health and Illness. 2005;27(4):468–89. [37] Yang LH, Kleinman A, Link BG, Phelan JC, Lee S, Good B. Culture and stigma: Adding

[38] Rifkin SB, Walt G. Why health improves: Defining the issues concerning

[39] Newell KW. Selective primary health care: the counter revolution. Social Science &

[40] Magnussen L, Ehiri J, Jolly P. Comprehensive Versus Selective Primary Health Care: Lessons For Global Health Policy. Health Aff. 2004 May 1;23(3):167–76. [41] Walsh J, Warren K. Selective primary health care: an interim strategy for disease control

in developing countries. N Engl J Med. 1979 Nov 1;301(18):967–74.

psychosocial environment, or material conditions. BMJ. 2000 Apr;320(7243):1200–4.

Walker D, Weller PF, editors. Tropical Infectious Diseases. Principles, Pathogens

moral experience to stigma theory. Social Science & Medicine. 2007 Apr;64(7):1524–35.

[`]comprehensive primary health care' and [`]selective primary health care'. Social

Control of Neglected Tropical Diseases. PLoS Negl Trop Dis. 2009 Nov 24;3(11):e559.

diseases 1: the ongoing neglect in the neglected tropical diseases. Health Res Policy

health equity through action on the social determinants of health. The Lancet. 2008

on neglected diseases of poverty: continuing and emerging themes. PLoS Negl

patients with a neglected disease? A qualitative study of lymphatic filariasis. PLoS

diseases. The Lancet. 2010 Jan 16;375(9710):239–47.

Syst. 2010;8:32.

Nov;372(9650):1661–9.

Trop Dis. 2009;3(2):e332.

Negl Trop Dis. 2007;1(2):e128.

Organ. 2008 Jul;86(7):499–499.

Medicine. 1988;26(9):903–6.

Science & Medicine. 1986;23(6):559–66.

Health Organization. 1979;57(6):887–902.

Health Organization. 1979;57(4):499–512.

Science & Medicine. 1993 Aug;37(4):441–3.

aetiology. Int. J. Epidemiol. 2004 Aug 1;33(4):691–700.

[24] Hotez P. Measuring Neglect. PLoS Negl Trop Dis. 2007 Nov 28;1(2):e118.


http://www.who.int/neglected\_diseases/disease\_management/en/index.html

[2] Molyneux DH. Neglected tropical diseases--beyond the tipping point? The Lancet. 2010

[3] Hotez PJ, Kamath A. Neglected tropical diseases in sub-saharan Africa: review of their prevalence, distribution, and disease burden. PLoS Negl Trop Dis. 2009;3(8):e412. [4] Hotez PJ. Stigma: The Stealth Weapon of the NTD. PLoS Negl Trop Dis. 2008 Apr

[5] Lopez AD, Mathers CD. Measuring the global burden of disease and epidemiological transitions: 2002-2030. Ann Trop Med Parasitol. 2006 Sep;100(5-6):481–99. [6] Das S. Rising trend of non-communicable diseases in low socioeconomic areas. Natl Med

[7] Schneider M, Bradshaw D, Steyn K, Norman R, Laubscher R. Poverty and non-

[8] Gwatkin DR, Guillot M, Heuveline P. The burden of disease among the global poor.

[9] de-Graft Aikins A, Unwin N, Agyemang C, Allotey P, Campbell C, Arhinful D. Tackling

[10] World Health Organization. Noncommunicable diseases country profiles 2011

[11] The global burden of chronic diseases [Internet]. [cited 2011 Sep 19];Available from: http://www.who.int/nutrition/topics/2\_background/en/index.html [12] McCoy D, Kembhavi G, Patel J, Luintel A. The Bill & Melinda Gates Foundation's grantmaking programme for global health. Lancet. 2009 May 9;373(9675):1645–53. [13] Ravishankar N, Gubbins P, Cooley RJ, Leach-Kemon K, Michaud CM, Jamison DT, et al.

[14] Crane BB, Dusenberry J. Power and Politics in International Funding for Reproductive

[15] Alleviating The Suffering Caused By River Blindness And Lymphatic Filariasis

[16] Musgrove P, Hotez PJ. Turning Neglected Tropical Diseases Into Forgotten Maladies.

[17] Hotez P, Bethony J, Brooker S, Albonico M. Eliminating neglected diseases in Africa.

[18] Hotez PJ, Fenwick A, Savioli L, Molyneux DH. Rescuing the bottom billion through control of neglected tropical diseases. The Lancet. 373(9674):1570–5. [19] Rosenfield PL, Golladay F, Davidson RK. The economics of parasitic diseases: Research

[20] Hotez PJ, Molyneux DH, Fenwick A, Ottesen E, Ehrlich Sachs S, Sachs JD. Incorporating

http://www.who.int/neglected\_diseases/disease\_management/en/index.html

a Rapid-Impact Package for Neglected Tropical Diseases with Programs for HIV/AIDS, Tuberculosis, and Malaria. PLoS Medicine. 2006 May 1;3(5):e102 EP -. [21] WHO | Innovative and Intensified Disease Management (IDM) [Internet]. [cited 2009

communicable diseases in South Africa. Scand J Public Health. 2009 Mar;37(2):176–86.

Africa's chronic disease burden: from the local to the global. Globalization and

Financing of global health: tracking development assistance for health from 1990 to

Health: the US Global Gag Rule. Reproductive Health Matters. 2004

(Elephantiasis) | Mectizan Donation Program [Internet]. [cited 2011 Sep

Jan 2;375(9708):3–4.

J India. 2007 Dec;20(6):319.

Lancet. 1999;354(9178):586–9.

[Internet]. Available from: http://bit.ly/nG9Hu8

2007. Lancet. 2009 Jun 20;373(9681):2113–24.

19];Available from: http://www.mectizan.org/

priorities. Social Science & Medicine. 1984;19(10):1117–26.

Health Aff. 2009 Nov 1;28(6):1691–706.

The Lancet. 365(9477):2089.

Dec 10]; Available from:

Health. 2010;6(1):5.

Nov;12(24):128–37.

30;2(4):e230.


**17** 

*Romania* 

Dan Riga1, Sorin Riga1,

**Health-Longevity Medicine in the Global World** 

Daniela Motoc2, Simona Geacăr3 and Traian Ionescu4

*Al. Obregia Clin. Hosp. Psychiatry, Bucharest,* 

*4Romanian Academy of Medical Sciences, Bucharest,* 

*but will interest his patient in the care of the human frame,* 

*The doctor of the future will give no medicine,* 

*in diet and the cause and prevention of disease.* 

American inventor, scientist, and businessman

**Thomas Alva Edison** (1847-1931),

*1Academy of Romanian Scientists, Dept. Stress Res. & Prophylaxis,* 

*2Centre Appl. Physiol. & Mol. Biol., V. Goldis Western University, Arad,* 

*3Faculty of Psychology and Education Sciences, University of Bucharest, Bucharest,* 

Health in the human life cycles produces healthy longevity. The construction of healthlongevity can be accomplished through primary prophylaxis, namely education, promotion,

As such, medicine seeks to achieve the prevention of disease; it aspires to treat all pathologies, as secondary prophylaxis and leads to recovery after illnesses, as tertiary

The common elements of longevity health sciences - LHS (Cutler et al., 2005a) and mental health - MH (Knapp et al., 2007) consist of personal sanogenesis at an individual level, and

Nowadays it is time to promote and apply the ancient wisdom concerning health and

Actual scientific data about health strategy (human biology and risk factors, behaviour and lifestyle, health care systems, the environment), technological medical progress, information

**1.2 Objectives for health-longevity medicine. Past, present and future** 

**1. Introduction** 

prophylaxis.

**1.1 Health in ontogenesis** 

training, protection and prevention.

public health in relation to the societal dimension.

healing concepts alongside medical ones.


http://www.internationalhealthjournal.com/article/S1876-3413(10)00053-7/abstract


### **Health-Longevity Medicine in the Global World**

Dan Riga1, Sorin Riga1,

Daniela Motoc2, Simona Geacăr3 and Traian Ionescu4 *1Academy of Romanian Scientists, Dept. Stress Res. & Prophylaxis, Al. Obregia Clin. Hosp. Psychiatry, Bucharest, 2Centre Appl. Physiol. & Mol. Biol., V. Goldis Western University, Arad, 3Faculty of Psychology and Education Sciences, University of Bucharest, Bucharest, 4Romanian Academy of Medical Sciences, Bucharest, Romania* 

> *The doctor of the future will give no medicine, but will interest his patient in the care of the human frame, in diet and the cause and prevention of disease.*  **Thomas Alva Edison** (1847-1931), American inventor, scientist, and businessman

#### **1. Introduction**

346 Public Health – Methodology, Environmental and Systems Issues

[42] Reidpath DD, Allotey P, Pokhrel S. Social sciences research in neglected tropical diseases 2: A bibliographic analysis. Health Res Policy Syst. 2011;9(1):1. [43] Allotey P, Reidpath D, Ghalib H, Pagnoni F, Skelly W. Efficacious, effective, and

[44] The CDI Study Group. Community-directed interventions for priority health problems

[45] Community-directed interventions for integrated delivery of a health package against

 http://www.internationalhealthjournal.com/article/S1876-3413(10)00053-7/abstract [46] Atun R, de Jongh T, Secci F, Ohiri K, Adeyi O. A systematic review of the evidence on

[47] Lowry C, Schuklenk U. Two Models in Global Health Ethics. Public Health Ethics. 2009

[48] Partners In Health (PIH), Health Care for the Poor [Internet]. [cited 2009 Dec

[49] Kuper H, Solomon AW, Buchan J, Zondervan M, Foster A, Mabey D. A critical review

[50] Krieger N. Questioning epidemiology: objectivity, advocacy, and socially responsible science [editorial; comment]. Am J Public Health. 1999;89(8):1151–3. [51] Hotez PJ. Training the Next Generation of Global Health Scientists: A School of Appropriate Technology for Global Health. PLoS Negl Trop Dis. 2008;2(8):e279. [52] McCoy D, Kembhavi G, Patel J, Luintel A. The Bill & Melinda Gates Foundation's grantmaking programme for global health. Lancet. 2009 May 9;373(9675):1645–53. [53] Hotez P, Ottesen E, Fenwick A, Molyneux D. The neglected tropical diseases: the

[54] PLoS Neglected Tropical Diseases: Holidays in the Sun and the Caribbean's Forgotten

 http://www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pntd.0000239 [55] Muela Ribera J, Peeters Grietens K, Toomer E, Hausmann-Muela S. A Word of Caution

[56] Parker M, Allen T, Hastings J. Resisting Control of Neglected Tropical Diseases:

[57] Phua K-L, Lee LK. Meeting the Challenge of Epidemic Infectious Disease Outbreaks: An Agenda for Research. Journal of Public Health Policy. 2005;26(1):122–32. [58] Phua K-L. Fighting the Battle Against Infectious Diseases: Contributions of Selected

effectiveness [Internet]. [cited 2011 Sep 12];Available from:

18];Available from: http://www.pih.org/home.html

elimination. Adv Exp Med Biol. 2006;582:23–33.

PLoS Negl Trop Dis. 2009 Oct 27;3(10):e445.

BMC Public Health. 2008;8(1):343.

Organization. 2010 Jul 1;88:509–18.

Planning. 2010 Jan 1;25(1):1–14.

Nov 1;2(3):276–84.

2003 Jun;3(6):372–81.

of-Sele.pdf):5.

embedded interventions: Implementation research in infectious disease control.

in Africa: results of a multicountry study. Bulletin of the World Health

major health problems in rural Uganda: perceptions on the strategy and its

integration of targeted health interventions into health systems. Health Policy and

of the SAFE strategy for the prevention of blinding trachoma. Lancet Infect Dis.

ancient afflictions of stigma and poverty and the prospects for their control and

Burden of Neglected Tropical Diseases [Internet]. [cited 2008 Nov 17];Available from:

against the Stigma Trend in Neglected Tropical Disease Research and Control.

Dilemmas in the Mass Treatment of Schistosomiasis and Soil-Transmitted Helminths in North-West Uganda. Journal of Biosocial Science. 2007;40(02):161–81.

Social Science Disciplines. Infectious Diseases: Research and Treatment. 2009 Nov 9;2009(1728-IDRT-Fighting-the-Battle-Against-Infectious-Diseases:-Contributions-

#### **1.1 Health in ontogenesis**

Health in the human life cycles produces healthy longevity. The construction of healthlongevity can be accomplished through primary prophylaxis, namely education, promotion, training, protection and prevention.

As such, medicine seeks to achieve the prevention of disease; it aspires to treat all pathologies, as secondary prophylaxis and leads to recovery after illnesses, as tertiary prophylaxis.

The common elements of longevity health sciences - LHS (Cutler et al., 2005a) and mental health - MH (Knapp et al., 2007) consist of personal sanogenesis at an individual level, and public health in relation to the societal dimension.

#### **1.2 Objectives for health-longevity medicine. Past, present and future**

Nowadays it is time to promote and apply the ancient wisdom concerning health and healing concepts alongside medical ones.

Actual scientific data about health strategy (human biology and risk factors, behaviour and lifestyle, health care systems, the environment), technological medical progress, information

Health-Longevity Medicine in the Global World 349

movements of the tiger, the deer, the bear, the monkey and the crane. In Huà Tuó's medical system, the therapeutic use of movement was inspired from nature: *Running water never grows stale, and the doorpost is never eaten away by wood decay. For the same reason, if we do physical activity on a regular basis, we can remain in good health and keep disease away. Regular exercises stimulate blood flow and the circulation of the qi* (*energy*)*, thus maintaining the agility of* 

The doctrines of Mediterranean ancient medicine are also based on dietary (rational

Hippocrates of Cos (Kos), c460 B.C. - c370 B.C., one of the most outstanding figures in the history of medicine, emphasized the importance of diet: *Let thy food be thy medicine and thy medicine be thy food* (Hanson, 2006). Moreover, the veneration of the human body as well as daily and professional physical activity were extensively spread in Hellas. Palaestra (special arranged places and also a type of physical exercises) and the Ancient Olympic Games are

The Romans, who conquered, took over and enriched Greek civilization, also had great respect for a harmonious development of the human body. Besides this, they pointed out the necessity and simultaneity of the sanogenetic binomial psychic ↔ body. The old adage: *Mens sana in corpore sano, Satyrae X (Book IV, Satyrae X, Line 356 - 10.356),* Decimus Iunius Iuvenalis (c60 A.D. - c135 A.D.), Roman poet, in still famous and up-to-date even now (D. Riga et al., 2009c).

The principles of preventative medicine and competitive health-vitality have been welldocumented in human history since ancient times. Unfortunately, current civilizations and human beings could not manage, up to the present, to transform these principles into their

From this perspective, the strategic key in public health is represented by stress medicine

**Figure 1** shows the multi-factorial progress, which localizes stress bio-medicine at the




boundary/interface between normality-health-longevity and ageing-disease.


The integrative concept (from molecule to individual and society) groups together:

**2.2 Preventative medicine in Greek and Roman antiquity** 

daily routine or integrate them into their lifestyles.

(stressology), adaptology and MH (S. Riga and D. Riga, 2008).


**3. From health to disease** 

**3.1 Stress bio-medicine** 

ICD-10, 1992);

al., 2005c);

et al., 1992).

*the body* (Lin, 2000).

only two examples.

nutrition) and physical exercises.

technology and information technology and communication (ITC), together with experience and the practice of developed countries should be integrated at a regional and global level.

In addition, new concepts can be used and applied to the understanding of the complexity of healthy-longevity medicine at a global level:


#### **2. Health and preventative medicine in ancient times**

#### **2.1 Prophylaxis and physical activity in traditional Chinese medicine**

Dating back thousands of years, the practice of traditional Chinese medicine includes Yinyangism and Daoism as philosophical concepts, holistic and integrative medical concepts, phytotherapy (herbal medicine) and dietary therapy, acupuncture, Shiatsu and Tui na massage, movement therapy, Qigong, Taiji and other methods of maintaining health and vitality.

A remarkable characteristic of the Chinese system of natural healthcare is its prophylactic side. A programmatic document in this direction is the first Chinese medical text (c2600 B.C.). It stipulates: *Superior doctors prevent the disease. Mediocre doctors treat the disease before evident. Inferior doctors treat the full-blown disease* (Unschuld, 2003). In addition, this famous manuscript *Huángdi Neijing Suwen (Inner Canon: Basic Questions),* also known as *The Inner Canon of Huángdi* or *Yellow Emperor's Inner Canon*, book written between 2698 B.C. - 2596 B.C. presents a dialogue between the Yellow Emperor (Huángdi) and Qibo (Qi Bo, Chi Bo), his minister and advisor, an excellent physician and the father of massage treatment. Another quote from this treatise shows the importance of prophylaxis: *To treat an illness after it has already set in or to smother a riot already spread is liked digging for a fountain when you're already thirsty or making weapons after the war has already begun. Isn't it too late, I wonder?* (Lin, 2000).

A further defining feature of the traditional Chinese therapeutic system is the promotion of movement and physical activity in maintaining health and treating illness. The famous Chinese physician Huà Tuó (c145 A.D. - c208 A.D.), the first person in China to use anaesthesia in surgery, created a series of exercises called *Wuqinxi or Frolics* (*Exercise*) *of the Five Animals*, towards the end of the 2nd Century A.D. The exercises mimicked the

technology and information technology and communication (ITC), together with experience and the practice of developed countries should be integrated at a regional and global level. In addition, new concepts can be used and applied to the understanding of the complexity






Dating back thousands of years, the practice of traditional Chinese medicine includes Yinyangism and Daoism as philosophical concepts, holistic and integrative medical concepts, phytotherapy (herbal medicine) and dietary therapy, acupuncture, Shiatsu and Tui na massage, movement therapy, Qigong, Taiji and other methods of maintaining health

A remarkable characteristic of the Chinese system of natural healthcare is its prophylactic side. A programmatic document in this direction is the first Chinese medical text (c2600 B.C.). It stipulates: *Superior doctors prevent the disease. Mediocre doctors treat the disease before evident. Inferior doctors treat the full-blown disease* (Unschuld, 2003). In addition, this famous manuscript *Huángdi Neijing Suwen (Inner Canon: Basic Questions),* also known as *The Inner Canon of Huángdi* or *Yellow Emperor's Inner Canon*, book written between 2698 B.C. - 2596 B.C. presents a dialogue between the Yellow Emperor (Huángdi) and Qibo (Qi Bo, Chi Bo), his minister and advisor, an excellent physician and the father of massage treatment. Another quote from this treatise shows the importance of prophylaxis: *To treat an illness after it has already set in or to smother a riot already spread is liked digging for a fountain when you're already thirsty or making weapons after the war has already begun. Isn't it too late, I wonder?* (Lin, 2000). A further defining feature of the traditional Chinese therapeutic system is the promotion of movement and physical activity in maintaining health and treating illness. The famous Chinese physician Huà Tuó (c145 A.D. - c208 A.D.), the first person in China to use anaesthesia in surgery, created a series of exercises called *Wuqinxi or Frolics* (*Exercise*) *of the Five Animals*, towards the end of the 2nd Century A.D. The exercises mimicked the

longevity health sciences and life extension (S. Riga et al., 2010d);



**2.1 Prophylaxis and physical activity in traditional Chinese medicine** 

**2. Health and preventative medicine in ancient times** 



of healthy-longevity medicine at a global level:

Europe, 1986; Knapp et al., 2007);

and S. Riga, 1995-2005);

2005);

al., 2004b);

and vitality.

movements of the tiger, the deer, the bear, the monkey and the crane. In Huà Tuó's medical system, the therapeutic use of movement was inspired from nature: *Running water never grows stale, and the doorpost is never eaten away by wood decay. For the same reason, if we do physical activity on a regular basis, we can remain in good health and keep disease away. Regular exercises stimulate blood flow and the circulation of the qi* (*energy*)*, thus maintaining the agility of the body* (Lin, 2000).

#### **2.2 Preventative medicine in Greek and Roman antiquity**

The doctrines of Mediterranean ancient medicine are also based on dietary (rational nutrition) and physical exercises.

Hippocrates of Cos (Kos), c460 B.C. - c370 B.C., one of the most outstanding figures in the history of medicine, emphasized the importance of diet: *Let thy food be thy medicine and thy medicine be thy food* (Hanson, 2006). Moreover, the veneration of the human body as well as daily and professional physical activity were extensively spread in Hellas. Palaestra (special arranged places and also a type of physical exercises) and the Ancient Olympic Games are only two examples.

The Romans, who conquered, took over and enriched Greek civilization, also had great respect for a harmonious development of the human body. Besides this, they pointed out the necessity and simultaneity of the sanogenetic binomial psychic ↔ body. The old adage: *Mens sana in corpore sano, Satyrae X (Book IV, Satyrae X, Line 356 - 10.356),* Decimus Iunius Iuvenalis (c60 A.D. - c135 A.D.), Roman poet, in still famous and up-to-date even now (D. Riga et al., 2009c).

The principles of preventative medicine and competitive health-vitality have been welldocumented in human history since ancient times. Unfortunately, current civilizations and human beings could not manage, up to the present, to transform these principles into their daily routine or integrate them into their lifestyles.

### **3. From health to disease**

#### **3.1 Stress bio-medicine**

From this perspective, the strategic key in public health is represented by stress medicine (stressology), adaptology and MH (S. Riga and D. Riga, 2008).

**Figure 1** shows the multi-factorial progress, which localizes stress bio-medicine at the boundary/interface between normality-health-longevity and ageing-disease.

The integrative concept (from molecule to individual and society) groups together:


Health-Longevity Medicine in the Global World 351

Fig. 2. Dynamic structure of destructive cascade: distress impairment ageing disease.

namely into manifest diseases; and

Time acts in a very complex way:

(Cutler, 1996; Miwa et al., 2008).

From human healthy life/longevity to old age/poly-pathologies

**3.4 Risk factors and preclinical stages of ageing and disease** 



In addition, free radical attacks, oxidative stress and antioxidant deficits are amplifiable and worsen in accordance with a pattern of destructive synergism. Therefore, the accumulation of distress, impairment and ageing is aggravated in oxidative stress (chronic) diseases

"Risk factor" (an epidemiological concept) is a variable (characteristic, condition or behaviour) associated with an increased risk of disease (or infection, or injury). Sometimes, "determinant" is also used, being a variable associated with either increased or decreased risk. Risks factors

are co-relational and not necessarily causal, since correlation does not imply causation. They are categorized into *intrinsic* "within oneself" and *extrinsic* "outside" influences.

components of the cascade successively represent both cause and effect.

Fig. 1. Oxidative stress in stress bio-medicine, health, ageing and disease

In conclusion, the new concept of stress in bio-medicine represents the primary cause (the beginning) of various human illnesses: pathological manifestations of acute and chronic psychic stress, stress-related disorders, free radical diseases, oxidative stress-associated pathologies, accelerated impairment and ageing (premature senescence), diseases of lifestyle and civilization, nervous and body inflammatory-degenerative pathologies and senility.

#### **3.2 Antagonism of health construction versus human pathology**

Public health strategies and policies, as well as everyday preventative-prophylactic and medical-curative practice, are substantiated in dynamics by two opposite tetrads (cascades), (D. Riga and S. Riga, 2007; S. Riga et al., 2009a). These concepts also represent two antagonistic fundamental pathways:


Therefore, health construction is in total opposition to the development of human pathology. Health construction promotes and protects sanogenesis and impedes the appearance and evolution of disease.

#### **3.3 Dynamic structure of destructive cascade**

*Stress ↔ ageing tetrad (distress ↔ impairment ↔ ageing ↔ disease)* is a progressively destructive, entropic and time-dependent phenomenon: from primary processes and chronic manifestations (distress, impairment, ageing) to chronic illnesses. The dynamic pattern of this cascade is shown in **Figure 2** (D. Riga and S. Riga, 2007).

Fig. 1. Oxidative stress in stress bio-medicine, health, ageing and disease

**3.2 Antagonism of health construction versus human pathology** 

ageing/active, healthy longevity anti-illnesses/anti-diseases.

antagonistic fundamental pathways:

appearance and evolution of disease.

**3.3 Dynamic structure of destructive cascade** 

this cascade is shown in **Figure 2** (D. Riga and S. Riga, 2007).

In conclusion, the new concept of stress in bio-medicine represents the primary cause (the beginning) of various human illnesses: pathological manifestations of acute and chronic psychic stress, stress-related disorders, free radical diseases, oxidative stress-associated pathologies, accelerated impairment and ageing (premature senescence), diseases of lifestyle and civilization, nervous and body inflammatory-degenerative pathologies and senility.

Public health strategies and policies, as well as everyday preventative-prophylactic and medical-curative practice, are substantiated in dynamics by two opposite tetrads (cascades), (D. Riga and S. Riga, 2007; S. Riga et al., 2009a). These concepts also represent two


Therefore, health construction is in total opposition to the development of human pathology. Health construction promotes and protects sanogenesis and impedes the

*Stress ↔ ageing tetrad (distress ↔ impairment ↔ ageing ↔ disease)* is a progressively destructive, entropic and time-dependent phenomenon: from primary processes and chronic manifestations (distress, impairment, ageing) to chronic illnesses. The dynamic pattern of

Fig. 2. Dynamic structure of destructive cascade: distress impairment ageing disease. From human healthy life/longevity to old age/poly-pathologies

Time acts in a very complex way:


In addition, free radical attacks, oxidative stress and antioxidant deficits are amplifiable and worsen in accordance with a pattern of destructive synergism. Therefore, the accumulation of distress, impairment and ageing is aggravated in oxidative stress (chronic) diseases (Cutler, 1996; Miwa et al., 2008).

#### **3.4 Risk factors and preclinical stages of ageing and disease**

"Risk factor" (an epidemiological concept) is a variable (characteristic, condition or behaviour) associated with an increased risk of disease (or infection, or injury). Sometimes, "determinant" is also used, being a variable associated with either increased or decreased risk. Risks factors are co-relational and not necessarily causal, since correlation does not imply causation.

They are categorized into *intrinsic* "within oneself" and *extrinsic* "outside" influences.

Health-Longevity Medicine in the Global World 353

The impact of risk factors on health is represented by preclinical (infra-, sub-clinical) phases of disease, which are the chronic-silent periods. The action of risk factors, diseases of lifestyle and silent pathologies (e.g. hypertension, hyperglycaemia etc.) cumulate their

In the pre-senescence and pre-disease period of the individual, knowledge of the preclinical phase of disorders obliges one to perform sub-clinical diagnosis and evaluation, and as a

The preclinical diagnosis of ageing and disease involves the investigation of oxidative stress -inflammatory disorders by establishing a pre-morbid individual profile: assays of

The increase of oxidative damages (evaluated in blood/serum, urine and breath) and a decrease of protective/defence antioxidant capacity (in serum), together with the augmentation of inflammation markers (in serum) will lead over the course of time to changes in the proper state of differentiation (Cutler, 2005b): cancer, senescence and

LHS and MH are in essence a form of health promotion associated with preventative




(–) in a negative register, *stress ↔ ageing tetrad*: aetio-pathogenic and morbigenerating

(+) in a positive register, *health ↔ longevity tetrad:* resources, strategies and therapies

Essentially, *bio-medical gerontology* is the global and interdisciplinary study of ageing phenomena in phylogeny, ontogeny and medicine, while *clinical gerontology* and *geriatrics*  are the medicine of ill old people (consequences of senescence and senility). In opposition with geriatrics, *anti-ageing medicine* and *positive ageing* are causal and preventative (from childhood and adolescence). Therefore, anti-ageing medicine is focused on health and longevity development, in conformity with genetic programming, the theoretical estimate of the maximum human lifespan being around 125 years (Weon and Je, 2009). *Longevity health sciences* and *SENS (Strategies for Engineered Negligible Senescence*) involve the utilization of advanced studies and translational medicine in public policies, in health and longevity (causes, resources, means, evaluations, programs and strategies) (D. Riga, 2003; de Grey,

biomarkers for the oxidative stress - inflammation status (Cutler et al., 2005c).

**4.1 Longevity health sciences and mental health. Common characteristics** 

them meaning the development of the other one and vice versa;

old adult 3rd age (65-85 years) 4th age (over 85 years);

negative effects and thus they self-amplify into cascades of diseases.

consequence determines personalized prevention.

**4. Construction of human health-longevity** 

medicine. For this reason (S. Riga et al., 2009a):

is manifested antagonistically:

2004; D. Riga and S. Riga, 2007).

factors, ways and processes;

for longevity and mental health.

senility.

In another classification, risk factors are divided into four domains:


Some examples of risk factors connected to a specific disease in the second part of life and in the ageing period:


Controlling health risk factor, in relation to type, number and intensity, is paramount to the development of a global health strategy. Risk factors:






Some examples of risk factors connected to a specific disease in the second part of life and in






Controlling health risk factor, in relation to type, number and intensity, is paramount to the

*social interaction, low income, limited access to social healthcare services*)*.* 

In another classification, risk factors are divided into four domains:

*high cholesterol levels, obesity* and *diabetes mellitus*);

diabetes; high LDL-cholesterol levels; smoking;

chemical and physical agents; socioeconomic factors.


development of a global health strategy. Risk factors:



dementia, low level of education);

*behaviour*);

*civilization;* 

the ageing period:

genes);

and combinations;


The impact of risk factors on health is represented by preclinical (infra-, sub-clinical) phases of disease, which are the chronic-silent periods. The action of risk factors, diseases of lifestyle and silent pathologies (e.g. hypertension, hyperglycaemia etc.) cumulate their negative effects and thus they self-amplify into cascades of diseases.

In the pre-senescence and pre-disease period of the individual, knowledge of the preclinical phase of disorders obliges one to perform sub-clinical diagnosis and evaluation, and as a consequence determines personalized prevention.

The preclinical diagnosis of ageing and disease involves the investigation of oxidative stress -inflammatory disorders by establishing a pre-morbid individual profile: assays of biomarkers for the oxidative stress - inflammation status (Cutler et al., 2005c).

The increase of oxidative damages (evaluated in blood/serum, urine and breath) and a decrease of protective/defence antioxidant capacity (in serum), together with the augmentation of inflammation markers (in serum) will lead over the course of time to changes in the proper state of differentiation (Cutler, 2005b): cancer, senescence and senility.

### **4. Construction of human health-longevity**

#### **4.1 Longevity health sciences and mental health. Common characteristics**

LHS and MH are in essence a form of health promotion associated with preventative medicine. For this reason (S. Riga et al., 2009a):

	- (–) in a negative register, *stress ↔ ageing tetrad*: aetio-pathogenic and morbigenerating factors, ways and processes;
	- (+) in a positive register, *health ↔ longevity tetrad:* resources, strategies and therapies for longevity and mental health.

Essentially, *bio-medical gerontology* is the global and interdisciplinary study of ageing phenomena in phylogeny, ontogeny and medicine, while *clinical gerontology* and *geriatrics*  are the medicine of ill old people (consequences of senescence and senility). In opposition with geriatrics, *anti-ageing medicine* and *positive ageing* are causal and preventative (from childhood and adolescence). Therefore, anti-ageing medicine is focused on health and longevity development, in conformity with genetic programming, the theoretical estimate of the maximum human lifespan being around 125 years (Weon and Je, 2009). *Longevity health sciences* and *SENS (Strategies for Engineered Negligible Senescence*) involve the utilization of advanced studies and translational medicine in public policies, in health and longevity (causes, resources, means, evaluations, programs and strategies) (D. Riga, 2003; de Grey, 2004; D. Riga and S. Riga, 2007).

Health-Longevity Medicine in the Global World 355


There is a positive correlation between nourishment and exercise. Both rational nutrition and regular physical activity contribute to maintaining and improving good health (Simopoulos, 2005). Moreover, the palaestric solution also takes into account the bio-psychosocio-ecological human dimension (S. Riga et al., 2010c). Physical education is a contributing factor in biologically and socially harmonizing a human being, as well as in integrating humans in their natural surroundings. In palaestric education, healthy nutrition is the 1st strategy for health-longevity. An unhealthy diet represents a major risk factor in noncommunicable/chronic diseases, in the causation of global morbidity and for mortality. A lifestyle including physical activity is the 2nd principle and remedy. Physical inactivity represents a pathological habit, which increases the prevalence of 25 chronic diseases and

At present, there is strong global concern in relation to educating individuals in view of leading a healthier lifestyle, irrespective of age. In this sense, the palaestric paradigm, scientifically backed up by a large number of studies and researches, is prefigured as a valid solution. *The Declaration of Olympia,* May 28-29, 1996, drawn out and published one hundred years after 1896, when the modern and contemporary Olympic games were resumed in Athens, and the *WHO Documents and Recommendations* and the *European Union Legislation*  (*White paper on a Strategy for Europe on Nutrition, Overweight and Obesity related Health Issue,*  2007; *White paper on Sport,* 2007) officially advocate the necessity of physical culture and

1. Nutrition and physical activity interact in harmony and are the two most important positive factors that contribute to metabolic fitness and health interacting with the genetic endowment of the individual. Genes define opportunities for health and susceptibility to disease, while environmental factors determine which susceptible individuals will develop illness. Therefore, individual variation may need to be considered to achieve optimal health and to correct disorders associated with

2. Every child and adult needs sufficient food and physical activity to express their genetic potential for growth, development, and health. Insufficient consumption of energy, protein, essential fatty acids, vitamins (particularly vitamins A, C, D, E and the B complex) and minerals (particularly calcium, iron, iodine, potassium and zinc), and inadequate opportunities for physical activity impair the attainment of overall health

3. Balancing physical activity and good nutrition for fitness is best illustrated by the concept of energy intake and output. For sedentary populations, physical activity must be increased; for populations engaging in intense occupational and/or recreational physical activities, food consumption may need to be increased to meet their energy


cardiovascular diseases, chronic fatigue syndrome.

produces more than 2 million deaths worldwide.

education for each individual, as well as for the entire human society.

**4.4.1 Ancient Olympia, Greece, May 28-29, 1996 (Simopoulos, 2005)** 

micronutrient deficiency, dietary imbalance and a sedentary lifestyle.

**4.4 Declaration of Olympia on nutrition and fitness** 

and musculoskeletal function.

needs.

#### **4.2 From health to health-longevity**

Man is a bio-psycho-social being, in close interrelation with his environment. Therefore, the bio-psycho-socio-ecological dimension of contemporary humans is fundamental for healthlongevity (S. Riga et al., 2010c).

On the other hand, the 1946 WHO definition of health (*a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity)* confirms the bio-psychosocio-ecological determinant of contemporary man. The definition of healthy ageing (Haber, 2003) comprises the following three components:


At present, the percentage of determining factors in ensuring health is as follows:


Their control at national, regional and global levels involves coherent and efficient measures and strategies.

#### **4.3 Palaestric civilization**

The concept of palaestric civilization is an integrative global health conception (D. Riga and S. Riga, 2010a). At present, it comprises the beliefs, customs and culture of the ancients, the Renaissance ideals of physical beauty attained through exercise, the 19th - 20th Century efforts to institutionalize, generalize and popularize physical education and sports, and contemporary strategies of complementary health nutrition-physical activity.

The palaestric principles, characteristics which are clearly defined and highly positive, are:


The palaestric remedies work quite efficiently owing to the strong, long-term, multiple, positive effects that daily physical activity displays. Thus, they are important factors in:


Man is a bio-psycho-social being, in close interrelation with his environment. Therefore, the bio-psycho-socio-ecological dimension of contemporary humans is fundamental for health-

On the other hand, the 1946 WHO definition of health (*a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity)* confirms the bio-psychosocio-ecological determinant of contemporary man. The definition of healthy ageing (Haber,




Their control at national, regional and global levels involves coherent and efficient measures

The concept of palaestric civilization is an integrative global health conception (D. Riga and S. Riga, 2010a). At present, it comprises the beliefs, customs and culture of the ancients, the Renaissance ideals of physical beauty attained through exercise, the 19th - 20th Century efforts to institutionalize, generalize and popularize physical education and sports, and

The palaestric principles, characteristics which are clearly defined and highly positive, are:


The palaestric remedies work quite efficiently owing to the strong, long-term, multiple, positive effects that daily physical activity displays. Thus, they are important factors in:



contemporary strategies of complementary health nutrition-physical activity.


At present, the percentage of determining factors in ensuring health is as follows:

**4.2 From health to health-longevity** 

2003) comprises the following three components:

concepts for increasing healthy lifestyle habits;

longevity (S. Riga et al., 2010c).

structural health risks;

medical care systems.


and strategies.

cost;

**4.3 Palaestric civilization**

balancing (D. Riga and S. Riga, 2007).



There is a positive correlation between nourishment and exercise. Both rational nutrition and regular physical activity contribute to maintaining and improving good health (Simopoulos, 2005). Moreover, the palaestric solution also takes into account the bio-psychosocio-ecological human dimension (S. Riga et al., 2010c). Physical education is a contributing factor in biologically and socially harmonizing a human being, as well as in integrating humans in their natural surroundings. In palaestric education, healthy nutrition is the 1st strategy for health-longevity. An unhealthy diet represents a major risk factor in noncommunicable/chronic diseases, in the causation of global morbidity and for mortality. A lifestyle including physical activity is the 2nd principle and remedy. Physical inactivity represents a pathological habit, which increases the prevalence of 25 chronic diseases and produces more than 2 million deaths worldwide.

At present, there is strong global concern in relation to educating individuals in view of leading a healthier lifestyle, irrespective of age. In this sense, the palaestric paradigm, scientifically backed up by a large number of studies and researches, is prefigured as a valid solution. *The Declaration of Olympia,* May 28-29, 1996, drawn out and published one hundred years after 1896, when the modern and contemporary Olympic games were resumed in Athens, and the *WHO Documents and Recommendations* and the *European Union Legislation*  (*White paper on a Strategy for Europe on Nutrition, Overweight and Obesity related Health Issue,*  2007; *White paper on Sport,* 2007) officially advocate the necessity of physical culture and education for each individual, as well as for the entire human society.

#### **4.4 Declaration of Olympia on nutrition and fitness**

#### **4.4.1 Ancient Olympia, Greece, May 28-29, 1996 (Simopoulos, 2005)**


Health-Longevity Medicine in the Global World 357






For competitive and long-term health-longevity, this original therapy must be associated



"Targets for Health for All - 2000" is a global strategy envisioned by the WHO and represents a programmatic document (WHO, Regional Office for Europe, 1986): "Primary health care is the most important single element in the reorientation of the health care system and will require very strong support" (p. 11). For this objective, "Lifestyles conductive to health" (Ch. 4) and a "Healthy environment" (Ch. 5) become fundamental.

The six important subjects and the four dimensions of health promotion were very well

Health for all implies *equity.* This means that the present inequalities in health between

 The aim is to give a positive sense of health so that they can make full use of their physical, mental and emotional capacities. The main emphasis should therefore be on

 Health for all will be achieved by people themselves. A well-informed, well-motivated and actively *participating community* is a key element for the attainment of the common

countries and within countries should be reduced as far as possible.


The drug-therapy was elaborated by association of the following active principles:

and/or aminoethyl phenoxyacetamides;

The process for manufacturing the drug stipulates:


neurometabolic activators;

Demirovic, 2009).

emphasized:

goal.

**5. Health-longevity strategy** 

gastrosoluble and enterosoluble, the last being enteric coated; - prolonged-release of vasodilator from the enterosoluble unit.



**5.1 Quality of life for all. The WHO public health policy** 

"Six major themes run throughout the whole book.

*health promotion* and the prevention of disease.

magnesium and iodine;

phosphate and sulphate.

and integrated with:

acetamides with potassium, zinc and lithium;


#### **4.5 New conception - strategy - therapeutics in pro-longevity medicine**

Anti-stress, anti-impairment, anti-ageing and anti-pathology therapy is a new specific, simultaneous and synergistic strategy and conception in preventative, curative and recovery medicine (Class of the Antagonic-Stress® drugs), (D. Riga and S. Riga, 1995-2005).

The therapy acts aetio-pathogenically in antagonizing and attenuating the *stress ↔ ageing tetrad (mental-biologic-oxidative-inflammatory distress ↔ impairment-wear and tear ↔ normal and accelerated ageing-inflammaging ↔ poly-pathologies as stress- and age-associated diseases),* at metabolic, subcellular, cellular, tissual, organic and systemic levels. This way, the entropic cascade of *stress ↔ ageing* is replaced with the *health ↔ longevity,* anti-entropic, protectivetherapeutic *tetrad*: anti-stress/eustress/adaptation anti-impairment/vitality/resistance anti-ageing/active, healthy longevity anti-illnesses/anti-diseases. In addition, this first-hand restorative therapy recovers the anti-oxidative capacity/reserve/defence, a feature of the human body which has a direct relation with health-longevity.

4. Nutrient intakes should match more closely human evolutionary heritage. The choice of foods should lead to a diverse diet high in fruits and vegetables and rich in essential

5. The current level of physical activity should match more closely our genetic endowment. [The] reestablishment of regular physical activity into everyday life on a daily basis is essential for physical, mental and spiritual well-being. For all ages and both genders the physical activity should be appropriately vigorous and of sufficient duration, frequency, and intensity, using large muscle groups rhythmically and repetitively. Special attention to adequate nutrition should be given to competitive

6. The attainment of metabolic fitness through energy balance, good nutrition and physical activity reduces the risk of and forms the treatment framework for many modern lifestyle diseases such as diabetes mellitus, hypertension, osteoporosis, some cancers, obesity, and cardiovascular disorders. Metabolic fitness maintains and improves musculoskeletal function, mobility, and the activities of daily living into old

7. Education regarding healthy nutrition and physical activity must begin early and continue throughout life. Nutrition and physical activity must be interwoven into the curriculum of school age children and of educators, nutritionists and other health professionals. Positive role models must be developed and prompted by society and the

8. Major personal behavioural changes supported by the family, the community, and societal resources are necessary to reject unhealthy lifestyles and to embrace an active

9. National governments and the private sector must coordinate their efforts to encourage good nutrition and physical activity throughout the life cycle and thus increase the pool

10. The ancient Greeks (Hellenes) attained a high level of civilization based on good nutrition, regular physical activity, and intellectual development. They strove for excellence in mind and body. Modern men, women, and children can emulate this Olympic ideal and become swifter, stronger and fitter through regular physical activity

Anti-stress, anti-impairment, anti-ageing and anti-pathology therapy is a new specific, simultaneous and synergistic strategy and conception in preventative, curative and recovery

The therapy acts aetio-pathogenically in antagonizing and attenuating the *stress ↔ ageing tetrad (mental-biologic-oxidative-inflammatory distress ↔ impairment-wear and tear ↔ normal and accelerated ageing-inflammaging ↔ poly-pathologies as stress- and age-associated diseases),* at metabolic, subcellular, cellular, tissual, organic and systemic levels. This way, the entropic cascade of *stress ↔ ageing* is replaced with the *health ↔ longevity,* anti-entropic, protectivetherapeutic *tetrad*: anti-stress/eustress/adaptation anti-impairment/vitality/resistance anti-ageing/active, healthy longevity anti-illnesses/anti-diseases. In addition, this first-hand restorative therapy recovers the anti-oxidative capacity/reserve/defence, a

of physically fit individuals who emulate the Olympic ideal.

**4.5 New conception - strategy - therapeutics in pro-longevity medicine** 

medicine (Class of the Antagonic-Stress® drugs), (D. Riga and S. Riga, 1995-2005).

feature of the human body which has a direct relation with health-longevity.

nutrients, particularly protective antioxidants and essential fatty acids.

athletes.

age.

media.

lifestyle and good nutrition.

and good nutrition".

The drug-therapy was elaborated by association of the following active principles:


The process for manufacturing the drug stipulates:


For competitive and long-term health-longevity, this original therapy must be associated and integrated with:


#### **5. Health-longevity strategy**

#### **5.1 Quality of life for all. The WHO public health policy**

"Targets for Health for All - 2000" is a global strategy envisioned by the WHO and represents a programmatic document (WHO, Regional Office for Europe, 1986): "Primary health care is the most important single element in the reorientation of the health care system and will require very strong support" (p. 11). For this objective, "Lifestyles conductive to health" (Ch. 4) and a "Healthy environment" (Ch. 5) become fundamental.

The six important subjects and the four dimensions of health promotion were very well emphasized:

"Six major themes run throughout the whole book.


Health-Longevity Medicine in the Global World 359


services (S. Riga et al., 2009a; S. Riga et al., 2011a).

Fig. 3. Modern pyramid of (mental) medical services.

Optimal mix recommended by WHO (2007)

Fig. 4. New pyramid of (mental) health services.

Advanced paradigm in (mental) health - longevity services (2009)


"Thus, health for all in Europe has four dimensions as regards health outcomes, involving action in order to:


The WHO (a specialized agency of the United Nations, primarily responsible for international public health) published, in 1987, an essential tool: "Measurement in health promotion and protection" (Abelin et al., 1987). This WHO manual represents a new health movement for a global strategy, promoting positive health, in the socio-ecological paradigm of health. Therefore, "the main goal of health promotion is to maintain or improve health potential" (p. 19).

Also, on October 12, 1990, the WHO teleconference cautions against "diseases of lifestyle", which are the cause of 70-80% of premature deaths in industrialized countries. Thus, health promotion signifies the prevention of stress-related diseases (Cooper, 1996).

Therefore, the quality of life for all represents the promotion of positive health, a new socioecological paradigm of health and preventative medicine (S. Riga and D. Riga, 2009b).

#### **5.2 Health ↔ longevity tetrad**

Mental (psychic, behavioural) and somatic (body, metabolic) health with the construction of the health-longevity couple represent the medicine of the future. The *health ↔ longevity tetrad (anti-stress ↔ anti-impairment ↔ anti-ageing ↔ anti-diseases)* is in total opposition with the stress ↔ ageing cascade.

LHS and MH have common principles and strategies. Both:


 Health for all requires the coordinated action of all sectors concerned. The health authorities can deal only with a part of the problems to be solved, and *multisectoral cooperation* is the only way of effectively ensuring the prerequisites for health, promoting healthy policies and reducing risks in the physical, economic and social environment. The focus of the health care system should be on *primary health care* - meeting the basic health needs of each community through services provided as close as possible to where people live and work, readily accessible and acceptable to all, and based on full

 Health problems transcend national frontiers. Pollution and trade in health-damaging products are obvious examples of problems whose solution requires *international* 

"Thus, health for all in Europe has four dimensions as regards health outcomes, involving

*ensure equity in health,* by reducing the present gap in health status between countries

 *add life to years,* by ensuring the full development and use of people's integral or residual physical and mental capacity to derive the full benefit from it and to cope with

*add years to life,* by reducing premature deaths, and thereby increasing life expectancy"

The WHO (a specialized agency of the United Nations, primarily responsible for international public health) published, in 1987, an essential tool: "Measurement in health promotion and protection" (Abelin et al., 1987). This WHO manual represents a new health movement for a global strategy, promoting positive health, in the socio-ecological paradigm of health. Therefore, "the main goal of health promotion is to maintain or improve health

Also, on October 12, 1990, the WHO teleconference cautions against "diseases of lifestyle", which are the cause of 70-80% of premature deaths in industrialized countries. Thus, health

Therefore, the quality of life for all represents the promotion of positive health, a new socioecological paradigm of health and preventative medicine (S. Riga and D. Riga, 2009b).

Mental (psychic, behavioural) and somatic (body, metabolic) health with the construction of the health-longevity couple represent the medicine of the future. The *health ↔ longevity tetrad (anti-stress ↔ anti-impairment ↔ anti-ageing ↔ anti-diseases)* is in total opposition with


promotion signifies the prevention of stress-related diseases (Cooper, 1996).

LHS and MH have common principles and strategies. Both:

community participation.

and groups within countries;

*add health to life,* by reducing disease and disability;

*cooperation*" (pp. 5-6).

life in a healthy way;

**5.2 Health ↔ longevity tetrad** 

the stress ↔ ageing cascade.

recovery;

action in order to:

(p. 23).

potential" (p. 19).


Fig. 3. Modern pyramid of (mental) medical services. Optimal mix recommended by WHO (2007)

Fig. 4. New pyramid of (mental) health services.

Advanced paradigm in (mental) health - longevity services (2009)

Health-Longevity Medicine in the Global World 361

The First Law *(Law of use and disuse),* in its extended form, enunciated by Jean-Baptiste Lamarck (1744-1828), the French naturalist, is very important for the health-longevity strategy: *In every animal which has not passed the limit of its development, a more frequent and continuous use of any organ gradually strengthens, develops and enlarges that organ, and gives it a power proportional to the length of time it has been so used; while the permanent disuse of any organ imperceptibly weakens and deteriorates it, and progressively diminishes its functional capacity, until* 

As an actual concept, it becomes "use it or lose it" (engl.)/"utilisez-la ou perdez-la" (fr.), both for neurons (Swaab, 1991) as well as for mental activity (Roth, 1975; Giurgea, 1993), namely therapy for cerebral activation, utilized in sanogenesis, prophylaxis of neuro-

*At a national (societal) level,* for an increased efficacy of health-longevity strategies, two



Now, is the time to create global standards in the training of health promotion. For this reason, the International Institute for Health promotion was organized in 1996 at the American University in Washington, DC (Kirsten, 2010), as an interdisciplinary network of specialists from various fields, and also of academic, governmental and non- governmental

In our new conception, the aim of health-longevity is health promotion together with illness prevention and the improvement of the quality of life. Moreover, the advantages of the proposed public health strategies and policies (pyramid of health) are low societal costs compared to the enduring treatments for chronic diseases. Therefore, a new millennium


Consequently, future medicine will be and must be the medicine of health, mainly the planning of personalized and public health, together with the strategies of longevity,

The ageing of the population (implicitly chronic diseases) and also mental/behavioural disorders are in rapid expansion. Due to the high public costs, these phenomena will force society towards a new health policy: health protection/promotion and preventative/prophylactic medicine. Consequently, in the global world, the future medicine

strategy for a healthy person's medicine must entail qualified interventions:

*At an individual (personalized) level* the continuous education of health is defining.

**5.4 Health-longevity - A global progress**

*it finally disappears* (Lamark, 1809, trans. 1914)*.*

directions must be covered:

and maintenance.

oxidative - inflammatory stress).

somatic and mental health.

organizations.

degenerative diseases and against pathological ageing.

precocious discovery of illnesses, followed by:

The societal cost/benefit ratio is decisively in favour of health-longevity promotion, in comparison with current medical care systems, represented by polyclinics, hospitals and sanatoriums. The cost/benefit ratio will always rank prevention and prophylaxis as higher place than therapeutics and recovery whenever savings and economic factors are involved.

#### **5.3 New health-longevity strategy. Structure of health as a pyramid**

This original paradigm is structured in *a new pyramid* of health-longevity services (S. Riga and D. Riga, 2009a; S. Riga et al., 2011a), with five levels:


An optimal mix of ecological, bio-medical and care systems and services in the promotion of health-longevity integrates the costs (left side), the frequency of needs (right side) and the quantity of services needed (presented on a horizontal line). The most favourable and viable combination is structured as a new pyramid of health-longevity services (**Figure 4**), (S. Riga et al., 2010d; S. Riga et al., 2011a).

From the base to the top, the hierarchy of services needed comprises five levels:


The societal cost/benefit ratio is decisively in favour of health-longevity promotion, in comparison with current medical care systems, represented by polyclinics, hospitals and sanatoriums. The cost/benefit ratio will always rank prevention and prophylaxis as higher place than therapeutics and recovery whenever savings and economic factors are

This original paradigm is structured in *a new pyramid* of health-longevity services (S. Riga

1. Ecology: "the health" of the environment, permanent human healthy conceptions and

2. The culture of sanogenesis, which involves education, learning, construction,

3. Rational life and use of health-longevity resources: balanced diet and often dietary restriction, regular physical activity, cerebral metabolic activation, cognitive and social

5. Sub-clinical (infra-clinical) medicine, with developmental origins of health and diseases, risk factors for health, biologic and psychic impairment, pre-senescence, pre-illness and

An optimal mix of ecological, bio-medical and care systems and services in the promotion of health-longevity integrates the costs (left side), the frequency of needs (right side) and the quantity of services needed (presented on a horizontal line). The most favourable and viable combination is structured as a new pyramid of health-longevity services (**Figure 4**), (S. Riga

1. Ecology: the "health" of the environment (natural, artificial, societal, regional and, finally, global - the earth), (WHO, Regional Office for Europe, 1986; Abelin et al., 1987); 2. The continuous education, learning and training of sanogenesis (Abelin et al., 1987; S.

2nd stage (maintenance training/coaching improvement continuity /

3. The rational utilization of personal life and health-longevity resources (Klatz and Goldman, 2003; Le Bourg, 2003; Simopoulous, 2005; D. Riga et al., 2006b): diet, physical activity, cerebral activation (psychic, nutraceutical, metabolic, psychological

4. Health protection promotion development and preventative medicine (primary prophylaxis), (WHO, Regional Office for Europe, 1986; Abelin et al., 1987; Knapp et al.,

5. Infra-clinical medicine in pre-senescence and pre-pathology (Cutler, 1996; Cutler et al., 2005a; D. Riga and S. Riga, 2007): diagnosis - evaluation - intervention for risk factors, inductors of pre-senescence, pre-illness and silent pathology and, finally, for diseases

(markers of oxidative stress and inflammation, cancer antigens etc.).

., 2009b): 1st stage (cognitive education construction development) and

**5.3 New health-longevity strategy. Structure of health as a pyramid** 

actions on the surroundings, normal human-environment interactions;

From the base to the top, the hierarchy of services needed comprises five levels:

development, training, maintenance, continuity and permanence;

4. Health protection (promotion) and preventative medicine;

and D. Riga, 2009a; S. Riga et al., 2011a), with five levels:

stimulation, hormesis;

silent pathologies.

et al., 2010d; S. Riga et al., 2011a).

Riga et al

permanence);

and social);

2007; S. Riga and D. Riga, 2008);

involved.

#### **5.4 Health-longevity - A global progress**

The First Law *(Law of use and disuse),* in its extended form, enunciated by Jean-Baptiste Lamarck (1744-1828), the French naturalist, is very important for the health-longevity strategy: *In every animal which has not passed the limit of its development, a more frequent and continuous use of any organ gradually strengthens, develops and enlarges that organ, and gives it a power proportional to the length of time it has been so used; while the permanent disuse of any organ imperceptibly weakens and deteriorates it, and progressively diminishes its functional capacity, until it finally disappears* (Lamark, 1809, trans. 1914)*.*

As an actual concept, it becomes "use it or lose it" (engl.)/"utilisez-la ou perdez-la" (fr.), both for neurons (Swaab, 1991) as well as for mental activity (Roth, 1975; Giurgea, 1993), namely therapy for cerebral activation, utilized in sanogenesis, prophylaxis of neurodegenerative diseases and against pathological ageing.

*At an individual (personalized) level* the continuous education of health is defining.

*At a national (societal) level,* for an increased efficacy of health-longevity strategies, two directions must be covered:


Now, is the time to create global standards in the training of health promotion. For this reason, the International Institute for Health promotion was organized in 1996 at the American University in Washington, DC (Kirsten, 2010), as an interdisciplinary network of specialists from various fields, and also of academic, governmental and non- governmental organizations.

In our new conception, the aim of health-longevity is health promotion together with illness prevention and the improvement of the quality of life. Moreover, the advantages of the proposed public health strategies and policies (pyramid of health) are low societal costs compared to the enduring treatments for chronic diseases. Therefore, a new millennium strategy for a healthy person's medicine must entail qualified interventions:


Consequently, future medicine will be and must be the medicine of health, mainly the planning of personalized and public health, together with the strategies of longevity, somatic and mental health.

The ageing of the population (implicitly chronic diseases) and also mental/behavioural disorders are in rapid expansion. Due to the high public costs, these phenomena will force society towards a new health policy: health protection/promotion and preventative/prophylactic medicine. Consequently, in the global world, the future medicine

Health-Longevity Medicine in the Global World 363

[6] Cutler R. G. 1996. The molecular and evolutionary aspects of human aging and

[7] Cutler R. G., Harman S. M., Heward C., Gibbons M., Eds. 2005a. *Longevity Health* 

[8] Cutler R. G. 2005b. Oxidative stress profiling. Part I. Its potential importance in the

[9] Cutler R. G., Plummer J., Chowdhury K., Heward C. 2005c. Oxidative stress profiling. Part II. Theory, technology and practice. *Ann. N. Y. Acad. Sci.* 1055: 136-158. [10] de Grey A. D. N. J., Ed. 2004. *Strategies for Engineered Negligible Senescence. Why Genuine* 

[11] Fahy G. M., West M. D, Coles L. S., Harris S. B., Eds. 2010. *The Future of Aging. Pathways* 

[12] Funk M., Drew N., Saraceno B. 2007. Global perspective on mental health policy and

[13] Giurgea C. E. 1993. *Le vieillissement cérébral normal et réussi. Le défi du XXIe siècle.*

[14] Haber D. 2003. *Health Promotion and Aging. Practical Applications for Health Professionals,* 

[15] Hanson A. E. 2006. *Hippocrates: the "Greek Miracle" in Medicine.* L. T. Pearcy, The

[16] Harman D. 1984. Free radical theory of aging: the "free radical" diseases. *Age.* 7: 111-

[17] Klatz R., Goldman R. 2003. *The New Anti-Aging Revolution.* Basic Health Publ. North

[18] Knapp M., McDaid D., Mossialos E., Thornicroft G., Eds. 2007. *Mental Health Policy and* 

[19] Kristen W. 2010. Creating global standards in health promotion training - the

[20] Lamarck J.-B. 1914. *Philosophie zoologique, ou exposition des considérations relatives à l'histoire naturelle des animaux, 1809.* Trans. by H. Elliot. Macmillan. London, UK. [21] Le Bourg E. 2003. Antioxidants as Modulators. In: *Modulating Aging and Longevity.* S. I.

[22] Lin H. B. 2000. *Chinese Health Care Secrets. A Natural Lifestyle Approach.* Llewellyn Publ.,

[23] Miwa S., Beckman K. B., Muller F. L., Eds. 2008. *Oxidative Stress in Aging. From Model Systems to Human Diseases.* Humana Press-Springer Science. Totowa, NJ.

*Practice Across Europe.* Open University Press. McGraw-Hill Education.

International Institute for Health Promotion. *Palestrica of the 3rd Millennium -* 

optimization of human health. *Ann. N. Y. Acad. Sci.* 1055: 93-135.

Liebert. New York, NY.

Mardaga. Liège, BE.

131.

Bergen, NJ.

Maidenhead, UK.

St. Paul, MN.

3rd ed. Springer. New York, NY.

Episcopal Academy. Merion, PA.

*Civilization and Sport.* 11: 291-292.

S. Rattan, Ed.: 183-203. Kluwer. Dordrecht, NL.

Academy of Sciences. New York, NY.

Academy of Sciences. New York, NY.

*to Human Life Extension.* Springer. Dordrecht, NL.

longevity. In: *Advances in Anti-Aging Medicine.* R. Klatz, Ed.: 71-99. Mary Ann

*Sciences. The Phoenix Conference.* Ann. N. Y. Acad. Sci, Vol. 1055. New York

*Control of Aging May Be Foreseeable.* Ann. N. Y. Acad. Sci, Vol. 1019. New York

service development issues: the WHO angle. In: *Mental Health Policy and Practice across Europe. The future direction of mental health care.* M. Knapp, D. McDaid, E. Mossialos & G. Thornicroft, Eds.: 426-440. Open University Press. New York, NY.

will be the medicine of health: the planning of personalized/public health and strategies of longevity/mental health.

In 2002, non-communicable diseases accounted for 60% of total mortality worldwide and 46% of the global burden of disease (WHO, 2003). This disease burden is expected to increase from 46% in 2002 to 60% in 2020. The major causes of this are represented by five factors (high blood pressure, high cholesterol, low intake of vegetables and fruits, high body mass index and physical inactivity) from the top 10 global disease burden factors enumerated by the WHO. These current risk levels (a worldwide risk diagram) predict major increases in chronic diseases, as a poly-pathology of ageing.

On May 2004, at the 56th World Health Assembly, the WHO substantiated an important global public health initiative (Waxman, 2005), the main targets of which were diet, physical activity and health.

### **6. Conclusions**

The progress in science, medicine, technology and communication imposes global policies strategies - standards in health promotion from the WHO regarding education, training, expertise, culture and research.

Contemporary civilization should therefore substantiate key competences:


Health-longevity medicine is a new concept for public health, health promotion and protection, in accordance with world demographic tendencies. This strategy for future health at a global level reunites preventative (prophylaxis and hygiene) medicine, LHS, MH and the human bio-psycho-socio-ecological dimension.

#### **7. References**


will be the medicine of health: the planning of personalized/public health and strategies of

In 2002, non-communicable diseases accounted for 60% of total mortality worldwide and 46% of the global burden of disease (WHO, 2003). This disease burden is expected to increase from 46% in 2002 to 60% in 2020. The major causes of this are represented by five factors (high blood pressure, high cholesterol, low intake of vegetables and fruits, high body mass index and physical inactivity) from the top 10 global disease burden factors enumerated by the WHO. These current risk levels (a worldwide risk diagram) predict

On May 2004, at the 56th World Health Assembly, the WHO substantiated an important global public health initiative (Waxman, 2005), the main targets of which were diet, physical

The progress in science, medicine, technology and communication imposes global policies strategies - standards in health promotion from the WHO regarding education, training,

Health-longevity medicine is a new concept for public health, health promotion and protection, in accordance with world demographic tendencies. This strategy for future health at a global level reunites preventative (prophylaxis and hygiene) medicine, LHS, MH

[1] Abelin T., Brzezinski Z. J., Carstairs V. D. L., Eds. 1987. *Measurement in Health Promotion* 

[2] Bogdan V., Bogdan A. 2009. The sanogenetic role of physical activity. Why should we

[3] Commission of the European Communities. 2007. *White Paper on a Strategy for Europe on* 

ph\_determinants/life\_style/nutrition/documents/nutrition\_wp\_ ro.pdf

[5] Cooper C. L., Ed. 1996. *Handbook of Stress, Medicine and Health.* CRC Press. Boca Raton,

Organization, Regional Office for Europe. Copenhagen, DK.

[4] Commission of the European Communities. 2007. *White Paper on Sport.* http://ec.europa.eu/ sport/whitepaper/wp\_on\_sport\_ro.pdf

*and Protection.* WHO Regional Publications, European Series No. 22. World Health

wait until it is too late? *Palestrica of the 3rd Millennium - Civilization and Sport.* 10: 48-

*Nutrition, Overweight and Obesity related Health Issue*. http://ec.europa.eu/health/

major increases in chronic diseases, as a poly-pathology of ageing.

Contemporary civilization should therefore substantiate key competences:

longevity/mental health.

activity and health.

**6. Conclusions** 

**7. References** 

53.

FL.

expertise, culture and research.




and the human bio-psycho-socio-ecological dimension.


Health-Longevity Medicine in the Global World 365

[38] Riga S., Riga D., Danăilă L., Mihăilescu A., Motoc D., Moş L., Schneider, Fr. 2009b.

[39] Riga D., Riga S., Moş L., Motoc D., Schneider Fr. 2009c. Pro-longevity life styles.

[40] Riga D., Riga S. 2010a. Palestra's paradigm. *Palestrica of the 3rd Millennium - Civilization* 

[41] Riga D., Riga S., Ardelean A., Schneider Fr. 2010b. Health, longevity and ecology - an

[42] Riga S., Riga D., Ardelean A., Schneider Fr. 2010c. The contemporary man in his biopsycho-socio-ecological dimension. *Fiziologia-Physiology,* 20(2): 8-10. [43] Riga S., Riga D., Mihăilescu A., Motoc D., Moş L, Schneider Fr. 2010d. Longevity health sciences and mental health as future medicine. *Ann. N.Y. Acad. Sci.* 1197: 184-187. [44] Riga S., Riga D., Ghinescu M., Mihăilescu A., Motoc D., Geacăr S. 2011a. Health-

[45] Riga D., Riga S. 2011b. The Science of Ageing - Global Progress, *Rejuvenation Res.* 14:

[48] Simopoulous A. P., Ed. 2005. *Nutrition and Fitness.* Vol. 1 - *Obesity, the Metabolic* 

[50] Swaab, D. F. 1991. Brain aging and Alzheimer's disease, "wear and tear" versus "use it

[51] Unschuld P. U. 2003. *Huang Di nei jing su wen: Nature, Knowledge, Imagery in an Ancient* 

[52] Waxman A. 2005. Why a global strategy on diet, physical activity and health? In:

[53] Weon B. M., Je J. H. 2009. Theoretical estimation of maximum human lifespan.

[54] WHO, Regional Office for Europe. 1986. *Targets for Health for All - 2000. Targets in* 

[55] WHO. 1992. *The ICD-10. Classification of Mental and Behavioural Disorders. Clinical Descriptions and Diagnostic Guidelines.* World Health Organization. Geneva, CH.

*Nutrition and Fitness: Mental Health, Aging, and the Implementation of a Healthy Diet and Physical Activity Lifestyle.* Vol. 2. A. P. Simopoulous, Ed.: 162-166. Karger. Basel,

*Support of the European Regional Strategy for Health for All.* World Health

*Chinese Medical Text.* University of California Press, Berkeley, CA.

Organization, Regional Office for Europe. Copenhagen, DK.

*Syndrome, Cardiovascular Disease, and Cancer.* Vol. 2 - *Mental Health, Aging, and the Implementation of a Healthy Diet and Physical Activity Lifestyle.* Karger. Basel, CH. [49] Slater T. F., Block G., Eds. 1991. Antioxidant vitamins and -carotene in disease

integrated paradigm. *Fiziologia-Physiology,* 20(1): 13-16.

[46] Roth M. 1975. The diagnosis of dementia. *Br. J. Psychiatry.* 125(9): 87-99. [47] Selye H. 1976. Stress in Health and Disease. Butterworths. Boston, MA.

prevention. *Am. J. Clin. Nutr.* 53(S1): 189S-396S.

or lose it". *Neurobiol. Aging.* 12: 317-324.

*Congress.* Québec, CA, May 18-20, 2009.

*Civilization and Sport.* 10: 138-144.

*and Sport.* 11: 7-9.

2011.

CH.

*Biogerontology.* 10: 65-71.

573-577.

Longevity science and mental health - unification of their concepts and strategies, essential key for the future medicine. *13th IABG (Int. Assoc. Biomed. Gerontol.)* 

Importance of physical activity and sport. *Palestrica of the 3rd Millennium -* 

Longevity Pyramid in the Anti-Aging Global Progress. *61st Annual Scientific Meeting of the British Society for Research on Ageing - BSRA & 14th Congress of the International Association of Biological Gerontology - IABG,* Brighton, UK, July 11-14,


[24] Muller D. P. R., Goss-Sampson M. A., MacEvilly C. J. 1992. Antioxidant deficiency and

[25] Newnham J. P., Ross M. G., Eds. 2009. *Early Life Origins of Human Health and Disease.*

[26] Rattan S. I. S., Demirovic D. 2009. Hormesis and aging. In: *Hormesis: a revolution in* 

[27] Riga D., Riga S. 1995-2005. *Anti-stress, anti-impairment and anti-aging drugs and process* 

[28] EPO: EUR. Pat. 1999 (17 countries - AT, BE, CH, DE, DK, ES, FR, GB, IE, IT, LI, LU,

[29] AU Pat. 1998, KR Pat. 1999, RU Pat. 2000, US Pat. 2001, CN Pat. 2001, CA Pat. 2002, JP

[30] Riga D. 2003. SENS acquires SENSe: present and future anti-aging strategies. *J. Anti-*

[31] Riga D., Riga S., Schneider Fr. 2004a. Regenerative medicine: Antagonic-Stress®

[32] Riga S., Riga D., Schneider Fr. 2004b. Prolongevity medicine: Antagonic-Stress® drug in

[33] Riga D., Riga S., Hălălău F., Schneider Fr. 2006a. Lipofuscin and ceroid pigments -

[34] Riga D., Riga S., Hălălău F., Schneider Fr. 2006b. Neurono-glial mechanisms in brain

[35] Riga D., Riga S. 2007. *Anti-Aging Medicine and Longevity Sciences* (Romanian lang.).

[36] Riga S., Riga D. 2008. *Stressology, Adaptology and Mental Health* (Romanian lang.). Cartea

[37] Riga S., Riga D., Danailă L., Mihăilescu A., Motoc D., Moş L., Schneider, Fr. 2009a.

therapy in distress and aging. I. Preclinical synthesis - 2003. *Ann. N.Y. Acad. Sci.*

distress, geriatrics and related diseases. II. Clinical review - 2003. *Ann. N.Y. Acad.* 

markers of normal and pathological brain aging. In *Anti-Aging Therapeutics,* Vol. 8, R. Klatz, R. Goldman, Eds.: 213-221. American Academy of Anti-Aging Medicine.

protection, aging deceleration and neuro-psycho-longevity. In *Anti-Aging Therapeutics,* Vol. 8, R. Klatz, R. Goldman, Eds.: 223-236. American Academy of

New politics for global health and longevity: complementarity of anti-aging medicine with mental health. *19th IAGG (Int. Assoc. Gerontol. Geriatrics) World Congress.* July 5-9, 2009. Paris, FR. *Abstract* PB7 495. *J. Nutr. Health Aging.* 13(S1):

Eds.: 62-73. Springer. Berlin, DE.

WIPO, PCT: PCT/WO 95/33486;

*Aging Med. (Rejuvenation Res.)* 6: 231-236.

Anti-Aging Medicine. Chicago, IL.

Universitara Publ. Bucharest, RO.

Cartea Universitara Publ. Bucharest, RO.

Karger. Basel, CH.

Springer. New York, NY.

MC, NL, PT, RO, SE);

Pat. 2003, BR Pat. 2005.

1019: 396-400.

Chicago, IL.

S475.

*Sci.* 1019: 401-405.

neurological disease in humans and experimental animals. In: *Free Radicals in the Brain. Aging, Neurological and Mental Disorders.* L. Packer, L. Prilipko & Y. Christen,

*biology toxicology and medicine.* M. P. Mattson & E. Calabrese, Eds.: 153-175.

*for manufacturing thereof (Class of the Antagonic-Stress® drugs/therapy - Dr. Dan Riga & Dr. Sorin Riga),* 64 pp., a new conception - strategy - therapeutics with 27 worldwide patents in 3 international organizations, 25 states and 5 continents:


Life expectancy is the key aggregated indicator of a country's well-being along with gross domestic product and living standards. While Russia approaches the group of developed countries in terms of per capita GDP, it is strikingly different in terms of the living standards and the dynamics of life expectancy. Thus, life expectancy among males in Russia has not only not increased since the 1970s, but has dropped to barely above 60 years (Fig.1). The low living standards and lack of improvement in life expectancy dynamics in Russia are in contrast with the experience of the majority of developed countries and countries with transitional economies. Thus, male life expectancy at birth in Finland has increased from 66 years in 1970 to 76 years in 2007, in Norway from 71 to 77 years and in Sweden from 72 to 78 years during the same period. In the Czech Republic male life expectancy has increased from 66 to 68 years. Female life expectancy in these countries reveals comparable dynamics. Russia has still to go into an upward trend (both for men and for women) characteristic of

all the developed and the majority of the developing countries.

France

<sup>1970</sup> <sup>1980</sup> <sup>1990</sup> <sup>2000</sup> <sup>2010</sup> Year

Finland, the Czech Republic, and the Russian Federation.

*Source:* European Health for All Database, 2011.

Finland Czech Republic

Russian Federation

B. Females

Fig. 1. Life expectancy at birth, 1970-2007, male (left) and female (right). Top down: France,

Numerous studies of the causes of high mortality among the Russian population all confirm the negative impact of excessive alcohol consumption (Leon et al, 1997; Shkolnikov et al,

**1. Introduction** 

A. Males

Irina Denisova1 and Marina Kartseva2

*2Centre for Economic and Financial Research, Moscow* 

*1New Economic School, Moscow* 

France

1970 1980 1990 2000 2010 Year

Finland Czech Republic

Russian Federation

*Russia* 

[56] WHO. 2003. *Shaping the Future. The World Health Report.* World Health Organization. Geneva, CH. **18**

Irina Denisova1 and Marina Kartseva2

*1New Economic School, Moscow 2Centre for Economic and Financial Research, Moscow Russia* 

#### **1. Introduction**

366 Public Health – Methodology, Environmental and Systems Issues

[56] WHO. 2003. *Shaping the Future. The World Health Report.* World Health Organization.

Life expectancy is the key aggregated indicator of a country's well-being along with gross domestic product and living standards. While Russia approaches the group of developed countries in terms of per capita GDP, it is strikingly different in terms of the living standards and the dynamics of life expectancy. Thus, life expectancy among males in Russia has not only not increased since the 1970s, but has dropped to barely above 60 years (Fig.1). The low living standards and lack of improvement in life expectancy dynamics in Russia are in contrast with the experience of the majority of developed countries and countries with transitional economies. Thus, male life expectancy at birth in Finland has increased from 66 years in 1970 to 76 years in 2007, in Norway from 71 to 77 years and in Sweden from 72 to 78 years during the same period. In the Czech Republic male life expectancy has increased from 66 to 68 years. Female life expectancy in these countries reveals comparable dynamics. Russia has still to go into an upward trend (both for men and for women) characteristic of all the developed and the majority of the developing countries.

*Source:* European Health for All Database, 2011.

Fig. 1. Life expectancy at birth, 1970-2007, male (left) and female (right). Top down: France, Finland, the Czech Republic, and the Russian Federation.

Numerous studies of the causes of high mortality among the Russian population all confirm the negative impact of excessive alcohol consumption (Leon et al, 1997; Shkolnikov et al,

Aggregate consumption in Russia is higher than in the countries of Europe, although not much higher than in the Czech Republic, France and Germany. At the same time, the general trend of consumption in Europe and the US is a gradual decline in alcohol consumption (in litres of pure alcohol) since the 1980s, with the trend more manifest in Europe than in the US. Strong drinks are being replaced with lighter ones. Thus, for example, in the period between 1988 and 1998 consumption of spirits in Italy dropped by 50%, consumption of wine by 18% while consumption of beer increased by 15%. In Great Britain consumption of spirits and beer dropped by 28% and 17% respectively while wine consumption increased by a third (27%). During the same period in Europe as a whole consumption of spirits dropped by 23.2%, consumption of wine dropped by 3.6%, while consumption of beer increased by 3.6%3. Similar trends have been noted not only in developed countries. Thus in the majority of Latin American countries consumption of

For Russia the experience of North European countries where consumption patterns are historically similar to Russia is of the greatest interest. Figs. 3 and 4 show the dynamics of aggregate registered consumption of alcohol, beer, spirits and wine in Iceland, Finland, Norway and Sweden. As seen from the charts, all these countries witnessed dramatic changes in the structure of alcohol consumption in the 1980s and 1990s. The consumption of spirits dropped significantly: by 1.5 litres of pure alcohol per person in Norway, by 2 litres in Iceland and Finland and by almost 3 litres in Sweden. At the same time the total consumption of alcohol has not diminished and has actually grown a little because the consumption of spirits has been replaced with the consumption of beer and wine. As a result these countries moved from the group of countries with predominant consumption of

Fig. 3. Aggregate (registered) consumption of alcohol in Iceland (left) and Finland (right), consumption of beer, strong spirits and wine. Litres of pure alcohol per capita of 15 + per

3 The calculations use data not from all the European countries, but from countries with larger populations (Belgium, Great Britain, France, Germany, Spain, Italy, Poland, the Czech Republic,

1960 1970 1980 1990 2000 2010 Year Total Beer Wine Spirits

Source: National Research and Development Centre for Welfare and Health (STAKES), Finland 1961-2008

Litres of pure alcohol

alcohol is going down and consumption of beer is going up.

strong spirits to countries with predominant consumption of beer.

1960 1970 1980 1990 2000 2010 Year Total Beer Wine Spirits

Source: World Drink Trends (WDT) 1961-1999; Statistics Iceland 2000-2007

Portugal and Switzerland).

0

year.

2

4

Litres of pure alcohol

6

8

1998; Brainerd and Cutler, 2005; Leon, 2007; Nemtsov, 2002). The majority of studies use aggregated death certificate data, which limits a more detailed study of the impact of alcohol consumption patterns on health and ultimately on the risk of death1. The data of the Russian Longitudinal Monitoring Survey (RLMS-HSE) make it possible to identify types of alcohol consumption and analyze the impact of the main types on health and the risk of death. Section 2 analyzes aggregate alcohol consumption in Russia and Europe. Section 3 is devoted to the structure of alcohol consumption in Russia. Section 4 reports the results of the assessment of the impact of alcohol consumption on health and mortality in Russia. Section 5 is devoted to the experience of European countries in implementing active antialcohol policies. Section 6 concludes.

#### **2. Alcohol consumption in Russia and Europe**

The total registered consumption of alcohol in Russia in 2008 reached 11.5 litres of pure alcohol per person above the age of 15 (Fig.2). The consumption of spirits increased by 233% between 1988 and 1998, the consumption of beer by 31%, while the consumption of wine dropped slightly by 6% (World Drink Trends, 1999, Global Status Report on Alcohol, 2004). The production of illicit (unregistered) products adds almost 5 litres, according to expert assessments2. That adds up to 16 litres of pure alcohol per citizen over 15 years of age (the Ministry of Healthcare and Social Development puts the figure at 18 litres). It has to be noted that unregistered alcohol consumption is not a peculiarly Russian phenomenon. In the majority of West European countries unregistered consumption is put by experts at between 5 and 20%, and sometimes at as much as a third of registered consumption.

Fig. 2. Total (registered) consumption of alcohol in Russia, consumption of beer, spirits and wine. Litres of pure alcohol per capita of 15 + per year.

<sup>1</sup> A small group of studies are based on micro-data collected either with the express purpose of identifying the impact of harmful habits on the risk of death (surveys of the relatives of the dead in Izhevsk), or for other purposes (lipids test program).

<sup>2</sup> European Addiction Research (2001), Gilinskiy Y. (2000).

1998; Brainerd and Cutler, 2005; Leon, 2007; Nemtsov, 2002). The majority of studies use aggregated death certificate data, which limits a more detailed study of the impact of alcohol consumption patterns on health and ultimately on the risk of death1. The data of the Russian Longitudinal Monitoring Survey (RLMS-HSE) make it possible to identify types of alcohol consumption and analyze the impact of the main types on health and the risk of death. Section 2 analyzes aggregate alcohol consumption in Russia and Europe. Section 3 is devoted to the structure of alcohol consumption in Russia. Section 4 reports the results of the assessment of the impact of alcohol consumption on health and mortality in Russia. Section 5 is devoted to the experience of European countries in implementing active anti-

The total registered consumption of alcohol in Russia in 2008 reached 11.5 litres of pure alcohol per person above the age of 15 (Fig.2). The consumption of spirits increased by 233% between 1988 and 1998, the consumption of beer by 31%, while the consumption of wine dropped slightly by 6% (World Drink Trends, 1999, Global Status Report on Alcohol, 2004). The production of illicit (unregistered) products adds almost 5 litres, according to expert assessments2. That adds up to 16 litres of pure alcohol per citizen over 15 years of age (the Ministry of Healthcare and Social Development puts the figure at 18 litres). It has to be noted that unregistered alcohol consumption is not a peculiarly Russian phenomenon. In the majority of West European countries unregistered consumption is put by experts at

between 5 and 20%, and sometimes at as much as a third of registered consumption.

1960 1970 1980 1990 2000 2010 Year Total Beer Wine Spirits

Fig. 2. Total (registered) consumption of alcohol in Russia, consumption of beer, spirits and

World Drink Trends (WDT) 1963-1999; Russia Federal State Statistical Service 2000-2008

1 A small group of studies are based on micro-data collected either with the express purpose of identifying the impact of harmful habits on the risk of death (surveys of the relatives of the dead in

alcohol policies. Section 6 concludes.

0

Source:

Izhevsk), or for other purposes (lipids test program). 2 European Addiction Research (2001), Gilinskiy Y. (2000).

wine. Litres of pure alcohol per capita of 15 + per year.

5

Litres of pure alcohol

10

15

**2. Alcohol consumption in Russia and Europe** 

Aggregate consumption in Russia is higher than in the countries of Europe, although not much higher than in the Czech Republic, France and Germany. At the same time, the general trend of consumption in Europe and the US is a gradual decline in alcohol consumption (in litres of pure alcohol) since the 1980s, with the trend more manifest in Europe than in the US. Strong drinks are being replaced with lighter ones. Thus, for example, in the period between 1988 and 1998 consumption of spirits in Italy dropped by 50%, consumption of wine by 18% while consumption of beer increased by 15%. In Great Britain consumption of spirits and beer dropped by 28% and 17% respectively while wine consumption increased by a third (27%). During the same period in Europe as a whole consumption of spirits dropped by 23.2%, consumption of wine dropped by 3.6%, while consumption of beer increased by 3.6%3. Similar trends have been noted not only in developed countries. Thus in the majority of Latin American countries consumption of alcohol is going down and consumption of beer is going up.

For Russia the experience of North European countries where consumption patterns are historically similar to Russia is of the greatest interest. Figs. 3 and 4 show the dynamics of aggregate registered consumption of alcohol, beer, spirits and wine in Iceland, Finland, Norway and Sweden. As seen from the charts, all these countries witnessed dramatic changes in the structure of alcohol consumption in the 1980s and 1990s. The consumption of spirits dropped significantly: by 1.5 litres of pure alcohol per person in Norway, by 2 litres in Iceland and Finland and by almost 3 litres in Sweden. At the same time the total consumption of alcohol has not diminished and has actually grown a little because the consumption of spirits has been replaced with the consumption of beer and wine. As a result these countries moved from the group of countries with predominant consumption of strong spirits to countries with predominant consumption of beer.

Fig. 3. Aggregate (registered) consumption of alcohol in Iceland (left) and Finland (right), consumption of beer, strong spirits and wine. Litres of pure alcohol per capita of 15 + per year.

<sup>3</sup> The calculations use data not from all the European countries, but from countries with larger populations (Belgium, Great Britain, France, Germany, Spain, Italy, Poland, the Czech Republic, Portugal and Switzerland).

<sup>1970</sup> <sup>1980</sup> <sup>1990</sup> <sup>2000</sup> <sup>2010</sup> Years

Fig. 6. Standardized coefficients of death from ischemic heart disease chronic diseases per

On the whole aggregate alcohol consumption in Russia, although higher than in developed countries, is not so much higher as to explain the differences in mortality rate and life expectancy. It is true that the rate of alcohol-related deaths per litre consumed in Russia is substantially higher than similar indicators in Western Europe. The main reasons for that, as noted by scholars (e.g., Nemtsov, 2009) are the specific structure of consumption (a larger share of strong drinks), the northern type of alcohol consumption (large doses within a short time), the low standard of healthcare (especially the treatment of drug and alcohol addiction) as well as the traditional neglect of Russian people of their

As noted above, the type of consumption is a key characteristic of alcohol consumption (no less important than the amounts). The pattern of consumption is determined by the type of drinks in terms of strength and quality and the time and places when and where alcohol is consumed. Epidemiological studies in various countries show that the risk of cardiovascular diseases among those who drink a glass of wine a day is on average 32% less than among those who do not drink at all. A similar indicator for beer is 22% (Di Castelnuovo et al, 2002). Nemtsov (2009) notes that the impact of the pattern of consumption on the nation's health has been poorly studied by Russian narcologists. At the same time studies in other countries note that the "ideal structure" of alcohol consumption – the ratio that minimizes negative consequences – is consumption in which beer accounts for 50%, wine for 35% and spirits for 15% (Edwards et al., 1994). In 2002, according to official alcohol sales figures (that do not take into account illicit alcohol)

Russia

France

**3. Structure of alcohol consumption: frequency, volumes, beverages** 

0

*Source:* European health for all database, 2011

1000 persons in France and Russia.

state of health.

50

100

SDR per 1000

150

Fig. 4. Aggregate (registered) consumption of alcohol in Norway (left) and Sweden (right), consumption of beer, strong alcoholic beverages and wine. Litres of pure alcohol per capita of 15 + per year.

Changes in the structure of consumption, while not the only cause of increased life expectancy in the North European countries, have undoubtedly had a positive impact on bringing down the death rate and increasing life expectancy in these countries (see Fig.1). The change in the structure of alcohol consumption in Northern Europe has been the result of a massive, large-scale and sustained anti-alcohol policy in these countries. These measures will be discussed in more detail in Section 5.

It has to be noted that the switch from predominant consumption of spirits (hard liquor) to the consumption of beer or wine does not in itself guarantee lower risks of death. Another crucial factor is the frequency and volumes of alcohol consumption. Thus, France, which is traditionally a wine-drinking nation (Fig.5) has managed to reduce alcohol consumption almost by half between the 1960s and 2000 due to the reduction of wine consumption. The drop in consumption reduced the deaths from cardiovascular diseases (Fig.6). At the same time growing alcohol consumption, above all of spirits, in Russia has resulted in a growing death rate from these diseases.

Fig. 5. Total (registered) alcohol consumption in France (left) and Russia (right), consumption of beer, strong alcoholic beverages and wine. Litres of pure alcohol per capita of 15 + per year.

0

Fig. 4. Aggregate (registered) consumption of alcohol in Norway (left) and Sweden (right), consumption of beer, strong alcoholic beverages and wine. Litres of pure alcohol per capita

Changes in the structure of consumption, while not the only cause of increased life expectancy in the North European countries, have undoubtedly had a positive impact on bringing down the death rate and increasing life expectancy in these countries (see Fig.1). The change in the structure of alcohol consumption in Northern Europe has been the result of a massive, large-scale and sustained anti-alcohol policy in these countries. These

It has to be noted that the switch from predominant consumption of spirits (hard liquor) to the consumption of beer or wine does not in itself guarantee lower risks of death. Another crucial factor is the frequency and volumes of alcohol consumption. Thus, France, which is traditionally a wine-drinking nation (Fig.5) has managed to reduce alcohol consumption almost by half between the 1960s and 2000 due to the reduction of wine consumption. The drop in consumption reduced the deaths from cardiovascular diseases (Fig.6). At the same time growing alcohol consumption, above all of spirits, in Russia has resulted in a growing

> 0

Fig. 5. Total (registered) alcohol consumption in France (left) and Russia (right),

consumption of beer, strong alcoholic beverages and wine. Litres of pure alcohol per capita

Source:

5

Litres of pure alcohol

10

15

1960 1970 1980 1990 2000 2010 Year Total Beer Wine Spirits

<sup>1960</sup> <sup>1970</sup> <sup>1980</sup> <sup>1990</sup> <sup>2000</sup> <sup>2010</sup> Year Total Beer Wine Spirits

World Drink Trends (WDT) 1963-1999; Russia Federal State Statistical Service 2000-2008

Source: World Drink Trends (WDT) 1961-1998; Norwegian Institute for Health & Welfare (STAKES) 1999-2006

2

4

Litres of pure alcohol

6

8

0

Statistics Norway 1981-2008

death rate from these diseases.

Source:

of 15 + per year.

Litres of pure alcohol

of 15 + per year.

<sup>1960</sup> <sup>1970</sup> <sup>1980</sup> <sup>1990</sup> <sup>2000</sup> <sup>2010</sup> Year Total Beer Wine Spirits Source: World Drink Trends (WDT) 1961-1966; Norwegian Institute for Alcohol and Drug Research (SIRUS) 1967-1980;

measures will be discussed in more detail in Section 5.

<sup>1960</sup> <sup>1970</sup> <sup>1980</sup> <sup>1990</sup> <sup>2000</sup> <sup>2010</sup> Year Total Beer Wine Spirits

World Drink Trends (WDT) 1961-1999; merged data (ISEE + OIV for wine) 2000-2006

2

4

Litres of pure alcohol

6

8

*Source:* European health for all database, 2011

Fig. 6. Standardized coefficients of death from ischemic heart disease chronic diseases per 1000 persons in France and Russia.

On the whole aggregate alcohol consumption in Russia, although higher than in developed countries, is not so much higher as to explain the differences in mortality rate and life expectancy. It is true that the rate of alcohol-related deaths per litre consumed in Russia is substantially higher than similar indicators in Western Europe. The main reasons for that, as noted by scholars (e.g., Nemtsov, 2009) are the specific structure of consumption (a larger share of strong drinks), the northern type of alcohol consumption (large doses within a short time), the low standard of healthcare (especially the treatment of drug and alcohol addiction) as well as the traditional neglect of Russian people of their state of health.

#### **3. Structure of alcohol consumption: frequency, volumes, beverages**

As noted above, the type of consumption is a key characteristic of alcohol consumption (no less important than the amounts). The pattern of consumption is determined by the type of drinks in terms of strength and quality and the time and places when and where alcohol is consumed. Epidemiological studies in various countries show that the risk of cardiovascular diseases among those who drink a glass of wine a day is on average 32% less than among those who do not drink at all. A similar indicator for beer is 22% (Di Castelnuovo et al, 2002). Nemtsov (2009) notes that the impact of the pattern of consumption on the nation's health has been poorly studied by Russian narcologists. At the same time studies in other countries note that the "ideal structure" of alcohol consumption – the ratio that minimizes negative consequences – is consumption in which beer accounts for 50%, wine for 35% and spirits for 15% (Edwards et al., 1994). In 2002, according to official alcohol sales figures (that do not take into account illicit alcohol)

0

Fig. 8. Consumption of alcohol in Russia: by income group (left) and educational group

share of non-drinkers in the 18-24 age group increased from 14.4% to 20.4%.

20.4%

group (right). Percentage of total number of respondents in age groups.

29.7%

The share of abstainers (those who do not drink any alcohol) in the 18-24 and 14-16 age groups is shown in Fig.9. Among teenagers aged 14-16 about 25% consume alcohol and 75% are abstainers. The share of those who do not consume alcohol has grown somewhat in recent years. A similar trend of growing abstinence is revealed in the 18-24 age group: among women that share increased from 23% in 2006 to almost 30% in 2008; among men the

Source: RLMS,2006-2008

64.6%

Source: RLMS,2006-2008

0

Fig. 9. Share of abstainers (non-drinkers) in Russia: 18-24 age group (left) and 14-16 age

The share of drinkers in different age groups is an important but not the only characteristic of a nation's alcohol consumption. Thus, in France, which has managed to diminish total alcohol consumption in recent years, more than 90% of the adult population and nearly 80% of persons aged 17-19 consume alcohol (WHO Global Status Report on Alcohol, 2004).

20

40

60

80

69.2%

General Primary vocational Secondary vocational Higher professional

77.2% 74.9% 73.3% 75.7%

2006 2007 2008

Males Females

Share (%) of abstainers in Russia among teenagers aged 16-18, 2006-2008

Consumption of any alcoholic beverages: by education group

20

40

Share of those who have consumed alcohol

(in % of respondents)

60

80

0

Source: RLMS,2006-2008

14.4%

Source: RLMS,2006-2008

0

10

20

30

23.2%

18.8%

2006 2007 2008

Males Females

26.5%

Share (%) of abstainers in Russia among citizens aged 18-24, 2006-2008

(right). Percentage of total answers.

Low income 2 3 4 High income

Consumption of any alcoholic beverages: by income group

20

40

Share of those who have consumed alcohol

(in % of respondents)

60

strong beverages accounted for 35% of the total consumption. The figure is obviously grossly understated because it does not take into account illicit production (both industrial and domestic).

The Russian Longitudinal Monitoring Survey (RLMS-HSE) makes it possible to analyze the structure of alcohol consumption by Russian households on the basis of respondents' answers4. According to the RLMS-HSE, about three quarters of the adult Russian population consume some kind of alcohol (Fig.7). The figure of drinkers is higher among males in all the age groups. The share of alcohol consumption is higher in the main age groups and a little lower in the 18-25 age group and among over 55s.

Fig. 7. Alcohol consumption in Russia5: total (left) and men and women by age groups (right). Percentage of total number of respondents.

It has to be noted that the share of alcohol drinkers is higher in groups with higher incomes and among those who have finished vocational training schools (PTU) or have higher education, although the difference in consumption depending on education is not great (Fig.8).

<sup>4</sup> RLMS-HSE is a nationally representative longitudinal survey of Russian households conducted since 1992 by the Demoscope Centre, the RAS Sociology Institute and the University of North Carolina at Chapel Hill (USA) Population Center. The National Research University Higher School of Economics (Moscow) joined the group in 2008. Cooperation with the top world centers for the study of the behavior of households in forming the sample, developing the questionnaire, recruiting and training interviewers earned this study a high degree of trust among Russian and foreign scholars and decision-makers. The RLMS-HSE data are nationally representative and are based on a survey of more than 4,000 households per year which amounts to more than 10,000 adults per year. The sample is from a two-stage random draw of dwellings from the population from the micro census of 1989. The dwellings are surveyed each year with some additional dwellings added in the later periods of the survey to meet the national representation criteria (http://www.cpc.unc.edu/projects/rlms-hse). 5 Respondents were asked whether they had consumed any alcohol (including beer) in the last 30 days.

strong beverages accounted for 35% of the total consumption. The figure is obviously grossly understated because it does not take into account illicit production (both

The Russian Longitudinal Monitoring Survey (RLMS-HSE) makes it possible to analyze the structure of alcohol consumption by Russian households on the basis of respondents' answers4. According to the RLMS-HSE, about three quarters of the adult Russian population consume some kind of alcohol (Fig.7). The figure of drinkers is higher among males in all the age groups. The share of alcohol consumption is higher in the main age groups and a

> 0

Fig. 7. Alcohol consumption in Russia5: total (left) and men and women by age groups

It has to be noted that the share of alcohol drinkers is higher in groups with higher incomes and among those who have finished vocational training schools (PTU) or have higher education, although the difference in consumption depending on education is not great

4 RLMS-HSE is a nationally representative longitudinal survey of Russian households conducted since 1992 by the Demoscope Centre, the RAS Sociology Institute and the University of North Carolina at Chapel Hill (USA) Population Center. The National Research University Higher School of Economics (Moscow) joined the group in 2008. Cooperation with the top world centers for the study of the behavior of households in forming the sample, developing the questionnaire, recruiting and training interviewers earned this study a high degree of trust among Russian and foreign scholars and decision-makers. The RLMS-HSE data are nationally representative and are based on a survey of more than 4,000 households per year which amounts to more than 10,000 adults per year. The sample is from a two-stage random draw of dwellings from the population from the micro census of 1989. The dwellings are surveyed each year with some additional dwellings added in the later periods of the survey to meet the national representation criteria (http://www.cpc.unc.edu/projects/rlms-hse).

5 Respondents were asked whether they had consumed any alcohol (including beer) in the last

Source: RLMS,2006-2008

<25 25-39 40-55 55+ Males Females Males Females Males Females Males Females

Alcohol consumption among males and females, age groups

20

40

Share of those who have consumed alcohol

(in % of respondents)

60

80

industrial and domestic).

78.4%

2008

72.7%

21.6%

27.3%

Sourse: RLMS,2006-2008

(Fig.8).

30 days.

little lower in the 18-25 age group and among over 55s.

2006 2007

Alcohol consumption in Russia by people over 18 in 2006-2008

Drink alcohol Do not drink alcohol

(right). Percentage of total number of respondents.

75.0%

25.0%

Fig. 8. Consumption of alcohol in Russia: by income group (left) and educational group (right). Percentage of total answers.

The share of abstainers (those who do not drink any alcohol) in the 18-24 and 14-16 age groups is shown in Fig.9. Among teenagers aged 14-16 about 25% consume alcohol and 75% are abstainers. The share of those who do not consume alcohol has grown somewhat in recent years. A similar trend of growing abstinence is revealed in the 18-24 age group: among women that share increased from 23% in 2006 to almost 30% in 2008; among men the share of non-drinkers in the 18-24 age group increased from 14.4% to 20.4%.

Fig. 9. Share of abstainers (non-drinkers) in Russia: 18-24 age group (left) and 14-16 age group (right). Percentage of total number of respondents in age groups.

The share of drinkers in different age groups is an important but not the only characteristic of a nation's alcohol consumption. Thus, in France, which has managed to diminish total alcohol consumption in recent years, more than 90% of the adult population and nearly 80% of persons aged 17-19 consume alcohol (WHO Global Status Report on Alcohol, 2004).

education may indicate a replacement of these drinks with wine among the better educated

0

A comparison of the frequency of alcohol consumption in Russia and some West European countries (Table 1) shows a similarity with Finland and Sweden. Indeed, the percentage of men who frequently consume alcohol (every day or 4-5 times a week) is 6.3% in Russia, 8% in Finland and 7% in Sweden. A further 35% of Russian men drink once or 2-3 times a week. Similar figures are reported in Sweden (40%) and Finland (50%). Russian women do not drink more frequently than women in the Nordic countries. This type of consumption contrasts with consumption in the southern countries: in Italy, for example, 45% of men and 30% of women drink (usually wine) every day or 4-5 times a week. The figures for France

Fig. 11. Structure of alcohol consumption in Russia: by income group (left) and by

2-3 times a week

Once a week

Finland 4 4 20 32 19 7 8 6 France 21 5 19 23 7 5 6 13 Germany 12 6 24 18 11 11 7 12 Italy 42 3 17 14 4 4 6 11 Sweden 3 4 16 24 23 12 12 7 UK 9 16 31 18 8 4 4 11 Russia (RLMS) 2.8 3.5 15.4 19.6 20.3 8.4 n.a. 30

Finland 2 2 7 22 22 14 24 8 France 9 3 10 16 9 12 14 27 Germany 5 2 13 20 15 10 17 18 Italy 26 4 10 12 8 4 14 22 Sweden 1 1 5 17 2 17 23 13 UK 5 6 18 22 12 10 11 14 Russia (RLMS) 0.5 0.5 3.5 10 20.5 15 n.a. 50

Table 1. Frequency (%) of alcohol consumption, West Europe and Russia, men and women

*Source:* Alcohol in post-war Europe (2001), Table 5.1, p. 107 for Western Europe and authors'

2-3 times a month

Once a month

Once or several times a year

Do not drink

educational group (right). Percentage of total number of drinkers.

4-5 times a week

Source: RLMS,2006-2008

General Primary vocational Secondary vocational Higher professional

Beer Dry wine Fortified wine Home made liquor

Vodka

Structure of alcohol consumption by education groups

20

40

Percentage of total number of drinkers

60

groups.

0

*Males:*

*Females:*

calculations for Russia

Source: RLMS,2006-2008

Low income 2 3 4 High income

Beer Dry wine Fortified wine Home made liquor

Vodka

are 26% for men and 11% for women.

Every day

Structure of alcohol consumption: income categories

20

40

Percentage of total number of drinkers

60

80

However, the fact that the overwhelming majority drink dry wine, and then in small or medium doses, puts France in an upward trend in terms of life expectancy. Russia is still characterized by the predominant consumption on strong alcoholic beverages.

The structure of alcohol consumption in Russia as reflected in the share of those who consume this or that type of drink, is shown in Fig.10. As seen from the charts, in Russia about 70% of men and nearly 50% of women drink beer. The next most popular drink is vodka and other strong spirits, consumed by more than 60% of men and 37% of women. About 12% of men and 5% of women drink home-made alcohol. About 40% of women and 11% of men drink dry wine or champagne. Thus, the most popular alcoholic beverages in Russia are vodka and home-produced alcohol, on the one hand, and beer on the other. At the same time, if one recalls Fig.2 which shows total consumption of beer and spirits in Russia in litres of pure alcohol, the absolute predominance of vodka cannot be disputed, whereas beer and wine account for only a small share of total alcohol consumption. This indicates the type of consumption: vodka is drunk more frequently and in larger quantities whereas beer and wine is drunk less frequently and in smaller quantities.

Fig. 10. Structure of alcohol consumption in Russia: by gender (left) and by age groups (right). Percentage of total number of drinkers.

It is notable that the consumption of beer, on the one hand, and of vodka and home brewed alcohol on the other reveals substantial differences by age group (Fig.10, right-hand side). Indeed, the distribution of beer consumers is tilted towards younger age groups whereas consumption of vodka is more characteristic of older age groups. This picture may attest to the beginnings of change in the pattern of consumption and a shift from predominantly strong alcoholic beverages towards beer. Whether the trend turns out to be sustained remains to be seen.

The structures of alcohol consumption by income groups and education are shown in Fig.11. The share of vodka and beer in the structure of consumption in different income groups is approximately the same, with beer consumption slightly higher in the lower-income groups. At the same time there is a marked trend of increased share of those who drink wine and champagne in the higher-income groups. Thus in the first (lowest) quantile only 16% of alcohol consumers drink wine and in the fifth (top) quantile the percentage is 31%. Similarly the consumption of wine and champagne is more common among people with a higher level of education. The lower share of vodka and beer drinkers in the groups with a higher

However, the fact that the overwhelming majority drink dry wine, and then in small or medium doses, puts France in an upward trend in terms of life expectancy. Russia is still

The structure of alcohol consumption in Russia as reflected in the share of those who consume this or that type of drink, is shown in Fig.10. As seen from the charts, in Russia about 70% of men and nearly 50% of women drink beer. The next most popular drink is vodka and other strong spirits, consumed by more than 60% of men and 37% of women. About 12% of men and 5% of women drink home-made alcohol. About 40% of women and 11% of men drink dry wine or champagne. Thus, the most popular alcoholic beverages in Russia are vodka and home-produced alcohol, on the one hand, and beer on the other. At the same time, if one recalls Fig.2 which shows total consumption of beer and spirits in Russia in litres of pure alcohol, the absolute predominance of vodka cannot be disputed, whereas beer and wine account for only a small share of total alcohol consumption. This indicates the type of consumption: vodka is drunk more frequently and in larger quantities

> 0

Fig. 10. Structure of alcohol consumption in Russia: by gender (left) and by age groups

It is notable that the consumption of beer, on the one hand, and of vodka and home brewed alcohol on the other reveals substantial differences by age group (Fig.10, right-hand side). Indeed, the distribution of beer consumers is tilted towards younger age groups whereas consumption of vodka is more characteristic of older age groups. This picture may attest to the beginnings of change in the pattern of consumption and a shift from predominantly strong alcoholic beverages towards beer. Whether the trend turns out to be sustained

The structures of alcohol consumption by income groups and education are shown in Fig.11. The share of vodka and beer in the structure of consumption in different income groups is approximately the same, with beer consumption slightly higher in the lower-income groups. At the same time there is a marked trend of increased share of those who drink wine and champagne in the higher-income groups. Thus in the first (lowest) quantile only 16% of alcohol consumers drink wine and in the fifth (top) quantile the percentage is 31%. Similarly the consumption of wine and champagne is more common among people with a higher level of education. The lower share of vodka and beer drinkers in the groups with a higher

Source: RLMS,2006-2008

<25 25-39 40-55 55+

Beer Dry wine Fortified wine Home made liquor

Vodka

Structure of alcohol consumption by agegroup

20

40

Percentage of total number of drinkers

60

80

characterized by the predominant consumption on strong alcoholic beverages.

whereas beer and wine is drunk less frequently and in smaller quantities.

Males Females

Beer Dry wine Fortified wine Home made liquor

(right). Percentage of total number of drinkers.

Vodka

Structure of alcohol consumption: males and females

0

Source: RLMS,2006-2008

remains to be seen.

20

40

Percentage of total number of drinkers

60

80

education may indicate a replacement of these drinks with wine among the better educated groups.

Fig. 11. Structure of alcohol consumption in Russia: by income group (left) and by educational group (right). Percentage of total number of drinkers.

A comparison of the frequency of alcohol consumption in Russia and some West European countries (Table 1) shows a similarity with Finland and Sweden. Indeed, the percentage of men who frequently consume alcohol (every day or 4-5 times a week) is 6.3% in Russia, 8% in Finland and 7% in Sweden. A further 35% of Russian men drink once or 2-3 times a week. Similar figures are reported in Sweden (40%) and Finland (50%). Russian women do not drink more frequently than women in the Nordic countries. This type of consumption contrasts with consumption in the southern countries: in Italy, for example, 45% of men and 30% of women drink (usually wine) every day or 4-5 times a week. The figures for France are 26% for men and 11% for women.


*Source:* Alcohol in post-war Europe (2001), Table 5.1, p. 107 for Western Europe and authors' calculations for Russia

Table 1. Frequency (%) of alcohol consumption, West Europe and Russia, men and women

<sup>1</sup> <sup>2</sup> <sup>3</sup> <sup>4</sup> <sup>5</sup> <sup>6</sup> <sup>7</sup> <sup>8</sup> <sup>9</sup> <sup>10</sup> Deciles

Every day 4-6 times a week2-3 times a week Once a week 2-3 times a month Once a month

Fig. 14. Structure of alcohol consumption by frequency (% of those who drank alcohol).

This section presents the results of the estimates of the impact of alcohol consumption on the health and risk of death in Russia based on the data of the Russian Longitudinal Monitoring

**4. The impact of alcohol consumption on health and risk of death** 

Vodka only Vodka and homemade liqour Vodka and wine Vodka, wine and beer Vodka and beer Beer only Beer and wine Wine only Other

Beer Vodka

*Source:* Authors calculations based on RLMS-HSE, 2005 using Andrienko and Nemtsov, 2005 approach. Fig. 13. Structure of alcohol consumption by income groups in Russia (1 – the poorest, 10 –

Structure of alcohol consumption by frequency

Other Home-made liquor Wine

the richest), ml ethanol a day

0

Source: RLMS,2006-2008

20

40

60

Percentage of total number of drinkers

80

100

ml of ethanol a day

The frequency of alcohol consumption hardly varies in different income groups and varies only slightly by education group (Fig.12). The better educated drink less frequently: the share of those who drink every day or 4-6 times a week among graduates of vocational training schools is 7% and among graduates of secondary professional schools and higher education institutions 4%. The number of those who drink 2-3 times a month is 5% higher among university graduates: 37% versus 32% among graduates of vocational secondary schools. These differences reflect more moderate alcohol consumption among women who happen to be better educated.

Fig. 12. Frequency of alcohol consumption in Russia: by income group (left) and by education group (right). Percentage of total number of drinkers.

Differences in the structure of alcohol types and frequency of consumption manifest themselves in differences in the average quantity of ml of ethanol consumed. The differences in the average daily consumption of ethanol between different income groups are shown in Fig.13. As seen from the chart, consumption of ethanol is the highest in the first three income groups (the poorest) which is due to the prevalence of the consumption of vodka and home brewed alcohol in these groups. At the same time the high income groups in the 8th, 9th and 10th deciles show a high consumption of ethanol comparable to the 3rd and 4th income groups, which is a consequence of the high consumption of vodka in top deciles.

The structure of alcoholic drinks consumption by frequency is shown in Fig. 14. As seen from the chart, the prevalent type of alcohol consumption in Russia is the drinking of vodka separately or in combination with other drinks. This type of consumption is more pronounced among frequent drinkers: almost 60% of those who drink every day or 4-6 times a week drink vodka, separately or in combination with other drinks. Among those who drink less frequently vodka drinkers account for more than half. At the same time it is noticeable that the share of those who drink wine and beer, but do not drink vodka is higher among the groups of infrequent drinkers (once a year or 2-3 times a month) than among other groups.

The frequency of alcohol consumption hardly varies in different income groups and varies only slightly by education group (Fig.12). The better educated drink less frequently: the share of those who drink every day or 4-6 times a week among graduates of vocational training schools is 7% and among graduates of secondary professional schools and higher education institutions 4%. The number of those who drink 2-3 times a month is 5% higher among university graduates: 37% versus 32% among graduates of vocational secondary schools. These differences reflect more moderate alcohol consumption among women who

> 0

Fig. 12. Frequency of alcohol consumption in Russia: by income group (left) and by

Differences in the structure of alcohol types and frequency of consumption manifest themselves in differences in the average quantity of ml of ethanol consumed. The differences in the average daily consumption of ethanol between different income groups are shown in Fig.13. As seen from the chart, consumption of ethanol is the highest in the first three income groups (the poorest) which is due to the prevalence of the consumption of vodka and home brewed alcohol in these groups. At the same time the high income groups in the 8th, 9th and 10th deciles show a high consumption of ethanol comparable to the 3rd and 4th income groups, which is a consequence of the high consumption of vodka

The structure of alcoholic drinks consumption by frequency is shown in Fig. 14. As seen from the chart, the prevalent type of alcohol consumption in Russia is the drinking of vodka separately or in combination with other drinks. This type of consumption is more pronounced among frequent drinkers: almost 60% of those who drink every day or 4-6 times a week drink vodka, separately or in combination with other drinks. Among those who drink less frequently vodka drinkers account for more than half. At the same time it is noticeable that the share of those who drink wine and beer, but do not drink vodka is higher among the groups of infrequent drinkers (once a year or 2-3 times a month) than among

Source: RLMS,2006-2008

General Primary vocational Secondary vocational Higher professional

Every day 4-6 times a week 2-3 times a week Once a week 2-3 times a month Once a month

Frequency of alcohol consumption by education group

10

20

Percentage of total number of drinkers

30

40

happen to be better educated.

Low income 2 3 4 High income

Every day 4-6 times a week 2-3 times a week Once a week 2-3 times a month Once a month

education group (right). Percentage of total number of drinkers.

Frequency of alcohol consumption: income groups

0

Source: RLMS,2006-2008

in top deciles.

other groups.

10

20

Percentage of total number of drinkers

30

40

Fig. 14. Structure of alcohol consumption by frequency (% of those who drank alcohol).

#### **4. The impact of alcohol consumption on health and risk of death**

This section presents the results of the estimates of the impact of alcohol consumption on the health and risk of death in Russia based on the data of the Russian Longitudinal Monitoring

Self-accessed health Males and females Males Females

Age -0.02 -0.02 -0.021 -0.021 -0.018 -0.018 0.035 0.037 0.032

Married 0.032 0.032 0.031 0.031 0.029 0.029 -0.14 -0.172 -0.12

Junior or secondary professional education -0.01 -0.01 -0.029 -0.029 0.004 0.004 -0.085 -0.063 -0.099

Higher education 0.063 0.063 0.056 0.056 0.057 0.056 -0.211 -0.219 -0.193

Log of real per capita income, 1992 prices 0.022 0.022 0.019 0.019 0.023 0.023 -0.075 -0.088 -0.066

Self-perceived status, respect rank on 9-step ladder 0.027 0.027 0.035 0.036 0.018 0.018 -0.035 -0.053 -0.02

[0.014]\* [0.015] [0.033] Frequent vodka drinker (pure and in mix) -0.029 -0.023 -0.025 0.092 0.084 0.066

Frequent beer drinker (no vodka) 0.002 0.012 0.021 -0.105 -0.122 -0.187

Smokes -0.06 -0.06 -0.041 -0.041 -0.07 -0.071 0.038 -0.024 0.07

Body mass index 0.029 0.029 0.111 0.111 0.007 0.007 -0.064 -0.184 -0.017

Body mass index squared/1000 -0.538 -0.539 -1.891 -1.891 -0.241 -0.241 1.158 2.998 0.503

Unemployed -0.002 -0.002 0.004 0.004 -0.002 -0.002 0.082 0.031 0.1

Urban settlement -0.061 -0.061 -0.062 -0.062 -0.06 -0.06 0.034 0.046 0.026

Constant 3.197 3.196 2.288 2.287 3.575 3.575 -0.87 0.737 -1.705

Year dummies Yes Yes Yes Yes Yes Yes Yes Yes Yes Number of observations 75037 75037 34083 34083 40954 40954 75265 34204 41061 R squared 0.19 0.19 0.17 0.17 0.18 0.18 0.12 0.12 0.12

Age -0.016 -0.016 -0.023 -0.023 -0.01 -0.01 0.004 0.004 0.006 0.003

Married 0.031 0.031 0.038 0.038 0.034 0.034 -0.002 -0.002 -0.006 -0.001

Log of real per capita income, 1992 prices 0.007 0.007 0.006 0.006 0.008 0.008 -0.005 -0.005 -0.005 -0.006

Self-perceived status, respect rank on 9-step ladder 0.01 0.01 0.013 0.013 0.007 0.007 -0.002 -0.002 -0.003 -0.002

Frequent vodka drinker (pure and in mix) -0.028 -0.008 -0.13 0.017 0.01 0.056

Frequent beer drinker (no vodka) 0.017 0.042 -0.037 -0.005 -0.004 -0.015

Smokes -0.011 -0.012 0.01 0.01 -0.048 -0.048 -0.012 -0.012 -0.022 0.003

Body mass index 0.015 0.015 0.052 0.052 0.005 0.005 -0.008 -0.008 -0.021 -0.005

Body mass index squared/1000 -0.15 -0.15 -0.71 -0.711 -0.057 -0.057 0.073 0.073 0.277 0.045

Constant 3.451 3.451 3.252 3.254 3.338 3.338 0.15 0.149 0.262 0.163

Number of observations 75054 75054 34097 34097 40957 40957 75283 75283 34219 41064 Number of individuals (groups) 19026 19026 9025 9025 10002 10002 19056 19056 9043 10014 R squared 0.16 0.16 0.15 0.15 0.16 0.16 0.06 0.06 0.06 0.05

The results of the assessment of the impact of alcohol on risk of death are shown in Table 4. As seen from the table, frequent consumption of alcohol, above all of strong spirits, increases the risk of death. Simple consumption of vodka or beer does not yield a statistically significant effect. Frequent consumption of alcohol increases the risk of death by 60 percentage points. Frequent consumption of vodka increases the risk of death by 66 percentage points whereas

Table 3. Influence of alcohol consumption on health, panel fixed effects, 1994-2007

frequent consumption of beer does not have a statistically significant effect.

[0.013]\*\* [0.015] [0.031]\*\*\* [0.006]\*\*\*

Males and females Males Females Males and females

Frequent alcohol drinker -0.028 -0.008 -0.098 0.017

p , p ,

Table 2. Influence of alcohol consumption on health, pooled cross-section, 1994-2007

[0.006]\*\*\* [0.006]\*\*\* [0.017]\*\*\*

Gender: Males 0.209 0.209 -0.202

Frequent alcohol drinker -0.025 -0.016 -0.021

p p

Standard errors in brackets; \* significant at 10%; \*\* significant at 5%; \*\*\* significant at 1%

Standard errors in brackets; \* significant at 10%; \*\* significant at 5%; \*\*\* significant at 1%

[0.000]\*\*\* [0.000]\*\*\* [0.000]\*\*\* [0.000]\*\*\* [0.000]\*\*\*[0.000]\*\*\* [0.001]\*\*\* [0.001]\*\*\* [0.001]\*\*\*

[0.005]\*\*\* [0.005]\*\*\* [0.009]\*\*\* [0.009]\*\*\* [0.007]\*\*\*[0.007]\*\*\* [0.015]\*\*\* [0.026]\*\*\* [0.019]\*\*\*

[0.006]\* [0.006]\* [0.009]\*\*\* [0.009]\*\*\* [0.007] [0.007] [0.016]\*\*\* [0.026]\*\* [0.020]\*\*\*

[0.008]\*\*\* [0.008]\*\*\* [0.012]\*\*\* [0.012]\*\*\* [0.009]\*\*\*[0.009]\*\*\* [0.022]\*\*\* [0.038]\*\*\* [0.027]\*\*\*

[0.003]\*\*\* [0.003]\*\*\* [0.004]\*\*\* [0.004]\*\*\* [0.004]\*\*\*[0.004]\*\*\* [0.008]\*\*\* [0.012]\*\*\* [0.010]\*\*\*

[0.001]\*\*\* [0.001]\*\*\* [0.002]\*\*\* [0.002]\*\*\* [0.002]\*\*\*[0.002]\*\*\* [0.004]\*\*\* [0.006]\*\*\* [0.005]\*\*\*

[0.006]\*\*\* [0.006]\*\*\* [0.007]\*\*\* [0.007]\*\*\* [0.008]\*\*\*[0.008]\*\*\* [0.017]\*\* [0.024] [0.026]\*\*\*

[0.017]\* [0.017]\* [0.025]\*\*\* [0.025]\*\*\* [0.011] [0.011] [0.003]\*\*\* [0.058]\*\*\* [0.028]

[0.304]\* [0.304]\* [0.468]\*\*\* [0.468]\*\*\* [0.195] [0.195] [0.047]\*\*\* [1.082]\*\*\* [0.452]

[0.011] [0.011] [0.017] [0.017] [0.015] [0.015] [0.032]\*\* [0.052] [0.042]\*\*

[0.005]\*\*\* [0.005]\*\*\* [0.008]\*\*\* [0.008]\*\*\* [0.007]\*\*\*[0.007]\*\*\* [0.015]\*\* [0.023]\*\* [0.019]

[0.230]\*\*\* [0.230]\*\*\* [0.321]\*\*\* [0.321]\*\*\* [0.155]\*\*\*[0.155]\*\*\* [0.084]\*\*\* [0.756] [0.380]\*\*\*

[0.001]\*\*\* [0.001]\*\*\* [0.001]\*\*\* [0.001]\*\*\* [0.001]\*\*\*[0.001]\*\*\*[0.000]\*\*\* [0.000]\*\*\* [0.000]\*\*\* [0.000]\*\*\*

[0.007]\*\*\* [0.007]\*\*\* [0.011]\*\*\* [0.011]\*\*\* [0.008]\*\*\*[0.008]\*\*\* [0.003] [0.003] [0.005] [0.005]

[0.003]\*\* [0.003]\*\* [0.004] [0.004] [0.004]\*\* [0.004]\*\* [0.001]\*\*\* [0.001]\*\*\* [0.002]\*\* [0.002]\*\*\*

[0.001]\*\*\* [0.001]\*\*\* [0.002]\*\*\* [0.002]\*\*\* [0.002]\*\*\*[0.002]\*\*\*[0.001]\*\*\* [0.001]\*\*\* [0.001]\*\*\* [0.001]\*\*

[0.010] [0.010] [0.013] [0.013] [0.014]\*\*\*[0.014]\*\*\*[0.005]\*\*\* [0.005]\*\* [0.006]\*\*\* [0.008]

[0.003]\*\*\* [0.003]\*\*\* [0.008]\*\*\* [0.008]\*\*\* [0.003] [0.003] [0.001]\*\*\* [0.001]\*\*\* [0.003]\*\*\* [0.002]\*\*\*

[0.036]\*\*\* [0.036]\*\*\* [0.130]\*\*\* [0.130]\*\*\* [0.037] [0.037] [0.018]\*\*\* [0.018]\*\*\* [0.056]\*\*\* [0.020]\*\*

[0.050]\*\*\* [0.050]\*\*\* [0.117]\*\*\* [0.117]\*\*\* [0.060]\*\*\*[0.060]\*\*\*[0.025]\*\*\* [0.025]\*\*\* [0.050]\*\*\* [0.033]\*\*\*

[0.015]\* [0.017] [0.039]\*\*\* [0.007]\*\* [0.007] [0.021]\*\*\*

Self-accessed health Bad and very bad health

[0.029] [0.035] [0.059] [0.014] [0.015] [0.032]

[0.017]\* [0.018] [0.043] [0.043]\*\* [0.048]\* [0.113]

[0.031] [0.035] [0.066] [0.101] [0.115] [0.212]

Males and females Males Females

Males Females

Bad and very bad health

Survey. The RLMS-HSE questionnaire contains a wide range of questions characterizing various aspects of the behavior of individuals in the family and in the labor market and detailed information on harmful habits and health indicators. In addition, the longitudinal character of the study makes it possible to trace the behavior trajectories of respondents over many years and to study the causes of death.

The regressions cited below test the impact of frequent alcohol consumption on health (Tables 2 and 3) and the risk of death (Table 4) and separates the overall effect of frequent consumption of alcohol from frequent consumption of vodka (straight or in combination) and divide frequent alcohol consumption into frequent consumption of vodka (straight or mixed) and frequent consumption of beer (separately or mixed with drinks other than vodka). RLMS makes it possible to determine how frequently and what beverages an individual drinks. We have identified a group of those who consume alcohol every day or 4- 6 times a week, calling it "frequent drinkers". In addition we have identified two subgroups among the frequent drinkers: those who drink vodka, separately or in combination with other drinks ("frequent vodka drinkers") and those who drink beer, but do not drink vodka ("frequent beer drinkers").

The health variable used is the person's own assessment of his/ her state of health (very bad, bad, satisfactory, good and very good). We use all the categories as well as define the binary variable: bad and very bad health versus all the other variants. Death is registered in the sample on the basis of the information provided by the household head when the unit is surveyed at least two rounds in a row. A household head is asked to report whether any household member is missing during the survey round and the reason for that member being not in the household. One of the reasons reported is the death of the household member. More details on the measurement and methodology could be found in Denisova (2010).

In all cases we control for gender, age, the respondent's education, per capita household income, place of residence, body mass index and smoking (whether or not the respondent smokes). We also control for the individual's assessment of his own social status on a ninepoint scale ("respected – not respected"). This makes it possible to take into account the impact of constant psychological stress on a person's health and separate that impact from the impact from alcohol consumption.

The impact of alcohol consumption on health is estimated based on pooled cross-section for 1994-2007 (Table 2) and on a panel for the same years (Table 3). The impact of alcohol consumption on the risk of death is estimated with Gompertz proportional hazard model (Table 4).

The results of the estimates of the impact of alcohol consumption on health in Table 2 show that frequent alcohol consumption harms health. Thus, frequent alcohol consumption increases the probability of having bad or very bad health by 7 percentage points. Moreover, frequent alcohol consumption that includes vodka leads to health deterioration (the risk of bad health increases by 9 percentage points) whereas frequent consumption of beer does not have a statistically significant effect on health. The negative impact of frequent alcohol consumption on health is stable regardless of the method of assessment and of control for individual specific recorded effects in particular (Table 3). Frequent alcohol consumption increases the probability of bad or very bad health by 17 percentage points, with the entire effect caused by frequent consumption of vodka.

Survey. The RLMS-HSE questionnaire contains a wide range of questions characterizing various aspects of the behavior of individuals in the family and in the labor market and detailed information on harmful habits and health indicators. In addition, the longitudinal character of the study makes it possible to trace the behavior trajectories of respondents over

The regressions cited below test the impact of frequent alcohol consumption on health (Tables 2 and 3) and the risk of death (Table 4) and separates the overall effect of frequent consumption of alcohol from frequent consumption of vodka (straight or in combination) and divide frequent alcohol consumption into frequent consumption of vodka (straight or mixed) and frequent consumption of beer (separately or mixed with drinks other than vodka). RLMS makes it possible to determine how frequently and what beverages an individual drinks. We have identified a group of those who consume alcohol every day or 4- 6 times a week, calling it "frequent drinkers". In addition we have identified two subgroups among the frequent drinkers: those who drink vodka, separately or in combination with other drinks ("frequent vodka drinkers") and those who drink beer, but do not drink vodka

The health variable used is the person's own assessment of his/ her state of health (very bad, bad, satisfactory, good and very good). We use all the categories as well as define the binary variable: bad and very bad health versus all the other variants. Death is registered in the sample on the basis of the information provided by the household head when the unit is surveyed at least two rounds in a row. A household head is asked to report whether any household member is missing during the survey round and the reason for that member being not in the household. One of the reasons reported is the death of the household member. More

In all cases we control for gender, age, the respondent's education, per capita household income, place of residence, body mass index and smoking (whether or not the respondent smokes). We also control for the individual's assessment of his own social status on a ninepoint scale ("respected – not respected"). This makes it possible to take into account the impact of constant psychological stress on a person's health and separate that impact from

The impact of alcohol consumption on health is estimated based on pooled cross-section for 1994-2007 (Table 2) and on a panel for the same years (Table 3). The impact of alcohol consumption on the risk of death is estimated with Gompertz proportional hazard model

The results of the estimates of the impact of alcohol consumption on health in Table 2 show that frequent alcohol consumption harms health. Thus, frequent alcohol consumption increases the probability of having bad or very bad health by 7 percentage points. Moreover, frequent alcohol consumption that includes vodka leads to health deterioration (the risk of bad health increases by 9 percentage points) whereas frequent consumption of beer does not have a statistically significant effect on health. The negative impact of frequent alcohol consumption on health is stable regardless of the method of assessment and of control for individual specific recorded effects in particular (Table 3). Frequent alcohol consumption increases the probability of bad or very bad health by 17 percentage points, with the entire

details on the measurement and methodology could be found in Denisova (2010).

many years and to study the causes of death.

("frequent beer drinkers").

the impact from alcohol consumption.

effect caused by frequent consumption of vodka.

(Table 4).


#### Table 2. Influence of alcohol consumption on health, pooled cross-section, 1994-2007


#### Table 3. Influence of alcohol consumption on health, panel fixed effects, 1994-2007

The results of the assessment of the impact of alcohol on risk of death are shown in Table 4. As seen from the table, frequent consumption of alcohol, above all of strong spirits, increases the risk of death. Simple consumption of vodka or beer does not yield a statistically significant effect. Frequent consumption of alcohol increases the risk of death by 60 percentage points. Frequent consumption of vodka increases the risk of death by 66 percentage points whereas frequent consumption of beer does not have a statistically significant effect.

The results obtained can be represented as differences in survival functions for those who frequently drink strong alcoholic beverages and those who rarely or never consume strong liquor. Such functions are represented in Fig. 15. As seen from the ratio of the curves, frequent consumption of vodka shortens life by an average 9-10 years. At the same time, as noted above, frequent beer consumption has not yielded a statistically significant result.

Predicted surv iv al f unctions f or binge drinkers

20 30 40 50 60 70 analysis time heavy\_dr=0 heavy\_dr=1

Fig. 15. Predicted survival curves: frequent drinkers of strong liquor (broken line) and infrequent drinkers and non-drinkers (solid line). The forecast is based on estimates

**5. Anti-alcohol policy measures: The experience of European countries** 

Thus, the regression analysis based on longitudinal data makes it possible to isolate the impact of various types of alcohol consumption on the health and mortality controlled for the impact of other groups of factors. Our results attest to a strong negative impact of frequent alcohol consumption on health and the risk of death. Moderate alcohol consumption does not exert a statistically significant effect. In addition, the negative impact of frequent consumption of strong alcoholic beverages is greater than the effect of frequent consumption of wine and beer: frequent consumption of vodka shortens life by an average 9-10 years, whereas no statistically significant impact of frequent beer drinking has been

The experience of the countries of Northern Europe in encouraging people to switch from the consumption of mainly strong alcoholic beverages to lighter ones (beer and wine) shows active use of excise policy measures. Table 5 contains information on excise rates on alcohol, intermediate products, wine and beer in European countries in 2010. As seen from the table, the excise rates in the North European countries are significantly higher than in other countries, and excise on alcohol is 2-4 times higher than excise on beer (in liters of pure alcohol). In some other European countries the gap between excise on spirits and beer is sixfold, although excise is much lower than in the North European countries in absolute terms.

.8

presented in Table 3.

revealed.

.85

.9

Survival

.95

1


Table 4. Determinants of mortality, working age population, 18-65, parametric Gompertz regression

Household in poverty: the 1st poverty episode 0.86 0.853 0.86 0.854

Household in poverty: the 2nd, 3d, ... poverty episodes 1.373 1.338 1.369 1.343

Consumption decile (within year) 0.981 0.98 0.98 0.975

Economic rank on 9-step ladder 0.973 0.97 0.972 0.971

Respect rank on 9-step ladder 0.947 0.945 0.946 0.947

Concern about getting necessities 1.088 1.065 1.083 1.077

Smokes 1.582 1.577 1.584 1.563

Frequent alcohol drinker 1.594 1.514

Vodka/hard liquids drinker 1.142 1.117

Beer drinker 1.021 0.999

Relative price of vodka to bread in locality 1.015 1.015 1.015 1.015

Unemployed 1.495 1.503 1.498 1.498

Experience as entrepreneur/self-employed 0.472 0.472 0.471 0.472

Mobile in labor market 0.488 0.493 0.489 0.492

Could not afford or find prescribed medicine 1.179 1.144 1.174 1.149

Gender: Males 3.478 3.484 3.481 3.434

Married 1.081 1.07 1.077 1.073

Family size, number of people in family 1.161 1.163 1.161 1.163

Children in family 0.769 0.754 0.769 0.753

Junior or secondary professional 0.847 0.836 0.852 0.839

University degree or higher 0.649 0.647 0.652 0.649

Urban settlement 0.758 0.744 0.755 0.743

*Gompertz function coefficients* 0.053 0.053 0.053 0.053

Observations 70715 70513 70715 70513 No. of subjects 17606 17596 17606 17596 No. of failures 420 418 420 418 Log Pseudolikelihood -603.07 -602.64 -603.24 -600.36

Table 4. Determinants of mortality, working age population, 18-65, parametric Gompertz

*Health undicators* Yes\*\*\* Yes\*\*\*

Robust standard errors in brackets; \* significant at 10%; \*\* significant at 5%; \*\*\* significant at 1%

Frequent vodka drinker 1.663

Frequent beer drinker 1.243

*Economic well-being*

*Self-perceived status*

*Stress indicator*

*Alchohol availability*

*Labor market experience*

*Health care accessibility*

regression

*Social and individual human capital*

Education: secondary school and below - reference category

*Habits*

(1) (2) (3) (4)

[0.045]\*\*\* [0.045]\*\*\* [0.045]\*\*\* [0.045]\*\*\*

[0.227]\* [0.230]\* [0.226]\* [0.232]\*

[0.154] [0.155] [0.155] [0.154]

[0.035] [0.035] [0.035] [0.035]

[0.023]\*\* [0.023]\*\* [0.023]\*\* [0.023]\*\*

[0.113] [0.112] [0.112] [0.113]

[0.193]\*\*\* [0.191]\*\*\* [0.193]\*\*\* [0.188]\*\*\*

[0.282]\*\*\* [0.273]\*\*

[0.011] [0.011] [0.011] [0.011] (1) (2) (3) (4)

[0.363]\* [0.361]\* [0.365]\* [0.363]\*

[0.182]\* [0.182]\* [0.181]\* [0.182]\*

[0.087]\*\*\* [0.087]\*\*\* [0.087]\*\*\* [0.087]\*\*\*

[0.264] [0.269] [0.262] [0.270]

[0.453]\*\*\* [0.476]\*\*\* [0.453]\*\*\* [0.466]\*\*\*

[0.114] [0.114] [0.114] [0.115]

[0.041]\*\*\* [0.042]\*\*\* [0.041]\*\*\* [0.042]\*\*\*

[0.112]\* [0.110]\* [0.112]\* [0.111]\*

[0.087] [0.087]\* [0.089] [0.087]\*

[0.123]\*\* [0.124]\*\* [0.124]\*\* [0.124]\*\*

[0.072]\*\*\* [0.076]\*\*\* [0.071]\*\*\* [0.076]\*\*\*

[0.004]\*\*\* [0.004]\*\*\* [0.004]\*\*\* [0.004]\*\*\*

[0.123] [0.124]

[0.136] [0.132]

[0.324]\*\*\*

[0.726]

The results obtained can be represented as differences in survival functions for those who frequently drink strong alcoholic beverages and those who rarely or never consume strong liquor. Such functions are represented in Fig. 15. As seen from the ratio of the curves, frequent consumption of vodka shortens life by an average 9-10 years. At the same time, as noted above, frequent beer consumption has not yielded a statistically significant result.

Fig. 15. Predicted survival curves: frequent drinkers of strong liquor (broken line) and infrequent drinkers and non-drinkers (solid line). The forecast is based on estimates presented in Table 3.

Thus, the regression analysis based on longitudinal data makes it possible to isolate the impact of various types of alcohol consumption on the health and mortality controlled for the impact of other groups of factors. Our results attest to a strong negative impact of frequent alcohol consumption on health and the risk of death. Moderate alcohol consumption does not exert a statistically significant effect. In addition, the negative impact of frequent consumption of strong alcoholic beverages is greater than the effect of frequent consumption of wine and beer: frequent consumption of vodka shortens life by an average 9-10 years, whereas no statistically significant impact of frequent beer drinking has been revealed.

#### **5. Anti-alcohol policy measures: The experience of European countries**

The experience of the countries of Northern Europe in encouraging people to switch from the consumption of mainly strong alcoholic beverages to lighter ones (beer and wine) shows active use of excise policy measures. Table 5 contains information on excise rates on alcohol, intermediate products, wine and beer in European countries in 2010. As seen from the table, the excise rates in the North European countries are significantly higher than in other countries, and excise on alcohol is 2-4 times higher than excise on beer (in liters of pure alcohol). In some other European countries the gap between excise on spirits and beer is sixfold, although excise is much lower than in the North European countries in absolute terms.

The effectiveness of the use of price mechanisms to limit alcohol consumption depends on how price-elastic demand for alcoholic beverages is. Assessments of the elasticity of demand for alcoholic beverages in the European countries and Russia will be found in Table 6.

Finland, Sweden, Norway -0.782 0.752

and Spain -0.216 0.752

Belgium, Denmark, Ireland, UK -0.495 0.752

Netherlands -1.466 0.752

 Vodka -1.774 0.524 Beer -3.017 1.114 Wine -1.045 1.304

Table 6. Elasticity of demand for alcoholic beverages in the countries of Europe and Russia

As seen from the table the assessment of the elasticity of demand for vodka, beer and wine depending on price in Russia is much higher than the same indicators for the European countries and is comparable to the elasticity of demand in the Netherlands. This suggests that price measures of influencing alcohol consumption – increasing excise on strong beverages in order to encourage people to switch to types of alcohol consumption that cause less harm to health – can be effective. In Russia the experience of the past decades has revealed a relative cheapening of vodka. Thus in the late 1980s the ratio of vodka and beer prices was such that one could buy nine bottles of beer for the price of one bottle of vodka. At present it can buy on average 3-4 bottles of beer (and some vodkas are even cheaper).

Along with price measures, an effective anti-alcohol policy must include other measures: the system of control of the production and sale of alcohol, restriction of the sale of alcohol outside restaurants, bars, etc., restrictions on the minimum age of the customer to whom alcohol can be sold, restrictions on alcohol advertising, on sponsorship of sporting and youth events, and on consumption of alcohol in public places. All the European countries, and not only the northern ones, have significantly strengthened their anti-alcohol policies in the last 50 years.

Mortality dynamics in Russia are due in large part to excessive alcohol consumption. In Russia consumption of strong alcoholic beverages exceeds the consumption of beer and wine both in terms of the aggregate volume and prevalence among the population. This "northern" type of consumption is characteristic of all the income and education groups.

There is a trend for vodka consumption to shift towards the older age group while young people are switching to the consumption of beer. Whether this is a sustained trend is unclear. There is a trend for better educated and wealthier people to switch to the

*Source:* Leppanen et al, 2001 for European countries, Andrienko and Nemtsov, 2005 for Russia

*Country Price elasticity Income elasticity*

Austria, France, Greece, Italy, Portugal

Russia

**6. Conclusions** 

consumption of wine rather than hard liquor.

Similar calculations of the ratio of excise on various types of alcoholic drinks in Russia could be found in the bottom line in Table 5. As seen from the table, excise on all alcoholic beverages in Russia is several times lower than in European countries. Moreover, the structure of excise tax in Russia differs drastically from the structure in excise in Europe. Russia has a very low excise on distilled spirits: 5.25 euros against 49.21 euros in Sweden (and even 85.36 euros in Norway) and 10 euros in Austria. The excise rate on wine in Russia is close to the rates of wine-consuming countries of southern Europe, a mere 80 eurocents. The rate of tax on beer increased significantly in 2010 but is much lower than the similar rates in North Europe, UK and Ireland in absolute terms. It is though comparable – and even higher if income differences are taken into account – with excise rates in beerconsuming countries. Beer excise amounts to 26 euros in Finland, 19.87 euros in Ireland, 18.08 euro in UK, 17.07 euros in Sweden, but is only 1.73 euros in Germany, 4.4 euros in Austria, 4.9 euros in Netherlands and 4.5 euros in Russia. In addition, strong beer (upward of 8.6%) is common in Russia, unlike in Europe.


*Source*: CEPS, Summary of EU Member States at

http://www.europeanspirits.org/OurIndustry/TaxationIndustry.asp (Rates as of January 2010) for Europe and Federal Law No. 171-FZ for Russia (converted according to 40 rubles per euro exchange rate).

Table 5. Alcohol excise rates (euros per litre of pure alcohol), Russia and Europe, 2010

On the whole excise rates on alcohol in Russia are rather low, especially for distilled spirits, even with due account of the differences in the purchasing power of the population in Europe and Russia. Excise rates on distilled spirits in Russia are strikingly low when compared to the rates in countries with unhealthy high alcohol consumption and high share of consumption of hard liquids. Moreover, the ratios of excise rates on distilled spirits and beer are in sharp contrast to those in all European countries. Wine excise rate is comparable to wine-consuming countries of Europe. The policy of reducing alcohol consumption dictates an increase of excise on all alcoholic products. If Russians are to be induced to consume less alcohol and strong alcoholic beverages in particular, excise on distilled spirits must grow faster than on other goods.

Similar calculations of the ratio of excise on various types of alcoholic drinks in Russia could be found in the bottom line in Table 5. As seen from the table, excise on all alcoholic beverages in Russia is several times lower than in European countries. Moreover, the structure of excise tax in Russia differs drastically from the structure in excise in Europe. Russia has a very low excise on distilled spirits: 5.25 euros against 49.21 euros in Sweden (and even 85.36 euros in Norway) and 10 euros in Austria. The excise rate on wine in Russia is close to the rates of wine-consuming countries of southern Europe, a mere 80 eurocents. The rate of tax on beer increased significantly in 2010 but is much lower than the similar rates in North Europe, UK and Ireland in absolute terms. It is though comparable – and even higher if income differences are taken into account – with excise rates in beerconsuming countries. Beer excise amounts to 26 euros in Finland, 19.87 euros in Ireland, 18.08 euro in UK, 17.07 euros in Sweden, but is only 1.73 euros in Germany, 4.4 euros in Austria, 4.9 euros in Netherlands and 4.5 euros in Russia. In addition, strong beer (upward

*Country Distilled spirits Wine (11%) Beer (5%)* Austria 10.03 0 4.4 Belgium 17.52 4.28 3.76 Denmark 20.14 7.42 6.84 Finland 39.4 25.47 26 France 15.12 0.3 2.71 Germany 13.04 0 1.73 Greece 15.7 0 3.58 Ireland 31.13 23.81 19.87 Italy 8 0 5.17 Netherlands 15.04 6.23 4.9 Portugal 10 0 2.76 Spain 8.3 0 2 Sweden 49.21 19.25 17.07 UK 24.85 21.59 18.08 Russia 5.25 0.8 4.5

http://www.europeanspirits.org/OurIndustry/TaxationIndustry.asp (Rates as of January 2010) for Europe and Federal Law No. 171-FZ for Russia (converted according to 40 rubles per euro exchange rate). Table 5. Alcohol excise rates (euros per litre of pure alcohol), Russia and Europe, 2010

On the whole excise rates on alcohol in Russia are rather low, especially for distilled spirits, even with due account of the differences in the purchasing power of the population in Europe and Russia. Excise rates on distilled spirits in Russia are strikingly low when compared to the rates in countries with unhealthy high alcohol consumption and high share of consumption of hard liquids. Moreover, the ratios of excise rates on distilled spirits and beer are in sharp contrast to those in all European countries. Wine excise rate is comparable to wine-consuming countries of Europe. The policy of reducing alcohol consumption dictates an increase of excise on all alcoholic products. If Russians are to be induced to consume less alcohol and strong alcoholic beverages in particular, excise on distilled spirits

of 8.6%) is common in Russia, unlike in Europe.

*Source*: CEPS, Summary of EU Member States at

must grow faster than on other goods.

The effectiveness of the use of price mechanisms to limit alcohol consumption depends on how price-elastic demand for alcoholic beverages is. Assessments of the elasticity of demand for alcoholic beverages in the European countries and Russia will be found in Table 6.


*Source:* Leppanen et al, 2001 for European countries, Andrienko and Nemtsov, 2005 for Russia

Table 6. Elasticity of demand for alcoholic beverages in the countries of Europe and Russia

As seen from the table the assessment of the elasticity of demand for vodka, beer and wine depending on price in Russia is much higher than the same indicators for the European countries and is comparable to the elasticity of demand in the Netherlands. This suggests that price measures of influencing alcohol consumption – increasing excise on strong beverages in order to encourage people to switch to types of alcohol consumption that cause less harm to health – can be effective. In Russia the experience of the past decades has revealed a relative cheapening of vodka. Thus in the late 1980s the ratio of vodka and beer prices was such that one could buy nine bottles of beer for the price of one bottle of vodka. At present it can buy on average 3-4 bottles of beer (and some vodkas are even cheaper).

Along with price measures, an effective anti-alcohol policy must include other measures: the system of control of the production and sale of alcohol, restriction of the sale of alcohol outside restaurants, bars, etc., restrictions on the minimum age of the customer to whom alcohol can be sold, restrictions on alcohol advertising, on sponsorship of sporting and youth events, and on consumption of alcohol in public places. All the European countries, and not only the northern ones, have significantly strengthened their anti-alcohol policies in the last 50 years.

#### **6. Conclusions**

Mortality dynamics in Russia are due in large part to excessive alcohol consumption. In Russia consumption of strong alcoholic beverages exceeds the consumption of beer and wine both in terms of the aggregate volume and prevalence among the population. This "northern" type of consumption is characteristic of all the income and education groups.

There is a trend for vodka consumption to shift towards the older age group while young people are switching to the consumption of beer. Whether this is a sustained trend is unclear. There is a trend for better educated and wealthier people to switch to the consumption of wine rather than hard liquor.

[11] Edwards, G., Anderson, P., Babor, T. F., Casswell, S., Ferrence, R., Giesbrecht, N.,

[12] European Health for All database (HFA-DB). 2008. Copenhagen, WHO Regional Office

[13] Foxcroft, D. R., Ireland, D., Lister-Sharp, D. J., Lowe, G., and Breen, R. (2003). "Longer-

[14] Gilinskiy Y. (2000) Analysis of statistics on some forms of social deviation in St.

[15] Grube, J. W. & Nygaard, P. (2001). "Adolescent Drinking and Alcohol Policy."

[16] Harkin, A.M., Anderson, P. & Lehto, J. (1995). *Alcohol in Europe: A Health Perspective*. Copenhagen: World Health Organization Regional Office for Europe. [17] Karlsson, T. and Österberg, E. (2001). *"A Scale of Formal Alcohol Control Policy in 15* 

[18] Leon, David (2007). "Hazardous Alcohol Drinking and Premature Mortality in Russia: a Population Based Case-Control Study," *Lancet,*Vol.369, Issue 9578, pp.2002-2009. [19] Leon, David A., L. Chenet, Vladimir Shkolnikov, Sergei Zakharov, Judith Shapiro,

[20] Leppanen, K., Sullstrom, R. & Suoniemi, I. (2001) *"The Consumption of Alcohol in* 

[21] Makela P., K. Tryggvesson, and I. Rossow (2002). "Who drinks more or less when

[23] Nemtsov A. (2002). "Alcohol-related harm losses in Russia in the 1980s and 1990s".

[24] Osterberg E. (1995). "Do alcohol prices affect consumption and related problems?

[25] Osterberg E. (2001). *Pricing and Taxation.* Handbook on alcohol dependence and related

pp. 17-70. Helsinki, Nordic Council for Alcohol and Drug Research. [22] Makela К., E. Osterberg, and P. Sulkunen (1981). "Drinking in Finland. Increasing

Lint, pp. 31-60. Toronto: Addiction Research Foundation.

Edwards, pp. 145-163. Oxford: Oxford University Press

*Addiction.* 97. 1413—1425.

*and the Public Good* (Oxford, Oxford University Press).

for Europe (http://www.euro.who.int/hfadb).

review". *Addiction, 98*, 397–411.

Alcohol and Drug Research (NAD)

*Contemporary Drug Problems*, 28, 87-131.

Alcohol and Drugs), (EnglishSupplement): 117-31.

№ 80. 1998).

88.

благо / Ред. Г. Эдвардc. Региональные публикации ВОЗ. Европейская серия

Godfrey, C., Holder, H.D., Lemmens, P., Mäkelä, K., Midanik, L., Norström, T., Österberg, E., Romelsjö, A., Room, R., Simpura, J. & Skog, O.-J. (1994) *Alcohol Policy* 

term primary prevention for alcohol misuse in young people: A systematic

Petersburg from 1980 to 1995. In: Leifman H, Edgren-Henrichson N, eds. *Statistics on alcohol, drugs and crime in the Baltic Sea region.* Helsinki, Nordic Council for

*European Countries."* Nordisk Alkohol& Narkotikatidskrift (Nordic Studies on

Galina Rakhmanova, Sergei Vassin, and Martin McKee (1997). "Huge Variation in Russian Mortality Rates 1984-94: Artifact, Alcohol, or What?" *Lancet*, 350, pp.383-

*Fourteen European Countries. A Comparative Econometric Analysis"* (Helsinki, Stakes).

policies change? The evidence from 50 years of Nordic studies. The effects of Nordic alcohol policies: Analyses of changes in control systems". Ed. by R. Room,

alcohol availability in a monopoly state. Alcohol, society, and the state 2: The history of control policy in seven countries". Ed. by E. Single, P. Morgan, and J. de

Alcohol and public policy. Evidence and issues." Ed. by H. Holder and G.

problems / Ed. by N. Heather, T. Peters, T. Stockwell, pp. 685-698. London: Wiley.

An analysis of the impact on health and mortality attests to a strong negative impact of frequent alcohol consumption. Moderate alcohol consumption does not produce a statistically significant negative effect.

The negative impact of frequent consumption of hard liquor exceeds that of the consumption of wine and beer. Frequent consumption of vodka shortens the lifespan by an average 9-10 years while no statistically significant impact has been revealed of frequent consumption of beer.

An active anti-alcohol policy must include both price and non-price measures. The policy aimed at reducing alcohol consumption calls for a rise of excise on all the alcoholic products. If Russians are to be encouraged to switch to lighter drinks, excise on hard liquor must grow faster than other excise rates.

There is a large untapped potential for the use of non-price anti-alcohol measures aimed at reducing alcohol consumption in Russia. The experience of North European countries which have succeeded in switching from the consumption of predominantly hard liquor to the consumption of beer and wine and significantly cutting the consumption of hard liquor is of particular relevance.

#### **7. References**


An analysis of the impact on health and mortality attests to a strong negative impact of frequent alcohol consumption. Moderate alcohol consumption does not produce a

The negative impact of frequent consumption of hard liquor exceeds that of the consumption of wine and beer. Frequent consumption of vodka shortens the lifespan by an average 9-10 years while no statistically significant impact has been revealed of frequent

An active anti-alcohol policy must include both price and non-price measures. The policy aimed at reducing alcohol consumption calls for a rise of excise on all the alcoholic products. If Russians are to be encouraged to switch to lighter drinks, excise on hard liquor must grow

There is a large untapped potential for the use of non-price anti-alcohol measures aimed at reducing alcohol consumption in Russia. The experience of North European countries which have succeeded in switching from the consumption of predominantly hard liquor to the consumption of beer and wine and significantly cutting the consumption of hard liquor is of

[1] *Alcohol in Postwar Europe.* Consumption, Drinking Patterns? Consequences and policy

[2] Alcohol per capita consumption, patterns of drinking and abstention worldwide after

[3] Andrienko, Yuri, and Alexander Nemtsov (2005). "Estimation of Individual Alcohol

[4] Babor, T. F., Caetano, R., Caswell, S., Edwards, G., Giesbrecht, N., Graham, K., et al.

[5] Braninerd, Elizabeth and David M.Cutler (2005). "Autopsy of an Empire: Understanding

[6] Bruun, K., Edwards, G., Lumio, M., Makela, K., Pan, L., Popham, R. E. et al. (1975)

[7] Chaloupka, F., Grossman, M. and Saffer, H. (2002). "The effects of price on

[8] Denisova, Irina (2010) "Adult mortality in Russia: a microanalysis", *Economics of* 

[9] Di Castelnuovo, Augusto, Serenella Rotondo, Licia Iacoviello, Maria Benedetta Donati,

[10] Edwards G. et аl. (1994). *Alcohol policy and the public good.* Oxford: Oxford University

Relation to Vascular Risk" *Circulation*, 105, 2836-2844.

1995. Appendix 2. *European Addiction Research*, 2001, 7(3):155–157.

responses in 15 European countries (2001) Thor Norstrom (editor). National

Demand," *Economics Education and Research Consortium, Working Paper series*, 05/10.

(2003). *Alcohol: No ordinary commodity. Research and public policy*. Oxford, United

Mortality in Russia and the Former Soviet Union", *Journal of Economic Perspectives,* 

*Alcohol Control Policies in Public Health Perspective.* Finnish Foundation for Alcohol

alcohol consumption and alcohol-related problems". *Alcohol Research and Health*.

Giovanni de Gaetano (2002) "Meta-Analysis of Wine and Beer Consumption in

Press (Издание на русском языке: Алкогольная политика и общественное

statistically significant negative effect.

consumption of beer.

particular relevance.

**7. References** 

faster than other excise rates.

Institute of Public Health, Sweden.

Kingdom: Oxford University Press.

19, 1, pp.107-130.

Studies, Helsinki.

*Transition,* Vol.18(2), 333-363.

(26)1: 22-34.

благо / Ред. Г. Эдвардc. Региональные публикации ВОЗ. Европейская серия № 80. 1998).


**19** 

*1Japan 2France 3USA* 

**Insomnia and Its Correlates:** 

*National Instutute of Mental Health, NCNP, Tokyo,* 

*3Department of Psychiatry, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania* 

Yuichiro Abe1,2 and Anne Germain3

*1Department of Psychophysiology,* 

*2Policlinique, ASM13, Gentilly,* 

**Current Concepts, Epidemiology,** 

**Pathophysiology and Future Remarks** 

Insomnia is a common sleep disorder. People suffering from insomnia generally report not only sleep-related symptoms such as difficulty initiating, maintaining, obtaining sufficient restorative sleep, but also experience various daytime impairment reflective of sleep deficits (Buysse, 2008; Riemann et al., 2011). The generic term "insomnia" as a diagnostic entity is defined as a complaint of sleep problems coupled with impairment of daytime functioning, including reduced alertness, fatigue, exhaustion, dysphoria and other symptoms. The complaints have to endure for at least 4 weeks to be diagnosed as insomnia, according to the

 Chronic insomnia is a "24-hour disease", meaning not only reduces the quality of sleep during the night, but also causes a variety of impairments in mental and physical functioning during the daytime (Bonnet & Arand, 1995, 2011). Although some patients who have this problem may not report it as such, inadequate sleep has been associated with reduced physical health and mental health (Morin & Espie, 2004; LeBlanc et al., 2007). Thus, many people are likely those who are in the "pre-insomnia" moment, and do not even consider themselves insomniacs (Bastien et al., 2004). Chronic insomnia is also associated with both human and socioeconomic costs, such as increased long-term absenteeism at work, reduced performance and productivity, and increased industrial accidents and health-care costs. This impact could be explained by three points: 1) comorbid mental (psychiatric) conditions, 2) comorbid medical

In primary care, practitioners usually prescribe medication such as hypnotics without for such insomnia complaints. However, the use of these sedative agents is often problematic, especially when patients have kept a good QOL activity in daily life (Riemann et al., 2011).

current diagnostic classification manual (Abe & Mishima, 2008).

conditions and 3) socioeconomic impact of insomnia (Mai & Buysse, 2008).

**1. Introduction** 


### **Insomnia and Its Correlates: Current Concepts, Epidemiology, Pathophysiology and Future Remarks**

Yuichiro Abe1,2 and Anne Germain3

*1Department of Psychophysiology, National Instutute of Mental Health, NCNP, Tokyo, 2Policlinique, ASM13, Gentilly, 3Department of Psychiatry, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania 1Japan 2France 3USA* 

#### **1. Introduction**

386 Public Health – Methodology, Environmental and Systems Issues

[26] Österberg, E. & Karlsson, T. (2002) *Alcohol Policies in EU Member States and Norway. A* 

[27] Rehn, N., Room, R., & Edwards, G. (2001). *Alcohol in the European Region - Consumption,* 

[28] Shkolnikov, V.M., G.A Cornia, D.A. Leon, and F. Mesle (1998). "Causes of the Russian

[29] Wagenaar A. and Toomey T. (2000). "Alcohol policy: gaps between current research."

[30] Wagenaar, A. and Holder, H. (1995) "Changes in Alcohol Consumption Resulting from

[31] WHO Global Status Report on Alcohol 2004, Country Profiles, World Health

[33] Nemtsov A. (2009) Alcohol History of Russia: the latest period. Moscow: Librokom

*Harm, and Policies.* Copenhagen: World Health Organization Regional Office for

Mortality Crisis: Evidence and Interpretations," *World Development*, 26, 11, pp.1995-

the Elimination of Retail Wine Monopolies: Result from Five U.S. States". *Journal of* 

*Collection of Country Reports* (Helsinki, Stakes).

*Contemporary drug problems*, 27:681-733.

*Studies on Alcohol*, Vol .56, No. 5.

[32] WHO report on alcohol consumption, 2007

Organization 2004

(in Russian)

Europe.

2011.

Insomnia is a common sleep disorder. People suffering from insomnia generally report not only sleep-related symptoms such as difficulty initiating, maintaining, obtaining sufficient restorative sleep, but also experience various daytime impairment reflective of sleep deficits (Buysse, 2008; Riemann et al., 2011). The generic term "insomnia" as a diagnostic entity is defined as a complaint of sleep problems coupled with impairment of daytime functioning, including reduced alertness, fatigue, exhaustion, dysphoria and other symptoms. The complaints have to endure for at least 4 weeks to be diagnosed as insomnia, according to the current diagnostic classification manual (Abe & Mishima, 2008).

 Chronic insomnia is a "24-hour disease", meaning not only reduces the quality of sleep during the night, but also causes a variety of impairments in mental and physical functioning during the daytime (Bonnet & Arand, 1995, 2011). Although some patients who have this problem may not report it as such, inadequate sleep has been associated with reduced physical health and mental health (Morin & Espie, 2004; LeBlanc et al., 2007). Thus, many people are likely those who are in the "pre-insomnia" moment, and do not even consider themselves insomniacs (Bastien et al., 2004). Chronic insomnia is also associated with both human and socioeconomic costs, such as increased long-term absenteeism at work, reduced performance and productivity, and increased industrial accidents and health-care costs. This impact could be explained by three points: 1) comorbid mental (psychiatric) conditions, 2) comorbid medical conditions and 3) socioeconomic impact of insomnia (Mai & Buysse, 2008).

In primary care, practitioners usually prescribe medication such as hypnotics without for such insomnia complaints. However, the use of these sedative agents is often problematic, especially when patients have kept a good QOL activity in daily life (Riemann et al., 2011).

Insomnia and Its Correlates:

sleep.

about sleep.

ICSD-2 General Criteria for insomnia (2005):

DSM-5 proposed Insomnia Disorder (2010).


opportunity for sleep.

(> 3 months).

DSM-5 (2010)

functioning (e.g., fatigue, sleepiness).

D. The sleep difficulty occurs at least three nights per week. E. The sleep difficulty is present for at least three months.

B. Report of one or more of the following symptoms:

sleep without caregiver intervention

resistance or inability to sleep independently.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 389

A. A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically unrestorative or poor in quality. In children, the sleep difficulty is often reported by the caretaker and may consist of observed bedtime

B. The above sleep difficulty occurs despite adequate opportunity and circumstances for

C. At least one of the following forms of daytime impairment related to the nighttime sleep difficulty is reported by the patient: fatigue or malaise; attention, concentration, or memory impairment; social or vocational dysfunction or poor school performance; mood disturbance or irritability; daytime sleepiness; motivation, energy, or initiative reduction; proneness for errors or accidents at work or while driving; tension, headaches, or gastrointestinal symptoms in response to sleep loss; concerns or worries

A. The predominant complaint is dissatisfaction with sleep quantity or quality made by



the patient (or by a caregiver or family in the case of children or elderly).

difficulty returning to sleep without caregiver intervention) - Early morning awakening with inability to return to sleep


F. The sleep difficulty occurs despite adequate age-appropriate circumstances and

\* Duration: i. Acute insomnia (< 1month); ii. Sub acute insomnia (1-3 months); iii. Persistant insomnia

\* Clinically Comorbid Conditions: i. Psychiatric disorder; ii. Medical disorder; iii. Another disorder. Table 1. General criteria for insomnia in ICSD-2 (2005) and insomnia disorder in proposed

The mere augmentation of medication runs a risk of exacerbating daytime impairment itself. The continued widespread use of sedative medication to treat insomnia raises concern about the potential for long term tolerance and addiction, particularly where insomnia is the presenting complaint of missed diagnoses such as comorbid depression and anxiety disorder, or when adverse effects might be a problem—for example, falls in older adults (Riemann et al., 2011).

We will review about insomnia in terms of several aspects: its concept, epidemiology, pathophysiology, psychobehavioral correlates and possible psychiatric interventions. At the same time, we will show our own epidemiological study about Japanese people with insomnia based on the general population sample, and present some clinical case studies in order to describe several aspects of insomnia comorbid with mental disorders. We will also mention the correlates of nightmares, sleep disturbances related to suicidality and alcoholism as current important clinical and research topics. Finally, we will comment on future remarks based on the current society in Japan aftermath of Tsunami disaster in March 2011. In discussing mainly insomnia and nightmare, we used the terms "sleep disturbances" and "sleep problems" interchangeably in this paper, following the context.

#### **2. Current definition and prevalence of insomnia**

The reported prevalence of insomnia in the general population varies widely, ranging between 4.4% and 48%, depending on sample characteristics and the definition of insomnia (Ohayon, 2002). According to the American Sleep Disorders Association International Classification of Sleep Disorders (ICSD-2) published in 2005, its coding manual, insomnia refers to "a repeated difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime impairment and lasting for at least one month." (AASM, 2005).

#### **2.1 DSM-5 proposed criteria of insomnia**

The major current diagnostic systems ICD-10 (International Classification of Disorders 10th edition) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, APA) includes sections on insomnia and several sleep disorders. Both ICD-10 and DSM-IV are currently under review (Riemann et al., 2011). Contemporary psychiatry has been greatly influenced by these nosographic changes. In 2010, the DSM-V proposed criteria were tentatively manifested, which might be espected to increase the significance of the notion of sleep disturbances, after the presumable publication of DSM-V in 2013. It is under discussion whether the category primary/secondary insomnia should be replaced by the term « insomnia disorder ». In any case, this would emphasize the independence of the category in favor of the insomnia comorbidity concept, as suggested by the State of the Science conference on insomnia (NIH, 2005).

The concept and diagnostic criterion of insomnia are still fluctuating. In orde to become familiar with the current nosographic controversy, we show Table 1, which explains the general criteria for insomnia in ICSD-2, as well as the draft criteria for insomnia disorder in DSM-5 draft published in 2010 (Proposed DSM-5 Draft, 2010).

#### ICSD-2 General Criteria for insomnia (2005):

388 Public Health – Methodology, Environmental and Systems Issues

The mere augmentation of medication runs a risk of exacerbating daytime impairment itself. The continued widespread use of sedative medication to treat insomnia raises concern about the potential for long term tolerance and addiction, particularly where insomnia is the presenting complaint of missed diagnoses such as comorbid depression and anxiety disorder, or when adverse effects might be a problem—for example, falls in older adults

We will review about insomnia in terms of several aspects: its concept, epidemiology, pathophysiology, psychobehavioral correlates and possible psychiatric interventions. At the same time, we will show our own epidemiological study about Japanese people with insomnia based on the general population sample, and present some clinical case studies in order to describe several aspects of insomnia comorbid with mental disorders. We will also mention the correlates of nightmares, sleep disturbances related to suicidality and alcoholism as current important clinical and research topics. Finally, we will comment on future remarks based on the current society in Japan aftermath of Tsunami disaster in March 2011. In discussing mainly insomnia and nightmare, we used the terms "sleep disturbances" and "sleep problems" interchangeably in this paper,

The reported prevalence of insomnia in the general population varies widely, ranging between 4.4% and 48%, depending on sample characteristics and the definition of insomnia (Ohayon, 2002). According to the American Sleep Disorders Association International Classification of Sleep Disorders (ICSD-2) published in 2005, its coding manual, insomnia refers to "a repeated difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime

The major current diagnostic systems ICD-10 (International Classification of Disorders 10th edition) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, APA) includes sections on insomnia and several sleep disorders. Both ICD-10 and DSM-IV are currently under review (Riemann et al., 2011). Contemporary psychiatry has been greatly influenced by these nosographic changes. In 2010, the DSM-V proposed criteria were tentatively manifested, which might be espected to increase the significance of the notion of sleep disturbances, after the presumable publication of DSM-V in 2013. It is under discussion whether the category primary/secondary insomnia should be replaced by the term « insomnia disorder ». In any case, this would emphasize the independence of the category in favor of the insomnia comorbidity concept, as suggested by the State of the Science

The concept and diagnostic criterion of insomnia are still fluctuating. In orde to become familiar with the current nosographic controversy, we show Table 1, which explains the general criteria for insomnia in ICSD-2, as well as the draft criteria for insomnia disorder in

(Riemann et al., 2011).

following the context.

**2. Current definition and prevalence of insomnia** 

**2.1 DSM-5 proposed criteria of insomnia** 

conference on insomnia (NIH, 2005).

impairment and lasting for at least one month." (AASM, 2005).

DSM-5 draft published in 2010 (Proposed DSM-5 Draft, 2010).


DSM-5 proposed Insomnia Disorder (2010).

	- Difficulty initiating sleep; in children this may be manifested as difficulty initiating sleep without caregiver intervention
	- Difficulty maintaining sleep characterized by frequent awakenings or problems returning to sleep after awakenings (in children this may be manifested as difficulty returning to sleep without caregiver intervention)
	- Early morning awakening with inability to return to sleep
	- Non restorative sleep
	- Prolonged resistance to going to bed and/or bedtime struggles (children)

\* Duration: i. Acute insomnia (< 1month); ii. Sub acute insomnia (1-3 months); iii. Persistant insomnia (> 3 months).

\* Clinically Comorbid Conditions: i. Psychiatric disorder; ii. Medical disorder; iii. Another disorder.

Table 1. General criteria for insomnia in ICSD-2 (2005) and insomnia disorder in proposed DSM-5 (2010)

Insomnia and Its Correlates:

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 391

It is possible that the complaints from participants were related to physical or psychological problems, which are separate issues from insomnia. However, as far as we know, there is no validated self-reporting tool about which researchers are in consensus for accurately measuring daytime impairments due to insomnia (Ohayon & Lemoine, 2004; Shekleton et al., 2010). One of the main reasons for this overdiagnosis of insomnia is that we used « daytime impairment » related to insomnia, including various items such as fatigue. This result implies one important subject, that is to say, "fatigue" itself can be regarded as a core symptom of insomnia (Choquet et al., 1993; Riemann et al., 2011). In recent literature, daytime sleepiness, hypersomnia and fatigue are common symptoms of depression (Franzen & Buysse, 2008). But, such symptoms can occur independently, or they may occur secondarily to insomnia comorbidity, as well as short- or long-term side effects of

antidepressant medications themselves (Riemann et al., 2011).

mechanism of insomnia (Spielman et al., 1987; Ellis et al., 2011).

cognitive factors (Basta et al., 2007; Riemann et al., 2010).

**3.1 Development of chronic insomnia: 3P model** 

**3. The current psychobiological model of insomnia: Hyperarousal model** 

Although pathophysiology of insomnia remains to be explored, physiological hyperarousal evidenced by cognitive, endocrine, and neurophysiologic variables has been revealed to be involved in onset and development of insomnia (Bonnet, 1995, 2010; Riemann et al., 2010). Patients with insomnia suffer from cognitive deficit. Characteristically, they report their sleep and psychoperformance to be worse than are objectively measured (Endo, 1962; Orff et al., 2007). This "perceived" deficit is exactly what aggravates the QOL of insomniac patients and let them fall in a vicious cycle (Abe & Mishima, 2008). Also, insomnia is often induced by stressful events, and is assumed to develop by the 3P model (predisposing, precipitating and perpetuating factors), proposed by Spielman that is widely used to explain the onset

There is a need for clarification of pathophysiology of insomnia for development of efficient treatment skills and critical prevention of chronic insomnia. Just recently, reductions in hippocampal volume size have been reported in patients suffering from primary insomnia in brain research (Riemann et al., 2009). In the light of neurobiological theories of sleep-wake regulation, insomnia may be conceptualised as the final common pathway of the interaction of a genetic vulnerability to an imbalance between arousing and sleep-inducing brain centres, which is triggered by psychosocial and/or medical stressors, with perpetuating mechanisms such as maladaptive behaviours, learned sleep-preventing associations and

According to Spielman, insomnia is often induced by stressful events, and assumed to develop by his 3P model (predisposing, precipitating and perpetuating factors), that is widely used to explain the onset mechanism of insomnia (Spielman et al., 1987). Factors leading to the onset and worsening of insomnia are multidimensional in nature, and many life events and life stresses can result in acute insomnia. Inadequate stress coping behavior also precipitates insomnia, and heightens uneasiness and tension around being unable to sleep, thereby perpetuating the sleeplessness (Abe & Mishima, 2008). Furthermore, insomniacs may often engage in poor sleep hygiene, such as having an inadequate sleep environment, lack of daytime activities, and excessive afternoon napping. It is reported that the majority of people with insomnia attempt to cope with sleep problems in various ways,

#### **2.2 Japanese general population sample, re-analysed**

Following this current insomnia concepts, we reanalyzed our Japanese population representative sample of 24,551 adults performed in 2000 (Abe et al., 2011). The present study was conducted using partial data from the Active Survey of Health andWelfare performed in June 2000 by the Ministry of Health, Labour and Welfare. To provide a representative sample of the general population in Japan, the survey was conducted through public health centers in 300 target areas randomly selected from the 881, 851 national census areas nationwide. The self-administered questionnaire consisted of 44 items covering the general health status, physical and psychological complaints and sleep habits and problems. We first selected cases reporting the presence of both insomnia symptoms and physical/psychological complaints during the past one month, identified based on the responses to the survey questionnaire about sleep problems and daytime functioning during the past one month. Then we excluded cases reporting a common comorbid sleep disorder (sleep-disordered breathing and restless leg syndrome).

The result was that we found a fairly high prevalence of insomnia (43.4%) as defined in this study (see Table 2) compared to before in the general population sample in Japan. Although previous studies have pointed out that Japanese people tend to underreport their sleep problems, because of cultural reticence compared with those in Western cultures, our results did not necessarily align with these studies (Abe & Mishima, 2008; Abe et al., 2011).

Possible reasons for the higher prevalence of insomnia obtained in our study include the following. First, following the ICSD-2 criteria, an item on "nonrestorative sleep" was added to our definition of insomnia. Secondly, our sample may have included cases with shortterm insomnia occurring in less than the past one month (e.g. adjustment insomnia) in the absence of specifications on the duration and frequency of insomnia symptoms. The case definition of insomnia based partially on the ICSD-2 and DSM-IV was more liberal than the original definitions of the disorder. Lastly, the greatest factor responsible for such a higher prevalence rate was the inadequate assessment of daytime impairments associated with insomnia (Ohayon & Lemoine, 2004).


Table 2. Presence of insomnia and insomnia comorbid with depression, by age, group and sex in a sample of the general Japanese adult population, conducted in 2000 (n=24, 551) .

Following this current insomnia concepts, we reanalyzed our Japanese population representative sample of 24,551 adults performed in 2000 (Abe et al., 2011). The present study was conducted using partial data from the Active Survey of Health andWelfare performed in June 2000 by the Ministry of Health, Labour and Welfare. To provide a representative sample of the general population in Japan, the survey was conducted through public health centers in 300 target areas randomly selected from the 881, 851 national census areas nationwide. The self-administered questionnaire consisted of 44 items covering the general health status, physical and psychological complaints and sleep habits and problems. We first selected cases reporting the presence of both insomnia symptoms and physical/psychological complaints during the past one month, identified based on the responses to the survey questionnaire about sleep problems and daytime functioning during the past one month. Then we excluded cases reporting a common comorbid sleep disorder

The result was that we found a fairly high prevalence of insomnia (43.4%) as defined in this study (see Table 2) compared to before in the general population sample in Japan. Although previous studies have pointed out that Japanese people tend to underreport their sleep problems, because of cultural reticence compared with those in Western cultures, our results did not necessarily align with these studies (Abe & Mishima, 2008;

Possible reasons for the higher prevalence of insomnia obtained in our study include the following. First, following the ICSD-2 criteria, an item on "nonrestorative sleep" was added to our definition of insomnia. Secondly, our sample may have included cases with shortterm insomnia occurring in less than the past one month (e.g. adjustment insomnia) in the absence of specifications on the duration and frequency of insomnia symptoms. The case definition of insomnia based partially on the ICSD-2 and DSM-IV was more liberal than the original definitions of the disorder. Lastly, the greatest factor responsible for such a higher prevalence rate was the inadequate assessment of daytime impairments associated with

Table 2. Presence of insomnia and insomnia comorbid with depression, by age, group and sex in a sample of the general Japanese adult population, conducted in 2000 (n=24, 551) .

**2.2 Japanese general population sample, re-analysed** 

(sleep-disordered breathing and restless leg syndrome).

Abe et al., 2011).

insomnia (Ohayon & Lemoine, 2004).

It is possible that the complaints from participants were related to physical or psychological problems, which are separate issues from insomnia. However, as far as we know, there is no validated self-reporting tool about which researchers are in consensus for accurately measuring daytime impairments due to insomnia (Ohayon & Lemoine, 2004; Shekleton et al., 2010). One of the main reasons for this overdiagnosis of insomnia is that we used « daytime impairment » related to insomnia, including various items such as fatigue. This result implies one important subject, that is to say, "fatigue" itself can be regarded as a core symptom of insomnia (Choquet et al., 1993; Riemann et al., 2011). In recent literature, daytime sleepiness, hypersomnia and fatigue are common symptoms of depression (Franzen & Buysse, 2008). But, such symptoms can occur independently, or they may occur secondarily to insomnia comorbidity, as well as short- or long-term side effects of antidepressant medications themselves (Riemann et al., 2011).

#### **3. The current psychobiological model of insomnia: Hyperarousal model**

Although pathophysiology of insomnia remains to be explored, physiological hyperarousal evidenced by cognitive, endocrine, and neurophysiologic variables has been revealed to be involved in onset and development of insomnia (Bonnet, 1995, 2010; Riemann et al., 2010). Patients with insomnia suffer from cognitive deficit. Characteristically, they report their sleep and psychoperformance to be worse than are objectively measured (Endo, 1962; Orff et al., 2007). This "perceived" deficit is exactly what aggravates the QOL of insomniac patients and let them fall in a vicious cycle (Abe & Mishima, 2008). Also, insomnia is often induced by stressful events, and is assumed to develop by the 3P model (predisposing, precipitating and perpetuating factors), proposed by Spielman that is widely used to explain the onset mechanism of insomnia (Spielman et al., 1987; Ellis et al., 2011).

There is a need for clarification of pathophysiology of insomnia for development of efficient treatment skills and critical prevention of chronic insomnia. Just recently, reductions in hippocampal volume size have been reported in patients suffering from primary insomnia in brain research (Riemann et al., 2009). In the light of neurobiological theories of sleep-wake regulation, insomnia may be conceptualised as the final common pathway of the interaction of a genetic vulnerability to an imbalance between arousing and sleep-inducing brain centres, which is triggered by psychosocial and/or medical stressors, with perpetuating mechanisms such as maladaptive behaviours, learned sleep-preventing associations and cognitive factors (Basta et al., 2007; Riemann et al., 2010).

#### **3.1 Development of chronic insomnia: 3P model**

According to Spielman, insomnia is often induced by stressful events, and assumed to develop by his 3P model (predisposing, precipitating and perpetuating factors), that is widely used to explain the onset mechanism of insomnia (Spielman et al., 1987). Factors leading to the onset and worsening of insomnia are multidimensional in nature, and many life events and life stresses can result in acute insomnia. Inadequate stress coping behavior also precipitates insomnia, and heightens uneasiness and tension around being unable to sleep, thereby perpetuating the sleeplessness (Abe & Mishima, 2008). Furthermore, insomniacs may often engage in poor sleep hygiene, such as having an inadequate sleep environment, lack of daytime activities, and excessive afternoon napping. It is reported that the majority of people with insomnia attempt to cope with sleep problems in various ways,

Insomnia and Its Correlates:

**4.1 Insomnia-depression** 

**4.2 Insomnia-anxiety** 

depressive disorders (Riemann et al., 2003).

2008).

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 393

only minor deficits in this population, investigating neuropsychological tests in large sample sizes might reveal stable deficits in the insomnia patients population (Edinger et al.,

In terms of descriptive symptomatology, insomnia symptoms often coexist with depressive and anxiety symptoms. As many as 90% of patients with depression will have sleep quality complaints (Tsuno et al., 2005). Alongside insomnia being the most common symptom of depression and anxiety disorder, persistent insomnia is a risk or exacerbating factor of

In a Japanese general population sample, the presence of insomnia comorbid with depression was 5.5% with a rate of 12.7% among the sample of people with insomnia (Abe et al., 2011). In line with this, Ford & Kamerow reported 14.0% as a prevalence of insomnia co-occurring with depression in a study based on 7954 American households (Ford & Kamerow, 1989). These studies showed that the frequency of insomnia comorbid with depression observed in Western countries is stable among Japanese adults as well (approximately one seventh of the insomnia population). Vollarath *et al*. state that insomnia constitutes an independent syndrome (Vollath et al., 1989), and Buysse *et al*. suggest that insomnia and depression are commonly comorbid, and insomnia comorbid with depression is an important intermediate phenotype (Buysse et al., 2008). Following the current insomnia-depression literature, we can consider as follows: (1) Insomnia and depression are bidirectionally related; (2) Insomnia is a risk factor for developing depression and (3) Insomnia is a risk factor for poor depression outcomes. Taken together, treating insomnia

In general, insomniacs manifest their multi-complaints and they often have a comorbidity with anxiety disorders. Harvey *et al.* proposed her cognitive model of insomnia, explaining that excessive worriness about insomnia itself exacerbates insomnia. Bader *et al.* suggested that adverse childhood experiences are associated with sleep in primary insomnia (Bader et al, 2007 ), and Gregory *et al.* reported that familial conflicts in childhood predicted later insomnia, a modest but robust longitudinal link between family conflict during childhood

With regard to the comorbidity with anxiety disorder, the potential pathological link between insomnia and PTSD (posttraumatic stress disorder) and alcohol dependence should be more investigated. Especially, sleep disturbances have been considered the hallmark of PTSD for decades. Since insomnia has been observed in 90% of PTSD cases, both pharmacologic and psychosocial context of sleep of trauma should be needed to improve

Clinically, sleep disturbances are common among individuals with posttraumatic stress disorder (PTSD), which are often resistant to first-line recommended treatments

may favorably impacts the trajectory of depression (Franzen & Buysse, 2008).

and insomnia experienced at 18 years of age. (Gregory et al., 2006).

**4.3 Case Study 1; PTSD coexist with sleep disturbances** 

comorbid insomnia (Hendin et al., 2008 ).

**4. Symptomatic overlap: Insomnia-depression-anxiety connection** 

have fewer adaptive coping skills, rely more on emotion-focused coping strategies than on problem-solving strategies and report lower feelings of mastery (Vollath et al., 1989). Reduced quality of life associated with insomnia has already been reported in a general population sample (LeBlanc et al., 2007).

#### **3.2 Brief empirical evidence about insomnia**

Since the classical study of Monroe *et al*., the validity of the hyperarousal concepts in patients with insomnia has been tested by measuring autonomous variables, including ECG-derived heart rate and heart rate variability, body temperature, whole-body metabolism and galvanic skin response (Riemann et al., 2010). The majority of studies measuring such variables in insomnia documented an increased arousal tone in this patient group. However, it is still unclear whether increased autonomic activity is causing insomnia or whether vice versa, insomnia and its sleep loss triggers increased autonomic activity.

Bastien *et al.* investigated a group of 285 patients evaluated for insomnia at a sleep medical clinic and found that 35% had a positive history for a sleep disturbances (Bastien & Morin, 2000). Dauvilliers *et al.* described that of 77 patients with primary insomnia, 72.7% reported familial insomnia compared to 24.1% in a non-insomnia control group in a French population sample (Dauvilliers et al*.*, 2005). Similar result was reported by Morin's group from a Canadian polulation sample (Beaulieu-Bonneau et al., 2007). Drake *et al.* suggested that 37% of the variance in vulnerability to stress-related insomnia in siblings could be explained by familial aggregation (Drake et al., 2008).

Neuroimaging studies in insomnia are now widely used in human basic sleep research.. A PET study, condulted by Nofzinger *et al*., acquired data from 7 chronic insomniacs and 20 good sleeper controls during wakefulness and during consolidated Non-REM sleep. Patients with insomnia exhibited increased global glucose metabolism during wakefulness and Non-REM sleep. Patients with insomnia exhibited smaller declines in relative glucose metabolism from wakefulness to Non-REM sleep in wake promoting regions including the ascending reticular activation system. Reduced relative metabolism in the prefrontal cortex was found in insomniac while awake (Nofzinger et al., 2004). Another recent pilot study, using manual morphometry of structural magnetic resonance images showed that out of several regions of interest only one significant difference concerning a bilateral reduction of hippocampal volumes was found between 8 chronic insomniacs and 8 healthy control sleepers (Riemann et al., 2007). It remains to be determined whether these alterations of hippocampal structures are directly related to the insomnia. Nevertheless, these studies referred to above have taught us that the development of chronic insomnia is associated with measurable alterations of brain function pointing to Central Nervous System hyperarousal with a vulnerable familial aggregation.

The study of daytime performance in patients with insomnia has been driven by the assumption that short-term or chronic sleep loss has a negative impact on daytime functioning. Thus, such a compensatory effot might play an important role in the opposing effects of sleep deficits and hyperarousal that influence daytime performance.

The study of Orff *et al.* showed no impairments at all objective measures of cognitive performance in insomnia patients, with a discrepancy between subjective reports of deficits and objective neuropsychological tests (Orff et al., 2007). Despite the fact that there might be only minor deficits in this population, investigating neuropsychological tests in large sample sizes might reveal stable deficits in the insomnia patients population (Edinger et al., 2008).

#### **4. Symptomatic overlap: Insomnia-depression-anxiety connection**

#### **4.1 Insomnia-depression**

392 Public Health – Methodology, Environmental and Systems Issues

have fewer adaptive coping skills, rely more on emotion-focused coping strategies than on problem-solving strategies and report lower feelings of mastery (Vollath et al., 1989). Reduced quality of life associated with insomnia has already been reported in a general

Since the classical study of Monroe *et al*., the validity of the hyperarousal concepts in patients with insomnia has been tested by measuring autonomous variables, including ECG-derived heart rate and heart rate variability, body temperature, whole-body metabolism and galvanic skin response (Riemann et al., 2010). The majority of studies measuring such variables in insomnia documented an increased arousal tone in this patient group. However, it is still unclear whether increased autonomic activity is causing insomnia or whether vice versa, insomnia and its sleep loss triggers increased autonomic activity.

Bastien *et al.* investigated a group of 285 patients evaluated for insomnia at a sleep medical clinic and found that 35% had a positive history for a sleep disturbances (Bastien & Morin, 2000). Dauvilliers *et al.* described that of 77 patients with primary insomnia, 72.7% reported familial insomnia compared to 24.1% in a non-insomnia control group in a French population sample (Dauvilliers et al*.*, 2005). Similar result was reported by Morin's group from a Canadian polulation sample (Beaulieu-Bonneau et al., 2007). Drake *et al.* suggested that 37% of the variance in vulnerability to stress-related insomnia in siblings could be

Neuroimaging studies in insomnia are now widely used in human basic sleep research.. A PET study, condulted by Nofzinger *et al*., acquired data from 7 chronic insomniacs and 20 good sleeper controls during wakefulness and during consolidated Non-REM sleep. Patients with insomnia exhibited increased global glucose metabolism during wakefulness and Non-REM sleep. Patients with insomnia exhibited smaller declines in relative glucose metabolism from wakefulness to Non-REM sleep in wake promoting regions including the ascending reticular activation system. Reduced relative metabolism in the prefrontal cortex was found in insomniac while awake (Nofzinger et al., 2004). Another recent pilot study, using manual morphometry of structural magnetic resonance images showed that out of several regions of interest only one significant difference concerning a bilateral reduction of hippocampal volumes was found between 8 chronic insomniacs and 8 healthy control sleepers (Riemann et al., 2007). It remains to be determined whether these alterations of hippocampal structures are directly related to the insomnia. Nevertheless, these studies referred to above have taught us that the development of chronic insomnia is associated with measurable alterations of brain function pointing to Central Nervous System

The study of daytime performance in patients with insomnia has been driven by the assumption that short-term or chronic sleep loss has a negative impact on daytime functioning. Thus, such a compensatory effot might play an important role in the opposing

The study of Orff *et al.* showed no impairments at all objective measures of cognitive performance in insomnia patients, with a discrepancy between subjective reports of deficits and objective neuropsychological tests (Orff et al., 2007). Despite the fact that there might be

effects of sleep deficits and hyperarousal that influence daytime performance.

population sample (LeBlanc et al., 2007).

**3.2 Brief empirical evidence about insomnia** 

explained by familial aggregation (Drake et al., 2008).

hyperarousal with a vulnerable familial aggregation.

In terms of descriptive symptomatology, insomnia symptoms often coexist with depressive and anxiety symptoms. As many as 90% of patients with depression will have sleep quality complaints (Tsuno et al., 2005). Alongside insomnia being the most common symptom of depression and anxiety disorder, persistent insomnia is a risk or exacerbating factor of depressive disorders (Riemann et al., 2003).

In a Japanese general population sample, the presence of insomnia comorbid with depression was 5.5% with a rate of 12.7% among the sample of people with insomnia (Abe et al., 2011). In line with this, Ford & Kamerow reported 14.0% as a prevalence of insomnia co-occurring with depression in a study based on 7954 American households (Ford & Kamerow, 1989). These studies showed that the frequency of insomnia comorbid with depression observed in Western countries is stable among Japanese adults as well (approximately one seventh of the insomnia population). Vollarath *et al*. state that insomnia constitutes an independent syndrome (Vollath et al., 1989), and Buysse *et al*. suggest that insomnia and depression are commonly comorbid, and insomnia comorbid with depression is an important intermediate phenotype (Buysse et al., 2008). Following the current insomnia-depression literature, we can consider as follows: (1) Insomnia and depression are bidirectionally related; (2) Insomnia is a risk factor for developing depression and (3) Insomnia is a risk factor for poor depression outcomes. Taken together, treating insomnia may favorably impacts the trajectory of depression (Franzen & Buysse, 2008).

#### **4.2 Insomnia-anxiety**

In general, insomniacs manifest their multi-complaints and they often have a comorbidity with anxiety disorders. Harvey *et al.* proposed her cognitive model of insomnia, explaining that excessive worriness about insomnia itself exacerbates insomnia. Bader *et al.* suggested that adverse childhood experiences are associated with sleep in primary insomnia (Bader et al, 2007 ), and Gregory *et al.* reported that familial conflicts in childhood predicted later insomnia, a modest but robust longitudinal link between family conflict during childhood and insomnia experienced at 18 years of age. (Gregory et al., 2006).

With regard to the comorbidity with anxiety disorder, the potential pathological link between insomnia and PTSD (posttraumatic stress disorder) and alcohol dependence should be more investigated. Especially, sleep disturbances have been considered the hallmark of PTSD for decades. Since insomnia has been observed in 90% of PTSD cases, both pharmacologic and psychosocial context of sleep of trauma should be needed to improve comorbid insomnia (Hendin et al., 2008 ).

#### **4.3 Case Study 1; PTSD coexist with sleep disturbances**

Clinically, sleep disturbances are common among individuals with posttraumatic stress disorder (PTSD), which are often resistant to first-line recommended treatments

Insomnia and Its Correlates:

PSQI Addendum for PTSD

a. Feel hot flashes:

screaming:

b. Feel general nervousness:

**4.4 PSQI-A scale** 

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 395

As this case description shows, PTSD patients report a wide variety of subjective complaints. These subjective sleep disturbances are non-specific and also observed in other sleep disorders and psychiatric clinical samples. For example, PTSD and depressed patients show similar global score on The Pittsburgh Sleep Quality Index, one of the most frequently used self-report instruments to assess sleep quality. Disruptive nocturnal behaviors (DNB), such as trauma-related nightmares, may represent more specific sleep disturbances in PTSD. Recently, Germain *et al.* developed the PSQI Addendum for PTSD (PSQI-A), a brief sleep scale for PTSD, to evaluate DNB (Germain et al., 2005). This self-report instrument consists of 7 items that focus on the frequency of seven DNB, and includes three additional items regarding the frequency of anxiety and anger accompanying DNB and the timing of these events during tht night (Table 3). Such an assessment may support the clinical utility of

assessing DNB to determine the need for further PTSD evaluation and intervention.

1. During the past month, how often have you had troubles sleeping because you…

f. Had episodes of terror or screaming during sleep without fully awaking:

Table 3. Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) (Germain et al., 2005)

Factors leading to the onset and worsening of insomnia are multidimensional in nature, and many life events and life stresses can result in acute insomnia. Inadequate stress coping behavior also precipitates insomnia, and heightens uneasiness and tension around being unable to sleep, thereby perpetuating the sleeplessness. Furthermore, insomniacs may often engage in poor sleep hygiene, such as having an inadequate sleep environment, lack of daytime activities, and excessive afternoon napping (Abe et al., 2011). The majority of people with insomnia attempt to cope with sleep problems in various ways, have fewer adaptive coping skills, rely more on emotion-focused coping strategies than on problemsolving strategies and report lower feelings of mastery (LeBlanc et al., 2007 ). Reduced quality of life associated with insomnia has already been reported in a general population sample. We have recently studied specific daily stress coping behaviors (SCBs) and sleep hygiene practices (SHPs) of people with insomnia in our Japanese population based sample.

g. Had episodes of "acting out" your dreams, such as kicking, punching, running , or

c. Had memories or nightmares of a traumatic experience:

e. Had bad dreams, not related to traumatic memories:

c. What time of night did most memories/nightmares occur? .

d. Had severe anxiety or panic, not related to traumatic memories:

2. If you had memories or nightmares of a traumatic experiences during sleep a. How much anxiety did you feel during the memories/nightmares? b. How much anger did you feel during the memories/ nightmares?

**4.5 Stress coping and sleep hygiene among Japanese people with insomnia** 

(Singareddy & Balon, 2001). Recently, many studies and clinical experiences have suggested that sleep disturbances mainly representing insomnia and nightmare, have a distinct risk of suicide (Nadorff et al., 2011). If not, as some Holocaust survivors presented, impaired sleep and frequent nightmares had been considerable problems, even 45 years after the liberation (Rosen et al., 1991).

This PTSD patient, a 40 year-old careered woman, still suffered from her residual sleep disturbance, even if she partially recovered from her PTSD symptoms and improved her quality of life again, resulting in returning to her work environment. She was firstly presented an anxiety related with insomnia in the context of the accidental loss of her husband in front of her, at the age of 36. This event led her to consult a psychiatrist for the first time, and she has continued to be treated with medication and an individual psychotherapy regularly once a month. Her insomnia, nightmare and occasional suicidal ideation made her continue to maintain her treatment. Of importance, this patient exacerbated suicide ideation every year the day of incident approached. Outside her stabilized period, every time the clinician tried to reduce her nocturnal treament, she exacerbated her sleep complaints and related somatic complaints, alluding to the clinician her suicidal ideations.

For more than three decades, sleep disturbance had been considered the hallmark of PTSD (Hendin et al., 2008; Nadorff et al., 2011). Since insomnia has been observed in 90% of PTSD cases and nightmare related to the trauma in 70%, this is understandable (Hendin et al., 2008). In this case, the clinician has mainly prescribed paroxetine (10-20 mg) and trazodone (25-50 mg) at night to improve subjective sleep disturbances. One of the paradoxical difficulties in psychopharmacology is that there has been increasing awareness of psychotropic-related sleep disruptions in PTSD patients. Especially, it is reported that selective serotonin reuptake inhibitors (SSRIs), usually prescribed as a first-line medication to PTSD, have conversely been associated with clusters of side effects, including insomnia and nightmare symptoms (Li et al., 2010). Trazodone, prescribed at low dose, may reverse the SSRI-induced insomnia; increases the antidepressant effects of SSRIs; promotes sleep through its sedative properties; and suppresses rapid eye movement sleep, thus reducing nightmares associated with PTSD (Sungareddy & Balon, 2001). This case showed that the residual symptoms related with sleep in PTSD resisted, even though the traumatic event had passed away and the patient recovered on a social function level. Probably, most experienced psychiatrists must have had the same treatment impressions before. It is true that sleep disturbance should be more than a marker of PTSD and hence may be important in the identification of suicidal ideation (Nadorff et al., 2011). Recently, Hendin et al. (2008) have insisted on the equal importance of the psychosocial context of trauma in treating sleep disturbance associated with PTSD. It is stressed again that sleep assessment should be considered in the evaluation of suicide risk in PTSD. Both pharmacological and psychotherapeutic approaches to the disorder have concentrated on improving sleep complaints. This case showed us the necessity of long-term sleep-focused approach in order to treat patients suffering from PTSD with suicidal ideation. That implies that incorporating individual psychotherapy, combined with sleep hygiene approach, can lead the patient to recovery from traumatic event in the long term setting. The emotional consequence of suicide will be devastating to the victim's family, friends, community, and society. Studies of incidence, risk and protective factors related to sleep disturbances need to be high on the research agenda across many countries.

#### **4.4 PSQI-A scale**

394 Public Health – Methodology, Environmental and Systems Issues

(Singareddy & Balon, 2001). Recently, many studies and clinical experiences have suggested that sleep disturbances mainly representing insomnia and nightmare, have a distinct risk of suicide (Nadorff et al., 2011). If not, as some Holocaust survivors presented, impaired sleep and frequent nightmares had been considerable problems, even 45 years after the liberation

This PTSD patient, a 40 year-old careered woman, still suffered from her residual sleep disturbance, even if she partially recovered from her PTSD symptoms and improved her quality of life again, resulting in returning to her work environment. She was firstly presented an anxiety related with insomnia in the context of the accidental loss of her husband in front of her, at the age of 36. This event led her to consult a psychiatrist for the first time, and she has continued to be treated with medication and an individual psychotherapy regularly once a month. Her insomnia, nightmare and occasional suicidal ideation made her continue to maintain her treatment. Of importance, this patient exacerbated suicide ideation every year the day of incident approached. Outside her stabilized period, every time the clinician tried to reduce her nocturnal treament, she exacerbated her sleep complaints and related somatic

For more than three decades, sleep disturbance had been considered the hallmark of PTSD (Hendin et al., 2008; Nadorff et al., 2011). Since insomnia has been observed in 90% of PTSD cases and nightmare related to the trauma in 70%, this is understandable (Hendin et al., 2008). In this case, the clinician has mainly prescribed paroxetine (10-20 mg) and trazodone (25-50 mg) at night to improve subjective sleep disturbances. One of the paradoxical difficulties in psychopharmacology is that there has been increasing awareness of psychotropic-related sleep disruptions in PTSD patients. Especially, it is reported that selective serotonin reuptake inhibitors (SSRIs), usually prescribed as a first-line medication to PTSD, have conversely been associated with clusters of side effects, including insomnia and nightmare symptoms (Li et al., 2010). Trazodone, prescribed at low dose, may reverse the SSRI-induced insomnia; increases the antidepressant effects of SSRIs; promotes sleep through its sedative properties; and suppresses rapid eye movement sleep, thus reducing nightmares associated with PTSD (Sungareddy & Balon, 2001). This case showed that the residual symptoms related with sleep in PTSD resisted, even though the traumatic event had passed away and the patient recovered on a social function level. Probably, most experienced psychiatrists must have had the same treatment impressions before. It is true that sleep disturbance should be more than a marker of PTSD and hence may be important in the identification of suicidal ideation (Nadorff et al., 2011). Recently, Hendin et al. (2008) have insisted on the equal importance of the psychosocial context of trauma in treating sleep disturbance associated with PTSD. It is stressed again that sleep assessment should be considered in the evaluation of suicide risk in PTSD. Both pharmacological and psychotherapeutic approaches to the disorder have concentrated on improving sleep complaints. This case showed us the necessity of long-term sleep-focused approach in order to treat patients suffering from PTSD with suicidal ideation. That implies that incorporating individual psychotherapy, combined with sleep hygiene approach, can lead the patient to recovery from traumatic event in the long term setting. The emotional consequence of suicide will be devastating to the victim's family, friends, community, and society. Studies of incidence, risk and protective factors related to sleep disturbances need to be high on the

complaints, alluding to the clinician her suicidal ideations.

research agenda across many countries.

(Rosen et al., 1991).

As this case description shows, PTSD patients report a wide variety of subjective complaints. These subjective sleep disturbances are non-specific and also observed in other sleep disorders and psychiatric clinical samples. For example, PTSD and depressed patients show similar global score on The Pittsburgh Sleep Quality Index, one of the most frequently used self-report instruments to assess sleep quality. Disruptive nocturnal behaviors (DNB), such as trauma-related nightmares, may represent more specific sleep disturbances in PTSD. Recently, Germain *et al.* developed the PSQI Addendum for PTSD (PSQI-A), a brief sleep scale for PTSD, to evaluate DNB (Germain et al., 2005). This self-report instrument consists of 7 items that focus on the frequency of seven DNB, and includes three additional items regarding the frequency of anxiety and anger accompanying DNB and the timing of these events during tht night (Table 3). Such an assessment may support the clinical utility of assessing DNB to determine the need for further PTSD evaluation and intervention.

#### PSQI Addendum for PTSD

	- a. Feel hot flashes:
	- b. Feel general nervousness:
	- c. Had memories or nightmares of a traumatic experience:
	- d. Had severe anxiety or panic, not related to traumatic memories:
	- e. Had bad dreams, not related to traumatic memories:
	- f. Had episodes of terror or screaming during sleep without fully awaking:
	- g. Had episodes of "acting out" your dreams, such as kicking, punching, running , or screaming:
	- a. How much anxiety did you feel during the memories/nightmares?
	- b. How much anger did you feel during the memories/ nightmares?

Table 3. Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) (Germain et al., 2005)

#### **4.5 Stress coping and sleep hygiene among Japanese people with insomnia**

Factors leading to the onset and worsening of insomnia are multidimensional in nature, and many life events and life stresses can result in acute insomnia. Inadequate stress coping behavior also precipitates insomnia, and heightens uneasiness and tension around being unable to sleep, thereby perpetuating the sleeplessness. Furthermore, insomniacs may often engage in poor sleep hygiene, such as having an inadequate sleep environment, lack of daytime activities, and excessive afternoon napping (Abe et al., 2011). The majority of people with insomnia attempt to cope with sleep problems in various ways, have fewer adaptive coping skills, rely more on emotion-focused coping strategies than on problemsolving strategies and report lower feelings of mastery (LeBlanc et al., 2007 ). Reduced quality of life associated with insomnia has already been reported in a general population sample. We have recently studied specific daily stress coping behaviors (SCBs) and sleep hygiene practices (SHPs) of people with insomnia in our Japanese population based sample.

Insomnia and Its Correlates:

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 397

Abe *et al.* have recently studied several specific daily stress coping behaviors and sleep hygiene practices of people with adult insomnia in the Japanese adult general population (Abe et al., 2011). As a result, they clarified that Japanese adults with insomnia might also engage in various maladaptive conducts. They also found that people with insomnia may not necessarily engage in the same behaviors and practices as insomniacs comorbid with depression. Although this study mainly targeted adults, future research needs to examine these aspects among minors in order to clarify the onset of insomnia and its temporal development into chronic adult insomnia. Such minors may be characterized by vulnerabilities in how they perceive and experience stressful life events negatively during adolescent periods. Most of them are not seeking help, thus possibly they will continue to engage in self-help maladaptive practices, such as substance abuse, until they are finally diagnosed with chronic insomnia or depression later (Vollath et al., 1989; Wong et al., 2009).

As far as we know, our study is the first report that investigates stress-coping behaviors among people with insomnia in the general adult population. According to the classical formulation by Lazarus and Folkman (1984), coping behavior refers to cognitive and behavioral efforts to manage external and internal demands (Morin & Espie, 2004). There are two types of coping behaviors: problem-focused and emotion-focused behaviors. With regards to the coping behaviors among people with insomnia, Morin *et al*. indicate that, compared with good sleepers, people with insomnia are apt to perceive their lifestyle as more stressful and choose more emotion-focused coping behaviors (Morin et al., 2003). This does not contradict reports indicating that people with insomnia tend to internalize stress, affecting emotions (Basta et al., 2007). Similar trends were observed in the sample of people with insomnia in this study (Abe et al., 2011). Our multivariable logistic regression analysis revealed that, among the seven SCBs, insomnia was positively related to the emotionfocused coping behaviors of bearing, smoking, eating, and TV/radio. Bearing had the strongest positive correlation with insomnia (OR = 1.69), and an even stronger correlation with insomnia comorbid with depression (OR = 3.44). Therefore, this study indicates that problem-focused behaviors represented by Problem-solving could be helpful in overcoming insomnia. While Ease was not significantly related to insomnia, it had a significant relation with insomnia comorbid with depression (OR = 0.74). This indicates that people with insomnia may not necessarily engage in the same stress-coping behavior as insomniacs comorbid with depression. The present findings indicate that novel therapeutic strategies need to be developed, taking into account both characteristics of insomnia and depression. This study further revealed a strong positive association between Smoking and insomnia (OR = 1.26). Previous research in Europe and in the United States indicates a relationship between nicotine consumption through smoking and poor sleep quality (Morin & Espie, 2004). Furthermore, the strong association between Smoking and insomnia comorbid with depression (OR = 1.73) indicates that individuals with insomnia comorbid with depression tend to rely on more unhealthy coping strategies in their daily life. Our results might highlight the importance of strongly urging people complaining of insomnia to quit smoking. Eating was significantly related to insomnia. A previous epidemiological study reported that irregular eating habits and subjective sleep insufficiency were closely associated. TV/Radio is also significantly related to insomnia. Morin *et al*. indicated that many individuals initiate a variety of self-help strategies to alleviate insomnia, including listening to music and relaxation (Morin et al, 2006). In fact, these individuals may

**4.5.1 Stress coping behaviors among people with insomnia** 

As a result, we clarified that Japanese adults with insomnia might also engage in various maladaptive SCBs and SHPs (Table 4). Most importantly, we found that people with insomnia may not necessarily engage in the same SCB as insomniacs comorbid with depression (Abe & Mishima, 2008). It has often been considered that treatment with insomnia played a bunch of treatments of depression. But, our findings indicated that novel therapeutic strategies need to be developed, taking into account both characteristics of insomnia and depression. These kinds of concrete findings about daily behaviors related with insomnia may offer critical insights for developing effective sleep educational preventive programs in public health, as reported by Morin's group in Canada (Morin et al, 2006). For example, concerning substance dependence, the association between insomnia and its self-medication with alcoholism has been acknowledged (Brower et al., 2001). Our unpublished data in alcoholic groups in Japan also showed that the majority of middle-aged alcoholic patients entering treatment reported insomnia symptoms and recognized themselves their diminished quality of sleep (Asami et al., 2011).


Table 4. Stress coping behavoir and sleep hygien practices in the Japanese general adult sample

As a result, we clarified that Japanese adults with insomnia might also engage in various maladaptive SCBs and SHPs (Table 4). Most importantly, we found that people with insomnia may not necessarily engage in the same SCB as insomniacs comorbid with depression (Abe & Mishima, 2008). It has often been considered that treatment with insomnia played a bunch of treatments of depression. But, our findings indicated that novel therapeutic strategies need to be developed, taking into account both characteristics of insomnia and depression. These kinds of concrete findings about daily behaviors related with insomnia may offer critical insights for developing effective sleep educational preventive programs in public health, as reported by Morin's group in Canada (Morin et al, 2006). For example, concerning substance dependence, the association between insomnia and its self-medication with alcoholism has been acknowledged (Brower et al., 2001). Our unpublished data in alcoholic groups in Japan also showed that the majority of middle-aged alcoholic patients entering treatment reported insomnia symptoms and recognized

Table 4. Stress coping behavoir and sleep hygien practices in the Japanese general adult

sample

themselves their diminished quality of sleep (Asami et al., 2011).

Abe *et al.* have recently studied several specific daily stress coping behaviors and sleep hygiene practices of people with adult insomnia in the Japanese adult general population (Abe et al., 2011). As a result, they clarified that Japanese adults with insomnia might also engage in various maladaptive conducts. They also found that people with insomnia may not necessarily engage in the same behaviors and practices as insomniacs comorbid with depression. Although this study mainly targeted adults, future research needs to examine these aspects among minors in order to clarify the onset of insomnia and its temporal development into chronic adult insomnia. Such minors may be characterized by vulnerabilities in how they perceive and experience stressful life events negatively during adolescent periods. Most of them are not seeking help, thus possibly they will continue to engage in self-help maladaptive practices, such as substance abuse, until they are finally diagnosed with chronic insomnia or depression later (Vollath et al., 1989; Wong et al., 2009).

#### **4.5.1 Stress coping behaviors among people with insomnia**

As far as we know, our study is the first report that investigates stress-coping behaviors among people with insomnia in the general adult population. According to the classical formulation by Lazarus and Folkman (1984), coping behavior refers to cognitive and behavioral efforts to manage external and internal demands (Morin & Espie, 2004). There are two types of coping behaviors: problem-focused and emotion-focused behaviors. With regards to the coping behaviors among people with insomnia, Morin *et al*. indicate that, compared with good sleepers, people with insomnia are apt to perceive their lifestyle as more stressful and choose more emotion-focused coping behaviors (Morin et al., 2003). This does not contradict reports indicating that people with insomnia tend to internalize stress, affecting emotions (Basta et al., 2007). Similar trends were observed in the sample of people with insomnia in this study (Abe et al., 2011). Our multivariable logistic regression analysis revealed that, among the seven SCBs, insomnia was positively related to the emotionfocused coping behaviors of bearing, smoking, eating, and TV/radio. Bearing had the strongest positive correlation with insomnia (OR = 1.69), and an even stronger correlation with insomnia comorbid with depression (OR = 3.44). Therefore, this study indicates that problem-focused behaviors represented by Problem-solving could be helpful in overcoming insomnia. While Ease was not significantly related to insomnia, it had a significant relation with insomnia comorbid with depression (OR = 0.74). This indicates that people with insomnia may not necessarily engage in the same stress-coping behavior as insomniacs comorbid with depression. The present findings indicate that novel therapeutic strategies need to be developed, taking into account both characteristics of insomnia and depression. This study further revealed a strong positive association between Smoking and insomnia (OR = 1.26). Previous research in Europe and in the United States indicates a relationship between nicotine consumption through smoking and poor sleep quality (Morin & Espie, 2004). Furthermore, the strong association between Smoking and insomnia comorbid with depression (OR = 1.73) indicates that individuals with insomnia comorbid with depression tend to rely on more unhealthy coping strategies in their daily life. Our results might highlight the importance of strongly urging people complaining of insomnia to quit smoking. Eating was significantly related to insomnia. A previous epidemiological study reported that irregular eating habits and subjective sleep insufficiency were closely associated. TV/Radio is also significantly related to insomnia. Morin *et al*. indicated that many individuals initiate a variety of self-help strategies to alleviate insomnia, including listening to music and relaxation (Morin et al, 2006). In fact, these individuals may

Insomnia and Its Correlates:

partner (Troxel & Germain, 2011).

in misleading conclusions (Safer, 1997).

**5.1 Epidemiology: Prevalence of adolescent insomnia** 

**5. Adolescent insomnia** 

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 399

and physiological hyperarousal may play an important role in the development and maintenance of the disorder. This hyperarousal concept has just recently been summarized in several review articles. Riemann *et al.* pointed out that it is important to note that two effects are, at least to some extent, opposing in chronic insomnia: on the one hand, sleep deficits or chronic minor sleep loss affects neurobiological processes and neuropsychological performance; on the other hand, there is the elevated arousal level which can be measured in several physiological systems (Riemann et al., 2011). These opposing processes might construct the rather paradoxal psychopathology of insomnia (Baglioni et al., 2010; Riemann et al., 2010, 2011). Needless to say, further studies will be needed to clarify the relationship between insomnia related hyperarousal and suicidality. Perhaps, subtyping insomnia patients according to signs of hyperarousal and the intensity of daytime impairment, such as the intensity of fatigue, might offer a way to disentangle the pathology of suicidality. In this sense, attachment theory may provide a useful framework for considering how the socio-emotional climate influences affect and arousal across the lifespan, and may be particularly important for understanding psychopathology of insomnia. For example, anxious attachment styles which are characterized by 'hyper-activating' strategies during times of threat or stress, may predispose an individual to insomnia by influencing stressarousal systems and cognitions related to the emotional and physical availability of the

Adolescents experience changes in their opposing societal demands, such as early schoolstart times and an increase in the significance of social roles coincide with these physiologic changes (Brand & Kirov, 2011; Liu & Buysse, 2006). These incongruous demands may explain why adolescents are prone to sleep disturbances, such as delayed phase sleep syndrome and insomnia. The multiple changes that adolescents experience can be very stressful, and serve as precipitating factors that activate biological and/or psychological

Studies in adults have already found that insomnia is associated with psychological problems (Singareddy & Balon, 2001). However, little research has explored the relationship between insomnia and mental health during adolescence and young adulthood. Substantially less research has evaluated insomnia and psychological disorders in adolescents. Safer D.J. suggested that adolescents differed from adults in suicidal behavior in their greater attempt rate, higher attempt/completion ratio, and lower rates of short and intermediate completion following psychiatric treatment. He claimed that the frequent practice of combining adult and adolescent suicide and suicide behavior findings can result

Youth and adolescent suicidality constitutes a major public health problem, ranking among the leading causes of death for young people in many countries worldwide. Risk for completed suicide increases dramatically during adolescence, and research implicates an array of associated factors from genetic, biological, psychosocial, and cognitive domains (Bridge et al., 2006; Brand & Kirov, 2011). Sleep disturbances are prevalent not only among adults but also among 10–40% of adolescents (Liu et al., 2000; Johnson et al., 2006; Roane & Taylor, 2008). An estimated 10.7% of adolescents in the general population experience insomnia according to

diathesis, and subsequently, to the development of other mental health problems.

experiment with a variety of these passive emotional focused self-help remedies for a considerable period of time before seeking professional help (Morin & Espie, 2004).

#### **4.5.2 Sleep hygine pracitices among people with insomnia**

There have been several studies that have shown that individuals with insomnia often engage in some inappropriate sleep practices. In a population-based sample of 258 insomniacs, Jefferson *et al*. reported that, compared with healthy people, insomniacs more habitually drank alcohol before going to bed (Jefferson et al., 2005). Our study also demonstrated that alcohol consumption before going to bed is positively related to insomnia. Research in the United States suggests that drinking alcohol is an important risk factor for sleep problems. In their comparison of sleep habits among people in ten different countries, Soldatos *et al*. found that Japan ranked the highest in terms of the prevalence of alcohol use as a sleep aid (30.3%) (Soldatos et al., 2005). Thus, it is critical to provide sleep hygiene education about minimizing alcohol consumption before bedtime to people with insomnia. Our analysis further found that Books/Music was also positively related to insomnia. Some previous studies have reported that reading behavior is significantly more frequent among groups with insomnia than control groups. Morin *et al*. found in their epidemiological survey of a general population in Canada that insomnia syndrome sufferers use music (OR = 2.6) and reading (OR = 1.8) as self-help strategies to facilitate sleeping (Morin et al. 2006). In our study, combining Books and Music into one item in the questionnaire may have comparatively reduced the odds ratio (Table 4). One epidemiological study among Japanese indicates that poor exercise habits are associated with insomnia. Based on this finding, we hypothesized that physical activity would be an inhibiting factor for insomnia symptoms; however, there was no significant relationship between Exercise and insomnia. Previous research suggests that daytime physical activity improves sleep. The inconsistency in the findings might be attributable to the lack of information available regarding the type (level), duration, and frequency of physical activity in our study. While Bath was slightly related to insomnia, it had no significant association with insomnia comorbid with depression. Subjective sleep sufficiency is better for individuals when they take a bath before going to bed rather than when they do not. Taken together, these observations may indicate that taking a bath improves the subjective quality of comorbid depression. By contrast with previous studies, our analysis found no significant association between Regularity and insomnia. This may be attributable to the fact that we did not define the behaviors belonging to this SHP in a concrete manner. Regular exposure to photic and nonphotic time cues (Zeitgebers) for the circadian clock system supposedly stabilizes the acrophases of the sleep–wake rhythm as well as the physiological rhythm, allowing one to fall asleep and maintain sleep more easily (Wirz-Justice et al., 2009). The strong negative association between Regularity and insomnia comorbid with depression (OR = 0.64) found in the present study supports a treatment emphasis on regularity for mood disorders including bipolar disorder.

#### **4.6 Future remarks about insomnia**

The studies of the relationship between insomnia and suicidality started from investigating the relationship between depression and suicidality. It is still needed to clarify whether insomnia could be a distinct factor related to suicidality, even controlling for depression (Pigeon & Caine, 2010). Suicide prevention of depression often includes insomnia, but they are not always in line and insomnia has a distinct psychopathology, different from the one of depression. According to current etiological models of insomnia, a cognitive, emotional and physiological hyperarousal may play an important role in the development and maintenance of the disorder. This hyperarousal concept has just recently been summarized in several review articles. Riemann *et al.* pointed out that it is important to note that two effects are, at least to some extent, opposing in chronic insomnia: on the one hand, sleep deficits or chronic minor sleep loss affects neurobiological processes and neuropsychological performance; on the other hand, there is the elevated arousal level which can be measured in several physiological systems (Riemann et al., 2011). These opposing processes might construct the rather paradoxal psychopathology of insomnia (Baglioni et al., 2010; Riemann et al., 2010, 2011). Needless to say, further studies will be needed to clarify the relationship between insomnia related hyperarousal and suicidality. Perhaps, subtyping insomnia patients according to signs of hyperarousal and the intensity of daytime impairment, such as the intensity of fatigue, might offer a way to disentangle the pathology of suicidality. In this sense, attachment theory may provide a useful framework for considering how the socio-emotional climate influences affect and arousal across the lifespan, and may be particularly important for understanding psychopathology of insomnia. For example, anxious attachment styles which are characterized by 'hyper-activating' strategies during times of threat or stress, may predispose an individual to insomnia by influencing stressarousal systems and cognitions related to the emotional and physical availability of the partner (Troxel & Germain, 2011).

#### **5. Adolescent insomnia**

398 Public Health – Methodology, Environmental and Systems Issues

experiment with a variety of these passive emotional focused self-help remedies for a

There have been several studies that have shown that individuals with insomnia often engage in some inappropriate sleep practices. In a population-based sample of 258 insomniacs, Jefferson *et al*. reported that, compared with healthy people, insomniacs more habitually drank alcohol before going to bed (Jefferson et al., 2005). Our study also demonstrated that alcohol consumption before going to bed is positively related to insomnia. Research in the United States suggests that drinking alcohol is an important risk factor for sleep problems. In their comparison of sleep habits among people in ten different countries, Soldatos *et al*. found that Japan ranked the highest in terms of the prevalence of alcohol use as a sleep aid (30.3%) (Soldatos et al., 2005). Thus, it is critical to provide sleep hygiene education about minimizing alcohol consumption before bedtime to people with insomnia. Our analysis further found that Books/Music was also positively related to insomnia. Some previous studies have reported that reading behavior is significantly more frequent among groups with insomnia than control groups. Morin *et al*. found in their epidemiological survey of a general population in Canada that insomnia syndrome sufferers use music (OR = 2.6) and reading (OR = 1.8) as self-help strategies to facilitate sleeping (Morin et al. 2006). In our study, combining Books and Music into one item in the questionnaire may have comparatively reduced the odds ratio (Table 4). One epidemiological study among Japanese indicates that poor exercise habits are associated with insomnia. Based on this finding, we hypothesized that physical activity would be an inhibiting factor for insomnia symptoms; however, there was no significant relationship between Exercise and insomnia. Previous research suggests that daytime physical activity improves sleep. The inconsistency in the findings might be attributable to the lack of information available regarding the type (level), duration, and frequency of physical activity in our study. While Bath was slightly related to insomnia, it had no significant association with insomnia comorbid with depression. Subjective sleep sufficiency is better for individuals when they take a bath before going to bed rather than when they do not. Taken together, these observations may indicate that taking a bath improves the subjective quality of comorbid depression. By contrast with previous studies, our analysis found no significant association between Regularity and insomnia. This may be attributable to the fact that we did not define the behaviors belonging to this SHP in a concrete manner. Regular exposure to photic and nonphotic time cues (Zeitgebers) for the circadian clock system supposedly stabilizes the acrophases of the sleep–wake rhythm as well as the physiological rhythm, allowing one to fall asleep and maintain sleep more easily (Wirz-Justice et al., 2009). The strong negative association between Regularity and insomnia comorbid with depression (OR = 0.64) found in the present study supports a treatment emphasis on regularity for mood disorders including bipolar

The studies of the relationship between insomnia and suicidality started from investigating the relationship between depression and suicidality. It is still needed to clarify whether insomnia could be a distinct factor related to suicidality, even controlling for depression (Pigeon & Caine, 2010). Suicide prevention of depression often includes insomnia, but they are not always in line and insomnia has a distinct psychopathology, different from the one of depression. According to current etiological models of insomnia, a cognitive, emotional

considerable period of time before seeking professional help (Morin & Espie, 2004).

**4.5.2 Sleep hygine pracitices among people with insomnia** 

disorder.

**4.6 Future remarks about insomnia** 

Adolescents experience changes in their opposing societal demands, such as early schoolstart times and an increase in the significance of social roles coincide with these physiologic changes (Brand & Kirov, 2011; Liu & Buysse, 2006). These incongruous demands may explain why adolescents are prone to sleep disturbances, such as delayed phase sleep syndrome and insomnia. The multiple changes that adolescents experience can be very stressful, and serve as precipitating factors that activate biological and/or psychological diathesis, and subsequently, to the development of other mental health problems.

Studies in adults have already found that insomnia is associated with psychological problems (Singareddy & Balon, 2001). However, little research has explored the relationship between insomnia and mental health during adolescence and young adulthood. Substantially less research has evaluated insomnia and psychological disorders in adolescents. Safer D.J. suggested that adolescents differed from adults in suicidal behavior in their greater attempt rate, higher attempt/completion ratio, and lower rates of short and intermediate completion following psychiatric treatment. He claimed that the frequent practice of combining adult and adolescent suicide and suicide behavior findings can result in misleading conclusions (Safer, 1997).

#### **5.1 Epidemiology: Prevalence of adolescent insomnia**

Youth and adolescent suicidality constitutes a major public health problem, ranking among the leading causes of death for young people in many countries worldwide. Risk for completed suicide increases dramatically during adolescence, and research implicates an array of associated factors from genetic, biological, psychosocial, and cognitive domains (Bridge et al., 2006; Brand & Kirov, 2011). Sleep disturbances are prevalent not only among adults but also among 10–40% of adolescents (Liu et al., 2000; Johnson et al., 2006; Roane & Taylor, 2008). An estimated 10.7% of adolescents in the general population experience insomnia according to

Insomnia and Its Correlates:

to dysphoria (Tamas et al., 2007).

ideation in primary care.

changes in this population (Liu & Buysse, 2006).

positive emotions on sleep among adolescents and youth adults.

**6.1 Sleep disturbances in mental health epidemiology** 

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 401

with adolescent suicide, such as stress and contagion, bullying and peer victimization may also be different from adults. Alcohol and drug abuse contribute significantly to the risk of suicide in teenagers (Apter et al., 1995). Additional potential contributors to suicidal behavior in depressed adolescents are early defined traits such as temperament and emotional regulation. One recent study suggests that suicidal youth are characterized by highly maladaptive regulatory responses and low adaptive emotional regulation responses

College students will be an ideal population to examine sleep disturbances and mental health relationships (Yang et al., 2003; Taylor et al., 2010; Nardoff et al., 2011). Yang *et al*. investigated the 1,922 first year college students' coping strategies for sleep disturbances and their effectiveness in Taiwan (Yang et al., 2003). They pointed out the relative lack of effective coping strategies for the management of such problems in this population. The results showed that taking naps and adjusting sleep schedules were coping strategies associated with better sleep quality. As mentioned throughout, the young adult age group is particularly susceptible to the onset of major psychiatric disorders. If so, the next logical step would be to develop primary and secondary sleep prevention programs for behavioral

Brand *et al*. evaluated the effect of early stage intense romantic love on sleep quality in 113 adolescents (mean age: 17.8) (Brand et al., 2007, 2010). The research showed that adolescents reported significantly less daily sleepiness, higher daily concentration, more physical activity, and better mood compared to the other groups. Intense love in adolescents seems to be comparable with hypomanic state of bipolar mood spectrum. Intense positive emotions could disturb sleep quantity through the presence of heightened psychophysiological arousal, while improving perceived sleep quality and daytime activity. At least, combined PSG or actigraphic studies may be needed to understand the effects of such intense and

**6. Another symptomatic aspect: Insomnia and nightmare, distinct suicide risk?** 

Clinical observations have showed that nocturnal sleep disturbances, including insomnia and recurrent nightmares, represent common distressing sleep complaints that might have important prognostic and therapeutic implications in psychiatric patients. Epidemiological studies have demonstrated that insomnia, nightmares, and sleep insufficiency are associated with elevated risk for suicide. Several studies have suggested an independent predictive role of nightmares in future suicidal behavior. It should be more noticed that nightmares may be more than a marker of PTSD and really important in the identification of suicidal

There is a consensus that one growing area of research in mental health includes the study of the relationship between sleep disturbances and suicidality in this decade (Ağargün & Beşiroğlu, 2005; Bernert et al., 2005; Bernert & Joiner, 2007; Pigeon & Caine, 2010). Increasing evidence in both clinical and epidemiological studies suggests that disturbances in sleep are

**5.3 Sleep problems in highschoolers, students and youth sample** 

DSM-IV criteria (Johnson et al., 2006). Roane & Tayler also showed that insomnia symptoms were reported by 9.4% of the 4495 adolescents, 12 to 18 years old, suggesting that one out of ten adolescents met the criteria for insomnia (Roane & Taylor, 2008). The authors examined adolescent insomnia as a risk factor for mental health problems in a longitudinal study. They concluded that insomnia should be treated with specific interventions as an independent disorder in adolescents (Taylor & Roane, 2010). The Japanese research team of Ohida *et al.* has performed large-scale epidemiological studies on the sleep status of Japanese adolescents (Ohida et al., 2004; Kaneita et al., 2006). In a survey of approximately 106,300 Japanese junior and high school students, 30.6% reported an average sleep duration of less than 6h per night. Of these, 12.5% reported excessive daytime sleepiness, and 40% were not satisfied with their sleep quality (Ohida et al., 2004). Another survey reported that 23.5% of adolescents experienced symptoms of insomnia (Kaneita et al., 2006). Most studies of sleep disturbances among adolescents have focused on sleep deprivation and insomnia, and other types of sleep disturbances have not been adequately addressed.

#### **5.2 Adolescent insomnia and suicidality**

Sleep undergoes substantial changes during adolescence and suicide risk begins to increase during this period as well (Liu & Buysse, 2006; Wong et al., 2011). Adolescent sleep is characterized by widespread sleep restriction, irregular sleep schedules, daytime sleepiness, and elevated risk for sleep disturbances (Gangwisch et al., 2010). Sleep is indispensable in terms of brain maturation and learning for adolescents. Maladaptive sleep habits prevent them from growing, even run a risk of increasing suicide ideation. Sleep loss or disturbances are likely to signal an increased risk of future suicidal action in adolescents. Large-scale prospective studies and neurobiological studies are needed for a better understanding of the complex relationship between sleep, psychopathology, and youth suicidal behavior.

Research with adolescents has demonstrated a clear relationship between suicidal ideation and sleep problems. Cross-sectional studies have found that adolescents with insomnia experience more depressive symptoms, and suicide ideations and attempts and are more likely to use alcohol, cigarettes, illicit drugs, or a combination of these substances. In a provident epidemiological study of French teenagers, Choquet *et al*. found that adolescents with suicidal ideation reported more insomnia as well as more nightmares than adolescents who denied suicidal ideation (Choquet & Menke, 1990). In their subsequent study, suicidal ideation was linked to more sleep difficulties and frequent feelings of daytime tiredness (Choquet et al., 1993). It follows that the findings linking sleep disturbance with suicidality may serve as a proxy for severity of insomnia comorbid with depression more generally.

Better understanding the relationship between disturbed sleep and suicidality in adolescents may also serve for suicide prevention with this population (Goldstein et al., 2008). There is evidence to suggest that some factors associated with adolescent suicide may be different from adult suicide (Safer, 1997). For example, although impulsive–aggressive behavior is a common risk factor for both adult and teenage suicide, aggression and impulsivity are traits highly related to suicidal behavior in adolescents (Apter et al., 1995). Higher levels of impulsive aggressiveness play a greater role in suicide among younger individuals with importance decreasing with age. Adolescents with aggression and conduct disorders may be suicidal even in the absence of depression. Psychosocial factors associated

DSM-IV criteria (Johnson et al., 2006). Roane & Tayler also showed that insomnia symptoms were reported by 9.4% of the 4495 adolescents, 12 to 18 years old, suggesting that one out of ten adolescents met the criteria for insomnia (Roane & Taylor, 2008). The authors examined adolescent insomnia as a risk factor for mental health problems in a longitudinal study. They concluded that insomnia should be treated with specific interventions as an independent disorder in adolescents (Taylor & Roane, 2010). The Japanese research team of Ohida *et al.* has performed large-scale epidemiological studies on the sleep status of Japanese adolescents (Ohida et al., 2004; Kaneita et al., 2006). In a survey of approximately 106,300 Japanese junior and high school students, 30.6% reported an average sleep duration of less than 6h per night. Of these, 12.5% reported excessive daytime sleepiness, and 40% were not satisfied with their sleep quality (Ohida et al., 2004). Another survey reported that 23.5% of adolescents experienced symptoms of insomnia (Kaneita et al., 2006). Most studies of sleep disturbances among adolescents have focused on sleep deprivation and insomnia, and other types of sleep

Sleep undergoes substantial changes during adolescence and suicide risk begins to increase during this period as well (Liu & Buysse, 2006; Wong et al., 2011). Adolescent sleep is characterized by widespread sleep restriction, irregular sleep schedules, daytime sleepiness, and elevated risk for sleep disturbances (Gangwisch et al., 2010). Sleep is indispensable in terms of brain maturation and learning for adolescents. Maladaptive sleep habits prevent them from growing, even run a risk of increasing suicide ideation. Sleep loss or disturbances are likely to signal an increased risk of future suicidal action in adolescents. Large-scale prospective studies and neurobiological studies are needed for a better understanding of the

complex relationship between sleep, psychopathology, and youth suicidal behavior.

Research with adolescents has demonstrated a clear relationship between suicidal ideation and sleep problems. Cross-sectional studies have found that adolescents with insomnia experience more depressive symptoms, and suicide ideations and attempts and are more likely to use alcohol, cigarettes, illicit drugs, or a combination of these substances. In a provident epidemiological study of French teenagers, Choquet *et al*. found that adolescents with suicidal ideation reported more insomnia as well as more nightmares than adolescents who denied suicidal ideation (Choquet & Menke, 1990). In their subsequent study, suicidal ideation was linked to more sleep difficulties and frequent feelings of daytime tiredness (Choquet et al., 1993). It follows that the findings linking sleep disturbance with suicidality may serve as a proxy for severity of insomnia

Better understanding the relationship between disturbed sleep and suicidality in adolescents may also serve for suicide prevention with this population (Goldstein et al., 2008). There is evidence to suggest that some factors associated with adolescent suicide may be different from adult suicide (Safer, 1997). For example, although impulsive–aggressive behavior is a common risk factor for both adult and teenage suicide, aggression and impulsivity are traits highly related to suicidal behavior in adolescents (Apter et al., 1995). Higher levels of impulsive aggressiveness play a greater role in suicide among younger individuals with importance decreasing with age. Adolescents with aggression and conduct disorders may be suicidal even in the absence of depression. Psychosocial factors associated

disturbances have not been adequately addressed.

**5.2 Adolescent insomnia and suicidality** 

comorbid with depression more generally.

with adolescent suicide, such as stress and contagion, bullying and peer victimization may also be different from adults. Alcohol and drug abuse contribute significantly to the risk of suicide in teenagers (Apter et al., 1995). Additional potential contributors to suicidal behavior in depressed adolescents are early defined traits such as temperament and emotional regulation. One recent study suggests that suicidal youth are characterized by highly maladaptive regulatory responses and low adaptive emotional regulation responses to dysphoria (Tamas et al., 2007).

#### **5.3 Sleep problems in highschoolers, students and youth sample**

College students will be an ideal population to examine sleep disturbances and mental health relationships (Yang et al., 2003; Taylor et al., 2010; Nardoff et al., 2011). Yang *et al*. investigated the 1,922 first year college students' coping strategies for sleep disturbances and their effectiveness in Taiwan (Yang et al., 2003). They pointed out the relative lack of effective coping strategies for the management of such problems in this population. The results showed that taking naps and adjusting sleep schedules were coping strategies associated with better sleep quality. As mentioned throughout, the young adult age group is particularly susceptible to the onset of major psychiatric disorders. If so, the next logical step would be to develop primary and secondary sleep prevention programs for behavioral changes in this population (Liu & Buysse, 2006).

Brand *et al*. evaluated the effect of early stage intense romantic love on sleep quality in 113 adolescents (mean age: 17.8) (Brand et al., 2007, 2010). The research showed that adolescents reported significantly less daily sleepiness, higher daily concentration, more physical activity, and better mood compared to the other groups. Intense love in adolescents seems to be comparable with hypomanic state of bipolar mood spectrum. Intense positive emotions could disturb sleep quantity through the presence of heightened psychophysiological arousal, while improving perceived sleep quality and daytime activity. At least, combined PSG or actigraphic studies may be needed to understand the effects of such intense and positive emotions on sleep among adolescents and youth adults.

#### **6. Another symptomatic aspect: Insomnia and nightmare, distinct suicide risk?**

Clinical observations have showed that nocturnal sleep disturbances, including insomnia and recurrent nightmares, represent common distressing sleep complaints that might have important prognostic and therapeutic implications in psychiatric patients. Epidemiological studies have demonstrated that insomnia, nightmares, and sleep insufficiency are associated with elevated risk for suicide. Several studies have suggested an independent predictive role of nightmares in future suicidal behavior. It should be more noticed that nightmares may be more than a marker of PTSD and really important in the identification of suicidal ideation in primary care.

#### **6.1 Sleep disturbances in mental health epidemiology**

There is a consensus that one growing area of research in mental health includes the study of the relationship between sleep disturbances and suicidality in this decade (Ağargün & Beşiroğlu, 2005; Bernert et al., 2005; Bernert & Joiner, 2007; Pigeon & Caine, 2010). Increasing evidence in both clinical and epidemiological studies suggests that disturbances in sleep are

Insomnia and Its Correlates:

purposes.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 403

retrospectively reviewed for a 7-year period in Tokyo to examine time-of-day and documented suicide attempts. Results indicated that suicide attempts showed a peak earlier

Selvi *et al.* assessed 80 patients clinically diagnosed with major depression and 80 healthy subjects who were demographically matched with the patient group (Selvi et al., 2010). Results showed that morningness-type circadian rhythm may play as a significant relief factor after the onset of major depression, but sleep variables of chronotype and sleep quality did not significantly predict suicide ideation after controlling for depressive symptoms in the major depression group. They concluded that suicide ideation and poor sleep quality were antecedents of depression symptom severity in patients with major depression. They discussed these findings under the theoretical assumptions concerning possible relations

In studying time-related risk factors, additional research is needed, particularly studies that better define the severity of suicidal behaviors. It will be important for such studies to carefully distinguish suicide attempts and deliberate self-harm with an intent to die from self harm behaviors without suicidal intent. Investigation of the timing of sleep and suicidal acts may inform risk assessment procedures, emergency responding and surveillance, as well as treatment (Bernert & Joiner, 2007). There is an association between circadian rhythms and suicidality. This topic has always been investigated in terms of diurnal fluctuation of symptoms related to depression or Seasonal Affective Disorder (Wirz-Justice et al., 2009). Future research will also be necessary to thoroughly evaluate chronobiological correlates of suicidality in non-clinical samples for preventative

Sleep abnormalities are common in patients with suicidal behavior. Sleep complaints such as insomnia, hypersomnia, nightmare, and sleep panic attacks are frequent in suicidal adolescents and adults. Results from school-based survey in the USA indicate that whereas insomnia and hypersomnia independently increase risk for suicidal ideation in adolescents, the presence of both insomnia and hypersomnia incurs further increased suicidal risk in this population (Roberts et al., 2001). In another study, a significant and temporal relationship between sleep problems and completed suicide has been observed (Goldstein et al., 2008). Considerable evidence supports a strong link between sleep disturbances and suicidality

In 2003, an innovative theoretical model, called "sleep synaptic hypothesis", reflecting on the significance of slow-wave activity and its homeostatic regulation was proposed (Tononi & Cirelli, 2003). According to this hypothesis, neuroplastic processes occurring during wakefulness result in a net increase in synaptic strength in many brain circuits. The role of sleep is to downscale synaptic strength to a baseline level that is energetically sustainable, makes efficient use of gray matter space, and is beneficial for learning and memory. Thus, sleep is the price we have to pay for plasticity, and its goal is the homeostatic regulation of the total synaptic weight impinging on neuron (Tononi & Cirelli, 2003, 2006). It has been suggested that wakefulness is associated with synaptic potentiation in several cortical circuits; synaptic potentiation is tied to the homeostatic regulation of slow-wave activity;

in the evening (18h00) compared to the morning (Motohashi, 1990).

**6.3 Sleep homeostasis hypothesis and suicidality** 

but the pathway remains to be established (Sher, 2008).

between chronotype, sleep quality, depression, and suicidality (Selvi et al., 2010).

associated with an elevated risk for suicidal behaviors. Both sleep disorders and general sleep complaints appear to be linked to greater levels of suicidal ideation and depression, as well as both attempted and completed suicide (Fawcett et al., 1990; Ağargün et al., 1997; Krakow et al., 2000). As these provident studies have already stressed, one major expected suggestion is that sleep disturbances may have prognostic significance in predicting suicide among patients with depression. A recent study conducted in Japan, Fujino *et al.* showed that, among 13,259 middle-aged adults, only difficulty maintaining sleep (sleep maintenance insomnia), compared to other sleep disturbances (e.g., difficulty initiating sleep, nonrestorative sleep), significantly predicted death by suicide 14 years later (Fujino et al., 2005). But, depression was not accounted for when examining the association between sleep and completed suicide. Such findings would often elucidate whether sleep disturbances stand alone as a risk factor for completed suicide or, conversely, whether such sleep complaints simply vary with increased depressive symptoms (Ağargün & Beşiroğlu, 2005; Fujino et al., 2005). Sleep problems and more specifically, significant changes in sleep, have been considered as warning signs of suicide in many mental health policies. Thus, improvement in the identification of risk factors for suicidal behaviors and possible early intervention and postvention thus ultimately enhance our competence to intervene and prevent death by suicide (Krakow et al., 2011).

Fawcett *et al.* conducted the first study to prospectively examine sleep, depression and suicide in 1990 (Fawcett et al., 1990). They considered insomnia to be one of the 'modifiable risks' for suicide in patients with depression. Ağargün *et al.* demonstrated a significant association between poor sleep quality and suicidal behavior in depression (Ağargün et al., 1997). Further studies will be needed to the posssible intervention with regard to suicidality.

Again, does insomnia (sleep disturbances) still manifest distinct suicide risk, even controlling after several confounding factors? During several years, many studies and clinical experiences have tried to investigate this concern (Wojnar et al., 2009; Li et al., 2010; Pigeon & Caine, 2010). But, this question was already asked nearly one century ago by a British doctor. In 1914, in the medical journal Lancet, Pronger wrote an epoch-making article, entitled "Insomnia and Suicide" (Pronger, 1914). His clinical intuition still impresses us enormously, even about one century afterwards. A recent clinical case report stressed again that sleep assessment should be considered in the evaluation of suicide risk in depressed patients (Mahgoub, 2009).

#### **6.2 Chronobiogical factors and diurnal fluctuation of suicidality**

The study of chronobiological factors in the relationship between sleep and suicidal behaviors remains a largely unexplored, yet fruitful area of research (Ağargün & Beşiroğlu, 2005; Bernert & Joiner, 2007). A diurnal variation in the tiling of self-injurious behaviors and completed suicide is supported by several reports. Blenkiron *et al*. prospectively assessed 158 patients presenting at a hospital referred for psychiatric assessment due to deliberate self-harm (Blenkiron et al., 2000). The authors classified these deliberate self-harm incidents as suicide attempters, and concluded that the frequency of these acts were higher in the evening and lower in the early morning hours. They also showed a bimodal peak in frequency for deliberate self-harm among older and younger adults. And they concluded that the severity of deliberate self-harm appeared to vary according to the time of day (Blenkiron et al., 2000). In another study in Japan, ambulance report records were

associated with an elevated risk for suicidal behaviors. Both sleep disorders and general sleep complaints appear to be linked to greater levels of suicidal ideation and depression, as well as both attempted and completed suicide (Fawcett et al., 1990; Ağargün et al., 1997; Krakow et al., 2000). As these provident studies have already stressed, one major expected suggestion is that sleep disturbances may have prognostic significance in predicting suicide among patients with depression. A recent study conducted in Japan, Fujino *et al.* showed that, among 13,259 middle-aged adults, only difficulty maintaining sleep (sleep maintenance insomnia), compared to other sleep disturbances (e.g., difficulty initiating sleep, nonrestorative sleep), significantly predicted death by suicide 14 years later (Fujino et al., 2005). But, depression was not accounted for when examining the association between sleep and completed suicide. Such findings would often elucidate whether sleep disturbances stand alone as a risk factor for completed suicide or, conversely, whether such sleep complaints simply vary with increased depressive symptoms (Ağargün & Beşiroğlu, 2005; Fujino et al., 2005). Sleep problems and more specifically, significant changes in sleep, have been considered as warning signs of suicide in many mental health policies. Thus, improvement in the identification of risk factors for suicidal behaviors and possible early intervention and postvention thus ultimately enhance our competence to intervene and

Fawcett *et al.* conducted the first study to prospectively examine sleep, depression and suicide in 1990 (Fawcett et al., 1990). They considered insomnia to be one of the 'modifiable risks' for suicide in patients with depression. Ağargün *et al.* demonstrated a significant association between poor sleep quality and suicidal behavior in depression (Ağargün et al., 1997). Further studies will be needed to the posssible intervention with regard to suicidality. Again, does insomnia (sleep disturbances) still manifest distinct suicide risk, even controlling after several confounding factors? During several years, many studies and clinical experiences have tried to investigate this concern (Wojnar et al., 2009; Li et al., 2010; Pigeon & Caine, 2010). But, this question was already asked nearly one century ago by a British doctor. In 1914, in the medical journal Lancet, Pronger wrote an epoch-making article, entitled "Insomnia and Suicide" (Pronger, 1914). His clinical intuition still impresses us enormously, even about one century afterwards. A recent clinical case report stressed again that sleep assessment should be considered in the evaluation of suicide risk in

The study of chronobiological factors in the relationship between sleep and suicidal behaviors remains a largely unexplored, yet fruitful area of research (Ağargün & Beşiroğlu, 2005; Bernert & Joiner, 2007). A diurnal variation in the tiling of self-injurious behaviors and completed suicide is supported by several reports. Blenkiron *et al*. prospectively assessed 158 patients presenting at a hospital referred for psychiatric assessment due to deliberate self-harm (Blenkiron et al., 2000). The authors classified these deliberate self-harm incidents as suicide attempters, and concluded that the frequency of these acts were higher in the evening and lower in the early morning hours. They also showed a bimodal peak in frequency for deliberate self-harm among older and younger adults. And they concluded that the severity of deliberate self-harm appeared to vary according to the time of day (Blenkiron et al., 2000). In another study in Japan, ambulance report records were

prevent death by suicide (Krakow et al., 2011).

depressed patients (Mahgoub, 2009).

**6.2 Chronobiogical factors and diurnal fluctuation of suicidality** 

retrospectively reviewed for a 7-year period in Tokyo to examine time-of-day and documented suicide attempts. Results indicated that suicide attempts showed a peak earlier in the evening (18h00) compared to the morning (Motohashi, 1990).

Selvi *et al.* assessed 80 patients clinically diagnosed with major depression and 80 healthy subjects who were demographically matched with the patient group (Selvi et al., 2010). Results showed that morningness-type circadian rhythm may play as a significant relief factor after the onset of major depression, but sleep variables of chronotype and sleep quality did not significantly predict suicide ideation after controlling for depressive symptoms in the major depression group. They concluded that suicide ideation and poor sleep quality were antecedents of depression symptom severity in patients with major depression. They discussed these findings under the theoretical assumptions concerning possible relations between chronotype, sleep quality, depression, and suicidality (Selvi et al., 2010).

In studying time-related risk factors, additional research is needed, particularly studies that better define the severity of suicidal behaviors. It will be important for such studies to carefully distinguish suicide attempts and deliberate self-harm with an intent to die from self harm behaviors without suicidal intent. Investigation of the timing of sleep and suicidal acts may inform risk assessment procedures, emergency responding and surveillance, as well as treatment (Bernert & Joiner, 2007). There is an association between circadian rhythms and suicidality. This topic has always been investigated in terms of diurnal fluctuation of symptoms related to depression or Seasonal Affective Disorder (Wirz-Justice et al., 2009). Future research will also be necessary to thoroughly evaluate chronobiological correlates of suicidality in non-clinical samples for preventative purposes.

#### **6.3 Sleep homeostasis hypothesis and suicidality**

Sleep abnormalities are common in patients with suicidal behavior. Sleep complaints such as insomnia, hypersomnia, nightmare, and sleep panic attacks are frequent in suicidal adolescents and adults. Results from school-based survey in the USA indicate that whereas insomnia and hypersomnia independently increase risk for suicidal ideation in adolescents, the presence of both insomnia and hypersomnia incurs further increased suicidal risk in this population (Roberts et al., 2001). In another study, a significant and temporal relationship between sleep problems and completed suicide has been observed (Goldstein et al., 2008). Considerable evidence supports a strong link between sleep disturbances and suicidality but the pathway remains to be established (Sher, 2008).

In 2003, an innovative theoretical model, called "sleep synaptic hypothesis", reflecting on the significance of slow-wave activity and its homeostatic regulation was proposed (Tononi & Cirelli, 2003). According to this hypothesis, neuroplastic processes occurring during wakefulness result in a net increase in synaptic strength in many brain circuits. The role of sleep is to downscale synaptic strength to a baseline level that is energetically sustainable, makes efficient use of gray matter space, and is beneficial for learning and memory. Thus, sleep is the price we have to pay for plasticity, and its goal is the homeostatic regulation of the total synaptic weight impinging on neuron (Tononi & Cirelli, 2003, 2006). It has been suggested that wakefulness is associated with synaptic potentiation in several cortical circuits; synaptic potentiation is tied to the homeostatic regulation of slow-wave activity;

Insomnia and Its Correlates:

Nightmare Disorder

alert.

areas of functioning.

medical condition.

**7.2 Nightmare; Etiology** 

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 405

A. Repeated occurrences of extended, extremely dysphoric and well-remembered dreams that usually involve efforts to avoid threats to survival, security or physical integrity

B. On awakening from the dysphoric dreams, the person rapidly becomes oriented and

C. The dream experience, or the sleep disturbance produced by awakening from it, causes clinically significant distress or impairment in social, occupational, or other important

D. The dysphoric dreams do not occur exclusively during the course of another mental disorder (e.g., a delirium, Posttraumatic Stress Disorder) and are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general

Because nightmares are often, but not necessarily, associated with PTSD, many specialists distinguish post-traumatic and non-traumatic (idiopathic) nightmares (Hasler & Germain, 2009; Levin & Nielsen, 2009). Post-traumatic nightmares reflect the long-lasting effect of a wakeful traumatic experience, whereas the cause of non-traumatic nightmares is unknown. Numerous studies have found that nightmare frequency is associated with psychopathological symptoms (Levin & Nielsen, 2007), but because most of these studies do not strictly distinguish between post-traumatic and non-traumatic nightmares, the interpretation of the results is ambiguous. Levin & Nielsen described six broad psychopathological categories that are associated with nightmares: anxiety symptoms, neuroticism and global symptom reporting, schizophrenia-spectrum disorders, other psychiatric disorders, behavioral health problems and sleep disturbances, and PTSD (Levin & Nielsen, 2007). A common feature of these pathologies is notable waking emotional distress, suggesting that nightmares may play a role in processing of these experiences. The studied reviewed above also suggest that the connection between early experiences, brain development, and nightmare experiences might involve failures in emotion regulation (Nielsen et al, 2006; Levin & Nielsen, 2009). Current models of nightmare production seem to emphasize negative emotionality as having a central role in determining dream affects. Ağargün *et al.* previously reported that the prevalence of childhood traumatic experiences was higher among adult who ''often'' had nightmares than among adults who ''sometimes'' or ''never'' had nightmares (Ağargün et al., 2003). With regard to the associations between nightmares and mental health status, Nielsen *et al*. studied adolescents (aged 13–16) and reported a significant association between the frequency of nightmares and the level of anxiety (Nielsen et al., 2006). To date, very few studies have investigated the prevalence of nightmares in adolescents, compared to adults. In Japan, analyzing 90,081 nationwide adolescent sampled data, Munezawa *et al.* showed that the prevalence of nightmares was 35.2% among Japanese adolescents (more than one third) (Munezawa et al., 2011). The results of this study should be considered in the prevention of nightmares among Japanese

and that generally occur during the second half of the major sleep episode.

Table 5. DSM-5 proposed criteria for nightmare disorder ([84], 2010).

slow-wave activity is associated with synaptic downscaling; and active synaptic downscaling occurring during sleep is beneficial for cellular functions and is tied to overnight performance improvement.

Hence, many aspects of behavioral performance improve after sleep and are negatively affected by sleep deprivation, and it is conceivable that avoiding synaptic overload by maintaining synaptic homeostasis would be beneficial for many cellular processes, such as energy metabolism and membrane maintenance. Clinically, sleep deprivation may affect fatigue complaints and the production of dreams, which is particularly important for adolescent's development. It is possible that disruption of synaptic homeostasis underlies sleep abnormalities, leading or contributing to suicidal behavior. Serotonergic mechanisms may affect sleep regulation, are implicated in the pathophysiology of suicidal behavior, and may be involved in the relation between sleep abnormalities, synaptic homeostasis and suicidal behavior (Sher, 2008). Taken together, theoretically, sleep difficulties should be considered in prevention and intervention effort for patients at risk for suicide. Prevention effort should target good sleep hygiene and early detection and treatment of problematic sleep patterns in order to decrease risk for suicide (Liu & Buysse, 2006). Better understanding of the relationship between disturbed sleep and suicidality may serve to inform effort for suicide prevention.

#### **7. Nightmares**

#### **7.1 Nightmare; Definition and epidemiology**

Both insomnia and nightmare showed classical and, at the same time, a novel symptomatic aspect in psychiatric epidemiology. Clinical observations have showed that nocturnal sleep disturbances, including insomnia and recurrent nightmares, represent common distressing sleep complaints that might have important prognostic and therapeutic implications in psychiatric patients. Epidemiological studies have demonstrated that insomnia, nightmares, and sleep insufficiency are associated with elevated risk for suicide (Hasler & Germain, 2009).

Dreams are a remarkable experiment in psychology and neuroscience, conducted every night in every sleeping person. They show that the human brain, disconnected from the environment, can generate an entire world of conscious experiences by itself (Nir & Tononi, 2010). Both DSM-IV and ICSD-2 criteria converge on defining nightmares as intensely disturbing dreams that awaken the dreamer to a fully conscious state and generally occur in the latter half of the sleep period (Table 5.).

Lifetime prevalence of nightmares in the general population is unknown, but large epidemiological studies indicate that about 85% of adults have experienced at least one nightmare within the past year (Levin & Nielsen, 2007). Further investigations suggest that the prevalence may almost approach 100%! The estimated frequency of clinically significant nightmares (occurring at least weekly) is 4–10% in the general population (Nielsen et al., 2006). Similar rates are reported from different cultures. There is a significant gender difference in nightmare frequency, with women of all ages reporting nightmares more frequently than men. Age is also relevant: nightmares are less frequent among the elderly (Levin & Nielsen, 2007; Nielsen et al., 2006).

#### Nightmare Disorder

404 Public Health – Methodology, Environmental and Systems Issues

slow-wave activity is associated with synaptic downscaling; and active synaptic downscaling occurring during sleep is beneficial for cellular functions and is tied to

Hence, many aspects of behavioral performance improve after sleep and are negatively affected by sleep deprivation, and it is conceivable that avoiding synaptic overload by maintaining synaptic homeostasis would be beneficial for many cellular processes, such as energy metabolism and membrane maintenance. Clinically, sleep deprivation may affect fatigue complaints and the production of dreams, which is particularly important for adolescent's development. It is possible that disruption of synaptic homeostasis underlies sleep abnormalities, leading or contributing to suicidal behavior. Serotonergic mechanisms may affect sleep regulation, are implicated in the pathophysiology of suicidal behavior, and may be involved in the relation between sleep abnormalities, synaptic homeostasis and suicidal behavior (Sher, 2008). Taken together, theoretically, sleep difficulties should be considered in prevention and intervention effort for patients at risk for suicide. Prevention effort should target good sleep hygiene and early detection and treatment of problematic sleep patterns in order to decrease risk for suicide (Liu & Buysse, 2006). Better understanding of the relationship between disturbed sleep and suicidality may serve to

Both insomnia and nightmare showed classical and, at the same time, a novel symptomatic aspect in psychiatric epidemiology. Clinical observations have showed that nocturnal sleep disturbances, including insomnia and recurrent nightmares, represent common distressing sleep complaints that might have important prognostic and therapeutic implications in psychiatric patients. Epidemiological studies have demonstrated that insomnia, nightmares, and sleep insufficiency are associated with elevated risk for suicide (Hasler & Germain,

Dreams are a remarkable experiment in psychology and neuroscience, conducted every night in every sleeping person. They show that the human brain, disconnected from the environment, can generate an entire world of conscious experiences by itself (Nir & Tononi, 2010). Both DSM-IV and ICSD-2 criteria converge on defining nightmares as intensely disturbing dreams that awaken the dreamer to a fully conscious state and generally occur in

Lifetime prevalence of nightmares in the general population is unknown, but large epidemiological studies indicate that about 85% of adults have experienced at least one nightmare within the past year (Levin & Nielsen, 2007). Further investigations suggest that the prevalence may almost approach 100%! The estimated frequency of clinically significant nightmares (occurring at least weekly) is 4–10% in the general population (Nielsen et al., 2006). Similar rates are reported from different cultures. There is a significant gender difference in nightmare frequency, with women of all ages reporting nightmares more frequently than men. Age is also relevant: nightmares are less frequent among the elderly

overnight performance improvement.

inform effort for suicide prevention.

**7.1 Nightmare; Definition and epidemiology** 

the latter half of the sleep period (Table 5.).

(Levin & Nielsen, 2007; Nielsen et al., 2006).

**7. Nightmares** 

2009).


Table 5. DSM-5 proposed criteria for nightmare disorder ([84], 2010).

#### **7.2 Nightmare; Etiology**

Because nightmares are often, but not necessarily, associated with PTSD, many specialists distinguish post-traumatic and non-traumatic (idiopathic) nightmares (Hasler & Germain, 2009; Levin & Nielsen, 2009). Post-traumatic nightmares reflect the long-lasting effect of a wakeful traumatic experience, whereas the cause of non-traumatic nightmares is unknown. Numerous studies have found that nightmare frequency is associated with psychopathological symptoms (Levin & Nielsen, 2007), but because most of these studies do not strictly distinguish between post-traumatic and non-traumatic nightmares, the interpretation of the results is ambiguous. Levin & Nielsen described six broad psychopathological categories that are associated with nightmares: anxiety symptoms, neuroticism and global symptom reporting, schizophrenia-spectrum disorders, other psychiatric disorders, behavioral health problems and sleep disturbances, and PTSD (Levin & Nielsen, 2007). A common feature of these pathologies is notable waking emotional distress, suggesting that nightmares may play a role in processing of these experiences. The studied reviewed above also suggest that the connection between early experiences, brain development, and nightmare experiences might involve failures in emotion regulation (Nielsen et al, 2006; Levin & Nielsen, 2009). Current models of nightmare production seem to emphasize negative emotionality as having a central role in determining dream affects. Ağargün *et al.* previously reported that the prevalence of childhood traumatic experiences was higher among adult who ''often'' had nightmares than among adults who ''sometimes'' or ''never'' had nightmares (Ağargün et al., 2003). With regard to the associations between nightmares and mental health status, Nielsen *et al*. studied adolescents (aged 13–16) and reported a significant association between the frequency of nightmares and the level of anxiety (Nielsen et al., 2006). To date, very few studies have investigated the prevalence of nightmares in adolescents, compared to adults. In Japan, analyzing 90,081 nationwide adolescent sampled data, Munezawa *et al.* showed that the prevalence of nightmares was 35.2% among Japanese adolescents (more than one third) (Munezawa et al., 2011). The results of this study should be considered in the prevention of nightmares among Japanese

Insomnia and Its Correlates:

**8.1.1 Case study 2** 

to his insomnia.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 407

nightmare related to the trauma in 70%, this is understandable (Hendin et al., 2008). Besides, recently, Nadorff *et al.* clearly showed that nightmare symptoms may be "more than" a marker of PTSD, and hence may be important in the identification of suicidal ideation

Despite significant contributions made in the area of chronic insomnia, the area of acute insomnia has received comparatively little attention (Ellis et al., 2011). Overall, the findings from the review will highlight the need for a structured diagnosis of acute insomnia as the first step in a research and treatment strategy. Psychiatric and medical disorders are often associated with sleep disorders, especially acute insomnia which is a crucial element in clinical practices. Therefore, clinicians have to organize specific remedies for co-occurring acute insomnia itself. Recently the notion of sleep psychiatry (psychiatric therapeutic approach, both biologically and psychologically, based on sleep science) has gathered much attention worldwide (Goblin et al., 2004). Taking these points into account, when addressing potential treatment implications based on this conceptualisation of acute insomnia, three questions emerge: 1) Is it possible that acute insomnia can be identified and/or responded to in a timely manner?; 2) Is it possible that an intervention for acute insomnia has the potential to derail the occurrence of chronic insomnia?; 3) What would the optimal treatment approach be? Here, we will present a case study in order to show the possible efficiency of early sleep psychiatric intervention, mainly focusing on the subjective

Mr. T., a 25-year-old man, had a long history of OCD (Obsessive-Complusive Disorder) with recurrent obsessive thoughts of touching dirt and compulsive cleaning since his preadolescence. Firstly, at the age of 18, he consulted a psychiatrist for the purpose of treating his depressive symptoms after his father's sudden death. His depressive symptoms improved and then stabilized for several years with the aid of pharmacologic treatment (sulpiride 30mg, clorazepate 7.5mg and paroxetine 20mg). After graduating from professional school, he was able to work as a computer engineer in an urban company in spite of the persistence of his obsessive symptoms. One winter, he was addressed to our outpatient clinic by his general practitioner. His symptoms had already stabilized because of

After four months of our follow-up, that spring, he was transferred to another section in his company. This change of social environment made him cogitate about his interpersonal relationship with other colleagues, which provoked acute insomnia symptoms, such as difficulty falling asleep and nighttime awaking. Additionally, he also suffered from daytime impairment related to his insomnia, especially hypersomnia and daytime sleepiness. He said, "I can't concentrate on my work because I have to fight to get to sleep" and "I feel afraid of falling asleep". Typically, the fear of insomnia was exacerbated. In other words, he was very afraid of losing his career position in his new section caused by the daytime impairments (e.g., losing concentration and diminished performance), which he attributed

following several previous literatures (Nadorff et al., 2011).

**8.1 Acute insomnia, the emergence of sleep psychiatry** 

experience of the individual with acute insomnia (Abe et al., 2012).

the same medication as a long-term maintenance treatment for OCD.

**8. Future remarks and treatment implications** 

adolescents. They concluded that it is important to maintain regular sleep habits for preventing this symptom, and proposed that health education about regular sleep habits should be promoted among Japanese adolescents in a near future.

#### **7.3 Nightmare and attachment**

Interestingly, from the viewpoint of both attachment theory and epidemiology, Csóka *et al.* have hypothesized that adults who experienced early maternal separation (before one year of age and lasting at least one month) would report more frequent nightmares and bad dreams (Csóka et al., 2011). In the frame of the Hungarostudy Epidemiological Panel, 5020 subjects interviewed, significant associations were found between early maternal separation and both frequent nightmare experience in adulthood and increased frequency of oppressive and bad dreams. Current depression scores fully mediated the association between early separation and nightmares, but not the association between early separation and negative dream affects. The authors interpreted these findings as a trait-like enhancement of negative emotionality in adults who experienced early maternal separation. This enhancement influences the content of dreams and, when it takes the form of depression, also influences the frequency of nightmares. The effect of early maternal separation on nightmares and bad dreams is relevant, which merits further attention (Csóka et al., 2011).

#### **7.4 Nightmare and suicidality**

As we have mentioned above, frequent nightmares have been noted to be related to suicidality in depressed patients, particularly among women (Ağargün et al., 1998). A prospective follow-up study in a sample drawn from the general population also reported that the frequency of nightmares is directly related to the risk of suicide (Tanskanen et al., 2001; Turvey et al., 2002; Bernert, et al., 2005; Sjöström et al., 2007; Nadorff et al., 2011). Among those, Bernert *et al*. directly addressed the real question regarding research indicating that sleep disturbances may be specifically linked to suicidal behaviors: Is this link largely explained by depressive symptoms or how are specific symptoms of sleep disturbances relate to suicidal symptoms when controlling for depression? The 176 outpatients completed measures on sleep disturbances, suicidal symptoms. They controlled for depressive symptoms to establish a link between sleep disturbances and suicidality. They found that insomnia and nightmare symptoms were associated with both depressive symptoms and suicidality before controlling depressive symptoms. After controlling for depressive symptoms, only nightmares demonstrated an association with suicidal ideation. Another significant finding was that nightmares were particularly associated with suicidality among women compared to men. Before controlling for gender, a non-significant trend emerged between nightmare symptoms and suicidality, and this relationship remained after controlling for depression. After controlling for gender, the link between nightmare symptoms and suicidal ideation was statistically significant. This finding indicates that the association between nightmares and suicidality, while controlling for depression, was somewhat stronger among women versus among men (Bernert, et al., 2005).

For more than three decades, sleep disturbance had been considered the hallmark of posttraumatic stress disorder. Since insomnia has been observed in 90% of PTSD cases and nightmare related to the trauma in 70%, this is understandable (Hendin et al., 2008). Besides, recently, Nadorff *et al.* clearly showed that nightmare symptoms may be "more than" a marker of PTSD, and hence may be important in the identification of suicidal ideation following several previous literatures (Nadorff et al., 2011).

#### **8. Future remarks and treatment implications**

#### **8.1 Acute insomnia, the emergence of sleep psychiatry**

Despite significant contributions made in the area of chronic insomnia, the area of acute insomnia has received comparatively little attention (Ellis et al., 2011). Overall, the findings from the review will highlight the need for a structured diagnosis of acute insomnia as the first step in a research and treatment strategy. Psychiatric and medical disorders are often associated with sleep disorders, especially acute insomnia which is a crucial element in clinical practices. Therefore, clinicians have to organize specific remedies for co-occurring acute insomnia itself. Recently the notion of sleep psychiatry (psychiatric therapeutic approach, both biologically and psychologically, based on sleep science) has gathered much attention worldwide (Goblin et al., 2004). Taking these points into account, when addressing potential treatment implications based on this conceptualisation of acute insomnia, three questions emerge: 1) Is it possible that acute insomnia can be identified and/or responded to in a timely manner?; 2) Is it possible that an intervention for acute insomnia has the potential to derail the occurrence of chronic insomnia?; 3) What would the optimal treatment approach be? Here, we will present a case study in order to show the possible efficiency of early sleep psychiatric intervention, mainly focusing on the subjective experience of the individual with acute insomnia (Abe et al., 2012).

#### **8.1.1 Case study 2**

406 Public Health – Methodology, Environmental and Systems Issues

adolescents. They concluded that it is important to maintain regular sleep habits for preventing this symptom, and proposed that health education about regular sleep habits

Interestingly, from the viewpoint of both attachment theory and epidemiology, Csóka *et al.* have hypothesized that adults who experienced early maternal separation (before one year of age and lasting at least one month) would report more frequent nightmares and bad dreams (Csóka et al., 2011). In the frame of the Hungarostudy Epidemiological Panel, 5020 subjects interviewed, significant associations were found between early maternal separation and both frequent nightmare experience in adulthood and increased frequency of oppressive and bad dreams. Current depression scores fully mediated the association between early separation and nightmares, but not the association between early separation and negative dream affects. The authors interpreted these findings as a trait-like enhancement of negative emotionality in adults who experienced early maternal separation. This enhancement influences the content of dreams and, when it takes the form of depression, also influences the frequency of nightmares. The effect of early maternal separation on nightmares and bad dreams is relevant, which merits further attention (Csóka

As we have mentioned above, frequent nightmares have been noted to be related to suicidality in depressed patients, particularly among women (Ağargün et al., 1998). A prospective follow-up study in a sample drawn from the general population also reported that the frequency of nightmares is directly related to the risk of suicide (Tanskanen et al., 2001; Turvey et al., 2002; Bernert, et al., 2005; Sjöström et al., 2007; Nadorff et al., 2011). Among those, Bernert *et al*. directly addressed the real question regarding research indicating that sleep disturbances may be specifically linked to suicidal behaviors: Is this link largely explained by depressive symptoms or how are specific symptoms of sleep disturbances relate to suicidal symptoms when controlling for depression? The 176 outpatients completed measures on sleep disturbances, suicidal symptoms. They controlled for depressive symptoms to establish a link between sleep disturbances and suicidality. They found that insomnia and nightmare symptoms were associated with both depressive symptoms and suicidality before controlling depressive symptoms. After controlling for depressive symptoms, only nightmares demonstrated an association with suicidal ideation. Another significant finding was that nightmares were particularly associated with suicidality among women compared to men. Before controlling for gender, a non-significant trend emerged between nightmare symptoms and suicidality, and this relationship remained after controlling for depression. After controlling for gender, the link between nightmare symptoms and suicidal ideation was statistically significant. This finding indicates that the association between nightmares and suicidality, while controlling for depression, was somewhat stronger among women versus among

For more than three decades, sleep disturbance had been considered the hallmark of posttraumatic stress disorder. Since insomnia has been observed in 90% of PTSD cases and

should be promoted among Japanese adolescents in a near future.

**7.3 Nightmare and attachment** 

**7.4 Nightmare and suicidality** 

men (Bernert, et al., 2005).

et al., 2011).

Mr. T., a 25-year-old man, had a long history of OCD (Obsessive-Complusive Disorder) with recurrent obsessive thoughts of touching dirt and compulsive cleaning since his preadolescence. Firstly, at the age of 18, he consulted a psychiatrist for the purpose of treating his depressive symptoms after his father's sudden death. His depressive symptoms improved and then stabilized for several years with the aid of pharmacologic treatment (sulpiride 30mg, clorazepate 7.5mg and paroxetine 20mg). After graduating from professional school, he was able to work as a computer engineer in an urban company in spite of the persistence of his obsessive symptoms. One winter, he was addressed to our outpatient clinic by his general practitioner. His symptoms had already stabilized because of the same medication as a long-term maintenance treatment for OCD.

After four months of our follow-up, that spring, he was transferred to another section in his company. This change of social environment made him cogitate about his interpersonal relationship with other colleagues, which provoked acute insomnia symptoms, such as difficulty falling asleep and nighttime awaking. Additionally, he also suffered from daytime impairment related to his insomnia, especially hypersomnia and daytime sleepiness. He said, "I can't concentrate on my work because I have to fight to get to sleep" and "I feel afraid of falling asleep". Typically, the fear of insomnia was exacerbated. In other words, he was very afraid of losing his career position in his new section caused by the daytime impairments (e.g., losing concentration and diminished performance), which he attributed to his insomnia.

Insomnia and Its Correlates:

perceived overwhelming threat.

**8.2 Alcoholism and insomnia** 

(Brower et al., 2001).

1989).

this case.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 409

hypnotics has eventually had negative consequences in their everyday QOLs, such as daytime sleepiness and diminished concentration. Traditionally, Morita Therapy, a unique psychotherapy originated in Japan was devised for treating classical neurotic disorder. That concept has evolved the phenomenology of insomniacs as a subjective fabricated nature, claiming that clinicians are liable to make an error by just giving hypnotics to help the patient's feeling of sleeplessness without attempting radical cure on him. In this case, theoretically we applied some conventional concepts of Morita therapy to the treatment, utilizing the latest home monitoring instruments. We have to understand the fundamental phenomenology of diminished quality of sleep, and then give feedback to the acute insomniacs themselves in an appropriate way. To explain this process in the Morita theory, we attempted to stop exacerbating "psychic interaction" of acute insomniacs. This way of feedback may have something in common with the current well-developing Mindful-Based Cognitive Behavioral Therapy for insomnia. Despite their nature of subjective-objective discrepancy, individuals suffering from acute insomnia are situated under a subjectively

We may stress that focusing on how sleep state misperception could be a particularly central aspect of insomnia within the context of OCD. From this case study, it appears that the treatment was largely successful because the actigraphic records helped to correct the patient's misperceptions. Perhaps, such a focused intervention has a non-specific and positive psychotherapeutic effect. This could also have implications about the possible application of actigraphy to treat sleep problems within anxiety disorders. A home monitoring system, such as actigraphy, not only provides satisfactory objective evaluation, but also a supportive psychotherapeutic effect in diminishing fear and anxiety related with acute insomnia. Getting an individual to recognize at an early stage, and providing him with treatment pathway guided by actigraph to deal with, were crucial in

Some researchers have investigated between sleep disturbances in an adolescent period and its temporal development of substance abuse. The role of alcohol in the suicidal process warrants special attention (Gromov, I & Gromov, D, 2009; Wong et al., 2010). Adolescents may also be considered to choose drinking habits and substance abuse as a self-help sleep habit in order to escape negative suicide ideation. The association between insomnia and its self-medication with alcoholism has been acknowledged. The relationship between sleep problems and substance use/abuse has been demonstrated in both adults and adolescents. Insomnia has been shown to prospectively predict alcohol problems among some adults

One recent unpublished data in alcoholic groups in a psychiatric hospital in Japan also showed that the majority of middle-aged alcoholic patients entering treatment reported insomnia symptoms and recognized themselves their diminished quality of sleep (Asami et al., 2011). In the Epidemiological Catchment Area study in the USA (n= 7,954), individuals with persistent insomnia at baseline were more likely than individuals without insomnia to experience the first onset of alcohol abuse or dependence one year later (Ford & Kamerow,

In order to improve acute insomnia symptoms, we treated him mainly with an early sleep psychiatric approach as a non-pharmacological intervention. Intentionally, we avoided increasing medication, because his principal concerns were strongly related with daytime impairment of insomnia. Adding another medication to improve sleep might run a risk of exacerbating daytime consequences of insomnia. In this situation, we treated him, making use of a home-monitoring actigraphy and an oxygen saturation tool. After two days of monitoring, the actigraphy always measured total sleep time and number of nighttime awakenings, so data showed that he had slept sufficiently during the night contrary to his complaints. As a first step, we supported him by showing him recorded sleep data, which suggested that his objective quality of sleep was different from his subjective complaining. This manifestation explained by itself a typical psychopathology of insomnia. This monitoring continued for a week. During this period, he was encouraged to visit our clinic 3 times a week for evaluation. Over nights, his actigraphic records always suggested longer and more consolidated sleep efficiency compared with his subjective intensity of insomnia complaints. As a next step, one night he was asked to get installed a portable oxygen saturation tool. The obtained data showed that some presence of hypoxemia during his sleep, which could partially explain the fragility of his sleep function. Also, he was found drinking alcohol and smoking just before going to bed. Moreover, he often surfed the web in eating snacks during the night on weekends. Therefore, we considered this above data as important evidence to strongly stop him from smoking and drinking before bedtime, and urging him to keep regular habits even at the weekend. With this intervention equipped with the home-monitored objective data, also based on sleep hygiene education (e.g. avoid bedside drinking, smoking, snacking and surfing the internet), his anxiety and fear of insomnia diminished dramatically and he spontaneously recovered from acute insomnia.

The lifetime prevalence of OCD is comparatively high at 2-3.5% of the population. While neither the core syndromal manifestations nor prominent associated features of OCD include sleep disturbances, patients suffering from OCD often complain about their sleep disturbance. Clinical observations show that their complaints are non-specific and persist. Previous sleep studies among patients with OCD are sparse and results inconsistent, often confounding with their comorbid depressive illness. Psychiatric disorders, such as neurotic disorders including OCD, are often associated with sleep disorders, especially insomnia which is a crucial element in clinical practices. Characteristically, insomniacs often complain about their sleep more than about the lack of it objectively measured. Therefore, we have to organize specific remedies for co-occurring acute insomnia itself. Possible other reasons for explaining his diminished quality of sleep in this case, were as follows; 1) presence of cooccurring subclinical depressive symptoms, 2) negative consequences of core OCD symptoms of sleep habits, 3) concurrent diurnal side effects of long-term prescribed medication. Clinically, these aspects must always be taken into consideration for managing sleep disturbance comorbid with neurotic disorders including OCD.

In this case, we attempted to have an early intervention in the vicious cycle of acute insomnia. This early sleep focused intervention prevented him from entering the chronic vicious cycle of psycho/physiological hyperarousal, which was supposed to play a central role in the pathophysiology of insomnia. We emphasize several suggestions about acute insomniac state. "I can't sleep", "I don't get enough sleep": This kind of complaints have often led to the easiest solution of direct prescriptions of hypnotics. The accumulation of

In order to improve acute insomnia symptoms, we treated him mainly with an early sleep psychiatric approach as a non-pharmacological intervention. Intentionally, we avoided increasing medication, because his principal concerns were strongly related with daytime impairment of insomnia. Adding another medication to improve sleep might run a risk of exacerbating daytime consequences of insomnia. In this situation, we treated him, making use of a home-monitoring actigraphy and an oxygen saturation tool. After two days of monitoring, the actigraphy always measured total sleep time and number of nighttime awakenings, so data showed that he had slept sufficiently during the night contrary to his complaints. As a first step, we supported him by showing him recorded sleep data, which suggested that his objective quality of sleep was different from his subjective complaining. This manifestation explained by itself a typical psychopathology of insomnia. This monitoring continued for a week. During this period, he was encouraged to visit our clinic 3 times a week for evaluation. Over nights, his actigraphic records always suggested longer and more consolidated sleep efficiency compared with his subjective intensity of insomnia complaints. As a next step, one night he was asked to get installed a portable oxygen saturation tool. The obtained data showed that some presence of hypoxemia during his sleep, which could partially explain the fragility of his sleep function. Also, he was found drinking alcohol and smoking just before going to bed. Moreover, he often surfed the web in eating snacks during the night on weekends. Therefore, we considered this above data as important evidence to strongly stop him from smoking and drinking before bedtime, and urging him to keep regular habits even at the weekend. With this intervention equipped with the home-monitored objective data, also based on sleep hygiene education (e.g. avoid bedside drinking, smoking, snacking and surfing the internet), his anxiety and fear of insomnia diminished dramatically and he spontaneously recovered from acute insomnia.

The lifetime prevalence of OCD is comparatively high at 2-3.5% of the population. While neither the core syndromal manifestations nor prominent associated features of OCD include sleep disturbances, patients suffering from OCD often complain about their sleep disturbance. Clinical observations show that their complaints are non-specific and persist. Previous sleep studies among patients with OCD are sparse and results inconsistent, often confounding with their comorbid depressive illness. Psychiatric disorders, such as neurotic disorders including OCD, are often associated with sleep disorders, especially insomnia which is a crucial element in clinical practices. Characteristically, insomniacs often complain about their sleep more than about the lack of it objectively measured. Therefore, we have to organize specific remedies for co-occurring acute insomnia itself. Possible other reasons for explaining his diminished quality of sleep in this case, were as follows; 1) presence of cooccurring subclinical depressive symptoms, 2) negative consequences of core OCD symptoms of sleep habits, 3) concurrent diurnal side effects of long-term prescribed medication. Clinically, these aspects must always be taken into consideration for managing

In this case, we attempted to have an early intervention in the vicious cycle of acute insomnia. This early sleep focused intervention prevented him from entering the chronic vicious cycle of psycho/physiological hyperarousal, which was supposed to play a central role in the pathophysiology of insomnia. We emphasize several suggestions about acute insomniac state. "I can't sleep", "I don't get enough sleep": This kind of complaints have often led to the easiest solution of direct prescriptions of hypnotics. The accumulation of

sleep disturbance comorbid with neurotic disorders including OCD.

hypnotics has eventually had negative consequences in their everyday QOLs, such as daytime sleepiness and diminished concentration. Traditionally, Morita Therapy, a unique psychotherapy originated in Japan was devised for treating classical neurotic disorder. That concept has evolved the phenomenology of insomniacs as a subjective fabricated nature, claiming that clinicians are liable to make an error by just giving hypnotics to help the patient's feeling of sleeplessness without attempting radical cure on him. In this case, theoretically we applied some conventional concepts of Morita therapy to the treatment, utilizing the latest home monitoring instruments. We have to understand the fundamental phenomenology of diminished quality of sleep, and then give feedback to the acute insomniacs themselves in an appropriate way. To explain this process in the Morita theory, we attempted to stop exacerbating "psychic interaction" of acute insomniacs. This way of feedback may have something in common with the current well-developing Mindful-Based Cognitive Behavioral Therapy for insomnia. Despite their nature of subjective-objective discrepancy, individuals suffering from acute insomnia are situated under a subjectively perceived overwhelming threat.

We may stress that focusing on how sleep state misperception could be a particularly central aspect of insomnia within the context of OCD. From this case study, it appears that the treatment was largely successful because the actigraphic records helped to correct the patient's misperceptions. Perhaps, such a focused intervention has a non-specific and positive psychotherapeutic effect. This could also have implications about the possible application of actigraphy to treat sleep problems within anxiety disorders. A home monitoring system, such as actigraphy, not only provides satisfactory objective evaluation, but also a supportive psychotherapeutic effect in diminishing fear and anxiety related with acute insomnia. Getting an individual to recognize at an early stage, and providing him with treatment pathway guided by actigraph to deal with, were crucial in this case.

#### **8.2 Alcoholism and insomnia**

Some researchers have investigated between sleep disturbances in an adolescent period and its temporal development of substance abuse. The role of alcohol in the suicidal process warrants special attention (Gromov, I & Gromov, D, 2009; Wong et al., 2010). Adolescents may also be considered to choose drinking habits and substance abuse as a self-help sleep habit in order to escape negative suicide ideation. The association between insomnia and its self-medication with alcoholism has been acknowledged. The relationship between sleep problems and substance use/abuse has been demonstrated in both adults and adolescents. Insomnia has been shown to prospectively predict alcohol problems among some adults (Brower et al., 2001).

One recent unpublished data in alcoholic groups in a psychiatric hospital in Japan also showed that the majority of middle-aged alcoholic patients entering treatment reported insomnia symptoms and recognized themselves their diminished quality of sleep (Asami et al., 2011). In the Epidemiological Catchment Area study in the USA (n= 7,954), individuals with persistent insomnia at baseline were more likely than individuals without insomnia to experience the first onset of alcohol abuse or dependence one year later (Ford & Kamerow, 1989).

Insomnia and Its Correlates:

**9. Brief summary and conclusion** 

**10. Acknowledgment** 

authors' institutions.

11, 62-68, [Article in Japanese].

**11. References** 

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 411

factors related to adult insomnia (Dollander, 2002). The author suggests some preventive perspective to face the etiology of adult insomnia, and points out limits of pharmacological treatment. From a clinical viewpoint, she succeeded in making methodological propositions to test the four exposed psychodynamic assumptions: 1) insomnia should be a result of anguish excess related to intrapsychic conflicts which can't lead to a mental elaboration; 2) insomnia should be a result of psychic functioning invalidation; 3) some insomnias are related to waking associated with repetitive nightmares, and 4) some insomnias are in relation with an impossibility to accept passive position. These aspects are still in a hypothetical model, but it should always be noted in constructing long-term treatment

In summary, clinical and epidemiological studies suggest that sleep disturbances (insomnia) are closely associated with suicidality and other correlates both in adult, and probably more importantly, in adolescent. In some cases, this association appears to exist above and beyond depression and PTSD. Nightmare shows a unique association with suicide risk, whereas additional research is needed to clarify both pathophysiology and symptomatology of insomnia. Studies should also be undertaken to determine the effects of adequate sleep and sleep hygiene promotion on mental health and suicide prevention. As the association between alcohol use and sleep has also been well documented among adults, researchers need to be aware of the pubertal development that takes place in sleep problems and their coping strategies. Circadian and homeostatic factors drive sleep. The sleep focused intervention studies may help us learn more about the fundamental role and homeostatic process of sleep dynamics in psychiatric disorder. Issues regarding the relationship between puberty and insomnia, the possible reciprocal relationships among circadian phase preference, sleep problems and alcohol use, mediators and moderators of such relationships (i.e. risk, protective and resilient factors), as well as potential gender differences on these

This work was partially supported by a Health Science Research Grant from the Ministry of Helth, Labour and Welfare. The authors report no other financial affiliation or relationship relevant to the subject of this article. The views expressed in this article are mainly those of one of the authors (Y.A) and do not necessarily reflect the official policy or position of the

[1] Abe, Y. & Mishima, K. (2008). The concepts and pathophysiology of insomnia. *Brain 21*,

[2] Abe, Y.; Mishima, K.; Kaneita, Y.; Li, L.; Ohida, T.; Nishikawa, T. & Uchiyama, M. (2011).

Stress coping behaviors and sleep hygiene practices in a sample of Japanese adults

strategy targeting on insomnia especially in the aftermath of trauma.

relationships were discussed in further research and clinical practices.

with insomnia. *Sleep and Biological Rhythm*, 9, 35–45.

Recently, Pieters *et al*. have investigated the associations between pubertal development, sleep preference, sleep problems, and alcohol use in 431 early adolescents (Pieters et al., 2010). Then, they studied whether the associations changed when controlling for adolescent internalizing and externalizing problems. Results showed that pubertal development was positively associated with sleep problems and more evening-type tendencies (e.g., favouring later bedtimes), which in turn were positively related to alcohol use. From this study, it can be concluded that both puberty and sleep regulation are important factors in explaining alcohol use in early adolescence. This research has shown again a possible bi-directional relation between alcohol use and sleep, while profound puberty-dependent transitions regarding sleep patterns take place in early adolescence. Moreover, puberty has been associated with an increase in alcohol use of adolescents. They provided valuable data to understand the relationship among puberty, sleep problems, and alcohol use. Questions regarding that association, the possible reciprocal relationships among circadian phase preference, sleep problems and alcohol use, mediators and moderators of such relationships, as well as potential gender differences on these relationships were discussed (Wong, 2010). To understand the relationships among pubertal development, sleep problems, and alcohol use, researchers need to be aware of the physiological changes that take place in puberty, as well as the psychosocial factors that are associated with such changes (Pieters et al., 2010).

To the best of our knowledge, Wong et al. s' several reports in the USA have been the only longitudinal study examining the relationship between childhood sleep problems and adolescent substance use (Wong et al., 2004, 2009, 2010). Following their early works from a community sample of high-risk families and controls (292 boys and 94 girls), they have also tested whether adolescent sleep problems and poor response inhibition mediated the relationship between childhood sleep problems and substance (alcohol and drug) outcomes in young adulthood (Wong et al., 2010). Eventually, longitudinal design should be useful. Prevention and intervention programs may want to consider the role of sleep problems and response inhibition on substance use and abuse.

#### **8.3 Insomnia and trauma in current Japanese society aftermath of tsunami disaster**

A massive 9.0-magnitude earthquake occurred in the Pacific Ocean near Northeast Japan on March 11, 2011, causing serious damage to Japan. The effect of the East Japan Earthquake will not terminate within months. Many survivors experienced observing the disaster of the tsunami wiping out everything, and those extraordinary experiences will surely cause trauma among many minors (children and adolescents) who survived this disaster (Takeda, 2011). Those affected adults and adolescents should be taken care of closely for the possible occurrence of post-traumatic stress disorder, in terms of daily stress coping and sleep hygiene parameters related with insomnia. How does such emotional affects predict insomnia and nightmare symptoms? Bereavement is a ubiquitous part of the human condition. Almost no person makes it through his or her life without having to cope with the loss of a loved one several different times. The loss of a parent, child, or grandparent can be very distressing. From now on, further research will be needed to investigate the relationship between bereavement, complicated grief and recovery sleep.

Before concluding this discussion, we cited another provident remark, proposed by a French psychologist. She challenged to develop an analysis of various external and intrapsychic factors related to adult insomnia (Dollander, 2002). The author suggests some preventive perspective to face the etiology of adult insomnia, and points out limits of pharmacological treatment. From a clinical viewpoint, she succeeded in making methodological propositions to test the four exposed psychodynamic assumptions: 1) insomnia should be a result of anguish excess related to intrapsychic conflicts which can't lead to a mental elaboration; 2) insomnia should be a result of psychic functioning invalidation; 3) some insomnias are related to waking associated with repetitive nightmares, and 4) some insomnias are in relation with an impossibility to accept passive position. These aspects are still in a hypothetical model, but it should always be noted in constructing long-term treatment strategy targeting on insomnia especially in the aftermath of trauma.

#### **9. Brief summary and conclusion**

410 Public Health – Methodology, Environmental and Systems Issues

Recently, Pieters *et al*. have investigated the associations between pubertal development, sleep preference, sleep problems, and alcohol use in 431 early adolescents (Pieters et al., 2010). Then, they studied whether the associations changed when controlling for adolescent internalizing and externalizing problems. Results showed that pubertal development was positively associated with sleep problems and more evening-type tendencies (e.g., favouring later bedtimes), which in turn were positively related to alcohol use. From this study, it can be concluded that both puberty and sleep regulation are important factors in explaining alcohol use in early adolescence. This research has shown again a possible bi-directional relation between alcohol use and sleep, while profound puberty-dependent transitions regarding sleep patterns take place in early adolescence. Moreover, puberty has been associated with an increase in alcohol use of adolescents. They provided valuable data to understand the relationship among puberty, sleep problems, and alcohol use. Questions regarding that association, the possible reciprocal relationships among circadian phase preference, sleep problems and alcohol use, mediators and moderators of such relationships, as well as potential gender differences on these relationships were discussed (Wong, 2010). To understand the relationships among pubertal development, sleep problems, and alcohol use, researchers need to be aware of the physiological changes that take place in puberty, as well as the psychosocial factors that are associated with such changes (Pieters et al., 2010). To the best of our knowledge, Wong et al. s' several reports in the USA have been the only longitudinal study examining the relationship between childhood sleep problems and adolescent substance use (Wong et al., 2004, 2009, 2010). Following their early works from a community sample of high-risk families and controls (292 boys and 94 girls), they have also tested whether adolescent sleep problems and poor response inhibition mediated the relationship between childhood sleep problems and substance (alcohol and drug) outcomes in young adulthood (Wong et al., 2010). Eventually, longitudinal design should be useful. Prevention and intervention programs may want to consider the role of sleep problems and

**8.3 Insomnia and trauma in current Japanese society aftermath of tsunami disaster**  A massive 9.0-magnitude earthquake occurred in the Pacific Ocean near Northeast Japan on March 11, 2011, causing serious damage to Japan. The effect of the East Japan Earthquake will not terminate within months. Many survivors experienced observing the disaster of the tsunami wiping out everything, and those extraordinary experiences will surely cause trauma among many minors (children and adolescents) who survived this disaster (Takeda, 2011). Those affected adults and adolescents should be taken care of closely for the possible occurrence of post-traumatic stress disorder, in terms of daily stress coping and sleep hygiene parameters related with insomnia. How does such emotional affects predict insomnia and nightmare symptoms? Bereavement is a ubiquitous part of the human condition. Almost no person makes it through his or her life without having to cope with the loss of a loved one several different times. The loss of a parent, child, or grandparent can be very distressing. From now on, further research will be needed to investigate the relationship between bereavement, complicated grief and

Before concluding this discussion, we cited another provident remark, proposed by a French psychologist. She challenged to develop an analysis of various external and intrapsychic

response inhibition on substance use and abuse.

recovery sleep.

In summary, clinical and epidemiological studies suggest that sleep disturbances (insomnia) are closely associated with suicidality and other correlates both in adult, and probably more importantly, in adolescent. In some cases, this association appears to exist above and beyond depression and PTSD. Nightmare shows a unique association with suicide risk, whereas additional research is needed to clarify both pathophysiology and symptomatology of insomnia. Studies should also be undertaken to determine the effects of adequate sleep and sleep hygiene promotion on mental health and suicide prevention. As the association between alcohol use and sleep has also been well documented among adults, researchers need to be aware of the pubertal development that takes place in sleep problems and their coping strategies. Circadian and homeostatic factors drive sleep. The sleep focused intervention studies may help us learn more about the fundamental role and homeostatic process of sleep dynamics in psychiatric disorder. Issues regarding the relationship between puberty and insomnia, the possible reciprocal relationships among circadian phase preference, sleep problems and alcohol use, mediators and moderators of such relationships (i.e. risk, protective and resilient factors), as well as potential gender differences on these relationships were discussed in further research and clinical practices.

#### **10. Acknowledgment**

This work was partially supported by a Health Science Research Grant from the Ministry of Helth, Labour and Welfare. The authors report no other financial affiliation or relationship relevant to the subject of this article. The views expressed in this article are mainly those of one of the authors (Y.A) and do not necessarily reflect the official policy or position of the authors' institutions.

#### **11. References**


Insomnia and Its Correlates:

1, 69-76.

404.

473–480.

81, 170-177.

French].

normal sleepers. *Sleep,* 18, 581–588.

*Sleep Med. Rev.,* 14, 9-15.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 413

[21] Bonnet, M.H. & Arand, D.L. (1995). 24-Hour metabolic rate in insomniacs and matched

[22] Bonnet M.H. & Arand, D.L. (2010). Hyperarousal and insomnia: state of the science.

[23] Brand, S.; Luethi, M.; von Planta, A; Hatzinger, M. & Holsboer-Trachsler, E. (2007).

[24] Brand, S. & Kirov, R. (2011). Sleep and its importance in adolescence and in common adolescent somatic and psychiatric conditions. *Int. J. Gen. Med,* 4, 425-442. [25] Bridge, J.A.; Goldstein, T.R. & Brent, D.A. (2006). Adolescent suicide and suicidal

[26] Brower, K.J.; Aldrich, M.S.; Robinson, E.A.; Zucker, R.A. & Greden, J.F. (2001).

[28] Buysse, DJ; Angst, J; Gamma, A; Ajdacic, V; Eich, D. & Rössler, W. (2008). Prevalence,

[29] Choquet, M. & Menke, H. (1990). Suicidal thoughts during early adolescence:

[30] Choquet, M.; Kovess, V. & Poutignat, N. (1993). Suicidal thoughts among adolescents:

[31] Csóka, S.; Simor, P.; Szabó, G.; Kopp, M.S. & Bódizs, R. (2011). Early maternal

[32] Dauvilliers, Y.; Morin, C.; Cervena, K.; Carlander, B.; Touchon, J.; Besset, A. & Billiard, M. (2005). Family studies in insomnia. *J. Psychosom. Res.*, 58, 271–278. [33] Dollander, M. (2002). Etiology of adult insomnia. *L'Encéphale*, 28, 493-502 [Article in

[34] Drake, C.L.; Scofield, H. & Roth, T. (2008). Vulnerability to insomnia: the role of

[35] Edinger, J.D., Means, M.; Carney, C. E. & Krystal, A.D. (2008). Psychomotor

[36] Ellis, J.G.; Gehrman, P.; Espie, C.A.; Riemann, D. & Perlis, M.L. (2011). Acute insomnia:

[37] Endo, S. (1962). The Psychophysiological Study of Neurotic insomnia. *Psychiatria et* 

[38] Fawcett, J.; Scheftner, W.A.; Fogg, L.; Clark, D.C.; Young, M.A.; Hedeker, D. &

[39] Ford, D. E. & Kamerow, D. B. (1989). Epidemiologic study of sleep disturbances and psychiatric disorders: an opportunity for prevention? *JAMA,* 262: 1479–1484.

performance deficits and their relation to prior nights' sleep among individuals

Current conceptualizations and future directions. *Sleep Med. Rev.,*

Gibbons, R. (1990). Time-related predictors of suicide in major affective disorder.

behavior. *Journal of Child Psychology and Psychiatry,* 47, 372-394.

[27] Buysse, D.J. (2008). Chronic insomnia. *Am. J. Psychiatry*, 165, 678–686.

an intercultural approach. *Adolescence,* 28, 111, 649-659.

Epidemiological Panel. *Attach Hum Dev.*, 13, 125-140.

familial aggregation. *Sleep Med.*, 9, 297–302.

with primary insomnia. *Sleep*, 31, 599–607.

doi:10.1016/j.smr. 2011.02.002.

*Neurologia Japonica*, 64, 673-707.

*Am. J. Psychiatry,* 147, 1189-1194.

Romantic love, hypomania, and sleep pattern in adolescents. *J. Adolesc. Health.*, 41,

Insomnia, self-medication, and relapse to alcoholism. *Am. J. Psychiatry,* 158, 399-

course, and comorbidity of insomnia and depression in young adults. *Sleep,* 31,

prevalence, associated troubles and help-seeking behavior. *Acta Psychiatr. Scand.,*

separation, nightmares, and bad dreams: results from the Hungarostudy


[3] Abe, Y.; Nishimura, G. & Endo, T. Early sleep psychiatric intervention for acute

[4] Ağargün, M.Y.; Kara, H. & Solmaz, M. (1997). Subjective sleep quality and suicidality in

[5] Ağargün, M.Y.; Cilli, A.S.; Kara, H.; Tarhan, N.; Kincir, F. & Oz, H. (1998). Repetitive and

[6] Ağargün, M.Y.; Kara, H.; Ozer, O.A..; Selvi, Y.; Kiran, U. & Kiran, S. (2003). Nightmares

[7] Ağargün, M.Y. & Beşiroğlu, L. (2005). Sleep and suicidality: do sleep disturbances

[8] AASM (American Academy of Sleep Medicine). (2005). *International Classification of Sleep* 

[9] American Psychiatric Association (APA). (2000). *Diagnostic and Statistical Manual of* 

[10] Apter, A.; Gothelf, D.; Orbach, I.; Weizman, R.; Ratzoni, G.; Har-Even, D. & Tyano, S.

[11] Asami, M.; Abe, Y.; Suzuki, R.; Hasuo, R.; Nirasawa, H.; Jukuroki, H. & Kakibuchi, Y.

[12] Bader, K.; Schäfer, V.; Schenkel, M.; Nissen, L. & Schwander, J. (2007). Adverse

[13] Basta, M.; Chrousos, G.P.; Vela-Bueno, A. & Vgontzas, A.N. (2007). Chronic Insomnia

[14] Baglioni, C.; Spiegelhalder, K.; Lombardo, C. & Riemann, D. (2010). Sleep and

[15] Bastien, C. & Morin, C. M. (2000). Familial incidence of insomnia. *J. Sleep Res.*, 9, 49–54. [16] Bastien, C. H.; Vallières, A. & Morin, C. M. (2004). Precipitating factors of insomnia.

[17] Beaulieu-Bonneau, S.; LeBlanc, M.; Merette, C.; Dauvilliers, Y. & Morin, C. (2007). Family history of insomnia in a population-based sample. *Sleep,* 30, 1739–1745. [18] Bernert, R.A.; Joiner, T.E. Jr.; Cukrowicz, KC; Schmidt, N.B. & Krakow B. (2005).

[19] Bernert, R. A. & Joiner, T.E. (2007). Sleep disturbances and suicide risk: A review of the

[20] Blenkiron, P; House, A. & Milnes, D. (2000). The timing of acts of deliberate self-harm:

is there any relation with suicidal intent, mental disorder or psychiatric

emotions: a focus on insomnia. *Sleep Med. Rev.,* 14, 4, 227-238.

Suicidality and sleep disturbances. *Sleep*, 28, 1135-1141.

literature. *Neuropsychiatr. Dis. Treat.,* 3, 735-743.

management? *J. Psychosom. Res,* 49, 3-6.

patients with majour depression. *J. Psychiatr. Res.*, 31, 377-381.

*J. Clin. Sleep Med*., in press.

*Psychiatry*, 39, 198-202.

Washington, D.C.

34, 912–918.

285-296.

Research, Oct 16.

*Behav. Sleep Med,* 2, 50–62.

*and Clin. Neurosciences*, 57, 139–145.

Medicine (ICSD-2). Westchester, IL.

predict suicide risk? *Sleep*, 28, 1039-1040.

and Stress System. *Sleep Med. Clin.*, 2, 279-91.

insomnia: Implications from a case of Obsessive-Compulsive Disorder (2012).

frightening dreams and suicidal behavior in patients with major depression. *Compr.* 

and dissociative experiences: The key role of childhood traumatic events. *Psychiatry* 

*Disorders, 2nd Ed.: Diagnostic and Coding Manual*. American Academy of Sleep

*Mental Disorders*, 4th edn. Text revision. American Psychiatric Association:

(1995). Correlation of suicidal and violent behavior in different diagnostic categories in hospitalized adolescent patients. *J. Am. Acad. Child Adolesc. Psychiatry*,

(2011). A study on the subjective sleep evaluation and the related factors in the alcoholic, presented at the 36th Annual Metting of Japanese Society of Sleep

childhood experiences associated with sleep in primary insomnia. *J. Sleep Res.*, 16,


Insomnia and Its Correlates:

482–528.

21, 232-233.

56-64.

*Dreaming,* 16, 145–158.

*Psychological Science,* 18, 84–88.

*Opin. Psychiatry,* 19, 288-293.

Treatment. Springer: New York.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 415

[58] LeBlanc, M.; Beaulieu-Bonneau, S.; Mérette, C.; Savard, J.; Ivers, H. & Morin, C.M.

[60] Levin, R. & Nielsen, T. (2009). Nightmares, bad dreams and emotion dysregulation: A

[61] Li, S.X., Lam, S.P.; Yu, M.W.; Zhang, J. & Wing, Y.K. (2010). Nocturnal sleep

clinical, epidemiologic, prospective study. *J. Clin. Psychiatry*, 71, 1440-1446. [62] Liu, X.C.; Uchiyama, M.; Okawa, M. & Kurita, H. (2000). Prevalence and correlates of self-reported sleep problems among Chinese adolescents. *Sleep,* 23, 27–34. [63] Liu, X. & Buysse, D.J. (2006). Sleep and youth suicidal behavior: a neglected field. *Curr.* 

[64] Mahgoub, N. A. (2009). Insomnia and suicide risk. *J. Neuropsychiatry Clin. Neurosci,* 2,

[65] Mai, E. & Buysse, D.J. (2008). Insomnia: Prevalence, Impact, Pathogenesis, Differential

[66] Morin, C.M.; Rodrigue, S. & Ivers, H. (2003). Role of stress, arousal, and coping skills in

[67] Morin, C.M. & Espie, C. (2004). Insomnia: A Clinical Guide to Assessment and

[68] Morin, C.M.; Leblanc, M.; Daley, M.; Gregoire, J.P. & Merette, C. (2006). Epidemiology

[69] Morrison, D.N.; McGee, R. & Stanton, W.R. (1992). Sleep problems in adolescence.

[70] Motohashi, Y. (1990). Circadian variation in suicide attempts in Tokyo from 1978 to

[71] Munezawa, T.; Kaneita, Y.; Osaki, Y.; Kanda, H.; Ohtsu, T.; Suzuki, H.; Minowa, M.;

[72] Nadorff, M. R.; Nazem, S. & Fiske, A. (2011). Insomnia symptoms, nightmares, and

[73] National Institutes of Health (NIH). (2005). National Institutes of Health state of the

[74] Nielsen, T.A.; Stenstrom, P. & Levin, R. (2006). Nightmare frequency as a function of

[75] Nir, Y. & Tononi, G. (2010). Dreaming and the brain: from phenomenology to

suicidal ideation in a college student sample. *Sleep,* 34, 93-98.

insomnia in adults. June 13–15, 2005, *Sleep,* 28, 1049–1057.

neurophysiology. *Trends Cogn. Sci.,* 14, 2, 88-100.

of insomnia: prevalence, self-help treatments, consultations, and determinants of

Suzuki, K.; Higuchi, S.; Mori, J. & Ohida, T. (2011). Nightmare and sleep paralysis among Japanese adolescents: a nationwide representative survey. *Sleep Med.*, 12,

science conference statement on manifestations and management of chronic

age, gender and September 11, 2001: Findings from an Internet questionnaire.

Diagnosis, and Evaluation. *Sleep Med. Clin*., 3, 2, 167-174.

primary insomnia. *Psychosom. Med.,* 65, 259–267.

help-seeking behaviors. *Sleep Med,* 7, 123–130.

*J. Am. Acad. Child. Adolesc. Psychiatry,* 31, 94–99.

1985. *Suicide Life Threat. Behav.,* 20, 533-539.

insomnia in a population-based sample. *J. Psychosom. Res.,* 63, 157–166. [59] Levin, R. & Nielsen, T.A. (2007). Disturbed dreaming, posttraumatic stress disorder,

(2007). Psychological and health-related quality of life factors associated with

and affect distress: A review and neurocognitive model. *Psychological Bulletin,* 133,

review and new neurocognitive model of dreaming. *Current Directions in* 

disturbances as a predictor of suicide attempts among psychiatric outpatients: a


[40] Franzen, P.L.& Buysse, D.J. (2008). Sleep disturbances and depression : risk

[41] Fujino, Y.; Mizoue, T; Tokui, N. & Yoshimura, T. (2005). Prospective cohort study of

[42] Gangwisch, J.E.; Babiss, L.A.; Malaspina, D.; Turner, J.B.; Zammit, G.K. & Posner, K.

[43] Gau, S. F. & Soong, W.T. (1995). Sleep problems of junior high school students in

[44] Germain. A.; Shear, K.; Monk, T.H.; Houck, P.R.; Reynolds, C.F.; Frank, E. & Buysse,

[45] Germain, A.; Buysse, D.J. & Nofzinger, E. (2008). Sleep-specific mechanisms

[46] Germain, A.; Hall, M.; Krakow, B.; Shear, K. M. & Buysse, D.J. (2005). A brief sleep

[47] Goldstein, T. R.; Bridge, J.A. & Brent, D.A. (2008). Sleep disturbance preceding completed suicide in adolescents. *J. Consult. Clin. Psychol.*, 76, 84-91. [48] Goblin, A.; Kravitz, H. & Keith, L. eds. (2004). Sleep Psychiatry. Taylor & Francis,

[49] Gregory, A.M.; Caspi, A.; Moffitt, T.E. & Poulton R. (2006). Family conflict in

[50] Gromov, I. & Gromov, D. (2009). Sleep and substance use and abuse in adolescents.

[51] Hasler, B. & Germain, A. (2009). Correlates and Treatments of Nightmares in Adults.

[52] Hendin, H.; Maltsberger, J.T. & Szanto, K. (2008). The psychosocial context of trauma

[53] Jefferson, C.D.; Drake, C.L.; Scofield, H.M., Myers, E.; McClure, T.; Roehrs, T. & Roth,

[54] Johnson, E.O.; Roth, T.; Schultz, L. & Breslau, N. (2006). Epidemiology of DSM-IV

[55] Kaneita, Y.; Ohida, T.; Osaki,Y.; Tanihata, T.; Minowa, M.; Suzuki, K.; Wada, K.;

[56] Krakow, B. ; Artar, A. & Warner, T.D. (2000). Sleep disorder, depression and suicidality

[57] Krakow, B.; Ribeiro, J.D.; Ulibarri, V.A.; Krakow, J. & Joiner, T.E. Jr. (2011). Sleep

T. (2005). Sleep hygiene practices in a population-based sample of insomniacs.

insomnia in adolescence: lifetime prevalence, chronicity, and an emergent gender

Kanda, H. & Hayashi, K. (2006). Insomnia among Japanese adolescents:

disturbances and suicidal ideation in sleep medical center patients. *J. Affect. Disord.,*

childhood: a predictor of later insomnia. *Sleep,* 29, 1063-1067.

*Child. Adolesc. Psychiatr. Clin. N. Am.*, 18, 929-946.

in treating PTSD patients. *Am. J. Psychiatry,* 165, 28-32.

anationwide representative survey. *Sleep,* 29, 1543–1550.

in female sexual assault survivors. *Crisis,* 21, 163-170.

*Clin. Neurosci.*, 10, 473-481.

Taipei. *Sleep,* 18, 667–673.

*Sleep Med Clin.,* 4, 507-517.

difference. *Pediatrics,* 117, 247-256.

*Sleep,* 28, 611–615.

131, 422-427.

3, 152-163.

London.

*Suicide Life-Threat Behav.*, 35, 2, 227–237.

hypotheses. *Sleep Med. Rev.*, 12, 3, 185-195.

for PTSD. *J. Anxiety Disord.*, 19, 2, 233-244.

suicidal ideation. *Sleep*, 33, 97-106.

relationships for sebsequent depression and therapeutic implications. *Dialogues* 

stress, life satisfaction, self-rated health, insomnia, and suicide death in Japan.

(2010). Earlier parental set bedtimes as a protective factor against depression and

D.J. (2006). Treating complicated grief: effects on sleep quality. *Behav. Sleep Med.*, 4,

underlying posttraumatic stress disorder: integrative review and neurobiological

scale for Posttraumatic Stress Disorder: Pittsburgh Sleep Quality Index Addendum


Insomnia and Its Correlates:

5–13.

May, 2010.

27, 1813-1828.

Current Concepts, Epidemiology, Pathophysiology and Future Remarks 417

[95] Selvi, Y.; Aydin, A.; Boysan, M., Atli, A.; Agargun, M.Y. & Besiroglu, L. (2010).

[96] Shekleton, J. A.; Rogers, N. L. & Rajaratnam, S.M. (2010). Searching for the daytime

[97] Sher, L. (2008). Sleep disturbances, synaptic homeostasis and suicidal behaviour. *Aust.* 

[98] Singareddy, R. K. & Balon, R. (2001). Sleep and suicide in psychiatric patients. *Ann.* 

[99] Sjöström, N.; Waern, M. & Hetta, J. (2007). Nightmares and sleep disturbances in

[100] Soldatos, C.R.; Allaert, F.A.; Ohta, T. & Dikeos, D. G. (2005). How do individuals sleep

[101] Sompo Japan Research Institute Inc. Disease Management Reporter in Japan No. 17,

[102] Spielman, A. J.; Caruso, L.S. & Glovinsky, P.B. (1987). A behavioral perspective on

[103] Tamas, Z.; Kovacs, M.; Gentzler, A.L.; Tepper, P.; Gadoros, J.; Kiss, E.; Kapornai, K. &

[104] Taylor, D. J. & Roane, B.M. (2010). Treatment of insomnia in adults and children: a

[105] Taylor, D. J.; Gardner, C.E; Bramoweth, A.D; Williams, J.M.; Roane, B. M.; Grieser, E.

[106] Tononi, G. & Cirelli, C. (2003). Sleep and synaptic homeostasis: a hypothesis. *Brain Res.* 

[107] Tononi, G. & Cirelli, C. (2006). Sleep function and synaptic homeostasis. *Sleep Med.* 

[108] Tsuno, N.; Besset, A. & Ritchie, K. (2005). Sleep and depression. *J. Clin. Psychiatry*, 66,

[109] Takeda, M. (2011). Mental health care and East Japan Great Earthquake. *Psychiatry* 

[110] Tanskanen, A.; Tuomilehto, J.; Viinamäki, H.; Vartiainen, E.; Lehtonen, J. & Puska, P.

[111] Troxel, W.M. & Germain, A. (2011). Insecure attachment is an independent correlate

[112] Turvey, C.L.; Conwell, Y.; Jones, M.P.; Phillips, C.; Simonsick, E.; Pearson J.L. &

of objective sleep disturbances in military veterans. *Sleep Med.*,

Wallace, R. (2002). Risk factors for late-life suicide: a prospective, community-based

(2001). Nightmares as predictors of suicide. *Sleep,* 24, 844-847.

practice-friendly review of research. *J. Clin. Psychol.*, 66, 1137-1147.

around the world? Results from a single-day survey in ten contries. *Sleep Med.,* 6,

Vetró, A. (2007). The relations of temperament and emotion self-regulation with suicidal behaviors in a clinical sample of depressed children in Hungary. *J. Abnorm.* 

A. & Tatum, J. I. (2011). Insomnia and Mental Health in College Students. *Behav.* 

impairments of primary insomnia. *Sleep Med. Rev.,* 14, 1, 47-60.

relation to suicidality in suicide attempters. *Sleep,* 30, 91-95.

insomnia treatment. *Psychiatr. Clin. North Am.*, 10, 541–553.

*N. Z. J. Psychiatry,* 2008, 42, 1072-1073.

*Clin. Psychiatry,* 13, 93-101.

*Child Psychol.,* 35, 640-652.

*Sleep Med.,* 9, 107-116.

*Bull.,* 62, 2, 143-150.

*Clin. Neurosciences,* 65, 207-212.

doi:10.1016/j.sleep.2011.07.005.

study. *Am. J. Geriatr. Psychiatry,* 10, 398-406.

*Rev.,* 10, 49-62.

1254–1269.

Associations between chronotype, sleep quality, suicidality, and depressive symptoms in patients with major depression and healthy controls. *Chronobiol Int.*,


[76] Nofzinger, E.A.; Buysse, D.J.; Germain, A.; Price, J.C.; Miewald, J.M. & Kupfer, D.J.

[77] Ohayon, M.M. (2002). Epidemiology of insomnia: what we know and what we still

[78] Ohayon, M. M. & Lemoine, P. (2004). Daytime consequences of insomnia complaints in the French general population. L'Encéphale, 222–227 [Article in French]. [79] Ohida, T.; Osaki, Y.; Doi, Y.; Tanihata, T.; Minowa, M.; Suzuki, K.; Wada, K.; Suzuki, K.

[80] Orff, H.J.; Drummond, S.P.; Nowakowski, S. & Perlis, M.L. (2007). Discrepancy

[81] Pandey, G. N. (2011). Neurobiology of adult and teenage suicide. *Asian Journal of* 

[82] Pieters, S.; Van der Vorst, H.; Burk, W.J.; Wiers, R.W. & Engels, R.C. (2010). Puberty-

[83] Pigeon, W.R. & Caine, E.D. (2010). Insomnia and the risk for suicide: does sleep medicine have interventions that can make a difference? *Sleep Med.*, 11, 9, 816-817. [84] Proposed Draft Revisions to DSM-5 Disorders and Criteria. (2010).

[86] Riemann, D. & Voderholzer, U. (2003). Primary insomnia: a risk factor to develop

[87] Riemann, D.; Voderholzer, U.; Spiegelhalder, K.; Hornyak, M.; Buysse, D.J.; Nissen, C. ;

[89] Riemann, D.; Spiegelhalder, K.; Feige, B.; Voderholzer, U.; Berger, M.; Perlis, M. &

[90] Riemann, D.; Spiegelhalder, K.; Espie, C.; Pollmächer, T. ; Léger, D.; Bassetti, C. & van

[91] Roane B.M. & Taylor, D.J. (2008). Adolescent insomnia as a risk factor for early adult

[92] Roberts, R. E.; Roberts, C.R. & Chen, I. G. (2001). Functioning of adolescents with symptoms of disturbed sleep. *Journal of Youth and Adolescence*, 30, 1-18. [93] Rosen, J.; Reynolds, C.F.3rd.; Yeager, A.L.; Houck, P.R. & Hurwitz, L.F. (1991). Sleep disturbances in survivors of the Nazi Holocaust. *Am. J. Psychiatry*, 148, 62-66. [94] Safer, D.J. (1997). Adolescent/adult differences in suicidal behavior and outcome. *Ann.* 

MRI-measured hippocampal volumes: a pilot study. *Sleep*, 30, 955–958. [88] Riemann, D.; Kloepfer, C. & Berger, M. (2009). Functional and structural brain

Hennig, J.; Perlis, M.L.; van Elst, L.T. & Feige, B. (2007). Chronic insomnia and

alterations in insomnia: implications for pathophysiology. *Eur. J. Neurosci.*, 29, 9,

Nissen, C. (2010). The hyperarousal model of insomnia: a review of the concept and

Someren, E. (2011). Chronic insomnia: clinical and research challenges--an agenda.

*Psychiatr,* 161, 11, 2126-2128.

*Psychiatry*, 4, 2-13.

*Res.,* 34, 1512-1518.

1754-1760.

http://www.dsm5.org/.

need to learn. *Sleep Med. Rev.,* 6, 97–111.

among Japanese adolescents. *Sleep,* 27, 978–985.

performance in insomnia. *Sleep,* 30, 1205-1211.

[85] Pronger, C.E. (1914). Insomnia and suicide. Lancet, 184: 1356–1359.

depression and substance abuse. *Sleep,* 31, 1351-1356.

depression? *J. Affect. Disord.* 76, 255–259.

its evidence. *Sleep Med Rev.* 14, 19-31.

*Pharmacopsychiatry*. 44, 1-14.

*Clin. Psychiatry,* 9, 61-66.

(2004). Functional neuroimaging evidence for hyperarousal in insomnia. *Am. J.* 

& Kaneita, Y. (2004). An epidemiological study of self-reported sleepproblems

between subjective symptomatology and objective neuropsychological

dependent sleep regulation and alcohol use in early adolescents. *Alcohol Clin. Exp.* 


**20** 

*USA* 

**Saving More than Lives:** 

*Albany Medical College,* 

*3Oncofertility Consortium* 

**A Gendered Analysis of the Importance** 

*1Alden March Bioethics Institute & Department of OBGYN,* 

*2Northwestern University, Feinberg School of Medicine,* 

**of Fertility Preservation for Cancer Patients** 

Lisa Campo-Engelstein1, Sarah Rodriguez2 and Shauna Gardino2,3

Cancer affects millions of Americans annually. Men's lifetime risk of developing cancer for all sites is 50%; women's lifetime risk is just over 33% (American Cancer Society, 2009). While cancer is generally perceived as a condition affecting people past their child-bearing years, nearly 10% of those diagnosed are under age 45 (Horner et al., 2009). Indeed, some of those diagnosed with cancer are still children. In 2006, an estimated 9,500 new cases of pediatric cancer were diagnosed in the United States (American Cancer Society, 2006). Because of recent breakthroughs and more aggressive treatments, the survival rate of those diagnosed with childhood cancer has risen to almost 80% (Clayman, Galvin, and Arnston, 2007). One estimate is that by 2010 one of every 250 adults will be a survivor of childhood

But while more aggressive treatments have meant more people survive cancer, these treatments have also resulted in impaired fertility or sterility for some. Given the numbers of children and adults within their child-bearing years diagnosed with, treated for, and surviving cancer, fertility concerns have emerged as a quality of life issue important to cancer survivors and their families. In one study of cancer survivors, 76% of those who were childless expressed a desire to have children in the future (Schover, 2009). Impaired fertility as a result of cancer treatment has physical as well as psychological effects. The existing literature on women whose fertility was impaired as a result of cancer treatment reveals an intense psychological distress; for these women, "psychological distress may result from, not only the loss of the physical ability to conceive, but also a symbolic loss of the option or idea of fertility, regardless of whether this would have been acted upon or achievable" (Carter et al, 2005, p. 93). Some studies on men have revealed similar levels of long-term distress over their impaired fertility as a result of cancer treatments (Schover, 2009) while other studies found that infertility is not nearly as devastating for men as it is for women. Though reproduction is valued by both women and men, as the conflicting responses to studies between women and men (and even among men) illustrate, there are often

**1. Introduction** 

cancer (Kinahan, 2007).


### **Saving More than Lives: A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients**

Lisa Campo-Engelstein1, Sarah Rodriguez2 and Shauna Gardino2,3 *1Alden March Bioethics Institute & Department of OBGYN, Albany Medical College, 2Northwestern University, Feinberg School of Medicine, 3Oncofertility Consortium USA* 

#### **1. Introduction**

418 Public Health – Methodology, Environmental and Systems Issues

[113] Vollath, M.; Wicki, W. & Angst, J. (1989). The Zurich Study VIII. Insomnia: association

[114] Wirz-Justice, A.; Benedetti, F. & Terman, M. (2009). Chronotherapeutics for Affective Disorders: A Clinician's Manual for Light and Wake Therapy. Basel, Karger. [115] Wojnar, M.; Ilgen, M.A.; Wojnar, J.; McCammon, R.J.; Valenstein, M. & Brower, K.J.

[116] Wong, M.M; Brower, K.J.; Fitzgerald, H.E. & Zucker, R.A. (2004). Sleep problems in

[117] Wong, M. M.; Brower, K.J. & Zucker, R.A. (2009). Childhood sleep problems, early

[118] Wong, M. M.; Brower, K. J.; Nigg, J.T. & Zucker, R.A. (2010a). Childhood sleep

[119] Wong, M, M. (2010b). Pubertal development, sleep problems, and alcohol use: a

[120] Wong, M.M.; Brower, K.J. & Zucker, R.A. (2011). Sleep problems, suicidal ideation, and

[121] Yang, C.M.; Wu, C.H.; Hsieh, M. H.; Liu, M.H. & Lu, F.H. (2003). Coping with sleep

self-harm behaviors in adolescence. *J. Psychiatr. Res.,* 45, 505-511.

young adulthood. *Alcohol. Clin. Exp. Res.,* 34, 1033-1044.

commentary. *Alcohol. Clin. Exp. Res.*, 34, 2019-2021.

*Psychiatry Neurol. Sci.,* 239, 113–124.

Replication. *J. Psychiatr. Res.*, 43, 526-531.

*Alcohol. Clin. Exp. Res.*, 28, 578-587.

Taiwan. *Behav. Med.*, 29, 133-138.

796.

with depression, anxiety, somatic symptoms, and course of insomnia. *Eur. Arch.* 

(2009). Sleep problems and suicidality in the National Comorbidity Survey

early childhood and early onset of alcohol and other drug use in adolescence.

onset of substance use and behavioral problems in adolescence. *Sleep Med.,* 10, 787-

problems, response inhibition, and alcohol and drug outcomes in adolescence and

disturbances among young adults: a survey of first-year college students in

Cancer affects millions of Americans annually. Men's lifetime risk of developing cancer for all sites is 50%; women's lifetime risk is just over 33% (American Cancer Society, 2009). While cancer is generally perceived as a condition affecting people past their child-bearing years, nearly 10% of those diagnosed are under age 45 (Horner et al., 2009). Indeed, some of those diagnosed with cancer are still children. In 2006, an estimated 9,500 new cases of pediatric cancer were diagnosed in the United States (American Cancer Society, 2006). Because of recent breakthroughs and more aggressive treatments, the survival rate of those diagnosed with childhood cancer has risen to almost 80% (Clayman, Galvin, and Arnston, 2007). One estimate is that by 2010 one of every 250 adults will be a survivor of childhood cancer (Kinahan, 2007).

But while more aggressive treatments have meant more people survive cancer, these treatments have also resulted in impaired fertility or sterility for some. Given the numbers of children and adults within their child-bearing years diagnosed with, treated for, and surviving cancer, fertility concerns have emerged as a quality of life issue important to cancer survivors and their families. In one study of cancer survivors, 76% of those who were childless expressed a desire to have children in the future (Schover, 2009). Impaired fertility as a result of cancer treatment has physical as well as psychological effects. The existing literature on women whose fertility was impaired as a result of cancer treatment reveals an intense psychological distress; for these women, "psychological distress may result from, not only the loss of the physical ability to conceive, but also a symbolic loss of the option or idea of fertility, regardless of whether this would have been acted upon or achievable" (Carter et al, 2005, p. 93). Some studies on men have revealed similar levels of long-term distress over their impaired fertility as a result of cancer treatments (Schover, 2009) while other studies found that infertility is not nearly as devastating for men as it is for women.

Though reproduction is valued by both women and men, as the conflicting responses to studies between women and men (and even among men) illustrate, there are often

Saving More than Lives:

Woodruff, 2009).

cancer.

**3. Examining the existing research on QOL and fertility** 

in fertility concerns may not be as prominent as once thought.

A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients 421

considered an experimental intervention by the American Society for Reproductive Medicine (ASRM). Neither embryo nor egg banking, however, are not good options for some newly diagnosed cancer patients because these procedures require a two-to-three week delay in cancer treatment and cannot be performed on those who have not yet reached puberty. For women or young girls for whom embryo or egg banking may not be an acceptable option, ovarian tissue cryopreservation offers another opportunity to protect their potential to parent. Ovarian tissue cryopreservation is a procedure in which one ovary is removed and ovarian tissue is frozen in small strips. Based on the woman's treatment plan, the strips can be transplanted back and potentially restore ovarian function. Researchers are also currently working on another way to use the tissue: maturing the follicles from the cryopreserved ovarian tissue within the laboratory. As the functional unit of the ovary, the follicles would ideally mature into eggs and then be fertilized, with the resulting embryo implanted back into the woman when she desires pregnancy (Jeruss and

As we will discuss in-depth in the next section, infertility has historically been associated with women. Indeed, early studies of fertility concerns among cancer patients and survivors claim that women value fertility to a greater extent than men. In 1987, Wasserman, Thomspon, Wilimas, and Fairclough (1987) determined that attitudes toward possible sterility differed dramatically between female and male Hodgkin's survivors, with females expressing much more concern about their childbearing potential than males. Five years later, Zelter published a literature review, concluding that women as a group seek more information and evaluation of their fertility status than men (Zelter, 1993). Schover, Rubicki, Martin, and Bringelsen (1999) followed up with another literature review, hypothesizing from gathered data that women are more distressed over infertility, more concerned about having children, and more likely to see parenthood as an integral part of their life goals when compared to men. Finally, Patridge et al (2004) found that women will even sacrifice the efficacy of cancer treatment to lessen their chances of infertility or sterility, describing how, if given a choice, young women with early-stage breast cancer may choose a less toxic regimen of chemotherapy even if it confers slightly less protection from recurrence of

However, a handful of studies have recognized that male cancer patients and survivors value their fertility as well. A 1990 study by Reiker et al of 153 testicular cancer survivors indicated that distress about infertility is also prevalent among men, particularly among those who have cancer treatments that are likely to severely impair fertility (Reiker, 1990). Similarly, a 2003 study by Green, Galvin, and Horne confirmed that infertility can cause long-term distress among men with cancer. The literature regarding fertility concerns among male cancer patients is scarce when compared to the number of studies that demonstrate the importance of fertility among female cancer patients, but nonetheless this data should not be ignored. A growing body of more recent literature is beginning to recognize fertility concerns among male cancer patients, concluding that gender differences

Indeed, a 1999 study by Schover et al, which used a questionnaire to examine 283 young cancer survivors, found that about 80% of cancer survivors viewed themselves positively as

differences in how women and men respond to infertility. Gender has been the focus of much analysis in ethics, but little work has been done looking at gendered narratives to analyze fertility concerns as a quality of life issue among men and women undergoing possible fertility-impairing treatment for cancer. Such an analysis is relevant in the current context because of the rise in the number of younger people being diagnosed with and surviving cancer and accompanying scientific and technological advances in fertility preservation techniques. In the context of cancer survivorship, fertility has become a distinct quality of life consideration, with an entire new field (oncofertility) now dedicated to promoting fertility preservation options for cancer patients and survivors. Since oncofertility is a novel discipline that bridges a variety of academic scholarships, existing conceptual frameworks are inadequate for analyses within this field. We propose a multidisciplinary approach to understand the gendered themes of infertility as a quality of life concern in the current context of oncofertility.

In doing so, we argue that exploring common cultural conceptions of gender is essential to understanding cancer patients' and their families' fertility preservation decision making when confronting potential infertility. Our analysis begins at the patient level with a discussion of the existing literature that describes gender differences among cancer patients regarding fertility, cancer treatment, and the effects of both on their quality of life. Uniquely, we contextualize these existing social science studies within a historical context, using a new perspective to attempt to explain the sometimes divergent responses between women and men and among men by focusing on the different ways men and women have been treated for infertility broadly since the nineteenth century. We build on this historical framework by conducting a gendered analysis of infertility and fertility choices that is centered in the current cultural climate. In this way, we address gender, infertility, and fertility choices from three distinct levels—the individual level, the contextualizing historical level, and the broader current cultural level—creating our own multidisciplinary framework. Our analysis offers an insightful approach, creating a new framework within which we are able to draw meaningful conclusions about the impact gendered responses to infertility have on cancer patients' medical care and how health care providers and researchers can incorporate this knowledge to improve patient care.

#### **2. Fertility preservation technologies**

The developing field of oncofertility is dedicated to providing fertility preservation options to cancer patients, and a number of alternatives currently exist for both men and women. Reproductively mature men confronting a cancer diagnosis can generate a sperm sample and cryopreserve (freeze) their gametes for later use. Ejaculation can be stimulated in young men and those too sick to produce a sperm sample, or an experimental testicular biopsy can be done; the resulting sample can be cryopreserved. The technology for freezing sperm is wellestablished and successful, leaving these men with a viable option to become a biological father after cancer. Freezing sperm is relatively inexpensive and easy to accomplish, thus a feasible option for men of all socioeconomic backgrounds and cancer types.

Women's reproductive potential can also be jeopardized during cancer treatment. The only established method of fertility preservation for women is embryo banking, but this is often not a palatable option for young and/or single women. Egg banking is gaining popularity because there is no reliance on a male donor (known or anonymous); however, it is still

differences in how women and men respond to infertility. Gender has been the focus of much analysis in ethics, but little work has been done looking at gendered narratives to analyze fertility concerns as a quality of life issue among men and women undergoing possible fertility-impairing treatment for cancer. Such an analysis is relevant in the current context because of the rise in the number of younger people being diagnosed with and surviving cancer and accompanying scientific and technological advances in fertility preservation techniques. In the context of cancer survivorship, fertility has become a distinct quality of life consideration, with an entire new field (oncofertility) now dedicated to promoting fertility preservation options for cancer patients and survivors. Since oncofertility is a novel discipline that bridges a variety of academic scholarships, existing conceptual frameworks are inadequate for analyses within this field. We propose a multidisciplinary approach to understand the gendered themes of infertility as a quality of life concern in the

In doing so, we argue that exploring common cultural conceptions of gender is essential to understanding cancer patients' and their families' fertility preservation decision making when confronting potential infertility. Our analysis begins at the patient level with a discussion of the existing literature that describes gender differences among cancer patients regarding fertility, cancer treatment, and the effects of both on their quality of life. Uniquely, we contextualize these existing social science studies within a historical context, using a new perspective to attempt to explain the sometimes divergent responses between women and men and among men by focusing on the different ways men and women have been treated for infertility broadly since the nineteenth century. We build on this historical framework by conducting a gendered analysis of infertility and fertility choices that is centered in the current cultural climate. In this way, we address gender, infertility, and fertility choices from three distinct levels—the individual level, the contextualizing historical level, and the broader current cultural level—creating our own multidisciplinary framework. Our analysis offers an insightful approach, creating a new framework within which we are able to draw meaningful conclusions about the impact gendered responses to infertility have on cancer patients' medical care and how health care providers and researchers can incorporate this

The developing field of oncofertility is dedicated to providing fertility preservation options to cancer patients, and a number of alternatives currently exist for both men and women. Reproductively mature men confronting a cancer diagnosis can generate a sperm sample and cryopreserve (freeze) their gametes for later use. Ejaculation can be stimulated in young men and those too sick to produce a sperm sample, or an experimental testicular biopsy can be done; the resulting sample can be cryopreserved. The technology for freezing sperm is wellestablished and successful, leaving these men with a viable option to become a biological father after cancer. Freezing sperm is relatively inexpensive and easy to accomplish, thus a

Women's reproductive potential can also be jeopardized during cancer treatment. The only established method of fertility preservation for women is embryo banking, but this is often not a palatable option for young and/or single women. Egg banking is gaining popularity because there is no reliance on a male donor (known or anonymous); however, it is still

feasible option for men of all socioeconomic backgrounds and cancer types.

current context of oncofertility.

knowledge to improve patient care.

**2. Fertility preservation technologies** 

considered an experimental intervention by the American Society for Reproductive Medicine (ASRM). Neither embryo nor egg banking, however, are not good options for some newly diagnosed cancer patients because these procedures require a two-to-three week delay in cancer treatment and cannot be performed on those who have not yet reached puberty. For women or young girls for whom embryo or egg banking may not be an acceptable option, ovarian tissue cryopreservation offers another opportunity to protect their potential to parent. Ovarian tissue cryopreservation is a procedure in which one ovary is removed and ovarian tissue is frozen in small strips. Based on the woman's treatment plan, the strips can be transplanted back and potentially restore ovarian function. Researchers are also currently working on another way to use the tissue: maturing the follicles from the cryopreserved ovarian tissue within the laboratory. As the functional unit of the ovary, the follicles would ideally mature into eggs and then be fertilized, with the resulting embryo implanted back into the woman when she desires pregnancy (Jeruss and Woodruff, 2009).

#### **3. Examining the existing research on QOL and fertility**

As we will discuss in-depth in the next section, infertility has historically been associated with women. Indeed, early studies of fertility concerns among cancer patients and survivors claim that women value fertility to a greater extent than men. In 1987, Wasserman, Thomspon, Wilimas, and Fairclough (1987) determined that attitudes toward possible sterility differed dramatically between female and male Hodgkin's survivors, with females expressing much more concern about their childbearing potential than males. Five years later, Zelter published a literature review, concluding that women as a group seek more information and evaluation of their fertility status than men (Zelter, 1993). Schover, Rubicki, Martin, and Bringelsen (1999) followed up with another literature review, hypothesizing from gathered data that women are more distressed over infertility, more concerned about having children, and more likely to see parenthood as an integral part of their life goals when compared to men. Finally, Patridge et al (2004) found that women will even sacrifice the efficacy of cancer treatment to lessen their chances of infertility or sterility, describing how, if given a choice, young women with early-stage breast cancer may choose a less toxic regimen of chemotherapy even if it confers slightly less protection from recurrence of cancer.

However, a handful of studies have recognized that male cancer patients and survivors value their fertility as well. A 1990 study by Reiker et al of 153 testicular cancer survivors indicated that distress about infertility is also prevalent among men, particularly among those who have cancer treatments that are likely to severely impair fertility (Reiker, 1990). Similarly, a 2003 study by Green, Galvin, and Horne confirmed that infertility can cause long-term distress among men with cancer. The literature regarding fertility concerns among male cancer patients is scarce when compared to the number of studies that demonstrate the importance of fertility among female cancer patients, but nonetheless this data should not be ignored. A growing body of more recent literature is beginning to recognize fertility concerns among male cancer patients, concluding that gender differences in fertility concerns may not be as prominent as once thought.

Indeed, a 1999 study by Schover et al, which used a questionnaire to examine 283 young cancer survivors, found that about 80% of cancer survivors viewed themselves positively as

Saving More than Lives:

female (Marsh and Ronner, 1996).

1996; May, 1995).

**5. Current cultural narratives: Women and infertility** 

A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients 423

roles (Marsh and Ronner, 1996). Being a mother, especially through pregnancy, began to be more strongly tied to being a woman. This change in the stress placed on biological motherhood as the core identifier for femininity, along with the rise in the profession of gynecology, prompted a change in the way involuntary childlessness was viewed, both popularly and medically. What had been regarded as barrenness, a personal misfortune, became infertility, a treatable condition. As Margaret Marsh and Wanda Ronner (1996) noted in their history of infertility in the United States, during the nineteenth century, involuntarily childless married women began to increasingly turn to medical expertise; by doing so, both clinicians and women accepted infertility as treatable. Infertility was now a recognized medical condition, but patients seeking treatment for it were still nearly all

Beginning in the late nineteenth century, Marsh and Ronner argue, women willingly underwent often invasive treatments, including various surgeries, to correct an impairment of their bodies in order to provide them with a chance for motherhood. By doing so, they sought a surgical restoration not just of their reproductive functions but also of their feminine identity. The convergence of motherhood as defining femininity with the increasing reliance on physicians to treat involuntarily childless women enabled a perception that infertility was a problem of and with the female body. This was reinforced as only women sought medical attention for infertility. For the majority of the nineteenth century, it was women alone who were considered, culturally and medically, to be infertile; men were only considered infertile if they were impotent (Marsh and Ronner, 1996). Infertility was characterized as a disease of the female body, and it was a disease that impaired a woman's ability to achieve her primary social role: motherhood (Apple, 1997; Marsh and Ronner, 1996). Women internalized infertility: a woman's inability to biologically bear children challenged the prevailing cultural norm that motherhood was the natural role for a feminine woman. Infertility, then, affected the way women saw their feminine selves. As Marsh and Ronner (1996) found when they examined infertility in the late nineteenth and early twentieth centuries in the United States, doctors treated women across racial, ethnic, and class lines, suggesting the link between reproduction and femininity extended across the demographic spectrum. As the twentieth century wore on, increasing numbers of women sought medical expertise to enable them to conceive, with a sharp rise in infertility treatments accompanying the baby boom following World War II. During this intense pronatalist period in American history, to not be pregnant or have children within two years of marriage marked some women as odd – possibly even suggesting a lack of femininity. This tie between a woman's ability to conceive and her femininity, though ebbing a bit in the 1970s, remained strong through the course of the twentieth century (Marsh and Ronner,

The cultural connection between a woman's reproductive ability and her feminine identity has strong historical foundations in how women have been treated for infertility, foundations that continue to frame cultural conceptions of femininity as well as individual women's conception of themselves as female. Women have, and continue to, internalize their infertility. The contemporary literature on women without a cancer diagnosis but with

actual or potential parents, with no observed gender-related differences in the wish to have children or distress about fertility (Schover, et al, 1999). Similarly, a 2004 study by Zebrack, Casillas, Nohr, Adams, and Zelter used semi-structured interviews to assess the impact of cancer on long-term cancer survivors' quality of life, concluding that both men and women expressed a desire to have children in the future (Zebrack, 2004). Finally, an exploratory qualitative study by Crawshaw (2010) found that fertility matters affected identity, wellbeing and life planning as well as reproductive function, regardless of gender.

Our literature review of gender differences in fertility concerns among cancer patients indicates that, at present, there is conflicting evidence, but understandings of these gendered differences may be changing. While older studies indicate that female cancer patients value their fertility more strongly than male cancer patients, newer research suggests that these attitudes may be changing as more male cancer patients are beginning to recognize and express their fertility-related distress. However, these disparate conclusions could also be explained by differing methodologies; the aforementioned studies range from semistructured interviews to questionnaires to literature reviews. As these studies are rooted in distinct and differing methodologies, drawing accurate comparisons between them may be complicated.

In the rest of the paper we explore factors that may account for the aforementioned discrepancies in the literature relating to fertility concerns among female and male cancer patients, using both historical and cultural frameworks to explain how these attitudes are developed and derived.

#### **4. Historical foundations: Women and infertility**

In order to better understand the basis for the differing ways women and men may view infertility today, and the lack of consensus about the value of fertility among men, we need to explore the differences in the ways men and women have been medically treated for infertility in this country. As we will next describe, medical treatment for infertility in the United States reinforced and reflected prevailing cultural ideas about masculinity and femininity.

Though Americans could consult medical guides in the late eighteenth century for recourse to alleviate an involuntarily childless marriage, it was during the nineteenth century when physicians became increasingly involved in treating, and patients began to increasingly seek medical intervention for, infertility (Marsh and Ronner, 1996). Almost always, however, the patients seeking treatment were women. Why? Though motherhood had earlier been a principal role for women, during the nineteenth century it increasingly became the defining role for women, especially white middle-class women (Apple, 1997; Marsh and Ronner, 1996). By the early nineteenth century, American society began to draw clearer lines between family and community. These lines changed how families were seen and composed, both of which had profound implications for women's conceptions of femininity and reproduction. During the course of the nineteenth century, biological parenthood rather than household composition came to define a family, and thus being a mother increasingly meant bearing one's own children. As part of this shift, biological motherhood was increasingly regarded as the primary and principal role of women – in contrast to women in colonial America, where motherhood, though important, was seen as only one of a woman's

actual or potential parents, with no observed gender-related differences in the wish to have children or distress about fertility (Schover, et al, 1999). Similarly, a 2004 study by Zebrack, Casillas, Nohr, Adams, and Zelter used semi-structured interviews to assess the impact of cancer on long-term cancer survivors' quality of life, concluding that both men and women expressed a desire to have children in the future (Zebrack, 2004). Finally, an exploratory qualitative study by Crawshaw (2010) found that fertility matters affected identity, well-

Our literature review of gender differences in fertility concerns among cancer patients indicates that, at present, there is conflicting evidence, but understandings of these gendered differences may be changing. While older studies indicate that female cancer patients value their fertility more strongly than male cancer patients, newer research suggests that these attitudes may be changing as more male cancer patients are beginning to recognize and express their fertility-related distress. However, these disparate conclusions could also be explained by differing methodologies; the aforementioned studies range from semistructured interviews to questionnaires to literature reviews. As these studies are rooted in distinct and differing methodologies, drawing accurate comparisons between them may be

In the rest of the paper we explore factors that may account for the aforementioned discrepancies in the literature relating to fertility concerns among female and male cancer patients, using both historical and cultural frameworks to explain how these attitudes are

In order to better understand the basis for the differing ways women and men may view infertility today, and the lack of consensus about the value of fertility among men, we need to explore the differences in the ways men and women have been medically treated for infertility in this country. As we will next describe, medical treatment for infertility in the United States reinforced and reflected prevailing cultural ideas about masculinity and

Though Americans could consult medical guides in the late eighteenth century for recourse to alleviate an involuntarily childless marriage, it was during the nineteenth century when physicians became increasingly involved in treating, and patients began to increasingly seek medical intervention for, infertility (Marsh and Ronner, 1996). Almost always, however, the patients seeking treatment were women. Why? Though motherhood had earlier been a principal role for women, during the nineteenth century it increasingly became the defining role for women, especially white middle-class women (Apple, 1997; Marsh and Ronner, 1996). By the early nineteenth century, American society began to draw clearer lines between family and community. These lines changed how families were seen and composed, both of which had profound implications for women's conceptions of femininity and reproduction. During the course of the nineteenth century, biological parenthood rather than household composition came to define a family, and thus being a mother increasingly meant bearing one's own children. As part of this shift, biological motherhood was increasingly regarded as the primary and principal role of women – in contrast to women in colonial America, where motherhood, though important, was seen as only one of a woman's

being and life planning as well as reproductive function, regardless of gender.

complicated.

femininity.

developed and derived.

**4. Historical foundations: Women and infertility** 

roles (Marsh and Ronner, 1996). Being a mother, especially through pregnancy, began to be more strongly tied to being a woman. This change in the stress placed on biological motherhood as the core identifier for femininity, along with the rise in the profession of gynecology, prompted a change in the way involuntary childlessness was viewed, both popularly and medically. What had been regarded as barrenness, a personal misfortune, became infertility, a treatable condition. As Margaret Marsh and Wanda Ronner (1996) noted in their history of infertility in the United States, during the nineteenth century, involuntarily childless married women began to increasingly turn to medical expertise; by doing so, both clinicians and women accepted infertility as treatable. Infertility was now a recognized medical condition, but patients seeking treatment for it were still nearly all female (Marsh and Ronner, 1996).

Beginning in the late nineteenth century, Marsh and Ronner argue, women willingly underwent often invasive treatments, including various surgeries, to correct an impairment of their bodies in order to provide them with a chance for motherhood. By doing so, they sought a surgical restoration not just of their reproductive functions but also of their feminine identity. The convergence of motherhood as defining femininity with the increasing reliance on physicians to treat involuntarily childless women enabled a perception that infertility was a problem of and with the female body. This was reinforced as only women sought medical attention for infertility. For the majority of the nineteenth century, it was women alone who were considered, culturally and medically, to be infertile; men were only considered infertile if they were impotent (Marsh and Ronner, 1996). Infertility was characterized as a disease of the female body, and it was a disease that impaired a woman's ability to achieve her primary social role: motherhood (Apple, 1997; Marsh and Ronner, 1996). Women internalized infertility: a woman's inability to biologically bear children challenged the prevailing cultural norm that motherhood was the natural role for a feminine woman. Infertility, then, affected the way women saw their feminine selves.

As Marsh and Ronner (1996) found when they examined infertility in the late nineteenth and early twentieth centuries in the United States, doctors treated women across racial, ethnic, and class lines, suggesting the link between reproduction and femininity extended across the demographic spectrum. As the twentieth century wore on, increasing numbers of women sought medical expertise to enable them to conceive, with a sharp rise in infertility treatments accompanying the baby boom following World War II. During this intense pronatalist period in American history, to not be pregnant or have children within two years of marriage marked some women as odd – possibly even suggesting a lack of femininity. This tie between a woman's ability to conceive and her femininity, though ebbing a bit in the 1970s, remained strong through the course of the twentieth century (Marsh and Ronner, 1996; May, 1995).

#### **5. Current cultural narratives: Women and infertility**

The cultural connection between a woman's reproductive ability and her feminine identity has strong historical foundations in how women have been treated for infertility, foundations that continue to frame cultural conceptions of femininity as well as individual women's conception of themselves as female. Women have, and continue to, internalize their infertility. The contemporary literature on women without a cancer diagnosis but with

Saving More than Lives:

impairment with virility.

A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients 425

recommended to other physicians the need to look at the sperm of husbands' when a woman came to them for the treatment of infertility, he also stressed the importance of whether or not the man was "capable of performing the sexual act" when analyzing if the

As the Blech case illustrates, male fertility was connected to virility through the twentieth century, even though physicians acknowledged that the viability of the semen was an identifiable factor. Though by the 1930s physicians recognized that infertility was comparable in both genders, and by the 1950s semen analysis had become a standard protocol for infertility intervention, women largely remained the focus of medical fertility treatment. More than one physician lamented in the first half of the twentieth century that too many of his peers were eager to first perform invasive procedures (such as surgery) on the wife before testing the viability of the husband's sperm (Marsh and Ronner, 1996; May 1995). But even with the knowledge that men were infertile as often as women, this gender difference in treatment continued for the course of the twentieth century. In 1963, the president of the American Society for the Study of Sterility (later called ASRM) explained at the group's annual meeting that such a protocol remained justified because many infertility specialists believed men were rarely infertile. But just as important, since women usually initiated medical treatment, their husbands were often left unexamined (May, 1995). So while the physiological knowledge was there and the understanding that men were as likely to be infertile as women was available, women were the ones being treated because they sought the medical intervention. Even if a physician could not find a physiological reason on the woman's body, both the woman and the physician frequently believed the impairment was with her body. From the nineteenth century to the present, women have most commonly sought medical intervention for infertility, often doing so in order to spare their husbands from possible humiliation – a humiliation based on the idea that an infertile

While femininity was tied to reproduction, and this tie held both culturally and medically over the course of the twentieth century, masculinity, in contrast, was tied to sexual virility. Here we are extending the work of Marsh and Ronner (1996) in their history of infertility in the United States to argue that there is a historical basis for the current differences of fertility-related distress among male cancer patients compared to female cancer patients: men's medical treatment was not so tied, and did not reinforce, infertility as an impairment of their bodies. When infertility was associated with men, it was generally seen as an

Virility remains a significant component of cultural conceptions of masculinity and men's gendered identities. Sexual prowess is often seen as a way of proving one's masculinity. Furthermore, the male genitals are generally central to a man's coherent sexual identity (Gurevich et al., 2004), and are associated with stereotypical masculine traits like "strength" and "courage" (Szasz, 1998). Because of the personal, as well as social, significance of the male genitals, having "misfunctioning" (e.g. impotent, prematurely ejaculating, infertile) genitals or genitals that look "abnormal" (e.g. small penis, missing a testicle) can diminish men's sense of masculinity. For instance, in a ranking of the most humiliating experiences for college age men, the top three had to do with sexual function and the appearance of

infertility was male or female factor (Blech, 1903, 45-46).

man was an impotent man (Marsh and Ronner, 1996; May, 1995).

**7. Current cultural narratives: Men and infertility** 

impaired fertility reveals a significant amount of stress and depression due to their condition. Women who are infertile but otherwise healthy are twice as likely to be depressed as fertile healthy women; indeed, these women report levels of psychological distress comparable to women with life-threatening illnesses (Davis and Dearman, 1991; Domar, Zuttermeister, 1993; Luske and Vacc, 1993). In her exploration of women's reactions to learning of their infertility, Gayle Letherby (2002) found that women experienced a profound shock to their sense of themselves, resulting in a challenge to their conception of identity as female.

What happens, then, to a woman's conception of herself when the option for biological motherhood is impaired or taken away because of her cancer diagnosis or cancer treatment? The existing literature on women whose fertility is impaired due to cancer treatment reveals similar psychological stress; for these women, "psychological distress may result from, not only the loss of the physical ability to conceive, but also a symbolic loss of the option or idea of fertility, regardless of whether this would have been acted upon or achievable" (Carter, et al., 2005, p. 93). The American Society of Clinical Oncology (ASCO) found that "surveys of cancer survivors have identified an increased risk of emotional distress on those who become infertile because of their treatment" (Lee et al., 2006, p. 2921). One study on young women with breast cancer found that "fertility concerns may complicate" their "treatment decision-making process" and that there is evidence these young women "may experience greater psychological distress and more difficulty with adjustment to the diagnosis and treatment of breast cancer" (Partridge, 2004, p. 4175). This actual or symbolic loss has potentially great implications for a woman's perceptions of herself as female, for motherhood is a culturally significant role most women see themselves in and which cancer potentially interrupts. Women whose cancer treatments threaten their fertility still want the experience of motherhood, most often biological motherhood (Lee et al., 2006, p. 2921). This equation of femininity with reproductive ability remains culturally resonant. Women today, as in the past, quite often tie their feminine identities to their reproductive capabilities; a cancer diagnosis is a recent, and additionally culturally powerful, component of a longer story concerning women, infertility, and medical treatment.

#### **6. Historical foundations: Men and infertility**

Women, as was just explored, were much more likely in both the nineteenth and the twentieth centuries to seek medical treatment for infertility. While this gender discrepancy was at first an outgrowth of the idea that only women were barren, and then that only women were infertile, it persisted even as physicians noted that there could be a male factor involved in infertility. Indeed, by the late nineteenth century, some gynecologists began calling for husbands to be examined when wives came seeking a cure for their childlessness. But even as the concept of barrenness gave way to infertility for women in the nineteenth century, very few doctors asked to examine a patient's husband, as most physicians still considered it rare for a virile man to be infertile (Marsh and Ronner, 1996). This cultural conception was reflected and reinforced medically in the nineteenth century. In the early twentieth century, after examining a young woman who had been married for six years and came to him for "relief" of her suffering from infertility, physician Gustavus Blech (1903) took a swab of semen from the young woman's vagina and looked at it under a microscope. He found "not a spermatozoon in sight." But though he noted this physiological matter, and

impaired fertility reveals a significant amount of stress and depression due to their condition. Women who are infertile but otherwise healthy are twice as likely to be depressed as fertile healthy women; indeed, these women report levels of psychological distress comparable to women with life-threatening illnesses (Davis and Dearman, 1991; Domar, Zuttermeister, 1993; Luske and Vacc, 1993). In her exploration of women's reactions to learning of their infertility, Gayle Letherby (2002) found that women experienced a profound shock to their sense of themselves, resulting in a challenge to their conception of

What happens, then, to a woman's conception of herself when the option for biological motherhood is impaired or taken away because of her cancer diagnosis or cancer treatment? The existing literature on women whose fertility is impaired due to cancer treatment reveals similar psychological stress; for these women, "psychological distress may result from, not only the loss of the physical ability to conceive, but also a symbolic loss of the option or idea of fertility, regardless of whether this would have been acted upon or achievable" (Carter, et al., 2005, p. 93). The American Society of Clinical Oncology (ASCO) found that "surveys of cancer survivors have identified an increased risk of emotional distress on those who become infertile because of their treatment" (Lee et al., 2006, p. 2921). One study on young women with breast cancer found that "fertility concerns may complicate" their "treatment decision-making process" and that there is evidence these young women "may experience greater psychological distress and more difficulty with adjustment to the diagnosis and treatment of breast cancer" (Partridge, 2004, p. 4175). This actual or symbolic loss has potentially great implications for a woman's perceptions of herself as female, for motherhood is a culturally significant role most women see themselves in and which cancer potentially interrupts. Women whose cancer treatments threaten their fertility still want the experience of motherhood, most often biological motherhood (Lee et al., 2006, p. 2921). This equation of femininity with reproductive ability remains culturally resonant. Women today, as in the past, quite often tie their feminine identities to their reproductive capabilities; a cancer diagnosis is a recent, and additionally culturally powerful, component of a longer

Women, as was just explored, were much more likely in both the nineteenth and the twentieth centuries to seek medical treatment for infertility. While this gender discrepancy was at first an outgrowth of the idea that only women were barren, and then that only women were infertile, it persisted even as physicians noted that there could be a male factor involved in infertility. Indeed, by the late nineteenth century, some gynecologists began calling for husbands to be examined when wives came seeking a cure for their childlessness. But even as the concept of barrenness gave way to infertility for women in the nineteenth century, very few doctors asked to examine a patient's husband, as most physicians still considered it rare for a virile man to be infertile (Marsh and Ronner, 1996). This cultural conception was reflected and reinforced medically in the nineteenth century. In the early twentieth century, after examining a young woman who had been married for six years and came to him for "relief" of her suffering from infertility, physician Gustavus Blech (1903) took a swab of semen from the young woman's vagina and looked at it under a microscope. He found "not a spermatozoon in sight." But though he noted this physiological matter, and

story concerning women, infertility, and medical treatment.

**6. Historical foundations: Men and infertility** 

identity as female.

recommended to other physicians the need to look at the sperm of husbands' when a woman came to them for the treatment of infertility, he also stressed the importance of whether or not the man was "capable of performing the sexual act" when analyzing if the infertility was male or female factor (Blech, 1903, 45-46).

As the Blech case illustrates, male fertility was connected to virility through the twentieth century, even though physicians acknowledged that the viability of the semen was an identifiable factor. Though by the 1930s physicians recognized that infertility was comparable in both genders, and by the 1950s semen analysis had become a standard protocol for infertility intervention, women largely remained the focus of medical fertility treatment. More than one physician lamented in the first half of the twentieth century that too many of his peers were eager to first perform invasive procedures (such as surgery) on the wife before testing the viability of the husband's sperm (Marsh and Ronner, 1996; May 1995). But even with the knowledge that men were infertile as often as women, this gender difference in treatment continued for the course of the twentieth century. In 1963, the president of the American Society for the Study of Sterility (later called ASRM) explained at the group's annual meeting that such a protocol remained justified because many infertility specialists believed men were rarely infertile. But just as important, since women usually initiated medical treatment, their husbands were often left unexamined (May, 1995). So while the physiological knowledge was there and the understanding that men were as likely to be infertile as women was available, women were the ones being treated because they sought the medical intervention. Even if a physician could not find a physiological reason on the woman's body, both the woman and the physician frequently believed the impairment was with her body. From the nineteenth century to the present, women have most commonly sought medical intervention for infertility, often doing so in order to spare their husbands from possible humiliation – a humiliation based on the idea that an infertile man was an impotent man (Marsh and Ronner, 1996; May, 1995).

While femininity was tied to reproduction, and this tie held both culturally and medically over the course of the twentieth century, masculinity, in contrast, was tied to sexual virility. Here we are extending the work of Marsh and Ronner (1996) in their history of infertility in the United States to argue that there is a historical basis for the current differences of fertility-related distress among male cancer patients compared to female cancer patients: men's medical treatment was not so tied, and did not reinforce, infertility as an impairment of their bodies. When infertility was associated with men, it was generally seen as an impairment with virility.

#### **7. Current cultural narratives: Men and infertility**

Virility remains a significant component of cultural conceptions of masculinity and men's gendered identities. Sexual prowess is often seen as a way of proving one's masculinity. Furthermore, the male genitals are generally central to a man's coherent sexual identity (Gurevich et al., 2004), and are associated with stereotypical masculine traits like "strength" and "courage" (Szasz, 1998). Because of the personal, as well as social, significance of the male genitals, having "misfunctioning" (e.g. impotent, prematurely ejaculating, infertile) genitals or genitals that look "abnormal" (e.g. small penis, missing a testicle) can diminish men's sense of masculinity. For instance, in a ranking of the most humiliating experiences for college age men, the top three had to do with sexual function and the appearance of

Saving More than Lives:

his infertility (Becker, 1994; Daniels, 2006).

A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients 427

masculinity result in cultural understandings of infertility as an indicator of emasculation. Cynthia Daniels (2006), a political scientist researching the politics of reproduction, asserts that "the ability to biologically father one's children remains a hallmark of one's manhood, and infertility remains a source of masculine shame" (p.161). Specifically, questions about the viability of sperm production incite questions about the viability of masculinity (Gurevich 2004; Daniels 2006) This association is reflected in the secrecy and stigma surrounding heterosexual couples using sperm donation and results in practices like "matching" sperm donors to the physical traits and characteristics of the social father to hide

In addition to threatening masculinity, infertility may adversely affect men because it leaves their desire for biological children unfulfilled. Yet, this reason may play a smaller role for men than for women. The cultural pressure for women to have biological children and the fact that motherhood is an important part of many women's identity are thought to be a significant factor in why infertility is so devastating to women. That "[t]here is, in American society, no 'fatherhood mandate' with the same force and intensity as the 'motherhood mandate'" may

While there is still less pressure for men to be biological fathers compared to the pressure women feel to be mothers (at least in the U.S.), men are much more active in their children's lives than even a generation ago. We see this change reflected in new concepts and policies. For example, the concept of a stay-at-home dad is relatively recent. This term probably did not exist, or at the very least was not ubiquitous, a couple of generations ago. Today, the U.S. Census Bureau estimates that there are 143,000 stay-at-home dads. Men's involvement in primary caretaking of children is also seen in policies like extending maternity leave to men through paternity leave. A recent study shows that 89% of men took some time off after

Men's increased involvement in their children's lives shows not only that fatherhood is extremely significant for many men, but also that men's active participation in their children's lives is becoming more socially acceptable. Indeed, gender norms surrounding fatherhood are changing, which influences the value men place on becoming biological fathers. Fatherhood today seems to play a greater role in men's identity and their vision of an ideal life. This social change helps explain the mixed results on the importance of fertility to male cancer patients as illustrated in the quality of life surveys. We are in a time of transition in which more men are value active fatherhood, but there are still men who adhere to traditional gender roles. The survey results mirror this transition, as some surveys show that men are less interested in parenthood than women and other studies reveal that men's and women's interest in fertility are equivalent. If men's interest in fatherhood continues to grow, we can expect that in the future, studies will uniformly find that women

The persistent gender bias – women's bodies demand medical intervention while men's bodies are left alone as long as there is a physical sign of sexual potency – is a historically important cultural phenomenon that continues to shape current conceptions of femininity, masculinity, and fertility. Understanding the history of the differences in medical treatment

explain, at least in part, men's less strong reaction to infertility (Greil 1991, p. 64).

the birth of their child (Nepomnyaschy and Waldfogel, 2007).

and men equally value parenthood.

**8. Clinical implications and conclusions** 

genitals: 1. unable to maintain an erection during sex; 2. losing a testicle to cancer; 3. being teased about penis size (Mormon, 2000).

This trend holds true for men facing cancer, especially those with cancer affecting the genitals: listing the second most humiliating experience as losing a testicle to cancer highlights the deleterious effects cancer can have on men's self-worth and identity. A qualitative study on men with testicular cancer found that definitions of masculinity continue to be strongly tied to sexual performance and the appearance of "normal" genitals, both of which can be threatened by cancer and cancer treatments (Gurevich et al., 2004).

Whereas the centrality of virility and male genitals to men's sexual identity is supported in the literature (Gurevich, et al., 2004), the importance of fertility for men—the desire to have biological children and the role fertility plays in their identity—is not just ambiguous, but is often contradictory. As previously discussed, some studies found male cancer patients value their fertility as much as female cancer patients whereas other studies show that women value their fertility much more than men. Much of the broader literature on infertility in the general population, not just cancer patients, supports the latter finding. In his interviews with mainly white, middle-class, heterosexual married couples facing infertility,1 Arthur Greil (1991) found that the husbands were more likely to view the experience of infertility as disappointing, though not as a threat to their identity. The wives, in contrast, saw infertility as devastating, something that spoiled their identities and signified their role failure as woman, wife, and mother (Greil, 1991). Furthermore, in a review of the literature, Greil discusses how both qualitative and quantitative studies show that women react more negatively to infertility (e.g. have lower self-esteem, blame themselves for their infertility, feel defective, etc.) than men (Greil, 2010). Even when the couple is suffering from male factor infertility, most of the literature concludes that this does not seem to change men's response to infertility (Greil, 1997).

Given that infertility is not as devastating for men as impotence or abnormal genitals, it is not surprising that a diagnosis of sterility ranks lower (in fifth place) on the list of the most humiliating experiences for college men than experiences that are more closely connected to sexual performance and the appearance of "normal" genitals (Mormon, 2000).2 It is worth noting that men older than traditional college age students (18-22 years old) may have come up with a different ranking; while college age men are typically trying to avoid fatherhood and consequently do not value fertility as much at this stage in their lives, older men are probably more interested in becoming a father and thus may find a diagnosis of sterility more troubling.

While sterility and infertility may not top the list as the most humiliating experience for young men, they are still negative experiences. A large reason for this is the close relationship between men's virility and fertility (Inhorn, 2002). The historical association of infertility with impotence and the importance of virility to current conceptions of

<sup>1</sup> White, middle-class, heterosexual married couples are the most common participants of many empirical studies on infertility in part because they are the social group most likely to seek out infertility treatment. In the last handful of years, however, more research has been done on people of color and infertility. See, for example, Becker et al., Jain, and White et al.

<sup>2</sup> Having a rectal exam ranks fourth. While this experience does not directly deal with male sexuality, being penetrated is usually associated with women, which is in part why this experience is humiliating.

genitals: 1. unable to maintain an erection during sex; 2. losing a testicle to cancer; 3. being

This trend holds true for men facing cancer, especially those with cancer affecting the genitals: listing the second most humiliating experience as losing a testicle to cancer highlights the deleterious effects cancer can have on men's self-worth and identity. A qualitative study on men with testicular cancer found that definitions of masculinity continue to be strongly tied to sexual performance and the appearance of "normal" genitals, both of which can be threatened by cancer and cancer treatments (Gurevich et al., 2004).

Whereas the centrality of virility and male genitals to men's sexual identity is supported in the literature (Gurevich, et al., 2004), the importance of fertility for men—the desire to have biological children and the role fertility plays in their identity—is not just ambiguous, but is often contradictory. As previously discussed, some studies found male cancer patients value their fertility as much as female cancer patients whereas other studies show that women value their fertility much more than men. Much of the broader literature on infertility in the general population, not just cancer patients, supports the latter finding. In his interviews with mainly white, middle-class, heterosexual married couples facing infertility,1 Arthur Greil (1991) found that the husbands were more likely to view the experience of infertility as disappointing, though not as a threat to their identity. The wives, in contrast, saw infertility as devastating, something that spoiled their identities and signified their role failure as woman, wife, and mother (Greil, 1991). Furthermore, in a review of the literature, Greil discusses how both qualitative and quantitative studies show that women react more negatively to infertility (e.g. have lower self-esteem, blame themselves for their infertility, feel defective, etc.) than men (Greil, 2010). Even when the couple is suffering from male factor infertility, most of the literature concludes that this does not seem to change men's

Given that infertility is not as devastating for men as impotence or abnormal genitals, it is not surprising that a diagnosis of sterility ranks lower (in fifth place) on the list of the most humiliating experiences for college men than experiences that are more closely connected to sexual performance and the appearance of "normal" genitals (Mormon, 2000).2 It is worth noting that men older than traditional college age students (18-22 years old) may have come up with a different ranking; while college age men are typically trying to avoid fatherhood and consequently do not value fertility as much at this stage in their lives, older men are probably more interested in becoming a father and thus may find a diagnosis of sterility

While sterility and infertility may not top the list as the most humiliating experience for young men, they are still negative experiences. A large reason for this is the close relationship between men's virility and fertility (Inhorn, 2002). The historical association of infertility with impotence and the importance of virility to current conceptions of

1 White, middle-class, heterosexual married couples are the most common participants of many empirical studies on infertility in part because they are the social group most likely to seek out infertility treatment. In the last handful of years, however, more research has been done on people of color and

2 Having a rectal exam ranks fourth. While this experience does not directly deal with male sexuality, being penetrated is usually associated with women, which is in part why this experience is humiliating.

infertility. See, for example, Becker et al., Jain, and White et al.

teased about penis size (Mormon, 2000).

response to infertility (Greil, 1997).

more troubling.

masculinity result in cultural understandings of infertility as an indicator of emasculation. Cynthia Daniels (2006), a political scientist researching the politics of reproduction, asserts that "the ability to biologically father one's children remains a hallmark of one's manhood, and infertility remains a source of masculine shame" (p.161). Specifically, questions about the viability of sperm production incite questions about the viability of masculinity (Gurevich 2004; Daniels 2006) This association is reflected in the secrecy and stigma surrounding heterosexual couples using sperm donation and results in practices like "matching" sperm donors to the physical traits and characteristics of the social father to hide his infertility (Becker, 1994; Daniels, 2006).

In addition to threatening masculinity, infertility may adversely affect men because it leaves their desire for biological children unfulfilled. Yet, this reason may play a smaller role for men than for women. The cultural pressure for women to have biological children and the fact that motherhood is an important part of many women's identity are thought to be a significant factor in why infertility is so devastating to women. That "[t]here is, in American society, no 'fatherhood mandate' with the same force and intensity as the 'motherhood mandate'" may explain, at least in part, men's less strong reaction to infertility (Greil 1991, p. 64).

While there is still less pressure for men to be biological fathers compared to the pressure women feel to be mothers (at least in the U.S.), men are much more active in their children's lives than even a generation ago. We see this change reflected in new concepts and policies. For example, the concept of a stay-at-home dad is relatively recent. This term probably did not exist, or at the very least was not ubiquitous, a couple of generations ago. Today, the U.S. Census Bureau estimates that there are 143,000 stay-at-home dads. Men's involvement in primary caretaking of children is also seen in policies like extending maternity leave to men through paternity leave. A recent study shows that 89% of men took some time off after the birth of their child (Nepomnyaschy and Waldfogel, 2007).

Men's increased involvement in their children's lives shows not only that fatherhood is extremely significant for many men, but also that men's active participation in their children's lives is becoming more socially acceptable. Indeed, gender norms surrounding fatherhood are changing, which influences the value men place on becoming biological fathers. Fatherhood today seems to play a greater role in men's identity and their vision of an ideal life. This social change helps explain the mixed results on the importance of fertility to male cancer patients as illustrated in the quality of life surveys. We are in a time of transition in which more men are value active fatherhood, but there are still men who adhere to traditional gender roles. The survey results mirror this transition, as some surveys show that men are less interested in parenthood than women and other studies reveal that men's and women's interest in fertility are equivalent. If men's interest in fatherhood continues to grow, we can expect that in the future, studies will uniformly find that women and men equally value parenthood.

#### **8. Clinical implications and conclusions**

The persistent gender bias – women's bodies demand medical intervention while men's bodies are left alone as long as there is a physical sign of sexual potency – is a historically important cultural phenomenon that continues to shape current conceptions of femininity, masculinity, and fertility. Understanding the history of the differences in medical treatment

Saving More than Lives:

**9. Acknowledgement** 

Society.

Society.

5RL1HD058296.

**10. References** 

A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients 429

both provider and patient education materials that contextualize fertility preservation choices within the social environments in which they occur, as well as offering patients coping strategies that recognize their unique gendered responses, we can help address relevant patient concerns and enhance decision-making capabilities. Jordan et al. (1999) has recognized that significant gender differences exist in coping strategies for infertility, and these differences need to be addressed in the development of patient education materials that offer coping strategies (Jordan, 1999). Both historically and presently, infertility has been described as a devastating diagnosis for cancer patients, both female and male. Recognizing and outlining the historical influences that have contributed in creating this distress, as well as the current social factors that reinforce it, is a step in the right direction. Incorporating these analyses into the development of interdisciplinary patient and provider education materials is the next step towards translating these findings into clinical practice.

This research was supported by the Oncofertility Consortium NIH 8UL1DE019587,

American Cancer Society. (2006). Cancer facts and figures 2006. Atlanta: American Cancer

American Cancer Society. (2008). Cancer facts and figures 2008. Atlanta: American Cancer

Apple, R. D., Golden, J. (1997). Introduction. In R. D. Apple and J. Golden (Eds)., Mothers and motherhood: readings in American history. Columbus: Ohio State University Press. Bardwell, W. A., Profant, J., Casden, D. R., Dimsdale, J.E., Ancoli-Israel S., Natarajan, L.,

women treated for early-stage breast cancer. *Psychooncology*, *17*(1), 9-18. Becker, G., M. Castrillo, Rebecca Jackson et al. (2006). Infertility among low-income Latinos.

Becker, G. and R. Nachtigall. (1994) 'Born to a mother': The cultural construction of risk in infertility treatment in the U.S. *Social Science & Medicine, 39*(4), 507-518. Blech, G. M. (1903). *The Practitioner's guide to the diagnosis and treatment of diseases of women.* 

Carter J, Rowland K, Chi D, et al. (2005). Gynecologic cancer treatment and the impact of

Campo-Engelstein, L. "Consistency in Insurance Coverage for Iatrogenic Conditions Resulting

Carver, C. S. (1997). You want to measure coping but your protocol's too long: Consider the Brief COPE. *International Journal of Behavioral Medicine*, *4*, 92-100.

from Cancer Treatment Including Fertility Preservation." Journal of Clinical

http://www.cancer.org/docroot/PRO/content/PRO\_1\_1\_Cancer\_Statistics\_2009\_

Rock, C.L., Pierce, J.P., and Women's Healthy Eating & Living (WHEL) Study Group. (2008). The relative importance of specific risk factors for insomnia in

American Cancer Society. (2009). Cancer statistics 2009 presentation.

cancer-related infertility. *Gynecol Oncol, 97*, 90-95.

Presentation.asp (October 12, 2009).

*Fertility & Sterility,* 85(4): p. 882-7.

Chicago: M. Robertson.

Oncology 28.8 (March 10, 2010)

of infertility provides a unique contextualization of contemporary cancer patients' views on their fertility and the possibility of their future infertility. Quality of life studies consistently show that fertility is very important to female cancer patients and while the results for male cancer patients are mixed, many men do strongly value their fertility. These social science studies, however, are often not translated into clinical practice by health care providers. Instead, many providers continue to make assumptions "based on the patient's age, sex, diagnosis, culture, and partnership status without checking with the patient" (Horden and Street, 2007, p. 227). Furthermore, providers' personal characteristics (e.g. age, sex, etc.) can also influence whether they discuss fertility preservation treatment with their patients. For example, a recent study found that female oncologists were more likely to refer their patients to a reproductive endocrinologist or infertility specialist compared to male oncologists. While discussions and referrals for fertility preservation among adult cancer patients are improving, they remain suboptimal: only forty-seven percent of respondents always or often refer cancer patients of childbearing age to a reproductive endocrinologist or infertility specialist (Quinn, 2009). Health care providers need to openly address potential infertility as a consequence of cancer treatment so that their patients are informed about and offered fertility preservation options.

By contextualizing female and male cancer patients' views on infertility within a historical framework, we have shown that these differences in views are not innate, but rather are shaped by gender norms, both historical and current. Understanding the social factors that influence people's views on infertility will enable health care providers to better aid their patients in their fertility preservation decision making. In other words, situating patients within their social environment, rather than seeing them as free floating individuals or reducing them to their diseases, allows providers to acknowledge the various social factors that contribute to and are at stake in decisions about fertility preservation treatment. Familiarity with gender norms as well as recognition they are changing (especially the role of fatherhood for men) equips providers with the ability to understand the discrepancy between women's and men's views and the discrepancy among men's views on infertility. This can help providers be more empathetic to their patients' needs and concerns, while at the same time not pigeonholing patients by sex/gender.

Various health organizations, including ASCO and ASRM, have issued guidelines on fertility preservation to their practitioners for all cancer patients stating that "the available evidence suggests that fertility preservation is of great importance to many people diagnosed with cancer" (Lee, 2006, p. 2921; Ethics Committee of ASRM, 2005). While it is important for these organizations to set guidelines, the mere existence and dissemination of guidelines may not be enough to make substantial changes in provider referrals for fertility preservation treatment. A deeper appreciation for the social factors involved in patients' views on infertility may engender greater change and specifically more referrals for fertility preservation treatment. Safeguarding fertility for cancer patients should be considered as important of a quality of life issue as breast reconstruction and hair replacement (Campo-Engelstein, 2010), and the options for fertility preservation should be part of the discussion regarding a patient's cancer treatment – regardless of gender. Doing so respects both women's and men's desire to be – or at least retain the possibility of being – biological parents.

The best way to ensure that these historical foundations and social factors are integrated into clinical care is through the development of an appropriate intervention. By creating both provider and patient education materials that contextualize fertility preservation choices within the social environments in which they occur, as well as offering patients coping strategies that recognize their unique gendered responses, we can help address relevant patient concerns and enhance decision-making capabilities. Jordan et al. (1999) has recognized that significant gender differences exist in coping strategies for infertility, and these differences need to be addressed in the development of patient education materials that offer coping strategies (Jordan, 1999). Both historically and presently, infertility has been described as a devastating diagnosis for cancer patients, both female and male. Recognizing and outlining the historical influences that have contributed in creating this distress, as well as the current social factors that reinforce it, is a step in the right direction. Incorporating these analyses into the development of interdisciplinary patient and provider education materials is the next step towards translating these findings into clinical practice.

#### **9. Acknowledgement**

This research was supported by the Oncofertility Consortium NIH 8UL1DE019587, 5RL1HD058296.

#### **10. References**

428 Public Health – Methodology, Environmental and Systems Issues

of infertility provides a unique contextualization of contemporary cancer patients' views on their fertility and the possibility of their future infertility. Quality of life studies consistently show that fertility is very important to female cancer patients and while the results for male cancer patients are mixed, many men do strongly value their fertility. These social science studies, however, are often not translated into clinical practice by health care providers. Instead, many providers continue to make assumptions "based on the patient's age, sex, diagnosis, culture, and partnership status without checking with the patient" (Horden and Street, 2007, p. 227). Furthermore, providers' personal characteristics (e.g. age, sex, etc.) can also influence whether they discuss fertility preservation treatment with their patients. For example, a recent study found that female oncologists were more likely to refer their patients to a reproductive endocrinologist or infertility specialist compared to male oncologists. While discussions and referrals for fertility preservation among adult cancer patients are improving, they remain suboptimal: only forty-seven percent of respondents always or often refer cancer patients of childbearing age to a reproductive endocrinologist or infertility specialist (Quinn, 2009). Health care providers need to openly address potential infertility as a consequence of cancer treatment so that their patients are informed about and

By contextualizing female and male cancer patients' views on infertility within a historical framework, we have shown that these differences in views are not innate, but rather are shaped by gender norms, both historical and current. Understanding the social factors that influence people's views on infertility will enable health care providers to better aid their patients in their fertility preservation decision making. In other words, situating patients within their social environment, rather than seeing them as free floating individuals or reducing them to their diseases, allows providers to acknowledge the various social factors that contribute to and are at stake in decisions about fertility preservation treatment. Familiarity with gender norms as well as recognition they are changing (especially the role of fatherhood for men) equips providers with the ability to understand the discrepancy between women's and men's views and the discrepancy among men's views on infertility. This can help providers be more empathetic to their patients' needs and concerns, while at

Various health organizations, including ASCO and ASRM, have issued guidelines on fertility preservation to their practitioners for all cancer patients stating that "the available evidence suggests that fertility preservation is of great importance to many people diagnosed with cancer" (Lee, 2006, p. 2921; Ethics Committee of ASRM, 2005). While it is important for these organizations to set guidelines, the mere existence and dissemination of guidelines may not be enough to make substantial changes in provider referrals for fertility preservation treatment. A deeper appreciation for the social factors involved in patients' views on infertility may engender greater change and specifically more referrals for fertility preservation treatment. Safeguarding fertility for cancer patients should be considered as important of a quality of life issue as breast reconstruction and hair replacement (Campo-Engelstein, 2010), and the options for fertility preservation should be part of the discussion regarding a patient's cancer treatment – regardless of gender. Doing so respects both women's and men's desire to be – or at least

The best way to ensure that these historical foundations and social factors are integrated into clinical care is through the development of an appropriate intervention. By creating

offered fertility preservation options.

the same time not pigeonholing patients by sex/gender.

retain the possibility of being – biological parents.


Saving More than Lives:

A Gendered Analysis of the Importance of Fertility Preservation for Cancer Patients 431

Jeruss, J. S. and Woodruff, T. K. (2009). Preservation of fertility in patients with cancer. *The* 

Jordan, A., and Revenson, T. A. (1999). Gender differences in coping with infertility: A meta-

Kinahan, K. E., Didwania, A., and Nieman, C. L. (2007). Childhood cancer: Fertility and

Letherby, G. (2002). Challenging dominant discourses: Identity and change and the

Lee, S. J., Schover, L. R., Partridge, A. H., Patrizio, P., Wallace, W. H., Hagerty, K., Beck, L.

Loscalzo MJ, Clark KL. The psychosocial context of cancer-related infertility. In: Woodruff

Lukse, M. D., and Vacc, N. A. (1999). Grief, depression, and coping in women undergoing

May, E. T. (1995). *Barren in the promised land: Childless Americans and the pursuit of happiness.* 

Mormon, M.T. (2000). The influence of fear appeals, message design, and masculinity on

National Cancer Institute. (2006). Facing forward: life after cancer treatment. Washington,

Nepomnyaschy, L. and Waldfogel, J. (2007). Paternity leave and fathers' involvement with

Patridge, A. H., Gelber, S., Peppercorn, J., Sampson, E., Knudsen, K., Laufer, M., Rosenberg, R.,

young women with breast cancer. *Journal of Clinical Oncology*, *22*, 4174-4183. Quinn, G. P., Cadaparampil, S. T., Lee, J. H., Jacobsen, P.B., Bepler, G., Lancaster, J., Keefe,

Radloff, L.S. (1977). The CES-D scale: A self report depression scale for research in the

Rieker, P. P., Fitzgerald, E. M., Kalish, L. A. (1990). Adaptive behavioral responses to potential infertility among survivors of testis cancer. *Journal of Clinical Oncology*, *8*, 347 – 55. Saito, K., Suzuki, K., Iwasaki, A., Yumura, Y., Kubota, Y. (2005). Sperm cryopreservation

Schover, L. R. (1999). Psychosocial aspects of infertility and decisions about reproduction in young cancer survivors: a review. *Medical and Pediatric Oncology*, *33*:53-59.

general population. *Applied Psychological Measurement, 1*, 385-401.

psychosocial implications. In Woodruff, T. K. and Snyder, K. A. (eds). *Oncofertility:* 

experience of 'infertility' and 'involuntary childlessness'. *Journal of Gender Studies,*

N., Brennan, L. V., Oktay, K. (2006). American Society of Clinical Oncology recommendations on fertility preservation in cancer patients," *Journal of Clinical* 

TK, Snyder KA, editors. Oncofertility: Fertility Preservation for Cancer Survivors.

men's motivation to perform the testicular self-exam. *Journal of Applied* 

DC: U.S. Department of Health and Human Services, National Institutes of Health.

their young children: Evidence from the American ECLS-B. *Community, Work &* 

Przypyszny, M., Rein, A., Winer, E. P. (2004). Web-based survey of fertility issues in

D. L., and Albrecht, T. L. (2009). Physician referral for fertility preservation in oncology patients: A national study of practice behaviors. *Journal of Clinical* 

before cancer chemotherapy helps in the emotional battle against cancer. *Cancer*,

*New England Journal of Medicine*, *360*(9), 902-911.

*11*, 277-288 (ref. on pg. 279).

*Oncology, 24* (18), 2917-2931.

New York: Basic Books.

*Family*, *10*, (4), 427 – 453.

*Oncology*, *27*(35), 5952-5967.

*104*,521-524.

New York: Springer, 2007:180-190.

*Communication Research 28*, 81-116.

analysis. *Journal of Behavioral Medicine*, *22*(4), 341- 358.

*Fertility preservation for cancer survivors*. New York: Springer.

infertility treatment. *Obstetrics & Gynecology, 93* (2), 245-51.


submission, posted to the SEER web site, 2009.

Jain, T. (2006). Socioeconomic and racial disparities among infertility patients seeking care. *Fertility & Sterility,* 85(4): p. 876-81.

Chang V.T., Hwang S.S., Feuerman M., Kasimis B.S., Thaler H.T. (2000). The memorial symptom assessment scale short form (MSAS-SF). *Cancer, 89*(5), 1162-71. Clayman, M. L., Galvin, K. M., and Arnston, P. (2007). Shared decision making: Fertility and

Connell S., Patterson C., Newman B. (2006). A qualitative analysis of reproductive issues

Crawshaw, M. A., Sloper, P. (2010) 'Swimming against the tide' – the influence of fertility

Daniels, C. R. (2006). *Exposing men: The science and politics of male reproduction*. New York,

Davis, D. C., Dearman, C. N. (1991). Coping strategies of infertile women. *Journal of* 

DevCan: Probability of Developing or Dying of Cancer Software, Version 6.3.0 Statistical Research and Applications Branch, NCI, 2008. http://srab.cancer.gov/devcan. Duman, A. D., Zuttermeister, P.C., Friedman, R. (1993). The psychological impact of

Dunn J., Steginga, S. K. (2009). Young women's experience of breast cancer: Defining young

Ethics Committee of the American Society for Reproductive Medicine. (2005). Fertility

Green D. H., Galvin, H., and Horne, B. (2003). The psycho-social impact of fertility on young male cancer survivors: A qualitative investigation. *Psychooncology, 12*,141-152. Greil, A. L. (1991). *Not yet pregnant: Infertility couples in contemporary America*. New

Greil, A. L., et al. 2010. The experience of infertility: A review of recent literature. *Sociology of* 

Gurevich, M., Bishop, S., Bower, J., Malka, M., and Nyhof-Young, J. (2004). (Dis)embodying gender and sexuality in testicular cancer. *Social Science & Medicine*, *58*, 1597-1607. Heinemann, K., Ruebig, A., Potthoff, P., Schneider, H., Strelow, F., Heinemann, L. and Minh

Horden, A. J., and Street, A. F. (2007). Communicating about patient sexuality and intimacy

Horner, M. J., Ries, L. A. G., Krapcho, M., Neyman, N., Aminou, R., Howlader, N.,

http://seer.cancer.gov/csr/1975\_2006/, based on November 2008 SEER data

Jain, T. (2006). Socioeconomic and racial disparities among infertility patients seeking care.

Review, 1975-2006, National Cancer Institute. Bethesda, MD,

Thai, D. (2004). The menopause rating scale (MRS) scale: A methodological review.

after cancer: Mismatched expectations and unmet needs. *Medical Journal of* 

Altekruse, S. F., Feuer, E. J., Huang L., Mariotto, A., Miller, B. A., Lewis, D. R., Eisner, M. P., Stinchcomb, D. G., Edwards, B. K. (eds). SEER Cancer Statistics

*preservation for cancer survivors*. New York: Springer.

*Obstetric, Gynecologic, & Neonatal Nursing, 20* (3), 221-8.

and identifying concerns. *Psychooncology*, *9*, 137-146.

*European Journal of Cancer Care*, Jan 19.

Brunswick: Rutgers University Press.

*Health and Quality of Life Outcomes*, *2*, 45-52.

submission, posted to the SEER web site, 2009.

*Fertility & Sterility,* 85(4): p. 876-81.

*Health & Illness, 32*(1):140–62.

*Australia, 186*(5), 224-227.

Oxford University Press.

52.

1628.

pediatric cancers. In Woodruff, T. K. and Snyder, K. A., eds. *Oncofertility: Fertility* 

raised by young Australian women with breast cancer. *Health Care Women, 27*, 94-110.

matters on the transition to adulthood or survivorship following adolescent cancer.

infertility. *Journal of Psychosomatic Obstetrics and Gynecology*, 14 (Suppl S. Dec.), 45-

preservation and reproduction in cancer patients. *Fertility and Sterility, 83* (6), 1622-


Schover, L.R., Rubicki, L.A., Martin, B.A., Bringelsen, K.A. (1999). Having children after cancer. A pilot survey of survivors' attitudes and experiences. *Cancer, 86*, 697-709. Schover, L.R., Brey, K., Lichtin, A., Lipshultz, L.I., Jeha, S. (2002a). Knowledge and

Schover, L.R., Brey, K., Lichtin, A., Lipshultz, L. I., Jeha, S. (2002b). Oncologists' attitudes

Szasz, I. (1998). Masculine identity and the meanings of sexuality: A review of research in

Tschudin, S., Bitzer, J. (2009). Psychological aspects of fertility preservation in men and

U.S. Census Bureau. Press release: Father's day. http://www.census.gov/Press-

Ware, J. E., Sherbourne, C. (1992). The MOS 36-Item short-form health survey (SF-36): A conceptual framework and item selection. *Medical Care*, *30* (6), 473-483. Wasserman, A. L., Thompson, E. I., Wilimas, J.A., and Fairclough, D.L. (1987). The

Wenzel, L., Dogan-Ates, A., Habbal, R., Berkowitz, R., Goldstein, D.P., Bernstein, M.,

White, L., J. McQuillan, and A.L. Greil. (2006). Explaining disparities in treatment seeking:

Zanagnolo, V., Sartori, R., Trussardi, E., Pasinetti, B., Maggino, T. (2005). Preservation of

Zebrack, B. J., Casillas, J., Nohr, L., Adams, H., Zelter, L. K. (2004). Fertility issues for young

Zelter, L. K. (1993). Cancer in adolescents and young adults: Psychosocial aspects in long-

adult survivors of childhood cancer. *Psychooncology, 13*, 689-699.

survivors. *Journal of Clinical Oncology, 20*, 1880-1889.

Mexico. *Reproductive Health Matters, 6*(12), 97-104.

Published June 12, 2006. Accessed March 11, 2010.

*American Journal of Diseases of Children, 141*:626-631.

*of the National Cancer Institute Monographs,* 34, 94-98.

term survivors. *Cancer, 71*(Suppl 10), 3463-3468.

*Reproductive Biology, 12*3, 235-243.

The case of infertility. *Fertility & Sterility*, 85(4): p. 853-7.

*Oncology, 2*, 1890-1897.

*Update, 1:* 1-11.

experience regarding cancer, infertility, and sperm banking in younger male

and practices regarding banking sperm before cancer treatment. *Journal of Clinical* 

women affected by cancer and other life-threatening diseases. *Human Reproduction* 

Release/www/releases/archives/facts\_for\_features\_special\_editions/006794.html.

psychological status of survivors of childhood/adolescent Hodgkin's Disease.

Khusman, B.C., Osann, K., Newlands, E., Secki, M.J., Hancock, B., Cella, D. (2005). Defining and measuring reproductive concerns of female cancer survivors. *Journal* 

ovarian function, reproductive ability and emotional attitudes in parents with malignant ovarian tumors. *European Journal of Obstetrics & Gynecology and* 

### *Edited by Jay Maddock*

Public health can be thought of as a series of complex systems. Many things that individual living in high income countries take for granted like the control of infectious disease, clean, potable water, low infant mortality rates require a high functioning systems comprised of numerous actors, locations and interactions to work. Many people only notice public health when that system fails. This book explores several systems in public health including aspects of the food system, health care system and emerging issues including waste minimization in nanosilver. Several chapters address global health concerns including non-communicable disease prevention, poverty and health-longevity medicine. The book also presents several novel methodologies for better modeling and assessment of essential public health issues.

Public Health - Methodology, Environmental and Systems Issues

Public Health

Methodology, Environmental

and Systems Issues

*Edited by Jay Maddock*

Photo by malija / iStock