**2.1 Old vs. Young**

## *2.1.1 Fair innings*

The philosophical framework termed "fair innings" posits that each human has an equal right to experience each phase (age) of life. Therefore if the same intervention could extend for one year the life of a 60-year-old or a 26-year-old, then the younger patient should preferentially get the intervention so they have their "fair-inning" at


*Data was retrieved from the National Vital Statistics Reports Final Death Reports. The color coding represents better values in green (low deaths, low disease duration, and decreased deaths over time) adn worse values in red. https://pubmed.ncbi.nlm.nih.gov/25075874/ https://pubmed.ncbi.nlm.nih.gov/32501199/*

#### **Table 1.**

*Duration of Disease vs. Population Effect.*

*Ethical Issues Which Have Prevented the U.S. from Maximizing Quality of Life Years DOI: http://dx.doi.org/10.5772/intechopen.97561*

**Figure 2.** *Length of Public Health Issues vs. Population Effect.*

living the age of 27. Human lifespan has roughly doubled in the last century, from roughly 40 to 80 years of life in the developed world. Does a child that is born into the world that now lives 10% longer than their parents have the scaled protection to get to the world's future average lifespan (10% older than their parents), or do fair innings apply as a static set of years based on the oldest generations having care rationed? If nations had been rationing care based on the "fair innings" philosophy they would have possibly undervalued young years of life if they were not taking into account the projected increase in lifespan for younger generations. Recently the lifespan in the United States decreased for the first time in decades due to a combination of macro health issues (obesity, opiod overdose, and suicide epidemics). While the current U.S. healthcare system does not ration care based on fair innings principles, if it had done so and taken into account the longstanding historical increases in lifespan younger generations would have received more resources than deemed fair in hindsight since their projected lifespan has dropped from historical trends. One of the most important aspects for implementing allotment of healthcare resources based on QALYs is for the electorate to have supreme confidence in its fairness. The use of fair innings is very transparent in taking from one group (older) to give to another group (younger), and any projection based on moving average lifespans could increase the publics distrust in QALY use for policy decisions.

#### *2.1.2 Rule of Rescue*

In 1986 Albert Jonsen coined the term "Rule of Rescue" which described the medical community's unwillingness to allow patients to die, even when a high cost to save them made the QALY calculation suggest the resources would be better used elsewhere [23]. Jonsen described examples of sitting on various committees to decide the value of interventions (artificial heart, cardiac transplantation, amniocentesis, liver transplant, autologous bone marrow transplantation), and a recurring theme emerged in which the debate would go down a consistent path

detailing the high cost per QALY only to end abruptly with the group deciding the lives must be saved. These expensive transplant procedures are still covered in the United States despite continued poor QALY analysis. As genetic knowledge and biomedical technologies have continued to advance, the list of expensive procedures that deliver increased QALYs to patients, however the absolute cost and % of GDP spent on healthcare has also continued to rise. The incremental cost effectiveness ratio per QALY needs to be calculated for these high ticket items. For example, the recent chimeric antigen receptor T cell therapy (CAR-T therapy) [24] appears cost effective 95% of the time, assuming a willingness to pay \$100,000 USD for each QALY gained, despite costing roughly half a million dollars USD in the United States (depending on the type of B-cell malignancy) [25]. The incremental cost-effectiveness ratio (ICER) for CAR-T was found to be somewhere between roughly \$64,000/QALY and \$175,000 depending on the study and assumptions for average 5-year progression-free survival (PFS) [25–27].

The Rule of Rescues inability to allow an overly expensive life to end has resoundingly caused a decrease in quality of life years. Attempts have been made over the last half century in the United States to limit excessive expenditures for care during the last two years of life, but almost all have failed. Some have argued the rule of rescue is defensible even from a utilitarian point of view in that the citizenry will have increased "well-being" because they desire living in a community that values life, and while that trend is likely true it cannot defend the rule of rescue without bounds [28]. Most see the rule of rescue as contradicting the utilitarian nature of QALY optimization for healthcare expenditures.

The Affordable Care Act (ACA, also known as Obamacare) was the greatest leap towards universal coverage in the United States in the last 50 years (since Medicaid was signed into law in 1965), but is not close to the single payer systems that Europe has long implemented. The ACA initially proposed paying physicians if they provided voluntary counseling to Medicare patients about end-of-life care options, advance directives, or living wills. During the 2009 presidential debate Sarah Palin famously termed these clauses "death panels" describing a future where doctors decided whose parents would die. These aspects of the bill were removed before final passage as result of public pressure.

#### *2.1.3 Standard gamble*

The standard gamble is a more patient specific measure of if a medical intervention should be done. **Figure 3** shows a simple standard gamble in which a health intervention could result in either a better or worse outcomes than no intervention (e.g. an organ transplant). The probability p of the best outcome (healthy), is changed until the patient has no preference over whether to get the medical intervention or not, at which point their personalized standard gamble has been calculated [22]. There are other standard gamble scenarios/diagrams when, for example, no outcome results in death, or any intervention outcome is higher than lack of intervention.

#### **2.2 Women vs. Men**

#### *2.2.1 Pregnancy*

Should a pregnant woman in need of care have QALYs counted for herself and her baby, just herself, just her baby, and how does the age of the fetus change that calculus? If one adheres to the "fair innings" paradigm (see above), then the early years of a newborn are more valuable than the mothers later years. It seems clear that if a female near term needed resources her QALY measurement should, at a minimum, be the

*Ethical Issues Which Have Prevented the U.S. from Maximizing Quality of Life Years DOI: http://dx.doi.org/10.5772/intechopen.97561*

**Figure 3.** *Standard Gamble.*

greater childs QALYs if fair innings were being taken into account. QALYs are often not scaled by age (no fair innings implementation) and the pregnant female would have resources assigned worth double a single person (with equal weight for her and her child). In reality there are often not even the attempted use of QALYs in such situations in the United States, because lethal pregnancy issues are handled like other Emergency Department critical patients following the rule of rescue (see above) in that any resources are used to save the lives at that moment. Costs of infertility treatment share many of these same QALY accounting issues, and have other societal/ethical issues in addition. For example, early this century the UK 's National Institute for Clinical Excellence (NICE) covered infertility costs but explicitly excluded "social infertility" which includes a woman being single or homosexual. Under that paradigm a woman 40 years of age that has fertility issues could qualify for in vitro fertilization (IVF) over a woman half her age that happens to be single and/or a lesbian [29]. Similarly to how the rule of rescue trumps all other QALY calculations, societal norms can have a trumping effect of completely removing groups from medical coverage. A common delimiter for excluding a group from medical coverage is if there is a nonmedical lifestyle action/intervention to effect the same increase in QALYs, such as finding a male spouse in the above example. To the authors' knowledge no country has seriously addressed this issue in any way other than looking at them on a case by case basis by a panel (e.g. by health experts, philosophers, politicians).

#### *2.2.2 Sex lifespan differences*

Women live longer than men across the globe (~8% or 6 years). Roughly \$100,000 USD more is spent on women's health than men during their life (\$375,000 \$275,000). Since healthcare later in life is more expensive this translates to women costing society more as they live longer during an expensive healthcare phase. Roughly half (45%) of women's increased healthcare costs come just from this longer lifespan. However individual situations could have calculations suggesting women get more than parity in resources. For example, if 50-year-old male and a 51-year-old female needed the same resource (such as an organ transplant)

the longer female lifespan could suggest even a slightly older woman should take precedence over her junior male counterpart.

### **3. Organ Donor Waitlist**

The transplant of organs could theoretically have extremely positive QALY returns per dollar spent, depending on the age. There are a plethora of ethical issues that arise from organ donations however, such as how important is the patient's age, their relation to the organ donor, the duration of organ viability after transplantation, or the degree to which their personal actions resulted in their need for an organ transplant.

If a young child in need of an organ could live a full life time with one transplant the QALY calculations would likely result in societies funding these transplants without any second guessing. Indeed curably treating young patients with a lethal disease is the best scenario to maximize QALYs gained, if comparing similarly priced interventions. However, organ transplants often do not alleviate a patient's disease for a normal lifespan. For example, cystic fibrosis (CF) patients most often die from lung failure due to thick mucus and biofilm accumulation leading to necrosis of the tissue. Lung transplants are done for CF patients but transplants usually only perform sufficiently for 5 years. CF patients can now live over 40 years, double the 20 year lifespan they had half a century ago. Therefore, contrary to other QALY based interventions, transplants are not recommended for the younger CF patients.

While most donated organs come from donors after they have died, there are also living organ donations. Directed living organ donation, the most common type as opposed to non-directed organ donation, allows the donor to choose the recipient (often a family member) [30]. Even the most rigorous ordering of donor recipients using rankings to maximize QALYs can suddenly be shortcut by directed living organ donors. This is an example where there is a limited supply (of organs) and the calculations to maximize QALYs changes because a family member is willing to increase that limited supply but only if used in the manner they want. Therefore there are times when a healthcare system can increase QALYs at the sacrifice of absolute ethical parity of all patients based on their need.

Smokers receiving lung transplants is another case example highlighting societies' concern about funding healthcare solutions for ailments which has been self-inflicted. More than a third of lung transplants in the U.S. are for former smokers (40%), but they often only qualify once they have proven they have quit smoking. This achieves two outcomes. Most quantifiably it increases QALYs in that a lung transplant given to someone who will never smoke again, will on average produce more QALYs than if the lung transplant were given to someone that immediately starts smoking multiple packs a day after surgery. It also addresses the moral issue, allowing the donor and society to feel like the gift of the organ is being valued by the recipient. However one study showed after smokers receive lung transplants 11% admitted they resumed smoking, with another 6% showing high levels of urinary cotinine (a metabolite of nicotine). These values are similar to heart and renal transplant recipients, who reported smoking after transplantation at a frequency of 21% and 25% respectively [31].

#### **4. Self-inflicted medical issues**

#### **4.1 Smokers**

There are many health issues for which the individual is primarily responsible. Smoking and alcoholism may be the best examples. A recent study showed that

*Ethical Issues Which Have Prevented the U.S. from Maximizing Quality of Life Years DOI: http://dx.doi.org/10.5772/intechopen.97561*

cessation of smoking alone could save up to 12 years of life [32]. Should the population that lives a healthier lifestyle pay for the less healthy lifestyle chosen by other individuals? Even cases that seem extremely clear, such as smoking, are often more complicated. For example, those living in Beijing, China have the exposure equivalent to smoking 25 cigarettes per day, just from breathing in the high particulate air [33, 34]. It seems unfair to not cover the respiratory issues of a child born in Bejing, just because those same respiratory issues are self-induced by a heavy smoker in the countryside.

#### **4.2 Alcoholism**

For a decade scientific papers appeared to show low levels of alcohol could be beneficial, with people pointing to the resveratrol in wine as an epigenetic antiaging molecule, or the blue zones of the world that consumed red wine such as Italy. In reality their high fish, high vegetable, and low calorie diet are greater life prolonging life styles. It also turns out in many of these studies the alcohol "abstainer" groups had prior alcoholics included in them, who had previously changed their lifestyle to never consume alcohol. While the abstainer group had slightly poorer health than the one drink a day group, it is likely that could be due to prior damage the alcoholics had done to their body before becoming abstainers. Such scientific errors will cause resources to be misallocated if QALYs are used coarsely to allocate every dime of resource. Should alcoholics be required to quit drinking before receiving a liver transplant? Is one drink a day ok for them. One drink a day should be physically ok for the transplanted liver, but could cause the patient to slip and start drinking heavily again. Heavy alcohol consumption clearly causes cirrhosis of the liver, however contrary to the lay public's view this is the second leading cause of cirrhosis (while hepatitis C is the leading cause) [35]. Not publicly funding healthcare for self-induced ailments clearly could save significant percentages of healthcare expenditures. However, it could lead to patients lying about their health habits and is difficult to implement fairly given the multimodal hazards for multiple diseases.

#### **4.3 Diabetes**

Diabetes and Alzheimer disease are two of the most serious medical conditions the developed world must grapple with. Both diseases are increasing rapidly in the population, while patients are able to live with the conditions for over a decade. Alzheimer's will not be discussed as there are excellent reviews of the issues [36–38], but in short it poses a problem in that there is no treatment on the horizon. Diabetes (type II) on the other hand is extremely targetable, with reduced caloric consumption and exercise literally at the patients finger tips. However, both of these solutions have some socioeconomic interacting factors. Wealthier people can afford the time for leisure exercise, and can buy more expensive but healthier food that is less calorically dense (e.g. fresh vegetables). Some of these caveats are not as pernicious as they sound. While some fresh vegetables can be expensive and perishable, frozen vegetables, potatoes, and legumes are all healthy and cheap with a long shelf life. In addition, while difficult, anyone can choose to "just eat less" which actually has a negative cost. The true social cost to reduced calorie intervention is in building and supporting structures to increase the success rate obese individuals have in transitioning from an unhealthy to healthy lifestyle.

Are genetic predispositions a disability? Generally any inherited disorder is more likely to have healthcare solutions funded for it than self-imposed maladies. Historically these inherited disabilities have been very binary, e.g. an extreme life threatening autosomal recessively inherited disease in which a child had the poor

misfortune, 25% chance, of getting both deleterious alleles from their mom and dad. However we are now getting genetic knowledge that a person is only predisposed to ailments, which often have environmental causes as well. For example obese grandparents can pass on epigenetic modifications to their grandchildren that makes them 4-fold more likely to be diabetic. Is that a self-induced ailment? The grandparents might have caused their metabolic disorder by overeating, but the grandchildren clearly started birth with a biological handicap.

Hemodialysis, the most common form of dialysis, performs the kidneys function by taking a patient's blood through a filter outside of their body (cleaning it), and then returning it to their body. Dialysis is a one of the most common, expensive, and recurring treatments in developed countries, with diabetics greatly predisposed to need treatment [39]. Diabetics, by definition, cannot control their blood glucose levels and their kidneys are therefore working overtime to continually secrete excess sugar from the blood, often ending in organ failure. Early type II diabetics (<5 years of disease) do not cost society a lot in healthcare, with depression being the costliest comorbidity (64–82% increase). However, the later nonfatal complications have much larger increases in healthcare costs: end-stage renal disease with dialysis (201–599%), hemorrhagic/ischemic stroke (37–376%), and amputation of upper/ lower-extremities (13–279%). Fatal complications had even larger cost increases with cardiovascular death being the most expensive (1,784–2,001%), but "othercause deaths" being costly as well (1,285–1,584%) [40]. The rule of rescue makes these later expensive interventions covered, while spending that money on prevention earlier would save more QALYs/\$.

### **5. Extreme examples affecting QALYs**

When assigning QALYs gained by a medical intervention both the duration of extra time lived and the quality of that time need to be measured, with the former being a much easier/reproducible value to calculate. There are many extreme health scenarios (e.g. wars, population changes, climate change, paradigm shifts creating seemingly unlimited resources) that are useful examples to walk through when considering how QALYs should be measured and used to alot resources.

#### **5.1 War**

Warfare represents an extreme environment in which both the broad and mortal health need can bring clarity to how we perform our healthcare resource allocation decisions. During war the local healthcare capability can change quickly as resources are stressed both geographically and temporally. Medical triage during war is needed to use the limited medical personal and resources for those most likely to benefit from that care. In extreme examples this can include neglecting dying patients who could be saved during less strenuous times.

Medics are viewed as more important because they can in the immediate future save more lives. The future potential of one to increase QALYs of others is a thorny topic. How far in the future can you predict this and how certain do you need to be? The argument has been made that richer people that own companies could have more highly weighted QALYs because they employ others, raise the Gross Domestic Product (GDP), which causes a greater tax base to contribute more taxes towards the healthcare infrastructure therefore increasing the resources to improve QALYs. Such an argument clarifies a known tradeoff when measuring and using QALYs: there are times when a known method to increase QALYs is openly not desired or acted on because of the consensus that it would not be fair. Therefore, while QALYs

*Ethical Issues Which Have Prevented the U.S. from Maximizing Quality of Life Years DOI: http://dx.doi.org/10.5772/intechopen.97561*

are usually presented in a completely utilitarian view, their implementation openly breaks this at will when there is a consensus that the increased utility would come at the cost of equality for the program's participants. This favoring of fairness over utility may be because the equality or lack thereof is apparent immediately at each decision point, whereas the utility gain is often deferred temporally (sometimes as long as decades into the future).

#### **5.2 Population explosion vs. collapse**

The value assigned to a new human life can change during an individual's life or as a society evolves. Early in life people may not be ready to care for a child and choose to terminate pregnancies, saving their resources for the average 1–3 children they want to have later in their life. As nations become more wealthy their population chooses to have less children, investing more resources in the quality of each life. In the last two centuries human population has grown exponentially. If the total sum of QALYs were measured over that time, the last 200 years, they would clearly also follow a similar, and likely steeper, exponential increase. Not only has lifespan increased but quality of life has increased. While people are unaware of how much life has improved [41], poverty and related health issues have decreased outside the first world nations during the last 50 years [42].

#### *5.2.1 Climate catastrophe*

With the rising global population and use of fossil fuels, there has been a causal rise in the global warming gas carbon dioxide (CO2). Earth CO2 atmospheric levels are now at 418 parts per million (ppm), a third higher than they were after world war II. Deleterious climate effects have already occurred [43] (e.g. acidification of the ocean, bleaching of coral reefs, sea level rise submerging island nations, increased hurricane activity, droughts, crop loss, famine). In 2006 Patz and Olson estimated that climate change had already caused 5,000,000 DALYs in a 30 year timeframe, which was mostly burdened by the developing countries [44]. Scientists are even more concerned about future tipping points which the earth would be unlikely to recover from for many decades. Recently Schneider et al. showed a level of 1,200 ppm CO2 could cause the disappearance of climate cooling clouds covering the ocean and result in 8°C (14F) rise in global temperature [45]. Such a dramatic change would melt all of Greenland and much (if not all) of Antarctica's glaciers, raising sea level and flooding all coastal cities globally, in which roughly 20% of the world's population lives.

When millions, or billions, of humans are affected by such a foreseeable super event the weightings of actionable paths forward often have large ranges of uncertainty. What is the likelihood of such an event happening and of suggested interventions preventing the negative effects? What will be the health consequences of such a large portion of the earth having to relocate. The situation becomes more dire the faster the migration of people has to happen. While sea level rise is universally understandable and viewable, a faster and perhaps more pernicious effect will likely be rising air temperature. While humans are amazingly adaptable to different temperature zones we do have an upper temperature limit, the wet-bulb temperature (TW) of 35°C (95°F). Above this temperature humans cannot shed heat, and if a region attained this temperature for extended periods it would be impossible for humans to live there without air conditioning. In a business-as-usual emission model, Representative Concentration Pathway (RCP) 8.5, parts of the Middle East and South Asia could regularly exceed this 35°C threshold in the near future [46–48]. Deaths have not historically been cataloged at or above this 35°C limit

#### *Health-Related Quality of Life - Measurement Tools, Predictors and Modifiers*

because lethal issues can occur before that temperature limit is reached. In 2020 Raymond et al. reviewed weather stations globally and found many TW around 31°C and two stations above the human limit of 35°C [49]. Most of these temperatures occurred for short periods, 1–2 hours, but a fearsome spike in TW was found to occur in some coastal locations where an afternoon breeze could bring in humidity from the water spiking the wet bulb temperature. Dubai is already planning a city that will be enclosed in a dome, called "Mall of the World" and cover 48 million square feet while taking 10 years to complete. This domed city would protect the citizenry from inhospitable heat, while acting in a second fashion as a place to study a closed ecosystem with an eye towards building cities on the moon or mars.

#### *5.2.2 Small populations*

The value societies assign to growing their population can vary for a myriad of reasons, such as predominant religious doctrine. There has been recent excitement about human travel to the moon and mars, with permanent settlement on the latter. If there were a mars base with less than 10,000 people the QALY analysis to save a newborn compared to a 80 year old would likely be different than the same question on earth. In this thought experiment the fair innings would likely trump the rule of rescue on Mars when assigning health resources to young vs. old.

#### *5.2.3 Unlimited resources*

In the next 50–100 years humanity may have nearly unlimited resources: energy (e.g. solar panels, fusion) and robotics/machines to perform the necessary tasks for humans to thrive (e.g. farming food, building shelter, developing and raising children). Under such a paradigm the younger generation is not an imposition on older generations so there would not be as much of a downside to increasing birth rates. Humanity has historically seemed insatiable in its use of resources so such a paradigm may never arise, but if it did for even a few generations (somewhat like fossil fuels did for energy use at times) then QALYs would have to be fought over less as the world would be less of a zero sum game.

These extreme examples point out that QALYs between groups are useful to view how resources are assigned in different situations, highlighting societal norms that can override QALY analysis. It is fairly easy to determine the Life Years (LY) saved when measuring a QALY, harder to measure the Quality (Q ), and perhaps hardest to incorporate the QALY to limit resource use in one area compared to another when confronted by societal norms that push against this.

### **6. Cost transparency**

#### **6.1 Insurance deductions**

A common modern occurrence in the United States is for an insured patient to receive a medical bill in which over 90% of the cost has been deducted through agreements between the insurance company and the medical supplier. The remaining bill is paid by the insurance company and the patients copay, or by the patient if they haven't met their deductible limit. With people's healthcare plan changing annually in the U.S. for multiple reasons (e.g. loss of job, changing job, moving to a different state, employer change in plan options, change in medical conditioning warranting upgrading or downgrading coverage), patients realistically rarely know the cost of medically covered procedures prior to obtaining care.

## **6.2 Care across health systems**

In the United States the lack of universal healthcare or a single payer system makes it harder to collect data on where and what healthcare dollars are being spent on. Large hospital systems are much better at measuring costs and expenditures within their network, than cities are at measuring the same across multiple networks. As an example between 2002 and 2016 patients with Heart Failure (HF) had a decrease in mortality (6.8% to 4.9%) and length of stay in a hospital (8.6 to 6.5 days) respectively. However they had an increase in cost per stay (\$14,301 to \$17,925) due to more extensive complications and procedures during the stay. At the same time their post-hospital expenses went up from 2002 to 2016 including discharge to long-term care (20.8% to 25.6%) [50]. Hospitals can save money by getting patients out the door quickly, but the society and patients are worse off if they leave the hospital only to encounter greater expenses and long-term discharge times.
