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6
Ethical Considerations and Caveats

The recommendations in this report regarding priorities in the development of vaccines over the next 10 and 20 years relies directly on the measurement of the burden of disease in recipient populations for each vaccine. The model employed by the committee allows comparisons of vaccines in quantitative terms for their relative cost-effectiveness in reducing the burden of disease. There are ethical or value judgments and assumptions built into this model, and it would be imprudent for policymakers to assume that the model alone constitutes a completely ethically appropriate and uncontroversial standard for priorities in resource allocation for vaccine development. This chapter will first discuss those ethical and value judgments implicit in the model and, secondly, those that present unresolved complexities. These unresolved matters tend, for the most part, to center on issues of fairness and justice. It is especially important for policymakers to be explicitly aware of these unresolved issues since it would often be inappropriate to move directly from the relative ranking of vaccine priorities yielded by the model to final priorities for policy without talking them into account.

Since resources for vaccine development, as for any publicly supported health intervention, are inevitably scarce, it may seem to be a virtual truism that these limited resources should be directed to those vaccines that would achieve the greatest reduction in the burden of disease. But the allocation of public resources by policymakers, for vaccine development as elsewhere, must be just or fair to the public that will be affected by the prioritization.

There are two main reasons the committee has not attempted to build ethical or value judgments about justice or fairness in allocation into the quantitative model. First, although much effort in health policy has been devoted to the development and validation of measures of the burden of disease, very little work



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Vaccines for the 21st Century: A Tool for Decisionmaking 6 Ethical Considerations and Caveats The recommendations in this report regarding priorities in the development of vaccines over the next 10 and 20 years relies directly on the measurement of the burden of disease in recipient populations for each vaccine. The model employed by the committee allows comparisons of vaccines in quantitative terms for their relative cost-effectiveness in reducing the burden of disease. There are ethical or value judgments and assumptions built into this model, and it would be imprudent for policymakers to assume that the model alone constitutes a completely ethically appropriate and uncontroversial standard for priorities in resource allocation for vaccine development. This chapter will first discuss those ethical and value judgments implicit in the model and, secondly, those that present unresolved complexities. These unresolved matters tend, for the most part, to center on issues of fairness and justice. It is especially important for policymakers to be explicitly aware of these unresolved issues since it would often be inappropriate to move directly from the relative ranking of vaccine priorities yielded by the model to final priorities for policy without talking them into account. Since resources for vaccine development, as for any publicly supported health intervention, are inevitably scarce, it may seem to be a virtual truism that these limited resources should be directed to those vaccines that would achieve the greatest reduction in the burden of disease. But the allocation of public resources by policymakers, for vaccine development as elsewhere, must be just or fair to the public that will be affected by the prioritization. There are two main reasons the committee has not attempted to build ethical or value judgments about justice or fairness in allocation into the quantitative model. First, although much effort in health policy has been devoted to the development and validation of measures of the burden of disease, very little work

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Vaccines for the 21st Century: A Tool for Decisionmaking has been done to integrate these considerations of fairness into cost-benefit or cost-effectiveness measures. To the extent that cost-effectiveness measures sometimes conflict with fairness, such integration of considerations of fairness into the measures could amount to partial abandonment of the cost-effectiveness standard. Second, these issues of fairness remain controversial, and there is no clear consensus with which the committee could have justified building specific positions into our model. For these reasons, it is common in studies like the committee’s to employ a cost-effectiveness analysis to develop a priority list, and then to remind policymakers who will make use of the list that they must, of course, also consider distributive issues of fairness or justice concerning the distribution of benefits and burdens in the ultimate priorities that they adopt. While the committee was unable, for the two reasons cited above, to integrate these issues of fairness or justice into the formal model, the committee does attempt to advance attention to these issues beyond what they typically receive by discussing briefly the nature of some of the more important considerations and illustrating where they arise in determining priorities for vaccine development. Before discussing ethical issues in the development and use of the model for prioritization of new vaccine development, the committee wants to underscore one important ethical limitation that was imposed from the outset by the scope of work: the committee was asked to consider only the U.S. health needs of the population. In some cases this resulted in diseases with a very high burden of disease worldwide, such as malaria, cholera, and shistosomiasis, not even appearing on the final list of candidates that the committee included in the analysis. In other cases, vaccines for diseases that were considered might have received a very different ranking if our study had not been restricted to the U.S. population. It would have been a challenge beyond our resources and mandate to include an assessment of international disease burden as an additional quantitative factor in this model, and the committee did not undertake this. Clearly, U.S. government agencies like National Institute of Allergy and Infectious Diseases and the other components of the National Institutes of Health are justified in giving priority to the needs of U.S. citizens whose tax dollars support their work. However, a wide variety of government-supported programs and activities, from direct foreign aid and overseas disaster relief programs to support for international peacekeeping, human rights, and third-world development efforts, are concerned with the well-being of the population beyond our borders and reflect our recognition of international responsibilities even if they sometimes serve U.S. interests as well. Especially in an area like medical research in general and vaccine development in particular, in which the United States has long been a world leader, the committee believes that ethically justified priorities for new vaccine development cannot ignore health needs beyond our own borders. Both governmental agencies and private organizations that make use of this report are urged not to ignore worldwide needs and opportunities for disease prevention from new vaccine development.

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Vaccines for the 21st Century: A Tool for Decisionmaking ETHICAL AND VALUE JUDGMENTS BUILT INTO THE MODEL These comments begin with the main ethical or value judgments built into the quantitative model that the committee developed and employed. All QALYs Count Equally The quality-adjusted life year (QALY) has been widely used in health care and other contexts in recent years to compare the outcomes of different health or other interventions. The calculation of QALYs is described in Chapters 4 and 5. The QALY measures the impact an illness or a health intervention on an individuals’ expected years of life and their quality of life. The QALY measure assumes that an additional year of life has the same value regardless of the age of the person who receives it, assuming the life years are of comparable quality; for example, assuming no difference in quality, an additional life year secured for an infant, a 30-year-old, and a 75-year-old all have equal value. In this respect, all QALYs have equal value no matter who receives them or how old individuals are when they receive them. Recently, a measure of the burden of illness in terms of disability-adjusted life years (DALYs) was developed for the World Bank and World Health Organization (Murray and Lopez, 1996). In contrast to QALYs, DALYs assign different values to years of life depending on age, and independent of differences in health-related quality of life. Roughly, DALYs assign relatively low value to a year of life in infancy and childhood, significantly greater value in the economically productive young adult years, and less value again at older ages. The principal rationale offered for this difference in the social value of life extension based on age was that it is common in many countries for persons to fill different social roles at different ages. In particular, because both the young and the old tend to depend on adults in their productive years for their well-being, the social value of life extension during adult life, as opposed to childhood and old age, was deemed greater. The committee chose QALYs rather than DALYs because it believes the proper societal perspective on the value of extending its members’ lives focuses on the value to those individuals of extending their lives, not the value of those lives to others. Using the latter perspective would bring in other differentiations between individuals in their social and economic value to others that the committee believes should not be given ethical significance in health care resource allocation in general, or vaccine development priorities in particular.

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Vaccines for the 21st Century: A Tool for Decisionmaking Years of Life at Different Ages Are Weighted by Quality There is one important respect in which the committee’s model does not assign equal value to year of life no matter the age at which a person receives it. The model does not assume that population-averaged levels of health status are the same at all ages, since that assumption is clearly false. The model therefore does use population-based age-related adjustments for average health status of populations at different ages; for example, because the health status of the average 45-year-old is higher than that of the average 80-year-old, the model adjusts the value of life extension to reflect this difference and thereby assigns higher quality-adjustment value to a year of life at age 45 than at age 80. This does not give different value to a year of life at different ages simply because of the difference in age, but is only a way of adjusting for differences in average health status of populations at different ages. It also should not be confused with the age-weighting of the DALY which assigns different value to a year of life based simply on age itself and independent of the health-related quality of that life-year for the person who receives it. The Value of Life Extension with and without Disabilities There is a further respect in which adjustments for differences in the health-related quality of life of added life years is ethically controversial. Some vaccines are developed for a disease to which specific populations may be vulnerable because of predisposing conditions that also reduce their health-related quality of life. The vaccine will not affect the underlying health condition, nor its impact on the person’s quality of life. For example, people with untreated AIDS have a reduced health-related quality of life, as measured with the HUI, and are predisposed to other infectious diseases. Preventing those other infectious diseases by itself will not affect the quality of life decrement due to AIDS. On the other hand, the current influenza vaccine does not prevent all disease in elderly persons, but it does tend to avert life-threatening illness. In each of these cases, the value of preventing death or illness, or alternatively of the years of life gained, will be reduced according to the effects that the preexisting condition or the resultant limitation have on the health-related quality of life of survivors. This means, to use the example of a vaccine to be given to prevent opportunistic infections in patients with AIDS (who have an already compromised quality of life), that a year of life extension for the patients with AIDS will have less value than a year of life extension produced by a different vaccine given to healthy persons or which leaves survivors with their initial healthy quality of life. In the context of disabilities, of which AIDS is an example covered by the Americans with Disabilities Act, it has been charged that this method of valuing health benefits discriminates against persons with disabilities

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Vaccines for the 21st Century: A Tool for Decisionmaking by holding that their lives, and preserving their lives, are of less value than the lives of persons without disabilities. This is a deep and troubling difficulty for any prioritization method that adjusts the value of preventing death or life extension by the health-related quality of the additional life years produced. It is not one that the committee can fully explore here, much less resolve. In support of valuing life extension in this way is the uncontroversial point that any individual will value a treatment that extends his or her life with full quality of life over an alternative treatment that will provide an equal period of life extension, but with a seriously compromised quality of life. The committee’s model extends this difference in the value of alternative life-extending interventions, based on differences in the quality of those life years, from the case of a single person choosing alternative treatments or interventions for herself, to the case of the social judgments of the value of life-extending interventions for different persons. Here, the person with the compromised quality of life might reasonably argue that a year of life extension is of no less value to her, despite its compromised quality, than a year of life extension is to a person who has no limitation in quality of life. The alternative for each person without the life-extending intervention is the same, namely death; each loses everything if he or she loses his or her life. It might therefore be argued, for example, that so long as the life extension provides a quality of life acceptable to the person who receives it, it should be given a value or importance equal to that of extending another person’s life at a higher level of quality. Our analytic model does not take this last position, however, but instead adjusts the value of all life-extending interventions both for the length and quality of the years of life-extension. Members of the committee disagreed about the correct resolution of this difficulty. Consequently, the committee has followed the standard procedure of adjusting the value of life extension according to the health-related quality of the life extended, not just in intrapersonal choices and evaluations of alternative health care interventions, but in the interpersonal choices and evaluations required by our prioritization process as well. Our analytic model can also potentially discriminate against the disabled who receive vaccines that prevent morbidity, not just mortality. This can occur when the disability acts as a co-morbid condition reducing the benefits from disease treatment or prevention, and when the presence of the disability makes disease treatment or prevention more costly. Here, as at a number of points, the committee explicitly notes the ethical issue and the position the methodology used in the analysis takes regarding it, but does not purport to have established conclusively that this position is the correct position.

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Vaccines for the 21st Century: A Tool for Decisionmaking Discount Rates for Costs and Benefits The committee’s analytic model uses a discount rate of 3% per year for the costs and benefits of vaccine programs. This might seem to be simply an economic or accounting matter, unrelated to any ethical or value judgments, but it is not. Use of a discount rate for economic resources that represent the costs of producing a benefit is not ethically controversial. If an investment of resources produces an economic benefit or return—for example, in money—it is more valuable if that benefit is produced immediately than if the same economic benefit is produced 10 years hence. In the first case, the economic return can be invested over the subsequent 10 years and so will yield a substantially greater sum at the end of that period than in the second case, where the same initial return is not produced until the end of 10 years. Likewise, if a benefit—either an economic benefit or a direct improvement in people’s health status—will be produced at some fixed time in the future, say again 10 years hence, it is better to be able to pay the costs of producing the benefit as late as possible—for example in 10 years instead of immediately—because the funds can then be invested to earn a return in the meantime until they must be expended; fewer current dollars are necessary to produce a given sum of money to pay the costs of the benefit if they are not needed until some time in the future. The ethically controversial issue is whether a given degree and period of improvement in well-being is of greater value the sooner it occurs, and of less value the longer its occurrence is delayed. If two vaccines are typically given at the same age, but the first prevents a disease with a given burden within the first year after being given, while the second prevents a disease with the same burden in the 10th year after being given, is the health benefit of the second vaccine of less value than that of the first? Haemophilus influenzae b (Hib) vaccine, which is given to infants to prevent meningitis in the first year or two after vaccine administration, is an example of the first sort. Hepatitis B vaccine given to infants to reduce risk of liver cancer in adulthood is an example of the second sort. Applying a discount rate directly to benefits of health interventions measured as changes in well-being leads to the conclusion that the first vaccine provides a greater health benefit. It is important to be clear about the nature of this issue, and not to confuse it with two other issues. First, the later improvement in well-being may be worth less than the immediate improvement if there is more uncertainty about realizing the benefit because of its later occurrence. Future benefits and costs should be discounted for their uncertainty. However, later effects on well-being are not necessarily less certain than immediate effects. Second, sometimes a near-term improvement in well-being, such as restoring or preventing a person’s loss of a particular function now as opposed to 10 years hence, will be of greater value because the improvement will have a positive impact on the person’s level of function and well-being over the intervening 10 years. This difference in well-being because of the time at which the restoration or prevention of loss of function occurs will be captured directly by apply-

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Vaccines for the 21st Century: A Tool for Decisionmaking ing a QALY measure to the person’s life over those 10 years. No discount rate need be applied to changes in well-being to reflect this difference. Applying a discount rate directly to well-being assumes a pure time preference for well-being, a preference for achieving gains sooner rather than later and incurring losses later rather than sooner. The ethically controversial nature of this assumption can be seen with a simple example. It will be more valuable to prevent pain or suffering of a given duration and magnitude today than to prevent pain or suffering of a greater magnitude and duration in the future, so long as applying the discount rate to the future pain brings down its present disvalue to less than the disvalue of the current pain. But that appears to say that the life with more pain or suffering is better than the life with less, simply because of when the pain occurs in the person’s life. Despite these complexities, it is common to apply a discount rate in studies such as this to both costs and health benefits, and there are technical problems and apparent paradoxes that arise if only costs but not health benefits are discounted (Gold et al., 1996). The committee has therefore chosen to follow common practice and to use a discount rate for economic costs as well as health benefits. We have shown in Chapter 4 (the previous chapter on methods) in the discussion of the hypothetical Vaccine X the difference doing so makes in comparison with not discounting well-being. Which Benefits and Costs Should Be Counted in the Prioritization Process? The committee’s analytic model for prioritizing different potential vaccines attempts to measure the direct health benefits to the potential vaccine recipients from diseases prevented by those vaccines. This excludes two kinds of indirect benefits from consideration. First, sometimes there are nonhealth benefits to vaccine recipients, such as prevention of lost wages when the diseases prevented typically result in significant periods of time away from work. Second, sometimes there are indirect benefits to others besides the direct recipients of a vaccine. For example, some childhood diseases, such as varicella typically require a parent to stay home from work to care for the child, resulting in lost wages to the parent and economic costs to the parent’s employer. Many other diseases affecting adults during parenting years can result in the need for child care because of the parent’s illness or death. The committee believes that counting these indirect and nonhealth benefits can result in ethically unacceptable discrimination. For example, counting the prevention of lost wages among the benefits of a particular vaccination program will result in lower priority being given to the prevention of diseases typically acquired during the nonworking years of a person’s life, specifically childhood and old age. It would also discriminate against diseases that affect lower-income individuals disproportionately, whose lost wages will be less on average than those of higher income groups. (In the development of vaccines for international

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Vaccines for the 21st Century: A Tool for Decisionmaking use, this discriminatory impact would be far greater and would disproportionately favor vaccines used in developed countries.) We recognize that these nonhealth and indirect benefits to others are real benefits. Indeed, especially from a public health perspective for making resource allocation and investment decisions, it may appear incompatible with a cost-effectiveness prioritization to selectively ignore some benefits. But this is only one place among others that the committee cites in this chapter at which ethical concerns place some constraint on the single-minded maximization of benefits that an unconstrained cost-effectiveness standard would yield. In the calculation of costs too, there are (potentially ethically) problematic implications of giving weight to the indirect costs of vaccination programs, as well as to their direct costs and the direct health care costs avoided for treatment of the disease prevented by the vaccination program. For example, if the indirect effects of smoking are considered, it may not be cost-effective to prevent smoking, although doing so would prevent the health care costs associated with treatment of smoking-related disease. Individuals who would have died earlier from those diseases will now live longer and incur other health care and nonhealth care costs, including the costs of treating whatever diseases they eventually die of, as well as the costs of public welfare and retirement benefits like Social Security. Yet any possible increase in overall social costs from a smoking prevention program is typically rejected as a reason for not pursuing, or downgrading the importance of, smoking prevention. The same kinds of issues would arise concerning the prioritization of different vaccines if weight were given to the indirect costs of the different vaccine programs. For example, vaccines for life-threatening diseases that typically affect adults around normal retirement ages will have the additional indirect social cost of extending Social Security payments to those who otherwise would have died of those diseases. This would be a factor not only for traditional vaccines for diseases like pneumococcal pneumonia or influenza, but also for cancer vaccines likely to become available in coming years. Here again, however, the complexity of the ethical issue arises from the fact that such cost savings are real savings, even if the committee decides not to give them weight in prioritizing potential vaccination programs, and there may be broader public policy perspectives from which their consideration would be ethically defensible. CONSIDERATIONS OF JUSTICE Small Benefits to Many Versus Large Benefits to a Few The analytic model the committee has developed compares vaccines on the basis of the total direct health benefits they would produce in reducing the burdens of disease. Leaving differences in costs aside, the model is sensitive only to the total burden imposed by different diseases, not to differences in how overall disease burdens are distributed to individuals. This is consonant with typical

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Vaccines for the 21st Century: A Tool for Decisionmaking public health perspectives that look to the overall health benefits of different disease prevention programs targeted to a given population, but it overlooks a factor that is ethically important in many people’s judgments about health care priorities. For many people, preventing (or treating) a disease that has an extremely large disease burden for each affected individual has higher ethical priority than preventing a widespread disease that has a much smaller disease burden for each individual, even if the much higher incidence of the latter disease makes its aggregate burden equal to or even greater than that of the former disease. Many people think that the relative priority for treating different diseases should be determined by their relative severity for the individuals who contract them. From this perspective, the relative priority of treating different diseases is determined by a one-to-one comparison of those diseases—the relative severity of one case of disease A versus one case of disease B. But this way of thinking about priorities ignores differences in incidence and in turn in the overall or aggregate level of disease burden from diseases A and B. In the context of vaccines, diseases like chicken pox, mononucleosis, or diarrhea in infancy have a high incidence but a relatively low disease burden for individuals in typical cases (see our HUI calculations). On the other hand, a disease like tetanus or meningitis has a much lower incidence but a much greater disease burden for the individuals who contract it. Because of the difference in overall disease burden, our model has the potential to yield the result that a higher priority should be given to preventing the high-incidence/low-individual-burden disease than to preventing the low-incidence/high-individual-burden disease. This result might be defended by distinguishing between the clinical context, in which a physician treats individual patients, and the public health context in which health care resource allocation decisions are made that will affect different groups in the population. In the clinical context, a physician forced to prioritize between individual patients typically will treat first the patient who will suffer the more serious consequences without treatment or will benefit the most from treatment, even if that will prevent him or her treating a larger number of less seriously ill patients. The sickest patient, if he or she can be effectively treated, has the greatest, or first, claim on the physician’s efforts. But from a public health or social perspective, arguably the appropriate perspective for the committee’s task regarding public priorities for development of vaccines that will be available to the public at large, the potential overall or aggregate effects of alternative vaccines on the public health may seem the appropriate perspective. Even from a public health perspective, however, there is controversy as to whether the ethically correct stance is a maximizing perspective that gives priority to producing the maximum aggregate benefits, whether by large benefits to a few or by small benefits to many. A recent prominent example in which that perspective was rejected for setting public health care treatment priorities may be helpful. In an early stage of reforming its Medicaid program, the state of Oregon ranked all treatment-patient condition pairs by what was essentially a

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Vaccines for the 21st Century: A Tool for Decisionmaking cost-effectiveness standard, from the treatment providing the highest health benefit per dollar spent to the one providing the least benefit for its costs. The intent was to then use limited resources to cover treatments that would produce the greatest health benefits with the money available. One result of this ranking was that capping teeth for exposed pulp was ranked just above appendectomies for acute appendicitis, despite the fact that the latter is a life-saving intervention in most cases. There were technical controversies about Oregon’s methodology, but the fundamental reason for this result was that capping a tooth is vastly less expensive than doing an appendectomy—Oregon estimated that it could pay for tooth capping for 150 patients for the cost of each appendectomy. The Oregon Health Services Commission, the body responsible for developing the proposed revision of the state’s Medicaid plan, found this result unacceptable, as did the public; from a one-by-one comparison of treatments, it was clearly a higher priority to fund appendectomies than tooth capping. To avoid results such as this, Oregon essentially abandoned its cost-effectiveness ranking in favor of a relative-benefit ranking that disregarded the cost differences that lead to aggregating small benefits to many patients against large benefits to a few. Oregon did this from a social or public perspective of deciding how to allocate limited public resources, which is also the committee’s perspective, not just from a clinical perspective where physicians confront individual patients one-by-one. Moreover, unacceptable or unintuitive results because of aggregation can arise not only from large differences in costs of health interventions, but from large differences in the incidence of different diseases. This latter version of the aggregation problem is the form it will typically take in the context of vaccine development, where very serious but relatively uncommon diseases like meningitis must be compared with much less serious but much more common diseases like mononucleosis (caused by Epstein-Barr virus) or diarrhea (caused by rotavirus and other infectious agents). Even from a public health perspective, it is ethically controversial when, and for what reasons, small benefits to many patients may be aggregated so as to have higher priority than large benefits to a few. We did not attempt to resolve this issue, but have used a methodology that places no restrictions on such aggregation. Policymakers using our report should be attentive to this issue and must decide whether vaccine programs that provide small benefits to many should receive higher priority than other programs that provide large benefits to a few, so long as the former produce larger aggregate benefits. What Priority Should Be Given to the Worst-Off or Sickest? It is easy to confuse the question of priority to the sickest with the aggregation problem just discussed, since both our vaccine and nonvaccine examples of aggregation put a few of the sickest up against many less sick, but the issues are distinct. An initial abstract example applied to treatment instead of prevention

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Vaccines for the 21st Century: A Tool for Decisionmaking will make the point most clearly. Suppose group A patients have a serious disease that leaves them with a health utility level of .25 as measured by the HUI, and their HUI level would be raised only to .45 with the best available treatment because no treatment is very effective for their disease. A similar number of group B patients have a health utility level of .60 because they have a considerably less serious disease, but since treatment for their disease is more effective although no more costly than for Group A patients, it would raise their health utility to .90. Suppose we only have funds to treat one of these groups. Should we prefer to treat B because doing so would produce a 50% greater benefit than treating A (an increase in HUI of .3 for group B compared to an increase in HUI of .2 for group A) or should we give priority to treating group A who are sicker or worse-off? There is some empirical evidence that when asked about choices like this, most persons, both in this country and elsewhere, would prefer to treat the sickest or worst-off in our example group A, even at the cost of a significant reduction in overall benefits, compared with treating the less sick or better off, that is group B. This may be because they view doing so as fairer or more just. Justice or fairness may favor preferring first to help group A who suffer from the worse or greater disadvantage; to treat group B instead would only widen the already undeserved difference in the levels of well-being between A and B. If group A is treated, their level of well-being after successful treatment (.45) will still be below that of B even if that group receives no treatment (.60). Some people would prefer to treat group A over group B because they believe that treatment would be subjectively more important for persons in group A, despite the greater measured benefit that could be produced for B. Although setting priorities among potential vaccines does not involve choices about treatments of different diseases, but rather choices between different diseases that might be prevented, the committee believes essentially the same issue is at stake. The issue is what priority, if any, should be given to patients who would be the sickest if their disease is not prevented—for example, preventing opportunistic infections such as cryptosporidiosis in patients with AIDS whose health status will remain low because of their AIDS—compared to greater health benefits that could be produced by preventing generally less serious diseases like mumps or chicken pox in patients without AIDS or other serious predisposing conditions. Part of the complexity of this issue is that virtually no one would prefer not to treat the sickest, no matter how costly their treatment and how small the benefit to them from doing so, and no matter how beneficial and how inexpensive the treatment for the less sick. If fairness or equity is what is at stake here, there is a limit to how much gain in the well-being of others we will sacrifice in order to treat all fairly or equitably by giving priority to those with the most serious diseases. However, there does not seem to be any objective, principled basis for determining how much gain in overall well-being should be sacrificed in order to treat the sickest or, more generally, to avoid different forms or instances of unfairness. Here again, there is no consensus among ordinary persons, bioethi-

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Vaccines for the 21st Century: A Tool for Decisionmaking cists, or health policy analysts about whether, first, fairness or equity requires some priority be given to the sickest or worst-off and, second, if so, how much and in what circumstances. Although this controversy has prevented the committee from attempting to incorporate any such priority into our analytic model, it is no reason for policymakers to ignore the issue in setting priorities for vaccine development or, for that matter, for health care allocation and investment more generally. That is why the committee has flagged, briefly discussed, and given examples of the issues that arise specifically in the prioritization of potential vaccines. Fair Chances Versus Best Outcomes The final issue of justice or fairness in the distribution of health benefits to which the committee calls attention here has been characterized as the conflict between fair chances and best outcomes. The conflict is most pressing when the health care intervention is life-saving, and not all whose lives are threatened can be saved, although it arises when the threat is to health and function as well. The issue has received the most attention in the context of organ transplantation where there is a scarcity of life-saving organs such as hearts and lungs, resulting in many deaths each year of patients waiting for an organ for transplant. An abstract example in the area of transplantation illustrates the problem. Suppose two patients are each in need of a heart transplant to prevent imminent death, but only one heart is available for transplant. Patient A has a life expectancy with a transplant of 10 years and patient B has a life expectancy with a transplant of 9 years, with no difference in their expected quality of life. (Of course, precise estimates of this sort are typically not possible, but the point is that there is a small difference in the expected benefits to be gained depending on which patient gets the scarce organ). Once again, if the we wish to use scarce resources to maximize health benefits or QALYs, then we should straightaway prefer patient A. But patient B might argue that it is unfair to give her no chance to receive the scarce heart. Just like A, she needs the heart for life itself and will lose everything—that is, her life—if she does not receive it. It is unfair, B charges, to give the organ to A because of the small difference in expected benefits from doing so; that difference is too small to justly determine who lives and who dies. Instead, each should receive a fair chance of getting the organ, which might in this case be either an equal chance through a random selection between A and B, or a weighted lottery that gives the patient who would benefit more some greater likelihood of being selected to receive the organ. Like the other two considerations of justice just discussed, this too is far more complex and controversial than the committee can pursue here, but it is another example of when society might reasonably choose to constrain resource allocation aimed at maximizing health benefits in order to be fair to the individuals who will be affected by the resource allocation.

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Vaccines for the 21st Century: A Tool for Decisionmaking Does this conflict arise in choices about priorities for vaccine development? Perhaps the closest parallel would be a choice between potential vaccines for two life-threatening diseases, A and B, where A has a slightly greater burden of disease than B because there is a slightly greater incidence of A than B. If A is given priority over B, and a successful vaccine to prevent A is developed and employed, but no effort is supported to develop a vaccine for B, then people who develop life-threatening disease B may complain that they did not have a fair chance to survive through the development of a vaccine to prevent their disease. There are at least three considerations that mitigate this ethical conflict in the context of vaccine development as compared with organ transplantation. The first is that vaccine development need not be an all-or-nothing choice, as in the case of recipient selection for scarce heart transplants, but a matter of the relative priority for funding to be given to the development of vaccines for different diseases. If disease A is given a higher priority for vaccine development than disease B because of A’s greater burden of disease, this need not and typically does not mean that no resources go to the development of a vaccine for B, but rather that a greater effort with more resources will go to A than to B. Suppose the effort to develop the vaccine for A succeeds, while the effort for B fails, at least in part because of the lesser effort and resources that went to B. Individuals who contract B cannot complain that the small difference in expected benefits from a vaccine for A instead of for B was an unfair basis for selecting who will live—those who would have contracted A—and who will die—those who contract B. The small difference in expected benefits from a vaccine for A as opposed to B resulted only in a comparable small difference in the effort and resources devoted to vaccine development for A and B. Even if that small difference results in the earlier development of a vaccine for A than for B, it is not obvious that that is unfair to those who contract B and even die from it. The second consideration that mitigates some of the conflict between fair chances and best outcomes in the case of vaccine development is that the prioritization of different potential vaccines is not a choice between identified patients, as in organ transplantation, but a choice between potential vaccines for different diseases made for the most part before we know which individuals will contract the different diseases. In that respect, the prioritization of disease A over B is not a life-and-death choice between identified patients who have diseases A or B because it is made before we know who will get A or B, even if the choice will eventually have life-and-death consequences for identified individuals (in fact, with the disease for which a successful vaccine is developed and deployed, the individuals who would have died from that disease without the vaccine will typically never be identified or known). It could be argued that before one knows whether one will get disease A or B, one would give greater priority to preventing whichever has the greater disease burden. Thus, it is less clear that the vaccine development choice in favor of the disease with the greatest health burdens and potential benefits is unfair to those who contract the lower priority disease for which a vaccine was not developed, than is the choice of transplant recipients in our earlier example.

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Vaccines for the 21st Century: A Tool for Decisionmaking The third consideration that mitigates some of the fair chances and best outcomes conflict in the case of vaccine development is that the diseases for which vaccines are sought are frequently not, at least usually, life threatening to most people who experience them, but often instead only have some impact on individuals’ health status, and often for only a limited period of time. In these cases, the difference in impact on individuals who avoid a disease because a vaccine was developed and individuals who contract a disease for which no vaccine was developed is much less, and so the possible concern about fairness is less compelling. CONCLUSION The committee emphasizes that the aim in this chapter has been to identify some of the principal ethical issues involved in developing and using the model presented in this report to help set priorities for vaccine development. The use of a quantitative analytic model for determining those priorities can help focus those ethical issues, just as it helps focus the various empirical considerations that bear on the recommendation for priorities. The committee has tried to say enough about these ethical issues to give readers a sense of the nature of the controversies. In some cases, the committee has given reasons for the ethical position our quantitative model and recommendations take on the issues, but in others the aim was only to focus the issue for policymakers who will make use of this report.