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Ethical Considerations and Caveats
Pages 109-122

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From page 109...
... 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.
From page 110...
... 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.
From page 111...
... 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.
From page 112...
... 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.
From page 113...
... 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.
From page 114...
... 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.
From page 115...
... 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.
From page 116...
... 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.
From page 117...
... 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.
From page 118...
... 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.
From page 119...
... 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.
From page 120...
... 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.
From page 121...
... 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.
From page 122...
... 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.


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