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SC-01 JUSTICE AND THE STANDARD OF CARE Emanuel, Ezekiel J Justice is essential to determining the standard of care for clinical research. As part of research, people cannot be denied medical services that they are entitled to, except in specific cases. This entitlement determines the kind of interventions that must be included as standard of care in research. However, what people are entitled to cannot simply be based on what services they actually receive, because this could result from injustice. Determining what they are entitled to is based upon considerations of distributive justice. Conflicts of the standard of care can be traced to conflicts in conceptions of justice. Londons Global Egalitarianism claims that international medical research [itself] is not morally permissible until a more equal distribution of global resources occurs. Thus standard of care is not even an issue, because any clinical research is currently unethical. This seems untenable for empirical reasons about the source of inequality, witness India and China, and because it would only worsen the 90-10 divide, focusing all research on diseases of the rich. Rawlss Law of the Peoples contends that great wealth is not required for a just flourishing society, only a hospitable political culture matters, witness Kerala; most societies in the world are not so poor that they cannot become just. Thus, the duty of foreign assistance is limited to helping establish a just society; since this does not require substantial wealth, aid beyond eliminating grinding poverty is not required. Rawlss view of justice suggests that people are entitled to what they are currently receiving, and the appropriate standard of care would be the current care people are receiving in the host country. At the opposite pole is a radical equality view that holds that all people, regardless of country, are entitled to about the same well-being. Justice requires people to transfer their wealth as long as it can increase the well-being of others more than it decreases their own. This is a Singer type version of utilitarianism. It would mean people everywhere should be entitled to the best care available anywhere and would endorse the Declaration of Helsinkis best proven method anywhere in the world view. Finally, limited cosmopolitanism holds that we are required to create institutions that give other individuals the opportunities for a flourishing life; there is no demand for equality of well-being or resources. We need not develop a full theory of justice, but focus on justice in health alone. The well known relationship of increases in life span compared to health spending has an asymptote at $500 per person per year, provides guidance on what is necessary in health given people and opportunity to flourish. That is, the health care people are entitled to in an international order that complies with the limited cosmopolitan view of justice is the services they would get for $500 per person per year. In 1997, long course AZT cost $800 per person and would not have been the standard of care. Today, triple ARV therapy costs under $300 per year making it standard of care. This limited cosmopolitan conception of justice provides a way to both justify and operationalize the notion of highest attainable and sustainable standard of care. Ezekiel J. Emanuel, M.D., Ph.D. |
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