Barry R. Bloom, Ph.D., Investigator
Howard Hughes Medical Institute,
Albert Einstein College of Medicine
A discussion at the February Council meeting in research ethics highlighted issues bearing on future therapeutic and vaccine trials in developing countries. Former Council member Barry Bloom, Ph.D. of the Albert Einstein College of Medicine led with a presentation following up his recently published paper in Science, January 9, 1998. A long-standing NIAID grantee and MERIT awardee, Dr. Bloom wrote that milieu-based differences in ethical vantage points have become key: what may be ethical in the U.S. may not be ethical in a poor, developing country. Vast discrepancies in standards of care have not been adequately taken into account by international guidelines.
Dr. Bloom explored the dilemmas and debate surrounding a recent trial in third world countries testing AZT to prevent maternal-infant transmission. Further, unresolved ethical issues will have an impact on HIV vaccine research. Ambiguity and conflicting concepts in the international guidelines give major headaches to investigators and policy makers, though some guidelines are changing.
International guidelines are silent on the economic and technical capacity of the host country, focusing instead on providing trial participants the best treatments. The guidelines do not say whether, researchers can use a placebo if there is no treatment available in the host country.
Vaccine research could be thwarted by the ethical need after the completion of a successful trial to provide the product to the entire country.
Clearer international guidelines would certainly simplify things for the Institute and the researchers it supports. The American Medical Association has asked the World Medical Association to consider revising the Helsinki document changing "best proven treatment" to "appropriate treatment." This would help resolve the dilemma of what to do when the best proven treatment is unclear. Further, an organ of the United Nations coordinating that agency’s AIDS efforts, called UNAIDS, is actively addressing bioethical issues.
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