Case #1535.0

Ethics in International Research: the Debate over Clinical Trials of AZT to Prevent Mother-to-Infant Transmission of HIV in Developing Nations

Publication Date: September 01, 1999
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Abstract:
Breakthroughs in the early 1990s in the treatment of AIDS in the US and other developed countries were bleakly complemented by continued increases in the incidence of AIDS and persistently high mortality rates in poor countries, especially those in Africa. The high cost of treatment "cocktails" made mass distribution of such drugs impractical--but did not preclude a search for less expensive, somewhat effective treatments. There was particular interest in any regimen that could prevent the transfer of the AIDS virus from mother to newborn. But when international research agencies--including the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) in the US--undertook trials of such treatments in Africa, a medical ethics watchdog group lead a high-profile protest. The group, Public Citizen, asserted that it was unethical to test a treatment regimen of the drug AZT against a control group receiving a placebo when it was clear that some treatment with the drug is better than none. Designers of the experiments argued however, that only a comparison with a placebo group could provide definitive results in the context of developing countries. This case frames the ethical issues involved in medical testing in developing nations; specifically it frames the conflict facing policymakers such as those in NIH and CDC who, having endorsed the AIDS trials in Africa, had to weigh the objections raised by advocacy groups and a prestigious medical journal.

Learning Objective:
This case frames the ethical issues involved in medical testing in developing nations; specifically it frames the conflict facing policymakers such as those in NIH and CDC who, having endorsed the AIDS trials in Africa, had to weigh the objections raised by advocacy groups and a prestigious medical journal.

Other Details

Case Author:
Esther Scott
Faculty Lead:
Richard A. Cash and Michael Bennish
Pages (incl. exhibits):
34
Setting:
United States
Language:
English
Funding Source:
National Institutes of Health