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1999 Third World HIV Prevention Trials

Third World HIV Prevention Trials. In February 1994, the Data Safety and Monitoring Board of the U.S. National Institute of Allergies and Infectious Diseases interrupted AIDS Clinical Trial Group (ACTG) Study 076 (22). The preliminary data revealed a statistically significant and dramatic difference in vertical HIV transmission rates from mothers to their newborns, between women who received the active regimen and the placebo group.

The regimen quickly became the standard of care in industrialized nations, where no trial that would deny access to the ACTG 076 regimen or to a potentially equivalent intervention would satisfy the requirements of ethical review. In developing countries, however, the costs of the 076 regimen ($800 for the drug alone) put it out of reach. It was, therefore, a matter of some urgency that trials begin to determine whether radically cheaper alternatives could reduce maternal-fetal HIV transmission. The CDC and NIH launched nine placebo-controlled trials, all subject to careful ethical review, in developing countries.

Nevertheless, on 18 September 1997, Marcia Angell, executive editor of the New England Journal of Medicine, denounced the placebo-control trials in Africa, Asia, and the Caribbean. Citing the Declaration of Helsinki for authority, she noted that control groups had to be provided with the best current therapy, not simply that which was available locally. Taking her lead from Lurie and Wolfe, who first drew the comparison to Tuskegee in regard to the Third World studies as they had in Alaska, she argued, ‘The justifications are reminiscent of those for the Tuskegee study: Women in the Third World would not receive antiretroviral treatment anyway, so the investigators are simply observing what would happen to the subject’s infants if there were no study.’

However problematic the efforts to obtain informed consent in the Third World, investigators clearly made efforts to inform the enrolled women that they would be part of a study to reduce maternal transmission of HIV and that some would receive a placebo. No attempt was made to exploit the social vulnerability of the women involved. Indeed, it was the very poverty of the nations within which these women lived that served as the predicate for the challenged studies. Only to the extent that these women could be said to have a realizable claim on the care available in industrialized nations would the conduct of a placebo control trial have mirrored the deprivation of Tuskegee. But then any trial to find a cheaper and potentially less effective regimen–whether placebo controlled or not–would have been unethical as well. To the extent that the search for a less costly and potentially less effective intervention could be justified by the desperate need to find affordable interventions, the analogy to Tuskegee entailed a gross distortion.

Yet to the extent that women in poor countries have a moral–as contrasted with a realizable–claim on the care available to women in industrialized nations, critics helped to underscore the profound injustice that characterizes the world distribution of medical resources. Unfortunately, the invocation of Tuskegee launched a furious methodological debate that diverted attention from an analysis of the very poverty and inequality that necessitated the challenged studies.

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