IT'S AIDS, NOT TUSKEGEE

By DAVID D. HO, M.D.

In the current issue of the New England Journal of Medicine, Peter Lurie and Dr. Sidney Wolfe of the advocacy group Public Citizen charge that some U.S.-sponsored AIDS-research projects in Africa are unethical. The Journal's editor, Dr. Marcia Angell, goes even further, comparing these studies to the infamous Tuskegee experiment in which black men in the South were deliberately deceived and denied effective treatment in order to determine the natural course of syphilis infection. This comparison is inflammatory and unfair, and could make a desperate situation even worse.

Doctors in the U.S. have known since 1994 that the drug AZT can substantially reduce the chance of transmission of the AIDS virus from an infected woman to her newborn child. Unfortunately, administering AZT to pregnant women is complicated and quite expensive--about $1,000 per mother. That's far beyond the means of most developing countries, where 1,000 newborns are infected each day.

Hoping to find an AZT regimen they could afford, African researchers sought sponsorship from U.S. health agencies and launched a number of scientific studies in which some mothers were given short treatments with AZT and some, for the purpose of comparison, received a placebo. It is the inclusion of these placebo groups that the critics find objectionable. Giving a sugar pill to an AIDS patient is considered ethically unacceptable in the U.S. To give one to a pregnant African, Dr. Angell writes, shows a "callous disregard of [a patient's] welfare for the sake of research goals."

These clinical trials, however, were created for Africans, by Africans, with the good of their people in mind and with their informed consent. The studies were designed to be responsive to local needs and to the constraints of each study site. African scientists have argued that it is not in their best interest to include a complicated and costly AZT regimen for the sake of comparison when such a regimen is not only unaffordable but logistically infeasible. They have, instead, opted for a study design that is achievable in practice and is likely to provide lifesaving answers expeditiously, even though it includes a group of women receiving a placebo. While the inclusion of this placebo group would not be acceptable in the U.S., the sad truth is that giving nothing is the current standard of care in Africa.

The ethical debate here is obviously a complex one, without a clear distinction between right and wrong. Comparisons to Tuskegee don't help; neither does the imposition of Western views, or what Dr. Edward Mbidde of Uganda calls "ethical imperialism." Calm and careful deliberations are in order. Insisting on the infeasible in the name of ethical purity is counterproductive in the struggle to stop this deadly virus.

Dr. David Ho is director of the Aaron Diamond AIDS Research Center in New York City and TIME's 1996 Man of the Year.