Placebos, Ethics, and Women

In AIDS ravaged Africa, a controversial drug study is leaving pregnant women at risk and stirring outrage. As President Clinton publicly apologized to the survivors and families of the infamous Tuskegee syphilis study, in which the U.S. Public Health Service withheld treatment form black males with syphilis (not to mention their wives) so that it could observe the disease's progression, it's happening again.

This time though, the disease is AIDS. The participants are 1,500 poor, pregnant, HIV-positive African women. The study is a two-and-a-half-year, $690,000 inquest being conducted by the Centers for Disease Control. Half the women in the CDC study are receiving a regimen of AZT, while the other half, the "control group" are being given placebos. Although control groups are a standard component of many drug trials, outraged critics (chiefly the DC based watchdog group Public Citizen) charge that their use in this life or death study is unethical and runs against US federal regulations. The CDC is also conducting a similar study in Thailand. Meanwhile, the National Institute of Health (NIH) is separately conducting seven studies in Ethiopia, Uganda, Tanzania, and Malawi. Six similar studies are being carried out by foreign governments, mostly in Africa.

In a stern letter to secretary Donna Shalala (whose Department of Health and Human Services funds the CDC and NIH), a panel of physicians from Public Citizen charges that the studies are "a clear violation of all of the major international ethical guidelines, including the Helsinki agreement and Nuremberg Code." Researchers involved in these experiments have exploited the inadequacies of the health care systems in these developing countries to conduct research they would they would never even consider in the U.S. "It's Tuskegee, part two," says Dr. Sidney Wolfe, "and this time many more people will die."

The African AZT trials are different from Tuskegee in many regards. The women know they are HIV-positive. They are told that they have the opportunity to participate in a study and, most importantly, they're told that if they do participate, they will randomly be given either AZT or a placebo. The aspect to which protesting doctors object, and which they claim most resembles Tuskegee, is this: Overseeing the placebo group requires physicians to withhold AZT treatment while hundreds of black, mostly poor and illiterate pregnant females - and potentially, their babies - die wretched, painful deaths.

Dr. Nieberg, a CDC associate director of science, refutes the charge that it is unethical. "Women who would ordinarily not have access to anything receive either AZT or a placebo in these trials. No one is denied any medicine that they would have outside the study. If the women were denied a drug that's available to the general population, that would clearly be unethical."

Authors of the protest letter say: "We think the study should be redesigned. The comparison arm should be some form of AZT similar to that given in 076."

(editorial note: Why isn't AZT available to PWA's in other parts of the world anyway? Could it be GREED? It's our understanding that these studies are designed to refine the dosages of AZT currently given to pregnant HIV positive women in the U.S. Whether the researchers are trying to up the dose or lower it, I don't know. In either case the "control group" could be given some form of treatment and the researchers could still find the answer to their question. Our best guess is that the reason they are not doing this is because the Department of Health and Human Services and the manufacturers of AZT, Glaxo-Wellcome, won't pay for it. How unethical is that? If you have concerns about these studies, NOW is the time to speak up. Contact "Public Citizen" in Washington DC @ 202.588.1000)