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As President Clinton publicly apologizes to the survivors and families of the infamous Tuskegee syphilis study, in which the U.S. Public Health Service withheld treatment from black males with syphilis so that it could observe the disease's progression, Allen contends that it is 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 Center 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 D.C.-based watchdog group Public Citizen) charges that their use in this life-or-death study is unethical and runs against U.S. 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, again mostly in Africa.
In a stern 11-page letter to cabinet 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 the Nuremberg Code.
"Researchers involved in these experiments have exploited the inadequacies of the heath-care systems in these developing countries to conduct research they would never even consider in the U.S.," the letter states. "It's Tuskegee, part two," says Public Citizen's 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. Phillip Nieberg, a CDC associate director of science who worked on the study, 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."
This does little to appease Dr. Peter Lurie, the South African-born research associate who was the architect of the protest letter. "We think the study should be redesigned. The comparison arm should be some form of AZT similar to that given in 076," he says, referring the code number for the standard U.S. regimen of AZT .
Founded in 1992 as a joint venture between Quincy Jones and Time Inc. Ventures, the urban music and culture magazine, based in New York and published 10 times a year, has more than doubled its circulation over the last three years, increasing to 500,000. VIBE was sold to VIBE Ventures, a partnership led by Jones and Robert L. Miller, in June 1996. Recently, VIBE Ventures acquired SPIN magazine and next month will launch its own late-night TV show titled VIBE with Columbia TriStar Television Distribution. Its web site, VIBEonline, is located at www.vibe.com .
CONTACT: Vibe Magazine, New York Audrey Addison, 212/522-1722
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