# E-DRUG: HIV trials in developing countries **URL:** \ **Category:** e-drug\ **Created:** [February 19, 1998, 10:04pm UTC](https://talk.edrugplus.org/t/e-drug-hiv-trials-in-developing-countries/2151 "1998-02-19T22:04:52Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![srahmad](https://avatars.discourse-cdn.com/v4/letter/s/e56c9b/32.png) [@srahmad](https://talk.edrugplus.org/u/srahmad)\ **Post date:** [February 19, 1998, 10:04pm UTC](https://talk.edrugplus.org/t/e-drug-hiv-trials-in-developing-countries/2151/1 "1998-02-19T22:04:52Z")
E-DRUG: HIV trials in developing countries ------------------------------------------ New York Times, February 19, 1998 U.S. Ends Overseas H.I.V. Studies Involving Placebos By SHERYL GAY STOLBERG Saying they have finally found a cheap way for developing nations to use the drug AZT to reduce mother-to-infant transmission of the AIDS virus, U.S. government health officials announced Wednesday that they are suspending the use of dummy pills in a series of controversial overseas experiments on pregnant women. The announcement, by the Centers for Disease Control and Prevention, left people on both sides of the debate elated, but for different reasons. Defenders of the government-financed studies said the findings -- that $80 worth of AZT given during the last four weeks of pregnancy can cut transmission of the virus in half -- will have a dramatic impact on many developing nations, which have been devastated by AIDS. Critics, who had called the use of the placebo unethical, pronounced themselves vindicated because the women in the experiments will now get AZT instead of dummy pills. "I'm delighted," said Dr. Marcia Angell, editor of The New England Journal of Medicine, who in an editorial last year likened the studies to the infamous Tuskegee experiments, in which treatment for syphilis was withheld from poor black men. "Better late than never," Dr. Angell said. The controversial studies -- which have involved 12,211 women in Thailand, the Dominican Republic, Ethiopia, Ivory Coast, Uganda, Tanzania and South Africa -- were based on one of the most dramatic discoveries of the AIDS epidemic: the finding, four years ago, that use of the drug AZT during pregnancy could cut the risk of mother-to-infant transmission by two-thirds. Today, as a result of that discovery, HIV-infected women in the United States are routinely given AZT during the last 12 weeks of pregnancy. They also receive intravenous infusions of the drug during delivery, and their babies take the medicine for six weeks after being born. This is commonly called the "076 regimen," after the number assigned to the federal study that proved it effective. But the 076 regimen is expensive -- $800 per patient, including the infusions and drugs for the the babies -- and too complicated for use in the Third World, where access to medical care is poor. Yet every day, an estimated 1,600 HIV-infected babies are born worldwide, most of them in developing nations. So when the 076 results were published, officials at the United Nations, the World Health Organization, the National Institutes of Health in Bethesda, Md., and the CDC in Atlanta set out to find a way to translate the results to the Third World. They settled on experiments in which half the women were given a short course of AZT and half were given dummy pills. The studies were controversial even among the government's own researchers; most recently, the debate cast a shadow over the confirmation of Dr. David Satcher, the new surgeon general who previously headed the CDC. Now, the first of those studies, conducted on 393 women in Thailand, is complete. The study found that women who were given AZT during the last four weeks during pregnancy, as well as during labor and delivery, had half the risk of giving birth to a HIV-positive baby as those who received the placebo. "We are very pleased," said Dr. Phillip Nieburg, a CDC official involved with the experiments. "The controversy was unfortunate, but we feel that the placebo-controlled trial that we did was very necessary." Others echoed Nieburg's sentiments. "It's just wonderful news," said Mark Harrington, policy director for the Treatment Action Group, an advocacy organization. "If we can get this incredible health benefit for $80 bucks a pop, then we can really make a difference around the world." How much difference the study will make, however, remains to be seen. While $80 may sound inexpensive, it is eight times what most developing nations spend per capita on health care each year. Harrington called on the manufacturer of AZT, Glaxo-Wellcome, to provide the drug to developing nations at a steeply discounted price. And Dr. Joseph Saba, who chairs the international working group that coordinated the experiments, said he is trying to "set up plans on how we move on and who does what." But the advocacy group Public Citizen, which has repeatedly condemned the project, said researchers should have known the answer to the most pressing question -- whether a short course of AZT would work -- all along. Dr. Sidney M. Wolfe, who directs Public Citizen's Health Research Group, obtained data on a subset of patients from the original 076 trial. He said that among those who received AZT for an average of seven weeks, the risk of transmission was cut by two-thirds. Government officials said those data were unreliable, but Wolfe maintained that the figures should have been taken into account. "This is inexcusable, sloppy research," he said. "They have wasted a large number of lives and a huge amount of money." -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.