AIDS Groups Worried About Backlash Against Nevirapine Use in Pregnant Women, Say Drug Only Way to Prevent MTCT
December 21, 2004
Some HIV/AIDS treatment groups have expressed "alarm" about a possible backlash against the use of the antiretroviral drug nevirapine among pregnant women to reduce the risk of mother-to-child HIV transmission because of a recent series of Associated Press articles concerning clinical trials of the drug, the New York Times reports (McNeil, New York Times, 12/21). The articles concerned NIH's research on the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to reduce the risk of vertical HIV transmission. The initial results from the research, which began in 1997, showed that the drug prevented HIV transmission to newborns in as many as half of the births. However, by early 2002, medical safety specialists, an auditor with NIH and the drug's manufacturer Boehringer Ingelheim all cited "widespread" problems with the research in Uganda -- including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research for 15 months from spring 2002 to summer 2003 to review the trial and take corrective steps. Earlier this month, Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, admitted that he altered a safety report on the use of nevirapine in pregnant women to change its conclusions and remove negative information about the drug (Kaiser Daily HIV/AIDS Report, 12/20).
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South African opposition parties have called for the continued use of nevirapine to reduce the risk of mother-to-child HIV transmission in response to a letter posted on the ruling party's Web site last week, South Africa's Business Day reports (Mabuza, Business Day, 12/20). Last week, the African National Congress accused the United States of treating Africans like "guinea pigs" and "entering into a conspiracy" with a German pharmaceutical manufacturer to conceal potential adverse effects of nevirapine. The letter also implied that there had been numerous deaths because of nevirapine use that had been covered up by U.S. officials "to promote their own ends" (Kaiser Daily HIV/AIDS Report, 12/20). Costa Gazi, a spokesperson for the Pan Africanist Congress, said that "hundreds of thousands" of HIV-positive women in countries such as South Africa and Brazil have taken the drug "without any side effect," according to Business Day. "The ANC is still angry that the Constitutional Court ordered government to supply HIV-positive mothers with a drug to prevent the transmission of the virus to their children. President (Thabo) Mbeki has not yet grasped the fact that the deadliest enemy facing the country is the scourge of HIV," Gazi said. Butch Steyn, a spokesperson for the Democratic Alliance, said that nevirapine currently is the only feasible method of preventing vertical HIV transmission, according to Business Day (Business Day, 12/20).
NPR's "NPR News with Tony Cox" on Monday included a discussion about the controversy surrounding nevirapine. Guests on the program included Rev. Jesse Jackson, founder of the not-for-profit organization Rainbow/PUSH Coalition; Dr. Clifford Lane, acting deputy director of the National Institute of Allergy and Infectious Diseases; and Ivan Walks, former head of the Washington D.C. Department of Health (Cox, "NPR News with Tony Cox," NPR, 12/20). The complete segment is available online in RealPlayer.
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.