AIDS Activists Threaten Legal Action if South African Government Rejects Critical AIDS Drug
August 8, 2002
South African AIDS activists threatened on Wednesday to sue the body that regulates medicines if it withdraws its approval of nevirapine for use in stopping HIV's spread from pregnant women to their babies. South Africa's Medicines Control Council said this week it was still reconsidering its approval of the drug following questions about a key study used in the approval process. Rescinding the approval would nullify a recent constitutional court decision forcing the government to distribute the drug to all HIV-infected pregnant women.Adapted from:
Activists said they were outraged the council was still investigating the drug. "I can say without a shadow of a doubt ... we'll take them to court on this," said Mark Heywood, head of the AIDS Law Project at the University of Witwatersrand. "And we'll do it with the best scientific authorities in the world." Activists fear the government, notorious for its sluggish response to the AIDS crisis, is pressuring the council to reject nevirapine, and that it could misrepresent the current discussions as proof the drug is toxic. Studies show nevirapine given to HIV-pregnant women during labor and to their newborn babies can reduce HIV transmission by up to 50 percent.
The South African debate over nevirapine intensified in March after its manufacturer, Boehringer-Ingelheim, withdrew its application to the US Food and Drug Administration to market the drug to prevent mother-to-child transmission. The FDA noted irregularities with a Ugandan study supporting the application. US officials have repeatedly emphasized that the drug still has FDA approval for other AIDS treatments. Company officials have said the problem was simply one of paperwork and did not reflect on the integrity of the study. US doctors remain free to prescribe the drug as they wish, including to prevent mother-to-child transmission -- a purpose for which nevirapine is endorsed by the World Health Organization and UNAIDS.
Medicines Control Council Registrar Precious Matsoso said on Wednesday that the body was awaiting further documentation from the Ugandan study before deciding whether to rescind nevirapine's approval to prevent mother-to-child transmission.
08.07.02; Jeremiah Marquez
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.