Activists Threaten to Take Legal Action if South African Medicines Control Council Pulls Approval of Nevirapine
South African AIDS activists have threatened to pursue legal action if the government's Medicines Control Council rescinds its approval of the antiretroviral drug nevirapine, AP/Yahoo! News reports (Marquez, AP/Yahoo! News, 8/7). Last week, the MCC announced that it was conducting a review of its approval of nevirapine, which is used to reduce the risk of mother-to-child HIV transmission, due to "serious concerns" about the drug's safety and efficacy. MCC officials said they were concerned by manufacturer Boehringer Ingelheim's decision to withdraw an application pending with the U.S. FDA to market the drug for prevention of mother-to-child transmission because of problems with a 1999 Ugandan study on which the application was based. The questions related to the procedure, not the validity, of the study, which found that use of the drug during childbirth can reduce HIV transmission to infants, according to the manufacturer (Kaiser Daily HIV/AIDS Report, 8/6). Mark Heywood, head of the AIDS Law Project at the University of Witwatersrand, said that "without a shadow of doubt" activists would sue to prevent the government from banning the drug. Some activists are concerned that the government is "pressuring" the MCC to reject nevirapine so that it can "misrepresent the current discussions as proof the drug is toxic" (AP/Yahoo! News, 8/7).
Public Health Action
Earlier this year, the government was ordered to comply with a court mandate stating that all HIV-positive pregnant women presenting for labor at state hospitals or clinics be provided with the drug to reduce the odds of transmitting the virus to their infants. Nevirapine was mentioned specifically in the original court order; however, the ruling stated that the government "is not precluded from adapting its policy in a manner consistent with the Constitution if equally appropriate or better methods (of preventing vertical HIV transmission) become available" (Kaiser Daily HIV/AIDS Report, 8/6). Precious Matsoso, registrar for the MCC, said that the council was waiting to review more records from the Ugandan study before issuing a ruling on nevirapine but would not be deterred from rescinding the drug's approval by threats of legal action if it found evidence that warranted such action. "We can't stop people from suing, can we? But we can't sit back when we have a duty and a responsibility to act in the interest of public health. ... It would be irresponsible," she said (AP/Yahoo! News, 8/7).