South African Medicines Control Council Calls for Alternate Nevirapine Efficacy Data in 90 Days, Could Ban Use of Drug
Officials from South Africa's Medicines Control Council have said that they will prohibit the use of nevirapine to prevent mother-to-child HIV transmission unless drug maker Boehringer Ingelheim provides data proving that the drug is safe, Reuters reports (Quinn, Reuters, 7/30). Last year, the South African government approved nevirapine for universal distribution to state hospitals in an attempt to reduce the nation's mother-to-child HIV transmission rate. The announcement followed a Pretoria High Court ruling in December 2001 that said that the government must provide nevirapine to HIV-positive pregnant women through the public health system. The government appealed the decision, citing concerns over the drug's safety and efficacy, but the Constitutional Court in July 2002 denied the appeal, saying that the government's restriction of the drug's distribution to 18 pilot sites "fell short of its constitutional obligation to offer the best treatment available" (Kaiser Daily HIV/AIDS Report, 10/11/02).
MCC officials said that they have "rejected" a 1999 Ugandan study that showed the drug's efficacy in preventing vertical HIV transmission, according to Reuters. MCC Chief Precious Matsoso said that the study had "numerous procedural flaws," and he gave the company 90 days to offer additional safety and efficacy information (Reuters, 7/30). MCC's concerns center around reporting and documentation in the Uganda trial, although no evidence has been found to show that the study's conclusions were invalid or that any participants had been placed at an increased risk of harm, Reuters reports (Chege, Reuters, 7/31). Boehringer Ingelheim in March 2002 pulled its FDA application for the right to market nevirapine in the United States for the prevention of mother-to-child HIV transmission after FDA regulators said they uncovered procedural problems with the study. The drug is approved for use in adults in the United States, and the U.S. Public Health Service Task Force endorses its use for prevention of vertical HIV transmission (Kaiser Daily HIV/AIDS Report, 7/9/02). In March 2002, FDA officials said that concerns over the drug's safety were "unwarranted" (Kaiser Daily HIV/AIDS Report, 3/25/02). If the drug maker fails to provide alternate data, the government will revoke nevirapine's temporary approval, Reuters reports. Matsoso said, "We have to be cautious. If information is available that meets rigorous scientific standards, we will look at it" (Reuters, 7/30).
South African Health Minister Dr. Manto Tshabalala-Msimang at a news conference yesterday said, "I think [MCC officials] want to emphasize the same standards that apply to the developed world and the United States should apply to the developing world." She added, "We can't have double standards. We can't have something that's only good for Africa and not good for developed countries" (Reuters/New York Times, 8/1). Kevin McKenna, a Boehringer Ingelheim spokesperson, said that the company would attempt to work with the MCC and "eradicate their concerns" about nevirapine, which earlier this month was endorsed by the World Health Organization (Altenroxel, Star, 7/30). He added, "The overall scientific validity of (the Ugandan trial) is not questioned. The scientific community accepts this single, low dose [of nevirapine] is an appropriate medication to reduce the risk of mother-to-child transmission." Nathan Geffen of the South African HIV/AIDS advocacy group Treatment Action Campaign said, "If new evidence has come to light, the council should make it available." He added that if the MCC were to deregister the drug, the government should provide hospitals and clinics with "adequate warning" to develop alternative treatment plans, according to Business Day (Kahn, Business Day, 7/31).