South African Health Minister Calls Nevirapine ‘Poison’; Observers Worry Government Will Continue to Fight Court Order Mandating Distribution of the Drug
South African Health Minister Dr. Manto Tshabalala-Msimang on Sunday said that the antiretroviral drug nevirapine is "poison" and that she is unhappy that South Africa's Constitutional Court has ruled that the national government must provide the drug to pregnant women in order to prevent vertical HIV transmission, Newsday reports. "The High Court has decided the Constitution says I must give my people a drug that isn't approved by the [U.S.] FDA. I must poison my people," Tshabalala-Msimang said while attending the XIV International AIDS Conference in Barcelona, Spain (Garrett, Newsday, 7/8). South Africa's Constitutional Court last week denied the government's right to appeal the Pretoria High Court's December ruling that the government must provide nevirapine to HIV-positive pregnant women in state hospitals. Chief Justice Arthur Chaskalson said 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," and he ordered the government to immediately "remove the restrictions that prevent nevirapine from being made available for the purpose of reducing risk of mother-to-child transmission of HIV at public hospitals and clinics that are not research and training sites" (Kaiser Daily HIV/AIDS Report, 7/5). The government in April announced that it may launch a program to provide universal access to nevirapine for HIV-positive pregnant women by December, although it continued its appeal of the High Court ruling based on broader "constitutional issues" (Kaiser Daily HIV/AIDS Report, 4/19). Tshabalala-Msimang said that the government will "implement [the ruling] because we are forced to implement," but Newsday reports that the minister's "unhappiness with the ruling" and her comparison of nevirapine to poison "may signal an intention to continue to thwart use of the drug."
No FDA Okay?
Tshabalala-Msimang's statements regarding nevirapine and the FDA stem from the fact that the FDA has never approved single-dose nevirapine for prevention of vertical HIV transmission in the United States (Newsday, 7/8). Nevirapine manufacturer Boehringer-Ingelheim in March pulled its FDA application for the right to market nevirapine in the United States for this purpose after FDA regulators said they uncovered procedural problems with a 1999 study of the medication. Nevirapine 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, 3/25).
Dr. James McIntyre, director of the perinatal HIV research unit at the University of the Witwatersrand in Soweto, South Africa, said that Tshabalala-Msimang's comments left him "speechless." He said, "All we hoped was that the drug would be used the way the World Health Organization [and other] international agencies say it should" (Newsday, 7/8). In March, WHO and UNAIDS released a statement supporting use of nevirapine to prevent vertical HIV transmission. Their guidelines state that a single dose of nevirapine can be used during delivery to prevent vertical HIV transmission (Kaiser Daily HIV/AIDS Report, 3/27). HHS Secretary Tommy Thompson has also said that nevirapine should be considered safe for use for pregnant women (Newsday, 7/8).