by Adele Baleta The Lancet Volume 360, Number 9331 10 August 2002 South African doctors, activists, and politicians have vowed to fight plans by the country's drug regulatory authority to withdraw nevirapine for the prevention of intrapartum HIV transmission. The Medicines Control Council (MCC) said last week that it has decided to review the registration of nevirapine because it had concerns about the drug's efficacy and toxicity. Leading AIDS activists, the Treatment Action Campaign (TAC), said they would challenge the MCC in court if it decided to ban nevirapine because there was overwhelming evidence that the drug was safe for the prevention of mother-to-child transmission (MTCT) of HIV. Nevirapine is registered in South Africa for the treatment of HIV/AIDS patients and for the prevention of MTCT. The MCC's concerns are directed only at the latter use of the drug. The MCC's registrar, Precious Matsotso, denied the council wanted to ban the drug. The MCC will make a final decision next month after it has considered a report from the US FDA, which is reviewing data from a nevirapine trial done recently in Uganda, she said. Meanwhile, pressure has been increasing on the South African government to improve access to antiretroviral drugs. The South African Medical Association, which represents 16 000 doctors, said it will send a delegation to the health ministry to express their disquiet at the current situation. The chairman of the association, Kgosi Letlape, said at their annual council meeting on July 27 that doctors could no longer be a part of a system "that commits genocide". The medical profession needs to draft its own treatment policy and doctors should intervene where the government was slow to act, he added. Further heavyweight support came from Nelson Mandela who met leading AIDS activist, Zackie Achmat, on July 27. Achmat refuses to take antiretrovitrals until the government "drops its denialist agenda". Mandela followed his weekend meeting with Achmat by requesting a meeting with President Mbeki. Mbeki and Mandela met on Aug 1 but refused to disclose any details about their discussions. However Mandela did say that he supported the government's stance that research into antiretroviral drugs in an African context was necessary to ensure that if there was a nationwide roll-out of treatment, it should be safe. "But of course what worries everybody is the number of people who are dying almost daily", he said. The MCC's change of heart over nevirapine came after Boehringer Ingelheim told the Council earlier this year that it was withdrawing its application to the US FDA to have the drug registered for prevention of MTCT. This came after the FDA found that the documentation concerning the company's recent nevirapine trial in Uganda--HIVNET 012--did not meet its requirements. Early results from the study were published (see Lancet 1999; 354: 795) and were used as a basis for registering the drug in South Africa. Matsoso said on Aug 4 that the FDA's action was a cause for concern and the MCC wanted to see if the data from the trial was still credible. Boehringer Ingelheim spokesperson, Kevin McKenna, said the council had not informed him of any decision to withdraw nevirapine in South Africa but said the safety and efficacy of the drug was above question. Glenda Grey, co-director of the HIV Perinatal Research Unit at Chris Hani Baragwanath Hospital, believes the MCC must review all available information about the drug. However she found the MCC's position suspect, adding that although there were administrative problems with the HIVNET trial, WHO, UNAIDS, and the US government have still endorsed the safety and effectiveness of nevirapine She told The Lancet that the MCC must weigh up the risks and benefits. "But surely it's criminal to undermine a safe drug when there is an epidemic and children are dying like flies." The MCC's motivations have also been questioned by opposition politicians who said they would defy a ban. They said the so-called independent MCC was bowing under political pressure from government. TAC national manager Nathan Geffen believes the MCC, with the backing of the government, has a hidden agenda to undermine the constitutional court's judgment on July 5, which forced the government to provide nevirapine to all HIV-positive pregnant mothers. "We believe they continue to cast aspersions on nevirapine because they do not want to roll out. This is because there is strong support for AIDS denialists by government." For more background on Nevirapine go here.
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