August 19, 2003
Scientists in Uganda have dismissed claims by the South African Medicines Control Council that the findings of studies aimed at determining if nevirapine is safe and effective in preventing mother-to-child transmission of HIV are invalid, New Vision/AllAfrica.com reports (New Vision/AllAfrica.com, 8/18). MCC officials earlier this month rejected the results of a 1999 Ugandan study that found that the drug is effective in preventing vertical HIV transmission, and MCC Chief Precious Matsoso gave the company 90 days to offer additional safety and efficacy information. The government has said that it will revoke nevirapine's temporary approval if the drug maker fails to provide alternate data. Matsoso said that there were "glaring differences between the designs" of the Ugandan study and the South African Intrapartum Nevirapine Trial (SAINT). Although the MCC is "mindful of the government's constitutional obligation to provide" the drug under a July 2002 Constitutional Court ruling, researchers and policy makers should consider other options in case the drug is deregistered, Matsoso said (Kaiser Daily HIV/AIDS Report, 8/7). Francis Mmiro, who carried out the Ugandan study, said that the MCC's decision was "more political than scientific," according to New Vision/AllAfrica.com. Dr. Paul Bakaki, a pediatric researcher with the Makerere University-Johns Hopkins University collaboration project, said that further research in other countries had confirmed the safety and effectiveness of the drug. "We have not seen anybody dying from toxicity from this drug. If [the MCC] is talking about toxicity, then why are they allowing [nevirapine] for treatment of AIDS patients, which is even for a longer period?" Mmiro said, adding that 60 other countries use nevirapine. An FDA investigation into the results of the Ugandan study in March 2002 found that despite flaws in the study's documentation, the drug is still safe and effective (New Vision/AllAfrica.com, 8/18).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2003 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.