August 7, 2002 Study Can Clear Air On Nevirapine
Di Caelers THE question mark hanging over nevirapine, the drug used extensively in the Western Cape to prevent mother-to-child transmission of HIV, will be cleared up, believes manufacturer Boehringer Ingelheim. The answer, the company says, will come from specialists of the United States's prestigious research body the National Institutes of Health (NIH), which is filing relevant data in Uganda "as we speak". Nevirapine, proven in drug trials to cut mother-to-child transmission of HIV by at least half, is at the centre of a new storm after weekend disclosures that it may be deregistered by the Medicines Control Council. The council is due to take a decision next month. The latest fracas, which has led to new threats of court action from Aids activist group the Treatment Action Campaign, is a repeat of a similar situation earlier this year when the drug was first threatened with deregistration. Both times, the same administrative hiccup over documentation in the Ugandan study of nevirapine has been at the root of the problem. The Ugandan problems led to Boehringer Ingelheim withdrawing an application for nevirapine's registration for mother-to-child use in the US, sparking off concerns about use of the drug here. But yesterday Kevin McKenna, the company's technical director, reiterated comments made by his company in March that the problems were technical and nothing to do with the efficacy of the drug. Specialists from the National Institutes of Health, which sponsored the Ugandan study, were in Uganda refiling data to prepare for a US Food and Drug Administration inspection of the clinical site. "When we applied for registration for nevirapine for mother-to-child use in the US, the Food and Drug Administration expressed an interest in going to Uganda to inspect the site," said McKenna. "We and the National Institutes of Health decided to review the site ahead of their visit and decided the documentation wasn't in adequate order. "We asked the FDA for an extension and when they couldn't give us one we withdrew our application for registration rather than have them refuse it, intending to re-submit it later." The company, however, stood by the clinical conclusions of the study, along with the World Health Organisation and UNaids, which had given nevirapine the go-ahead. "A National Institutes of Health team is in Uganda as we speak putting together the documentation which will be reviewed by the FDA and we are confident this will lead to a solution to the problem." McKenna said his company was called to a standard meeting by the MCC at the end of last month to give an update on the Uganda study findings, but it had no information that the council was considering deregistering the drug. Since the controversy erupted again, MCC registrar Precious Matsoso has said on radio she did not "know where this thing of banning comes from". In April, following initial concerns, top National Institutes of Health officials spoke out to scotch speculation here over the safety of nevirapine, saying unequivocally that the drug dramatically reduced mother-to-child transmission of HIV, and was very safe, particularly in terms of the single dose to mother and baby used commonly in South Africa. John La Montagne, deputy director of the NIH's National Institute of Allergy and Infectious Diseases, said then that the Ugandan study was not the only source of reliable data on the benefits of nevirapine for mother-to-child use. There was also data from the US and South Africa itself that confirmed the safety and efficacy of the drug. For more background on Nevirapine go here.  TORONTO
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