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Controversy in South Africa Over HIV Drug - 2002-08-05


AIDS activists in South Africa are reacting angrily to reports the government is considering restricting the use of a drug that has been shown to be effective in preventing mother-to-baby transmission of HIV, the virus that causes AIDS. The government thinks the controversy is being blown out of proportion.

The latest furor erupted after a Sunday newspaper reported the Medicines Control Council is considering whether to keep allowing doctors to prescribe the drug Nevirapine to pregnant women.

The Medicines Control Council (MCC) is the government agency that regulates drugs for use in South Africa. It approved Nevirapine based on a Ugandan study called HIVNET012.

But the drug's manufacturer, Boehringer Ingelheim, admits there were problems with the study. And so the MCC is reviewing whether it needs to revoke the drug's approval.

Two inexpensive doses of Nevirapine have been shown to be effective in stopping the transmission of HIV from mothers to their babies during childbirth. The Treatment Action Campaign (TAC) has long worked to make the drug more widely available in South Africa.

Treatment Action Campaign spokesman Mark Heywood says suddenly withdrawing Nevirapine could confuse patients and cause thousands of new HIV infections in children. He says the problems in the HIVNET012 study are just technicalities that have nothing to do with the safety or efficacy of Nevirapine.

"So in view of that, we cannot understand why suddenly noises are being made about the possible de-registration of Nevirapine," he said. "If it is necessary to conduct an investigation into HIVNET012, the original Ugandan study, then it should be done carefully and sensitively, rather than in a ham-fisted manner which causes public confusion."

Mr. Heywood says there have been no reports of serious side effects from Nevirapine, which has been in widespread use in South Africa for the past year.

He accuses the Medicines Control Council of bowing to political pressure from government officials who oppose the use of anti-retroviral drugs such as Nevirapine.

But MCC registrar Precious Matsoso told VOA that her agency has approved 17 anti-retroviral drugs. She says the review of Nevirapine's status has nothing to do with politics.

"I just think it is absolute nonsense. What they are saying is utter nonsense because we have approved anti-retrovirals," she said. "Politicians have expressed concerns, but we have never de-registered them. We think they have value, there is value in the use of ARV's. We think that South Africans should have access. Personally, I think they should."

Mrs. Matsoso says she thinks the uproar is a result of a misunderstanding over what the Nevirapine review is all about. She said her agency would not yank the drug off the market without good reason.

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