Global Policy Forum

By Mawande Jubasi

The fate of the controversial Aids drug nevirapine hangs in the balance, with the Medicines Control Council set to take a final decision on whether HIV-positive pregnant women in South Africa should continue using it.

The council confirmed this week that it was reviewing its approval of the drug because it had "serious concerns" about its effectiveness and toxicity.

The Sunday Times has established that the council grilled the drug's manufacturer, Boehringer Ingelheim, in a heated meeting two weeks ago. The company was asked to explain alleged deaths from the drug in Uganda and why it had withdrawn an application for approval in the US.

The registrar of the council, Precious Matsoso, said it would release a final report in September on the review of their findings on the drug's future use. "We are reviewing their compliance with the South African Medicines Control Act, specifically for the mother-to-child transmission programme. If we prove that they have not complied, we will be guided by the law and its regulations . . . and we can ask them to withdraw."

If registration is withdrawn, thousands of mothers with HIV will have to stop receiving nevirapine treatment.

The move comes just months after the Cabinet approved the use of nevirapine by these women and weeks after the Constitutional Court ordered government to expedite provision of the drug.

Last week the council established a watchdog body to monitor "adverse events" related to antiretroviral therapy. Matsoso said the Pharmacovigilance Unit had already started monitoring hospitals and clinics where the drug was being administered.

She refused to discuss the meeting with the drug company, saying it was "covered under the Official Secrets Act". Boehringer Ingelheim's technical director, Kevin McKenna, also refused to comment.

But the chairman of the council, Professor Peter Eagles, said Boehringer Ingelheim had been asked to explain its withdrawal of its application to the Food and Drug Administration, the US equivalent of the Medicines Control Council.

"They said the data they needed was with the National Institute of Health in the US. At the moment that is the data and reports we are still waiting for and until such time as we have the reports, we cannot decide on the way forward," he said.

Eagles said the company was asked to provide information on rumours about deaths during the nevirapine trials conducted in Uganda between 1997 and 1999.

McKenna rejected the rumours this week.

The drug's possible deregistration has elicited widespread comment.

The head of the HIV/Aids research unit at the Nelson R Mandela School of Medicine at the University of Natal, Professor Jerry Coovadia, said he believed that such a decision would be "quite disastrous" for the government's HIV/Aids programme.

He said the World Health Organisation and the Barcelona Aids conference had reaffirmed the essential need for antiretrovirals, including nevirapine, for global programmes on the prevention of mother-to-child transmission of HIV/Aids.

Dr Glenda Gray, head of the child health research unit at the Chris Hani Baragwanath Hospital in Soweto, said they were using nevirapine to treat an average of 22 new cases every day.

She said she could not understand why the efficacy and safety of the drug was being questioned when this had been addressed during a study on nevirapine in SA in 2000.

Professor Alan Whiteside, head of health economics and the HIV/Aids research division at the University of Natal, said if talk about the possible deregistering of nevirapine were true, the message from the government to the Treatment Action Campaign and other Aids activists would be that "you may think you have won the war, but you have only won the battle".

Sibani Mngadi, spokesman for the Minister of Health, said the Medicines Control Council was an independent body charged with regulating medicines in the country, and the department could not intervene. It would be guided by the outcomes of the process within the council.

He said the health minister had nothing to do with the registration or deregistration of any medicines or drugs including nevirapine.

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