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AIDS drug ban will be 'a disaster'

Graeme Hosken & Nalisha Kalideen. The Mercury, 4 August 2002. Reprinted courtesy of Independent Newspapers (Pty) Ltd.
University of KwaZulu-Natal-based AIDS expert Jerry Coovadia said the withdrawal of the anti-retroviral drug Nevirapine would be disastrous for South Africa and especially KwaZulu-Natal, which has the highest incidence of AIDS in the country.

Coovadia was reacting on Sunday night to reports that the drug could be de-registered because of serious concerns about its safety. The Medicines Control Council has questioned the effectiveness and toxicity of the drug.

Coovadia defended the safety of the drug, saying he had been through arguments about its toxicity numerous times. The side-effects, which were very rare, included damage to the white blood cells, liver dysfunction and a number of different skin rashes.

Coovadia was quick to point out that the side-effects were most often reversible. "The fact that the drug is only given once also makes the occurrence of side-effects very unusual," he said.

"All drugs and vaccines cause serious side-effects, but we do not for a second say: 'Let's discontinue the measles or polio vaccinations or common anti-biotics like penicillin.'"

"What we do is make a balanced assessment between the side-effects and the drug's benefits, and when the benefits outweigh the side-effects, the drug is recommended. In my professional opinion the pros of Nevirapine far outweigh the cons," he said.

"The consensus is that Nevirapine is safe and effective for the prevention of mother-to-child transmission, and is appropriate for developing countries because it is affordable and the administration is very simple."

Coovadia said if the drug were banned it would be a disaster for the government's HIV/AIDS programme "because it would mean going back to square one where there will be no treatment for mother-to-child transmission unless someone finds an alternative".

"Another effect is that thousands of women who are eligible for this drug will not receive it, meaning that their children, who would have been prevented from being born HIV-positive, will become infected," he said.

Nearly 70 000 babies are born HIV-positive every year.

Banning the drug would rekindle the disputes which saw civil society and the government locked in battle for years and would be detrimental to the government's AIDS programme.

"The withdrawal would also create a wider gap between the government and the country's people, and the population will gradually lose faith in the government's public health policy," he said.

AIDS organisations have also expressed outrage at the Council's decision to review the safety of Nevirapine.

The Treatment Action Campaign issued a statement late on Sunday saying the Medicines Control Council was losing its independence and was not acting on the basis of ensuring access to safe and effective AIDS medicines.

But Nevirapine's manufacturer says approval for the drug will not be withdrawn by the council as the drug's effectiveness and toxicity are not in question.

A spokesperson for Boehringer Ingelheim, Mr Kevin McKenna, said that statements saying Nevirapine would be withdrawn because of concern about its safety were incorrect.

"I was not informed about any moves of the MCC to do that (withdraw Nevirapine). They would only do that if they had great concern about the safety and effectiveness of it and there is absolutely no basis to the question of the safety or effectiveness of the drug," he said.

He said allegations about deaths of participants in a Ugandan trial were unfounded and he had seen documentation to that effect.

"The unreported deaths are rumours," McKenna said.

Earlier this week, Precious Matsoso, registrar of the Medicines Control Council, said that for anyone to say the Council was going to deregister Nevirapine was a "misrepresentation" of what the Council was trying to do. She was unavailable for comment at the time of going to press.

Opposition parties reacted to the report with anger, and some vowed to defy a ban, reports Christelle Terreblanche.

Patricia De Lille of the Pan Africanist Congress said her party was giving "notice to the Minister of Health". "She must just try to ban Nevirapine. We will definitely defy the ban," she said.

Dr Ruth Rabinowitz, health spokesperson of the IFP, which is rolling out Nevirapine in KwaZulu-Natal, said: "This is unbelievable - just another smoke-screen of the government, finding another way not to roll out Nevirapine."
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