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'We will defy ban on nevirapine'
Christelle Terreblanche, Nalisha Kalideen and Sapa. August 04 2002. Reprinted courtesy of Independent Newspapers (Pty) Ltd.
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Parliament's health committee will meet the Medicines Control Council (MCC) within the next month to discuss a possible ban on the AIDS drug nevirapine.
The committee's chair, James Ngculu of the ANC, was reacting to a report on Sunday that the MCC was reviewing its approval of nevirapine because it had serious concerns about its effectiveness and toxicity.
The Sunday Times reported that the MCC is set to take a final decision next month on whether HIV-positive pregnant women in South Africa should continue using nevirapine.
Ngculu indicated, however, that he was not sure whether to take the report seriously. "I am taking it with a pinch of salt," he said.
"I don't think it is true, but the committee will look into it. It is urgent."
A provisional meeting was scheduled for early next month. In the meantime, opposition parties reacted to the report with anger, some vowing to defy a ban.
If registration is withdrawn, thousands of mothers with HIV will stop receiving Nevirapine treatment.
Patricia de Lille of the Pan Africanist Congress said her party was "giving notice" to Health Minister Manto Tshabalala-Msimang.
"She must just try to ban nevirapine. We will definitely defy the ban, whether they say it is toxic or not," she warned.
De Lille also charged that the MCC was not independent and that the registrar, Precious Matsoso, who was quoted in the report, was "a political appointment".
"More than 80 countries have tried and tested it, so this is just another attempt not to provide nevirapine," De Lille said.
Dr Ruth Rabinowitz, the Inkatha Freedom Party's health spokesperson, said: "This is unbelievable, just another smokescreen. The government is looking for another way not to roll out Nevirapine.
"The IFP is just going to go ahead to issue a full rollout."
Sandy Kalyan of the Democratic Alliance also pointed fingers at the Health Ministry, which she suspects of interfering with the MCC.
"It think Manto Tshabalala-Msimang is behind this hidden agenda, so that she does not have to comply with the Constitutional Court ruling (to roll out Nevirapine to prevent mother-to-child transmission of HIV)," Kalyan said.
The African Christian Democratic Party's Cherilyn Dudley said she was "quite sure" the possible ban was the result of political involvement.
"It is shocking that they are doing this. It needs to be delved into. If only the MCC was independent."
The MCC reportedly grilled the drug's manufacturer, Boehringer Ingelheim, during 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 United States.
The MCC's Matsoso said the council would release a final report on the review of its findings on the drug's future next month.
Last week, the council established a watchdog body to monitor "adverse events" related to anti-retroviral therapy.
Professor James McIntyre, co-director of the HIV Perinatal Research Unit at Chris Hani Baragwanath Hospital, which conducted nevirapine trials that proved the effectiveness of the drug, said the withdrawal of the drug would be to the detriment of the country.
He said it was the duty of the MCC to review all the information around the drug, but added that he believed it was safe.
"I think it is a very effective drug. Although some concerns have been raised about the administrative paperwork of the Ugandan trial, the World Health Organisation hasn't changed its recommendation, and the US Public Health Department hasn't changed its recommendations either," he said.
"Nevirapine has shown to be effective in reducing the transmission of HIV/AIDS and showed limited side-effects," said McIntyre.
The Treatment Action Campaign has also accused the MCC of losing its independence.
"There is overwhelming evidence that nevirapine is safe for mother-to-child transmission (MTCT). Not a single serious side-effect has been reported when Nevirapine has been used for this purpose," TAC national manager Nathan Geffen said.
"We are very concerned that Precious Matsoso and Peter Eagles (MCC chairperson) are not acting on the basis of ensuring access to safe and effective medicine, but rather with political motivation."
If nevirapine were banned, it would make a nightmare of the MTCT programmes that were being rolled out, he said.
Boehringer Ingelheim spokesperson Kevin McKenna said that statements that nevirapine would be withdrawn because of concern regarding the safety of the drug were incorrect.
"I was not informed about any moves of the MCC to withdraw Nevirapine. The council would only do that if it 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. |
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