The Medicines Control Council was clearly losing its independence and was not acting on the basis of ensuring access to safe and effective Aids medicines, the Treatment Action Campaign said on Sunday.
It was reacting to news reports that the MCC was reviewing its approval of the anti-Aids drug nevirapine, because it had ”serious concerns” about its effectiveness and toxicity.
TAC national manager Nathan Geffen told Sapa: ”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.
”We are very concerned that Precious Matsoso (MCC registrar) and Peter Eagles (MCC chairman) are not acting on the basis of ensuring access to safe and effective medicine, but rather with political motivation.”
If nevirapine was banned it would make a nightmare of the MTCT programmes that were being rolled out, he said.
On the recent Constitutional Court judgment which ruled in favour of the TAC and its bid to speed up the provision of nevirapine to pregnant HIV-positive women, he said: ”They are trying to scuttle the process. It’s (the MCC) clearly losing its independence”.
The Constitutional Court judgment, however, does not rest solely on nevirapine to reduce MTCT of HIV. The judgment clearly states that government is not precluded from adapting its policy in a manner consistent with the Constitution if equally appropriate or better methods become available.
Political analyst Richard Calland in a radio broadcast on Sunday, said the judgment allowed the use of other drugs, if nevirapine was no longer appropriate.
Meanwhile, Pan Africanist Congress MP and Aids activist Patricia de Lille told Sapa: ”We are giving notice that we will defy any decision by the MCC”.
De Lille also accused the MCC of bowing to political pressure from Health Minister Manto Tshabalala-Msimang, whose controversial views on antiretroviral drugs and nevirapine have resulted in calls for her resignation.
”They’ll go to any length not to provide nevirapine.” It was absolute nonsense to say the MCC was independent from government, she said.
”Those people who wanted to keep it independent were fired. Precious Matsoso was a political appointment and there takes political instructions,” De Lille said.
In his reaction, Dr Ashraf Grimwood, of the Medical Research Council’s Aids Vaccine initiative, said that if the drug was removed from the MTCT programme, it would have a major public health ramifications.
Two hundred children were born HIV-positive daily, and with nevirapine this could be reduced to 100 a day.
However, he was pleased that the issue had become public ahead of the health summit.
The Sunday Times reported that the MCC was set to take a final decision next month on whether HIV-positive pregnant women in South Africa should continue to use nevirapine.
Matsoso was quoted as saying: ”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 regulation… and we can ask them to withdraw.”
Eagles said the council had asked Boehringer Ingelheim, the company that manufactures nevirapine, to explain its withdrawal of its application to the US Food and Drug Administration. The company was also asked to provide information on rumours about deaths during the nevirapine trials in Uganda between 1997 and 1999.
Those who have criticised the MCC’s proposed action include the head of the HIV/Aids research unit at the University of Natal, Professor Jerry Coovadia.
A decision to ban nevirapine would be ”quite disastrous” for the government’s HIV/Aids programme, he reportedly said.
Dr Glenda Gray, head of the child research unit at Chris Hani Baragwanath Hospital, 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 South Africa in 2000.
Health Ministry representative Sibani Mngadi told the Sunday Times the MCC was an independent body charged with regulating medicines, and the department could not intervene. – Sapa