Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
South African Press Association (Johannesburg) - August 5, 2002
"We haven't decided on an exact legal route yet but we will make sure that any reverse decision is heard. We're not going to quietly sit by if this is a serious threat," the TAC's Mark Heywood told reporters in Johannesburg.
He was reacting to newspaper reports at the weekend that the MCC was reviewing its approval of nevirapine because it had concerns about its effectiveness and toxicity.
MCC registrar Precious Matsoso told Sapa on Monday the organisation would first consider upcoming developments regarding a Ugandan study on nevirapine before deciding about its future registration.
"I don't know where this thing of banning comes from. I don't know why this big fuss about one drug," she said.
Heywood, however, said the MCC's behaviour was suspect.
Shortly before the start of two key court cases about the government's Aids policy, the MCC issued statements expressing concern about the safety of nevirapine.
"We find that unbecoming behaviour and it certainly raises questions about them.
We have cause for concern. We hope the MCC will not risk its sterling reputation of being independent of the government."
He urged the council to review the use of the drug in an objective, careful and scientific manner.
"They should insulate themselves from political pressure."
Heywood said there was no reason to question the safety of nevirapine.
Earlier this year, the Constitutional Court ordered the government to provide the drug to pregnant women in all state hospitals. This was after the government opted to appeal a similar high court order in favour of the TAC.
Nevirapine is registered in South Africa for treating HIV/Aids patients and for the prevention of mother-to-child transmission (MTCT) of the virus.
The manufacturer, Boehringer Ingelheim, withdrew its application to the United States Food and Drug Administration (FDA) to have the drug registered for MTCT prevention a few months ago.
This came after the FDA found that the documentation of a nevirapine study done in Uganda -- the so-called HIVNET 012 -- did not meet its requirements.
The HIVNET 012 study was used as a basis for the registration of the drug in South Africa. After withdrawing its application to the FDA, Boehringer Ingelheim informed the MCC of this decision.
"That was of concern to us," Matsoso said.
However, the MCC had been informed that remonitoring was being done in Uganda.
"That will inform us if the data is still credible," she said.
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