SOUTH AFRICA DRUGS AUTHORITY REVIEWING NEVIRAPINE

Business Day (South Africa) 22 March 2002

As the Treatment Action Campaign (TAC) was in court on Friday to prevent the government from appealing an order forcing it to provide the anti-AIDS drug, nevirapine, outside the existing pilot sites, the Medicines Control Council (MCC) is considering reviewing the registration of the drug.

This follows reports of irregularities during human trials of the drug in Uganda.

The TAC's action in the Pretoria High Court follows a court permission obtained by the government last week to approach the Constitutional Court for an appeal against an earlier order last December that the government provides the drug to all pregnant HIV-positive mothers.

In a letter to Health Minister Manto Tshabalala-Msimang on Wednesday, the MCC said it had been brought to its attention that the United States? Food and Drug Administration (FDA) "an equivalent of the MCC in South Africa" had raised concerns at the findings last week of irregularities in the study on the use of nevirapine to reduce mother-to-child transmission of HIV in Uganda.

The MCC quoted pharmaceuticals Boehringer Ingelheim as saying that an audit commissioned by the NIH, the sponsors of the Uganda study, had revealed deficiencies in source documentation, whose results were discussed with the FDA on March 14.

It (MCC) told Tshabalala-Msimang that it was currently in contact with the FDA, NIH and Boehringer Ingelheim to get further information.

"We are to review nevirapine in the light of these developments and will inform you of the decision as soon as information is available." Nevirapine is presently registered for use in South Africa, but not in the US for the same purpose.

Tshabalala-Msimang on Friday denied during a national radio interview that she had ever ordered the MCC to withdraw the nevirapine licence. But her spokesman Sibani Mngadi was quoted by the Citizen newspaper on Friday as saying that, based on the FDA's findings, nevirapine's registration in South Africa would have to be reviewed.

The FDA's concerns over the (Ugandan) human trials on the drug's safety and efficacy could revive arguments within President Thabo Mbeki's AIDS Panel where dissidents "and Mbeki himself" have been cautioning against the universal use of anti-retrovirals.

Meanwhile, the Mail & Guardian reported on Friday that the late presidential spokesman Parks Mankahlana died of an AIDS-related ailment.

The newspaper quoted a document which it said the African National Congress was sending out to its structures and which implied that Mankahlana had AIDS and that he was killed by anti-retrovirals.

The M&G further said the ANC document also claimed that 12-year-old AIDS activist, Nkosi Johnson, died of anti-retrovirals that he "was forced to consume".

According to the newspaper the decision to dispatch the document was taken at the ANC's national executive committee meeting last weekend. It was called to deliberate the government's AIDS policy following calls by former president Nelson Mandela?s on authorities to provide free access to nevirapine in public hospitals and clinics.

In another development, the Pretoria High Court heard that the possibility nevirapine could be de-registered should have no effect on the government's obligation to provide it to prevent mother-to-child-transmission of HIV.

Gilbert Marcus, SC, was arguing on behalf of the Treatment Action Campaign in its counter-application to prevent the government from appealing against an order that it should provide nevirapine to HIV positive pregnant women at state hospitals, where the capacity existed and it was medically indicated.

Marumo Moerane, SC for government, said in the light of Ugandan developments, health authorities had to exercise extreme caution in administering nevirapine. The MCC might decide to de-register it.