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) - March 22, 2002
In a statement issued in Johannesburg, the institute -- part of the US's National Institutes of Health -- said while the collection of data in a Ugandan study into the use of the drug "may not conform to FDA (Food and Drug Administration) regulatory requirements", nevirapine was still "a major public health advance in resource-poor settings".
The FDA licences medicines in the North American country.
The NIAD statement comes after continued arguments over the safety and efficacy of nevirapine following reports that the FDA was probing irregularities during human trials of the drug in Uganda.
The Medicines Control Council (MCC) -- South Africa's equivalent of the FDA -- has already informed Health Minister Manto Tshabalala-Msimang that it was considering reviewing the drug in the light of the FDA's findings.
Anti-Aids drugs proponents, including the Treatment Action Campaign (TAC), opposition political parties and prominent figures such as former presidents Nelson Mandela and Jimmy Carter of the US, have repeatedly cited the Ugandan Aids programme as an example of how nevirapine can successfully reduce MTCT.
But the African National Congress-led government has steadfastly refused to allow the distribution of the drug outside the 18 pilot project sites and has insisted on thorough tests on its toxicity before it can be made widely available.
Only the Western Cape and KwaZulu-Natal are dispensing the drug outside of the pilot sites.
The TAC has won a court action to compel the government to provide the drug, but the government is to ask the Constitutional Court to hear its appeal against the order.
The FDA findings have raised questions about the reporting and documentation of the HIVNet 012 study on the use of Viramune (an active nevirapine ingredient) monotherapy to reduce mother-to-child transmission of HIV.
The HIVNet 012 study is a multi-site Ugandan study which was conducted by the NIAD on the use of nevirapine.
This study was critical to the MCC's approval of the drug which is presently not registered in the US.
The Ugandan trials have established that nevirapine can reduce the infection of babies by their HIV-positive pregnant mothers by nearly a half -- with no serious side effects 18 months after the trial was first conducted.
In a letter to Tshabalala-Msimang on Wednesday, the MCC quoted pharmaceutical company Boehringer Ingelheim as saying an audit commissioned by US National Institute of Health had revealed deficiencies in source documentation of HIVNet 012's Ugandan trials.
MCC chairman Professor Peter Eagles could not be reached for comment on Friday because he was said to be abroad.
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