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SOUTH AFRICAN VIRAMUNE HIV/AIDS CONTROVERSY CONTINUES TO GROW

January 19, 2005

Following December's accusations in the international press that German drug major Boehringer-Ingelheim distorted study results on its Viramune (Nevirapine) HIV/AIDS treatment, controversy over the drug continues to grow. Activists, medical practitioners and politicians in South Africa continue to issue contrary claims over the effectiveness of the drug, which is a relatively inexpensive single-dose treatment blocking transmission of the retrovirus from mother to child.

Concerns over the drug began in 2002, when "procedural" flaws in the drug's Ugandan trials allegedly led Boehringer-Ingelheim to withdraw its application for a US FDA approval for the treatment. South African health authorities subsequently rejected the trial's findings, and the government placed the product under review in July 2004. Last month, the ruling ANC added to the controversy by accusing the US National Institutes of Health (NIH) of covering up evidence of harmful side effects.

It is now widely feared that politically motivated hostility to the drug could lead to its withdrawal in South Africa, eight years after its introduction. The drug is widely available in the country, due to its low cost (at some US$4 per dose) compared to combination therapies, as well as its reported capacity to halve HIV transmission rates between mother and child. Although there is a risk that mothers become resistant to the drug, activist groups fear that a withdrawal could jeopardise affordable treatment in a country where HIV/AIDS therapy provision is widely regarded as inadequate.