Daily Mail & Guardian (Johannesburg) - 01 August 2003

Nevirapine is an anti-retroviral whose reputation for success in mother-to-child transmission cases is based on a single set of tests, conducted in Uganda, that were not originally intended to meet the stringent standards of the United States Food and Drug Administration. An application by its manufacturer, Boehringer-Ingelheim, to register it in the US for mother-to-child transmission was, therefore, rejected. Our Medicines Control Council (MCC), which originally registered the drug on the strength of the Ugandan research, has now gone the same route. It has given Boehringer-Ingelheim 90 days to supply additional data proving the drug's safety and efficacy, failing which it will deregister nevirapine for prescription to pregnant HIV-infected women.

Those active in the Aids treatment field accused the company this week of "opportunism" and "shoddiness" in submitting paperwork that was clearly flawed. But this does not fully excuse the MCC, which has chosen to override the WHO endorsement, as well as considerable independent research confirming that the drug is safe to use and that it works. This includes a recent report by the US-based National Institute of Health, a reputable body that conducted the original Ugandan tests.

It is unlikely that there has been direct official government pressure on the MCC. But there are said to be individuals on the council who have bees in their bonnet about anti-retrovirals in general, and nevirapine in particular. Critics suggest the council has become more "sensitive" to government thinking since the coup three years ago that resulted in the axing of its chairperson, Professor Peter Folb, and its restructuring. It is certainly interesting that all the controversies in which the council has been embroiled in recent years have arisen in the HIV/Aids context, including rows over Virodene and AZT.

Aids dissidents in official circles should be careful about crowing too loudly about the threatened demise of nevirapine. To ensure the government will not be shackled to the drug if better remedies become available, the Constitutional Court ordered the provision of nevirapine or an adequate alternative in mother-to-child cases. The implication is that if nevirapine is deregistered, public health institutions will have to supply something at least as effective to pregnant mothers with HIV. That is likely to be AZT, or a cocktail including AZT, Minister of Health Manto Tshabalala-Msimang's pet bogey. AZT is more effective than nevirapine in checking the transmission of the virus from mother to baby. But it will be expensive for the government, and more complicated to administer.
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