http://bmj.com/cgi/content/full/324/7341/807/a

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Collections under which this article appears: HIV Infection/AIDS Pregnancy International health

BMJ 2002;324:807 ( 6 April )

News

HIV drug under review as firm withdraws FDA application

Pat Sidley, Johannesburg

South Africa's already confused and controversial policy on HIV and AIDS was plunged into further disagreement last week as the German pharmaceutical manufacturer Boehringer Ingelheim announced that it would withdraw its application to the US Food and Drug Administration for its antiretroviral drug nevirapine to be registered in the United States for use in preventing HIV transmission from mother to child.

The drug has been registered for use in adults and children with HIV and AIDS, but in South Africa it has received registration only for use in reducing the risk of HIV transmission from mother to child. Now South Africa's drug registration authority, the Medicines Control Council, has said it will be reviewing the registration of the drug for the application in question following the withdrawal of the US application.

The FDA has not given clear reasons for its hesitancy over the registration, but the researchers of the US National Institutes of Health, who did the original research, say the concerns are over documentation.

The news broke as AIDS activists, doctors, and scientists were already shocked by the announcement by the ruling African National Congress that it would not roll out any further its very limited pilot sites through which it provides the drug to pregnant women with HIV. And it further frustrated activists and doctors as they were on their way back to the High Court in a continuing court battle aimed at forcing the African National Congress government to make the drug more widely available through its public healthcare facilities.

South African scientists working in the AIDS field have been shunned by the government and have found themselves attacked and vilified by the African National Congress in some of the documentation it has circulated.

This has included Professor Malegapuru Makgoba, who heads the Medical Research Councilwhich last year published figures showing that HIV/AIDS was the leading cause of death in the country. The government would have preferred the figures to remain hidden, and it has now launched an investigation into the leaking of the figures.

In February, former president Nelson Mandela stepped into the fray, stating he believed that antiretroviral treatment should be made available through the public health system. He took the issue up with the government and the African National Congressbut has found that his pleas have fallen on deaf ears.

The party meeting that was called to hear the issues accepted the continuing "dissident" line, which casts doubt on the causal link between HIV and AIDS. Antiretrovirals have been ruled out and Mr Mandela's views shunned in their entirety.

Late last year the Pretoria High Court had granted an application to the Treatment Action Campaign and several hundred state employed doctors and nurses to force the government to provide nevirapine more widely.

The activists returned to ask the court to enforce the order while the issue was being appealed in the Constitutional Court. Boehringer Ingelheim's withdrawal of its application to the FDA coincided with a return to court of the parties to decide whether that latest ruling could be appealed or not.

© BMJ 2002
 

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