E-drug: HIV drug under review
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[Copied as fair use. HH]
HIV drug under review as firm withdraws FDA application
BMJ 2002;324:807 (6 April 2002)
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 Council which 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 Congress but 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.
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