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South Africa Still Doubts Value of AIDS Drug

August 1, 2003
By REUTERS
PRETORIA, South Africa, July 31 (Reuters) - South Africa
today repeated its concern about a drug that has been used
to protect babies from AIDS, saying American researchers
had raised similar doubts.
The South African Medicines Control Council set off a
dispute this week when it told a German drug maker,
Boehringer Ingelheim that it had rejected a Ugandan study
used to show the effectiveness of the drug, nevirapine,
when used to block transmission from mother to child of the
virus that causes AIDS.
The council gave Boehringer 90 days to submit fresh
information on safety and effectiveness or have the drug's
approval revoked, a move that activists say would be a huge
step backward for South Africa, where an estimated 4.7
million people are infected with the AIDS virus, the
world's highest caseload.
"I think they want to emphasize the same standards that
apply to the developed world and the United States should
apply to the developing world," the health minister, Dr.
Manto Tshabalala-Msimang, said at a news conference. "We
can't have double standards. We can't have something that's
only good for Africa and not good for developed countries."
The minister is embroiled in a feud with AIDS activists
over the government's reluctance to provide antiretroviral
drugs.
Last year a court ordered South Africa's government to
provide nevirapine to pregnant H.I.V.-positive mothers and
their babies at all public hospitals. AIDS activists say
they believe the order would also require the government to
provide alternative treatment if nevirapine were banned.
Nevirapine has been approved by the World Health
Organization, and American regulators and Boehringer have
emphasized that they consider the drug neither unsafe nor
ineffective.
The medical council's concerns revolve around reporting and
documentation in the 1999 Uganda trial, although no
evidence was found to indicate that its conclusions were
invalid or that any of the participants had been placed at
an increased risk. American regulators raised similar
doubts last year, and Boehringer dropped plans to seek
permission to widen marketing of nevirapine in the United
States.
http://www.nytimes.com/2003/08/01/international/africa/01AIDS.html?ex=1060756494&ei=1&en=e9ae2060b530335f
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