E-drug: NYT: South Africa May Bar AIDS Drug in Childbirth
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[Copied as fair use. KM]
New York Times
August 7, 2002
South Africa May Bar AIDS Drug in Childbirth
By RACHEL L. SWARNS
OHANNESBURG, Aug. 5 � South Africa's drug safety board is considering
reversing a decision that would have allowed the AIDS drug nevirapine to be
used to prevent the transmission of H.I.V. from mothers to newborn babies, a
move that is stirring outrage among advocates for AIDS patients.
One tablet of nevirapine taken by a pregnant woman during labor, along with
a single dose for the newborn, can reduce the risk of transmission of the
AIDS virus to the infant by as much as 50 percent. For that reason, the
Medicines Control Council approved the drug for such use last year. The
decision was hailed as an important step toward curbing the explosive
epidemic in this country, which has more people infected with the AIDS virus
than any other nation.
But officials at the council, the South African equivalent of the Food and
Drug Administration in the United States, said this week that they had
serious concerns about the drug.
They pointed to questions raised recently by the F.D.A. about procedural
problems found in a nevirapine drug trial in Uganda in 1999. The officials
said they were also worried about creating resistance to the drug among the
pregnant women who took it. Nevirapine is used in triple therapy treatments,
which prolong the lives of AIDS patients, and officials fear that pregnant
women who take the drug to protect their babies might not benefit from
triple therapy in the future.
South Africa, however, appears to be alone in suggesting that these concerns
may outweigh the benefits of the drug.
Officials from the National Institutes of Health in the United States have
emphasized that they believe that nevirapine is safe and effective and that
the F.D.A. is concerned only about problems with paperwork and documentation
in the drug trial. The United Nations and the World Health Organization have
also issued a joint statement reiterating that their experts, too, are
convinced that nevirapine is safe.
Precious Matsoso, the registrar of the Medicines Control Council, said the
board had yet to make a final decision about whether the drug should be used
to prevent mother-to-child transmission of the AIDS virus. She said the
council would not be swayed by the flood of criticism from advocates for
AIDS patients.
"We are not going to promote bad science," Ms. Matsoso said in an interview.
"If someone challenges the data's credibility, we have to make sure it is
correct."
Ms. Matsoso emphasized that nevirapine would keep its approval for triple
therapy treatment, no matter what was decided about its use in preventing
mother-to-child transmission of H.I.V. But the council's deliberations
revived serious questions about South Africa's handling of the AIDS
epidemic.
President Thabo Mbeki and other politicians within the African National
Congress have worried publicly about the toxicity of drugs used to treat
AIDS. Their reluctance to provide those commonly prescribed in the West has
touched off an outcry here and abroad and tarnished the reputation of South
Africa's leaders.
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