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NIH
Panel Defends Nevirapine Perinatal HIV Prevention Study
By Maggie Fox
A
report from the Institute of Medicine of the National Academies
on Thursday defended a study that led to the widespread use of a
nevirapine (Viramune)
to prevent perinatal HIV infection,
saying allegations the research was flawed were unfounded.
AIDS
activists and researchers said they hoped the report would lay to
rest any doubts about the safety and benefits of using nevirapine
and other drugs to prevent vertical
HIV transmission.
The
IoM was asked to investigate allegations by Dr. Jonathan Fishbein,
a National Institutes of Health researcher, who attacked the HIVNET
012 study that led to the widespread use of nevirapine.
Dr.
Fishbein said the study, conducted in Uganda, was sloppy and did
not warn women of the risks of toxicity
and resistance. He
could not immediately be reached for comment.
The
NIH said his allegations were false and endangered the lives of
infants because people would be afraid to use a valuable drug. His
attacks were used by politicians and groups in some countries to
justify allegations of abuse of Africans in medical research trials.
The
IoM panel said it found no sloppy research or other major problems
in the trial. "The data from the HIVNET 012 study, which showed
that nevirapine effectively prevents many infants from contracting
HIV from their infected mothers, are sound and reliable," said
James Ware, a professor of biostatistics at the Harvard School of
Public Health who chaired the panel.
"None
of the shortcomings that we discovered upon reviewing the data and
conducting our own original analysis of source documents indicates
a need to retract or discount the study's findings."
The
panel's report concluded that the researchers at Johns Hopkins University
in Baltimore and Uganda's Makerere University conducted the trial
ethically and in accordance with U.S. and international standards
for research and patient care.
"This
was what we were looking for," said Mark Isaac of the Elizabeth
Glaser Pediatric AIDS Foundation.
Moving Ahead with Treatment
"This
recent controversy was an unfortunate distraction," added Isaac,
whose group provides nevirapine and other drugs to children in developing
nations.
More
than 39 million people worldwide are infected with HIV and most
of the new infections are now in women of childbearing age.
The
trial of more than 1000 mothers and newborns in Uganda between 1997
and 1999 was the main basis for using single-dose of nevirapine,
made by Germany's Boehringer Ingelheim under the brand name Viramune,
to prevent mother-to-child transmission.
A single dose given to the mother at the start of labor and to the
neonate cuts transmission by 47%.
Experts
say there are alternatives to nevirapine for newborns, including
combination drug therapy. Studies show adding Combivir
(AZT and 3TC), made by GlaxoSmithKline Plc, to the nevirapine
dose reduces mother-to-child transmission even more.
When
Combivir or AZT alone was added to nevirapine at birth, only 4.7%
of infants born to infected mothers became infected.
"Other
drugs are actually more effective [than nevirapine]," Isaac
said. "But there are huge parts of the developing
world where there is nothing else right now, and most
of the world has nothing at all."
04/08/05
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