Activists and researchers rally behind AIDS drug for mothers
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By Erika Check
Nevirapine trial was not flawed, say researchers.
[WASHINGTON] Scientists and patient advocates this week united
to defend an HIV treatment against allegations that a key clini-
cal trial of the drug was flawed.
The drug, nevirapine, is used to help prevent mother-to-baby
transmission of HIV. But stories published by the Associated
Press earlier this month re-ignited controversy in Africa over
whether nevirapine is safe and effective, raising fears that
many women there will stop taking the drug.
The allegations relate to a clinical trial - known as HIVNET 012
and funded by the US National Institutes of Health (NIH) - which
began in 1997 in Uganda. In 1999 and in 2003, the scientists
running the trial reported that nevirapine drastically cut
mother-to-child transmission of HIV. The findings led to
successful transmission prevention programmes around the world.
The Associated Press stories drew on internal communications be-
tween Edmund Tramont, head of the NIH's Division of AIDS, and
his subordinates, who were concerned about standards of record
keeping in the trial. Tramont, however, believed that a thorough
review of the study had validated the conclusions that nevirap-
ine was safe and effective, and stated this in a final report in
March 2003.
Scientists and advocates are standing by Tramont's conclusion,
pointing out that independent trials in South Africa, Malawi and
Thailand have confirmed it. But nevirapine has long been a
flash point in the AIDS epidemic, especially in South Africa
(see Nature 430, 389; 2004), and the latest stories have revived
vitriolic arguments about its use.
The African National Congress, the governing party in South Af-
rica, issued an unsigned statement on 17 December, alleging that
the drug was not proven to be safe but that the United States
"was happy that the peoples of Africa should be used as guinea
pigs". And on 16 December, the US political leader and civil-
rights activist Jesse Jackson branded the NIH's continued sup-
port for the drug "a crime against humanity".
The NIH has asked the Institute of Medicine to perform an inde-
pendent study of HIVNET 012, which will report in March. Offi-
cials at the NIH admit that the trial was not done perfectly,
but they strongly support Tramont's decision to back the drug's
use over the opinions of some of his subordinates.
"There certainly were elements of the study that could have been
done better," says Clifford Lane, acting deputy director of the
National Institute of Allergy and Infectious Diseases (NIAID).
"But there's nothing that has in any way invalidated the conclu-
sion that single-dose nevirapine is effective for reducing
mother-to-child transmission."
Strong support Academics also defended the conclusion. "Ed Tra-
mont is a man of integrity and common sense, and he has probably
done more than anybody at the NIH to improve the infrastructure
for conducting these trials in developing countries," says
Brooks Jackson, a pathologist at Johns Hopkins Medicine in Bal-
timore, who led HIVNET 012.
Brooks Jackson adds that he stands by the trial's results:
"There's no question in my mind that single-dose nevirapine is
safe and efficacious, and now that's been supported by several
other studies independent of ours."
Even activists who often clash with the NIAID say that top sci-
entists there correctly interpreted evidence from the trial, de-
spite some flaws in the study. "The data discrepancies don't al-
ter the fundamental fundings," says Gregg Gonsalves of Gay Men's
Health Crisis, an AIDS lobby group in New York.
The furore over HIVNET 012 underscores the difficulties of doing
clinical trials in developing countries. "You get criticized be-
cause some people feel you should provide the same exact stan-
dard of care as you do in the United States, and it's just not
feasible," says Brooks Jackson. "On the other hand, you get
criticized for doing regimens that are too difficult or cost too
much or are not realistic, so you're sort of caught in the mid-
dle."
But activists are worried that the latest controversy is under-
mining efforts to prevent HIV transmission in Africa. "There are
already mothers who are refusing to take nevirapine," says Ar-
thur Ammann, a doctor and president of Global Strategies for HIV
Prevention, a non- profit organization based in San Rafael,
California. "This is the most successful therapy in the entire
AIDS epidemic. It should not be attacked."