E-DRUG: HIV trials in developing countries

[James Love <love@cptech.org>]

>From E-DRUG

Subject:  E-DRUG: HIV trials in developing countries
     Date: Thu, 19 Feb 1998 17:04:52 -0500 (EST)
     From: srahmad@essential.org
       To: e-drug@usa.healthnet.org

E-DRUG: HIV trials in developing countries
------------------------------------------
New York Times, February 19, 1998

U.S. Ends Overseas H.I.V. Studies Involving Placebos
By SHERYL GAY STOLBERG

Saying they have finally found a cheap way for developing nations to use
the drug AZT to reduce mother-to-infant transmission of the AIDS virus,
U.S. government health officials announced Wednesday that they are
suspending the use of dummy pills in a series of controversial overseas
experiments on pregnant women. 

The announcement, by the Centers for Disease Control and Prevention,
left people on both sides of the debate elated, but for different
reasons. 

Defenders of the government-financed studies said the findings -- that
$80 worth of AZT given during the last four weeks of pregnancy can cut
transmission of the virus in half -- will have a dramatic impact on many 
developing nations, which have been devastated by AIDS. 

Critics, who had called the use of the placebo unethical, pronounced
themselves vindicated because the women in the experiments will now get
AZT instead of dummy pills. 

"I'm delighted," said Dr. Marcia Angell, editor of The New England
Journal of Medicine, who in an editorial last year likened the studies
to the infamous Tuskegee experiments, in which treatment for syphilis
was withheld from poor black men. "Better late than never," Dr. Angell
said. 

The controversial studies -- which have involved 12,211 women in
Thailand, the Dominican Republic, Ethiopia, Ivory Coast, Uganda,
Tanzania and South Africa -- were based on one of the most dramatic
discoveries of the AIDS epidemic: the finding, four years ago, that use
of the drug AZT during pregnancy could cut the risk of mother-to-infant
transmission by two-thirds. 

Today, as a result of that discovery, HIV-infected women in the United
States are routinely given AZT during the last 12 weeks of pregnancy.
They also receive intravenous infusions of the drug during delivery, and
their babies take the medicine for six weeks after being born. 

This is commonly called the "076 regimen," after the number assigned to
the federal study that proved it effective. 

But the 076 regimen is expensive -- $800 per patient, including the
infusions and drugs for the the babies -- and too complicated for use in
the Third World, where access to medical care is poor. Yet every day, an
estimated 1,600 HIV-infected babies are born worldwide, most of them in
developing nations. So when the 076 results were published, officials at
the United Nations, the World Health Organization, the National
Institutes of Health in Bethesda, Md., and the CDC in Atlanta set out to
find a way to translate the results to the Third World. 

They settled on experiments in which half the women were given a short
course of AZT and half were given dummy pills. The studies were
controversial even among the government's own researchers; most
recently, the debate cast a shadow over the confirmation of Dr. David
Satcher, the new surgeon general who previously headed the CDC. 

Now, the first of those studies, conducted on 393 women in Thailand, is
complete. The study found that women who were given AZT during the last
four weeks during pregnancy, as well as during labor and delivery, had
half the risk of giving birth to a HIV-positive baby as those who
received the placebo. 

"We are very pleased," said Dr. Phillip Nieburg, a CDC official involved
with the experiments. "The controversy was unfortunate, but we feel that
the placebo-controlled trial that we did was very necessary." 

Others echoed Nieburg's sentiments. "It's just wonderful news," said
Mark Harrington, policy director for the Treatment Action Group, an
advocacy organization. "If we can get this incredible health benefit for
$80 bucks a pop, then we can really make a difference around the world." 

How much difference the study will make, however, remains to be seen.
While $80 may sound inexpensive, it is eight times what most developing
nations spend per capita on health care each year. 

Harrington called on the manufacturer of AZT, Glaxo-Wellcome, to provide
the drug to developing nations at a steeply discounted price. And Dr.
Joseph Saba, who chairs the international working group that coordinated
the experiments, said he is trying to "set up plans on how we move on
and who does what." 

But the advocacy group Public Citizen, which has repeatedly condemned
the project, said researchers should have known the answer to the most
pressing question -- whether a short course of AZT would work -- all
along. 

Dr. Sidney M. Wolfe, who directs Public Citizen's Health Research
Group,  obtained data on a subset of patients from the original 076
trial. He said  that among those who received AZT for an average of
seven weeks, the risk of transmission was cut by two-thirds. 

Government officials said those data were unreliable, but Wolfe
maintained  that the figures should have been taken into account. "This
is inexcusable, sloppy research," he said. "They have wasted a large
number of lives and a huge amount of money."