E-DRUG: HIV trials in developing countries

[srahmad@essential.org]

E-DRUG: HIV trials in developing countries
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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."

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