E-DRUG: AZT trials in developing countries (contd.)
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From the Press: New York Times October 24, 1997
Plan to Use Placebo in African Test on H.I.V. Is Scrapped
By SHERYL STOLBERG
WASHINGTON -- A team of researchers at Johns Hopkins University has
abandoned plans to use dummy pills in an experiment on Ethiopian
women who are pregnant and infected with the AIDS virus. The use of
the dummy pills as a placebo has renewed intense debate over the
ethics of a series of federally financed studies in the Third World.
The study, which is to begin in late February or early March and will
be paid for by the National Institutes of Health, was initially
designed to see whether a short course of the anti-viral drug AZT is
more effective than a placebo in reducing transmission of the AIDS
virus, HIV, from a pregnant woman to her baby. But because it is
routine for pregnant women in the United States to receive AZT, there
has been bitter controversy about the use of dummy pills in the
foreign studies.
A spokeswoman at the Johns Hopkins School of Public Health said
Thursday that the researchers did not change the design of the
Ethiopian study in response to the controversy. Rather, said Liz
Pettengill, the spokeswoman, the scientists are expecting that a
study under way in Thailand will prove that a short course of AZT is
more effective than placebo.
If that is the case, she said, there is no need for the Johns Hopkins
researchers to employ the dummy pills in their study.
According to Jack Killen, who directs the Division of AIDS at the
National Institute on Allergy and Infectious Diseases, preliminary
results from the Thailand study are expected in January. At that
point, he said, all the studies will be re-evaluated, including
current tests in the Ivory Coast and Tanzania and one planned for
Uganda. If the short course of AZT is proved effective, none of the
studies will continue to use placebo, he said.
"This has been part of a plan from the very beginning," Killen said.
"It's not like a light bulb just went off: 'Oh, my goodness, we've got
to look at the Thai study."
Note from the moderator:
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Please make a note of Serena Parker's (Management Sciences for Health)
phone number to obtain International Drug Price Indicator Guide is
1-703-524-6575. The phone number in the earlier posting was for a
different person at MSH. Apologies to all parties for any
inconvenience.
Syed Rizwanuddin Ahmad
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