Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
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United Press International; Wednesday, September 17, 1997 6:08 PM EDT
Mara Bovsun in New York
Journal editor Dr. Marcia Angell (as "Angel") says, "There appears to be a general retreat from the clear principles enunciated in the Nuremberg Code and the Declaration of Helsinki as applied to research in the Third World."
Angell says that the "retreat from ethical principles" can be explained, in part, by competitive and regulatory pressures of the drug business, in which results must come quickly, cheaply and with few obstacles.
She says because of this emphasis on cost and speed, "it seems as if we have not come very far from Tuskegee," the notorious 40-year experiment in which poor black men were denied available treatments for syphilis.
A key issue is the use of placebo, in which patients get no treatment, in clinical trials.
She says two articles in the NEJM highlight the problem. In one, researchers in Uganda compared a therapy to prevent tuberculosis to placebo in HIV infected patients.
In another article, researchers from Public Citizen charge the United States is funding unethical African, Asian and the Caribbean studies, designed to prevent AIDS-infected mothers from passing the disease onto their babies.
Most of the studies compare a drug treatment to placebo, even though an AZT-based regimen has been shown to cut transmission by two-thirds. The Public Citizen doctors say the trials should compare the new approaches to the proven AZT standard.
Jack Killen, director of the division of AIDS at the National Institute of Allergy and Infectious Diseases, says it would be worse to conduct AZT experiments in Third World countries that can neither afford nor implement programs using the expensive, complex drug therapy.
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