A consumer health organization is accusing the Johns Hopkins University and other U.S. research institutions of violating international rules of ethics by withholding proven AIDS treatments from women and children in overseas experiments.

Public Citizen Health Research charged that nine federally funded experiments could cause about 1,000 newborns in Africa, Asia and the Caribbean to die needlessly. Six of the studies are under Hopkins supervision.

"It's Tuskegee Part Two, and this time many more people will die," said Dr. Sidney Wolfe, director of the Washington-based advocacy group. "Tuskegee" was a four-decade study in which the government tracked the ravages of syphilis in poor, black men of rural Alabama -- withholding a cure when it was discovered.

Dr. Neal Halsey, a Hopkins professor of international health, said the group misunderstood studies that are intended to find less expensive and more practical ways to stem transmission of the human immunodeficiency virus from infected women to their babies.

Halsey, who is planning a study in the Dominican Republic, said international research guidelines "do not call for imposing all standards of care on developing countries. This is impractical and resented by developing country officials and practitioners."

Three years ago, a large study held in the United States and France produced striking evidence that the drug AZT lowered mother-to-baby transmission by about two-thirds.

The study established as standard practice the so-called "076 protocol" in which AZT is given orally to women during pregnancy and intravenously during delivery. Oral doses are given to babies for six weeks after birth.

Halsey said the regimen costs $800 to $1,000 per woman -- too much for many developing countries. Also, its requirement of an early HIV diagnosis, frequent medical visits and intravenous AZT during delivery are often unrealistic.

Studies cited by Public Citizen test alternative treatments and shorter, simpler courses of AZT.

Dr. Peter Lurie, a researcher with Public Citizen, said he did not fault researchers for testing new ways to give AZT. But he took issue with studies that use placebos for purposes of comparison.

As an example, he cited a planned experiment in Ethiopia in which two groups of women will receive differing courses of AZT. A third group will get placebos.

"We don't mind if people want to adjust the timing or dose of AZT in an attempt to find something less costly and less toxic," Lurie said. "We do object to number three, where you get nothing."

But Halsey said transmission rates vary greatly from country to country, making it foolish to apply results from Western countries to other cultures.

"In order to evaluate the shorter regimen, you have to have a comparison," he said. "You can't just give the drug to everyone."

Pub Date: 4/23/97

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