Hopkins, U.S. might drop placebos in AIDS drug test Tuskegee comparison discounted in AZT trial planned for Ethiopia

October 24, 1997|By Jonathan Bor | Jonathan Bor,SUN STAFF

Denying they are succumbing to criticism that they are repeating mistakes of the Tuskegee experiments, Johns Hopkins and federal health officials said yesterday that they might drop -- placebos from an AIDS prevention trial to be held in Ethiopia next year.

Marc Kusinitz, a spokesman for the Johns Hopkins School of Medicine, said the placebo segment of the study will be abandoned. He said the decision was based on preliminary evidence from a study in Thailand showing benefits of an experimental therapy.

Details were to be announced today, Kusinitz said.

Dr. Alfred Sommer, dean of the Johns Hopkins School of Hygiene and Public Health, said researchers will scrub the use of placebos if a similar experiment in Thailand shows that short courses of the drug AZT curb transmission of the AIDS virus from pregnant women to their babies.

"Nothing has really changed," said Sommer, insisting that researchers planned all along to respond to information flowing from trials conducted in other developing nations. "We're constantly adjusting our design to take advantage of available data."

This was the first time since the controversy erupted in April that Hopkins officials said they were open to withdrawing the dummy pills from the study. In the past, they have steadfastly maintained that they could not determine if scaled-down AZT was effective without comparing it to the absence of therapy -- a placebo.

An official with the United Nation's AIDS program said Hopkins ++ researchers told him at a recent meeting that they indeed plan to withdraw the placebo arm of the trial -- although he, too, insisted they were not caving into pressure.

"They decided at this stage that it didn't make sense to start with the placebo-controlled study," said Dr. Joseph Saba, a clinical research associate with U.N. AIDS. That program is conducting similar studies in Uganda, Tanzania and South Africa.

With recruitment of volunteers scheduled to begin early next year, the Hopkins trial would be getting under way as data from Thailand and other nations were emerging. Results showing the benefits of short-course AZT would cause Hopkins to abruptly drop placebos from its study.

The latest chapter in the controversy was touched off yesterday when Dr. Sidney Wolfe, director of a consumer health organization in Washington, maintained in a letter to Health Secretary Donna E. Shalala that Hopkins realized that it could not justify placebos on ethical or scientific grounds.

Wolfe said he had heard from "four independent sources at Johns Hopkins" that the decision to drop placebos had been made. In light of this, he urged her to cancel plans to use dummy pills in trials planned for Africa involving several other mothers and infants.

"Since these Johns Hopkins researchers have -- to their credit -- acknowledged the error of their ways, how can any of the other studies involving placebos be allowed to continue as planned?" wrote Wolfe, director of Public Citizen Health Research Group.

"It's pretty clear what their plan is," Wolfe said in an interview. "It has not yet been cleared through Ethiopian researchers."

A Shalala spokesman said yesterday afternoon that she had not read the letter, which was faxed to her office that morning.

"We're not going to comment on every little jag in the story," he said. "We're keenly aware of the ethical issues involved. We're always open to new information."

Controversy over a series of U.S.-sponsored experiments began April, when Public Citizen charged that the use of placebos would needlessly deny therapies to women and cause hundreds of babies to contract the fatal AIDS virus.

The debate escalated last month when the prestigious New England Journal of Medicine criticized the studies in a stinging editorial -- repeating Wolfe's charge that U.S. researchers were engaging in Tuskegee-style research.

"Tuskegee" was a four-decade trial in which U.S. researchers observed the natural course of syphilis in Southern black men -- withholding treatment even after penicillin emerged as a proven cure. The trial was halted in the 1970s.

In 1994, a clinical trial in the United States showed that a lengthy course of AZT given to mothers during pregnancy, labor and delivery -- and to babies during the first few weeks of life -- cut the transmission rate by two-thirds. With the so-called "076 protocol," just 7 percent of babies were born infected.

But researchers have acknowledged that the therapy, which costs about $1,000, is unrealistic for developing countries with limited money to protect the health of its citizens. The overseas studies are being sponsored by the National Institutes of Health and the U.S. Centers for Disease Control and Prevention.

Dr. Jack Killen, director of the AIDS Division at the National Institute of Allergy and Infectious Disease, said researchers will take a new look at the trials in January, when interim data from the Thailand studies becomes available. They will drop placebos from the Ethiopia study if trials show that the treatment significantly reduced the transmission rate.

"So they are doing exactly what has been planned by the investigators all along in this manner, which is to plan for all but possible contingents," Killen said. "To have it misrepresented is really inflammatory."

Several other experiments involving placebos -- including a Hopkins study in Uganda -- would be redesigned if the current trial produces favorable results.

"Like a stack of dominoes, everything will be rethought," he said.

Pub Date: 10/24/97

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