Panel backs results of Hopkins study on AIDS medicine

Despite some flaws, research in Uganda regarded as `solid trial'

April 08, 2005|By Jonathan Bor | Jonathan Bor,SUN STAFF

An expert medical panel has found no evidence that flaws in a Johns Hopkins study in Uganda aimed at preventing the spread of HIV from mother to baby were serious enough to cast doubt on the results, panel members said yesterday.

The group, convened last year by the government's Institute of Medicine to answer criticisms that the study was riddled with errors, concluded that the experiment was scientifically and ethically sound.

"It is my feeling that this was a very solid trial with very clean and convincing results that I feel were presented in a very fair and balanced way," Stephen W. Lagakos, a Harvard biostatistician and panel member, said at a briefing yesterday.

The Uganda study, which ran from 1997 through 1999, found that a single dose of a drug given to mothers during labor, and then to their newborn babies, cut the rate of HIV transmission in half. The drug, nevirapine, which sells for less than $4 a dose, has been supplied free of charge by its German manufacturer to tens of thousands of recipients.

Dr. Mark Klein, a panel member who runs an AIDS program at Baylor College of Medicine in Houston, called nevirapine "the cornerstone of efforts to reduce mother-to-child transmission of HIV in resource-poor countries, especially in Africa."

A longer drug regimen used in the United States has cut the transmission rate here to less than 2 percent. But at $3,000 to $5,000 per patient, its cost is prohibitive for impoverished nations. For that reason, scientists have sought a cheaper, more practical treatment for developing nations - even if the results aren't as good.

The study, conducted by scientists from the Johns Hopkins School of Medicine and Uganda's Makerere University, measured single-dose nevirapine against a short course of AZT, another commonly used AIDS medication.

"I think myself and my Ugandan colleagues are very pleased and gratified that the IOM's exhaustive report not only supports our findings but the conduct of the study and its obvious benefits for thousands of Ugandans," said Dr. Brooks Jackson, a Hopkins pathologist and the study's principal investigator.

Six years ago, Jackson and others reported in the British medical journal The Lancet that nevirapine cut HIV transmission to 12 percent, compared to AZT's 20 percent.

Doctors were unable to say how those results compared with no treatment at all. However, scientists have observed elsewhere that without treatment, HIV transmission occurs at least 30 percent of the time.

In its report, the institute said scientists underreported some adverse events - usually illnesses - among mothers and babies in the study. But it said the omissions occurred in cases where participants had multiple symptoms, and scientists reported some but not all.

Further, the panel said those illnesses occurred in an environment where diseases such as malaria and pneumonia are rampant. In most if not all cases, the patients' symptoms were related to endemic diseases - not the anti-AIDS drugs.

"There is no reason to believe these were specifically drug-associated events," Klein said.

An earlier review of the study by the federal Office for Human Research Protections identified several violations of U.S. safety rules, such as a failure to ensure patients understood potential risks.

Further criticism came from Dr. Jonathan Fishbein, an expert hired by the National Institutes of Health to improve the agency's research practices. Fishbein could not be reached for comment yesterday.

Because of these issues, the National Institutes of Health shut down the Uganda research for 15 months to review the science. Later, a top NIH official was accused of dismissing concerns about the study raised by members of his staff. Subsequently, NIH asked the Institute of Medicine to review the research independently.

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