Panel defends study behind AIDS drug for babies

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Medical experts on Thursday defended a study that led to the widespread use of a single AIDS drug called nevirapine to protect newborns, saying allegations the research was flawed were unfounded.

AIDS activists and researchers said they hoped the report would lay to rest any doubts about the safety and benefits of using nevirapine and other drugs to protect babies.

The Institute of Medicine, an independent group that advises the U.S. government, was asked to investigate allegations by Dr. Jonathan Fishbein, a National Institutes of Health researcher, who attacked the main study that led to the widespread use of nevirapine.

Fishbein said the study, conducted in Uganda and called HIVNET 012, was sloppily conducted and did not warn women of the risks of toxicity and resistance.

He could not immediately be reached for comment.

The NIH said his allegations were false and endangered the lives of babies because people would be afraid to use a valuable drug. His attacks were used by politicians and groups in some countries to justify allegations of abuse of Africans in medical research trials.

The IoM panel said it found no sloppy research or other major problems in the trial.

“The data from the HIVNET 012 study, which showed that nevirapine effectively prevents many infants from contracting HIV from their infected mothers, are sound and reliable,” said James Ware, a professor of biostatistics at the Harvard School of Public Health who chaired the panel.

“None of the shortcomings that we discovered upon reviewing the data and conducting our own original analysis of source documents indicates a need to retract or discount the study’s findings.”

The panel’s report said the researchers at Johns Hopkins University in Baltimore and Uganda’s Makerere University conducted the trial ethically and in accordance with U.S. and international standards for research and patient care.

“This was what we were looking for,” said Mark Isaac of the Elizabeth Glaser Pediatric AIDS Foundation.

MOVING AHEAD WITH TREATMENT

“This recent controversy was an unfortunate distraction,” added Isaac, whose group provides nevirapine and other drugs to children in developing nations.

More than 39 million people around the world are infected with the fatal and incurable AIDS virus, and most of the new infections are now in women of childbearing age.

Using drugs just before delivery can protect a baby, who otherwise has about a 25 percent chance of being infected at birth by an HIV-positive mother.

The trial of more than 1,000 mothers and newborns in Uganda between 1997 and 1999 was the main basis for using a single dose of nevirapine, made by Germany’s Boehringer Ingelheim under the brand name Viramune, to prevent mother-to-child transmission.

A single dose given to the mother as she goes into labor and to the baby at birth cuts transmission by 47 percent.

Experts say there are alternatives to nevirapine for newborns, including full cocktails of various HIV drugs.

Studies show adding a drug called Combivir to the nevirapine dose reduces mother-to-child transmission even more. Combivir, made by GlaxoSmithKline Plc, contains two HIV drugs called AZT and 3TC.

When Combivir or simply AZT was added to nevirapine at birth, only 4.7 percent of the babies born to infected mothers became infected themselves.

“Other drugs are actually more effective (than nevirapine)” Isaac said. “But there are huge parts of the developing world where there is nothing else right now, and most of the world has nothing at all, let alone nevirapine.”

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