Panel in US disputes drug trial allegations

Apr 10 2005

Medical experts have been forced to defend a study conducted in Uganda and called HIVNET 012 that led to the widespread use of a single AIDS drug called nevirapine to protect newborns, after allegations by Dr. Jonathan Fishbein, a National Institutes of Health researcher, that the research was flawed and the conclusions were unfounded.

The Institute of Medicine, an independent group that advises the U.S. government, was asked to investigate the allegations by Fishbein who attacked the main study saying it was sloppily conducted and did not warn women of the risks of toxicity and resistance. The report led to the widespread use of nevirapine. The IoM panel said it found no sloppy research or any other major problems in the trial.

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

AIDS activists and researchers say they hope the investigation will eliminate any doubts about the safety and benefits of using nevirapine and other drugs to protect babies.

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.

When they reviewed the data they did not find shortcomings or any need to retract or discount the study's findings.

The NIH does not agree with Fishbein and says his allegations were false and endangered the lives of babies because people would be afraid to use the drug. His attacks have been used by politicians and groups in some countries to justify allegations of abuse of Africans in medical research trials.

Mark Isaac of the Elizabeth Glaser Paediatric AIDS Foundation whose group provides nevirapine and other drugs to children in developing nations says the controversy was an unfortunate distraction. More than 39 million people around the world are infected with the AIDS virus, and most new infections are now in women of childbearing age. Using drugs just before delivery can protect a baby, who would otherwise have a 25 percent chance of being infected at birth by an HIV-positive mother.

Issac says other drugs are actually more effective than nevirapine but there is presently in huge parts of the developing world nothing else.

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 Ingelheimunder the brand name Viramune, to prevent mother-to-child transmission.

A single dose given to the mother as she goes into labour 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 and 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.