IOM report should end nevirapine controversy, HIVMA says

04/08/05

The HIV Medicine Association (HIVMA) is pleased that the Institute of Medicine (IOM) has reaffirmed nevirapine's safety and efficacy to prevent mother-to-child transmission of HIV.

"IOM has confirmed that nevirapine is a valuable tool to prevent mother-to-child transmission in the many places hardest hit by the AIDS pandemic where no other alternative is available," says obstetrician/gynecologist Susan Cu-Uvin, MD, member of the HIVMA Board of Directors and an AIDS researcher working in the Philippines, Cambodia, and India. "Now we all need to turn our attention to getting the best available anti-AIDS drugs to the millions who need them, including pregnant women."

In its review of HIVNET 012, a study on single-dose nevirapine conducted in Uganda in the late 1990s funded by the National Institutes of Health (NIH), IOM today found that the study was conducted appropriately and ethically, although there were some problems with data collection and record keeping. However, IOM said those errors did not bias the results of the study: that single-dose nevirapine cuts the risk of mother-to-child transmission of HIV nearly in half.

"The IOM panel was made up of some of the most highly respected experts in HIV/AIDS research, biostatistics, and bioethics," says pediatrician Kathryn Edwards, MD, of Vanderbilt University Medical Center, who was a member of the HIVNET Data Safety Monitoring Board. "We're fortunate to have such an esteemed group give their stamp of approval to the study's conduct and findings."

Infectious diseases physician and HIVMA board member Kimberly Smith, MD, MPH adds, "IOM also affirmed the high ethical standards of research conducted under NIH's auspices. We hope this report will help to reassure the developing world about the good intentions of AIDS researchers."

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