Safety of AIDS drug to prevent mother-to-child transmission of HIV questioned

Dec 14 2004

In light of several recent drug industry scandals roiling the nation's public health and raising serious questions about the US bodies that license and regulate the industry -- and startling new revelations today concerning National Institutes of Health (NIH) officials and the safety of a brand name AIDS drug used to prevent mother-to-child transmission of the HIV -- the AIDS Healthcare Foundation (AHF), today will call upon the US government to create a new, independent blue ribbon commission or panel to review all drug research.

"The FDA and NIH are clearly letting the American public -- and the world at large -- down with regard to their so-called roles as regulatory bodies overseeing the safety and efficacy of our drug supply," said Michael Weinstein, AIDS Healthcare Foundation president. "From Vioxx to the flu vaccine, we've recently seen the deadly consequences of not having truly independent voices in the approval, licensing and regulation of our nation's drugs. The system is riddled with conflict of interest and needs to be fixed. The creation of a new independent body to review all drug industry research would be a good first step."

Earlier today, it was reported that NIH officials kept data on the safety of Boehringer Ingelheim's AIDS drug, nevirapine, from FDA and White House officials prior to the launch of PEPFAR, President Bush's ambitious $15 billion global AIDS program. The data, from a flawed study in Uganda, raise significant safety questions about a relatively easy and inexpensive way to prevent mother-to-child (MTC) transmission of the HIV. The regimen has been widely used in the developing world to prevent HIV infections in newborns.

"More than 90 percent of researchers and scientists working at the NIH also receive some form of drug industry money," added AHF's Weinstein. "The fox really is watching the henhouse, and as a result, the credibility of these agencies is shot and the public's trust has been squandered."

"With regard to MTC transmission and nevirapine, we believe the best course is to treat the entire family unit, mother and child," said Dr. Charles Farthing, AHF's Chief of Medicine. "There are ethical issues that arise if one tries to prevent HIV infection in a newborn, yet lets the mother go untreated and die. Who then cares for this HIV-negative child?"

"We also have grave concerns about the possibility that people in resource-poor countries around the world may be participating in studies and research treatments that the drug companies might not undertake here in the US and that should cease," added AHF's Weinstein. "However, more and more people in Africa and the developing world are living now because they are beginning to have access to such life-saving AIDS drugs, and these setbacks with the FDA and NIH should be no excuse to slow the process of rolling out proven treatments. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust and one which the world can look to."

http://www.aidshealth.org/