Most Members of IOM Panel Investigating Ugandan Nevirapine Study Receive NIH Funding, Associated Press Reports

Two-thirds of the members of an Institute of Medicine panel investigating an NIH-funded study of the antiretroviral drug nevirapine among pregnant women in Uganda receive grant money -- ranging from $120,000 to $2 million annually -- from NIH, according to agency documents and interviews conducted by the Associated Press, the AP/Yahoo! News reports (Solomon, AP/Yahoo! News, 3/16). The IOM panel is investigating an NIH-funded clinical trial that began in 1997 to study the use of single-dose nevirapine among HIV-positive pregnant women in Uganda to determine the drug's ability to prevent vertical HIV transmission. The initial results showed that the drug prevented HIV transmission to newborns in as many as half of births. However, by early 2002, medical safety specialists and auditors with NIH, as well as the drug's manufacturer Boehringer Ingelheim, cited "widespread" administrative problems with the research in Uganda. Because of the reported problems, NIH suspended the research from spring 2002 to summer 2003 in order to review the trial and take corrective steps. The National Institute of Allergy and Infectious Diseases in a "Q & A" document regarding the trial said that nevirapine is a "safe and effective" treatment to reduce the risk of vertical HIV transmission and that reviews of the study data "have found only a very small number of serious adverse reactions that potentially might be due to nevirapine" (Kaiser Daily HIV/AIDS Report, 1/3).

Grant Details
Six of the IOM panel's nine members currently receive grant money from NIH, some directly from NIAID, the agency "at the center" of the investigation, according to the AP/Yahoo! News. Other panel members receive funding from NIH's Fogarty International Center, which funds research worldwide on issues ranging from HIV/AIDS to mental health. The panel members currently receiving NIH grant money include:

• Dr. Mark Kline, a pediatric AIDS specialist at Baylor College of Medicine, who receives between $250,000 and $300,000 annually from NIH;
  
  
• Dr. Wafaa El-Sadr, a professor of epidemiology at Columbia University's Mailman School of Public Health, who received approximately $2 million from NIAID last year;
  
  
• Stephen Lagakos, director of Harvard University's Center for Biostatistics in AIDS Research, which received $242,700 from NIH over the past year;
  
  
• Richard Landis, a biostatistics expert from the University of Pennsylvania, who received $136,229 from NIAID in 2004;
  
  
• Dr. Charles van der Horst from the University of North Carolina-Chapel Hill, who helped manage an NIH study examining the side effects of antiretroviral medications, which last year received more than $120,000 in NIH funding; and
  
  
• George Rutherford, an epidemiologist at the University of California-San Francisco School of Medicine, who was awarded a five-year grant from FIC in 2001 for AIDS training and research. He received $243,308 in the past year.

Reaction
IOM said that it knew about the six members' "financial ties" to NIH but allowed their participation because they have "special expertise," receive a "minority" of their overall funding from NIH and won their grants "competitively," according to the AP/Yahoo! News. "When you get into some of these fields or areas, you are not talking about a really huge pool of experts who can be candidates or experts," NIH spokesperson Christine Stencel said, adding, "In this case, a lot of the great candidates potentially would have had funding from NIH. ... Do you keep off of your committee every great expert out there because they can't have a single penny from NIH or do you strive for a balance, keeping any possible connection like that to an absolute best possible minimum?" She added that IOM rejected two other potential panel members because they received a majority of their funding from NIH or from drug companies with ties to HIV/AIDS research. However, Senate Finance Committee Chair Chuck Grassley (R-Iowa) said that any financial ties to NIH might create a conflict of interest that "sullies any conclusions they make," the AP/Yahoo! News reports. "If there's financial interest, there's a conflict, and that's a factor to consider when sizing up objectivity," he said. Some legal and medical ethicists say that, although IOM likely did not violate any laws, it should have "done more to alert the public to the financial conflicts" in the case, especially because some panel members have an "ongoing financial relationship" with NIH, according to the AP/Yahoo! News. "Essentially, what the public will want to know about this report is: is this a whitewash or is it actually independent?" Kathleen Clark, a government ethics expert at Washington University in St. Louis, said, adding, "It is interesting that [IOM] revealed this only in response to an inquiry from Sen. Grassley and from the media. That's problematic" (AP/Yahoo! News, 3/16).