Panel Will Investigate NIH Conflict of Interest Allegations, Director Tells Senate Subcommittee
NIH Director Elias Zerhouni on Thursday told the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education that a panel chaired by two "highly respected scientists from the public and private sectors" will investigate allegations of conflict of interest among NIH employees who received consulting fees and stock options from drug companies, the Washington Post reports (Weiss, Washington Post, 1/23). The allegations surfaced when the Los Angeles Times reported results of an investigation that found evidence of hundreds of consulting payments to various NIH officials. Such payments are often hidden from public view because a 1998 legal opinion from the Office of Government Ethics allows more than 94% of NIH's top-paid employees to keep their consulting income confidential. Zerhouni last month acknowledged concerns about consulting agreements between drug companies and agency employees and ordered a review of consulting fees paid to NIH scientists. On Jan. 16, Reps. Sherrod Brown (D-Ohio), John Dingell (D-Mich.) and Henry Waxman (D-Calif.) also asked the General Accounting Office to investigate NIH scientists' collaborations with drug companies (California Healthline, 1/20). Zerhouni said the new panel's co-chairs will be National Academy of Sciences President Bruce Alberts and Lockheed Martin Executive Committee Chair Norman Augustine, and other panelists will include members of the Advisory Committee to the Director of NIH, the NIH Director's Council of Public Representatives and outside experts selected in consultation with Alberts and Augustine (Washington Post, 1/23). The panel will consider whether a distinction should be made between outside collaborations held by researchers with decision-making authority, such as institute directors, and those involving employees who do not. Zerhouni said decision-makers who hold such positions may create the appearance that private industry can influence NIH's research (Grady, New York Times, 1/23). "Our public health mission, written in law, is too important to have it undermined by any real or perceived conflicts of interest," he said (Washington Post, 1/23).
Zerhouni also told the subcommittee that an internal review of all outside projects found that of about 6,000 scientists employed at NIH, 228 had a total of 365 outside consulting agreements this month, the New York Times reports (New York Times, 1/23). Since 1999, a total of 527 NIH employees have held such agreements with 1,515 outside employers. However, Zerhouni noted that top-level agency employees have stopped accepting consulting fees and stock options from drug companies, saying, "As of this moment, no director has any outside biotechnology or pharmaceutical relationship." Zerhouni added that he has seen no evidence that paid consulting with biomedical companies has influenced medical decisions or compromised patient safety at NIH (Willman/Marino, Los Angeles Times, 1/23). However, there were two instances in which scientists said they had "unknowingly wandered into terrain" that might constitute a real or perceived conflict of interest, the Post reports. In one case, NIH Clinical Center Director John Gallin's wife purchased stock in a company with which Gallin was collaborating, and Gallin did not report the purchase for two years because he was unaware his wife held the stock. In the other case, National Institute of Arthritis and Musculoskeletal and Skin Diseases Director Stephen Katz collaborated with Schering AG while the institute was involved in a clinical trial of a drug made by one of the company's U.S. subsidiaries, Berlex; Katz said he was unaware Berlex was related to Schering (Washington Post, 1/23).
Sen. Arlen Specter (R-Pa.) said that NIH must take steps to stop secret consulting deals and eliminate the appearance of conflicts of interest, adding, "This subcommittee is prepared to do it if you don't" (New York Times, 1/23). Specter also said that if such problems continue, it may "provide fodder for those in Congress who want to cut NIH funding," CongressDaily reports (Heil, CongressDaily, 1/22). Zerhouni said that while he wanted to await the new panel's recommendations before implementing new regulations, he "generally supported" requiring more public disclosure and imposing tighter restrictions on consulting arrangements, the Los Angeles Times reports (Los Angeles Times, 1/23). Federal rules prohibit NIH from publicly disclosing all collaborations, but NIH officials are open to changing regulations that would require more, or perhaps all, of the arrangements public, Zerhouni said (Washington Post, 1/23). He added that he wanted to "completely review" the decision in 1995 to lift restrictions on paid outside consulting (Los Angeles Times, 1/23).
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