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National Institutes of Health (NIH) Director Elias A. Zerhouni brought his agency's “blue ribbon” panel report on conflict-of-interest policies to Congress yesterday (May 12), only to face critical questions from both Democratic and Republican lawmakers angry that officials had not been more forthcoming about disclosing financial ties between government scientists and industry.
“Some NIH scientists are either very close to the line or have crossed the line” of ethics violations, charged Rep. James C. Greenwood (R-Pa.), chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations. “If we are serious about upholding the highest ethical standards at the NIH, then NIH scientists should not even be close to the line.”
Acknowledging that scientists must maintain “unimpeachable integrity,” Zerhouni repeatedly promised to work closely with Congress to revamp NIH conflict-of-interest procedures. While he said that he “would sleep so much better” if all outside consulting activities were prohibited, Zerhouni argued that “collaborations with the nongovernmental research community are vital” to advance scientific research and translate discoveries into therapies. “I plead with you to be open-minded about the academic activities of our scientists,” he told the lawmakers.
Implementing one of the recommendations contained in the conflict-of-interest panel's report issued last week (May 6), Zerhouni announced that he has asked the Office of Government Ethics to require an additional 500 senior NIH officials in policymaking positions to file public financial disclosure reports. This would be on top of about 93 senior officials who had been instructed to do so earlier this year. Previously, most of these officials had only been required to file confidential reports.
Zerhouni was accompanied yesterday by the blue ribbon panel's cochairmen—Norman R. Augustine, retired chairman of Lockheed Martin, and Bruce Alberts, president of the National Academy of Sciences. Subcommittee members challenged many of the panel's findings and assumptions, including whether consulting was really needed to recruit and retain top intramural scientists and whether “bona fide” awards were really legitimate. “You have to have faith that research grants are given by merit and not because someone got a big honorarium,” said Rep. Joe Barton (R-Tex.), chairman of the House Energy and Commerce Committee.
Barton, Greenwood, and other lawmakers criticized the NIH and the Department of Health and Human Services (DHHS) for not supplying the subcommittee with financial records about NIH consulting deals. “We have found NIH to be less than cooperative, and that is going to change,” Barton said. “You can go back to your agency and tell all your directors and administrative officials that they can cooperate, or we will make them cooperate coercively.”
Greenwood said some drug companies had responded to subcommittee requests for financial information and promised to press other companies to do so. The subcommittee displayed slides revealing financial details of 12 NIH scientists and officials whose outside consulting had collectively netted them more than $2.5 million over the past decade. “How do we know these people were focusing on their NIH work?” asked Rep. Diana DeGette (D-Col.).
The subcommittee also displayed slides showing consulting agreements between seven companies and NIH scientists. Melissa Kitner-Triolo, a research psychologist with the National Institute on Aging, was listed as receiving more than $120,000 in fees and travel expenses from Wyeth Pharmaceuticals since 2001. She told The Scientist yesterday that she was unaware her name and finances had been displayed in Congress and declined further comment.
Subcommittee members also questioned Zerhouni about a Los Angeles Times story claiming that the blue ribbon panel had uncovered permissive practices that were not included in its final report. Zerhouni said the newspaper story appeared to be based on E-mail exchanges and not official meeting minutes, but promised to look into it further.
Also yesterday, DHHS published final guidelines on how medical schools, institutional review boards, and researchers could protect people from possible harm caused by financial conflicts of interest that may arise in human research studies. The guidance document suggests—but does not require—various mechanisms to manage such conflicts, including reducing and disclosing the financial interest and separating responsibilities for financial and research decision making.
Rep. Peter Deutsch (D-Fla.), the subcommittee's ranking minority member, urged Zerhouni “to end the practice of NIH researchers taking anything of value from drug or biotech companies.” But Zerhouni said such an action “would be bad for science, unfair to the employees, and ultimately hinder our efforts to improve the nation's health.”
References
| 1. | | [http://www.nih.gov/about/ethics_COI_panelreport.pdf]
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| | | Report of the National Institutes of Health: Blue Ribbon Panel on Conflict of Interest Policies, May 5, 2004 Return to citation in text:
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| 2. | | [http://www.the-scientist.com/news/20040507/03/]
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| | | T. Agres, “Top NIHers can't consult,” The Scientist, May 7, 2004. Return to citation in text:
[1]
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| 3. | | [http://www.latimes.com/news/nationworld/nation/la-na-nih12may12,1,3001166.story]
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| | | D. Willman, “NIH conflict findings left out,” Los Angeles Times, May 12, 2004. Return to citation in text:
[1]
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| 4. | | [http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf]
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| | | Department of Health and Human Services, “Financial relationships and interests in research involving human subjects: Guidance for human subject protection,” Federal Register, 69, May 12, 2004. Return to citation in text:
[1]
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