NIH To Announce Consulting Restrictions To Curb Conflicts of Interest
In an effort to end "lucrative deals that have led to conflict-of-interest inquiries," all NIH staff scientists will be banned from accepting consulting fees or other income from pharmaceutical companies, according to revised ethics guidelines to be announced Tuesday, the Los Angeles Times reports (Willman, Los Angeles Times, 2/1). In December 2003, a Los Angeles Times article reported evidence of hundreds of consulting payments from pharmaceutical and biotech companies to a number of NIH employees. In response, the House Energy and Commerce Subcommittee on Oversight and Investigations began to investigate the allegations.
NIH Director Elias Zerhouni in January 2004 directed an NIH Blue Ribbon Committee on Conflict of Interest Policies to investigate the allegations. As part of the investigation, subcommittee Chair Jim Greenwood (R-Pa.) contacted 20 pharmaceutical companies about consulting agreements they had with NIH employees and found that about 100 of the 264 reported agreements were allegedly unknown to agency officials. Zerhouni in June 2004 proposed a number of revisions to NIH ethics rules, such as a ban on consulting agreements for senior NIH officials, but an Office of Government Ethics report in July 2004 found that the proposal would not adequately address conflict-of-interest concerns (California Healthline, 1/28).
Zerhouni has said that he favored allowing agency scientists to collaborate with companies to convert NIH discoveries into medical products (Los Angeles Times, 2/1). Zerhouni previously has said that a ban on all outside consulting would turn NIH into "a convent" and would not be in keeping with Congress' expectations that the institutes' research lead to cures (Harris, New York Times, 2/1). However, the blue ribbon panel's findings did not recognize any such benefit. In September 2004, Zerhouni proposed a one-year moratorium on paid consulting at NIH. However, it was never carried out.
The new restrictions, drafted by NIH administrators, OGE and HHS officials, will prohibit all NIH scientists from accepting consulting fees, speaking fees or any form of income from all biomedical companies, professional societies and other outside institutions. The new rules may be reassessed after one year, but officials familiar with the issue said they believe the changes will be made permanent. According to those familiar with the changes, the ban also will:
- Require scientists to sell or dispose of pharmaceutical or biotechnology firm stock or stock options they hold;
- Allow government employees to accept paid outside positions as physicians at hospitals or clinical settings;
- Permit government employees in some cases to accept fees from universities for teaching or writing and editing services; and
- Expand the number of NIH employees required to file annual financial-disclosure reports (Los Angeles Times, 2/1).
Rep. Diana DeGette (D-Colo.) on Monday called the guidelines "a major step toward restoring public confidence" in NIH (New York Times, 2/1). She added, "NIH's ethics requirements were appallingly lax -- not at all what the public would expect from our nation's premier research institution."
Rep. Henry Waxman (D-Calif.) in a statement said, "[W]e need to restore integrity and trust in NIH. I am glad NIH recognizes it has a problem and is now beginning to address these issues" (Los Angeles Times, 2/1).
However, Johns Hopkins Medical School director of neuroscience Solomon Snyder, who consults for several for-profit companies, said consulting relationships are important, according to the Long Island Newsday. He said, "Drug companies rely on basic science discoveries to find and develop new substances. Prohibiting these relationships could impair medical progress and the health of the country."
Fred Goodwin, a professor of psychiatry at George Washington University and former scientific director of the National Institute of Mental Health, said, "If scientists are asked to consult, it means that these companies realize they have something important to say" (Talan, Long Island Newsday, 2/1).