Zerhouni Announces Revised Ethics Rules for Agency Employees
NIH Director Elias Zerhouni on Thursday announced final ethics regulations for agency employees that are designed to reduce conflicts of interest, Dow Jones/Wall Street Journal reports (Corbett Dooren, Dow Jones/Wall Street Journal, 8/26). NIH will soften some of the rules initially proposed in February but will impose a ban on outside consulting for pharmaceutical companies, according to the Washington Post (Connolly, Washington Post, 8/26). The original draft rules stated that NIH employees would not be permitted to enter outside consulting agreements with pharmaceutical companies, hospitals, health insurers and health care providers.
The rules also would have mandated that about 6,000 top NIH employees could not hold stock in pharmaceutical or biotechnology companies, and current stockholders in the group would have had to sell their shares. Moves by two researchers to delay acceptance of or depart from positions at NIH because of concerns over the rules prompted Zerhouni in April to consider revisions. According to Zerhouni, the provision to require NIH employees to sell stock could have limited the ability of the agency to recruit and retain researchers (California Healthline, 6/15).
Under the revised rules, only the top 200 NIH executives will be required to maintain holdings at or below $15,000 in individual pharmaceutical and biotechnology companies (Harris, New York Times, 8/26). Those staff members also will be required to keep investments in health care sector funds at or below $50,000 (Dow Jones/Wall Street Journal, 8/26). Lower-level employees will be asked to tell their supervisors about potential conflicts of interest in their investments but will not be required to file disclosures (Washington Post, 8/26).
NIH staff will be prohibited from accepting consulting fees from pharmaceutical, biotechnology or medical-device manufacturing companies; health care providers or insurers; and NIH-sponsored research institutions (Dow Jones/Wall Street Journal, 8/26). Zerhouni lifted a rule that would have prohibited NIH scientists from participating in academic and independent science organizations, with the stipulation that such organizations cannot be funded by a pharmaceutical company or other health care entity.
The final rules will take effect on Tuesday. Senior staff members affected by the investment rules will have until Jan. 30 to divest stocks that pose a conflict of interest (Washington Post, 8/26). Zerhouni said he would re-examine the rules in one year to ensure they have not compromised the agency's ability to attract top scientists (New York Times, 8/26).
Zerhouni said, "These rules are the most restrictive of any rules we know about in the world of biomedical research. Many employees asked that we loosen the ban on paid outside consulting. We elected not to. ... I think we should have a total ban" (Willman, Los Angeles Times, 8/26). He added, "Our research should be based on scientific evidence that is not influenced by any other factors" (New York Times, 8/26). According to Zerhouni, "Maintaining the ban is the best way to protect the agency at this juncture. ... Congress should be fully reassured we have addressed the fundamental issue of public trust and the integrity of the science" (Washington Post, 8/26).
Sen. Edward Kennedy (D-Mass.) said, "It is essential for NIH to meet stringent ethical standards, while allowing the exchange of ideas and information that is the lifeblood of scientific theory. The new regulations strike that balance effectively. They guard against improper conflicts of interest, and will allow NIH to continue to attract researchers of the highest caliber" (Freking, AP/Las Vegas Sun, 8/25).
Ezekial Emanuel, chair of the executive committee of the Assembly of Scientists -- a group that filed, then withdrew, a lawsuit against the old rules -- said, "This is a very good step forward, but it doesn't end the issue" (New York Times, 8/26).
Sidney Wolfe, director of Public Citizen's Health Research Group, said the revisions represent a "huge retrenchment" that leaves loopholes for NIH employees to accept industry money (Washington Post, 8/26).