NIH Director Defends New Ethics Guidelines, Remains ‘Sympathetic’ to Agency Scientists

NIH Director Elias Zerhouni on Thursday met with senior-level agency scientists -- many of whom have criticized NIH's "sweeping new ethics regulations" -- and "defended the rules" while being "sympathetic to their grievances," the Baltimore Sun reports (Baer, Baltimore Sun, 2/25).

The rules, announced on Feb. 1, would restrict the ability of NIH employees to enter outside consulting agreements with pharmaceutical companies, hospitals, health insurers and health care providers. The revised guidelines also would mandate that about 6,000 top NIH employees cannot hold stock in pharmaceutical or biotech companies and require current stockholders in the group to sell their shares (California Healthline, 2/24).

The regulations are open to public comment for one year before becoming final.

Researchers at the meeting provided Zerhouni with the "loose outlines" of an alternative set of ethics guidelines, after saying the government's proposed restrictions "will hurt the agency's ability to recruit and retain top scientists," the Sun reports (Baltimore Sun, 2/25).

The alternate rules would exempt NIH employees who are not institute directors, clinical directors and officials with significant authority at the agency from some restrictions on consulting agreements and stock ownership. Under the alternative guidelines, NIH scientists could continue to receive payments for consulting and speaking at health care companies and academic institutions, provided that the agreements are not related to their specific areas of work.

The alternative guidelines also would allow nonscientific NIH employees, as well as spouses and children of employees, to own unrestricted amounts of stock in any company (California Healthline, 2/24).

According to the Sun, Zerhouni at the meeting "repeatedly urged" researchers to express their criticisms of the revised guidelines to HHS, which wrote the regulations along with the Office of Government Ethics.

Cynthia Dunbar, senior investigator at the National Heart, Lung and Blood Institute, said, "No promises were made by [Zerhouni] to us," but added, "He clearly understood our position and clearly has many of the same concerns. I got the impression he really does want to work with us. He is part of NIH."

Michael Gottesman, deputy director for intramural research at NIH, said the comments from scientists "will be collected, and those that are valid will have some impact on the regulations" (Baltimore Sun, 2/25).