NIH chief defends new rules on ethics

Scientists give Zerhouni outlines of alternative regulations they propose

February 25, 2005|By Susan Baer | Susan Baer,SUN NATIONAL STAFF

WASHINGTON - National Institutes of Health Director Elias A. Zerhouni, meeting with scientists who have railed against sweeping new ethics regulations, defended the rules aimed at halting conflict-of-interest problems. But scientists at yesterday's two-hour meeting said they found the agency director sympathetic to their grievances.

"He clearly understood our position and clearly has many of the same concerns," said Cynthia Dunbar, senior investigator of the National Heart, Lung and Blood Institute. "I got the impression he really does want to work with us. He is part of NIH."

Dunbar said, "No promises were made by him to us." But she and an NIH official at the private meeting said Zerhouni repeatedly urged the scientists to voice their specific complaints about the rules to the Department of Health and Human Services, via its Web site. HHS officials wrote the regulations along with officials of the Office of Government Ethics.

The senior-level scientists, representing many of the more than 5,000 researchers on the Bethesda campus, presented to Zerhouni the loose outlines of an alternative set of rules they are proposing. They have said their chief concern is that new prohibitions on outside consulting activities and restrictions on stock ownership in biomedical companies for all employees and their families will hurt the agency's ability to recruit and retain top scientists.

"Dr. Zerhouni urged people to exercise their right to comment," said Michael Gottesman, deputy director for intramural research at NIH. Although the new regulations are not expected to be relaxed in any major way, Gottesman said the comments from scientists "will be collected, and those that are valid will have some impact on the regulations."

The regulations, announced by Zerhouni this month, are subject to public comment for one year before they are deemed final.

Gottesman said the agency's investigation of some arrangements between its scientists and private industry have shown the need for "a much clearer set of ethical standards that are applied consistently."

The new rules were imposed after disclosures by the Los Angeles Times of conflicts of interest among agency scientists, some of whom had been collecting handsome sums as consultants to biotechnology or drug companies that stood to benefit from their recommendations to doctors.

Members of Congress investigating the agency contacted drug companies on their own and last year said they had found evidence of about 100 NIH employees who had worked for private companies without getting approval from the agency as rules required.

Earlier this week, an NIH official said Congress was mistaken in at least half of the cases members had identified as problematic. The employees in question had, in fact, sought permission for their activities.

Gottesman said yesterday that the cases referred by Congress were only a "small part of our concerns" over conflict of interest violations. He said a variety of problems have been identified through the agency's review, and "we're getting ready to try and evaluate what rules have been violated."

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