NIH keeps ban on scientists taking consulting fees from drugmakers

After review, agency announces rules to avoid conflicts of interest

August 26, 2005|By David Willman | David Willman,LOS ANGELES TIMES

WASHINGTON - After six months of review, the National Institutes of Health will retain its ban against agency scientists taking consulting fees from drug companies but will not require the scientists to sell all their industry stock holdings, the agency announced yesterday.

Scientists at NIH also will now be allowed to accept fees for delivering lectures to some groups and for serving on data-safety-monitoring boards, so long as any financial support from the companies is first paid to an intermediary organization, such as a college or a hospital, as an "unrestricted grant." The data-monitoring boards are intended to protect patients who are administered experimental drugs or other treatments in clinical studies.

Millions in fees paid

The revised ethics rules were described by NIH Director Elias A. Zerhouni, who in February announced interim restrictions after learning about millions of dollars in fees and stock options paid by the companies to senior agency scientists.

The revisions also were approved by the U.S. Office of Government Ethics. Zerhouni, alluding to criticisms and other comments received in recent months from at least 1,300 NIH employees, said the restrictions that he unveiled in February "may have been calibrated a little too stringently." Still, Zerhouni said that the final rules, which go into effect next week, remain rigorous.

"These rules are the most restrictive of any rules we know about in the world of biomedical research," Zerhouni said in a 50-minute conference call with reporters. "Many employees asked that we loosen the ban on paid outside consulting. We elected not to. ... I think we should have a total ban." The consulting ban has been in effect since February.

Zerhouni also said in a prepared statement:

"We have a balanced set of conflict-of-interest rules that protect the integrity of NIH and its ability to provide the American public with an unbiased and trusted source of scientific and health information, while preserving our ability to recruit and retain world-class scientists and staff."

Recent reviews overseen by Zerhouni's staff and by the inspector general of the Department of Health and Human Services have reflected the severity of conflicts of interest at the NIH:

In July, Zerhouni told members of Congress that 44 of a sample of 81 scientists had violated the agency's then-existing standards. Some of the scientists consulted for companies without seeking required approval, consulted in areas that overlapped their government duties, or "consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation," Zerhouni said.

More recently, the inspector general's office reported that, in 81 percent of the cases it reviewed, NIH officials had approved scientists' requests to moonlight for the drug companies and other outside organizations without gathering enough information to know whether the arrangements posed conflicts of interest.

Full details of the rules will be published next week in the Federal Register.

200 must sell stock

As described by Zerhouni, the revised rules require only about 200 of the most senior NIH officials to sell stock holdings valued at $15,000 or more in any biomedical company.

Howard A. Young, a microbiologist and section chief at the National Cancer Institute, said yesterday by e-mail that he was "encouraged by the changes."

Young, who in recent years accepted stock options from a viral-research firm as allowed by the NIH's earlier rules, now serves on the executive committee of the Assembly of Scientists, a group of NIH employees that has fought to overturn the more restrictive rules.

On March 9, the Assembly of Scientists proposed alternative ethics rules that would have allowed most government scientists, including laboratory and branch chiefs, to resume paid consulting for drug or biotechnology companies.

Dr. Sidney M. Wolfe of Public Citizen, a consumer-advocacy group, said yesterday that the newly announced rules open loopholes that might subvert the ban on consulting fees.

Zerhouni has said that the revisions are needed to help attract and retain quality scientists. Yesterday he said the revisions would allow "better academic interactions."

The Los Angeles Times is a Tribune Publishing newspaper.

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