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NIH Is Pressured to Bar Drug Industry Stipends

August 06, 2004|David Willman | Times Staff Writer

WASHINGTON — The National Institutes of Health's recent proposals for cleaning up conflicts of interest do not reach far enough, the nation's chief ethics officer has concluded, putting new pressure on the agency to ban all drug industry payments to its scientists.

In a 20-page report, the head of the Office of Government Ethics said that NIH was beset with a "permissive culture" and that firm, across-the-board restrictions were needed to restore public confidence in the nation's preeminent medical-research agency. A copy of the report, dated July 26, was obtained by the Los Angeles Times.

The report is a setback for the director of NIH, Dr. Elias A. Zerhouni, who in June proposed banning agency directors and certain other top officials from taking industry payments while allowing most NIH scientists to continue to accept consulting deals.

The acceptance of drug company consulting fees by federal researchers at the NIH has raised questions about the ability of the agency to maintain the independence in its scientific inquiries.

Zerhouni's staff has conferred over the last six weeks with the Office of Government Ethics regarding his proposals, officials said. The office must approve or disapprove any new conflict-of-interest regulations.

The head of the Office of Government Ethics, Marilyn L. Glynn, said in the report that without tougher standards, NIH "could give the appearance that some level of misuse of office is tolerable."

The time had passed, she said, for trusting NIH leaders to make appropriate changes.

"Ceding authority to NIH officials to direct the NIH ethics program might be a viable arrangement if NIH had a history of adequately addressing the types of problems confronting NIH at this time," Glynn said. "Unfortunately, the opposite is true.... NIH has had a permissive culture on matters relating to outside compensation for more than a decade."

Glynn said that recent sampling by her staff had found a "significant number" of outside arrangements involving NIH employees which "were not approved in a timely manner" by NIH management. Many other outside arrangements, she said, "appeared not to have been approved at all."

The report was addressed to an attorney with the Department of Health and Human Services, and was also sent to Zerhouni's office. A spokesman at NIH, John Burklow, said agency officials contended that "the strong policies we are developing will address the problems identified and we look forward to working with OGE."

In the report, Glynn urged Zerhouni and other administration officials to quickly "develop and propose new supplemental standards of conduct specifically to address the kinds of consulting activities that have raised recent concerns."

Glynn cited paid consulting arrangements between drug companies and NIH scientists, including deals that raised "the appearance of the use of public office for private gain." Glynn asked Zerhouni to respond by late September to her office's report. She said a follow-up review would be conducted within the next six months.

On June 22, Zerhouni had described a broad package of reforms during testimony to the House Energy and Commerce subcommittee on oversight and investigations. The panel opened its investigation of the company consulting deals with NIH employees in response to a December 2003 report in The Times which documented hundreds of consulting deals, totaling millions of dollars, between industry and NIH scientists.

One top NIH official cited in the article, Dr. Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, participated in several agency discussions regarding the conduct of a clinical study that tested a drug provided by the U.S. subsidiary of a company for which he was a paid consultant. The article also reported that Dr. John I. Gallin, director of the NIH Clinical Center -- the nation's largest research center for medical research on humans -- failed for two years to disclose ownership of as much as $50,000 worth of stock in a company that had collaborated on clinical studies with the NIH.

In his June 22 testimony, Zerhouni said he would seek a "total ban" on paid consulting with pharmaceutical or biotechnology companies for the directors, deputy directors, scientific directors and clinical-research directors of all of NIH's 27 research institutes and centers. However, he would allow thousands of other NIH employees -- including the chiefs of laboratories -- to remain eligible to accept industry consulting payments.

Glynn questioned whether the potential for conflicts of interest among those allowed to continue consulting "may be at least as great, if not greater" than those who would be banned from such deals under Zerhouni's formula.

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