New ethics rules at NIH

Top scientists now required to reveal financial ties to companies dealing with agency

By | March 4, 2004

Senior officials at the National Institutes of Health (NIH) must now file public financial disclosure forms revealing their incomes as well as any stock, fees, and payments from pharmaceutical and biotechnology companies that have dealings with the agency. The policy change was announced Monday (March 1) at the first meeting of NIH's Blue Ribbon Panel on Conflict of Interest Policies. Previously, NIH officials had been required to disclose this information, but the reports remained confidential.

Edgar M. Swindell, associate general counsel for ethics at the Department of Health and Human Services, told the panel that all NIH directors, deputy directors, scientific directors, and clinical directors are now required to file public disclosure forms, known as SF 278s, rather than the confidential OGE 450s. The change, which was requested by NIH director Elias A. Zerhouni and issued February 6, affects 66 senior officials. "An evaluation is underway to identify other positions with equivalent authority and responsibilities who may meet the statutory test" for public filing, Swindell said. "The assistance of the panel in that endeavor will be welcome."

Zerhouni instructed the 10-member conflict of interest panel to review the NIH's rules and procedures regarding financial conflicts of interest and to make recommendations within 60 days. While telling the panel to "leave no stone unturned," Zerhouni also cautioned against making "one-size-fits-all" or "blanket" suggestions. The panel is co-chaired by Bruce Alberts, president of the National Academy of Sciences, and Norman R. Augustine, chairman of the executive committee of Lockheed Martin. NIH has created a Web site where it will post conflict of interest resources and information.

An examination of the NIH's policies was triggered after the Los Angeles Times reported in December 2003 that several high-level NIH scientists and officials have received more than $2.5 million in consulting fees and stock options from drug companies, including some doing business with the agency. In January, Zerhouni restructured NIH's system for implementing ethics regulations, suspended approval of all new consulting deals, and appointed the ethics task force. The consulting deals have become the topic of a Senate hearing and other inquiries on Capitol Hill. Zerhouni and other senior NIH officials have denied any impropriety.

Swindell invited the ethics panel to also consider the broader issues involved. "I would ask the panel to evaluate whether NIH employees should hold 'drug or biotech' stocks or be allowed to consult with companies in these industries," he said. A related issue is whether NIH employees should be allowed to accept awards and lecture fees from universities or institutes that receive research grants or do business with the NIH, he said.

"Keep in mind that a strict resolution of the question likely would preclude the NIH director from receiving the Nobel Prize in physiology or medicine because the awarding entity, the Karolinska Institute, collaborates in research matters with the NIH," Swindell added. But practically speaking, if the consulting process were stopped, "what effect would such a prohibition have on recruitment and retention of eminent scientists? If not a total ban for all employees, should senior employees, at least, be subject to such a ban?" he asked.

Officials and representatives of professional research societies have argued that NIH needs to be competitive if it is to recruit talented people. "We have to be cautious not to diminish NIH's ability to attract and retain the best scientific leaders in medical research," NIH spokesman John Burklow told The Scientist. "NIH must do what it can to enable top scientists to consult," said Robert D. Wells, president of the Federation of American Societies for Experimental Biology. "But, of course, it must be done with the appropriate guidelines and rules and regulations."

Two House Democrats last week (February 26) asked 10 major pharmaceutical companies to reveal how much they have paid in stock options, consulting fees, and other financial arrangements to NIH scientists since 1995. The letters were sent by Rep. Henry A. Waxman (D-Calif.), ranking minority member of the House Committee on Government Reform, and Sherrod Brown (D-Ohio), ranking minority member of the Energy and Commerce Subcommittee on Health.

The companies, including Allergan, Bristol-Myers Squibb, and Merck, were also asked to name the NIH employees and describe "the exact nature of the financial arrangement, the duties performed by the scientists, [and] the duration and time frame of the financial arrangement." The companies were asked to respond by March 11.

Waxman and Brown have also asked the General Accounting Office, the investigative arm of Congress, to look into the consulting arrangements. The Department of Health and Human Services inspector general also has opened an inquiry into NIH's conflict of interest policies.

Rep. James Greenwood (R-Penn.), chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, has questioned NIH's use of consulting fees to pay senior scientists and institute directors more than they otherwise would be entitled to earn. Greenwood's subcommittee plans to hold public hearings on this and the consulting contracts later this year.

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