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Volume 5, #6The Scientist March 18, 1991 NIH GUIDELINES COULD FACE A VETO FROM WHITE HOUSE Author: Jeffrey Mervis Date: March 18, 1991 WASHINGTON--The Bush administration is unlikely to endorse any conflict of interest regulations that require clinical scientists to do anything more than disclose financial holdings in the companies whose products they are evaluating, according to White House officials. National Institutes of Health administrators have recently completed work on proposed guidelines that suggest a more stringent policy, and are awaiting approval from the Department of Health and Human Services to announce them publicly. But a report released last month by the biotechnology working group within the President's Council on Competitiveness makes clear that the administration sees no reason to go beyond simple disclosure. "Any blanket policy that goes beyond that would interfere with the proper functioning of the [federal] agency," explained Larry Lindsay, special assistant to the president for policy development and chairman of the working group, at a press briefing on the 19-page report. "We think that there's a balance that must be struck between the free flow of scientific information and fraud, and we are not going to tell [federal agencies or universities] to go any further than disclosure." Biomedical scientists who attended a workshop held last fall at NIH appeared to reach a consensus that disclosure is necessary but not sufficient to avoid the appearance of conflicts of interest, and that investigators should not have any direct financial links to companies whose products they are evaluating. In contrast, the report from the competitiveness council, which focuses on the scientific, regulatory, and financial components of a national biotechnology policy, says that any guidelines need only "require full financial disclosure of relationships between federally supported or employed scientists and commercial entities" for those involved in clinical trials. Lindsay, an economist who has been nominated to become a member of the Federal Reserve Board, said at the press briefing that each potential conflict of interest should be handled on a case-by-case basis by the appropriate federal agency or university where the scientist is employed. And he said he wasn't troubled by the group's failure to suggest specific criteria to be applied to determine whether a conflict exists that would disqualify the investigator from participating in a clinical trial. "I can't define it, but you know it when you see it," Lindsay said about how officials should detect any improper relationships. Asked if such a policy would send a message to investigators that nothing was off-limits, he replied, "If somebody discloses that they have $4 million at stake in a company whose products are involved in a Stage 3 clinical trial, then I suppose that their supervisor would take the appropriate action." Such an attitude suggests that the proposed NIH guidelines could face tough sledding when they are circulated among all the relevant agencies for comment. In fact, one member of the biotechnology working group says it is all but certain that the NIH proposal would be altered. "We have several opportunities to have input on these guidelines, and I'm sure that we'll make our views known," he says. "In fact, if there is disagreement between an agency and the Office of Management and Budget on a regulatory matter, we'll be asked to resolve the matter." The official also poured cold water on the hopes of NIH officials for a speedy approval of the proposed regulations. "I wouldn't hold my breath waiting for this to appear," he says. "It's going to be quite a while." --J.M.

NIH GUIDELINES COULD FACE A VETO FROM WHITE HOUSE

Mar 17, 1991

NIH GUIDELINES COULD FACE A VETO FROM WHITE HOUSE

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