Agency under siege

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    Conflicts-of-interest at the US National Institutes of Health justify the agency's ethics crackdown.

    The latest information to emerge from an investigation by Congress into potentially unethical links between outside companies and researchers at the US National Institutes of Health (NIH) isn't particularly encouraging.

    At the request of Congress, the biomedical research agency has been looking into the activities of 81 researchers whose names appeared on lists of consultants provided by biotechnology and pharmaceutical companies, but who hadn't declared their interest to the NIH.

    Earlier this month, the NIH's director, Elias Zerhouni, told Joe Barton (Republican, Texas), chair of the House Committee on Energy and Commerce, that about half of the 81 were found to be in breach of the ethics rules that were in force at the time of their consultancy work. Most of the infractions were minor, but eight have been referred to the health department's inspector-general for further investigation.

    The steady drip of this sort of information into the public domain since December 2003, when the Los Angeles Times first reported a few egregious examples of conflict-of-interest at the NIH, is taking its toll on the public reputations of the agency and its staff.

    Zerhouni has moved swiftly to confront the issue. His clampdown on consultancy arrangements and on the holding of investments among thousands of NIH employees has caused much wailing and gnashing of teeth at the agency's main campus in Bethesda, Maryland. But the rules are being implemented with extended deadlines to allow people sufficient time to alter their financial arrangements.

    The clampdown leaves the NIH's intramural staff in a bind, unable to collaborate closely with the biotechnology industry at a time when such interactions have become almost routine for researchers in some sub-disciplines. At some stage, collaboration between researchers and industry must be redeveloped on a basis that will be consistent with the public's reasonable expectations of publicly funded researchers.

    Details of the latest batch of infractions haven't been released, but many of them are probably minor, such as meeting an off-site collaborator without requesting a half-day's vacation. Congress is angry because the interactions weren't properly reported under the NIH's previous ethics regime. In some cases, that happened not out of any nefarious intent, but because the NIH is a large and diffuse federation of centres and institutes.

    Now Barton's committee wants to centralize the agency. A draft reauthorization bill for the agency would give far more authority to the director's office, and support additional and extensive monitoring and reporting functions there, as well as giving the director more power to enforce cooperation between institutes and centres.

    Some reform is due, but this measure goes too far. The NIH needs to modernize, but shouldn't overthrow the autonomy of centres and institutes that has served it so well in the past.

    The eventual solution should involve a mixture of self-awareness and common sense. Researchers need to recognize that the conflict-of-interest issue can no longer be brushed off as something for politicians and the press to worry about. The cases that have already been exposed at the NIH amply demonstrate how germane the matter is to biomedical research.

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    Agency under siege. Nature 436, 304 (2005) doi:10.1038/436304a

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