Scrutiny of Moonlighting Scientists Criticized

Ethics officials at the National Institutes of Health often approved senior scientists’ requests to moonlight for drug companies and other outside organizations without gathering adequate documentation to help judge whether the arrangements posed conflicts of interest, federal inspectors have found.

In 81% of the recent outside arrangements reviewed by the inspector general of the U.S. Department of Health and Human Services, ethics officials were found to have approved the deals on the basis of limited information. This and other findings are included in a report by the inspector general that is to be made public today.

“In no instance was the documentation we reviewed adequate for us to make a definitive determination regarding whether an activity was appropriate,” the report said. “Inadequate documentation for outside activities can, intentionally or unintentionally, hide potential violations.”

The report found that information submitted by the scientists to NIH ethics officials “included insufficient detail regarding the nature of the outside activities, the nature of employees’ official job duties, the differences between the outside activities and their official job duties, the outside organizations, and any NIH funding or partnerships with the outside organizations.”

The advance descriptions of the outside positions that NIH scientists proposed to take “were too general to demonstrate that employees’ official duties would not overlap,” the report said.

The inspector general’s reviewers “could not determine the appropriateness of eight activities, and they also determined that two of the activities appeared to violate regulations.”

The report also said, “It is quite possible that, due to the approach taken in this review, we have underestimated the number of activities that should not have been approved.”

A copy of the 72-page report was obtained Thursday by the Los Angeles Times.

The review marks another condemnation of the NIH’s recent policies governing moonlighting by agency scientists. In July 2004, the chief of the Office of Government Ethics concluded that the NIH had a “permissive culture” toward conflicts of interest. The lax policies were largely the result of an agencywide lifting of controls in late 1995 by the director of the NIH at the time, Dr. Harold E. Varmus.

Varmus’ successor, Dr. Elias A. Zerhouni, announced sweeping restrictions in February, citing reports by The Times in 2003 and 2004 that exposed the payments by pharmaceutical and biotechnology companies of millions of dollars in consulting fees and stock to NIH scientists.

Zerhouni -- prodded by the Department of Health and Human Services, the Office of Government Ethics and congressional leaders from both parties -- agreed to prohibit NIH employees from accepting any further payments from pharmaceutical or biotechnology companies.

A group of NIH scientists is actively resisting the tougher ethics rules, which include a provision that would force employees to divest their stock in biomedical companies. They have hired a law and lobbying firm and have called for Zerhouni to relax the ban on consulting for drug companies and to rescind the stock-divestiture provision, which has not yet been implemented.

Zerhouni has said that he is weighing the criticisms and would consider easing the restrictions if he concluded that they were inhibiting the NIH’s ability to retain or recruit qualified scientists.

In a written reply to the inspector general, Zerhouni cited the corrective actions that had been taken recently. He said that he generally agreed with the inspector general’s findings, conclusions and recommendations.

The inspector general’s review focused on the activities from 2001 through 2003 of 174 senior scientists, a fraction of the agency’s more than 5,000 researchers.

Of the 174 whose paperwork was reviewed, 69 requested and received approvals to work with outside organizations. The review focused only on those scientists who, as of January 2004, were required to file a publicly accessible financial disclosure report.

Among those covered by the review were directors, deputy directors and scientific directors of the NIH’s research institutes. The terms of the inspector general’s review excluded many other influential scientists, including laboratory and branch chiefs.

The inspector general found that among the 174 scientists reviewed, NIH ethics officials approved 319 of 355 requested outside engagements -- 90% of the total. Of those, 45 involved consulting or scientific-advisory arrangements with biomedical companies.

Other outside activities were described by the report as “teaching/lecturing,” speaking, and serving on nonscientific boards or committees.

Representatives of the inspector general acknowledged Thursday in briefings with congressional staff members that their review did not survey all of the NIH scientists who had worked for biomedical companies. Last year, the House Energy and Commerce Committee contacted 20 biomedical companies and learned that those firms alone had employed 81 NIH scientists who had failed to get required permission or to disclose the income.

At a hearing on June 22, 2004, the committee’s top Democrat, Rep. John D. Dingell of Michigan, chided the inspector general for conducting what he termed noninvestigative “desk audits.” Dingell was not available to comment Thursday, according to an aide.

A spokeswoman for Daniel R. Levinson, Health and Human Services’ inspector general, declined to comment.