NIH needs 'drastic changes'

WASHINGTON, DC—National Institutes of Health (NIH) director Elias A. Zerhouni yesterday (June 22) told Congress that "drastic changes" are needed to effect a "major reform" of the NIH's ethics rules, practices, and procedures. "I believe we have been lax," Zerhouni told members of the House Energy and Commerce Subcommittee on Oversight and Investigations. "I regret that the reputation of NIH has been challenged over ethics concerns and that the conduct of individual scientists who have devoted their lives to battling disease and easing the suffering of millions of patients has been questioned."While stopping short of admitting wrongdoing on the part of NIH and its employees, Zerhouni said, "In retrospect, there was not a sufficient safeguard against the perception of conflict of interest."Yesterday's hearing was the third in a series triggered by reports that several high-level NIH scientists and officials had received more than $2.5 million in consulting fees and stock options from pharmaceutical and biotech companies over the past 10 years. The subcommittee has also examined consulting deals at the Food and Drug Administration. "It is unpleasant to face the harsh truth about the results of the apparently lax ethics culture at NIH," said Rep. Joe Barton (R-Tex.), chairman of the Energy and Commerce Committee, "but it is a process that we must go through to ensure that the NIH will continue to be the world's premier medical institution."Zerhouni, accompanied by Alex Azar, general counsel for the Department of Health and Human Services (DHHS), NIH's parent agency, yesterday outlined a series of proposed corrective measures. While many of these had been recommended last month by a special NIH "blue ribbon panel," others, even more stringent, were recently developed in consultation with DHHS. Zerhouni noted that implementing many of these recommendations would require changes to government ethics regulations and, in some cases, new legislation. Among Zerhouni's recommendations were that all senior NIH employees and all employees involved in extramural funding decisions would be prohibited from any paid consulting with industry. Consulting would be capped at 400 hours per year and compensation could not exceed 25% of the base salary (the blue ribbon panel had recommended a 50% salary limit). Payment in the form of stock or stock options would be prohibited. Any employee filing a financial disclosure form would be prohibited from owning stock in any individual biotech and drug company. Other employees would be limited to $5000 in stock holdings, and all would be prohibited from serving on corporate boards of pharmaceutical or biotech companies.Congressional reaction was mixed. "With what you have proposed, and what we may have to do legislatively, NIH will end up with the highest ethical standards of any agency in the federal government," said subcommittee chairman James C. Greenwood (R-Pa.).But Rep. Diana DeGette (D-Colo.) dissented. "In the absence of a bright-line test, it will be difficult to prevent abuses of the past," she said. Azar said that as a lawyer, he too preferred bright-line rules, such as "complete prohibitions, which are easy to administer and interpret." But he noted that even the subcommittee has experienced "difficulty in applying complicated rules to real-world scenarios."Despite general praise for Zerhouni's recommendations, Greenwood was critical of what he called ongoing ethics and financial problems at the NIH. He noted "a significant number of troubling discrepancies" between NIH's files and consulting records obtained from drug companies.For example, NIH had no records of 100 consulting contracts out of a sample of 264 such arrangements. Greenwood cited as an example Trey Sunderland, chief of geriatric psychiatry at the National Institute of Mental Health (NIMH), who Greenwood said had been paid more than $517,000 in consulting fees, honoraria, and expense reimbursements since 1999. NIH had no outside activity request forms for these activities, and Sunderland's financial disclosure reports did not include these payments, he said.Zerhouni said he had "grave concerns" about the matter and promised to investigate. Sunderland did not return telephone and E-mail requests for comment yesterday from The Scientist. A colleague at NIMH said Sunderland would not be in the office this week.Greenwood also noted particular objection to the NIH's past practice of using so-called Title 42 payments, intended for consultants, to boost the pay of full-time NIH employees by nearly $5 million since 1999. "The gaming must end," he said. "I am prepared to support a straightforward approach to providing good salaries to NIH employees, worthy of the crown jewel of the US government."

NIH needs 'drastic changes'

Zerhouni outlines 'major reform' to curtail conflicts of interest following months of scrutiny

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