NIH Ethics Problems More Widespread Than Previously Thought, Committee Finds Probe indicates dozens of scientists violated NIH rules on outside research WASHINGTON – An internal National Institutes of Health (NIH) review shows that dozens of scientists employed by the government have done work for pharmaceutical companies in violation of ethics requirements, indicating the scope of the agency’s ethical woes is greater than previously known. The findings come in response to a bipartisan letter the full committee chairman and ranking member - U.S. Reps. Joe Barton, R-Texas, and John Dingell, D-Mich., respectively - sent on March 10th to NIH Director Elias Zerhouni, concerning the status of NIH's internal review of possible unreported and undisclosed outside consulting agreements by NIH scientists. Committee leaders released the data today due to the compelling public interest. Last year the Committee staff identified a sample of 81 individual scientists hired by drug companies between 1999 and 2004 whose consulting agreements were not listed in NIH information provided to the committee. For example, the agreements reported by drug maker Pfizer, Inc., ranged from a minimum of $500 to a maximum of $517,000 over the five year period, and typically involved several thousand dollars per scientist. Once notified of the discrepancies between NIH and drug company records, the NIH launched an internal review of the 81 individual scientists. In a July 8th letter to the Committee, the NIH reported that of those 81 scientists, 37 were “cleared” and 44 were found to have violated one or more of three existing NIH rules: reporting the income on financial disclosure forms (where necessary), taking personal leave to do private work; and seeking prior approval for the arrangements. Thirty-six of the scientists are still employed at NIH and have been referred for possible disciplinary action. Nine of those thirty-six have also been referred to the HHS Office of Inspector General for investigation of possible criminal violations. Barton and Dingell commended Dr. Zerhouni for his ongoing efforts to adopt a more stringent ethics policy and they renewed calls for Congress to approve the first NIH reauthorization bill since 1993. “The NIH is home to many of the best and brightest scientific minds the world has to offer,” Barton said. “Congress has advanced their work to fight disease and save lives by doubling their budget in recent years. “But, along with financial backing, the NIH must have the support of the American people. These findings indicate that the ethical problems are more systemic and severe than previously known. They also demonstrate the need for NIH to issue the final ethics rule as soon as possible. I wholeheartedly support the work of Dr. Zerhouni to root out any conflicts of interest – real or apparent – while ensuring that scientists can collaborate with the private sector to advance public health. Dr. Zerhouni is to be commended for handling a difficult matter with great skill,” Barton said. “Dr. Zerhouni has provided extraordinary leadership at the NIH during an ethical crisis that was not of his making,” said Dingell. “He analyzed the mounting evidence of misconduct among a minority of NIH employees, determined the systemic basis of the problem, moved carefully to identify those involved, and revised the rules to uphold proper ethical standards.” Barton also underscored the need for Congress to reauthorize the NIH this year. “The Director should have the authority to direct and the flexibility to move dollars among institutes and centers to encourage promising research. We must recognize that expanding biomedical research in the 21st century requires the NIH to function efficiently,” he said. Since the Oversight and Investigations subcommittee launched its review in 2003, its actions include the following: The O&I subcommittee held three hearings in May and June of 2004 on NIH ethics concerns. The focus of these hearings was the unnoticed and often unregulated practice of NIH scientists engaging in paid, private consulting with drug and biotechnology companies. At the last hearing in June 2004, the subcommittee learned that a substantial number of NIH scientists engaged in drug company consulting without notice or approval by the NIH. One NIH scientist was reported to have received more than $517,000 in the last five years to advise a drug company on his area of expertise. NIH reported that the scientist failed to seek approval for these activities and did not report them on his financial disclosure reports. The subcommittee's investigation also featured the case of two government scientists who were working on a diagnostic test for cancer in official partnership with a private company. Hearings showed that they also had engaged in an outside consulting arrangement with yet another company, a competitor of the first. While these two scientists consulted with the second company, progress on the official partnership slowed to a standstill. ####