CONFLICT OF INTEREST ALLEGATIONS ADDRESSED AT THE NATIONAL INSTITUTES OF HEALTH

January 15, 2004

On December 7, 2003, the Los Angeles Times reported that scientists, who at the time were ranking officials at the National Institutes of Health (NIH), collected consulting fees and stock options from biomedical companies. These arrangements were reportedly kept secret from the public. NIH Director Elias Zerhouni then ordered an immediate review of every outside consulting relationship entered into by an NIH employee within the last five years to confirm that all rules and regulations were followed and that the activities were in the best interest of the public.

NIH's first comments came two days later. John Burklow, associate director for communications at NIH, announced the NIH position. He said, "The NIH's first priority is to uphold its high standards for patient safety, ethical practices and scientific excellence. We are concerned about the recent allegations about how NIH manages conflicts of interest. NIH takes this issue very seriously. Even though we want our scientists to stay involved in the science and health community beyond NIH and share their knowledge broadly, we recognize there must be stringent standards and transparent policies for managing potential conflicts of interest. Full disclosure is essential, and we must continue to protect the patients' safety and the public's interest while advancing science to address important health problems. We also are committed to doing everything possible to avoid even the perception of a conflict."

In response to the Times' findings, Dr. Ruth L. Kirschstein, Senior Advisor to the Director of NIH, said she would "think about" whether administrators should learn more about a company's ties to the NIH before approving the consulting arrangements. "Systems can always be tightened up," said Kirschstein. "And perhaps, based on this, we will do so."

These same LA Times articles have prompted House Energy and Commerce Committee Chairman Billy Tauzin (R-LA) and Oversight and Investigation Subcommittee Chair James Greenwood (R-PA) to order NIH to turn over nine points of information or sets of documents relating to consulting agreements between NIH employees and drug companies and other outside activities. Hill sources say Sen. Arlen Specter (R-PA), chair of the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee is likely to hold at least one hearing on consulting agreements between NIH employees and biomedical firms some time in January.

Related Issues

The financial conflict of interest threshold for extramural researchers serving on NIH scientific review panels is set at $10,000 under a final rule published in the Federal Register on January 5, 2004 by the agency. The rule, which takes effect February 4, 2004, also codifies recommendations developed in a public process during 1996 and published in the NIH Guide for Grants and Contracts on June 27, 1997. The main reason for the January 5th posting, according to NIH, is to reinforce the fact that non-federal members of the regular study sections and special emphasis panels who provide scientific peer review for grant and contract applications are not appointed as "Special Government Employees," and, therefore, are not subject to the same conflict of interest rules as federal employees.

The $10,000 financial threshold involves all sources of financial benefit, including honoraria, fees and stock holdings, both currently held and accruing over a year long period. A conflicted reviewer will not be able to participate in a review unless the NIH director deems the reviewer's relationship is with a component of a large organization of which an unrelated component is seeking funds or that his or her relationship is with a component of a large organization of which an unrelated component is seeking funds. This threshold will be reevaluated by the NIH director periodically and adjusted in response to inflation after public notice and comment.