NIH Improperly Implicated Many Scientists for Alleged Conflicts of Interests in Internal Investigation

A "detailed NIH review" has found that the agency improperly implicated more than half and possibly as many as 80% of about 100 scientists alleged to have violated conflict-of-interest guidelines as part of a previous internal investigation that prompted NIH Director Elias Zerhouni last month to implement new "severe restrictions" on agency employees, the Washington Post reports (Weiss, Washington Post, 2/23).

Zerhouni in January 2004 directed an NIH Blue Ribbon Committee on Conflict of Interest Policies to investigate the allegations. On Feb. 1, he announced revised ethics guidelines that restricted the ability of NIH employees to enter outside consulting agreements with pharmaceutical companies, hospitals, health insurers and health care providers. The guidelines also mandated that about 6,000 top NIH employees cannot hold stock in pharmaceutical or biotech companies and required current stockholders in the group to sell their shares.

The move followed an investigation by the House Energy and Commerce Subcommittee on Oversight and Investigations into hundreds of consulting payments from pharmaceutical and biotechnology companies to a number of NIH employees (California Healthline, 2/1).

The NIH review examined about 100 scientists with whom pharmaceutical companies said they had consulting agreements that were allegedly unknown to agency officials.

According to the review, some of the improper allegations resulted because of the time period examined. The NIH internal investigation examined consulting agreements through Dec. 31, 2003, but the pharmaceutical companies also provided the names of scientists with whom they had agreements in 2004. The review found that most of the scientists examined had obtained NIH approval for the consulting agreements.

In addition, NIH in some cases had coded some of the consulting agreements as other activities, and in other cases the individuals with whom pharmaceutical companies said they had agreements had the same names as NIH scientists but were not agency employees, according to the review.

The "unexpected finding" of the NIH review has "undermined the rationale" behind the revised ethics guidelines for agency employees and has prompted a "simmering backlash" among some who maintain that Zerhouni should have sought "a better measure of the problem before succumbing to pressure from Congress and the government ethics office," the Post reports.

NIH Deputy Director Raynard Kington, chief ethics officer for the agency, said that the number of ethics violations "is just one dimension of this problem," adding, "There is also the severity of the problems." Kington said that Zerhouni implemented the revised ethics guidelines based on a number of reviews, adding, "We came to the conclusion the system was not at a point where we could carefully monitor and manage the types of conflict we can identify."

Kington said that in the future NIH might allow certain exceptions to the guidelines.

Some NIH employees "are gearing up for a fight" in court and have consulted with the American Civil Liberties Union about allegations that the revised ethics guidelines violated their privacy and free speech rights, the Post reports. In addition, the Assembly of Scientists at NIH has considered other litigation to exempt from the guidelines agency employees who are not involved in funding decisions.

According to the Post, the guidelines "have already begun to discourage medical residents and fellows" from positions at NIH. Abner Notkins, chief of experimental medicine at the National Institute of Dental and Craniofacial Research, said, "All of us are in favor of strong regulations to avoid conflicts of interest," but the guidelines "go to an extreme. We're hearing from a number of people that they want to leave. And a number of people who were about to start here have said they are now thinking they will not come" (Weiss, Washington Post, 2/23).

The "excessively permissive" ethical guidelines previously in place at NIH, as well as "their excessively lax enforcement, justified an overhaul," but the revised guidelines "go too far," a Post editorial states. The guidelines "threaten to harm the ability of the institutes to attract and retain top scientists without providing significant extra safeguards against conflicts of interest," the editorial states, adding that a "well-balanced set of restrictions" previously proposed by Zerhouni would have proved more effective.

According to the editorial, although NIH scientists "shouldn't have any investments related to their research," an "across-the-board ban ... goes too far." The editorial states that "in light of today's report," an HHS review of the guidelines scheduled for some time in the next year "should come sooner rather than later" (Washington Post, 2/23).