NIH director defends moves at ‘high church’ of research

Amid criticism from his own employees, congressional overseers and members of the scientific community, National Institutes of Health (NIH) Director Elias Zerhouni strongly defended his nearly three-year tenure in an interview with The Hill yesterday.

The NIH has been subjected to intense scrutiny because of a series of controversial policies implemented by Zerhouni and a historic federal investment between fiscal years 1998 and 2003 that doubled the agency’s budget from $13.65 billion to $27.17 billion.

“I don’t think there is any other better way to lead an agency” than to address problems “head on,” said the Algerian-born former Johns Hopkins University professor.

In the past year, the NIH has been buffeted by bad publicity surrounding several of Zerhouni’s policies.

A plan to permit free public access to the results of federally funded research has been decried by some as too weak. A landmark trial of an HIV/AIDS drug in Uganda has faced numerous questions about its results and the conduct of its researchers and their superiors at the NIH. Researchers have complained that the agency is moving from its focus on basic research as its funding has leveled out.

Intense resistance met a plan launched in February designed to minimize financial conflicts of interest among NIH employees.

Pressed by congressional investigators, the NIH determined that its previous rules were permitting agency employees to enter into financial agreements with private firms that could have created conflicts of interest.

These represented “a major problem” that “shouldn’t be belittled,” said Zerhouni.

Rep. Chris Van Hollen (D-Md.), whose district includes the NIH campus, has received numerous complaints from agency employees, one staffer said. “The overwhelming majority … are very concerned about the effect of the new rules” on NIH’s ability to hire and keep top scientists, the staffer said.

Van Hollen is drafting a letter with other members urging Zerhouni to modify the policy.
Zerhouni insisted that the rules are necessary. “No matter what, the public trust must not be jeopardized,” he said. “If we lose the public trust, we lose research.”

“That trust is a fragile thing,” agreed David Korn, a senior vice president of the Association of American Medical Colleges. Korn described Zerhouni’s handling of the ethics issue as “measured [and] nuanced.”

The NIH ethics policy also enjoys the strong support of House Energy and Commerce Committee Chairman Joe Barton (R-Texas) and ranking member John Dingell (D-Mich.).

Zerhouni laid the blame for the ethical problems at the feet of policies put in place by his predecessor, Harold Varmus, who served from November 1993 to December 1999.

“NIH suffered from, in my view, rules that were a little lax,” as well as a culture that was resistant to restraints on outside activities, Zerhouni said. “The profound, deleterious impact” of those policies surprised Zerhouni when he took office, he said.

Pointing also to the lengthy gap between Varmus’s departure and his nomination, Zerhouni said the agency lacked strategic direction.

Indirectly referring to Varmus, Zerhouni said the NIH was hampered by “diffuse,” “ineffective” and “inefficient” decisionmaking for 10 years. The agency underwent “growth without a lot of coordination,” he said.

Varmus could not be immediately reached for comment.

Some observers concurred that many of the NIH’s problems have been simmering for some time. “A little bit of digging has uncovered a lot of concerns,” said Kei Koizumi, who tracks research funding for the American Association for the Advancement of Science.

The doubling of the agency’s budget brought along new pitfalls, Zerhouni indicated. “The agency, having experienced a period of growth, has increased in complexity,” he said.

Trying to redirect money that was allocated during the interregnum has presented a particularly thorny problem, said Zerhouni.

Koizumi said, “With the vastly increased resources, there’s been this greater desire … to see the results.” He pointed to increased spending on bioterrorism-related research as an example.

Barton intends to undertake a sweeping reauthorization of the agency this year that could centralize the setting of priorities in the director’s office. Zerhouni has put in place a number of policies designed to leverage the agency’s resources across its 27 institutes and centers.

Zerhouni said that changes in the NIH’s approach represent a “rebalancing” of the research and development process toward research that translates basic discovery into new applications.

Calling the agency “the high church” of research, Korn said people have higher expectations of the NIH than other institutions. A spokesman for the Federation of American Societies for Experimental Biology said, “People’s concern about NIH has been raised as a result of the good things [it has] done.”