Two members of Congress have asked National Institutes of Health Director Elias A. Zerhouni to delay for 90 days the implementation of controversial new rules that aim to minimize conflicts of interest among NIH scientists.
The request to place the pending rules on hold, faxed to Zerhouni late last week by Reps. Chris Van Hollen (D-Md.) and Thomas M. Davis III (R-Va.), echoes a similar bipartisan call by senators who recently told Zerhouni that the proposed rules, while well intentioned, "go overboard."
The letter arrived as yet another prominent NIH scientist let it be known he would resign: Arthur J. Atkinson Jr., a clinical pharmacologist who advises the director of the agency's newly expanded $635 million clinical research center. Atkinson, 67, had been considering retirement, but the looming rule changes precipitated his decision, sources said.
Among other changes, the new rules will require thousands of NIH employees and their spouses to divest all stock holdings in medical and biotechnology companies -- a move that many employees have said will place them in serious economic jeopardy, especially given the market's current slump.
"Our concern centers around the likelihood that the regulations in their current form will seriously erode the ability to recruit and retain scientists and medical professionals," wrote Davis and Van Hollen, whose Maryland district includes the NIH's Bethesda campus. "We urge you to immediately suspend the new regulations for 90 days until you have had time to fully assess the impact these regulations will have on NIH."
Zerhouni announced the new rules in February after learning that some NIH scientists had not properly disclosed consulting arrangements with drug and biotechnology companies. The changes were negotiated with the Department of Health and Human Services and the Office of Government Ethics.
The new rules ban all biomedical company consulting; severely restrict other paid and unpaid outside professional activities; and place strict limits on -- and, for thousands of employees, totally ban -- ownership of biomedical company stocks.
Last week, in an e-mail that drew a fresh round of groans from NIH scientists, some research leaders were advised to file formal "outside activity" requests for every scientific journal for which they occasionally review article submissions -- a routine, unpaid professional activity not previously subject to oversight.
The stock rules, which have been most divisive, were delayed for 90 days in early April by HHS Secretary Mike Leavitt and are now set to take effect July 3.
A handful of scientists, including one institute director, have already said they will depart because of the new rules. A Duke University researcher selected last fall to direct the agency's environmental science institute also recently told Zerhouni he was reconsidering that appointment, which was to begin this month, in light of the changes.
On April 6, the two ranking members of the Senate Appropriations Subcommittee on Labor, Health, Human Services and Education -- Sens. Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa) -- criticized Zerhouni about the changes.
"These are too onerous. They've got to be redone, and they've got to be redone soon before you start losing more people out of there," Harkin said to Zerhouni after relating a story of an NIH scientist who was leaving the agency because the divestiture rule would gut the nest egg she'd saved for her retirement and for her child's college education. "I mean, sometimes we tend to see a conflict of interest and we go overboard," Harkin said, "and I think we've gone overboard here."
Zerhouni has recently begun to emphasize in his comments that he is not personally responsible or even supportive of the divestiture rules, which are virtually the same as those in place for regulatory scientists at the Food and Drug Administration. "I'm as concerned as you are," he told Harkin at the hearing. "That part of the rule, frankly, is the one that I think we need to reevaluate very quickly."
In a brief interview yesterday, Zerhouni said the rule changes are still "a work in progress" and noted that "nobody has been asked to divest anything yet." He said Leavitt has been "very responsive and is very concerned that we end up with a fair and balanced rule that protects the public trust while not creating an undue burden on our employees."
Atkinson, the latest to depart from NIH, could not be reached for comment yesterday. In addition to his advisory duties at the clinical center, he has been serving as director of the clinical pharmacology research associate training program -- a role that won him plaudits from PhDs for his teaching abilities.
In 2000, he was named a "master" in clinical pharmacology by the American College of Physicians-American Society of Internal Medicine, "for his distinguished contributions to internal medicine." In 2003, he was the recipient of a distinguished service award from the American Society for Clinical Pharmacology and Therapeutics, of which he once served as president.
Staff researcher Meg Smith contributed to this report.