A top official at the National Institutes of Health yesterday detailed restrictions and disclosure requirements soon to be imposed on agency scientists who wish to consult for outside companies -- a response to a string of embarrassing revelations about lucrative contracts and other apparent conflicts of interest.
The new oversight system, which officials expect to be in place within six months, will ban anyone with even indirect authority over NIH grants from consulting for drug or biotechnology companies. It will also place limits on stock ownership and require that more details of approved outside activities be open to the public, said NIH Deputy Director Raynard S. Kington, who described the restrictions yesterday in an interview at the agency's Bethesda campus.
NIH official Raynard S. Kington:
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The changes come in the wake of a stinging eight-month congressional inquiry, an investigation by the federal Office of Government Ethics, an internal agency review, an analysis by a commission of independent experts, and -- perhaps most difficult for the venerable institution -- a slow but steady stream of disclosures about NIH scientists who had allegedly engaged in unethical collaborations with drug and biotech companies.
"What we have clearly concluded is that the system was not working," Kington said. And although some details are still in flux, Kington said, "we anticipate support" from the House Energy and Commerce subcommittee on oversight and investigations, whose painfully public probe has threatened the agency's reputation and damaged morale.
While some scientists have quietly grumbled about the anticipated restrictions, interviews indicated that many have grown to accept them as inevitable. Kington said he believes morale will pick up once the current period of "uncertainty" has passed.
But the agency is not necessarily out of the woods. NIH auditors are still combing through a list of more than 100 alleged instances in which scientists consulted for companies without telling their agency bosses, as has long been required.
In the most dramatic allegation publicized to date, drug giant Pfizer Inc. told the subcommittee that Trey Sunderland, a researcher at the National Institute of Mental Health, was paid $517,000 in consulting fees, honoraria and expense reimbursements over the past five years. Initial scans of NIH records indicated that the arrangement was not disclosed as required. Sunderland did not respond to phone messages left at his home and his office yesterday.
Unless the vast majority of such cases prove to be erroneous or attributable to minor and unintentional bookkeeping lapses, the subcommittee may cast a fresh net for more data and hold additional hearings, according to sources close to the investigation, who spoke on the condition that they not be named.
Other wild cards that could detour the agency's attempt at closure include ongoing investigations by the Department of Health and Human Services inspector general and the Government Accountability Office, and uncertainties about the investigative tack to be taken by Rep. Joe Barton (R-Tex.). Barton recently took over the congressional inquiry after Rep. James C. Greenwood (R-Pa.) recused himself because he is departing for a job in the biotech industry.
The new restrictions go well beyond those initially proposed by an outside committee created by NIH Director Elias A. Zerhouni months ago. Bruce Alberts, president of the National Academy of Sciences and co-chairman of that committee, said the stricter rules are appropriate given the recent revelations that many NIH scientists may have broken basic disclosure rules -- lapses uncovered by Greenwood's subcommittee through direct inquiries to drug companies.
"I'm outraged by that behavior, and I think we've all been betrayed," Alberts said. "We were all astounded."
Kington said about a dozen NIH auditors are looking into the records of the alleged violations. He predicted that the number of actual violations of ethics rules will be "small."
The new rules, which are not anticipated to require legislation, will flatly prohibit consulting for pharmaceutical or biotech companies by NIH employees with grantmaking powers or their supervisors, including institute, deputy, clinical and scientific directors. The goal, Kington said, is to ban outside company consulting for "anyone in a position to influence grants."
Lower-ranking scientists will be allowed to consult -- an activity that scientists say is important not only for the income but because of the prestige, intellectual stimulation and potential to speed the translation of research into cures. But they will have to limit those activities to a maximum of 400 hours per year (about eight hours per week), none of it during federal work time, Kington said. Total outside earnings can not exceed 25 percent of the person's base salary, and no more than half of that money can come from a single source.
No NIH employee will be able to accept stock or stock options as payment for outside work -- a decision based on the idea that stock ownership increases the potential for conflict of interest because it deepens a person's commitment to a company. More generally, some scientists will probably face restrictions on their ownership of stock in any biomedical company, Kington said.
All paid outside activities will be subject to at least one new level of review by an ethics advisory committee that Zerhouni has already created, with Kington serving as final arbiter. And many approved arrangements will be subject to random audits.
Paid speaking engagements will not be allowed at any institution that accepts NIH money, effectively eliminating every U.S. research university as a paying venue. But employees can be compensated for speaking at nonprofit organizations, editing textbooks, teaching other doctors or practicing medicine, and they can accept awards that appear on a soon-to-be-created list of "bona fide" awards.