Medical Device Daily Washington Writer

WASHINGTON — New ethics guidelines rolled out by the leadership of the National Institutes of Health (NIH; Bethesda, Maryland), aimed at repairing a damaged public image, angered employees and could create internal problems for the organization.

“I think that anybody who had any kind of clear ethical foresight could easily have foreseen the effect of this,“ said Rushworth Kidder, founder and president of the Institute for Global Ethics (Camden, Maine). “My worry is that the effect will be to decimate the ranks of the NIH at the very highest level.“

Namely, concerns quickly arose that the new rules could adversely affect employee retention and recruitment.

Over the past year, the NIH has worked to address perceived conflict-of-interest issues that stem from the outside consulting activities of its employees who have reaped financial benefits from the biotech and pharmaceutical industries. During testimony before a congressional committee last summer, NIH Director Elias Zerhouni said, “drastic changes are needed.“

As a result, the new regulation focuses on outside consulting with pharmaceutical and biotechnology companies, financial holdings and awards for all of the agency's employees. “This regulation is critical to restoring the integrity of the NIH and the public trust,“ Zerhouni said in a memo distributed last week to all NIH employees, “and I fully support it.“

The guidelines prohibit staffers from engaging in certain outside employment with pharmaceutical and biotechnology companies, supported research institutions, healthcare providers and insurers and related trade, professional or similar associations. Stock holdings in biotechnology and pharmaceutical companies are not allowed for employees who are required to file public and confidential financial disclosure reports, and are restricted for other staff.

That latter provision, in particular, drew the ire of employees during a staff-only meeting held last week at NIH headquarters. According to an account in The Washington Post, a number of staff members voiced their displeasure over the new equity divestment rules. Kidder said such irritation showed that the newly drafted policy overstepped its intent.

“I don't see how I, as a taxpayer, am benefited by insisting that secretaries at the NIH can't own stock in certain companies,“ Kidder told Medical Device Daily's sister publication, BioWorld Today. “I don't think that's taking us where we want to go. It needs more finesse, more nuance and needs to be more clearly targeted.“

Further addressing the stock divestiture issue, he noted that current market conditions might not be optimal. Officials at the NIH did not respond to attempts to seek their comment, but in Zerhouni's memo, he said that staffers will have several months to sell the prohibited holdings, “during which time you may seek an exceptional circumstances exception to this provision or apply for a special tax document that will allow for the deferral of any capital gains tax owed as a result of the sale of the stock.“

The regulation was developed in concert with the Department of Health and Human Services (HHS) and the Office of Government Ethics, a federal agency devoted to executive branch-wide ethics standards. HHS, the agency under which the NIH falls, intends to further evaluate provisions regarding outside activities and financial holdings within the next year and could revise them.

But Kidder again questioned such a tactic. “I think the notion of putting [the ethics guidelines] in a trial form is actually a failure of due diligence on their part, a failure to think hard about the consequences,“ he said. “You could say, 'We had to try it and see.' Well, we don't run NASA [the National Aeronautics and Space Administration] that way, saying, 'Let's just see whether this thing blows up while it's in space, and if it does, we'll go back to the drawing board.'“

But he does not question the NIH's motive behind drafting the new policy. Along those lines, Kidder does not doubt Zerhouni's assertion on the importance of trust, as Zerhouni himself told the congressional committee last summer.

“Our public health mission is too important to have it undermined by any real or perceived conflicts of interest,“ Zerhouni had said. “It is imperative that Congress and the American people trust that the decisions made by our scientists are motivated solely by public health priorities and scientific opportunities, not personal financial concerns.“

Also at that meeting, Zerhouni said that the consulting practices were rooted in a 1995 change of prior ethics rules and policies that resulted, in part, out of the NIH's desire to better its recruitment and retention.

“I strongly believe that this regulation and all of its provisions are necessary and will strengthen the programs and operations of the NIH,“ Zerhouni added in his memo. “It will also help us regain the public's trust that has eroded because of the actions of a few.“

Going forward, NIH scientists will continue to be able to conduct academic activities such as teaching at universities, writing textbooks, performing scientific journal reviews, participating in scientific meetings and providing general lectures to physicians and scientists at continuing professional education and similar events. They also are permitted to practice medicine as appropriate.

But Kidder, whose 15-year-old organization counsels and trains other organizations on creating ethical cultures, said that might not be enough. He wondered why no one inside the NIH tried to stop the final draft of the guidelines before considering the policy's potential ramifications on internal morale.

“My only sadness is that they rammed it through, apparently,“ he said. “They rushed in without the sufficient consideration of the thoughtful tradition of ethics and things that they really should have foreseen.“

Perhaps, he added, Zerhouni and others at the top might rethink their decision and rework the policy in the coming weeks.

“I think it's the right thing to do,“ Kidder said. “We forgive, but we don't forgive the stonewalling.“

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