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Rules Are Killing Good Science

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Henry I. Miller, a fellow at the Hoover Institution and the Competitive Enterprise Institute, was an official at the NIH and the Food and Drug Administration from 1977 to 1994.

The National Institutes of Health has used a bazooka to kill a mosquito. And now the NIH is facing a revolt from its scientists, who are suffering collateral damage. The scientists are outraged by the draconian new NIH regulations that bar them from part-time consulting for biomedical companies (paid or unpaid), restrict their service on company boards, limit their acceptance of prizes, and prohibit senior staff members (and their families) from owning stock in drug, medical device or biotech companies.

These new restrictions are an overreaction to congressional displeasure over revelations that several dozen NIH employees (out of a workforce of more than 17,000) failed to comply fully with the old ethics rules requiring them to disclose outside activities to the NIH. Several top scientists reportedly received hundreds of thousands of dollars in consulting fees but failed to report this outside employment. There have been, however, no allegations of substantive wrongdoing; no claims of, for instance, manipulated stock values, fraud, injured patients or compromised federal research. What this boils down to is the perception -- but not the reality -- of possible misconduct.

Requiring that federal employees disclose outside consulting arrangements is entirely appropriate, and an NIH scientist should not hold significant equity in or be an officer of a company that wants to sell something to his agency, or whose product he is testing in a clinical trial; nor should he receive cash awards from institutions whose grants he can influence. But aside from these restrictions, as long as an NIH employee adequately performs his job and discloses extramural activities, he should enjoy significant latitude to become involved in outside part-time employment or volunteer work, as is largely the case in academia.

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The new regulations, which went into effect Feb. 3, are already exerting a chilling effect that inevitably will diminish one of the world’s most prestigious biomedical research organizations. Under the new rules, one scientist was prohibited from accepting an unpaid adjunct professorship at Johns Hopkins University because the appointment’s free campus parking might induce him to favor the university; never mind that the scientist has no say over grant decisions, and even offered to refuse the parking pass.

The NIH’s best and brightest researchers -- in particular, those most likely to be sought as consultants and to receive awards -- will be forced to chose between the freedom from grant-writing that federal scientists enjoy and an altogether more laissez-faire professional existence in academia or industry. Several senior scientists last week announced their intention to leave government service.

Deputy NIH Director Raynard S. Kington defends the new restrictions: “Our No. 1 priority was to ensure the public’s trust in the integrity of the science of this agency.” Shouldn’t the No. 1 priority of the NIH be to produce high-quality science, an accomplishment that will become more difficult with the institution’s lessened attractiveness to the creme de la creme of the scientific world? Kington himself, as the NIH’s chief ethics officer, is culpable for the institution’s failure to enforce the previous, more moderate -- and perfectly adequate -- ethics rules.

Sadly, this compromise of one of the world’s great research institutions is only one symptom of the mediocre quality of the Bush administration’s health and science appointments in general. Previous NIH directors -- renowned academic physician James Wyngaarden in the 1980s and Nobel Prize winner Harold Varmus (who calls the new rules “a heavy-handed solution”) during the 1990s, for instance -- would have been able to stand up to their political masters, but the current director, Elias Zerhouni, apparently is not up to the task.

In crafting the new, punitive conflict-of-interest rules, federal officials have acted like bureaucrats instead of problem-solvers. The moral of this saga is that if our governmental institutions are to operate effectively, the people who are part of the policy-making apparatus must zealously represent the public interest, wherever it lies. If they are placed in the position of having to defend the indefensible, resignation is an honorable option.

America will pay the price if the nation’s preeminent research institution is jeopardized, and its accomplishments diminished. Heaven protect us from the good intentions of bureaucrats.

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