Bureaucrats upending NIH

The National Institutes of Health (NIH) faces a revolt by its employees over new, draconian conflict-of-interest rules. They ban all consulting (paid or unpaid) for biomedical companies, restrict teaching and service on company boards, severely limit acceptance of prizes, and prohibit senior staff members (and families) from owning stock in drug, medical device or biotech firms. Such strictures have applied earlier only to employees of regulatory agencies like the Food and Drug Administration and Securities and Exchange Commission.

The new restrictions — an exaggerated, bureaucratic response to congressional displeasure about revelations a few NIH employees (out of 17,500) committed minor technical violations — could ruin one of the world’s premier medical research institutions.

Although some NIH employees earned large consulting fees from drug or biotech companies — and violated existing rules by failing to report this outside employment — there have been no allegations of substantive wrongdoing that, for example, manipulated stock values, defrauded the government or private parties, injured patients or compromised federal research. In other words, this is all about the perception — but not the reality — of possible misconduct.

Required disclosure of outside consulting arrangements by federal employees is entirely appropriate, and an NIH scientist should not hold significant equity positions in or be an officer of a company that wants to sell 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 affect.

But aside from these restrictions, as long as an NIH employee does his job adequately and discloses extramural consulting, teaching, medical practice and so forth, he should enjoy significant latitude to become involved in outside part-time employment or volunteer activities, as is done in academia.

The journal Nature offered an example of the effects these rules will have on recruiting and retention at NIH. It described a brilliant young engineer-turned-physician who in medical school invented a device that embeds, processes and sections pathology specimens. He licensed the machine to a small biotech company for which he worked part-time, and he hoped to continue that association while completing an NIH pathology fellowship. Now prohibited from even minimal interaction with the company, he is reconsidering the fellowship.

Worst of all will be the effect on NIH’s best and brightest senior scientists — those likeliest to be sought out as consultants and to receive awards (and to be recruited to industry or academia). For example, last month when NIH officials circulated the announcement of competition for the prestigious Paul Marks Prize for Cancer Research, a $50,000 award sponsored by the Memorial Sloan-Kettering Cancer Center in New York, they noted, “Federal employees … could accept the honor and the plaque, but not the monetary prize.” It is difficult to see the logic of such a prohibition but easy to see how pre-eminent NIH scientists will increasingly find the less restrictive atmosphere of academia more appealing than the one-size-fits-all shackles of the federal government. Several have already announced their intention to depart.

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.” However, NIH’s No. 1 priority should be to produce high-quality science — which will become more difficult as the institution becomes less attractive to the creme de la creme of the scientific world.

Ensconced in his federally funded ivory tower, Dr. Kington seems oblivious that virtually no one outside the Beltway gives a lab rat’s backside about the nuances of the NIH ethics rules. Moreover, as the NIH’s chief ethics officer since January 2004, arguably he could have enforced the previous, more moderate — and perfectly adequate — version of the ethics rules stringently enough (and with appropriate publicity) to head off the new punitive regulations.

The downfall 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 in the 1990s, for example — could have stood up to their political masters and to Congress, but the current, uneminent director, Elias Zerhouni, apparently is not up to that.

Courage and determination to do the right thing are essential in government officials at the highest levels. When I worked at FDA, a sibling agency of NIH, there was a period when staffers of Rep. John Dingell, Michigan Democrat, ran roughshod over the agency. His investigators wandered through FDA offices uninvited, harassing employees and unceremoniously helping themselves to confidential materials, many containing trade secrets protected by federal law.

Finally, though Mr. Dingell chaired the agency House oversight committee, acting FDA Commissioner James Benson put his foot down and demanded the illegal activity stop. And it did.

The moral of this sad saga is, if our governmental institutions are to operate effectively, policymakers must zealously and intelligently represent the public interest, wherever it lies — no matter whose feathers are ruffled.

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