TCS Daily

The Scientists Revolt (Because Their Bosses Are Revolting)

By Henry I. Miller - March 18, 2005 12:00 AM

The National Institutes of Health (NIH) is facing 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, place severe limits on the acceptance of prizes, and prohibit senior staff members (and their families) from owning stock in drug, medical device or biotech companies. These are the kinds of strictures that in the past have been applied 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 over revelations that a few NIH employees (out of a workforce of 17,500) had 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, committed fraud on 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 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 affect. But aside from these restrictions, as long as an NIH employee adequately performs his job 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 the case in academia.

The journal Nature offered an example of the impacts these rules will have on recruiting and retention at NIH. It described the plight of a brilliant young engineer-turned-physician who while 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 a pathology fellowship at NIH. But he's now prohibited from even minimal interaction with the company and is reconsidering the fellowship.

Worst of all will be the impact on NIH's best and brightest senior scientists -- those most likely to be sought out as consultants and to receive awards (and also 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 that "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 preeminent 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.

In as collegial and academic an institution as NIH, such bureaucratic overkill is especially discordant. As Donald Kennedy, editor of the journal Science and former FDA Commissioner and former president of Stanford University has observed: "There are two kinds of moral action. One is the power to sanction. The second is the opportunity to develop a kind of community consensus of what should be approved and what should be disapproved. If arrived at correctly, the second is more powerful and more long lasting than any centralized decision."

Deputy NIH Director Raynard S. Kington defends the new restrictions: "Our number one priority was to ensure the public's trust in the integrity of the science of this agency." It is a weak justification: The number one priority of NIH should be actually to produce high quality science -- which will become more difficult as the institution becomes less attractive to the crème de la crème of the scientific world. Moreover, ensconced in his federally-funded ivory tower, Dr. Kington seems oblivious to the fact virtually no one outside the Beltway gives a lab rat's backside about the nuances of the ethics rules at NIH. Moreover, Dr. 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 -- version of the ethics rules.

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 (who called the new rules "a heavy-handed solution") during the 1990s, for example -- would have been able to stand up to their political masters and to Congress, but the current director, the un-eminent Elias Zerhouni, apparently is not up to the task.

Even absent imposing stature, sometimes courage and determination to do the right thing can be an effective substitute. During the 1980's while I was an official at FDA, which is a sibling agency of NIH, there was a period when staffers of Congressman John Dingell (D-Michigan) were running roughshod over the agency. His investigators wandered through FDA offices uninvited, harassing employees and unceremoniously helping themselves to confidential materials, many of which contained trade secrets protected by federal law. Finally, although the all-powerful Dingell chaired the House committee that exerted oversight over the agency, the acting FDA commissioner, James Benson, put his foot down and demanded that this illegal activity stop. It did.

The moral of this sad saga is that if our governmental institutions are to operate effectively, the people who are part of the policy-making apparatus must zealously and intelligently represent the public interest, wherever it lies, and no matter whose feathers are ruffled along the way.

Henry I. Miller is a fellow at the Hoover Institution and Competitive Enterprise Institute and the author of "The Frankenfood Myth," which was selected by Barron's as one of the 25 Best Books of 2004. From 1977 to 1994, he was an official at the NIH and FDA.

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