Scientists are Revolting

From: kathleen (kathleen.dickson_at_snet.net)
Date: 03/26/05

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    Date: 25 Mar 2005 17:36:11 -0800

       "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."

    Dr. Henry I. Miller

    Fellow, The Hoover Institution

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    The Scientists Revolt (Because Their Bosses Are Revolting)

    By Henry I. Miller Published 03/18/2005

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    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.

  • Next message: Brent: "Re: The Medical Science Business"

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