Propaganda from ACSH Director on FDA / silicone breast implants

Discussion in 'Health and medical' started by Ilena, Mar 2, 2004.

  1. Ilena

    Ilena Guest

    Note from Ilena: Miller has been an Industry Junk Science Voice for
    years ... both Hoover and ACSH are corporate funded front groups with
    silicone money greasing their well financed and distributed
    "opinions".

    Unfortunately, McClellan's brave stand on failing Inamed's silicone
    gel implants may have cost him the FDA position, it appears.

    ~~~~~~~~~~~~


    http://www.latimes.com/news/opinion/commentary/la-oe-miller1mar01,1,2656259.story


    Lackadaisical FDA Needs a Dose of Vitality From a New Chief

    The outgoing commissioner did little to address the agency's
    problems.


    EXCERPT: Another abject failure was the FDA's unexpected decision —
    contrary to the advice of an advisory committee — to leave in place
    severe restrictions on silicone breast implants imposed more than a
    decade ago because of safety concerns. Those concerns were unfounded,
    virtually destroyed an industry and needlessly terrified tens of
    thousands of American women.

    ~~~~~~~~~~~~~~~~~~~~~~~


    By Henry I. Miller, Henry I. Miller, a fellow at the Hoover
    Institution, is the author of "To America's Health: A Proposal to
    Reform the FDA" (2000, Hoover Institution Press). From 1979 to 1994,
    he was an official at the




    FDA Commissioner Mark McClellan is leaving his position after only 16
    months in office, far less time than it took for the search committee
    to find him. Although few would question that McClellan is engaging
    and smart, he leaves with mediocre accomplishments and with the agency
    little better off than he found it.

    McClellan did little to reform the culture of risk-aversion and the
    fear of innovation that pervades the FDA. The subtext of regulatory
    agencies — not just the FDA — is that career bureaucrats generally
    care more about staying out of trouble than about public health. That
    biases them against timely approvals of innovative products. Yet
    McClellan removed not a single senior career bureaucrat.

    Despite increasingly more powerful and precise technologies for drug
    discovery, purification and production, development costs have soared.
    One reason is that the highly risk-averse FDA keeps raising the bar
    for approval, especially for innovative, high-tech products. Human
    gene therapy and other treatments tailored to individual patients have
    been hit especially hard. Americans are literally dying for reform.

    On McClellan's watch, the FDA continued to throw rigid,
    one-size-fits-all solutions at non-problems. An example is the
    agency's decision to deny any drug company the ability to obtain
    multiple trademarks for the same drug — for example, Sarafem/Prozac
    and Propecia/Proscar — even if they are different formulations for
    different ailments.

    McClellan also failed to modernize the FDA's bureaucratic approach to
    regulating old drugs that have been on the market for decades without
    significant concerns about safety or efficacy but still lack FDA
    approval.

    The FDA has said that if the manufacturer of one of these drugs
    expends the effort and expense to obtain an approval, all of its
    competitors will be forced off the market until they also obtain
    approvals. This recently occurred with extended-release guaifenesin, a
    well-known cough suppressant. The FDA justified forcing competitors
    off the market as necessary to "protect the integrity of the drug
    approval process," but the outcome has been exactly the opposite: With
    no incremental protection of public health, the approved product now
    sells for 700% of the price of comparable products prior to the FDA's
    action.

    There were other failures of policy and decision-making during
    McClellan's tenure. One is the FDA's record on the regulation of
    biotech foods. At the same time that U.S. Trade Representative Robert
    Zoellick and other senior officials in the Bush administration were
    working for more science-based treatment of biotech foods (that is,
    those produced from gene-spliced organisms) internationally, they were
    outflanked by European and American bureaucrats at the deliberations
    of the food standards agencies of the United Nations. The U.S.
    delegation to these negotiations was led by a senior FDA food
    regulator, Robert Lake, whom McClellan repeatedly refused to rein in.

    Another abject failure was the FDA's unexpected decision — contrary to
    the advice of an advisory committee — to leave in place severe
    restrictions on silicone breast implants imposed more than a decade
    ago because of safety concerns. Those concerns were unfounded,
    virtually destroyed an industry and needlessly terrified tens of
    thousands of American women.

    Still another was the agency's unwillingness to permit the Plan B
    morning-after contraceptive to be sold over the counter, a decision
    that reeks of politics.

    These are not the actions of an FDA head who believes in
    science-driven public policy, data as the basis for regulatory
    decisions, the right of patients and physicians to assume a modicum of
    responsibility for the risk of medical interventions, and banning
    politics from regulation. But that is what we need in McClellan's
    successor.
     
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