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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