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June 15 2006
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How Can the FDA Ever Improve Drug Safety?

The Institute of Medicine organized a meeting for behavior experts, statisticians and scientists to help guide the Food and Drug Administration (FDA), which has faced criticism for its handling of issues such as suicide risk among youths who take antidepressants and heart risks of the now-withdrawn arthritis drug Vioxx.

At a workshop that discussed risks and benefits of prescription drugs, panelists called for:

  • Less advertising hype and more information to help patients and doctors decide whether to take prescription drugs

  • Simpler information on drug risks and benefits, such as graphics and charts of basic facts and drug comparisons

  • Toning down drug advertisements so patients can make logical choices

    FDA officials said the agency would consider the advice, but noted that the current issues are not as serious as past issues that have called for major changes at the FDA.

    While in 2005 the drug industry voluntarily made their ads more balanced, they also spent $11 billion on drug ads for consumers and promotions for doctors.




  • Dr. Mercola Dr. Mercola's Comments:

    So these changes are welcome because, as currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of the drug industry. It views the drug industry as its client, and the client is someone whose interest you represent.

    Most people have no idea that 80 percent of the resources at the FDA is geared toward the approval of new drugs and 20 percent is for everything else, including drug safety.

    Folks, their primary purpose is to get drugs approved, plain and simple.

    But to add major insult to injury, when the Prescription Drug User Fee Act came into play in 1992 the drug companies actually started to fund the FDA. I know it sounds like something straight from a science fiction novel, but I assure you that this is true.

    It is the classic case of the fox guarding the henhouse.

    How can you possibly trust a system in which the people who approve the drugs are also the ones who oversee the post-marketing regulation of the drug?

    Then of course there is the rampant conflict of interest present at the FDA when its "expert" panels that are assigned the responsibility of approving drugs are actually paid shills for the drug companies.

    The most egregious recent example of this was when 10 of the 32 FDA drug advisers whose total votes favored the controversial painkillers Celebrex, Bextra and Vioxx had financial ties to the industry.

    So wake up if you haven't already done so and realize that the FDA, as currently configured, is not there to protect your health. Please remember that one of its primary purposes is to help multi-national drug companies increase their profits.


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