the fda: an agency out of control

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THE FDA: AN AGENCY OUT OF CONTROL
Part 1 of 2





By Byron J. Richards, CCN

February 9, 2007

NewsWithViews.com

The FDA is steamrolling its way to a grand vision of repressive health care based on profits for Big Pharma and new biotech companies at the expense of human health.

Human death means little to the FDA, permitting mass killings of Americans while protecting Big Pharma profits. This year the FDA is being given more money (federal funding up 5% to 1.5 billion) without any accountability or effective Congressional oversight. This means that instead of using the money to meaningfully improve drug safety, the FDA will carry on its pet projects that include forwarding the health component of the Bush administration’s North American Union, limiting health freedom by harassing dietary supplement companies so as to reduce access to safe and effective drug competition, and actively turning the FDA into a drug company.

A current case in point is the heart bypass drug, Trasylol, a medication often given so patients don’t bleed too much during surgery. A study published in the February 7, 2007 issue of the Journal of the American Medical Association showed that Trasylol was found to significantly increase the risk of death in the subsequent five-year period following heart bypass surgery. The data predicts that for the 246,000 Americans receiving this drug in 2005, over 19,000 will needlessly die in the following five-year period. FDA warnings in early 2006, weak as they were, curtailed the blockbuster growth of the drug, and it appears the drug lost about 20% of its sales compared to 2005. This means that roughly 15,000 Americans receiving Trasylol in 2006 will needlessly die over the next five years because the FDA twiddled its thumbs to protect Bayer from an avalanche of lawsuits, even while Bayer lied point blank to the FDA (the Justice Department should be investigating). You heard me correctly, the head of the FDA, Andrew von Eschenbach, made an administrative decision to leave Trasylol on the market to protect Bayer, brushing aside a blatant Bayer cover-up. Of course, the problem is ongoing in 2007, exposing innocent Americans to unnecessary risk that is likely to result in an additional 1000 deaths per month (over the next five-year period).

Bayer was expecting Trasylol to be its next blockbuster drug and was in Phase III trials to use the drug for all kinds of common operations (these trials were dropped in January 2007). While Bayer made $291 million on the drug in 2005, the drug generated over 1.2 billion in treatment fees for the friends of Bayer due to all of its damaging side effects.


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