Summary

It's difficult to assign any positive attributes to a group of people who knew about the deadly dangers of anti-inflammatory drugs, and the suicidal side effects of antidepressant drugs, and yet did absolutely nothing to warn the American public. Even worse, they buried the evidence, censored their own scientists and attacked dissenting views in the medical community.

New technology isn't the answer here. What the FDA needs is new ethics. And I don't think you can buy those.

Original source:
http://www.sciencedaily.com/releases/2004/11/041108025356.htm

Details

• The University of Rochester Medical Center has a new tool to assess whether a medication might be harmful to the heart.
• The technology addresses a major health issue -- drug toxicity -- illustrated most recently by Merck's voluntary withdrawal of Vioxx from the market after concerns that it may cause heart attacks and strokes.
• FDA Issues Public Health Advisory On Vioxx As Its Manufacturer Voluntarily Withdraws The Product (October 6, 2004) -- The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by ...
• Vanderbilt Research Shows High Doses Of Popular Pain Reliever Prescribed Despite Heart Risk (July 13, 2004) -- The evidence is growing: chronic, high-dose consumption of the arthritis pain reliever Vioxx can raise blood pressure and the risk of serious heart problems.
• Jean-Philippe Couderc, a biomedical engineer, developed a software program that provides a simpler, more accurate way to analyze the electrocardiograms (EKGs) of people who volunteer for clinical trials to test new drugs.
• The Food and Drug Administration purchased a copy of the technology, called COMPAS, which stands for Comprehensive Analysis of Repolarization Signal.
• More comprehensive testing of the heart's reaction to medications is not only important for the success of any new drug, but it became an FDA requirement two years ago.
• To meet this standard, most companies that design Phase I and II clinical trials require thousands of volunteer subjects to undergo an extensive physical examination, which includes a review of a patient's 24-hour EKG.
• Therefore, the goal among those who are developing and testing new treatments is to identify the cardiovascular risks to patients at the earliest possible stage.

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