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In a letter to the FDA dated March 10, 2005, a group of health and consumer advocates said the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of arthritis pain drugs known as Cox-2 inhibitors, including Vioxx and Celebrex, to serve on a panel charged with evaluating those drugs. Last month, Center for Science in Public Interests (CSPI) found that of 32 experts serving on the FDA's Arthritis Drug and Drug Safety Advisory Committee, ten had received funding from Pfizer, Merck, or Novartis.
My major concern is that the (FDA) approved the release of Vioxx to health patients knowing, the high risk and the side effects it would have on patients who already have serious health issues with prescription drugs. My question is, what roll did the Inclusion/Exclusion Criteria play, if any, and what about the Protocol inwhich all of this is based through clinical trial and research which includes: Treatment trials, Preventive trials, Diagnostic trials, Screening trials, and Quality of Life trials. This event with Vioxx should have ever happen not at the expense of human life was it MONEY was the (FDA) getting kickbacks from the Pharmaceutical Company (MERCK). Please explain!
|Jennifer Mathes, Ph.D.|