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  • #1808
    Anonymous
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    Hi friends,
    Recently I came across a few news items I thought would be of interest to you. This is about FDA.
    This is an organisation which the entire medical profession world over look to know about the veracity of the claims by pharmaceutical companies when they introduce new molecules in the market. Once cleared by FDA, we have no doubt about the drug which we prescribe to our ailing patients in a bid to save their lives.
    I request my friends to go through the following link which is only a few days’ old. This is about thousands of lawsuits currently filed against Bayer AG and Janssen Pharmaceuticals in reference to their new-generation, blood-thinning drug Xarelto (Rivaroxaban, an anticoagulant) . The controversies discussed in the article have gained significant public attention recently, and have been noted in publications such as The New York Times and Business Insider. According to details, American and European drug regulators have begun investigations designed to help indicate whether a defective blood-clotting test device called an International Normalized Ration could have influenced the outcome of several clinical trial tests conducted on the drug which eventually led to its FDA-approval.
    The FDA based its approval of Xarelto for atrial fibrillation on a clinical trial called ROCKET AF that involved more than 14,000 patients in 45 countries over several years. The trial was coordinated by the Duke Clinical Research Institute, which tests drugs for pharmaceutical companies. Califf, who is now a deputy commissioner at the FDA, founded that institute and co-chaired the ROCKET AF executive committee.
    I request my friends to read the above paragraph once more to know the conflict of interest between the pharmaceutical companies and FDA
    Blood testing devices of the make used in the ROCKET AF trial were the subject of two FDA warning letters before the trial began and an FDA recall notice after the trial ended. The recall notice said devices marketed under the INRatio name could deliver falsely low test results with potentially deadly consequences.
    In the court filing Friday, lawyers suing Johnson & Johnson over Xarelto argued that falsely low test results would lead to trial subjects in the warfarin group being given too much of that blood thinner, causing them to suffer more bleeding
    http://www.wowktv.com/story/31451442/xa … ent-device
    http://www.pogo.org/blog/2016/02/new-cl … aliff.html

    Please go to another link given below, which is also interesting and at the same time disturbing our psyche.
    http://www.fda.gov/AboutFDA/CentersOffi … 452317.htm

    UA Mohammed

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