The Vioxx Recall - Merck and FDA

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The Central Problem

In the Merck, the FDA, and the Vioxx Recall case study, the question as to whether or not Merck conducted itself in a socially responsible and ethical manner with regard to Vioxx is the central problem we will examine in this case. Many argue that the sole problem lies within the pharmaceutical company Merck and Co., Inc., and while that may in fact be the case, other parties such as the Food and Drug Administration (FDA) can be held responsible as well. Merck a “research driven” pharmaceutical company “dedicated to putting patients first,” is one of the largest pharmaceutical companies throughout the world (Presley, 2). The American pharmaceutical giant manufactures, markets, research and develops a variety of health products worldwide. Vioxx, a selective COX-2 inhibitor drug designed to treat pain and inflammation, is one of such products that became the company’s bestselling-prescription painkiller; after the FDA approved the drug for treatment in May of 1999. The blockbuster drug generated more than 2.1 billion dollars in sales throughout the United States alone and proved to be a winning product for the company. A few years later in 2004, the drug was voluntarily recalled by Merck after results from a clinical trial [it conducted] resulted in findings of increased heart attacks amongst users who had been on the drug for over eighteen months. (Presley, 1) Prior to these findings, studies conducted by VIGOR, Cleveland Clinic, and Kaiser Permanente also yielded results of the drugs’ risks associated with increased heart attacks; however, Merck ignored such warnings—including a warning letter from the FDA about the risks associated with the drug. Once the company learned of the findings from its internal stu...

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