vioxx recall

Topics: Pharmacology, Food and Drug Administration, Pharmaceutical industry Pages: 4 (979 words) Published: April 14, 2014


The Vioxx Recall: A Case Study

Outline:
i) Introduction
ii) The Case: Profit versus Safety
iii) An analysis of the Ethical Issues
a) Cover up of Vioxx Safety concerns
b) Control of Information
c) Direct Marketing of prescription Drugs
iv) The role of legislation

Introduction
The Vioxx debate had at its center a leading pharmaceutical company that enjoyed a good run of blockbuster drug releases in the 1990’s. This particular drug was envisioned to follow in the path of its predecessors in terms of successful returns. The debate started at a critical time for Merck & Co.; when patents on some of its main drugs were expiring and the drug stood as the product that would maintain profits in the face of a looming fall in sales of the drugs whose patents were due for termination (Crawford & Benedetto, 2006). The company needed a lifeline, and Vioxx positioned itself rightly to provide that. The case: profit versus safety

The timeline of the controversy surrounding the anti-inflammatory drug goes back as early as 1997, three years after its discovery in 1994. Researchers at the company were concerned that the drug had a potentially lethal side-effect; clinical trials done on a control group indicated that it increased the chances of blood clots that caused heart complications (Ruschmann, 2007). Despite of these concerns, Merck submitted the New Drug Application to the U.S Food and Drug Administration for approval in 1998. It took 6 months to approve Vioxx for marketing by the FDA, instead of the conventional 2 year period for similar drugs (Lawrence & Weber, 2008). This was attributed to the speculative cozy ‘dalliance’ between Merck and the regulatory agency (Brody, 2007). The drug’s release to the market was followed by a steep growth trajectory in sales and subsequent profits. At this time, the drug manufacturing company initiated a study to find out whether Vioxx would suppress colon polyps (Ruschmann, 2007). The...
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