The Vioixx Recall: A Case

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
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,
The FDA had to step in and compel Merck to clearly address the issue by labeling the drug packaging with information on the possible side effects, and to stop falsely advertising and promoting the drug. As late as 2003, the company’s foot was still on the gas trying hard to dispel safety issues. The turning point came in 2004 when the FDA ostensibly approved Vioxx for the treatment of rheumatoid arthritis in children; a move that sucked the drug further into controversy. Successive events and sustained studies by researchers led to the highly publicized Vioxx recall in September 30th 2004, when Merck pulled the drug from the market (Hartley, 2010).
Exit the drug and enter the Justice Department: Investigations into the company’s handling of the drug began in earnest, with the Senate Finance Committee being tasked with hearing the case against Merck and the FDA. The regulatory agency did not escape glaring stains on its mandate to ensure safety of consumables and came under heavy criticism from one of its own lead researchers, Dr. David J. Graham. A Texas State Court jury found the company guilty in a product liability trial, imposing a $254 million fine as a punitive measure (Brody,