The Vioxx Recall: A Case Study
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
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 results, while affirming that the drug had an outcome of fewer stomach problems, confirmed the earlier fears of increasing cardiovascular risks. Company executives made efforts to play down the significance of the outcome, arguing that these results were “consistent with expectations” of an allowance for side-effects pegged on drugs (Crawford & Benedetto, 2006). Safety concerns were propounded in 2001 following the results of this study. 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, 2007). An analysis of the Ethical Issues
This case raised several ethical issues as far as health and corporate discipline were concerned. Evidence collected over time indicated that the Company was fully aware of the safety risks posed by its blockbuster drug, prior to its approval by the FDA, use and subsequent withdrawal. This cover up may have resulted in worsening the conditions of the millions of patients who used the drug and may have been the cause of death in some of the instances. The Wall Street Journal published an article on November 1st 2004 laying bare the Company’s occupational misdemeanor (Lawrence & Weber, 2008). More serious was the FDA’s collusion in speculating with the health of consumers who transcended the boundaries of the United States. The company’s maneuvers to control information disclosed by its hired consultant physicians on the dangers of their product exposed its preference for profit over safety. Such information needed to be made open to consumers, researchers and critics so that the safety issues got a chance to be addressed adequately before the drug was approved for treatment purposes. This case also put to light the loopholes in allowing pharmaceutical companies to directly market their prescription drugs to consumers. Merck spent money in the region of half a billion dollars on marketing and advertisement of Vioxx (Hartley, 2010). While acknowledging that Pharmaceutical companies operate as business entities, the underlying issue here is that such a move may hold precedence over doctor’s advice in the purchase and consumption of prescription drugs. Arguably, advertisement here would play the role of the doctor, the outcome of which is anyone’s guess. The role of legislation
Consumer (read patient) welfare pushed the US Congress to contemplate a legislation that would forbid pharmaceutical companies or any other company selling drugs to advertise their products directly to consumers, until safety was ascertained and doctors were sufficiently acquainted with the drugs (Lawrence & Weber, 2008). This timely legislation could effectively raise the moral bar and streamline the safety standards of drugs and cushion patients against another Merck & Co.’s Vioxx.
Brody, H. (2007). Hooked: Ethics, the Medical Profession, and the Pharmaceutical
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Crawford, C. M., & Benedetto, A. (2006). New products management. New York: McGraw-Hill/Irwin.
Hartley, R. F. (2010). Management Mistakes and Successes. Hoboken: John Wiley
Lawrence, A. T., & Weber, J. (2008). Business and society: stakeholders, ethics,
public policy. New York: McGraw-Hill Irwin.
Ruschmann, P. (2007). Prescription and Non-Prescription Drugs. New York City: