The paper “Merck Sharp & Dohme Corp's Ethical Problem - Selling Untested Drugs Has Claimed Human Lives" is a great example of a case study on social science. Merck Sharp & Dohme Corp. has been a recently merged corporation between Merck and Schering-Plough in November of 2009 (Merck Sharp & Dohme Corp.: Our History). Its rich and challenging historical backdrop was traced 161 years ago in 1851 in Berlin where Dr. Ernst Christian Friedrich Schering was identified to be instrumental in the development and sales of pharmaceutical products. The New Merck’s mission statement stipulates the need “to provide innovative, distinctive products and services that save and improve lives and satisfy customer needs, to be recognized as a great place to work, and to provide investors with a superior rate of return” (Merck Sharp & Dhome Corp.: Vision Mission Statements).
On May 20, 1999, Merck applied and received the FDA approval for the marketing of Vioxx, an arthritix pain reliever. As indicated in a report written by Presley, “by the end of 1999, over 5 million prescriptions had been written for Vioxx and it had been launched in
47 countries” (Merck & Co. Inc. 39; cited in Presley 2). As testing protocols necessitate, Vioxx was further tested through a trial known as “VIGOR (Vioxx Gastrointestinal Outcomes Research) study, and involved 8,000 individuals” (Presley 3). On the 23rd of November, 2000, “the VIGOR results were published in the New England Journal of Medicine (NEJM). The study showed that Vioxx patients were five times more likely to experience adverse cardiovascular (CV) events than patients taking naproxen” (Presley 6). Finally, on the 24th of September, 2004, five years after Vioxx was approved by the FDA, Merck decided to withdraw the drug from the market (Presley 8).
Statement of the Issue
The ethical issue is the insufficient clinical trial of Vioxx that led to the deaths of patients who were prescribed with the drug; dishonesty, lying and nondisclosure of the eminent dangers of using the drug; and as reported “Merck directed its 3,000-person Vioxx sales force to avoid discussions with doctors about the cardiovascular risks identified in a major clinical trial of the drug in 2000. Sales representatives were told instead to rely on a “Cardiovascular Card" that said Vioxx was protecting the heart rather than potentially harming it” (Kaufman par. 2).
Analysis of the Issue
From the facts presented, one could deduce that the organization virtually violated its mission of providing safe and innovative products that would enhance the well-being of its clientele. Further, the ethical issue was exacerbated by the intended misleading of Merck executives, to wit: “in the push to improve the product’s image, Marketing and Sales excluded the VIGOR trial results on its informational card and even relied on a safety analysis that the FDA considered inappropriate. In fact, the CV card indicated that Vioxx could be 8 to 11 times safer than other anti-inflammatory drugs, information that was not in agreement with the published data” (Presley 6).
In this regard, there was latent misleading on the reliability and safety for using Vioxx but was still pushed to be marketed for profitable pursuit. Merck is, therefore, guilty of dishonesty by lying and unwillingness to tell the truth (Ferrell, Fraedrich and Ferrell 64) and violations of health and safety standards. As explicitly stated in the organization’s Code of Conduct on Health and Safety: “We conduct our operations with the highest regard for the safety and health of employees and the protection of the general public” (Merck 16).
As reported by Kaufman, “a 2004 study by FDA safety officer David Graham and others estimated that Vioxx caused as many as 140,000 heart attacks and strokes and killed as many as 55,000 people. Vioxx, which was approved by the FDA in May 1999, reached $2 billion in sales in two years, faster than any drug in Merck's history” (par. 15). The instrumental and remarkable success in financial terms proved to be too significant to eminently admit the health and safety hazards that have been sporadically reported to Merck executives.
Description of Resolution
Eventually, published reports and mounting concerns on the safety of Vioxx led to further studies and trials on the drug to include its efficacy for Alzheimer’s disease and colon polyps. As disclosed, “these additional trials consistently showed safety risks associated with Vioxx. On September 28, 2004, Merck requested an emergency meeting with the FDA. In the meeting, Merck shared data from the colon polyps study with the FDA. Two days later, on September 30, 2004, Merck made a public announcement that it planned to withdraw Vioxx from the market—nearly five years after initial safety concerns had surfaced” (Presley 8). Likewise, as reported by Kaufman, the long time CEO of Merck, Raymond V. Gilmartin, resigned on May 5, 2005 in the midst of the investigation conducted by the House of Committee on Government Reform regarding the anomalies and breach of ethical codes of standard during the dispensation and marketing of the Vioxx over the 5 years within which it was aggressively marketed.
One strongly believes that management should have made a public apology for the hazards brought about by the marketing and dispensation of Vioxx. There was not any mention that the organization admitted that they made a mistake and violated ethical issues in this case. At the onset, when VIGOR reports were revealed increased preponderance for CV risks, Merck should have resorted to recalling this drug and improving on the components that made it a health risk and endangered the safety of the patients taking it. That move would have been the most viable and ethical decision that would comply with their mission statement and would have improved the corporate image to the general public.