Despite the application for approval to the FDA, Merck scientists, marketers, and managers had expressed concerns regarding Vioxx as early as 1996. A company memo from 1996 showed reluctance by Merck to conduct a Vioxx gastrointestinal outcomes research (VIGOR) study. To participate, study patients would have to stop taking aspirin, which protected them against heart attacks. Patients on a Vioxx-only regimen had a “substantial chance that significantly higher rates of cardiovascular problems would occur.” By 1999, the FDA had approved Vioxx and in May 1999 it went on sale. In November 1999 however, results of the VIGOR study were already showing proof of double the average instances of cardiovascular problems compared to Vioxx alternatives
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Dilemmas posed to management.
Merck’s management had to decide on a course of action that addressed the two possible ethical issues: should management stop the release of Vioxx despite the high costs already sunk into research and development as well as the company’s desperate need for a new patented drug to boost falling profit margins?
Alternatively they had to decide whether to proceed with the release as scheduled despite their awareness of dangerous cardiovascular side effects and higher incidence of heart attacks when there still existed the possibility that later study data would show prove Vioxx was not any less safe than other NSAID alternatives and the cardiovascular events were statistically insignificant.
What actions did management actually take?
Management eventually withdrew Vioxx from the market voluntarily but only did so in 2004, after evidence of Vioxx’s harmful side-effects was insurmountable and the public upheaval inevitable.
Cost/benefit analysis of management’s course of action. The matrix below illustrates the costs and benefits to individual stakeholders as a result of Merck’s course of action. Ethical principles
Dilemmas posed to management.
Merck’s management had to decide on a course of action that addressed the two possible ethical issues: should management stop the release of Vioxx despite the high costs already sunk into research and development as well as the company’s desperate need for a new patented drug to boost falling profit margins?
Alternatively they had to decide whether to proceed with the release as scheduled despite their awareness of dangerous cardiovascular side effects and higher incidence of heart attacks when there still existed the possibility that later study data would show prove Vioxx was not any less safe than other NSAID alternatives and the cardiovascular events were statistically insignificant.
What actions did management actually take?
Management eventually withdrew Vioxx from the market voluntarily but only did so in 2004, after evidence of Vioxx’s harmful side-effects was insurmountable and the public upheaval inevitable.
Cost/benefit analysis of management’s course of action. The matrix below illustrates the costs and benefits to individual stakeholders as a result of Merck’s course of action. Ethical principles