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In what has been billed as the largest prescription-drug withdrawal in history, on the 30th of September, 2014, Merck withdrew Rofecoxib (Vioxx) following what Topol (2004) cites as excessive stroke and myocardial infarctions risk associated with the drug. The withdrawal came in the light of an FDA approval five years earlier and $2.5 billion in sales. At the time of its withdrawal, the medicine had been taken by a total of 80 million patients. Topol (2004) is of the opinion that this particular debacle could have been avoided had clear warning signs not been ignored along the way. The primary leaders in this particular case were leadership at the FDA and Merck’s senior executives.
The entre fiasco is representative of a colossal failure of leadership. Rodger Stodgill (as cited in Northouse, 2016) points out that some of the key traits of leadership include “persistence, insight, initiative, self-confidence, responsibility, cooperativeness, tolerance, influence and sociability” (21). Other traits, according to Daft (2007), are inclusive of integrity, intelligence, and honesty. Leaders at both the FDA and Merck lacked several of these traits. This is more so the case in as far as integrity, responsibility, and insight are concerned. While the senior executives at Merck was blinded by the company’s commercial interests and, hence, totally ignored the safety concerns raised, the leadership at the FDA failed in its mandate to promote and preserve public health. This reeks of lack of responsibility in both cases. Amongst other things, the need to conduct a trial assessing the cardiovascular benefit as well as risk of refecoxib and celecoxib was ignored all along by both the FDA (despite having not only the mandate, but also the authority for such an initiative) and Merck. The latter entity largely focused its attention on a PR campaign meant to deflate averse cardiovascular effects concerns. This was clearly lack of insight in as far as discerning the impact of certain courses of action. Sales were valued over safety – demonstrating lack of integrity on the part of Merck’s top leadership.
References
Daft, R. (2007). The Leadership Experience (4th ed.). Mason, OH: Cengage Learning.
Northouse, P.G. (2016). Leadership: Theory and Practice (7th ed.). Washington, DC: SAGE Publications.
Tropol, E.J. (2004). Failing the Public Health — Rofecoxib, Merck, and the FDA. N Engl J Med., 351(17), 1707-1709.
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