Vioxx and the Merck Team Effor

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at Duke Universit y Institutions in Crisis VIOXX AND THE MERCK TEAM EFFORT Holly Presley On May 20, 1999, the FDA approved Merck’s application to market Vioxx, a new arthritis pain-reliever. The effort to create a successful drug at Merck was no small task; not only did the company need to develop, test, and receive approval for a new product – it also needed to make sure the drug was successfully marketed to the right consumers. To heighten the appeal of Vioxx, Merck had began an additional clinical trial in January in hopes of establishing that their drug caused fewer gastrointestinal problems than a commonly used alternative, naproxen (generic Aleve®). An independently chaired Data Safety and Monitoring Board, which monitored the clinical trial, noted a heightened risk for cardiovascular events in the second month of the 3-month trial. Despite what now appear to be clear warning signs, Merck continued to aggressively market the drug. Amid mounting concerns Merck finally withdrew the drug five years after its release. This retrospective case illustrates competing understandings of mission across organizational subdivisions and the difficulty of regulating drug safety in a market context. This work is licensed under the Creative Commons Attribution - Noncommercial - No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/. You may reproduce this work for non-commercial use if you use the entire document and attribute the source: The Kenan Institute for Ethics at Duke University. Case Studies in Ethics dukeethics.org Introduction Merck was established in the U.S. in 1891, but its roots trace back to Friedrich Jacob Merck’s purchase of a German drug store in 1668.1 Today the company is a top tier global entity, a “research-driven” pharmaceutical company “dedicated to
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