Institutions in Crisis: Vioxx and the Merck Team Effort

Instructions:
In order to do this case, there is a little bit of prep work before reading the material. 
So first, review the elements of the case here first on NPR.Links to an external site.
Then read: Vioxx Case (Presley)Download Vioxx Case (Presley)
MerckLinks to an external site. is a major pharmaceutical companyLinks to an external site. that depends on patents and innovations.  The patents of Fosamax and Zocor expired in 2006.  Merck had planned Vioxx to be its next Blockbuster drug. 
What might Merck have done when information came out that Vioxx caused Cardiovascular problems?
Was it ethical for Merck to withdraw sponsorship of researchers who took issue with Merck’s marketing of Vioxx? And was it good strategy?
Compare Merck’s actions in influencing reported research results on Vioxx to the strategy of the tobacco companies in the 1950’s as they countered research that established a link between smoking and cancer?
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.
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Case Studies in Ethics
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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 putting patients first.”2 Merck’s mission is to “provide society with superior products…that improve
the quality of life and satisfy customer needs; provide employees with meaningful work…and investors with a
superior rate of return.”3 As a long time player in the U.S. pharmaceutical industry, Merck has had extensive
experience in assigning and dividing complex tasks among its many specialized departments. Specialization allows
Merck to operate efficiently and bring new drugs to American patients.
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. By the end of 1999, over 5 million prescriptions had been written for Vioxx and it had been launched in
47 countries. 4
The Vioxx launch went particularly well, and Merck splashed its success across the front page of its Annual Report
with the lead, “Vioxx: Our biggest, fastest and best launch ever.”5 New Vioxx sales came at an important time for
Merck. The exclusive patents to four major drugs were scheduled to expire in 2000 and 2001. The company faced
plummeting revenues once generic equivalents entered the market. According to one industry analyst, “Vioxx was
Merck’s savior.”6 Although internal teams were raising questions about the safety risks associated with Vioxx in
early 2000, the company’s first quarter financial statements cited Vioxx for leading sales growth within the company
and touted it as the “fastest growing prescription arthritis medicine in the United States.”7 In 2001, however, safety
concerns about the drug were becoming public. Three years later, on September 30, 2004, Merck pulled Vioxx off
the market. The Acting Commissioner of the FDA commended the action, stating “Merck did the right thing by
promptly reporting these findings to [the] FDA and voluntarily withdrawing the product from the market.”8