Merck and Vioxx

Sophie Spallas, Katie Gaitan, Lindsey Estrada, Kenton Johnsen,

Harrison Lo, Colette Garcia
What are the important characteristics of Merck at the
time of the case?
Four patents set to expire in 2000 and 2001
The public would learn that Merck scientists left out key data on heart
patients to make the drug seem safer.
Accused of fabricating study results to suit the companys needs, continually
thwarting an FDA scientist from revealing the drugs problems and skirting
federal drug regulations.

Current painkillers were known to cause gastrointestinal problems for users, and
Vioxx was proven to be better than current drugs on the market
Merck Characteristics at time of the case (continued)
Merck had a close relationship with the FDA
Led to a back-and-forth with labeling protocol that omitted key information about the
drug
Accused of working together to keep the drug on the market for longer and quiet the
health concerns
Shares plunged after pulling the drug from the market
Cost billions of dollars in stock revenue
How Important was Vioxx to Merck
Four of their exclusive patents were going to expire between 2000 and
2001
Would lose revenue b/c similar drugs would enter the market
They needed to make the money back that they spend producing and
marketing the Vioxx
Internally it was referred to as the great drug. The front page of Mercks
annual report read: Vioxx: Our biggest, fastest and best launch ever.
They had received a lot of good press when the drug originally came out
Timeline of important events
1999 JAN: Merck launched the VIGOR study.

2000 MAY: Merck submitted VIGOR paper to NEJM for publication (but only included 17/20 heart attacks)

2001 FEB: The FDA published all results (including heart attacks 18, 19, and 20) on its website.

2002 - 2004: Many studies pointed to Vioxx for increasing risk of cardiovascular problems.

2004 SEP: Merck withdrew Vioxx after study showed the drug increased risk of heart attack after taking it for 18 months.

2005 AUG: Texas state jury returned a verdict against Merck in the first case to go to trial.

2006 MAR: VIGOR authors argued that 18, 19, and 20 occurred after the prespecified cutoff date, but the date was a month
earlier than the gastrointestinal cutoff date.

2007 NOV: Merck agreed to pay $4.85 billion to end thousands of lawsuits.
References
https://www.drugwatch.com/vioxx/recall/

http://www.nytimes.com/2004/09/30/business/merck-pulls-vioxx-painkiller-from-market-an
d-stock-plunges.html?_r=0

https://web.duke.edu/kenanethics/CaseStudies/Vioxx.pdf

http://www.fiercepharma.com/special-report/merck-vioxx