Healthy Skepticism Library item: 7570

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Publication type: Journal Article

Krumholz HM, Hines HH, Ross JS, Presler AH, Egilman DS.
What have we learnt from Vioxx?
BMJ 2007 Jan 20; 334:(7585):120
http://www.bmj.com/cgi/content/full/334/7585/120

Abstract:

In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. But researchers and journals can still benefit from this case if they learn from the mistakes, write Harlan Krumholz and colleagues

Rofecoxib (Vioxx) was introduced by Merck in 1999 as an effective, safer alternative to non-steroidal anti-inflammatory drugs for the treatment of pain associated with osteoarthritis. It was subsequently found to increase the risk of cardiovascular disease and withdrawn from the worldwide market. Merck now faces legal claims from nearly 30 000 people who had cardiovascular events while taking the drug.1 The company has stated that it will fight each case, denying liability.2 Our recent participation in litigation at the request of plaintiffs provided a unique opportunity to thoroughly examine and reflect on much of the accumulated court documents, research, and other evidence. This story offers important lessons about how best to promote constructive collaboration between academic medicine and industry.

Early suspicion of cardiovascular risk
Since the early development of rofecoxib, some scientists at Merck were concerned that the drug might adversely affect the cardiovascular system by altering the ratio of prostacyclin to thromboxane, . . .

The VIGOR study

Obscuring the risk

Short and long term use

Medical journals

Promoting constructive collaboration

Summary points