BMJ  2007;334:120-123 (20 January), doi:10.1136/bmj.39024.487720.68

Feature

What have we learnt from Vioxx?

Harlan M Krumholz, Harold H Hines Junior professor of medicine and epidemiology and public health1, Joseph S Ross, instructor2, Amos H Presler, research associate3, David S Egilman, clinical associate professor4

1 Department of Medicine, Yale University School of Medicine, 333 Cedar Street, PO Box 208088, New Haven, CT 06520-8088, USA, 2 Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, USA, 3 Never Again Consulting, Attleboro, MA, USA, 4 Department of Bio Med Community Health, Brown University, Providence, RI, USA

Correspondence to: H M Krumholz harlan.krumholz@yale.edu

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

The first 150 words of the full text of this article appear below.

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 It was subsequently found to increase the risk of cardiovascular disease and withdrawn from the worldwide market.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, which act . . . [Full text of this article]

The VIGOR study


Obscuring the risk


Short and long term use


Medical journals


Promoting constructive collaboration


Summary points

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