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 It was subsequently found to increase the risk of cardiovascular disease and withdrawn from the worldwide market.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

CiteULike
Complore
Connotea
Del.icio.us
Digg
Reddit
Technorati What's this?
Relevant Articles
-
Has the hunt for conflicts of interest gone too far? Yes
- Thomas P Stossel
BMJ 2008 336: 476.
[Extract]
[Full Text]
[PDF]
-
Direct to consumer advertising of drugs in Europe
- Nicola Magrini and Maria Font
BMJ 2007 335: 526.
[Extract]
[Full Text]
[PDF]
-
Merck appeals rofecoxib verdict
- Janice Hopkins Tanne
BMJ 2007 334: 607.
[Extract]
[Full Text]
[PDF]
This article has been cited by other articles:
-
Lo, B., Kriegstein, A., Grady, D.
(2008). Clinical trials in stem cell transplantation: guidelines for scientific and ethical review. Clin Trials
5: 517-522
[Abstract]
-
Aldred, R.
(2008). Ethical and Political Issues in Contemporary Research Relationships. Sociology
42: 887-903
[Abstract]
-
Hill, K. P., Ross, J. S., Egilman, D. S., Krumholz, H. M.
(2008). The ADVANTAGE Seeding Trial: A Review of Internal Documents. ANN INTERN MED
149: 251-258
[Abstract]
[Full text]
-
Ross, J. S., Hill, K. P., Egilman, D. S., Krumholz, H. M.
(2008). Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation. JAMA
299: 1800-1812
[Abstract]
[Full text]
-
Stossel, T. P
(2008). Has the hunt for conflicts of interest gone too far? Yes. BMJ
336: 476-476
[Full text]
-
Magrini, N., Font, M.
(2007). Direct to consumer advertising of drugs in Europe. BMJ
335: 526-526
[Full text]
-
Loscalzo, J.
(2007). Entrepreneurship in the Medical Academy: Possibilities and Challenges in Commercialization of Research Discoveries. Circulation
115: 1504-1507
[Full text]
-
Antman, E. M., Bennett, J. S., Daugherty, A., Furberg, C., Roberts, H., Taubert, K. A.
(2007). Use of Nonsteroidal Antiinflammatory Drugs: An Update for Clinicians: A Scientific Statement From the American Heart Association. Circulation
115: 1634-1642
[Full text]
Rapid Responses:
Read all Rapid Responses
- A great deal to learn
- Radhika Vohra
bmj.com, 20 Jan 2007
[Full text]
- Some day, we may have to swallow the bitter pill
- Rajan TD
bmj.com, 20 Jan 2007
[Full text]
- Hindsight
- zahid bashir
bmj.com, 26 Jan 2007
[Full text]
- We have not learnt enough
- Edward Auersperg
bmj.com, 27 Jan 2007
[Full text]
- competing toxicity-what about the gut?
- Maarten Boers
bmj.com, 31 Jan 2007
[Full text]
- correction: and what about the gut?
- Maarten Boers
bmj.com, 2 Feb 2007
[Full text]
- Aspirin versus acetaminophen for pain control in patients with cardiovascular and gastrointestinal risk factors
- Michal R. Pijak
bmj.com, 6 Feb 2007
[Full text]
- Assessing adverse events in randomised controlled trials : a challenge for methodologists
- Isabelle Pitrou
bmj.com, 23 Feb 2007
[Full text]
- On Selective Learning
- Theordore V.H. Mayer
bmj.com, 24 Feb 2007
[Full text]
- Re: On Selective Learning
- Mark E. McConnell
bmj.com, 16 Mar 2007
[Full text]
- Re: On Selective Learning
- David S. Egilman, et al.
bmj.com, 9 Apr 2007
[Full text]