A NEJM editor found out that additional data linking Vioxx to cardiovascular risk was deleted from a major study (VIGOR) published five years ago. Merck researchers deleted the data 2 days before submitting the paper manuscript.The authors underreported the number of heart attacks suffered by Vioxx patients, claiming that there were 17 heart attacks when there were actually 20.
The additional events were disclosed to the FDA in 2000.
NEJM Editor-in-chief Jeffery Drazen says: "There's a difference between the letter of the law and the spirit of the law, and what Merck did conformed with the letter of the law. But in my opinion, it broke the spirit of the law because you're using human subjects, participants in this trial, and you're putting them at risk".
On Dec 8, NEJM released an editorial entitled "Expression of Concern" which asks the VIGOR authors to submit a correction of the manuscript.
"Is this Watergate for Merck?", asks Kevin, M.D.
References:
Medical Journal Says Merck Concealed Vioxx Data - NYTimes
Merck's Deleted Data - Forbes.com
Medical Journal: Vioxx Paper Flawed - NPR
A Vioxx Bomb Drops. Or Does It? - In the Pipeline
Watergate scandal - Wikipedia
Rofecoxib - Wikipedia
Image source: Wikipedia
A new case in the UK is of interest. The links with the current VIOXX reports are only too clear. We blame these companies but equally culpable are the academics fronting studies about which they know nothing (or worse still know are incorrect and misleading). These Universities and academics give manipulated science a veneeer of credibility. This unbelievable case in Sheffield (UK) involved an academic who demanded data underlying reports ghostwritten in his name by Procter and Gamble about their osteoporosis medicine Actonel. The whole article (particularly the reports in the Observer from 4 December merit some detailed reading).
ReplyDeleteCorrespondence in Observer 11 Dec 2005
http://observer.guardian.co.uk/letters/story/0,6903,1664590,00.html
Observer on 11 December 2005
http://observer.guardian.co.uk/uk_news/story/0,6903,1664688,00.html
Article in THES last thursday
http://www.thes.co.uk/story.aspx?story_id=2026632
Doctor accuses drugs giant of 'unethical' secrecy
(Observer 4th December)
http://observer.guardian.co.uk/uk_news/story/0,6903,1657302,00.html
How the drugs giant and a lone academic went to war
(Observer 4th December)
http://observer.guardian.co.uk/uk_news/story/0,6903,1657275,00.html