PointofLaw.com
 Subscribe Subscribe   Find us on Twitter Follow POL on Twitter  
   
 
   

 

 

WSJ Reports Merck Witness has become a liability in Vioxx Trials

| No Comments


Today's Wall St. Journal reports that Merck's most powerful defense witness may have become a distinct liability. [subscription required]. This piece elaborates on Ted Frank's Dec. 10 entry, below.

Merck's witness, Dr. Alise Reicin, was an author of a key NEJM study comparing Vioxx to a competitor's product. The November 2000 study stated that in a study of Vioxx versus naproxen, an older, generic painkiller, 0.4% of Vioxx users had heart attacks compared with 0.1% of naproxen users. The study's aggregate numbers, which weren't in the article, showed that 17 out of about 4,000 Vioxx users had heart attacks versus four of 4,000 naproxen users. Merck explained the difference by concluding that naproxen helps prevent heart attacks, though no clinical trials have shown that to be the case.

The article didn't mention an additional three heart attacks among Vioxx users, which occurred after the article was submitted for publication. These deaths raised the total heart attacks to 20 of 4,000 patients, or 0.5%. The additional deaths didn't affect Merck's conclusions at all. Nor was there any misstatement -- the facts were exactly as reported as of the date of submission for publication.

Merck said last week that it excluded the three heart attacks because they took place after the cut-off date the scientists had set for measuring benefits or risks. And the attorney for Merck noted that the additional heart attacks wouldn't have changed the conclusions of the journal article. Despite this, plaintiff in the federal Vioxx case on Friday asked for a mistrial on grounds of fraud. The judge has taken the motion under advisement, and will presumably only rule on it if Merck wins a jury verdict (the jury is still out as of this writing).

So, let's see, the failure to submit information irrelevant to a medical journal article has diminished the credibility of an author of the article. Makes sense to me!

Leave a comment

Once submitted, the comment will first be reviewed by our editors and is not guaranteed to be published. Point of Law editors reserve the right to edit, delete, move, or mark as spam any and all comments. They also have the right to block access to any one or group from commenting or from the entire blog. A comment which does not add to the conversation, runs of on an inappropriate tangent, or kills the conversation may be edited, moved, or deleted.

The views and opinions of those providing comments are those of the author of the comment alone, and even if allowed onto the site do not reflect the opinions of Point of Law bloggers or the Manhattan Institute for Policy Research or any employee thereof. Comments submitted to Point of Law are the sole responsibility of their authors, and the author will take full responsibility for the comment, including any asserted liability for defamation or any other cause of action, and neither the Manhattan Institute nor its insurance carriers will assume responsibility for the comment merely because the Institute has provided the forum for its posting.

 

 


Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.