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Healthy Skepticism Library item: 16846

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Silverman E
Merck, Shareholders And Vioxx Fraud In 2001
Pharmalot 2009 Dec 1
http://www.pharmalot.com/2009/12/merck-lawyers-concede-vioxx-fraud-in-2001/


Full text:

So can Merck have it both ways? For years, the drugmaker has argued there was no evidence to suggest that Vioxx was causing heart attacks and strokes before its September 2004 withdrawal. As recently as last month, Merck dismissed a new analysis in the Archives of Internal Medicine purporting to show links between the painkiller and cardiovascular disease could have been detected going back to 2000 (please see here).
Now, though, Merck lawyers are arguing before the US Supreme Court that, based on publicly available information, shareholders could have detected possible securities fraud back in September 2001. Shareholders, however, filed lawsuits in November 2003 alleging the drugmaker misled them by downplaying clinical-trial data suggesting Vioxx caused increased cardiovascular risks.
The time difference is crucial. At issue is when investors should have known there was possible securities fraud and Merck lawyers argue the two-year statute of limitations expired by the time lawsuits were filed, so shareholders are out of luck. As an example, they cited an FDA warning letter sent in September 2001 alleging Merck misrepresented Vioxx by minimizing the potential to increase heart attack risks.
One can argue that proving securities fraud may not be precisely the same thing as proving that Merck knew and failed to disclose there was a serious problem with its drug, and that patients were harmed. In any event, there does seem to be a degree of irony involved as Merck continues to tell patients there was no reason to suggest any problem in 2001 when, in fact, shareholders should have known a problem existed.
Here is the transcript from the arguments before the Supreme Court, and you can read more here, here and here

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963