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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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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.