Painkillers: Merck is back with another ‘safe’ drug

How to succeed in business, lesson 439:  Tenacity and persistence.  This lesson’s case study is drug company Merck.  The company is currently fighting the world’s largest civil action suit over its COX-2 painkiller Vioxx, which is being blamed for causing heart failure, sometimes fatal.  So far, the courts seem to agree with the patients and their families.

Undaunted, Merck is pressing for approval of another COX-2 painkiller, Arcoxia (etoricoxib).  It points to the results of several trials, known as the Multinational Etoricoxib and Diclofenac Arthritis Long-Term program (MEDAL), that suggest the drug is as safe as diclofenac, another painkiller, and didn’t increase the risk of heart failure.  
But Dr David Graham, the ‘whistleblower’ at the Food and Drug Administration (FDA), which is considering the licence application, claims that Merck is not playing fair.

The MEDAL study is “well-known to be especially poor at identifying safety risks between drugs, thereby stacking the deck in favour of its drug”, he says.
 
In fact, Voltaren (diclofenac) is known to increase the risk of heart attack.

OK, so let’s move on to lesson 440, When Tenacity and persistence isn’t enough. . .

(Source:  Journal of the American Medical Association, early release article, posted 12 September 2006).


E-news broadcast 5 October 2006 No.298 [Subscribe]