Arthritis painkiller drug Vioxx: No limit to drug companys greed

You may remember the fiasco surrounding the giant drug company Merck and the arthritis painkiller drug Vioxx. It gave us a glimpse of the astounding greed and deception that goes on when a drug company puts a priority on marketing at the expense of consumer safety.  
 

Vioxx: How low can you go?  

 
For those who may be new to the Vioxx mess, here's a quick recap:
* We first warned HSI members about the risks of
Vioxx back in 2002
* In 2004, Merck took Vioxx off the market after
a study revealed cardiovascular risks
associated with the drug
* According to a US Senate investigation, Food
and Drug Administration (FDA) officials tried to suppress a report prepared by the agency that concluded '27,000 heart attacks and sudden cardiac deaths' could have been avoided if patients had been using Celebrex instead of Vioxx The first of possibly thousands of lawsuits filed against Merck began in 2005. So far, Merck has won three and lost three. But now those three losses are in serious jeopardy of being overturned. 
 
One of the few strong points in the Merck defence has been a statement that appeared in The New England Journal of Medicine (NEJM) supporting data suggesting the drug's risks became a problem only after 18 months of use. 
 
In a past e-Alert I told you about a trial testimony by Dr Eric Topol, chairman of the cardiovascular medicine department at the Cleveland Clinic in the US. The trial concerned a man who had a fatal heart attack after only one month of Vioxx use. Dr. Topol cited research that revealed Vioxx might prompt heart attacks at any time after use begins.  
 

Vioxx: From concern to correction

The worm began to turn in December 2005 when NEJM editors issued an 'expression of concern' stating that damaging clinical evidence had been suppressed. 
 
Last week, NEJM editors issued a correction that will appear in the July 13 issue. 
 
NEJM executive editor Dr. Gregory D. Curfman told US newspaper the Boston Globe that the correction is intended to make clear that any suggestion that heart attack risk only occurs after 18 months of Vioxx use is 'a misinterpretation of the data.' 
 
Oh stop being so polite! Just come out and say it!
Merck deliberately concealed important data that makes the 18-month claim a lie! Dr. Curfman was more to the point last December when he gave this statement to HealthDay: 'We have very solid evidence that important data on cardiac events was deleted or withheld, which rendered the study of suboptimal quality.' 
 
Suboptimal? How about 'worthless'? 
 
In response, to the NEJM correction, Merck representatives stated that the company 'stands behind the original results' that appeared in the journal. 
 
And to cap off this disaster - beyond all recognition - the Globe reports that Merck has sent an analysis to the FDA that indicates Vioxx heart risks may persist for one full year after a patient discontinues use. 
 
This would all have a comical aspect if not for the deaths and devastated families Vioxx has left in its wake.  
 

Vioxx: A new era

 
Here's what's really sad: If Vioxx were taken off the market today, all of the thousands of current pending lawsuits against Merck might never make it to court. 
 
A new ruling by the FDA went into effect last week, making it much more difficult for consumers to submit liability claims. 

Sources:

'Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial' New England Journal of Medicine, Posted online before publication, 6/26/06, content.nejm.org 'Only a Few Months of Vioxx Could Harm Heart, Journal Says' Diedtra Henderson, The Boston Globe, 6/27/06, boston.com 'New England Journal Charges Merck Deleted Vioxx Study Data' Amanda Gardner, HealthDay, 12/8/05, yahoo.com 'Putative Contributors to the Secular Increase in
Obesity: Exploring the Roads Less Traveled'
International Journal of Obesity, 6/27/06, nature.com/ijo 'New Look at Obesity: Scientists List Fat Top 10'
Marilynn Marchione, Chicago Sun Times, 6/28/06, suntimes.com