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News & Views

Vioxx lawsuits: The Vioxx saga continues


Date: 05/01/06
 
Keywords: Other Ailments,
I have a guilty pleasure, but I don't mind admitting it: Whenever time allows, I like to switch on SKY and watch Judge Judy.

I have a guilty pleasure, but I don't mind admitting it: Whenever time allows, I like to switch on SKY and watch Judge Judy. What can I say? I guess I like my justice tart with a no-nonsense razor edge.

I thought of Judge Judy when I heard the news that the most recent Vioxx lawsuit in the US ended in a mistrial, prompted by a hung jury. You may have heard about the mistrial, and you may have heard that the editors of the New England Journal of Medicine (NEJM) accused executives at Merck & Co. (the maker of Vioxx) of suppressing damaging clinical evidence about their drug.

What you probably didn't hear about was a devastating testimony in the trial. And I couldn't help but wonder: What would Judge Judy have said?

Merck still defends its deadly cash cow drug
No one who has watched the Vioxx scandal unfold is surprised that it's turning into ugly train wreck. We saw this crash coming more than a year ago when the good folks at Merck suddenly pulled Vioxx off the US market.

Before the latest trial jumped the tracks last week, jurors heard an astonishing testimony from Dr. Eric Topol, chairman of the cardiovascular medicine department at the Cleveland Clinic. An Associated Press (AP) article nicely captured Dr. Topol's professional anger. Here are four highlights of his testimony, along with my guess on what Judge Judy's commentary to Merck lawyers might have been:

1) Window of risk
This trial concerned a man who had a fatal heart attack after only one month on Vioxx. Merck executives claim that heart attack risk associated with Vioxx only emerges after a year and a half of use. But Dr. Topol contended that existing research shows Vioxx may prompt heart attacks at any time after use begins.

Judy: 'See my forehead? It doesn't say stupid here!'

2) Negative results suppressed
Dr. Topol told the court that a 1999 trial sponsored by Merck showed that Vioxx was responsible for a 760 percent excess rate of heart attacks when tested against a placebo and another pain reliever. Merck executives decided not to publish that study.

Judy: 'There is NO excuse for that!'

3) Playing fast and loose with the facts A 2000 study that found Vioxx increased heart attack rate by five times compared to another pain reliever called naproxen. In defense of their cash-cow drug, Merck executives noted that naproxen has cardioprotective qualities. This supposed difference between the drugs might have won over some non-skeptics, but not Dr. Topol, who explained that naproxen has NOT been shown to have any such cardioprotective qualities.

Judy: 'Don't try and pull the wool over my eyes!'

4) Negative results suppressed - Part 2 Dr. Topol explained that when he compared the published study of the 2000 trial with US Food and Drug Administration (FDA) records of the study, the number of heart attacks and deaths were higher in the non-published FDA data. His take on the inconsistency: 'scientific misconduct.'

Judy: 'Get out of my courtroom and I never want to see you in here again!'

Drug giant swamped in lawsuits
With the hung jury derailment of the recent trial, you might wonder if Dr. Topol's comments fell on deaf ears. But consider this: According to a report in the New York Times, the trial was assumed at the outset to be leaning strongly in Merck's favour. And apparently there was only one member of the jury who refused to side with the other jurors in finding Merck liable.

In other words, Merck just barely squeaked by when they were expecting a done deal. The suit will be retried next year.

So the scorecard on the three Vioxx trials we've seen so far shows Vioxx with one win, one loss and a draw. By current estimates there may be as many as 7,000 more Vioxx lawsuits pending against Merck, and potential liability could run as high as $50 billion dollars.

Is $50 billion excessive? Reread Dr. Topol's testimony and then consider the fact that Merck aggressively marketed a drug that was obviously deadly.

Judy (to Merck execs): 'The only one you have to blame is yourself!'

And the lawsuits arent only pending in the US. Here in the UK around 400,000 people took Vioxx to treat arthritis pain since its launch in 1999 till it was pulled off the market in September 2004.

I will be keeping an eye out for any pending lawsuits involving UK Vioxx victims.

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