Vioxx Lawsuit Ends in a Mistrial I have a guilty pleasure, but I don't mind admitting it: Whenever time allows, I like to 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 last week when I heard the news that the most recent Vioxx lawsuit 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 (it didn't get nearly as much coverage) was a devastating testimony in the trial. And I couldn't help but wonder: What would Judge Judy have said? 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 market. (For a full rundown of the Vioxx follies, see the e-Alerts "Man's Best Friend" 10/4/04, and "Hasty Pudding" 2/24/05.) Before the latest trial jumped the tracks last week, jurors heard an astonishing testimony from Eric Topol, M.D., 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? Stupid it doesn't say 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 pee on my leg and tell me it's raining!" 4) Negative results suppressed - Part 2 Dr. Topol explained that when he compared the published study of the 2000 trial with 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!" With the hung jury derailment of last week's 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 favor. 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 slam dunk. 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. Is $50 billion excessive? Reread Dr. Topol's testimony and then consider Merck's very aggressive marketing campaign for a drug that was obviously deadly. Judy (to Merck execs): "The only one you have to blame is yourself!" Sources:
"Doctor: Merck's Habits 'Appalling'" Associated Press, 12/4/05, cbsnews.com
"New England Journal Charges Merck Deleted Vioxx Study Data" Amanda Gardner, HealthDay News, 12/8/05, news.yahoo.com | 
