A (well-deserved) death by 4,750 cuts? Vioxx Trial on Trial, part 2 In the last Daily Dose, I wrote to you about how the 3 top Editors at the New England Journal of Medicine attempted (in a December 8th, 2005 editorial) to correct the record on the Vioxx drug trial they first reported in 2000 - the infamous VIGOR study in which 17 patients "officially" suffered heart attacks compared to Naproxen's 4… As I've reported before in the Daily Dose, Merck attributed this disparity to what they called Naproxen's "protective" effects, not Vioxx's heart-attack-inducing ones. For the record, I've never seen ANY evidence that convinces me that Naproxen or any other anti-inflammatory medicine (including aspirin) has any kind of heart-protective quality. I HAVE seen evidence suggesting the opposite - but I digress… According to an Associated Press article on the controversy, the total number of heart attacks within the Vioxx () study group from the VIGOR research was actually 20, not 17. The fact that the 3 additional attacks occurred after the "data collection" period following the study gave Merck a loophole to avoid reporting it to the Journal for their original 2000 article. Here's why these extra heart attacks are important - aside from the sobering fact that three poor souls had heart attacks they likely never would have had they not signed up for the trial: The VIGOR study is a key element of most plaintiffs' cases against Vioxx maker Merck. And if it becomes widely assumed that Merck shirked their moral responsibility to disclose the full scope of negative side effects on a technicality (a data deadline), it could go even worse for them in court than it already is. As I've reported before in the Dose, the very first Vioxx trial settled (last fall in a Texas court) resulted in what I'm almost certain is the largest jury award to an individual's next of kin in tort history: $253 million… That's right, more than a quarter BILLION dollars. So far, Merck is batting .500 in court - two clean wins and two punishing losses. The second judgment against them came earlier this month, in an Atlantic City, New Jersey trial. According to an AP article on the case, the decision came as quite a shock to both the defendant and analysts following the case. Apparently, the 77-year-old plaintiff was a diabetic in poor health. Merck's lawyers were no doubt certain of their ability to cast doubt on whether the man's non-fatal heart attack was Vioxx-related or not… The jury saw it differently, however, and awarded the man $4.5 million dollars. Compared to the previous mammoth award, this is not an Earth-shaking settlement, but it's significant nonetheless. Keep reading and I'll tell you why… Here's why this latest case is perhaps so pertinent to the future of Vioxx proceedings: If a 77-year-old diabetic at risk of heart trouble without Cox-2 drugs even entering into the equation can be proven in court to be a victim of Vioxx instead of his own diabetes, it could be a very telling bellwether of the potential tenor of juries in the more than 9,500 Vioxx trials still pending on court dockets nationwide. In fact, according to the AP article on the trial, a number of legal analysts think this decision may cause Merck to re-evaluate its strategy of trying these cases one by one. Of course, before that first quarter-billion dollar settlement, a lot of these same analysts estimated the Vioxx debacle might ultimately cost Merck no more than $20-25 billion dollars… Now, they're talking more like $50 billion for the whole deal, an earlier AP article estimates. But this doesn't add up to me at all. Here's what I mean: Let's just say for the sake of argument that Merck does try these cases individually, and that the win-one-lose-one trend continues and they ultimately pay out on only half of them. That's 4,750 settlements, divided into $50 billion = $10,526.315 per settlement. This includes lawyers' fees and the costs of prosecution. Not a whole lot of money. Now, want to hear something mind-boggling? The average of the two settlements so far ACTUALLY AWARDED to Vioxx plaintiffs is $128,750,000. Multiply this times the 4,750 estimate losses and you get… $611,562,500,000. Nearly 2/3 of a trillion dollars. That's more than 60% of the GDP of Mexico, and nearly 1/4 of the U.S. annual budget for 2006. Think that would sink even Big Pharma big gun Merck? Without a doubt. And apparently, they're thinking along those lines, too. Earlier this month, the drug giant announced plans to lay off 7,000 and close 8 manufacturing plants worldwide… Could it be the beginning of the end for the first corporate casualty of the coming "war on drugs" against hazardous prescriptions? One can hope, anyway. Adding it up - before we're all statistics ourselves, William Campbell Douglass II, MD
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