Merck and the Vioxx Decision
James Hamilton has a very nice post on the dubious nature of this decision. Hamilton walks us through some of the statistical arguments and concludes the following,
So how do you explain these issues to a Texas jury? Well, the defendants argued these 5 to 1 odds aren’t statistically significant, to which the plaintiff’s lawyer Mark Lanier offered this folksy rejoinder (hat tip: Newmark’s Door):
Have you got $6 on you? I’m going to give you a dollar and you give me the six. It is not statistically significant in the difference. What do you think, are you in or out?
Sure, Mr. Lanier, I’m in, though here’s how the deal actually works– you give me the dollar, but you don’t know whether I give you $6 or I give you nothing. Or, to be a little more accurate, even if there actually is an elevated risk of the magnitude the studies suggest but can’t prove, the question is whether I might want to accept a 1 in 4,000 risk of dying from a heart attack in order to get the only medication that makes my pain bearable and a mobile life livable. And if I say no to the Vioxx, I may end up taking something that is less effective for my pain but has risks of its own.
And now I have a question for Mr. Lanier. How did we arrive at a system in which 12 random Texans are assigned responsibility for evaluating the scientific merits of statistical evidence of this type, weighing the costs and benefits, and potentially sending a productive blue-chip American company into bankruptcy protection?
I strongly recommend reading the entire post. For one thing while the Lancet study ultimately relied on 10 people. The study started with 8,143 patients who had a heart attack, of which 68 were taking a nonsteroidal anti-inflammatory drug (Vioxx is a nonsteroidal anti-inflammatory drug ). Also, the study looked at 31,496 patients who had not had heart attacks, but had also taken a nonsteroidal anti-inflammatory drug (NSAID). In the end the risks of taking a NSAID was not statistically significant in general, but there was a statistically significant dose-effect relationship. However, those statistics are based on just 10 patients–2 from the group with heart attacks and 8 from the group with no heart attacks.
In short, it looks like the legal system failed to accurately evaluate the weight of the statistical evidence. This is of course not at all unsurprising.
I saw a lot of the presentations during the clinical trials of Vioxx (I ran the AV gear for many of the meetings, and prepped or edited a lot of the slides), and there was *no* indication of any serious cardiac side effects in any of the major clinical trials. They were looking for some, and it just didn’t show up in the stats in the official trials.
Some of the doctors involved have mentioned that they *think* that any cardiac side effects *might* be a drug or food interaction issue, but it would cost a couple of billion more to figure out what it might be, and it’s not worth the cost…
The main question you have to ask yourself is if Merck management knew about the risks of vioxx and decided unilaterally that it was acceptable and that the public and FDA didn’t need to know because it was so small. Recent email and Merck documents discovered by Reuters that as soon as 1998 Merck was trying to reformulate vioxx for cardiovascular risk. Also email documents showed that head scientists at Merck were worried and warned Merck management about the cardiovascular risks of vioxx. Your right that people are willing to accept medicines that aren’t 100% safe but people deserve to know all of the risks. Management cant unilaterally decide by themselves that the risks are so small, they don’t need to tell anybody. Thats the problem, that Merck unilaterally decide to keep the cardiovascular problems a secret, till it was too late and proved Tobe Little bit more then a small problem.
I can’t say that the Texas jury was right or wrong, I think the jury, made up of ordinary citizens, vented their anger at Merck because it was a way for them to express their disgust at the drug companies for the high price of drugs. What it says to other companies is, If you rip me off, then you will someday end up paying the price. If you really think about it, it’s about the only way the ordinary average citizen can do something about it.
No, they vented their anger at Merck because the lawyers did a good job of proving that Merck lied and covered up dangers of the drug, EVEN THOUGH it doesn’t appear that said dangers had anything to do with THIS man’s death.
It’s still wrong, but it’s a bit more defensible than Herb’s explanation.
Does anyone think this verdict has a prayer’s chance in hell of surviving the Texas appellate courts?