Great post on the statistical signifigance of the Vioxx results from Econbrowser. Frankly, given how low the relative increase in risk is, I don't understand why patients aren't being given the option of taking Vioxx after being rigorously informed of the potential side effects.
Posted by Jane Galt at August 24, 2005 12:13 PM | TrackBack | Technorati inbound linksBecause if the patient dies even after being rigorously informed of the risks, their family WILL sue.
Frankly the jury for this one ought to be shot.
"Studies reflect that about 16,500 patients die and another 100,000 are hospitalized annually as a result gastrointestinal bleeding from the use of these NSAID medications for chronic pain. The number of people who have suffered heart attacks and strokes as a result of the long-term use of Vioxx pale in comparison to these numbers."
This is from a link in the article that Jane links to. This really explains why Vioxx, Celebrex, and other COX-2 inhibitors are such a big deal--they are safer alternatives for many people (including me) EVEN WITH THE SLIGHTLY ELEVATED RISKS FROM VIOXX than traditional NSAID's.
I think that the defense team seriously underestimated the hatred that many people have for large companies. The tobacco cases should have taught the lawyers a lesson.
As for juries, they tend to be average people. People too bright are bounced, as is anyone who has any knowledge of anything at all. Want to hear something scary? JURORS ARE AVERAGE PEOPLE, and the mean IQ of the population (by definition) is 100. I would venture to say that all of the readers of this blog have an IQ at least one standard deviation above the mean.
"Frankly, given how low the relative increase in risk is, I don't understand why patients aren't being given the option of taking Vioxx after being rigorously informed of the potential side effects."
Real easy. Because Merck pushed the product to consumers as generally superior to standard NSAIDs for all patients. They aren't. They are only better for some patients subject to gastric bleeding. They could have taken the marketing approach you suggested, but didn't.
Yeah, yeah, I know. I'm sure that any Ph.D. chemist who reads the package insert can figure it out. But I am a Ph.D. chemist, and I'm sick and tired of correcting drug-company-induced misimpressions for my friends. Let Merck fry.
Because Merck pushed the product to consumers as generally superior to standard NSAIDs for all patients. They aren't. They are only better for some patients subject to gastric bleeding.
And thankfully, patients are able to use their psychic powers to determine, in advance, whether they'll suffer gastric bleeding from their medication. So really, Merck was just being greedy. Because patients never want to hedge their bets or anything.
Jurors are not _statistically_ average people, because people of higher intelligence are far more likely to be excluded from jury service. (They're likely to have the kind of high-paying jobs which are powerful motivators to evade service. And even if they don't try or want to evade service, they're frequently excluded during voir dire, because trial lawyers assume anyone who knows anything about even the general subject matter of the trial is going to be incurably biased.)
There is no counterbalancing force excluding jurors of below-normal-but-above-"retarded" intelligence.
The typical jury is thus, on average, stupider than the general population. And when you consider how stupid the general population can be...well, it's a frightening thought. :)
Thank-you, Jane, for your comment. As ludicrous as the judgment against Merck was, the crime in the story is how many people will be damaged by taking a non-Vioxx medication.
In addition, companies will have to bombard physicians will virtually every imaginable side-effect, thus rendering their decision-making discretionary power impotent. I mean, with a flood of potential side-effects for every drug for every condition, sorting the probabilities becomes difficult.
Remember Bendectin? This was a drug for the treatment of nausea in pregnancy. It was pulled from the market, not because of any demonstrated risk, but because too many lawyers were willing to hope to find a jury stupid enough to attribute any birth defect to the drug.
"There is no counterbalancing force excluding jurors of below-normal-but-above-"retarded" intelligence."
Sure there is. There are the guys/gals at the other counsel table. In any case, one party has the facts and law on its side. The other party does not. In most cases, both parties (or at least their lawyers) know who they are and whether they will be counting on the facts and the law or on confusing the jury. (Btw, it's not always the plaintiff who's relying on confusion.)
The side with the facts and the law doesn't want a stupid jury any more than the other side wants a smart one. Both sides get to strike the same number of potential jurors.
As a University physician, I agree with sentiments that our legal system (no, not just torts) is seriously flawed. However, Hamilton seriously mis-states the medical issues, which I mentioned in his blog. The best way to estimate the effect of a drug (good or bad) is from randomized controlled trials (RCTs) where patients are randomized between two treatments. The Graham study which he quotes was not randomized and therefore of low value in estimating drug effects. If we have no RCTs we make do with observational studies like the Graham study. For Vioxx, we have two large RCTs:
The VIGOR trial (8076 patients) & the APPROVe trial (2586 patients). The APPROVe trial had more statistical flaws. Here are their results
VIGOR relative risk of myocardial infarction 5 times higher with Vioxx (50 mg) than those who got Naproxen – it’s in the summary of the paper published in 2000, on the first page
APPROVe relative risk of “serious cardiac events” including but is not limited to documented “heart attack”- 31 Vioxx, 12 placebo controls- relative risk 2.8 –see Table 2 of Bresalier paper. In addition 25 Vioxx patients and 7 controls developed hypertension which was not considered a serious cardiovascular event. Here the Vioxx dose was lower, 25 mg, and the difference in outcomes was not significant until people took the drug for 18 months.
Two weeks of 12.5 mg Vioxx probably has no impact on cardiac risk. For a 60 year old, the increased risk can be up to 5 times greater which is very serious. I would try safer NSAIDs like Ibuprofen & Naproxen before using a COX-2 inhibitor myself - maybe not in a 20 year with a documented history of bleeding ulcer. I like to read econbrowser and other economist’s blogs (like DeLong), but I don’t post about the details of economics. Medicine is equally complex.
Bob Snodgrass, Torrance, CA
Are juries stupid, average or above-average in intelligence? The premise that they are stupid begins with the assumption that stupid people respond to jury summons in the same proportion as intelligent people. This is not the case, at least in urban Texas. Most, i.e. 75% of jurors summoned in Harris County, Texas (Houston) are 'no shows.' Those who do respond tend to be responsible, fairly civic-minded, conservative and very cynical. Runaway juries are the exception, not the rule, and they are generally the product of either a very bad draw on the larger jury pool or a bad judge helping a favorite lawyer 'clean up' a panel to the end that the dumbasses decide the case.
I've talked with a number of lawyers directly involved in the Vioxx runaway. My first comment is "thanks for pissing off the rest of the world." The responses I get really do not belong in the public domain. Suffice it to say that there may wll have been more than enough human error and frailty outside the jury box to contribute to the debacle.
I am not defending the amount of the verdict, which was absurd, nor am I suggesting that Merck had it coming. I am defending the jury system because I've made it work too many times for large companies in serious personal injury and wrongful death cases. I am also, in the larger sense, underimpressed with the logic of many posters who are using a relatively isolated instance to justify a broad, generalized indictment.
People who don't try cases for a living lack a sufficent basis for condemning the entire system. It is an imperfect system. It isn't the hell on earth many seem to think it is.
The issue wasn't the statistics. It was Merck's policy and/or practice -- unfortunately for them documented in lots of internal emails -- to push Vioxx hard while denying relevant info to the physicians that they encouraged to prescribe it. The jury may not have been competent biologists and statisticians (and for better or for worse, folks, that's the trial-by-jury system; I for one would be loath to trade it in); but they could recognize fraud and willful malfeasance when they saw it, and THAT'S why they decided to stick it to Merck.
This is not the case, at least in urban Texas. Most, i.e. 75% of jurors summoned in Harris County, Texas (Houston) are 'no shows.' Those who do respond tend to be responsible, fairly civic-minded, conservative and very cynical.The tobacco cases should have taught the lawyers a lesson.
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