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December 08, 2005

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Comments

Stan

Hmmmm....and Ted is conspicuously absent....

Ted

"Conspicuously absent"? Geez, I can't go to a Christmas party and then have dinner with Christina Hoff Sommers, I have to respond to an Evan post in under 3 hours? Which one of you is going to spring for a Blackberry so I can get instant notice when Evan makes a phony-baloney post?

The NEJM editorial looks awfully fishy to me.

* The "omitted" data in question was outside the pre-determined scope of the study and wasn't available until after NEJM had signed off on the original article.

* The "omitted" data was revealed to the FDA in 2000 and published in 2001, and the NEJM editorialists admit they knew about it then four years ago.

* The "omitted" data doesn't materially change any of the conclusions of the study.

Why make a press release at 5 pm on the day of the closing argument? This looks like an attempt to taint the federal jury--and the NEJM editorial writers say they got their information from a deposition.

The after-market drop was much greater--the stock was down to 28. Excellent buying opportunity once the market realizes this is a story about nothing. One day I'm going to open a hedge fund and make a mint just on plaintiff-planted press releases.

Stan, I'm beginning to wonder whether you're really a defense lawyer. If you'd ever worked on a case of any significance, you'd see this sort of garbage tactic all the time and would know not to view it so credulously.

Ted

Oh, and the "omitted" data was right there on the Vioxx label after Merck negotiated with the FDA about the proper warning. Really now.

Ragout

Now Ted says the NEJM press release "looks like an attempt to taint the federal jury" and calls it a "plaintiff-planted" press release. Well, I guess if top universities are filled with tenured junk scientists, as Ted claims, the NEJM might be too.

Ted, I notice that the AEI seems to have a reputable scientist (Calfee) on its tort reform staff, and that he's never endorsed a single one of your wild accusations. That doesn't bother you at all?

Ted

The NEJM sat on this for four years and suddenly decided that it was such a scandal that it merited not just an editorial, but a press release announcing the editorial, and that its editors should be available to the press in the evening to sneer at the Merck response without addressing Merck's explanation or identifying precisely what the material difference is between Bombardier and the fully published VIGOR that justifies the sweeping statements in the editorial. (The last is especially curious given the underlying accusation is one of omission.) This is unusual for a scientist, but all too typical for an attorney trying to manipulate the press. So, yes, I'm suspicious of the motivations, and I don't think it's "wild" to note that that editorial is irresponsible and fishy based on the information NEJM has released and omitted to date.

Calfee is a resident fellow who works on his own issues rather than "on the tort reform staff." He doesn't answer to me, and I don't answer to him. I don't know whether he would agree with my assessment in the lengthier Point of Law post; I did discuss the issue with him when I saw him tonight socially, and he made a valuable observation that changed my assessment, but if he has something to say on the subject publicly one way or the other agreeing or disagreeing with me, he'll make his own statement.

Ted

Evan adds: the NEJM editors are alleging that the manuscript of the key VIGOR study was altered.

I just submitted a piece for publication to the Arkansas Law Review. I hereby admit that my manuscript was altered in the process of editing it. Lock me up now.

What manuscript submitted to NEJM hasn't been altered?

As I reread Bombardier, I still don't see a single sentence in there that's materially changed by the "missing" information. The editorial singles out the sentence "The difference in the rates of myocardial infarction between the rofecoxib and naproxen groups was not significant among the patients without indications for aspirin therapy as secondary prophylaxis" but the editorial's own Table 2 shows that this sentence is accurate even with the additional incidents added in. The abstract doesn't change with the additional information, either. The rate of MI in non-aspirin-indicated patients was 0.2% before the additional data is added, and 0.2% after the additional data is added. The sentence in Bombardier that reads "These [aspirin-indicated] patients accounted for 38 percent of the patients in the study who had myocardial infarctions" would instead read "These patients accounted for 33 percent of the patients in the study who had myocardial infarctions." So where's the material difference?

Now, if it's routine for medical journals to change the pre-established scope of a study to reflect new data, I acknowledge that that's meaningful. But Curfman didn't say that.

stan

Ted,

I am not all that experienced. I completely missed the "premier medical journal in the country conspiring with the plaintiff and subsequently releasing nationwide press release damning my client" tactic. I really should be more on guard.

Evan

Ted: There's a huge difference between the VIGOR study and your article to the Arkansas Law Review. Also, when you quoted my post in your last comment, you left out half my sentence. It's not merely that the VIGOR study was altered, but that it seems to have been altered to omit material information about the real cardiovascular risk of Vioxx.

It will be interesting to see how this news plays out, but I think you're really going on out a limb with this one. I don't know if you've factored into your analysis how revered the NEJM is as an institution. The news about the NEJM and the VIGOR study might turn a lot of the fence-sitting doctors against Merck. Keep in mind that in every lawsuit, several different treating doctors will be called to testify. Every doctor who prescribed Vioxx is potentially a witness in a case. Those doctors will be offering important testimony on the effect of warning labels and other issues. If they feel the same skepticism about Merck's actions with respect to the VIGOR study that led the NEJM editors to write their editorial, it could be quite a turning point in the litigation.

What about the issue of Merck's credibility following this news? Have you addressed that or am I missing it? What's the innocent explanation that's going to put Merck's actions in a better light? Do you think an innocent explanation is even needed?

One more point. I think your theory that the NEJM editors--the three top editors--are working in cahoots with plaintiffs' lawyers is really off the wall. You say the editors "sat on this for four years" but the editorial--which is very short, by the way--says they didn't learn the news about the alteration of data until late last month. Where are you getting that information about four years? And which plaintiffs' lawyers are the NEJM editors working with? You often write as if plaintiffs' lawyers all work as a single, cohesive group controlled by a solitary devious brain stored in a deep subbasement at the ATLA headquarters, but that's not how it is in real life. There are thousands of lawyers working on Vioxx cases and most of them have wildly different views about the litigation. But I don't think any of them are in real tight with the editors of the NEJM. In fact, those editors probably view plaintiffs' lawyers a lot like you do. There wouldn't be any love lost there. The simpler explanation is that the NEJM editors were troubled by what they learned in late November and are now concerned about the reputation of their great institution. I'm sure they don't want their publication to be perceived as something that's controlled by--that is, not independent of--the drug companies. That their editorial coincided with a closing argument in a trial is not surprising. Since there might be trials going on back to back for years, it would have been difficult to publish the editorial when something significant wasn't happening in the litigation world.

Ted

Evan, you're right in many ways; what's going to matter is the soundbite, rather than the underlying materiality of the facts, and NEJM, on their own or otherwise, has crafted a soundbite that a plaintiff's lawyer couldn't have drafted any better, and attorneys will be able to use the editorial effectively whether or not it's accurate. That NEJM timed the release in the manner most damaging to Merck, and that the editorial makes assertions that their own data patently doesn't support, may well reflect NEJM's editors' dissatisfaction with Merck rather than any conspiracy. There's certainly a lot of resentment in the medical community over pharmaceutical marketing in the DTC era, and that resentment has been fanned well by other plaintiff-planted press stories in the New York Times that give misleading descriptions of Merck training and internal documents. I don't have any evidence of a conspiracy. The scenario could be the one Evan describes, it could reflect persuasive lobbying (directly or indirectly), it could be something else. All I said was that the totality of the circumstances was fishy, and I still think it is. Will Curfman suddenly become a well-paid expert witness? Probably not, but I also won't be surprised if he does.

I know of a law firm that had a pretty solid practice dealing with the fallout of bogus plaintiff-planted stories that supposedly credible news organizations would repeat credulously. I don't see why NEJM is any more immune to this than Emmy-winning newsmagazines, though Evan is correct that NEJM certainly has a good deal more goodwill to burn than Merck does right now in the medical community.

As data manipulation goes, the materiality of what Merck did in even the worst-case scenario isn't anywhere nearly as egregious as what Graham did openly in The Lancet, and noone has called Graham on it. Which is why I'm flabbergasted at the NEJM's reaction, which, at best, seems to reflect severe hindsight bias.

There are many reasons to delete tables from papers. Just the other day, ragout complained that Merck was improperly including strokes in measurements of CV effects in its discussion of VIGOR instead of just focusing on MIs because doing so made Vioxx look safer; now NEJM complains that Merck didn't include the stroke data when it focused on MIs in its NEJM publication of VIGOR.

"The editors first became aware of the additional [MIs] in 2001 when updated data was made public by the [FDA]."

Merck's innocent explanation in their press release is reasonable and straightforward. I don't know whether it's consistent with standard practice of medical journal papers, and the press hasn't yet asked the right questions to determine whether Merck's statement is disingenuous; unfortunately, the "he said, she said" style of modern journalism doesn't give much incentive to delve deeper when only one of two sides can possibly be correct.

The reason why, to me, the most innocent explanation makes the most sense, is that I can't imagine what motivation a dozen doctors would have to risk their professional careers over minor adjustments in data or presentation that doesn't materially change the conclusions of the paper, especially when the full data set will become public in a few months anyway. Of course, it's not impossible for people to do pointlessly stupid things if they don't think they'll get caught, and there may be other factors I'm not considering. There's always a cognitive bias in interpreting events to fit with one's previous statements, and I, like any other human being, do need to be personally on guard against that bias and ensure that I don't take a pretzelled position. If new evidence requires me to change my mind about some things I said a couple of months ago, it's better for me to change my mind. At the moment, the NEJM editorial looks like an overreaction at the very least, and I'd have to think that they would've fired their most persuasive arguments already rather than leading off with the ones that don't cut the mustard.

Justinian

I'd be curious how Merck can innocently explain away this quote from the NEJM article:

"We determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000."

Of course, the reason the NEJM chose to issue its first ever "expression of concern" isn't because it appears that Merck intentionally deleted relevant data, but because of the omnipotent plaintiffs' bar...

mythago

For crying out loud, the brain isn't in a sub-basement. ATLA put it right up in the sun room. You can go see it for yourself if you get tickets in advance.

The idea that NEJM doctors would have anything nice to say to or about plaintiffs' attorneys is laughable. Did Ms. Sommers give you a tinfoil hat for Christmas, Ted?

Ted

There was a very good discussion of this on Derek Lowe's blog. The doctors and scientists there were more outraged at NEJM than I was. One said:

There are any number of changes that a manuscript could go through prior to submission for any number of reasons. I've been known to put "fake" data into a manuscript in progress just as a placeholder to work out formatting, for example. Or to write in throw-away notes for sections I don't want to work on right away, such as "discuss BS paper by Smith et al. and why it's wrong". All of which could be greatly misconstrued by someone--especially someone with an agenda.

Another said:

The real question is whether conclusions are changed. Considering all patients, there was a significant difference in MI even without the new data, as correctly reported in the paper. For the nonaspirin group, there was no difference reported in the paper, and when you throw in the new events, there's still no difference (as Derek pointed out). Again, the paper remains correct. Finally, the most important question, where the risk comes from. The paper ascribes the added risk to the high risk aspirin group. The risk differential here is so large that even 3 new nonaspirin events don't change it; high risk patients on rofecoxib are keeling over at a rate 20x that of their low-risk cohorts (8+% vs 0.5%). Curfman calls this conclusion "misleading", but the new data gives you the same conclusion as the old!

So are calculations made "incorrect"? Only in a way that an innumerate reader would care about. Are the conclusions "incorrect" and/or "misleading"? No and no. This is basic stuff -- I doubt this "Editorial" would have made it through peer review without changes. I wonder what process NEJM used to assess it before going ahead and publishing? And will they be reconsidering that process going forward?

Matt

Ted, I don't think I've ever enjoyed reading you as much as I have these last few days.

Tom

Any thoughts on the Vioxx mistrial???

Evan

Tom: If the news accounts were accurate, the mistrial was good for the plaintiff, as the plaintiff only had one juror in her camp. If the case is retried, the evidence will probably come in differently. The NEJM news about the VIGOR study raises the issues I mentioned in the "update" to the post. Next time around, the plaintiff will probably do better.

Whether the mistrial means much to the overall Vioxx litigation, I'm not sure. There were some evidentiary rulings before the trial began that had greater significance, and would have had greater significance whether or not the plaintiff in this particular trial won or lost. That's the real story, but I guess it's easier for the media to report about the Vioxx litigation like a football game: 1 loss, 1 win, 1 tie or whatever.

I've been trying not to post about every Vioxx news report on the weblog because I'm not sure if most readers are as interested in it as I am.

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