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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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« Grand Rounds | Main | An Expensive Way Back for Celebrex »

December 13, 2005

The New England Journal of Legal Immunity?

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Posted by Derek

Why did the New England Journal of Medicine come out with their "expression of concern" last Friday? The more I think about the situation, the more I'm coming to agree with a speculation that I first saw over at Medpundit.

Don't get me wrong: I think Merck had every intention of making their VIGOR data look as good as possible when the study was published. Companies do that, and they should be punished when they push things too far. But if these three MI cases that we're disputing really did occur after the cutoff date for the study, then Merck had every right to exclude them from the data. (They had to be reported to the FDA, though, which is exactly what happened when it came time for approval). So why is the journal so worked up?

I don't know if this was a deliberate attempt (as some have speculated) to affect the outcome of the first Federal Vioxx case (now declared a mistrial). I hope not. But what I do think is that it was an attempt to clear the NEJM as a target of future lawsuits. Look at the sequence of events: the journal discovers the editing discrepency four years ago, but does nothing. Vioxx goes to the FDA for approval, goes on the market, sells in huge amounts, is hit with concerns over cardiac safety, is withdrawn from the market and is the subject of FDA and Congressional hearings. During this whole time, the journal and its editors say. . .nothing. Merck is hit with hundreds, then thousands of lawsuits. The first case goes to trial, and Merck loses with a huge jury award. But they win the second one, as the weeks and months go on. And the New England Journal keeps quiet.

Then the first Federal case starts up, and the journal's editor is brought in to give a deposition. And now the editorial staff springs into action, rushing out an unprecedented comment on a paper from their own journal that manages to publish on a Friday afternoon. All of a sudden, somehow, things couldn't wait.

Could it be that the plaintiff's attorneys, while questioning Gregory Curfman, mentioned that there could be more targets for litigation than just Merck? You run a prestigious journal there. . .probably influenced a lot of physicians to prescribe Vioxx, eh? Didn't see anything odd in the cardiovascular data, you say? Why, that's nearly a tort right there. . . I don't like to think that this is what happened. But it's not impossible, either. The journal's actions look like those of an organization that fears the legal discovery process. And why would you fear that, unless you fear that you'll be sued?

Comments (18) + TrackBacks (1) | Category: Cardiovascular Disease


COMMENTS

1. Matt on December 13, 2005 10:46 PM writes...

Under what possible theory of liability would the NEJM be held liable? Stick to the science.

Permalink to Comment

2. Derek Lowe on December 13, 2005 11:07 PM writes...

Matt, under what possible theory of liability are many suits brought? I'm not saying that this is what's happened here, but I can't rule it out, either. This revelation - a gift to the plaintiff's bar - has been sitting around at the NEJM for years now, and something finally shook it out of them. What was it?

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3. Matt on December 13, 2005 11:21 PM writes...

Negligence, fraud, breach of contract, etc. are all theories that are used. The speculation you're engaging in is more befitting Overlawyered than this blog.

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4. Jim Hu on December 14, 2005 12:38 AM writes...

Derek, your earlier post stimulated me to look at the followups on the story - the trackback from the post I wrote has scrolled off due to the Grand Rounds pings, so I don't know if you saw it while you were assembling everything else.

IANAL, but I agree that they're acted like people worried about something. They dug the files up right after Vioxx was withdrawn...and then didn't say anything for a year. Also, the original paper was around the time of a scandal about industry-friendly review at NEJM.

Matt, if you're the Matt I think you are (I recall a Matt commenting a lot about malpractice on various blogs after other Grand Rounds), you're a lawyer, right? Would NEJM be vulnerable if accused of conspiring with Merck to hide the cardio risks of Vioxx based on, say, choice of reviewers?

Permalink to Comment

5. Matt on December 14, 2005 12:47 AM writes...

I wouldn't think they could unless someone could show that they relied on the NEJM recommendation and that the NEJM had a specific duty to them. It's just too far a reach for a court to honor it. If it were a viable cause of action, someone would have done something like successfully make a claim against Forbes for favorable articles on a company that subsequently tanked.

It's really not that surprising that they discovered this now. They had received a subpoena for a deposition and they reviewed their files in preparation for it. A closer look turned it up.

Permalink to Comment

6. Jim Hu on December 14, 2005 1:42 AM writes...

I guess what I haven't seen is when the subpoena was served. The coverage says they did the review a year ago...deposition was last month, but these things do drag out, don't they. But this is how the editor described events to the Boston Globe:

'A blockbuster drug was withdrawn from the market, and we had published a pivotal article on that drug, and we wanted to refresh our memory on what was in the file," Curfman said.

Forbes says:
The editors weren't sure what to make of the finding, so they kept quiet.

That suggests to me that the subpoena was later. Or that they're spinning to make it look that way.

So... Forbes wouldn't be liable if they not only pumped the stock but also had data in their possession that showed it was going to tank? I wonder if Eliot Spitzer agrees on that.

Unlike Forbes, NEJM claims authority based on peer review. And they don't say that past performance is not a guarantee of future returns. The whole point of scientific/med publications is that the phenomena described are supposed to be predictable and reproducible. You don't think you could get the deceased's MD to say on the stand: "I discount the stuff from the pharma flacks, but this was good enough to be published in the top medical journal so I thought the risks must be low"?

Permalink to Comment

7. Jim Hu on December 14, 2005 1:53 AM writes...

Weird...I wrote a reply comment and it said it would be held for moderation. Never seen that here before (and I hope it doesn't result in a double post). Shorter version:

The coverage says that they reviewed as soon as they heard about the withdrawal and "weren't sure what to make of the finding, so they kept quiet"...for a year. Not clear about the timing of the subpoena.

Not sure I buy the Forbes analogy - what if they knew it was going to tank and flacked it anyway?

Permalink to Comment

8. Kyra on December 14, 2005 7:31 AM writes...

The bottom line is that the NEJM is not the esteemed journal it purports itself to be. Past editors lambast industry while accepting the very research they are ridiculing. You need cut-off dates and such for publication but they should have pulled back the curtain in terms of patient care. One could make the case they are no better than Merck in terms of protecting their interests instead of that of the patient or physician.

Permalink to Comment

9. JSinger on December 14, 2005 8:38 AM writes...

Honestly, I hadn't made that observation on the previous stories here because I'd thought it was obvious that this was a panicky CYA move on the legal front!

Matt: Something you may not have caught, that I think is what is making the scientists suspicious, is that this is completely outside any normal practice for handling this sort of matter.

Permalink to Comment

10. Matt on December 14, 2005 8:51 AM writes...

That may be true that it is. I certainly can't speak to that. I can't imagine the editors are deposed over many articles, though.

Still, though, I have yet to hear a viable cause of action which would make the NEJM liable to anyone. And I'm sure they have fine lawyers that would advise them of that.

Permalink to Comment

11. P.K. Scott on December 14, 2005 8:53 AM writes...

While NEJM probably wouldn't have any legal liability, I am quite sure the editors would like to do all that they can to avoid being deposed again in any of these Vioxx cases. However, I can't help but think this will backfire on them. Why should any pharmaceutical company publish a clinical trial in NEJM after this for fear of NEJM doing the same thing to them?

Permalink to Comment

12. John Johnson on December 14, 2005 9:32 AM writes...

Whether NEJM is legally liable or not is almost a secondary question. Just fielding the lawsuits is something I'm sure every pharma company has built into the budget because, well, no drug is absolutely safe and people sue. However, I doubt that NEJM is as prepared.

Permalink to Comment

13. biohombre on December 14, 2005 10:08 AM writes...

I tend to agree with Derek's questioning. My question for Matt: Are you confident that there is NO STATE in which the NEJM could be implicated in a legal action?

Permalink to Comment

14. Matt on December 14, 2005 10:53 AM writes...

What they are doing would not make it less likely for them to be deposed. If it would do anything it would make them MORE likely to be deposed.

As for being "implicated" in a legal action, anyone can be "implicated". Any crazy person can file a small claims suit against anyone even without a lawyer. Doesn't mean it will go anywhere. It can't be judged meritless until it exists, and we don't allow court clerks to judge merit.

Permalink to Comment

15. Palo on December 14, 2005 11:44 AM writes...

The NEJM clearly says: "Until the end of November 2005, we believed that these were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000".

By saying that "the journal discovers the editing discrepency four years ago, but does nothing", your are mistakenly emphasizing the the wrong problem.
I don't think the issue is really the discrepancy. That, the editors might have known, but they could have thought (correctly in my view) that there was a good reason for the change in the table (maybe the data was wrong in the first draft) The issue is that now they found out that the authors KNEW that the data was legit and deliberately changed it.

Permalink to Comment

16. Greedy Trial Lawyer on December 15, 2005 7:11 AM writes...

If the fear of facing discovery depositions or becoming a defendant in a lawsuit is what caused the NEJM to publish the "expression of concern" I believe the public has been well served by our civil justice and tort systems. The entire Vioxx disaster demonstrates why Greedy Trial Lawyers are needed.

Permalink to Comment

17. tom bartlett on December 15, 2005 8:32 AM writes...

To Greedy Trial Lawyer: our country has NOT been well served. Merck did nothing wrong, and they will have to spend millions proving this. This whole thing, at the end of the day enrichs ONLY the scum-sucking lawyers.

Permalink to Comment

18. Susan on December 16, 2005 5:14 AM writes...

Great info! Maybe it's offtopic, but i just wanted to say, that O, it's really interesting to read everything this with comments... You,professionals, discuss here a lot of interesting things on different news =). Thanks =)

Permalink to Comment

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