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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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March 13, 2008

Pfizer vs. the NEJM: A Legal Showdown

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Posted by Derek

Today (March 13) at 3 PM EST, there's a hearing scheduled on a legal motion that could change the way scientific results are published in this country. Pfizer is being sued over injuries that plaintiffs believe came from their use of Celebrex, one of the world’s only remaining Cox-2 inhibitor drugs. (I saw a Celebrex tv ad the other day, a surreal thing which was basically a lengthy recitation of FDA-mandated side effect language accompanied by jazzy graphics). Everyone with a Cox-2 compound is being sued from every direction, as a matter of course. The company is, naturally, casting around for any weapon that comes to hand for its defense, as did Merck when that same sky began to come down on them.

But Pfizer’s lawyers (DLA Piper LLP of Boston) are apparently (your choice, multiple answers permitted) more aggressive, more unscrupulous, or more clueless than Merck’s. Among the points at issue are several papers from the New England Journal of Medicine. According to the motion, which I paid to download from PACER, two of the particularly contentious ones are this one on complications after cardiac surgery and this one on cardiac risk during a colon cancer trial. So Pfizer has served the journal’s editors with a series of subpoenas. They’re seeking to open the files on these manuscripts – reviewer comments, reviewer names, editorial correspondence, rejected submissions, the lot. What are they hoping to find? Oh, who knows – whatever’s there: ”Scientific journals such as NEJM may have received manuscripts that contain exonerating data for Celebrex and Bextra which would be relevant for Pfizer's causation defense” say the lawyers. The journal refused to comply, so Pfizer has now filed a motion in district court in Massachusetts to compel them to open up.

What's particularly interesting is the the journal has, to some extent, already done so. According to Pfizer's "Motion to Compel", the editors "produced a sampling of forms identifying the names of manuscript authors and their financial disclosures, correspondence between NEJM editors and authors regarding suggested editorial changes and acceptance and rejection letters". The motion goes on to say, though, that the editors had the nerve to ignore the broader fishing expedition, only releasing documents for authors specifically named in the subpoenas, not "any and all" documents related to Celebrex or Bextra. They also withheld several documents under the umbrella of peer review and internal editoral processes. Thus, the request to open up the whole thing.

I’ve never heard of this maneuver before. Staff members of the NEJM gave depositions in the early phases of the Merck litigation, since the journal was in the middle of the Vioxx fighting. (They’d “expressed concern” several times about the studies that had appeared in their own pages and passed through their own review process). But even then, I don’t think that Merck wanted to open up the editorial files, and you’d think that if anyone had something to gain by it, they would.

Pfizer’s motion seems to me more like a SLAPP, combined with standard fishing expedition tactics. Their legal team doesn’t seem to think that any of this will be a problem, at least as far as you can tell from their public statements. They say in their motion that they don’t see any harm coming to the NEJM if they comply – heavens, why not? Reviewers will just line up to look over clinical trial publications if they think that their confidentiality can be breached in case of a lawsuit, won’t they? And the rest of the scientific publishing world could look for the same treatment, any time someone published data that might be relevant to someone’s court case, somewhere. Oh, joy.

Pfizer’s motion states that ” The public has no interest in protecting the editorial process of a scientific journal”. Now, it’s not like the peer review process is a sacred trust, but it’s the best we’ve been able to come up with so far. It reminds me of Churchill’s comment about democracy being the worst form of government until you look at the alternatives. I realize that it’s the place of trial lawyers and defense teams to scuffle around beating each other with whatever they can pick up, but I really don’t think that they should be allowed to break this particular piece of furniture.

And I can’t see how the current review process won’t get broken if Pfizer’s motion is granted. The whole issue is whether the journal's editors can claim privilege - if so, they don't have to release, and if not, they most certainly do. This can't help but set a precedent, one way or another. If there's no privilege involved in the editorial process, a lot of qualified and competent reviewers will start turning down any manuscript that might someday be involved in legal action. (Which, in the medical field, might be most of them). The public actually does have an interest in seeing that there is a feasible editorial process for scientific journals in general, and I hope that the judge rules accordingly.

In the meantime, for all my friends at Pfizer and for all the other scientists there with integrity and good sense: my condolences. Your company isn’t doing you any favors this week.

(One of the first mentions of all this was on the Wall Street Journal’s Health Blog. The comments that attach to it are quite interesting, dividing between the hands-off-peer-review crowd and a bunch of people who want to see the NEJM taken down a few pegs. I can sympathize with that impulse, but there has to be a better way to do it than this. And there’s more commentary from Donald Kennedy, editor of Science, here (you can pretty much guess what he thinks about this great idea).

Comments (18) + TrackBacks (0) | Category: Cardiovascular Disease | The Scientific Literature | Toxicology | Why Everyone Loves Us


COMMENTS

1. sror on March 13, 2008 9:43 AM writes...

Pfizers best bet was to keep on comparing celebrex to some of older COX inhibitors that have similar MI / CVD risk profiles. They had a very good chance in defending that position because good data already exists or can be generated quite quickly. IMHO they have chosen the wrong approach to the problem.

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2. anon on March 13, 2008 11:39 AM writes...

I don't get your concern. Surely the editorial / review process is not so shockingly crap that it has to hide behind privilege?

(Still thinking about your post, may post more later. I was going to say something like, surely the review process is a valid scientific process under the Daubert Standard ... but then again, it isn't, is it?

This lead me to start pondering about the nature of knowledge and epistemeology etc etc).

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3. MTK on March 13, 2008 3:01 PM writes...

anon,

Are you a scientist that has published and reviewed papers? I ask not out of elitism or anything, but only because I think that most scientists would agree with Derek's sentiments and that most would agree that confidentiality is critical to the peer-review process. If you are someone very familiar with the process, I'd like to know why you think the Pfizer action will not adversely effect the process.

I don't quite understand your statements regarding the Daubert Standard, which as I recall is about admissibility of expert testimony, although I'm not a lawyer, so perhaps it does apply here. The crap-hiding-behind-privilege statement is also puzzling to me. What do you mean by that?

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4. TFox on March 13, 2008 3:47 PM writes...

I'm no lawyer, but I'd be surprised if the court didn't allow the requested discovery. NEJM's view seems to be that their internal editorial policy ought to trump the court's ability to fairly decide a case based on all the available evidence. Courts tend to disagree with that sort of thing, and they are the ones who get to decide. If there's a compelling public interest in maintaining confidentiality of something (which is pretty rare; mostly your private affairs are no longer so once they end up in court), the court has ways to do that, such as keeping things under seal. But you still have to give up the info. It'd be interesting to read analysis from an actual lawyer, especially one trying to defend NEJM's position.

A completely separate question is whether this is good public policy. I think I'd argue that it is; imagine a world where Congress or the courts carved out a special new kind of privilege for journals, one that not even a court could breach. Talking to your editor now has the same meaning as talking to your lawyer or your priest. Everyone with something to hide would create a journal...

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5. MTK on March 13, 2008 4:12 PM writes...

In thinking about the case at hand, could not a compromise be that NEJM hand over the copies of the documents, but that the identities of the reviewers and any hints to their identity be excised. Regardless of who the reviewers may be, any case is going to be somewhat a battle of the hired experts anyway, so while Pfizer may argue that some evidence may be present in the reviews, I'm not sure how they could argue that the reviewers' identities are important.

Can the judge grant part of the motion?

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6. CMC guy on March 13, 2008 5:23 PM writes...

Maybe I am stretching a bit but wouldn't journals such a NEJM be more akin to newspapers and magazine who do maintain protected confidential sources. I lean toward view that could potentially be harmful to process as Derek indicates although under hope that submitters, editors and reviewers always act honorably without bias in their conveyance of scientific information (which unfortunately is not world we live in)

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7. sroy on March 13, 2008 6:46 PM writes...

Maybe Pfizer's lawyers should google " Pyrrhic victory ".

Then again they are paid by billable hours, so it is their interest to create more work.

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8. Kelly on March 13, 2008 8:32 PM writes...

An interesting article

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9. Gibbon1 on March 14, 2008 3:23 AM writes...

"Maybe I am stretching a bit but wouldn't journals such a NEJM be more akin to newspapers and magazine who do maintain protected confidential sources."

I don't think there is any stretching involved at all.

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10. anon on March 14, 2008 10:42 AM writes...

MTK - my comments boil down to:- does the editorial / review process need to be privileged? If it does need to be privileged, doesn't that suggest that there is something wrong with the process?

(The Daubert comment was speculation as to the motives of the lawyers).

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11. Still Scared of Dinosaurs on March 14, 2008 11:30 AM writes...

IANALSTMBTC* - One possibility would be that anyone named in the NEJM corresponcence might be challengeable as an expert witness. If Pfizer's lawyers thought that they could eliminate some of their strongest critics from appearing in court it might be worth the costs of the action to them. If this is unlikely does it suggest any similar benefit?

*IANALSTMBTC = I Am Not A Lawyer So This Might Be Total Crap

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12. Anonymous on March 14, 2008 12:43 PM writes...

anon,

My short answer is "No".

The long answer is that confidentiality does not suggest the process is wrong, because it is the centerpiece of the process. Due to confidentiality, reviewers are free to criticize, trash, or reject a manuscript without fear of the repercussions. For example, let's say you get a manuscript to review from someone you know sits on a NIH review committee. You might not be so critical of that manuscript if you've got a grant application for review. Or let's say the paper's author would very likely be reviewing one of your manuscripts in the future, once again you'd be less likely to be open about it. There are a lot of other examples of how confidentiality protects the integrity of the process. As in most cases confidentiality is meant to encourage openness not hide anything. Of course, this means that editors need to be diligent about avoiding potential conflicts of interest and that reviewers need to be upfront about disclosing potential conflicts of interest.

Still scared,

That's a good point. I guess the other scenario that came to mind subsequently was that if someone were now expert witness for the plaintiff, but had not expressed concerns as a reviewer that they could blunt that testimony.

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13. Still Scared of Dinosaurs on March 14, 2008 3:01 PM writes...

Anonymous...'xactly! I kinda though I was in the right ballpark but unsure of what was realistic and likely to be effective in court. I think your take is much more likely...and it raises the additional idea in my mind that if the expert reviewers as a group had reasonable differences of opinion about safety then it is reasonable to claim that the company didn't ignore clear evidence that the drug was unsafe. I don't think this assertion would sway a lot of opion on a jury (or a blog) and it would only require coding reviewers not identifying them by name.

As far as confidential comments from reviewers, the danger is that reviewers will undercut competitors for the glory of dominance in a research area. I'm sure any number of posters here could name an area of research in which they could name most of the folks who would be asked to review their papers. One bad apple and you have a delay in publication in a journal with lower prestige. As you said, diligence is required...maybe we could find a respected blogger who could request his readers to send in their peer review horror stories.

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14. Suicyte on March 15, 2008 11:51 AM writes...

Just in case anybody is interested, i also have a post with some thoughts on the Pfizer vs. NEJM stuff. It is from february, though, so it doesn't contain the latest information. http://suicyte.wordpress.com/2008/02/28/review-confidentiality-and-related-issues/

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15. MTK on March 18, 2008 11:53 AM writes...

Update: The Court ruled against Pfizer stating that they did not adequately address how the peer review documents would help their case. Therefore, the judge ruled that whatever probative value could be gained did not outweigh the harm that would have been done.

http://sciencenow.sciencemag.org/cgi/content/full/2008/314/1

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16. Richard on March 20, 2008 9:47 AM writes...

Careful - that Science story says that the Court ruled against Pfizer in the case of documents they were seeking from JAMA. We are still waiting for the NEJM decision.

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17. jk on March 31, 2008 9:45 PM writes...

As a physician and clinical researcher, I can easily state the NEJM and JAMA created a witch hunt against Merck and Pfizer to generate sales of their journals. The more they bash them, the greater the media play, and the more journals (and ad space)they sell. What is to be looked for in the subpoena aren't names, but what was said. Confidentiality could be maintained, but what might be shown by the editors' comments back to the authors was a bias by the journal to only publish that which inflames the controversy and thereby sells journals. For example, it is well known the NEJM takes months to review a paper. Yet when they wanted to have an issue dedicated to Vioxx deaths, they had articles slide through in WEEKS in order to get them to the media's attention. Yes, the editorial and reviewer comments should be seen, but not the reviewers' nor editors' names.

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