<I>NEJM</I> punishes reviewer for breaking embargo - The Scientist

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By The Scientist Staff

NEJM punishes reviewer for breaking embargo Was his treatment justified? Tell us what you think [Published 23rd April 2007 01:45 PM GMT]

The New England Journal of Medicine has banned Martin Leon, a cardiologist at the Cardiovascular Research Foundation, from reviewing studies and contributing editorials or reviews for five years, as a punishment for telling colleagues at an American College of Cardiology symposium that a trial comparing medication to stents for the treatment of clogged coronaries "was rigged to fail-and it did." The data was to be presented two days later, and published in NEJM soon after. The journal lifted its embargo early once the Wall Street Journal's health blog reported Leon's comments on March 25. (theheart.org first reported the ban story here, and the WSJ picked up on the story here.) So, were the journal's actions justifiable? Critics of medical and scientific journals have previously called for ending the so-called "Ingelfinger Rule" that puts restrictions on what authors can say about their studies before publication. For example, Vincent Kiernan's recent book makes this argument in a compelling way. The difference here, however, is that Leon wasn't an author; he was a reviewer of the paper. Notably, the NEJM didn't punish the authors of the paper, nor did they sanction the Wall Street Journal. "From the information we gathered, we were certain that an embargo break had occurred, and the WSJ was just reporting what it heard," NEJM spokesperson Karen Pederson told theheart.org. "The embargo was broken at the meeting, not by the WSJ." We'd like to hear from you on the subject of embargoes. To what extent should journals restrict researchers on papers that have been accepted for publication? What effect are blogging and other forms of instantaneous publication having on the reporting of scientific studies? And do you think that the time is right to reevaluate the embargo process? Post your comments here. By The Scientist Staff mail@the-scientist.com Original posting on WSJ's health blog http://blogs.wsj.com/health/2007/03/25/courage-to-stent W. E. Boden et. al., "Optimal medical therapy with or without PCI for stable coronary disease," NEJM, April 12, 2007 (published online March 26, 2007) http://content.nejm.org/cgi/content/abstract/356/15/1503 theheart.org's coverage of action against Leon http://www.theheart.org/article/786165.do WSJ health blog's coverage of action against Leon http://blogs.wsj.com/health/2007/04/19/prominent-cardiologist-rebuked-by-medical-journal J. Toy, "The Ingelfinger Rule: Franz Ingelfinger at the New England Journal of Medicine, 1967-1977," Science Editor , November-December 2002 http://www.councilscienceeditors.org/members/securedDocuments/v25n6p195-198.pdf Vincent Kiernan's Embargoed Science http://www.press.uillinois.edu/s06/kiernan.html Send us your comments for posting http://www.the-scientist.com/forum/addcomment/53112

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Comment on this news story

NEJM Punishes Reviewer......

by David Perlman

[Comment posted 2007-12-03 16:41:05]

Since I rebelled against the Ingelfinger rule many years ago when Dr. I. was still alive and editing the NEJM, and since I successfully proposed a more sensible embargo policy to his successors (which I then debated with Larry Altman of the NYT who HATES embargoes too)I still believe they can be helpful, particularly for us poor provincial reporters who don't get to attend all kinds of meetings where beans are spilled privately to favored journalists. (Forgive my long sentence ad nauseam.)
Anyway I find obeying pub. date embargoes set by Science, Nature, Lancet, NEJM, and other journals perfectly appropriate. As to arbitrary ones set by university PR people and others in the flackery business, I do object to them and have told them why I'm not going to obey them when I think they're unjustified.

Executive Director, InHealth

by Martyn Howgill

[Comment posted 2007-12-03 15:26:41]

A journal?s content and audience is entirely different from material reported in the NYT or the Horton Headlight. By forcing news media to withhold information in the public interest, arguably lives are at risk.

That said eliminating embargoes would place a burden on public media to understand the significance of new studies and to avoid sensationalizing. The value of peer-review is that bad science is weeded out through the vetting process.

I suspect media go along with the current system so that peer-reviewers can do the vetting, journals can signal the level of importance, and news can then carry with it the authority of a credible source.

Update: ACC sanctions Leon

by Ivan Oransky, Deputy Editor, The Scientist

[Comment posted 2007-05-22 15:26:43]

We received the following statement from the American College of Cardiology this morning:

The American College of Cardiology's Board of Trustees has approved sanctions against Martin B. Leon, M.D., F.A.C.C., arising from his statements that resulted in the breach and consequent premature lifting of the embargo on the COURAGE trial data presented at American College of Cardiologyￂﾒs 56th Annual Scientific Session in March. The Board accepted the recommendation of the College's Ethics and Discipline Committee to issue a letter of censure to and prohibit participation of Dr. Leon as a presenter, reviewer, or panelist during the ACC's next annual scientific session in Chicago in March 2008.

Embargo

by DS

[Comment posted 2007-04-24 22:37:05]

The journal was perfectly justified in banning the reviewer. It was irresponsible and unethical for the reviewer to break the news, news that wasn't his to tell. The "Ingelfinger Rule" isn't even the issue. In today's world of rapid economic gains and losses due to high tech communications, he was particularly negligent. A reviewer can mishandle the data to the extent that a competitor can use the information, in a way detrimental to the authors and the journal. Aside from financial risks, the reviewer took confidential information and "leaked" it. As reviewers in the scientific field are expected to self-regulate ethical and scientific issues, I think that we need to be held to a stricter standard of behaviour. The journal should be applauded for it's action, not condenmed.

Reviewers agreements and obligations

by R Bourey

[Comment posted 2007-04-24 20:27:42]

This has nothing to do with embargo - a word that by definition refers appropriately to issues of commerce. The fact the NEJM bars authors from discussing their own work is a separate issue. In this case, yet another reviewer couldn't resist a premature editorial comment on a paper he was privileged to review. He weighed his obligation to point out poor science at a propitious moment with his obligation to confidentiality as a reviewer. Wouldn't it be easier if more reviewers and editors simply axed these papers before publication?

I see the punishment as a reflection of the (appropriately) defensive position of the NEJM staff; they publish their share of high-profile studies riddled with design and statistical errors. (C.f., Freiman JA, Chalmers TC, Smith H Jr, Kuebler RR. Related Articles, The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. N Engl J Med. 1978 Sep 28;299(13):690-4.)

Embargo Restrictions

by Gary Levin MD

[Comment posted 2007-04-24 16:29:16]

I think once an article has been accepted for publication, releases of the information should not be considered unethical or illegal.

The issues should be reviewed in terms of today's technology, transparency and rapidity of electronic communications.

The caveat here is " accepted for publication".
Sometimes there are delays of months between acceptance and actual print journals.

Delaying of negative results, or adverse reactions
may necessitate informing physicians and the public about such matters.

misplaced question on embargo practice

by John Rodgers

[Comment posted 2007-04-24 16:02:37]

This issue here is not the utility of embargo policies but whether or not an egregious break of confidentiality took place, and what the appropriate response to that should be. Peer review is precious to science and medicine, and too often inadequate. At the same time, reviewing is hardly ever rewarded except in 'heaven'.

Wrong target

by Jeremy Wickins

[Comment posted 2007-04-23 20:31:13]

I echo what some other commentators have said here - there are two entirely separate issues. The issue that gave rise to this story is nothing to do with the Ingelfinger Embargo, and everything to do with unprofessional, and possibly illegal (under contract law), conduct by Martin Leon. If a reviewer has serious concerns about the article he is reviewing, then it should be taken to the editor - that is what peer-review is all about! Even if the reviewer does this and the recommendation is ignored, their is no way under the contract between reviewer and publication that any comments can be made pre-publication. It is breach of confidentiality, pure and simple.

The issue of the Ingelfinger Embargo is complex, involving free speech, control of results, copyright, confidentiality, and contract law. I'm old-fashioned enough to believe that the people who do the research have a rebuttable right, and possibly a duty, to do and say anything with and about the work they have done, but the issue of funding is vital - the old English saying "He who pays the piper calls the tune" is operative here.

Embargo

by Errol Prasad

[Comment posted 2007-04-23 19:41:28]

NEJM is justified to censor the reviewer. Rules and regulations for reviewers are clearly delineated. If the reviewer had issues he should have discussed it with the NEJM Editor first, and/or refused to review the manuscript. If it is time to re-evaluate the embargo process than lets do it, but don't put the cart before the horse.

NEJM embargo

by Rolando Calderon

[Comment posted 2007-04-23 17:30:20]

The problem is that frequently the studies are funded by the industry and revealing the results in advance has repercusion in Wall Street and the NYSE.That is the problem.
Rolando Calderon,M.D Lima PERU

this wasn't breach of embargo; this was breach of confidentiality

by Eve Barak

[Comment posted 2007-04-23 16:38:05]

If the article is correct that the spiller of the beans was a reviewer of the paper, then this constitutes a breach of confidentiality. This has nothing to do with "embargo" of news.

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