Boston, MA (Updated April 23, 2007) - Less than a month after the COURAGE trial results were purportedly leaked preembargo by Dr Martin Leon (Columbia University, New York, NY) and others at a satellite symposium, the New England Journal of Medicine (NEJM) has opted to remove Leon from its stable of peer reviewers, an authoritative source—who asked to remain anonymous—told heartwire. The NEJM will also not be inviting Leon—one of the world's most recognized interventional cardiology researchers—to author reviews or editorials for the journal for the next five years.

Leon, who agreed to speak with heartwire, acknowledged that he learned of the NEJM's decision by letter, which made no mention relating to the submission of original research articles to the NEJM, and an NEJM spokesperson confirmed that the journal would not "take any step that would preclude high-quality research from being published."

To heartwire, Leon said, "I do not want to comment on the fairness of this decision, as I have great respect for the NEJM editorial leadership."

The COURAGE trial was scheduled for presentation March 27, 2007 during the final late-breaking clinical-trials session of the American College of Cardiology (ACC) 2007 Scientific Sessions, but members of the press were permitted to unveil the results one day early after the Wall Street Journal (WSJ) reported details of the trial, discussed at a Boston Scientific evening symposium on the 25th. At that time, the ACC and NEJM jointly decided to lift the embargo on the trial, and ACC president Dr James Dove told heartwire the college would be investigating.

Now, an ACC spokesperson confirmed that the matter has been referred to the ACC's committee on ethics and discipline, which is still reviewing the situation. They will ultimately make a recommendation to the ACC's board of trustees, and any sanction will be made available to the public. The ACC spokesperson also stated that the college "has not been contacted by any federal or other entities in connection with this matter."

Leon told heartwire he has "been given the opportunity to present corroborating evidence to explain my viewpoint"—this evidence is currently under consideration by the ACC ethic's committee.

"I do not believe that it would be appropriate to comment on the specifics or the process until the ACC has made a final determination. As I have previously discussed. . . . I do not believe that I violated either the spirit or the substance of the embargo, but rather that I was victimized by an overly enthusiastic reporter in the audience who misinterpreted my general opinions to be a 'declaration of study outcomes.' None of the actual results from COURAGE were discussed, and my opinions were shared by several of the other physician panelists."

The NEJM has a policy of not confirming or denying the identity of its reviewers, saying that the peer-review and editorial process is confidential; it therefore would not discuss details of its decision with heartwire. In a statement, NEJM spokesperson Karen Pederson commented, "Any breach of ethics by a reviewer would be considered a serious but private matter. We would not make information about the actions taken a matter of public record."

Pederson also confirmed that no sanctions are being levied against the journalist who wrote the WSJ story, Keith J Winstein. "From the information we gathered, we were certain that an embargo break had occurred, and the WSJ was just reporting what it heard. The embargo was broken at the meeting, not by the WSJ."

As previously reported by heartwire, the WSJ quoted Leon as saying, during the symposium, that COURAGE was "rigged to fail, and it did."

At the time, Leon told heartwire that he and other panelists were asked about their "interpretation of what we imagined the COURAGE trial results might be. . . . No data from the study were discussed, no reference to where the study was being published was discussed, none whatever."

But Leon also confirmed that he did mention he had been a reviewer for the COURAGE paper in the NEJM, a disclosure that casts into question just how speculative his comments about COURAGE could have been. That admission seems now to have come back to bite him.

Pederson insisted that the NEJM takes "very seriously" the need to keep reviewers confidential, adding that the COURAGE trial had more than one reviewer. "Whether or not a reviewer decides to honor that confidentiality, we still need to do it out of respect for the authors and out of respect for the process," she said. "There are a number of reasons why we stop using reviewers, and it's usually because they're not responsive or their reviews aren't very useful. But a breach of ethics is a very rare occurrence."

She also pointed out: "Reviewers are told specifically that the information is confidential and not to be shared."