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April 19, 2007 -- 12:26pm EDT

Banned in Boston
In today's news from theheart.org, Shelley Wood reports that the Boston-based New England Journal of Medicine has banned Marty Leon from its panel of peer-reviewers, and furthermore will not be inviting Dr. Leon, one of the highest profile interventional cardiologists in the world, to write reviews or editorials for the Journal for a period of five years.

This action was taken in response to Leon's alleged breaking of the press embargo around the COURAGE trial, which was scheduled to be presented on Tuesday morning, March 27, at this year's American College of Cardiology annual meeting in New Orleans -- and simultaneously published online by the New England Journal. The five-year COURAGE trial studied whether angioplasty/stents added to medical therapy provided any additional benefit in reducing death and heart attack in stable patients.

In the weeks leading up to the ACC, the trial had been the subject of much press hype and statements from non-interventional cardiologists that, if the results showed no benefit for stents over drug therapy, it would "shake the foundations of interventional cardiology" -- a throwing down of the gauntlet to stent-evangelists like Marty Leon, one of the builders of that foundation.

As for the embargo, the Thursday before the ACC began, the NEJM gave the results of the COURAGE trial to all health reporters, this one included, so that we could prepare our stories. We were allowed to reveal those results to anyone we interviewed for an article. We just weren't supposed to publish or discuss the results in public until Tuesday morning.

Fast forward to Sunday night the 25th at the Hilton New Orleans Riverside hotel. The first two days of ACC presentations and PowerPoints were now over and many interventionalists were attending a free reception (food with open bar) and an evening "satellite symposium" about drug-eluting stents, sponsored by Boston Scientific. The final speaker was Marty Leon.

As Keith Winstein reported two hours later in the Wall Street Journal's Health Blog:

Leon...tipped the audience of several hundred doctors to the embargoed conclusions of the Courage trial about stents...adding that he had reviewed the Courage study after it was submitted to a medical journal. "It was rigged to fail, and it did," he said...."There's going to be an onslaught.... A lot of people have been taking shots at us, and we need to go on the offense for a while."

Boom. The Battle of New Orleans had begun. Or was it just "Marty Gras"? In any case, the whiff of grapeshot wafted across Convention Center Boulevard. Monday morning's WSJ ran a more detailed story. The embargo was broken. ACC and NEJM leadership was furious. They hastily scheduled a press conference and made the following statement:

At 1 p.m. Central time on Monday, the American College of Cardiology lifted the media embargo on the COURAGE trial that was to be presented on Tuesday. The decision was made after the College discovered that information related to the study’s results was released Sunday evening and that information was made public in a media article.... We are extremely disappointed that this individual or individuals released this information, betraying the confidentiality of the scholarly process and the professional integrity of the scientific community. The American College of Cardiology will be considering strong sanctions against the individual or individuals involved.

Boom. Boom.

Dr. William Boden, lead author of the COURAGE trial, was very disappointed at having to scurry around and not present the results of his five-year's worth of arduous study at the appointed time and place.

Now, not quite four weeks later, the New England Journal of Medicine has levied its penalty -- the ACC has yet to announce what, if any, sanctions it will take.

As for Dr. Leon, he has denied breaking the embargo, saying that his comments had been misunderstood, taken out of context by a journalist, that he didn't reveal any results, that he was talking to a room of cardiologists and did not know who was in the audience.

And as for Keith Winstein, the Wall Street Journal reporter, the NEJM stated that it did not have a problem with his article, because he was only reporting on the embargo break. Winstein reported to us receiving a similar sentiment from Steve Nissen, president of the ACC.

This incident, however, has a bit more back story -- which I'll be discussing in short order.

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