Shalom “Shal” Jacobovitz will be the new chief executive officer of the American College of Cardiology, the ACC announced today. Jacobovitz is currently the president of the US division of Actelion Pharmaceuticals, best known for its pulmonary hypertension drugs.
Click here to read the complete story on Forbes.
The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation.
To understand this event we first need to know what happened in the week before the ACC. And there’s a major gap in the story that has not come out before that I think holds the key to a full understanding of the story.
More than a week before the scheduled presentation I received an email invitation from a PR firm representing Boston Scientific:
“If you have any interest in speaking about the trial under embargo with Dr. Ken Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific, I have a few slivers of availability early next week. As you know, the embargo lifts at the time of presentation and I’ll need written confirmation of your embargo agreement.”
Now I’ve been down this road before, as some of you may recall. Several years ago I was offered embargoed access to data from an important upcoming trial by Medtronic (suggesting that this is a systemic problem) under the condition that I agree to a briefing from a trial investigator. I told the company that I would respect the embargo but that I wanted to review the data on my own and that I would get back to them if I had any questions. Their response: no briefing, no data.
Here’s the problem in both cases: forcibly linking access to the trial data with a company-arranged briefing is an egregious perversion of the embargo system.
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Click here to read the full post on Forbes.
UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that the scheduled presentation of the results at the main opening session of the meeting would not take place.
By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the principal investigator of the trial, David Holmes, would only “present the acute procedural safety results” from the trial. Then the company reversed itself two days later and announced that Holmes would present all three co-primary endpoints.
Holmes intended presentation this morning at the ACC in San Francisco makes clear why there was so much confusion. (The slides from his presentation have been made available to the media.) Although the trial results appear largely positive, the trial missed one of its three primary endpoints, and experts will likely spend a lot of time and energy trying to interpret the results.
Click here to read the full story on Forbes.
Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.
Read my complete story on Forbes, along with a list of the late-breakers.
