Given the fallout from ACC.13, where the PREVAIL study was pulled from the late-breaking lineup because the trial sponsor released the data before the embargo lift, many have continued to question the embargo process, especially due to the increasing frequency of such events. Cardiovascular Business spoke with Ajay J. Kirtane, MD, about this controversial topic.
Kirtane, chief academic officer and director of the interventional cardiology fellowship program at Columbia University Medical Center/NewYork-Presbyterian Hospital in New York City, responded to these questions via email:
Are there flaws in the current embargo process for the cardiovascular medical meetings?
It seems that virtually every major cardiovascular meeting has had an embargo-related issue over the past few years. Aside from "breaks" of the embargo, it has become more and more commonplace for companies to release the "overall" trial results due to shareholder and earnings-related issues. Therefore, the meaning of an "embargo" seems to have been lessened somewhat over the past few years.
Should press be able to vet clinical data before it has been presented to and debated among the cardiovascular community?
This is a tough question. I don't see why the press should be vetting these data before the medical community per se. In fact, the press rely heavily on opinion leaders to formulate (or color) their assessment of major trial results.
Is there an alternate approach?
Actually, I think a novel format should be considered to a process where the trial results are presented (could be online or on a restricted call de-novo to all) for an honest and critical debate among selected medical professionals and the press. This presentation could then serve as the basis for further press coverage. This, in some respects, would prevent "over-spinning" of the data.
Based on the changing face of blockbuster trials and the results unveiled, are annual medical meetings losing their relevance?
Not at all. The networking opportunities and educational opportunities are better than ever. However, the era of the hyped late-breaking trial (where everyone waits with bated breath until the trial results are presented) seems to be at an end, because increasingly trials have had their overall results released to the press ahead of time. While that's unfortunate, it is also just a function of the information age in which we live. I am increasingly unsure that embargoed late-breaking clinical trials are necessarily driving meeting attendance.
While this process is unlikely to resolve itself in the near future, there is a growing awareness of the consternation surrounding the process. In the American College of Cardiology’s press survey of the annual meeting process, they specifically asked about whether it is helpful to have simultaneous publications with the peer-reviewed journals.
As Kirtane intimated, the current trend toward having information available immediately in this digital age may ultimately swing the pendulum of the current embargo process more than anything.