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December 12, 2006 -- 2:45pm EDT

The FDA Stent Panel: A Catalytic Converter
I'm reflecting on last week's FDA panel, convened to discuss the issue of drug-eluting stent safety and late stent thrombosis. I plan to write over the next couple days about what happened there, but the important thing is that something DID happen there.

There were over 25 presentations given by industry representatives, cardiologists, surgeons, the three major professional cardiology groups, me and a patient who visits our Forum -- and for two days from 8:00am on, the panelists listened and asked questions, sometimes probing, sometimes challenging, and they debated among themselves whether to recommend that the FDA attach stronger warnings, change the labels, lengthen the recommended duration of Plavix or Ticlid and aspirin.

Even though the panel wound up disagreeing on several key issues and did not recommend many of the label changes that they might have (indeed, it is ultimately the FDA's decision as to what to do officially; the panel is only advisory) the bottom line is that these issues, which are complicated and unfortunately not easy to judge due to lack of sufficient and "good" data, these issues were aired in public, in a room of 500, many of whom were reporters, seated against the walls, close to power outlets, tapping away non-stop on their laptops and condensing the proceedings into stories instantly filed with the home office.

Regardless of the final recommendations, the current state of knowledge about these devices, the pluses and minuses, saw the light of day -- actually two days. And as they went on, one heard the constant refrain of the panel -- how does this translate into clinical benefit for our patients? I've observed lots of professional meetings where interventionalists debate p-values, relative risk assessment, which device is better, etc. But here you had a broader spectrum of active participants: clinical cardiologists, surgeons, statisticians, regulators, me, and The Patient (who truly moved the meeting with his story and plea for more support).

The FDA may or may not take any regulatory action right now. But the real action was the meeting itself. The cats were all let out of their bags. This time the FDA used its power as a catalyst: something that enables a reaction without becoming part of it. And that reaction, both professional and private, will certainly result in some self-imposed limitations on use of these devices in certain patients, because physicians will be weighing the risk/benefit more -- even though the risk is very very low (I'll be talking more about this later).

Hopefully what will happen is that, given more appropriate patient selection and compliance strategies (more on this later, as well), patients who are best served by drug-eluting stents, and there are many, will get them with confidence, and that those who may not do as well, won't.

The FDA has come under much criticism in recent days, some from yours truly. There is no question that the agency needs to profoundly improve post-market monitoring and clarify for the public the meaning of "off-label" use of drugs and devices. But this event was impressive in its scope -- and the ability for the public to speak and influence decisions in a very direct way was not unlike some Board meetings I have attended in the little village where I live. My thoughts were echoed by Daniel G. Schultz, MD, the Director of FDA's Center for Devices and Radiological Health, who concluded the panel:

"This meeting needed to happen... In the past I think sometimes we shied away from bringing these kinds of controversial issues. But to me what these last two days have demonstrated is that this is the best way, maybe the only way, to get some moving forward, if not resolution, of this kind of complicated issue."

In coming posts, I'll be exploring some of the technical issues and specific concerns about these devices, the media reporting of the meeting, and the post-panel ad campaign to win the (yes) hearts and minds of patients and physicians.

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