Most Popular Angioplasty Web Site
Stent Center Stent Center
with support from Medtronic Cardiovascular
Patient Advocate Tells FDA Drug-Eluting Stent Safety Panel: Public Deserves Better
Patients say regulators aren't listening, public needs information about devices

December 8, 2006 -- Gaithersburg, Maryland -- On the first day of the FDA's advisory panel hearings on drug-eluting stent safety, product manufacturers vigorously defended their devices. In the succession of PowerPoint presentations and research reports, Burt Cohen of Angioplasty.Org, a popular website for heart patients, was the lone voice on behalf of thousands of concerned patients.

The focus of the meeting is on the risk of potentially fatal blood clots, or late stent thrombosis, with drug-eluting stents. Cohen believes regulators have not paid enough attention to patient complaints, and that patients need more information when choosing to have heart stents implanted.

"A year ago I wrote the FDA, informing them that Angioplasty.Org was hearing from a number of patients with problems and questions after drug-eluting stents,” Cohen testified to the panel. “I told the FDA we had hundreds of anecdotal adverse event reports." The FDA did not pursue these reports. Cohen continued, "The time has come for the FDA to fit real world, anecdotal, self-reported patient experience into its information gathering.”

Cohen expressed concern about possible hypersensitivity to stent polymers, "Is hypersensitivity a safety issue? I don't know, but we have over 200 postings from patients whose doctors cannot explain their severe and on-going symptoms, all of which started after drug-eluting stent implantation." He urged the panel to recommend research in this area.

Cohen reported that, although stent patients have to take antiplatelet drugs (brand name Plavix) because stents raise blood clot risk, the use of Plavix in most stent procedures is considered "off-label" and has not been the subject of clinical trials by its manufacturer.

"Stents plus Plavix is a package deal," said Cohen, who explained that many patients come to his site to learn about these drugs, but blamed FDA policy for the fact that there has been no investment in patient education by the drug-makers. "Because it is an off-label use, the drug companies aren't legally allowed to support public education.

"We are now hearing every single day from stent patients who have questions about Plavix.... When the government approves devices that necessitate life-saving pharmaceutical regimens, it’s not enough to rely on a 1-line package insert, 5 minutes of in-office instruction or even breezy 4-color brochures.

"Patients need the information that will enable them to participate meaningfully in the decision whether to get a drug-eluting stent and to commit to serious medications. But, given current FDA policies, where will the money come from to improve compliance strategies and to support education initiatives like ours?"

The panel may recommend extended use of Plavix, given late stent thrombosis concerns. Says Cohen, "Whatever antiplatelet regimen this panel recommends, the compliance issue will continue to be a life and death problem. Patients deserve genuine, substantive information. If the profession and regulators want to minimize safety problems, I urge them to listen much more closely to what patients are trying to tell them."

Five million drug-eluting stents have been implanted in the past three years. Angioplasty.Org, an independent educational site gets 90,000 visitors a month looking for information about these devices.

We invite readers to comment on Cohen's testimony.