Patient
Advocate Tells FDA Drug-Eluting Stent Safety Panel: Public Deserves
Better
Patients say regulators aren't listening,
public needs information about devices
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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.
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