November
21,
2006 -- 2:45pm ET
Eentsy Weentsy Time Bombs -- or -- The Pen is
Mightier Than the Clot
Just when I was thinking that the popular
press coverage of the late stent thrombosis issue with drug-eluting
stents (DES) had been relatively balanced, along comes this
bizarre piece out of NBC News this morning from highly-regarded "chief
science and health
reporter", Robert Bazell.
There are so many things wrong with this
article that it's hard to know where to begin discussing it. So for
now I'll just quickly give Mr. Bazell a few suggestions on how to
improve his report.
Tip #1: Know Your Audience
When you're writing to people who have weak coronaries,
you might not want to lead with:
"Millions of Americans could be walking around with tiny
time bombs in their hearts."
At least not without a roller-coaster warning at the top. I'll wager
more stent patients will experience health problems just from reading
this sentence than
from their drug-eluting
stents.
When the news headlines mis-reported the CHARISMA trial
back in March, stent patients got very scared and some immediately
and incorrectly stopped taking their Plavix
and aspirin. As a result, a few of them had heart attacks (Dr. Tim
Henry of Abbott
Northwestern in Minneapolis related to me at least one of his patients
where this
occurred --
we're sure there were others.)
It is not a public service to misreport and mischaracterize health
issues, especially when the incomplete information might lead
patients to panic and harm themselves.
Tip #2: Know Your Facts
The following statements made in this article are totally incorrect
(my commentary follows each statement in italics):
"They [drug-eluting stents] may be doing more
harm than good."
(Even doctors who are critical of drug-eluting
stents agree that late stent thrombosis is a very low frequency
problem -- and many interventional cardiologists, like Dr. Jeffrey
Moses of Columbia-Presbyterian Medical Center in New York, feel
that the lower restenosis rates
of DES have prevented heart attacks, as well as repeat interventions,
which carry their
own complication rates.)
"many top doctors...admit they are in uncharted
waters with a frightening problem that was largely unanticipated."
(Concerns about increased risk of stent thrombosis were raised
immediately upon approval of the first DES in the fall
of 2003 -- studies at that time showed a rate equal to that of
bare metal stents.)
"the DES's end up as a piece of metal sticking
out in the artery."
(A disturbingly unhealthy visual --
not only incorrect but this would be different than a bare metal
stent in what way?)
"The FDA panel may well recommend they not be used
at all."
(In the words of Dr. Jeffrey Moses to me earlier today,
this article "...is doing a disservice. To suggest that the FDA
is going to withdraw these stents is preposterous! That's not
what this panel is about.")
"The origin of this terrifying problem is that medical
devices...get tested for a few months in a few hundred or at
most a few thousand
of people before the FDA approves them."
(The various Cypher
and Taxus trials involved thousands of patients over a minimum
12-month period -- the Cypher approval in April 2003 came after
two-year followup in the initial RAVEL trial.)
Tip #3: Know Your Controversies
I'm not by any means saying that drug-eluting stents are without
flaws and should be given to everyone. Most cardiologists
agree that patients who aren't going to be able to maintain the
required antiplatelet therapy (Plavix and aspirin for 6 or more
months) might be better off with a bare metal stent in certain
situations. Even DES evangelists like
Dr. Moses have told us they would consider using a bare metal
stent in certain straight-forward cases (a single blockage in
a very wide artery).
But many U.S.
cardiologists take issue with the data presented in the European
studies, which
they say incorrectly portrayed bare
metal stents
as having far less clotting issues. The recent TCT meeting reported
data that came to different conclusions and also redefined what
should be considered a "stent thrombosis" -- the controversy,
to some extent, has taken the form of a USA
vs. Europe dispute.
Hopefully the FDA open-to-the-public hearings, set for
December 7-8, will help clarify some of these issues. We
posted a "Patient
Advisory" on the issue of late stent thrombosis, most recently
revised over a month ago, and see nothing that would change its recommendations
(based on those of leading cardiologists).
We agree with Dr. Moses. To use the terms "frightening",
"terrifying", "lethal devices" and "time bombs" in an article read
by millions of heart patients is irresponsible fear-mongering. Patients
are able to discern some of the finer points of these issues, something
Angioplasty.Org strives to deliver. In fact, Dr. Sanjay Kaul, author
of the American College of Cardiology editorial cited in the MSNBC
article, recently complimented Angioplasty.Org:
"...a
wonderful website. Very accurate, very balanced, and clearly having
the best interest for the patients and for the professional community
in mind. I want to commend you for that. Even critics like me enjoy
your website!"
Does more need to be done to ensure the safety of these
devices? Of course. No one disputes that. And while perspective is
necessary, so is caring for the individual patient.
Next year marks
the 30th anniversary of the first balloon angioplasty
-- a procedure that has
revolutionized the treatment
of coronary artery disease. And the technology has advanced tremendously.
But
as Andreas Gruentzig, the inventor of coronary angioplasty, told
me back in 1985:
"I am speaking all the time about complications.
You may wonder and will say, 'Well he's talking about complications
from the beginning to the end. Why is he doing dilatation
[angioplasty]?' Well fortunately those complications are rather
minor in percentage. And that's the reason I speak up about complications.
It is
not because
it
is
such a major problem, but it is always my major concern in
selecting patients or treating patients."
By the way, the photo (reproduced above)
that illustrated the MSNBC story, depicts an open surgical procedure,
not an angioplasty....
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