March-April
2006 Archives:
April 1, 2006
"Fantastic Voyage": Truth is
Stranger
Last weekend saw the passing at 89 of film
director Richard
Fleischer. So why is a story about the man who made "Conan
The Destroyer" and "20,000
Leagues Under The Sea" in the Stent Blog? Not because
he directed "Doctor
Doolittle", but because he helmed the visionary film of
1966, "Fantastic
Voyage", in which a team of physicians, armed with laser
weapons, is shrunk and injected into a famous scientist's circulatory
system. They travel to his brain where they zap! a blood clot that
is threatening his life.
When I produced live case demonstration courses
for cardiologists, I always used that clip to introduce a laser angioplasty
case -- it was eerie to watch Edmund O'Brien and Raquel Welch laser-blasting
a blood clot, and then (slow dissolve to 20 years later) watch Drs.
Richard Myler and David Cumberland open up a blocked leg artery with
a eerie green glowing laser catheter -- on live TV. Zap! Buzz!
I always wondered if the idea for "Fantastic
Voyage" came from reality. The movie was made in 1966 and the trailer (which
you MUST see -- courtesy of the NY Times -- free registration required) states
it was two years in the making. So the film was conceived in 1964
-- the year in which Dr.
Charles Dotter performed the very first angioplasty. He not only
invented the concept and coined the term, but he made his own 16mm
movie about it.
In
August of 1964, Dotter appeared in LIFE Magazine (they went for the
mad scientist angle) and the idea of treating arterial blockages
from the inside out was publicized for the first time. Who's to say
sci-fi author Jerome
Bixby didn't read it and say, "Hey. My next screenplay!"
The U.S. medical community thought similarly that
Dotter's concept was the stuff of science fiction and nixed it. But
Dr. Eberhart Zeitler of Germany saw its genius and began teaching
courses in Dotter's technique. And just about the time that he had
gathered a "new wave" of physicians around him, "Fantastic
Voyage" was released. Zeitler, in his own words to me:
"Oh,
it was futuristic. It was futuristic! We all had the feeling
that's the way we have to go. That's fantastic! It was at the
time in which also an American movie exists in which a man
was beamed small enough that you can inject him through a carotid
artery. And this man, inside a body, looking inside of the
body
diagnostic!
"No question, further on we will have
possibilities to look clear and now we have it -- now we have
angioscopy, now we intravascular ultrasound. Still we are not
beamed small to go inside directly -- but it was at this time.
So this movie on one side and what we are doing...that's really
crazy, no?"
Yes, in 1966 it was really crazy. And also, by
the way, Dr.
Andreas Gruentzig attended one of Dr. Zeitler's courses, thought
the idea was not crazy, but interesting. He felt it needed a refinement:
a balloon -- one which he invented and a few years later did the first
coronary angioplasty. And today this crazy idea is the number
one treatment for coronary artery disease.
Truth is stranger than fiction.
March 19, 2006
Blame the Messenger: Reporting on Plavix
and Aspirin
Gee! I guess the big problem with patients
is that they don't know how to read plain English. That must
be why, as the American College of Cardiology puts it in their
Thursday Public
Health Alert (italics mine):
"Recent media reports regarding the results
of the CHARISMA Trial may be misinterpreted by patients with
coronary stents and other conditions, causing these patients
to inappropriately stop taking the anti-clotting drug clopidogrel
(Plavix®)."
Those pesky patients, putting their lives in danger
by misinterpreting the following finely-nuanced reports that appeared
nationwide only hours after the CHARISMA results were made public
last Sunday.
My point here is that how could patients who have
been prescribed Plavix and aspirin by their cardiologists NOT be
terrified by these headlines? Especially when the widely-reprinted
AP story begins:
"People taking the blood thinner Plavix
on top of aspirin to try to prevent heart attacks, as many
doctors recommend, now have good reason to stop."
As many doctors recommend? Good reason to stop? So
is the message here that your doctor has made a terrible mistake
by giving you a deadly mix of drugs and you'd better take this matter
into your own hands?
When I saw the news, I immediately realized the
problem -- not only were the headlines inflammatory (medical pun
intended) implying some type of toxic interaction between Plavix
and aspirin, but the articles themselves left out a critical piece
of information. The CHARISMA study was about expanding the
applications for Plavix; it had nothing at all to do with the many
patients who currently take these drugs as per FDA-approved indications
-- patients for whom the drug combo is of proven benefit. And life-saving
benefit. For years it's been known that Plavix (clopidogrel) and
aspirin are essential for stent patients to take to prevent blood
clotting inside a stent, called stent thrombosis, an incident which
is fatal more than 1/3 of the time!!
So by Monday noon I had posted our own Public
Health Alert, also written a warning at our very popular Plavix
and Aspirin Discussion Forum and ran a Google Ad, directing
people to these pages. At least Internet searchers would get the
right information: stent patients, don't stop taking your meds
without talking to your doctor.
As the week went on, I found no other place where
this vitally important caveat for stent patients appeared. I couldn't
understand how so many reporters could be at a major cardiology meeting
and not be aware of these fundamental medical facts. I also saw the
traffic on Angioplasty.Org increase explosively by 50%, with the
number one search term being, you guessed it, "Plavix and aspirin".
Finally, four days later, both the American Heart
Association (AHA) and American College of Cardiology (ACC) posted
a "Patient
Guidance" and the above-mentioned "Health
Alert" and Friday, in an Emily
Litella moment, a whole slew of news reports appeared stating, "remember
that thing about stopping taking Plavix and aspirin together...never
mind!" For example, on March 17, the Wall
Street Journal wrote:
In the wake of news accounts of the study, doctors'
offices were inundated with phone calls. "Patients are really misunderstanding
this," said Steven E. Nissen, cardiologist at the Cleveland Clinic
and president of the American College of Cardiology. "I'm really
worried about losing people." Happy St. Patrick's Day! Hope we didn't lose you.
* * * * *
So what's to be learned from this roller-coaster?
(Other than that you should always read Angioplasty.Org for
the most accurate reporting.) Well, to the cardiologists who met
last weekend in Atlanta, I would remind them that, while these annual
meetings previously comprised mostly scholarly arcane symposia with
little interest for the general public, in today's world there are
probably as many business reporters, financial analysts, media buyers,
venture capitalists and industry representatives at the ACC as there
are cardiologists. And the media's thirst for a sexy (or death-y)
headline will not go unquenched!
This is a fact learned in the early days of angioplasty
-- and since Angioplasty.Org's history
timeline was utilized
by this year's ACC i2 Interventional Summit (with our permission,
of course) I feel vindicated in boring everyone with a short two-paragraph
history lesson.
Charles
Dotter, a radiologist in Oregon, invented angioplasty. Surgeons
thought him crazy. When this photo of him appeared in the August
14, 1964 issue of LIFE Magazine, everyone else thought him crazy
too and, for all intents and purposes, the concept of opening blocked
arteries non-surgically was ended in this country for almost 15
years. Dotter was personally and professionally burned by the bright
lights of the media.
When
Zurich-based angiologist Andreas
Gruentzig took Dotter's concept and successfully applied it to
the heart in 1977, the first thing his patient did was to call the
newspapers. But Gruentzig kept the press away from the hospital because
he knew the danger of prematurely reporting on a procedure that had
not yet been duplicated. His careful, cautious and scientific nuturing
of angioplasty is credited with its position today as the most oft-performed
cardiac procedure.
So, cardiologists -- when you publish reports or
make speeches, you have to be aware how the retail and business press
are going to spin it.
And please don't blame patients for misinterpreting
these reports. They only know what they read in the papers!
* * * * *
** A media note: the original
Associated Press article, issued on Sunday, March 12 at
7:15pm was titled, "Taking Plavix With Aspirin Proves
Risky" -- the article went through 6 online versions
and on Monday was finalized with a slightly less yellow
headline "Doubt Raised on Aspirin-Blood Thinner Combo" and
two added sentences: "Nothing in the study changes
recommendations that people who recently have had heart
attacks or a procedure to unclog an artery take those medicines.
This study dealt with expanding use of the drug to other
people." Unfortunately, hundreds of newspapers had
picked up the initial article on Sunday night and went
with it. |
|
March 13, 2006
Plavix and Aspirin -- Stent Patients, Don't
Stop Taking Your Meds
So you've just had a stent put in and
your cardiologist has prescribed aspirin and Plavix (clopidogrel)
for a year. And you're watching KARE11-TV in Minneapolis and
see a news story, titled "Plavix
and Aspirin a Dangerous Combination". This combination
doubles the risk of death, says the reporter.
You might try calling your cardiologist to
find out why you were given such a dangerous drug combination,
but most likely the line is busy because all his/her other patients
are calling about the same thing. (We're getting questions as well
in our Forum topic on
the subject.)
No doubt today doctors across the country
are fielding questions from patients -- and the genesis for these
reports is the CHARISMA study, presented yesterday at the annual
meeting of the American College of Cardiology -- or rather the
relatively misleading headlines about that study (some of the articles
themselves are a bit clearer, but editors tend to go for attention-grabbing
headlines; I call them dreadlines.)
So, first off and most important: if you
have a stent, a recent angioplasty, heart attack, been diagnosed
with acute coronary syndrome, etc. don't stop taking your Plavix/aspirin
combo without discussing it with your doctor!
What has been left out of the scores of news articles
I've read this morning is that nothing in this study changes
the current indications for patients with Acute Coronary Syndrome,
recent heart attack or coronary intervention with balloon or stent.
And more importantly, if you have had a stent placed, stopping Plavix
and aspirin could be very dangerous!
The combination of Plavix and aspirin has been
shown in many studies to be a definite benefit to patients with confirmed
vascular disease and premature withdrawal of Plavix, especially for
patients with drug-eluting stents, can increase the incidence of
stent thrombosis (blood clotting inside the stent). This has been
the subject of other studies and a topic I have discussed before.
So the bottom line: the misleading media reports
about this study are confusing and could be dangerous to heart patients.
For more on what the study really showed, read
on.
CHARISMA (Clopidogrel for High Atherothrombotic
Risk and Ischemic Stabilization Management and Avoidance) was a study funded
by sanofi-aventis and Bristol-Myers Squibb Company, the people
who make Plavix. The study was designed to determine if clopidogrel
(Plavix) and aspirin together were of benefit as a preventative therapy.
The company obviously hoped that the results would be positive --
there's a lot of money to be made if the drug was shown to prevent
coronary events. They were disappointed, to say the least.
The patient population was made up of two
groups: symptomatic patients with established atherothrombotic
disease (80%) and asymptomatic patients -- those with multiple
risk factors (high blood pressure, etc.) for atherothrombotic events
(20%) but who had not yet experienced the symptoms of vascular
disease. The results did show a little benefit (about 1%) in the
symptomatic patients, but not enough to warrant prescribing the
combination therapy.
The surprise to researchers was that the
asymptomatic group (those without actual disease) showed a higher
rate of death from cardiovascular causes, from 2.2% in the aspirin
only to 3.9% in the combination of aspirin plus Plavix. It is this
subset of patients that has generated the headlines. One of the
primary investigators for the CHARISMA
study, Dr. Deepak Bhatt of the Cleveland Clinic, stated that the
results mean that "dual antiplatelet therapy should not be used
in patients without a history of established vascular disease. "
So the CHARISMA study is very important. It cautions
against prescribing Plavix (clopidogrel) as a preventative therapy,
especially when simple aspirin works as well or better. But for patients
who already have more advanced disease, to the point where angioplasty
has been performed, the dual antiplatelet combination of aspirin
and Plavix is a life-saver.
|