October 29, 2005
The Numbers Game
When millions and billions of shareholder
dollars depend on tenths of a percent, it's understandable why
companies play the drug-eluting stent "numbers game".
Johnson & Johnson/Cordis played it at the ACC in March, citing
a numeric trend in the REALITY trial that showed an increased risk
of stent thrombosis in the competing Taxus stent -- I discussed
this in detail back then ("Trials
and Tribulations") but the bottom line was that, if you
looked at the trial design, numbers of patients, p values, etc.
there was no statistically significant thrombosis increase.
That did not stop J&J/Cordis from proclaiming "REALITY
Trial Data Suggest Drug-Eluting Stents Differ Significantly in
Rate of Blood Clot Formation-Stent Thrombosis" in a press
release during the ACC. However, we and others have consistently
stated that there really is no proven safety advantage of one stent
over the other -- this group now seems to include Cordis' own clinical
vice president, Dr. Dennis Donohoe, who admitted to Barron's during
last week's TCT 2005 that there was no significant difference
in safety between Cypher and Taxus. Of course, the damage
to Boston Scientific had been done and their market share in the
from a high of 70% (and that was after the recall
of summer '04)) to about 55% last quarter.
Boston Scientific, having
been "caught flat-footed in terms of medical marketing at the
ACC", according to its interventional cardiology President Hank
Kucheman, has since put into place a "medical affairs group
that works in conjunction with its selling organization to better
clarify data messaging to physicians". They've also started
a "drug-eluting stent Speakers' Bureau" so doctors can "talk
about the facts in a data-driven fact-based way in the marketplace".
So this striving for no-spin clean empirical scientific
data must be why Boston Scientific claims in its latest
press release that the data from the recently reported STENT
Registry "revealed a numerical trend favoring the TAXUS stent",
even though lead investigator Dr. Charles Simonton concluded (quoted
"Currently, in US real-world practice,
sirolimus-eluting stents and paclitaxel-eluting stents appear
to have comparable clinical and safety outcomes..."
Yes, it is true that the data showed slightly better
numbers for the Taxus stent, but the "p
value", a number which helps show whether or not the actual
numeric differences have any "significant statistical difference",
given the population studied, did
not show any statistical differences between the two stents.
"So what!" you say? Well the problem
here is that these Stent Wars have civilian casualties when the marketing
feud spills over into the population at large -- especially when
the combatants issue public press releases that find their way into
the headlines of local papers and TV news throughout the country.
Take the example of Bill from Illinois who wrote into our site very
worried about his upcoming stent procedure -- having read some negative
news articles about the Taxus, should he demand that the doctor use
a Cypher? Or is Taxus okay? (We've gotten similar emails worrying
about the Cypher.)
The civilian casualties I am speaking of are less
physical and more psychological. It's one thing to "dis" the
competition's laundry detergent in public, but quite another when
you're discussing a metal sleeve that is going to be placed permanently
inside your customer's heart. How does a patient feel when he reads
that the Cypher is better one week after having a Taxus inserted
in his left coronary artery?
Regarding the Stent Wars, Dr. Gregg Stone has stated, "I
think the winner is patients. I think both these devices
perform very, very well, are overall safe and very effective."
Wouldn't it be reassuring if we could data-message
that in a fact-based way to Bill from Illinois?
October 28, 2005
The Live Demonstration Course
Just a quick addition to yesterday's
remembrance of Andreas Gruentzig -- his other invention besides
angioplasty was the "live demonstration course". He couldn't
teach his technique to enough cardiologists by having them visit
his lab in Zurich, so he used live TV and interactive audio and
created a learning experience. From 28 docs in 1978 to 10,000 at
this month's TCT, the live demonstration course has been one of
the major ways physicians learn new techniques.
Gary Roubin of Lenox Hill Heart & Vascular
Institute of NY worked with Gruentzig at Emory in Atlanta -- in this video
clip, Dr. Roubin, who will be conducting his own
live demonstration course in November, discusses not only the
role of this educational tool, but his thoughts on how Gruentzig
might view today's developments (stents, etc.) in the field he started.
October 27, 2005
It Was Twenty Years Ago Today...
Well, if there were a Sergeant Pepper in
the field of interventional cardiology, it would be Andreas
Gruentzig. He most certainly taught the band to play -- he
did the first coronary angioplasty (video
clip) in 1977 and made his life's mission teaching the procedure
to other cardiologists. And it was twenty years ago today that,
at the age of only 45, he took off in his twin engine Beechcraft
from his vacation home in the coastal islands of Georgia to get
to his office at Emory Hospital in Atlanta and ran into the edge
of a hurricane, and crashed -- tragically killing both him and
I had interviewed Andreas on video only a few weeks
before, getting his "take" on the current state of angioplasty.
This was all before the era of stents -- a device that changed the
procedure significantly, virtually eliminating the problem of emergency
bypass surgery. The video I was working on (for USCI -- does anyone
remember them?) was going to be Andreas' answer to the expansion
of angioplasty and its movement toward more and more complex cases,
some say led by the "cowboys" of interventional cardiology.
Parts of that interview can be viewed on
his bio page here.
I edited the video and sent him a copy via fedex.
It arrived on his desk on Monday morning October 28th. That same
day, Dr. Richard Schatz had scheduled an appointment with Andreas
to show him his new device: the Palmaz-Schatz stent! You
can see a video clip of Dr. Schatz discussing his excitement about
presenting his stent to the "father of angioplasty".
Unfortunately Gruentzig never got to see either the video or the
stent. And ironically, over the following decade, the introduction
of the stent expanded Gruentzig's procedure to the point where it
overtook surgery as the treatment of choice for coronary artery disease.
In September of 1985 I attended Andreas' last course
at Emory and he gave tribute to the three great "fathers" of
interventional cardiology: Charles Dotter, Mason Sones and Mel Judkins.
Each had contributed to the process that culminated in angioplasty.
All three had passed away in 1985. When Andreas paid tribute to them,
the last thing anyone thought was that he would join them within
a few weeks.
October 24, 2005
Pay Attention To That Wo/Man Behind The
"Aha!", you say. He's just taking
the L. Frank Baum references too far (my last entry, anticipating
my trip to the TCT, was titled, "Off
To See The Wizards"). But imagine my surprise when one
of my final meetings at TCT was a press conference featuring
-- Dr. Oz!
No kidding. Dr.
Mehmet C. Oz, Professor of Surgery and Director of the Columbia
University Cardiovascular Institute in the Emerald City of NY.
And we must remember that one of the great accomplishments of the
fictional Oz was to give the Tin Man a heart.
Dr. Oz has been preaching his philosophy (which
merges surgical and complementary medicine) in several books, on
many talk shows (yes, on Oprah!)
and on this particular Thursday, at the TCT. He brought along his
new book, "YOU:
The Owner's Manual", and the subject of this presentation
was "The Critical Role of Nurses in Patient Education".
With him were three nurse/administrators from the same hospital.
They work alongside of the well-known interventional practice of
Marty Leon, Gregg Stone, Jeffrey Moses, et al whose group puts on
the annual TCT. And they are part of a model program for patient
In the title of this entry, I say "pay
attention", because the message of this small presentation
(only a dozen of us press were in attendence) was for me one of
the most important I heard. All week long thousands of cardiologists,
marketing managers, stock analysts, device manufacturers, etc.
had been gathering in vast, darkened theaters, watching live broadcasts
of procedures from around the world, featuring the latest hi-tech
equipment; they had been attending the multitude of symposia and
presentations, discussing which drug-eluting stent is better, whether
carotid stenting is as good as surgery, and so on -- all extremely
important clinical topics that will affect the lives of millions
But this one-hour talk, given in the press meeting
room, explored a problem which affects every patient who has a procedure
-- education, follow-up, compliance -- in short helping the patient
achieve a better outcome; I believe the phrase is "nursing back
to health". And unlike the device/drug/doctor-based solutions
being projected throughout the giant halls of the Washington Convention
Center, what was being discussed here was the kind of low-tech, people-based
program that could have very significant benefits in patient outcomes.
The nursing staff and Dr. Oz detailed a program
that is in place at their hospital and, as I listened to them, I
kept thinking about all the patients who write into our Forum,
asking basic questions that their healthcare providers should be
but aren't answering: when can I start exercising? why do I have
a fluttering in my chest? how long do I have to take this prescription?
what do I need to do to prevent this from recurring?
I listened and asked my question to the panel: "Your
program is terrific. It does so many things that need to be done.
And while there are some other hospitals that have similar programs,
there are all too many places where patients get little or no help
post-procedure? How can a program like this be exported and (here's
the kicker) who will pay for it?"
There was no quick or complete answer to this question,
and it's one I hope to explore in a future article. But as I left
and walked through the halls, through the half-city-block exhibit
area, now feverishly being dismantled and packed for travel to the
next medical extravaganza, past the waiting transport buses paneled
with ads for statins and stents, I couldn't help but think how it
wouldn't take but a small percentage of all these budgets to invest
in a patient education/prevention initiative. A funded campaign to
give information, education and support to patients, especially those
who are having an intervention, would indeed save lives, or at least
improve quality of lives, to equal the effect of all the sparkling
technology surrounding me.
October 15, 2005
Off To See The Wizards
I'll be traveling to Washington DC this
week to attend the TCT 2005 -- can you say "Transcatheter
Cardiovascular Therapeutics" three times fast? If so, you
might find this annual meeting interesting.You and the estimated
10,000 other attendees who will be descending on the Convention
Center for a week of live TV (angioplasty and stent procedures
beamed from around the globe, ostensibly to show off a new piece
of equipment, a new technique, but, as more than one cardiologist
has told me, it's not unlike NASCAR -- you want to see the race,
but everyone's waiting for the crash), PowerPoint lectures, simulation
trailers where you can try your skill at placing a carotid stent
in "Roger" (okay I made the name up -- I'll tell you
the actual name later this week), PowerPoint symposia, "Sponsored
Events" (breakfast or dinner meetings held outside the actual
TCT, but within a couple blocks in a posh hotel, lotsa food, wine
or espresso, mints, and more PowerPoint presentations, usually
showing how the product of the particular sponsoring company is
better than the one being shown in the hotel around the corner),
highly anticipated presentations of clinical trial results (these
are "blinded" -- the highly guarded results are only
known to a few -- kinda like the Oscars -- did the stent work?
did it meet its "end-point"? will the company get FDA
approval? will the stock go up?), the Exhibit Hall with its scores
of company booths, both big (giant video walls, entire cath labs,
conference areas, espresso bars) and small (Joe, the Director of
Marketing, will show you his latest brochure) and, did I say, PowerPoint
Curious to me is that there are 10,000 attendees
to the American Board of Internal Medicine, there are only 4,796
certified interventional cardiologists in the U.S. -- total. And
hopefully, for angioplasty patients, a percentage of them will not
be in Washington this week. (Hint: maybe you want to schedule your
stent procedure for next week.)
So who else is there? Well, it's an international
event, so some non-U.S. cardiologists are there. Then there are the
cardiologists who don't actually do interventional procedures, and
other healthcare professionals, nurses and technicians. And let's
not forget the press -- you no doubt will be seeing heart-related
stories in the news this week.
But more and more, there are the "related" professions:
device manufacturer marketing teams, company executives, sales reps,
venture capitalists, stock analysts. For them the TCT is a bit like
what the patients face when they are wheeled into the cath lab --
the TCT is their cath lab: will their new device succeed?
will the doctors like the way it handles? will their company be healthy
or will it need a long recovery period? The business of medicine
is big business, and many dollars are spent promoting various therapies
and products at this meeting (and the others held around the world
-- but this is the biggest in this field). Just stand in the Exhibit
Hall as the TV monitors start to beam the presentation of a major
clinical trial for the latest drug-eluting stent. Most of the docs
are in the assembly room where the presentation is occurring, but
in the Exhibit Hall, the sales reps suddenly all migrate to their
home booths and, if the results are good for their company, a cheer
goes up or applause...yay for us!
Monday morning some results from the Endeavor drug-eluting
stent trials will be presented and these will to a great extent determine
the speed with which Medtronic can get approval and market their
stent in the U.S. They've been talking 2007. I've heard opinions
that the results may not be that substantial and that they may be
looking at 2008. But these are only opinions because no one knows
until...well you get the picture.
More to follow.
October 9, 2005
Dr. Jekyll, I Presume...
Today's New York Times Week in Review features
an article, titled "When
the Doctors Are Their Own Best Guinea Pigs" (the NYT article
includes a link to Angioplasty.Org and our
video about Dr. Werner Forssmann). The article, prompted by
the recent awarding of a Nobel Prize to Dr. Barry J. Marshall for
the discovery that bacteria caused ulcers, discusses how a number
of important medical discoveries have been made through self-experimentation.
The Times story also sports a still from one of the many "Dr.
Jekyll and Mr. Hyde" movies to illustrate the self-experimentation
But there's another side to the Jekyll and Hyde
reference (ironic, eh?) because, like poor Dr. Jekyll, many doctors
and scientists today who discover new treatments will soon be face-to-face
with their own "other selves". And I guess "poor Dr.
Jekyll" was a not a good word choice, because in modern times
the material rewards of discovery are great, and the temptations
to succumb to the glitter are enormous.
Research, innovation and discovery in the medical
world share this complex Jekyll-Hyde duality: the motivation of so
many is to the "pure" discovery of truth, to help others
and treat diseases; intertwined is the baser reality of the world
of capital, marketing, business, money -- which, of course, must
be credited with distributing and making these innovations available
to us all.
In the novella, Dr. Jekyll, having discovered his
Mr. Hyde, found himself increasingly unable to stop from becoming
him, until ultimately Mr. Hyde became permanent.This past summer
saw several major product recalls of life-saving heart devices, replete
with accusations that company officials and/or government regulators
knew of the problems and failed to disclose them to doctors and their
patients. The courts will ultimately decide fault, damages, etc.
(Utterson, the lawyer, is the character who discovers the
truth about Dr. Jekyll in the novella) but it might be useful to
try and separate the good/bad Jekyll/Hyde components and to mull
over some of these issues -- maybe we can come up with a better system.
To wit, there's another video on our website, titled "Devices,
Ethics and Money: 20 Years Later" and in it a number of
pioneers in the field of angioplasty looked back at the changes
that have occurred since its invention in 1977 by the very charismatic
Andreas Gruentzig. You can view the seven-minute RealVideo clip,
but here's a sampling:
Marketing is at a much higher
level today than it ever was before.... There are tremendous
ethical conflicts that face physicians that develop products.
When a physician aligns himself with industry, industry would
like nothing more than for that person to champion their particular
product. And, of course, there have to be inherent conflicts
here that are financial in nature that can influence judgement.
I think Andreas never succumbed to those pressures.
-- Geoffrey O. Hartzler, MD (first
to treat heart attack patients with angioplasty, 1980)
We're having to study things where there's
money behind it to study it. If you develop a new pill to do
something, it's got to be a very expensive pill. I mean, we can't
develop simple solutions because nobody's paying for them. And
so research, as it's driven more and more by industry, entrepeneurial
activities -- and there's nothing wrong with that -- but if that
becomes over-balanced, where's the pure research going to come
from to solve questions that may not be in the interests of a
B. King, III, MD (Gruentzig's partner in Atlanta
and former President of the American College of Cardiology)
There was no commercial venture in 1979 at
all. A little company made it for Andreas but I know that the
monetary part of this was negligible, in fact, probably negative,
both for the doctors and maybe for the company. I know myself,
for example, I never charged a patient for angioplasty for the
first three-and-a-half years...because I felt that we still had
a lot to learn. It wasn't to make money. This was an adventure!
This was a scientific and intellectual challenge that we were
possessed with! So what did money have to do with this? What
did equity have to do with this? It wasn't any of those things.
K. Myler, MD (performed the first angioplasty in
the U.S., 1978)
[Andreas] was a person who had us look at technology
in a lot of different ways and really understand the humanity
of the technology and the implications of how it should be used
appropriately, not simply for the greatest value for the shareholder....
That to me is a lesson that has been dimmed, I think, in the
years, particularly since his death.
E. Abele, co-founder, Boston Scientific
* * * *
By the way, as regards Dr. Jekyll, Scottish author
of the story Robert Louis Stevenson insisted it be be
pronounced"Gee-kill". And my favorite film
rendition of the tale was the 1941
movie starring Spencer Tracy and directed by Victor Fleming ("Gone
With the Wind", "Wizard of Oz")
October 7, 2005
Four Minus Two Equals Two -- Hands, That
Sounds like simple third grade arithmetic,
but the profits of one of the largest device manufacturers may
balance on such a simple equation. As
reported by Reuters today, the success of Medtronic's Endeavor
drug-eluting stent program is less dependent right now on whether
or not the stent "works" than on obtaining the license
to Rapid Exchange technology -- a design which allows one operator
to perform a stent placement (i.e. "two hands") as
opposed to the current configuration of two operators ("four
Medtronic developed the Endeavor stent which has received the
CE approval of the European Union. Results from the Endeavor III
trial, which will compare the performance of the Endeavor to that
of the Johnson & Johnson/Cordis Cypher stent, are scheduled to
be presented at this
year's TCT meeting on October 17.
And the preliminary results have been very good.
According to Dr. Jean Fajadet, Clinique Pasteur Unité de Cardiologie
Interventionnelle, Toulouse, France, “Endeavor represents a
very important addition to the options we can offer our patients
undergoing stent procedures.”
So here's the deal. Traditional angioplasty requires
four hands: the cardiologist places one hand on the introducer sheath
and the other on the balloon/stent catheter while his/her assistant
manipulates the guide wire that everything else is anchored around.
It's a complex four-handed procedure that requires precise coordination
between the cardiologist and the assistant. The RX or rapid exchange
system allows one person (two hands) to perform the entire procedure.This
advance, pioneered by Swiss cardiologist Dr. Bernhard Meier and California-based
Dr. Paul Yock, is currently the "property" of three companies:
Guidant, Johnson &Johnson, and Boston Scientific. It has obvious
advantages, economic being at the top (one person vs. two).
The FTC may require that in order to pass muster
to acquire Guidant, J&J must divest itself of exclusive RX technology
and license it to other companies. And the thought is that J&J
will license RX technology to Abbott and not Medtronic. Why? Because
Medtronic is a more serious competitor to J&J than Abbott is.
The final irony? The drug that Medtronic has licensed
to coat its stent is ABT-578 -- ABT being short for "Abbott",
the drug's manufacturer.