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December
10,
2010 -- 3:45pm EST
Stent Accusations: The U.S. Senate Tries to Drum
Up COURAGE
Monday's 172-page
Senate Finance Committee Staff Report on the overuse of coronary
stents by Dr. Mark Midei at St. Joseph's Hospital in Maryland has
been all over the news -- over
300 articles to date, claiming fraud, malpractice,
pig roasts, threats to reporters -- all of which serve to rekindle
the
"anti-stent" sentiment that followed on the heels of the
COURAGE study back in 2007. In fact, Dr. William Boden, principal
investigator for COURAGE, was interviewed for the Senate report,
which characterized him as follows:
Dr. Boden was the lead investigator of
COURAGE, a 2007 Department of Veterans Affairs funded study
published in the New England Journal of Medicine. According
to the Wall Street Journal, COURAGE "shook the world of
cardiology" when it found that cardiac stent procedures,
also referred to as percutaneous coronary interventions (PCIs) "usually
yield no additional benefit when used with a cocktail of generic
drugs in patients suffering from chronic chest pain."
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Well that sort of indicts the entire world of interventional
cardiology, doesn't it? (Not to mention that Senators seem to
go for anything with the word "cocktail" in it.) This Senate
report is saying that stents are basically useless! Just take your
generic drugs and you'll be fine. Of course, unmentioned is that
fact that
the COURAGE study received considerable funding from Big
Pharma. Also
unmentioned is the fact that 1/3 of the COURAGE medicine-only cohort
wound up switching over to stenting because their pain was not
being relieved. For our analysis
of COURAGE, read our article: "Don't
Cancel Your Angioplasty or Heart Stent Yet, Say Patient Advocates."
Back to my point: the
Senate report quotes (above) a somewhat
flawed Wall Street Journal article
that appeared earlier this year, titled "A
Simple Health-Care Fix Fizzles Out" -- you can read my way
too lengthy critique of that article here: "Stents
Downgraded by Wall Street Journal: If Only It Were That Simple ."
COURAGE is actually
a very important study and the real message is that it is
okay to take a "wait
and see" strategy when dealing with stable angina patients; that
you are not endangering their lives by treating them with "optimal
medical therapy" first. If they don't improve, you can always implant
a stent at a later date. This was already the recommendation
in the practice guidelines for stable angina -- and COURAGE gave
this approach more weight.
But the message was NOT that stents are unnecessary --
in fact, in the case of acute myocardial infarction (AMI), stents
are considered to be the gold standard of care! Implanting a stent
in a patient who is having a heart attack can actually stop the heart
attack from
progressing, saving heart muscle and preventing a life limited by
heart failure. I discuss this in my blog post, "Heart
Attack and Angioplasty: A Public Education Challenge" and I mention
Dr. William O'Neill, who pioneered the use
of angioplasty in cases of heart attack.
Well
I spoke with Dr. O'Neill about the situation in Maryland earlier
this week. Because he has a unique perspective on the
stenting done by Dr. Midei --
he was asked by Midei's legal team to review many of the cases in
question. He also has strong feelings about the way this case has
been characterized in the press. Here's what Dr. O'Neill told
Angioplasty.Org about Dr. Midei:
I've looked at his records and I've actually
interviewed him on a case by case basis to understand what
he was thinking.... And there's
always things you could do differently. But I looked at over
100 films. And
an operator's patterns will emerge. He could be operating
on completely clean coronaries, which he never did. He could
be doing totally ridiculous kinds of procedures, which he never
did. And he could have been deploying stents in incorrect ways,
which he wasn’t. So my conclusion was that he was a very fast,
very efficient operator and I saw nothing that was incorrect
in the way that he was performing cases.
What I'm really concerned about is that this
is the kind of media circus that destroys the lives
and
reputations
of innocent people. And we have this culture now of "guilty
until proven innocent." Both of the articles in the New
York Times and in the Wall Street Journal just started
all of this with the assumption that Midei has been guilty of something....
And the
initial premise is incorrect.
So when do we correct the record
for this guy when all is said and done? He's going to be exonerated
at his trial. He hasn’t
been convicted of any crime and there haven’t been any medical
sanctions brought against him, so for God's sake, give the guy
the presumption of innocence until something is actually proven
that
he did wrong. |
O'Neill went on to discuss where the real controversy
is: cases where the blockages were in the
area of "intermediate
severity." On an angiogram, these blockages might look moderate or
mild, but O'Neill said Midei had a clinical rationale for performing
stenting on these patients.
As I've written over the past few days, much of this
controversy of whether or not these blockages were significant enough
to stent, might have
been resolved through the use of a new tool, called Fractional
Flow Reserve (FFR). But FFR was not available at Midei's hospital (although
he claims he had "pushed for it"); instead he had to rely on
the patient's clinical symptoms and the X-ray video, called an angiogram.
Dr. O'Neill also had comments on the accuracy of angiograms:
I think we've known for almost 25 years
that visual assessment of angiograms is irreproducible and
inaccurate. Every angiographer knows you can go frame by frame
and make a lesion anywhere from 20-70% just by the frame that
you pick when you look at an angiogram. The lesson that the
interventional community needs to learn is that you have to
be really careful about documenting why you are treating moderate
severity lesions. And when in doubt, either use IVUS or an
FFR to make sure that you can prove to people that the lesion
is severe enough to need to be treated.
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A final part of this story (and please forgive the
length of this post -- but on Monday I
did warn you...) -- the final
part is the "involvement" of the stent manufacturer Abbott. There
are a number of emails back
and forth between Abbott executives and Dr. Midei. One from John
Capek, who
headed up Abbott's vascular division, congratulated
Midei for having implanted a record 30 stents in one day. Another
from Dave Pacitti, Abbott VP of Global Marketing was a bit rougher
-- when Baltimore
Sun business reporter Jay Hancock penned some
of the initial accusations
against Midei, Pacitti emailed a subordinate in Baltimore, "Someone
needs to take this writer outside and kick his ass! Do I need to
send in the Philly mob?" Ouch.
And then there was the $2,000 smoked pig roast that Abbott provided for
Midei and his cath lab staff (prices vary, depending on which newspaper
you read). And finally, when Midei lost his privileges at St. Joe's,
Abbott hired him on as a $30,000-plus consultant to teach others
(here and abroad) about their new drug-eluting stent, the XIENCE
V.
The accusations against Abbott are that they were pushing
the use and overuse of their stent -- that making money was all that
mattered. And reading
through the emails quoted in the Senate
Report reveals an undeniable
and appalling insensitivity, especially to anyone "outside" of the
industry.
Of course, no one at Abbott was thinking "outside" the
industry; they
were consumed by
something else.
Abbott's second generation XIENCE
V drug-eluting stent (DES) was
approved by the FDA on July
2, 2008. This was the
first drug-eluting stent approved in the U.S. in over four years.
It was also the first
major product for Abbott Vascular, which was formed two years earlier
when Boston Scientific bought Guidant and spun off the stent division
to Abbott Labs. (Abbott Vascular even moved into Guidant's old
HQ in Santa Clara, California.)
Suddenly Abbott was in a position to take on Boston Scientific's
market-leading TAXUS stent. Without question, during the summer of
'08, the competitive juices were flowing
in Santa
Clara. The company
finally had a shot
at a multi-billion dollar market (XIENCE has since prevailed, becoming
the dominant DES -- for now). Midei's "30 stent day" occurred
less than 2 months after FDA approval. So the enthusiasm which I
can only characterize as "football fever", having
seen sales forces erupt in cheers during the presentation of a positive
clinical study -- this
was the subtext for all the celebrating around Midei's work. (For the
record, all of the studies of the XIENCE V stent have shown it
to be superior to the
earlier generation of DES: safer and more effective...just sayin'.)
But accusations of fraud, secret incentives, etc. are
all in the news -- and this is placing a significant
burden on Abbott, especially the PR department! The
comments and emails made
public are most
embarrassing. And it's something that's always bothered me at the
various conferences and trade shows I attend in this field. There's
a lot of understandable enthusiasm from the sales force, for sure
-- but remember, this is all about people who have coronary artery
disease, whose arteries are getting clogged up, people who are terrified
of
being chronically ill or dying. So maybe all this exposure isn't
such a bad thing. (For
more on this topic, read the guest
blog from Deborah Shaw,
our education editor.)
For the record, Abbott, reacting to this new firestorm,
sent me their "statement
of sobriety" the day the report was released, which I reprint here
in its entirety:
The treatment of
patients is Abbott’s
highest priority and something we take very seriously. Interventional
cardiologists have a number of tools at their disposal to treat
artery disease, and years of training and education that guide
their decisions about optimal treatments for their patients.
Our vascular business is the leader in coronary stents because
we offer doctors the best medical technology for their patients.
Abbott doesn’t condone inappropriate use of medical products
or of the health care system.
Dr. Midei has been a highly regarded physician in his field,
with whom Abbott had consulted in the past. Our consulting
relationship with Dr. Midei ended early this year.
The individual emails referenced in the report and specific
events highlighted are being addressed internally. We recognize
that there were some inappropriate individual communications.
These matters are being addressed internally.
Abbott has internal policies on interactions with health
care professionals, which conform to industry codes. We are
addressing the matters referenced in the report in accordance
with our policies. |
What with all this internal addressing, it should be
an interesting couple of weeks in Santa Clara....
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