December 10, 2010 -- 3:45pm EST
Stent Accusations: The U.S. Senate Tries
to Drum Up COURAGE
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."
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.
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
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
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
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.
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 --
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
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
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....
December 10, 2010 -- 3:45pm EST
Emails and Ethos: the Senate Stent Report,
a Corporate Culture Wake-up Call?
(The following is a guest commentary
from Deborah Shaw, Director of Education at Angioplasty.Org.)
These leaked Abbott emails (in the Senate
Finance Committee Report on Cardiac Stents regarding Dr.
Midei in Maryland) reveal that healthcare marketing professionals,
especially those that aren't involved directly in patient care,
sometimes forget that this is serious stuff. It's about life
and death: the work they do profoundly affects sick, vulnerable
people who are afraid they might die, and who could be your dad
or your daughter.
The media response occurs in a climate where
there is, in fact, evidence and concern that American healthcare
is overly interventional and procedure-oriented. Everyone in the
field knows there are some physicians who probably jump into stenting
too quickly in borderline cases. It's a question of professional
opinion and probably not a question of negligence, but overly aggressive
treatment is real.
The outcry from the media, and the Senate's investigation,
is simplistic, inaccurate and misleading, but it demonstrates a decline
in the public trust. I'd urge industry folks to think of this as
a warning sign, a wake-up call, kind of like finding out your cholesterol
is climbing (and I'm sure their blood pressure is). It might be time
to do some diagnostics on your company's climate, ethos, tone. Communicating
the science behind medical products that offer genuine improvement
in efficacy and patient outcomes is what ought to be the focus of
sales efforts, not fashioning the flashiest trade show event, lavishly
courting physician-suitors, or taking a gung-ho "How do we do it?
Volume!!" marketing approach.
Doing good things and making money are not oppositional
goals: well-managed companies with good products do make profits.
But the first responsibility, the mission, for healthcare organizations,
is to improve the quality of patients' lives; after that, and only
after that, is the objective to maximize sales. That sounds naive
and idealistic to some industry professionals (and it's very hard
to get those individuals to invest in substantive public education
because it's not quantifiable, doesn't contribute to quarterly results).
But this might be a good moment for industry leaders to check in
on the mission, and make sure your company's focus is on the long-term
business of science in the interest of patients, over the more short-sighted
science of business in the interest of market penetration. In the
long run it's the more profitable approach -- and less likely to
lead to hysterical Senate investigations.
Staying on, and communicating, that mission requires
visionary corporate leadership, objective analysis of data, difficult
choices that put prudence, patients and science in the forefront,
and vigilance in keeping the corporate culture on track.
December 7, 2010 -- 4:55pm EST
Fractional Flow Reserve and Stents
interventional cardiologist William
Fearon of Stanford sat down with Angioplasty.Org recently to
talk about a better way to judge if a patient might benefit from
a stent. Instead of looking at the x-ray angiogram and saying, "That's
a 70% blockage -- let's put a stent in there and you'll feel much
better," Dr. Fearon advocates the use of a thin pressure wire
which actually measures the flow through the narrowing. The technology
is called Fractional
Flow Reserve or FFR.
Turns out that sometimes what looks like a blockage
on the x-ray isn't always restricting the flow enough to cause ischemia
(reduced oxygen to the heart muscle which usually, but not always,
results in angina). And vice-versa, sometimes ischemia/angina is
being caused by an area that doesn't look so bad on the angiogram.
You can read all about FAME,
the ground-breaking study that Dr. Fearon was involved in, and also the
two-year results -- but the bottom line is that FFR resulted
in one-third fewer stents being used, and one-third fewer heart attacks
As I mentioned yesterday,
these findings have a direct relevance to the "Midei in Maryland" firestorm
that has erupted over the accusations in the 172-page
Senate Finance Committee Staff Report on the overuse of cardiac
So you ask, why wasn't Midei using FFR to make
these decisions? Well, number one -- the FAME study wasn't published
until January 2009, after most of this "alleged unnecessary
stenting" had been done and, number two, even today only 15%
of labs use this technology. Actually there's a number three: Dr.
Midei's hospital, St. Joseph's Medical Center, accused him of failing
to use FFR but, according to an
article on theheart.org, Midei counter-claimed that:
...he was the one who had fought SJMC "tooth
and nail" to purchase the FFR technology, and while he ultimately
was successful, the center's FFR program was not even up and
running the day he was discharged.
FYI, Fractional Flow Reserve (FFR) pressure wires
are manufactured by two companies: Volcano
Corporation and St. Jude Medical.
December 6, 2010 -- 1:15pm EST
wrote about this issue over a month ago (see "To
Stent or Not to Stent: That is the Question!") but today's
newspapers are filled once again with the sad story of Maryland
cardiologist Dr. Mark Midei, St. Joseph's Medical Center and the
alleged hundreds of unnecessary stents placed in patients who didn't
need them. This sudden renewed interest comes as the Senate investigational
report by Senators Baucus and Grassley into this matter was made
available -- and into the mix of the story was added a pig roast,
the Philadelphia mob, Abbott Vascular's celebration of Midei implanting
30 of their stents in a single day and an email from a company
executive, suggesting that someone take a Baltimore Sun reporter
outside and "kick his ass!"
Hello PR Department.
I've got a number of thoughts about all this and
will post a more extensive commentary later on, but one major issue
in this whole saga is whether or not the stent placements were "unnecessary",
and I ask readers to go back to my October
post. Doctors can disagree on whether a stent is called for --
especially when they are being guided by the angiogram (X-ray image).
And in Midei's case, two sets of well-known and highly-respected
cardiologists have disagreed in most of the disputed cases.
But a technology exists that would have added a
whole data set to these cases: it's called Fractional
Flow Reserve (FFR) and it yields a number that can be used as
a decision-point about whether to stent or not. The technology is
backed up by two-year results from a
major study (FAME) that showed improved outcomes with less stents
when decision-making was guided by FFR instead of angiography alone
-- and the use of FFR has been bolstered by an increased level of
evidence from the recent
AHA/ACC/SCAI Guidelines Update.
So why is it used in only 15% of cath labs?