[Of one of my mentors we were wont to say, "He may not always be right, but he is always confident."]
Lately I've been writing about eminence-based medicine... In
response to these posts, Saurabh Jha, MBBS, a well-known radiologist and
health-policy critic, asked me on Twitter: "How do you find these utter
gems?!"
I was surprised by Jha's question, because the evidence for
this phenomenon -- eminence-based medicine trumping evidence-based medicine --
seems overwhelming.
But then I realized Jha's question was legitimate, because
there's actually remarkably little hard proof, though I suspect it really is a
big dirty secret that every doctor knows in his or her heart.
For this reason, I think Bernhard Meier, the interventional
cardiologist I've been writing about, deserves praise for, at the very least,
being so honest and forthright. In his article in European Heart Journal and in
his response to my questions he was perfectly willing to explain and defend his
position. One of the refreshing aspects of Meier's positions is that he readily
admits that his actions fly in the face of evidence-based medicine. In his EHJ
article, he specifically stated that randomized controlled trials are an
artifact of the past. His beliefs and practices, he explained, were developed
from his long experience at the pinnacle of interventional cardiology.
By contrast, most eminence-based medicine is dressed up in
the guise of evidence-based medicine. The distinguished thought leader will
provide a ceaseless barrage of statistics, of which he (or she, but usually he)
will have an unparalleled mastery. At each step of the argument, the logic will
appear flawless, even brilliant. But, in general, the entire purpose of the
talk will be to "prove" the thought leader's opinion, despite the
complete lack of genuine reliable evidence, or to disprove the actual evidence
that exists, because it fails to support that opinion.
But the responsibility for eminence-based medicine goes well
beyond the elite coterie of experts. The real problem is the culture of
medicine, which rewards the hubris of eminence and actively punishes or offers
subtle disincentives to anyone who question this process.
In this respect, medicine mirrors the rest of life. Medical
training is disturbingly similar to military training, where immediate and
unreflecting obedience is the goal. Both basic training and residency are
designed to break down the mindset and instincts of a young person in order to
mold them to the needs of the profession. In both, the submission to authority
is a central tenet.
It is the rare exception when a physician questions the
practice of another physician. I've been told by several cardiologists that
large portions of the Maryland cardiology community had been aware for years
that Mark Midei implanted stents in patients who didn't need them. No one said
anything. In my career as a journalist, I've stumbled across many similar cases…
The Annals piece was shocking, but even more shocking was a
comment from one physician: "I suspect that the real challenge would be to
find anyone in health care who does not have a story to tell about such
witnessed abuses."
“Generating and publishing evidence is a tedious job,”
writes Bernhard Meier (University Hospital of Bern, Switzerland), one of the
top interventional cardiologists in the world, in the European Heart Journal.
“Waiting for the results of randomized trials may preclude patients from an
apparently good thing while the trials are ongoing.”
The problem, it should be unnecessary to point out, is that
what often seems like “an apparently good thing” turns out, after careful
scrutiny with good evidence, to be not good at all, and perhaps even harmful.
And, ahem, expensive. Just because you are an interventional cardiologist doesn’t
mean you are infallible or can see into the future.
Medicine has always existed somewhat uncomfortably in the
dual worlds of science and belief. Beliefs derive from tradition or good ideas.
Interventional cardiology is a field built on good ideas— balloon angioplasty,
stents, and TAVR, to name a few. But we tend to forget that the field is also
littered with the corpses of good ideas that didn’t work and even caused harm—
just think of laser angioplasty, atherectomy, or radiation to prevent restenosis.
Further, it’s important to recognize that even the good ideas that work out
aren’t panaceas— they need to be carefully studied to find out precisely which
patients derive benefit, and this is not an easy question to answer by any
means. The best stent in the world can only bring harm to someone who doesn’t
need it…
For Meier, evidence-based medicine is a relic of the past,
though he acknowledges that it is “an uncontestedly laudable product of the
last century.” He continues: “Collecting
evidence in a randomized fashion, ideally with double-blind, double-dummy, and
sham-controlled design, could well be overrated. Currently, it is a declared
holy grail but that may take bizarre shapes.”
Meier goes on to rail against RCTs, though he doesn’t
provide any good examples: “Even more grotesquely misleading conclusions
can emanate from poorly conceived or sloppily conducted randomized trials.
Current publication criteria for randomized trials do not allow one to alter
the endpoint of a study after the study has commenced. Neither do they allow
one to hypothesize in the abstract or the final conclusions of the paper on how
the results might have been if the design or endpoints of the study had been chosen
differently.”
One of Meier’s main points seems to be that there was far
too much resistance for far too long of drug-eluting stents. Essentially he
argues that all patients (though he never defines who that group might be)
should receive a DES. Back when there were concerns about stent thrombosis with
DESs Meier argues that “all patients should have received them.”…
Meier ends with a passionate defense of PFO closure, the
benefits of which have been “underestimated because of imperfect designs of the
respective randomized trials.”…
This is an extremely dangerous
proposition. Meier doesn’t even mention the alternative possibility that the
absence of evidence could lead to full adoption for decades of a harmful device…
As an editorialist wrote when the
CLOSURE 1 trial was finally published: “During the 9 years it took for the
results of this trial to be reported, approximately 80,000 patients have had a
patent foramen ovale closed with the use of a device at an average cost of $10,000
per procedure. Even if only half these patients were treated by this method for
the purpose of preventing stroke, it would suggest that during that period of
time $400 million was spent on a procedure that had no apparent benefit, to say
nothing of the potential clinical risks involved.
Interventional cardiologists who
argue that devices should be used without supporting RCTs because the trials
are impossible to perform remind me of the defendant accused of murdering his
parents who asked the judge for mercy because he was an unfortunate orphan.
http://cardiobrief.org/2016/07/22/interventional-cardiology-and-the-rejection-of-science/
In the early days of minimally invasive CABG, a top cardiac
surgeon at a top hospital decided to try out the new technique. He then
performed many of his cases this way. He meticulously documented the results,
obtaining an angiogram on each and every patient immediately after surgery.
After about 80 or so cases, he recognized that his results were better with
traditional open CABG, he modified his approach, and ultimately, reverted back
to standard CABG via a median sternotomy. The surgeon did not seek IRB
approval, nor did he seek approval of insurance companies to incorporate an
immediate post-operative angiogram, though presumably he explained to the
patients that they were going to undergo a new, less invasive operation. As far
as my source knew, no one every raised a question about any of this, though my
source said that he couldn’t help thinking to himself how different things are
on the cardiology side of things. He joked that if he had wanted to demo a new
type of surgical glove, he would have been required to get IRB approval.
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