Tuesday, August 9, 2016

Eminence-based medicine

[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.


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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