COMMENTARY

Clinician-Scientists: Impartiality Co-opted?

John M. Mandrola, MD

Disclosures

September 25, 2018

The applause was remarkable, not just for its intensity, or that it brought emotion to the face of the speaker, but that it occurred at a "scientific" meeting. The stage cameras in the massive auditorium panned to a rapturous audience at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 meeting.

It was as if the home team had scored, or perhaps a politician at a rally had landed an applause line. I've never felt this sort of passion at a medical meeting.

COAPT[1] delivered astonishing results for the percutaneous MitraClip device (Abbott), and, if confirmed, this will be good news for a small percentage of patients with heart failure and secondary mitral regurgitation.

My question: Should medical science be this emotional?

At the recent European Society of Cardiology (ESC) Congress 2018, two large trials[2,3] of aspirin for primary prevention produced a wealth of knowledge that will help millions of patients avoid an unnecessary drug. Terrific science. No applause. No emotion.

And…how often have you heard null results described as "disappointing"?

It's not only interventional cardiology. Diabetes specialists applauded results of the EMPA-REG trial[4] in 2015. Electrophysiologists, too, celebrated results of two recent trials on catheter ablation.[5,6]

Clinician scientists want it both ways: They want to be seen as enthusiastic innovators and fair judges of science. To hint that doctors who investigate the drugs or devices that they use every day to earn a living could be (slightly) biased brings scorn: "How dare you suggest I am biased!"  

But how else does one square the ebullience of positive trials with the sadness and apologies of negative trials, especially when positive trials bring treasure to the investigators.

The theatrical setup to COAPT invites cynicism. Shortly before the trial presentation, Dr Saibal Kar, an interventional cardiologist at Cedars-Sinai Medical Center in Los Angeles and the leading enroller in COAPT, presented two cases of patients with secondary mitral regurgitation and heart failure. He said both patients were enrolled in COAPT: one to control, the other to the MitraClip. The patient in the control group had multiple admissions for heart failure, begged for the device, but died before he could be crossed over. The patient who got the device rose up like Lazarus.

Seriously? This is anchoring used by car salesman. Cherry picking 2 cases in a trial of 600 makes one look more like a marketer than a fair judge of science. I mean no malice to Dr Kar, or to the organizers of TCT, but if you behave like this, you can't bristle when people suggest bias.

Are consumers of medical evidence supposed to ignore the fact that industry supports the research, the researchers' institutions, the professional societies, the journals, and, yes, even the media?

I take care of patients, I've been a patient. And I love evidence. I do not oppose physician-industry collaboration or innovation. But I also struggle with the lack of balance among many (not all) key opinion leaders who have strong industry ties.

The COAPT results needed no spin or theatrics. A more robust mention of COAPT's limitations, the missing data, the smaller number of eligible patients after 1 year, and the unblinded nature of the trial would have enhanced trust in the results. The same criticisms apply to my electrophysiology colleagues: The CASTLE-AF and CABANA presentations on catheter ablation of atrial fibrillation came with little talk of the limitations.

Of course, sorting out biases and the impartial judging of science is complicated. There are no easy fixes. Some simple suggestions: Journal editors should force a paragraph on limitations in the abstract, big trials might receive more balanced commentary if presented at more neutral meetings, and panels of trial discussants should include at least one nonconflicted evidence expert.

This is no small matter. Hubris, hype, and spin breed mistrust. And since science has a trust problem, our leaders could stop making it worse.

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