Skepticism in Science and Cardiology

Recognizing bias as we move from eminence-based to evidence-based medicine

I’m often asked by patients why I call myself the skeptical cardiologist. Some are concerned that a skeptical attitude may not be the best one in their physician.

But the scientific bases of medicine have advanced primarily due to skeptics; individuals who questioned the conventional wisdom that had become entrenched dogma.

Andreas Vesalius established the modern science of anatomy by boldly challenging what was in human anatomy textbooks written a thousand years earlier by Galen and others. As chair of anatomy and surgery at the University of Padua he began dissecting human cadavers and ultimately published De Fabrica in 1543. He was vilified at the time by authorities but his revolutionary approach of direct observation began the path to modern medicine.

Vesalius is the earliest of many skeptics in medicine who have moved us into the era of evidence or science-based medicine from what has been termed eminence-based medicine.

I’ve always had a strong skeptical/scientific approach to life and information but prior to coming out as the skeptical cardiologist I had not honed my scientific literature appraisal skills nor used them as vigorously as I should have in the field of nutrition. Upon being challenged to provide scientific support for consuming less dairy fat I realized that this dogma of cardiovascular nutrition, something I had read in guidelines and review articles for decades was entirely unsupported by the scientific literature.

After this epiphany, the skeptical cardiologist was born and I’ve written in many other related medical fields on similar unsupported but widely propagated recommendations in cardiology.

These include invasive procedures or devices, new medications, supplements. and lifestyle changes..

Science-based Skepticism Leads to Medical Conservatism

The true medical skeptic is also going to be a medical conservative.

Dr. John Mandrola, a cardiologist, has become the most prominent legitimate voice of skepticism (and thereby medical conservatism) with respect to cardiovascular therapeutics and procedures in recent years Remarkably, he is frequently critical of the overutilization of procedures in his own field of electrophysiology (such has LAA occlusion) something which is very rare and very refreshing.

Mandrola produces an excellent podcast, This Week in Cardiology, which I highly recommend to all in the medical or cardiology field. In the June 2 TWIC podcast he analyzed a recent study that looked at the effectiveness of a device implanted in the pulmonary artery of patients with heart failure called cardio-MEMs.

MONITOR HF is a Dutch RCT comparing the use of the CardioMEMS pulmonary artery (PA) monitoring device in 348 patients with heart failure (HF). It found improved quality of life in those patients who underwent the invasive device implantation but no reduction in mortality.

This was a randomized but open-label trial therefore the group receiving the invasive device implantation knew it. Given the powerful influence of the placebo effect on subjective outcomes like quality of life, the patients randomized to getting the invasive procedure were bound to report better scores irrespective of the effects of the procedure.

As Mandrola writes:

But this is terrible. You have a totally broken trial. You cannot assess QOL when one arm gets an invasive treatment, and the other arm gets nothing. It would be like a pain trial wherein one group is told their injection has strong doses of morphine and the other arm is told it gets nothing.

The worst part is that this is spun by the authors and the editorialist as positive. Media covers it as positive.

It contributes to the marketing power of an expensive device that shows little to no evidence of efficacy. Recall that GUIDE-HF failed to meet its primary endpoint, but gained approval based on a post-hoc pre-COVID sub-analysis that barely met significance.

The part of Mandrola’s critique in TWIC that I really like follows. In it he outlines how the industry money involved in trying to market devices like cardio-MEMS circulates and influences everyone involved.

Almost invariably, when the skeptic encounters unsupported recommendations or papers “spinning” the results of studies, some element of bias is the cause. The medical device industry has lots of money that seeps into academic and clinical medicine in countless ways.

The optimists have industry backing. They have the dollars. The dollars from industry not only support researchers and editorialists, but they also support the professional societies, and they infuse the guidelines, which are translated to standard of care.

Dollars from industry fund a big part of our major professional cardiology organization and they boost income for hospitals and cardiologists.

Walk through the expo of any cardiology meeting and you can see the influence. One company at the American College of Cardiology (ACC) meeting had a NASCAR with drug-labeling on it.

• CardioMEMS is a perfect example. A skeptic has no chance. Not only does the device make money for the company, but each time it transmits data, it creates a bill.

• It’s a cash machine for all the “stakeholders.”

• Profit is fine if it improved quality of life or extended life, but, obviously, anyone who looks at the data, without the spin would know it doesn’t do those things.

• Now consider that the company that makes the device contributes to professional societies. It will be written into the guidelines. It’s not a fair fight.

Mandrola picked on CardioMEMS in this case but cites many other examples: including drugs (like Sacubitril/valsartan aka Entresto), left atrial appendage occlusion, and early AFIB ablation.

And I agree with him in each of these areas.

How to Tell a Skeptic from a Crank

Many Americans have lost trust in the established institutions that convey the findings of scientific studies and, as a consequence, the public health recommendations that flow from hugely important organizations like the CDC and the FDA are being widely ignored.

This environment has allowed wildly unscientific public influencers to proliferate and profit and gain prominence.

How can the average citizen determine what sources of information are reliable and truly science-based?

Prior to becoming the skeptical cardiologist I thought this was pretty straightforward but it is now clear to me that the authorities I trusted in academia, industry and government deviate regularly from science-based conclusions and recommendations when it is convenient or due to their biases.

My goal as a scientific skeptic and in writing the skeptical cardiologist is to provide readers and patients with unbiased science-based information and to aid them in identifying other sources of information that are appropriately skeptical, science-based and free of the biases described above.

Skeptically Yours,

-ACP