Be Careful What You Share: How Clinical Research Can Be Used -- and Abused

I recently popped down to the US from British Columbia for a family visit, with much of the time spent searching for a PCR test that would be resulted within 72 hours (which no one would guarantee), currently required of all Canadians returning home. Ultimately, I had three negative results in hand as well as proof of vaccination and an extensive quarantine plan ready for the border agent, who really only wanted to know the exact volume of my hard cider stash.

But since I had to visit several drug stores to get tested, I took advantage of the opportunity to get my flu vaccine. Despite minimal arm discomfort, I was up all night with neck and shoulder pain. The following morning, I did routine yearly lab testing for a Longitudinal Study on Aging. To my great surprise, the results returning days later showed a 100-fold increase in my (normally almost unmeasurable) hsCRP levels. This prompted some quick research.

Indeed, I learned, influenza vaccines can be associated with transient increases in acute phase reactants (such as CRP), albeit typically in the 1.5 x normal range. I had also received my Moderna booster exactly 2 weeks prior.

Looking for any evidence of COVID vaccination as a possible confounder, I discovered an abstract published by Circulation from the most recent American Heart Association (AHA) meeting by Steven R. Gundry, MD, a cardiac transplant surgeon turned preventive cardiologist. He has quite a popular lay following for his books, as well as appearances on PBS. And he sells his book and supplements on a website, something any entrepreneurial medical practitioner is entitled to do but which often seems to evoke envy or disdain in colleagues.

Although Gundry's dietary recommendations are highly unorthodox, they are hardly dangerous. I see no indication online that he is an anti-vaxxer.

The abstract concerned his routine office use of an AHA-accepted test to predict ACS risk: the PULS test. The Protein Unstable Lesion Signature test, validated via the MESA study, is a nontraditional measure of 5-year ACS risk that is significantly more reliable than lipid levels or even screening imaging studies, because it correlates with soft plaque burden and endothelial damage by measuring immunologic response. It is fully covered by Medicare.

Gundry noticed that a large number of his preventive cardiology patients, who are regularly tested, experienced more than a doubling of several PULS parameters (associated in other studies with endothelial and myocardial damage) within a period of days to weeks after COVID vaccination (except Johnson & Johnson).

He warned about a possible association between vaccination and inflammation, as via several mechanisms that are suggested by specific elevations of three PULS test components (FAS, FAS-ligand, and hepatocyte growth factor) suggestive of increased ACS risk.

The Plot Thickens

You can probably predict what happened next. Anti-vaxxers seized upon the abstract, using motivated reasoning to raise the possibility of an association with an abnormal test result used to predict increased ACS risk, as proof positive that COVID vaccinations are dangerous, if not deadly.

Surely, this was not something within the author's ability to control. But Gundry's abstract was subsequently subjected to an "Expression of Concern" by the AHA, something that so far as I can tell has occurred only a handful of times in their journal's history. I suppose an "EOC" does not carry the same weight as a retraction, but the distinction may be lost on alert readers. Or maybe not.

The abstract was the subject of a fairly vicious tweet by a PhD malaria researcher blaming Gundry for a typographical error (that is a very common auto-correct for "PULS"). Further, the tweeter, Lander Foquet, criticized Gundry for not explicitly stating that his office-based research finding was anecdotal in nature, or the seemingly obvious that any association with the vaccine as the most likely source of reversible inflammation indicated by the testing was speculative, rather than proven conclusively. Foquet also faulted Gundry for not providing a full statistical analysis for this noncontrolled clinical office observation.

His coup de grâce ? Gundry did not list in his abstract that he sells supplements and therefore has a conflict of interest. Really?

Medical Breakthrough vs Reputational Damage

I spoke with the company that developed the PULS test (which, full disclosure, I have taken myself and occasionally used in our practice as a means of encouraging preventive cardiac self-care). It seems they are seeing dramatic elevations in several PULS test parameters following infection by COVID itself, during post-acute COVID syndrome, and yes, in the wake of immunization against it.

Given the overwhelming vascular manifestations in acute COVID, the similarities of many chronic COVID manifestations to other virally mediated illnesses, and the well-known associations of several vaccines with some of the very same or similar syndromes as the viruses they are directed against (eg, Guillain-Barré, myalgic encephalomyelitis, neuralgic amyotrophy), you would expect that any possible clues that might help to elucidate what is going on with this virus might be welcomed. The likelihood of endothelial injury as a significant underlying disease pathology is mounting, and perhaps supported by Gundry's patients' experience with PULS test abnormalities after vaccination.

But because of the malign influence of political beliefs on interpretation of science by nonscientists, coupled with overreaction by scientific vigilantes and publishers, physicians who make potentially relevant observations about their specialized patient populations may find themselves castigated. Thus, we suffer twice: first from misinterpretation and ignorance promulgated by zealots, and then from overly meticulous demands for absolute scientific validity, even in a mere abstract, by purists.

There are probably other clinicians out there with cogent observations about their patients exposed to this virus (or its parts), who will be reluctant to risk their reputations by sharing their observations openly, between ideologues in the current politically charged populace and the dog-eat-dog scientific environment. We are basically undermining community sources of knowledge about a once-in-a-lifetime deadly pandemic, through perniciously motivated forms of dissemination, now complicated by puritanical censorship.

Ultimately, I arrived safely home, with no recurrence of pain. Possibly protected by the endothelium-sparing effects of cider? Will continue to so hope.

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