Abstract linking COVID-19 vaccines to heart trouble risk earns expression of concern

A leading heart journal has issued an expression of concern for a meeting abstract it published earlier this year by a cardiac surgeon who sells dietary supplements of questionable utility.

The case is the second involving a recent meeting of the American Heart Association.

The abstract, titled “Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning,” was presented at the AHA’s 2021 Scientific Sessions in mid-November and was published in Circulation

The author was Steven Gundry, a cardiac surgeon by training who now sells dietary supplements on his website. Gundry also sees patients at the Center for Restorative Medicine and International Heart & Lung Institute in California and offers advice on YouTube.

But critics have accused Gundry of peddling worthless — if ultimately expensive — advice. 

According to the abstract, which is riddled with errors, including the name of the test (it’s PULS, not PLUS): 

Our group has been using the PLUS Cardiac Test (GD Biosciences, Inc, Irvine, CA) a clinically validated measurement of multiple protein biomarkers which generates a score predicting the 5 yr risk (percentage chance) of a new Acute Coronary Syndrome (ACS). The score is based on changes from the norm of multiple protein biomarkers including IL-16, a proinflammatory cytokine, soluble Fas, an inducer of apoptosis, and Hepatocyte Growth Factor (HGF)which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue, among other markers. Elevation above the norm increases the PULS score, while decreases below the norm lowers the PULS score.The score has been measured every 3-6 months in our patient population for 8 years. Recently, with the advent of the mRNA COVID 19 vaccines (vac) by Moderna and Pfizer, dramatic changes in the PULS score became apparent in most patients.This report summarizes those results. A total of 566 pts, aged 28 to 97, M:F ratio 1:1 seen in a preventive cardiology practice had a new PULS test drawn from 2 to 10 weeks following the 2nd COVID shot and was compared to the previous PULS score drawn 3 to 5 months previously pre- shot. Baseline IL-16 increased from 35=/-20 above the norm to 82 =/- 75 above the norm post-vac; sFas increased from 22+/- 15 above the norm to 46=/-24 above the norm post-vac; HGF increased from 42+/-12 above the norm to 86+/-31 above the norm post-vac. These changes resulted in an increase of the PULS score from 11% 5 yr ACS risk to 25% 5 yr ACS risk. At the time of this report, these changes persist for at least 2.5 months post second dose of vac.We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.

The study was picked up by several outlets that have a tendency to publish doubts about vaccines, as well as by more than 53,000 Twitter users, according to Altmetric.  It also caught the attention of Aseem Malhotra, a  British cardiologist who has been making claims about the heart risks of the Covid-19 vaccines, and who has alleged that he knows of researchers who are suppressing similar findings for fear of losing their funding. 

The EoC states

This article expresses concern regarding abstract “Abstract 10712: Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning” which originally published November 8, 2021; https://www.ahajournals.org/doi/10.1161/circ.144.suppl_1.10712

Soon after publication of the above abstract in Circulation, it was brought to the American Heart Association Committee on Scientific Sessions Program’s attention that there are potential errors in the abstract. Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used. 

We are publishing this Expression of Concern until a suitable correction is published to indicate that the abstract in its current version may not be reliable.

Gundry, through his assistant, told us that he had “no comment” on the journal’s decision. 

Malhotra — a correction of whose we covered in 2014 and who has found himself in a “media war of words” over his views on statins — did not immediately respond to a request for comment.

We emailed Joseph Hill, the editor in chief of the journal, with questions about the notice. Hill didn’t respond, but we received the following email from Michelle Kirkwood, the director of national science media relations at the AHA:

The specific abstract referenced is under additional review by our Scientific Sessions Program Committee, and an Expression of Concern was posted on the abstract, as of 10:00 am CT, Nov. 24, 2021. The Expression of Concern indicates that the abstract, in its current version, may not be reliable. A correction from the research author has been requested and is due to the American Heart Association by 6:00 pm ET, Friday, Dec. 3, 2021. The author’s corrections will undergo review before publication. 

Kirkwood added: 

Abstracts are brief summary documents, 400 words or less, describing the key details of a research project. Abstracts are considered preliminary research and represent the beginning of a scientific conversation on the findings, which may then, ultimately, result in a full manuscript published in a peer-reviewed scientific journal. The statements and conclusions of studies that are presented at the American Heart Association’s scientific meetings are solely those of the study authors and do not necessarily reflect the Association’s policy or position. The Association makes no representation or guarantee as to their accuracy or reliability.

Scientific discovery must include room for robust discourse including alternate views and debate, testing of hypotheses from every possible angle, and review and feedback from experts around the world. This dynamic and rigorous process is critical to scientific and medical advancements. 

We agree. But we also think major medical and scientific societies should do at least a little vetting of abstracts before they accept, let alone publish, them — or make it far more clear that it “makes no representation or guarantee as to their accuracy or reliability” before, rather than only after, serious questions are raised. [See an update on this post.]

Take, for example, another abstract that was due to be presented at the same AHA meeting. The study in question claimed to show, according to an AHA press release, that “E-cigarette users face 15% higher risk of stroke at a younger age than traditional smokers.”

But that press release was deleted — you can read an archived version here — with this note:

This abstract will no longer be presented at Scientific Sessions 2021. Unfortunately, the researchers were not able to complete their presentation.

That seemed puzzling. The AHA issued a press release about a presentation that hadn’t even been submitted in full? Meanwhile, the UK’s Science Media Centre posted comments from experts questioning the abstract, including one that suggested the abstract had similar problems to one about vaping and heart attacks that ended up being retracted.

We asked corresponding author Urvish Patel, research scholar and chief education officer in the department of public health and neurology at the Icahn School of Medicine at Mount Sinai in New York City, for an explanation. He told us that it was a problem with AHA’s servers, and that an AHA journal has invited him and his co-authors to submit the paper:

According to my timezone we were late by 8 min and that is due to servers issue of the AHA. 

Looks like server started working  late night so AHA committee  got it next morning. 

Manuscript Submission has invited by AHA Stroke journal. 

Stay tuned.

Update, 2000 UTC, 12/1/21: Kirkwood added:

Abstracts are not peer reviewed. Abstracts are curated by independent review panels who are blinded to the authors, and they receive consideration solely on the basis of their potential for contributing to the diversity of scientific dialogue that takes place during a given scientific meeting. This is a generally accepted practice within the scientific research community and a practice followed by the American Heart Association.

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19 thoughts on “Abstract linking COVID-19 vaccines to heart trouble risk earns expression of concern”

  1. 400 words may be a short communication, but in theory will not have any ‘fluff’. Main results & statistics can be described there. If they are not & there are other errors, one can seriously wonder about the quality of the submission, the data collection itself & the analysis. If there has been so little attention to detail in submitting the abstract this says a lot about the priorities that the scientific team places on sending an accurate message to their peers…

  2. I graphed the data from the abstract, it doesn’t support the claims, basically, the inflammatory markers are not elevated. The error bars are very wide and overlap substantially between pre- and post- vax measures, which means there is no meaningful difference between the figures. There is a large range of other issues with the data, but principally they are using an algorithm that is meant to weigh long-term risk factors against the risk of cardiac events, not transient changes associated with infection or vaccination as well as using an algorithm meant for individual risk to estimate group risk without reporting confidence intervals.

    1. Hi Ian – by error bars, do you mean the margin of errors they provided? for example, the IL-16 measure changed from 35 +- 20 to 82 +- 75? I agree that when the margin of error is almost identical to the actual statistic, you can’t conclude there is any significant difference. To me, that suggests the change was almost random.

      –An aspiring infodemiologist

    2. thanks for bringing sound commentaries – we need to be watchful of inflammation and not throw out everything under the sun away, but when i was sent the abstract i had the same reservations, so THANK YOU

  3. This is an obvious attempt to discredit the abstract and smear the author to protect the current vaccine narrative. Red flags in the above are logical fallacies used – noting the author sells supplements and does business on YouTube – this is guilt by association and poisoning the well, as you know it will create distrust to the author with the audience. Scientists and researchers are being suppressed by fear of not getting more funding if they go against the grain.

    1. The enormous data variability which precludes any conclusions and the total lack of support for the headline claim are what invalidates this abstract, the conflict of interest which was not declared in the abstract is just one further data point.

    2. I would love to see your analysis of this ‘abstract’, showing how this ‘research’ was properly conducted and analyzed.

      I think that this abstract shows that people are not scared to publish every little thing, regardless of the validity of the data.

  4. This is the cancel culture at its best. You are destroying the country. Lets leave the data be until further studies. Dont destroy the data until you know its false. By doing this you are being destructive to the truth and to people’s lives.

    1. “Don’t destroy the data?” What data do you think are being “destroyed?”

      I don’t think you understand what an Expression of Concern is. And you certainly didn’t understand this one—the journal is asking for MORE information, not less. They’re asking for correction and clarification, not “cancellation.”

    2. No, this is not cancel culture, it is peer review. Wildly inaccurate data which can’t support the claims you make AND complete lack of evidence of the headline claim warrants more than just an expression of concern, this warrants withdrawal of the abstract (there is no data to destroy, read the abstract).

    3. What are you ‘Concerned’ about? Obviously not about amateurish research being published or about ‘researchers’ being asked questions about their conclusions.

  5. I may have concerns if this was the only data that expressed concerns about the detrimental effects of the vaccine. This is only a very small fraction of evidence in addition to the vast amount of empirical observations, statistical studies and autopsies conducted internationally documenting the dangers of this vaccine. All ignored by the pro medical mRNA vaccine train. Trying to discredit other valuable evidence by highlighting one study just doesn’t hold water.

    1. We’d appreciate the evidence, please (and no, don’t go back to VAERS). Don’t defend a lousy ‘study’ by saying there’s better – just show the better data. And how does the risk of cardiac events due to vaccine compare to the risk of cardiac events due to the virus itself? Clinical equipoise is an important concept.

  6. I sent an email to the abstract author a couple of weeks ago and have not received a reply. I asked if Covid vaccination status and PULS score data could be independent variables. My observation is that around the time of many vaccinations the air quality in California was horrible with the widespread wildfires. Perhaps the increase in PULS scores could be explained by a dependent variable such as air pollution.

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