The COVID-19 vaccines have been associated with warnings of heart inflammatory issues such as myocarditis. In fact, all of the Scandinavian countries (Denmark, Sweden, Norway, Finland and Iceland) have paused or halted the use of Moderna to better understand the risks associated with this particular mRNA-based vaccine. In what could represent bombshell data a recent entry in the American Heart Association (AHA) journal Circulation authored by the provocative Dr. Steven R. Gundry connects the COVID-19 mRNA vaccines with endothelial inflammatory markers and ACS risk in a foreboding cautionary assessment. A cardiac surgeon by training, Dr. Gundry left traditional medicine to embrace a healthy lifestyle, nutritional/plant-based diets and the microbiome movement—the health of bacterial flora for example. By using a state-of-the-art diagnostic called PULS Cardiac Test the author sought to clinically verify the measurements of multiple protein biomarkers producing a probability score for new Acute Coronary Syndrome (ACS). What are the concerns of Dr. Gundry and why isn’t this kind of information more prevalent? The answers to this real-world study, based on continuous testing of 566 patients should be further investigated.
TrialSite offers a summarized and hopefully simplified snapshot of this recent research conducted with the PULS (Protein Unstable Lesion Signature) Test. Produced by GD Biosciences located in Irvine, California the PULS Test measures the most clinically significant protein biomarkers that measure the body’s immune response to arterial injury. Typically, such injuries contribute to the formation and advancement of cardiac lesions, which over time become unstable and consequently rupture. This becomes a cardiac event.
The Investigator
Dr. Gundry is no ordinary guy. An author as well as practicing doctor and former cardiac surgeon he has run his own clinic conducting investigations into how lifestyle and diet impact health. An important and noble cause particularly in a world with rapidly growing obesity challenges—and all that follows such a trend. Gundry supports his operations with the sales of various supplements and can be seen on the internet with some of those long infomercials.
Dr. Gundry runs practices at waitlist-only clinics such as the Center for Restorative Medicine and the International Heart & Lung Institute both in tony Palm Springs and Santa Barbara, CA respectively.
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Monetizing on A Notable Past
Back in the 1990s Dr. Gundry conducted cardiac surgery research and in fact emerged as a pioneer in infant heart transplant surgery. He became a New York Times best-selling author cranking out books including The Plant Paradox: The Hidden Dangers in “Healthy” Foods That Cause Disease and Weight Gain.
Gundry has claimed that a particular protein derived from certain plants (lectins) trigger inflammation leading to myriad modern diseases. He introduced the “Plant Paradox diet” precluding lectins yet critics suggest this body of research a “pseudoscience.” For example, some of the healthiest cultures are associated with a lectin rich diet. Gundry has been monetizing his work which opens him up to claims of conflict of interest. Regardless, Gundry’s recent piece in AHA’s Circulation merited review.
The Test
PULS is used by cardiologists as it can validate risks in multi-ethnic populations, produce outcome data that demonstrates clinical utility associated with identification of at-risk patients while confirming to various medical industry standards and guidelines.
Dr. Gundry and team used the PULS to predict the probability of Acute Coronary Syndrome (ACS), any condition caused by a sudden reduction or blockage of blood flow to the heart.
How is the score derived?
The test score is based on the delta from a normal baseline score of multiple protein biomarkers, such as:
BiomarkerBrief OverviewIL-16A proinflammatory cytokineSoluble FasInducer of apoptosisHepatocyte Growth Factor (HCG)Marker for chemotaxis of T-cells into epithelium & cardiac tissue, among others
Once these various biomarkers are aggregated and analyzed the score is applied. The PULS score is elevated if the norm increases while if below a certain baseline it is considered below the norm.
The Baseline
This study included a patient population under continuous care for eight years. Dr. Gundry reports that the practice has measured the patient’s scores for every 3 to 6 months for the duration. Over the eight-year period the data has settled into particular patterns.
Historical Event Leads to Big Change
By March 2020 the COVID-19 pandemic swept the globe including Dr. Gundry’s practices in Palm Springs and Satna Barbara, California. Gundry and staff observed marked changes in the cardiac biomarker-focused, predictive scores.
Of course, a big change starting in December 2020 and into 2021 was the first mass vaccination –that is where an entire national population was exposed to a novel mRNA-based vaccine in the middle of a pandemic. With vaccination rates high in California undoubtedly a good percentage of the Gundry practice patient base was vaccinated with either Moderna (mRNA-1273 or Spikevax) or Pfizer-BioNtech (BNT162b2 or Comirnaty).
The Test Results
So, what happened before the mass vaccinations in response to the COVID-19 pandemic and after?
Dr. Gundry’s patient base involved those in an ongoing preventive cardiology practice. As part of that practice, he designed a real-world study to measure before and after vaccination cardiac-focused biomarkers.
Gundry and staff ran tests on 566 patients split evenly between males and females who ranged in age from 28 to 97 years old. Each patient had a new PULS test conducted from two (2) to ten (10) weeks after the second COVID-19 vaccine shot.
What did Gundry and team find? See the table for test score results before and after COVID-19 vaccination with either mRNA-1273 or BNT162b2.
PULS Biomarker Test Results Pre-Post Full COVID Vaccination
BiomarkerBefore COVID VaccineAfter COVID VaccineBaseline IL-1635=/120 above the norm82=/- 75 above the normsFas22 +/-15 above the norm46 = /-24 above the normHCG42+/- 12 above the norm86 +/-31 above the norm
In the aggregate Dr. Gundry reports in Circulation that the PULS score increased from 11% 5-year ACS risk to 25% 5-year ACS risk. This means that the probability for a cardiac event has more than doubled due to the vaccination event.
By the time Gundry and staff authored the study results for the review, the changes in scores persisted for at least 2.5 months after the second jab of the mRNA-based vaccine.
Conclusion
Based on the methodical testing of 566 patients at two preventive cardiac care clinics in both Palm Springs and Santa Barbara, California the lead physician in this real-world study came to the conclusion that based on the PULS cardiac test measuring multiple relevant biomarkers a disturbing observation must be shared with the TrialSite community.
Dr. Gundry concluded that both the Moderna and Pfizer-BioNTech mRNA-based COVID-19 vaccines problematically boost inflammation on the endothelium and T cell infiltration of cardiac muscle and could likely correlate to observations of increased thrombosis, cardiomyopathy as well as other adverse events post COVID-19 immunization.
Lead Research/Investigator
Steven R. Gundry, MD