No Credible Evidence COVID-19 mRNA Vaccines ‘Dramatically Increase’ Heart Attack Risk, Contrary to Flawed Abstract – FactCheck.org

“It is not proof that people should not get vaccines. What it should be interpreted as is proof that the vaccine works,” he told us in an interview. “The best course of action for people is still to get vaccinated. And the real risk is in people who get COVID because of the intensity of the inflammatory response is significantly higher, than induced by the vaccine.”

AHA’s Grant said statements and conclusions of research presented at the association’s meetings or journals “are solely those of the study authors and do not necessarily reflect the Association’s policy or position.” The abstracts presented in a meeting are “intended to prompt scientific discourse” and the programming is not intended “to evaluate scientific validity.” Nonetheless, she said AHA is “reviewing its existing abstract submission processes.”

“The Association regrets any confusion regarding the Association’s position on COVID-19 vaccine, especially among the lay public who may be unfamiliar with scientific meetings. The American Heart Association itself has been unequivocal in its belief in and support of vaccination as the best available public health strategy to address the pandemic. The American Heart Association continues to fully support the CDC’s COVID-19 vaccination recommendations,” she wrote in an email to FactCheck.org.

The PULS Cardiac Test

Gundry’s controversial abstract summarizes the results of a test that claims to be able to predict a patient’s five-year risk of suffering an Acute Coronary Syndrome, or what AHA defines as an “umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked,” such as a heart attack. 

The PULS (Protein Unstable Lesion Signature) Cardiac Test (misspelled once in the abstract as PLUS Cardiac Test) is a blood test that its makers say can identify endothelial damage by measuring nine protein biomarkers: hepatocyte growth factor, eotaxin, monocyte-specific chemokine 3, cutaneous T-cell-attracting chemokine, interleukin 16, Fas ligand, soluble Fas, HDL, and HbA1c. 

Measurements of these biomarkers above the norm create a higher “PULS score,” and measurements below the norm lowers create a lower score. The score are categorized into risk categories: normal, borderline or elevated.  

Is it worth mentioning that none of the experts reached for this story were familiar with the PULS test, which has been questioned by experts online after Gundry’s abstract was published. According to a press release, as of June, the company had sold 120,000 tests since its launching in 2018.

Gundry’s preliminary research compared scores from 566 patients, aged 28 to 97, with an equal mix of males and females. It says measurements were taken three to five months before the administration of mRNA COVID-19 vaccines and then two to 10 weeks after a second dose. There is no detail on whether the patients had any other health conditions or previous heart issues. The abstract says measurements for three of the nine biomarkers — IL-16, sFas and HGF — increased.

“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,” the abstract reads.

Dr. Luigi Adamo, the director for cardiac immunology in the Johns Hopkins University Division of Cardiology who studies the relationship between the immune system and cardiac function, told FactCheck.org he had not heard about the PULS cardiac test before, but he looked it up on our request.

“This test estimates the risk of having clinically significant coronary artery disease using a combination of clinical variables such as age and sex and serum levels of biomarkers that are associated with inflammation and/or atherosclerosis. Chronic elevation in non-specific markers of inflammation such as C reactive protein has been associated with an increased risk of heart attacks and therefore, conceptually, this makes sense to me,” Adamo told us in an email.

However, he said he did not understand its use to assess heart disease risk in people who have received an mRNA COVID-19 vaccine. 

“Vaccination is designed to induce a controlled inflammatory response with the goal of preparing the body to ‘fight’ the targeted pathogen. It is therefore expected that administration of a vaccine induces a transient increase in inflammatory mediators in the serum. However, this cannot be automatically interpreted as an increase in the risk of having a heart attack. Even if the mRNA vaccines caused a sustained elevation of specific serum biomarkers of inflammation, the prognostic value of this change in terms of risk of heart attacks would need to be validated with population data,” Adamo wrote.

Harrington, the test co-developer, agreed. He said all vaccines induce that kind of response and that the results of the test in this situation are not something to be concerned about.

“It should not be surprising to anyone that a vaccine temporarily stimulates a transient inflammatory response, which the PULS test is sensitive enough to capture. But does that mean that those people are at risk, or you shouldn’t get vaccinated? Absolutely not,” he said. 

The Abstract

Gundry’s abstract has been criticized by many for its sloppiness and lack of details. 

Johns Hopkins’ Adamo told us that even though by definition abstracts provide very little information, this one stands out “because it provides almost no information to support some very bold conclusions.” He added, “Its conclusions overall appear unsubstantiated.” 

Jeffrey Morris, director of the division of biostatistics at the University of Pennsylvania, said the limitations in the abstract, such as “the lack of details on the patient selection, analysis approach, and other details,” make it “impossible to evaluate.”  

“It appears the sample is a selective sample taken from a clinical practice,” Morris wrote. “Without knowledge of what subset were sampled/not sampled and their demographics, and what procedure was used to select these samples for processing, we cannot rule out the results driven by selection bias.”

The numbers in the abstract, he added, are impossible to understand. For example, in the results presented for the protein biomarker changes, Gundry uses symbols such as “=/-“ or “+/- ” without any context or explanation. Morris says it’s not clear whether the numbers are means, standard deviations, standard errors or a range of values. “And they don’t provide any statistical test to see whether the difference is statistically significant,” Morris said. 

Gundry has been criticized in the past for using an abstract for a poster presentation as if it contained peer-reviewed, validated findings. There is no evidence that he’s doing that now, as there are no references to this research on any of his website or social media platforms. But there is evidence that the abstract is flawed and being misrepresented by others to claim that vaccines cause heart attacks.

Update, Dec. 22: On Dec. 21, AHA published several corrections to the abstract, emphasizing that the findings were observational in nature. The original abstract name, “Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning,” was revised to “Observational Findings of PULS Cardiac Test Findings for Inflammatory Markers in Patients Receiving mRNA Vaccines.” Among other corrections, the abstract now states that the PULS Cardiac Test is “clinically utilized,” rather than being “clinically validated,” and concludes: “the mRNA vacs numerically increase (but not statistically tested) the markers IL-16, Fas, and HGF, all markers previously described by others for denoting inflammation on the endothelium and T cell infiltration of cardiac muscle, in a consecutive series of a single clinic patient population receiving mRNA vaccines without a control group.”

The correction adds some information to the methodology, such as that each patient served as their own control and that there was “no comparison made with unvaccinated patients or pts treated with other vaccines.” It also states that a “number of typographical errors” were corrected and that “[n]o statistical comparison was done in this observational study.” Additionally, the abstract no longer claims that changes on the cardiac test following second-dose vaccination persist “for at least 2.5 months.”

Clarification, Dec. 16: Grant, a spokesperson for the AHA, clarified that Gundry has submitted a corrected abstract, but it has yet to be approved. “We received them and as part of the back and forth process – yet they are not final until accepted/published,” she said.  

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

“Myocarditis and Pericarditis After mRNA COVID-19 Vaccination.” Centers for Disease Control and Prevention. Updated 12 Nov 2021, accessed 10 Dec 2021. 

Mallapatu, Smriti. “Heart-inflammation risk from Pfizer COVID vaccine is very low.” Nature. 8 Oct 2021. 

Abbasi, Jennifer. “Researchers Investigate What COVID-19 Does to the Heart.” JAMA. 10 Feb 2021.

Mitrani, Raul D., et al. “COVID-19 cardiac injury: Implications for long-term surveillance and outcomes in survivors.” Heart Rhythm. 26 Jun 2020.

“Heart inflammation, COVID-19 and the rare side effects of the vaccine.” UC Davis Health. 2 Sep 2021. 

Puntmann, Valentina O., et al. “Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19).” JAMA Cardiology. 27 Jul 2020. 

“Expression of Concern: Abstract 10712: Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning.” Circulation. 24 Nov 2021. Accessed 13 Dec 2021. 

Gundry, Steven R. “Abstract 10712: Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning.” Circulation. 8 Nov 2021. Accessed 13 Dec 2021. 

Gundrymd.com. Accessed 10 Dec 2021. 

Drgundry.com. Accessed 10 Dec 2021. 

Rosenbloom, Cara. “Going ‘lectin-free’ is the latest pseudoscience diet fad.” Washington Post. 6 Jul 2017.

Watson, John. “Lectins: Are These Food-Based Proteins Friend or Foe?” Medscape. 17 Aug 2018.

Stiles, Steve. “AHA Challenges Diet Doctor’s Study Alleging COVID Vax Risks.” Medscape. 7 Dec 2021.

Gorski, David. “How antivaxxers weaponized an abstract by a Goop doctor against COVID-19 vaccines.” Respectful Insolence. 24 Nov 2021.

Jurinske, Casey. “120,000th PULS Cardiac Test™ Order.” Press release. Predective Health Diagnostics Company. 14 Jun 2021.

Panjwani, Abbas. “Concerns raised about legitimacy of research linking vaccines and heart attacks.” Full Fact. 30 Nov 2021. 

Reuters Fact Check. “Fact Check-Research abstract is not reliable evidence of a link between mRNA vaccines and heart disease.” Reuters. 26 Nov 2021. 

Scott Lewinsky, John. “U.K. Educator Uses YouTube To Treat Panic Of Coronavirus Myths.” Forbes. 7 Feb 2020. 

Harris, Margot. “An emergency nurse went viral on YouTube for his videos on the coronavirus, bringing in millions of views on his health and science lectures.” Insider. 16 Mar 2020. 

Grant, Suzanne. American Heart Association Media Relations. Emails sent to FactCheck.org 2 Dec 2021, 10 Dec 2021. 

Harrington, Douglas S. Chairman of Predictive Health Diagnostics Company and Laboratory Director of Morningstar Laboratories. Interview with FactCheck.org. 10 Dec 2021. 

PULS Cardiac Test website. Accessed 10 Dec 2021. 

Adamo, Luigi. Director for Cardiac Immunology in the Johns Hopkins University Division of Cardiology. Email sent to FactCheck.org. 8 Dec 2021. 

Morris, Jeffrey S. Director of the division of biostatistics at the University of Pennsylvania. Email sent to FactCheck.org. 2 Dec 2021. 

Hamblin, James. “The Next Gluten.” The Atlantic. 24 Apr 2017.

Haigh, Joshua. “What is the science behind The Goop Lab’s claims?” 8 Feb 2020. 

Collie, Meghan. “Experts fact-check health claims in Netflix’s ‘The Goop Lab’.” Global News. 24 Jan 2020. 

Khazan, Olga. “The Baffling Rise of Goop.” 12 Sep 2017.

Campbell, T. Colin, and Thomas Campbell. “‘The Plant Paradox’ by Steven Gundry MD– A Commentary.” Center for Nutrition Studies. Updated 3 Jan 2019.