An anti-vaccine group run by the discredited James Lyon-Weiler tried to show that the COVID-19 vaccines are linked to myocarditis in a vain attempt to discredit them. The paper they published was just retracted. Of course.
Ironically, when the paper was published last week, I was going to write about it. However, it lasted about a week before Retraction Watch reported that the publisher retracted it. So, I’ll write about how this is a terrible article and why it got retracted (actually, the publisher isn’t being transparent, so we really don’t know).
Simply, myocarditis, also known as inflammatory cardiomyopathy, is a very rare inflammation of the heart muscle. Symptoms may include shortness of breath, chest pain, decreased ability to exercise, and an irregular heartbeat. The duration of the condition can vary from hours to months. Complications of myocarditis may include heart failure due to dilated cardiomyopathy or cardiac arrest.
Most of the time, myocarditis is caused by an infection that reaches the heart. When it does, the immune cells that fight the infection enter the heart. These immune cells produce biochemicals that can damage the heart muscle. Consequently, the heart itself can become thick, swollen, and weak.
Many of the cases are caused by a virus that reaches the heart. These can include influenza virus (flu), coxsackievirus, cytomegalovirus, adenovirus, and others. The condition may also be caused by bacterial infections such as Lyme disease, streptococcus, mycoplasma, and chlamydia.
As you can see, some sort of infectious pathogens, such as viruses and bacteria, are almost always implicated in the etiology of myocarditis. And remember, all of the COVID-19 vaccines do not contain the live SARS-CoV-2 virus, they only have a piece of code for the spike protein of the virus.
In the vast majority of cases, the effects are temporary, and the condition resolves itself.
There does appear to be a link between the mRNA COVID-19 vaccines and myocarditis (along with the related condition, pericarditis). Also, I have written extensively about the relationship between myocarditis and the COVID-19 mRNA vaccines – it is extremely rare, about 2-3 out of 100,000 doses, and that it seems to occur most frequently in young males.
However, the CDC continues to recommend the vaccines for any age group that has FDA approval. They do include a list of recommendations to observe for myocarditis and pericarditis.
Also, Israel is examining the issue after observing an increase in risk for myocarditis after the COVID-19 mRNA vaccine. However, and this is important, they are still giving the Pfizer vaccine to their population.
So, no one is disputing that there might be a link between the COVID-19 mRNA vaccines and myocarditis – it’s just that it is extremely rare and not very serious in the vast majority of cases.
The retracted paper
“A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” by Jessica Rose and Peter A.McCullough, was published in Current Problems in Cardiology on October 1. Now, you will notice that the link for the article is from the Wayback Machine, which allows one to link to links that are no longer valid. Because this article was retracted, it can no longer be found on the publisher’s website.
The terse statement from Elsevier for the retracted article says:
The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.
That’s not very informative, but I’ll take a stab at why it was retracted.
- Conflicts of interest Part 1. The authors claim that they had “nothing to disclose.” That would be nice if it were true, but it isn’t. Jessica Rose is affiliated with Institute of Pure and Applied Knowledge (IPAK), Public Health Policy Initiative (PHPI). IPAK is run by anti-vaccine quack James Lyon-Weiler, about whom we’ve written extensively. Lyon-Weiler and his anti-vaccine “institute” have no vaccine scientists involved with it and have no serious credibility in the world of science. This is most definitely a conflict of interest, and Dr. Rose should know that.
- Conflicts of interest Part 2. Rose’s co-author, Peter McCullough runs the Truth for Health Foundation, a COVID-19 and vaccine denial group that pushes faith-based medical treatments. Along with Rose, they have serious anti-vaccine credentials which qualify as conflicts of interest.
- Conflicts of interest Part 3. Both Rose and McCullough are affiliated with America’s Frontline Doctors, another anti-vaccine, anti-mask, COVID-19 denialist group. They prefer pseudoscientifically-based treatments such as ivermectin and hydroxychloroquine. They cannot be trusted with vaccine data.
- VAERS again. Once again, we have Vaccine Adverse Events Reporting System (VAERS) dumpster diving. Anti-vaxxers love to create “gotcha” moments by diving into a database that provides nothing more than testimonials and reports that do not establish correlation, let alone causation. Real vaccine researchers, such as this one, use the Vaccine Safety Datalink, or VSD, to ascertain correlation (and possible causation). VSD allows the researcher to access medical records, making case-control and cohort studies so much easier to develop and analyze. But VSD is not so good for those who prefer pseudoscience – finding evidence to support their anti-vaccine pre-ordained conclusions.
- Bias statement 1. The authors wrote “dose 2 is generally administered 3 weeks following the first dose assuming the individual survives dose 1 without any major complications, including death.” They’re showing their anti-vaccine bias.
- Bias statement 2. “The BNT162b2, mRNA-1273, Ad26.COV2.S products have not been approved or licensed by the U.S. Food and Drug Administration (FDA), having been authorized instead for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.” We have covered this nonsense about an Emergency Use Authorization – vaccines that get an EUA are still reviewed as thoroughly as any other vaccine.
- Bias statement 3. Rose and McCullough write “it has recently been shown that the spike protein itself systemically traffics inducing damage within cells, at the cell surface, and through circulation with endothelial damage and thrombosis.” I have not seen any evidence of this, although it is possible that the virus, which uses the spike protein to attach to the cell may cause this. But that would be for the whole virus, not a piece of it.
- Bias statement 4. They also write, “The clinical implications of acute myocarditis in younger individuals as a result of uncontrolled production of the SARS-CoV-2 spike protein within cardiac myocytes and cardiac support cells is unknown. If myocarditis has developed after the first injection, then second administrations and boosters should be avoided.” They provided no citations to support this claim, yet they write it as if it were factual. It isn’t. Boosters are needed, and they are demonstrably safe.
- Confounders. One of the problems with the VAERS database, amongst many, is that you cannot establish confounders, Was there something about the myocarditis group that made it different from those without myocarditis, such as smoking or obesity? The authors did not even mention confounding variables – it’s like they missed one of the basics of epidemiology, but then again, I have no indication that either have ANY background in epidemiology.
- Citations. Oh my, the citations. I didn’t go through all of them, but some of them actually debunk what was written.
It’s amusing, but the article finds that myocarditis is extremely rare, even when diving into the VAERS database. The problem is that VAERS doesn’t provide a control that is, well, controlled.
If I were to do this same study with VSD, I would search through the database for myocarditis cases. Then I’d search for COVID-19 (or any vaccination) in those patients with myocarditis. Then I’d determine the number of days before myocarditis diagnosis to see if there were temporal effects.
Then I would determine, statistically, if there was a difference in risk of myocarditis between the vaccinated or unvaccinated groups.
Or I could take the whole database, divide it into vaccinated and unvaccinated groups, and see what the risk of myocarditis was.
Rose and McCullough just wanted to write an article to “prove” that the COVID-19 vaccine causes harm. But we know that there is a link between the COVID-19 vaccines and myocarditis, but it is a very rare event. And their speculation that somehow this indicates some serious condition when it mostly is not, was what made their article so worthless.
What we have here is another retracted anti-vaccine article that goes to the dustbin of science.
- Cooper LT Jr. Myocarditis. N Engl J Med. 2009 Apr 9;360(15):1526-38. doi: 10.1056/NEJMra0800028. PMID: 19357408; PMCID: PMC5814110.
- Fung G, Luo H, Qiu Y, Yang D, McManus B. Myocarditis. Circ Res. 2016 Feb 5;118(3):496-514. doi: 10.1161/CIRCRESAHA.115.306573. PMID: 26846643.
- Rose J, McCullough PA. TEMPORARY REMOVAL. A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products. Curr Probl Cardiol. 2021 Sep 30:101011. doi: 10.1016/j.cpcardiol.2021.101011. Epub ahead of print. PMID: 34601006; PMCID: PMC8483988.
- Siripanthong B, Nazarian S, Muser D, Deo R, Santangeli P, Khanji MY, Cooper LT Jr, Chahal CAA. Recognizing COVID-19-related myocarditis: The possible pathophysiology and proposed guideline for diagnosis and management. Heart Rhythm. 2020 Sep;17(9):1463-1471. doi: 10.1016/j.hrthm.2020.05.001. Epub 2020 May 5. PMID: 32387246; PMCID: PMC7199677.
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