Recently, this analysis has gained huge popularity in social media. The results indicate that there is an 84% higher risk of cardiac-related deaths among males aged 18-39 within 28 days after taking mRNA vaccines. It was publicly shared by Joseph Ladapo, Surgeon General of Florida. On this basis, the Florida Department of Health issued guidelines discouraging the administration of mRNA vaccines to men. The document is anonymous, has not passed the scientific review process and contains numerous errors, which makes the conclusions drawn on its basis unreliable.
The information originally published by Joseph Ladapo was reshared, among others, by Paweł Basiukiewicz, Ordo Medicus or dr Piotr Witczak. It was also referenced on LegaArtis portal, in an article resembling a simple machine translation.
Credibility of the analysis
The document labelled as an “analysis” by Ladapo is not a scientific publication. It was not published in a scientific magazine, which means that most likely it didn’t undergo the review process (you can read about the evaluation of the value of scientific work in our earlier article). The document also lacks the official letterhead of the Florida Department of Health, as well as the names of the authors or their affiliations. It is therefore not entirely clear who, apart from Ladapo, is responsible for this publication.
Dr. Deepti Gurdasani, a clinical epidemiologist, points out in her tweet that the authors claim to have taken into account all the causes of natural and cardiac-related deaths, but have in fact ruled out COVID-19-related deaths altogether. Gurdasani also notes that in their summary they took into account all deaths that occurred up to 28 days after vaccination, and treated them as post-vaccination deaths, which they then compared with the probability of death in the period above 28 days, that is, in the period when the persons in question are already dead. Since the dead cannot die again, this comparison is at rather puzzling, to say the least.
Dr. Kristen Panthagani, a resident at Yale New Haven Hospital, also pointed out that whoever prepared this analysis used International Classification of Diseases (ICD-10) codes, specifically codes 130 to 152 for “other heart diseases” (see page 319). This category includes not only inflammatory cardiomyopathy (code 140 and 141), but also, for example, mitral regurgitation, alcoholic cardiomyopathy, but above all – cardiac arrest, which may accompany diseases unrelated to the heart and is often entered in death certificates of people who died naturally and for unexplained reasons. In order to screen out unrelated cases, the death certificates should have been compared with the patient’s medical records. This, however, the authors of the document did not do, which they admitted themselves:
This study cannot determine the causative nature of a participant’s death. We used death certificate data and not medical records. COVID testing status was unknown for those who did not die of/with COVID. Cardiac-related deaths were ascertained if an ACME code of 13o-152 were on their death certificate, thus, the underlying cause of death may not be cardiac-related.
Dr. Panthagani further notes that the study did not include people who had had a documented COVID-19 infection, which indicates that, contrary to what the authors wrote, they had access to medical records.
Regarding the limitations of the study, it is worth mentioning that the document itself comprises 8 pages, the last of which lists the sources, and 3 of them present a table with results. Of the remaining four, an entire one page contains the limitations of the study. Apart from the above-mentioned fragment, also in this part the authors admit, among other things, that the research group was very small. Finally, it should be noted that when a vaccination risk assessment is carried out, the risk caused by such vaccine should be compared with the risk posed by the disease it protects against. This was also not taken into account in this analysis.
The lack of a review process, numerous errors pointed out by experts and the anonymity of the authors make the results unreliable, and such analysis should not serve as a basis for issuing recommendations.
There is in fact a risk of inflammatory cardiomyopathy after administration of mRNA vaccine, albeit very low. We have already described this in December 2021. It mainly affects males under the age of 30, and if it does occur, it almost always gives mild symptoms and passes quickly. It is also known that the risk of inflammatory cardiomyopathy for people infected with SARS-CoV-2 is 16 to 18 times higher than in case of healthy people, and 6 to 34 times higher than after administration of mRNA vaccine.
Joseph Ladapo is not a specialist in infectious diseases, but he gained publicity after publishing several articles in the Wall Street Journal, in which he undermined the safety of COVID-19 vaccinations and the legitimacy of wearing face masks. The controversy arose when Ladapo refused to wear a mask during a meeting with a senator who was suffering from breast cancer. His texts attracted the attention of the governor of Florida Ron DeSantis (Republican Party), who in 2021 offered him supervision of the Florida Department of Health.
Ladapo was also one of 20 health care professionals who signed a petition to the FDA against the expedited approval of Pfizer and Moderna vaccines. He also objected to the vaccination of children against COVID-19, which caused outrage of the American Academy of Pediatrics, among others. The Florida Department of Health also advocated against pre-ordering vaccines for children after the FDA issued an emergency use authorisation of vaccines for children under the age of 5. Ultimately, Florida was the only state that had not ordered them earlier.
Ladapo is also a member of the right-wing, anti-vaccination organisation called America’s Frontline Doctors. This organisation promoted, among others, untested therapies and misinformed on the issue of vaccines. Its founder, Simone Gold, was arrested for 2 months during the attack on the Capitol on 6 January, 2021.
The document provided by Joseph Ladapo is not a scientific publication, it contains numerous methodological errors, and the authors themselves, who remain anonymous, emphasise that it does not indicate causes of deaths, which in fact may not be cardiac-related. In addition, the small size of the research group means that such firm conclusions should not be drawn on this basis. In view of these errors and limitations, the conclusions of this analysis cannot be considered reliable.
The risk of inflammatory cardiomyopathy for people infected with SARS-CoV-2 is 16 to 18 times higher compared to healthy people, and 6 to 34 times higher than after administration of mRNA vaccine. Following a risk-benefit assessment, the CDC considered that the benefits of vaccination exceed the potential risks.
The best summary of the situation is the comment by the previously mentioned Dr. Deepti Gurdasani:
I do want to say very clearly – I do think vaccine injury occurs, and I think it is important to understand, study, and treat. But this piece isn’t about vaccine injury – it’s just pseudoscience. The benefits of vaccines at population level far exceed the risks. That is not to minimise the suffering of those who have been vaccine injured. They deserve to be listened to, investigated and treated. But posts like this don’t do them justice- it makes it even harder for them to access support, be believed, and be cared for.
Dr Deepti Gurdasani: https://twitter.com/dgurdasani1/status/1578894014132408320
Dr Kristen Panthagani: https://twitter.com/kmpanthagani/status/1578921562761465857