TAMPA, Fla. (WFLA) — A recently removed, then restored, Twitter post by Florida Surgeon General Dr. Joseph Ladapo about mRNA COVID-19 vaccines for male patients is stirring discussion and debate on the social media platform.
Now, Ladapo’s Friday tweet, linking to a self controlled case study by the Florida Department of Health on myocarditis risk within 28 days of receiving a COVID-19 mRNA vaccine has spawned discussion over the study’s methodology.
Announcing the study’s publication on Oct. 7, Ladapo tweeted that it was an analysis “the public needs to be aware of.” His tweet said the analysis showed that male patients ages 18 to 39 had “an increased risk of cardiac-related death” and that “FL[orida] will not be silent on the truth.”
The study, itself
The accompanying press release from FDOH about the state’s study said the department had “studied mortality risk following mRNA COVID-19 vaccination,” and found “an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination.”
As a result, Ladapo updated state health guidance for COVID-19 to now recommend against any mRNA vaccines for male patients in that age group.
Additionally, the state analysis said it found a 10% increased risk for cardiac-related death within 28 days of vaccination for men over 60. The FDOH release also reiterated previous guidance, recommending “against use in healthy children and adolescents 5 years old to 17 years old.,” which it said now also includes “recommendations against COVID-19 vaccination among infants and children under 5 years old, which has since been issued under Emergency Use Authorization.”
Turning to the data published by FDOH, the study examined “Flroida residents aged 18 years or older who died within 25 weeks of COVID-19 vaccination” since December 15, 2020, when the distribution of COVID vaccines first began.
Before detailing the results, the study described its population methodology and setting, showing how it limited the body of patients studied.
“Individuals were excluded if they (1) had a documented COVID-19 infection, (2) experienced a COVID-19 associated death, (3) received a booster, or (4) received their last COVID-19 vaccination after December 8, 2021 (to ensure each individual had the 25-week follow-up period to experience the event of interest),” the study said. “To allow for death registration, the study end date for both analyses was June 1, 2022.”
The study does note that while it found a higher risk of cardiac-related deaths in its analysis, the data itself was preliminary and “should be interpreted with caution.” Additionally, while listing its own limitations, the study says “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.”
The conversation, online: Ladapo
The surgeon general’s post on Twitter was reportedly taken down on Oct. 9, but then reinstated. A screenshot of the tweet following the removal reads the post “violated the Twitter Rules.” The post was later restored.
On Monday, Ladapo created a new thread on Twitter discussing the study’s results and process, saying he loved the “discussion that we’ve stimulated” and praising discussing science “transparently instead of trying to cancel one another.” In the thread, Ladapo responds to three critiques of the study.
The critiques, and responses:
|#1 “Diagnosis codes for cardiac-related deaths are imperfect.”||“Yes! But that is true for every subgroup we examined. Only in young men was the risk extremely high, and it was also increased in older men.”|
|#2 “COVID test information was only available on death certificates.“||“No! We used all of our data resources-test results, vaccine records, death records-to exclude individuals who had documented COVID-19 infection, as we write in the Methods section.”|
|#3 “The sample size is too small.“||“3a. Elevated cardiac risk was also found in older men, and there were thousands of deaths in this group.”|
|“3b. The total cardiac deaths meeting inclusion criteria among young men was 77, not 20, as has been going around the web.”|
|“3c. Read the references about the method! Self-controlled case series tell us whether events (death) are occurring unusually close to an exposure (mRNA Covid vaccine), or whether their timing is due to chance.”|
|“3c cont. Even if the sample size was half of what it is, if events cluster after an exposure, that is valuable information about causation.”|
Closing out his responses in the thread, Ladapo asked if it was “is it really that hard to imagine that mRNA COVID-19 vaccines that increase myocarditis in young men by 10x, 20x, or 30x (see Karlstad et al, JAMA Cardiology, 2022) also increase the risk of cardiac death in that age group?”
According to Ladapo, “Of course it’s not, and we all know that.”
The conversation, online: Critics
Responding to Ladapo’s thread about the study, Dr. Deepti Gurdasani, a clinical epidemiologist and senior lecturer in machine learning at Queen Mary University in London went through the surgeon general’s points, and the study, critiquing its data and methods.
Gurdasani first took issue with transparency of the study and some of the death data itself, saying that by not revealing the study’s authors, it was not transparent. Additionally, she asked why people “who’ve died in the first 28 days post-vax in the denominator for the second period” were included by the authors, saying that “people can’t die twice.”
Additionally, Gurdasani asked why all COVID-19 deaths were excluded from “all-cause mortality.”
Gurdasani, further into the response thread, said no one was contesting vaccine-associated myocarditis, but instead that critics were contesting “that the study shows increased risk of cardiac death in young people,” which she wrote it does not. Instead, Gurdasani said the study doesn’t show what Ladapo described, and that the statistical analysis itself was not sound.
In detail, Gurdasani said “no one is contesting vax associated myocarditis- which happens, is rare & typically mild. It’s less severe than COVID myocarditis, which can be fatal. What we’re contesting is a very flawed analysis reportedly shows increase in cardiac death post-vax in young men.”
Back in March, Ladapo had warned against getting the vaccine at all if the patient was healthy and didn’t have preexisting autoimmune conditions. Critical commentary on Ladapo’s vaccine position led to Gov. Ron DeSantis saying the surgeon general had been “blackballed” for having a different view than other medical professionals.
In April, a study by the U.S. Centers for Disease Control and Prevention linked the risk of myocarditis and the mRNA vaccines, it’s a position the surgeon general held earlier, urging Floridians to be careful due to the risk to young, male patients for heart conditions and possible fatality.
She called for the scientific community to openly and transparently discuss vaccine injury, like myocarditis diagnoses caused by vaccination, but that “anti-vax conspiracy and pseudoscience” instead “obstruct” and “undermine” experiences of those who are actually vaccine injured and in “need of urgent attention and care.”
Another user, while analyzing the data from the study, noted that the study itself shows the vaccines “reduce your risk of non-COVID death,” which they said Ladapo did not mention during his announcement of the study, or thread on it following restoration of his Oct. 7 tweet. The user, called Health Nerd on Twitter, said their big issue with the FDOH study is “that the paper is incredibly short and contains very little information.”
WFLA.com has reached out to Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, NIAID, and the CDC for comment on FDOH’s study and analysis.