Science-Based Medicine has been fighting antivaccine misinformation for over a decade. Antivax quacks and the people who believed them were the main sources of pseudoscientific misinformation in our early days. Think of Andrew Wakefield, Robert Sears, Paul Thomas, and others. It didn't take long for the antivax propagandists to spread fear and doubt when the COVID-19 vaccine hit. They were soon joined by a new generation of antivax physicians and propagandists, as evidenced by the rise of the hydroxychloroquine - promoting America's Frontline Doctors in 2020. A man named Dr. Joseph Ladapo was among that group of doctors. The people of the US in general, as well as the people of Florida, were caught off guard by Dr. Lapado and his rejection of public health interventions. The governor hired Dr. Ladapo to promote the message of "rejecting fear" as a public health strategy. Public health officials have noted.
Equally troubling for his critics was Dr. Ladapo’s failure to reject more fringe views on virus treatments, including the drugs hydroxychloroquine and ivermectin. He joined Mr. DeSantis in clamoring for the federal government to supply some monoclonal antibody treatments even after they had been deemed ineffective against the Omicron variant, which dominated caseloads. “To say he’s out of the mainstream would be an understatement,” said Dr. Ashish K. Jha, dean of the Brown University School of Public Health. “His views are not only very unorthodox — they don’t make any sense.”
One of his supervisors at UCLA stated in an evaluation requested by the Florida Senate as part of a background check that Ladapo's hands-off approach toward managing COVID-19 made his colleagues feel uncomfortable.
Question: “Would you recommend the applicant for employment as a surgeon general of Florida and confidence in his ability, honesty and integrity to perform related duties?” Answer: “No. In my opinion the people of Florida would be better served by a surgeon general who grounds his policy decisions and recommendations in the best scientific evidence rather than opinions.” Then, there was a vague prompt called “personal relations (rapport with co-workers, supervisor).” The complete response: “I cannot answer… because Dr. Ladapo’s opinions, published in a number of popular media outlets, were contrary to the best scientific evidence available about the Covid-19 pandemic and caused concern among a large number of his research and clinical colleagues and subordinates who felt that his opinions violated the Hippocratic Oath that physicians do no harm. This situation created stress and acrimony among his co-workers and supervisors during the last year and a half of his employment. It is important to note that during this time at UCLA, he met all of the contractual obligations for the position that he was hired to perform, which is the underpinning of my otherwise satisfactory evaluation.”
It was definitely damning with faint praise. I fear that the evaluation made Dr. Ladapo more attractive to the governor and senate. It's no longer debatable to me that Dr. Ladapo has become an antivaxxer to be in charge of your state's public health policy That is why the governor wanted Dr. Ladapo to cover his policy choices with a veneer of plausible science.
The State Surgeon General now recommends against the COVID-19 mRNA vaccines for males ages 18-39 years old. Individuals and health care providers should also be aware that this analysis1 found: Floridians are encouraged to discuss all the potential benefits and risks of receiving mRNA COVID-19 vaccines with their health care provider. The risk associated with mRNA vaccination should be weighed against the risk associated with COVID-19 infection. The part about non-mRNA-based vaccines doesn't show the effect. If the intent of the press release was anything other than antivax, there would be a section about how all adults should bevaccinated against COVID-19 but with the caveat that young men should receive vaccines that aren't based on mRNA technology It was funny but I didn't see it. Maybe I didn't notice something. The study doesn't show that the vaccine is riskier than getting it. I have never seen a state warn people not to get vaccinations based on a poor quality study. On Friday, Florida issued an official press release that said a vaccine was more dangerous than the disease.
Today, State Surgeon General Dr. Joseph A. Ladapo has announced new guidance regarding mRNA vaccines. The Florida Department of Health (Department) conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety. This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group. Non-mRNA vaccines were not found to have these increased risks. As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines. Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision. “Studying the safety and efficacy of any medications, including vaccines, is an important component of public health,” said Surgeon General Dr. Joseph Ladapo. “Far less attention has been paid to safety and the concerns of many individuals have been dismissed – these are important findings that should be communicated to Floridians.” The analysis can be found here. The guidance can be found here.
Let's start digging. The study doesn't really show what Dr. Ladapo claims it shows, so I will move on to the guidance. We will see how news sources and antivaccine media have amplified the study so that it goes far beyond the state of Florida. I wonder if the authors of the commentary about self-controlled case series feel the same way about antivaxers in Florida. It is a really strange study in several ways. No authors are listed in the first place. I can see that. I wouldn't want my name associated with the study if I were forced to produce it. This study wasn't peer reviewed. It was published by the Florida Department of Health. I could claim that it is a good study if I published it here on my not-so- secret other website. No one would believe me if I said something I didn't really mean. I would have liked to see an authors' list and a statement that this study had been submitted to a peer-reviewed journal for consideration of publication in order to take this as a serious effort. I didn't see anything. Enough of my commentary. I hope I have enough justification for my opinions of the study. The goal is to evaluate the risks of all-cause and cardiac-related mortality after the vaccine. The methods were stated clearly.
The self-controlled case series (SCCS) method adapted to evaluate death as the outcome was used.1,2 The SCCS method, originally developed to assess vaccine safety, utilizes within-person comparisons to estimate the temporal association between a transient exposure and an acute event.1 The SCCS method estimates relative incidence (RI) by comparing incidence during a defined high-risk period following exposure with incidence during a control period (i.e., all time in the follow-up period that is not the risk period).1–4 A major strength of the SCCS method is that fixed-time confounders, such as health related risk-factors, are controlled for.1,3 The primary analysis utilized the SCCS method developed for single exposures that cannot be repeated.1,3,4 Since mRNA vaccinations require a multidose schedule, a simple modification was employed, where the last vaccination preceding death was used as the single exposure.2 In this method, the within-individual comparison is between the immediate post-exposure period and later post-exposure periods.3
The rubber hits the road and the deficiencies of this methodology become apparent. The study ended on June 1, 2022.
For the primary analysis, Florida residents aged 18 years or older who died within 25-weeks of COVID-19 vaccination since the start of the vaccination roll-out (December 15, 2020) were included. 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).
I was surprised that the study excluded residents who had died from COVID-19 infections. One wonders if that's the case. Does one wonder? Excluding them from the analysis is a sign that the vaccine was intended to prevent death from COVID-19. In order to compare death rates among those who did and did not get COVID-19, it would have been better to include and exclude COVID-19- related outcomes. I don't know why the authors didn't do that. I know that. I am aware of why the primary outcomes were chosen this way.
The exposure of interest was the 28-day risk period following COVID-19 vaccination. Two outcomes were assessed. Natural all-cause deaths (i.e., excluding homicides, suicides, and accidents) and cardiac-related deaths. Cardiac-related deaths were included if their death record contained an ICD-10 code of I30-I52. For the primary analysis, only participants that experienced the exposure and outcome were included in this study.
ICD30 is related to pericarditis and I52 is related to other heart disorders. If you want, you can look at the entire list here. It includes valve disorders, myocarditis, cardiomyopathy, cardiac arrest, and more. They didn't include ICD code I5A, which is non-traumatic. I wondered if there would be an epidemic of cardiac death if you believed that the vaccines were causing it. The authors included every cardiac diagnosis, even ones that aren't thought to be related to COVID-19 vaccines. There is evidence that the vaccine can increase the risk of myocarditis. It's possible that the vaccines are linked to arrthymias. It's difficult to associate them with any valve disease. After I wrote this section, Dr. Panthagani pointed it out in a different way. A couple things to note about this methodology:1. ICD-10 codes are not necessarily accurate or specific. 2. There isn't a clear rationale why they included these specific ICD-10 codes vs other cardiac-related codes (i.e. ischemic heart disease is not included?) pic.twitter.com/YqkOKioexX
The Department continues to stand by its Guidance for Pediatric COVID-19 Vaccines issued March 2022, which recommends against use in healthy children and adolescents 5 years old to 17 years old. This now includes recommendations against COVID-19 vaccination among infants and children under 5 years old, which has since been issued under Emergency Use Authorization.
Dr. Ladapo issues a press release
A bad, bad study
Kristen Panthagani is a doctor and a PhD.
Her point here is appreciated the most.
In short, this list is too broad to be meaningful, excludes some cardiac issues but not others, and most of the diagnoses are far more likely to be caused by other ongoing disease processes rather than vaccination.
Kristen Panthagani is a doctor and a PhD.
It's absolutely true. The authors included a wastebasket of cardiac diagnoses in their analysis, including ones without a plausible link to vaccine, and ones that are often included in death certificates as the final cause of death.
Dr. Deepti Gurdasani provided a diagram at the top of her thread discussing the study's key flaws.
I've tried to capture many of the key flaws visually in the FL study (non-peer reviewed & anonymous authors!) being shared by their surgeon general- rampantly in a single figure. Please do share and tag if you see someone citing it & report @FLSurgeonGen tweet as misinformation. pic.twitter.com/zVPGjWqamd
— Dr. Deepti Gurdasani (@dgurdasani1) October 9, 2022
The methods section was one of the main weaknesses in the analysis. The chart conveys the information in a more compact form than I could have in my writeup, and that's why I like it.
Follow-up began on the day of their last COVID-19 vaccination. Participants were not censored upon death, rather, they were followed for the entire 25-week follow-up period.1–4
The issue of why the authors excluded the cause of death that the vaccines were designed to prevent was mentioned first.
But they don't make this clear at all when they discuss the results- they refer to deaths as 'all causes' of natural death. But excluding the major cause of death that vaccines prevent? Even so, the study still finds a reduction in 'all cause death' post-vaccine!!
— Dr. Deepti Gurdasani (@dgurdasani1) October 9, 2022
Some of the findings arebizarre.
In the 28 days following vaccination, no increase in risk was observed for all-cause deaths. A statistically significant decrease was observed for participants 60 years or older in the 28 days following vaccination (RI = 0.97, 95% CI = 0.94 – 0.99).
There was a decrease in mortality among older people. It's obvious that the answer is correct. After another finding that found no benefit in "all-cause mortality", the authors wanted to emphasize that finding.
Further notes are provided by Dr. Gurdasani.
What this does is underestimate the risk in period 2, because it assumes that people in period 1 are still able to die when they're not. They should not be in the denominator, but apparently are. So the denominator in period 2 is bigger than it should be, underestimating risk.
— Dr. Deepti Gurdasani (@dgurdasani1) October 9, 2022
Antivaxxers like to play with numbers. When convenient, they ignore the denominator and manipulate it when they want a specific result.
In their discussion, the authors admit this limitation.
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 I3-I52 were on their death certificate, thus, the underlying cause of death may not be cardiac-related.
The anonymous authors couldn't say for certain if all their deaths were cardiac deaths.
When they write, the authors acknowledge Dr. Gurdasani's critique.
While this method has been used to assess risk of death following COVID-19 vaccination,2 it violates the assumption that an event does not affect subsequent exposure (for mRNA vaccines), which may introduce bias.6 Further, it does not consider the multidose vaccination schedule required for mRNA vaccination.
Not everyone was as harsh on the study design as I have been. Prof. Jeffrey Morris agrees with the criticism that not censoring deaths that occur in the first 28 day period from consideration in the second reporting period violates the assumptions underlying the method.
I've looked more into their report/references on SCCS for death events.
The methods description is quite terse, but (1) starting follow up at time of last vaccine dose and (2) comparing death rates in the first 28d post-dose to 28d-25wk could appropriately adjust for this bias…— Prof Jeffrey S Morris (@jsm2334) October 8, 2022
He cited a study that used the same methodology in the UK and was published as a preprint in March of this year. It was interesting that the study found that.
The design of the UK study was different from the Florida study. The UK study didn't exclude COVID-19 and found a six-fold increased risk of cardiac death within six weeks of being exposed to the disease.
Although there is a risk of myocarditis or myopericarditis with COVID-19, there is no evidence of increased risk of cardiac or all-cause mortality following COVID-19 vaccination in young people aged 12 to 29. Given the increased risk of mortality following SARS-CoV-2 infection in this group, the risk-benefit analysis favours COVID-19 vaccination for this age group.
And.
Whilst COVID-19 vaccination has been linked to an increased risk of myocarditis and other cardiac events in young people, our study shows that there is no evidence of increased risk of death due to cardiac events, which suggest that cases of myocarditis or myopericarditis due to the COVID-19 vaccination are unlikely to be fatal. This provides reassurance that the benefits of COVID-19 vaccines outweigh the risks even in young people.
The problem is large. The authors chose not to use the analysis to estimate the risk-benefit ratio for the vaccine. Why didn't they do that analysis? I believe you know the answer to that question. The UK investigators concluded that the balance favors the COVID-19 vaccine in young people. That is not what Dr. Ladapo wanted to say. I'm pretty sure that they probably did an analysis but didn't include it in the paper. If the authors did an analysis that didn't exclude COVID-19 cases, I wouldn't support publishing the study. A deceptive result is provided by failure to do so.
The reference to the study was provided by Dr. Panthagani. This study looked at specific diagnoses and confirmed them with medical record review. The study was able to show how to exclude COVID-19 cases. Wait, but? I wonder if the Florida authors did that. Not quite. It's a good idea to exclude those deaths from being listed on the death certificate. They didn't look at COVID-19 status.
So they didn't know whether or not people had COVID, unless it was listed on their death certificate.
(As a side note, this sneaky use of language in the methods section is a red flag. I don't like it.)
Kristen Panthagani is a doctor and a PhD.
Overall, this means that susceptibility to COVID confounded their analysis, and COVID (not COVID vaccination) very well could have contributed to some of these deaths.
Why?
Recall that after vaccination, it takes a little time for immunity to kick in.
Kristen Panthagani is a doctor and a PhD.
It is important to compare the risks of the vaccine against the risks of the disease when performing a risk assessment. The anonymous authors of this study did not do this. They didn't do a lot of standard sensitivity analyses to test their conclusions. The people did not.
The sample size is small for an epidemiological study of uncommon adverse events from vaccines. There were a grand total of 20 deaths among the age group, which means that if a small number of them were misclassified, the result would go away. Kyle Sheldrick analyzed the study. I have been harsher on it than he has been.
Dr. Sheldrick wrote a note.
They looked only at people who died within 25 weeks of vaccination vaccination, to see whether they disproportionately died in the first 4 weeks, vs the next 21.
This is a valid way to look for vaccine side effects! But you have to be cautious about interpreting the results…
— Kyle Sheldrick (@K_Sheldrick) October 9, 2022
Now the study is not well reported. It doesn't follow STROBE, and we don't know how many people (if any) were excluded for other reasons despite dying in the study period. But we can sanity check this number.
— Kyle Sheldrick (@K_Sheldrick) October 9, 2022
STROBE is an initiative of epidemiologists, methodologists, statisticians, researchers and journal editors who are involved in the conduct and dissemination of observational studies. He's correct as well. A lot of elements important in STROBE were not listed in the checklists.
Dr. Sheldrick accepts that there could be 9 additional cardiac deaths in men between the ages of 18 and 39 because of the vaccine. He dislikes the spin on the study more than the study itself. I can see the utility in showing why their results still don't justify the recommendation not to vaccine men under 40, even though I'm not as sure as he is.
He does this by assuming that the death rate from COVID-19 will decrease in this population.
That's not exactly what Florida was saying though. they are NOW saying the risk for men under 39 is too high. So I, as a 34 year old male, shouldn't get vaccinated.
Is this fair?
How low would the risks have to be for this to be true?
— Kyle Sheldrick (@K_Sheldrick) October 9, 2022
I'm open to the idea that covid risk is dropping!
But the amount of drop you'd need to make a one off ~0.0005% absolute cardiac risk increase relevant (for adults) is pretty close to needing to wipe out covid completely and forever.
That's… not realistic
— Kyle Sheldrick (@K_Sheldrick) October 9, 2022
I disagree with Dr. Sheldrake that the study shows that there were nine additional deaths among the 1.8 million men who received the vaccine. It wouldn't take many misattributed deaths in that group to make that apparent increase in cardiac mortality no longer statistically significant and the lack of any attempt to verify cause of death with medical records are major sources of bias. Even if you accept the results as accurate, Dr. Sheldrake will point out that there is no evidence to support Dr. Ladapo's conclusion. I made myself of the anonymous authors for not doing an analysis of COVID-19 cases and trying to determine a risk-benefit ratio for the vaccine. The authors didn't report that. I said that they probably did that analysis but that Dr. Ladapo held it back.
The study was taken at face value as well. He said that he didn't care what the authors left out.
5/n So, main findings. In the 28 days after getting any vaccine:
1. People were less likely of any cause2. People (esp young men) were more likely to die of "cardiac-related" causes
3. People were MUCH LESS likely to die of NON "cardiac-related" causes
— Health Nerd (@GidMK) October 9, 2022
He came up with an estimate of non-Cardiac mortality.
10/n Now, third point. Given the information for all-cause and cardiac mortality, we can back-calculate the rate of death and number of days at risk for NON-cardiac mortality as well!
— Health Nerd (@GidMK) October 9, 2022
I will disagree a little bit here. Even if this was a mistake and the true range of ICD codes was I 3-I52, there would still be a lot of diagnoses with no biologically plausible link to vaccinations. Still, that's still something.
12/n This effect is even bigger for younger people – for someone aged 18-39, getting a COVID-19 vaccination was associated with a whopping 45% (23-61%) reduction in non-cardiac death! Huge!
— Health Nerd (@GidMK) October 9, 2022
I have to tell the truth. The analysis done by Meyerowtiz-Katz makes it clear that the study was used to make it sound like the COVID-19 vaccine is dangerous. The analysis doesn't show what Dr. Ladapo says it shows.
It is not surprising that the usual suspects amplify this study as proof that the COVID-19 vaccine is more harmful than beneficial. I looked at some of the usual suspects, and here is a small sample of what I found.
You can demonstrate for yourself by simply typing the URL for the Florida press release into the search box.
Thanks to Gov. Ron DeSantis, the entire state medical and public health apparatus of Florida has become a tool for spreading misinformation. This study with anonymous authors was published by an actual state public health apparatus. It has succeeded in serving as a scientific justification for antivaccine messages.
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