The Florida Study and the public health hypocrites
On October 7th, 6 pm, the Florida Department of Health sent out a bulletin announcing new guidance from Florida Surgeon General Dr. Joseph Ladapo that recommended against males aged 18-39 years of age from receiving mRNA COVID-19 vaccines. This was based on a study commissioned by Florida that found an 84% increase in the relative incidence of cardiac-related death within 28 days after mRNA vaccination.
The response from the media was immediate and impressive. Twitter briefly deleted the Surgeon General’s tweet for violating “the Twitter rules” of service before reversing itself on the same day.
Six days after the Florida bulletin was released, Googling “ladapo Florida study” pulls up multiple media articles from ‘experts’ slamming the Surgeon General’s ‘science’.
The editor of the esteemed Science Journal Holden Thorpe quickly pushed out an editorial decrying the “anti-vax disinfo spread by the FL Surgeon General”. He made sure to tag some large accounts known for their COVID19 objectivity through the pandemic.
Dan Diamond, a current Washington Post journalist and long time Republican scalp hunter who happened to pen one of the articles panning the Florida study, Eric Topol , a cardiologist so powerful that he managed to delay approval of the COVID vaccines until after the 2020 elections had been decided, and media darling virologist Angie Rasmussen. that actual journalist Paul Thacker chronicles well.
The editor of Science went on to screech about the unacceptability that the MD PhD Florida Surgeon General from Harvard described as brilliant by colleagues was actually admitted as faculty at the University of Florida medical school. The incoherent rage from the evangelical science left is fun to document but at this rate I will never make it to the actual study that has upset the partisan hacks that masquerade as scientists.
The Study
The Florida study in question used a method called a Self-Controlled Case-Series (SCCS) that was “originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose.”
You are reading that correctly. The choice of method is an accepted method of trying to link adverse events to a vaccine. Unfortunately all methods that involve looking backwards at data that has been collected has certain limitations as can be seen in a chart from the well regarded States Serum Institute in Denmark.
The best way of figuring out if a novel therapeutic has side effects is with a randomized control trial where half the trial participants are randomly assigned to a placebo. The problem with randomized control trial is that particular circumstances don’t always allow for the perfect trial. In the case of COVID, there was a particular urgency to create a vaccine that would limit death at a time when the virus had just wreaked havoc. So there were a number of shortcuts that were taken - symptomatic covid positive cases was used as an endpoint instead of severe disease, and after a few months when it seemed that the group in the vaccine arm were much less likely to test positive for covid, the control group was offered the vaccine, breaking randomization.
The other major issue with the randomized control trial was that compared to the number of people who would be eligible for the vaccine (hundreds of millions in the US alone), the trials were relatively small (tens of thousands). This meant that the trials were not going to be large enough to capture rare side effects of the vaccine. In effect, the novel vaccines couldn’t really be judged as safe and effective if there were thousands of teenagers in the randomized control trials and tens of millions of teenagers were going to be the recipients of the vaccine. Perfect knowledge doesn't exist in medicine, but the ‘safe and effective’ tag was a reasonable educated guess.
Once the vaccine was out and being administered everywhere to everyone, it becomes really really challenging to figure out if adverse events happening after vaccine administration are truly related or just happenstance.
We know the randomized controlled trials did not give us all the information we needed because the one signal that did become obvious by the Spring of 2021 was that myocarditis cases appeared to be clustering after the second dose of the mrna vaccines. These cases weren’t seen at an appreciable rate in the original randomized controlled trials because there just weren’t enough young men in the original trials.
So the heart of the controversy about vaccine related adverse events relates to the limitations of the original randomized controlled trials which then necessitate a variety of analyses to look for vaccine adverse events.
The other major handicap in this space is that there is an intense amount of pressure to generate the ‘right’ data when it comes to vaccines. Vaccines apparently occupy a very holy place in the minds of the public health monolith that currently rules the world. Protecting the public’s perception of vaccines is regarded as so important that any negative news about a vaccine that has received the seal of public health and therefore government approval is basically not allowed.
Its quite a pickle for public health authorities to be in - they need widespread compliance, but any negative news, no matter how nuanced, will destroy confidence, and therefore compliance. The lesson from the Johnson and Johnson vaccine which was a one-shot non-mRNA vaccine wasn’t pretty. The CDC/FDA paused distribution of this vaccine momentarily because of a rare, but real devastating complication that emerged in young healthy women who had received the vaccine - a platelet destroying blood clotting disorder that could cause a severe brain stroke. When the authorities allowed administration of the JnJ product again, no one wanted it, and pharmacies didn’t stock it.
This would be why it took months for the CDC to acknowledge myocarditis as an adverse event linked to vaccines, and when they finally did they made sure to let everyone know that it was mild (never was prior to COVID), and the benefits for vaccination exceeded the risks for everyone.
So it should be easy to understand the consternation among the evangelicals in power when the Florida Dept. of Health puts out a message recommending against vaccination because of their analysis of the data. Instead of a reasoned, relatively dispassionate discussion about the pro’s and cons of the study, we were treated to shrieking editorials from the current COVID papacy trying to excommunicate the heretic Ladapo.
The facts are that the Florida study was methodologically modeled after the well regarded/respected United Kingdom Office for National Statistics, though there are some important distinctions that are worth noting. The advantages of the Self controlled Case Series over other analytic methods is that studying the same population at different times accounts for differences between individuals that may result in outcome differences — people who get a 4th vaccine dose and do really really well may be doing well because 80% of 4th dosers may be 40 year old personal trainers who only eat celery for lunch. Comparing Tom 2 weeks after the vaccine to Tom at an earlier or later point in time gets around the pesky issue of trying to compare Tom to Raju.
The Florida Study compared a time period ~4 weeks after exposure to the vaccine to a time period between 4 weeks and 25 weeks after exposure. The problem with this is that the 2 shot mRNA vaccination schedule in the United States was spread out by only about 4 weeks which means a death within the 28 day time frame after the second vaccine would give the appearance of risk of death from the vaccines being doubled, even though the actual risk of death after vaccine exposure was constant. (Excellent pictorial explainer from Dr. Jeffrey Morris here). There is also the issue of the small number of events that occurred in the defined at risk period - 7 total deaths in 18-24 year olds, 5 of which that were judged to be cardiac related based on ICD 10 codes on a death certificate. Numbers this small make for fragile conclusions.
But there are things we do know.
We know young men have higher rates of myocarditis after the mRNA vaccines. We know the vast majority of these cases that are brought to the attention of the health system do not end in severe morbidity or mortality. The type of study Florida attempted to do is important because it looks at a signal of all deaths after vaccine delivery regardless of whether a diagnosis of myocarditis was rendered. Cardiologists should be concerned that any therapeutic with this much cardiac irritability could potentially result in severe fulminant cases that never make it to the hospital. Luckily, the real world experience, and even this Florida study, confirms that cardiac deaths after vaccine administration are rare events.
This doesn’t mean we should stop looking for this signal, especially if our public health overlords continue to double and triple down on an n+1 vaccination strategy for all comers regardless of underlying risk factors, or the number of prior infections a 18 year old may have recovered from.
In the end, the response to the Florida study ends up being more instructive than the study itself. If the same study with the same methods were used to conclude that COVID-19 increased cardiac death, there would be no convulsions in the public health church, and no calls to burn the heretics within.
There is no good evidence that masking 3 year olds at school in 2022 does anything.
There is no good evidence Long COVID threatens a third of the population outside of some curious suburban enclaves and demographics.
There is no good evidence that schools needed to close for large parts of the last 2 years.
There is no good evidence that keeping unvaccinated professional tennis players from traveling to the United States protects the citizenry.
There is no good evidence that specialized filtration systems were ever needed in schools before they opened.
The list of what has been public health dogma that has clearly defined harms with little plausibility or evidence of benefit is long, and keeps growing daily.
The risks to the public don’t come from data points generated by the out-of-the-box Florida Department of Health, the risks are from the illuminati that perceives science as a tool to rebuild the world in their warped image.
They win only if you close your eyes.
Anish Koka is a cardiologist. Follow him on twitter @anish_koka. Also give a listen to this great interview with epidemiologist Dr. Tracy Hoeg on the Florida study.
Brilliant. Thank you for writing it.
Thank you from Canada. Just downloaded your interview with Hoeg. Lastly, Paul Thacker is brilliant. Along with yours, another never miss substack.