Florida Surgeon General Warns Against Young Men Getting Covid-19 mRNA Vaccines, What’s His Justification?

On October 7, the Office of Florida’s Surgeon General Joseph A. Ladapo, MD, PhD, issued a “heartfelt,” so to speak, announcement. And it was a doozy. Ladapo recommended “against males aged 18 to 39 from receiving mRNA Covid-19 vaccines,” essentially going against the recommendations of the Centers for Disease Control and Prevention (CDC) and numerous other scientific organizations around the world. So what evidence did Ladapo provide to support this recommendation? Did he say that he surveyed all of the existing scientific literature? Nope. Did Ladapo look at all of the available data? Not exactly. The only “evidence” presented was an “analysis” apparently conducted by the Florida Department of Health. Ladapo claimed that this “analysis” found “an increased risk of cardiac-related death among men 18-39” on the following tweet:

You may ask yourself why the word “analysis” is in quotes above. Well, such a word in and of itself doesn’t say much. Heck your significant other could say something like, “I’ve done an analysis of our relationship and have decided to run off with that person from the circus,” even though you might question the scientific accuracy of such an analysis. As you can see, Ladapo’s tweet claimed that “FL will not be silent on the truth.” OK, so let’s look at the truth behind the analysis that Ladapo had cited.

First of all, it’s important to note that this “analysis” has not been published in a reputable scientific journal. This is a key distinction because anyone can post something on a web site and call it an “analysis” just like anyone can upload a video of themselves interviewing their cats on to YouTube and call themselves a talk show host. There’s no indication that this analysis has undergone a full and proper review by experts in the field to determine whether it was done properly and whether the conclusions actually match the results.

Now, typically, when you have questions about an “analysis,” you can simply contact the authors of the “analysis,” right? Umm, that would be a bit difficult to do in this case since the document provided did not list any author names, assuming that the authors’ names weren’t “doctor blankedly-blank” and “doctor invisible.” Moreover, the document was on a plain PDF without any official Florida Department of Health markings. So it’s not clear who in the Florida Department of Health besides Ladapo may have signed off on the report.

Moving on to the contents of the document itself, the Methods section was rather scant and difficult to follow as Deepti Gurdasani, PhD, a clinical epidemiologist, statistical geneticist, and senior lecturer in machine learning at the Queen Mary University of London, indicated at the beginning of the following tweet thread:

Ideally, a Methods section is supposed to provide enough details so that others could potentially reproduce the analysis. The Methods section did use a fair amount of jargon such as saying that the “analysis” used a self-controlled case series (SCCS) method but did not provide more explanation as to why the “analysis” employed SCCS versus other available and more widely-used methods. Granted, a self-controlled case series is not the opposite of an out-of-control case series method. This method has “individuals act as their own control—i.e., comparisons are made within individuals,” and has been used previously to evaluate vaccine safety. However, previous use doesn’t necessarily mean that SCCS is the best method to employ in this situation. Saying that you used a method simply because it’s been used before would be a bit like saying that you decided to get a mullet in the form of a gecko simply because someone else has done so previously.

Plus, an epidemiological method is like a condom. Just using it is not enough. You’ve got to use it properly. Gurdasani pointed out that the “analysis” compared the rate of death during the 28 days after someone got a vaccine with the rate of death during “later periods,” from 29 days after up to 25 weeks after vaccination:

It’s a little confusing why the authors of this “analysis,” whoever they may be, chose this SCCS approach rather than simply comparing those who had gotten the Covid-19 mRNA vaccines with those who hadn’t. In other words, why use people as their own controls when other clearly relevant controls are available. Moreover, it’s not clear why this “analysis” excluded deaths from Covid-19. That’s kind of weird since you are presumably getting the vaccine to prevent such deaths. Plus, it’s not as if such deaths have been uncommon. After all, we have been and are still in, you know, a Covid-19 pandemic.

Gurdasani went on to show how the specific approach used in this “analysis” could easily skew results to suggesting that more people died during the 28 days after vaccination versus the later periods:

In other words, if someone died during Period 1 (i.e., the first 28 days after getting vaccinated), why the heck are you still counting them as being alive during Period 2 (i,e, the later period that comes after the 28 day period)? Won’t that artificially inflate the denominator for Period 2 and thus seemingly reduce the rate of death for that Period?

These certainly weren’t the only flaws brought up by scientists on social media. Kristen Panthagani, MD, PhD, a resident physician and Yale Emergency Scholar at Yale New Haven Hospital, questioned on Twitter the way that this “analysis” was counting cardiac-related deaths:

As Panthagani emphasized, the “gee-wonder-who-conducted-this-analysis” authors used a particular International Classification of Diseases 10 (ICD-10) code to determine cardiac-related deaths while not using other seemingly relevant ICF-10 codes. There’s a two-word term for doing such a thing that begins with the name of a red, round fruit that is delicious in pies and ends with the word “picking.” Yes, choosing only the “Other forms of heart disease” ICD-10 code to identify cardiac-related deaths makes you wonder how much “cherry-picking” had occurred.

That’s not all in terms of flaws. In her You Can Know Things blog, Panthagani listed other things that you can know, or perhaps should know about this “analysis.” ICD-10 codes can be notoriously inaccurate in identifying the conditions that a patient may have since medical doctors tend to use such codes for billing purposes. That’s why it can important in studies to check the patients’ medical records to verify such diagnoses. The “who-are-they” authors of this “analysis” didn’t seem to do such medical record checking, even though doing so wouldn’t have been too arduous a task, given the relatively small sample size, with 20 deaths among males between the ages of 18 and 39 years who had received an mRNA vaccine. Oh, and the small sample size was another issue raised by Panthagani: from a statistical sense, 20 deaths may have not been enough to draw any strong conclusions.

That apparently didn’t prevent Ladapo and the Florida Department of Health announcement from drawing some pretty strong conclusions: “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,” and “the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group.” Yeah, all of that would be quite a leap and would fly in the face of all the available scientific evidence to date, which brings up a final big flaw with the document that described this “analysis.” Typically scientific publications will mention other studies and what is already known about the matter at hand. The U.S. Food and Drug Administration (FDA) Facts Sheets for the Moderna and Pfizer/BioNTech Covid-19 mRNA vaccines already include warnings about myocarditis, which is inflammation of heart muscle, and pericarditis, which is inflammation of the membranes that wrap around the heart, as potential but rare side effects of the vaccine. The Centers for Disease Control and Prevention (CDC) has already clearly indicated that, “Data from multiple studies show a rare risk for myocarditis and/or pericarditis following receipt of mRNA Covid-19 vaccines.” So it’s not as if they are covering up the existence of such side effects. The CDC also has added that “For most cases of myocarditis and pericarditis following vaccination with an mRNA Covid-19 vaccine, patients who presented for medical care have responded well to medications and rest and had prompt improvement of symptoms” and that “Preliminary data from surveys conducted at least 90 days after the myocarditis diagnosis showed most patients were fully recovered from their myocarditis.” Yet, the document did not mention any of these studies and explain why this “analysis” would somehow trump all of the other previous studies and data.

The heart of the matter is that Covid-19 itself can lead to myocarditis, pericarditis, and potentially other heart-related problems. As I’ve described previously for Forbes, studies have shown that the risk of these heart-related problems occurring from Covid-19 may be much higher than the risk of such problems after getting the Covid-19 mRNA vaccine. Sure, getting a Covid-19 mRNA vaccine doesn’t come with zero risk. Nothing in life has no risk. Instead, decisions in life are about comparing the risks associated with each option. That’s why any analysis of Covid-19 mRNA vaccines must take into account not only the risk of getting the vaccine but the risk of not getting it.

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