Column: In threat to public health, Florida publishes flawed and unscientific anti-vaccine ‘study’
The spread of anti-vaccine misinformation and disinformation has become one of the defining public health challenges of our time — so dangerous that it prompted the California legislature to make the practice grounds for revoking a doctor’s license.
But what can we do when this pseudoscientific claptrap comes from an agency of a state government, dressed up as a public health recommendation?
The question arises from a new vaccine recommendation issued by Joseph Ladapo, Florida’s surgeon general. Ladapo has been labeled a “quack” and a “COVID crank.” If there has been any doubt that these labels are justified, they should be dispelled by his latest action.
This is the first time that we’ve seen a state government weaponize bad science to spread anti-vaccine disinformation as official policy.
— David Gorski, pseudoscience debunker
In a “guidance” issued Friday, Ladapo recommended against males aged 18-39 receiving the mRNA vaccines for COVID. These are the Moderna and Pfizer vaccines most widely used in the United States.
To justify his recommendation, Ladapo referred to a study purporting to show an elevated risk of cardiac-related death among males in that age range within 28 days of receiving the vaccines.
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As numerous qualified professionals have pointed out, however, the study is so sloppy and incoherent that it amounts to a monument of pseudoscience.
“This is the first time that we’ve seen a state government weaponize bad science to spread anti-vaccine disinformation as official policy,” wrote David Gorski, a surgical oncologist and veteran debunker of anti-vaccine balderdash. Gorski identified Florida’s action as “a dangerous new escalation in anti-vaccine propaganda.”
Ladapo’s recommendation has less to do with any effort to apply science to vaccine policy than with his well-documented practice of applying politics to health policy — specifically, the politics of Florida’s Republican Gov. Ron DeSantis, Ladapo’s patron. It exploits the inability of laypersons to understand the fine points of scientific research, especially when it has become the subject of political grandstanding.
Warnings of retribution, pictures of guillotines — anti-vaxxers are becoming more unhinged in their fight against pandemic policies.
“For somebody who doesn’t have the background to dig through a study, it’s very hard to know whether it’s valid,” says Kristen Panthagani, a ER doctor and medical data expert at Yale who subjected the Florida study to painstaking analysis online. “People have been put in the position where they have to figure it out for themselves, and that’s a really challenging spot to be in.”
In his campaign to succeed Donald Trump as standard-bearer of the GOP’s far-right wing, DeSantis has positioned himself as perhaps the nation’s leading official anti-vaxxer and dispenser of COVID disinformation. The harvest can be measured in dead bodies: Florida’s overall death rate from COVID is the 13th worst in the nation. (California, which took its public health responsibilities seriously, ranks 40th.)
What’s most dangerous about this latest action on COVID vaccines is that, because it has the veneer of scientific research, it risks metastasizing nationwide. If that happens, it will raise the national death toll from the pandemic.
The science involved in this episode is so bad, indeed, that Twitter initially blocked Ladapo’s tweet about the study. The tweet was later restored, but not before DeSantis’ spokesman attacked the platform for having “censored” Ladapo — an “Orwellian move” in the words of the spokesman, Bryan Griffin.
Unfortunately, Orwell is no longer with us to say what he thinks of this flagrantly dishonest misuse of his name, having died in 1950. Anyway, Twitter was right to kill Ladapo’s tweet, and wrong to restore it.
We’ll have more to say about Ladapo’s background in a moment. First, let’s examine this so-called analysis cited by Ladapo.
The first two red flags are that the analysis isn’t a peer-reviewed study, but rather a text document with limited data, and its authors aren’t identified — no names, no institutional affiliations, no professional qualifications are listed.
The study supposedly examined the health outcomes of Floridians over 18 within 25 weeks — that is, about six months — after receiving the COVID vaccine. It claimed to find what Ladapo calculated to be “an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination.”
Florida’s new surgeon general, Joseph Ladapo, has questioned the safety of COVID vaccines, despite overwhelming evidence that they are safe and effective.
Experts reviewing the document say the researchers either put their thumbs on the scale here, or didn’t know what they were doing in assessing health outcomes.
For one thing, the study sample excluded anyone with a documented COVID infection or COVID-related death — in other words, it excluded anyone with a health outcome that the vaccines were designed to prevent. That meant that the researchers couldn’t judge the efficacy of the vaccines in preventing illness against the vaccines’ purported harms.
That’s important because Ladapo claimed in his press release that “the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group.”
The study itself, however, points to exactly the opposite conclusion. If one takes its own figures at face value, the study suggests that the mRNA vaccines caused about nine additional cardiac deaths in the 18-39 age group, but avoided more than 300 COVID deaths.
It’s true that the mRNA vaccines are associated with a slightly higher risk of myocarditis, a heart inflammation. But other studies have found that the post-vaccination condition is milder and less likely than other forms to cause death.
As pointed out by Kyle Sheldrick, an Australian neurosurgeon who crunched these numbers, that’s “a very good deal.” It means that the benefit of vaccination hugely outweighs the risk of cardiac-related death in the subject group.
The study, in fact, found that the vaccines weren’t associated with a higher risk of death from all causes; in fact they led to a lower risk of death in all age groups, including males 18-39. Even if one accepts that the mRNA vaccines caused a higher risk of myocarditis, that phenomenon was swamped by the lower risk of death from all causes in that age group.
Still, there are grounds not to take the study’s calculation of vaccine-caused cardiac-related deaths seriously. The study calculated cardiac deaths by examining the cause-of-death codes on Florida death certificates. That’s not a suitable data set for the purpose, said Panthagani.
Florida Gov. Ron DeSantis thinks boasting about his anti-lockdown stance and attacking Anthony Fauci are a winning political play for him, even as COVID rages out of control in his state.
Among other problems, the codes aren’t very specific — one is for “cardiac arrest” and another for “heart failure” — and none applies to a heart condition traceable to the vaccines. Cardiac arrest can occur for many reasons, including an underlying illness or COVID-19 itself.
As Panthagani noted, cardiac arrest can be the terminal event for many different diseases, not just cardiac issues.
The anonymous authors acknowledge that they made no effort to determine the actual cause of death of anyone in the sample. In purported cardiac cases, they concede, “the underlying cause of death may not be cardiac-related.”
When all is said and done, the sample size of males 18-39 who died of supposed cardiac issues in the 28 days after receiving an mRNA vaccine was only 20, so tiny that even a miscalculation here or there would render the result statistically insignificant.
“Their sample size is quite small and they’ve lumped together a lot of random cardiac things,” Panthagani told me. “Using a small sample size and a noisy data set is a recipe for unreliable results.”
The study itself cited only “a modestly increased risk for cardiac-related mortality 28 days following vaccination.” Ladapo, in his recommendation, called it an “abnormally high risk.” This is the language of partisan flimflam, not sober healthcare policymaking. The paper he cites bristles with warnings about its limitations, including that the data “should be interpreted with caution,” which is precisely what Ladapo didn’t do.
So why did he issue such an alarmist recommendation against vaccinating young males with the mRNA vaccines? His record contains some clues.
As I reported earlier, Ladapo has questioned the safety of COVID vaccines, despite overwhelming evidence that they are safe and effective. He has touted the antimalarial drug hydroxychloroquine and the anti-parasitic drug ivermectin as treatments for COVID-19, despite the lack of any evidence that they serve that purpose.
Florida Gov. DeSantis is running a victory lap over his COVID-19 response as the press plays along.
He has been associated with the fringe group calling itself “America’s Frontline Doctors.” Indeed, he spoke at the notorious event in July 2020 at which its members promoted hydroxychloroquine and that featured a presentation by Texas doctor Stella Immanuel, who is also known for her belief that witches and demons affect people’s health.
As his first official act as state surgeon general, Ladapo signed an order taking away local school districts’ authority to order children exposed to people with positive coronavirus tests to be quarantined or kept out of class. In October 2021, shortly after his appointment by DeSantis, Ladapo showed up at a meeting with a Florida legislator without wearing a mask, even after she informed him that she was undergoing breast cancer treatment and therefore was particularly susceptible to infection.
“He just wouldn’t do it,” she said. “And he was smug, arrogant and smiling. And I think he enjoyed making it difficult on me.” The legislator threw him out of her office.
Ladapo’s professional resume included a stint on the faculty at UCLA’s medical school. A background check by the Florida Senate before a vote for his confirmation yielded mixed results, at best.
Asked whether she would recommend his appointment as surgeon general, his supervisor at UCLA, Carol Mangione, replied: “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.”
She added: “Dr. Ladapo’s opinions ... 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.”
That brings us back to California’s new law against medical disinformation.
The law, Assembly Bill 2098, which Gov. Gavin Newsom signed on Sept. 30, reflects the legislative finding that “some of the most dangerous propagators of inaccurate information regarding the COVID-19 vaccines are licensed healthcare professionals.” It defines “the dissemination of misinformation or disinformation related to the SARS-CoV-2 coronavirus” as “unprofessional conduct,” clearing the path to action against the medical licenses of violators by the California medical and osteopathic boards.
That finding is long overdue. In August 2021, the Federation of State Medical Boards felt compelled to issue a stark warning to medical professionals that “physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license.”
Few actions against doctors have followed. The new law, however, puts meat on the bones of the federation’s warning, at least in California. It should come as no surprise, however, that the law has already come under legal attack from the anti-vaccine lobby.
The two plaintiffs in a lawsuit filed Oct. 4 in Los Angeles federal court, California physicians Mark McDonald and Jeffrey Barke, assert that the law “chills” the free speech rights of medical professionals by imposing “official government-approved orthodoxy.”
The plaintiffs both admit to disseminating claims about COVID treatments that are at odds with accepted medical opinion. McDonald says in the lawsuit that he has opposed mask mandates for adults and schoolchildren, has supported treating COVID with ivermectin and hydroxychloroquine, and questioned the safety and efficacy of COVID vaccines. He says in the lawsuit that the California Medical Board is investigating an anonymous allegation that he has spread misinformation about COVID on social media. The board’s website doesn’t mention any such investigation.
Barke also says in the lawsuit that he has opposed mask mandates, advocated for ivermectin and hydroxychloroquine, and questioned the safety of COVID vaccines.
Ladapo and DeSantis claim that their interest is in protecting the public from unsafe responses to COVID. By muddying the water with false claims and pseudoscience, they have done just the opposite.
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