Florida surgeon general altered key findings in study on Covid-19 vaccine safety

Researchers with the Johns Hopkins Bloomberg School of Public Health and University of Florida, who viewed Ladapo’s edits on the study and have followed the issue closely, criticized the surgeon general for making the changes. One said it appears Ladapo altered the study out of political — not scientific — concerns.

“I think it’s a lie,” Matt Hitchings, an assistant professor of biostatistics at the University of Florida, said of Ladapo’s assertion that the Covid-19 vaccine causes cardiac death in young men. “To say this — based on what we’ve seen, and how this analysis was made — it’s a lie.”

Ladapo used the final document in October to bolster disputed claims that Pfizer-BioNTech and Moderna vaccines were dangerous to young men. | Jenny Kane/AP Photo

The newly released draft of the eight-page study, provided by the Florida Department of Health, indicates that it initially stated that there was no significant risk associated with the Covid-19 vaccines for young men. But “Dr. L’s Edits,” as the document is titled, reveal that Ladapo replaced that language to say that men between 18 and 39 years old are at high risk of heart illness from two Covid vaccines that use mRNA technology.

“Results from the stratified analysis for cardiac related death following vaccination suggests mRNA vaccination may be driving the increased risk in males, especially among males aged 18-39,” Ladapo wrote in the draft. “The risk associated with mRNA vaccination should be weighed against the risk associated with COVID-19 infection.”

In a statement to POLITICO, Ladapo said revisions and refinements are a normal part of assessing surveillance data and that he has the appropriate expertise and training to make those decisions.

“To say that I ‘removed an analysis’ for a particular outcome is an implicit denial of the fact that the public has been the recipient of biased data and interpretations since the beginning of the mRNA COVID-19 vaccine campaign,” he said. “I have never been afraid of disagreement with peers or media.”

He also said that he determined the study was worthwhile since “the federal government and Big Pharma continue to misrepresent risks associated with these vaccines.”

The DeSantis administration referred questions to Florida’s Department of Health.

Ladapo, a Harvard-trained doctor who held professorships at UCLA and NYU, specializes in cardiovascular diseases and gained attention nationally during the pandemic after he authored op-eds in the Wall Street Journal and USA Today questioning the safety of Covid-19 vaccines and the effectiveness of mask-wearing and lockdowns.

He was also a supporter of hydroxychloroquine, an anti-malaria drug that former President Donald Trump often praised as a treatment for Covid. The FDA later withdrew emergency authorization for its use.

Ladapo was picked by DeSantis in September 2021 to become the state’s surgeon general as DeSantis waged war against President Joe Biden’s Covid-related restrictions and ordered the state to ban mask-wearing requirements in schools and employer-issued vaccine mandates.

Ladapo drew criticism in part because he was affiliated with the conservative America’s Frontline Doctors, a group founded to fight Covid restrictions by anti-vaccine advocate Simone Gold. Ladapo devoted an entire chapter to his friendship with Gold in a memoir he published last year titled “Transcend Fear.”

Yet the researchers who viewed a copy of the edits said Ladapo removed an important analysis that would have contradicted his recommendation. Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, called Ladapo’s changes “really troubling.”

“He took out stuff that didn’t support his position,” Salmon said. “That’s really a problem.”

Hitchings chastised the integrity of Ladapo’s study after it was released last fall but is now much more critical.

“What’s clear from the previous analysis, and even more clear from Dr. L’s edits, is that absolutely there was a political motivation behind the final analysis that was produced,” Hitchings said. “Key information was withheld from the public that would have allowed them or other experts to interpret this in context.”

Ladapo’s edits also shed new light on an anonymous internal complaint he faced last year. The complaint, which the Florida Department of Health’s inspector general investigated, accused Ladapo of “scientific fraud” for allegedly manipulating the final draft of the study.

The inspector general stopped probing the complaint after the anonymous person failed to respond to emails. In a previous interview with POLITICO, Ladapo said the accusations were “factually false.”