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FLORIDA HEALTH OFFICIALS REMOVED KEY DATA FROM COVID VACCINE REPORT

The surgeon general’s guidance against the vaccine for young men ignored results
showing infection was a greater risk for cardiac-related deaths.
178
2.5k
12



Florida Surgeon General Joseph Ladapo, left, speaks at a news conference with
Florida Gov. Ron DeSantis in 2022. State officials removed data from a state
analysis of cardiac-related deaths that Ladapo used in October to justify his
recommendation that young men should not get the mRNA COVID-19 vaccine. The
missing data showed that catching the virus created a far higher risk of a
heart-related death. [ WILFREDO LEE | AP ]
By
 * Christopher O'DonnellTimes staff


Published Yesterday|Updated 4 hours ago
Advertisement


Florida Surgeon General Joseph Ladapo announced in October that young men should
not get the COVID-19 vaccine, guidance that runs counter to medical advice
issued by the Centers for Disease Control and Prevention.

His recommendation was based on a state analysis that showed the risk of
cardiac-related deaths increased significantly for some age groups after
receiving a vaccine. It has been criticized by experts, including professors and
epidemiologists at the University of Florida, where Ladapo is employed as a
professor.

Now, draft versions of the analysis obtained by the Tampa Bay Times show that
this recommendation was made despite the state having contradictory data. It
showed that catching COVID-19 could increase the chances of a cardiac-related
death much more than getting the vaccine.



That data was included in an earlier version of the state’s analysis but was
missing from the final version compiled and posted online by the Florida
Department of Health. Ladapo did not reference the contradictory data in a
release posted by the state.

The Times’ records request asked for all previous versions of the state analysis
made public on Oct. 7. The documents show that, before the final version was
released, at least five drafts had been produced. One version included a data
table showing the number of cardiac-related deaths from infection. The
conclusion in four of the drafts provided a counterpoint to Ladapo’s assertion
about the vaccine.

Four epidemiologists who reviewed the drafts said the omission is inexplicable
and flawed from a scientific standpoint. They said that, based on the missing
data, Ladapo’s recommendation should be rescinded.

Matt Hitchings, an infectious disease epidemiologist and professor of
biostatistics at the University of Florida, said it seems that sections of the
analysis were omitted because they did not fit the narrative the surgeon general
wanted to push.

“This is a grave violation of research integrity,” Hitchings said. “(The
vaccine) has done a lot to advance the health of people of Florida and he’s
encouraging people to mistrust it.”

The surgeon general and the state’s health department have frequently questioned
the safety of messenger ribonucleic acid or mRNA vaccines developed to counter
COVID-19. Last year, Florida became the first state to recommend against
vaccines for healthy children and it was the only state to not preorder
coronavirus vaccines for children under 5.



Ladapo declined to answer specific questions about why the data showing the
higher risk to Floridians from infection was removed. In an emailed statement,
he said that he stands by his guidance and that this is not the first time he
has faced criticism for his approach to COVID-19.

“As surgeon general, my decisions continue to be led by the raw science — not
fear,” he said. “Far less attention has been paid to safety of the COVID-19
vaccines and many concerns have been dismissed — these are important findings
that should be communicated to Floridians.”

His statement also included a link to a Gov. Ron DeSantis news release from
December announcing that the governor had petitioned the Florida Supreme Court
to impanel a statewide grand jury to “investigate any and all wrongdoing in
Florida with respect to COVID-19 vaccines.”


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“It is irresponsible to roll over and allow the pharmaceutical companies to
dictate health guidance that allows them to line their pockets when public
health officials experience the severity of the impacts firsthand in their
communities,” Ladapo said in his statement. The court has yet to take any
action.



The published eight-page state analysis linked data from Florida’s reportable
disease repository known as Merlin, the Florida State Health Online Tracking
System, and death records from the state’s vital statistics bureau.



It examined cases of adult Floridians who died within a 25-week period from the
start of the vaccination roll-out in December 2020 and detailed deaths occurring
within 28 days of receiving a vaccination.

It reported that there was only a “modest” increased risk from the vaccine
except for males ages 18 to 39, where it found an 84% higher incidence of
cardiac-related deaths.

Ladapo cited that number in the state’s nonbinding recommendation, saying the
“abnormally high” risk of cardiac complications from a COVID-19 shot “likely”
outweighs the benefits of vaccination.

That finding was based on 20 deaths, too small a sample size for such a
far-reaching conclusion, according to a column by four University of Florida
epidemiologists that highlighted concerns and flaws with the analysis. The
scientists also noted that Ladapo’s finding was not backed up with clinical data
proving that the cause of deaths fits the criteria.

Further, the data on the risk of infection omitted from the published report
shows that catching COVID presents a far greater risk for that same age group.

For Floridians ages 18 to 24, the incidence of cardiac-related deaths from
infection was more than 10 times higher than from the vaccine and more than five
times higher for ages 25 to 39. That data was not broken down by sex.



The state epidemiologists who worked on the report also arrived at a different
conclusion than Ladapo, the drafts suggest.

“The risk associated with COVID-19 infection clearly outweighs any potential
risks associated with mRNA vaccination,” one version states.

“The small risk associated with mRNA vaccination should be balanced against the
much larger risk associated with COVID-19 infection,” another version says. A
similar sentence appeared in the published conclusion but the “much larger”
modifier had been removed.

The state’s analysis was also criticized for not including a sensitivity
analysis, a method of proving that the results remain consistent even when
changing some of the assumptions used in the calculations.

A sensitivity analysis was present in three versions of the draft and suggests
that the increased risk for young men from the vaccine is not significant, said
Jonathan Laxton, a physician and assistant professor of medicine at the
University of Manitoba.

“It’s a double check that didn’t confirm that finding,” Laxton said.

Faculty at the University of Florida’s College of Medicine, including Hitchings,
circulated a report in January that was critical of the published analysis. It
characterized the research and the subsequent recommendation as being of “highly
questionable merit” but concluded it did not rise to research misconduct.



David Norton, UF vice president for research, said in a statement that because
Ladapo oversaw this research in his role with the state and not in his role as a
faculty member, UF’s Office of Research Integrity, Security and Compliance “has
no standing to consider the allegations or concerns regarding research
integrity” mentioned in the report.

After reviewing the draft reports, Hitchings said the final analysis is akin to
academic dishonesty.

“You can call it a lie by omission,” he said.

The downplaying of the elevated risk of cardiac-related deaths from infection
remains the biggest concern for Katrine Wallace, an epidemiologist at the
University of Illinois, Chicago. The state has denied Floridians the information
they need to make an informed decision on the vaccine, she said.

“As a scientist, and as a parent, it would be important for me to know the
cardiac risk from COVID versus that of the vaccine,” she said. “That context is
huge — and it’s gone.”

Up next:Florida COVID cases and deaths not included in latest CDC data


--------------------------------------------------------------------------------

 * Christopher O'Donnell
   
   Health and Medicine Reporter
   
   

--------------------------------------------------------------------------------




Read More




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