Most concerning, over a median follow-up of 159 days, 60% of individuals (98/161) with initial late gadolinium enhancement
Things are not going well at the FDA. Recent headlines declare: Inside the Staff Exodus and Tanking Morale That Threaten Makary’s FDA and Inside the Collapse of the F.D.A. Meanwhile, dangerous diseases are spreading. Recent headlines declare: Measles Cases in the U.S. Hit the Highest Total Recorded in More Than 30 Years, ‘Fighting to Breathe’: Whooping Cough Surges as Vaccination Rates Drop, Pediatric Flu Deaths Hit Record High For Non-Pandemic Season, and CDC Says COVID-19 Cases Rising in 25 States.
Yet, at this moment, with all that’s going on, the FDA’s leaders, Drs. Marty Makary and Vinay Prasad, have devoted most of their time and energy to protecting Americans from the grave “dangers” of COVID vaccines. Using their government power to repeatedly override vaccine-experts and reject our medical freedom has been their top priority. As Dr. Georgios Pappas put it:
The policy proposed by Prasad and Makary violates the right of individual persons to protect themselves from an infection with considerable mid- and long-term sequelae.
Drs. Makary and Prasad initially made their case in a widely panned NEJM editorial, An Evidence-Based Approach to Covid-19 Vaccination. This was followed this up by an official FDA warning and a JAMA editorial titled US FDA Safety Labeling Change for mRNA COVID-19 Vaccines.
Their own data shows the absurdity of their concern. Drs. Makary and Prasad revealed the COVID vaccine was totally safe for nearly everyone. They had to dig deep to find a problem with it, and so they turned to their favorite topic, vaccine-myocarditis. Drs. Makary and Prasad have been obsessed with this side effect for 4 years, producing a deluge of spooky content to encourage COVID infections in unvaccinated young people.
In their JAMA article, Drs. Makary and Prasad said vaccine-myocarditis occurred in males aged 12-24 years at a rate of 1 in 37,000. They revealed that nearly all patients fully recover, something that’s been known for years, and that a lingering MRI abnormality in 60% of them was the “most concerning” part about it all. They wrote:
Most concerning, over a median follow-up of 159 days, 60% of individuals (98/161) with initial late gadolinium enhancement (LGE) had persistence and a minority (5% [5/98]) had worsening LGE and symptoms. A total of 4% of patients (11/272) continued to have arrhythmias at a median follow-up of 31 days and 2% required antiarrhythmic medications. These findings raise questions about the benefit-risk assessment for COVID-19 vaccination in healthy male adolescents and young adults.
This translates to 1 in 61,500 overall young men overall, or about 450 abnormal MRIs if every American male age 12-24 were to get the vaccine. Those are the stakes. That’s what all the fuss is about. By way of comparison, at the peak of the Omicron wave in January 2022, nearly 1,000 children were being hospitalized with COVID every day.
Dr. Prasad also devoted an entire speech to this MRI finding. Listen to how serious and sober he is as he discusses late gadolinium enhancement after the vaccine. It is “not benign,” he said.
Breathless coverage of rare anecdotes of MIS-C & death in kids
Dr. Prasad didn’t always feet this way. In his article Setting the Record Straight: There is No ‘Covid Heart’, he argued that late gadolinium enhancement after myocarditis was “no special reason to worry”. Is myocarditis dangerous or not? According to our medical establishment, myocarditis is dangerous only when it is caused by the vaccine.
In reality, COVID myocarditis killed some young people, while the vaccine has not, and COVID’s harms are not restricted to myocarditis. However, our medical establishment has a long history of treating vaccine side effects more seriously than anything COVID could do. In their view, it was a “truly unacceptable” to accurately report that vaccine-myocarditis was almost always “mild“, however it was “breathless” to even mention literal death from COVID. That was just “rare anecdotes,” just 19 dead kids in a single month. He spoke in a vulgar, unprofessional manner about anyone who disagreed.
While our medical establishment treated entirely hypothetical risks from the vaccine with the utmost seriousness, nothing the virus did mattered them. Just listen to how Dr. Prasad spoke about children going to the hospital with COVID during the Delta wave versus how he spoke about “subclinical myocarditis“- which is nothing more than an abnormal value in a kid who feels fine. He never worried that repeat COVID infections might not be good for kids.
And this is all still going on today. Compare how Dr. Makary speaks about “vaccine injuries” versus his casual dismissal of children dying of measles. “We have to be honest with people,” he said as he embraced “soft eugenics” and falsely claimed only children with underlying medical conditions were vulnerable to measles.
The observed vaccine efficacy was 100%
While our medical establishment claims to value data and evidence, SBM readers know this performative nonsense. Though both the virus and vaccine were new, they greatly overhyped the vaccine in early 2021, promising it offered perfect protection against severe disease, blocked transmission, and would end the pandemic. When reality proved otherwise, they turned against the vaccine with a vengeance rather than admit error.
Our medical establishment always opposed vaccinating children, and Dr. Prasad started his anti-vaccine campaign in January 2021 months before there was any data about the pediatric COVID vaccine when he thought the pandemic was “abating“. In the video below, from February 2021, Dr. Prasad spread obviously fake statistics- COVID only kills 1 in a million children– and fear mongered about mundane vaccine side effects such as headaches and fevers. There was no data about the pediatric COVID vaccine at the time, but Dr. Prasad’s mind was already made up.
The data from the randomized-controlled trial (RCT) in adolescents was released in March 2021 via a company press release. It was published in the NEJM in May 2021, and all 16 COVID cases occurred in the placebo group. The Delta and Omicron variants arrived later that year causing unprecedented sickness in children. The AAP says COVID hospitalized 234,000 children over all the first four years of the pandemic. Unsurprisingly, dozens of observational studies have since shown its value in limiting these rare, but grave COVID harms in children. None of this mattered to Dr. Prasad. You can read his entire body of work and not learn any of this. He didn’t feel his readers deserved to learn these basic facts from him.
While Dr. Prasad never devoted a single thought to any child harmed by COVID, he made an overwhelming amount of scary content like this.
Similarly, as Omicron loomed in December 2021, our medical establishment laughed at and mocked anyone who wanted the first booster dose. Even though the results were only available as a press release at the time, an RCT of 10,000 people showed that it was safe and 95% effective at preventing COVID. It was published in the NEJM several months later, and it doesn’t take a genius to imagine a vaccine dose that lowered infection rates would also lessen severe disease.
The results from a large observational study were also available when this podcast aired. It found:
Vaccine effectiveness evaluated at least 7 days after receipt of the third dose, compared with receiving only two doses at least 5 months ago, was estimated to be 93% (231 events for two doses vs 29 events for three doses; 95% CI 88–97) for admission to hospital, 92% (157 vs 17 events; 82–97) for severe disease, and 81% (44 vs seven events; 59–97) for COVID-19-related death
None of this mattered to our medical establishment. No RCT, no observational trial, no COVID variant, no packed pediatric hospital or dead child altered their anti-vaccine ideology one bit. They never looked back. They didn’t care at all.
It’s data from families that say their kids have been acting with bad behavior … and they eliminate the petroleum-based food dyes and the behavior improves. That is data.
In their JAMA article, Drs. Makary and Prasad predictably demanded new “randomized controlled trials (RCTs) in these populations prior to issuing further marketing approvals.” In contrast, when it comes to things they want to be true, anything goes. They are fine limiting vaccines without RCTs, and commenting on another trivial risk, petroleum-based food dyes, Dr. Makary recently said:
We have a lot of data and it may not necessarily be the traditional 50 year randomized control trial follow up. It’s data from families that say their kids have been acting with bad behavior … and they eliminate the petroleum-based food dyes and the behavior improves. That is data.
For our medical establishment, the drone-like phrase: gold-standard science and common sense, gold-standard science and common sense, gold-standard science and common sense, common sense and good science means: We will demand incredible evidence for things we don’t want to be true and use vibes to justify things we want to be true. As Dr. Ben Mazer put it:
In the current health administration, we’re witnessing the birth of a new medical philosophy: EBMOFCV Evidence-Based Medicine only for Covid Vaccines
This risk-taking approach may, in part, be responsible for widespread loss of trust in public health and medicine
Despite their inglorious track record of failed predictions and pro-virus disinformation, Drs. Prasad and Makary had the audacity to end their JAMA article by speaking about trust. They wrote:
During the COVID-19 pandemic, broad, one-size-fits-all mandates were aggressively pursued, requiring vaccines in populations with potentially net-negative benefit-risk profiles. This risk-taking approach may, in part, be responsible for widespread loss of trust in public health and medicine and growing hesitancy against all vaccination. Public trust takes decades to build, but can be forfeited in a single action. The FDA’s class SLC action on mRNA products represents one step toward rebuilding that trust.
I know whom I blame for the “widespread loss of trust in public health and medicine and growing hesitancy against all vaccination” and it has nothing to do with a rare, temporary vaccine side effect that was widely-publicized and discussed.
Though it was recently scrubbed from the FDA’s website to make it seem as if it had been covered it up, the FDA warned about vaccine-myocarditis as early as June 2021. So did the CDC. It was hardly some state secret. I’ve written extensively on this side effect, starting in June 2021. So have many others. No one is just now discovering it thanks to the courage of Drs. Makary and Prasad, and they are the only ones who talk about it constantly today. Americans are not breathing a collective sigh of relief because finally, they put an end to our national nightmare of vaccine-myocarditis. No one thinks Drs. Makary and Prasad are heroes because they saved a narrow demographic group the minuscule risk of an abnormal MRI after a voluntary vaccine.
The medical freedom community is calling for the resignation of podcaster surgeon Marty Makary, the new FDA Commissioner.
Fortunately, it’s not my job to restore trust in the FDA. That is up to its leaders, and it’s not going well for them. Prior to assuming office, Dr. Prasad gave interviews called Stop Trusting the Public Health Establishment, and many people absorbed his message. Now, the knives are out for them from all directions. Cranks are “calling for the resignation of podcaster surgeon Marty Makary” because they haven’t banned all COVID vaccines, and a recent editorial in the Washington Times titled Trump Agenda For Biotech Being Sabotaged From Within was all about Dr. Prasad. It said:
An affinity for central planning is the hallmark of progressive thinking. Dr. Prasad’s FDA is moving away from the America First principle of trusting parents and doctors to make medical decisions back toward the failed Obama-Biden approach, which lets unelected, unaccountable bureaucrats decide who gets a chance at life. He wants the government to define what counts as “effective” or “appropriate” and force families to beg for permission from unelected elites in Washington.
Dr. Prasad’s rise is an example of what Mr. Trump means when he refers to “the deep state.” He is a careerist insider, left-wing ideologue working from within to hollow out the president’s biotech revolution by ceding administrative and regulatory power back to the bureaucrats and the woke elite. Mr. Trump should remove him from his posts before he pushes his personal, anti-MAGA agenda any further, causing irreparable harm to the American biotech industry.
Meanwhile, medical organizations with relevant expertise are suing them, and vaccine experts are rightfully mocking them. They are utterly silent as their boss does all he can to contribute to “growing hesitancy against all vaccination.” They don’t really care about that at all.
Trust in our medical establishment is justifiably tanking, and 100 more articles and podcasts about an MRI abnormality won’t fix that. Incredibly, ensconced in a bubble of their own creation, Drs. Makary and Prasad seem to actually have fallen for their absurd notion that a rare, “mild” vaccine side effect was the root cause of mistrust for millions of furious Americans. Once the FDA finally comes clean about vaccine-myocarditis, everything will be just fine. I could have told them they were high on their own supply and wrong about all that.
Drs. Makary and Prasad are the medical establishment now. It’s our right to hold them accountable, and it’s their job to earn our trust. They are failing badly. They signed up for this, and they only have 3.5 more years to go, though sadly the rest of us are along for the ride.