109 Comments

I do not agree with your dismissal of Dr. Ladapo's concerns around the potential dangers of the mRNA products. This is a complex issue which requires a much more thorough analysis than you have presented.

1) The quantity of DNA fragments deemed acceptable is based on traditional vaccines which are not encapsulated in LNPs which are specifically designed to protect the encapsulated mRNA (and the trace DNA contaminants) until they can enter a host cell's cytosol. In other words the risk of these DNA contaminants are greater when they are encapsulated inside the lipid delivery mechanism. Yet the FDA has not modified their assessment of risk accordingly. It is illogical to compare mRNA inside of LNPs with traditional vaccines.

2) Ladapo is NOT claiming that these products WILL result in the integration of said fragments into our genome. He is merely asking for evidence that they WON'T. Citing genotoxicy studies isn't, as he says, adequate to ensure this is may not be happening on a small scale.

3) Your statement "It is biologically impossible for random DNA fragments to integrate into our genes" is not substantiated by the arguments given. In fact it contradicts Dr. Marks' assurance that it is "implausible". There is a world of difference between impossible and implausible, especially given the fact that billions of people have been vaccinated. The reason why Dr. Marks has a tempered position is that he knows that FDA's own guidance around DNA vaccines acknowledges that integration is a possibility even though DNA vaccines do not have DNA integrase in them either. The fact that contaminant DNA "lacks stability" does not mean that none will survive long enough to be integrated.

4) This leads to your position about "billions" being relatively tiny compared to "trillions". No argument there. But a billion is a big number on its own, especially with regard to "implausibility". If only one in a million DNA contaminant strands get integrated that would result in thousands of cells with altered DNA.

5) We all agree that LNPs go places outside of the deltoid muscle. The bio distribution study you cite indicates that 0.1% get to the ovaries and testes. Is that really trivial? At what level would it be non-trivial in your opinion? Two points about this. The levels in the ovaries attained that concentration after 48 hours. Levels were still rising when the observational period ended. We don't know how much eventually ends up there. Moreover, this study was only made public after a FOIA request to the Japanese medical authorities in the Spring of 2021. Why didn't the FDA know about it? Isn't it their job to demand these studies from the vaccine manufacturers? How many people would have had second thoughts about getting jabbed if they knew that a small portion of the inoculate would migrate to the spleen, the liver, the heart, the ovaries and the brain? Would their concerns have been reasonable?

6) The lipid nanoparticles aren't just little bubbles of fat. The design of these particles is one of the major breakthroughs in bringing these products to market. They are designed differently depending on the payload being delivered. Medicine in the form of cancer therapy will be encapsulated in a different kind of "bubble" than an mRNA vaccine. The LNPs for these vaccines are designed to be pro inflammatory to incite an immunologic response. It should be of some embarrassment to the FDA that the bio distribution studies show that these things go all over the place, albeit in limited quantities. That being the case, one cannot dismiss the possibility that these particles could be responsible for organ inflammation in the form of irregular menses, myo/pericarditis, bells palsy, transverse myelitis, etc. etc. in a small subset of vaccine recipients. Given the fact that a quarter of a billion people in this country have gotten the vaccine that the three hundred thousand serious adverse events reported in VAERS may be due to the vaccine? Shouldn't we expect the CDC to do a serious investigation into these reports on behalf of the public?

7) 8,288 Floridians have lost their life to Covid-19? Your citation does not indicate the vaccination status of those fatalities. Are you suggesting that they were all unvaccinated? What exactly are you insinuating here? That Ladapo is somehow responsible for their deaths? He didn't prohibit people from getting the jab. 70% of Floridians are fully vaccinated.

There's a lot more we don't know about this technology. Posts like this do not aid in discovering more. mRNA technology could eventually be a transformative weapon against disease and infection but right now the public doesn't trust it, and for good reason. By dismissing reasonable requests for more information in this fashion you are unwittingly doing far more damage than you realize.

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You forget that the rest of the stuff you posted on Substack—basically a farrago of every wackadoodle conspiracy narrative and far right talking point ever floated—can be seen by anyone.

But, hey: who wouldn't take respect someone whose bio reads: "I am a board certified anesthesiologist, electrical engineer, author and wannabe standup comic." /s

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Which one(s) of the enumerated points do you disagree with?

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Sounds like he read "Rules for Radicals". "If you can't win a debate with facts, attack the messenger." At least he didn't play the trump card - "RACIST!"

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No, it's rules for not wasting time with obvious crackpots. Setting aside for the moment that "wannabe standup comic" Madhava Setty didn't bother presenting any actual facts.

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Still a non-answer without any factual rebuttals. But plenty time wasted attacking the messenger. Saul Alinsky would be proud.

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Thanks for reading her drivel so I don't have to! Brandolini's Law is real

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True. Hence my preferred use of sarcasm to deal with obvious crackpots. The same result is achieved, since I know from experience that the true conspiracy believer will reject any evidence that does not comport with the narrative in the first place.

“Never play chess with a pigeon. The pigeon just knocks all the pieces over. Then shits all over the board. Then struts around like it won.”

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Sorry to have to say this, but sounds like YOU are the pigeon and "the true conspiracy believer." You have only rejected the information Dr. Setty offered that does not comport to your narrative, with no intelligible counter moves, and you're doing all the (admitted) sarcastic strutting.

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"No I'm not, YOU are!"

That's always such a persuasive argument. Also "Doctor" Setty didn't offer anything but unsourced opinions. Should they ever present any actual claims with citations from reputable sources (i.e. not some random YouTube video) to support them, we can maybe deal with that.

Got some serious projection going on there, guy.

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My post is not to argue with you. It is to inform you how you appear. Your response is predictable. What's with the quotations around "Doctor?" Do you question the man's credentials? Do YOU have any? For the record, Dr. Setty a recognized engineer and medical authority, trained at the world's finest universities. Was chief of residents at an Ivy League medical school hospital. For the last quarter century he's served patients daily with life and death issues, with not a blemish on his record. He is a wanna be comic because it takes an awesome sense of humor to deal with completely unqualified people such as yourself who troll otherwise intelligent discussion boards like this with their trivial emotional responses. Did you even know what a lipid nanoparticle is before mouthing off to Dr. Setty? Would you care to debate Dr. Setty on matters of science? I'm sorry to have to be so condescending to your childish intellect, but really, it is time for you to be seated and let adults continue this important discussion. https://www.madhavasettymd.com/bio

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Ladapo altered the research findings from a study on COVID vaccines. It's important to have this context.

https://www.politico.com/news/2023/04/24/florida-surgeon-general-covid-vaccine-00093510

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In fairness to the surgeon general, he did not alter data, he revised the interpretation of the data. It was an internal document, not a published study. Based on the data from Florida's DPH, do you disagree with his assessment?

A far more concerning issue around important data is around the way Pfizer delayed reporting of cardiac deaths in their vaccine until after they were granted EUA:

https://ijvtpr.com/index.php/IJVTPR/article/view/86/224

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The journal you're citing -"International Journal of Vaccine Theory, Practice, and Research" - is not reputable. Please read this:

https://healthfeedback.org/claimreview/preventing-deaths-isnt-sole-benefit-covid19-vaccination-contrary-epoch-times-article/

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I would suggest reading the article before reading an article about the article. In any case, the data dump from Pfizer is publicly available if you are interested in refuting the author’s analysis.

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From the article: "Ladapo’s changes, released as part of a public records request, presented the risks of cardiac death to be more severe than previous versions of the study."

"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."

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That's an accurate account. Based on the data Dr. Ladapo was correct in identifying the subset of people where the risk out weighed the benefit. If you will recall at the time he was not critical of all Covid vaccines, just those with the mRNA vector for young men. He recommended that that subgroup receive the J&J DNA vaccine.

I am interested to know why you disagree with his analysis of that dataset.

Another interesting question is why was he so mercilessly attacked for what was a tiny concession to the Covid vaccine hesitant. To me it seemed obvious that the medical orthodoxy could not give an inch. Why? Could it be because it would be a tacit admission that mistakes were made?

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Is it possible to test for integration of DNA fragments into the human genome? If so, could it be done in circulating nucleated white blood cells? Or in biopsies that were already being done on ovaries?

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That's a good question. Probably, given the fact that we can sequence a person's genome when necessary. If we could do that kind of study we should be asking why haven't we. I am just a member of the public at large who understands that we cannot be certain about anything, especially in regard to something this complicated. This is why I find this blithe dismissal so disquieting.

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Don't see any actual data, analysis of data or cited studies to back up your objection to the report presented on why "fragments of DNA" has resulted in hurting anybody or showing that the life-saving contribution of mRNA vaccines would be diminished by the "theories" you seem to favor. Have you ever seen anyone gasping for breath from a respiratory infection - and wondering if maybe they just should have got that vaccine? Probably not. I'd rather rely on the network of scientific consultations and testing that precede any vaccine or drug approval than your "theories." Too bad science isn't apparently a subject people understand anymore.

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Jan 5Liked by Katelyn Jetelina

Thank you very much for an excellent analysis and response to more misinformation from Florida. Unfortunately, Ladapo's statement already hit the national press and was widely reported. This article needs to be sent to the news media so they can report the truth.

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Each piece of Dis & Misinformation should directly attacked especially given waste water data & under reported hospitalization & deaths gtaphsbof Holidays surge which will continue through mid January.

Full disclosure I have a JD not a MD. I did deliver over 30 years of pro-bono (free) legal work on incorrect medical billing.

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It seems that Dr Ladapo wants to go back to the old way of doing science, by questioning everything. He doesn’t seem to realize the enormous cost savings that have become available since we started accepting whatever the FDA says as “science”. Next thing you know, he’s going to want to roll back the Reagan Revolution!

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Love the adroit use of language; it does not, however, equate to understanding of

scientific method.

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Questioning is the very first element to the scientific method, is it not? Dr. Ladapo is demanding that evidence of the FDA's hypothesis that DNA contaminants are harmless be shared. I suggest that he has an excellent understanding of the scientific method.

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Jan 5Liked by Katelyn Jetelina

As a Floridian, emergency manager AND advocate for persons with disabilities, thank you so much for posting this. This "doctor" is a serious danger to public health and my fellow Floridians. His efforts and actions have seriously impacted me and my team at work's ability to increase vaccine access to those with disabilities.

And another reason I am so glad to have left that agency before he got arrived. Again, thank you for posting this. You are appreciated.

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"Regardless, we have been tracking the safety of Covid-19 vaccines at unprecedented levels across the globe for more than three years. Scientific evidence from the lab, clinical trials, and epidemiological real-world data continue to verify a highly favorable profile of benefit to risk of Covid-19 vaccines."

Which clinical trial demonstrated a mortality benefit? a hospitalization benefit? It most certainly was not the Phase III Pfizer trial that led to the approval of the mRNA vaccine. There is no evidence of a "highly favorable profile of benefit to risk" for a healthy 30 year-old, for example. None. Yet these shots continue to get pushed on everyone.

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founding

Disappear back under your bridge, troll

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Can you please share the clinical trial which demonstrated a mortality benefit? Would you agree that Pfizer's did not?

Do you believe that there is a highly favorable benefit to risk profile for a healthy 30 year old? On what grounds exactly?

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founding

He is a and has made it clear that he is from his many prior comments.

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Paul, I hope you realize that the only reason people aren't bothering to engage with you is Brandolini's Law

Zzzzzz

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Floridian here. Ladapo is a danger to public health and safety. He's already lied multiple times and should not be Surgeon General much less be allowed to have a medical license. He's violated his oath both as SG and as a physician. He does nothing but harm. He's part of the reason Florida still has one of the the highest Covid death rates in the country. They stopped tracking everything years ago so we have no accurate data about Covid. And they continue to lie to people who put the rest of us in danger on a daily basis. DeathSantis would make the vaccines illegal if he could and there was at least one petition to do so already. I still cannot safely participate in public life because of people like Ladapo and constant lies and bad messaging.

Now I have a question about DNA. We know that DNA from every pregnancy stays inside the mother forever after birth. And that the DNA can cause cancer later in life (not always). Why doesn't the female body break down those DNA fragments? Is it because the DNA isn't technically foreign because the body recognizes it from gestation?

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There can be free fetal DNA fragments circulating after birth.

Respectfully, please supply two citations:

1) That DNA fragments last “forever”. (They don’t. All DNA is quite fragile and breaks down. It can only persist if it has a way of replicating, and free DNA fragments can’t do that.)

2) That free DNA causes cancer.

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I said can 'cause cancer' and 'not always'. Ther have been studies on this that I have read.

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Please provide peer-review citations.

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Another Floridian here too and yes. He and Reichstag Ron are very much a clear and present danger to our state.

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I wish we could sue to remove them for being a danger to public health and safety. Their policies and lies are killing people.

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Shame on Dr Ladapo! By prioritizing the health of Floridia’s people over the health of Pfizer’s bottom line, he has selfishly advanced his own career and left millions of stockholders poorer in his wake.

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Thank you for your excellent response. I am a medical provider in Florida and got his email and was about to forward that to you. You beat me to it. Thanks

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Katelyn and Guests

Thank you so so much for this perspective. Without your expertise, it would be very hard for people to understand how dangerous it can be to safety-test these vaccines. We KNOW as a matter of theory that they are safe. If we keep demanding tests, sooner or later a red flag will appear and then where are we? The companies would probably be required to add some expensive procedure for removing DNA from their products, and profits would suffer. They would suffer. And avoiding suffering is the noble purpose of medical science.

We know for sure that DNA cannot integrate into the genome, so it is uber-important that we don't run the lab tests that might cast doubt on this scientific certainty. The very profits of Moderna and Pfizer are at stake here -- the profits that they use so efficiently to reward their investors for keeping us safe.

Yes, adding safety tests for mRNA is certain to cause a great deal of death and destruction in the long run. I'm so so grateful to you for having the wisdom to point this out to the stupid public, people like me who don't have the education to understand that safety testing can be really, really bad for public health.

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So did you not read the article or did you just find it hard to understand the information contained therein?

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I read the article and, the same morning, listened to Dr Buckhaults's testimony. I applied my own judgment, which seems to make more sense, and I invite you to do the same. https://www.youtube.com/watch?v=IEWHhrHiiTY

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Well, Josh, your sneer is very artful. Almost as awesome as the selling of colored capsules and calling them Fruits and Veggies.

Results count. The run to pass way above 1.3 million COVID deaths in the US was pretty well stopped.

You can go to clinicaltrials.gov to learn if/how safety was ascertained.

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The elephant in the room is that CDC has a website for reporting vax side-effects. It's voluntary, so no quantitative information can be calculated, but large trends can be perceived. The month that the COVID vaccines came out, the rate of reports to VAERS went up 50x and stayed up for 2 years. Fifty times the rate of side-effects. Fifty times the death reports, compared to all vaccines in the past.

Put this together with the fact that the mRNA vaccines were hastily tested and rushed to market under highly-politicized circumstances, and you begin to understand why we should be demanding rigorous safety tests, and not making decisions based on expectations or theory.

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You can get the VAERS data and have at it. https://vaers.hhs.gov/data.html Consider that the vaccination program was millions of doses, so it stands to reason you get more reporting. Specifically, a report to VAERS does not mean that a vaccine caused an adverse event nor establish causal effects. Also, increased public awareness and media can cause increase reporting and the CDC advertised it. The point is to separate the normal side effects (such as normally happens after a IM shot) for an actual adverse effect. Also, some were health issues that would have developed without the vaccine. Yes, there were adverse effects but most were not. Also, the vaccines were already in the works, so 17 years of development.

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Thank you for the link to VAERS. I have downloaded the data and done my own analysis. The "17 years of development" included no safety testing in humans. And the "millions of doses" was in the same ballpark as yearly flu vaccines and scheduled childhood vaccines. There were hundreds of millions of doses of traditional vaccines in 2020, and the total number of reported deaths was about 420. In 2021, there were hundreds of millions of doses of mRNA vaccines and the total number of deaths was over 21,000. Of course, correlation does not equal causation, but shouldn't we be taking a close look at this?

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It is shameful how much money people are making from anti-vaccine propaganda. I laud the Pharma companies that are promoting their products -- certainly NOT propagandizing -- with their only thought being for the health of the public, and with a selfless refusal to profit from selling vaccines.

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Ummm, we have looked into this.

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Many anti-vaccine groups distort the VAERS data for their own political purposes. This is why many people don't trust the anti-vax groups.

https://www.factcheck.org/2023/06/scicheck-what-vaers-can-and-cant-do-and-how-anti-vaccination-groups-habitually-misuse-its-data/

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Many organizations that call themselves fact checkers don't disclose that they have financial ties to the pharmaceutical industry. That is why many people don't trust the fact checkers.

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VAERS was established as a concession to the public following the National Childhood Vaccine Injury act of 1986 when vaccine manufacturers were indemnified from any liability with regard to their products. This system was built to alert the CDC of safety issues with regard to vaccines. It has its flaws. It isn't designed to prove causality, it was designed a signal capturing system so that adverse events could be investigated. The alarms were going off within a few months of mRNA vaccine deployment but they are being ignored. Now there are three hundred thousand serious adverse events reported and few, if any, are being investigated by the very organization that built it. At what point will we, as the public, demand that the CDC do their job?

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Not quite so, the CDC did investigate J&J vaccines for GBS and TTS. This lead to the withdrawal of the EUA. https://www.beckershospitalreview.com/patient-safety-outcomes/cdc-examines-adverse-reactions-to-j-j-shot-7-things-to-know.html

I should also remind you of the rare Myocarditis cases were investigated as well. Of course, the cases greatly increase in COVID-19. The guidance is now 12 weeks instead of the 3-4 week between first and second dose which greatly decreased cases. https://news.yale.edu/2023/05/05/yale-study-reveals-insights-post-vaccine-heart-inflammation-cases

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Yes. Those are the few. The CDC never investigated the myocarditis reports in VAERS. They only acknowledged that it was happening based on Israeli data in June, 2021.

There are thousands of reports in VAERS of events that fit a myo/pericarditis symptom constellation that have not been investigated.

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A simple reply to vaccine critics:

What do you suppose would have if you injected yourself with a cc of sterilized steak? Would you turn into a cow?????

Erm...

No.

NOTHING would happen except you’d get a local very unpleasant tissue response.

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Steak injection. Reading this almost caused me to lose bladder control in public

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My wife is very clear. Keep my day job.

"But honey, I'm retired."

;)

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Lemme guess - urologist? I can see how inducing incontinence could be useful there

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Nope. Pediatrician. I liked Mr. Wizard....

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Sadly, these claims cause those already on the side of misinformation to dig in further, and those on the side of evidence based science to invest more time on distractions.

Question ms are important and anyone should feel like they should ask for more data and more information.

But this, this, is simply political dog whistling and these self serving individuals are leading to the loss of loved ones and increased medical costs... that we all pay for.

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Wonderful analysis. I can't help but wonder why the AMA or some similar certifying agency doesn't publish a rebuttal to the continuous stream of dis-information coming from the Florida Surgeon Generals office

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Thank you for this article. I saw an article yesterday about the Florida Surgeon General and my first thought was, how does this doc still have a license? I'm guessing that in any other state, the regulatory board would be questioning him. Hopefully, the general public can see past his misguidance and will decide to ignore him.

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They don't and won't in most cases. They've been brainwashed by the GOP lies and fear-mongering. We haven't gotten past 68% vaccination with the first 2 doses. Almost no one masks and mask mandates are illegal even in hospitals in Florida. If DeathSantis had his way the vaccines would be illegal here too.

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He is a political appointee and DeathSantis looked for and found the most radical anti-vaxxer he could find. His republican worshipping state senate overwhelmingly confirmed the "doctor."

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Jan 5·edited Jan 5

Thank you for such a clear and concise explanation (and happy New Year)! Naive question: why aren't we seeing very public genuine, curiosity-driven discussion among those who hold these widely differing perspectives (moderated by someone who knows how to keep the discussion from turning into debate or worse)? Distant 2nd choice: Dr. Ladapo responds to your points in the way that a scientist ought to. 3rd alternative (which is what we have now): News/opinion bubbles whose members are increasingly convinced they're right.

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Your question is far from naive. There’s nothing wrong with disagreeing with Dr. Lapado. This is a discussion about science. The scientific process will eventually arrive at the best approximation of objective reality but only if dialogue is not just allowed but is fiercely defended by ALL sides.

Attacking the character of those who hold a certain view may win some points in the short run but at what cost? How would you know if you were wrong if you don’t allow opposing opinions to surface?

We have witnessed an erosion of reason in the last few years which I have never seen before.

This substack has hundreds of thousands of followers but one must be a paid subscriber to comment. There’s nothing wrong with that. However the sentiments of the comments may not represent the majority opinion. I would caution readers to not get swayed by an opinion’s popularity in such an environment.

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I would welcome this.

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Apparently Ladapo also said the vaccines are the Mark of the Beast, so you know he's reliable! /s

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Well I will say that after getting my updated COVID vaccine a couple of weeks ago, my cellphone has had amazing 10G coverage. :)

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10G? Amateur. I'm at 50G now. Even without a phone. I can feel the mRNA coursing through my veins

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LOLOL!!!!

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Actually, I take that back, he said it's the "anti-Christ" (which makes even less sense)

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Thank you so much for your analysis. As a psychiatrist, the science of this had been outside my expertise to evaluate. I do make recommendations to my patients regarding vaccination and they often have questions for me about Covid safety. I have an additional question about a contemporary issue regarding mRNA vaccines. What are your thoughts regarding the observations that repeated mRNA vaccinations can increase IgG4 levels and, therefore, have unintended negative consequences?

Thanks again for your excellent newsletter!

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I just saw someone talking about that(scientist) and the Ig4 thing isn't really a cause for concern.

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Thank you for your prompt and clear analysis of the science regarding these vaccines. I am glad I subscribe to YLE. I worked for 31 years in 2 Florida county health departments, and salute the dedicated workers remaining, despite politicized leadership. I have ¨Unsubscribed ¨ from further Florida DOH announcements. Steven A. Hale M.D. (retired)

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Did the Florida Surgeon General sleep during his biochemistry classes?

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