Florida pulls the plug on mRNA COVID vaccines for males 18-39

[Chalkie]

A study by the State of Florida found that cardiac related mortality was higher in males 18-39 within the 28 day period following an mRNA vaccine. I believe this would be the pFizer and Moderna vaccines with the Johnson & Johnson and Astra-Zeneca vaccines being acceptable. They found an 84% increase in cardiac related deaths in that age group. The study this guidance is based on can be found here.

Edited October 9, 2022 by Chalkie

[Jim & Wilma]

The source of this guidance is the FL Surgeon General, an individual not well respected by his peers. 

[Chalkie]

1 hour ago, Jim & Wilma said:

The source of this guidance is the FL Surgeon General, an individual not well respected by his peers. 

And you know this how? The study certainly was not conducted by him solely and nowhere in that document is surgeon general mentioned. I don't see that your comment adds anything to the conversation. 

[Jim & Wilma]

13 hours ago, Chalkie said:

And you know this how? The study certainly was not conducted by him solely and nowhere in that document is surgeon general mentioned. I don't see that your comment adds anything to the conversation. 

I rely on peer reviewed medical sources for my guidance, not an individual’s “analysis”. Is there ANY peer reviewed source that supports the FL Surgeon General’s conclusion? No there isn’t and there won’t be any. This should inform us on the quality of the source.

[Chalkie]

8 hours ago, Jim & Wilma said:

I rely on peer reviewed medical sources for my guidance, not an individual’s “analysis”. Is there ANY peer reviewed source that supports the FL Surgeon General’s conclusion? No there isn’t and there won’t be any. This should inform us on the quality of the source.

I wasn't aware that peer reviews were popularity contests. However, if you actually read all of that link you find all the facts and figures laid out and you could draw your own conclusions on that data. To say more would lead to politics so I will refrain.

[Kirk W]

Florida Surgeon General Warns Against Young Men Getting Covid-19 mRNA Vaccines, What’s His Justification?   Forbes Healthcare, Oct 9, 2022,11:28am EDT

[Jim & Wilma]

38 minutes ago, Chalkie said:

. . .  if you actually read all of that link you find all the facts and figures . . . 

The study notes that,

“Additional studies should be conducted to further understand the risks and benefits of vaccination of males between 25-39.”

It is this further study that is lacking. 

[Chalkie]

2 hours ago, Jim & Wilma said:

It is this further study that is lacking. 

Yes, further study is needed but that is no reason to toss out the initial conclusion. By that logic we would not have had any of the COVID vaccines we had when we had them since they were all initially approved for use without completing all the steps normally needed for approval. 

 

[Jim & Wilma]

2 hours ago, Chalkie said:

Yes, further study is needed but that is no reason to toss out the initial conclusion.

 

My point in our discussion was to try to advise against taking the conclusion of a single individual before the medical community has an opportunity to assess the significance of the FL report.

Vaccine trials and approval process follow a very thorough process involving experts within academia, industry and government.  For your reading entertainment . . . https://www.cdc.gov/vaccines/basics/test-approve.html

[Jaydrvr]

"The only “evidence” presented was an “analysis” apparently conducted by the Florida Department of Health."

While I agree with your overall premise, I'm not seeing where this analysis was the product of a single individual. What am I missing in your view on this? Jay

 

[2gypsies]

The 'study' was first done by Edward Dowd an equity investment executive linked to Steve Bannon.  He doesn't have any medical background.  He claimed 84% between 25-44 yr old.

Then comes the Florida guy who states 84% between 18-39 yr old.  Coincidence of the 84%?

The 'study' was not peer-reviewed and doesn't contain a list of authors who penned the analysis.  

https://www.reuters.com/article/factcheck-excess-mortality/fact-check-no-evidence-that-people-aged-25-44-experienced-an-84-increase-in-excess-mortality-due-to-covid-vaccine-rollout-idUSL2N2VS1BI

 

[Jim & Wilma]

3 hours ago, Jaydrvr said:

What am I missing in your view on this?

The title of this post is the conclusion of one man. It’s the “analysis” of the FL Surgeon General and his conclusion that I believe is premature and likely flawed given his previous statements and positions.
I have no argument with the written report and having taken graduate courses in statistics, I’m just smart enough to let others digest the data and make their assessments.
It’ll be interesting to follow this through and see what conclusions other sources come to. 

Edited October 10, 2022 by Jim & Wilma
Spelin

[RV_]

Gary here is the Wiki on him. I'll pass on anything this guy recommends.  Please follow his recommendations if you want but he can't use recommendations and made up experiences to gain credibility while the people he references say he has none of the experience he cited in some, and completely took out of context misrepresenting the works of others. One highlight: "Ladapo was confirmed by the Senate on February 23, 2022; during background checks, his former UCLA supervisor refused a positive recommendation, noting that Ladapo's "hands-off" approach towards tackling COVID-19 had violated the Hippocratic oath and had distressed colleagues."

Joseph Ladapo had violated the Hippocratic oath and had distressed colleagues."?????

From Wikipedia, the free encyclopedia

 

Joseph Ladapo

Surgeon General of Florida
Incumbent
Assumed office September 21, 2021
Governor	Ron DeSantis
Preceded by	Scott Rivkees
Personal details
Born	1978/1979 (age 43–44) Nigeria
Education	Wake Forest University (BA) Harvard University (MD, PhD)

Joseph A. Ladapo (born 1978/1979)^[1] is an American physician who is the surgeon general of Florida.

During the COVID-19 pandemic, Ladapo has promoted unproven treatments, opposed vaccine mandates, questioned vaccine safety, and associated with America's Frontline Doctors, a right-wing group known to promote falsehoods about the pandemic.^{[8][9][10][11]}In March 2022, as the Surgeon General of Florida, he misrepresented work by fellow scholars to recommend that healthy children not be vaccinated against COVID-19, a decision that also went contrary to the Centers for Disease Control and Prevention and American Academy of Pediatrics.^[12][13] Since then, Ladapo has banned gender-affirming counselling, hormonal therapies, and related medications for transgender and nonbinary children, contravening relevant guidelines by a host of professional organizations.^{[14][15][16]"}

COVID-19 pandemic and Florida surgeon generalship

During the COVID-19 pandemic, Ladapo had promoted unproven treatments — hydroxychloroquine and ivermectin —, questioned the safety of vaccines, opposed lockdown mandates, and associated with America's Frontline Doctors, a far-right group known for promoting falsehoods about the pandemic.^{[8][9][10][19]} In a March 24, 2020, opinion column in USA Today, Ladapo argued against lockdowns deriving from his experience in treating COVID-19 patients at UCLA, an assertion he repeated in a later column published by the Wall Street Journal.^[20] However, UCLA staff scheduling roster did not have him assigned to treat COVID patients, and several of his colleagues rejected that he had treated any COVID-19 patient at UCLA ever.^[20][21]

With passage of time, he became a vocal supporter of Governor of Florida, Ron DeSantis' COVID-19 policies that ran against mainstream medical consensus.^[22][19] On September 21, 2021, he was appointed to be the Surgeon General of the state, replacing Scott Rivkees, pending confirmation by the State Senate. Simultaneously, he was also appointed an associate professor at University of Florida Health in a fast-tracked hiring process, initiated after the Board of Trustees chair — a DeSantis advisor — had sent his resume to the UF Health president.^[6] Faculties have since alleged that university administrators downplayed information about Ladapo's controversial views on COVID-19 before the vote on his tenure.^[23]

On appointment, Ladapo critiqued the "senseless" fear-driven cult of vaccination — characterizing vaccines as one of the many equally preventative arms of pandemic management — and would repeal quarantine rules for schoolchildren exposed to COVID-19 as his first executive action.^[18][9]The next month, Ladapo courted controversy after refusing to wear a mask while in a meeting with State Senator Tina Polsky, who had been diagnosed with breast cancer and was set to undergo radiation therapy;^[24] he defended his actions on the ground that masking hindered effective communication.^[25] Ladapo was confirmed by the Senate on February 23, 2022; during background checks, his former UCLA supervisor refused a positive recommendation, noting that Ladapo's "hands-off" approach towards tackling COVID-19 had violated the Hippocratic oath and had distressed colleagues.^[7][26][27]

In March, Ladapo recommended that healthy children in Florida not be vaccinated against COVID-19; thus, Florida became the first state to contradict relevant guidelines by CDC and the American Academy of Pediatrics.^[12][28]All of the "experts" who were cited by Ladapo were not consulted in the process; they disagree with the recommendation and accuse him of de-contextualizing their arguments.^[13] Since then, Ladapo has shifted focus to transgender healthcare — holding professional organizations such as the American Academy of Pediatrics and the Endocrine Society as politically motivated, he has restricted gender-affirming counselling, hormonal therapies, and related medications for transgender and nonbinary children.^[14][15][16]

Source:

https://en.wikipedia.org/wiki/Joseph_Ladapo

Edited October 10, 2022 by RV_

[RV_]

Feds rebuke Florida surgeon general’s advice to young men on COVID vaccine

Caroline Catherman, Orlando Sentinel

Mon, October 10, 2022 at 5:26 PM

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said the study’s results do not justify Ladapo’s recommendation.

The study did not find that COVID-19 vaccination was associated with more deaths overall, just that it was associated with a “modestly increased” risk of cardiac-related deaths.

“What’s so scary, so troubling to me, is that when you read the discussion, the discussion of the findings does not match with the action,” Marks said. “The discussion notes all of the weaknesses, including the fact that there’s not any decrease in all-cause mortality here.”

In contrast, the study found catching COVID-19 was associated with a “substantially higher” risk of both total deaths and cardiac-related deaths.

“From a public health perspective, I care about having more people alive at the end of the day,” Marks said. “The idea that, you know, that we’re going to have more people dead, but at least they won’t be dead of cardiac causes, I find that very challenging to understand. And that seems to be what’s being said here.”

Source:

https://www.yahoo.com/now/feds-rebuke-florida-surgeon-general-232600027.html

 

[RV_]

Excerpt from Forbes:

"So what evidence did Ladapo provide to support this recommendation? Did he say that he surveyed all of the existing scientific literature? Nope. Did Ladapo look at all of the available data? Not exactly. The only “evidence” presented was an “analysis” apparently conducted by the Florida Department of Health. Ladapo claimed that this “analysis” found “an increased risk of cardiac-related death among men 18-39” in the following tweet: (See link at bottom)

You may ask yourself why the word “analysis” is in quotes above. Well, such a word in and of itself doesn’t say much. Heck your significant other could say something like, “I’ve done an analysis of our relationship and have decided to run off with that person from the circus,” even though you might question the scientific accuracy of such an analysis. As you can see, Ladapo’s tweet claimed that “FL will not be silent on the truth.” OK, so let’s look at the truth behind the analysis that Ladapo had cited.

First of all, it’s important to note that this “analysis” has not been published in a reputable scientific journal. This is a key distinction because anyone can post something on a web site and call it an “analysis” just like anyone can upload a video of themselves interviewing their cats on to YouTube and call themselves a talk show host. There’s no indication that this “analysis” has undergone a full and proper review by experts in the field to determine whether it was done properly and whether the conclusions actually match the results.

Now, typically, when you have questions about an “analysis,” you can simply contact the authors of the “analysis,” right? Umm, that would be a bit difficult to do in this case since the document provided did not list any author names, assuming that the authors’ names weren’t “doctor blankedly-blank” and “doctor invisible.” Moreover, the document was on a plain PDF without any official Florida Department of Health markings. So it’s not clear who in the Florida Department of Health besides Ladapo may have signed off on the report.

Ideally, a Methods section is supposed to provide enough details so that others could potentially reproduce the analysis. The Methods section did include a fair amount of jargon such as saying that the “analysis” utilized a self-controlled case series (SCCS) method but did not provide more explanation as to why the “analysis” employed the SCCS method rather than other available and more widely-used methods. Granted, a self-controlled case series is not the opposite of an out-of-control case series method. This method has “individuals act as their own control—i.e., comparisons are made within individuals,” and has been used previously to evaluate vaccine safety. However, previous use doesn’t necessarily mean that SCCS would be the best method to employ in this situation. Saying that you used a method simply because it’s been used before would be a bit like saying that you decided to get a mullet in the form of a gecko simply because someone else had done so previously.

Plus, an epidemiological method is like a condom. Simply using it is not enough. You’ve got to use it properly. Gurdasani pointed out that the “analysis” compared the rate of death during the 28 days after someone got a vaccine with the rate of death during “later periods,” from 29 days after up to 25 weeks after vaccination:

It’s a little confusing as to why the authors of this “analysis,” whoever they may be, chose this SCCS approach rather than simply comparing those who had gotten the Covid-19 mRNA vaccines with those who hadn’t. In other words, why use people as their own controls when other clearly relevant controls are available.

Moreover, it’s not clear why this “analysis” excluded deaths from Covid-19. That’s kind of weird since you are presumably getting the vaccine to prevent such deaths. Plus, it’s not as if such deaths have been uncommon. After all, we have been and are still in, you know, a Covid-19 pandemic.

Gurdasani went on to show how the specific approach used in this “analysis” could easily skew results to suggesting that more people died during the 28 days after vaccination versus the later periods:

In other words, if someone died during Period 1 (i.e., the first 28 days after getting vaccinated), why the heck are you still counting them as being alive during Period 2 (i,e, the later period that comes after the 28 day period)? Won’t that artificially inflate the denominator for Period 2 and thus seemingly reduce the rate of death for that Period? That doesn’t seem right, period.

These certainly weren’t the only flaws brought up by scientists on social media. Kristen Panthagani, MD, PhD, a resident physician and Yale Emergency Scholar at Yale New Haven Hospital, questioned on Twitter the way that this “analysis” was counting cardiac-related deaths:

As Panthagani emphasized, the “gee-wonder-who-conducted-this-analysis” authors used a particular International Classification of Diseases 10 (ICD-10) code to determine cardiac-related deaths while not using other seemingly relevant ICF-10 codes. There’s a two-word term for doing such a thing that begins with the name of a red, round fruit that is delicious in pies and ends with the word “picking.” Yes, choosing only the “Other forms of heart disease” ICD-10 code to identify cardiac-related deaths makes you wonder how much “cherry-picking” had occurred.

That’s not all in terms of flaws. In her You Can Know Things blog, Panthagani listed other things that you can know, or perhaps should know about this “analysis.” ICD-10 codes can be notoriously inaccurate in identifying the conditions that a patient may have since medical doctors tend to use such codes for billing purposes. That’s why it can important in studies to check the patients’ medical records to verify such diagnoses. The “who-are-they” authors of this “analysis” didn’t seem to do such medical record checking, even though doing so wouldn’t have been too arduous a task, given the relatively small sample size, with 20 deaths among males between the ages of 18 and 39 years who had received an mRNA vaccine. Oh, and the small sample size was another issue raised by Panthagani: from a statistical sense, 20 deaths may have not been enough to draw any strong conclusions.

That apparently didn’t prevent Ladapo and the Florida Department of Health announcement from drawing some pretty strong conclusions: “This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination,” and “the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group.” Yeah, all of that would be quite a leap and would fly in the face of all the available scientific evidence to date.

This brings up a final big flaw with the document that described this “analysis.” Typically scientific publications will mention other prior studies and what is already known about the matter at hand. The U.S. Food and Drug Administration (FDA) Facts Sheets for the Moderna and Pfizer/BioNTech Covid-19 mRNA vaccines already include warnings about myocarditis, which is inflammation of heart muscle, and pericarditis, which is inflammation of the membranes that wrap around the heart, as potential but rare side effects of the vaccine. The Centers for Disease Control and Prevention (CDC) has already clearly indicated that, “Data from multiple studies show a rare risk for myocarditis and/or pericarditis following receipt of mRNA Covid-19 vaccines.” So it’s not as if they are covering up the existence of such side effects.

The CDC also has added that “For most cases of myocarditis and pericarditis following vaccination with an mRNA Covid-19 vaccine, patients who presented for medical care have responded well to medications and rest and had prompt improvement of symptoms” and that “Preliminary data from surveys conducted at least 90 days after the myocarditis diagnosis showed most patients were fully recovered from their myocarditis.” Yet, the document did not mention any of these studies and explain why this “analysis” would somehow trump all of the other previous studies and data.

The heart of the matter is that Covid-19 itself can lead to myocarditis, pericarditis, and potentially other heart-related problems. As I’ve described previously for Forbes, studies have shown that the risk of these heart-related problems occurring from Covid-19 may be much higher than the risk of such problems after getting the Covid-19 mRNA vaccine. Sure, getting a Covid-19 mRNA vaccine doesn’t come with zero risk. Nothing in life has no risk. Heck a red baseball cap could serious maim you under certain circumstances. Instead, decisions in life are about comparing the risks associated with each option. That’s why any analysis of Covid-19 mRNA vaccines must take into account not only the risk of getting the vaccine but the risk of not getting it."

Much more and the Doctor's comments in the Source:

https://www.forbes.com/sites/brucelee/2022/10/09/florida-surgeon-general-warns-against-young-men-getting-covid-19-mrna-vaccines-whats-his-justification/?sh=1f36ca8a4105

Note all the doctors and researchers and experts in the fields that are quoted by Forbes?

 

Edited October 11, 2022 by RV_

[HMFunk]

On 10/9/2022 at 7:47 AM, Jim & Wilma said:

The source of this guidance is the FL Surgeon General, an individual not well respected by his peers. 

The source of this guidance is facing objections from folks who disagree with his stance and the political views of his boss (the FL Governor), not  because they can articulate cogent responses to his decisions and the cited studies upon which his policies are based.

Travel Free!

[Kirk W]

Sadly, for too many people in the country, Covid-19 and related decisions has become more a political issue than one of healthcare and medical science.   🤥

[Chalkie]

1 hour ago, Kirk W said:

Sadly, for too many people in the country, Covid-19 and related decisions has become more a political issue than one of healthcare and medical science.   🤥

Exactly. And unfortunately any studies that pursue an avenue that is not in lockstep with the "official" view is then shut down as misinformation, or not a respected source, or not peer reviewed. I am sorry I posted this as I knew it would become political. Kirk, if you want to lock it, please do.

[rollinbrian]

Pretty good breakdown here:

https://arstechnica.com/science/2022/10/that-florida-analysis-on-covid-vaccines-is-you-guessed-it-total-garbage/

Ars Tech is my go to place for analysis.

[DanZemke]

I've been an Ars Technica paid subscriber, for many years.  Beth Mole doesn't do politics.

"Beth is Ars Technica’s health reporter. She’s interested in biomedical research, infectious disease, health policy and law, and has a Ph.D. in microbiology."

Earlier in this thread, the assertion was made, that those of us who disagree with the claims are doing it for political reasons.  

B. S.

"The source of this guidance is facing objections from folks who disagree with his stance and the political views of his boss (the FL Governor), not  because they can articulate cogent responses to his decisions and the cited studies upon which his policies are based."

Beth's article is cogent response to the "study".  To me, trying to label all of the negative feedback, from Health experts as political, is a just lame form of misdirection.  

The study does not support the claim, and politics has nothing to do with it.

[Randyretired]

I just read a report that 2/3 of US people report they will delay or not receive the new vaccine.   I don't think that many belong to any one political party.  

[2gypsies]

4 hours ago, Randyretired said:

I just read a report that 2/3 of US people report they will delay or not receive the new vaccine.   I don't think that many belong to any one political party.  

Where's the link to the report?

[docj]

On 10/9/2022 at 7:22 AM, Chalkie said:

A study by the State of Florida found that cardiac related mortality was higher in males 18-39 within the 28 day period following an mRNA vaccine. I believe this would be the pFizer and Moderna vaccines with the Johnson & Johnson and Astra-Zeneca vaccines being acceptable. They found an 84% increase in cardiac related deaths in that age group. The study this guidance is based on can be found here.

Not everyone agrees with this so-called study and and many of the objectors have medical credentials that are at least as good or better than these of the FL surgeon general.  https://www.politico.com/news/2022/10/11/medical-experts-reject-florida-surgeon-generals-covid-vaccine-guidance-00061352

Edited October 12, 2022 by docj

[Chalkie]

23 hours ago, Randyretired said:

I just read a report that 2/3 of US people report they will delay or not receive the new vaccine.   I don't think that many belong to any one political party.  

I don't know about a particular report but the Washington Post reports that only 4% of eligible persons have gotten the booster so far ahead of the winter surge. 

[Kirk W]

11.5M Americans have received updated COVID booster: CDC

 

October 12, 2022, 4:11 PM     ABC News Medical Correspondent Mary Kekatos