About that myocarditis warning that the good-FDA slapped on Pfizer jab...
First, I apologize for previously confusing directions about this. We were trying to find the fastest and easiest technical way to get people to sign on to our letter to RFK Jr and HHS, urging MAHA admin to deliver on their campaign promises. If you are interested, you can sign on this website (it is a group affiliated with Dr. Mary Talley Bowden, but the page is separate to collect signatures to our letter). We are told we will get a formal response from HHS.
Second, this stack congratulates our dear freedom leader Robert Malone on his appointment to ACIP!
Just so my readers are aware,
asked Robert politely if he wanted to sign our letter to RFK Jr , and she got this in return:Urging for removal of mRNA shots from market qualifies as a hate group, in the newly appointed ACIP committee member’s opinion. Well, duh, of course that would be the case if one holds patents for mRNA and has financial interest in several pharmaceutical companies and military industrial complex. Malone is the CEO of RW Malone MD, LLC, a consulting firm; the specific clients are not detailed but the firm is stated to have "yielded clients billions of dollars". His past industry roles include CMO at Alchem Laboratories, CEO of Atheric Pharmaceutical, and Director of Clinical Development at Solvay Pharmaceuticals (now Abbvie). But these are “good” conflicts of interest, you see, not the “bad” ones, like in those other ACIP members that got fired. God help us all when our DARPA/DTRA man is in charge of vaccine recommendations! Such as this:
Additionally, Malone is a compassionate empath, saving humanity and always putting others ahead of himself. What a sweetheart!
The healthiest way to deal with these clown committees like ACIP is to completely ignore what they say. They have no legal power anyway. The qualifications to get on those committees include getting it wrong on mRNA jabs and giving other people bad advice about them from the very beginning. You see, in government, “moderate” position requires you to lie at least 50% of the time. That’s called “moderate”, because the truth is an extreme, hateful and “ideological” to them, i.e. completely unacceptable. People who ignored the Big [5.5 tall in heels] Beautiful [ugh…] Expert’s recommendations about mRNA did very well for themselves, unlike dear Robert who “nearly died” from shooting up the shit juice “for travel”. Just as he says - can’t fix stupid! So, don’t be like Robert! Be like Pfizer and ignore the FDA.
My story below illustrates this point. I spent some time discussing Robert Malone’s complete lack of ethics for a reason which will be clear here. He is a liar and has no problem promoting dangerous lies for his own political, and of course, financial benefit.
Many of you likely heard this great news: The FDA finally put a warning on Comirnaty label for myocarditis and pericarditis. A major MAHA achievement. You knew this, right? I thought I knew this, too.
This article by one Lauren Lee was republished by Robert Malone on his Malone News substack. I don’t know who Lauren Lee is, but her whole piece is an example of inspired mutilation of the truth to promote the desired political narrative. I read it because it was forwarded to me by one of the readers who wanted to scold me for being a MAHA party-pooper and not trusting the plan enough… I thank them for doing this, because without reading this piece, I wouldn’t have realized that I shouldn’t have taken the story about FDA amending Comirnaty label as a fact. I am correcting this mistake now.
Here is what Lauren Lee has written and Malone News republished about this:
4. The FDA’s Secret Demand Letter
Then came the fourth blow, perhaps the most underreported of them all.
A letter from the FDA—which quietly appeared on it’s website last week—shows that regulators have demanded Pfizer and Moderna update their labels to include findings of myocardial injury following vaccination.
The letter cites multiple long-term observational studies, including one showing 278 out of 331 patients experiencing post-vaccine cardiac symptoms.
It warns that failure to comply places the companies in violation of federal law (FDCA section 505(o)(4)). If ignored, their products will be labeled “misbranded,” opening the door to a full market recall.
Kennedy didn’t need a microphone… He simply used the law.
What an exciting, stunning and brave use of pharmaceutical law, I thought! Why do this “quietly” though? And why is it a “secret demand letter” if it’s posted on the FDA site? This will become clear in a moment. The FDA letter states:
Note the date - April 17, 2025.
It appears that the FDA finally, after all these years and billions of doses and thousands of myocarditis reports, including from their own presentations years back… ok, stop… that was bad Biden-FDA… now, good Trump-FDA noticed the data and science!!! They finally noticed the cardiac injury which leads to premature death in many cases, but they did notice after all. The FDA demands that Pfizer updates their label with the following language:
Furthermore, the FDA cites its enforcement power should Pfizer fail to comply within 30 days of this letter, i.e. by May 17, 2025. They cite the pharmaceutical law that authorizes them to slap a warning on this product. Note the stern language warning Pfizer that failure to comply may result in their product being misbranded under FDCA:
Alright, this seems legit and very much in the interest of making America healthy and stuff. We should join Lauren Lee and Robert Malone and celebrate an heroic MAHA victory, right? Maybe, but first let’s do what I previously forgot to do and verify by looking at the new, revised and updated Pfizer label that’s hanging on the FDA website today:
Oops… this is embarrassing. The language in Sections 5 and 6 remains unrevised and has not been updated since October 2024:
The language of the label is the same Orwellian bullshit that had been there before, under the bad Biden regime: “you may end up in the ICU from heart damage, but it’s good for you”. Also note the funny part that Comirnaty might not work for immunocompromised people - and that’s exactly who should get it first, fresh from the shit brewing factory without placebo controlled trials according to Drs. Makary and Prasad’s new, good-MAHA-FDA policy.
I hope it is obvious that the 30 day deadline has come and gone, and Pfizer breezily ignored the very sternly worded FDA letter. Science did not win this time…
But what about the law that the FDA cited in the demand the change in the label? Can’t they prosecute Pfizer now for clear violation of that law???
Well, oops again. I don’t know what happened to those very smart FDA lawyers who until very recently knew exactly what law applies to EUA Countermeasures under ongoing PREP Act declaration of the never-ending public health emergency of grave concern, which may or may not originated from a deadly CBRN weapon, aka GOF Wuhan virus that nobody has seen IRL. Maybe they slept through the issuance of this FDA demand letter?
However, Pfizer’s lawyers are neither stupid nor sleeping at $1000/hr on their jobs! This is the correct law that applies and they seem to know it well:
Do you see the bolded part = “shall not be deemed adulterated or misbranded”? Well, take that FDA with your sternly worded letters about Comirnaty being misbranded under a totally inapplicable law!
Do you see how this Kayfabe wrestling between FDA and Pfizer was designed for small-brained creatures like Lauren Lee and lying snakes like Robert Malone so that they can snow you with “MAHA wins” messaging while pushing mRNA onto “the vulnerable”? Yes, anyone still falling for this is vulnerable in their heads for blindly believing these characters. The FDA letter about revising Comirnaty label is a fake performative maneuver.
I really hope that all the dimwitted mooing and baaing about “leading with science, not hate!” will finally become obvious to most covid dissenters… Covid was never a public health issue, and mRNA vaxxes have nothing to do with science, data or pharmaceutical product regulations. These are weapons, being deliberately deployed, with FDA as a captured agency fronting genocide and eugenics as public health and lying on behalf of those who are deploying these weapons.
The FDA does not have any regulatory or enforcement power over EUA Countermeasures, no matter what they say in media about it. They are lying big time and our job is to be aware of these lies and call them out, no matter which administration or party or favorite political figure is in charge. This is not personal to them, as they don’t care how many they kill or injure, and it shouldn’t be personal to us. It’s war. Nobody is coming to save you. Do not comply.
Art for today: Peony in a blue glass, watercolor, 5x7 in.