Loading ...The significance and importance of this cannot be overestimated.” Never fear; the debates over covid-era policies and the jabs remain very much alive. It isn’t over.
JEFF CHILDERS SUNDAY COFFEE AND COVID TODAY IS PAYWALLED …A MOST IMPORTANT PIECE…SO HERE YOU GO GOLDTENT
YOU’RE WELCOME
MEET THE NEW HERO ON THE BLOCK
Back in August, Vinay Prasad was fighting to keep his post as the newly appointed Director of the Center for Biologics Evaluation and Research —the FDA’s vaccine approval arm. None less than Laura Loomer had targeted him as a liberal mole. Prasad was temporarily ousted, but in a dramatic turnaround story, several weeks later, FDA Director Marty Makary reeled him back in.
This story should lay any concerns about Dr. Prasad to rest.
Yesterday, deep state ne’er-do-wells leaked a scathing, six-page, single-spaced internal memo that Prasad apparently sent to the entire CBER staff, inviting them to quit if they don’t like it. He did not mince words. He practically accused the CBER team of killing kids with their sold-out vaccine policies favoring pharma companies and ignoring evidence-based science.
The entire point of Prasad’s memo was to lay out his vision for reforming the way CBER approves vaccines, using the covid shots as a disastrous negative example of how badly the current procedures have failed. And he ended the memo with a curt suggestion: “Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor.”
? To give you an idea of how spicy the six-page memo was, it began with announcing (or reminding) the CBER team that, out of only 96 pediatric deaths reviewed by Prasad’s team of investigators, at least ten were directly linked to myocarditis, and almost certainly produced by the covid shots. Here is Prasad’s very first paragraph:
Cue the media hysteria! NBC quoted vaccine salesman and grandfatherly war criminal Dr. Paul Offit, who indignantly sputtered, “This is sort of science by press release is irresponsible and dangerous!” It wasn’t a press release, you moron, it was a private memo leaked by insubordinate staff. Disgraced former FDA vaccine director Peter Marks —who was fired by RFK earlier this year— cried, “This memo conveys a very troubling mixture of misrepresentation and lies!”
Offit and Marks were it; the complete cohort of “vaccine experts” quoted by NBC’s article opposing Dr. Prasad’s memo. So.
The Society of Professional Journalists’ code of ethics directs journalists to “provide access to source material when it is relevant and appropriate.” But NBC did not link to Prasad’s memo. You don’t need to read it; we will tell you what to think. Haha. Fortunately, we have other ways to find things now. Here is the link to Prasad’s memo.
https://www.washingtonpost.com/documents/3042d15c-676b-48ac-8148-1a2204ef420e.pdf
Fully’s note I you don’t read the whole memo at least not the end
Having said this, I remain open to vigorous discussions and debate on these
topics, as I have always been. I am open minded to modifications or alterations.
As you can imagine, I believe these debates should be private, internal to FDA,
until they are ready to be made public. I don’t endorse selective reporting of our
meetings and documents. Some staff may not agree with these core principles
and operating principles. Please submit your resignation letters to your supervisor
and CC my deputy Katherine Szarama.
For those who choose to remain in CBER, I look forward to working with you,
learning from you, discussing with you, and interacting with you on our shared
mission: to elevate vaccine science to 21st century evidence based medicine.
Vinay Prasad MD MPH
CBER Director, CMSO US FD
What NBC’s whiny vaccine experts did not do was engage directly with any of Prasad’s claims. At all. They didn’t even try to deny that at least ten kids were killed. They just whinged about VAERS (the system they created and use for lots of things, when it suits them, for crying out loud) and chirped angrily about “misinformation.” But we see them for what they are: white-coat pretenders.
Team Sanity had a completely different take. For example, mRNA pioneer and new member of the FDA’s vaccine advisory committee, Dr. Robert Malone, said on his Substack that, “I am stunned, gobsmacked by his letter. The significance and importance of this letter in the context of US and global vaccine policy cannot be overestimated. This is a revolution, the likes of which I never expected to see in my lifetime.”
? You can’t find Malone’s ‘revolution’ mentioned anywhere in the NBC story, or any of the other corporate media reports, which were all as useless as gum on a boot heel. They tried to cabin Prasad’s memo into a tidy little box called criticizing the covid shots. But the memo was much bigger than that.
“It is not our role to lower evidentiary standards or mask safety concerns to create artificial financial incentives to make vaccines,” Dr. Prasad wrote to his staff. Instead, going forward, he said that, “CBER’s general approach will be to direct vaccine regulation towards evidence-based medicine.”
“We will revise the annual flu vaccine framework,” Prasad told staff, “which is an evidence-based catastrophe of low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.” He added, “we will reappraise safety and be honest in vaccine labels.”
That’s when he started tossing out science grenades: “At FDA, we have not been focused on understanding the benefits and harms of giving multiple vaccines at the same time,” Prasad wrote, but “staff will be tasked with writing guidelines to reflect these changes, and the mission of CBER will change to reflect this worldview.”
In other words, FDA will study and adjust to the combined risks from potential interactions or burdens of giving different vaccines at the same time. This has never been done— probably not accidentally. And needless to say, if the FDA concludes the safest route is to give kids vaccine doses one at a time, parents will not make 76 trips to the doctor for each kid.
That one change would probably drive vaccine rates into the basement.
But the sentence that really soaked Dr. Offit’s corn flakes was when Prasad promised, “we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints,” but rather, “vaccine makers will have to show their products reduce infections, and not merely generate antibody titers.”
He was saying that, on his watch, the FDA would stop approving vaccines solely because they raise some lab marker (like increased antibody levels) that is assumed to predict a benefit, absent direct evidence of real clinical benefit and acceptable safety. For decades, the FDA and other regulators have used simplified substitute indicators to approve shots for pregnant women and other vulnerable groups, on the rationale that complete drug trials would be impractical.
To most lay folks, this violates the precautionary logic we apply in everyday life: if something can seriously hurt you, you only accept it when you can see that it actually helps, not just that it shifts a lab number. Regulators and pharma researchers, though, have built a whole framework that sometimes lets surrogate markers stand in for real?world benefits, especially when trials would be expensive, slow, or ethically complicated.
For populations with low baseline risk and limited upside —like healthy children, young adults, pregnant women without major comorbidities— the gap between “raised the right antibodies” and “clearly reduced bad outcomes” matters a lot, because any non?trivial harm can flip the net balance.
? Taken together, Dr. Prasad’s roadmap for CBER reform is, as Dr. Malone suggested, “revolutionary” and it “cannot be overstated.” This isn’t just a debate over how many of ten pediatric death cases should be attributed to covid vaccine side-effects. Prasad’s memo is nothing less than a direct threat to the entrenched vaccine regulatory-industrial complex. That is why the usual suspects have boiled out of their nests like angry wasps, loudly complaining like old men returning soup at a diner.
So that’s one reason to celebrate. The second reason to celebrate is that obviously the rancorous debates over covid jabs and pandemic policy continue in full force inside the agencies. So if you had ever been convinced by black-pillers that Kennedy and his team were co-opted, I humbly present Prasad’s memo as Exhibit A.
The war continues. Fiercer than ever. You just aren’t hearing about it, because media is ignoring the story.
After all, remember who the media’s real customer is. The customers are not readers or viewers. The audience, and its attention, are the product. Media’s actual customers —the ones who buy the product— are advertisers. Yet NBC’s story included no conflict?of?interest note regarding NBC’s or Comcast’s financial dependence on pharma ads, not even a lame statement about how firewalls are maintained between the advertising department and health coverage.
The fact that the media is beholden to pharma should be better known. After all, it’s been proven.
In a 2019 study on pharma advertising titled, “Pharmaceutical advertising biases media reports on drug safety,” diligent sociologists —after a shockingly large amount of work— unsurprisingly concluded that “newspapers are less likely to report on a drug’s side effects if they obtained more advertising dollars from the drug’s producing company.” They even quantified the effect: “a newspaper that receives an additional $100,000 of advertising in the 14 days prior to the publication of an article on its advertising client’s drug is 9% to 20% less likely to mention side effects of this drug. This effect increases with higher amounts of advertising dollars.”
In other words, they used math. “Our results,” the researchers drily concluded, “indicate that pharmaceutical advertising reduces the extent to which the media reports on potential harms of their advertising clients’ drugs.” Thus, “as a result of the biased reporting, the public’s perception of drug safety is likely to be distorted and public health can eventually be adversely affected.”
Ha! In other words, the more money pharma pays media for advertisements, the less media reports on side effects or safety issues. It is simple. And that, my friends, is science. Do not be a denier.
Past generations used to understand this even without scientific studies, as evidenced by several ancient folk sayings that nobody living apparently learned anything from. Don’t bite the hand that feeds you, Florida old-timers would always say, laughing themselves silly, while feeding live chickens to alligators. Or if you prefer: He who pays the piper calls the tune. (The latter expression was coined by Samuel J. Piper, who went around during the Civil War with a pet monkey who would either play “Dixie” or “The Battle Hymn of the Republic” on a portable organ, depending on who paid, until Piper got shot in a duel and the monkey ran off somewhere.)
Important historical context aside, the point is: nobody criticizes their biggest customers, or they won’t stay in business very long. And, just saying, more money was spent on covid jab advertising than on any other drug in history. So.