Another day, another episode of the new FDA lying just like the old FDA... plus self dealing by MAHA Action.
This post is a compilation of recent happenings at HHS and MAHA machinations.
RFK Jr claims inability to override decisions by unruly staffers:
On July 10, MAHA-FDA lied by “fully approving” Moderna’s mRNA shots for “unhealthy” children 6 mo+. This generated an outrage from the vaguely defined health freedom community, at least those people who have not completely sold their conscience in exchange for the spot at the government/pharma trough.
The MAHA apologists with Bob Malone in charge furiously went to work feeding scripts lifted straight out of Shakespeare plays to their delusional followers, specifically this line: “Robert Kennedy was on vacation and his staffers didn’t tell him!” Malone’s article linked here is a fine example of propaganda. Among other things he asserts that thanks to this fake “approval” the covid shots are no longer EUAs. This is categorically false. The shots are Countermeasures and are listed under the Countermeasures Injury Compensation Program, and not NVICP. All Countermeasures are EUAs governed by Chapter 564 of FD&CA. Yes, in general all vaccines are unregulated poisons, however, details like these matter in educating the public. An EUA cannot transmutate into a “full approval” without ending the PREP Act declaration and it’s EUA Countermeasure status first, then going through the real investigational clinical trials program. Malone knows this. Makary, Prasad and Kennedy all know this. Yet, they continue to lie to the public about the true legal status of the covid shorts and mislead the parents into poisoning their children.
Reportedly, upon discovering the act of treachery behind his back from the unruly servants, the HHS boss Kennedy got enraged and fired both his chief of staff and her deputy. The latter may have intentionally rammed Kennedy’s government issued vehicle in the parking lot. Gosh, those dastardly scheming staffers!
This reminds me of the famous firing act, when Trump 1.0 “fired” Jennifer Santos for going ahead of the POTUS and singlehandedly disbursing $50B to pharma under Operation Warp Speed. Media drama ensued, Jennifer was swiftly relocated to a cushy spot in the Navy, but her unauthorized decision stood! Take that POTUS…
Well, take that RFK Jr! You can fire and replace staffers all you want, but their decisions somehow prevail… go figure….
…While Prasad overrides the decisions of unruly staffers all the time…
The unruly staffers seem to be running the pharma marketing department formerly known as the FDA. “Prasad again overrode FDA vaccine reviewers, this time on Moderna’s Covid shot for young kids”, writes mainstream pharma press:
The FDA’s vaccines and biologics chief Vinay Prasad overrode the agency’s vaccine reviewers for a third time in recent weeks, when he narrowed the approval of Moderna’s Covid-19 shot to a smaller population of young children, according to a recently published document.
The 3 instances of overriding recommendations of professional review teams are all referring to covid vaccine applications for Novavax and Moderna.
This is obviously designed to compare these acts by Prasad to the famous “over-ruling” act of Peter Marks, who approved Sarepta’s Duchenne drug against the recommendations of all review teams at FDA. The drug since then killed 3 patients (that the company admits to).
In a very curious Decisional Letter, Vinay Prasad wrote the following things, which happen to be true as separate statements, but spell a lie when put together in a memo:
“the Applicant has never shown a reduction in severe COVID-19, hospitalization, ICU stays or death in a randomized study in children”
“the Applicant has not shown that COVID-19 vaccination reduces long covid or transmission in any setting at any age with high quality data”
“although COVID-19 vaccines have been given to billions of individuals and the harms have been studied in depth, no one knows if these products have harms that only materialize 10 or 20 years later”
“much of the Applicant’s submission concerns immunogenicity or the body’s ability to make antibodies that neutralize the virus […] Antibodies are not gold standard science, and one cannot be certain of net clinical benefit merely because antibodies are increased”
“The CBER OCD and FDA Commissioner have published the framework in the New England Journal of Medicine”
“We do not have substantial certainty benefits outweigh risks for healthy children based on the totality of data in this submission”
Vinay Prasad states correctly that antibodies are meaningless and that there has never been any data produced demonstrating clinical benefit (reduction in hospitalization) with mRNA shots in children (ALL children), yet he is certain the “unhealthy” children will benefit from these shots. He also states that there is no long-term safety data in children, and there are significant risks with these shots, yet, again, magically they are good for “unhealthy” children.
The memo is curious because Prasad and FDA Commissioner Marty Makary released new covid vaccine approval policy, spelling out that future approvals would be limited to people 65 and older, and younger people with risk factors. It is not clear why staff reviewers believed they were entitled to completely disregard those new guidelines from their bosses. To me this signals that Prasad and Makary have no effective control of the FDA staff.
As of mid-March, 12.8% of kids 6 months to 17 years old got the updated Covid vaccine, according to CDC data. This means approximately 9 million children got poisoned with mRNA under Kennedy, Makary and Prasad’s watch.
Public opinion on mRNA shots is clearly low: a November 2024 survey by the CDC found that giving a child a Covid vaccine ranked last among actions parents would consider to help their kid not get sick from a respiratory illness. Only 36% of parents said they were very or somewhat likely to get their child vaccinated against Covid, compared to 55% for the flu.
Good start, but we need to drive these numbers to zero, and MAHA leadership together with MAHA-branded self dealing organizations (addressed below) are actively fighting this trend and working to grow the market of sick and injured children for pharma.
…While Makary pushes boldface lies and shills drugs for his masters…
In other news, Jan Jekielek interviewed the FDA Commissioner Makary for American Thought Leaders. No hard questions were asked in that interview. Due to time limitations and the fact I have a severe vomiting reflex whenever I hear Makary speak, I am going to address just one snippet of this propaganda piece disguised as an interview. Transcript of the clip, with my comments and questions that Jan Jekielek will never be allowed to ask:
Makary: We have a situation whereby we would love these companies to run a proper randomized control trial…
“Would love”? I thought the sole job of the FDA is to ensure that the pharma companies follow the law that requires properly collected safety and efficacy data against placebo control BEFORE the product can be marketed to the public, and especially for children. How about simply following that law?
If you [fully] reject the COVID vaccines as they come to you for approval, then you have no leverage to be able to ask the company to do that.
Oh look! You actually do follow that law, but not with the holy untouchable vaccines…When you issued 200 Complete Response Letters this year (i.e. rejections of product approvals by the FDA) did your heart bleed for them like it does for mRNA Countermeasures, Marty? Why did you reject the 200 drugs leaving yourself “no leverage” to ask them to run a prospective randomized controlled trial?
And those studies may never be done. We don't commission studies at the FDA. These are gigantic and expensive studies that, in my opinion, desperately need to be done…And I would like the data to come out to tell us what the truth is.
Right! That’s what this guy said too, in 2018 at the Milken Institute together with Rick Bright of BARDA, almost tearfully - “we need the entity of excitement” … and to “blow up the FDA approval process”, because mRNA keeps failing and nobody wants this junk, remember?
Continuing Makary’s ATL clip, he is rationalizing his “finish off the unhealthy” mRNA policy:
…So we basically said we're not going to approve COVID vaccines in low-risk and healthy Americans without a randomized control clinical study first. …Now, in the situations where you've got a kid with immuno suppression from HIV and a cancer therapy with chemotherapy, where they have an incredible immune susceptibility, and their doctor feels like they would benefit from a COVID shot, we're sticking to the promise of Secretary Kennedy that we're not going to take anyone's vaccines away from them. And if you want a vaccine, you can get a vaccine. …For people who think that we approved a COVID vaccine for say, healthy children, that's incorrect. That's not true. It's for those high-risk exceptions where a doctor feels strongly. And as a matter of fact, ACIP has already echoed the views of others in in saying that we're no longer going to push these COVID vaccines in healthy subjects.
Notice that he is even lying about his own lies. The policy that he co-authored with Prasad does not say “mRNA shots are for children with HIV and cancer or similar disease severity only”. That would be bad enough - recommending massive autoimmunity and cancer causing agent to people with no “immune system” (whatever that is) left and those already suffering from cancer! However, the policy Makary co-authored with Prasad prescribes these poisons to an incredibly wide groups of people and children, comprising roughly 75% of the US population, even including “sedentary lifestyle” as the category of “vulnerable” who should be jabbed with never-tested-against-placebo injections. And the part about “doctor feels strongly” - gosh, which doctor doesn’t feel strongly about the HHS bonus that is the only thing standing between him and his bankruptcy?
What’s astonishing in the above is not the fact that Makary is lying, that’s par for the course in government. Makary is so devoted to the crime cartel that he has only recently joined that he is willingly making himself an accessory to democide, the crime he did not originally commit, but he is now hard at work covering up.
But if covering up democide wasn’t enough! Makary, an enthusiastic rookie at the FDA, has to prove himself for his masters. Despite the FDA not being authorized to offer medical advice or advertise drugs, he unabashedly shills hormone replacement therapy on social media, i.e. promoting the drugs that have been associated with cancer, as a cure for non existent medical condition, otherwise known as being a woman over certain age:
For avoidance of doubt as to who Makary’s masters are:
Some things never change:
…While MAHA Action is self-dealing…
Finally, let’s talk about various MAHA orgs, specifically MAHA Action. This organization is a 501(c )4 non-profit, i.e. a political lobbying organization. These types of lobbying corporations are frequently used for channeling large amounts of money for political aims, while covering it up as grass roots activism and “education”. There is no information disclosed on MAHA Action website as to the ownership of this company, nor about their leadership/management. Why is it a secret as to who is behind the group that asks the gullible public to donate to “MAHA” lobbying?
MAHA Action organized a zoom call on July 23:
On this call, Tony Lyons stated: "We are running a program now where we've raised $2.5 million in the last month and we're putting that into national advertising campaigns and we have one small ad that we're going to show once I stop talking, but they're going to be hundreds and hundreds of these ads and we're going to keep raising money to get our messages out through advertising through social media through lobbying in any way we can."
So, Tony Lyons says that they have raised major funding in 1 month to run a marketing campaign. Who are the main donors? I am sure there were a bunch of deluded followers of Malone and other MAHA propagandists who chipped in, but there must have been some “whales” in the mix, too, to reach $2.5 million in 1 month. This kind of cash is not something gathered by $5 donations from a bunch of useful idiots. As becomes clear from the content of the MAHA Action advertising campaign, these whales could well be pharma companies themselves. If I were Pfizer, I would be enthusiastic having MAHA work for me by diverting attention from vaccines to food and pesticides. And I would be overjoyed at how cheaply they could be bought, too!
Let’s recall the federal law governing lobbying organizations:
Lobbying Disclosure Act - (LDA):
If a 501(c)(4) lobbies federal lawmakers, it may need to:
Register as a lobbying entity
File quarterly reports on lobbying expenditures and issues lobbied
Report names of lobbyists and covered officials contacted
This information is found nowhere on the MAHA Action website.
Furthermore, Robert Malone was a speaker at the MAHA Action zoom call on July 23. Is he part of MAHA Action leadership? We don’t know since that’s a secret. However, even him speaking at this lobbying group runs as a potential serious violation of Hatch Act, and at a minimum severe conflict of interest. As a government consultant (co-chair of ACIP) he is subject to the federal lobbying regulations. Special Government Employees (SGEs) and consultants are subject to specific ethics laws and restrictions that may limit or prohibit certain activities like lobbying or fundraising for 501(c)(4) organizations, especially if there's overlap with their official duties. When lobbying the federal government (18 U.S.C. § 203, § 205):
SGEs may be restricted from representing or lobbying to the federal government on behalf of another entity (like a 501(c)(4)), if the matter involves the federal agency where they serve.
Clearly, there is an overlap with Malone’s duties on the ACIP: he is helping to defend vaccines and especially mRNA shots for pharma.
Robert Malone's message in the video, on behalf of MAHA Action was designed to divert all attention from vaccines to pesticides. This was the overall goal of this telecon, with emphasis on “-con” as well as the goal of MAHA Action org, i.e. continue the strategy of Anything But Vaccines. They are making a big deal out of the Congress attempting to give pesticide companies the same liability shield as they have bestowed on pharma companies. Yes, that’s bad, I am not arguing with this. However, just like the WHO distraction from domestic laws, this is a distraction from the fact that pesticides already have this liability shield since 2017. It’s called PREP Act declaration for public health emergency. As I have written many times over the past 3 years, pesticides (organophosphates and carbamates) are ALREADY covered by the PREP Act, and this declaration has been outstanding since 2017, currently until the end of 2027:
And do you know who has the power to terminate this liability shield, i.e. the HHS Secretary RFK Jr? Did Bob Malone or any MAHA Action self dealers tell you this? Of course, not! They want you to give them your money and your watch to tell you what time of the day it is… while continuing to push poison mRNA vaccines and other “biologics”!
Finally, even banning all pesticides is not going to make any child healthier, as long as they are forced and coerced into the CDC poisoning schedule, to which ACIP with Bob Malone in charge just added yet another “recommended” poison, monoclonal antibodies made from cancer cells and hamster ovaries, to be injected into all newborns and gifting $1.6 billion to Merck. I wonder what Malone’s cut was?
Bottom line here: please do not be a useful idiot. DO NOT donate money to MAHA Action or any other MAHA branded shop, such as MAHA Institute or MAHA PAC, etc.
Art for today: Yellow and White Roses, oil on panel, 9x12 in.
Thanks for the shenanigans update, Sasha.
"Meet the new Boss, same as the old Boss." 🎼
Thanks Sasha! I got sucked into the hype around the liability shield for pesticides because the illegal legal framework they want to push through is so similar to when they passed the PREP Act. But you’re right about ABV!!! It’s so interesting that they’re making this big push now for all middle aged women to go back on HRT after everyone had realized how dangerous it is. I wonder if they’re doing this dance where they’re allowing some talk of modifying the childhood vax schedule but then forcing a different cash cow down everyone’s throats (if that’s what HRT is - I don’t know if it’s lucrative now that it’s generic. Or are there “new” formulations that can rake in the big bucks?)