You didn't want that mRNA vax tested only on 8 mice? Marty Makary, FDA, has a solution - no more mice!

Makary plan is to revolutionize the FDA by abolishing ALL animal testing entirely, and abolishing all clinical trials for "rare diseases".

by Sasha Latypova

Newly-installed FDA Commissioner Marty Makary announced banning of dangerous food dyes that you might accidentally consume in a red sprinkle on a cupcake:

The MAHA crowd is having a massive collective orgasm from too much winning! Imagine, all of our chronic diseases are now solved because we got rid of the dangerous petroleum based cake frosting!! Yippeee!!

In the meantime, 9 million children got jabbed with poisonous petroleum based mRNA and 100s of other petroleum + rotting matter-n-shit poison cocktails, colloquially known as “vaccines”.

I am not going to belabor the food dyes, and my readers know that it’s a distraction. I already wrote about it here. I am eating a Red3 sprinkled cupcake as I type this.

This article is about something NOT trumpeted by the White House or by the media - mainstream and “alternative” alike. The heavily-promoted food dye story is covering up a much more important actions by the FDA that they don’t want you to pay attention to. Makary also announced (quietly) a plan to begin phasing out ALL animal testing in drug development! In addition, he wants to eliminate clinical trial requirements completely for something defined as “rare diseases” (discussed in this interview with Megyn Kelly).

Under the 11-page “roadmap” published in April, the goal is for animal testing to become “the exception rather than the norm” in the next three to five years. The plan aims to “improve drug safety” by using alternative ways to conduct toxicology studies in the preclinical phase, through the use of AI modeling and a technology called organoids, which are lab-grown cultures of human cells that can mimic and recreate organs. By now, all of us are aware that when the government does something to “improve safety” they mean to kill us. Makary’s proposal illustrates this point well.

As an executive summary of my reaction to this: it’s lunacy, with strong One Health agenda overtones. If Makary believes the nonsense outlined in the FDA strategy paper, he is an incompetent fool.

This particular derangement is not rare, and it typically afflicts those who have never produced anything real in their professional life. Sadly, most doctors and scientists today are at high risk of this condition. They operate in a reality almost entirely divorced from the real reality. Their many years of debt-laden “training” amounts to turning off any critical thinking accompanied by an intense schooling in blind obedience to the government-funded dogma. They are taught to ignore the patients in front of them and treat computer models - collect “tests” that are based on computer models and then prescribe what computer models tell them to prescribe. The scientists, on the other hand are only responsive to “data” and “models” no matter how dumb, fraudulent or irrelevant. Ok, enough with my little rant here, let’s look in detail at what genius MAHA-FDA plan we’ve got.

Makary’s plan to eliminate all animal testing:

Makary’s plan states that the animal testing is a poor predictor of human safety and efficacy and, therefore, it should be replaced with “new innovative things” that NOBODY understands at all! I should clarify, that Makary is certainly not the author of this strategy, since he has just assumed his role as the FDA Commissioner. The hype and promises of “human on a chip” replacing all preclinical testing has been on and off fad in the industry since I can remember. Here is one example from 10 years ago. I attended several meetings where Janet Woodcock, was making these promises years ago. This is one of the white papers every new administration routinely pulls off the shelf to pretend that they are “visionaries”. Nevertheless, here is what they are saying will replace the animal testing, specifically “new things”:

Due to the limitations of animal testing as well as ethical concerns about animals testing, there has been increased focus within the scientific community on New Approach Methodologies (NAMs). NAMs encompass in vitro human-based systems, in silico modeling, and other innovative platforms that can collectively evaluate immunogenicity, toxicity, and pharmacodynamics in humans and provide an opportunity to improve the predictive relevance of preclinical drug testing while reducing or replacing animal use. NAMs also have enormous cost saving potential (6).

Reference 6 above goes to a commercial lab provider news website which says that monoclonal antibodies are expensive to develop. Ok then! The urgency for the FDA is to make them cheaper so that more profit can be made faster. This is probably because Janet Woodcock and Peter Marks (or their affiliates) hold stock or sit on boards of monoclonal antibody companies, and they urgently need Makary to relax the rules. What do you think the public health agencies are for - public health? LMAO. Clearly, the FDA’s job is to make pharma shareholder returns juicer…

Are “in-vitro human-based systems”, “in-silico modeling” and “other innovative platforms” better than existing animal models in predicting safety/efficacy of new drugs in development?

ABSOLUTELY NOT.

Zero, zilch, nada data exists that would indicate that these “new things” have a better predictive value than animal testing. In fact, they are much worse than animal testing at predicting anything (briefly discussed below).

Given that nobody has the slightest clue about the predictive value of these “new things”, why are they so attractive to Makary that, mere 2 weeks on the job, the first thing he is proposing is to replace the centuries-old area of drug development where vast knowledge of toxicology has been accumulated on various classes of chemicals?

It is true that animal testing does not predict 100% the safety and efficacy of the new drugs, however, it does provide crucial insights and is very very useful in characterizing safe dosages and studying reproductive toxicity, as well as a battery of toxicological screenings without which human clinical trial volunteers would be at an excessive risk. For all their limitations, the animal studies are quite predictive - do you remember the now scrubbed form the internet ferret studies of mRNA vaxxes where all ferrets died on “viral challenge”? They were quite predictive of the covid-shot induced VAIDS! Do you recall the Moderna and Pfizer reproductive tox studies in rats which produced numerous congenital abnormalities, ~300%+ increase in embryo loss, skeletal malformations, toxicity to mothers, transfer of mRNA to fetus and into milk? Do you remember that the FDA lied to the public and covered it up?

Even fraudulent animal studies of mRNA vax showed great predictive value for all the damage that they were going to produce in people:

Therein is the answer to the unusual haste and desire to shut down the animal research. Makary needs to urgently eliminate the regulatory knowledge which is now a liability to the FDA and to pharmas. No studies on well-understood animal systems = no possibility of anyone pointing at the previously obtained animal data (like several of us, ex-pharma people did for covid shots) saying - hey FDA, you knew thousands of people will be hurt before you authorized this shit. Hey Makary, you knew this and you still pushed the mRNA shots on pregnant women!

Remember the skeletal malformations in rat studies for covid shots? Turns out those animal studies were predictive after all (credit William Makis, MD):

Let’s briefly look at what Makary is advertising as the “new things” which will replace the animal studies. The technologies listed in the FDA position paper are a hodge-podge of decades-old approaches that have been extensively used and NOT replaced animal tests as they fail to provide more accurate data, and some very new hairbrained stuff like “organoids”.

In Vitro Human-Derived Systems (Organoids and Microphysiological Systems):

Organoids are self-organizing cell cultures (e.g. liver organoids, gut organoids) that model native tissue architecture and function. Organ-on-a-chip devices go a step further by incorporating microfluidic flow, mechanical forces, and multi-cell type co-cultures on a bioengineered chip, emulating the in vivo environment. For example, a human Liver-Chip can co-culture hepatocytes with non-parenchymal cells under perfusion, displaying liver-like metabolism and responses. These platforms maintain human-specific biology that animals lack, allowing detection of effects that only manifest in human tissue. Notably, microphysiological systems can be as predictive (or more predictive) of human responses than animal tests (9)

Reference 9 goes to National Academies Consensus Report on Chemical Engineering. No support for the statement that these “organoid” systems can be or are more predictive than animal studies can be found there. However, one of the main topics discussed in this report are “the need for decarbonization”, “sustainability” and other WEF aligned objectives. The report is also blaming China for everything China is supposed to be blamed… all good. Let’s see if other references are providing any better support for the idea that the animal testing is no longer needed:

A recent example is a Human Liver-Chip, which was recently evaluated for its ability to predict drug-induced liver injury (DILI) and accepted into FDA’s Innovative Science and Technology for Advancing New Drugs (ISTAND) pilot program. In a validation study, the Liver-Chip correctly identified 87% of hepatotoxic drugs that caused liver injury in patients (10).

Reference 10 is a paper published in Nature testing a “Liver-Chip” (a bench experiment with liver cells from 2 donors) on 7 small-molecule drugs with known liver toxicity profile. This model showed 80% sensitivity, i.e. it correctly identified 80% of the known liver-toxic agents. This is definitely NOT any evidence of better precision and accuracy to justify the removal of the entire preclinical assessments for all new drugs! For one, the FDA strategy states that they want to use the “organoid” models for monoclonal antibodies first, yet the data they are referencing as proof that this would work is a study of 7 small-molecule drugs - not the same thing at all! In addition, in the referenced study only 2 parameters of liver toxicity are assessed, that’s not sufficient for safety evaluation of anything. Finally, this is only a liver tox test. Preclinical toxicology batteries deal with dozens of various toxicities to multiple organ classes, not just the liver.

Other methods mentioned in Makary’s FDA strategy paper include long ago failed approaches like High Throughput Screening and In-Silico Modeling. Both are bullshit software based screening of chemical models. Similar to the DOMANE nonsense for which Bob Malone got a $20M grant from DTRA to rubber stamp the hospital murder weapon remdesivir as “maybe effective”. That’s what these models are really good for - making false claims of safety and efficacy with pretty graphs.

In addition to the hairbrained “organoids”, Makary wants to abolish the clinical trials entirely for the so-called “rare diseases”!

Eliminate clinical trials for “rare diseases”:

Makary proposes to make drug approvals “on a conditional basis” without a randomized trial. Instead, the agency would closely monitor patients on the drugs until there’s a clearer signal in the data, he said. If by “closely monitor” they mean what the FDA did denying the mRNA vax injuries and deaths that exploded VAERS database, please don’t walk, run for the hills.

Why is Makary in such a hurry to do this? Not hard to guess. He urgently needs to provide cover for Peter Marks, who famously over-ruled objections of ALL FDA reviewers and singlehandedly “approved” Sarepta’s gene therapy. Since the “Peter-approval” the drug killed a 16 yo patient who has been duped into taking it by “Peter-approval”. This oopsy needs a liability cover stat! Hence the proposal that “rare diseases” really don’t need clinical trials so that there will be no more FDA reviewer objections as a potential liability for Peter Marks and his successor(s). According to the industry press release:

The proposal builds on work by former CBER Director Peter Marks who stated that accelerated approvals will be the norm for rare disease gene therapies, as well as a bill from then-Sen. Mike Braun (R-IN) and Sen. Kirsten Gillibrand (D-NY), to create a new way for the FDA to grant time-limited provisional approval to rare disease drugs that substantially demonstrate early evidence of safety and efficacy.

In summary, these FDA strategies are a very dangerous fantasies, and I hope they remain fantasies. The good news is that this administration has <4 years to make any changes, and that’s nearly not enough time to replace preclinical testing with total bullshit that Makary is endorsing here. Let’s stay optimistic.

---

Go paid at the $5 a month level, and we will send you both the PDF and e-Pub versions of “Government” - The Biggest Scam in History… Exposed! and a coupon code for 10% off anything in the Government-Scam.com/Store.

Go paid at the $50 a year level, and we will send you a free paperback edition of Etienne’s book “Government” - The Biggest Scam in History… Exposed! OR a 64GB Liberator flash drive if you live in the US. If you are international, we will give you a $10 credit towards shipping if you agree to pay the remainder.

Support us at the $250 Founding Member Level and get a signed high-resolution hardcover of “Government” + Liberator flash drive + Larken Rose’s The Most Dangerous Superstition + Art of Liberty Foundation Stickers delivered anywhere in the world. Our only option for signed copies besides catching Etienne @ an event.