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An American Affidavit

Sunday, April 7, 2024

On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.

 

On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.

Part 6 of series.

Orientation for new readers

American Domestic Bioterrorism Program

Tools for dismantling kill box anti-law


Bailiwick reporting and analysis


March 24, 2024 - Katherine Watt email to Sasha Latypova

I've been thinking about the FDA regulation and guidance changes that sped up during the 1990s. Since the FDA’s function regarding biological products, especially vaccines, was non-regulatory from the beginning because the contents have always been toxic mixtures intended to harm recipients, I wondered why they would need or want to get rid of or change the way the earlier rules were/are inapplicable and unenforceable. 

Part of the reason has to do with pretend-oversight events by Congress, such as after thalidomide in the late 1950s, after some Government Accountability Office (GAO) and news reports about vaccines in the early 1970s, and then after the military anthrax vaccine events in the early 1990s. After each such event, a new shuffling of departments and/or set of non-rule rules came into play.

I think another reason is that the non-regulation rules had to be aligned with technical improvements in the ability to sequence biological and genetic samples.

If it’s correct that the 1990s were the beginning of more widespread laboratory access to equipment and computer software capable of processing samples and producing a more accurate, detailed gene map of what was in the samples, and the graduates of more biology and chemistry programs would have known how to use that equipment and interpret that data as they started filling the lab positions at FDA, then there would have been a need to make sure that the equipment either never got installed at FDA, or got installed in alignment with proper indoctrination of the incoming FDA lab technicians/inspectors alongside the elimination of the procedures for manufacturers to submit samples and protocols to be tested by the FDA technicians.

Probably that also aligned with the increased ability of the poisoners to insert specific types of damaging gene fragments, with a greater knowledge about what those sequences would do in vivo.

In other words, the poisons pre-1990s were somewhat more crude, and since 1990s are somewhat more refined. Still dirty bombs, but dirty bombs whose components can increasingly be identified, as the separation chemistry techniques and software and sequence-matching databases get better.

Kevin McKernan’s work is an example of what an FDA technician could have done, if the manufacturers had had to submit samples, and if FDA had had to run the samples and produce accurate, public reports about the results.

Does this line up with what you know about the development of chromatography and related techniques, equipment, software and databases since the 1990s?


March 24, 2024 - Sasha Latypova email to Katherine Watt

Yes, in general this would be the evolution. 

Kevin McKernan's lab is a good example. He is set up to perform only one aspect of impurity testing: plasmid DNA removal. 

There are many more things that would need to be tested properly to identify RNA stability, LNP stability, other impurities, etc. 

The evolution of tools to characterize what is being produced by bio-chemistry methods is very important. 

I didn't work in the area of biologics, so I am not too familiar with these methods and the current state of technology. 

From what I read in Pfizer's leaked manufacturing documents, however, a very large portion of the characterization techniques were either missing or de-novo invented by Pfizer, and thus were black box, unvalidated, non-standard techniques that would normally require a separate approval. So, this area of manufacture is basically still an unknown.

They can't demonstrate that they make what they claim.  It is, of course, on purpose. 

This also explains why FDA removed all the requirements for testing samples by the inspectors in 2019, because they knew there is no way to do this, and the inspectors themselves would have raised concerns.


From another email exchange, with a reader who holds the view that the killers possess the knowledge and manufacturing methods to develop “high quality heterogeneous products that specifically target multiple physiological processes and cause variable expected (on target) and unexpected disease (off target) outcomes.”

Sasha Latypova:

There is no "gene targeting" whatsoever. 

They cannot manufacture what they claim they do. 

As I said in an interview with Malik, their CRISPR and other "gene targeting" claims amount to claiming that they can bake a loaf of bread with exact number of holes of exact size in exact locations. 

They cannot do that. 

They can't even make the loaves weigh the same every time. 

The manufacturing quality control is non-existent. 

They don't even have methods to evaluate LNP size, and can't figure out what those might be.


Katherine Watt:

I think researchers who have studied Gardisil, Covid-19 and other vaccines have correctly identified some of the mechanisms of injury caused by some of the possible contents of the studied products, keeping in mind that the main sources for information about what may be in the products, are manufacturers, who provide only false and incomplete/redacted information to regulators and regulators, who provide only false and incomplete/redacted information to the public and to academic researchers.

My understanding of all vaccines — based on my understanding of drug manufacturing, communicable disease control, and public health emergency law — is that since the beginning of their modern use, as far back as the mid-1800s, then increasing use starting in the first decade of the 20th century, vaccines have been mixtures comprised primarily of fragments of foreign (xeno) proteins whose basic function is to interfere with and damage normal cells and normal cell growth, division, repair and destruction processes. 

The exact composition of each batch, lot and vial contents is not predictable, because the manufacturing processes themselves don’t lend themselves to standardization. Biological products result from biological processes, which are complex and highly variable. As sequencing equipment and techniques became more sensitive and widely available in the 1990s, the protein fragments have become increasingly identifiable, but the only way to identify all of the fragments in each vial, would be to test all of the contents, leaving none for use.

Also, identification of all the fragments would lead to public knowledge of their inherent and intentional toxicity; this is why the regulatory systems had to develop more complex written forms and justifications for non-regulation over the last several decades.

The chemical components (i.e. adjuvants and preservatives) have their own toxicity profiles, and are more subject to standardization.

On a population-wide scale, therefore, people who want to induce infertility, cancer, heart disease, autoimmune disorders, and all the other observed disorders that have increased throughout the 20th century and exploded since 2021, have not needed or wanted, and still do not need or want, predictability of effect for a given vial or dose (or series of doses), as used on a specific individual.

They need and want widespread, non-critical trust in the class of products known as vaccines combined with mass, ongoing, serial use of the products, which are widely varying, protein-fragment-rich and toxic-chemical-rich mixtures whose compositions are highly unpredictable and which are not subject to testing to identify their contents before use.

The less predictable the effects on a per-dose, per-target basis under social conditions of high, non-critical trust in vaccines as a product class, the better for the killers, because the chain of causation is more difficult to discern.

The only change the killers have needed or wanted to introduce over time to increase infertility, cancers, and other causes of premature death, has been to increase the concentration and variety of the toxic protein fragments and toxic chemical compounds, while maintaining and increasing non-critical public trust in the product class and increasing the number of doses on the child and adult immunization schedules.

They maintain the high levels of non-critical public trust in the vaccine product class, in two main ways.

First, they attribute all observed adverse effects to non-vaccine causes and attempt to discredit and suppress all information that correctly identifies vaccines as intentional toxins, preventing sound investigation into vaccines as the primary causes.

Second, they suggest that if, hypothetically, some vaccines have some adverse effects, those effects are due to specific, predictable, identifiable components with specific, predictable, identifiable effects, thus reinforcing the false notion that vaccines generally are a class of products whose contents and effects are specific, predictable and identifiable, thus maintaining and/or increasing non-critical public trust in the product class.

This is why I'm working to disrupt public trust in the entire class of products known as vaccines, not only Covid-19 vaccines.

One way to confirm or refute the claim that all vaccines are heterogeneous mixtures of intentional toxins, would be to subject vials of all vaccines promoted by the CDC through the child and adult immunization schedules, to complete, accurate genetic sequencing and chemical analyses, at research laboratories equipped with the appropriate sequencing and analytical tools and databases.

That’s why complete, accurate, publicly-reported genetic sequencing and chemical analysis of vaccines isn’t done and why FDA changes biological product manufacturing rules over time, to more fully legalize the non-conduct of such investigations.


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