Sasha Latypova's Presentation on Intent to Harm
in relation to the Good Manufacturing Practices
https://boxcast.tv/view-embed/the-defender-show-with-sasha-latypova-j5nfh8tox98hrrzepb6z
"INTENT TO HARM"
Overall characterization of what is going on: the federal and most of the state governments are gone and captured. Whatever is running the federal gov agencies (e.g. HHS) really intends to kill you, or at least substantially injure you, damage your reproductive capacity and repossess your assets in the process. The aim is to reduce the population and terrorize the survivors enough to establish a totalitarian control over much of the world’s territory. Nobody is coming to save you, your survival and that of your children is in your hands only. Do not comply.
Now for details:
Most of my writing on these topics should be understood in conjunction with legal history research by Katherine Watt. I am explaining what rules and regulations are being broken by the HHS/FDA/all public health actors, and Katherine has found how our laws have been subverted over time to enable this. Recently Katherine put together an excellent summary presentation for a conference in Ireland, and this provides a very good starting point: [LINK]
We are at war in the US and globally. Public Health Emergencies have largely the same legal status as war declarations (National Emergency). PHE (PHEIC) declarations effectively suspend the Constitution, let the Executive branch (including DOD and HHS) usurp the power and neuter the Legislative and Judicial branches of the government. Once initiated, there are no stopping conditions.
PREP Act declarations by the HHS Secretary can be viewed as announcements of use of certain types of weapons as well as provision of liability coverage for those deploying them (largely through the healthcare system), just as military in combat zones are exempt from injury claims from those they kill and injure as enemy combatants.
Deployment of the bio-chemical poisons advertised as “vaccines” or any other medical countermeasures (for covid or another made-up “pandemic”) does not depend on federal or state pharmaceutical regulations and are not subject to any consumer or research subject protections, such as informed consent rules. Thus, any activities advertised as “clinical trials” or regulatory actions in relation to these bio-chemical materials are theatrics to fool the public and especially the professional class into believing this is a health event, and that they are receiving (or administering) treatments. This is explained in more detail in this post - Intent to Harm.
Bio-chemical poisons advertised as “vaccines” were pushed on unsuspecting public and fooled professionals under a “bait and switch” scheme where FDA approval (BLA) was a sham and the actual delivered product always (with exception of tiny amount of 35K doses) substituted with the Emergency Use Authorized (EUA) version of the product. This is explained in detail in this post, as well as the allegations in this important legal complaint.
The role of DOD: All covid countermeasures were ordered by the US Department of Defense (DOD), typically as “demonstrations” via Other Transactions Authority contracts. DOD oversaw the development, manufacture, and distribution of the countermeasures. Hundreds of contracts for covid countermeasures became available via FOIA and SEC disclosures in partially-redacted form. The contracts include the removal of all liability for the manufacturers and any contractors along the supply and distribution chain under the 2005 PREP Act and related federal legislation except in case of willful misconduct. While the DOD/BARDA countermeasure contracts refer to safety and efficacy requirements for vaccines and mention current Good Manufacturing Practices (cGMP) compliance, this language in contract is designed to fool the reader as it is in fact unenforceable. These compliance items are explicitly carved out as “not in scope” of the contract and not being paid for nor ordered by the US Government. Judge Truncale agreed with this interpretation when dismissing Brook Jackson’s case v Pfizer under False Claims Act. The case is now being appealed.
Use of Emergency Use Authorized (EUA) covered countermeasures under a declared Public Health Emergency cannot constitute a clinical investigation (21 USC 360bbb-3(k)), therefore these countermeasures could not be tested for safety or efficacy in accordance with US law (21 CFR 312 and 21 CFR 601), nor could compliance with current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GxP in general) be enforced by the FDA. This legal fact was known to high-level FDA officials, to DOD and BARDA officials and to the pharmaceutical companies signing these contracts. This fact was not known to the public, clinical investigators, clinical trial subjects, or the lower-level employees of the pharmaceutical companies and the US Government.
The implications of the above can not be overstated. Senior Executive Service officials within the U.S. Government authorized and funded the deployment of bio-chemical poisons on Americans and others without clarifying their “prototype” and “large scale demonstration” legal status, making the materials not subject to normal regulatory oversight, all while knowingly and willfully maintaining a fraudulent pseudo-“regulatory” presentation to the public.
These poisons have harmed and killed and continue to harm and kill Americans and other people around the world.
The Covid countermeasures deployment program has been partially coordinated through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and via several other public, private, hybrid and quasi-governmental entities, including but not limited to: the FDA’s Medical Countermeasures Initiative (MCMi); BARDA; and the Medical Chemical, Biological, Radiological, Nuclear [CBRN] Defense Consortium (MCDC).[1]
For legal frameworks utilized and their history, see Katherine Watt’s writing on Bailiwick News: LINK:
Six primary enabling statutes include:
Title 21 – Federal Food and Drugs Act, at §360bbb et seq, “Expanded access to unapproved therapies and diagnostics,” as established in 1997;
Title 42 – Public Health Service Act, at §247d et seq, “Public health emergencies,” as established in 1983;
Title 42 – Public Health Service Act, at §300hh et seq, “National All-Hazards Preparedness for Public Health Emergencies,” as established in 2002;
Title 42 – Public Health Service Act, at §300aa-1 et seq, “Vaccines,” as established in 1986;
Title 10 – Armed Forces Act, at §4021 et seq, “Research projects: transactions other than contracts and grants,” as established for DoD use for “prototype” contracting in 2015;
Title 50, Chapter 32, §1511 et seq, “Chemical and Biological Warfare,” as established in 1969.
For additional in-depth analysis, Patrick Delaney from Life Site News interviewed me and Katherine Watt and has written up 4 excellent articles on these topics here.
[1] 42 USC 300hh-10a. PHEMCE membership shall include: (1) The Assistant Secretary for Preparedness and Response; (2) The Director of the Centers for Disease Control and Prevention; (3) The Director of the National Institutes of Health; (4) The Commissioner of Food and Drugs; (5) The Secretary of Defense; (6) The Secretary of Homeland Security; (7) The Secretary of Agriculture; (8) The Secretary of Veterans Affairs; (9) The Director of National Intelligence; (10) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases, and the Director of the Office of Public Health Preparedness and Response, as the [HHS] Secretary determines appropriate.
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