Non-validated, non-diagnostic, non-tests for bird flu and other unidentified, non-isolated, non-pathogenic molecules.
Updated Aug. 2, 2024
Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law
UPDATED Aug. 2, 2024. See below.
FDA’s response to the diagnostic fakery of Covid-19 testing carried out using non-validated, non-diagnostic Emergency Use Authorization (EUA) “in vitro diagnostics” (IVDs), was to speed things up.
As the bird flu performance enters the second act — the part where people stick swabs up their noses and into test kits, and then believe that the read-out says something meaningful about their health — it’s possible for observers to also get quicker at seeing FDA non-regulation as part of the show.
This post applies knowledge about FDA’s historical record of non-regulation/pretense-regulation of biological products, as described in the Bailiwick series on that subject,1 to current events.
Readers interested in confirming my quick analysis of recent FDA acts are encouraged to read the FDA Influenza Diagnostic Tests web page alongside two Federal Register notices addressing “laboratory developed tests” (LDTs) and alongside events as they unfold.
Reader sent me a link to an FDA web page and asked for my thoughts:
July 22, 2024 - FDA Influenza Diagnostic Tests - “…Laboratory developed tests (LDTs) for Highly Pathogenic Avian Influenza (HPAI) offered by clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing currently fall under the FDA’s general enforcement discretion approach for LDTs. The FDA generally does not expect clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing to request marketing authorization from the FDA for their LDTs for HPAI prior to them offering those LDTs. And the FDA would not issue EUAs for such IVDs given that there is no relevant [FDCA] section 564 declaration…”
The preamble is followed by a description of “Highly Pathogenic Avian Influenza” (HPAI) and a “list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans.”
KW reply, revised/expanded
The first step in the legalization of use of poisonous and harmful drugs, devices and biological products is the PHE determination [Federal Register July 24, 2024, effective July 18, 2024].
EUA declarations are the second step in the sequence, and can be issued if an active PHE determination is in place.
EUA declarations provide blanket coverage for broad categories of products.
Feb. 7, 2024 - On recursive, iterative legal instruments and intentional legal ambiguities. Description of the sequence for Covid products:
Feb. 4, 2020 is the effective date for four public health emergency determinations issued by then-Secretary of Health and Human Services Alex Azar under the Food Drug and Cosmetics Act, to support [EUA] declarations that “circumstances exist justifying the authorization of emergency use” of several product classes.
The determinations and declarations together enabled the subsequent issuance of PREP Act declarations and Emergency Use Authorization (EUA) letters of authorization (LOAs) to specific weapons manufacturers for specific products, exempting the contractors and everyone else in the supply, distribution and use chain from civil and criminal liability for the injuries and deaths that would be caused, intentionally, by use of those weapons on human targets, intentionally deceived into thinking they were receiving regulated medicinal products, instead of the intentionally-toxic poisons they were actually receiving.
All four of those PHE determinations, and the derivative declarations, are still in force today…
Dec. 15, 2023 - The PCR test viewed from the legal kill box perspective, listing the four EUA declarations issued for broad categories of Covid products:
“…(1) in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (85 FR 7316);
(2) personal respiratory protective devices, also known as masks; (85 FR 13907);
(3) medical devices, including alternative products used as medical devices, also known as ventilators and ventilator accessories. (85 FR 17335);
(4) drugs and biological products, also known as "Covid-19 vaccines" along with Remdesivir, molnuparivir and others. (85 FR 18250)…”
Then there’s a third step, the specific Letters of Authorization issued by FDA officials for specific products manufactured by specific companies. For example: Dec. 11, 2020 LOA for Pfizer; Dec. 18, 2020 LOA for Moderna, 86 FR 5200.
The FDA also put out a notice of final rule a few months ago, addressing laboratory developed tests or LDTs.
Oct. 3, 2023 - HHS FDA Notice of Proposed Rule, Medical Devices, Laboratory Developed Tests. (88 FR 68006)
May 6, 2024 - HHS FDA Notice of Final Rule, Medical Devices, Laboratory Developed Tests. (89 FR 37286)
The Final Rule took effect July 5, 2024.
From the summary:
"Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs."
I have not read the two Federal Register notices in detail. I’ve skimmed them.
My interpretation of the new rule’s legal effect is based on my knowledge of how HHS and FDA officials have historically used the rulemaking system to suspend, waive, exempt, render discretionary and otherwise eliminate the applicability of apparent rules.
It’s also based on my understanding that the apparent rules are non-rules because FDA has never established objective, assessable physical standards for product identity, safety, efficacy or purity.
The charade is performed to hide from the public, FDA’s non-regulatory, pretense-only function, and also to hide the Department of Justice’s non-enforcement, pretense-only function as a federal law enforcement agency that does not ensure FDA enforcement of drug, device and biological product regulations.
DOJ instead helps FDA cover up its failure to establish standards for biological product and biological-product-based diagnostic device identity, safety, efficacy and purity, and helps FDA cover up its failure to enforce the standards FDA has never established.
I think the new LDT rule is a way for HHS and FDA — during the bird flu public health emergency that the HHS Secretary has unilaterally determined he would like the whole world to join him in pretending, exists — to avoid doing Step 2 (issuing EUA declarations for broad product categories) and doing Step 3 (issuing Letters of Authorization for specific products).
I think it’s a way to remove even more of the pretend obstacles that have never actually stood between harmful products and the product-consuming public.
The new rule has added another layer of plausible deniability between the pharmas and the FDA, so both can say that neither is responsible for validating the tests, which are inherently unvalidatable anyway, because biological products are inherently unstable and heterogenous.
Put slightly differently, it’s a new layer of buffering between pharmas and FDA so that both can hide, from the public, the non-validated character of the allegedly diagnostic devices.
Again, readers interested in confirming my quick analysis of recent FDA acts are encouraged to read the FDA Influenza Diagnostic Tests web page alongside two Federal Register notices addressing “laboratory developed tests” (LDTs) and alongside events as they unfold.
Don’t get tested for bird flu.
There’s nothing specific for the tests to find, so every possible result is fraudulent.
Also, practice clucking like a chicken, so you can quietly start doing that — in a kind, comforting way — whenever friends and neighbors and co-workers try to talk to you about their bird flu fears and their bird flu test results.
Fear not.
Pray the Rosary.
Updated July 31, 2024 with comment from Sasha Latypova:
I can tell you what a typical clinical validation of a diagnostic test might look like. If the test is intended to come with diagnostic claims by the manufacturer (e.g. it can be used directly by a consumer without physician's interpretation), then the validation is similar to a clinical trial program for drug approval. And it could be even more complex, because of (2).
In general the following things must be demonstrated:
Compliance with cGMP in manufacturing of the test and all its components and raw materials.
Clinical validity/predictive value of the biomarker measured by the diagnostic test. If "bird flu" PCR sequence from a human sample is what is being measured, then there must be a trial showing that this sequence above certain threshold of detection is associated with the actual clinical illness with defined symptoms, course and outcomes. This of course has never been done and nobody is planning to do it.
Characterization of the false-positive/false-negative rates of diagnosis with a given test. Since (2) is not done, (3) is not going to be done either.
Since no diagnostic tests ever test for the full "virus" sequence (they are too large), there also needs to be validation of the primer used in the test, i.e. what part of the alleged virus is tested and what validation exists that this part can uniquely identify the "virus." None of this has been done with covid tests, and we know that papaya, goat, Coca-Cola and many other things test "positive."
Updated Aug. 2, 2024 with information from Lydia Hazel
Lydia Hazel, the reader who sent the links to the FDA page “Influenza Diagnostic Tests” addressed above, continued studying the government records and confirmed that there is, in fact, an active emergency use declaration in place for pandemic influenza diagnostic devices.
Hazel wrote:
On the avian flu, it appears the FDA is lying here when FDA says “the FDA would not issue EUAs for such IVDs given that there is no relevant [FDCA] section 564 declaration…”
The amended Public Health Emergency determination signed July 18, 2024 by current HHS Secretary Xavier Becerra explicitly states that the emergency use declaration covering in vitro diagnostics originally put into effect as of April 19, 2013, remains in effect:
“...Because H7N9 is an influenza A virus with pandemic potential, the declaration issued on April 19, 2013, pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of avian influenza A (H7N9) virus, and that is based on the April 19, 2013, determination, remains in effect until that declaration is terminated in accordance with section 564 of the FD&C Act.”
For readers interested in tracking HHS activity for bird flu since 2007, I’ve compiled most of the relevant Federal Register entries and linked them below.2
Takeaway message remains:
Don’t be afraid.
Don’t take diagnostic tests
Don’t take vaccines.
The legal structure has been set up only to deceive people into being afraid of non-threats, and taking poisons, thinking they’re medicines that will protect or treat the non-threat.
Have no FOMO.
It’s a good idea to miss out on being filled with fear and being poisoned.
FDA non-regulation of biological products and vaccines, series:
March 8, 2024 - Part 1: Mutual Recognition Agreements. First in series on legal links connecting domestic and international non-regulation of non-medicines
March 12, 2024 - Part 2: Statutory and regulatory definitions for drugs, biological products, and biosimilars
March 15, 2024 - Part 3: Deregulation of biological product manufacturing, mid-1990s to present
March 20, 2024 - Part 4: Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals
March 21, 2024 - Part 5: Vaccine and related biological product manufacturing as US government-licensed poison manufacturing Evidence from November 1986 'mandate for safer childhood vaccines' codified at 42 USC 300aa-27, and July 2018 stipulation by HHS.
April 3, 2024 - Part 6: On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.
April 25, 2024 - Part 7: Terms, phrases and organizations involved in worldwide regulatory and manufacturing deception surrounding vaccines and other biological products.
May 21, 2024 - Part 8: There is no legal limit to the amount of so-called contamination that can legally be included in vaccines or any other biological products.
May 25, 2024 - Part 9: On FDA buildings as virtual mailboxes to project the public illusion of biological product manufacturing regulation.
June 4, 2024 - Part 10: Sen. Rand Paul, FDA Modernization Act 2.0, and animal testing of new drugs.
June 17, 2024 - Part 11: Pretense of biological product manufacturing de-regulation layered on pretense of biological product manufacturing regulation.
July 5, 2024 - Part 12: 120+ years of legalized, US-government-led pharmaceutical fraud.
Pandemic influenza PHE, EUA and PREP Act notices, letters of authorization.