Indication, Labeling and Fraud

Effective for what?

"The Emperor's New Clothes"

Short story by Hans Christian Andersen. Illustration by Vilhelm Pedersen, Andersen's first illustrator

We have been repeatedly told that the modified-mRNA COVID “vaccine” products are safe and effective. Those two words have been drummed into our heads via official government communications, marketing, and “Mockingbird” corporate media surrogates. These marketing/propaganda efforts are consistent with the field of psychology known as neurolinguistic programming- essentially hypnotism.

Both words are fraudulent in the case of the COVID modified-mRNA “vaccine” products.

The lack of safety has been described and demonstrated at length, most notoriously in the case of myocarditis, as has the repeated and concerted efforts of Government officials from within the USG and across the world to withhold and suppress information, data, and discussion of the lack of safety of these products.

But what about the claim that these products are “effective”?

Like safety, effectiveness is a broad term which can mean many different things. In theory, one could define a vaccine as being effective if it elicits an innate or adaptive immune response, without making any claims about the potential benefits of that immune response. One could then design and perform clinical trials to demonstrate that an immune response was generated in the majority of research volunteers after receiving the product. Technically, one could then obtain FDA marketing authorization (licensure) for such a product based on that claim. But who would care? Only the most corrupt financially incentivized physicians would prescribe such a product. It would be unlikely that insurers would reimburse for such a product- because there would be no clear linkage between the administered product and a beneficial health outcome. I am allergic - ergo my body makes an immune response - to a certain type of hay (fescue). Does that make fescue hay a vaccine? You get the point. Effectiveness is entirely context dependent. And the context for claiming effectiveness is defined by the labeled “Indication” for the product, which in turn is derived from the design of the clinical trials performed to support licensure for that indication.

What is a given product effective for?

Entirely context dependent, and in the case of real world pharmaceutical product development, the answer to this question drives the entire product development plan. For the big boys like Novartis, even this question is secondary to the fundamental questions of unmet market need and size. If there is a billion dollar (annual) global health market that has not been addressed, Novartis will invest in product development to meet that need - regardless of whether or not it has a specific product candidate. Less than a billion? Novartis is generally uninterested in investing. And typically that investment will be driven by some sort of mock up of an “indication” which the marketing people determine is sufficiently robust to support penetration into that market.

That is the normal course of affairs.

But in the case of the COVIDcrisis, it is now clear that the US Government, working in cooperation with the CCP/PLA and other State and non-State actors (specifically including EcoHealth Alliance), created their own market, cooperated with its subcontractors (Pfizer and Moderna) to create and sell a product to address the unmet medical need to other countries across the world, and then aggressively controlled that market to create a monopoly through censorship and propaganda methods. Only allowing market entry of their engineered and endorsed product - the COVID gene therapy-based “vaccines”.

Both the US HHS (FDA and CDC) and the US DoD, together with WHO and the Gates Foundation, have been at the center of this monopolistic, illegal and immoral racketeering. This global crime against humanity. These agencies and NGO were actively supported in this crime by the Five Eyes Intelligence alliance and a wide range of “Mockingbird media” partners who profited enormously from their collusion.

That is the inconvenient truth which underlies all of this sorry tale.

And that is a gross perversion of my industry (clinical research) and the broader pharmaceutical industry. In general, Pharma is indeed corrupt in so many ways, but like the US Government not all who labor in that industry are corrupt, and there are many ethical companies committed to actually improving human health.

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The FDA traces its legislative authority and charter back to the Pure Food and Drug Act of 1906. The main purpose of the act was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products. Limitation to foreign and interstate traffic being consequent to US Constitutional restrictions on the authority of the Federal government relative to states. States retain the authority to regulate the practice of medicine- not the feds.

The act required that active ingredients be clearly identified on the label of a drug's packaging, and that drugs do not fall below purity levels established by the United States Pharmacopeia or the National Formulary. Since then there have been many amendments to this act as well as supplemental legislation, but the act remains at the core of the FDA mission.

In the case of the modified-mRNA “vaccine” products, the FDA has failed to comply with its own legislative mandate. These products are mislabeled and misbranded. Specifically, they contain toxic active ingredients (for example DNA fragments) which are not disclosed on the label, and therefore meet criteria for mislabeling, lack of purity and adulteration.

Furthermore, the claimed indications for these products are clearly false, and were known to be false at the time that the products were authorized for marketing. The package insert is part of the labeling. Therefore, they are also misbranded due to false labeling claims.

I assert that this constitutes regulatory fraud on the part of the FDA, and the specific individuals responsible for this fraud should be held legally accountable- beginning with the active/acting FDA commissioners at the time and since, and the director of the Center for Biologics Evaluation and Research.

I recently published an investigative essay covering the consequences of fraudulent labeling of an opioid drug, which resulted in jail time and personal fines for responsible corporate leaders, and a total of approximately 2B$ in fines for the corporation (Indivior) determined to be guilty of this fraud.

In the case of the Emergency Use Authorizations and subsequent market authorizations granted for these modified-mRNA products, a strong case can be made that the FDA (together with the DoD) acted as the actual “sponsors” of the products, and the pharmaceutical manufacturers acted as subcontractors to the US Federal Government and these specific agencies. In effect, the fox has been and continues to guard the henhouse.

Here is the FDA webpage for Comirnaty, which clearly indicates a false claim.

Indication:

• For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Here is the FDA webpage for SpikeVax. Same deal.

Indication:

• For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older

The claims that these products are indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are demonstrably false. No data has ever been provided to indicate that these products prevent COVID-19 disease. This is clearly a fraudulent claim, as virtually all are aware based on personal experience.

The FDA, CDC, and various corporate media apologists and surrogates have repeatedly asserted that the products are effective because they reduce disease severity and death. That claim is currently disputed and inconsistent with data from across the world demonstrating negative effectiveness in reducing death and/or disease after some lag period after injection ranging from a few weeks to a few months.

But from a legal regulatory position, a claim of reduced death or disease severity risk is irrelevant, because there is no labeled claim that these products were licensed (authorized for interstate transport and marketing) for that purpose. Reduction in risk of death and/or disease from COVID was not part of the regulatory basis for approval. It is that simple. It could have been, but it is not. And if it were to have been designated as an endpoint and indication, that would have required well controlled clinical trials to demonstrate that endpoint.

These are post-facto attempts to justify continued marketing of a fraudulently labeled ineffective product.

The FDA has four core mission requirements relating to pharmaceutical products:

1. Ensuring proper Labeling- Pharmaceutical products must be properly labeled, and the active ingredients of these products (including vaccines, vitamins and supplements) must be listed on the label. The label is to include claimed indications for use, and those claims must be supported by solid evidence. Strict labeling guidelines have been established by the FDA.

   Guidance for Industry Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

   By regulation, all express or implied claims in labeling must be supported by substantial evidence (see footnote). If unsubstantiated claims currently exist in labeling, the applicant must revise the labeling to remove such claims (§ 201.56(a)(3)).

   See § 201.56(a)(3). See also §§ 201.57(c)(2)(iii), (c)(2)(iv), (c)(2)(v), (c)(7)(iii), and (c)(15)(i), and 201.80(c)(2)(i), (c)(2)(ii), (g)(4), and (m)(1)(i).

2. Ensuring Purity- The labeled product must be pure and not adulterated. The US legal definition for adulteration with a specific focus on the FDA licensed modified-mRNA “vaccines” has been covered in a prior Substack essay.

Adulteration is defined (in CFR Title 21, CHAPTER 9, SUBCHAPTER V § 351) as follows (partially redacted for focus and simplification):

A drug or device shall be deemed to be adulterated—

(a)Poisonous, insanitary, etc., ingredients; adequate controls in manufacture

(B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.

(b) Strength, quality, or purity differing from official compendium

If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made.

(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium

If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

(d) Mixture with or substitution of another substance

If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.

3. Ensuring that the product is effective for the labeled indication. Under 21 CFR 314.50(d)(5)(v), the Integrated Summary of Efficacy (ISE) must include:

   • An integrated summary of the data demonstrating substantial evidence of effectiveness for each claimed indication

   • Evidence that supports the dosage and administration section of the labeling, including support for the recommended dosage and dose interval

   • Effectiveness data analyzed by sex, age, and racial subgroups, identifying any modifications of dosing for specific subgroups

   • Effectiveness data from other subgroups of the population of patients treated, when appropriate, such as patients with renal failure or patients with different levels of severity of the disease

Just to recap, there are no data meeting criteria for substantial evidence of effectiveness for the claimed indications of preventing Coronavirus disease 2019 (COVID). These products do not have that activity.

Furthermore, there are no data to support the recommended dosage or dosing interval. For example, the dosage of SpikeVax was arbitrarily selected by a committee managed by US Army Colonel Vic Suarez. I know that from personal communication. Dosage selection was not data based, and there were no dose escalation or dose timing clinical studies performed. As to dosage and dosing interval, what has been observed is an ad-hoc moving goalpost strategy where each time the products are demonstrated to fail to be effective, another dose is recommended without adequate clinical data to support that decision. This is essentially a textbook demonstration of arbitrary and capricious regulatory behavior.

4. Ensuring Safety- According to the FDA’s own mission statement (What We Do), “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices”. Unfortunately, in contrast to efficacy, there are no specific FDA guidances defining what is considered “safe”, rather there is only information on how safety is to be monitored. Therefore, the term “Safety” is entirely subjective, context dependent on the opinion(s) of FDA personnel and administrators.

   A product is determined “safe” because FDA administrators say it is safe, no matter what others may determine. Such an assertion of safety cannot be readily challenged in federal court due to the Chevron Deference Supreme Court decision, which establishes that administrative agencies of the Federal Government are considered the definitive expert in the domains which they regulate. The intrinsic conflict of interest in the case where federal agencies (FDA and DoD) effectively act as both the sponsor and regulator of a new drug or biologic product licensure package is clear, compelling, and self-evident. This is also intrinsically arbitrary and capricious.

The regulatory history and monopolistic racketeering practices underpinning the US Government-sponsored SARS-CoV-2 modified-mRNA vaccines will go down in history as one of the darkest moments in the modern history of FDA, CDC, and the entire vaccine enterprise. Unless, of course, the US Government and its enablers are effective in continuing to deploy its considerable propaganda and PsyWar technological assets to block accountability.

But this is not the only example of Pharmaceutical Industry regulatory fraud and malfeasance in modern history, and more examples of such public-private partnership malfeasance may soon be revealed.

Additional examples include:

Merck’s Vioxx, as summarized in this blog post found at the Union of Concerned Scientists.

Here is a large list of FDA-Approved Prescription Drugs Later Pulled from the Market by the FDA.

Here is a list of six major FDA-approved drug products previously recalled for health concerns.

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In Conclusion

The genetic therapy technology-based SARS-CoV-2/COVID “vaccines” are not safe, and they do not even come close to meeting their efficacy endpoint as defined by their licensed indications. They are neither safe nor effective based on their labeled indication. They are impure and adulterated. Whether or not they reduce (clearly they do not prevent) the incidence of severe disease and death from COVID-19 disease is irrelevant from a regulatory perspective.

The US FDA, CDC, and DoD have all illegally conspired and colluded to advance and obtain regulatory authorization to market (and mandate) these ineffective and adulterated products. These organizations, specific individuals within these organizations, their subcontractors and colluding organizations involved in marketing these products (corporate media etc.) must be held legally accountable for this racketeering.

As myself and others have been calling for, for well over a year now, these illegal, ineffective, adulterated and hazardous products must be withdrawn from both US and global markets.

For the safety of humankind.

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