Regulation Schmegulation.

Massive adoption of a new technology with little evaluation of the outcomes.

Massive adoption of a new technology with little evaluation of the outcomes.

Sound familiar? Well it should, because the abundant and inconvenient “issues” associated with the herd culling murder shots is not a new thing. Proper testing, approval, conflict of interest, and informed consent ((NEVER MIND THOSE PESKY OUTCOMES)) have never been top of the priority list for our regulatory bodies.

For drugs. Or for devices.

The device aspect of our piss poor “regulatory” situation is covered very well in the documentary, The Bleeding Edge. I find it very relevant right now. Particularly considering the recent developments in the ongoing MURDERING OF THE WORLD agenda.

I’ll just add that the herd culling murder shots use this mRNA platform that is often referred to as TECHNOLOGY…which sounds a lot more like a device than a drug to me. But what do I know. Y’all know I’m not a doctor or a nurse or a lawyer or an expert on contracts or regulation or blah blah blah…so, I’m literally just thinking out loud and you should take it for what it is. But I am putting a pin in this right here, right now. I’ve never heard anyone refer to the “MMR TECHNOLOGY”. Or the “Penicillin TECHNOLOGY”. Idk…sounds awfully device-y. Who cares.

Anyway….

"With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified. With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective," the spokeswoman added. (source)

The Bleeding Edge

Here’s a clip of the FDA’s premarket approval hearing of the Essure sterilization device. Who knew premarket approval meetings were so HILARIOUS????

Let’s just define some shit real quick.

Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

• (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

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In other news, Pfizer is thankfully partnering with a variety of collaborators.

Partnering and Collaboration to Advance mRNA Science

To further build our internal capabilities, collaboration and partnership are key elements of Pfizer’s mRNA strategy. A variety of licensing and research collaborations have been initiated to further the development of mRNA-based vaccines and treatment options, including:

• An ongoing collaboration with BioNTech to advance candidates including COVID-19 and shingles. Pfizer and BioNTech also have a collaboration on flu that was initiated in 2018.

• A Development and Option agreement with Acuitas Therapeutics, which will provide an option to license Acuitas’ lipid nanoparticle delivery system for up to 10 targets for vaccine or therapeutic development.

• An exclusive research collaboration with Beam Therapeutics, which is focused on in vivo -based editing programs for a range of rare genetic diseases of the liver, muscle and central nervous system.

• A strategic research collaboration and license with Telesis BIO to access and further develop Telesis Bio’s enzymatic DNA synthesis technology for potential application by Pfizer for its mRNA-based vaccines and other biopharma products.

🤗 You know I had to check out these super exciting collaborators 🤗

Telesis Bio

Empowers researchers with end-to-end solutions and tools they need to rapidly and securely design, code, and create synthetic DNA. Experience up to 20x increases in productivity to your product development cycles. Creators of the BioXp® system — the world’s only synthetic biology workstation — and the industry-standard Gibson Assembly® method, provide comprehensive end-to-end solutions across your synthetic biology workflows, Telesis Bio Inc. is accelerating advances in the fields of personalized medicine, biologics drug discovery, vaccine development, genome editing, and cell and gene therapy.

WOOT WOOT!!

3 days 👏🏼👏🏼!!! Rushing things sure has gone well in the past. Let’s make it faster!

Beam Therapeutics

Base editing is an emerging class of investigational precision genetic medicines designed to overcome the limitations of existing approaches and expand the potential of genetic medicine.

Our delivery strategy is to establish a suite of clinically validated TECHNOLOGIES, including electroporation, nonviral and viral delivery modalities.

What is electroporation, you ask?

Electroporation is a very popular and highly efficient method of transfection. During electroporation, an electrical pulse is used to create temporary pores in cell membranes through which substances like nucleic acids can pass. This versatile method can be used for all cell types and for transfection of DNA, RNA, mRNA, RNPs, or proteins.

SOUNDS AWESOME!!! Where can I sign up. Or better yet, where can I sign my kid up?!?!?

Oh, look! CVS is running clinical trials for experimental mRNA vaccines. Perf!

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Pfizer Disclosure Notice

The information contained in this release is as of January 10, 2022. Pfizer assumes no obligation [glad Pfizer hasn’t started feeling compelled to obligation. Phew!] to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the potential of mRNA and LNP technology and a research collaboration between Pfizer and Beam focused on in vivo base editing programs for three targets for rare genetic diseases of the liver, muscle, and central nervous system, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; whether the collaboration between Pfizer and Beam will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K … www.sec.gov and www.pfizer.com.

Cool.

Have you heard of cancer?

I’ve heard it’s on the rise. But maybe that’s another conspiracy theory. Or just a rumor.

Hey, did you know that existing “regulations” and stuff can be bypassed and expedited if there are drug shortages OR for serious or life-threatening diseases?

Is cancer life threatening? I wonder if a rapid increase in cancer cases might create a shortage in medicines and therapies.

I wonder….

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

This guidance provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions1 with our recommendations on the expedited development and review of these therapies, including as provided under section 506(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (source)

Ex. Ord. No. 13588. Reducing Prescription Drug Shortages

Section 1. Policy. Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life-threatening conditions.

For example, over approximately the last 5 years, data indicates that the use of sterile injectable cancer treatments has increased by about 20 percent, without a corresponding increase in production capacity

The Food and Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to address this problem through its existing regulatory framework. While the root problems and many of their solutions are outside of the FDA's control, the agency has worked cooperatively with manufacturers to prevent or mitigate shortages by expediting review of certain regulatory submissions and adopting a flexible approach to drug manufacturing and importation regulations where appropriate. As a result, the FDA prevented 137 drug shortages in 2010 and 2011. Despite these successes, however, the problem of drug shortages has continued to grow.

::FDA pats self on back::

Many different factors contribute to drug shortages [like meeebeee herd culling murder shots. ::STFU Sarah::], and solving this critical public health problem will require a multifaceted approach [Oh good, my favorite kind]. An important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity.

As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.

Sec. 3. Expedited Regulatory Review. To the extent practicable, and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply, the FDA shall take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages.

§356g. Standards for regenerative medicine and regenerative advanced therapies

"(a) Draft Guidance.—Not later than 1 year after the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. In doing so, the Secretary shall specifically address—

"(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products;

What are regenerative advanced therapies? I’m so glad you asked!!

Regenerative advanced therapies

is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;

Gosh, this is such a coinkydink… LOOK WHO’S A GAME CHANGER 🥳

mRNA - A game changer in regenerative medicine, cell-based therapy and reprogramming strategies

After thirty years of intensive research shaping and optimizing the technology, the approval of the first mRNA-based formulation by the EMA and FDA in order to stop the COVID-19 pandemic was a breakthrough in mRNA research. The astonishing success of these vaccines have brought the mRNA platform into the spotlight of the scientific community. The remarkable persistence of the groundwork is mainly attributed to the exceptional benefits of mRNA application, including the biological origin, immediate but transitory mechanism of action, non-integrative properties, safe and relatively simple manufacturing as well as the flexibility to produce any desired protein. Based on these advantages, a practical implementation of in vitro transcribed mRNA has been considered in most areas of medicine. In this review, we discuss the key preconditions for the rise of the mRNA in the medical field, including the unique structural and functional features of the mRNA molecule and its vehicles, which are crucial aspects for a production of potent mRNA-based therapeutics. Further, we focus on the utility of mRNA tools particularly in the scope of regenerative medicine, i.e. cell reprogramming approaches or manipulation strategies for targeted tissue restoration. Finally, we highlight the strong clinical potential but also the remaining hurdles to overcome for the mRNA-based regenerative therapy, which is only a few steps away from becoming a reality.

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Yep. You read that correctly.

Let’s take a look at the

“ASTONISHING SUCCESS OF THESE VACCINES”,

shall we….

DEVASTATING: Fully-Vaxxed New Zealand Suffers a Staggering 3000% Spike in Excess Deaths

If you are age 40-49, and vaccinated, you have a 104% or greater likelihood of dying

Dr. William Makis: Turbo Cancer in Children Ages 10-19. Sarcoma Link to Pfizer COVID-19 mRNA Vaccine

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✨✨✨✨✨✨THE FUTURE MAY BE BRIGHTER ✨✨✨✨✨✨

Great news!…It already is!

The Alliance for mRNA Medicines (AMM) is the leading global organization dedicated to advancing and advocating for mRNA and next-generation encoding RNA therapeutics and vaccines for the benefit of patients, public health, and society. Our mission is to propel the future of mRNA medicine, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA.

Who’s on board????

All these motherfuckers 👇🏼

So the FDA ain’t pulling shit off the market and let’s get ready for the AMM launch 🤗

Is it a device? Is is a drug? Is it a regenerative medicine therapy?

It’s everything! Put your shades on. Our future is bright as fuck.

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I imagine there aren’t many people still reading this ridiculously long rant, but if you are, thank you. My tone is a little bitter this evening. Actually a lot bitter. I’ll probably share a bit more of this in another post, but I am SEEING the evidence of the graphs I shared above in real time. Like A LOT. I can NAME five people with (or who had) glioblastoma right now. I have had multiple clients recently diagnosed with cancer. YOUNG people. Additionally, the treatment recommendations are often concerning. For example, if someone has endometrial cancer, why would a DaVinci surgery (in couple of months, hey, you know cancer…just get to it when you can) be recommended with no information regarding the VERY REAL possible outcomes. My sister in law lost her mother to this potential outcome, that was not realistically articulated. I have multiple clients attending multiple funerals in a single week. Pancreatic cancer? I could name 7 off the top of my head. I could go on, but I’ll save it.

What I have an incredibly hard time figuring out is how these people are working it out with their conscience? When they tuck their children in at night. When they lay their heads on their pillows. I’m including the pharmaceutical reps, the medical device sales reps, the pharmacists, the doctors….ALL OF YOU. How are you staying quiet? If I’m seeing it, I know good goddamn well you are. Hell, you spent YEARS being TRAINED to see it. Speak the fuck up, cowards. And stop participating in democide.

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