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Hurricane60's avatar

Toby - Are there are articles, presentations, books, on the way FDA (or other entities) conduct pharmacovigilance and related critiques? How does a government entity determine that there is a problem with a pharmaceutical they have licensed?

I am aware of FAERS and VAERS. Are there other processes that are used to detect intervention harms?

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Laura Kasner's avatar

Toby - looks like someone posing as you has hijacked your comments.

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Toby Rogers's avatar

Can you post a link so that I can see what’s going on?

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Laura Kasner's avatar

They disappeared. I tried to link the comment but was unable.

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Laura Kasner's avatar

Scan your comments to this substack post. You will see them. If not, let me know.

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Toby Rogers's avatar

I’m looking right now and I cannot seem to find what you are referring to.

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Toby Rogers's avatar

Da heck? I'll check it out.

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MikeTomAus's avatar

Brilliant analysis, Toby.

EBM is a substitute for thinking.

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inge jarl clausen's avatar

Quantum Self-Regulation as Developmental Physics

The fact that the infant’s body stores a pre-cognitive map of time, space, and mass shows a continuity between physics and psychology. This is the deep link:

Quantum indeterminacy and early affective flux mirror each other.

Coherence in both emerges through relational entanglement—a caregiver, a field, a resonance.

Thus: self-regulation isn’t learned—it’s revealed, through feeling-based attunement with a reality too vast to fully conceptualize.

Reality orientation, then, becomes an emotional negotiation with quantum constraints. Self-regulation, the foundation of health, cannot be reduced to lab values. It depends on a functional relationship between past and present, biology and biography.

Evolutionary memory—our phylogenetic inheritance—meets lived experience—our ontogenetic path—in every breath, every reaction.

A trauma, a caress, a pattern of thought—each alters the body’s dialogue with the world.

Understanding a human being requires listening to both the deep timeline of the species and the immediate time of the person.

https://vegetativetraining.wordpress.com/cosmology-of-experience/

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Sherri's avatar

What a gift you and this article is. Dr Rapedi? Shared this me.

Yes there are a lot of big words, and wtightly so.

You have hit the nail on the HEAD❤️

When I was reviewing an article? By Brazil's Flavio Cadajonnie? A well published MD/Researcher. I Believe around 2021 he had set up a BIG RCT for IVEY, but early into it

He found his controls were dying at a substantial rate. He knew the study would be discredited by

U know who,

if he changed to ANECDOTAL? format?

Because I believe he is a man of virtue like RAPIDI?(Sorry Dyslexia in action), he DCed the RCT❤️, Saving thousands of lives.

Refreshing to see REAL SCIENCE and exposing the narrative for what it is.

Unfortunately our front line doctors that have done exactly what you have talked about have lost their licenses ......now and ever since Rockafella:) High Jack Mx took over😢

Be well, so grateful I got to see this. Will have to review later when brain is fully charged and use it as a late B day present, along w the first series❤️

❤️✊❤️

❤️🙏❤️

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Baldmichael's avatar

Some more anagrams of 'Evidenced-Based medicine' which suggest it is a bad idea.

- admen indices be deceived

- nice deviancies embedded

- baddies deceived nice men

- bedded in decisive menace

In any event, statistics have always been a bad idea to make decisions about individuals health.

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Anthony's avatar

Hey Toby, love what you do, thank you and keep it up. I really enjoyed listening to your presentations on both the Darkhorse and Trish Wood's podcasts recently, maybe enjoyed is the wrong word but they were great presentations/interviews.

I wanted to probe a little bit on section 5 above, Popperians vs EBM. Where you quote Miller and Shahar saying "It is impossible to construct a system of inductive logic" and "If anyone insists on rules for statistical interpretation of the results of a test (e.g. P < 0.05), he [sic] should be reminded that there are no such logical rules — neither in physics nor in clinical research" it sounds as though logic is the arbiter of what is valid or invalid when it comes to interpreting experimental results. However, when discussing the n of 1 philosophy you quote Shahar again "One may ask how doctors are to make medical decisions in the presence of permanent uncertainty. The answer is very simple: on the basis of some interpretation of empirical experience — a subjective exercise with no universally accepted logical rules" which sounds like logic is not the arbiter of these disagreements.

This seems a little inconsistent to me and I was curious to get your take on it.

Thanks again :)

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Amy Harlib's avatar

It was NEVER about health! The Powers That Should Not Be were ALWAYS about they want you DEAD or a SLAVE! This is a painful truth to accept but we the people must wake up and fight back! And toxic injections/pills were/are a huge part of their arsenal!

MISTAKES WERE NOT MADE! THEY can't get rid of the 'useless eaters' fast enough!

Peddling pure WORTHLESS poison! Folks have to wake up to reality: health comes from organic diet, daily exercise and clean living and never from a needle or a pill except in dire, rare traumatic injuries.

Proudly ANTI-VAXX! Reiterating for the sake of newbies and to support this post.

Ban all vaccine jabs! There has never been a 'safe and effective' vaccine since Edward Jenner's fraud over 200 years ago as per 'Dissolving Illusions' by Suzanne Humphries and 'Turtles All the Way Down' by Anonymous. Health can never come from a needle or pills, but from healthy eating, healthy exercise and healthy living! virustruth.net

CREATIVITY! ARTISTRY! IMAGINATION! SPIRITUALITY! HUMOR! LOVING KINDNESS! These are the best ways to fight THEM!

I also have a landline, a wired laptop and a wired monitor screen, and I never had or will have those infernal mobile devices designed to enslave you. I also use cash as much as possible, no cash is TOTAL SLAVERY.

It is heartbreaking to witness the holocausts happening and so many fellow citizens are brainwashed/bamboozled by the propaganda media, they are oblivious!

This horrifying Gates, Governor 'Gruesome Newscum', 'Lone Scum', Soros, 'Benedict' Biden and Harris and even Trump, Vance, and 'Ramaswampy' et al are blatant fully owned and operated puppets of their globalist technocrat parasite masters same as other numerous 'PUBLIC SERPENTS' infesting by design from above, the bureaucratic apparatus.

Can't say this often enough! The Military/Industrial Complex and the Biowarfare/industrial Complex, WEF agenda and the evils assaulting humanity are from one and the same source - it is the 99% against the diabolical GREED of the 0.01% who should not be in charge of anything!

The monsters in human skin suits who rule the world get a sadistic vampiric thrill and boost from perpetrating the vilest most demonic crimes against the most vulnerable (babies and small children) and then corrupting the system to get away with it scot free! We the People must stop them, there are a lot more of us than them!

Please check out this substack! ponerology.substack.com

JAB INJURIES: GROSS CALAMARI BLOOD CLOTS/AUTISM TSUNAMI/SADS/TURBO CANCER/BIZARRE TERMINAL ILLNESSES: More tragic victims of the ruling parasite genocidal enslavement agenda, sacrificed on the altar of psychopathic greed and hatred of humanity.

And BIG pHARMa is an arsenal making permanently sickly addicted slaves dependent on their products - the complete opposite of actual health.

Can't say this often enough!

SCREW THE HYPOCHONDRIA GERMAPHOBIC FEAR HYSTERIA! DO NOT CONSENT! Avian flu is for the birds! RESIST!

KEEP FIGHTING! All the perps who pushed this greatest crime against humanity, all the way down to the local level, must get their comeuppances!

Divide and rule! Agents provocateurs anyone, FALSE FLAGS, propaganda social engineering psyops? Keeping us proles at each others' throats while the globalist technocrat predators laugh all the way to the BIS and The Bank of Rothschild's!

BURN BACK BETTER!

HELL NO TO STARGATE! HELL NO TO DEEPSEEK! HELL NO TO AI! technocracy.news

Life everywhere is being assaulted by THE TECHNOCRATIC OMNIWAR! RESIST! DO NOT CONSENT TO ALL THINGS DIGITAL, 'SMART', AI, 5G, NO CASH - ALL OF IT! dhughes.substack.com Technocrat ruling class psychos get a sadistic thrill from their powers over life and death and hurting all who stand in their way and they need the resources worldwide to build their digital total slavery control grids (herd survivors into 15 minute city digital prisons)!

AI is designed to be anti-human/anti-life programmed by technocrat control freak psychos - garbage in = garbage out. Everyone got along just fine without all these absurd and downright satanic electronic gadgets that did not exist until recently. NOBODY NEEDS THIS AI CRAP!

PSYCHOPATHS! MEGALOMANIACS!

Bless and thank you for doing what you do.

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Toby Rogers's avatar

At this point it's pretty clear to me that EBM has failed and GRADE is a criminal enterprise (for laundering bad data on behalf of Pharma). That being said, I'm open to lots of possibilities on the best path forward.

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Jen's avatar

One must question where the funding for EBM comes from. Since such EBM studies come from Pharma, take it with a huge grain of salt. Maybe even do the opposite

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Bob's avatar

Thank you for exposing something that had never occurred to me (but was vaguely annoying): What EBM actually is: A fraud - and for making it concrete in my mind so that I can attack it.

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George's avatar

The Summing Up Thanks To Dr. J.J.Couey From Gigaohmbiological.com

1. Intramuscular injection is just a spectacularly dumb idea from the late 1800s. Cutaneous immunization works, just not always predicably. It is also painful and scars.

2. There was an anticipated rise in all-cause mortality (ACM) that remains and may even continue to increase in the future. This anticipated rise in ACM could have bankrupt many Western nations and is the biological signal being MANAGED with

manslaughter and lies. Many of these lies are told on social media by coordinated liars scripted to in turn promote or oppose other liars on the same script.

3. Modern RNA virology has also been used to strengthen and extend this Illusion. Claiming to find genetic signals in the wild, RNA virology then uses pure quantities of synthetic recombinant DNA or RNA TRANSFECTION in both cell cultures and animal models. This is fraud.

4. Coordinated liars fooled all of us into solving the Mystery of the Novel Virus. "Where did it come from? Who is responsible?" Participating in this Theater (even passively) coerced all of us into accepting several false premises, including that we were all in danger, and that we could be in danger again in the future.

5. RNA cannot be the basis for a pandemic because it has none of the special chemical characteristics that DNA supposedly has. When was the last DNA based pandemic? Gain of Function is a Mythology created by DOD+HHS to make an RNA pandemic biologically plausible. It is not.

6. These injections were actually old technologies-sometimes differentiated as TRANSFORMATION (adenovirus vectors, DNA) and TRANSFECTION (RNA)—that were just renamed and reformulated to be treated as new countermeasures, avoid regulation, and allow for the claiming of new intellectual property. This is fraud for which the PREP act emergency was a required moving part. Now the FDA will now be made irrelevant.

7. There is an irreducibly complex Background of genetic signals around us. A huge percentage but not all of these signals are related to bacteria and bacteriophages. The use of PCR in both virology and medicine make no effort to differentiate from this Background, using neither positive nor negative controls, as well as offering no reference scalar. The continued fraudulent use of PCR as a medical diagnostic creates a valuable medical remnant stream ideal for the Human Genome Project objectives. 8. The Health Freedom Movement can be seen as fake because of decades of failure to realize any of these Truths, especially #1. There are witting and unwitting participants. Ralph Baric, Peter Daszak, Paul Offit, Mary Holland, Andrew Wakefield, Polly Tommy, Vincent Racaniello, Pierre Kory, Robert Malone, and Robert F Kennedy are all part of One Malevolent Script. It is that bad.

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blablavatskaya's avatar

omg that tidbit about medecine not being science — BINGO ! — what a concise summation of the last 120 years of medical tyranny. how easy was medecine to control once it was categorized as a science and those poor schlubs of doctors mere technicians. it was only a matter of time before they were factory workers.

I just ordered Kathryn Montgomery's book. thanks so much!

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Richard Amerling, MD's avatar

Toby, this is absolute gold. Where have you been hiding?

Please read my post on restoring science to medicine. https://richardamerlingmd437332.substack.com/p/restoring-science-to-medicine

We are kindred spirits, my friend.

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Peter Yim's avatar

Quite remarkably - the philosophy of science has a real practical application - ie in addressing the shortcomings of modern medicine.

I would add - on a practical level - that to the extent that medical science can be resuscitated - the emphasis needs to shift from the current standard in which conflict-of-interest statements are a pro forma after thought. In medical science 2.0 - the curriculum vitae with respect to author integrity - must be the core of any publication. In particular - to what extent has the author demonstrated that he/she is able to defy authority?

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Brandon is not your bro's avatar

The RVU’s built into these young doctors contracts are a big issue IMO , on many levels.

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