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21st Century Cures Act and FDA's Codification: The Risks of "Minimal Risk" Waivers

Informed Consent is an Inviolable Basic Human Right. FDA's New Lax Rule on Informed Consent Could Compromise Public Health and Ethical Standards. IPAK will Require Informed Consent for All Studies.

James Lyons-Weiler
Jul 11, 2024

https://popularrationalism.substack.com/p/21st-century-cures-act-and-fdas-codification

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Anyone who spreads fear of microbes and believes that the "corona" pandemic is real is viewed with suspicion in enlightened circles. The narrative of profit-oriented bioterrorists is based on the naive fear that the strength of our immune system is not sufficient to survive in the face of "dangerous" (but in reality useful) microbes. Robert Malone is one of those who spread such narratives. Dr Mike Yeadon is also one of his harshest critics. Here is an article by Uwe Alschner :

Even in 2024 Robert Malone still does not question, let alone rule out, transfection of kids.

Jonathan Couey with yet another piece of evidence of how Robert Malone is distracting the audience from the real issue: Transfection of Healthy Humans is criminally negligent, at best.

This is a clip from Gigaohm Biological highlighting how Robert Malone, in 2024, still dances around “risk/benefit-ratios” having to be assessed for Informed Consent.
Dr. Jonathan Couey rightly points out that Mr. Malone, who due to his professional expertise should know better, goes about arguing various dimensions of “risk stratification”. However, he only does so for the dimensions of “virus” vs. “vaccince”, which he continues to euphemize. He does not at all talk about the lack of any rationale for permanently transfecting healthy children (or any healthy human, for that matter).

Uwe Alschner
Jul 31, 2024

https://neveragainisnowglobal.substack.com/p/even-in-2024-robert-malone-still

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THERE WAS NO PANDEMIC - THE ULTIMATE PROOF.

DR. MIKE YEADON SAID THIS BACK 2020.

If someone shortens this proven lie and simply claims that there was "no pandemic of the vaccinated", they are not your friend.

Aug 01, 2024

https://suavek1.substack.com/p/there-was-no-pandemic-the-ultimate

https://open.substack.com/pub/suavek1/p/there-was-no-pandemic-the-ultimate

Thanks as always to Suavek for skilful combination of news reports from Germany and what many of us were saying about “the pandemic”.

I was certainly not in the front rank of calling the pandemic a fraud, though I was all over the pretend diagnostic tests, based on PCR & later, lateral flow tests, purporting to diagnose “a case”. I don’t recall thinking much about the significance of the use of the word “pandemic” until later. But I was clear very quickly that there was no kind of public health emergency. That was always fake.
Best wishes
Mike

https://open.substack.com/pub/bailiwicknews/p/non-validated-non-diagnostic-non

In this piece, legal researcher Katherine Watt has investigated the way in which FDA pretends to regulate diagnostic tests.
As she puts it, the wording of regulations serves only to suspend or waive any quality criteria that might otherwise have held these tests to be meaningful.
So if anyone says that bird flu tests are authorised by FDA, they’re not.
They’re non valid, not tests for a nonexistent virus and imaginary disease.
Don’t get tested. It only encourages them to further the fraud. Practise clucking to show your contempt.

Best wishes
Mike

https://open.substack.com/pub/jamesroguski/p/honoring-kary-mullis

As a mark of how normalised I still was, early in 2020, when I learned of Dr Mullis’ death just before Event 201, it didn’t occur to me that he might have been murdered. My wife however was immediately suspicious, just as she had been re Princess Diana.

We don’t know for sure how Mullis died but it’s one hell of a convenient coincidence if it was natural causes. He wouldn’t have been silent.

Even if there were respiratory viruses that cause acute illnesses such as colds and flu, and even if PCR was conducted carefully, finding a partial sequence is still meaningless. It doesn’t say you’re ill nor that you have been ill or that you’re contagious. Not one element of this charade is even capable of yielding what the authorities claim for it. All the “positive results” are false positives.

Do not get tested. You validate one of the Big Club’s prime control mechanisms by doing so.

RIP Dr Kary Mullis.

Best wishes
Mike

A comment :

Just around the time they started touting the PCR tests as the 'gold standard', there was a comment or two about Mullis not approving their use that way. Trying to check that, I was headed off by one of the early Fact Checks, denying any such thing, as he had died before the event.

After Lombardy, when early papers were noting a very high prevalence of Vit D deficiency in those 'affected'...and no health officials seemed to care, or to even look at that...I went back and watched and read Mullis's views on the misuse of PCR testing...and his famous challenges to corrupt Fauci...then realized I had been snookered and intentionally deceived by the media.

Never again, from that point in.

https://t.me/DrMikeYeadonsolochannelChat/91591

“Hell is Empty and the Devils are All Here”. William Shakespeare, “The Tempest”, 1623.

A worthy quote given what had happened since very late in 2019.

The eagle eyed will notice that the author continue to believe acute respiratory illnesses are viral in nature.

Other than that, I believe he’s “got it” & has laid out well what’s been going on and what’s at stake.

Best wishes
Mike

https://www.globalresearch.ca/there-never-was-a-virus-there-never-was-a-pandemic/5841105

ALL OF THE COVID STUFF:

WAS A BIG FAT LIE

Dave Smith.
US comedian, has had a meteoric rise borne of a sharp intellect and a most powerful bullshit detector.

We salute Dave Smith
@freedomtirade
hEuRisTiC mOnTaGe

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"What they created was not a vaccine."

— Dr. Charles Hoffe

May 03, 2023 - Vancouver, British Columbia

https://suavek1.substack.com/p/the-mass-murder-is-obvious-but-continues

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The Bird Flu Blues: The Sky Is Falling…Again

By Michael BryantJuly 19, 2024

https://healthfreedomdefense.org/the-bird-flu-blues-the-sky-is-falling-again/

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What was already known back then, and why doesn’t everyone want to know this to this day? Are we dealing with gaps in knowledge or memory?

Whitch pandemic? Everything from A to Z was a lie. The old evidence refreshed.

Aug 03, 2024

https://suavek1.substack.com/p/what-was-already-known-back-then

Cheap debt (partially supplied via the yen carry trade ) has made the Everything Bubble possible. Close down this source of funds and everything from office buildings to US banks to AI stocks will be hit hard. And — since fixing this problem will simply blow up other parts of the leveraged speculating universe — there is no solution, only a choice of crises.

Welcome to the end of the fiat currency experiment. Buy gold. https://rubino.substack.com/p/japan-enters-its-death-spiral

Most highly censored clinical paper of the pandemic demonstrated COVID-19 vaccination is the cause of death at autopsy.

73.9% of autopsies after COVID-19 vaccination adjudicated the vaccine as the cause of death. The Bio-Pharmaceutical Complex has pressured Lancet SSRN and now Elsevier Forensic Science International to cover-up this safety signal! After contract, copyright, fees paid, and publication on June 21 2024, the editors have indicated the paper will be retracted in violation of the Committee on Publication Ethics (COPE) Guidelines.

STUDY :
https://sciencedirect.com/science/article/pii/S0379073824001968

The post came directly from Dr. Roger Hodkinson :

https://t.me/RogerHodkinson/2829

An article about this study :

https://slaynews.com/news/74-all-deaths-directly-linked-covid-shots-autopsy-data-shows/

https://substack.com/@bailiwicknews/note/c-64261294

I think Katherine Watt makes some wise comments here.

It’s important in my opinion to keep telling people that you’re being deliberately frightened by the perpetrators, about fake climate change & fake pandemics of fake viral pathogens.

You do not need “early treatment of birdie flu” any more than you needed “early treatment for covid19”, those grounds being that neither are real.

Anyone persuading you otherwise, especially if they’re attempting to sell you anything for real money, be suspicious of them.

Can you imagine calling out the worst ever mass attack upon humanity and you have the profit motive anywhere in your heart?

Best wishes
Mike

https://x.com/denisrancourt/status/1820187161565474989

I no longer regard such comments as in the slightest bit in error.

Those who won’t look at the clinical data and epidemiological evidence surprise me when they continue to claim that there’s been a “pandemic” (these don’t exist), a nationwide or even worldwide “public health emergency” & that despite all the negative information, persist in claiming there’s a new illness in “covid19”, caused by a “virus”, “SARS-CoV-2”.

How can it be that so many evidently smart people either have not reviewed the negative evidence or have drawn the opposite conclusions from it?

I would honestly be very interested to hear from a medically or scientifically qualified person who does think there’s been a “pandemic”

Best wishes
Mike

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"Covid" was a fiction. Here is some collected evidence.

( ... )
Average age of “Covid death” is greater than the average life expectancy. The average age of a “Covid death” in the UK is 82.5 years. In Italy, it’s 86. Germany, 83. Switzerland, 86. Canada, 86. The US, 78, Australia, 82.
( ... )

https://off-guardian.org/2023/03/24/40-facts-you-need-to-know-the-real-story-of-covid/

https://x.com/wideawake_media/status/1820415127545328094

Old interviews now. I’ve been posted by others on X, for which I’m grateful. But compare the traffic to similar posts. X continues to censor, so it’s laughable that some pretend it’s the home of free speech.

Best wishes
Mike

https://twdown.net/

twdown.net
Twitter Video Downloader Online

https://twdown.net/

Here you can save videos from Twitter before they are censored. I learned this (very late) only because of Dr. Yedon. Maybe someone needs it. Maybe I was the only one back then who didn’t know how to do it…?