Posted on 03/24/2024 8:25:56 PM PDT by Auntie Mame
In a significant blow to patient autonomy, informed consent has been quietly revoked just 77 years after it was codified in the Nuremberg Code.
On the 21st of December 2023, as we were frantically preparing for the festive season, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a final ruling to amend a provision of the 21st Century Cures Act. This allowed
…an exception from the requirement to obtain informed consent when a clinical investigation poses no more than a minimal risk to the human subject…
This ruling went into effect on January 22nd, 2024, which means it’s already standard practice across America.
So, what is the 21st Century Cures Act? It is a controversial Law enacted by the 114th United States Congress in January 2016 with strong support from the pharmaceutical industry. The Act was designed to
…accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes [?]…[emphasis added]
Some of the provisions within this Act make for uncomfortable reading. For example, the Act supported:
High-risk, high-reward research [Sec. 2036].
Novel clinical trial designs [Sec. 3021]
Encouraging vaccine innovation [Sec. 3093].
This Act granted the National Institutes of Health (NIH) legal protection to pursue high-risk, novel vaccine research. A strong case could be made that these provisions capture all the necessary architecture required for much of the evil that transpired over the past four years.
Overturning patient-informed consent was another stated goal of the original Act. Buried under Section 3024 was the provision to develop an
Informed consent waiver or alteration for clinical investigation.
Scholars of medical history understand that the concept of informed consent, something we all take for granted today, is a relatively new phenomenon codified in its modern understanding as one of the critical principles of the Nuremberg Code in 1947. It is inconceivable that just 77 years after Nuremberg, the door has once again opened for state-sanctioned medical experimentation on potentially uninformed and unwilling citizens.
According to this amendment, the state alone, acting through the NIH, the FDA, and the Centers for Disease Control and Prevention (CDC), will decide what is considered a “minimal risk” and, most concerning, will determine:
…appropriate safeguards to protect the rights, safety, and welfare of human subjects.
Notice the term subjects, not patients, persons, individuals, or citizens…but subjects. In asymmetrical power relationships such as clinician/patient, it is understood that the passive subject will comply with the rulings and mandates of their medical masters. The use of the term subjects also serves to dehumanise. The dehumanisation of populations was a critical component of Nazi human experimentation and, as Hannah Arendt argued, is an essential step toward denying citizens “…the right to have rights.”
This ruling also allows researchers and their misguided evangelical billionaire backers to potentially pursue dangerous experimental programs such as Bill Gates’ mosquito vaccines, mRNA vaccines in livestock, and vaccines in aerosols. This Act encourages these novel and high-risk programs, with medical studies approved as ‘minimal risk’ by the regulators no longer requiring researchers and pharmaceutical companies to obtain patient consent. Yet, the histories of pharmacology and medicine are plagued with clinical investigations and interventions that were thought to pose no more than minimal risk to humans but went on to cause immeasurable pain, suffering, and death.
This amendment represents merely a first tentative step as the US government tests the waters to see what it can get away with. Given the lack of attention this ruling received in both the corporate press and independent media, the government is likely to feel emboldened to widen its scope. Thus, this decision represents the beginning of a chilling revisionism in Western medical history, as patient autonomy is again forsaken.
This ruling, to be actioned by potentially corrupt scientists, health bureaucrats, and captured health and drug regulators, is another step toward a dystopian future unimaginable just five years ago. No doubt the infrastructure to implement this decree is already being constructed by the same groupthink cultists responsible for the nightmarish pandemic lockdowns, continuing to place the pursuit of profit and the greater good above individual choice, bodily autonomy, and informed consent.
I avoided the vaxx the first time, and anyone that tries to push it on me will have a 0% survival rate.
No more than a minimal risk according to whom?
According to the FDA, and its DOD overlords, the original mRNA gene therapy injection met that criteria. If course, this was cataclysmically false.....but what’s a few million people maimed and killed among Federal agency friends?
Outrageous and Terrifying!
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Nuremberg 2.0 is effectively impossible.
I guess the government can get back to work on that Tuskegee Syphilis study.
This got a chuckle out of me, but yep, I think the statement is accurate.
The timing for restarting it is perfect.
Back in the day Joe said to Cornpop “If you don’t sign up for this study then you ain’t black!”
A horde is a large group of people.
True.
yeah, and who was in the majority when this evil bill was conceived and passed?
‘The bill was originally introduced as the Tsunami Warning, Education, and Research Act of 2015 (see S. 533).
On Nov. 30, 2016, the House replaced the text of H.R. 34 completely with provisions similar to H.R. 6, an earlier version of the 21st Century Cures Act.’
PING
The WWII Nazi’s were rank amateurs compared to the monsters of Big Pharma stalking us now. Crimes against humanity being perpetrated today are a cry for erecting gallows for hangings even louder than at Nuremberg.
📌
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The SCIENCE must get done, but there’s cake at the end.
bump
A good friend's father was hospitalized a few years ago with a heart attack and hooked up to machines. The attending doctor didn't think the old man would make it.
My friend, respecting Dad's wishes to not be on machines, signed a paper approving the de-machining and putting the Dad on "comfort care" which (IN GENERAL) is basically no curative care.
That was ok - that was the Dad's wishes.
The old man pulled through, but the hospital refused to put Dad back on fluids or nutrition because - you guessed it - "comfort care" IN THAT HOSPITAL and for THAT DOCTOR is effectively Terri Schaivo-style starvation and dehydration.
They said, food and water was a medical treatment and thus "curative" and AGAINST the rules of "comfort care."
My friend was stunned. And the attending and her team wouldn't budge - ”you signed the document giving consent.”
For the next few days, my friend and siblings heard from scores of nurses etc that withholding fluids was effectively "the right thing to do"....very Terri Schaivo-like. They also threw in “Dad live a good long life” and “he will never come back the way he was.”
It took a virtual miracle whereby a different doctor intervened, said the father clearly wasn't terminal, and put the old man back on nutrition and fluids.
While my friend's Dad passed away peacefully in his sleep a few weeks later, it was on the Dad’s terms.
It’s also worth noting that the siblings were split on “comfort care.” There WAS a view that it was ok for Dad to dehydrate to death. Someone even said that dehydration is painless; I hear the total opposite during the Schaivo murder.
Euthanasia is, technically, illegal. And I know many people would be OK if fluids were withheld when it is THEIR time to go. Fair enough.
But euthanasia can be made legal if you're not careful with the Fine Print or vetting the "mercy killing" mindset of the attending.
Pile on top of that story, this article and the removal of informed consent, and you got a real ballgame on your hands.
CAKE? I love cake!!!
I can’t wait! It will be worth it!
(The cake is a lie.)
We would always use the “cake is a lie” reference at work whenever management promised us a reward for jumping through impossible hoops only to find out there was no actual reward other than a finger in our eye.
Reference from video game Portal.
Auntie Mame could be right either way. ;=)
EC
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