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Brownstone Institute

The Era of Informed Consent is Over

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6 minute read

From the Brownstone Institute

BY Victor DalzielVICTOR DALZIEL

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 vaccinesmRNA 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.

Author

  • Victor Dalziel

    Victor Dalziel is an Australian content creator, academic researcher, and writer. Victor has a master’s degree in international relations and a PhD in Philosophy and has worked, studied, and presented across the globe.

Brownstone Institute

The Deplorable Ethics of a Preemptive Pardon for Fauci

Published on

From the Brownstone Institute

By Alex Washburne 

Anthony “I represent science” Fauci can now stand beside Richard “I am not a crook” Nixon in the history books as someone who received the poison pill of a preemptive pardon.

While Nixon was pardoned for specific charges related to Watergate, the exact crimes for which Fauci was pardoned are not specified. Rather, the pardon specifies:

Baseless and politically motivated investigations wreak havoc on the lives, safety, and financial security of targeted individuals and their families. Even when individuals have done nothing wrong – and in fact have done the right things – and will ultimately be exonerated, the mere fact of being investigated and prosecuted can irreparably damage reputations and finances.

In other words, the dying breath of the Biden administration appears to be pardoning Fauci for crimes he didn’t commit, which would seem to make a pardon null and void. The pardon goes further than simply granting clemency for crimes. Clemency usually alleviates the punishment associated with a crime, but here Biden attempts to alleviate the burden of investigations and prosecutions, the likes of which our justice system uses to uncover crimes.

It’s one thing to pardon someone who has been subjected to a fair trial and convicted, to say they have already paid their dues. Gerald Ford, in his pardon of Richard Nixon, admitted that Nixon had already paid the high cost of resigning from the highest office in the land. Nixon’s resignation came as the final chapter of prolonged investigations into his illegal and unpresidential conduct during Watergate, and those investigations provided us the truth we needed to know that Nixon was a crook and move on content that his ignominious reputation was carve d into stone for all of history.

Fauci, meanwhile, has evaded investigations on matters far more serious than Watergate. In 2017, DARPA organized a grant call – the PREEMPT call – aiming to preempt pathogen spillover from wildlife to people. In 2018 a newly formed collaborative group of scientists from the US, Singapore, and Wuhan wrote a grant – the DEFUSE grant – proposing to modify a bat sarbecovirus in Wuhan in a very unusual way. DARPA did not fund the team because their work was too risky for the Department of Defense, but in 2019 Fauci’s NIAID funded this exact set of scientists who never wrote a paper together prior or since. In late 2019, SARS-CoV-2 emerged in Wuhan with the precise modifications proposed in the DEFUSE grant submitted to PREEMPT.

It’s reasonable to be concerned that this line of research funded by Fauci’s NIAID may have caused the pandemic. In fact, if we’re sharp-penciled and honest with our probabilities, it’s likely beyond reasonable doubt that SARS-CoV-2 emerged as a consequence of research proposed in DEFUSE. What we don’t know, however, is whether the research proceeded with US involvement or not.

Congress used its constitutionally-granted investigation and oversight responsibilities to investigate and oversee NIAID in search of answers. In the process of these investigations, they found endless pages of emails with unjustified redactions, evidence that Fauci’s FOIA lady could “make emails disappear,” Fauci’s right-hand-man David Morens aided the DEFUSE authors as they navigated disciplinary measures at NIH and NIAID, and there were significant concerns that NIAID sought to obstruct investigations and destroy federal records.

Such obstructive actions did not inspire confidence in the innocence of Anthony Fauci or the US scientists he funded in 2019. On the contrary, Fauci testified twice under oath saying NIAID did not fund gain-of-function research of concern in Wuhan…but then we discovered a 2018 progress report of research NIAID funded in Wuhan revealing research they funded had enhanced the transmissibility of a bat SARS-related coronavirus 10,000 times higher than the wild virus. That is, indisputably, gain-of-function research of concern. Fauci thus lied to the American public and perjured himself in his testimony to Congress, and Senator Rand Paul (R-KY) has referred Fauci’s perjury charges to the Department of Justice.

What was NIAID trying to preempt with their obstruction of Congressional investigations? What is Biden trying to preempt with his pardon of Fauci? Why do we not have the 2019 NIAID progress report from the PI’s who submitted DEFUSE to PREEMPT and later received funding from NIAID?

It is deplorable for Biden to preemptively pardon Fauci on his last day in office, with so little known about the research NIAID funded in 2019 and voters so clearly eager to learn more. With Nixon’s preemptive pardon, the truth of his wrongdoing was known and all that was left was punishment. With Fauci’s preemptive pardon, the truth is not yet known, NIAID officials in Fauci’s orbit violated federal records laws in their effort to avoid the truth from being known, and Biden didn’t preemptively pardon Fauci to grant clemency and alleviate punishment, but to stop investigations and prosecutions the likes of which could uncover the truth.

I’m not a Constitutional scholar prepared to argue the legality of this maneuver, but I am an ethical human being, a scientist who contributed another grant to the PREEMPT call, and a scientist who helped uncover some of the evidence consistent with a lab origin and quantify the likelihood of a lab origin from research proposed in the DEFUSE grant. Any ethical human being knows that we need to know what caused the pandemic, and to deprive the citizenry of such information from open investigations of NIAID research in 2019 would be to deprive us of critical information we need to self-govern and elect people who manage scientific risks in ways we see fit. As a scientist, there are critical questions about bioattribution that require testing, and the way to test our hypotheses is to uncover the redacted and withheld documents from Fauci’s NIAID in 2019.

The Biden administration’s dying breath was to pardon Anthony Fauci not for the convictions for crimes he didn’t commit (?) but to avoid investigations that could be a reputational and financial burden for Anthony Fauci. A pardon to preempt an investigation is not a pardon; it is obstruction. The Biden administration’s dying breath is to obstruct our pursuit of truth and reconciliation on the ultimate cause of 1 million Americans’ dying breaths.

To remind everyone what we still need to know, it helps to look through the peephole of what we’ve already found to inspire curiosity about what else we’d find if only the peephole could be widened. Below is one of the precious few emails investigative journalists pursuing FOIAs against NIAID have managed to obtain from the critical period when SARS-CoV-2 is believed to have emerged. The email connects DEFUSE PI’s Peter Daszak (EcoHealth Alliance), Ralph Baric (UNC), Linfa Wang (Duke-NUS), Ben Hu (Wuhan Institute of Virology), Shi ZhengLi (Wuhan Institute of Virology) and others in October 2019. The subject line “NIAID SARS-CoV Call – October 30/31” connects these authors to NIAID.

It is approximately in that time range – October/November 2019 – when SARS-CoV-2 is hypothesized to have entered the human population in Wuhan. When it emerged, SARS-CoV-2 was unique among sarbecoviruses in having a furin cleavage site, as proposed by these authors in their 2019 DEFUSE grant. Of all the places the furin cleavage site could be, the furin cleavage site of SARS-CoV-2 was in the S1/S2 junction of the Spike protein, precisely as proposed by these authors.

In order to insert a furin cleavage site in a SARS-CoV, however, the researchers would’ve needed to build a reverse genetic system, i.e. a DNA copy of the virus. SARS-CoV-2 is unique among coronaviruses in having exactly the fingerprint we would expect from reverse genetic systems. There is an unusual even spacing in the cutting/pasting sites for the enzymes BsaI and BsmBI and an anomalous hot-spot of silent mutations in precisely these sites, exactly as researchers at the Wuhan Institute of Virology have done for other coronavirus reverse genetic systems. The odds of such an extreme synthetic-looking pattern occurring in nature are, conservatively, about 1 in 50 billion.

The virus did not emerge in Bangkok, Hanoi, Bago, Kunming, Guangdong, or any of the myriad other places with similar animal trade networks and greater contact rates between people and sarbecovirus reservoirs. No. The virus emerged in Wuhan, the exact place and time one would expect from DEFUSE.

With all the evidence pointing the hounds towards NIAID, it is essential for global health security that we further investigate the research NIAID funded in 2019. It is imperative for our constitutional democracy, for our ability to self-govern, that we learn the truth. The only way to learn the truth is to investigate NIAID, the agency Fauci led for 38 years, the agency that funded gain-of-function research of concern, the agency named in the October 2019 call by DEFUSE PI’s, the agency that funded this exact group in 2019.

A preemptive pardon prior to the discovery of truth is a fancy name for obstruction of justice. The Biden administration’s dying breath must be challenged, and we must allow Congress and the incoming administration to investigate the possibility that Anthony Fauci’s NIAID-supported research caused the Covid-19 pandemic.

Republished from the author’s Substack

Author

Alex Washburne is a mathematical biologist and the founder and chief scientist at Selva Analytics. He studies competition in ecological, epidemiological, and economic systems research, with research on covid epidemiology, the economic impacts of pandemic policy, and stock market response to epidemiological news.

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Brownstone Institute

It’s Time to Retire ‘Misinformation’

Published on

From the Brownstone Institute

By  Pierre Kory 

This article was co-authored with Mary Beth Pfieffer.

In a seismic political shift, Republicans have laid claim to an issue that Democrats left in the gutter—the declining health of Americans. True, it took a Democrat with a famous name to ask why so many people are chronically illdisabled, and dying younger than in 47 other countries. But the message resonated with the GOP.

We have a proposal in this unfolding milieu. Let’s have a serious, nuanced discussion. Let’s retire labels that have been weaponized against Robert F. Kennedy, Jr., nominated for Health and Human Services Secretary, and many people like him.

Start with discarding threadbare words like “conspiracy theory,” “anti-vax,” and the ever-changing “misinformation.”

These linguistic sleights of hand have been deployed—by government, media, and vested interests—to dismiss policy critics and thwart debate. If post-election developments tell us anything, it is that such scorn may no longer work for a population skeptical of government overreach.

Although RFK has been lambasted for months in the press, he just scored a 47 percent approval rating in a CBS poll.

Americans are asking: Is RFK on to something?

Perhaps, as he contends, a 1986 law that all but absolved vaccine manufacturers from liability has spawned an industry driven more by profit than protection.

Maybe Americans agree with RFK that the FDA, which gets 69 percent of its budget from pharmaceutical companies, is potentially compromised. Maybe Big Pharma, similarly, gets a free pass from the television news media that it generously supports. The US and New Zealand, incidentally, are the only nations on earth that allow “direct-to-consumer” TV ads.

Finally, just maybe there’s a straight line from this unhealthy alliance to the growing list of 80 childhood shots, inevitably approved after cursory industry studies with no placebo controls. The Hepatitis B vaccine trial, for one, monitored the effects on newborns for just five days. Babies are given three doses of this questionably necessary product—intended to prevent a disease spread through sex and drug use.

Pointing out such conflicts and flaws earns critics a label: “anti-vaxxer.”

Misinformation?

If RFK is accused of being extreme or misdirected, consider the Covid-19 axioms that Americans were told by their government.

The first: The pandemic started in animals in Wuhan, China. To think otherwise, Wikipedia states, is a “conspiracy theory,” fueled by “misplaced suspicion” and “anti-Chinese racism.”

Not so fast. In a new 520-page report, a Congressional subcommittee linked the outbreak to risky US-supported virus research at a Wuhan lab at the pandemic epicenter. After 25 hearings, the subcommittee found no evidence of “natural origin.”

Is the report a slam dunk? Maybe not. But neither is an outright dismissal of a lab leak.

The same goes for other pandemic dogma, including the utility of (ineffective) masks, (harmful) lockdowns, (arbitrary) six-foot spacing, and, most prominently, vaccines that millions were coerced to take and that harmed some.

Americans were told, wrongly, that two shots would prevent Covid and stop the spread. Natural immunity from previous infection was ignored to maximize vaccine uptake.

Yet there was scant scientific support for vaccinating babies with little risk, which few other countries did; pregnant women (whose deaths soared 40 percent after the rollout), and healthy adolescents, including some who suffered a heart injury called myocarditis. The CDC calls the condition “rare;” but a new study found 223 times more cases in 2021 than the average for all vaccines in the previous 30 years.

Truth Muzzled?

Beyond this, pandemic decrees were not open to question. Millions of social media posts were removed at the behest of the White House. The ranks grew both of well-funded fact-checkers and retractions of countervailing science.

The FDA, meantime, created a popular and false storyline that the Nobel Prize-winning early-treatment drug ivermectin was for horses, not people, and might cause coma and death. Under pressure from a federal court, the FDA removed its infamous webpage, but not before it cleared the way for unapproved vaccines, possible under the law only if no alternative was available.

An emergency situation can spawn official missteps. But they become insidious when dissent is suppressed and truth is molded to fit a narrative.

The government’s failures of transparency and oversight are why we are at this juncture today. RFK—should he overcome powerful opposition—may have the last word.

The conversation he proposes won’t mean the end of vaccines or of respect for science. It will mean accountability for what happened in Covid and reform of a dysfunctional system that made it possible.

Republished from RealClearHealth

Author

Dr. Pierre Kory is a Pulmonary and Critical Care Specialist, Teacher/Researcher. He is also the President Emeritus of the non-profit organization Front Line COVID-19 Critical Care Alliance whose mission is to develop the most effective, evidence/expertise-based COVID-19 treatment protocols.

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