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Brownstone Institute

The Era of Informed Consent is Over

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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.

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Brownstone Institute

The Media Refuses to Accept Covid Reality

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From the Brownstone Institute

By IAN MILLER

By late 2020, the media and public health establishment had two obsessions. One of their obsessions involved forcing the public to wear masks, even though the mountains of data and several studies had already confirmed that they don’t stop the transmission of respiratory viruses. The second obsession was forcing everyone to take Covid vaccines, regardless of their actual efficacy, risk of side effects, age or underlying health, or the vaccines’ rapidly waning efficacy.

Neither of those obsessions has abated, though even the most extreme, hardened Covid extremists have acknowledged that the vaccines were flawed, mandates were a mistake, and side effects should be acknowledged.

The media, unwilling to give up on the increased power, influence, and moral judgment it gained during the pandemic, has refused to accept that it effectively ended years ago.

So it’s no surprise that media outlets have noticed that, as we’ve seen every single summer since 2020, cases have increased, predominantly across the Western and Southern United States. Thankfully though, Los Angeles media, of course it had to be Los Angeles, has determined the culprit.

The Media Refuses to Accept Covid Reality

Turns out it’s not seasonality causing the increase, it’s outdated Covid vaccines and a lack of public masking, of course!

NBC Los Angeles “reported” that Covid cases in California and Los Angeles have “doubled” in the last month. This sounds horrifying and scary, doesn’t it? Yet it again, as is so often the case with Covid coverage, is misleading.

Let’s take a look at the current daily average of new cases in Los Angeles County:

Cases are so low they’re functionally indistinguishable from zero.

You can see why the media is scared, given how dramatic this surge appears to be compared to those in the previous four years. And thanks to NBC’s crack reporting and expert analysis, we know why this terrifying increase is happening. Spoiler alert: it’s all your fault that you haven’t controlled an uncontrollable respiratory virus with individual behavior that has no impact whatsoever on the spread of the coronavirus.

“People aren’t necessarily wearing masks; they’re not required to in certain places,” nurse practitioner Alice Benjamin, referenced as an expert by NBA LA said. “We’re traveling, we’re getting out for the summer. We also do have some reduced immunity. The vaccines will wane over time.”

Nowhere in the story is it mentioned that the massive jump in Covid cases in late 2021 and early 2022 happened immediately after LA County Public Health issued a press release celebrating the county for achieving 95+ percent masking rates at indoor businesses. No one seems willing or able to ask this nurse practitioner why she believes wearing masks would reduce this “surge,” if it failed so spectacularly in previous surges.

Endless Misinformation from ‘Experts’

She wasn’t done with the misinformation though. Benjamin warned that not enough Angelenos are getting the “updated” vaccine, which explains the summer increase.

“If you got it in October and later, that’s generally the updated vaccine,” Benjamin said. “If you got it prior to October, double check because if you did get the bivalent which has not been phased out, we recommend you do get an updated vaccine.”

And according to her, everyone should get it. Because the CDC said so.

“Per CDC recommendations, anyone 6 months or older should have at least one of the updated Covid vaccines,” Benjamin said.

Though, of course, no one on the crack NBC Los Angeles team thought to ask Benjamin why the “updated” October vaccine would help against the now common FLiRT variant when it emerged six months after the “updated” vaccine was released. Especially when the “study” process for booster doses is effectively nonexistent anyway. Pfizer and Moderna churn out a “targeted” dose that is supposed to protect against a variant that’s no longer circulating, never has to show any real-world benefit, and the regulatory agencies sign off on it, while the CDC recommends everyone get it.

Rinse, repeat.

Nor did anyone ask her what possible rationale there could be for forcing six-month-old babies to get vaccinated with a booster that has no studied efficacy against the currently circulating variant.

Her comments and the media reaction exemplify the problems with Covid discourse that started in 2020 and will apparently continue forever. A complete and purposeful ignorance of the facts, the data, and the evidence base. A willingness to advocate for the same sort of restrictions and interventions that have already failed. Ignorance of the booster process and endless appeals to public health authorities. Even though those authorities have made countless mistakes and refused to update their findings after being proven wrong.

The obvious question is: How does this type of absurdist discourse ever end? The answer, as we continue to see, is it doesn’t.

Republished from the author’s Substack

Author

Ian Miller is the author of “Unmasked: The Global Failure of COVID Mask Mandates.” His work has been featured on national television broadcasts, national and international news publications and referenced in multiple best selling books covering the pandemic. He writes a Substack newsletter, also titled “Unmasked.”

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Brownstone Institute

The Pandemic Excuse for a Corporatist Coup

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From the Brownstone Institute

By Jeffrey A. Tucker

We’ve just come across a document hosted by the Department of Homeland Security, posted March 2023, but written in 2007, that amounts to a full-blown corporatist imposition on the US, abolishing anything remotely resembling the Bill of Rights and Constitutional law. It is right there in plain sight for anyone curious enough to dig.

There is nothing in it that you haven’t already experienced with lockdowns. What makes it interesting are the participants in the forging of the plan, which is pretty much the whole of corporate America as it stood in 2007. It was a George W. Bush initiative. The conclusions are startling.

“Quarantine is a legally enforceable declaration that a government body may institute over individuals potentially exposed to a disease, but who are not symptomatic. If enacted, Federal quarantine laws will be coordinated between CDC and State and local public health officials, and, if necessary, law enforcement personnel…The government may also enact travel restrictions to limit the movement of people and products between geographic areas in an effort to limit disease transmission and spread. Authorities are currently reviewing possible plans to curtail international travel upon a pandemic’s emergence overseas.

“Limiting public assembly opportunities also helps limit the spread of disease. Concert halls, movie theaters, sports arenas, shopping malls, and other large public gathering places might close indefinitely during a pandemic—whether because of voluntary closures or government-imposed closures. Similarly, officials may close schools and non-essential businesses during pandemic waves in an effort to significantly slow disease transmission rates. These strategies aim to prevent the close interaction of individuals, the primary conduit of spreading the influenza virus. Even taking steps such as limiting person-to-person interactions within a distance of three feet or avoiding instances of casual close contact, such as shaking hands, will help limit disease spread.”

There we have it: the pandemic plans. They once seemed abstract. In 2020, they became very real. Your rights were deleted. No more freedom even to have house guests. In those days, the rule was to enforce only three feet of distance rather than six feet of distance, neither of which had any basis in science. Indeed, the actual scientific literature even at that time recommended against any physical interventions designed to limit the spread of respiratory viruses. They were known not to work. The entire profession of public health accepted that.

Therefore, for many years before lockdowns wrecked economic functioning, there had been two parallel tracks in operation, one intellectual/academic and one imposed by state/corporate managers. They had nothing to do with each other. This situation persisted for the better part of 15 years. Suddenly in 2020, there was a reckoning, and the state/corporate managers won it. Seemingly out of nowhere, liberty as we have long known it was gone.

Back in 2005, I first came across a Bush administration scheme, an early draft of the above, that would have ended freedom as we know it. It was a scheme for combating the bird flu, which officials back then imagined would involve universal quarantines, business and event closures, travel restrictions, and more.

wrote: “Even if the flu does come, and taxpayers have coughed up, the government will surely have a ball imposing travel restrictions, shutting down schools and businesses, quarantining cities, and banning public gatherings…It is a serious matter when the government purports to plan to abolish all liberty and nationalize all economic life and put every business under the control of the military, especially in the name of a bug that seems largely restricted to the bird population. Perhaps we should pay more attention. Perhaps such plans for the total state ought to even ruffle our feathers a bit.”

For years I wrote about this topic, trying to get others interested. It was all there in black and white. At the drop of a hat, under the guise of a pandemic that only state managers can declare, real or drummed up, freedom itself could be abolished. These plans were never legislated, debated, or publicly discussed. They were simply posted as the result of various consultations with experts, who worked out their totalitarian fantasies as if scripting a Hollywood film.

The 2007 blueprint is more explicit than anything I’ve seen. It comes from the National Infrastructure Advisory Council, which “includes executive leaders from the private sector and state/local government who advise the White House on how to reduce physical and cyber risks and improve the security and resilience of the nation’s critical infrastructure sectors. The NIAC is administered on behalf of the President in accordance with the Federal Advisory Committee Act under the authority of the Secretary of the US Department of Homeland Security.”

And who sat on this committee in 2007 that decided that governments “may close schools and non-essential businesses”? Let us see.

  • Mr. Edmund G. Archuleta, General Manager, El Paso Water Utilities
  • Mr. Alfred R. Berkeley III, Chairman and CEO, Pipeline Trading Group, LLC, and former President and Vice Chairman of NASDAQ
  • Chief Rebecca F. Denlinger, Fire Chief, Cobb County (Ga.) Fire and Emergency Services
  • Chief Gilbert G. Gallegos, Police Chief (ret.), City of Albuquerque, N.M. Police Department
  • Ms. Martha H. Marsh, President and CEO, Stanford Hospital and Clinics
  • Mr. James B. Nicholson, President and CEO, PVS Chemical, Inc.
  • Mr. Erle A. Nye, Chairman Emeritus, TXU Corp., NIAC Chairman
  • Mr. Bruce A. Rohde, Chairman and CEO Emeritus, ConAgra Foods, Inc.
  • Mr. John W. Thompson, Chairman and CEO, Symantec Corporation
  • Mr. Brent Baglien, ConAgra Foods, Inc.
  • Mr. David Barron, Bell South
  • Mr. Dan Bart, TIA
  • Mr. Scott Blanchette, Healthways
  • Ms. Donna Burns, Georgia Emergency Management Agency
  • Mr. Rob Clyde, Symantec Corporation
  • Mr. Scott Culp, Microsoft
  • Mr. Clay Detlefsen, International Dairy Foods Association
  • Mr. Dave Engaldo, The Options Clearing Corporation
  • Ms. Courtenay Enright, Symantec Corporation
  • Mr. Gary Gardner, American Gas Association
  • Mr. Bob Garfield, American Frozen Foods Institute
  • Ms. Joan Gehrke, PVS Chemical, Inc.
  • Ms. Sarah Gordon, Symantec
  • Mr. Mike Hickey, Verizon
  • Mr. Ron Hicks, Anadarko Petroleum Corporation
  • Mr. George Hender, The Options Clearing Corporation
  • Mr. James Hunter, City of Albuquerque, NM Emergency Management
  • Mr. Stan Johnson, North American Electric Reliability Council (NERC)
  • Mr. David Jones, El Paso Corporation
  • Inspector Jay Kopstein, Operations Division, New York City Police Department (NYPD)
  • Ms. Tiffany Jones, Symantec Corporation
  • Mr. Bruce Larson, American Water
  • Mr. Charlie Lathram, Business Executives for National Security (BENS)/BellSouth
  • Mr. Turner Madden, Madden & Patton
  • Chief Mary Beth Michos, Prince William County (Va.) Fire and Rescue
  • Mr. Bill Muston, TXU Corp.
  • Mr. Vijay Nilekani, Nuclear Energy Institute
  • Mr. Phil Reitinger, Microsoft
  • Mr. Rob Rolfsen, Cisco Systems, Inc.
  • Mr. Tim Roxey, Constellation
  • Ms. Charyl Sarber, Symantec
  • Mr. Lyman Shaffer, Pacific Gas and Electric,
  • Ms. Diane VanDeHei, Association of Metropolitan Water Agencies (AMWA)
  • Ms. Susan Vismor, Mellon Financial Corporation
  • Mr. Ken Watson, Cisco Systems, Inc.
  • Mr. Greg Wells, Southwest Airlines
  • Mr. Gino Zucca, Cisco Systems, Inc.
  • Department of Health and Human Services (HHS) Resources
  • Dr. Bruce Gellin, Rockefeller Foundation
  • Dr. Mary Mazanec
  • Dr. Stuart Nightingale, CDC
  • Ms. Julie Schafer
  • Dr. Ben Schwartz, CDC
  • Department of Homeland Security (DHS) Resources
  • Mr. James Caverly, Director, Infrastructure Partnerships Division
  • Ms. Nancy Wong, NIAC Designated Federal Officer (DFO)
  • Ms. Jenny Menna, NIAC Designated Federal Officer (DFO)
  • Dr. Til Jolly
  • Mr. Jon MacLaren
  • Ms. Laverne Madison
  • Ms. Kathie McCracken
  • Mr. Bucky Owens
  • Mr. Dale Brown, Contractor
  • Mr. John Dragseth, IP attorney, Contractor
  • Mr. Jeff Green, Contractor
  • Mr. Tim McCabe, Contractor
  • Mr. William B. Anderson, ITS America
  • Mr. Michael Arceneaux, Association of Metropolitan Water Agencies (AMWA)
  • Mr. Chad Callaghan, Marriott Corporation
  • Mr. Ted Cromwell, American Chemistry Council (ACC)
  • Ms. Jeanne Dumas, American Trucking Association (ATA)
  • Ms. Joan Harris, US Department of Transportation, Office of the Secretary
  • Mr. Greg Hull, American Public Transportation Association
  • Mr. Joe LaRocca, National Retail Federation
  • Mr. Jack McKlveen, United Parcel Service (UPS)
  • Ms. Beth Montgomery, Wal-Mart
  • Dr. J. Patrick O’Neal, Georgia Office of EMS/Trauma/EP
  • Mr. Roger Platt, The Real Estate Roundtable
  • Mr. Martin Rojas, American Trucking Association (ATA)
  • Mr. Timothy Sargent, Senior Chief, Economic Analysis and Forecasting Division, Economic and Fiscal Policy Branch, Finance Canada

In other words, big everything: food, energy, retail, computers, water, and you name it. It’s a corporatist dream team.

Consider ConAgra itself. What is that? It is Banquet, Chef Boyardee, Healthy Choice, Orville Redenbacher’s, Reddi-Wip, Slim Jim, Hunt’s Peter Pan Egg Beaters, Hebrew National, Marie Callender’s, P.F. Chang’s, Ranch Style Beans, Ro*Tel, Wolf Brand Chili, Angie’s, Duke’s, Gardein, Frontera, Bertolli, among many other seemingly independent brands that are all actually one company.

Now, ask yourself: why might all these companies favor a plan for lockdowns? Why might WalMart, for example? It stands to reason. Lockdowns are a massive interference with competitive capitalism. They provide the best possible subsidy to big business while shutting down independent small businesses and putting them at a huge disadvantage once the opening up happens.

In other words, it is an industrial racket, very much akin to interwar-style fascism, a corporatist combination of big business and big government. Throw pharma into the mix and you see exactly what came to pass in 2020, which amounted to the largest transfer of wealth from small and medium-sized business plus the middle class to wealthy industrialists in the history of humanity.

The document is open even about managing information flows: “The public and private sectors should align their communications, exercises, investments, and support activities absolutely with both the plan and priorities during a pandemic influenza event. Continue data gathering, analysis, reporting, and open review.”

There is nothing in any of this that fits with any Western tradition of law and liberty. Nothing. It was never approved by any democratic means. It was never part of any political campaign. It has never been the subject of any serious media examination. No think tank has ever pushed back on such plans in any systematic way.

The last serious attempt to debunk this whole apparatus was from D.H. Henderson in 2006. His two co-authors on that paper eventually came around to going along with lockdowns of 2020. Henderson died in 2016. One of the co-authors of the original article told me that if Dr. Henderson had been around, instead of Dr. Fauci, the lockdowns would never have taken place.

Here we are four years following the deployment of this lockdown machinery, and we are witness to what it destroys. It would be nice to say that the entire apparatus and theory behind it have been fully discredited.

But that is not correct. All the plans are still in place. There have been no changes in federal law. Not one effort has been made to dismantle the corporatist/biosecurity planning state that made all this possible. Every bit of it is in place for the next go-around.

Much of the authority for this whole coup traces to the Public Health Services Act of 1944, which was passed in wartime. For the first time in US history, it gave the federal government the power to quarantine. Even when the Biden administration was looking for some basis to justify its transportation mask mandate, it fell back to this one piece of legislation.

If anyone really wants to get to the root of this problem, there are decisive steps that need to be taken. The indemnification of pharma from liability for harm needs to be repealed. The court precedent of forced shots in Jacobson needs to be overthrown. But even more fundamentally, the quarantine power itself has to go, and that means the full repeal of the Public Health Services Act of 1944. That is the root of the problem. Freedom will not be safe until it is uprooted.

As it stands right now, everything that unfolded in 2020 and 2021 can happen again. Indeed, the plans are in place for exactly that.

Author

Jeffrey Tucker is Founder, Author, and President at Brownstone Institute. He is also Senior Economics Columnist for Epoch Times, author of 10 books, including Life After Lockdown, and many thousands of articles in the scholarly and popular press. He speaks widely on topics of economics, technology, social philosophy, and culture.

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