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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

RCMP seem more interested in House of Commons Pages than MP’s suspected of colluding with China

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From the Brownstone Institute

By Bruce Pardy 

Canadians shouldn’t have information about their wayward MPs, but the RCMP can’t have too much biometric information about regular people. It’s always a good time for a little fishing. Let’s run those prints, shall we?

Forget the members of Parliament who may have colluded with foreign governments. The real menace, the RCMP seem to think, are House of Commons pages. MPs suspected of foreign election interference should not be identified, the Mounties have insisted, but House of Commons staff must be fingerprinted. Serious threats to the country are hidden away, while innocent people are subjected to state surveillance. If you want to see how the managerial state (dys)functions, Canada is the place to be.

In June, the National Security and Intelligence Committee of Parliamentarians (NSICOP) tabled its redacted report that suggested at least 11 sitting MPs may have benefitted from foreign election interference. RCMP Commissioner Mike Duheme cautioned against releasing their identities. Canadians remained in the dark until Oct. 28 when Kevin Vuong, a former Liberal MP now sitting as an Independent, hosted a news conference to suggest who some of the parliamentarians may be. Like the RCMP, most of the country’s media didn’t seem interested.

But the RCMP are very interested in certain other things. For years, they have pushed for the federal civil service to be fingerprinted. Not just high security clearance for top-secret stuff, but across government departments. The Treasury Board adopted the standard in 2014 and the House of Commons currently requires fingerprinting for staff hired since 2017. The Senate implemented fingerprinting this year. The RCMP have claimed that the old policy of doing criminal background checks by name is obsolete and too expensive.

But stated rationales are rarely the real ones. Name-based background checks are not obsolete or expensive. Numerous police departments continue to use them. They do so, in part, because name checks do not compromise biometric privacy. Fingerprints are a form of biometric data, as unique as your DNA. Under the federal Identification of Criminals Act, you must be in custody and charged with a serious offence before law enforcement can take your prints. Canadians shouldn’t have information about their wayward MPs, but the RCMP can’t have too much biometric information about regular people. It’s always a good time for a little fishing. Let’s run those prints, shall we?

It’s designed to seem like a small deal. If House of Commons staff must give their fingerprints, that’s just a requirement of the job. Managerial bureaucracies prefer not to coerce directly but to create requirements that are “choices.” Fingerprints aren’t mandatory. You can choose to provide them or choose not to work on the Hill.

Sound familiar? That’s the way Covid vaccine mandates worked too. Vaccines were never mandatory. There were no fines or prison terms. But the alternative was to lose your job, social life, or ability to visit a dying parent. When the state controls everything, it doesn’t always need to dictate. Instead, it provides unpalatable choices and raises the stakes so that people choose correctly.

Government intrudes incrementally. Digital ID, for instance, will be offered as a convenient choice. You can, if you wish, carry your papers in the form of a QR code on your phone. Voluntary, of course. But later there will be extra hoops to jump through to apply for a driver’s licence or health card in the old form.

Eventually, analogue ID will cost more, because, after all, digital ID is more automated and cheaper to run. Some outlets will not recognize plastic identification. Eventually, the government will offer only digital ID. The old way will be discarded as antiquated and too expensive to maintain. The new regime will provide the capacity to keep tabs on people like never before. Privacy will be compromised without debate. The bureaucracy will change the landscape in the guise of practicality, convenience, and cost.

Each new round of procedures and requirements is only slightly more invasive than the last. But turn around and find you have travelled a long way from where you began. Eventually, people will need digital ID, fingerprints, DNA, vaccine records, and social credit scores to be employed. It’s not coercive, just required for the job.

Occasionally the curtain is pulled back. The federal government unleashed the Emergencies Act on the truckers and their supporters in February 2022. Jackboots in riot gear took down peaceful protesters for objecting to government policy. Authorities revealed their contempt for law-abiding but argumentative citizens. For an honest moment, the government was not incremental and insidious, but enraged and direct. When they come after you in the streets with batons, at least you can see what’s happening.

We still don’t know who colluded with China. But we can be confident that House of Commons staffers aren’t wanted for murder. The RCMP has fingerprints to prove it. Controlling the people and shielding the powerful are mandates of the modern managerial state.

Republished from the Epoch Times

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Brownstone Institute

The WHO Cannot Be Saved

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From the Brownstone Institute

By David Bell, Senior Scholar at Brownstone InstituteDavid BellRamesh ThakurRamesh Thakur  

If we were designing a new WHO now, no sane model would base its funding and direction primarily on the interests and advice of those who profit from illness. Rather, these would be based on accurate estimates of localized risks of the big killer diseases. The WHO was once independent of private interests, mostly core-funded, and able to set rational priorities. That WHO is gone.

The WHO was originally intended primarily to transfer capacity to struggling states emerging from colonialism and address their higher burdens of disease but lower administrative and financial capabilities. This prioritized fundamentals like sanitation, good nutrition, and competent health services that had brought long life to people in wealthier countries. Its focus now is more on stocking shelves with manufactured commodities. Its budget, staffing, and remit expand as actual country need and infectious disease mortality decline over the years.

While major gaps in underlying health equality remain, and were recently exacerbated by the WHO’s Covid-19 policies, the world is a very different place from 1948 when it was formed. Rather than acknowledging progress, however, we are told we are simply in an ‘inter-pandemic period,’ and the WHO and its partners should be given ever more responsibility and resources to save us from the next hypothetical outbreak (like Disease-X). Increasingly dependent on ‘specified’ funding from national and private interests heavily invested in profitable biotech fixes rather than the underlying drivers of good health,  the WHO looks more and more like other public-private partnerships that channel taxpayer money to the priorities of private industry.

Pandemics happen, but a proven natural one of major impact on life expectancy has not happened since pre-antibiotic era Spanish flu over a hundred years ago. We all understand that better nutrition, sewers, potable water, living conditions, antibiotics, and modern medicines protect us, yet we are told to be ever more fearful of the next outbreak. Covid happened, but it overwhelmingly affected the elderly in Europe and the Americas. Moreover, it looks, as the US government now makes clear, almost certainly a laboratory mistake by the very pandemic industry that is promoting the WHO’s new approach.

Collaborating on health internationally remains popular, as it should be in a heavily interdependent world. It also makes sense to prepare for severe rare events – most of us buy insurance. But we don’t exaggerate flood risk in order to expand the flood insurance industry, as anything we spend is money taken from our other needs.

Public health is no different. If we were designing a new WHO now, no sane model would base its funding and direction primarily on the interests and advice of those who profit from illness. Rather, these would be based on accurate estimates of localized risks of the big killer diseases. The WHO was once independent of private interests, mostly core-funded, and able to set rational priorities. That WHO is gone.

Over the past 80 years, the world has also changed. It makes no sense now to base thousands of health staff in one of the world’s most expensive (and healthiest!) cities, and it makes no sense in a technologically advancing world to keep centralizing control there. The WHO was structured in a time when most mail still went by steamship. It stands increasingly as an anomaly to its mission and to the world in which it works. Would a network of regional bodies tied to their local context not be more responsive and effective than a distant, disconnected, and centralized bureaucracy of thousands?

Amidst the broader turmoil roiling the post-1945 international liberal order, the recent US notice of withdrawal from the WHO presents a unique opportunity to rethink the type of international health institution the world needs, how that should operate, where, for what purpose, and for how long.

What should be the use-by date of an international institution? In the WHO’s case, either health is getting better as countries build capacity and it should be downsizing. Or health is getting worse, in which case the model has failed and we need something more fit for purpose.

The Trump administration’s actions are an opportunity to rebase international health cooperation on widely recognized standards of ethics and human rights. Countries and populations should be back in control, and those seeking profit from illness should have no role in decision-making. The WHO, at nearly 80 years old, comes from a bygone era, and is increasingly estranged from its world. We can do better. Fundamental change in the way we manage international health cooperation will be painful but ultimately healthy.

Authors

David Bell, Senior Scholar at Brownstone Institute

David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. David is a former medical officer and scientist at the World Health Organization (WHO), Programme Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and Director of Global Health Technologies at Intellectual Ventures Global Good Fund in Bellevue, WA, USA.

Ramesh Thakur

Ramesh Thakur, a Brownstone Institute Senior Scholar, is a former United Nations Assistant Secretary-General, and emeritus professor in the Crawford School of Public Policy, The Australian National University.

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