Consent and Information

Written by Robert W Malone MD, MS on January 3, 2024. Posted in Current News

I am often asked some form of the question “what caused you to come out of the closet and start criticizing the vaccines”.

On a related note, when interviewed by a reporter from the infamous Atlantic Monthly August 2021 hit piece, Stan Gromkowski (a former Vical colleague of mine) prophetically opined “He’s f***ing up his chances for a Nobel Prize.”

The answer to this persistent question is nicely summarized in the first essay which I wrote in objection to what was being done, titled “COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down.” published in Trial Site News on May 30, 2021 (three months before the defamatory Atlantic Monthly attack).

I guess that article struck a nerve, because it currently has over 19,000 likes; pretty good for an article on a specialty paid site targeting the clinical research industry.

The essay was prompted by a Saturday evening zoom call with a Canadian Physician who was pleading for me to help intervene with the Canadian authorities overseeing the “vaccine” campaign.

This specific physician later had his office raided and office computers damaged by the Canadian government for prescribing early treatment and writing vaccine exemptions, and has now being required to submit to the Canadian government re-education and contrition program for his sins if he wishes to retain the ability to practice medicine, much as has been required of Jordan Peterson.

But that was all in the future.

Talking until midnight Saturday, he had described what was being done in Canada to force toxic COVID “vaccines” on an unwitting population including children, imploring me to somehow intervene with Health Canada to stop the madness.

I told him I did not have the necessary connections, and there was nothing much I could do to help. Waking early the following Sunday, I realized there was something I actually could do to advance his cause.

I could dip into my extensive training in bioethics and write about the fundamental breaches of established biomedical ethics that were going on in Canada, and would soon migrate to USA, Australia, New Zealand, United Kingdom and across the western “democracies”.

The following is the core of my argument back then (May 2021), which I assert has withstood the test of time much better than the notorious Atlantic Monthly hit piece published three months later.

I believe that adult citizens must be allowed free will, the freedom to choose. This is particularly true in the case of clinical research.  These mRNA and recombinant adenovirus vaccine products remain experimental at this time. Furthermore, we are supposed to be doing rigorous, fact-based science and medicine. If rigorous and transparent evaluation of vaccine reactogenicity and treatment-emergent post-vaccination adverse events is not done, we (the public health, clinical research and vaccine developer communities) play right into the hands of anti-vaxxer memes and validate many of their arguments.

The suppression of information, discussion, and outright censorship concerning these current COVID vaccines which are based on gene therapy technologies cast a bad light on the entire vaccine enterprise.  It is my opinion that the adult public can handle information and open discussion. Furthermore, we must fully disclose any and all risks associated with these experimental research products.

In this context, the adult public are basically research subjects that are not being required to sign informed consent due to EUA waiver. But that does not mean that they do not deserve the full disclosure of risks that one would normally require in an informed consent document for a clinical trial.  And now some national authorities are calling on the deployment of EUA vaccines to adolescents and the young, which by definition are not able to directly provide informed consent to participate in clinical research  – written or otherwise.

The key point here is that what is being done by suppressing open disclosure and debate concerning the profile of adverse events associated with these vaccines violates fundamental bioethical principles for clinical research. This goes back to the Geneva convention and the Helsinki declaration. See https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

There must be informed consent for experimentation on human subjects. The human subjects – you, me, and the citizens of these countries – must be informed of risks.  As a community, we have already had a discussion and made our decision – we cannot compel prisoners, military recruits, or any other population of humans to participate in a clinical research study.  For example, see the Belmont report, which provided the rationale for US federal law Code of Federal Regulations 45 CFR 46 (subpart A), referred to as “The Federal Policy for the Protection of Human Subjects” (also known as the “Common Rule”).

Quoting from the Belmont Report:

“Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.”

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Information, comprehension, and voluntariness.  To my eyes, it appears that in many regions public health leadership has stepped over the line and is now violating the bedrock principles which form the foundation upon which the ethics of clinical research are built.  I believe that this must stop.  We must have transparent public disclosure of risks – in a broad sense – associated with these experimental vaccines.  It is either that, or the entire modern bioethical structure which supports human subjects research will have to be re-thought.

This was not a major intellectual leap. It was a simple restatement of the training in clinical research bioethics which I had received and which had been repeatedly reinforced over the prior decade.

No big deal, except that few if any were willing to make such a statement at that time. Long before the infamous Dark Horse or Rogan podcasts.

The failure to disclose the risks of the gene therapy-based COVID vaccines by the US and other “western” governments became widespread, chronic and well documented. Fast forwarding to the present, on December 22, 2023 investigative journalist Greg Piper of the alternative “Just The News” published yet another chapter in the abundant library of documented government withholding of key information concerning COVID genetic “vaccine” harms.

Misinformation for thee, not me? FDA had similar concerns as COVID vaccine skeptics, docs suggest

FOIA production shows agency wasn’t impressed by Pfizer plan to mitigate “endotoxins,” complained about insufficient cleaning in manufacturing, had no basis to claim post-vax heart inflammation was rare.

If an outsider raises questions about contamination of COVID-19 vaccines or how closely the Food and Drug Administration monitors for severe adverse events, the agency considers it a boon to misinformation that lowers vaccine uptake and hence kills people.

If the FDA itself raises these issues, that’s a different story…

The FDA documents, some heavily redacted under the FOIA exemption for trade secrets, show less daylight than may be thought between the agency and critics of federal COVID policy such as Florida Surgeon General Joseph Ladapo.

Mr. Piper went on to summarize a range of recent freedom of information act and court-ordered document disclosures which clearly demonstrate a systematic and intentional failure by the US Government to properly inform the public of the risks associated with accepting gene therapy-based COVID “vaccine” products.

• The CDC had no scientific research to back its public claim in January that people can safely get their COVID, flu and monkeypox vaccines “at the same time.”
• “Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, didn’t just tell Florida Surgeon General Joe Ladapo last week his concerns about DNA contamination were “quite implausible” but also shamed him for feeding what he considered misinformation that will cause preventable deaths. Yet an Aug. 6, 2021 email to Pfizer from CBER Senior Regulatory Review Officer Mike Smith about “endotoxins” – potential contaminants introduced in pharmaceutical manufacturing – shows the feds had similar concerns as they considered full approval for Pfizer’s Comirnaty.”
• “A month before then-acting FDA Commissioner Janet Woodcock told the media that post-vaccination heart inflammation “appears to be very low,” a CBER “surveillance” scientist made clear that the leader was not relying on the agency’s own data. Joyce Obidi reviewed how well CBER’s Sentinel Program, created under a 2007 law to monitor drug safety through electronic healthcare data, could “evaluate the serious risk for myocarditis and pericarditis” following Pfizer COVID vaccination in recipients 16 and older, the first population authorized for emergency use. “Post-authorization safety data identified serious risks for myocarditis and pericarditis after COMIRNATY, with increased risk in males under 30 years of age,” Obidi wrote in the May 18, 2021, memo, which is also buried in the agency’s 246-document public folder on materials related to Comirnaty’s approval.”
• Obidi also stated that “”Available data sources in the CBER Sentinel Program are NOT sufficient to identify the outcomes of myocarditis and pericarditis” and not “sufficiently powered to assess the magnitude of risk” for ages 12-30, she wrote.The program would need a minimum of 3-6 months followup data to check for “long-term sequelae,” and it cannot study subclinical myocarditis “because of the absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities,” according to Obidi. Sentinel’s data sources at full approval of Comirnaty did not have “sufficient power to assess the magnitude of risk in patients 12-30 years of age” and hence cannot assess the “serious risks of myocarditis and pericarditis, and subclinical myocarditis” associated with the vaccine.”
• “In another May 18, 2021, memo reviewing Pfizer’s proposed pharmacovigilance plan for its vaccine, Analytic Epidemiology Branch Medical Officer Deborah Thompson evaluated the company’s claim that “vaccine-associated enhanced disease” is just a “theoretical risk.” She cited Vaccine Adverse Events Reporting System reports of deaths in “fully vaccinated” patients at that early stage of vaccination. “Severe manifestations and death from COVID-19 raise the possibility” of VAED because it has “overlapping clinical manifestations with natural SARS-CoV-2 infection, making it difficult to differentiate VAED from severe” infection in VAERS reports.”
• Despite assurances otherwise from Peter Marks in his letter to the Florida Surgeon General, major manufacturing process good practices were breached. “In a Form 483 to Pfizer following inspections that uncovered possible or actual product adulteration, FDA investigators made 13 observations about procedures at Pfizer’s Andover, Massachusetts, manufacturing facility. They include “insufficient data to support product quality prior to the release” of vaccine batch FA8057. The observation says “a deviation [redacted] was initiated due to the multiple control limit excursions during [redacted]” and the “affected batch was manufactured with a process that deviated from the validated process parameters” and was “not put on stability until July 22, 2021.” It was released on a redacted date. An observation on “inadequate quality oversight” implies that Pfizer was late in adding a notation to a batch record that        “[redacted] exceeded the allowable [redacted].” The company’s quality assurance does not review “electronic data/reports” from a redacted manufacturing process “during batch record review or prior to batch release.” <Note: No clinical trial I have ever been involved in has been associated with an FDA 483 warning letter. This is no small matter.>
• Just the News asked the FDA prior to publication of this report on 22 December for its characterization of the FOIA-disclosed and related documents in light of Marks’ comments to Ladapo about feeding misinformation. A spokesperson responded two days later, saying the agency was working to provide an answer. As of 27 December, the FDA still has not provided a response.

At this point, the burden of publicly available documentation clearly demonstrates multiple examples of intentional breaches of informed consent by both the US Government and the Pharmaceutical Industry manufacturers of these products.

It is difficult to dispute that the US Government and the Pharmaceutical industry sponsors are colluding in a public-private partnership to suppress information concerning risks of these products.

Likewise, there has been an agreement between the UK and USA governments to suppress disclosure of information concerning risks and adverse events associated with these products.

In a historically normal regulatory and bioethical environment, this breach of international bioethical norms concerning informed consent would rise to the level of a clear-cut crime against humanity.

But in the “through the looking glass” world of COVID post late 2019, established legal, moral and ethical norms concerning patient and citizen rights to proper informed consent have all been turned upside down.

All of these clear-cut breaches ostensibly being actively “justified” by mockingbird media, the massive censorship-industrial complex and government officials as being in service of the public interest and the ‘greater good’.

The western five eyes alliance participants, deferring to the leadership of the US Government, are all acting in coordination and cooperation to disregard and hide the implications and consequences of their illegal and unethical actions.

This is being justified based on the following oft-repeated catechism, each element of which is demonstrably false or opposed to established western bioethical consensus:

1. COVID-19, the disease caused by infection with SARS-CoV-2, is highly pathogenic with a case fatality rate of 3.4 percent. <The actual case fatality rate was approximately 0.02 percent when this disease was first “modeled” in 2020 and is much lower now>
2. The gene therapy-based COVID-19 “vaccines” are safe and effective, are effective as prophylactics, are effective in preventing infection and spread of COVID-19 disease, and if taken by a sufficient fraction of the population <a moving goalpost> can be used to achieve herd immunity. <all of these previous claims are now clearly demonstrated unsupported falsehoods>
3. The gene therapy-based COVID-19 “vaccines” are effective at preventing severe disease and death from SARS-CoV-2, and have saved 14 million lives. <this 14 million lives saved claim turns out to be based on flawed mathematics, and all cause mortality data analysis indicates something more like 17 million lives lost globally due to the products>
4. Fully disclosing actual risks, morbidity and mortality data concerning the COVID-19 genetic vaccines will result in “increased vaccine hesitancy” and avoidable harm due to reduced “vaccine” (booster) uptake. <at this point in the outbreak, multiple data sources indicate that acceptance of boosters is associated with “negative effectiveness”, meaning that after a 2-3 month lag period (shorter in some studies) you are more likely to suffer death or severe COVID-19 disease – and other diseases- if you accept injection with these products than if you do not.>

This fourth point is a clear cut example of flawed logic. Flawed both in terms of the data on morbidity, mortality, and immune imprinting, as well as flawed bioethical reasoning.

Think this through with me. The essence of the statement is the governments’ assertions that “if the public knew about the risks that we know about, then they would choose not to accept those risks based on their assessment of the effectiveness of the product and the clinical risks of infection with the virus. Therefore there would be much more avoidable disease, disability and death from COVID-19 than would be saved from vaccine products not administered”.

And on the basis of this ill-logic, governments and Pharma are withholding adverse event data, and thereby are unilaterally making medical decisions for sovereign individuals and their children.

This is what we have come to. The ultimate embodiment of the nanny state, with corporatist allies. The State knows best, and will withhold medical information from the public which would cause members of that public to question its wisdom and decision making.

Basically, the State is asserting that it has the right to sentence you to increased risk of death and disease by purchasing (using tax dollars), mandating (vaccines for children program), distributing, enticing, and marketing an injectable product while censoring or defaming (using modern psychological warfare technologies) any and all who disagree or even have the temerity to question the decisions and rights of the State to do so.

Which brings me to my final points.

Most non-authoritarian governments, historically including the US Government under the US Constitution, rely on and derive their legitimacy from the consent of the governed. In return, the State is granted sole legitimate right to use violence and coercion against its own citizens.

Through their voting, in the context of a republic as defined by the US Constitution, the citizens authorize elected officials to act on their behalf. This is the essence of what is otherwise known as the “social contract” between government and the governed.

But that contract has been made obsolete by the rise of an unelected body, the permanent administrative state, which is now guided by a shadowy elite commonly referred to as the “Deep State”. This elite acts to steer an independent “inverse totalitarian” (Sheldon Wolin) permanent and unelected administrative state which is functionally parasitic (economically, socially, politically) on the citizenry.

This administrative state, which has developed its own culture and sense of entitlement, acts to protect its own self-assigned prerogatives, and holds itself separate from and above the citizenry. The social contract is between the governed and those elected to govern.

The permanent (unelected) administrative state is not a party to that relationship. The logic of social contract does not apply to either the administrative state or the deep state. Both are truly parasitic on the citizenry, including citizens economic activities and efforts to “establish Justice, insure domestic Tranquility, provide for the common defense, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity”.

The permanent administrative state benefits from the constitutionally authorized rights of the State to exercise violence and coercion on the governed, but it is protected from accountability for arbitrary and capricious or unconstitutional authoritarian activities.

The social contract is not merely broken, it has been made administratively obsolete via this unauthorized, arbitrary and capricious arrangement.

During the COVIDcrisis, it has become abundantly clear that the administrative state has acted extra-constitutionally, outside of its authority, in a wide variety of breaches of clauses relating to fundamentally protected freedoms such as assembly, religion, commerce, speech, property and a wide variety of related guaranteed rights and privileges.

A cowed, intimidated citizenry has been subjected to constant, escalating and irrational fear messaging from corporate (mockingbird) media. These media outlets have acted as agents of the administrative state via coordination with the intelligence operations and enforcers of the interests of the administrative state (CIA, FBI, DIA, etc.).

Furthermore, what we have seen during the COVIDcrisis is that the third (Judiciary) branch of the US Government, tasked with upholding the constitutional checks and balances system intended to protect the citizenry from unconstitutional predations by the State, has failed to perform its constitutional mandate and responsibilities.

In its actions, the judiciary has validated the dark assessment of anarcho-capitalists (ref: “Anatomy of the State”, Murray Rothbard) that the judiciary primarily functions to support and legitimize the State, rather than the fairy tale told to the citizenry that its primary function is to insure fairness, equity and compliance with the rule of law.

Consistent with this general theory, an argument can be made that our elected officials have either intentionally or unwittingly bypassed the social contract embodied in the US Constitution by creating an unelected, unaccountable permanent administration which is not bound by the terms and conditions of that contract.

The concept of social contract underpins the consent of the governed and relationship of citizens to the State. With the State actively acting and conspiring to withhold key information concerning the role of the State in engineering SARS-CoV-2, in circumventing normal processes and controls to insure safe and effective countermeasures (pharmaceutical and non-pharmaceutical) and acting in an arbitrary and capricious manner, and by intentionally withholding key information concerning the risks of medical products mandated or actively marketed by the State for treatment and prevention of COVID-19 disease, the State has clearly breached the social contract.

In the face of these arbitrary and capricious actions, a frightened, cowed and censored citizenry has essentially failed to take action in response to this breach of contract; meaning that there has been a violation of the agreed-upon terms and conditions of a binding contract between governed and the elected government (the US Constitution).

In sum, the Administrative State has repeatedly, knowingly, breached the terms of the US Constitution and hid its unlawful actions without suffering any consequences. Elected officials have failed to hold the unelected Administrative State accountable for its actions, and the other party in the contract – the citizenry- has failed to object.

Therefore, from a legal perspective, by failing to act in objection to this breach- by legislative oversight and actions, public protest, large scale civil disobedience or other means- both the citizenry and their elected representatives have functionally waived our rights to enforce that contract.

By failing to act in objection to what has been done, the citizenry have essentially agreed to a waiver by estoppel regarding their constitutional rights. A waiver by estoppel can occur when one party acts in such a way as to suggest that they have agreed to waive their contractual rights.

The “Great Reset”. All in the name of globalism, corporatism, and protection against a fabricated story concerning a highly lethal pathogen that wasn’t highly lethal.

Unquestioned and unquestionable Globalism, Utilitarianism, Marxism, Corporatism, and Malthusianism for all.

See more here substack.com

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