Articles, Interviews, and Presentations
Articles, Interviews, and Presentations
Robert W. Malone, MD, MS
Co-Chair, Advisory Council, Pono Coalition for Informed Consent; Inventor, mRNA Vaccines; Bio-Ethics Specialist
Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down. (TrialSiteNews.com, May 30, 2021)
I provide this brief essay for the TrialSite community because you are involved or at least interested in human subject clinical research. By way of background, please understand that I am a vaccine specialist and advocate, as well as the original inventor of the mRNA vaccine (and DNA vaccine) core platform technology. But I also have extensive training in bioethics from the University of Maryland, Walter Reed Army Institute of Research, and Harvard Medical School, and advanced clinical development and regulatory affairs are core competencies for me.
Before examining the bioethical foundations of current policy and practice which underpin experimental COVID vaccine deployment in many in many western nations, allow me to begin by sharing some “real world” first-hand evidence.
I was on a call with a Canadian primary care physician last week for a couple of hours. He related the story of the six (in his mind) highly unusual clinical cases of post-vaccination adverse events that he has personally observed in his practice involving vaccination of his patients withhe Pfizer mRNA vaccine product. Keep in mind that it was Canadian physicians – acting of their own accord – who filed the FOIA to gain access to the Pfizer vaccine IND.
What was most alarming to me was that my clinical primary practice physician colleague told me that each of these cases were reported as per the proper channels in Canada, and each was summarily determined to not be vaccine related by the authorities without significant investigation. Furthermore, he reported to me that any practicing physician in Canada who goes public with concerns about vaccine safety is subjected to a storm of derision from academic physicians and potential termination of employment (state-controlled socialized medicine) and loss of license to practice. This one face of censorship in the time of COVID.
But what are official public health leaders afraid of? Why is it necessary to suppress discussion and full disclosure of information concerning mRNA reactogenicity and safety risks? Let’s analyze the vaccine-related adverse event data rigorously. Is there information or patterns that can be found, such as the recent finding of the cardiomyopathy signals, or the latent virus reactivation signals? We should be enlisting the best biostatistics and machine learning experts to examine these data, and the results should- no must- be made available to the public promptly. Please follow along and take a moment to examine the underlying bioethics of this situation with me.
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.
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.
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.
I really think we need to “stop, children, what’s that sound – everybody look what’s going down” (For What it’s Worth, Buffalo Springfield)
Furthermore, as these vaccines are not yet market authorized (licensed), coercion of human subjects to participate in medical experimentation is specifically forbidden. Therefore, public health policies which meet generally accepted criteria for coercion to participate in clinical research are forbidden.
For example, if I were to propose a clinical trial involving children and entice participation by giving out ice cream to those willing to participate, any institutional human subjects safety board (IRB) in the United States would reject that protocol. If I were to propose a clinical research protocol wherein the population of a geographic region would lose personal liberties unless 70% of the population participated in my study, once again, that protocol would be rejected by any US IRB based on coercion of subject participation. No coercion to participate in the study is allowed. In human subject clinical research, in most countries of the world this is considered a bright line that cannot be crossed. So, now we are told to waive that requirement without even so much as open public discussion being allowed?
In conclusion, I hope that you will join me; stop to take a moment and consider for yourself what is going on. The logic seems clear to me.
Has that bright line been crossed? If so, what actions are to be taken? I look forward to learning from your thoughts and conclusions.
Co-Chair, Advisory Council, Pono Coalition for Informed Consent; Founder & President, Alliance for Human Research Protection; Holocaust Survivor
In her testimony before the German Corona Inquiry Committee, Vera Sharav draws comparisons to the Nazi regime (up to minute 20:00) and explains in the second half of the interview her theory why all this is happening. The German-language parts of the conversation are deleted. Full video at https://odysee.com/@Corona-Ausschuss:... (roughly 2:50:00 forward)
HISTORICAL PARALLELS WITH VERA SHARAV AND DR. ANDREW KAUFMAN
Dr. Kaufman and Holocaust Survivor Vera Sharav discuss the common subversion of the health system in WW II era Germany and the current COVID-19 great reset agenda.
Peter McCullough, MD, MPH
Co-Chair, Advisory Council, Pono Coalition for Informed Consent; Cardiologist; Chief Medical Advisor, Truth for Health Foundation
Study: Fully Vaccinated Healthcare Workers Carry 251 Times Viral Load, Pose Threat to Unvaccinated Patients, Co-Workers (Children's Health Defense, August 23, 2021)
A preprint paper by the prestigious Oxford University Clinical Research Group, published Aug. 10 in The Lancet, found vaccinated individuals carry 251 times the load of COVID-19 viruses in their nostrils compared to the unvaccinated.
A groundbreaking preprint paper by the prestigious Oxford University Clinical Research Group, published Aug. 10 in The Lancet, includes alarming findings devastating to the COVID vaccine rollout.
The study found vaccinated individuals carry 251 times the load of COVID-19 viruses in their nostrils compared to the unvaccinated.
While moderating the symptoms of infection, the jab allows vaccinated individuals to carry unusually high viral loads without becoming ill at first, potentially transforming them into presymptomatic superspreaders.
Shocking post-vaccination surges
This phenomenon may be the source of the shocking post-vaccination surges in heavily vaccinated populations globally.
The paper’s authors, Chau et al, demonstrated widespread vaccine failure and transmission under tightly controlled circumstances in a hospital lockdown in Ho Chi Minh City, Viet Nam.
The scientists studied healthcare workers who were unable to leave the hospital for two weeks. The data showed that fully vaccinated workers — about two months after injection with the Oxford/AstraZeneca COVID-19 vaccine (AZD1222) — acquired, carried and presumably transmitted the Delta variant to their vaccinated colleagues.
They almost certainly also passed the Delta infection to susceptible unvaccinated people, including their patients. Sequencing of strains confirmed the workers transmitted SARS-CoV-2 to one another.
This is consistent with the observations in the U.S. from Farinholt and colleagues, and congruent with comments by the director of the Centers for Disease Control and Prevention conceding COVID-19 vaccines have failed to stop transmission of SARS-CoV-2.
On Feb. 11, the World Health Organization indicated the AZD1222 vaccine efficacy of 63.09% against the development of symptomatic SARS-CoV-2 infection. The conclusions of the Chau paper support the warnings by leading medical experts that the partial, non-sterilizing immunity from the three notoriously “leaky” COVID-19 vaccines allow carriage of 251 times the viral load of SARS-CoV-2 as compared to samples from the pre-vaccination era in 2020.
Thus, we have a key piece to the puzzle explaining why the Delta outbreak is so formidable — fully vaccinated are participating as COVID-19 patients and acting as powerful Typhoid Mary-style super-spreaders of the infection.
Vaccinated individuals are blasting out concentrated viral explosions into their communities and fueling new COVID surges. Vaccinated healthcare workers are almost certainly infecting their coworkers and patients, causing horrendous collateral damage.
Continued vaccination will only make this problem worse
Continued vaccination will only make this problem worse, particularly among frontline doctors and nurses workers who are caring for vulnerable patients.
Health systems should drop vaccine mandates immediately, take stock of COVID-19 recovered workers who are robustly immune to Delta and consider the ramifications of their current vaccinated healthcare workers as potential threats to high risk patients and coworkers.
CLARIFICATION: The comparison of viral load between vaccinated and unvaccinated (pre-vaccine era) as reported in the Chau et al. 2021 Lancet preprint is between two different variants of SARS-CoV-2. Dr. McCullough states directly that samples were compared to those “from the pre-vaccination era of 2020.” Thus, differences between these two groups aren’t a result of vaccination status alone. The authors of the Chau et al. 2021 study in their rebuttal to our piece point out another preprint (Li et al. 2021) which reported a difference in viral load of ~1000 between patients infected with the Delta variant and patients infected with A/B. However, the vaccination status of the Delta variant patients in this preprint is not reported. Thus, no one here has done a direct comparison between unvaccinated Delta patients and unvaccinated A/B patients to determine the true difference in viral load. In two additional preprint scientific publications (Riemersma et al. 2021, Chia et al. 2021), comparable viral loads of the Delta variant of SARS-CoV-2 are reported among vaccinated and unvaccinated patients. However, this itself is an indictment of vaccine efficacy as both vaccinated and unvaccinated individuals possess the ability to spread the Delta variant. Simply stated, COVID vaccines have failed to stop transmission of SARS-CoV-2.