Title : Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down.
link : Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down.
Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down.
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By Robert W Malone, MD, MS
I provide this brief essay for the TrialSite community because you are involved or at least interested in human subjects clinical research. 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 night 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 the vaccination of his patients with the 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 (see here).
What was most alarming 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 is the face of censorship in the time of COVID. My question is, what are official public health leaders so afraid of? Let’s analyze the vaccine-related adverse event data rigorously. Is there information or patterns that can be found? 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 suggest for your consideration that adult citizens are not children to be dictated to by paternalistic public health authorities. They must be allowed free will, the freedom to choose. These products remain experimental vaccines at this time. Furthermore, we are supposed to be doing rigorous, fact-based science and medicine. If the 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. And the adult public can handle information and open discussion. They are grown-ups. They should not be treated like children.
In this context, the adult public is 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.
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. And as a community, we have already had this 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 here.
To my eyes, 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. Now. 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 that 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 country 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 IRB based on coercion of subject participation. No coercion to participate in the study. In human subjects clinical research, in most countries of the world, this is considered a bright line that cannot be crossed. So, now we are told to wave 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.
1) An unlicensed medical product deployed under emergency use authorization (EUA) remains an experimental product under clinical research development.
2) EUA authorized by national authorities basically grants a short-term right to administer the research product to human subjects without written informed consent.
3) The Geneva Convention, the Helsinki declaration, and the entire structure which supports ethical human subjects research requires that research subjects be fully informed of risks and must consent to participation without coercion.
Has that bright line been crossed? If so, what actions are to be taken? I look forward to learning from your thoughts and conclusions.
The line has been crossed so often it's been completely obliterated by the immoral actions of public health officials, politicians and other!
What do you think?
From earlier:
Canada’s Covid Vaccine Weekly Death and Injury Report- 76 Dead w Vaccine, Worsened Data Lag Continues
As bad as the Canadian data is week after week, it's probably much worse.
Thus Article Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down.
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