Bioethics and the mRNA Vaccines

Excerpt from an interview with Dr. Robert Malone, developer of the new mRNA technology used to deliver the Pfizer and Moderna vaccines. (Please read the entire article for a science-based, informative approach to understanding the new technology, or listen to the interview at the link below.)

Mr. Jekielek: Robert, on top of everything else, you’re actually a trained bioethicist. And you’ve already started addressing some of the ethical questions are conundrums around what’s happening or what you see happening. Give me a little bit of the scope of this as we start finishing---

Dr. Malone: I wrote… Thank you for that. And for that lead-in, I personally, I think this is one of the most important topics, is the bioethics of use of an experimental medicine and experimental vaccine.

And the genesis of this whole thought thread was a two-hour conversation with a Canadian physician a number of weeks ago, where he just poured his heart out about what he was seeing with his patients and what was going on in Canada. And I was left saying, “Well, thanks for sharing this, but I can’t help you. I don’t have anything.”

I woke up that Sunday morning with an aha moment. And I said, “I know what I can do for this guy. I can write a piece about bioethics, the bioethics of vaccination under emergency use authorization.”

So, I dug into rich literature that exists as well as federal law. That goes back to The Helsinki Accords, The Belmont report, et cetera, and looked at what are the fundamental principles of bioethics as they relate to use of an experimental product.

1) So point number one just summarize that, and this is, you can find it in The Code of Federal Regulations, it’s referred to as the Common Rule. So this is actually Federal Law. It’s not just words that academicians agree to. So the first thing is that an emergency use authorization product, which is what all these vaccines are, and many of the drugs, is an experimental product. It’s not yet licensed. So that’s point number one. They’re all experimental products.

2) Point number two, if you’re going to be administering experimental products to patients that falls under clinical research, medical research. And so, you have to follow the guidance for medical research. And I mentioned the Common Rule is codified in the Code of Federal Regulations.

a) The first clause, importantly in the Common Rule, is there has to be complete disclosure of risk. You know, intuitively what that means because when you buy a bottle of aspirin, you pull out this little piece of paper, and you look at that, and you go, “Holy Moly, this aspirin is going to kill me.” If you read all the way through, it could cause heart attacks or gastric erosions, or whatever. And you look at that, and you say, “Oh, I don’t know if I want to take that aspirin.”

But the truth is that the ones that are common are up at the top, and we all take aspirin or Tylenol or some version of that. That’s the level of disclosure of adverse event risk that must be provided to patients participating in clinical research. That level of information, as we’ve just been discussing, is censored. It’s not available. So we are not meeting the criteria for full disclosure of risk.

b) Second key principle is that that full disclosure has to be comprehensible and comprehended. Earlier on, I referred to thrombocytopenia, and you were like, “What the heck was that?” And I said, “Low platelets.” That’s a great example. The first one was scientific jargon that was incomprehensible to you. The second one you could understand. So these risks have to be conveyed using language that people can comprehend.

c) Third key principle, you cannot coerce. You cannot entice. The patient or the subject has to freely accept the experimental medicine of their own volition. All these messaging about, “You must take the vaccine. You must take the vaccine because otherwise and aunt Mary could get infected.” All of this messaging that the vaccine is safe, et cetera, all the peer pressure that’s happening around the vaccine, that’s coercion.

Now it gets even more florid with those nations. I don’t think we’ve done it here in the States, but the Canada has. We’re going to give out ice cream cones to get the kiddies to come and take the jab that’s been done. That’s coercion and enticement.

Then there’s the last little codicil in all this. We call it the age of consent. So we here in the States generally agree that the age of consent is 18. If you are at or below the age of consent, you need to have approval or consent from your parent or guardian to take an experimental medicine. They act as your agent because you’re not able to provide consent by definition.

We cannot, by law, have infants, children, and adolescents receiving experimental products without authorization of their parents.

Now, listening to this, [one] might say, “Well, we have this special case of an epidemic, and we have to all get vaccine. Why do we have to all get vaccine? What’s the logic behind that?” What we’re told is we have to all get vaccinated so we will reach herd immunity. That’s the logic.

The problem is that that is a fallacy. We have not gathered the data to even be able to calculate in these clinical trials what would give us herd immunity? What would herd immunity mean? It would mean that we have what’s called sterilizing immunity, or in some way, if we get infected, we don’t spread it to somebody else. That means that we’re not producing virus and shedding virus.

Just today, the World Health Organization made an announcement clear and unequivocal. You’ve got to start using masks because none of these vaccines are preventing infection. They’re preventing disease. They’re not preventing transmission, and they may be reducing transmission, but by how much we don’t know. And so we can’t calculate what the percent uptake is required to reach herd immunity, if we could reach herd immunity with these vaccines.

So there’s an underlying logic that’s been pushed out globally about why we have to take vaccine and how many of us have to take vaccine. And it’s not actually supported by data. And to my mind, that’s a problem. And it’s kind of gone all the way through this outbreak where key public health officials have felt comfortable substituting their opinion for evidence-based medicine.

And that always has to happen at the start of an outbreak because there’s no data. Somebody’s got to have expert opinion. We’re past that point. We have a lot of data, and it’s time we start relying on evidence to make public health decisions, and we’re not doing it.

So to my eye, from the bioethics, we appear to be failing to meet the Code of Federal Regulations, Federal Law, let alone fundamental precepts that go back to the end of World War II. We’re not providing full disclosure of risk. We’re not doing so in a way that’s readily comprehended by the public. And we are enticing, compelling, coercing, and otherwise not respecting the rights of the individual to choose what happens to their body.

And in my mind, that’s bedrock is we all have in Western society, the right to choose the State does not own our body, we do. Particularly for an experimental product.

I argue that we’ve crossed a line. It’s a bioethical line. It may actually be Federal Law that we’ve crossed. Inadvertently, I’m sure for all the best reasons, but if you go back, read the code, read the Nuremberg Code. What we’re doing is not aligned with fundamental principles. And as you know, this happens from time to time during war and crisis.

Cultures decide that it’s okay to bend the rules on some fundamentals of ethics, whether it’s torture, internment of populations, whatever. I believe they almost universally end up regretting it. And so, I’m trying to responsibly ethically with the credibility that I have in my CV, and because of my role in inventing this technology to alert people that I believe that we’re pushing and crossing some key lines here that we really should be respecting.

Mr. Jekielek: Robert, we’re going to have to finish up shortly, but I have probably about a few hours more worth of questions for you at this point. So we’ll have to actually invite you back. Any final thoughts before we finish up for today?

Dr. Malone: Yeah. If I can speak to your audience, like I said, it’s your body. In my recommendation, general recommendation is, in my opinion, these vaccines are saving lives. They’re saving many lives, particularly in the elderly. I get asked the question all the time, “Should I take this vaccine or that vaccine because I have this preexisting condition, an autoimmune disease, or whatever?”

And my recommendation is that you know your body best, you and your medical care provider, and that you have the right to accept or not accept a vaccine product, particularly an experimental one. And that you make your own decision. I can’t advise you, in the end neither can your physician completely advise you.

It’s up to you. It’s your body. It’s your choice. And I just suggest strongly that you take the time to get informed, do the best you can, and then make the decision that you think is right for you."

In Canada the Trudeau Administration is requiring the vaccination of school children as young as 7 years of age, without parental consent:

Bio-fascism in Canada...coming to the US.

The Biden Administration has already said that it wants to send canvassers to knock on your door and encourage (coerce?) you to get vaccinated. This is a violation of bioethics, point 2c) in the article above.

Biden's HHS chief, Xavier Becerra, said, “It’s absolutely the government’s right to know if you have been vaccinated. We spent trillions trying to keep you healthy of COVID. You don’t have to answer the door but I hope you do.”

Well, the brown stuff is going to hit the fan when the school year begins. How many mothers are going to allow their young children to be vaccinated with an experimental, cell-altering drug? We'll see. A flu vax is one thing, an experimental one is something quite different.