Interview below with Dr Patrick Gentempo.
This was made into an ‘e-book’ though reformatted it’s only about 10 pages. There is a link at the bottom to the text in a kind of presentational form.
The communication alluded to a longer interview but I couldn’t locate it.
There are a lot of useful points in this, I couldn’t summarise it without repeating most of it. Though it’s not unfathomly technical.
Malone is in my view an exceptionally clear speaker and speaks with integrity from a position of expertise and inside knowledge. His bio looks almost unbelievable as he seems to have worked in every discipline related to vaccines. When he speaks, everyone around him listens.
Not everything he says is damning for the vaccine - he is still very pro vaccine. His view of the risk ve benefit calculation for the covid vaccine went clearly ‘minus’ when they started extending the vaccine to children. Just like the JVC1 and the FDA, in fact. But his account of the shortcomings of the rushed process reveals a breathtakingly cavalier attitude to protocol and safety.
There are a couple of comments of mine in square brakets.
Evvy_dense
Dr Robert Malone, inventor of mRNA vaccines, speaks out
Introduction
When it comes to vaccines, Dr. Robert Malone is a true believer. His career has revolved around the research and development of vaccines and vaccine technology.
As such, his knowledge of the extent of work it takes to bring a vaccine or new medical technology to market is unparalleled. He possesses in-depth knowledge spanning from the ethics to the technicalities of these processes. At what point does a man like Dr. Malone wave the red flag of warning and speak out against what he has worked on his whole career?
Simply put, he feels compelled to do so when it is clear to him that his work is being improperly used. His deep commitment to ethics and the Hippocratic Oath compel his actions, and he fears that a technology is being widely disseminated that is not yet ready for prime time. Dr. Malone’s story is best told in his own words.
Be sure to catch the entirety of his compelling interview with Dr. Patrick Gentempo in Covid Revealed.
Introduction
Who is Doctor Robert Malone?
Dr. Malone is the discoverer of in-vitro and in-vivo RNA transfection and the inventor of mRNA vaccines, while he was at the Salk Institute in 1988. His research was continued at Vical in 1989, where the first in-vivo mammalian experiments were designed by him.
The mRNA, constructs, reagents were developed at the Salk institute and Vical by Dr. Malone. The initial patent disclosures were written by Dr. Malone in 1988-1989. Dr. Malone was also an inventor of DNA vaccines in 1988 and 1989. This work results in over 10 patents and numerous publications, yielding about 7000 citations for this work.
Dr. Malone has extensive research and development experience in the areas of pre-clinical discovery research, clinical trials, vaccines, gene therapy, bio-defense, and immunology. He has over twenty years of management and leadership experience in academia, pharmaceutical, and biotechnology industries, as well as in governmental and non-governmental organizations.
Dr. Malone specializes in clinical research, medical affairs, regulatory affairs, project management, proposal management (large grants and contracts), vaccines, and biodefense. This includes writing, developing, reviewing and managing vaccine, bio-threat, and biologics clinical trials and clinical development
strategies.
He has been involved in developing, designing, and providing oversight of approximately forty phase 1 clinical trials and twenty phase 2 clinical trials, as well as five phase 3 clinical trials. He has served as medical director/medical monitor on approximately forty phase 1 clinical trials, and on twenty phase
2 clinical trials, including those run at vaccine-focused Clinical Research Organizations. His proposal development work has yielded clients billions of dollars.
Scientifically trained at UC Davis, UC San Diego, and at the Salk Institute’s Molecular Biology and Virology laboratories, Dr. Malone is an internationally recognized scientist (virology, immunology, molecular biology) and is known as one of the original inventors of mRNA vaccination and DNA Vaccination.
His discoveries in mRNA nonviral delivery systems are considered the key to the current COVID-19 vaccine strategies.
Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines.
He received his medical training at Northwestern University (MD) and Harvard University (Clinical Research Post Graduate) medical school, and in Pathology at UC Davis. Dr. Malone has close to 100 peer-reviewed publications and published abstracts and has over 11,477 citations of his peer-reviewed publications, as verified by Google Scholar. His Google Scholar ranking is “outstanding” for impact factors. He has been an invited speaker at over 50 conferences, has chaired numerous conferences and he has sat on or served as chairperson on numerous NIAID and DoD study sections.
Visit him at his website: https://www.rwmalonemd.com/
This Bio can be found online at: https://www.rwmalonemd.com/about-us
His CV can be viewed on LinkdIn at: https://www.rwmalonemd.com/s/RWM-CV-22-July-2021.pdf
The Interview
The following are highlights from Dr. Patrick Gentempo’s riveting interview with Dr. Malone. Don’t miss COVID Revealed to catch every fascinating minute.
Dr. Patrick Gentempo: since your voice is contrary to what seems to be the agenda around this, they want to discredit you and they’re trying to find ways to do it. And you mentioned earlier that the Atlantic article… they published in the Atlantic and they were struggling trying to discredit you. But in my mind, I read it. I said, wow, they just very much validated his position here.
So now here we are. And suddenly all these years go by, nobody’s ever heard of mRNA vaccines before. And one question I have around that incidentally is, cause there’s even debate around whether this technically is a vaccine… you’re saying, Hey, you’re injecting something that creates an immune response. It helps you resist disease.
In that sense, it’s a vaccine, but is there a separate FDA definition of vaccine that this would not meet, or in your mind,
is this a vaccine?
Dr. Robert Malone: this is a gene therapy product, applied for the purpose of gene therapy technology, applied for the purpose of vaccination. Both of these are ad vectored in the mRNA. They are both fundamentally gene therapy technologies applied. One of the applications for these gene therapy
technologies is for vaccination. Moderna and Pfizer’s SEC reports explicitly acknowledged that these are gene therapy products and that the FDA at the time of those reports regulates them as gene therapy products.
So are they vaccines in my opinion? Yes, they are. They are intentionally devised and formulated and licensed or not licensed yet. There have been packages submitted for requesting licensure for the purpose of vaccination, prophylactic vaccination. Vaccination has got a lot of different kinds of branches… we have cancer vaccines. We have prophylactic vaccines that are preventative. We have therapeutic vaccines that are meant to enhance your immune response against something that you’ve already got as a disease. And each of these has different regulatory considerations that have to be dealt with.
In the United States, you’re seeking not only market authorization, but interstate commerce authorization because that’s the purview that the FDA has. So you have to say what you want it to be used for. You have the latitude to define that in a lot of different ways - in these cases, they appear to primarily be prosecuting for disease and death as endpoints, not prevention of infection. So that’s something that it’s a nuance that you’re not going to hear in the main press where it kind of matters.
Dr. Patrick Gentempo: It matters a great deal for two reasons. Number one, I think like you said, for what regulatory structure is applied to it. But number two, they don’t try to assert that this vaccine that’s out right now prevents you from getting to the disease or prevents you from spreading it necessarily.
Dr. Robert Malone: It’s important to understand that I didn’t just parachute into this with SARS-Cov 2. I’ve been doing multiple outbreaks. I was at the tip of the spear in bringing the Ebola vaccine forward and getting Merck engaged, et cetera.
And in this case, I got a call from a CIA officer that was in Wuhan in the fourth quarter of 2019, who alerted me on January 4th, that I needed to get my team spun up and start going because this virus looked like it was going to be a problem.
And I made a threat assessment, which is my usual practice. And I determined that based on what was known about Coronavirus vaccines and the difficulties associated with developing such, and the risk of antibody-dependent enhancement, and the timeline that’s going to be required for the development of a safe and effective vaccine.
The only option that we had in the short term was to identify repurpose drugs and develop those for this indication where they can repurpose drugs. Repurpose drugs are ivermectin, hydroxychloroquine, famotidine, fluvoxamine, celecoxib.
Dexamethasone is a repurposed drug. It was not originally licensed for this purpose.
And that’s a whole nother rabbit hole we can go down is how we approach that and what we’ve been doing since, but I’ve been working on the repurpose drug indication. In fact, just last week, we finally got FDA clearance to proceed with our large randomized clinical trials, outpatient and inpatient, for testing the drug combination that I’ve been prosecuting and leading the group on, which is the combination of high dose of
famotidine plus celecoxib. So I’ve been very sensitized and aware of everything that’s going on, but not focusing on vaccines intentionally.
I got kind of drawn into this whole controversy because people were seeking answers. I didn’t seek out this role of truth-teller or disambiguation wizard or whatever it is that I am these days… We’ve been focusing on repurposed drugs.
So, the vaccine story.
I had made the assessment that there were too many risks and it was going to take too long and to my great surprise OWS happened, Operation Warp Speed. ít’s important to understand for your listenership, that Moderna was to a significant extent a failing company prior to this that had been launched largely with DARPA money.
Dr. Patrick Gentempo: DARPA is military…
Dr. Robert Malone: it’s really kind of a branch of our intelligence service. DARPA are the people that actually did develop the internet … and many other things. Their role is to be out on the edge, coming up with new tech. So DARPA in the United States had funded Moderna.
The German government had funded BioNTech, which is kind of interesting. Historically, if you remember, there was a time when the Trump administration was trying to buy out the German company, BioNTech. BioNTech then licensed its product and technology to Pfizer. So really the Pfizer vaccine is the BioNTech vaccine and Pfizer and BioNTech made a conscious decision not to participate in accepting government dollars. And they didn’t participate in OWS. It was Moderna.
So we have these, gene therapy products, and they were rushed and we were told that they weren’t going to cut any corners, but they did.
I mean, you can’t take, what’s normally a decade-long process for developing a product, and ensuring its safety and efficacy, and compressing it into six to nine months and not cut some corners. That’s just absurd. But yet that’s what we were told they were doing.
Dr. Patrick Gentempo: So they’re pre-authorized under emergency use… so there’s an emergency. We’re going to basically throw out the rule book… So you had safety concerns. What were the safety concerns you had?
Dr. Robert Malone: it goes back and I mentioned this, this is the first thing that I got fact-checked on by Reuters… I had an ongoing dialogue every other week with three other senior scientists at the FDA that are outside of the review branch.
It’s how DC works. We had kind of an ongoing dialogue of what’s going on and what’s going on with drug repurposing. And what do you think about ivermectin? And last fall as they were rushing these spike-based vaccines forward, I contacted them.
I was sensitized to the fact that spike was not biologically inert… Literature clearly
demonstrated that there are two proteins in the SARS-1 virus, which directly activate the Cox-2 promoter to produce Cox-2. And then the arachidonic acid metabolites that are at the basis of some of the inflammatory cascade that happens that kind of kicks off, lights the fire. It’s kind of the match that lights the fire that results in biologic response.
Again, I forgot to get back to a comment you made earlier - the virus doesn’t cause the disease, it’s your body’s immune response against the virus.
So it’s kind of an important thing to segregate is we have the prodrome, which is the viremia prodrome, and then we have the hyperinflammatory response that happens in a subset of patients. And that’s the one that really puts you in the hospital and kills you.
The good news is there’s a bunch of anti-inflammatory drugs that can be used for that second phase. And we’ve just gone over that list in part, right?
So I was aware that there are two proteins in one of those, two proteins that turn on Cox-2, which lights the fire in this whole thing. This is the spike protein on the outside of the virus. So with any of these viruses, they’re under incredible evolutionary pressure to pack as much functionality in each of their proteins as they can.
Protein is among those that have multiple functions. And one of these functions seems to be NF-kappa B mediated signaling. That turns on Cox-2.
So I notified my colleagues at the FDA. I said, guys, you know, no one seems to be paying attention that spike has other activities. It’s not biologically inert. It’s not just a receptor-binding protein that binds ACE-2.
That alone would be enough because ACE-2 is an incredibly important protein for regulating all kinds of biological effects, not the least of which is blood pressure. So I let them know some of the papers, and what came back was, well, we sent these over to the review department and they really don’t think that they’re significant enough to cause any concerns and any hesitation in proceeding with the development of these strategies.
I can’t get into the brains of what goes on in the regulatory branch… Then the data came out more and more and more about spike and spike cytotoxicity. And so by the time that Bret Weinstein podcast rolls around, there was already the disclosure from the Salk Institute, for instance, that spike was directly cytotoxic - spike as produced by the virus.
So I made this statement, and Reuters fact-checked me and said, no, no, you’re wrong. Spike is not cytotoxic. The spike produced from the virus is cytotoxic, but not the spike produced from the vaccines.
A lot of these fact-checkers do this little game where they’ll take what you say and they’ll twist it slightly, create a straw man, and then they’ll refute the straw man. This has all been a big learning experience. I’ve never had this kind of interaction, you know, being fact-checked and attacked.
In fact, now there’s more and more data that have flooded out that, that the spike protein does open the blood-brain barrier. It is directly cytotoxic. It does affect vascular endothelium spike.
And then there was a series of statements made that, well, they knew this and they engineered the spike that they put into the vaccine so that it would be safe. This came out in the mainstream media as their reaction logic to what I had floated.
That’s got an intrinsic flaw. I like to talk about the time machine. Okay, for them to have engineered spike back then when they were rushing this thing through in early 2020 would have required that they had foreshadowing of all of these spikes cytotoxicities that weren’t discovered until almost a year later. A series of events happen in terms of molecular realignment in the structure of these proteins that injects the genome of the virus into the cell, infects the cell, that’s how that cascade happens…
So they engineered spike to stay open, so the pocket would be available. And that’s not even what you really want antibodies against in the first place, if you want to get a good immune response against it, but that’s what they did, but it had nothing to do with making it less toxic.
The rules are, and it’s the job of the pharmaceutical company or the NIH since they engineered the modern vaccine, or whomever in your regulatory portfolio, before you ever go into humans, you got to prove that things aren’t toxic.
I’ve never seen the documentation that shows that the engineered spike has been demonstrated to not have the known toxic biologic activities of the native spike to argue as the press does, and even the Salk Institute then kind of partially retracted and modified their statement. And they said, well, what we’ve claimed about direct cytotoxicity associated with spike applies to the native spike, but it doesn’t necessarily apply to the vaccine spike, but they don’t actually do any studies to show that it doesn’t apply.
And I try to live in the world of, do we have data, right? We shouldn’t make assertions about is something safe or not safe. Well, unless we can demonstrate it, I mean, this is what you’re supposed to do before you take it to market. You’re supposed to before you even put it into humans.
Dr. Patrick Gentempo: I mean, this is what you’re supposed to do before you take it to market.
Dr. Robert Malone: You’re supposed to, before you even put it into humans.
Dr. Robert Malone: It binds to ACE 2. And ACE two is everywhere. It’s in your vascular endothelial cells. It’s all over the place.
Dr. Patrick Gentempo: Is this why myocarditis, pericarditis? And these other…
Dr. Robert Malone: That seems to be more of a coagulopathy. I think that’s another problem. But yes,
spike goes all over. And the amount that you detect as free protein is probably just a tiny fraction because it’s in equilibrium with bound to ACE 2 protein, which is going to be a big sink.
And that’s in equilibrium with a spike that hasn’t been cut off of cells yet. No one’s ever measured all this stuff, which gets into another one of the huge bear traps here in terms of what the FDA did.
If you could take the Pfizer dossier… from the Japanese government as face value for what they knew at the time when they moved this into humans in a big way, they didn’t actually test the final drug product.
Dr. Robert Malone: They didn’t actually use the final formulation you’re supposed to use. Everything I’ve always been taught and what I’ve always thought we had to do - you have to use a near GMP or GMP manufactured, final product to do the pivotal toxicology tests of biodistribution, duration of expression, cell location, all this kind of stuff. They did none of that, but the governments just let them get away with
comp. [sic]
It appears taking data off the shelf that they had developed for other purposes and kind of slammed it all together. And, you know, to bless it and off we go. As a consequence of that strategy and not insisting that the gene therapy checklist beapplied, we have no real information about how much protein is being made, where it’s being made, and for how long.
Dr. Patrick Gentempo: So we’re flying blind in essence. Maybe it’s the idea that we’re going to just put it out in the world and then collect our data after we do it. I mean, it seems irresponsible.
Dr. Robert Malone: I concur. That’s why I had made the threat assessment that we should focus on repurposed drugs because to do it right, is going to take a long time. And furthermore, to establish safety when there’s this history of antibody-dependent enhancement.
And this history of autoimmune disease, and with vaccines in general, which often manifests over time, usually you need at least a year’s data, usually two years data after you’ve administered to a very large number of patients, willingly accepting that participation in those clinical trials, not forced or enticed, and you have to follow them rigorously to make sure that they don’t develop long-term adverse events like
autoimmunity. So they just flushed all that.
In this case, the FDA basically gave the pharmaceutical companies a complete pass, and they said, we’re not going to ask you to do anything in terms of safety follow-up… even though they said in their emergency authorization that antibody-dependent enhancement was a risk… It remains unresolved…they did nothing.
Dr. Patrick Gentempo: What is antibody-dependent enhancement?
Dr. Robert Malone: it’s one of a spectrum of processes whereby a vaccine causes enhanced disease.
[Contunues below]
