Ask Dr. Drew - How Reliable Are The Safety Trials For mRNA? Dr. Jessica Rose, Dr. Joseph Fraiman & Dr. Kelly Victory Discuss The Data and RCT Concerns – Ask Dr. Drew – Episode 261

Episode Date: September 10, 2023

Dr. Jessica Rose, Dr. Joseph Fraiman, and Dr. Kelly Victory return to discuss concerns about the reliability of safety trials for mRNA vaccines, and why some experts are saying that its RCT (randomized controlled trials) asked all of the wrong questions. Dr. Joseph Fraiman is an emergency medical physician from Louisiana. He is the former Medical Manager of Louisiana’s Urban Search Rescue Disaster Task Force 1. In a letter published in Vaccine, Dr. Fraiman led a group of physicians who warn “there are major shortcomings in the FDA’s recent publication of its first “near real-time surveillance” study.” Follow him at https://twitter.com/JosephFraiman/ Dr. Jessica Rose is a Canadian researcher with a Bachelor’s Degree in Applied Mathematics and a Master’s degree in Immunology from Memorial University of Newfoundland. She also holds a PhD in Computational Biology from Bar Ilan University and 2 Post Doctoral degrees: one in Molecular Biology from the Hebrew University of Jerusalem and one in Biochemistry from the Technion Institute of Technology. She was also accepted for a 2-month program as a senior researcher at the Weizmann Institute prior to completion of her latest post doctoral degree at the Technion. Her more recent research efforts are aimed at descriptive analysis of the Vaccine Adverse Event Reporting System (VAERS) data in efforts to make this data accessible to the public. Find Dr. Jessica Rose online at https://www.jessicasuniverse.com and https://jessicar.substack.com 「 SPONSORED BY 」 Find out more about the companies that make this show possible and get special discounts on amazing products at https://drdrew.com/sponsors • COZY EARTH - Say goodbye to hot, restless nights with soft, temperature-regulating bedding from Cozy Earth. Susan and Drew love Cozy Earth's sheets made with super-soft viscose from bamboo! Use code DREW at checkout to save 40% at https://drdrew.com/cozy • GENUCEL - Using a proprietary base formulated by a pharmacist, Genucel has created skincare that can dramatically improve the appearance of facial redness and under-eye puffiness. Genucel uses clinical levels of botanical extracts in their cruelty-free, natural, made-in-the-USA line of products. Get an extra discount with promo code DREW at https://genucel.com/drew • PRIMAL LIFE - Dr. Drew recommends Primal Life's 100% natural dental products to improve your mouth. Get a sparkling smile by using natural teeth whitener without harsh chemicals. For a limited time, get 60% off at https://drdrew.com/primal • THE WELLNESS COMPANY - Counteract harmful spike proteins with TWC's Signature Series Spike Support Formula containing nattokinase and selenium. Learn more about TWC's supplements at https://twc.health/drew • BIRCH GOLD - Don’t let your savings lose value. You can own physical gold and silver in a tax-sheltered retirement account, and Birch Gold will help you do it. Claim your free, no obligation info kit from Birch Gold at https://birchgold.com/drew 「 MEDICAL NOTE 」 The CDC states that COVID-19 vaccines are safe, effective, and reduce your risk of severe illness. You should always consult your personal physician before making any decisions about your health.  「 ABOUT THE SHOW 」 Ask Dr. Drew is produced by Kaleb Nation (https://kalebnation.com) and Susan Pinsky (https://twitter.com/firstladyoflove). This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. 「 ABOUT DR. DREW 」 Dr. Drew is a board-certified physician with over 35 years of national radio, NYT bestselling books, and countless TV shows bearing his name. He's known for Celebrity Rehab (VH1), Teen Mom OG (MTV), Dr. Drew After Dark (YMH), The Masked Singer (FOX), multiple hit podcasts, and the iconic Loveline radio show. Dr. Drew Pinsky received his undergraduate degree from Amherst College and his M.D. from the University of Southern California, School of Medicine. Read more at https://drdrew.com/about Learn more about your ad choices. Visit megaphone.fm/adchoices

Welcome to an early version of the show today on this Wednesday. Today we are very fortunate, of course, to be joined by Kelly Victory, as we always are on Wednesday. Dr. Jessica Rose comes back. She's a Canadian researcher. She has a degree in math, a master's in immunology. She holds a PhD in computational biology, doctoral degrees in molecular biology. She has also a degree in biochemistry, and she has been looking at the various data and very concerned about adverse events for some time. She has some updated data today on contamination of the vaccines. We are also very pleased to be joined by Dr. Joseph Freeman, ER doctor, physician from Louisiana, who's been very concerned about the approval process for medication and vaccines by the Federal Drug Administration, the FDA.

He manages Louisiana's Urban Search and Rescue Disaster Task Force. And he has led a group of physicians about these major shortcomings in the FDA's recent publications. And he has some recordings of his interaction with the FDA when he presented this data to them. We're going to get into that and more right after this. Our laws as it pertains to substances are draconian and bizarre. A psychopath started this. He was an alcoholic because of social media and pornography, PTSD, love addiction, fentanyl and heroin. Ridiculous.

I'm a doctor for f*** sake. Where the hell do you think I learned that? I'm just saying. You go to treatment before you kill people. I am a clinician. I observe things about these chemicals. Let's just deal with what's real. We used to get these calls on Loveline all the time. Educate adolescents and to prevent and to treat.

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performance. Visit birchgold.com slash drew to get your free info kit on gold. That is B-I-R-C-H-D-O-L-D dot com slash D-R-E-W. Welcome back. As I said, we got Jessica Rose and Joseph Freiman in here. I want to bring Jessica in here first. As I said, she's a Canadian researcher, a degree in math, a master's in immunology, a PhD in computational biology, molecular biology, and biochemistry. And in addition to a little vaccine talk today,

we're going to get an update about Maui. Please welcome Dr. Jessica Rose. There you are. Welcome back. Hi. Thanks for having me back. Pleasure to be here. You bet. Before we get into plasmids and all things vaccine, can you give us an update on what's going on with Maui? Probably not better than anybody. I'm a little confused about what's going on there. It appears as though there's definitely something being covered up, according to what I'm hearing from locals that I know and also don't know that you can hear on social media. They're talking into their phones about what's going on. But what I keep hearing since the beginning

is that there are children unaccounted for. And some people are claiming that they were actually stuck in their homes and perish the thought but burned. And other people are saying that they were actually stuck in their homes and perish the thought, but burned. And other people are saying that they're missing. And like, I don't know what the truth behind that is, but nonetheless on the subject matter, the most important things that I think we need to address are these events that led up to these potential

deaths because if even one kid died, that's too many kids to have died and people need to be held accountable. So whether it be leaving the fire before it was out, to put out a fire on the other side of the island, to treasure the water um to not sound the siren because it wasn't an official tsunami or because you know they're saying that the fire started due to outdated power lines etc i mean this these are all things that uh i mean someone needs to be held you know that's that's jessica i, I don't know on the government side. Unfortunately, they have these qualified immunities that allow them not to learn from their mistakes,

while the rest of us take profound punishment when we make mistakes. But I assure you, I spoke to a lawyer over the weekend. The lawyers are not actually directly involved in taking action. They are not missing this opportunity, I assure you. I assure you there is a lot going on. And associated with those actions is a tremendous amount of private investigative activity, that sort of thing, you know, sort of fact finding. So, and also you need to recognize that these attorneys that do this sort of work need every molecule of information because they hold these people accountable

to every single thing they find. And that's how they optimize their return on what they're working on. But it is on so I don't worry everybody the the legal system will have its way the government you know and with their need for I worry I when I saw now I worried about our situation here in California where we don't do forestry control I used to look up in these San Gabriel Mountains when I was a kid and it would they were crisscrossed with fire breaks

well, we stopped doing that because they interfered with the the Immigration of a mouse some mouse wasn't able to get across properly And so now and they would refuse to do the underbrush cleaning out which they need to do And when there is a fire which there will be it will be catastrophic catastrophic here in southern california you would think maui would be some sort of a cautionary tale no because government the individuals making the decisions have qualified immunity and they never learn because of that they have no skin in the game other than re-election which again in this state we seem to re-elect and

re-elect re-elect incompetence but i don't know whatever uh who am i to say yeah the the people who always seem to lose are the the actual people you know what i mean it's like of course the people who are invested the people who work hard the people who are invested, the people who work hard, the people who are expected to go back to work, even though they don't have a home or they can't even go to see if there's anything left from their belongings. I mean, it's yeah, I hope there's some kind of justice here. I'm I'm I'm putting all of my thoughts and energies into that. So. I think there will be ultimately, but again, it takes time, but I want to get Joseph Freiman and Kelly victory in here as soon as possible before we do. I'm

going to, what I'll do is I'll take a little break after we have this next topic, you and I give me what's going on. I keep hearing not rumors, but I keep reading material about plasmid contamination by the vaccines. Explain to people what a plasmid is, what the risk of a plasmid is, and what the evidence for this is. Okay, I'll try and do this very succinctly. Kevin McKernan is a genomics expert, and he found DNA in vials that he tested for some other thing. He was looking for a control. So this was not something he set out to do.

DNA should not be in the vials. There should only be modified mRNA in the vials. That's the first thing. The way that the DNA got in is because the process that they're using to manufacture the modified mRNA for encapsulation in lipid nanoparticles uses E. coli, which have these circular plasmids in them that encode the spike gene. So it's a method for making a lot of DNA for in vitro transcription to make the mRNA. So it's something that we do, but we haven't done this in the context of modified mRNA with these one methyl pseudouridines.

And so what we're thinking happened is at the last step, when they're supposed to purify the modified mRNA out using this enzyme that eats up the DNA such that you don't have any more DNA, was that the DNAs didn't work on what we're calling what, you know, might be hybrids. So the DNA might have fused to the mRNA, for lack of a better way of saying it, and that enzyme might not have worked to remove these things. So basically what happened is we, well, an hypothesis is that the DNA contamination in the vials that Kevin detected, and by the way, this has been reproduced

in other labs, which is the way that we're supposed to do this. If somebody finds something, you have to reproduce the results. This is the most important thing in science. So this has been done. But this is the working hypothesis as to how this DNA actually got brought over. It got mixed up in the mRNA because it wasn't properly taken out during the purification step and encapsulated in the lipid nanoparticles. So that's all Kevin and Philip Buchholz is one of the other confirming cancer specialists. He has his own lab as well. Separate vials, completely independent investigations found very, very similar things,

which is this DNA contamination. So there are many repercussions of this, of which we might be able to explain in some of the adverse events we're seeing. So that was a long summary, but that's what's going on. We got it. So there's a couple of questions. One we have for the average person, what is it about the DNA that is associated with adverse events? That's sort of one topic.

And then I was thinking about the biology of the DNA plasmids on unwinding and opening and fusing with mRNA. Do they have a theory about how that happened? Well, you have to linearize. Basically, you take it out of its circular shape before you do the in vitro transcription. I don't do this. I've never done it myself, but this is how it's done. You put it into its linear form. Somewhere along the line, we are hypothesizing that that's what happens. So DNA, RNA hybrids are a thing. And they create these little things called our loops, which, you know, I never mind what that is, but these can also create problems in vivo in terms of create creating genomic instability. So

John Greenewald, genomic instability in human cells, other human cells. Yeah. So yeah, interfering with normal processing in in terms of what happens genomically. So the other thing that I've heard in one of the conversations I've had with colleagues is that these little bits of DNA, they're not circular plasmids that are being transferred, they're like little bits. And according to one of these experts, these little bits more easily can integrate into the genome of humans. And the problem with that is, well, multifold.

They can actually get inserted inside very important genes. So say you get insertion of this little piece of DNA into an existing gene, you're going to mess up that gene's function. So again, this is all just our line of thinking right now as to the possible ways that this could go wrong. But back to the R loops, you don't really even need that if you're interfering with DNA repair, that's sufficient to cause massive issues. Yeah, everyone, if you want to know more about that, you can go

to the net, but not put the lactone newsletter that Kevin's newsletter, and he wrote an article called DNA-RNA hybrids, R-loops, and nucleus resistance of the mRNA vaccines. He explains this really well here. And there is a Nature paper that was published called R-loop-derived cytoplasmic RNA-DNA hybrids can activate an immune response. So basically, these things are there, they're a part of like nature, like it's, it's not a weird thing that our loops are created. The problem is that they can accumulate and that can cause problems. Again, Kevin, Kevin is the one to answer these questions in more detail, but all of these issues arise because of...

Sorry, go ahead. I was just going to say, I know also you're concerned about lipid nanoparticle polysaccharide contamination and changes as well. Yeah. So that was another issue that was of concern because of this process to method of, for lack of a better way of saying it, growing up the DNA using E. Coli. So we do this, like it's not something that's like, oh, we're using E. coli. That's not the big deal. The big deal is that when you use this as part of this process, you need to make sure that you don't take lipopolysaccharide, which is, you know, it's a part of this E. coli with you in your final product. So we always test or, you know, the people who test for these things test for endotoxin levels when they have a finished product to make sure that they're not exceeding some kind of accepted level.

Because if you inject someone with lipopolysaccharide, you're probably going to induce anaphylactic shock or septic shock. It's pretty bad. So it's interesting because Kelly actually mentioned, you know, that she has a PEG allergy and if she got injected with these things, she probably would go into anaphylactic shock. So it got me wondering that because we have seen a lot of reports of anaphylaxis following injection with these things. So I'm wondering if it isn't partially the PEG and also maybe the lipopolysaccharide. I don't know. We need to confirm all of this, but these are the hypotheticals that could potentially go wrong. And this is why we measure these things, not we, you know, me and my colleagues, but the people who test

for contaminants before they inject things into people, for example. You have to do this as part of good manufacturing practices and responsibility and all that stuff. So yeah, interesting to see what the redacted levels of the endotoxin are. Right. Have they been doing that? And by endotoxin, let me just explain to people that these E. coli, it's how they create the diarrheas and they create bad illness and things.

They release this lipopolysaccharide that's an endotoxin that's part of their makeup. But is this being done appropriately that they're testing for these things? Well, the only document that I've seen disclosed by the context of the SpikeFax product where they did measure endotoxin levels, the measurement was redacted. So that really blew my mind because I don't understand why a test result would be redacted so that really blew my mind because i i don't understand why a test result would be redacted uh i i can't even speculate i mean i have i i've i've thought well maybe the reason why they're redacting it is because it was above some accepted criteria and they didn't want people to know because it's not like they haven't done that before but again that's speculation um yeah it would be really interesting if um people we could prompt people who have labs to actually reproduce all of these findings that kevin and philip and and and everyone is are finding because

this affects everybody it really does yeah yeah this would be amazing if they could do that but i i just astonished at the way people feel they can hide information and not invite worst case speculation i just i just don't understand people do people not understand how the human it induces paranoia and speculation when you hide a. That's how human brains work. And if you're thinking is a little more paranoid than not, you can go way all over the place and fill in the unknown. It's sunshine, fresh air, conversation, discourse, repetition of results. That's why the scientific method. Right, exactly.

That's why it's always been since bacon that's the way it's been done and now all of a sudden and by bacon i mean francis bacon not not pork uh but that's uh and uh he's he invented he's really the first example of the experimental method the scientific method and and uh and it's always been done that way until the present moment. This is what people have got to understand. All right. And to that point, we're going to bring Joseph Freeman in after the break here. Jessica, you're going to stay with us.

We're going to bring Kelly in as well. Dr. Kelly Victor, of course. It's Wednesday. And I think we'll probably kick off with a conversation about the shortcomings of studies and randomized control trial we'll be right back fall is right around the corner which means dry flaky red skin from allergy season is coming with it but the best way to take care of your skin is with our skincare secret genucell you don't need to worry about that puffy tired eye look or those annoying dark spots

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This is uncharted territory, Drew. And here we are, Dr. Kelly Victory. I give you Jessica Rose, and after a few minutes, we'll bring in Dr. Freeman. Terrific. Hey, Jess, welcome back. So happy to have you here. Hey, let me just follow up on this issue about polyethylene glycol, PEG. I had huge concern about that from the very, very beginning as somebody who has a very severe, longstanding allergy to polyethylene glycol. It turns out that that's a very common allergy. PEG is used, a lot of people don't know this, in topical agents all the time. It's very commonly used, for example, in cosmetics, in sunscreens,

lotions, that kind of stuff. And that for me, and probably I'm guessing for the majority of people with that allergy doesn't cause concern. It's only when you take it orally. And I found out the hard way taking a medication that actually went under your tongue and the carrier was polyethylene glycol. And I developed a Stevens Johnson's type reaction and was very, yeah, profoundly ill. Yes, profoundly ill. And it turns out that that's not that uncommon. I can't imagine what would happen to me if I injected it. That's when I put it under my tongue. If somebody injected it into my arm, I can only imagine. And that's why I found it so stunning that physician after physician and nurse after nurse was perfectly happy to have me injected with it when I was in

the hospital, telling me that, don't worry, you're here. We can take care of you if you become deathly ill. Anyway, kind of these are different times. I want to change gears for one minute before we bring Dr. Freiman on. Jess, you posted a link to an article or a story about the study done in the UK, looking at all cause mortality in people vaccinated versus unvaccinated people in the UK. Is that something that you feel comfortable talking about? I won't do the study justice, but it looked at rates, all-cause mortality rates, and broke it down based on vaccination status in the UK. And it's a large group because they were looking at people over the age of 18, which in the UK is about 50 million people.

And it appeared to me, based on what you linked, that that study showed pretty clearly that the vaccine itself was the cause of increased mortality. Nothing else. Is that a study you can talk about? It's probably a cross post. So I'm not really the all cause mortality. Is that a study you can talk about? It's probably a cross post. So I'm not really the all cause mortality person, but yeah. So but I would comment that the weirdest part about it is the absolute lack of possibility that the increase in deaths, which doesn't have any known cause,

could absolutely not be due to these products that were rolled out in 2021. So yeah, that's the part about it that really boggles my mind. I mean, something is killing young people, healthy people. There are more people dying across the board. And this is data. I mean, this isn't, it's nothing more than data that's being collected.

So data doesn't lie. People lie. So something has to explain this. And the timing is unusual and makes it suspicious. So, yeah, it's yeah, that's that's what I would say about that. I mean, actually, somebody asked me the other day. It was a really good question. It was no, yeah, it was, it was a spinoff of an interview I saw with Catherine Austin Fitz. And she made a really interesting comment about how a lot of the adverse events that we're seeing can kind of easily be written off as kind of the end game of somebody's existing condition.

And I've been calling that symptom laundering. And I think that she's absolutely right. For somebody who's older or who has some kind of condition, an autoimmune condition or cancer, it seems like these things, for all intents and purposes, are absolutely ramping up all of these conditions. It's got some kind of immunological dysfunctional node.

But of course, not even the people are making the association back to the shots. They're just thinking, oh, well, this is just the disease course running its course, and this would have happened anyway. So I thought that was really interesting. So somebody asked me about that, and they said, well, what can we actually do to jostle people, to engage them into starting to think that maybe there's a connection between this and this. And not, well, go outside of that realm of possibility where this is just something, a problem that you've already had that is, you know, following through. Look at kids, look at healthy athletes. I mean, we already are, but this is, it's very, very important that we

push this because there's absolutely no reason for a child, for example, who's healthy to succumb to any kind of severe adverse event after getting an injection, unless it's because of the injection. So there's no way to argue with that. So yeah, it's- Yeah, well, to wit, I would say, the concept of this new diagnosis, sudden adult death syndrome, SADS, as if this was something that existed prior to the COVID vaccinations. They made up this new category called sudden adult death syndrome. What are you talking about? Honestly, that diagnosis did not exist. You're saying, what are you talking about? And people started throwing it around as if, oh, you know, SADS. I'm saying, no, I don't.

It's a made up diagnosis that didn't exist prior to the need to have something to label all of these people who are suddenly dropping dead with no other explanation. So I know that we want to bring Dr. Freiman into this conversation as well, but I will tee it up in this way before all four of us start talking. There's no question that we have seen this unprecedented number of adverse events. There's been a lot of daylight thrown on concerns about the trials, concerns about pharmaceutical companies owning the scientific journals, lots of conflicts of interest, and those sorts of things being exposed.

But suffice to say, this didn't just start in the past two or three years with COVID vaccinations. We have all become, certainly I and Drew have become much more aware of it, much more cognizant of the absolute sort of, what do you call it, ownership of the scientific journals by big pharma, those sorts of things, the way that the FDA and the CDC are corrupted, the amount of money that they're making on patents that they own and on and on and on. But suffice to say, this is not something that started yesterday. And so I want to kind of have that as the backdrop for the conversation that we have going forward for when Dr. Freiman exposes his conversation with the FDA and more the information that you, Jess, are throwing on these studies and what we're learning about these

particular injections, that this is not something that is new. And I think for me, it's the consummate existential crisis as a physician, because I really have to wonder what really, to what extent have the therapeutics that I have used, the scientific studies that I've relied upon, the constructs that were foundational, which of them really are on faulty, really shaky um because uh this has been we have exposed an awful lot in the last three years that isn't uh isn't particularly flattering on the uh industry of of medicine well i would say that go ahead jessica go ahead jess i just wanted to throw in it's it's absolutely true and it's it's kind of a mixed blessing that this has happened to shed light on these problems that are inherent in this entire system this

industry which is supposed to be about health but this mRNA stuff, the modified mRNA LNP platform thing, it really needs to stop because the trend now is that because these things have allegedly been proven to be safe and effective, and I'm being sarcastic here, they have not been. They've actually been, like, we've provided very strong evidence as a scientific community that they're not either of those things. And further, you know, follow up products which are going to be used in humans for cancer therapies. You watch for this. It's coming for other types of viruses, packaging, you know, all in one products using this mRNA attack, animal use, I mean, it's it's all coming. And the problem is going to be there aren't going to be any trials, there aren't going to be any tests done anymore, because it's proven to be safe. If people are just listening, I'm doing air quotes there. It's absolutely not the case. So this is the

danger. Like we, we really need to like ding, ding, ding the bell on these particular products and on the inherent problems. Yeah. No, you, you are spot on here, Jess. And I think that's a point that needs to be hammered home. I frequently get criticized when I say that these aren't safe and effective. People say, you know, mRNA technology has been around for 15, 20 years. I'm saying, you're right, it has. Let's be real clear. It's been around. It's been studied. And it has failed, and sometimes miserably, with tragic results where all of the test subjects died. It's not that we haven't tried to create a safe and effective mRNA shot in the past. It's that they have failed. They have failed over and over and over again. It has not been proven, and you are absolutely right. They have done sleight of hand. They have led people to believe

that these vaccines are safe and effective. And therefore, the platform is now safe and effective to use going forward. And they're going to use it for everything. And I've said from the beginning, this was their goal all along. This was always their goal to make mRNA a household word, to make people believe that it was a platform that was absolutely tried and true, nothing to worry about, and that people would accept this genetic modification as something that is something that we've always had in the way that you accept other vaccines or other technologies. So I think that that, to me, Jessica, is the single biggest risk of all of this, independent of all the horrific adverse events we've seen is their ability to

pull the wool over the eyes of people to believe that this platform itself has been safe and doesn't need further testing well let's uh let's get to the rcts and the and the flaws and the studies and whatnot we're going to bring dr joseph freiman in here actually but i want to say tooth what sorry oh wait he's back now sorry he had stepped away i was looking at his camera and he stepped away but he's there now you can continue sorry okay good uh but i was going to say vinay prasad has been complaining about these inadequacies and what comes to market for quite some time and uh i'll say that you know if there are issues with the mr technology so be it if somebody has a terminal illness and there's a possibility that that delivery system could help somebody with a life-threatening condition and turn that around, is worth the risk?

Is it worth the risk for a healthy 19-year-old to use that technology? That's a wholly different question. Unless we understand these things clearly, we're not doing our job. So speaking of that uh Dr Fryman has been worried about this long before we got to the table Kelly um and he's he has been talking to the FDA about some of the shortcomings Dr Freeman welcome back I'm going to turn it over Dr Victory but let me before I do just say could you just just sketch for people again a review of your of your review of the data and what you found you mean from from our study that we performed on from your study yeah what yes yes yes what

was different in your study versus what was what was reported by the fba a quick summary of it is we reanalyzed the original trials from the messenger RNA vaccines where Pfizer, Moderna. We identified that in the Pfizer trial, initially, there was an increase in serious adverse events. And basically, it has to do with how you count them. There was more events in the vaccine group than the placebo group. If anyone counts them, you will find that it's really not a debatable fact. The next part of our study was we looked

at a list that was created by a group called the Brighton Collaboration, which is a World Health Organization endorsed list of something called adverse events of special interest. And what this is are adverse events that are prior to the clinical trial. They said, look out for these. These are potential harms to look for. So we then took that list and said, are these increased in the messenger RNA vaccine clinical trials to get rid of statistical noise so that things that were probably not related to the vaccine would go away? And we could focus in kind of like a magnifying glass on these adverse events. And there we find that when you combine Pfizer and Moderna, they both appear to have an increase in these

serious adverse events of special interest. And together, it's quite clear the rate is about one in 800, one serious adverse event for every 800 participants in the original clinical trial, which is, I believe, it was about a 40% in that range, a 40% increase in these serious adverse events. And then the last part of our trial was we looked at this increase in serious adverse events versus in the clinical trial, how many people were prevented from being hospitalized by the COVID-19 vaccines, by the messenger RNA vaccines. And we found that for both in the Pfizer and the Moderna trial, it appeared that the messenger RNA vaccine was causing more serious adverse events than it was preventing. And I just want to be clear, there's lots of limitations on how to interpret that last part of the harm benefit analysis. Because,

you know, for example, if the trial had went longer, it's possible more, there would have been more hospitalization reductions. And if the trial was done in older people, maybe they would have found more hospitalization reductions. So it would have shifted it into another direction. And then on the other hand, if you did the trial in younger, healthier people, people who had been infected before, or if the trial maybe happened during a different variant, such as the one currently being experienced, where the hospitalization and death rate is much lower for each infection and the vaccines less effective there the the the harm-benefit would actually be worse and so you would actually end up with even the ratio would would end up being thrown in the other direction and that harm-benefit analysis is it's fragile is I guess what you would say and that things can throw it in either direction I I think, is the best way to interpret it. And that's the summary, a very quick summary.

And what were the special interest adverse events? If you could just sketch out some of those for us. I'm wondering if it includes some of the things I'm seeing. It's what's interesting because I'm seeing neuropathies and Pott syndrome and arrhythmias. And is that the stuff that was a serious special interest? Yes. All of those would have been included, I believe, onto the adverse events special interest list. From our trial, what it looks like is, is that there's, it's causing, it would be causing a very rare harms in many different, you know, regions, many different, you know, body systems. And so that when they add up, so because if you have, you know, 10 different

serious adverse events in 10 different different causes, 10 different ones, at a rate of one in 10,000, those add up, and then you have a serious adverse harm rate of one in a thousand. So lots of serious adverse events, they, they add up together. And what we saw in our trial that the most, the not, it's not more than 50%, it's probably 30, 40% were, but it was the most common are in the coagulation disorders, which are blood clotting and, and, and the most common are in the coagulation disorders, which are blood clotting and, and bleeding. Those are the, those are the ones that were the most increased in the vaccine

group compared to the placebo in Pfizer and in Moderna. But it's not that their rates so crazy, it's a, you know, three in 10,000, four in 10,000. And so, but then you add on these other ones, all the other random systems, like you just pointed out there and together, that's how you would get that one in 800 number. I'm trying to make sense of it. I've said many, many times that I think the adverse events to me, we are having a pandemic of the itises, you know, itis meaning inflammation, you know, it's pericarditis, neuritis, nephritis, hepatitis, colitis, you know, all of the itises. This is an inflammatory process. I'm not sure how the coagulation issues fit into that,

what it is about the inflammatory. I, you know, the, the clotting cascade was not my strong suit in medical school. I have a theory. No, I have a theory. Yeah. I have my theory is my theory from the beginning. My theory from the beginning has been that this is an endotheliitis and the endotheliitis is interacting with the bloodborne elements. And I, that's been confirmed by a couple of people that I've talked to. Yeah.

And so that, so again, that would fall into the itis, the pandemic of the itis. It's an inflammatory process in that case, in inflammation of the lining of the blood vessel that then attracts platelets and cause it serves as a nidus for a blood clot to form. So I think, Joe, you can verify this, that the adverse events of special interest, I think, mostly fall into, again, those inflammatory processes. There's something about these spike proteins or the spike proteins in conjunction with the lipid nanoparticles that causes this gross inflammatory process. Yeah, that would be, that was the general concern that started our, you know, this project was the discovery that the spike protein is causing endothelial dysregulation. And I mean the

spike protein that they, from the COVID vaccine, which is coincidentally the same spike protein messenger RNA that we put into the vaccine. Even that they're not the same, but if they weren't the same, then the vaccine wouldn't work. So it's a little confusing, the messaging on this, but the spike protein itself has been shown to cause endothelial dysregulation. So yes, and the blood system, it pretty much connects to every organ system of our body. So I would imagine the organs that are at the highest risk of endothelial dysfunction would be the ones that would end up suffering from such a problem. But I don't know the mechanism. That's not what our study was,

not mechanistic-based. Jessica can probably give you mechanism much better than I could. Well, I could comment. Marc Girardot, plugging him here, has done a lot of excellent work on this. And there's no doubt that this is about which cells are actually getting transfected, because whichever cells, and more likely, I'll just add that on, these are going to be the endothelial cells lining blood vessels. So you have entry of this product into your body, either intermuscularly, it's going to hit the capillaries, or maybe you're going to hit a vein or an artery. And in any case, it's going to enter the blood system, it just matters what the concentration or as Mark would put it, whether or not a bolus forms, bolus is just like a ball. So if you have

a concentrated amount of these lipid nanoparticles, and we're talking about like trillions of them, apparently, in a very small vessel, like a capillary, the likelihood of transfection is going to be really high just because of the conserved space. So if you have a punch of transfected cells, like in one region, then you're going to have all the things that come with that. You're going to have your spike protein translated, churned up, mounted on MHCs, CTL, sorry, I'm saying things that nobody knows what the words mean, but you're going to have an immune response mounted against those cells that put flags on their surfaces saying, hey, I have a foreign protein on me and they're gonna get destroyed.

So if you have a big local destruction, that's gonna cause your clotting pathway to get disturbed, over activated, and clots are gonna start to be thrown. And that's how you're potentially gonna get necrosis later on down the line. So that's what Mark has, has actually written a lot of articles on this and I prompt everyone to go read

them. He's, he's, he, he makes a lot of sense on a lot of this. And it really is just, it's, it's, it's like you said, it's about the circulatory system reaching every single part of the body, all the, all the tissue. And it's just the circulatory system reaching every single part of the body, all the, all the tissue. And it's just a numbers game. Like where, where is there a concentration? And is there a concentration of these lymphadenoparticles getting to somewhere? Could be the heart, could be the brain. It could be the wherever. Um, right. And of course, they're going to get there in the circulatory system. So yeah, sorry, I'm taking all the talk time. No, no. Yeah. So I want to take this topic and say,

okay, I'm just sitting here watching the screen myself and saying, here we are, four scientists who all have done the deep dive on this over the past three and a half, almost coming up on four years now. We all have a pretty deep understanding of the mechanisms of the rate of these incidences, you know, all the risks. We know all this. Okay. Let's change gears. Turns out we have some agencies in the United States whose job it is to know this stuff. Let's start with the FDA and the CDC and the NIH. So what I want to talk about, and I'll throw this first to you, Joe, if we know this, what did the FDA know?

When did they know it? Okay. And what did they do about it? Because it's, it's, it's implausible to think that just the four of us are so darn smart that we're the four who figured it out. And those poor, you know, uh, people slogging away at the FDA, just none of this crossed their radar and they have no reason to know this. Let's talk about from your perspective, Joe, what did the FDA know? When did they know it? And what did they do about it? I actually, you know, I'm all for, you know, giving the FDA problems when they're doing a bad job. And I think that the reason we bring this up here is essentially was a discussion that my group of authors from our study, we presented our study prior to publication because we kept getting rejected.

So we thought it was important for the FDA to know about our study. And they called us in for a meeting with essentially all of their top officials of biologics, basically for vaccines, vaccine safety. And we ended up having a meeting with them. And I think that, you know, there was a large amount of the, you know, even these top officials who I do think were actively concerned and looking for if the harms were true. And the issue that I felt in much of our discussion was that they need confirmation that the harms are absolutely 100% true. And before they're going to like pull the lever.

And so in statistics, right, you have, we say things are statistically significant when they're 95%, when we're saying it's 95% certain it's not random. But for harm, in my opinion, there's, if we're 80% certain that a thing's going to harm a population or, you know, 90% or, you know, this is, I think that we maybe need a different way of judging these things for harm versus benefit, because we

don't want to give out a drug that's not beneficial. That's pretty clear. We want to be real certain, because if you give out a drug that's not beneficial, you're only going to deliver harm. So you want to wait for that. And, uh, but I, I believe that the FDA has kind of resulted in their way of evaluating harm based off of our meeting was that they presume that the null hypothesis is true, that there is no harm until we, until they can absolutely demonstrate it and they can demonstrate it over and over again. And the problem is two questions. And go ahead and finish your thought, but then I want to ask question. Go ahead. The problem.

The problem is that the harms that we're most concerned about. So you have myocarditis, right? Which has, we know the vaccine causes, but it's a very, very rare event. I've seen it once or twice in 10 years as an ER doctor. But, and so, you know, if I, if I may, it's like, so that's not going to, you're not going to really see that so much increase, but imagine if you increase the heart attack by 10 or 20%, right? If you increase a heart attack by 10 or 20%, that's going to cause hundreds, a hundred thousand heart attacks in the country. But it's really difficult to see that. Imagine even just like the, this is a way of explaining kind of why it's so hard epidemiologically, but as an ER doctor, I'll maybe see one heart attack

a month. So let's say 12 a year. If we increase that 10%, 20%, we're talking about I'm going to see still about one a month. And I wouldn't notice that difference in terms of my day-to-day activities. And it turns out that when you try to do this in big epidemiological studies with millions and millions of people, you're not ever going to see that. Well, you will see it. And then on the next study, you won't see it. And then you'll see it again. And then you won't see that. Well, you will see it. And then on the next study, you won't see it. And then you'll see it again. And then you won't see it. And that's, our surveillance system is not designed to pick up something like that. It's not, it's simply not, it's not possible for it to pick up

small increases in pretty common, common causes of serious harm. But since you had, you had direct interaction with the FDA, which I have not, but it seems to me that you've laid out a fundamental flaw. If their approach fundamentally is we won't act until we have proof that harm is being caused. Can you imagine using that same thing if you're a manufacturing facility making a baby stroller or if you are an auto manufacturer making a car, if you were, if you were building a bridge and you had to prove that the wheels actually fall off the stroller. I would argue that this, this is a wholly new position by the FDA. I, I, it seemed to me that they were overly cautious. No, it's not. No, I, no, I do not believe this is a new position by the FDA. This is, I mean, even from the approval standpoint, the original concern

that I was pushing was this efficacy that you don't want people to take a drug unless we have certainty of efficacy. And we would imagine that how, how the FDA standard is supposed to be, you're supposed to have two randomized controlled trials, double blinded, and they're supposed to find an outcome that's of clinical, that's clinically meaningful. But if you go and look through the last 10, 20 years of FDA approvals, you will find a ton that are not blinded, a ton that are not randomized. There's not even another group. Placebo-controlled. Not even placebo-controlled.

And their outcome is not clinically meaningful and not replicated. And these drugs have still been getting approved. So this is, the COVID vaccine trials actually, in terms of if you look at the last 20 years of drug approvals, is actually not, it's definitely not the worst. It's far from the worst. We've actually had many more drugs. And then the other part, what I was talking about there is our surveillance system, which is supposed to be looking out for harms. And the problem is that if we don't do good, really well controlled clinical trials before we approve these drugs, we end up in this situation where we live in a world of uncertainty

and we have to rely on a lot of observational data where sometimes we can figure out some serious harms and we can identify those and then we withdraw those drugs. But once a drug is approved, we can't do randomized controlled trials on it anymore. And many of those drugs just live in uncertainty. And that is our current situation. And the COVID vaccine is an example of this in that we don't know if they because they didn't study hospitalization reduction specifically. They didn't study it over two to three years. You know, I take it like this. Right. You I remember, Drew, you said last time that you believed that overall there was it was beneficial in the elderly but you were

uncertain in the younger healthy population that's a fair belief correct the belief you don't know you don't know that because there wasn't correct a trial that we have to rely on and imagine like a hypothetical experiment was done and the covid COVID vaccine, placebo-controlled, double-blind, randomized control trial went on for two to three years. And it ended today. Now, imagine that. So everyone in this vaccine trial has been infected with COVID, multiple times, some of them. Now, who gets hospitalized more from everything? Because I imagine in this trial, the vaccinated group would get boosted whenever the CDC decided randomly that it was the time for them to get boosted, which they have done, which they do. They just make up a time, boost now, this group boost now. And if we just listen

to those, so we did it perfectly. Would the group that got the vaccine end up being hospitalized less when you take into account all the boosters, the reduction in COVID hospitalization that looks like it probably happened in the first six months, but less clear after boosters? So did it just delay hospitalization for six months? Did it? The answer is, actually, Danny, if you guys have an answer you think you know what how that trial would fall out like i i yeah it's a brilliant thought experiment well the reason i get bogged down go ahead jess i just think that's a brilliant thought experiment i didn't even extend my brain into that arena but yeah i imagine that uh well from what I'm seeing in the peer reviewed literature and on the ground and

from case studies, the people who are multiply injected would certainly represent most of the hospitalized people. But yeah, what an interesting thing that would have been. And also, if they hadn't injected all the placebo participants as well, that would be helpful. And it's a reasonable opinion. It's your belief. And the point of what I'm trying to say here is, and we could have someone else here who says, I believe that it would have had a great reduction in hospitalization down to the one-year-old. And that's their belief. The reality is we are uncertain to the answer to that question because we didn't answer it. And we're never going

to fully 100% know. Yet the problem here that I think exists probably within our population is that there's a group of people who are confident. Like you said, I don't know. I think maybe we're going to have more hospitalizations. And I'm sure, you know, Dr. Drew, I would presume and say, I think we'd see a benefit in the elderly. I guess Dr. Victory will say, I'm not so sure we'd see any benefit. I think it might be overall harm. But you would have a voice of uncertainty in what you're saying. The problem here is that there's a huge percentage of our population who's confident and certain that everyone ages six months and up would have a hospitalization reduction. This group of people, which includes our government, are irrationally confident. They're an irrationally confident group.

And now there's also on the other end of this, there are groups who are confident that if you give this, if this study was done, that every single person within this trial, every single age category will be harmed. This group is also irrationally confident. The entire, this is the majority of our population of this country is irrationally confident. And so it's, I apologize because I've definitely just offended a large portion of your audience on whichever one they are. But it's not what you're writing. But this is why this is this is why this is why the average vaccine takes and should take six to eight years to come to market because people shouldn't have to guess.

They shouldn't have to come to their own. What's your best guess conclusion? We should have this data. We should know what does happen to pregnant women when you inject them with this. We should know what do you actually decrease transmission by this thing? We should know what is the impact of multiply boosting people in rapid succession? Those are questions that are normally figured out during the 6, 8, 10, 12 years worth of testing that's supposed to happen before you launch something on the public, and certainly before you start doing something as unprecedented as mandating it for people against their will. Yes. Joseph, can I can I ask you what you think would have happened if we'd let this actually run? And also what your opinion on why it wasn't run for three years, for example? Do you believe the whole it was an emergency story?

If it was run for the entire time, what I believe is that, uh, is that it likely, I think it likely would have increased hospitalizations in, in, uh, below people 65. But, um, and in the older group, I initially thought that it would probably have reduced hospitalizations. However, now when I think about it over a two to three year time period, I think it may have possibly delayed it for six months, but I'm not so certain of the hospitalization

and death reductions that our observational studies are suggesting because in the clinical trial, we didn't see for the number, for once people were infected within the vaccinated group, in the clinical trial, we didn't see that those people got hospitalized less. That doesn't appear to be the case. They didn't be, they didn't see that those people got hospitalized less. That doesn't appear to be the case. And they also didn't appear to die less. So when it stopped preventing infections, and that became clear, and then it started just not preventing infections, but preventing hospitalization, I can't say that that's not possible. I just don't see any evidence from that from the clinical trial. So I question if that actually occurred or if it was a basically a classical observational bias that happens called a healthy user bias that we are healthy vaccine bias that tends to be seen in vaccine studies where you end up seeing a mortality benefit or a hospitalization benefit

in the group that got the vaccine. And so I just don't think that we could rely on, I don't think that we could rely on observational data for efficacy of drugs. That has classically been failed. That's been a classic failure. Every time we do this, we end up making a massive mistake. And it just happened time and time again through the history of medicine, of observational data misleading us into believing something's working when it isn't. Let me throw a wild card in here, Joe, as well. And would it affect your guess as to decrease in hospitalization rates, even in the older people, if we had allowed people to be treated, if we'd actually treated people with the readily available, safe and effective medications, everything from, you know,

steroids to ivermectin to all the things we could have done rather than antibiotics so that people weren't dying of bacterial pneumonia that could have easily been treated because it was simply called COVID and they were put on a ventilator and allowed to die. Yeah, these are, so, you know, would the fact that, because I would submit to you, and again, you know, we're all guessing here because the study wasn't done. But I think any positive benefit of the vaccines would be eliminated had people actually been allowed to be treated with the medications that we knew from the very beginning would have been very, very effective. It's a different study, though. I would I would I would push back.

And, you know, I, I fall into a category of people who've questioned the vaccine and I, I hold these alternative treatments to the same standard that, that I hold the vaccine in that, that I, I need to have the large scale randomized trials to, to really fully evaluate it. But can I, I'm sympathetic to the use of incredibly safe medications in people who are for conditions that are potentially deadly. I do that in emergency medicine and, you know, but without full evidence-based trials, of course,

but would I, can I, do I say for sure that I know which medicine's working and which one's not? But I'm sympathetic to using very safe medications that can be potentially life-saving. But I'm not willing to say I'm certain that any of these alternative medications that are plausible, had we studied them better, that they offered a benefit. You know, there's hints that they offered a benefit you know there's hints hey joe that they may be good but could you go i want to make sure we get this in before we run out of time which is this uncanny procedure the fda has in terms of determining certainty of adverse event in relation to a vaccine and i'm wondering you you you have some recordings legally recorded of your interaction with the FDA.

I wonder if you actually have the recording where they describe this guy. They got a guy that goes and determines whether something is or is not. It determines the impossible, whether something is or is not related to the vaccine with certainty? Here, I'll play the first thing here, which is what they said regarding, here, I'll just play this here. You've analyzed the total number of events rather than the number of people who had at least one event. So if you look at those tables at the top, it's sort of number of people with an SAE. Now, this is the first thing that they brought up, the first critique of our study.

They said we analyzed the number of events versus the number of participants. This seems like a statistical argument that's of irrelevance, but turns out that the FDA, for all of its previous drug studies, they don't count the number of serious adverse events that happen to people in a clinical trial. They only count the number of people who have them. So if you're a person who has multiple things, and especially imagine in a trial where you're given two doses of vaccine one, vaccine dose one, dose two. If you have a serious adverse,

if you have a heart attack after dose one, then you have a stroke or another heart attack after dose two. That's counted as one. And now the fact that the FDA just doesn't count the number of events at all, there's no reason to not also count that. I'm not saying that counting the number of participants is bad. No, no, no. They're both useful and give different information. FDA doesn't do it. And I would put out for anyone who's listening, if you want to go back through FDA

trials, because they have not done that in any of our prior trials. And that is a much more sensitive. It will catch more events. It will catch more harm because people who are sensitive to a drug's serious adverse events, turns out they're probably sensitive to more than one. That's just how medicine works. If you're going to get one bad one, you're probably more likely to get another bad one. And that has been not what our FDA has been doing, which concerned our group, i would say our entire group and they also i will continue on here from the fda's meeting here and they uh they didn't take here i will play this video this recording here we don't do statistical significance testing of raw numbers of aes because we don't consider that informative for multiplicity reasons and also because, for instance, if you look at the list of AESIs, there are many things that are SOCs are unlikely to arise from the same mechanism of action.

And a lot of people want to get their first significance test as a necessary lead. So the purpose here of what they're saying here is they're not doing statistical testing. Not statistical testing on adverse events. They are seriously, this is really insane to me. No kidding. They are, he seriously is saying there, we only just look. If there's a huge difference that's so obvious that we don't need a statistical test, then we say, okay, that's a big difference. Let's look into this.

That is absurd. Because then he goes on to say that the way that they look at these adverse events is they look at each one. And then there's a guy, this guy, that was the one who's saying this, that when they identify them, they try to connect it. They go, okay, is this in the right amount of time from the vaccine? Do they have any comorbidities? Maybe that's what explained this. But when you're using a novel vaccine, how you're supposed to know what serious adverse events are coming. And this blew the minds of all of the researchers I was working with, physicians and scientists, that the FDA was doing this in such a sense. Here, this is one of my co-authors

questioning them on this, about not using the fact that it's a randomized controlled trial. You've randomized these two groups. If there's more of something in one of the groups, there's one reason why there's more. It's the thing you use, the medical intervention. That's the whole reason we do randomized controlled trials. When you do observational studies, when you find the difference between groups, you're always like, oh, is it something else that we don't know about that we're not thinking about? It's called a confounder. It's the reason observational studies are so unreliable. Here, they're evaluating randomized controlled trial data the way you evaluate observational data, which is insane. Because I think I said this the last time I was here, a Vioxx heart attack. Someone has a Vioxx heart attack.

They come into my ER and they were taking Vioxx. And how do I know that that heart attack was from Vioxx? Or was that just a regular heart attack? And they would have had a heart attack if they weren't taking Vioxx. The only reason we know it is because in the randomized trials, more people who took Vioxx had heart attacks. That's all we know. It wasn't like the placebo had zero heart attacks. This is one of my co-authors here trying to hit this point home here.

... very likely to have occurred to them in any case, then that event is less likely to be related to the investigational problem. Right. It sounds like what's done in pharmacovigilance. But how do you then leverage the fact that you're dealing with a randomized trial? I'm not sure what you mean by that. Again, the the definition of hypothesis testing to look for a causal

relationship between the investigational product and placebo, again, is typically not done for a variety of reasons, one of which is the multiplicity concern. So he's saying there, multiplicity is the reason they don't do statistical testing we are not doing multiplicity saying if you test 100 200 different serious adverse events you're gonna find a false positive he's right we just combine them all we we ran one test it's one test all of them combined and then then if it's increased, you know, you have a problem with your drug. You don't know exactly which one of these adverse events is causing it, but you know, there's a problem if the vaccine group has a higher rate of them.

This is a, it was very, very concerning. This entire meeting terrified my entire work group, to be fully honest. They went on to explain to us that they then began to say that their rationale for not being concerned was essentially because of real-world data didn't confirm with what didn't connect. And if you believe in evidence-based medicine, that's not really how that works. If you find it in the clinical trial and the observational data isn't connecting it, that's a problem with your observational data, not the clinical trial. So they need to re-look at this. And here, this is... I guess what if I, your thesis that seems to me, if I understand it correctly, is that more people experience serious adverse events. There was a greater number of serious adverse events with the vaccines than there were people

who were prevented from having serious COVID-19. And that seems to be a little bit at odds at what my understanding is of understanding the global real world evidence and post-marketing surveillance. So I just... So that's a real big disconnect from anyone who understands evidence-based medicine, that you're going to compete your... They use the term real world data. I don't know when this term came into popularity, but real-world data is called observational data.

When I went to medical school, and I was taught it's not that reliable. Yet real-world data sounds great. It sounds, oh, it's the real world. That's the real thing. It just turns out it's not that reliable. And then we have this problem that I was thinking. Well, not only that, but we spoke to the Danish researcher that published that observational real-world data on lots having more adverse events than other lots.

You know, certain of the manufacturing seem to be associated with much higher adverse event rates. Could not get that published for two years, and since published, completely ignored. So there's some weird bias within the real-world data that's concerning as well. We were challenging them on that if their surveillance data is adequate. And one of my co-authors, who's a rheumatologist, a pediatric rheumatologist, had, he had this to say, it's, it's quite a taking a specialist. Um, this is just the end of one, but February 25th, I filed a VAERS report on a seven year old patient who had a cardiac arrest following his first.

Um, Pfizer vaccination. I was about 30, 30 hours after that he got the vaccine. Um, I didn't receive any follow up about it. Um, the patient died about eight days later. I submitted another email offering to update the, you know, the report with the death of the patient. Uh, it's been two weeks now. I still haven't

heard anything. So I'm wondering if there's more extensive surveillance than just fares-based surveillance for cases like this. And I would think that if the death of a seven-year-old following the vaccine is not, you know, meriting follow-up, either the system is totally overwhelmed or there's something wrong with the reporting system. I want to play you some of the responses to this because we're explaining to them that there's a, just from this man's, you know, one physician who just happens to be within our study group, this is his own experience with the VAERS experience, with VAERS. And here's what they have to say. Such interest. We're happy to make sure that it didn't get waylaid somewhere. Usually, pediatric deaths, I know that they have been very good about chasing down. I know because I've heard details of each of them uh in many cases

that doesn't mean that you this is this is the the worst response you could think with this man saying you didn't work and and i want to finish this word solid he our fda the fda instead what this should have been like is a holy this is a holy shit moment leaders of the FDA guy saying it's been two weeks since a kid died and you haven't contacted me saying okay we are going to figure out what went wrong here we're going to fix this problem you should have been contacted instead we're getting things about oh email us emails oh just write write a huge study and then get a meeting with the heads of the FDA. Then you can email us about something. Here, let's just go on.

Does that sound right, Steve? Yeah, but they should be followed up within a matter of days, actually. Just drop me an email or Rich and then we'll send it to our surveillance group. That's our surveillance group that's

our surveillance to make sure that you know it didn't i got it it did fall through the crack my guess is if anything it's just that they're behind but i can't believe they're i i can't believe something like this would fall through the cracks you can't believe something would like this it did fall through fingers but I think that the larger issue. And just to put that way. Very reasonable. Yes. You know, I should say, just to put this in some perspective, just a couple weeks ago,

the FDA reprimanded and shut down a baby formula manufacturing facility because four children were hospitalized and two of them subsequently died. That's tragic. Don't get me wrong. Tragic. But they shut down an entire manufacturing facility and pulled the product from the market because four children were hospitalized. Compare that to the tens of thousands of reports that we have on VAERS, which we know is grossly underreported, by the way. The V-safe, they pulled that entire surveillance system off and stopped it. In fact, one of you should talk about that, the V-safe system, which was kind of the backup specifically geared towards the COVID shots where VAERS takes all comers for vaccines. The V-safe was, again, not my system.

I didn't create it. None of us created it. It was created by them specifically to look at adverse events related to these vaccines. They have abdicated their responsibility to follow these up. If this doesn't piss off every American, then you are asleep at the wheel. Because what you are exposing, Dr. Freeman, I think is horrifying. This is the state of what we've got for the FDA. God help us.

Yeah, no, I have much more of this recording that is terrifying. It's a terrifying thing that I don't believe. Go on, please. I just want to tell you that this is common. I have regular conversations with the woman who created OpenBears, we're always going back and forth on this data. And it's a thing that if you file a report successfully into the system, which is a big deal, and it doesn't always happen for everyone that they go from having a temporary ID to a permanent ID. But if you try to do a follow-up report, i.e. if you originally filed for myocarditis and then that person died, it will never get done. It's almost a thing that you can say about VAERS. And it's true what you said.

It's like this is either the most inefficient system ever, or it's just kind of inherently designed that way. And I don't know why. I mean, it's well yes i can explain i think that my concern personally is that we have a system here of of uh the fda the fda is responsible for approving drugs peter marx who was in that meeting with us the is a head of biologics for vaccine safety he was there there? He actually is. He was in that meeting, yes.

This was the top, oh, this was a top level meeting of directors of biostats, directors of, this was from the directors across the biological departments. And he has a signature on the approval of a booster. I don't remember which one, but he has a signature on it. Now, the same people who are approving drugs are responsible for checking if they made a good idea, if that was a good idea. That is a serious conflict of interest that we have built into our system. The CDC is making

policy recommendations, and then they are the government of studying if their policy recommendations were a good idea. We have built a system that is totally not making sense. And then to cap this off, imagine that we allow these pharmaceutical companies to do their own trials, that they collect all of the data instead of someone like the NIH being responsible. Bored government workers just being unbiased saying, hey, does this thing reduce hospitalization? I don't know. Let's see. It's the most perfect use of bureaucracy. And we can figure out if things work or not. But if you use a pharmaceutical company which pays a research lab, clinical lab, to research this, which gets a new contract each time as long as it keeps finding good results, you're going to end up with not necessarily honest reviews. Like when I buy a Samsung TV, I don't read Samsung's reviews of the TV. I look to see independent reviews. You don't?

The way we are accepting drugs to be allowed into the population is essentially just reading the Samsung review that this has the best picture, the best sound, you know, and that is just a really serious issue that is easily preventable. We have the personnel, the researchers, to do these trials properly and figure out what drugs work and what don't. We have all the resources. We know exactly how to do it. We're not doing it. We are allowing corporations who have criminal records for lying to us. We're trusting them. Right.

This is, our system has major, major issues and people do need to be scared because this is, the COVID vaccine, this is the thing that brought people's attention to this issue. Right. Go and look through all of your drugs and see how they were approved. And go imagine doing the same amount of research onto every drug that a person's on the same way

that you've heard about the COVID vaccine. And I can assure you, it will not bring you confidence for many of them, especially anything that's of the last 20 years, approved in the last 20 years. No, and I think that's really, I'm cognizant of the time here, Drew. I think that this brings me full circle to the thing that I really wanted to focus on, which is that as bad as the, and these COVID vaccines in my estimation are horrific. They should have been pulled from the market, I believe, immediately. They should never have gone to market. But this problem far, far supersedes, it goes beyond what happened during COVID. As you're pointing out, Dr. Freeman, this is something

that has been longstanding, decades in the making. It's one of the things that Bobby Kennedy Jr., regardless of how you agree with him on other things, climate or otherwise, he has absolutely made a commitment to get to the bottom of this, this regulatory capture, the fact that we have pharmaceutical companies in bed with our agencies whose job it is to protect the safety and security of the American people, I think is a problem. Our scientific journals have been captured. You can't rely on anything you read in what I thought were the storied medical journals and on and on. So I think we are exposing a way bigger problem here that's going to need to be addressed. I remember Bobby's call was, as soon as he gets to office, where he'd get to office would be to call the majors publishers in and to threaten them with a RICO action if they don't get their acts right.

Joe, you were going to say something? Yeah. As before, what I was talking about, the majority of our population being irrationally confident in their viewpoints. At the other hand, I believe there's hope in that because there's a small, there's a minority of this population that is rationally uncertain and they are the counterpart to the irrationally confident. All three of you are in that rationally uncertain group and you all have probably slightly different opinions and that's totally okay. That's normal. And when things are uncertain, we're going to come to slightly different places in what we think is probably true.

But the problem is it's uncomfortable for most people to be uncertain. But people have to choose. Do you want to be rationally uncertain or do you want to be irrational? Because if you want to be confident that you know what's going on, you then have to also, you're choosing to be irrational. And we need more population in this rationally uncertain group so that we can possibly change this system to make it work for us, to protect us the way that it's supposed to. These agencies were built to protect us and they should and they can. We have the way, we have the means, we know how to do it and i can do i i want to add something in i want to add something very important in here that was taken

away by covid and that is the individual's practitioners clinical judgment joe i don't know about you but i see lots of covid lots of covid and it gives me a certain clinic sense of what's going on by the way i'm seeing the new variant come on board and it's quite different than the previous infections uh and it has remarkably uh responsive to paxlovid strangely uh but i don't use it because it's so mild it only lasts a day maybe three days and can be kind of intense and what it is i use the pax of it but but it's a totally different syndrome i'm seeing that is informing me that's helping me make decisions about vaccines or further vaccine therapy or treatment these the the individual practitioners

clinical judgment is a feature of our system that has been systematically taken away by physician extenders by centralization of decision making. And this is a major piece of our problem that doesn't even come into this conversation or the data you've brought in. I just wonder if you have a comment about that. Yeah, I also, I personally haven't hospitalized a patient with classical COVID-19 syndrome since February 2022. So it's been about a year and a half, maybe a bit longer.

Is that? Yeah. Since Omicron essentially came into effect, I haven't hospitalized a single patient. So I've hospitalized lots of patients with COVID. They had schizophrenia maybe with a psychosis episode or they were misdialysis. And it was like, oh, do you have a cough yeah i do now that you say it but this syndrome changed dramatically from what it was before and and it's and and it's changing again it's changing again and was that natural immunity was that natural immunity plus vaccine was it vaccine was the vaccine alone we don't have any way of parsing these things out or less pathogenic organism period you know it could have been just last less pathogenicity period but we can't parse these things out because they're not doing the studies

yes you know we know for certain yes but the but no the the thing changed in 20 the the solid change from when it went to omicron right it. It can't be that everyone just was infected. It's no, there's something, it stopped being a problem. The disease changed dramatically to go to zero hospitalizations anecdotally. Yeah, remarkably, it did exactly what every other virus has done from the beginning of time as it mutated. It became more transmissible more contagious and at the last time less lethal less severe it is the net it would be reportable it would be reportable

for a virus to mutate uh in the other direction i'm not saying it's never happened in the history of the universe but it would be reportable it would it would but based on those foia documents we saw yesterday maybe this isn't something from nature just just saying you know no interestingly you know how what it would do well interestingly and i have said this from the beginning because this was not from nature let's be clear it was not this was a lab-created virus but fortunately you know no, 100%, you heard it here first. No, 100%. But I will tell you. I agree.

The good news, the good news is in all seriousness, is that despite the fact that this was a lab-created virus, it mutated in ways that were exactly based on what a naturally occurring virus would do, which was great because had this started to mutate differently, if they'd found out some way to embed components in it, to splice pieces in that made it mutate differently than that, meaning those two things becoming more contagious, but the less time, less severe, we would have been in a heap of trouble as a species. Fortunately, that's not what happened despite the fact that it was lab created. Everyone's been very, very generous with their time. We are way, way over.

But Joe, I'm going to ask for one more thing. We really haven't highlighted the guy, the FDA, how they decide if something is a Vioxx related event or not, a vaccine related event or not. Do you have that on tape where he goes go say, we got a guy named John. John goes out and decides John, the plumber, John, the plumber goes out and says, is it a vaccine reaction? John Greenewald Yeah, let me see if we got this here for you. Um, that the him stating that exactly in those sense, he, he, he gets to it over and over,

but, um, using random music. David Schawel That was the most was the most to me of today's been a lot of astonishment but that was the most astonishing thing from our last conversation i want to put that out finish with that that's our that's our sort of uh return to tonic with a flurry this dude this dude, who, you know, did it. I got it here, I think. Very likely to have occurred to them in any case, then that event is less

likely to be related to the investigational product. We played this earlier here. I'm not sure what you mean by that. Again, using the randomization to do hypothesis testing to look for a causal relationship

between the investigational product and the PIVO, again, it's typically not done for a variety of reasons, one of which is the multiplicity concern, because we may have a case where there's no difference in total number birth of SBAs, but a substantial difference in a specific SFC, which is causal. And you've got to go around testing every PT, every SFC, and have believable hypothesis test results from that. I appreciate that. I think we're not looking at so much as hypothesis testing, but even just the notion that given you have a randomized trial, you can start with very crude level looking at all cause and looking at AESIs.

My impression is that's what the AESI list was indeed created for, is to have a better sort of a focused look at engineering hypotheses about what we might see. I think the AESI list, the Brighton list, I believe it was intended for primarily post-market fail. No, not true. I could be wrong about that. You are.

Critical review memos. So I'm sorry. This whole recording is a lot of boring talk between people who like statistics a lot. Yeah, yeah. But the content of it is explained with going into each individual case and looking at all these individual things. Next time I come on here, I will exactly identify these things because it's so boring to replay that I feel bad.

That's a date. That's a date. You have a date with us, a date to return and play some highlights. But I thank you both for spending time with us today. You've been very generous and been very insightful. A lot of interesting things have come up. And what we're supposed to do is raise questions, raise issues. And I think that's a lot of what, and then focus on weaknesses in the process. And that's what we're supposed to do. It's not like we're doing something

nefarious by doing this. That is our job and has always been our job. Kelly, you want to wrap up too? Yeah, I just, I would say that we have got to return critical thinking to medicine and certainly to these regulatory agencies. It is their job, as I said, to protect the American people, not come up with every which way from Sunday to explain away things. It's as if this is sort of a Saturday Night Live skit, if it weren't so tragic. These guys, I've met guys at the jiffy lube who have better critical thinking skills than these folks in the fda boardroom so thank you for sharing that jess it's always great to see you love your insights on all of this and your your scientific detail here so thanks to both of you for being here sorry for taking up so much of your uh of your time today, but I think this was a great conversation.

Agreed. Pleasure. See you back. Mechanics know everything. Thank. They do. They do. People don't question them the way they question us.

Okay, guys, we'll wrap it up with that. More bad is bad is usually. Yeah. Easy to understand. Exactly. Exactly.

All right. We'll be back on Tuesday, I think, by Jessica. And Kelly, are you with us on Tuesday next week? We're out tomorrow. I am not. I'm back. I'm back. No, I'm back.

I'm solo on Tuesday with Brian Hooker. Oh, that's what it is. Yes, that's right. Yeah, Brian Hooker, who co-authored a book with Bobby Kennedy Jr. about the vaccines. So I am doing a one-on-one with him on Tuesday the 12th. And then we've got my pal John Phillips. I think you're back on Wednesday with John Phillips. We're going to be talking on Wednesday. And then we've got Pierre Corey coming back the following week.

Great. We'll see you all with Kelly on Tuesday and me and Kelly on Wednesday. We'll see you on Tuesday. Thanks for joining us. Thanks. Ask Dr. Drew is produced by Caleb Nation and Susan Pinsky. As a reminder, the discussions here are not a substitute for medical care, diagnosis, or treatment. Thanks. Ask Dr. Drew is produced by Caleb Nation and Susan Pinsky. As a reminder, the discussions here are not a substitute for medical care, diagnosis,

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