Ask Dr. Drew - Sasha Latypova [Former Pharmaceutical R&D Executive] Uncovers Drug Research Fraud w/ Dr. Kelly Victory – Ask Dr. Drew – Episode 198

Episode Date: March 26, 2023

Sasha Latypova is a former pharmaceutical R&D executive with 25 years of experience in clinical trials, clinical technologies, and regulatory approvals. She owned and managed several contract research organizations and worked for more than 60 pharma companies worldwide. She interacted with the FDA as part of a scientific industry consortium on improving cardiac safety assessments in clinical trials. Follow her at https://twitter.com/sasha_latypova and read more at https://sashalatypova.substack.com 「 SPONSORED BY 」 • 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 • 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 10% off with promo code DREW at https://genucel.com/drew 「 MEDICAL NOTE 」 The CDC states that COVID-19 vaccines are safe, effective, and reduce your risk of severe illness. Hundreds of millions of people have received a COVID-19 vaccine, and serious adverse reactions are uncommon. Dr. Drew is a board-certified physician and Dr. Kelly Victory is a board-certified emergency specialist. Portions of this program will examine countervailing views on important medical issues. 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. 「 WITH DR. KELLY VICTORY 」 Dr. Kelly Victory MD is a board-certified trauma and emergency specialist with over 30 years of clinical experience. She served as CMO for Whole Health Management, delivering on-site healthcare services for Fortune 500 companies. She holds a BS from Duke University and her MD from the University of North Carolina. Follow her at https://earlycovidcare.org and https://twitter.com/DrKellyVictory. 「 GEAR PROVIDED BY 」 • BLUE MICS - Find your best sound at https://drdrew.com/blue • ELGATO - See how Elgato's lights transformed Dr. Drew's set: https://drdrew.com/sponsors/elgato/ 「 ABOUT DR. DREW 」 For over 30 years, Dr. Drew has answered questions and offered guidance to millions through popular shows like Celebrity Rehab (VH1), Dr. Drew On Call (HLN), Teen Mom OG (MTV), and the iconic radio show Loveline. Now, Dr. Drew is opening his phone lines to the world by streaming LIVE from his home studio. Watch all of Dr. Drew's latest shows at https://drdrew.tv Learn more about your ad choices. Visit megaphone.fm/adchoices

And welcome everyone. Of course, it is Wednesday and we will be here with Dr. Kelly Victory as we always are on Wednesday. And today our guest is Sasha Latapova. Let me tell you a little bit about her. She has 25 years of experience in clinical trials. She has worked for multiple pharma companies worldwide, interacted with the FDA, and has been part of the scientific industry, particularly on the side of improving cardiac safety assessment in clinical trials. She has some significant opinions and we would like to hear them. So let's get to them. 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. 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. If you have trouble, you can't stop and you want help stopping, I can help. I got a lot to say. I got a lot more to say bed mgm authorized gaming partner of the nba has your back all season long from tip off to the final buzzer you're always taken care of with a sports book born in Vegas.

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As I said, we will have Sasha Latipova here in just a minute. Of course, my wife and producer, Susan Pinsky, is standing by. And she says on the Rumble Rants that she's feeling old today. So I don't know why you would say such a thing, but did not escape my glance uh but you all have an opportunity to get on the rants there um i believe she may yet be able to moderate those rants but we don't know yet how to do so and of course i'm watching your restream i need to rumble's been very kind okay well that's good youtube uh opinions strong opinions but kind that's yeah but YouTube was a little sharp. Strong opinions, but kind. That's good. We appreciate that. Yeah, it's pretty good over there.

And Vicki Mail wasn't inflammatory enough for them, didn't get them all. It seemed like I'm pretty excited about that. Actually, Rumble was listening and not cursing at us. That's the whole point, everybody. That is the point. YouTube was a little hotter under the collar. Don't imagine you know everything. Just sit and listen.

I think that's a good way to approach a lot of the a lot of materials that we review here and we of course are out on Twitter spaces and we always try to get a couple calls in at some point in the show but I think Sasha will be an interesting guest and will be very much preoccupied with her you can follow her on her Twitter it's Sasha underscore Latipova L A T Y P O V A and check out her Substack Sasha Latipova at substack.com. And as I said, uh, she has an MBA from Dartmouth. She is a, uh, 25 years of experience in clinical trials, clinical

technologies, regulatory approvals. She has owned and managed several contract research organizations and worked for more than 60 pharma companies worldwide. She has had regular interaction with the FDA and has some interesting insight to offer. So please welcome Sasha Latapova. Hi, Dr. Drew. Thank you for inviting me. So a lot of what I thank you for being here. So a lot of what I have seen from your material is concern about manufacturing integrity and these sorts of things.

And that has been raised to me in the past as well, particularly as it pertains to mRNA integrity and protein particles that are produced in the mRNA. But give me an outline of what your basic position is. Well, that's where I started looking at the data very early on in 2021, when these injections were being rolled out. I looked at VAERS data, and I immediately realized that these products were not what we call a good manufacturing practice compliant. CGMP, a good manufacturing practice, is a set of laws in the United States by which FDA regulates interstate commerce in pharmaceuticals, foods, and cosmetics. And the compliance with these laws, which are very, very extensive, is what makes products safe for consumption, because you don't want to have something that

varies a thousand percent from week to week you know your favorite beer for example this week and the next week has a thousand percent performance difference well that product is extremely unsafe and that's how that's how we think about it um and what i realized for these products there is no cgmp compliance how did did you could you figure out, well, let me see, I'm going to come at it from this perspective. I saw some material flying around today where there was a FOIA report. Again, people are interpreting it as they will, but it looked to me like a FOIA report that at least suggested, which did not surprise me, that the regulatory agencies were anticipating a lot of adverse reactions, more than they would

normally ever put up with. But they were in a big hurry to get this out, and they were willing to take on more risk than we would normally take on. That does not surprise me. That's what it looked like to me. So I think that's what happened. What I find odd is that there's been no attempt to sort of bring it back to where we would normally expect the science, the sort of safety science to go, number one. And then number two, I want to ask you, how did you find out that these, CGRP you call it, is that right? The regulatory guidance or regulatory practices? Yeah. How do you know that there wasn't being did you are there FOIA documents out there that document this or there did you find

some internal how did you prove that well so there are three three uh stages i would say uh of discovery here first i was just looking simply at uh VAERS which is vaccine adverse event reporting system data which was the only data available to look at this. And I was looking at adverse events and deaths recorded for these injections in VAERS versus lot numbers of these products. Each product has a lot number. If you go to a pharmacy and buy aspirin, you will see lot number on the box. So the same goes for these products. All vaccines have lot numbers. And the lot number is recorded in the VAERS reports, not all the time because sometimes people don't know it and don't know when they're reporting to record it.

Sometimes they make typos, but for about 50% of the reports, these lots are available and they can be matched to CDC list of valid lots that were released in the United States. And I did that. And when I did that, I saw that some lots had practically no adverse events recorded, such as maybe two or three or 10, and some had 6,000. And within those, there were maybe 300 deaths. And that was horrible. And that's where I'm saying the variability, you know, thousand percent variability lot to lot. So when you see something like this, you know, immediately there's something really bad going on with the manufacturing. And these products are not CGMP compliant because the variability

is outside of the range of statistically controlled processes that we have for quality control. So this should be flagged. And by the way, for good manufacturing practice compliance, you're correct. There are safety monitoring systems throughout FDA, the FBI, drug enforcement arm, health authorities locally. Each manufacturer has their own system. So this kind of variability always gets flagged and products get removed from market or recalled. You get, for example, letters from your dealership, car dealership, saying this part number has been recalled. That's because they flagged something. It's doing this kind of analysis, looking at their systems.

So that was the first level. The second level, there were some regulatory documents leaked from European Medicines Agency at the time of approval. And these documents are for Pfizer, all of their what's called chemistry manufacturing controls section from their biologics license application. And that section actually has never been released publicly. They continue redacting all of this information, but this was leaked. And it was clear that European Medicines Agency reviewers wrote an objection to Pfizer's approval and said specifically, objection number one was Pfizer was not good manufacturing practice compliant. And that has still not been resolved.

These manufacturing facilities of Pfizer have not been inspected by the FDA at the time of the approval. Even later, they now started doing inspections, but only inspected some suppliers. Pfizer and Moderna have not been inspected, and we don't see those reports. So as far as I'm concerned, when European Medicines Agency said they were not in compliance, they still remain not in compliance. And finally, the final piece of the puzzle is actually by US law, or rather laws and statutes that are being utilized during this so-called crisis and so-called emergency.

Actually, this compliance is not required from these products. And that was the final piece that I realized after I started working with legal researchers and specifically Catherine Watt, who also writes legal analysis on Bailiwick News Substack. And she outlined very clearly that by U.S. Code 21 U.S.C. 360 BBB that's being utilized by everyone cited by FDA, cited by government accountability reports, use of emergency use authorized countermeasures, which is how these products are classified. They are not vaccines, not pharmaceuticals, they're countermeasures.

So use of these countermeasures, emergency use authorized under public health emergency cannot constitute clinical investigation. And therefore, no FDA rules, such as good manufacturing practices or clinical trial regulations, actually apply to these products. So by three methods, looking at the data, looking at the documents, and looking at the law, we can conclude definitively that these products are not good manufacturing practice compliance. But back to the sort of the FOIA thing I was talking about today, where there was an acceptance of higher than we would usually accept adverse events, is the fact that they are not mandating CG&P compliance just further evidence that that's just another area where under this emergency, they were willing to tolerate more what would otherwise have been unacceptable sorts of standards. Again, I can understand that given the circumstance, whether it was right or wrong

is a whole different question, but I understand it understand it the question what i don't understand is uh two years later why we're not filling in the gaps to bring things up to the standards that they should would have otherwise had were it not an emergency use countermeasure do you have any understanding of that yes yes because, because the status has not changed. They remain emergency uses rise countermeasures. And it remains the same situation where you're correct. They were, you know, they were stating that they're willing to tolerate higher than normal and relax some rules, but nobody has ever explained to American public just how much those rules were relaxed they're saying they relax the rules they actually threw them out of the window uh and uh forgot about them so so that it's a matter yeah so so but the well and yet though

let me interrupt and and say though well the status has changed, you've said, in that they are starting to, what did you call it, inspect. The inspections are beginning, so they just need to step them up, right? Are the inspections uncovering anything? Is there something we should be aware on that front? Yes. So the inspections that I'm aware of, that's another very curious feature of this exercise. As I said, in 2020 fda did no inspections in 2021 they started some of the inspections they inspected only a couple of suppliers i'm aware of of pfizer and moderna for example catalan which is a fill finish supplier

for moderna in indiana and ranchler which is a drug substance supplier for Pfizer in Germany, and then also Emergent BioSolution, which was a supplier for AstraZeneca and Janssen. All three failed miserably. There are forms 483 available from FDA with horrific violations horrific any you know any from the DEA you say DEA has it FDA or FDA has those forms for FDA I can send them to you as well they're publicly available and those are horrific violations uh by even having a form 483 means that you are not in compliance and you need to bring yourself back into compliance. So they issue these forms. They're huge, you know, 50 pages each or more with numerous, numerous, very bad violations and nothing happens. There is no enforcement. That's another mark of what's going on because the status but let me let me yeah i'm trying to make sense of

it that's that's my sort of desire today is make sense of what's happening so if i'm making sense of it i would say well you're right the status hasn't changed and therefore they don't have to do anything right and and and i and right and you're uh you've been a you've managed companies you know how companies behave if they don't have to do something, they don't do it. Right? Am I saying too much if I say that? No, that's correct. If there is no pharmaceutical manufacturer, if there is no requirement to be in compliance,

and then there is no liability such as through PrEP Act, their government gave them total liability protection. Then why would they do anything to comply? And then FDA actually goes and inspects and does no enforcement. Let me flip, let me sort of flip it around a little bit, and then we'll bring Dr. Kelly back in here. Is, you know, VAERS, you know, people argue that VAERS is not a very reliable way to look at things. And I think that's a viable position to take. Let's flip the data on its ear and say, if it's so bad, why aren't we seeing more problems? I mean, it really, given the number of people that have been vaccinated, it's sort of interesting that there aren't worse problems. In fact,

in the FOIA document I just saw today, however you interpret it, it looked like they were expecting a thousand adverse events a day on average. But why isn't it worse? What I found, because these products are not good manufacturing practice compliant, they are manufactured in an extremely sloppy way. And the only real, let's say, target or incentive for the manufacturers was to produce doses. Doses, lots and lots of doses, 100 million up to 500 million very quickly. And the scope of their contract is manufacturing demonstration and prototypes.

So all they have to do is ship lots and lots of doses. So what I observed is a very reckless, at huge speed, scale-up of manufacturing. They went from micrograms of RNA to hundreds of liters. One Pfizer lot today, FL0007, has 12 million doses, which translates to roughly 900 liters of RNA. This is straining imagination of what's possible or even what kind of equipment is available for these kinds of productions. So what happens in reality, when you have a huge batch of RNA, the enzymatic reactions can seize. It can also separate very heavily.

You know, if you have a large volume, more lipid will float to the top and there will be less on the bottom. So, and the filling is from the bottom. So when you start filling, you might be filling originally, you know, initially just water, and then later on more concentrated rna then when they shift they must have some way they must have some way of emulsifying or something if

you if you they do not really stir it if you stir it aggressively you break rna and rna is is extremely fragile so uh it's fragile it breaks into pieces I have researchers who've sequenced the vials, several of them, one in Europe, one recently in the US, they're finding huge number of small RNAs, which are dangerous, but they're not finding the pieces, the sequences that have been specified by the manufacturer because it's fragile and it breaks. And so that's what we're- They're not finding any of the full, wait, wait looking for. They're not finding any of the full mRNA? Or just the...

Oh, wow. Nope. They found... So the one researcher I've seen analysis from Europe, they found three possible matches to the longer lengths of RNA. But none of them were exact match. And then a whole bunch of small ones, just broken off pieces, which are not, as I said, they're not benign.

The small one has been, that's been reported before. I've seen other data showing the scattergram on that. And in fact, my understanding is that was brought up in a congressional hearing, and the drug company said they were aware, and it has no clinical significance in fact if i'm recalling correctly they may they put a positive spin on it it'll just add to the immunity did you see that testimony yes and and that's completely dishonest because uh small

RNAs uh micro it's called micro RNAs or short interfering RNAs uh they're described in the literature including numerous government reports as a potential bioweapon technology. And I'm sorry, I'm using this word. Some people get triggered by it, but I didn't write this. NIH wrote a textbook on it. And there is a chapter in it saying how these technologies can be weaponized, gene therapies, and small RNAs specifically. So I am shocked that our regulatory agencies find them completely benign and nothing to talk about. But these small pieces can interfere with cellular processes, can cause cancer, can

cause dysbiosis, and this has been described explicitly as a weaponizable technology. Let's take a little break with that bomb. If we drop that mic drop sort of description. And we will get back with Dr. Kelly Victorine here in just a moment. Again you can follow Dr. Ladopova at saschaladopova.stack.com and Sasha underscore Latipova, L-A-T-Y-P-O-V-A. And we'll be back with Dr. Kelly Victory to continue the conversation. I think you know how much Susan and I love our Genyacel skincare and how easy it is to try our one-of-a-kind customer packages bundled with our favorite products. Susan realized the other day that one of our kids

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on the entire population. This is uncharted territory, Drew. And Dr. Kelly Victory, I give you Sasha Latipova. Hi, Sasha. Thanks so much for being here. I know your time has been crazy. Your life, like mine, has been put in a blunder because of your involvement in this pandemic debacle. So thanks for being here.

I want to get back to this issue of the VAERS and specifically to the signals with regard to manufacturing irregularities, lack of compliance and all that. But before I do, I want to go back in time a little bit with regard to your past experience with pharmaceutical companies and really your experience with trials and those sorts of things. And let me say, by the way,

that I don't for a minute believe that somebody has to have a degree in science or be a physician in order to have some very, very important insights to what's going on. And your experience, I think, is germane. But I think it's important for our listeners to understand exactly how much experience you had with regard to things like clinical trials. So talk just for a minute about what your consulting company did and the sorts of things that you oversaw prior to COVID. Yes, I co-founded and managed several companies in clinical trial space over years. And most of them were focused on performance of clinical trials in humans, early phase, and with various technologies that help us analyze different types of data that we

need to collect in clinical trials and analyze it very precisely because it's a different precision requirement versus, let's say, clinical diagnosis or practice of medicine when you're just using. So I was using things like various imaging modalities, electrocardiograms, Holters, arrhythmia monitors, telemetry, and trying to figure out how to analyze this data from drug trials versus placebo and extract much more precise analytics to make sure we understand whether the drugs have potential safety signals as early as possible, because we did not want to continue development of a product and potentially expose patients in clinical trials to something that

could be dangerous if we could exclude that drug and sort of kill them early. That was always mantra to kill them early so we don't spend time and money and expose people to risk where we can find signals or we can also find if something is promising and we can exclude the risk early. That was a huge achievement too. So that was all my focus. And I worked, as I said, I worked in this area for about 60 clients, large and small pharmaceutical companies, ran hundreds of studies all over the world with all kinds of clinical research sites. It's very interesting work.

But I actually left the industry before COVID started and I was retired. I wasn't doing anything. I was just doing my art and enjoying myself. Was your company, as a consultant, were you involved in designing the clinical trials themselves? So you actually designed clinical trials to determine what would be an adequate trial to test something, correct? Yes, yes, correct. So we had to design the study, estimate the sample size that we need of those number of

subjects we need to enroll, what's going to be, you know, it's going to be parallel or crossover design and placebo controlled. And, you know, all sorts of issues go into the design. The design of a study takes months and sometimes takes years to properly design a study. So even before you started looking at the VAERS data, you know, John Q citizen, as an artist trying to get retired, enjoying your life about what was going on or not going on with regard to the studies that were being done on the COVID vaccines? Yes. I became concerned because I actually came across this mRNA class, which is gene therapies.

It was always designated as gene therapies until 2020, you know, when they changed the definition of vaccines to fit it in. But I came across this class professionally because there were some early phase studies that were being conducted and considered for these products, maybe around 2009, 2008, 2009. And at that time, there was a big scandal in the UK.

There was what we call first in human study conducted at Paracel, which is a clinical research organization. And they were conducting this first in human study for this gene therapy product. It was a small biotech. They subsequently went out of business, but the classes, this was the same.

And in that study, there were, it's a small, it was small study, eight healthy men. And I believe one or two died immediately. And a number of them got severe, severe injuries. I don't know how many survived.

And at that time, that shook the industry. We could not believe something. People were screaming at Paracel, why did you dose them all at the same time? And we just, we could not believe that something like this could happen. And this was a huge problem. And I read about this class then, and I realized how dangerous it was. So at that time, it was only developed for very, very severe conditions, such as terminal cancer, Huntington's disease, other very, very severe conditions.

And there are numerous regulatory guidances. FDA, as you know, regulates industry by publishing guidance documents. And for the gene therapy class, there were guidance documents created since 1998. And specifically after this scandal, the most recent guidance from 2015 before COVID was saying things like these products are very dangerous. They can cause death. They can cause cancer. They can cause uncontrollable and unstoppable protein expression, which is what happened with that study with Paracel. It can cause a huge cytokine storm type of reactions, blindness.

There were all sorts of warnings that FDA put out, and they said specifically you cannot give it to healthy volunteers. So that's a designation in clinical trials. If the regulators tells you you cannot test this product in healthy volunteers, it means the product is very dangerous. And it only designated to very, very, very niche, severe terminal conditions. And so that was the class as of 2013. Then we come to 2020.

I start reading the news stories that this is going to be given to pregnant women and children. Right. Well, yeah. Let me interject here just to be clear. The class you're talking about is the use of mRNA technology associated with lipid nanoparticle delivery system. And yes, this has been in development for more than 20 years. But as you point out, we have had previous experiences where they've had disastrous results. Many, many times never even made it into the human trials because all of the animals died. So if you saw that bit of video that's been released, it's gone viral of Anthony Fauci going door to door in Washington, DC. And this gentleman says to him, well, it hasn't been tested enough. And Anthony Fauci says, oh, this has been in testing for more than 20 years.

He fails to go on to mention, yes, with disastrous results every single time. This has never been done successfully. To be fair, to be fair. Well, hang on. hang on, guys. It has to have, there have to have been something that happened between what Sasha is describing and the deployment recently, or we would have, I mean, think of the level of catastrophe would have as it, as bad as we are concerned things might be, it would be a hell of a lot worse.

Right. So I, I think what, what only happened is they, they over diluted it versus what was being used. And again, I don't know if it's Pfizer's product, not Pfizer's product was the study I'm describing with Paracel. It was somebody else's product, just the same class. But I think nothing fundamentally changed about the safety of these products. They were in development for 20 years and failed every time. They failed specifically because they're not manufacturable to CGMP standards. You cannot assure, you cannot, as a manufacturer, you need to make sure that everything that you specify as a composition of your product on the label is in that vial and nothing over very, you know, very tight limits, especially because of nucleic acid material, very, very tight limits. And is that CGMP compliance you're talking about, is that because of what you described earlier in terms of the massive sort of distribution in these large lots?

Or are there other concerns that they had back then in terms of the massive sort of distribution in these large lots? Or are there other concerns that they had back then in terms of the manufacturing? Well, so the manufacturing, they could never make it stable. So it breaks, right? And even when you're making a small, very small quantity of this product in the lab or for animal studies, it's micrograms. It's really, really small. And so you could sort of control it.

But even then, I interviewed several researchers who made themselves the mRNA in a lab. And they said, you know, for animal studies, we make small quantities. Yes, it breaks. Yes, it has a lot of impurities, but we don't worry when we inject the rats. Well, you know, we are not rats.

Pregnant women are not rats. We should worry. Right. You know, and they're doing animal experiments for, you know, a couple of days, maybe a week. We have children who have the whole life ahead of them. Well, and on top of it, I have to say, you know, one of the ways, Drew, that they got around the fragility of the mRNA was the mRNA used in these COVID vaccines is synthetic. They substituted all of the uridine with pseudo-uridine to make it more stable so that they could be used. But as a result, the fragility of the mRNA in some ways worked to the benefit of the recipients because it would break down and go away.

When you create, substitute the pseudouridine, you ended up with something that seems to go on in perpetuity. It never goes away from what we can tell. And therefore, you keep expressing, in this case, the toxic spike proteins. And these are things that i'm sure yeah that's what i want sasha to talk about too because at very minimum what you and i kelly have been exposed to through dr cole and other places that the excessive spike protein is is the problem right and i what i've been wondering lately and and maybe Sasha can answer this question,

is there something about that pseudouridine or the instability or the broken products that are out there that could create this excessive production in certain people? In other words, could we, you know, some people have the vaccine and they're fine, but is part of the problem that this mRNA is producing too much spike in some way or continuing to produce? I'll let Sasha kind of address that.

Yeah, so there are numerous layers of issues here. So as I said, the sloppy manufacturing, so some people get over-concentrated mRNA, some people get nearly blanks because of the way they manufacture these huge batches very quickly. And then there's variability because the doses are manually prepared. Again, you know, this huge, huge variability added on top. So that explains part of it. Then some people, there's also individual variability that is very poorly understood. Some people can uptake the mRNA in their cells and then will continuously produce this, these,

um, you know, shed this, uh, substances into the environment and, and they damage their own immune system. They damage potential immune systems of people around them. Uh,

and so, uh, so we don't know, and there has no, never been, um, what, what is called a viable therapeutic window for these products,

meaning that those that would be good for producing the effects that we want and not producing the effects that we don't want. It does not exist for these products because of humongous variability inherent to manufacture and inherent in how people process these things. My question, I'd like to get back for a second to this issue of the manufacturing irregularities. You have been clearly been talking about lack of oversight or lack of consistency, lack of good manufacturing practices, which is certainly what anybody with any experience in manufacturing, that's the conclusion they would come to when you see this huge variation. Because as you point out, otherwise, the incidence of adverse offense should be relatively homogeneously distributed across all lots. Now, I will say, here's the

elephant in the room. Do you have any feeling whether or not this could have been not from a lack of adherence to good manufacturing, but something that was more purposeful? Do you believe that there's any possibility that the variation in lots is something that was part of this great experiment that we are all participating in. Yes, it's hard to figure this out without a more formal investigation, whether there was intent to introduce some substances. But the problem is that these products should be deemed de facto adulterated, because if something is not compliant with CGMP, they're de facto adulterated products, meaning that by accident or purposefully, the product can be adulterated given how how slowly it's been manufactured and no controls. And also these products can be misbranded and falsified because they're also not distributed

according to good distribution practices. They're distributed through DOD contractors and as a black box DOD operation. So the product is completely open to adulteration, whether purposeful or accidental, and misbranding and falsification. And none of it has been addressed. There's been no enforcement of any of those rules. Correct. No. Well, since you brought up the word, you said the word yourself, a bioweapon, and I'm not afraid of mentioning that. If you feel comfortable talking about it,

let's talk a little bit about this, really in the involvement of the Department of Defense and how that involvement facilitated, frankly, their ability to sidestep any real investigation into good manufacturing processes or to uncover really the amount of testing that was or wasn't done on these products. Yeah, so the manufacturing and distribution and financing of these products is essentially all been done under a Department of Defense. The biggest lie that was told to the American public is, remember, we were told this is a health event. This is an epidemic or pandemic from zoonotic origin. And you would be kicked off YouTube if you even suggested that this was from a lab, right? And what in reality happened, our government organized itself as if it was war from day one. The whole COVID response policy

is under National Security Council. National Security Council is advisory body to the President of the United States, consists of defense and intelligence, does not have health representatives on it. Then from there, the Operation Warp Speed was headed by the Department of Defense. We were told, again, it's just a collaboration with HHS. Oh, they're just doing logistics because Army is so great at, you know, driving the trucks around. But what in reality happened is they actually, on the organizational chart of Operation Warp Speed, Department of Defense is the chief operating officer, meaning they're in charge, reporting to the president or National Security Council.

And the HHS a chief advisor so you know they're they're ranked below i mean they don't have operational role they're just advising and then under that there was a whole huge u.s government executive structure which did everything which means so all of this reporting to DoD, they design the clinical trials, they implement manufacturing through existing contractors of the DoD, the legal, the legislative, the data monitoring. Pfizer had their own safety monitoring, but otherwise they utilized the same structure. And then all the contracts were written and structured with DOD.

So these are DOD pharma or DOD medical device. And it's not just the injections, it's all the therapeutics, it's all the diagnostics, all the COVID so-called countermeasures, which there are hundreds of contracts, were done through this methodology. And they were also done with the DoD's favorite contracting method, which is called Other Transaction Authority, which allows them humongous amount of secrecy, no accountability, no following any procurement rules. That's because it's just classified as other. So here we have DOD funding, designing, monitoring, implementing, distributing, and contracting sort of other. And then they're contracting for manufacturing demonstrations. All of these contracts say demonstrations, prototypes, countermeasures.

These are vague, fuzzy terms. They're not saying pharmaceutical products. They're not using pharmaceutical laws or CGMP. They are using this structure that has, you know, public health emergency, emergency use, countermeasures, prototypes, other. You know, so that's how we arrived. Okay, so what I was going to say, so the VAERS system, which is owned by, sort of co-owned by HHS and the CDC, their proverbial, you know, early warning system canary in the coal mine that they have chosen to ignore. given the DOD's role in all of this with the COVID vaccines, have they had any involvement in looking at the VAERS data? Or is anybody, other than those of us who are tremendously concerned about what's going on here, is anybody at the DOD been sort of tasked with looking at the VAERS system data? Or have they just washed their hands of it at the DOD?

I'm sure they're monitoring the data. In fact, the DOD and HHS together have about 11 different databases that we know of. Maybe there are some others that they have access to and they're including VAERS and, you know, there was V-safe also, which, which got released, but that was an app that people were using. And so, but they have many, many databases. They're very good. They're almost real time. They have great data.

We have no access to, we pay for that data as taxpayers, but we're not allowed to see it. We can see VAERS and we have been screaming at CDC, many of us, myself, you know, there are many researchers that are looking into this. Most recently, the Surgeon General of Florida, Dr. Ladapo, wrote a letter to Rochelle Walensky and Robert Califf asking, why do we have 4,000% increase in life-threatening conditions reported to VAERS in Florida? And that's a very good question because, yes, it's 4,000% increase, and that's actually representative of what is in VAERS. The minute these shots went out, that's the toll that we can see,

4,000% increase in life-threatening conditions. And so, yes, they are monitoring this data. They're collecting this data. They're seeing it. And that's why I have been saying that this is intentional, because if you see somebody counting the bodies for two years, and they're piling up, and we're screaming at them, what are you doing?

You have to stop. They're not doing anything. Hang on now. So what I'm seeing now whether it is accurate or not is a systematic rollout of data that shows that it's kovat causing the excess mortality and all these increase in disease states and some of that data looks good what worries me is that they never you never get any countervailing data published which

immediately i mean i've never seen anything in medicine where it only goes one direction and that's what's gotten me upset about a lot of the data that's out there right and we have large we have large go ahead go ahead sasha yeah i have to say that you know whatever you think of and people are saying oh it's just crazy anti-vaxxers all got together, started writing hundreds of thousands of reports all of a sudden, it's just, it's only COVID. But I looked at three days after vaccination, within three days of vaccination, we have 10,000 deaths,

deaths, hundreds of thousands of of severe conditions 4 100 of them on the day of vaccination right the person got vaccinated but i i i get those concerns i i get it i get it and again by the way it could be coveted plus vaccine or something who knows because they're not asking the question, which I find astonishing. If the person is going to die that day, why vaccinate them? If they have such severe COVID, you know, you're doctors, you know.

Yeah. Right. And the reality is we have large population, we have large population-based studies now that disprove this myth, for example, that myocarditis is more likely from COVID than from the vaccines. Because if you look at the data from the beginning— Well, that's the one—Kelly, that's interesting that it's the one diagnosis that seems they've conceded on, in spite of a long track record of data trying to dissuade us from that position. It's interesting to me.

Do we know how we got to the point where now they're saying, oh, yes, yes, myocarditis now is something that happens from the vaccine? Do we know why that switch? Again, it all gets so mysterious. People want to believe this. They want to pretend. Kelly, can you answer that? I'm sorry.

Well, as I say, it is evident from the leaked, well, not even leaked documents, FOIA released documents now that they were well aware of the increased risk of myocarditis and pericarditis related to the use of mRNA. This has been well known, well documented. And I think the only reason they've conceded on that singular point, Drew, is because essentially they've beenceded on that singular point, Drew, is because essentially they've been outed. But if you look at the data on all of the other conditions from the beginning of the pandemic until the rollout, we did not see increases in spontaneous miscarriages and

pulmonary embolisms and, you know, aneurysms of the, you know, cerebral aneurysms in young people and on and on. So one only needs to look at the data from prior to the rollout, I think, to really reveal what's going on here. And as Sasha said, if you're walking through the coal mine and the canary falls off the helmet, you are obligated to investigate it. That's what that's all about and well that's the part that i find so astonishing is that you know i i you know i watch all this conversation in the british parliament and in our congressional hearings about excess mortality this has been documented for the last what are we rolling into like two years now with excess mortality and nobody's systematically trying to explain that

except this data trickling well rolling out uh about the deleterious effects of COVID, which I'm sure there are. But there's got to be other things going on here. Let me ask you this, Sasha. Are you aware in your 25 years of experience managing and overseeing clinical trials. Have you ever witnessed the use of a drug or therapeutic in groups of people on whom that drug or therapeutic was never tested? No. And that's a big no-no, as you understand. And oftentimes, manufacturers don't want to, for example, they don't want to have bad reactions and then the drug gets associated with those reactions because they haven't tested and then they get this bad publicity for their products.

So they're themselves trying to avoid that typically of going into the populations that haven't been tested. Now, there's obviously also been cases where there's sort of off-label promotion and so forth. So that also exists. your repercussions if you are doing it and if you are giving it to a person for whom you know, and then it can be traced through your documentation and your internal data that you knew that that was counter-indicated, yet you've enrolled that person, for example. For example, the pregnancy is a huge thing. You have to do pregnancy testing, two types of contraception. If it hasn't been tested in pregnancy, then during the clinical trials, we have huge safeguards. Not only we test them for pregnancy, we consent them so that they're not planning to get pregnant. We require contraception. I mean, lots and lots of precautions nobody ever goes straight into pregnant women without uh this this product being approved for it in fact as drew will tell

you when you're a medical student uh you could always make a little cash on the side by volunteering to be a subject in any number of different kinds of ongoing trials. And it was always very frustrating to the women in our class that you could really not sign up for anything. It was all the guys who could do it. The guys could make 50 bucks, you know, eating six raw oysters and writing down, you know, their gastrointestinal side effects or they could do these things. And the women never could because simply out of an abundance of caution that you could potentially either be pregnant or be thinking about getting pregnant,

you couldn't even be a subject in the experiment. Same thing, if you look at these COVID, the minimal testing that was done, the paucity of testing that was done, specifically pregnant women, people with autoimmune diseases, the elderly, children, and importantly, anyone who had already had and recovered from COVID was specifically eliminated from those trials.

So the idea, and it's so important, you more than anyone, Sasha, know that the sacrosanct law in designing a clinical trial is whoever was included in the clinical trial, the results of that trial then can only be applied to those same groups of people. Yet they absolutely breached that from the start. Yes. And I also want to say about the pregnancy specifically, I reviewed preclinical packages that were foiled both for Moderna and for Pfizer. They were atrocious. They were full of fraud. They tested irrelevant test substances, called it tests for their product. For Moderna specifically, they admitted that in their single only GMP compliance study, or GLP rather, good laboratory practice compliance study,

in rats in pregnancy, they demonstrated skeletal malformations in the babies. And they admitted to statistically significant increase in those skeletal malformations in vaccinated rats. And that was, FDA had that in their possession in 2021, and they put on the label of Moderna specifically that there are no vaccine-related skeletal malformations. So they lied on behalf of Moderna. This data was not available until it got forward through a lawsuit. So we had to wait over a year for it to come out. As you remember, FDA and CDC and everyone aggressively propagandized pregnant women, mandated them if they were health workers, mandated them if they were police or other government employees. And that was, in my mind, that was an atrocity. It's an atrocity because they knew that this is dangerous.

And in fact, it's my understanding that Pfizer has even said that there is not adequate information in order to give informed consent in pregnancy for their products. So this entire thing has been, I mean, to me, it falls under the not just bad manufacturing or bad, this is evil as far as I'm concerned. And I think it's hard to come to any conclusion other than the one you said, which is that it's purposeful. Yeah, I don't know how you come to any other conclusion. I really don't. The clock's ticking down and I want to spend the last little bit sort of picking your brain or getting your thoughts, insights about where this is going. And what I mean that with that is, do you believe there will be fundamentally accountability? Will it happen through

lawsuits? How is this going to unfold in the next year, years? I honestly can't predict that because the legal battles have been largely unsuccessful so far. And this is because, you know, I can go into another hour discussion on this, but as I said, the laws that are being utilized here, preempting any judicial review, and even the Congress abandoned their power with respect to this on paper. None of this is constitutional, by the way, Congress has power and they do not have power to give up their power, but they did. And so what needs to happen, in my opinion, is either Congress needs to act, although that's kind of not very hopeful here, but states can act. States have their own legislator bodies, and many states have laws,

relevant laws that they can enforce. They manufacture noncompliance, call them adulterated products, seize them. So many states can act. Even local judges can act. Local law enforcement can act because this is a crime that has been ongoing and it continues until somebody says stop and somebody needs to be stepping in. I have a question. Why aren't other, I mean, every country in the world is involved in this, essentially nearly every country in any event. Why aren't other, I mean, every country in the world is involved in this, essentially nearly every country in any event. Why aren't other countries raising concerns or doing their own investigations?

Some countries have some legislators from Europe. As you know, they had many hearings on this. There are some that are much more vocal than others. I know many countries already are either outright prohibiting it for children or not recommending. So they basically started rolling back the programs because they realize how dangerous they are. I honestly, you know, I mostly focus on the US, but I do have some interactions with international communities. And we see the same pattern, the same laws being utilized, the same militarized structures. But as I said, other countries have made some strides in rolling back these dangerous products.

Yes, Australia, you know, Drew, Australia just came out. And given that their original stance was, you know, get vaccinated or off with your head or be locked in your house, you know, for the rest of time, they are now no longer recommending vaccines for anybody under the age of 60, if you are not immunocompromised. So they've done a 180. They are scrambling to get on the right side of history from what I can tell. But I think Sasha's right. I think that the United States is not alone with regard to the weaponization of this entire product. Last questions, Drew, I'll give it. You've given me lots of time today, which I appreciate. I had so much I wanted to talk to Sasha about. But last questions on your end.

I wonder if we wanted to take a couple of calls here we have people that uh have lots of strong feelings do you would that be a possibility you guys up for that sure always good with me okay let's do it really very quick this is uh Bianca uh and give her a chance to speak. We're getting these off Twitter spaces if people want to raise their hand there and be a speaker. What's that, Susan? Oh, she's going to change the lighting in here. Bianca, you have to unmute your mic

in the lower left-hand corner there. Oh, I thought I heard her. If not, if that doesn't step in, I might have to put you back in the audience there. Okay. There you are. There you are. What's happening? I'm watching you guys on Roku. Thank you so much, Dr. Drew. I appreciate your show and your honesty and your humility and your desire to put the truth out there.

Be it what it, even if you disagree, which at the beginning, I noticed that you were, like all of us, we didn't know what was going on. So thank you. My question to Sasha is, what, how does what's going on with the CBDC or CDBC

or the pandemic agreement accord, how is that going to, is it going to affect the future? And more importantly, what can we do to stop it? Because if this was bad, it's going to be on steroids. Are you talking about the World Health Organization agreement? Yes, that's what I think she is. Thank you, Bianca. Sasha? Yes, absolutely.

So this World Health Organization health regulations that they want to push through, it's an atrocity. It's basically solidification of what has transpired so far into law, into international law. And then, you know, not only Congress gives up their power, actually entire U.S. government gives up their power. And as long as the WHO wants to declare pandemic based on potential pathogen, a plant pathogen, something that's, you know,

and they will declare you a danger to uh trees and then they can quarantine you to track and trace do all sorts of uh it's just the the way it's written it's it's i mean if it wasn't so scary it would be very funny uh but uh what yeah you know it's your point i saw saw President Xi today say directly to Putin, you know, we're going to make things happen here. And he said things are happening fast. We've not had an opportunity like this in 100 years. Right. Hmm.

Yes. Interesting. 100 years ago in China. Hmm. Yes. Every totalitarian dream is coming true with these international health regulations. Now, what we also need to understand, largely, they're already in place. So what they have done in the past two and a half, three years, that's basically what they want to do in perpetuity.

And that's why they want to enshrine it into law into international law and what we can do is write to our uh congress people our representatives uh express your disagreement with it very loudly on social media everywhere uh these uh agents operate only in secrecy in darkness when people are not paying attention. Once they see us being vocal about it, pushing back, and people have done things like serving notice of, I'm not going to comply, even to your local sheriff or recorded in your county. I'm not going to comply with any of this because by constitution, none of this applies to me, which is true. So that's what we can do.

We can resist it and resist it very vocally and outright on social media everywhere. Then, you know, there are some breaks that can be put in. And also people become more aware when somebody is trying to slip something like this through, let's say, funding. That's their favorite mechanism. They will send funding directly to schools, towns, universities take a lot of money from the U.S. government, and that comes with terms and conditions that they will comply with measures like this. So that's where we have to be vigilant and pay attention to how our money is being spent what our towns and schools and

police departments are signing up to and just be involved in your community well sasha we uh greatly appreciate you coming in here and talking to dr victory and myself but uh really more importantly, I'm so glad you came out of retirement to start rallying the cage, to bring certain concerns. And, and I trust you will continue to sort of raise these issues as they come up.

Are you gaining just to wrap up? Are you gaining any traction? Is there anyone on the regulatory side or on the elected official side that is listening to your concerns? Yes, there have been several. Senator Johnson, I've interacted with him, for example, many times, has been very receptive. And as you know, he's had several very important hearings. And we hope that that will continue. We've spoken to several other Congress people. We have interactions with legislators at state levels.

And those are progressing very, very well. And so I think there's a momentum being built right now. And it's going in the right direction. Kelly, any last thoughts? Yeah, I think it's so important and I appreciate you so much. It is, as I said at the beginning, this cannot be done simply by physicians. It's voices like yours and your experience, decades of experience in research and design with pharmaceutical companies. It's Edward Dowd and his ability to understand numbers, having no science background. It's Bobby Kennedy with his decades of experience in vaccinology and issues with vaccines. It cannot

be, this is not a war that can be won just by physicians. Physicians are lousy generally in the first place at doing this. They're not used to fighting these battles. And I appreciate your involvement in this because we need this to be, this is an all hands on deck or we are going to, we're going to succumb. So thank you. Absolutely. Thank you so much for inviting me. Thank you.

Thank you for being so generous with your time with us. And Dr. Victory, you mentioned Ed Dowd. I'm going to talk to him on Friday and get a review of his numbers. And then on Wednesday, Tuesday, Tuesday,

I think we're going to have Robert Kennedy come in. Is that correct? Am I getting that? Yes. No, you're correct. You are correct. I'm on these next two shows.

I'll be with you on Friday with Ed Dowd, with an update on lots of the data that he's continuing to uncover. I hate to break it to you. Spoiler alert, it gets worse and worse. It does not get better with regard to disability data. It's so hard for me. I got to tell you, because I read all sides and some data looks good. Well, in fact, two rows. That's what bothers me about some of the data. I've noticed two distinct things that are happening in the literature.

There's A, people making the case that COVID is so dangerous and all the excess problems we're seeing here from COVID, and yet they seem to make no distinction between alpha, delta, and Omicron. And all their research is from alpha and delta. And these are different illnesses. And then the vaccine research looks too rosy where no one's having any vaccine injuries. And that just doesn't pass the sniff test. I mean, anybody who's given the vaccine has seen vaccine injuries.

That's just the way it is. It happens a lot. Of course. And the data do not lie. And Ed's really got his arms around that. Not only the adverse event, just the disability data, all of it. And he's understanding the timeline that I think really further dispels this issue of, was it just COVID? Because it clearly is tied to the vaccines and the rollout of the vaccines into those countries that are most highly vaccinated. I've said from the beginning, one only needs to look at Sub-Saharan Africa, where they are not experiencing any of this, these adverse events, and they did have COVID. So you simply cannot explain away the data.

And then we've got, as you said, we've got Bobby Kennedy coming back and I'm super excited for that on Tuesday the 28th. So we're gonna hear about everything he's working on, which is unbelievable. He's really been in the trench way before COVID as you know, but he brings so much to this discussion. Okay, well, Kelly, as always, thank you. And we'll see you on Friday at three o'clock,

Susan. Is that correct? Time? Yep. Pacific time, six o'clock Eastern and have a good couple of days. We'll see you all then on Friday. Thanks. Talk soon. 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. This show is intended for educational and informational purposes only. I am a licensed physician, but I am not a replacement for your personal doctor, and I am not practicing medicine here. Always remember that our understanding of medicine and science is constantly evolving. Though my opinion is based on the information that is available to me today, some of the contents of

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