The Highwire with Del Bigtree - EPISODE 378: SIRI TESTIFIES: NEW HAMPSHIRE PART 1

Episode Date: July 6, 2024

ICAN lead attorney, Aaron Siri, gives critical expert testimony before the New Hampshire House Committee on COVID Response Efficacy. Watch Part 1 of this revealing and informative on-the-record legisl...ative hearing.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

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Starting point is 00:00:05 Have you noticed that this show doesn't have any commercials? I'm not selling you diapers or vitamins or smoothies or gasoline. That's because I don't want any corporate sponsors telling me what I can investigate or what I can say. Instead, you are our sponsors. This is a production by our nonprofit, the Informed Consent Action Network. So if you want more investigations, if you want landmark legal wins, If you want hard-hitting news, if you want the truth, go to ICan Decide.org and donate now.
Starting point is 00:00:42 All right, everyone, we ready? Action. Good morning, good afternoon, good evening. Wherever you are out there in the world, it's time to step out onto the high wire. We have a very special high wire for you today. You know, many years ago, in fact, just at the end of 2016, I met a brilliant lawyer. I've been looking around. I've been traveling the country with the film vaxed,
Starting point is 00:01:23 which sort of threw me in the middle of this entire vaccine discussion. But we realized that we were never going to really fully move the needle until we could start winning in court. And so many lawyers were saying there's no way to go after vaccines. There's no way to use this issue. You can't get into courtrooms. They have liability protection. But then I met Aaron Siri. And Aaron, you know, we got into some conversations and we're looking at.
Starting point is 00:01:49 at the future and we're looking at the past and everything that had to do with vaccines. And he said, you know, I think that there's a way forward. We can start looking at who took on the liability, meaning the government of the United States. And so we partnered up, got together, and I started the nonprofit, the informed consent action network as a part of just trying to figure out a way we could raise funds to start bringing these lawsuits so we could get the conversation of vaccines into a court. room. Well, cut to now seven years later, we have the high wire ICANN is a booming success. We're the most successful nonprofit in this space when it comes to vaccines, especially in court.
Starting point is 00:02:32 And so today, instead of it really being my show, we're going to really let Aaron take over this show. As many of you have probably recognized, he's starting to testify at all of these different hearings across the country. We played one from Arizona. But more of and more representatives are saying, wait a minute, have you seen this guy Aaron Siri speak? And he brings all this evidence like he's in a courtroom. And so Aaron is doing more and more of these testimonies in front of congressional hearings around the country. And so just to talk a little bit about that and what we're about to watch is my honor and pleasure to be joined right now by Aaron Siri. Hey, Aaron. How's it going?
Starting point is 00:03:14 Hey, Del. Good to see you. I mean, first of all, how does this happen? I mean, did you know, it seems like your phone must be ringing off the hook right now, especially after COVID. A lot of politicians seem to be really starting to ask the right questions, I guess, which is something we dreamed about from the beginning. But where are all these hearings coming from? And how are they getting your number?
Starting point is 00:03:40 Fortunately, a lot of politicians are not letting what happened during COVID let go. I mean, that's really fortunate. Yeah. And what they're doing is that they're often forming joint Senate and Assembly House committees to investigate what happened during COVID. And in particular with regards to our civil liberties, individual rights. Right. Is what the government did right?
Starting point is 00:04:04 Is it wrong? What can we learn from what happened? How can we avoid repeating the harms to society and to our rights that occurred over the last two years. And so fortunately, they're not letting it go. And these committees that are forming, they are investigating essentially how were the rights of their citizens of that particular state trampled during the COVID years? And what can we learn to avoid trampling those rights? And obviously central to that question is vaccine mandates. Were they a good idea? Should we have done them? what did we do wrong? And it's been my, you know, I've been privileged to receive phone calls
Starting point is 00:04:47 from legislative representatives and those organizing these legislative committees formal, official legislative committees, to testify as an expert witness before them with regards to civil rights and mandated medicine. Now, I've noticed in these hearings, you're, you know, really getting into the childhood vaccine program. Is anyone asking, is that a lot of a part of their question or are you just using this opportunity to establish what happened during COVID and bringing the childhood vaccine program into the conversation, which is really what we're all trying to do right now is for everyone that just woke up during COVID and saying, wait a minute, I don't want to have this, you know, product rush on the market and then rush
Starting point is 00:05:29 to me and my kids. But as you and I both know, every childhood vaccine was made almost exactly the same way. But are you sort of taking the liberty to push that way? Are they actually asking questions about the childhood vaccine program? Well, listen, they want to understand how did we get into this situation with COVID vaccines? And to understand that, you have to understand how vaccines are treated. Because COVID vaccines,
Starting point is 00:05:51 they didn't just fall into an empty tabula rosa, regulatory and legal and social framework. They fell into a very fixed legal, regulatory, and social paradigm of how people think, treat vaccines. And so, if you ignore what preceded it,
Starting point is 00:06:09 It is actually hard to understand why would the FDA act this way? Why would they consider this clinical trial sufficient? Well, if you see clinical trials for childhood vaccines, you'd understand from the FDA's perspective, the COVID-19 vaccine clinical trial was incredibly robust. From the perspective of other drugs, it was lappable, but you have to understand that perspective. You have to understand the history of the CDC and vaccines and so forth. And unless you understand that, it's hard to understand how. how COVID-19 vaccines could be treated,
Starting point is 00:06:42 why they were treated the way they were. And hence, I mean, it's not that I, I think it's an incredible learning opportunity, obviously we welcome an opportunity to educate legislative representatives about childhood vaccines, but it's also necessary in order to educate them about COVID vaccines. So this hearing that you just recently did,
Starting point is 00:07:04 which we're about to dive into, where is this and what was the focus of this hearing exactly? So this was a hearing in New Hampshire. It was a joint committee hearing. As I noted, I get asked to do a lot of these, and I especially welcome the hearings where they tell me there's going to be a, so to speak, mixed bench, folks, legislative representatives from both sides of the aisle, so we can get a spectrum of individuals with different views. I really like it when there's some pushback, when people ask hard questions. That's what makes them even more interesting, create teachable moments. And so this committee in New Hampshire was formed.
Starting point is 00:07:41 They were going to investigate a number of issues, and in particular, vaccine mandates. I was asked to come in and testify for pretty much a significant portion of the day. It ended up being the entire day, actually. I ended up testifying for six and a half hours. All right. Well, we're not going to show all six hours, but we are going to get started in this really brilliant testimony. So this is part one of Siri testifies New Hampshire. And putting this together, I've thought about the mission and I've tried to put a presentation
Starting point is 00:08:26 that comports with the mission of the committee within the context of COVID vaccinations, as that is the area of expertise that I was asked to testify about. So I'll give you a little bit of background about myself. I work at a law firm that has 60 folks, about 40 of them, do pretty much exclusively vaccine work. So our firm, I believe, has the largest vaccine practice in the world that does not represent pharmaceutical companies. So we have a department that handles just vaccine injury claims. And you'll hear more about that later.
Starting point is 00:09:06 We don't bring those claims against pharmaceutical companies. You bring them against the federal government. We have a policy practice and exemption practice and various other intersections of the law and vaccines. I went to Berkeley for law school, and over 20 years later, I find myself doing an area of law that if you told me I'd be doing when I was in law school, I probably would have laughed and said, is there such a thing called vaccine law? What is that? But here I am. That is what I am doing now. It's not what I've always done. I clerked for the chief judge at the Supreme Court of Israel after law school for a year. And then I worked at Lathamawkins, one of the biggest firms in the country,
Starting point is 00:09:43 representing Goldman Sachs, Larry Ellison, for about six years after which I left. I left. I was working too much and my wife wanted me home more. I don't think that worked out either. Started my own practice, was still doing commercial litigation and eventually ended up doing this work starting about eight years ago and have been doing it increasingly so where that's now pretty much the primary focus of my practice. You might know some of the work we've done, you know, our firm handled, for example, the lawsuit against the Air Force that got a national injunction preventing the the Air Force from picking out over 10,000 members of the Air Force who did not want a COVID vaccine due to their sincerely held religious beliefs, often because of the intersection of that product and abortion. We brought the lawsuit against the FDA when they didn't want to release
Starting point is 00:10:33 the clinical trial data that they relied upon to license the COVID-19 vaccine. We handle a number of other lawsuits all around COVID vaccines during the last few years. And one of the things I'll say about the lawsuits that we do bring with regards to vaccines is that since I don't have a PhD after my name or an MD or DO, I don't get to just say things about vaccines. I have to prove them with clinical trial data, data, high impact journals, or they're just not going to work in a court setting. In doing those types of legal work, it's really forced us to be, I guess you would say, you know, real critical evaluators about the products for better or worse. And at the end of the day, that is something that I do think the public lose sight of sometimes,
Starting point is 00:11:23 not always, is that these are products, like kind of any other products. And they have safety profile. They have an efficacy profile. They have things they can do for sure. They have things they can't do. There are things that people think about them that are accurate in some areas and not in others. And sometimes often, there's just not information, not enough information to reach a conclusion about some things with regards to the products.
Starting point is 00:11:51 And so with that sort of brief introduction, I will go through some of the information about vaccines and COVID vaccines that I think are going to be helpful to understand the government, including New Hampshire's response during the COVID pandemic. Syrian Glimbs said that's the name of my firm, and a lot of the vaccine work that we do is on behalf of ICANN, and you'll see that's a nonprofit, and you'll see a lot of the things we discussed today. We're lawsuits and information gathered in lawsuits on behalf of ICANN.
Starting point is 00:12:29 To understand COVID-19 vaccines, in my opinion, you have to understand vaccines in general from a legal perspective and how they're treated in this country for decades before. If you want to understand how the FDA responded vis-a-vis COVID vaccines, how the CDC, how 50 state health departments, how various organs of the state and agencies acted regarding COVID vaccines, they didn't just act tabular rasa. They didn't just step into a zone that they had no precedent for. They stepped into basically, in my opinion, for the most part, business as usual, so to speak. with how they proceeded vis-a-vis COVID vaccines.
Starting point is 00:13:13 People look at co-vaccines and say there's something extraordinary. I think that from a regulatory legal perspective, they weren't that unique. And I'll walk you through that. And I think that understanding how vaccines were treated pre-COVID helps put in context how they were treated during COVID. I'm going to start by focusing on product safety, because I know that's been a little bit of a topic of debate around COVID vaccines. The question I start with is how is product safety assured in America?
Starting point is 00:13:49 How does this make sure cars are safer? Every product you see in your house is safer, your oven, pretty much every product you see in this room. Over time, over decades, they've gotten safer. I mean, cars, fuel tanks used to blow up, right? We don't see that anymore and so forth. And what drove that product safety? The primary thing that drives product safety are market forces. Companies exist for the most part to make a profit.
Starting point is 00:14:17 If they're going to make a product, they'll be profitable that drives their conduct. If there's going to be liability or they anticipate liability beyond what the revenues are, they don't make that product. They also don't continue selling that product. Market forces drive product safety. When you look to use cars as an example, and actually in law school, they use a lot of car cases as the prototype cases to teach. There was this, you know, one of the classic examples, there was a car company where the internal evaluation found that it would cost more to fix this component that made gas tanks explode than it would to pay for around the 10 people that died every year from those explosions. So they didn't fix it.
Starting point is 00:15:06 It was a cold, hard calculus to be sure, I hope corporate America doesn't typically act that way, but it did in that situation. But I think it's reflective of the kind of calculus that happens every day in corporate America. And to be sure, that's good. That's capitalism. We want that. We want companies to have a financial interest to drive innovation.
Starting point is 00:15:26 It's a good thing. And then the pushback they get is they know that if they hurt people, they can get sued. And that often conforms their conduct before the market, the product even gets to market, certainly after it gets to market, but also before it gets to market. A far weaker way that we assure product safety are regulators, no offense to government in any way. But when you do look at take a careful evaluation at most industries, and you look back at what has conformed their conduct, what has driven safety. it's typically been marked forces. When you think about class actions, you're reading the newspapers, about, oh, this product has an issue.
Starting point is 00:16:10 You don't hear about that typically. From a government warning, you typically hear about it from the New York Times or the CNN reporting on OZMPIC having this or that issue and so forth. And then even more so, product liability in class actions attorneys will make sure you see an ad about that injury online because they want you as a client. You can't avoid them if you use that product. No knock on lawyers. When it comes to market forces assuring product safety, I think understanding how market forces work with other vaccines will help put how COVID-19 vaccines were treated.
Starting point is 00:16:52 In the early 1980s, there were only three routine vaccines. That's it. There's DTP, MMR, and OPV. That's the sum total of all of the routine vaccines in the United States of America. And the damages they were having to pay and the liability they were incurring from the injuries for those products resulted in either the manufacturers going out of business for those three products or stopping to make the products to the point where it reached a crescendo where there was one manufacturer left for each of those three products. You can see I've got a quote there from Bruce Woods v. Wyatt. That's a U.S. Supreme Court decision that explained that the remaining manufacturer of DTP vaccine estimated that its potential tort liability exceeded its annual sales by a factor of 200. And the Institute of Medicine explained how by 1986 litigation costs had driven manufacturers essentially out of business from making those products. Well, Congress in its wisdom, instead of of forcing those manufacturers to do what every other product manufacturer has to do when their product causes more harm than it does good as measured by dollars. And that's the better or worse, how we do it in America, decided instead to pass the National Childhood Vaccine-Ajury Act of 1986. And what this law provided was that it's okay for the companies that made those
Starting point is 00:18:34 products continue selling them, they don't have to worry about liability exposure. As provided in the act, it immunized them from financial liability for the injuries caused by those three products. This way they didn't face the financial exposure. In your expertise in research, is there any other industry that you know of that gets a blanket liability like this. So when it comes to products, and I'll distinguish between products and certain services, but when it comes to products, the only other product, I'm not aware of any product, none, that enjoys the level of immunity to having to pay for injuries that vaccines enjoy. And it applies to childhood vaccines and any childhood vaccines used by adults, so pretty much all vaccines.
Starting point is 00:19:31 Now, when it comes to guns, for example, which is talked about what guns have immunity, the immunity that guns have is if the gun is used in the commission of a crime. The manufacturer has immunity to liability for the most part. But you can still, as a consumer, if I buy a gun, it has a design defect. I can sue the manufacturer of a gun for defectively designing a gun. I can sue them for other types of claims. But when it comes to vaccines, and it's right there in Bruce Soutts v. Wyeth, again, the U.S. Supreme Court affirmed because it was challenged that the law shouldn't actually provide this. It says the Vaccine Act preempts all design defect claims against vaccine manufacturers for injury or death caused by vaccine side effects.
Starting point is 00:20:20 Design defect claims are the primary way we assure safety. It's the way that, for example, the car example I described earlier, there was a better way to make that gas tank. There was a safer way to make it. And the primary claim there was a design defect claim. I mean, when you think about saws that now have shields on them, that's because the lawsuit said, hey, whoa, you sold me the saw. It does what it's supposed to do. Thank you. Right.
Starting point is 00:20:48 But if you had put like a three penny plastic piece on it, I still have my arm. Right? There are, when there are ready ways to improve a product, you can sue for a design defect claim, but you can never do that for a vaccine forever, meaning the state of those products in 1986 is essentially locked in, at least from the perspective of being able to bring a claim to, on the basis that you could have made it safe there. So to answer your question is, no, I'm not aware of any other product that has the immunity endured by vaccines. None. So, of course, that's for the United States of America. Are you familiar with, so are other countries able to go after? Because of course, you know, Pfizer-Modernal, these other companies have products that went, you know, to other countries as well. Are they able to go after these manufacturers? So if you're asking me specifically about COVID-19 vaccines, we have copies of the contract, procurement contracts from many of the countries around the world. And those contracts explicitly provided in almost in all the ones we've seen. And it's a lot of countries, just like the procurement contract in the United States. And actually, it's one of my slides later. It provides that the country will either give immunity or indemnify, essentially hold the company
Starting point is 00:22:10 harmless for injuries caused by the COVID vaccines using their countries contractually. But I think your question might have been broader in the first instance, which is do other countries for other vaccines have a immunity? And many of them do have this similar scheme that we have here in the United States. It's been very effective. And so it's been exported to lots of places in the world. Separately, you know, class actions and the type of justice system that we have here is not the same in other countries. So you can't bring the type of claims you can in other countries as you could here, whereas effectively. But many of them also do have that kind of liability shield as well. Prior to the National Childhood Vaccine Injury Act of 1986,
Starting point is 00:22:57 you had the previous slide that said that the court would exceed their annual sales by a factor of 200. Do we have any idea of the injuries that were happening, the numbers before this was implemented? The DTP vaccine in particular, I could tell you, has been withdrawn from the United States. So that's no longer here since 2000, essentially, it's not used. And even, I guess, you could call it the regulatory health establishment decided that the benefits, that the risks outweigh the benefits, at least vis-a-vis favoring a cellular protest. T-T-T, little A-key vaccine. So that did change over time. The level of harm caused by that vaccine, there's no debate that it causes harm. That it causes harm. Yeah, the level debate,
Starting point is 00:23:50 that is something that was debated and different studies were done. There were studies done by federal health authorities who were promoting, mandating, pushing mandates of the product. And there were some independent studies done. And I can tell you, they've reach different results. And, you know, but I'll leave that for a scientist to come and debate which one of those was better studies, better designed. But I can't tell you that, at least for that vaccine, it's the wholesale pertuss vaccines no longer used in the United States.
Starting point is 00:24:20 And I have a slide or two about that later as well. So I'll hold on the rest of my comment on that if I may. Well, that brings us to COVID-19 vaccines. So just wanted to make sure you have a backdrop of what the 1986 Act was. And so the 1986 Act applies to COVID vaccines as well. The immunity under the 1986 Act arguably applies when it is added to the routine childhood schedule by the CDC, and specifically ACE at the advisory committee on immunization practices, which is the CDC's advisory vaccine committee. When it's added, essentially, the immunity attaches. I qualify that only because
Starting point is 00:25:06 they're also supposed to be an exercise tax passed by Congress for COVID vaccines, which hasn't happened yet. But that's a separate question. As it stands right now, I think many would argue that the 86 Act immunity does apply to co-vaccines, but it is somewhat of a theoretical question because the COVID vaccine is afforded a separate level of immunity, and that is something called a craftback community. And that is a, it's the, you know, public readiness and emergency preparedness act. That is a law, different law passed by Congress, which provided that if the secretary of the Department of Health and Human Services declares that there's an emergency, and obviously there are different emergency declarations, the president can make one, different FDA can make emergency
Starting point is 00:25:56 youth authorizations. Those are different. This is under the relevant U.S. Code Tech under that, under that act. The Secretary of HHS can declare an emergency and with based on a perceived or potential pandemic, a pandemic, or other threats, and declare that any countermeasures developed to address that, that what it declared as a threat will, be afforded basically blanket immunity for the most part for any claims on the safety side, as well as the efficacy side, as well as the advertising side, which is what the statute provides. And at the very, very beginning of the COVID-19 pandemic, the Secretary of the Department of Health and Human Services declared COVID-19 a emergency and declared that any countermeasures developed
Starting point is 00:26:50 in response to COVID-19 would be afforded that immunity. And that was done very, right? at the very beginning. I've got the U.S. Code provision there, 42 U.S.C. 247D.6D. And it says manufacturers of any vaccine used to treat, prevent, or mitigate COVID-19, shall have liability immunity, including from suit and liability under federal and state law with respect to all claims for loss caused by arising out of or relating to or resulting from the administration to or the use of an individual of a, and then COVID-19 vaccine. but it's broader than that. It's also drugs. It's masks. It's anything that was used. Okay. So you have basically a product that's being developed with what I would consider a moral hazard.
Starting point is 00:27:38 The manufacturer stands to make billions of dollars, but as they're developing it, before they've even started, they're really just starting making it. they already know that when they design it, when they manufacture it, when they trial it, when they push it out, they don't have to worry about being sued for injuries their products causes. That, in my opinion, creates a big moral hazard, and it doesn't exist, to your point, a representative with any other product that I'm aware of on the market. And as I noted earlier, not only did the PEP Act immunity apply, the manufacturer of these products wanted to make sure that the prepbacked immunity would apply. In fact, which is why
Starting point is 00:28:26 in their statements of work, at least on the U.S. side, procurement contracts and so forth, they had, most of them had a contractual provision similar to this. This, I believe, was the Pfizer contract, one of the initial, I believe, Pfizer procurement contract. And it says the government may not use or authorize the use of any product or material provided under this agreement, which were COVID-19 vaccines unless such use occurs in the United States and is protected from liability under a declaration issued under the PEP Act or successor COVID-19 Prep Act declaration of equal or greater scope. It literally the United States government guaranteed that nobody would use the products that they were procuring unless PEP Act immunity applied and the government was one buying all the COVID-19
Starting point is 00:29:11 vaccines. So they were the point of origin for all COVID-19 vaccines in the United States. As far I'm aware operation warp speed took over the whole procurement function and purchased the vaccines that were then distributed in the United States. Okay. So with that backdrop about immunity, you know, and I think that's an very important point to consider when you're thinking about laws, regulations around these products. Obviously, you know, I think the reason there's so much debate around vaccines is because the main difference between a vaccine and a drug or a medical product or food or water or anything else is that is a legal issue, legal distinction. It's because people try to mandate them, try to force them on others. Many states have using school vaccines
Starting point is 00:30:05 as a proxy. Many states have philosophical exemptions. Parents can just opt out at will. And even in those states, most school vaccination rates are very high. Mandates, which are proof in the pudding that you don't need mandates to persuade people often, but there are a segment of population who often, and we could tell you that from our clients every day, shouldn't get vaccines. Either they or they watch their children get injured, and they don't want to continue participating. The problem often comes that for those folks sometimes, depending on the vaccine, depending on where they are, depending, they may not be able to go to school, get a job. And during the COVID pandemic, we saw potentially participate in all forms of civil society. And obviously that does a problem
Starting point is 00:30:54 for some folks, not for others, but for some. And, you know, the whole idea of rights is about protecting a minority, right? We don't need rights to protect majorities typically because they're a majority. They can kind of get the laws they want. often have the influence they want, not always. But they're really about protecting the minority and protect them from government intrusion, right? Overreach, and that's the whole Bill of Rights reform, limiting the government's ability to infringe on those.
Starting point is 00:31:25 I don't think we have to be so scared about stomping out the speech of what 90% of Americans want to say. It's what the 10% want to say that we need to protect, right, often, because 90% will get their way. All right. So what is the impact of giving immunity a liability. Well, again, I think it's instructive to look at how clinical trials were conducted before COVID-19 for other vaccines to then understand how clinical trials were conducted for COVID-19
Starting point is 00:31:53 vaccines, because there's a lot of debate around those trials. And I think putting them in the framework of what's done with other vaccines will help understand what it is the FDA was doing at the time. So, you know, why our clinical trial is critical? I think that's an important question. question to understand the answer to. To determine whether something is an alleged injury is causally, not correlation, causally related to a product, you typically need, typically need a prospective study that compares an exposed in an unexposed group. Looking at data retrospectively backwards, epidemiological studies are always
Starting point is 00:32:39 viewed as being unable to determine causation. So with that, and you can bring an epidemiologist to say that, which they'll readily all say, and we litigate that issue all day in vaccine court, the only time you really do a prospective, a forward-looking study with vaccines is in the clinical trial, meaning it's forward-looking in that you enroll people, you give one group the vaccine, you give one group you don't give the vaccine, and then you follow them, and you statistic. statistically compare the outcomes between the two groups. By doing that, you have the idea is to remove bias, the idea is to then see what does the outcome look like. The moment you instead say,
Starting point is 00:33:22 we're going to take an existing data set, and we're now going to try to evaluate that set for what happened, meaning looking based on the data, what happened in the past, there's always confounders. And those confounders are viewed as tainting those studies, and hence you can't determine a causation from them. Well, did you select people that were too old? They were too young. They did do this. I mean, you saw these debates happen. I think they spilled over into mainstream media, which was interesting to watch. It's interesting to watch the discussions about clinical trials in mainstream media. So clinical trials are critical because it is the only time you can do a placebo-controlled prospect of study of vaccines, pretty much. Once they've been
Starting point is 00:34:08 licensed, it is considered unethical to do a placebo-controlled clinical trial for a vaccine. It's considered an ethical. To do a study, you need to get something called IRB approval, where you get an ethics board to approve it, universities and so forth, the IRB committees all around the country. I'm not aware of a single IRB committee in this whole country that will approve a placebo-controlled clinical trial of a vaccine after its license. after it's license. So if you want to really understand the safety profile of vaccine and you want to be able to
Starting point is 00:34:44 know what injuries it actually causes, not what it's alleged to cause, but actually causes, you need a really good robust clinical trial. And I can tell you the clinical trial data is at our firm, when we get a parent, call us up and say, well, my child got a Hep B vaccine and now suffers from this type of neuropathy or dysodotidomia or whatever it is, ideally we'd love to just go to the clinical trial data, and see, well, what did that show between the exposed and unexposed? Okay. Apologies for interrupting. I just wanted to clarify a little bit because I want the cause of this to be very clear for anybody who's here and watching. Is it correct that the reason it would be considered unethical
Starting point is 00:35:25 to do this controlled study after licensing because the license brings with it a presumption of efficacy, which would then cause the withholding of that medication from the, you know, the placebo part of the trial? Is that where the unethical part comes in? Yeah, once they're licensed, they're deemed effective for the indication on the package insert. And that indication, for example, if it says to prevent pertussis disease, it is now considered unethical to withhold a product from a child that has an indication that
Starting point is 00:35:58 can withhold pertussis, that it can prevent pertustis disease. Right? It's because of the efficacy component, even if you, so that's why you can't do it. And clinical trials for most vaccines really focus on the efficacy components of it. I mean, that's how they're typically designed. I don't want to make conclusions re-statements. I'll let you judge for yourself. Let me just, I'll show you what the data shows, and you can make your own conclusions on that.
Starting point is 00:36:24 And so why is liability critical to how clinical trials are conducted? Liability from the manufacturer is critical because if the manufacturer knows they're going to be liable for the injuries that, you know, that the product, their making is going to cause, if it's a drug, for example, they want to know the safety profile before that product goes in the market because they could be facing company ending liability if it ends up hurting too many people. I mean, the whole reason drugs and vaccines are licensed because they can hurt some people, that's the idea, right? That's why you have to get them licensed. But they want to make sure it doesn't hurt too many people, right, in terms of the risk-benefit
Starting point is 00:37:06 analysis. That's what's often, at least the FDA would tell you safe and effective means. And so, if you take away that liability, though, from the manufacturer, they don't have that incentive. It has a direct impact in how they conduct clinical trials, and we can see that in practice. So on your screen, you can see this is from MoneyInck.com. I don't know how reliable that is. but I'm going to assume it's reliable. This is what they say are the five most top-selling drugs of all time from Pfizer. These are Pfizer's top most pre-COVID-19. Okay.
Starting point is 00:37:52 And so according to Money, Inc., these are the ones that made Pfizer the most money. Well, let's look through this list. On this list, you could see four of the products have a little bit of a different clinical trial that was relied upon to license these products. When in the first column, you could see is the name of the drug. And the second is the safety review period. This is how long adverse events were looked at after administration of the drug in the clinical trial, the lot upon to license that product.
Starting point is 00:38:22 You could see the very last footnote in this is the FDA website.gov. You can go to the FDA website and you can open up the package answer for every one of these. And in section 6.1, as required by federal regulations, it summarizes. the clinical trial relied upon to license each of these products. So you could see those numbers for yourself. You do not need to take my word or this pinkish chart. It's a word for it. It's right they're all on the FDA website. And you could see that for most of these, it was a multi-year period of review after looking for adverse events and that they compared the group getting Enbrel with a group getting a placebo, eloquist for seven years with a placebo and so forth. And they're all
Starting point is 00:39:08 also blinded. So the clinical trial investigators, they don't know who's getting the placebo, who's getting the drug. They follow them for that period of time. And then they eventually unblinded and they compare statistically the differential between those two groups. They do it statistically because you don't want to introduce bias. The manufacturer is the one who does the trial. And so this way, you don't even, you're not really sure what the drug will have affecting human beings. And so this way, by doing it this way, you could see based on a baseline of placebo, what does the safety profile look like? How does it impact the cardiovascular system? How does it impact your nervous system? How does it impact your digestive system? Go down the list of every organ system in your body,
Starting point is 00:39:48 and they do that, cancer rates and so forth. When it comes to vaccines, the design of these clinical trials are not as robust. PCV-13, that Prevnar 13, is given to babies at two, four, six months of life and then another shot later. That's the only vaccine on this list. And you can see the safety period was half a year and the control used was the PCV7, which was the prior version of Prevner 13, which is probably okay if Prevonar 7 had been licensed based in a placebo control trial, which we'll take a look at in a minute. But the thing is a half a year is actually pretty long for a safety review period in a vaccine clinical trial. These are the safety review periods and the control used to license the vaccines given in the first six months of
Starting point is 00:40:39 life. Each of these vaccines are given three times each in the first six months of life. And I can assure you that if those numbers look incredible to you, that there was only five days of safety review for the hepatitis B vaccine given to a newborn baby, it is incredible. And I didn't, if you told me that without showing me the proof, I wouldn't believe it either. And I'll show you the proof. If I was trying to make some stuff about vaccines, I wouldn't made that up because it doesn't sound credible or believable. But I'll show you that right now in a second. But before I do that, I just want to highlight the difference between how drugs, the clinical
Starting point is 00:41:21 trial used to license drugs versus the clinical trial relied upon to license most vaccines in terms of three features. How long the safety review is at, meaning how long. long do they monitor for adverse events after the injection? What did they compare it against and how well-powered it was, meaning how many people were in the trial? Those are three features and we'll make a good clinical trial. So let's take a look at the first one, Hepby, and I'll just show you to you directly because I'm going to just go on the internet. So we're going to go to FDA license vaccines. Okay? We're going to go to the FDA website. And these are all the
Starting point is 00:42:02 licensed vaccines in the United States. So anybody wants to go and see what was relied upon to license any vaccine license. It's right on this page. You scroll down, what you will see is there are four hepatitis B vaccines listed. Two of these are, only two of them are licensed for newborn babies, recombivax, HB, and endericksb. The other two are just for adults. So we'll click on the first one, recombavx HB. Then you can go to the package insert. Now, you know, whenever you get a drug, there's a little piece of paper inside the box. Well, if you open up that paper, As long as it's not an older drug that hasn't been updated, most of them have been, it will have a table of contents like the one you see on your screen right now.
Starting point is 00:42:41 And if you look at this table of contents, you will see Section 6.1 has a clinical trial experience. Federal regulations require that the manufacturer summarize what was the clinical trial allowed upon to license the product. So the manufacturer prepares this document, and the FDA approves this document. So we'll go down to Section 6.1 over Kambavax-HB. This is the entire summary, this section right here, other than the issues that they did note during the clinical trial that's just listed. 6.2 is the post-marketing experience.
Starting point is 00:43:13 And this paragraph describes the clinical trial a lot upon to license this vaccine for children. In three clinical studies, 434 doses of a combativex HB5 micrograms were administered to 147, healthy infants and children up to 10 years of age, who were monitored for five days after each dose. The first time I read that too, I thought, well, there must be more. Why would the FDA license this product for injection to babies with five days of monitoring? Because, you know, most autoimmune issues take weeks minimum to rise. I mean, you know, we deal with vaccine agents all the time. So just like it takes, for example, the immunity of the vaccines can provide against disease. It takes weeks without antigens, the antibodies to build up, self-antibodies,
Starting point is 00:44:02 antibodies that might attack self, those take at least weeks. And then many immune dysregulations like asthma take, you know, she's not diagnosed still a few years old, developmental issues, you name it. Most health issues are not going to be diagnosed in a newborn within five days. If it's caused by the product, it can take months, it can take years. That's why, for example, on all the other drugs we looked at, they review safety for years against the placebo. So here, on the other hand, what are we looking at? In terms of how well-powered it is, It's only got 147 children. That does not provide enough power to detect virtually anything.
Starting point is 00:44:39 Even if it were, there's no control group. And then separately, the monitoring is only five days. We FOIA the FDA, and so we've been doing this before COVID. We foyer the FDA for the actual documentation, just like we did for COVID vaccine, that the manufacturer submitted, presuming that in the documentation, you would find safety monitoring review, adverse events assessment that went on beyond the five days and it's five days of safety monitoring. That's what it is. And again, you don't need to take my word for it. You could see over there, I've got the first link is to the actual package entry we just looked at.
Starting point is 00:45:17 The second link is the clinical trial report that is on the ICANN website because we got the via FOIA request. But obviously, if you click on that, what you will see is the first page is that it's from the FDA. And then you'll see the actual clinical trial reports. And you can go into 1,000-something pages. If you're inclined, you can look through them yourself and see exactly what was submitted. Because remember, the FDA doesn't conduct clinical trials. I'm sure you guys know that already. The FDA just reviews the data submitted by the manufacturer to assess whether to the level that, to the FDA standard of safe and effective, it meets that standard. That's what it's doing.
Starting point is 00:45:55 This was a hard one for me. My daughter is a vaccine injured from the Heppe. And I didn't know this level. So there was no placebo at all in any study. She's 17 now. So do you know when this study was done? Was this when they first were rolling it out? I believe the, yeah, I believe the first of Rekamabaxi, I believe was licensed in 89.
Starting point is 00:46:23 I believe Endericksp was licensed in 91. Those would be the only two standalone hepby vaccines given to newborn babies. Have you seen just in time from what it used to be, of course, prior to 1986, a level of speeding things up in a sense of whether there's no clinical trials or very minimal in time frame as we get closer to here we are, you know, in COVID? Things have gone faster since 1986. But I don't, I mean, if you look at the vaccine schedule since 86, it's just been a, straight up trajectory. In fact, in the 90s, many 90s and 2000s, many of the vaccines currently on the childhood schedule came about. But for the COVID vaccine, which I think if you're asking me
Starting point is 00:47:09 about that, I don't see the COVID vaccine as rushed in the same way that the public, from my perspective, as being rushed in the same way that it's been in the news. All vaccines, vaccines have different technology. I mean, we use the term vaccines as a general term, but, for example, this vaccine is a recombinant technology. It's recombinant DNA. So this type of hepatitis B vaccine uses a very different technology, for example, than a measles vaccine, which is an attenuated vaccine, or tetanus or deuteria, which is a toxoid vaccine. They all have very scary, very different technologies, and often those technologies took very decades
Starting point is 00:47:50 to develop. So they were working on recombinant DNA technology for a very long time before they finally came out with this Hepha vaccine. When it comes to the MRNA, if you're focused, at least on the Pfizer and the Moderna products, obviously J&J, AstraZeneca, others had more traditional platforms. But the MRNA platform had been in development for decades, right? I mean, it took the science that underpins the creation of MRNA technology has, they've been working on that for a very long time.
Starting point is 00:48:17 I mean, first they were trying to figure out, well, how do we keep the RNA from not falling apart because the body immediately attacks it? So they took out the uridine, right? And they replaced it with a synthetic uridine as one of the amino acids in it. And so the body doesn't recognize it. And then they're like, well, that's still not good enough. We need to get it into the cell. So they, you know, positive, negative when they're in contact on the cell membrane,
Starting point is 00:48:40 and they'll let things in. And so they have the LNPs, lip banana particles with a different charge that they put the synthetic piece of mRNA in so forth. That didn't happen. And that didn't like COVID-19 didn't come around. boom, they came up with all that tech. And there's a ton of other tech related to it. That was decades of development.
Starting point is 00:48:57 The Barney Graham at NIA, the National Institute of Allergy and Infectious Disease, he runs the vaccine development division there. That's Fauci's Institute. Barnaghan's been working on a MRNA vaccine for the first COVID, for SARS-Co-1 for a long time, along with Moderna, before COVID-SARC-C-OV-2 came around before the current COVID virus came around. and so in many ways they they just kind of took these once they had the sequence they kind of that's why they were able to create it so fast they pretty much developed it from my perspective it's not that different i mean and the clinical trials also for the COVID vaccines i mean if
Starting point is 00:49:38 you're looking at clinical trials i mean compared to any other vaccine they were pretty robust in my opinion how long was safety reviewed COVID vaccines was often six for many of them six months how many people were in the trial how well powered they had all 30 to 40,000 people. And what was the control? They did have a placebo control, Pfizer-Maderna. They just vaccinated them after an average duration of two months once it was emergency use authorized.
Starting point is 00:50:01 So I don't know if that's my perspective on it. I think, I don't know, there's a lot of media outlets I might disagree with my view on that. Based upon some of the research that I've done in regards with just the technology, the MRNA technology, there's. been a lot of information showing, you know, what happened with animals. And, um, and so I, I, you know, we, yes, that it had been studied and worked on in research for a long time, but it wasn't ready for prime time just because of, you know, many of the animals died in those, you know, ferrets and, and whatnot in studies where created a hyperimmune response. And then,
Starting point is 00:50:46 just to make sure I'm not talking about mercury at the marasol right now. That's been pretty much removed from vaccines in 2000, but aluminum adjuvants, which is aluminum hydroxide, there's a few different kinds, those are used to create, for example, help create immune response. If I just inject you with a bunch of dead protein snippets, your body will probably just gobble it up and get rid of it. So if I just took, you know, a portion of the pertussis bacteria, which is, you know, basically it's all amino acid change, right, peptides, proteins, and I, it's dead. It's not. It's not. not replicating, it's not taking over your cells, and you just inject it into you. It's going to have a minimal immune response because your macrophages, your dendritic cells will gobble them up,
Starting point is 00:51:32 get rid of them. So you need to create an immune response. And how does the body know that there's danger to have an immune response? You need cellular death, okay? Viruses infect cells, they take them over, they take over the machinery, and they replicate themselves, and the immune system and then attacks on. Bacteria cause cellular death. And when you do, that debris, it causes your, you know, the inflammation that you see, which is basically the blood flowing in neutrophils, comp pouring out of your blood into that area.
Starting point is 00:52:01 You create inflammation. You have an immune response. And if it's sustained long enough, your body goes, oh, this is bad. It will start grabbing some of the pieces there and taking them to your lymph nose, looking for the correlate antigen to then create immunity, right? which we think of as adaptive immunity, right, versus the immunity that happens just at the site. So I'd say all that to say, aluminum adjuvants are still used in many vaccines as the primary ingredient, one of the primary as an active ingredient to create an immune response because
Starting point is 00:52:36 aluminum adjuvants cause cellular death. That's why an aluminum can can preserve stuff for forever. It kills everything. It's not, human beings have never been exposed to aluminum or. of human history. They're locked up with silica in the ground. We are the, you know, it's only in very, very modern history for the first time you beings have ever been. We have a use for iron in the body. We have a use for magnesium. Our bodies use all types of different kinds of metals. There's no biological use of aluminum in the body, none that we're aware of. But yet that's in vaccines.
Starting point is 00:53:08 And if you want to induce autoimmunity to something in a lab animal, you know what to inject them with? Lin-Madgevins. You pair it with what you want to create the, you know, the sensitivity to you, and there are, you know, lots of studies out there. So, yeah, you can find studies that show components of vaccines can cause harm out there. I don't, you know, I'm not sure it's unique to COVID vaccines per se. I think a main differential of COVID vaccine, if I may, is that, you know, with lots of these, like, you know, with hep B vaccines are given to a tiny cohort of children every year,
Starting point is 00:53:42 very small percent, and health care workers, a very, very small percent. of folks in America get that product every year. So it takes, you know, decades before you really get broad coverage. And so if there are going to be issues with that product, well, you're not going to know it from the clinical trial, unfortunately. And if it does happen within the population, it's going to happen at a slow accumulated rate where it could potentially bleed into the background rate. COVID vaccine was given to almost 300 million Americans very, very rapidly. So the issues that that product did have, you know, just focusing on the ones that are not, you know, the health authorities are willing to agree are causally related like myocytitis, paracoditis,
Starting point is 00:54:25 thrombosis, thrombinia, so and so forth. It's possible, for example, COVID vaccines had slowly been, you know, introduced in one quarter of time, and myracoditis among children had slowly increased over two decades. The ideology of that increase may have not ever been attributed to COVID-19 vaccines. So, but that's speculation, just to be sure what I just said. This is a deposition, just a little clip of a deposition I took and of the world's premier vaccinologists. So Dr. Stanley Plotkin, he's the developer of the Rubella vaccine.
Starting point is 00:55:01 He's worked on numerous other vaccines. You can go down the list. And literally the medical textbook on vaccines is called Plotkin's vaccines, which you could see that to the left. And this is my exchange with him with regards to precisely. the hepatitis B vaccine, recombavaccib we just looked at. And I think that that exchange helps bring home the importance of a clinical trial. It is my great honor to use the Stanley Plotkin gavel to open this meeting. It's our good friend and colleague, Dr. Stan Plotkin.
Starting point is 00:55:33 Dr. Plotkin. Virtually every country in the world is affected by his vaccines. He was involved in pivotal trials on anthrax, oral polio, rabies vaccine. Rebella vaccine, the rotovirus. vaccine, rabies. He has earned the Distinguished Physician Award of the Pediatric Infectious Disease Society, the Finland Award of the National Foundation for Infectious Diseases, the Hillman Award of the American Society for Microbiology, the French Legion of Honor, and the Bruce Medal in Preventive Medicine. He's a member of the Institute of Medicine and the French Academy of Medicine.
Starting point is 00:56:04 One of the very special things about him is the global impact that he's had, not just from the products, but from his book. He developed the standard textbook for vaccine. in 1988. Bill Gates calls his book a Bible for vaccinologists. I hope you all have indeed have read the book, and I hope it's more accurate than the Bible. He trained just a generation of scientists, including myself, to think like he thinks. Dr. Plotkin, earlier you testified that there are two Hep B vaccines in the market, one by Glaxo, GSC, that's Enderix B, and the other one is by Merck Recombovax-HB, right?
Starting point is 00:56:48 Yes. This is the product, the manufacturer insert for Recombo-Vax-H-B, correct? Yes. And the clinical trial experience would be found in Section 6.1, correct? Correct? Dr. Paquen? Yes. Okay.
Starting point is 00:57:06 In Section 6.1, when you look at the clinical trials that were done pre-licensure for Recombovax-HB, How long does it say that safety was monitored after each dose? Let's see. Five days. Is five days long enough to detect an autoimmune issue that arises after five days? No. Is five days long enough to detect any neurological disorder that arose from the vaccine after five days? No.
Starting point is 00:57:44 Okay. There is no control group, correct? It does not mention any control group, no. No. If you turn to section 6.2, under immune system disorders, does it say that there were reports of hypersensitive reactions, including anaphylactic, anaphylactoid reactions, bronchospasms, and uticaria, having been reported within the first few hours after vaccination? Yes. Have they been reports of hypersensitivity syndrome? Yes, that's what it states.
Starting point is 00:58:20 Does it reports of arthritis? It is mentioned. It also reports autoimmune diseases including systemic lupus erythematosis, lupus-like syndrome vasculitis, and polyteritis, nidoza as well, correct? Yes, that's what it states. And also it states that that under the nervous system disorders,
Starting point is 00:58:54 it states that after that have been reports of Guillambore syndrome, correct? Yes. As well as multiple sclerosis, exacerbation of multiple sclerosis, myelitis, including transverse myelitis, seizure, febrile seizure, peripheral neuropathy, including Bell's palsy,
Starting point is 00:59:17 radiculopathy. Radiculopathy. Thank you very much. muscle weakness, hypopheasia, and encephalitis, correct? Correct. These are events that are reported after vaccination. And as we've just discussed, in order to establish whether it's causal between the vaccine and the condition, you need a randomly, a randomized placebo-controlled study. But that was not done for this hepatitis B vaccine before.
Starting point is 00:59:52 licensure, was it? No. Okay. And given that the vaccine now appears on the CDC's recommended list, isn't it true that it would now be considered unethical to conduct such a study today? It would be, yes, it would be ethically difficult. There you have it directly from the world's leading vaccinologists. In terms of the importance of clinical trials, how you show up causation, and the issues with having clinical trial that's short. I didn't even talk about the fact it was underpowered in that clip. Pfizer's PCV-13, this is Previnar-13 vaccine. This is the one we looked at earlier.
Starting point is 01:00:33 Remember on that chart of five purportedly of Pfizer's five best-selling drugs. And so here it is on the CDC Childhood Schedule. When you look at the very top, that's from the package insert of Previnar 13. right there is actually a newer version that recently came out previn art 20 but previn art 13 is still available and when they did the clinical trial for previn art 13 they did six months of safety review still not long enough in my estimation for a baby but at least certainly for the work that we do we would like far longer safety review duration against a proper control but six months nonetheless and
Starting point is 01:01:20 In that clinical trial, you could see in the very top, it says serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Previna 13 recipients and 7.2% among Prevnar, that's Prevnar 7 recipients. Now understand, serious adverse event means something very, very serious for the FDA. What is a serious adverse event? Is a technical term used by the FDA typically for clinical trials? It means death, life-threatening, hospitalization, disability, or permanent damage, congenital anomaly, birth defect, require an invention to prevent permanent impairment or damage or other serious. It usually requires one of the other conditions above, along with another feature.
Starting point is 01:02:03 So when you look at serious adverse events, serious adverse events means something very serious. And these are typically you only enroll children who are healthy in these clinical trials. So you have healthy infants and toddlers who within six months, 8.2% of them have a serious adverse event. If 8.2% of all infants and toddlers had a serious adverse event every six months, that would be pretty bad in this country. But that said, it's deemed safe by the FDA because the comparator group, and that's how you do safety in clinical trials. as you compare the experimental group, that getting the experimental product along with the control group. And in this instance, they received the standard of care, which is considered appropriate, Previnar 7. And it could have been appropriate. Absolutely. If Previnar 7 had been licensed based on a placebo
Starting point is 01:03:03 control trial itself that was properly powered and so forth, so you knew the safety profile of ProvenR7, that, in my opinion, that would have been a valid comparator. But let's take a look at what the clinical trial was relied upon to license Previnar 7. In the chart right below that, you can see this is an excerpt from the clinical trial for Previnar 7. That clinical trial reviewed safety for 30 days, and the control group received, and you can see right there highlighted in the footnote, right, you can see it says control, dose 1, You can see Previnar 7 control, PrevonR7 control, right? And then it's got a little, like, a cross, it looks like. And if you go down, it defines what the control is.
Starting point is 01:03:51 And the control is an investigational, meaning not licensed, meaning experimental, investigational, meningoccal group C, conjugate vaccine, MNCC. This product was never licensed. So in the clinical trial to license Previnar 7, if you want to know why they did this, you got to talk to the FDA, but they did. FACs are just there black and white. They licensed Previnar 7 based on a clinical trial that compared it to another experimental vaccine. Again, if you told me this, I wouldn't believe you in the street. But this is on the FDA site.
Starting point is 01:04:36 You can see the links right there at the top of each room. You can go look at these yourself. And you can also pull out the underlying documentation from the manufacturer. It's interesting, too, because when we are doing, we got a lot of injury cases from this product. And when we do them, and you go to PubMed and you look at the post-marketing literature, the fact that this was not really studied before it was licensed properly is actually. ubiquitous in the literature itself. But in any event. So that's Previnar 13. And then we'll look at, last one is DTAP. You know, this is, this one was compared against DTP. So again, to highlight
Starting point is 01:05:23 the importance of what the control group receives, because otherwise, so what? So, you know, you get one group that's seven percent adverse event. Once eight percent, you say, well, that's similar. So it's safe. It might be safe by FDA standards, but I don't know how. how safe it would be from the perspective of a typical parent. And actually, there's no developed country that uses DTP anymore. It's only used in developing countries around the world. And interestingly, it's, and the current DTAB vaccine using the United States, you might say, well, that's better.
Starting point is 01:05:54 It's better in terms of safety profile than DTP from the data. That's for sure. I'm trying to understand if they understand. that the tort liability for DTP was times 200, and it was causing adverse effects. Yes. But then in this chart, they used that as the control? Yes. And maybe more troubling is the fact that one of the renowned clinics in Guinea-Bissau,
Starting point is 01:06:35 they're from their Danish, WHO experts and vaccines and so forth. Peter Abe, he's world-renowned. Until he published this study in a series of studies like this, then he was not so world-renowned anymore. So is it unique for this product because we know that many other medical products have side effects and sometimes it takes time. Like we know that Sperlin can have some severe side effects. We know that many people take statins and there are some new research that statins might be not so effective and have some side effects.
Starting point is 01:07:13 So what is it about vaccines that manufacturers were feeling threatened by that amount of potential tort against vaccines? They were causing injuries. So the worse, the injury, the more damages you get and the damages and the injuries, and the injuries, injuries were severe. So, you know, at that time, two of those three products are no longer with us, OPV and DTP, though the D and the T part are still part of D-TAP. I mean, maybe I could answer your question a little bit of a different way and say, look, there's, there are a lot of drugs that are made all the time, and a lot of times those drugs are made for very small populations. They're not meant for millions of people every year in a guaranteed market where it's mandated, right, often.
Starting point is 01:08:09 And yet, pharmaceutical companies find a way to make profit from those, even when they're given to a small group of sick people, right? So I, you know, the argument often made is that, well, they need to make money. Well, they're making a lot of money on vaccines. In fact, the increasing percentage of the portfolio of Merck, Pfizer, Sinofi, and GSK, particular. Derna's a newer player. Obviously, I don't know what's in the hearts and minds of the Congress when they passed the 1986 Act, though I can say that in the 70s there was the swine flu vaccine debacle who may recall that, and it caused GBS and other issues, and CDC, you know, denied it, then admitted part of it.
Starting point is 01:08:51 And so the manufacturers were afforded immunity, remember back then, because they, and that worked out well for them. And so, you know, from an industry perspective, the 86 Act made sense. Again, you know, you guys know, this legislative bodies are complex. Lots of people, lots of interests, lots of moving pieces. I'd rather litigate all the long than than to hang out in the halls of what you folks do. I give you guys a lot of credit to get along and it's wonderful. But, yeah, I mean, I think that that could have been instructive.
Starting point is 01:09:26 and certainly helped drive the industry. Also, the parents at that time, who had vaccine injured children actually also were helped drive the adoption of the act. But when its initial iteration didn't include immunity liability, its initial iteration was intended for compensating injured children in something called the vaccine injury compensation program. The liability protection was added at the last second. So, you know, it was a debated point.
Starting point is 01:09:54 But, you know, there was a, there was a, there was a, confluence of interests of different people who wanted different things and you ended up with what you ended up. My research on DPT, and I just wanted to, if you are familiar and I'm sure you are, wasn't we were kind of like forced into it. There were, wasn't there decades that went by where other countries had dropped that and we were still? Yeah, so Japan was the first in the 70s to switch off of wholesale pertussis. and other countries, as you noted, dropped it. By the 90s, I don't think there was virtually any developed country that was using.
Starting point is 01:10:35 I think we were probably one of the last ones. I would want to verify that. But I would have known this at one point because we had a long exchange with UNICEF about this precise product. Because all the studies show there's a dozen studies that show that actually kids who get DTP versus not have increased overall mortality. There's less deaths from tetanus, less deaths from pertussis, and less deaths from diphtheria, but all cause mortality amongst those who get DTP versus not. In this particular study, you could see right here in Guinea that was done by Peter Abe, you had 10 times the number of kids, 10 times with kids who died who got DTP only versus
Starting point is 01:11:19 kids who got nothing. So this is actually been. a big controversy at the WHO and UNICEF because UNICEF is the main procurer and distributor of DTP vaccine world. It's the most common widely used vaccine in the world. But in 2000, the WHO convened a, they have a bunch of advisory vaccine committees and they convened a committee to actually specifically look at what they call the non-specific effects of vaccines. Death beyond all-cause death would be considered a non-specific effect, meaning it's having effect that's not attended by the product. And the question was, you know, does this vaccine increase or reduce mortality? The WHA report from 2016, I believe, found about 15 studies. I think
Starting point is 01:12:10 around 12 of them showed an increased risk. Three showed, I believe, a decreased risk. And they found it inconclusive. Now, all those studies, mind you, are all, and this goes back to what we were talking my earlier, they're all retrospective epidemiological studies, as they must be. They're not prospective. They're not clinical trials. So proving causation, it's very difficult, right? Even though this study right, that it's on your screen, it's found a 10 times risk, even that from an epidemiological perspective cannot prove causation, because it's looking at it historically, hysterically. I mean, sometimes a body of evidence is just overwhelming. And they'll look at case reports, they'll put in all kinds of other things that they look at, and especially when they can
Starting point is 01:12:52 find a mechanism of action. So with all of that said, the conclusion that the WHO reached at the time was they said, well, there's three problems with all of these studies. Number one, they were introduced along with OPV vaccine. So we don't know what the effect of OPP is versus DTP. Number two, they were introduced in an environment where Deuterium tetheria tennous and pertussis were not common anymore. What would the numbers look like if you did the study when there was no vaccine around, right? Meaning when the vaccine would first introduce because that is, you have a different background population and disease. And those are the two.
Starting point is 01:13:37 And the third issue they took was they said it's not randomized sufficiently. Okay. So these folks, Abe, again, you can look them up. You can look up Peter Abe, Christine Ben. And they are, I mean, they'll tell you measles vaccines the best thing since sliced bread, right? They'll tell you that attenuated vaccines have the opposite effect. They did this study to address exactly those three issues. One, they looked at it without OPP, as you can see on this chart.
Starting point is 01:14:09 Two, they looked at the data from when DTP was first introduced into Guinea-Bissau to get rid of the background rate issue. and the way it was introduced was, is that they vaccinated kids based on basically birthdays, which is considered a valid form of randomization. So they said, hey, look, WHO, UNICEF, we addressed your three issues. So we actually, our firm had a long exchange with UNICEF about this. We said, here it is. This is the best data you're ever going to get, unless you do a clinical trial, which you're never going to do.
Starting point is 01:14:43 This is it. You're never getting better data than this. UNICEF engaged in an exchange and then decided that they didn't have a response. There is no better data. We demanded it over and over. They wouldn't provide it. We actually petition the ICC, which has jurisdiction over UNICEF, but they declined to investigate further. Anyways, that's a digression.
Starting point is 01:15:09 But yes, DTP, DPP was used as the control for DTAP. And so this shows you, I do all that to show the three real features, the important features of a clinical trial, which are how long the safety is reviewed. What was the control and how powered it is, how many people participated? And I'll show you what that looks like in the world of vaccines versus drugs. And I think that could help put into context how the FDA then approached COVID vaccines. Drugs are licensed in the, there's a drug division at the FDA, and then there's a biologics division. And the biologics division is just separate. And the biologics is primarily vaccines.
Starting point is 01:15:49 There are other biologics beyond vaccine, biological products. But that is, for them, those type of trials are pretty typical. If I'll throw this out there too, if anybody wants to see all the specifics for each of the, can you see the chart on your screen? Yeah. This is the, you can go to this chart and this chart has, for those who are interested, every single current vaccine, and it's got a link to the FDA website to the clinical trial data that was a lot of Pantilicin as well as a summary chart.
Starting point is 01:16:23 You can see what the control was. You can see how long the safety review period was after injection, and you could see the sources all back to the FDA, or in some instances, the sources are back to the ICANN website because it was done via FOIA. We foyer for most of these underlying documents to see. And a little note there that kind of gives some context for some of them to understand what was it because the current product, if they're testing against the prior product, then you want to know, okay, well, that prior product, what was that tested against? And obviously, that's important
Starting point is 01:16:55 to know. Okay. COVID-19 vaccines. So here we are. For the Pfizer-Moderna, there were about 15,000 to 20,000 folks in each in the experimental group versus the placebo group. We mentioned this earlier already. On average, there was a placebo control group. On average, it was for two months, meaning once it was emergency youth authorized, they vaccinated pretty much the entire placebo group, despite the FDA actually kind of pushing them, karma means not to do it, to the FDA's credit, frankly. But they did it anyway.
Starting point is 01:17:32 They sent letters out to all them essentially saying, hey, come and get this, more or less. And when I say an average of two months, just make sure what that means is some had been in the trial for four months, some had been in for one month, but on average, the placebo control group had been in for around two months. So there were some that were more than two months. Okay. And obviously that's in contrast to the other vaccines. So from the FDA's perspective, despite the public saying these clinical trials are not robust enough, they don't meet historical standards, these clinical trials are incredibly
Starting point is 01:18:06 robust based on historical standards. Certainly from the FDA perspective, certainly from the perspective of Dr. Peter Marks, who runs the bi-lodge division, the vaccine division of the FDA, I think he thinks these trials were incredible from his perspective. And when, you know, beyond what they typically had done historically, certainly from virtually all the childhood vaccines. Just a quick question on that. Now, you mentioned that the FDA pushed back and asked them to keep the placebo group. Is that my understanding?
Starting point is 01:18:38 Yes. the FDA preferred expressed a preference. And we know this, we have, you know, we do a lot of FOIA requests on the internal communications. They expressed a preference. And this is also spilled over into the media, too. This was not just in the internal documents. They expressed a preference that the placebo group remain intact. Obviously, not to the degree where the, the former governments felt they must.
Starting point is 01:19:04 But they did express a preference, at least certain corners of them did. know there was also an inter, you know, I don't know, familiar with Dr. Gruber and Dr. Krause at the FDA. They were the, they were the two people directly below Peter Marks. They quit and, you know, in the middle of it. And anyways, there are committee hearings like this right now where Peter Marks and all those folks are being hauled in is my understanding. And closed row rooms, though. Right. So I guess my question is, is if the FDA, could they have insisted or did they have any control over it and saying even though it is going to be used as an emergency use, you still need to keep that placebo group intact so that we can? So the procurement contracts had already been signed, pharmac companies had already received billions of dollars. The presidents of the United States, first Trump, then Biden, had both widely towered.
Starting point is 01:20:04 it and promoted these products to the American public. Assured everybody get it, Operation War Speed is in full swing. I don't think the pharma companies are probably very worried that the FDA was going to pull their authorizations. I'm going to speculate that. I'm going to go on a limb. Based upon specifically the control group and keeping that, in a sense, pure, doesn't history compared to other, I don't call the COVID injections vaccines, I can,
Starting point is 01:20:34 call them experimental gene therapy. I don't like using the word vaccine for it. But in any case, is there history of that happening? Does that usually happen in any other, you know, in history with other, quote unquote, traditional vaccines? I'm like where we're keeping things separate so we can have data stay in a pure fashion? Because after 30 days, you're saying they injected the placebo or the control group? It's a great question. Well, you're going to have to wait until next week to get the second part of this incredible hearing. If you want a taste of how dynamic that's about to get, I mean, we're just getting started.
Starting point is 01:21:17 Take a look at this. We have this study, 43,000 people over a period of six months at the height of the fear of the pandemic. Three died of COVID. What was the justification for the emergency in the first place? When you drill down into the causes of death, what you do find is that those that died from cardiovascular reasons were dying at twice the rate pretty much in the vaccinated group. Well, point is to reduce mortality, and if we're having more deaths in the vaccine group, that's an issue. It's not like 10 folks in the placebo group were in a plane crash. This is Maddie.
Starting point is 01:21:53 She goes in for a second Pfizer dose, not as just a person in the public as a clinical trial participant. within 24-hour issues in an emergency room that eventually resulted in her being in a wheelchair and a feeding tube. What did Pfizer tell the public about Maddie? It says there were no vaccine-related serious adverse events in a trial. That's what I told the public. I literally can't make that up. All right, everybody, you know, so much of what we do, I mean, we've got this amazing network, the informed consent action network, where we are experimenting in media in doing something that no one's ever done before.
Starting point is 01:22:30 Unlike any other news show you've ever seen, we bring you the news every week, and then we go and fight in court for the things that we are talking about. And that's why you're seeing these hearings. You're seeing what all of this work is done. All of your sharing the videos has given Aaron this sort of credibility that now your leaders, your politicians, the people that you have voted in are now reaching out to us and to Aaron say, could you come and bring your information and get on the record inside of our own hearings? We need to keep doing this work.
Starting point is 01:23:07 And obviously, we can go bigger and better, but only with your help. What makes all this possible is you the sponsors. We are not sponsored by, you know, any giant corporation. We don't want them telling us what to say or what to do. But that's why we need you. And without you, none of this is possible. Without you, Aaron is not traveling the country. I mean, just the cost of his travel, just getting him there.
Starting point is 01:23:31 And then all the cases that he's using it is evidence, every single red cent of that has been paid for by you are sponsors. So if you want more of this, if you want to know and hear that Aaron Siri is coming to a city near you and is actually going to be talking to your elected representatives, we need your help now. So please become a recurring donor. Go to the highwire.com. Just go to the top of the corner there. Hit Donate to I Can. That's the informed consent action network. We'd really love it to become a recurring donor for $24 a month. So many of you, actually, whether you know it a lot, many of you, the average donation is around, $20. But don't let that stop you. If you can only afford $1 a month, it actually really makes a difference. With all of you that are watching out there, you can't imagine how much we could do. I mean, honestly, I feel like we could change the world if every one of you just said, you know what, today I'm actually just going to get involved. I'm just going to even $1.
Starting point is 01:24:32 And I know it takes a huge effort to reach over that computer and actually do it. It must be take a huge effort because so many of you don't. And I love that you're watching, but why do you make this the week where you get involved so that every time we win a lawsuit and every time he appears in a hearing, Aaron Siri, that is, you'll be able to say, I had something to do with that. It really does make a difference. And I want you to know what it feels like to actually be involved and be making a difference in this world. For everybody that's been donating all these years, thank you so much.
Starting point is 01:25:06 I mean, what an incredible amount of information. And by the way, next week's episode, we're going to get deep into all of the issues, the personal issues now. Maddie DeGarry, who was in the trials, how Peter Marks of the FDA screwed everybody over. It's about to get really personal. You're not going to miss the episode next week. And I want to make sure that you all take this opportunity to sign up for Freedom Fest in two weeks. Before we go, we're going to be at Freedom Fest again.
Starting point is 01:25:34 It's in Las Vegas, which is. is going to be awesome. It was there two years ago. That's the place it should be. July 10th through the 13th. We're doing a live broadcast on that Thursday. I'm going to be speaking live. I'm going to be giving several panels. There it is. I'm talking about fascism via health at 1030 on July 12th. Fashion via help, a deeper look. I'm doing a panel at 1.30. Then vaccine stories that didn't make the news at 3 o'clock. First of all, the fact that Freedom Fest is covering all these issues and you get to meet all of these people that believe in liberty, in freedom. It's an amazing event, and it's a great excuse to go to Las Vegas. And you know what they say?
Starting point is 01:26:12 What happens in Vegas stays in Vegas. So you'll have to be there to know what's happening. I hope to see you there in two weeks. Next week, another, you know, great show coming up as we've talked about with Aaron Siri. It's also going to be Fourth of July, man. We're celebrating freedom. We're celebrating liberty. This is what the high wire is all about, bringing you the truth, the way only we can. I'll see you next week.

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