The Highwire with Del Bigtree - ICAN ATTORNEYS WIN AGAINST PFIZER AND MODERNA

Episode Date: May 27, 2023

Less than a year after successfully winning the fight to force Pfizer to release their COVID-19 vaccine trial data that the FDA was attempting to block for 75 years, ICAN’s Lead Counsel, Aaron Siri, Esq., joins Del with a new, updated ruling, and great news about what this ruling means for Pfizer and Moderna’s COVID vaccine trial data.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

Not only do we have this great news organization and now a book company, our legal department, which really makes up half the work that our nonprofit does, has been incredible. And at the heart of that is one of the great, and I think we'll go down as one of the greatest constitutional attorneys of all times, Aaron Siri. Well, you are all aware that he had massive success fighting the FDA. It's incredible. The FDA tried to block the Pfizer data, the clinical trial data, of the COVID-19 vaccine for 75 years. Think they have something to hide? Well, we didn't, you know, want them to hide it.

Neither did Aaron Siri, he got in there and made a difference. This is what that looked like in the news. A request from the FDA is sparking some legal pushback. A team of scientists and professors want to publish the data behind the federal government's approval of Pfizer's COVID-19 vaccine. There's just one problem, though. The FDA says it will take decades to process that paperwork. The FDA has been in the process of asking a federal court to give them somewhere between 55 years and 75 years to release all of their Pfizer vaccine safety data.

The FDA says it can't simply turn over the documents. Records must be reviewed and redacted. That is standard procedure with the freedom of information requests. As soon as the Pfizer vaccine was licensed, and in accordance with the FDA's own regulations that it be made quote unquote immediately available, we submitted a FOIA request. Rather than producing 500 pages a month, the FDA's proposed timeline, Pittman, the judge, ordered the agency to turn over 55,000 pages a month. That means all the Pfizer vaccine data should be public by the end of September, rather than the year 2097, the deadline that the FDA wanted.

We're very heartened that the judge agreed that it should be produced this year. And yes, we're confident that the FDA will comply with the judge's order and produce those documents as demanded. Well, it's my honor and pleasure to be joined right now by the one, the only Aaron Siri. Thanks for coming in studio today. All right. So originally they wanted 75 years to release all the Pfizer clinical data. And then we got them to hand it off like inside of a year.

What was it? 55,000 pages or something a month. What was that? Was that the number? Yeah. The FDA said there was about 450,000 pages to the court. Yeah. And so the judge ordered 55,000.

pages under the assumption it would be done within last year. And then somehow this week you managed to lop in the Moderna trial. So how is how's Moderna? I don't understand like you end up with the same judge and everything that just in Pfizer, which seems lucky because you know how he ruled on Pfizer. How does Medina end up in the same court? Well, the initial case where they wanted 75, at least 75 years, probably would have been longer, to produce where the FDA wanted to deposition,

produce that was for Pfizer's vaccine licensed for those 16 and older. Okay. You can only seek the documents under the relevant regulations from the FDA after it's been licensed. So as soon as Pfizer's vaccine was licensed for 16 and older, we FOIA for it for it. We appealed administratively. Went to court as soon as we can and we had that big fight. Later, after that, the FDA then licensed the Pfizer vaccine for 12 to 15-year-olds,

which included, if you were, you know, Maddie deGarry. was within that group. And they also licensed the vaccine for Moderna for 18 and older. So we separately, again on behalf of the doctor's group, and this time also on behalf of the DeGarry family, FOIA for all the documents the FDA relied upon for those two vaccines. And it was, so it was a separate lawsuit for that. We filed it in the same place as just, you know,

it's the same venue because same first name plaintiff. And it got assigned to the same judge, which makes sense. Yeah. We didn't have, you know. You don't have control over that, but it makes sense that they would just say this is. They're related. They're related cases. So they related the cases.

Obviously, we didn't have a say in the first time around because that's supposed to be random assignments. With that said, we went back. So this is take two. Right. And when we first filed the complaint in this lawsuit for the Modern and 12th, 15-year-olds. We filed it at a time where we expected the Pfizer 16 plus data has shortly come to an end. And so what was requested was that, and we assumed it would be the same number of pages, about another 400,000 pages or something. Right. So when filing the suit, the request in the

complaint was that the 50, that when the 16 plus Pfizer documents ended, it would just continue producing at a rate of 55,000 pages a month. Okay. Right? Because of the infrastructure in there for that. And the judge... Just going to the next age group. Let's just get the rest of it. And the judge in the first decision, you know, tried to strike a balance, as the judge said, between agency resources and transparency. And we want to do accord to the judge the guidance he had given us in the first case and not overstep too far. Yeah.

And so that is what was asked for. 55,000 pages continue when that was done. After we filed it, months, you know, there's a lot of stuff that goes on. You go back and forth to DOJ. months continue to pass and we're not even we're still not close to getting everything in the Pfizer 16 plus yeah and so we realize at some point whoa wait a second this is this is not going to end this is not going to work and then we find out that actually for the moderna that is their FDA saying that's 4.2 million pages I think they're learning their lesson about not being

transparent about the other pages and that it's another half a million for the 12 to 15 year old more than what they said for the 16 plus. So you're close to 5 million pages, and we realized that at that point, wait a second, asking for 55,000 pages a month, when FISA or 16 plus ends, that's going to be over a decade. Right.

And what are they saying? Are they saying we're down to just give it all at $55,000? Let's stick with the rate we're at. No. No, they didn't, I think, learn from the judge's guidance the first time around, where we tried to, to really take that into consideration, clients did. They did not. And they actually asked that

it be between one to 16,000 pages a month, depending on the type of documents you produced. So that would mean if they did all of it at 16,000 pages a month, that's like 23 years. But they clearly were indicating that we're going to do a lot of it at 1,000 pages a month. So again, we're talking decades and decades. And as the judge made clear, you know, he's in his 40s, but he doesn't want to be on the bench when this thing is still going on. Right. So during all... So I want this out before I'm retired here.

Yeah. And I'll tell you an interesting part of this, and I'll tell you what we actually ended up asking for. About two days before... What's crazy about all this is it's not... I mean, I just want to interject. Yeah. If it was Pfizer, okay, I would understand.

If it's been... You're up against a drug company. Like, they're up against our... This is our regulatory agency. They work for us. This is supposed to be transparency with the people. Like, we got your back, you know? Don't worry.

You know, Pfizer can be really scary, but we're the FDA. We're taking care of you. It's the opposite. They're the ones like deceiving, wanting low output, trying to, I don't know if it's high data or certainly slow roll. I mean, it's crazy that your government is like protecting this data that way. When it's corporate money-making data that the FDA should be saying, wow, we found problems here.

We got issues. I mean, just nothing's working the way we all believe. it should be. Yeah, you know, we've gone through this in prior segments, right, where since 1986, after the National Child of Exxin Interact was passed, it removed the normal relationship that these regulatory agencies have with pharmaceutical companies. Once you made them liable, now they're all on the team. The FDA, in my opinion, does not view itself as really a regulator. It views itself as a part. It views itself as a part partner with these pharmaceutical companies.

And one need look no further than the homepage of the FDA website recently, which shows what's basically a promotional ad for the bivalent COVID vaccine. Right. Not even licensed. Think about that. The FDA is supposed to be, what's its job, to review the safety and equity and decide whether it should be licensed? That's it.

What the heck is the FDA? They've been done the job of licensing themselves. Right. And the scientist who's the head of their vaccine division, their biologics division, Dr. Peter Marks, is putting out these cutesy videos on YouTube called Just a Minute, wait a minute, where he's promoting these vaccines and they're not even licensed. Getting a bivalent vaccine booster dose is critical to help protect yourself against the most severe outcomes of COVID-19, including hospitalization and death. So please consider getting your updated vaccine soon. So do you really think that the FDA, after going out and telling hundreds of millions of Americans, go ahead, go promoting, telling them to go take a product that's not even licensed yet,

could them be impartial in deciding whether to license them? Wait, oops. My bad. It's not safe. Just found something out. Found a safety signal. Everybody hold on in a second. How many people did I make it that? How many millions have got? How many injured that's on me? It's never going to happen. But even, it's not. But even stepping further back from that, why is it the FDA doing that? Why is it promoting? They don't promote heart medicine.

Why are they promoting this product? Because they view themselves as a partner with industry. Sadly, they should stick to their role, their minimal role of, you review the safety and efficacy to the standard that the FDA has for that, which let's not get started with that. But meets that standard, say to the FDA standard, we have deemed it safe and effective, release all the daddy rely upon, and your job is done.

That's it. You shouldn't be pom-pom cheerleading these products in the public. So anyways, and obviously there's a lot more to that. And, you know, I think one of the great documents out there, and I saw somebody recently, I think somebody, I saw somebody post this on social media, but ICAN did a letter exchange with the health and human services about vaccine safety. And I think that really highlights and brings into focus what we just talk about in a bigger context. But with that said, they had been effectively telling us until, relatively recently, they can't tell us exactly how many pages because we blew past the 450,000

pages. And we were like, whoa, wait a second. We don't look like we're close to done here. Swimed back to the Department of Justice and we said, can you please ask your client the FDA to tell us how many pages are left? And they wouldn't tell us. They even told us at one point, well, we're still trying to figure that out. Well, we foyer them in a different case to get the copy of the contract that they entered into to actually fulfill the judge's order of 55,000 pages a month from a year ago. And guess what that contract says? What? It says that they need somebody to review a company to review 1.2 million pages.

So a year ago, they knew it was 1.2 million pages. That's why they put out a request for bid. Is it like perjury or something? Is that like lying to the court? Well, it's certainly not. being forthright. And I think the judge as, I think the judge has taken note of the fact that they said 450 initially and we're not there. I think when the judge ordered 55,000 pages a month, he made clear in that initial decision. The point was transparency. And I judge, I believe,

expected that everything would be done last year. In fact, he said as much in his most recent order. We had an opportunity to actually put that in our papers and say, Your Honor, look at this. they're basically telling us up to weeks ago. They don't know how many pages. But a year ago, they have a document showing the 1.2 million pages. Wow. And so one of the things we did is we changed what we were asking for in the lawsuit. You know, the plaintiffs in that suit,

instead of asking 55,000 pages a month, when in our papers and in our motion seeking a production schedule and then an oral argument, which was, you know, an hour or 15-minute argument with the third mid-jia on the other side and before the federal judge. We said some really hard, I mean, really, really insightful, made some numerous, extremely insightful comments during the hearing. We decided, instead of asking for a rate, was to ask for just an end date.

So let's say we want this per date. We're just going to set a date when we want everything. Everything. Because our argument was this. In every other FOIA case, there's often a universe of, documents, you kind of know the universe, and so you can set a rate. But here, clearly, from the first go-around, started at $4.50, ended at $1.2 million. They're saying $5 million, but who knows where it really ends. And our argument was, look, Your Honor, the people that are in the

best positions to know how many actual pages are are the FDA. And the purpose of the Freedom of Information Act, the purpose of FOIA, the reason Congress enacted that law is so that we can have transparency as to what our government is doing. The government that we pay for, the people who work for us, the American people. And so we said transparency doesn't demand a rate. It demarons timely production. And what we asked for is that within six months of the order, all of the FISA 12 to 15, and within a year and a half of that, all of the Moderna.

And the judge gave us exactly what was requested. The judge ordered that within 24 months, all of this has to be produced. has ordered that we confer with the DOJ and submit a proposed schedule to the court by next week. So you go in, you're getting 55,000. FDA comes back, they want to drop that down to 1 to 16,000. So with that sort of 24 months to deliver all these millions of documents, do you figure out how many pages that would be? It would be a minimum of 180,000 pages on average per month to produce the current number.

And, you know, I think that, you know, it's really good to listen carefully when a judge is saying something. They've given you guidance, you should take it. Right. And should think about what it's saying. And I think the FDA just, again, I mean, they got backhanded. I mean, I don't know. You're probably not allowed to, like, sort of speak with any color. But, I mean, this judge looks like he just lowered the boomstick on the FDA.

I have a copy of the decision here. Okay. I'll read a few sentences from it. The order begins. This is the judge's order in which he ordered within 24 months. And he says, first words in the decision, democracy dies behind closed doors. To help prevent that from happening, Congress enacted the Freedom of Information Act. Frank, I couldn't have said it better.

That's exactly right. And then he goes on to say, oh, he's got a footnote here where he points out. he's not. He says, you know, talks about the prior case. Under the rate of production ordered by the court, all documents were set to be produced by November 1, 2022. That's what the court apparently expected. Because the 450,000 page estimation provided by the FDA, however, is nowhere close to the number of actual documents, 1.2 million, only 64% of total documents have been produced. Judge Gawans, going back to Moderna and 5 or 1215, the judge says, plaintiffs have shown an, and, urgent need to inform the public about the health and safety of the COVID-19 vaccines

based on the massive push to vaccinate, persistent effort to eradicate COVID-19, and continued government and private efforts to enforce these vaccines. Stale information is of little value, and the judge orders, all caps, bold, the parties to meet and conferrence submit a joint production rate that maximally reduces this burden by May 23rd, 2020. and the orders the FDA to produce all data information relating to the approval of the two vaccines by June 20, 25. So we have that there, and I will tell you this much, if I'm the FDA, and I want to show this court that actually I am for transparency, we are trying to be forthcoming with the public. We have nothing to hide. We did a great job. In 108 days, we reviewed all this stuff.

I think that maybe saying you're going to do 1,000 to 16,000 pages a month it wasn't a great way to show that to the judge. That was a bitter pill for a judge to take. I will let those read into that decision. Do you ever leave these things and just wonder what's happening in the back offices now

as these lawyers come back in? They certainly are getting applause. Well done. You just heard 55,000 pages and say no, 180,000 pages a month. I mean, there must be heads rolling over at the FDA right now. You don't speculate. You know, in the first case, they brought in a department of, well, they've tried different approaches.

Yeah. Man, Aaron, it's absolutely amazing. And we love the fact that you are, you know, out there in front crusading for the things that we care about. I just want, I think it's to take the opportunity in this moment to say all this is only possible because these amazing donors that we have. that are funding this work that, you know, make these moments happen, but you're the one on the front line that is delivering it, and it is really spectacular to have you on our team. I mean, I've said before, this is historic moments,

and it's showing how, I think I don't know if corrupt is the right word, but just, like you said, just how our system, this government, how it has just been totally taken over by a quarter, by corporate interests, is moving for the corporation, and it's only because of people like you and this work we're doing like can, that we can just pry this out of their hands and really get to the truth. And I look forward to seeing the end of the Spizer data and Moderna's coming down the pipe, but amazing work. I'm blessed to get to do the work.

All right. Well, keep it up. We're going to keep you busy. All right. Well, look, I mean, this is what all of you out there. I want you to take a moment. This is not Del Baitree. This isn't really even the high wire, what we are doing here in releasing this data, which is going to be used by scientists around the world to figure out what happened in this debacle known as the COVID vaccine rollout. All of this is made possible by those of you that donate to ICANN, the informed consent action network. Many of you get to watch the show and you're right along. You're probably pretty excited right now. But imagine how excited you be if you knew that you invested in this result for not only you, but your children and the children. the generations to come. This is spectacular what is being achieved here. And I want you to be a part

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