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Bulwark Takes
The FDA’s Vaccine Death Email Looks Like a Political Stunt (w/ Demetre Daskalakis)
00:25:26
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- [00:00]
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Sarah
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Jonathan
Hey everybody. So much is happening on vaccines. We've had changes to the official CDC website suggesting there's a link or might be a link between vaccines and autism. Just a few days ago, the director of the Food and Drug Administration sent out an email saying they had found evidence of deaths linked to the COVID vaccine. They were going to start changing the way they review vaccine safety. Both announcements caused a huge uproar in the scientific community from people who said these findings were not based in science and we're going to jeopardize public health. To help us sort out all of this, we have a very Special guest today, Dr. Demetri Daskalakis. Readers of the Bulwark or anyone following the headlines may know him as one of the scientists who left the CDC in August in protest of all the changes that were being ushered in by Secretary of Health and Human Services Robert F. Kennedy Jr. Dr. Daskal Dalazkas is here to tell us his views, give us a scientific perspective on everything that has happened so far and what might happen this week when a key advisory committee meets to make official recommendations for vaccines that will determine going forward who gets what vaccines and when. Dr. Daskalakis, thanks for joining us.
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Dr. Demetri Daskalakis
Thanks, Jonathan. Call me Dimitri. Nice to see you.
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Jonathan
All right, Dimitri, let's start. I mean there's so much, I mean it's crazy how much has happened just in the last few weeks. I think I want to start with the most recent development which was this email that went out from the FDA director announcing, with this bombshell announcement, theoretically that they had discovered a number of unreported, previously unreported, unconfirmed deaths from COVID shots and that going forward we would be changing the way we approve, we review and approve vaccines. How do we do we take that at face value?
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Dr. Demetri Daskalakis
You know, first of all, it was a very well curated email that I think was destined to be released. So I just want to start with. It was multi pages, went into great detail of like sort of internal sort of fda, you know, proceedings, but then didn't really give any information beyond sort of a statement that they've reviewed some deaths and identified that there were 10 that they, that they claim in the email or he claims in the email were related to COVID vaccine. Notably when you look at the history of this, the myocarditis, the inflammation of the, the heart was seen early in the vaccination effort with the COVID vaccine back when, if you remember, you had the primary series which was like one dose, then a few weeks later a second dose. Subsequently when the vaccines were more spread out, the signal for myocarditis or inflammation of the heart went down. And so that has become an exquisitely rare event. So, you know, per cdc and again, I didn't run the immunization safety office at cdc, but there's, there's not been a death that has been directly linked from the vaccine due to myocarditis. Now you know, that's, that's a complicated thing because, you know, I think that that's why the main piece of what I am thinking when I see Vinay's email is, you know, you need to show us the data. Obviously like that email may not be the place where you're going to show the data, but it would be foolish to to send that email out, not expecting that it was going to somehow, you know, be released to the media. So, you know, it was, like I said, very well curated. So I think, I think that the bottom line is like, we need to see the work, we need to sort of understand like how these deaths were reviewed, see how they were associated or not associated with COVID vaccine and the work that they did.
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Jonathan
And just so I want to make sure I understand. So I mean, this came at least according to the email, this was started with a review. There's a vaccine incident reporting system, right? Anybody can report what they believe to be an error injury. And that's simply. There's no verification of that. It's just, I think that, you know, it was it by doctors, clinicians or is it by patients? Is it by both?
- [05:44]
Dr. Demetri Daskalakis
So there's, there's a whole ecosystem, a whole multiple systems that people use to look at vaccine safety. The easiest, lowest threshold system is called the VAC theirs. So VAERS is a system where every, anyone in the world can submit and say, this happened to me after vaccine. And then that triggers additional investigation. And so what VAERS is, is a hypothesis generator. So you're trying to get like all the information in the world so that you can see if there's any trend or anything that looks like a signal. What theirs is not is a place to demonstrate causality. So it's not the system that you would use to say, you know, to say this is caused by this because it's really not built for that and it's very complex and again, very low threshold. So usually what happens is when there's something identified in that system, then other systems are used to pursue and confirm. So there's the vaccine safety data link, there's the CMS database that FDA holds, there's all sorts of different strategies used. And so in June, the Immunization Safety office did a great presentation around vaccine safety, also looking at deaths. And they really hadn't identified any signal that was in any of the systems. And in fact they actually presented some data that showed that individuals who were vaccinated against Covid had had lower death rates from other causes than the general population. So, you know, I think that the, that the couple of questions are like, how did you use theirs to be able to be confident enough to say that you've created causality or identified causality between the vaccine and a death, since that's not how the system is designed? And how are you going to square that with the fact that other data systems aren't showing the same thing. Now, I can't speak for what he has. He may have more data that we've not seen, in which case he should be calling an emergency meeting and not sending out an email. Right. If there's, if there's data that. Right. If there's data that he thinks needs to be shared. This is when people are getting COVID vaccine. So it seems weird that a Thanksgiving email would be the way that you would do this. If there's actually something going on that's of significance or different, then I think it's pretty important to move quickly. And I think that, that, that's not what I'm seeing. So I just. It's a little confusing.
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Jonathan
A couple of weeks ago, we saw a new statement about vaccines and autism. Just real quickly, what did the statement say? That. And I don't know this was coming or not, but yeah, the one that was put on the website, what did it say?
- [08:22]
Dr. Demetri Daskalakis
It, you know, pretty much took down the CDC website about vaccines and autism that, you know, that vaccines do not cause autism, and replaced it with this very strange document which is frankly, you know, the, the Talking Points for Children's Health Defense or RFK jr's Vax Unvaxed book that really says that, you know, I think the exact language is that it is not scientifically accurate to say that vaccines do not cause autism. And then they cited a bunch of information, including the 2012 Institute of Medicine report around autism, saying that that was somehow proof that this was a not scientific statement. So like I said, it is like saying that I have no evidence that umbrellas do not cause kittens. Right. Like, it's a very strange formulation. It's, it's trying to, it doesn't overtly say vaccines cause autism, but it's trying to create enough doubt and confusion for a couple of reasons. And you know, just to be clear, the National Academy of Medicine even made a statement around that very post that said that they don't support the statement that they actually continue to believe that based on their data and body of work that vaccines do not cause autism. There's like this, like cherry picking and distortion of data that sort of created this source document. And sadly, that's what the intent is. So they've created a source document that has the CDC seal of approval on it that says that vaccines, you know, in a roundabout way, vaccines may cause autism, which is not true. And the reason that they did that is now they have a source document to do all the other things that they want to do, such as Destabilizing the vaccine injury compensation program so they don't have to look for data or make it. They can just make a source document that is distortion and then use that to be able to justify making it really hard for people to get vaccines in America. Cause manufacturers are gonna be driven out of business.
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Jonathan
Vaccine injury program real quick. And I wanna get to this week's meeting, but just remind people why that's so important and how they could undermine that.
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Dr. Demetri Daskalakis
Yeah, and so vaccine injury compensation program was sort of formulated in the 80s to create an environment where VACC vaccine manufacturers could continue to make vaccines. And so not every vaccine is made by like some huge company. Some vaccines are made by smaller companies. So this thing was designed to both protect people as well as to frankly insulate the companies from a lot of claims. And so this means that it's like a lower threshold system that people can actually make their claims and potentially be compensated if they believe that something's happened that's related to vaccine. But it provides a little protection for the companies so that they don't have to be responsible for all of those so that they can keep manufacturing vaccines. And there's things on there that are real, like the data supports that there's like X, Y or Z effect of a vaccine that happens. And if someone has it through that compensation program, they can get compensated. So if you add autism or autism spectrum disorder, even though there is no proof that autism is caused by vaccines, that means that it opens the floodgate for people who are able to then put claims against that system. The system doesn't have infinite amounts of resources. So when that gets bankrupt, all of a sudden there's no more vaccine injury compensation program. And then litigation can start against the vaccine companies. Even though, you know, for autism, even though there's no evidence that vaccines cause autism. And then that means that they're going to start saying it's not worth being in this environment in the US producing vaccines and they may just stop making them. So that's what that is. Did that make sense?
- [12:25]
Jonathan
That's a way to undermine. Yeah, it does make sense. That does make sense. So we have this meeting coming up this week. ACIP is very Quickly, what is ACIP's job? Everyone says the Advisory Committee on Immunization Practices. What's their job?
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Dr. Demetri Daskalakis
So their job is to review the entirety of data and depending on sort of what the questions are, help formulate recommendations to the CDC director. And so their job is to, if there's a new vaccine or new data on a vaccine is to go over that data and then make a recommendation for who should get the vaccine. They're not regulatory, they don't approve the vaccine that is fda. They look at how effective the vaccine is, how safe it is, like if it's cost effective, what public health problem it's solving, and then they come up with a recommendation that then is voted on and goes up to the director of CDC to say yay or nay. It's not just the meeting. It is a whole series of work group meetings that happened before because there's a mammoth amount of data that needs to be reviewed to be able to get to the place of making a recommendation.
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Jonathan
Yeah, let's just pause on that for a second. So I mean, there's sort of two components here. First of all, there's the actual members, the voting members of ACIP who used to be this sort of rotating group of pretty widely respected scientists. And Kennedy, if I'm not mistaken, he got rid of everybody who was sitting on and has appointed every single member. Is that correct?
- [13:55]
Dr. Demetri Daskalakis
That's right. So it was, I think it was June 2025, he just fired all 17 members and then like has added members on. So I think initially it was a gang of five and now there's more that were added and you know, some, I mean, I'm going to say very important. Like I, you know, there are some people on there that are fabulous. Right. There's, there's a great pediatrician, there's an excellent pharmacist, there's an amazing psychiatrist. They actually like, you know, they're very balanced. And then there's a lot of other people that just sort of have an, have their own agenda or who are ideology clones with RFK Jr. And they're the vast majority of that committee. And so he's really fashioned it in a way where frankly all of the major medical associations really have said that they don't trust the ACIP anymore. The insurance association is not even looking at their recommendations at all right now. They're maintaining their coverage based on the pre zombie ACIP that we have now.
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Jonathan
The old acip. Right, right.
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Dr. Demetri Daskalakis
They call it Zombie. The Zombie ACIP versus the like original. Because like, it's kind of like, it's like, have you ever, you know that. That show the Last of Us? It's like the fungus in the brain, like it's taken over.
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Jonathan
Right.
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Dr. Demetri Daskalakis
That's what happened.
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Jonathan
Right, right, right. That's. That's pretty grim.
- [15:16]
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- [16:40]
Jonathan
One other thing you mentioned I think is so important for people to understand. So much of the work that would go into a SIP was done before the meetings in these working groups and they were staffed by CDC scientists and they would have one or two, I think, right, one or two members each from the, from the actual ASIP itself or, and, and that process, it feels like, is not working the same way as it used to. Is that correct?
- [16:58]
Dr. Demetri Daskalakis
So there are, my understanding is there have been work group meetings, but a couple of, you know, very important things happened. So, you know, the agenda of that workgroup, CDC no longer has anything to do with it. It's only driven by the, by the members. CDC has no say in who's going to be like members of that work group. So only the member is able to nominate people onto the work group. And so, you know, the liaison members from really reputable organizations, scientific and clinical organizations and public health organizations were removed. So now it's just whoever the, the lead wants to put in. And so, you know, the work groups are a lot different than they were. They are seemingly not following like any of the sort of process that had been part of acip. So it's unclear how they're going over the data systematically. Again, like, you don't want your policy fast and loose, you want it to be systematic and slow.
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Jonathan
And what. So they are meeting Thursday and Friday. What are the two or three big things to watch that are the big items that we should be paying attention to?
- [18:01]
Dr. Demetri Daskalakis
Yeah, I mean, I think day one is going to kind of be a conspiracy theory fest because it is a list of items that are all over the place, like vaccine safety adjuvants, which are the things, the components of a vaccine that makes your immune system respond better to the vaccine. So on the first day, they have a bunch of things that it's really hard to understand, like what they're going to be talking about because they're so general. Notably in the past, all of the presentations would already be up around the time public comment was open so people could review them and so that they could actually give meaningful public comment. But yet again, round three, nothing is up other than the agenda that's very vague. So no one's seen what they're presenting. So I think that they're going to be talking about safety concerns around adjuvants that have not played out in any science before. We don't know who's presenting. So it would be interesting to see what the track record is of the people presenting. Remember, we had a presentation from the former head of Children's Health defense around thimerosal that was completely not scientifically accurate but was elevated to a CDC platform. So I think day one is going to be a lot of that. Day two is all hepatitis B. And I think that that's going to be where they're going to be discussing whether or not it is appropriate to have a birth dose of hepatitis. Hepatitis B. So just for the record, the implementation of the birth dose of hepatitis B resulted in a huge decline in hepatitis B in kids, which MEANT that the 90% that would go on to chronic infection and the 25% of those that would die early didn't die because of the fact that this intervention was established. So I think that they're going to argue about whether or not you can test your way out of hepatitis B. And if the mother is negative, then there's no reason to give the vaccine. That does ignore that. 11% of transmissions happen in household or close contact. So mom can be negative, but there may be other people in the household or childcare that could have hepatitis B, that could result in trans in transmission. So they're gonna discuss it. I don't know, like, where they're gonna go. I Mean, the President said that he wanted the vaccine pushed to 12 years of age, which I think is bad. Briefing by Secretary Kennedy. Since Hepatitis B is not just a sexually transmitted infection, but is also something that's transmitted mother to child as well as by caregiver to child, and with pretty dire consequences. So that is the freedom.
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Jonathan
What are the. I think people just. So when hepatitis B and if a child gets it, I mean, what are we looking at down the road or immediately in terms of what can happen?
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Dr. Demetri Daskalakis
Nothing good. So first of all, vaccine is very well tolerated. Its risk benefit ratio is extremely favorable. There's nothing that would make you concerned about a safety signal. I can't imagine what they're going to present or who's going to present. I'm sure they're going to sort of create doubt around that somehow. But the bottom line is that if a child gets hepatitis B early in life, 90% of them go on to chronic infection, which means that it doesn't clear. So they, 90% of them will go on to have virus in their blood. And because of that, they get liver damage over time and also get liver cancer. And the statistic is that 25% of children who get hepatitis B early in life will die early, either from liver cancer or from scarring of the liver called cirrhosis. So the stakes are high and the risk is low. But this acip, all they know is risk. They never talk about risk benefit ratio and they distort the benefit because of the fact that they will claim that hepatitis B and they'll say this again. I bet money is not a problem in normal families. They said that last time, they're going to say it again. And I think that is a distortion, especially when you have children who are like, not only in households that may be at risk for hepatitis B, but may also be in childcare. And that could also be another risk for acquisition. So that's, I think, what we're looking at. And they're going, I don't know which direction they're going to go. I think that they're probably not going to remove access to hepatitis B vaccine. I think that they're just going to do what the only thing that they know how to do, which is to call it shared clinical decision making, to make it seem as if they're appeasing some of the folks who are looking at more medical freedom sort of considerations. Bottom line is like every vaccine is shared clinical decision making because you have to ask the parent to give the vaccine to the child. And so, you know, they're just going to create havoc and present data that I think will create doubt. And frankly, pediatricians may get worried from the liability perspective based on what they. What they talk about, even if it's not what they vote for.
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Jonathan
Shared decision making sounds fine. I mean, what's wrong with that? Isn't it. Shouldn't we. Yeah, I mean, what's wrong with recommending shared decision making?
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Dr. Demetri Daskalakis
So this is like the fun, the bizarre game that they're playing. So shared clinical decision making, you know, those words all sound fine. Everyone. Everyone's fine with that. Like, every. You know, that's. There's nothing wrong with the idea that. That to give a vaccine to a child, you have to talk to the parent about it. The problem is that it creates complexity in terms of billing, et cetera, et cetera. It's not just the words. It actually means something from the, like, operational perspective. And so they're gonna. And so that's the bottom line, Jonathan. Like, they're just gonna talk a lot and create a lot of doubt, and then they're just gonna say shared clinical decision making, which frankly adds some barriers. But net. NET is not anything that will remove access to the vaccine. So. But that's not their game. Their game is let's really destabilize trust in the vaccine and make people really anxious about it so that, you know, there's instability created in the schedule.
- [24:03]
Jonathan
There are people who will listen to somebody like you or this interview, and they're going to say, well, yeah, okay, but, you know, he's part of the problem. He's part of this, you know, public health establishment. They're all in bed with pharma. He can't trust any of these people. I'm sort of curious. What do you say? I mean, I'm sure you encounter this. What do you say to people like that?
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Dr. Demetri Daskalakis
Yeah, I think that the hard part is that, you know, there's so much noise that if you don't trust me, trust your pediatrician. Right. So that I think, is the bottom line. So I think that that's like that no matter what. You know, I am a doctor. I see patients. All of that is true. And I definitely recommend my patients stay up to date on their vaccines. I see adults, not kids. But bottom line is, like, I think that vaccines work. The data supports it, the risk benefit ratio is favorable. But if you. You shouldn't trust a politician. I'm not a politician. But you should also not trust people who are trying to promote conspiracy theories and to sort of create doubt where There is no reason to doubt. So I think that the bottom line is ask your doctor, ask your pediatrician about your kids, and that should really guide you correctly. There's so much noise going on right now that identifying or differentiating signal from noise is hard. And so whether you hear what I say is less relevant. What's more important is that you have that interaction with your healthcare provider and let them give you the data and the information rather than trusting, you know, RFK Jr. Or any of these sort of politically motivated people that are out in social media talking about vaccines.
- [25:42]
Jonathan
Did you ever think you'd be in a place where you'd be telling people not to trust the cdc?
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Dr. Demetri Daskalakis
Nope, never thought I would be. But I do think that, you know, it's hard to figure out what to trust, right? It's for people. It's hard to say, trust some of it, but don't trust the rest. I think that in this era, I think that you need to look at your doctor, look at your local health department, your state health department. They're not perfect, but I think that they're closer to the ground. And part of the role of the state and local health department is to actually be the ones to help you differentiate. Like, yeah, that data is still good, so we should, we should stick to that. But I think that I would be very cautious with CDC around vaccines and vaccine safety because the scientists are hijacked on a plane that's being run by people and the hijackers are running the website. So it's hard to trust it.
- [26:35]
Jonathan
Dimitri Daskalakis, thanks so much for taking the time to explain all of this. And I hope everybody will be watching and paying attention and finding sources they can trust on vaccine information. And I hope you follow the bulwark as well. If you like this video, hit like subscribe to our feed. We really do appreciate it. Thanks so much.
- [26:57]
Sarah
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- [27:02]
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Could you be more specific?
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I'm seeing a pattern here.
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- [27:27]
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