The Highwire with Del Bigtree - FDA SHIFTS GEARS ON COVID, FOOD AND CHEMICALS

Episode Date: May 31, 2025

Concrete shifts in U.S. health policy are taking shape as the FDA announces significant changes to its stance on COVID-19 vaccines, moving away from a one-size-fits-all approach. In addition, the agency is committing to an evidence-based overhaul of the long-criticized FDA food pyramid and is now setting its sights on legislative action targeting harmful weedkillers in the nation’s agricultural supply.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

The buzz here in D.C., in the health space, at least, is really these big moves. We've been waiting five years, essentially, for these moves on the COVID vaccination. There's really been, it's been an unscientific go ship from the get-go, and we've been sailing off into this direction, and no one knows what's going on. So we finally have some concrete movements, and this is an exciting time. It's an exciting point right now. So let's look at the FDA. So starting from the FDA, and this is the headlines that are making right now. The FDA is going to limit the COVID shot approval to elderly and those with medical conditions.

So I want to also go into Secretary Kennedy's HHS posts on X, and he had this to say. Among other things, he said the U.S. FDA is finally breaking away from the one-size-fits-all vaccine policy that authorized COVID shots for every American over six months old. The era of rubber-stamping COVID-boosters is over. And presumably, the safe and effective line, we have to expect that to fall off as well. because this is a gigantic statement here alone. We've had one-size-fits-all. The entire vaccination paradigm outside of COVID has been one-size-fits-all.

We've heard safe and effective. So this shift right here is the start, hopefully, of something we're going to see a wider conversation around evidence and actual science. Yeah, well, it's huge, but lots of debates on this, Jeffrey. I actually, I texted you this morning and said, I really want the details today because we're hearing things all over the map. I mean, is it really going to, you know, be taken off the childhood schedule? Or is it going to go to pregnant women?

So what are the real details? What do we know? What do we not know? Yeah. And in all honesty, this move has split the public because a lot of people, it's not fast enough. A lot of people, it's too fast. Some of the middle is just right. But we go to the New England Journal of Medicine.

So FDA had Dr. Martin McCarrie and then we have Ciber Biologics head, Vinay Prasad. They put out this study in New England Journal of Medicine, an evidence-based approach to COVID-19 vaccination. And for those that don't know, we really covered him. Dr. Vene Prasad, he came out against masking, lockdowns, and the science wasn't really supporting that. He was really railing against this. There was no science for boosters.

He was saying that had to stop. This was before he was installed at Sieber. Yeah. And also. And Sieber being, this is the Peter Mark's position? Is that correct? Absolutely. Yeah.

And he came out really hard also against myrocarditis and kids saying, look, there's more evidence that these shots are causing myocarditis compared to the COVID-American. compared to the actual virus. So he's been pretty outspoken on that. Now he stands alongside McCarrey to post this article in New England Journal of Medicine. So let's take a look at this. And the first picture I want to show you is a figure from that.

And it's the risks by country here. So you can see every other country pretty much in the developed nations, Australia to Canada, to United Kingdom. So this is their recommending, what they're recommending in their country. So you see Australia? They've been recommending this for quite some time. So the United States has been a gigantic outlier here just saying, hey, everyone take it. No problem. Kids, infants, everybody.

So you can see here eight in France, 80 and over and those at high risk. I mean, so the U.S. is finally catching up. This is a bare minimum they had to do, but they're finally catching up, 65 and older, and those in high risk. Now, one of the contentious parts here that I've been seeing from the public, we're questioning this next figure from this New England Journal of Medicine article. And this is it right here. These are the high-risk individuals. And you can see this list here. It's an extensive list. So goes the American chronic health disease issues. It's estimated that this is about 1 to 200 million Americans. You can go down this list. You can see people with diabetes. And this is at any age. So if you're high-risk at any age, they're still recommending this vaccine. And what I find interesting here is you have a health administration that prided itself's prime directive was to eliminate chronic disease. And yet, they're putting those with chronic disease still in the firing line, these kids with chronic disease in the fireline. So that's really what I think a lot of people are asking is if we have the sickest nation

of children in the world, which Robert Kennedy Jr. has stated, more than 50% have chronic illness, some say as high as 60%, obesity somewhere in the 30, you know, moving towards 50% range or certainly pre-diabetic, all of these issues, then even if you say, well, we're not recommended for healthy kids, that still leaves half of the nation's. children in the firing line. And did I see pregnancy is being listed as a, as a, yeah, there's a conversation back and forth. Is it going to be given to pregnant women? If it not, if you go on this list right at the bottom and it is right by smoking, it's pregnancy and recent pregnancy. That's still considered high risk. So the COVID vaccine, according to this, is still

recommended by the FDA for pregnant women and those recently pregnant. And obviously we've covered a lot of science that would contradict that conversation. So I'm hoping that move will be made in the future if they're going to look at evidence-based science. I hope that science is being done. Well, you know, what I want to say right here is that, you know, I recognize that there's science that has to be done. I recognize that, you know, I've said it. You can't just erase vaccines off the program or just be agenda driven. As soon as Robert Kennedy Jr. is out of the office, then whoever comes and just puts it right back on.

We have to have everybody nod together and say, we've all looked at the evidence together. We have to agree that it's the highest quality evidence, that it's reproducible, that everyone gets a shot at it. But meanwhile, you have people in real danger that are really in danger of this terrible vaccine. It seems to me with the Yale study that came out, we talked about it, that over 700 days now they're finding people that still have this spike protein after vaccination in their bloodstream, in their bodies. So many scientists now saying, look, the only way we can imagine explaining that is that. that the worst thing has happened. Is it possible that this vaccine, this MRI technology,

has inserted itself into the genome of these human beings? Meaning they are permanently altered for life. Their bodies could be spike protein manufacturing plants for the rest of their lives. Do they pass that on to their children? If they get pregnant, these are all questions now. And I think given that it's Yale University,

it certainly seems to me, what I would really like to see from Dr. Marty Macquarie and Venné Prasad right now is to say, look, If you've already contaminated your body with these and you want to get another booster, okay. But honestly, if you haven't touched this vaccine, we are highly recommending now that you stay away. Because we are seeing things. We may be altering our species as we speak.

And we do not want to do that if there's an issue here. We have a red flag, a very serious one out of you. Forget about all the rest of it, all the pericarditis, myocarditis, you know, all the issues around neuropathies that are at the heart of Follow the Silence, the film that just really, you know, you know, start exploding across the country last, last week. And then look at these numbers. I mean, you've got, you know, nearly 29,000 reported case of myracardite's, paraccharides, to a system most people don't even know exists.

And has also always been said to be unreporting Harvard University, saying that those numbers could very well be only 1% of what's actually going on. Look at the deaths there, 38,000 deaths. I mean, these numbers are appalling. For those reasons alone, I think you have to say to yourself, who are we really going to recommend this for? I guess you better be on your deathbed if we're even going to consider it in my perspective. And if you haven't gotten this vaccine or if you're a pregnant woman, why would we risk this in utero?

It just makes no sense. I really hope they get stronger than just sort of, you know, we're recommending that maybe you think about it. Right. And so we have this framework here. And we're hoping this is just the start of the scientific framework. And more work is going to be done with those extra layers of this lipidonot particle, the DNA contamination. I mean, it's nice to know. this thing stop symptomatic COVID. Great, that helps your recommendations, but let's go deeper.

So in this New England Journal of Medicine article, you have the new framework the FDA is proposing. Let's take a look at that here. So for 65 and older and those with risk factors, they're basically just looking, does this elicit a response from the immune system? That's all they want to know from the sponsors. But the sponsors have to do this. So these are the trials they now have to do even though? For the boosters, yes. For the boosters, okay, gotcha. For the boosters moving forward, they're not just going to rubber stamp these. And so then FDA is recommending post-marketing randomized placebo-controlled trials for people 50 to 64 without risk factors. So that's just general population. There's about 61.2 million people in that category they're recommending.

And then they're saying they actually said it's a free country. If the sponsor, if the pharmaceutical company wants to do tests for infants all the way up to 64-year-old's healthy, they can do that. And we'll look at it, the FDA, you can apply. We'll consider that. But we're not going to rubber stamp it. So these trials now, they need to look at symptomatic COVID. They need to look at secondary endpoints like hospitalization deaths.

They have to have placebo controls. And they have to be at least six-month follow-up to see if these immune responses and all of these things are actually holding. And it's not just a two, three-week pattern. Then it just drops off or you get into negative efficacy like we've seen so many studies. Right. So in the studies showing that after I think it was 15 weeks, you lose any protections you have from symptomatic disease.

and now you start being more likely to catch COVID. So it's actually helping the virus infect your body, which is insane. Multiple studies, Cleveland Clinic. Again, these are not just like airy, fairy, you know what I mean, herbalists. These are major institutions buying this. Yale, Cleveland Clinic. And I also want to point out that I think one of the changes that's being made,

and we really have to look at this and say, thank you very much, is we're getting away from just measuring antibodies as an endpoint. Well, it made antibodies there for the vaccine. must be working. No, do those antibodies actually protect? Do they actually reduce the, you know, the disease itself? Do they protect against spreading all of those things? Our people, is it reducing the amount of time in the hospital or visits to the hospital or even deaths? Now we're finally getting real endpoints, not these fake endpoints that have been driven by the pharmaceutical industry and the very like Pfizer and Moderna that make up their own rules to tell us how great their

own product is and the great safety studies that they did and the efficacy studies, that they did, and then they go, we all go, oh, great, and then they go on to make $100 billion. Exactly, exactly. So this is hopefully a start. It looks like it's a start, and we can build on that from there. In that space, it's positive, in my opinion. But the- It's definitely positive.

Let's be clear, we haven't seen anything like this at HHS. I don't think in my entire life. So finally something's happening. The question is, is it enough? I mean, you know, we got to get things done. We only have a few years here. Yes. And, you know.

Yeah, and so other things are also getting done. So the vaccination conversation is one piece of the Mahaha movement. Yeah. And as we sit here awaiting the Maha Commission's report, this is going to have a lot of things in there. one of the things that Kennedy, Senator Kennedy, Senator, I'm sorry, Secretary Kennedy has said is by August he's going to have basically a new food pyramid. And this is one of the headlines here. He's saying that new dietary guidelines will recommend Americans eat whole food. This is going to be released before August. This is going to replace the 140-page kind of situation that we have right now of just it's every direction. Process food's great.

Lucky Charms is awesome. So that's really hopeful. But one of the big hopeful things we reported a couple weeks ago, we showed Pepsi Cola's in their earnings call. They were having, they were forced to confront this massive shift. And that's also happening in other places. Goldman Sachs analysts are giving updates in their quarterly calls to their investors. and they're saying this, we expect the ongoing consumption shift, this is food in America, towards what's called better for you to continue.

These are people wanting better, healthier alternatives. While investors have also noted caution on snacking with risks related to rising GLP1 adoption, including the potential launch of oral options and regulation changes, for example, potential snap funding cuts for select categories, removal of certain dyes and additives, all in we see continued tailwinds for natural, organic, and, protein. So a lot, I mean, it's investor talk there, but they're saying basically these tailwinds, people want natural. If we don't get into organic and natural right away, we're going to start taking a hit as a company. But are they basically saying, like, with the GLP ones, that, you know,

essentially everyone is now paralyzing their stomach that we are making obese, so we better stop making people obese because they're going to stop eating food altogether. Then we're really screwed. I mean, like the context of that is amazing. Those are those injectable, zip- weight loss. Right. So, I mean, it's like a shark tank. They're saying, wait a man, this is cutting in in our profits now because people are eating less crappy food. Yeah, we're moving out of the heyday of making everybody fat because now they're taking the drug that's making them stop eating altogether.

It's killing some people, all sorts of side effects that, you know, I'm sure we'll talk about in the future we've talked about before. But interesting that Pepsi is feeling the pressure. They're feeling the heat now. Changes need to be made. I also want to point out there's a group called the Maha Coalition, not to be confused with the Maha Commission, that's a government. you know, sort of run group of experts inside the government, but a really great group of groups like, you know, I can, we sit at the table there,

children health defense, many great organizations weighing in, and some people from HHS have been visiting these meetings. And honestly, I heard from several people saying, you're not going to see that big a change in the food pyramid because it's set up the year before, and there's a certain amount of time where he can really change it and was funded by the Biden administration, and yada.

So it sounds like, it sounds like Bobby must have jumped through some boobs. If this thing really does shift the whole foods and makes a big sea change overnight, we were hearing just a few weeks ago that that wouldn't be possible. So again, very interesting to see if he's just saying, I don't care what the rules are or be sticking the rules. We're going to, you know, keep our eye on the prize here. And as we unpack this, people need to appreciate how many separate little battles that are going on within this whole health conversation. So we have medicines, medicine pricing, vaccines, vaccines, food. But we also have pesticides, herbicides, and the chemicals that are put on our food when it's growing.

And this is a conversation that we're seeing kind of a division within the administration. So this is an axios. It was talking about RFK Jr.'s next target is a common weed killer. So they're kind of pushing forward this idea that he's really looking at glyphosate, which he is, an atrazine. But then you have Wall Street Journal saying this, Trump officials bulk at RFK's attack on pesticides. And in that article, they're saying there's people at the EPA that they really, don't want glyphosate to be considered unhealthy or cancer-causing because that's going to hurt

business. You've got health versus business, Trump versus Kennedy. That's a very primal alignment battle that's really moving there. Hopefully they can, these are the two people that can reach across the aisle and really have this conversation. But really when it comes to food, we have atrazine. We have, it's been banned in seven EU countries. The U.S. just completely puts it on right now. All of our food. Obviously, glyphosate. I would say it's like over 80, some say 90% of our crops here in America. Right, absolutely. And so we have that conversation about that.

But there's another conversation going on with just food stuffs in general. And one of them is the American beef supply. Well, before we get into that, I just want to talk about the farming because, again, I'm sensitive to this just because I've gotten closer to politics and I've ever wanted to in my life. And you do have to recognize there is a real struggle here, right? at the heart of America is the farmer and the rancher. And, you know, we don't want to destroy the heart of America, which is what we've called it. They have been sort of, you know, made, I would say in many ways, made addicted to glyposate as a way of growing. They're now, you know, generation into, you know, GMO crops and spraying everything with glypacet,

crops made to not die under this deadly poison. Meanwhile, that poisons killing the earth and the soil as we know it. It's being used as a desiccant. When they don't make a GMO crop, it still kills it, so they use it on wheat. So it's sprayed and literally just coating our wheat before it's ground in the flour and the bread. All these things are issues. But honestly, like you look at this, I think there's, you know, a natural tug of war happening between Robert Kennedy Jr. and Brooke Rollins, Brooke Rollins being at the USDA, her job is to take

care of farmers, to make sure that they are, you know, making the goods, that we're distributing the goods. I mean, this is a huge export for America. It's a huge financial boom. And so if you suddenly overnight change the way that they have to farm, I mean, there are risks. We've talked about Sri Lanka when they suddenly went green and said, you can't use nitrogen anymore. That ended up having farmers committing suicide. They couldn't, their crops were all dying.

They didn't know how to do it. So, you know, riots in the country. Riots in the country. I mean, so, I mean, it's really easy to sit on our couches and go, you know, it's poisoning our food and we've got to get it out. And just, you know, none is, none is. much. Right. But how do we make that transition?

How do we actually make that transition in food supply where we do not destroy the American farmer, the families that are involved with that? Meanwhile, we're being poisoned by this stuff. It's destroying our gut biome. It's probably a huge contributor to the chronic disease epidemic. And here you have Robert Kennedy Jr., HHS Secretary. I mean, it's one of the first times I think we've ever seen a lawyer who literally won the first case against Monsanto and glyphosate in court.

I'm talking about Dwayne Johnson and the original settlement was like $289 million against Monsanto. They've gone on to lose billions and billions of dollars proving case after case after case with science in the room. This stuff causes non-hazin lymphoma. You know, they've got Donna Farmer who was, you know, the head of toxicology. I had her on a debate on the doctor's television show before I even gotten the vaccine issue. So this goes way back. And so what do we do? I mean, this is really, these are the things right now.

we do when the whole, you know, nation is sort of already contaminated by this control of corporate entities of pesticide and chemical companies, big ag, big food, big pharma, how do we wean ourselves off in a way where we don't collapse our economy, destroy everyone's lives as we know it while we're trying to get healthier? It's a very, very complicated task ahead. I just want to point that out. I wouldn't want to be Robert Kennedy Jr. I'm going to be, you know, probably whipping and driving saying we want it faster, but no one would really want to have to be doing this job right now. And the stakes couldn't be higher. Let's be honest here. People's lives are literally in danger, thousands of hundreds of thousands of thousands of people's

lives. And I think that what is happening at the FDA could be a step forward in showing this beginning of a scientific process. I mean, as we know, the full roundup formulation was never tested. So what's being sprayed is never, Glyf's a one component of that was tested. The rest of it has not been tested. So there's a huge conversation there. And you're in a race with trying to pass laws to, take, you know, liability away. Just like they do with vaccines. I mean, it's already passed, I think, two states now in America.

We keep reporting on that. So that pressure we're running out of time. Like, I mean, it feels like everyone is, everyone paused for a second. You're not allowed to take away, you know, liability. And we've got to figure out how to wean our stuff off of this stuff. Yeah, we're going to start doing some better press, better science.