Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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To realize the future America needs, we understand what's needed from us to face each threat head on. We've earned our place in the fight for our nation's future. We are Marines. We were made for this. Welcome to The Megyn Kelly Show, live on Sirius XM Channel 111 every weekday at noon east.

I'm Megan Kelly. Welcome to the Megan Kelly show. And we are at the FDA today speaking with the new commissioner, Dr. Marty McCary. I got to tell you, it was freaky walking into this building because they've been so demonized. They've demonized themselves over the whole COVID regime and the craziness of the past five years to walk in here and like, look around at like, these are some of the people who participated in this is sort of eerie, but it's

The good news is there's a new sheriff in town and Dr. Marty McCary is the real deal. He's a surgeon, scientist, has devoted his life to public health. He's the son of a doctor. He's a doctor. He's at the Johns Hopkins Hospital. He was performing surgery right up to the day he went in and started this job the day before. So he's had a lifelong interest in medicine and in public health more generally.

and has been very honest about things that are controversial like COVID and was an early seer on the things that the medical establishment was doing wrong and was totally fearless in speaking out against it with absolutely nothing to gain and actually a lot to lose. And that is how he became one of the trusted voices along with Dr. Jay Bhattacharya of Stanford, who's running NIH.

And of course, then there's Bobby Kennedy, not a doctor, but a lawyer who is atop them all as he runs HHS. So this is Dr. McCary's first interview as FDA commissioner. And there was a lot to cover. Like, how is he going to deal with the people here who can't stand any of the men I just mentioned, not to mention President Trump?

And how are we going to actually start enacting the Maha agenda that Kennedy and Trump and others have been pushing and talking about for so long when it comes to our food, never mind our drugs. There's a lot to go over, including the corruption that has gone on here for a long time with the revolving door of people wanting

Working here, approving drugs, and then immediately going to work at those drug companies. Working here and working with Big Pharma as they together decide whether the latest drug should be approved. He's all over it. We get into all of it. Enjoy.

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The pursuit to serve others is yours. Let it flourish. Find your purpose at Grand Canyon University. Private, Christian, affordable. Visit gcu.edu. Commissioner. Megan Kelly, great to see you. I mean, you were just on my set and you were just doctor. And now look at you. You could have stayed in the private sector, kept rolling in pretty good money. And you decided to take this job, which is an amazing thing for America. But why?

Well, welcome to the FDA, Megan. It's great to have you out here. You know, we are not on a good path as a country in terms of the health outcomes of the population. We do great with sophisticated operations and amazing drugs that can treat certain kinds of lymphoma and other types of cures. But when it comes to the health of the population right now, we have had this massive area that we're not talking about that we need to be talking about. And that is

the rise of all these chronic diseases. We've got one in six women now affected with autoimmune diseases. Half the kids are sick. Prediabetes affects about 20% of teens. 70% of kids are not qualifying for the military. So we've got to start talking about our problems and not just keep throwing medications at them. Causes and not just possible cures, which often don't turn out to be anything of the sort. So

Let me start here. You've been here 17 days? Day 17 today. All right. So what are the biggest things that you've learned so far? What's jumped out at you as a civilian who now suddenly is in government service? Well, I got to be honest with you. I had a lot of emotions the last day I was in the operating room the day before my Senate confirmation hearing. And so it's an entirely different world here. I am on a listening tour. We're talking to the career scientists. We're trying to make sure they have all the resources they need to do their job well.

We're trying to change the culture here to make it more of a teamwork culture. It's been very siloed. Each of the centers has developed their own fiefdom with their own communications department and lawyers and lobbyists for Congress and IT departments. The IT systems don't talk. They're on different systems.

So that's why you have, you know, VAERS and FAERS and CARES and 10 different adverse event reporting systems. We probably need one really good one. So I'm doing an inventory right now trying to assess the lay of the land. And then we're also trying to change the culture to a culture of teamwork, the scientific gold standard and common sense working together. And that is our goal right now. In medicine in general, there's this

divide, a push-pull right now between sort of the old school doctors and the new functional medicine doctors, the new MAHA push. And there's some resistance between the two. I don't have to tell you that. Are you seeing any of that reflected here? Do you think the folks here are open-minded to MAHA and functional medicine and doing things a different way?

We need both. We need, you know, as somebody who is a highly subspecialized pancreatic specialist, we need people who think broadly and think functionally and think about the fact that 90% of type 2 diabetes is curable by changing what you eat. Changing what you eat can actually take care of a certain type of rash that somebody develops, almost as good as some of these expensive biologics in

in certain circumstances. So we need people who think differently. We need fresh new ideas.

We need the old guard to ensure that we hold to rigorous scientific methodology. And we need fresh new ideas at the same time. So we're trying to bring all of that together now. And people have forgotten that the F in FDA stands for food. And so that is a major focus with Secretary Kennedy in this administration. Right. We're always so focused on the D, especially on the heels of COVID. And we think of the FDA, most of us, especially on the right, poorly.

because we feel like we were railroaded and doing things we didn't want to do. And especially, you know, before COVID, there was the opioid crisis and the FDA's role in that. So it has a bad rap, I think, generally with many in the country. So how do you turn that around? Well, I mean, we're still reeling back from some of the disastrous health care corruption that the government was involved in. The food pyramid, one of the greatest pieces of misinformation ever.

put out there that has informed school lunch programs, that has informed what people define as healthy. And so we now have a group that's reevaluating the nutrition guidance. We have a Maha commission that is going to be putting out a massive report

that doesn't just talk about calories in, calories out. It talks about food ingredients and chemicals that don't appear in nature that are going down the GI tracts of our nation's children every day, nonstop. And it may not be one ingredient that is driving some of these chronic diseases. It may not be one ingredient involved in attention deficit disorder.

it may be a cumulative burden of all of it. So we're now taking a much wider view. And you mentioned the opioid issue.

That probably is the quintessential example of what's wrong with a cozy relationship when the regulator agency is captured by the industry. The person who literally authorized OxyContin then went to work for Purdue Pharma. Curtis Wright. Exactly. He worked here. He authorized OxyContin. He approved a label that suggested it wasn't really that addictive, if at all.

And then after he left here, he went to work for Purdue Pharma, the very company he helped. Sweetheart deal. And that label was illegal, in my opinion. It was an indication for chronic pain for around the clock, long-term use. And it was based on a 14-day study.

And so that kind of mistake can result in a million Americans losing their lives. And when you don't have good post-approval monitoring, as this agency has not had, you discover things decades later. We discovered Vioxx killed maybe 38,000 plus Americans years after it was approved. We discovered a million Americans died of opioids and overdoses recently.

over a decade after the OxyContin label was given, why weren't we monitoring in real time people who were getting it immediately after approval? In part, the answer to that question is we couldn't do it. We didn't have the data. It was too sophisticated. You'd have to have everybody registered in a study. Now we have giant big data from electronic health records nationally. Now we can have our researchers and universities go in there

and look at everyone who's taken a new medication matched to somebody who's similar who is not taking that medication and look at the adverse event rate and ask, is it working? Is there a safety signal? When you don't do that, people get suspicious and they are suspicious about the cozy relationship sometimes that results in approvals.

And they're also suspicious when they hear stories and they don't have hard data. You don't have great rates about certain complications when you just have self-reported data. Self-reported data is terrible data. Yeah, it could be any. Like, how do you know if my sleepless night was due to the COVID vaccine or I'm stressed out? That's right. And in the void of good scientific data, every opinion fills that void. So we can do a better job.

And if we have good post-approval monitoring of drugs and devices, then we can also tell companies, hey, instead of doing two randomized controlled trials to get your drug on the market, how about one? And we'll take a close look in the post-approval monitoring how the drug is doing in real time immediately after it's approved. And that's particularly important when you're talking about rare diseases, when you talk about...

a genetic issue that affects 52 kids in the world. And that's a real thing. There is a condition that affects 52 or 15 kids. That's also a real thing. You can't expect the companies to do a randomized control trial. You'll kill innovation. You'll kill investment in those innovative ideas. You've got to say...

hey, this is a very difficult condition. It's incurable. It's fatal. It's a permanent disability. We're going to customize the approval process to the condition. And so we're going to be rolling out a new pathway for drugs, which is a pathway based on a plausible mechanism. If there's a rare condition or a condition that's

incurable, that affects a small number of people, we may be approving drugs based on a plausible mechanism on sort of a conditional basis. What does that mean? Put that in normal speak. Let's say there's a condition that affects 75 people in the world and there is a new treatment that makes sense physiologically. The mechanism is scientifically plausible that this treatment would help these individuals.

No one's forcing these medications on these individuals. If they want to try these new medications...

Even though we don't have a randomized controlled trial, because it's not feasible, we will allow that and at the same time monitor everybody who gets it so that we can make inferences as soon as the data speaks with a signal in the data. Wow. I like the sound of that. One of the questions I had when you were going over VAERS, which is the vaccine website where you go to upload your negative consequences, people know it from COVID, is how

Aren't those things only as good as the people who monitor them? Because you and I have talked before, we talked throughout COVID with doctors like who's a big fan of yours about the myocarditis that we were seeing, especially in young teenage boys as a result of the vaccine, especially the second shot and then the boosters. And those things were being uploaded to VAERS, but we weren't getting red alert warnings from the FDA. And

And so this is one of the reasons people don't trust the FDA. Like there's an agenda. They don't want to tell us about this negative side effect because they're much more concerned with forcing us to take the shot. There's been, look, there's, let's be honest, there's been an epidemic of distrust.

And part of it is warranted. And when you don't want to look at complications, the complication rate looks lower than it really is. And it makes products look safer than they really are. And so in the case of VAERS, you have something that could suggest something.

It's a screening tool. It could suggest that there's an issue, but you have to do a rigorous evaluation. If you don't follow up with a rigorous evaluation, that screening tool is not very useful. Or if you don't want to know. Exactly. But aren't the same people all here who didn't want to know when it was your predecessor and it was the Biden administration? We're going to know. We're going to do intense, comprehensive research. And that's why if we have

massive electronic health record data, which we now have through something called the Health Information Exchange.

we can have researchers go into there and look at real-world complication rates. So we're not relying on self-reported data from which you can make no inferences about rates. That's just a basic scientific methodologic principle. When you have a couple people saying, hey, I had this or I had this, you can't infer what the rate is, that is, the frequency per unit time. But when you have comprehensive data, which we only have now because of cloud storage ability, we couldn't do this 10 years ago,

We have now tremendous big data where we can go in there and look at here's 100,000 people who took this product. Let's follow them in the data de-identified to protect privacy and look at how many people came back to the hospital. Not just came back to the hospital with myocarditis coded, but who came into a clinic and said, my chest hurts.

Once you have good methodologic capture of outcomes, now you're looking at real rates. Will that happen? Because since Kennedy took over, and FDA is under Kennedy at HHS, people should know. When he took over, a guy named Peter Marks, who was here, it's FDA's former top vaccine regulator, well, he was forced out reportedly that you approved it. And then Kennedy said, okay, good, I'm fine. Get rid of him.

And in his resignation letters, a forced resignation reportedly, he said it's become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies. He accused Secretary Kennedy of undermining confidence in well-established vaccines. And then he accused Secretary Kennedy of wanting to access and directly edit

VAERS, which the FDA oversees, saying we don't trust them. He used an expletive. They would write over the data or erase the whole database. So I don't know what he's suggesting here, that Secretary Kennedy would go into VAERS. It seems to me it'd be more like the people who are pushing the vaccines on us who would go into the VAERS database and erase things. But you tell me whether Secretary Kennedy and you

should have access to VAERS and actually start figuring out whether, I mean, there's still parents who are getting their teenage boys the third, the fourth shot of the COVID vax, not knowing about the myocarditis.

Yeah, I mean, if you follow the guidelines as they've been written to the exact letter, a 12-year-old healthy, thin girl should be on her eighth COVID vaccine mRNA booster shot. And so Secretary Kennedy has called for gold standard science. And I can tell you, and Dr. Bhattacharya will tell you the same thing at the NIH,

is he has posed questions, but he is not engaging in the details of how real-game scientific methodology should be conducted. He's posing questions as is most of America right now. Again, I don't think VAERS is a good database because it is self-reported and not rates. On Peter Marks, I can tell you that

I never knew the guy. I never met him. He resigned before I came to office. Some people liked some of the things he did, and some people had concerns with some of the things he did. One of the biggest concerns, of course—

was that he pushed out the two top scientific vaccine experts here at the FDA. And this all came out in a House Judiciary hearing last summer. The two top vaccine experts at the FDA were pushed out by Peter Marks. It's not an opinion. It's in the congressional hearing. And as I recall, they were objecting to certain things that seemed arbitrary, like

mandates for children, vaccines for six-year-olds, that kind of thing. Exactly. They had concerns, according to their testimony, they had concerns over the COVID mRNA booster repeat strategy as a mandate in children.

And as you know, some people have said it makes no sense. We don't have good data on the risk benefit profile. The two top vaccine career scientists at the FDA, Dr. Gruber and Dr. Krause, head director and deputy director of the Vaccine Research Center here at the FDA, were forced out by Dr. Marks.

So, you know, sometimes you have to block out some of the noise where now he's taking a, you know, a different view. I never met the guy, but that's those are the different ideas people have. There's a lot of talented people who can do that job. Well, a lot of very smart people who are right now who are applying for that job. My guess in knowing you is you want people who welcome that kind of questioning. Let's have more questions. Let's search that up. Let's let's.

run that down not somebody who like we've had shuts down any questioning that doesn't tow the party line we're not going to be shutting down ideas ideas that may be different from my ideas we should welcome that science is based on challenging deeply held assumptions where there's no good evidence

what we call medical dogma. That is the scientific process. And so we shouldn't be shutting down other ideas. We should be inviting them. And that's why we're going to be having roundtable expert panels, FDA expert panels on menopause and hormone replacement therapy on a whole host of topics. Sorry about that. I'm queuing up a clip because I want to jump back to some reforms you're starting with. And

One of the big issues we touched on a minute ago, people like Curtis Wright. He's not the only one to leave the FDA and go right into big pharma. Almost every commissioner does. Scott Gottlieb, he was under Trump. He was the FDA commissioner, went right off to Pfizer. He came on my show and tried to tell me nothing to worry about with any side effects as he's working for Pfizer. It's like, we know we can't trust these people. So A, what are we going to do about those people? And B, what are we going to do about those people?

Is there anything else we need to worry about? Because it's not just people who are at FDA and leave. It's also panels of big pharma representatives who oversee the process as a drug gets approved here at FDA. Those are my two questions. Let me key it. I'm going to show you this clip here. So when Curtis Wright approved the original FDA label, was there internal pushback? Oh, yeah.

Diane Snitchler emailed him that Purdue's less addictive claims sounded like bullshit. What was Mr. Wright's response? He said, "Actually, Diane, this is literally true." So, Curtis Wright is the FDA medical review officer who approves an unprecedented label for Purdue, and then he goes and works for Purdue. So, do you think there's quid pro quo with Purdue to grant such generous wording? Yeah, well, I get that it has the appearance of a corruption.

but it's possible there wasn't. What Curtis Wright did is the way the industry works. It's a revolving fork where as soon as people leave the government, they go and work for the exact people they were regulating for five times the money. And it's all legal. What appears to be corruption is simply how the system works. Simply how the system works. So is that what, what, if anything is being done about that?

Well, we have to do two things. Number one is we have to partner with industry and pharma to facilitate the process, to make it user-friendly and expeditious. We shouldn't be in a receive-only mode. We want American pharma companies to do well and companies that do business in the United States to do well.

But the scientific evaluation needs to be independent. And that's why today we're announcing we are removing industry members, pharma members from FDA advisory committees. I was shocked when I learned that employees of big pharma companies sit on FDA advisory committees as members of those committees. So we're going to be replacing them whenever statutorily possible.

with patients and family caregivers. We are going to be inviting pharma companies to send representatives to the advisory committees, but they can sit with the rest of the public and watch and pose questions as the rest of the American public can.

So that speaks to, it doesn't stop at FDAers leaving and going directly to Big Pharma to work pushing the drugs they just approved while government employees. It's also while the FDA is approving those drugs, Big Pharma right now has a role in pushing for it, in advising the people who are the decision makers. And so on that second piece of it, at least, right now you're stopping that. Yeah.

We're stopping that for every committee where we can by statute, and we're replacing them with patients and family caregivers. And the idea is that...

There should not be a cozy relationship. There should be a user-friendly process for industry, but not a cozy relationship. Because let's be honest, a lot of people in the United States feel that the system is rigged. A lot of people feel that the relationship is too cozy between pharma and regulators. And so...

This is an agency that belongs to the American people. And so we can work with pharma and at the same time ensure that scientific evaluation process is totally independent. And on those advisory committees, the pharma and device members of those advisory committees

will say that they're non-voting members. But that is a sort of a close club of individuals that has a running dialogue and they meet and they become friendly. And it's okay to be friendly, but we need the scientific evaluation, the voting to be totally independent. And so people ask,

Are you anti-pharma or pro-pharma? And the reality is we're pro-pharma, but our evaluation has to be independent. And we cannot have any more indications for chronic pain written for a drug based on a 14-day study where the regulator then goes immediately and works for the company. That's the kind of thing that breeds distrust. And that's why people perceive that this agency, the FDA, has been captured by industry and

And it is not captured by industry. It is owned by the American people right now. How do we stop the first problem with all the FDA commissioners and the top head honchos doing their stint in government service and then going out to work for Big Pharma like they did in the Purdue Pharma case with Curtis Wright and making five times more?

I don't know. We live in a free country. I do know some of these individuals and they are good people and they're all God's children. They're doing what the market incentivizes. But when it comes to their influence on the operations of the FDA, that is something that we cannot tolerate. We cannot have people who leave as regulators go to the industry and we've thought about an ethics pledge. We've thought about all kinds of things.

It's non-binding because we live in a free country. You can't control someone after they leave an employer. But what we can do is create a culture here where people want to stay. We can ensure that people who leave don't have undue influence. And so many of the former... I have a suggestion for you. Yeah. If somebody leaves the FDA and goes to work for one of the drug companies...

Then you should look back to see whether they were involved in approving any of that company's drugs during their tenure over the previous five years. And it should kick in an automatic review on that drug and the approval.

When I got this nomination for the job, I cannot tell you how many lobbyists, former members of Congress, the swamp reached out to me. This is the swamp. I mean, I was in the operating room and the next day I discovered what the swamp was. You were swampy. Surrounded by the swamp creatures. Surrounded by the swamp creatures. And immediately, this is how it happens.

We want to help you with your confirmation. We want to write a letter on behalf of our company to the senators on your committee. We know these senators. We're going to talk to them if it's okay with you. And you know what I said? Don't talk to the senators. I don't want your letters. They're not for free. Those are obligations.

that then you feel indebted to return once you're in office. And I'd rather not get confirmed into this job than have those obligations. Right on. And you were confirmed. You're the only Trump nominee that's had as many Democrats cross over to support you.

You've gotten more than anybody. I think was it 5644? Yes, literally should be nothing political about the FDA. We're talking about values the Republican Democrat Independent moms came out and voted for President Trump and they believed in Secretary Kennedy's maha mish There's literally nothing political about looking at the influence of food colors and ingredients and evaluating the grass standard and getting infant formula without seed oil and added sugar and rewriting

our nutrition guidelines, which we're doing right now. These are the most apolitical things in society. Of course, you're going to have media try to spin things, of course, but I think people see through that. On the food, my daughter turned 14 this past Monday, and I was baking her a cake. I just got the Duncan Hines. I'm not going to lie. I can't do anything from scratch.

Then I just took a moment to look at what was in the icing, you know, with which you would use to write happy birthday. Everything in there was red dye number this, yellow dye number that, green dye number this. And I thought this could alternatively read carcinogen X, carcinogen Y. And that's where I drew the line. I'm sure there were tons of seed oils and so on in the cake itself. But my point is,

How does that even make its way onto the shelf where the vast majority of people have no idea that all those dyes that are in our food, but not in the Europeans...

can cause cancer. And so I'm giving my child cancer for her 14th birthday, which is a no. What I don't understand is if there's enough preliminary data to suggest that there may be carcinogenic effects or genomic disruption or associations with attention deficit disorder, or a whole plethora of families that are saying, hey, once we started eliminating these food

petrochemical food colorings from the food of my child, their behavior improved. When you have enough of that, it's not, look, they're not giant randomized control studies over 10 years for each food dye. We're not going to get that. But when you have enough preliminary data to suggest these petrochemical food dyes are concerning,

Who then would conclude, "You know what? Let's just risk it. It's fine. We'll wing it. The kids may be fine." Why do that? When we have all of these chronic diseases increasing right in front of our eyes that were rare a generation ago, one in 22 boys in California now has autism. I mean, when you have seen these statistics,

Who says, you know what, it might be, some of these ingredients have been suggested. Europe doesn't have them. They don't need them. The food prices are not higher because they use beet juice and carrot juice and watermelon juice. I know you had Vani Hari on. She's a great champion for that. We're taking a close look at this, and I think you're going to hear some action in the coming weeks on this. Before we go to the autism thing, because Kennedy made news on that too, on the drugs.

It's fun to demonize drug companies because we're all kind of ticked off, I think, about the COVID vaccines and so on. Not all, but many of us. However, they're not all bad. They do make some drugs that have helped a lot of people. America's drunk on Ozempic.

But I mean, like there are some actual, you know, serious drugs that can help people. And so one of the concerns behind people who back big pharma is how much is all of this, some of the stuff we're talking about, going to slow down the approval process for new drugs or drugs and testing? We're speeding up the approval process. We made an announcement last week that we are reducing the requirements for some perfunctory things.

like animal testing. Why are we testing every single drug in chimpanzees and dogs, usually beagles, because they're obedient? That's so sad. It's sad and it's unnecessary. Some of these drugs are already proved in other countries, in humans. So you have a drug already in use in humans in other countries and we're requiring animal testing before. So we are now, we've put out a release that we are now taking steps to reduce

the animal testing requirement. It's cruel to the animals sometimes. It's unnecessary. And we live in a modern world where we have computational modeling using AI that can evaluate a molecule and predict its toxicity in humans better than the animal testing. We also have something called organ-on-a-chip technology, where, say, liver cells are grown in the lab. Sounds like a terrible appetizer.

Yeah, I personally cannot eat liver. I've operated on the liver too much. Oh, God. One food I cannot do. No one wants organ on a chip. Yeah, organ on a chip. So in the lab, they grow these cells.

and then they introduce the drug. And you can actually see whether or not it injures the cells better than if you inject some bunny rabbit that is not gonna talk to you and say, "My liver hurts." So these new technologies have the promise of replacing some of this routine animal testing. You would cut six months out of that approval process. You lower R&D costs for pharma companies and inventors, which could lower drug prices for everyday Americans.

and it reduces animal use. There's too much animal use. Are there any other areas where AI can come and help as we move into the 21st century? Yeah, we're bringing in a team that is really exciting. They're going to introduce AI into the review process to help the reviewer, to make the reviewer's work stream much more streamlined and summarize things.

There are parts of the drug application that are so perfunctory, that are outdated, that could be streamlined, that could be abstracted with AI to help the reviewer. So here, like all other aspects of government that Trump is taking on,

You're saying there's actually too much red tape and we're red taping the wrong things, it sounds like you're saying. Why does it take 10 years to bring a drug to market in the United States because of the regulatory steps? I mean, people are dying. People need cures and meaningful treatments. And my predecessor in this role was focused—

as he stated, his number one goal was fighting misinformation. Well, our number one goal is delivering cures and meaningful treatments and healthier foods for Americans. That is our focus.

And so you've heard about consolidation or changes or cuts at the FDA. Those were not cuts to scientists or reviewers or inspectors. Absolutely none. They were cuts to communications staff, FDA's lobbyists to Congress and to the IT systems here where there's a lot of opportunity for efficiencies. Yes, there's been definitely there's been pushback on the number of people who were ousted. I think it was your predecessor who said the FDA, as we know it, is deficient.

gone, that the experts are gone. People with decades of institutional knowledge have been turfed, suggesting there might now be a safety issue here. There is a massive growth of FDA employees under the Biden administration. And when the media reports that there were cuts, which many were early retirements, people took early retirement, none were to scientific reviewers or inspectors or law enforcement at the FDA.

They were to IT communications, legislative affairs. And so what you're not hearing in the mainstream media

is that there was a 100% increase in the number of FDA employees since 2006. You have about 18,000 and it's been cut about 3,500 since you and Kennedy got here. So you're saying we had more like 9,000? We had 9,500 employees at the FDA in 2006. Oh, wow. And so when you report that there were cuts and you don't report that there was a 100% increase in employees in the preceding years,

that the number of employees doubled in the preceding years, that is misleading. And the people who we've gotten rid of, losing them is not going to slow down drug approval or safety procedures because they were, sounds like, more administrative people. There were no cuts to scientists, reviewers, or inspectors, or law enforcement. And my goal is to make sure that every one of those people has all the resources they need to do their job well.

Now, cuts are never perfect, and so we have done an assessment, and there are some individuals that we have invited back. There were a couple people who were taking the early retirement, and we were told of their sort of how well they performed here, and we encouraged them to stay.

But to not report that the agency has doubled since 2006 before this cut, in my opinion, is not telling the whole story. No, it's dishonest. It's dishonest. Is it swampy here? And by that, I mean, we had a report that when Secretary Kennedy came over and addressed the troops last Friday, some people got up and walked out. They were disgusted by him, which seems like a bad sign.

Yeah, I was in that room. Nobody got up and walked out. Now, we did stream it, so if somebody was watching it in their office and got up to go to the bathroom during the speech, maybe that constituted getting up and walking out. I don't know. I was in that room, and there was incredible energy in that room because he talked about how agencies that are set up to defend public safety

sometimes become captured by the organizations that they are set out to regulate. And he talked about the EPA has had a history where they have cycled and at times have been captured by the industry. And he encouraged people at the FDA to speak up, think independently, and that he had his full support behind them. So it was an incredible talk. And of course, you're going to hear a clip or a phrase pulled out out of context.

But I was in that room, nobody walked out. It was incredibly a strong message. The FDA is strong and we're gonna continue to be strong. And that's because we believe in the scientists. - How's your relationship with Bobby Kennedy?

It's good. You know, I got to know him during the nomination process, and I found that he always listens to me. He values scientists on questions where he has, you know, some skepticism or he has some honest questions that he wants to pose. And I think that's what we need. I mean, first of all, he represents America. There are...

President Trump and Robert F. Kennedy Jr. are the two most popular political people in the United States right now. That's polling data. That's not my opinion. That's polling data. And he represents the American people. He has questions. He wants the scientific process to run its course. And so he's posing the questions

And he values our opinion. Everything I put before him, he has valued my input on. And so we're going to see new studies come out. We're going to talk about chronic diseases. We're going to look at food and food ingredients. And he's provided some really great leadership. Are we redoing the food pyramid? We're redoing the food pyramid. Thank God. And no longer are we going to say it's...

You have to have these calories. It doesn't matter how you get them. It doesn't matter if it's all ultra-processed foods. It's just pure calories in, calories out. That dogma, which had no scientific support, was a massively underfunded endeavor. We let the industry tell us as a government what's healthy and what's not healthy. And even with the recent Biden administration suggestion to have front-of-package labeling,

They picked sodium, saturated fat, and added sugar in there. I think they got maybe one thing right out of those four, but they ignored a giant sloth of food ingredients. And so when you ignore...

A thousand chemicals, some of which are petrochemicals that have been introduced into the food supply simply because the industry has self-deemed them as safe. When you ignore that, then you can't call something healthy just because it has a low amount of

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Secretary Kennedy said this week that we are going to know what causes autism by September. Is that crazy talk? No, people want to know. A lot of...

parents have been dealing with kids with autism. I mean, one in 32 kids in America today have autism. We can't just keep medicating every kid with- It was one in 10,000 in the 90s. It was unheard of. The sort of repetitive motions, the tics, the heavy, the complete nonverbal child. Where did you see that in the 1940s and 50s?

And so we have to look at everything. And when you do science, you can't say, hey, we're going to do a study of what is causing this epidemic affecting one in 32 kids. But when you can't look at these potential causes, that's not how science is done. That's what we've been saying. And for the record, you're not saying it, but people are talking in part about vaccines because Kennedy has said it should be on the list of things we look at. Now, Chris,

Critics will say he's blaming it all on the vaccine. He's blaming autism on the vaccine. I've talked to him personally. That's not what he says. That's not what he's saying. They're growing up in a toxic stew. That's one of the many things. And in particular, like the aluminum that they put in it as a preservative, like we should be looking at everything they're consuming and we're forcing on them. I don't know what causes autism, but I'm deeply concerned about the rise. If I had to make a hypothesis as a scientist, not as a regulator, but as a scientist, I

And Dr. Bhattacharya is going to be launching a very impressive study using electronic health big data that we're helping curate.

I think it is the cumulative burden of all of these exposures, environmental and dietary, that alter the microbiome. Remember, 90% of the serotonin made, which is involved in mood and mental health, is from bacteria in the microbiome. That's where it's produced. And when you mess up the microbiome, when you carpet bomb the microbiome with all of these ingredients that don't appear in nature, these are novel chemicals.

What are we doing? So we've known for a long time as a scientific community that kids with autism have different stool composition, different biodiversity. So when you look at the billion different bacteria that live in the microbiome, there may be an association between change of the microbiome and autism and things that are changing the microbiome that we've not yet fully appreciated. And that could be a whole list of things. I've heard you talk many times with me and others about...

And this stuck out to me because I had C-sections, but about how vaginal births are in some ways much better for the baby because it will help their microbiome. Like going through the birth canal is very helpful to a baby's microbiome. But I was thinking about this because what we have now is a scenario in which C-sections are routinely pushed on mothers because it's easier for the OBGYN.

They can schedule their life more easily. The nursing staff supports it. They can get a wink or two, whereas the vaginal birth is a different story, natural, whatever. So the kid comes out without that advantage. Then we're very quick to prescribe antibiotics for young kids. Carpet bombing the microbiome. Over and over, even when they're little. We're not setting them up for success. Then we fill them full of processed foods, or maybe we give them infant formula that's riddled with processed or seed oils or added sugars that don't need to be there.

And then we, for a long time, didn't expose them to peanuts or other potential allergens, which made them weaker and more susceptible to these allergies.

And then, you know, there's all these antibiotics in foods and estrogen altering chemicals in foods. And now the child is basically hobbled in a lot of ways through absolutely no fault of their own. And really the parents either. The parents wouldn't have necessarily known not to do that. Your kid has strep. Your doctor says give him antibiotics. You do it. And then on top of that, we've got all these vaccines and we've got all these processed foods and we've got all this weird stuff and, you know, your cow milk. And it's so much.

And so it's almost like the system is set up to get your kids sick. And then we say, why is everybody getting colon cancer before they turn 25?

Right. No one's even taking a hard look at that. Now it seems like for the first time we have a team that's saying, no, we're taking a hard look at all of that. All of it. We have to look at all of it. I mean, if you look at how much children are suffering, they're in pain, they're depressed, they're dealing with injecting themselves with insulin, something you would rarely see a kid have type two diabetes in their teenage years a generation ago.

Now you've got 20% of kids who have diabetes or prediabetes. The vast majority are type 2 diabetes, right? We have only been talking about treating the rise in colon cancer in young people with new chemotherapy. New chemotherapy is not going to address the root causes. We need to do it, and we want to see new drugs come into market quickly.

But we've got to talk about what is insulting the microbiome, driving general body inflammation. We've got to talk about the two underlying causes of so many chronic diseases, in my opinion, insulin resistance and general body inflammation. And it's all the stuff that we put down. The body's immune system is reacting and causing some inflammation. So we're not just going to be looking at new chemo for colon cancer patients.

We're going to be focused on healthy food at the FDA. And we're looking at a school lunch grant program for schools that want to convert to healthier foods but don't know how and they need help. We want to help them. Is guidance coming out for parents on how to feed their child healthy?

in a healthy way. Whether, you know, saying this to you before we got started, the American breakfast right now is, you know, especially for kids, cereal, bagels, English muffins, toast, French toast. It's all carbs, Danish, right? It's all, all starchy carbs.

then God knows what they get at school for lunch. And even when you make them lunch, it's hard. You don't know what it's like. Chicken fingers, good or bad? Fried? Better than, you know, lunch meat? Probably. Well, what? Like people don't know. They don't know. They've had no real guidance. Are they going to get some?

So we are redoing the food pyramid, but this is like the number one issue right now in health in America is people don't know how to switch to healthier foods, right? And I wish, you know, there's zealots in every aspect of healthcare and you hear them, you know, the media gives them a lot of airtime and their issues are legitimate oftentimes. But I

I often look at these zealots and I say, I wish you would take 10% of your enthusiasm over this little issue in healthcare and actually talk about school lunches and healthy foods and educating parents on what to feed their children. And, you

sugary drinks that are ubiquitous and microplastics and seed oils and chemicals in the grass and all of it, all of it. So we're gonna see some guidance come out that I think is gonna be helpful. Schools that want to convert to healthier, more organic, more local and possible foods don't know how, and they got limited budgets. That's where we can provide some assistance. So on a pilot basis for schools that want to convert and don't know how,

We're going to help them get off the cupcakes. I didn't realize how many schools feed breakfast to children. Donuts, cupcakes, ding-dongs, French toast, as if it alludes to the French healthy living. Right, so it's more sophisticated. Right, more sophisticated, right. So this is where...

the entire medical establishment can pivot and focus on. And you're going to see grants coming out of the NIH. We're working in coordination with the NIH to make sure there's research in this area. You know, the NIH has really focused on genetics.

And the entire culture of the NIH and thus the entire academic medical community in the United States has been a culture focused on the genome. Based on the Francis Collins era that the gene is responsible for most of our health problems and the gene can solve most of our health problems. And you look at the NIH individual institutes within the National Institutes of Health and

And it's geneticists all over the place. You look at the Institute for Child Health at the NIH, and it's run by a geneticist who parades around finding a gene involved in some ultra-rare gene disorder. That's good, and it's important, but nobody is talking about the food our kids are eating. By the way, there's not much we can do about our genes.

The genes are not the problem of our, not the cause of our chronic disease epidemic. It's what we're doing or what is being done to children by adults today. Unknowingly, with good intentions sometimes, you go to the National Institute of Environmental Health at the NIH. Go to the website and you'll see the director has on there that they were involved in identifying a gene that may be associated with obesity. What are you doing? I mean, there's value in that research. How?

How about the ding-dongs and cupcakes and donuts and French toast that the kids are eating with government tax dollars every morning at school and nobody seems to be paying attention? And I've heard you say before, if you fix your microbiome, you actually might be less hungry, less prone to obesity. Like the things you were talking about are all to set people up for a healthier lifestyle that's a little easier. You know, that they may be victims to cravings that...

were created by this terrible food pyramid and them following the American diet that shoved down our throats. - Yeah, as a surgeon, I've had patients that would do everything to lose weight. They did all the right things. They switched to better foods and they would exercise. They couldn't lose weight. What was happening there? Can we learn from those individual patients? Maybe the microbiome was altered.

in a way that is not easy to fix by just switching back. Maybe all of those years, the cumulative insult to the microbiome was altered. Now there are some researchers doing this. I met the microbiome researcher at the NIH and it's like a tiny shop. Like this should be the main focus. - Yes. - You know, the NIH has collected DNA, all the DNA information on 1.2 million Americans. And you'll say, I didn't know about this. What, you know, what, why?

They have been doing it for the last six or seven years in search of a genetic basis for health disparities. And that entire... What does that mean? It means they want to understand why certain populations have more chronic diseases than others. And they believe that it's in the genome. And so they collected this giant genetic library. They would pay Americans, say, $25. 80% are African-American, Latino, or transgendered.

Because they want to unlock why they have different rates of chronic diseases. They have this massive library. When Jay Bhattacharya came into office, the previous director moved that entire database project to another office outside of the director's office. Maybe so he wouldn't touch it. Interesting. And what are they doing? I'm not saying there's no value in that, but you can't even tell us

how to lose weight. You can't even tell us what foods are healthy for children. You can't even tell us about seed oils or food dyes or ingredients that are added just for shelf life. And so that has been the entire culture of the medical establishment. And when they launched that project, they went to the oldest African-American church in Harlem. They went to

Atlanta, Detroit, and they recruited people from minority communities and they told them no longer is our medical recommendations going to be blanket. They're going to be custom tailored to your population. Good luck doing that with trans people. Okay, a couple of quick things.

One of your predecessors here has said you're going to have to expect massive pushback on all of this. Like it might be too pie in the sky that, for example, if we remove all ultra processed foods from school lunch programs, we might bankrupt a bunch of farmers. Like, are we too optimistic? You know, is it is the moonshot not possible? I think people are.

now discovering that they've been duped with an industry that has told them, don't worry, all this food is healthy for kids. It's low in calories. It has low fat. So, you know, go ahead and it's fine. That's sort of the between the lines message.

And I think they're very suspicious and they want to find an ingredient that accounts for the chronic disease epidemic. I don't believe there's any single ingredient. I think it's the entire gamut of less exercise, food chemicals, not eating the right foods, micronutrient poor foods. We have foods now in the United States that are basically grown with caffeine, you know, potassium, phosphorus, nitrogen in the roots.

And there's no nutrients. You know, there's a deficiency of good soil. And so you get micronutrient deficient food and you can eat a lot. But your satiety, that is your sense of feeling full, is not triggered because you're not getting those nutrients.

And so what you do is you have this weird feeling after you eat where you're kind of full and bloated, but you're still hungry. And some of those chemicals make you more hungry. The food industry, they're not bad people. They're actually good people. They've done what we as a society have asked them to do. And that is focus on food insecurity and mass production.

Now, however, seeing that these chronic diseases have skyrocketed in our country, in our generation, we've got to take a step back and ask, how can we get healthier foods out there? And I wanted to go back to the animal testing because this is something near and dear to my heart. I'm a big animal rights person. I do eat meat and animal products, and I get letters from PETA all the time. But the animal testing is a heartbreaker. And what Fauci was doing to the beagles is ridiculous.

really deeply disturbing. And what I never realized until you just said it right now is because they're compliant, which is just so sad. It's sad. So how do you stop that? Can we as humans stay safe in the drugs we consume and the products we consume without torturing sweet little beagles? And I will throw in a word for the bunnies and even the little lab rats, which, you know, animal torture just seems beneath us at this point in our evolution. But you tell me. God did not make these animals...

on planet Earth for us to do cruel things to them and subjugate them.

It does not seem right. And so we are doing everything we can, and we're taking a lot of steps to reduce animal testing requirements and to stop unnecessary animal testing. A single monoclonal antibody that was developed for approval used 144 chimpanzees in the animal testing requirement. What are we doing? And these chimpanzees are not

living with great sunlight and eating bananas. There is a problem here. And when you

realize that the computational models can do as good or better of a job in predicting when the lab-based organ cells tested or something called organoids, where you can actually grow an organ in a lab. And it's not a functional organ, but it has the properties of those cells. And you can test liver toxicity or heart toxicity or myocarditis

Those models should be replacing animal testing. So the first announcement we had when I came in as commissioner was to take steps to reduce unnecessary animal testing. Reduced by a lot? Like almost entirely? With a goal toward hitting entirely or what? I'd like to see as much reduction of unnecessary animal testing as humanly possible. Look, as a surgeon, we had pig labs at Johns Hopkins where...

the students and residents would learn how to do surgery on the pigs. I personally believed it had no impact on learning. They could have learned from

simulations, computerized simulations. They can learn from watching us in the operating room. It provided no edits because they were unnecessary. And every week or so, they would have pigs anesthetized in this big production. It was expensive. And in my opinion, it was unnecessary. We've got to modernize.

Okay, so last but not least, 3,500 gone in cooperation with Doge. Will there be more cuts? There are no plans for any mass cuts. Now, if somebody has not logged on to their VPN in two years, we don't want them working. If somebody's doing an incredible job, and we measure performance down to 15-minute increments with reviewers that are doing scientific reviews, the reviews are highly tracked.

And so if somebody's doing a good job doing that review, we want to encourage them and support. It's hard work. Doing the reviews is hard work. And so we want to do other things here at the FDA to support a great culture. Scientific forums, speakers, roundtables. We want to encourage them to spend some of their time doing creative work. And so we're doing a lot right now to create more of a teamwork culture.

and less of an individual siloed culture that is the culture that I walked into. It feels like you really want to make this a better place for people to work, more collegial, more of a feeling of camaraderie, a shared mission. Is it possible? You know, there are certain government agencies, I'm just going to say it, where they're hard left,

They can't stand Trump and there will be a natural resistance to his appointees trying to do anything to their agency. There are some of those folks here, but, you know, they're all God's children and I hope to work with all of them. So, you know, that's my job as a leader to try to win their confidence. And I hope to do it by upholding my mission to put out their gold standard science and common sense together. We can do both.

healthier food for children, rebuilding the public trust, and focusing not on the peripheral distractions, but focusing on cures and meaningful treatments for Americans. And when this is done, is there a chance you're going to a drug company? Zero chance.

In terms of if there's an inventor that I might have the chance to work with, I have no idea. When it comes to the large pharmaceutical companies, I'm not auditioning for a job with them. At the same time, I love them. I believe in love thy neighbor, and I hope we can work with them to create a great user-friendly process.

to chop down that 10-year time frame to an approval to a much shorter time frame. And I'm committed to work with them to get that down. I can't wait to see what you do. Thank you so much. Thank you, Megan. Thanks for being willing to do the job. Thanks for being a champion for my moms. My pleasure.

Ah, so interesting. I love him. I feel so much better that he's here, right? I feel like we're in good hands. He's got his work cut out for him and we'll stay tuned. We'll keep you updated on what happens over here. Now, in the meantime, I have got to tell you something important before we go. Okay.

Everyone loves when Maureen Callahan comes on, including me. And I told you the last time she came on that we were going to do, we did this long debrief on the Meghan Markle ridiculousness that on Netflix, her show, you know, showing you really tough things like how to dump pretzels into a bag. That's her new show. Well, we had this idea to do our own version of her show with love. I had a naughty word that I was going to use instead, but no, no.

We've done it is my point. Maureen and I have shot our own series and she's going to be on the show tomorrow with the presentation of what we came up with, which I think you're really going to enjoy. Here's just a little sneak peek. It's important to me to stay relatable.

I love to elevate a guest's visit. Microwave popcorn! You plop it right in there. It's so simple. Only the lazy people don't do this. Put it in a paper bag. Here we go. It's right behind you. Oh my god! You did it! We're going to put it in one of these special cellophane bags. It's okay. These aren't, it's not expensive like your clothes are.

- Look how fun that is. - These are amazing and you're going to absolutely love them. This, we're just gonna put into a different bag. They're spectacular. And then I just, and then I, where are you getting all these like mini brainstorms? I'm so impressed. Maybe in the next wave of our friendship, I'll try to explain it to you.

I died when I saw the first clip. I mean, it's a longer one than what you just saw there. I was with Abby. We cried. We were laughing so hard. I think you guys are going to love tomorrow's show and I can't wait to bring it to you. So we'll see you then. Thanks for listening to the Megyn Kelly show. No BS, no agenda and no fear.

Thank you.

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