Dr. Marty Makary
Appearances
Morning Wire
Trump Backs Off Tariffs & Al Green Censured | Afternoon Update | 3.6.25
Half of our nation's children are sick and nobody has really been doing anything meaningful on this front until we have gotten new momentum and enthusiasm from Secretary Kennedy and President Trump to finally address the root causes of these diseases, general body inflammation and generalized insulin resistance. And food has a big part of it.
Morning Wire
Trump Backs Off Tariffs & Al Green Censured | Afternoon Update | 3.6.25
When we eat foods with a lot of molecules that do not appear in nature, these are chemicals. These are chemicals that the industry insists are safe, a subset of which are concerning. There's a body of research now that suggests concern with some of these ingredients. We have to look at those ingredients.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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,
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
is he has posed questions, but he is not engaging in the details of how rigorous 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
It's in the congressional hearing.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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, you know, a different view. I never met the guy, but that's... Those are the different ideas people have on people.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
We are 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
A lot of people feel that the relationship is too cozy between pharma and regulators. 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
that this agency, the FDA, has been captured by industry, and it is not captured by industry. It is owned by the American people right now.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
And I'd rather not get confirmed into this job than have those obligations.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Yes. It literally should be nothing political about the FDA. We're talking about values. Look, Republican, Democrat, independent moms came out and voted for President Trump, and they believed in Secretary Kennedy's maha mish.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Of course, you're gonna have media try to spin things, of course, but I think people see through that.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 petrochemical food colorings from the food of my child, their behavior improved. When you have enough of that, it's not...
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 see 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 Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 approved in other countries in humans.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Yeah, I personally cannot eat liver. I've operated on the liver too much. Oh, God. That's 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 technology. to help the reviewer.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Commissioner. Megan Kelly, great to see you.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 100% increase in employees in the preceding years, that the number of employees doubled in the preceding years, that is misleading reporting.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 incredible.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 going to continue to be strong. And that's because we believe in the scientists. How's your relationship with Bobby Kennedy? It's good.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 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. President Trump and Robert F. Kennedy Jr.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
And no longer are we gonna say, you have to have these calories, it doesn't matter how you get them, 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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...
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 saturated fat. That's old dogma.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Now, 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. 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
And when you do science, you can't say, hey, we're going to do a study of what is causing this epidemic affecting 1 in 32 kids. But when you can't look at these potential causes, that's not how science is done.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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, and Dr. Bhattacharya is going to be launching a very impressive study using electronic health big data that we're helping curate.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
So when you look at the billion different bacteria that live in the microbiome, there may be an association between changing 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 2 diabetes in their teenage years a generation ago now you got 20 of kids who have diabetes or pre-diabetes the vast majority are type 2 diabetes right
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
So we've got to start talking about our problems and not just keep throwing medications at them.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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. We're going to be focused on healthy food at the FDA.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
They don't know.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
But 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 sugary drinks that are ubiquitous and microplastics and seed oils and chemicals in the grass and all of it.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Day 17 today.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
So we're going to see some guidance come out that I think is going to be helpful. So 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
The genes are 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
What are you doing? I mean, there's value in that research. 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?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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. The NIH has collected all the DNA information on 1.2 million Americans. And you'll say, I didn't know about this. Why?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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. And the IT systems don't talk. They're on different systems.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
So that's why you have 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
What are we doing? And these chimpanzees are not... living with great sunlight and eating bananas.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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,
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
I'd like to see as much reduction of unnecessary animal testing as humanly possible. 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 there gold standard science and common sense together. We can do both.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Thank you so much. Thank you, Megan. Thanks for being willing to do the job. Thanks for being a champion for my moms.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
We need both. We need somebody who is a highly sub-specialized 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...
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
take care of a certain type of rash that somebody develops, almost as good as some of these expensive biologics 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
The person who literally authorized OxyContin then went to work for Purdue Pharma. Curtis Wright. Exactly.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Sweetheart deal. And that label was illegal, in my opinion. It was 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
We discovered Vioxx killed maybe 38,000 plus Americans years after it was approved. We discovered a million Americans died of opioids and overdoses. 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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, match to somebody who's similar who is not taking that medication. And look at the adverse event rate and ask, is it working?
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 control trials to get your drug on the market,
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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 15 kids. That's also a real thing.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Let's say there's a condition that affects 75 people in the world and there's 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
There's been, look, 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 It's a screening tool. It could suggest that there's an issue.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
Exactly.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
We're gonna know, we're gonna 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.
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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
The Megyn Kelly Show
Fighting the Swamp and Conflicts of Interest, Truth About DOGE Cuts, and Finding Autism Cause, with FDA Commissioner Dr. Marty Makary | Ep. 1051
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.