The Ultimate Human with Gary Brecka - 229. Dr. Marty Makary: Vaccines, Chronic Disease, Drug Prices & Hormone Therapy

Starting point is 00:00:00 If we were to evaluate the U.S. healthcare system over the last 50 years in terms of the performance indicator of the health of the population, U.S. healthcare has been a 50-year failure. We have got to do something different. The pendulum has swung so far. We are one of the largest, if not the largest, the largest spend around health care worldwide. We're one of the sickest, the fittest, most disease-rid nations in the world. 42% of our children having at least one chronic disease. We don't have a lot of education around whole foods. We know that there's a lot of corruption in our nutritional research, which leads to things like poor food pyramid advice and nutritional guidelines. We've medicalized ordinary life and where we are drugging our nation's kids at scale and not talking about the underlying root causes.

Starting point is 00:00:45 And we ignore all those issues. And all we do is we give doctors a prescription pad and a surgical knife and say, go to work, fix all these problems. You're going to have a dysfunctional system. And that's where we are today. We're very good at disease management and symptom maintenance. We're not very good at disease prevention. Your intention is to try to keep people out of the system. Because we know that once they're in the system, they just continue to progress.

Starting point is 00:01:08 Do you have to have a sense of mission that you want to address a broken system? My number one priority is to deliver more cures and meaningful treatments and healthier food for children. And we're getting stuff done. In a perfect world, what would you like to see accomplished by our FDA for the betterment of the population? Look, our legacy, I hope, will be... Hey, guys, welcome back to the Ultimate Human Podcast. I'm your host, human biologist Gary Brecker, where we go down the road of everything,

Starting point is 00:01:47 anti-aging, biohacking, longevity, and everything in between. And I don't know if I've ever been more excited to run a podcast than the podcast. that I'm going to run today. This has been a long time in the making for influencers like myself and my community. This is a watershed moment for us to actually have access at this level to our federal government, the government agencies, and the people behind the curtain that are actually moving the ball down the field for the Make America Healthy Again agenda. And today, I'm really honored to have the 27th Commissioner of the United States Food and Drug Administration, Dr. Marty McCarrie. Thank you so much for coming on the podcast.

Starting point is 00:02:25 I'm going to be with you, Gary. Yeah, yeah. I mean, and first of all, I love how you got, you rolled in here. We had a whole food meal, right? Yeah, good stuff. And then you did your very first gold plunge. First cold plunge. It was quite an experience.

Starting point is 00:02:37 I wouldn't say I'm high risk of recurring and doing it again later today. High risk of recurrence. Yeah. Spoken like a true position. I think I'm good for a while. But no, you need to make this a regular part of your daily routine, Marty. How long was I in there for an hour? No, three minutes.

Starting point is 00:02:53 Three minutes. Wow. Three minutes at 52 degrees, but he did amazing. We did a sauna, then we did a steam room session, then we went right from the steam. He and Kyle Diamantus got right in the cold punch, and I'll give it to both of you guys. He stayed in there for the full three minutes.

Starting point is 00:03:09 And the best way to learn about something is to try it. Yeah, no, I congratulate you for that. You've got to admit you feel a little better. I do feel an endorphin rush. Yeah. Similar to when I run, say, 50-mileers, but I've never run a 50-mile. Okay.

Starting point is 00:03:22 If I did, that would be a similar. Not a high propensity for reoccurrence there either. Yeah, low risk of running long races. So, Marty, you are in charge of the Food and Drug Administration. So has that settled in yet? No, actually, it has not settled in yet. I still think about it a lot. Yeah, I mean.

Starting point is 00:03:41 Because the FDA oversees 20% of the U.S. economy. It's unbelievable. We've got offices in 50 countries. It's everything. It's cosmetics. It's food. It's tobacco and vape products. It's devices, wearables, microwave ovens, cats can.

Starting point is 00:03:57 Microwave ovens? Yeah, the radiation part of it. And then drugs, which is what we're known for, probably the most. I mean, it's a tremendous responsibility. But, you know, it's a bit decentralized. We have centers and center leaders, and it's running, it's going great. The FDA is strong and it's going to continue to be strong. I got to ask you, you know, what was the impetus for you to want to take on that kind of role?

Starting point is 00:04:22 because you came out of private practice, your background as a surgeon, right? I found out you ran one of the first frailty studies linking frailty to, you know, post-operative outcomes, which I find really fascinating. I probably read some of your work because, you know, we know frailty is one of the greatest risks to aging. It's one of the greatest predictors of mortality.

Starting point is 00:04:45 That's right. But what was it for you that made you say, I'm willing to take on this level of responsibility. Because, you know, in some ways, it's kind of thinkless work. It can't be a part of your get-rich-quick scheme either because it's not. Right. Yeah. Well, I think you have to have a sense of mission that you want to address a broken system.

Starting point is 00:05:10 And I've been at the bedside for a long time, 23 years on faculty at Johns Hopkins. I've had a great run in academic medicine. But when you break bad news and you want there to be something available or you want to have prevented the tragedy that you're watching unfold, it gives you a deep sense of purpose. And at the FDA, it is all about treatments and prevention and health and the food. People forget that the F stands for food. It doesn't stand for the word federal. A lot of people think it stands for federal.

Starting point is 00:05:49 So there was an FDA employee that thought it stood for federal. Well, they didn't read their paycheck. But, I mean, for the most part, there are amazing people that work there, amazing scientists, over 16,000 remarkable employees at the FDA. That is incredible. And so you have to have a sense of, look, we have to challenge deeply held assumptions. Why does it take 10 to 12 years for a new cure to come to market? Why do we accept these animal testing requirements that are now no longer necessary because we have better technology that predicts toxicity? Why do we allow this grass standard for food to continue to allow pollutants and chemicals to affect our U.S. food supply in ways we don't even fully appreciate?

Starting point is 00:06:41 And so you have to have a deep intellectual curiosity. And one thing I love about you, Gary, is you've got the intellectual curiosity to want to roam and not stay in a lane, but to ask any question that is necessary to try to get at a broader question, and that is, how do we improve health at a, at scale? Well, thank you, first of all. So, you know, when you came in to the Food and Drug Administration and you sort of went from having this myopic view as an outsider to a very introspective view as an insider, And you probably realized at that point the enormity of what you had just been appointed to do. How did you set the agenda for the, and the vision for the FDA? Because, you know, in a lot of ways, I mean, it's a government organization. There's got tons of bureaucracy.

Starting point is 00:07:35 It's very bloated. This is like an aircraft carrier that is going full speed in one direction. And you want to turn it around and start heading in the opposite. direction. And I've heard you many, many a time talk about the statistics that our nation is facing and the very grim statistics and how this didn't happen overnight. It happened over decades. And so there's like these deeply ingrained processes. And there's there are bureaucrats that are lifetime unappointed bureaucrats that are in these agencies. How do you come in at the top and effectuate real change? Well, first of all, you have to bring in a lot of good

Starting point is 00:08:14 people and we brought in phenomenal people. We explained our mission and vision, and we encouraged people to join that mission and vision. And if somebody says that they're not on board with the mission, then we're not afraid to move people if they block what we're trying to do. And what we're trying to do is very simple. And that is to deliver more cures and meaningful treatments to the American people and healthier food for children. Now, we do a lot of stuff. That's a mission state. That is the the directive that I have given to the agency, and I've said it a million times, and I think most employees at the agency can recite that off the tip of their tongue because the last commissioner in the Biden administration had said that his number one priority was fighting

Starting point is 00:08:59 misinformation. So I wanted to make it very clear. My number one priority is to deliver more cures and meaningful treatments and healthier food for children. And we're getting stuff done. For example, they talked about banning one food die for 35. years at the FDA for 35 years. Bantered around different committees? Committees, frameworks, you know, citizens, petitions. And when we got there within weeks, we took action to remove all nine petroleum-based food dyes from the U.S. food supply.

Starting point is 00:09:34 They've been talking about making the rejection letters of the FDA when drugs are rejected. It's been a mystery. Companies can spin the results. We talked about the value of radical transparency, where our rejection letters and acceptance letters are now public information. They've been talking about that for two decades. We got it done within a couple months. Hormone replacement therapy, fixing the very dangerous black box warnings that have done

Starting point is 00:10:03 tremendous damage. It was part of group think. It's a fascinating story. I know you've covered it. No, I want to talk about that. We can talk about it. But we got that done. We talk about SSRIs.

Starting point is 00:10:14 We talk about all sorts of sacred cow topics that you're not supposed to talk about because the medical establishment has already decided that it's a settled science. There's nothing to discuss here. Yeah. You know, it's fascinating is the entire premise of science is based on a question. You know, you learn about the hypothesis when you first start learning basic biology. And a hypothesis is a question. That's right.

Starting point is 00:10:41 If we do this, this should be the outcome, and then you test it. One of the things about a hypothesis, to be valid is that the results should be repeatable. And, you know, if we didn't question science, as we sit here today, we'd still be using leeches, we'd still be doing frontal lobotomies. I think the last one was done in 1969.

Starting point is 00:10:58 I mean, that's a barbaric, basically putting an ice pick through the eye socket and scrambling the frontal lobe of the brain. OBGYNs wouldn't be washing their hands before they delivered a baby because we didn't have microbial signs until, you know, late 1800s, turn of the 19th century, or 20th century. So I think the very premise of challenging the status quo is what sometimes is attacked. It's like, how dare you ask the question?

Starting point is 00:11:23 How dare you ask the science? The system is settled, you know, and just to broach the question, but we had a fascinating, and this happens with a lot of my guess, fascinating conversation at lunch today, because you got here, we sat down for lunch, and you talked about medical group think and medical dogma. And what I liked is you alleviated the blame from the individual physician because you talked about how the majority of people, and I think, you know, myself included when I wanted to study human biology, and I think nearly every physician on the planet begins with the premise of I want to help people. Yeah. Right? I want to make a difference. Yes. And talk a little bit about that for people that haven't gone through the medical system, about the grind and the dogma

Starting point is 00:12:06 and how you emerge from this system and now you're a part of this collective? Well, I will say, Gary, the young people that want to go into health care are beautiful people. They're doing it out of a sense of altruism, that there's something larger than ourselves, that contributing to the well-being of others is greater than any self-interest. It's a beautiful light that you see shining in a high school student that says, you know, I think I might want to be a nurse. they're different from their peers, a college student that says they want to be a psychiatrist and help people with schizophrenia or a nurse's aide who works in a nursing home.

Starting point is 00:12:47 It's a different group of people that have this incredible sense of compassion. And that's what unites all of us. If I meet a doctor in another country or a nurse at the train station, there's this incredible bond that we all have, that we have chosen a career at a sense of compassion. But what we do is we take these bright, creative, altruistic young people, and we beat them down for years and years. We give them this rope memorization and regurgitation curricula. And they come out as robotic. And they burn out. We burn them out. And then, of course, they're a little entitled. and you fast forward, and you go through this residency, medical school, memorize regurgitation thing,

Starting point is 00:13:41 and they're different people. I mean, the medical school essays, I would read of the pre-med students that applied to Johns Hopkins Medical School when I was there. 90% of them wanted to do missions, if not full-time, part of their practice. They wanted to do charity work locally or overseas. I mean, these are incredibly bright, creative, altruistic people. And then they come out reciting a canochism over and over again because it's a self-preservation survival mode. It's not their fault.

Starting point is 00:14:18 It's just like it's not the fault of six-year-olds that they're obese. This is something adults have done to children, right? It's not a willpower problem. it's something that the circumstance is defined. So we have to change medical school education. It is entirely broken. It is focused on treating disease with a whack-a-mole mindset, and we've not allowed these bright creative health professionals

Starting point is 00:14:49 to go upstream and deal with the underlying root causes. And so you don't talk about food and nutrition. The little nutrition education I got in medical school was misinformation because nutrition science, as you know, is... If you want protein to build lean muscle, but without the caloric impact or need to cut, you need perfect amino. It's pure essential amino acids, the building blocks of proteins in a precise form and ratio that allows for near 100% utilization in building lean muscle and no caloric impact. So we build protein six times as much as way, but with... without the excess body fat we normally get during bulking. This is the new era of protein supplementation, and it's real. If you want to build lean muscle without having to cut, you need perfect amino.

Starting point is 00:15:38 Now let's get back to the Ultimate Human podcast. Historically, one of the most corrupted sciences in all of science. And so we would be taught the dogma of Ansel Keys that natural saturated fat was at the root of the heart disease epidemic, ignoring the role of refinement. We're carbohydrates and fiber and the value of the soil that food comes from and the types of food that animals eat before those animals turn into food. So there's so much of that absent in the modern day world of medicine and medical education that we've got to fix it. We have to fix it. And I think it's because, you know, the pendulum has swung so far. We don't need to go through all the stats, but, you know, we are one of the largest, if not the largest

Starting point is 00:16:28 spender on health care worldwide. We're one of the sickest, the fattest, most disease riddenations in the world, civilized nations for sure. Morbid obesity, chronic, you know, multiple chronic disease in a single biome, 42% of our children having at least one chronic disease, which is just astounding. You don't see that in other countries. We don't have a lot of education around whole foods, around the importance of mobility, things like community connection, purpose go largely pushed aside as not having any impact on on lifespan or health span. What's really refreshing to me is I've heard you speak a number of times. One of the things that you talked about were some of the specific agenda items that the FDA is doing.

Starting point is 00:17:12 And I want to talk about some of those because you talked about, for example, the number of warning letters that went out during the last administration. I think it was one. the number of letters that went out under your administration and it was over 1,000. And if you could talk specifically about, you know, your orientation towards prevention versus treatment, you know, your intention is to try to keep people out of the system. Yeah. Right?

Starting point is 00:17:40 Because we know that once they're in the system, they just continue to progress, right? And this is what we have right now. We're very good at disease management and symptom maintenance. we're not very good at disease prevention and symptom alleviation or, you know, remission, you know, cure to use that word. So will you talk about some of the specific agenda items and certainly I would love to my audience to know what are some of the big wins at the FDA? And what are some of the, you know, agenda items, legislative items that you've got squarely in your crosshairs. You are like, I am going to accomplish these during my tenure.

Starting point is 00:18:18 Well, first of all, I think we have to be honest with ourselves. If we were to evaluate the U.S. healthcare system over the last 50 years, when it comes to gene therapy and sophisticated operations and proton beam therapy for cancer, it's been a sophisticated success story for some individuals. But if we talk about the U.S. healthcare system in terms of the performance indicator of the health of the population, U.S. health care has been a 50-year failure. We have got to do something different. We cannot just hope that the next gene therapy is going to solve all our problems or the next pill is going to come along. We have got to talk about school lunch programs, not just putting six-year-olds on Ozempic. We've got to talk about the quality

Starting point is 00:19:10 of sleep, not just putting somebody on first and second-line anti-hypertensives. We've got to to talk about natural light exposure, something I know that you talk about. Amazing. Think about what we do with kids. We take a kid in the middle of their circadian rhythm of a deep sleep, we rattle them, put them on a school bus while it's dark outside. Right. Not because it's good for their circadian rhythm or natural light exposure,

Starting point is 00:19:36 but because it's convenient for adults going to work. And then they sit under a microflashing fluorescent light all day long. sometimes with less natural light exposure than an inmate in a penitentiary. That is astounding. And then we hit them with massive glycemic indices. Over and over again, we pound them with things that make their insulin level spike. The cells don't like high sugar in the circulating system. So they try to block it.

Starting point is 00:20:06 We call it insulin resistance. And that blockage does damage. It's at the root of probably half the conditions we treat. 75% of health care costs go to... chronic diseases. Most chronic diseases are related to the same old problems of insulin resistance and inflammation. We get almost no education about in medical. Which are preventable. Which is avoidable and modifiable with diet and other things. We never talk about that. And then we tell a kid to sit still at a desk for seven hours and they have trouble doing it.

Starting point is 00:20:40 In the middle of those seven hours, we hit him hard with another high sugar, ultra-processed, glycemic, load, they can't sit still for seven straight hours sitting at a desk under a fluorescent light. And what do we do? We say you're a bad kid. We're going to drug you. Yeah, you have a behavioral disorder, a mood disorder, yeah. Yeah, we have a whole control disorder. Yeah, we got a lot of labels. We have a whole catalog of disorders that we can assign to you. I mean, the most bogus of all ICD diagnoses or DSM diagnoses in medicine is oppositional defiant disorder. Oh, that's a good one. I mean, what is that?

Starting point is 00:21:20 I don't know. A kid disagrees? Yeah. Disagre. Kid doesn't like the fluorescent light desk for seven hours. Now you have a diagnose. We've medicalized ordinary life. And when we have a mass societal level of the.

Starting point is 00:21:37 medicalization of ordinary life and where we are drugging our nation's kids at scale and not talking about the underlying root causes, the types of foods they eat, the importance of natural light, the value of community, the dangers of screened addiction. And we ignore all those issues. And all we do is we give doctors a prescription pad and a surgical knife and say, go to work, fix all these problems, you're going to have a dysfunctional system. Yeah. And that's where we are today. And I think that, you know, every parent that's listening to this, you know, just wholeheartedly agrees

Starting point is 00:22:16 and it's so thankful now that we have Food and Drug Administration that's actually listening and doing things. But, you know, in terms of specific line items that you're addressing, because the problem is so vast, you have to start somewhere, right? And so how do you start slowing the ship and changing direction? Because, you know, the Food and Drug Administration is not an independent, all-encompassing entity. I mean, you're fit into this governmental framework. You know, the Department of Agriculture, Health and Human Services, the National Institute of Health.

Starting point is 00:22:47 You know, we know that there's a lot of corruption in our nutritional research, which leads to things like poor food pyramid advice and nutritional guidelines. And can you talk a little bit about specifically where are we going from a nutritional perspective, of dietary guidelines, food pyramids, things that the masses can actually begin to rely on to make reasonable choices for, you know, food choices. Well, in talking about medical dogma, one of the greatest medical dogmas in modern history has been the broken food pyramid, written by the industry, not based on what the science supported, but based on what the companies wanted you to buy. And so we're rewriting

Starting point is 00:23:26 that. And I was excited to see you had Kyle Diamantas, our deputy commissioner for food on recently. Yeah, he's an amazing guy. Amazing. Very well spoken. Great background and really committed. You know, like most of the people I meet in the administration. Committed and in this purely for the betterment of kids and for the future generation. I mean, a very selfless guy. And that's the kind of person that we have brought in to the FDA. It's a new FDA. We are rewriting the dietary guidelines in food pyramid with USDA, you know, I'd say Department of Agriculture. And we're going to, end the 50-year war on natural saturated fat. We're going to talk about protein, the importance of

Starting point is 00:24:10 protein. It's been downplayed. It is very important to the body's physiology. We are going to talk about the type of grains and the importance of fiber. One of the sources of damage of the modern-day health of the nation has been the dogma that calories in equals calories out. And it's a zero-sum game. It didn't matter how you get those calories. It didn't matter if it's ultra-processed food or cardboard with sugar on it. It didn't matter. It's just you could walk it off. It was a equation that became the dogma. And this was what I was taught in medical school. It's done tremendous damage. We are finally going to talk about the importance of the quality of whole foods, fruits, vegetables, food that comes from...

Starting point is 00:25:03 Whole foods? Whole foods. Food that comes from animals that are raised well. So we're rewriting all that now. I think it's going to be an amazing moment in American history. And how soon will the new dietary guidelines be out? I think of the next... Within the next two months.

Starting point is 00:25:20 Within the next two months. Okay. And is this going to be... I mean, are we going to take the food pyramid out of the ground and flip it over and stick it back in the ground, basically. I guess, probably. It's almost like we're going to, the grains, which are the big, the base now might become the apex. Because you said we're going to talk about the importance of proteins.

Starting point is 00:25:39 I mean, and you, having been a surgeon and done work on frailty, I mean, you understand that sarcopenia, age-related muscle wasting, frailty like grip strength, inability to actually support your own weight. these are enormous risks to our elderly population. I watched it happen in my own father. You know, just, you know, he broke his humorous getting into the bathtub here over Thanksgiving last year. He ended up staying here for a couple extra months because, you know, he's gotten so frail in older ages.

Starting point is 00:26:14 But what are, you know, concrete things that you can do? Because, you know, there are some big legislative wins. I mean, I want to give you credit for, you know, felonic asses. you know, being added as a frontline events for some of these neurodevelopmental disorders. I love to see nutrients, raw materials, vitamins, minerals, amino acids being used to combat those deficiencies. Yes.

Starting point is 00:26:36 Big, you know, tip of the hat for removing the black box warnings from female hormone therapy, because as somebody who is married to a woman that just went through menopause, and someone that has been in the functional wellness space, for about 11 years, so many women suffered unnecessarily. And because as soon as you said estrogen, they thought breast cancer.

Starting point is 00:27:01 And you talked about a little bit about this study, the Women's Health Initiative, and how the study actually found the polar opposite of what was reported. How does that happen? How do you take data that's resolute and then restructure that data and create a mass misinformation,

Starting point is 00:27:22 campaign. What would be the impetus for something like that? It's, you know, it's old-fashioned medical dogma. Careers were built on certain ideas. So one hypothesis was that women should not be taken estrogen because it could increase the risk of breast cancer. And the guy who led that study, the famous women's health initiative study was first published in 2002, had gone on record, I found out when I looked into this. He'd gone on record saying in a medical journal, we have to stop the HRT bandwagon. In other words, wow. You know, we got to get women off this. Well, you haven't done this study yet. You know, the purpose of science is you evaluate the data as it comes in. And Albert Einstein had said the sign of an intelligent human being is someone

Starting point is 00:28:12 who evolves their position as the data comes in. And so we have to show humility. Well, I didn't see humility in the way that study was presented. There was no statistical significant increase in breast cancer in the women that got hormone replacement therapy compared to those who did not, the control group, in that original 2002 study, but they sold it to the media as an increase in breast cancer. But why do you think they would do that? I mean, if the study conclusion was something different, why not report the data? So was there a corrupt intent that was driving some kind of bottom line profit somewhere? There had to be an intentionality behind manipulating that data. You know, at least what's your opinion? I think there's a cognitive dissonance involved.

Starting point is 00:29:02 It's in psychology, they call it effort justification. It's the same justification by which this cycle of abuse continues in residency education in medicine or in fraternity hazing. It's this sense of, you know, I went through it, and then we glamorize it, and then it's okay. Entire careers were built. This was a $1 billion government-funded study, the largest study of any medical study of its kind. Yeah, it was massive. Up until that time. And so they were dead set on proving this association. Now the numbers, there was a slight increase in the number of breast cancer, non-fatal breast cancer cases diagnosed in that treatment group, but it was not statistically significant. So why do we do statistics if you're going to ignore when the statistics tell you

Starting point is 00:29:54 it's a difference attributable to noise in the data, not a true association? Now, there's been lots of criticism of the type of progesterone used called MPA, which is not a type commonly used in hormone therapy today. Now we have biodanicals, right? That's right. And some people say, well, that slight increase may have been attributed to that type of progesterone. What was hardly ever discussed was that if you were on estrogen alone in the study, that is, you had your uterus removed, in which case doctors generally do not recommend taking

Starting point is 00:30:30 progestin or progesterone, and so they're on estrogen alone. Well, they had a 22% reduced risk of breast cancer. Wow. Sort of a weird twist of irony. Now, I did some research, and I had found out that in the meeting of the scientists, before they announced that hormone therapy causes cancer, there were dissenting scientists who felt that they got ambushed. They were handed the final publication. They were showing up at a meeting at the Sofitel in Chicago for what they thought was a regularly scheduled meeting to review how the study was going. Okay. There were investigators from around the country. They convened. They thought this was a check-in meeting. And at the meeting, they were told, hey, you can throw out the agenda. We have a finding. And they said,

Starting point is 00:31:22 we found it causes breast cancer. And they were handed a final written manuscript. Wow. And they were like, well, you wrote the whole manuscript, we didn't know about this. And then they said, the leader says, and it's been submitted to the Journal of American Medical Association and accepted. And of course, they're like, we didn't, our names are on it. We didn't review it or have input. Right. And so a shouting match erupted. Wow.

Starting point is 00:31:50 And a couple of the guys said, you can't put this out there. You dangle something as sensitive as breast cancer to women. quote-unquote, you may never be able to put that genie back in the bottle. That's exactly what happened. It was prophetic. Wow. Now, it turns out that some of those people came out later and voiced their dissension against that group think at the time. And one of them was significantly punished.

Starting point is 00:32:19 He had his NIH funding removed for disagreeing with that party line. Wow. And you realize this was a person. personality, ego, battle that had little to do with the scientific evidence, masqueraded or camouflaged in high science. And the way that it went to the media before it was published, the media told the story that then, let's be honest, a lot of doctors get our, we get our news from the media. And so we see this study out of the NIH with all these big branded institutions like Harvard were part of the study. You just assumed that's the case. All these women were called and told,

Starting point is 00:32:58 stop taking it, or women would come in and ask about, hey, I'm having symptoms of menopause, what can I do? They were either never offered hormone replacement therapy or talked out of it. 50 million women were talked out of, never offered, or discouraged from taking hormone replacement therapy. Even though when you start it within 10 years of the onset of menopause, it not only reduces the short-term symptoms of menopause. That is the hot flashes, night sweats, mood swings, difficulty, sleep. Water retention, pain with sexual activity. But it also has profound long-term health benefits, reducing the risk of fatal heart attacks by 25 to 50 percent. I mean, that's the number one cause of death in women. Wow. Prevents osteoporosis better than anything else

Starting point is 00:33:57 out there. You can take all the calcium in the world. Right. We talked about this earlier too. Yeah. Yeah. Listen, there's what I share on this podcast and then there's what I share with my inner circle. If you've been following me for a while, you know how I hold nothing back here. But my VIP community, that's where the real

Starting point is 00:34:13 magic happens. Picture this. You're struggling with energy crashes, brain fog, or just feeling like you're not operating at your peak and you don't know where to get real answers. But here's what really sets this apart. You're not just getting my insights. When I have incredible guests on the podcast,

Starting point is 00:34:28 VIP members get to submit questions for a private podcast segment. So that world-renowned expert we just interviewed, you get exclusive access to their knowledge, tailored to your specific situation. This section is under the private podcast section in the Ultimate Human Community. And speaking of exclusive, you're getting my personal protocols, the exact tools I use for water fasting,

Starting point is 00:34:48 gut optimization, and morning routines that have taken me decades to perfect. This isn't theory. This is what works in the real world. The community launches challenges throughout the year where you get direct access to me and my network of experts. It's like having a personal health advisory board for less than $100 a month. Your health is your wealth, and this investment pays dividends for life. Join the VIP community at the ultimatehuman.com forward slash VIP and step into your ultimate potential. Now, let's get back to the Ultimate Human podcast.

Starting point is 00:35:17 I mean, you know, I often say if there was like one thing that you could choose to torture a woman, it's estrogen. I mean, you take away their estrogen. Yeah, you take away their estrogen. Skinny elasticity, you know, overnight, their skin begins to sag and wrinkle and become thinner. Mood changes, frozen shoulder, you know, depressive-like symptoms, mood numbness, loss of libido, water retention, you know, weight gain, hot flashes, all of those things. And I think it's just so unnecessary for women to suffer when you have a bioidentical solution that is relatively inexpensive. of that in most cases is covered by their health insurance that could completely turn their life around.

Starting point is 00:36:00 I mean, my wife entered menopause, and we've been very transparent about this, we've done podcasts about it, we put her Dutch test up on, you know, in the public domain, so she wouldn't be upset that I say this. But the wheels fell off the wagon, sort of so fast, you know, for my wife,

Starting point is 00:36:16 she was one of those that advanced very quickly into menopause, some women do it sort of very slowly and they can tolerate a lot of these changes. But literally like flicking light switch. Wow. Within days of starting hormone therapy, the symptoms started resolved. By the third week, frozen shoulder was gone. She didn't have the water retention. The brain fog had lifted. Her mood was noticeably different. And the biggest thing that we noticed was sleep. You know, her sleep started to normalize. And, you know, and I had seen this for the last 10,

Starting point is 00:36:49 11 years in our functional medicine clinic, because by the grace of God, we have a very good OBGYN that was our clinic director, and she's a functional OBGYN. So she was on the hormone bandwagon, you know, for years before it was. She never fell for the dog. She never fell for the dog, when she read the study herself, Dr. Sarda, big shout out to you. So, you know, and I just saw so many women's lives just change, and it's really sad that so many people have suffered. but this is really what the role of our Food and Drug Administration should be. In your view, and I asked this to Kyle too, in a perfect world because the sun's going to set on your tenure in another three years.

Starting point is 00:37:32 So during your four-year tenure as the, what is it, the 27th chairman of the Food and Drug Administration, in a perfect world, what would you like to see accomplished by our FDA for the betterment of the population, of American? people. Well, first of all, I'm glad to hear, I love your wife. Yeah. She's amazing. She is amazing. She came into the sauna fully clothed for the record. So Marty and Kyle and I are in there in her bathing suits. We're all sweaty of sauna. She got a text message from one of our, one of my clients. And she was like, I got to share this with you. She kept talking and talked. I'm like, how long can you stay in a sauna fully clothed? Fully clothed. I'm throwing water on the hot cold. So we're sweating.

Starting point is 00:38:16 But we got a lot of feedback on that. So the FDA jumped on the bandwagon 22 years ago and put these black box scary warnings. We remove those black box warnings. Big win for women, yeah. You know, I get women that stop me all the time and say thank you for setting the record straight. And if that alone is one of our lasting impacts, then I'll consider our time of success. But we've got very ambitious goals. We are eliminating animal testing that's unnecessary.

Starting point is 00:38:50 That's fantastic. That also lowers R&D costs. We are committed to lowering drug prices in a significant way. We have a protocol now to get drugs approved in weeks instead of the forever time. We are doing it with the same scientific integrity and not cutting any corners on the safety. We are making things transparent, adverse events, internal documents. There were stuff on myocarditis and the COVID shot in children. We went fully transparent with that stuff.

Starting point is 00:39:27 So you put the data out. I mean, nobody wants to touch the vaccines, but what we're there, I mean, you've put the data out on vaccines. And I know that there is no causal link between vaccines and there's a direct line to autism. But there is definitely data that we are over-vaccinating our children, whether there's 72 vaccines now, 79 vaccines on the schedule. Just before we came into office, yeah, there was a recommendation to give a six-year-old girl 70 more COVID shots in her average lifespan.

Starting point is 00:40:00 That is. One every year. One every year. And we don't know if, we don't know if it's necessary. Where's the data showing it's necessary? There's high population immunity. Many people feel that we've been lied to with medical dogma during the COVID years. The worst thing you can do as a doctor is to tell someone to do something with such absolutism

Starting point is 00:40:21 masqueraded as evidence-based, settled science when the actual data is very flimsy or not existent. And it's just your opinion. So unfortunately, we did see the use of science as political. propaganda. But look, our legacy, I hope, will be a healthier generation of children. We're doing so much on the healthy food side, stuff that Kyle talked about. We're looking at the thousand-plus chemicals that are in the European food supply that are not in the American, sorry, that are in the American food supply, that are not in the European food supply because of our grass regulation that we are changing. Yeah, that's amazing. We took action on pharma ads. Many of these ads can be

Starting point is 00:41:10 misleading. And so we're going to enforce the regulations. We're sending out those warning letters and letting the companies know you cannot, you know, create a misleading impression. Right. There's a regulation that says they can't be, create a misleading impression. And so we plan to enforce those regulations. That's great. They sent out zero letters last year. Yeah, I remember you talking about that, the Maha Summit, zero letters, and you had over a thousand that you'd sent out. Yeah. You know, just warning. I want to go back to the vaccines for a minute because it's a real hot topic.

Starting point is 00:41:39 And I think it's a hot topic because not because of the real science, but because of the, you know, political cloud that surrounds it. And if we lay politics aside for a minute and we understand that, you know, that pharmaceutical companies that make these vaccines that make it under the schedule are, you know, protected from liability. There's a liability shield for them. As a purely capitalistic move, if I could create a product and not have any liability, I would drive a truck through that, right? And I think that's what you see happen. You see the number of vaccines on the schedule absolutely explode. You know, what, 18 vaccines in the first 18 months of life, a lot of which are vaccinating

Starting point is 00:42:26 against statistically insignificant risk or almost non-existent risk. hepatitis B, for example, is there a review process for, excuse me, for these vaccines? Because the attack on the FDA, and I guess you, to a lesser extent, is that, you know, you're going to kill millions of people because you're banning vaccines, which has not happened. That's right. Which has not happened at all. I think you're, I mean, from my perspective, you're taking a very intelligent approach to say, hey, we can't have mandates for something where we don't have data, right?

Starting point is 00:43:03 We can still make it available if you choose, if through the informed consent process, you make the decision to be vaccinated or have your child vaccinated, but we're not going to say, to get into public school, you are required to have X, Y, and Z. So where do, where does the FDA land and where is the FDA going on its investigation of a vaccination? especially MRNA vaccines, which are highly controversial now. So we're going to return to a gold standard science threshold for approvals at the FDA. We're not going to be blindly rubber-stamping MRNA COVID vaccines every year in perpetuity with no data. That's the path that we've been on.

Starting point is 00:43:46 I like that. And it's a very different day today than it was back in 2020 when the vaccine was a good match for the circulating strain at the time. there was low natural immunity levels. We didn't understand a lot of what we know now. And we recognize that myocarditis is a real complication that is seen in young men and that some individuals' children have died from it. So we need all the information to be out there.

Starting point is 00:44:13 And our promise has been that we're not going to take away anybody's vaccines, but we are going to provide information so that people can make their decisions. that we at the FDA have a simple job, and that is when companies present data, we decide whether or not that data supports the claims they want to make about their products. That's our job. It's pretty simple. Yeah.

Starting point is 00:44:41 At the CDC, they decide what vaccines to recommend. And I know that there's an ongoing evaluation that is going on to look at that. And how in lockstep are you with the CDC? I mean, we really have different roles, but we do have a lot of conversations. And so, you know, we do an intensive review of the data, and sometimes we share the results of that directly. So, for example, there is an M RNA flu shot. MRNA vaccine technology is being used for other things now. Our philosophy is, that's great.

Starting point is 00:45:21 Let's see the data. and if something works, we will do what we do at the FDA, and that is approve it if the benefits outweigh the risks. Right. But it's going to be real gold standard science to say we're not going to allow pressure. We're not going to allow, you know, corruption. We're not going to allow political lobbyists to determine how we come to a decision. We're going to make it based on gold standard science.

Starting point is 00:45:48 people believe that the pharma industry thinks that they own the FDA but they don't own the FDA the FDA belongs to the American people wow so good to hear you say that we're going to keep it scientifically independent it is not a fourth branch of government it is within the executive branch and we are going to have a series of policies that we plan to implement the top policy of which is a return to independent, objective gold standard science. So when the MRNA flu shot failed in its clinical trial in seniors just weeks ago, it was announced, guess what that means? We're not going to be approving it. So you can't have a drug that doesn't work, get approved because of lobbyists and corporations. I have a charge from President Trump, and that is do what's

Starting point is 00:46:42 right, go big, go bold, and don't worry about the corporations and the lobbyists. And that's what I'm going to do. That's fantastic. It's so good to hear you say. So if I were looking down the lane of the FDA for the next three years and areas where it's going to widen, areas where it's going to narrow, I mean, obviously we need to widen the lanes for functional medicine-like treatments and modalities, lifestyle medicine, you know, which is things like dietary exercise, those kinds of things, peptides, for example, which have been used at scale and have been proven to be safe in the mass population. Where do you fall on some of these areas that I would consider them gray areas right now where they're kind of being done and people are benefiting

Starting point is 00:47:34 from it, but the FDA hasn't really taken a strong position like peptides, for example, which we be used in our practice and with astounding results, things like BBC 157 for tissue wound repair, for healing and sealing the gut, for people that had gut dysbiosis, Crohn's disease, diverticulitis, all sort of colitis, these inflammatory bowel conditions that were not responsive to anything other than high doses of corticosteroids, which just bought you another problem

Starting point is 00:48:05 down the road. Yeah. Where do you see some of the lanes potentially widening, if you can talk about it, potentially widening for some of these therapies. So I would say in the lane of cutting edge new areas, we've got to talk about the microbiome and we cannot use our old model of approving drugs for the microbiome.

Starting point is 00:48:26 If somebody has a probiotic that has a reasonable safety profile, we've got to have a different amount of regulatory flexibility for something like that, because the microbiome is a lining of a billion different bacteria that is in an equilibrium naturally in the body. And so things alter that microbiome and things can help repair that microbiome. And so if we wanna run a randomized trial

Starting point is 00:48:59 for each molecule or component of some probiotic therapy, we're gonna be spinning our wheels for a long time. 20 years, yeah. And so the agency, and this is common of regulatory agencies, tend to fall behind and not be able to keep up with the times. I agree. We talked about that. The microbiome is the biggest frontier of medicine that we are not talking about,

Starting point is 00:49:23 that we need to talk about. We know things mess up the microbiome and directly result in diseases. One of the biggest studies in modern medicine that has been ignored, and I think one of the most important studies, has been a recent study, out of the Mayo Clinic that looked at kids who got antibiotics in the first two years of life and then track them as to what diseases they developed later. Now, why would antibiotics potentially cause disease? Well, the theory is that it's, we know antibiotics alter the microbiome. It's almost like carpet bombing parts of the microbiome. And you get bacterial overgrowth. We don't

Starting point is 00:50:03 know what to do with it. We know overgrowth is associated with inflammation. And so here's I just wrote down some of these study results. The kids that got antibiotics in the first two years of life, 20% higher rate of obesity, 21% higher rate of learning disabilities, 32% higher risk of developing attention deficit disorder, 90% higher rate of asthma. 90% higher rates of asthma

Starting point is 00:50:33 in kids that were given multiple antibiotic doses. Any antibiotic exposure in the first two years of life. and there was what we call a dose-dependent relationship. The more courses of antibiotics a kid got, the greater the risk of obesity, learning disabilities, ADHD, asthma, Ciliac had a 200, nearly 300% higher risk. And if a kid took antibiotics. Wow. Crohn's disease, nearly a 300.

Starting point is 00:51:01 All these diseases are going up. Yeah. Crohn's disease was ultra rare a century ago. Yeah. Right now it's like. So was celiac. I mean, true celiac, you know, gluten allergy, gluten's been around forever. Now all of a sudden, everybody's allergic to gluten.

Starting point is 00:51:15 So it's not, this is not the riddle of the sphinx. This is a byproduct of an altered microbiome in an era where the microbiome is carpet bombed. It is altered with ultra-processed foods. It is perturbed in so many ways. Now, some of the things that perturbed the microbiome also save lives, like the antibiotics. antibiotics, c-sections, and other things. But half of antibiotics, at least, are unnecessary. That study after study shows that. Right. And the guy who invented or discovered antibiotics, Dr. Fleming in 1928, he warned about its overuse and abuse and how this would be an evil

Starting point is 00:52:01 and result in resistance. That's exactly what's going on. Right. So we've got to talk about the microbiome. Love that. And then on the other lane, I would say, we want to see a cure or meaningful treatment, and we're laser focused on this for type 1 diabetes, for certain types of cancer, for neurodegenerative disorders, for PTSD. I mean. And what are the promising frontiers for those kinds of diseases?

Starting point is 00:52:32 Because, you know, chemotherapy, surgical excision, radiation haven't really advanced leaps and bounds in the last two decades. No, they haven't. I've been taking care of pancreatic cancer for a good part of my career. It's roughly got the same five-year survival as it did 30 years ago. Right. We're talking about small, but there is a new K-RAS inhibitor molecule that is, for a subset of patients, appears to be miraculous, appears to be.

Starting point is 00:53:03 There is a new PD-1 inhibitor that has resolved. resulted in rectal cancer tumors melting away and disappearing right in front of the eyes of the physician over serial checks, what we call a complete pathologic response, no chemo, no radiation, no surgery. Wow. And so how does the population get access to these? So they have to have a certain type of gene mutation, microsatellite instability. It might be 5 to 10% of individuals with a GI cancer that have this gene.

Starting point is 00:53:38 Still, GIA cancers are so prevalent and they're absolutely exploding right now. I mean, colorectal cancer is on a parabolic tear right now. That's right. It's doubled in people under 55 in the last two decades. So we need new meaningful treatments that make sense. We have to address root causes with diabetes. There are some very promising new technology where islets are now infused and are not being rejected. Into the pancreas.

Starting point is 00:54:07 Donor islets? Donor eyelids injected into a human with type 1 diabetes, and traditionally the body rejects these eyelids, just like a foreign organ. And sometimes there's been protocols to try immunosuppression. Well, there's at least one potentially promising therapy where they have not seen the immune rejection, and the patients are not taking immunosuppression. Wow. That's a huge win.

Starting point is 00:54:36 You know I'm all about optimizing performance, and lately I've been using the ion weighted vest during my workouts, and it's been a game changer. It isn't your average weighted vest. It's designed to fit like a second skin, activating your core, improving blood flow, and even helping you with recovery while you train. What I love most is that the weight is perfectly distributed. It doesn't pull on your shoulders or throw off your alignment, whether I'm doing strength training or cardio, or just taking a walk. I'm burning more calories, building muscle, and building muscle. and pushing my endurance even further. If you're serious about leveling up your training

Starting point is 00:55:10 and unlocking your full potential, check out the ion-weighted vest at iongear.com. That's a-I-O-N-gear.com, and you can use code Ultimate for 10% off and start training smarter today. Now let's get back to the Ultimate Human Podcast. Look, so we have got to reach out to these companies,

Starting point is 00:55:28 the scientists and the developers that are working on this stuff and say, look, send us whatever data you got. We want to be walking through this process with you. Don't worry about the margins and the font size of your application. We want to partner with you. I personally will go to scientific reviewers at the FDA and ask them, are you seeing anything that looks amazing, game-changing,

Starting point is 00:55:52 something that gives you chills up your spine because of what it could mean for a population of patients with a disability or a certain condition? And most of the time they say, no, there's nothing I'm seeing that's that dramatic. but sometimes they do say, look, there's this thing. In animal studies, we're seeing this dramatic improvement, and maybe it's got some promise. Well, those are the applications we want to put at the front of the line, and so we're proactive.

Starting point is 00:56:20 Are you accelerating the process of the applications? You know, at the Maha Summit, you talked about a very specific case. I can't recall the specific case, but there was a, I think you were actually reading about a therapy. In the Newland Journal. Yeah, and, and, and, you know,

Starting point is 00:56:35 You, the FDA reached out to this company and said, hey, we'd like to fast track you. I mean, that's unheard of. Yeah, a form of congenital deafness. Congenal deafness, that's what it was. So in the New England Journal, they report that about 12 kids got this gene therapy, and three of them were able to get normal hearing. Wow. And I think another seven got improvement in hearing.

Starting point is 00:56:58 Well, what are we waiting for? Because kids are deaf, right? So we reached out to the company within a matter of days. we were able to issue them a national priority review voucher to get a decision out in weeks once they submit their data. And is this national priority review? Is this something new at the FDA? Is there like a, can I use this term, fast-tracked system now where we're, you know,

Starting point is 00:57:19 companies with novel therapies that have some evidence-based. And, you know, we talked about blood filtration, for example, and non-specificly in-use phreasis, therapeutic plasm exchange, serif blood filtration, and how I see. certainly I'm a big believer in these, just subtractive medicine of taking things out of the body that could be distracting its normal function, heavy metals, mold mycotoxins, parasites, viruses, microplastics, you know, these things that are causing biological havoc, right? Because our immune system is spending all of its time protecting us from those, but not policing us, right? and then there go the senescent cells

Starting point is 00:58:04 and circulating tumor cells and now you've got the genesis of chronic disease. Yeah, immune fatigue. Yeah, immunofatigue, yeah. Which, you know, I told you I was asked this question on a stage talk not too long ago about what is the one prevailing theory of aging that everyone would agree on?

Starting point is 00:58:21 And there's lots of theories of aging and I don't purport to say that this is the one. But immunophagic is one that, you know, a lot of leading MDs, PhDs, researchers would say, yes, that is a large category that we need to address. Like how do we empower the immune system to do what it does best?

Starting point is 00:58:43 Which is not just protect us, but also police us. You know, to actually keep senescent cells from sticking around for too long. Having cellular autophagy and, you know, go back to homeostasis, you know, regulating, you know, we call redox homeostasis, the balance between inflammation, and oxidation, you know, that, and there's nothing more powerful than our God-given innate immune

Starting point is 00:59:10 system. It's amazing, yeah. I mean, if you want to ask me, that's what got us out of the pandemic. So, you know, where does the FDA fall on some of these things like that? I would, maybe you call them gray areas like, you know, peptides where you have mass numbers of prescriptions that have been written with very little adverse effects and large data to finding benefit. How do you address an industry like that and say, rather than sort of turn to blind eye and just kind of let it quietly do what it's going to do on its own, how do we actually train an eye on this and widen the lanes for certain things, narrow the lanes for other things? Yes. Yeah. Well, we have to use some common sense. Yeah. And the peptide world is a very large bucket. So,

Starting point is 00:59:59 So we have to sort of review different groups and subgroups and ask ourselves, what is harmless, been out there for a long time and already has an established safety profile, what is equivalent to a drug in a current phase three clinical trial where we still don't know the results. On your question about, is this the first time we're doing a priority voucher review? It is the first time we're piloting a program to get a decision out in four to eight weeks or That's insane for the FDA. That's amazing.

Starting point is 01:00:32 I mean, they've had programs to get it down, you know, accelerated, breakthrough designated. There's all these terms that have been out there expedited. It sounds great. Yeah, sounds good. I hired a permit expediter for my last construction project. It took me three years. Yeah, who doesn't like the word expedite?

Starting point is 01:00:48 Yeah, we don't like that word. So, but we've got to try new things. The goal of lowering drug prices is such a major. that if we can lower R&D costs, get more drugs out faster and safer, then we can have more competition. We're lowering the barrier for generic versions of drugs, especially of the expensive biologic drugs. Those generic versions are called biosimilars, and it's been held for those companies to come to market after a biologic drugs patent expires or market exclusivity expires. I mean, with Humera, I think it took five years. Wow. And the average time

Starting point is 01:01:35 to develop about similar has been five to eight years. Well, we cut the R&D costs in half, and we cut the time in half. And so we're going to see a lot more generic versions. We want to move more to more drugs to over-the-counter. Why do you need a prescription for naloxone? Right. Right? What are we, who are we protected? Who's going to abuse that, by the way? Who's going to abuse it? If there's no abuse potential, if it's safe, if it's something that people can figure out with, you know, they can have a discussion with their doctor and decide, hey, this, you know, it may benefit you. And they're not going to abuse it for some, for the creation of something else in society.

Starting point is 01:02:23 And you don't need laboratory tests to monitor, say, your liver function when you start a drug. then what are we doing? Right. What are we doing? So we want to get more drugs to over the counter because... So that's where you can widen some of these lanes. Yeah, you can. And also when a drugs over the counter,

Starting point is 01:02:39 now it's got a price on the shelf of the pharmacy, right? Because you're picking it up. And now there's price competition. Right. It's no longer in a black box of the insurance company and the pharmacy benefit manager. Right. So there's a lot to do.

Starting point is 01:02:54 So there's so much to do. I think for folks that are in my industry, You know, we see, you know, when we had our clinic, we had a large population of patients that were going outside the United States for a lot of treatments, you know, mainly stem cells, exosomes. So they're having to go to third world countries. And some of these facilities are very, you know, they're U.S. doctors there and they're well-run facilities, but people are still going to Medellin, Tijuana, Panama, Costa Rica.

Starting point is 01:03:27 And I'm not throwing shade in any of those countries. Nicaragua, to get therapies that are helping them generate their joints, that are giving them promise for neurodegenerative disorders that are helping them repair tissues, amnionic stem cell injections for type 1 diabetes. And is there, in let's call it the stem cell biologic exosome space, is there a view that we might be able to bring this back in under the FDA's purvey in a reasonable time frame so people can have access to safe evidence-backed therapies that include some of these biologics like stem cells. Where do you see that lane widening?

Starting point is 01:04:17 Yeah, we've got to modernize. And so if people are all leaving the United States for a therapy that has good data to support it, what are we doing? And we're just blocking people from access to therapies that may have good data. If a therapy has good data, we'd like to see it. And we've got to get over these sort of prejudices that exist sometimes, not among the scientists at the FDA, but larger prejudices that the medical establishment has had. And I'm being honest because I was a part of the medical establishment in all of its

Starting point is 01:04:50 academic regalia at all the top – I trained in a bunch of the top institutions, Harvard Johns Hopkins, Georgetown. And let's be honest, well, we don't know what to do with some new therapy. We just downplay it and say, oh, we don't have a 10-year randomized controlled trial. Therefore, you know, it's bad. No, that means you don't have a 10-year randomized controlled trial. It's a scientific unknown. Maybe there's other ways of learning.

Starting point is 01:05:19 Big data, for example. Big data. We talked about parachutes. We've never done a randomized clinical trial on parachutes. Yeah, where's the randomized trial on parachutes? You can see it in front of your eyes that it's saving lives, right? I mean, who wants to be randomized to jump off a plane without courage? I want to see who signs up for that control group.

Starting point is 01:05:35 I want to be in the control group. I remember, Gary, at Johns Hopkins, and this is to the point that we need to listen to patients and realize that we can learn from patients. There was a patient with brain cancer, a certain type of incurable glioblastoma multiform, brain cancer at Johns Hopkins. I didn't know the patient, but this case is well known. And the guy beat the odds and is a long-term survivor. You really rarely see a long-term survivor.

Starting point is 01:06:11 Yeah, the last time was terrible. Yeah, terrible, right. And no one's really cured of it, but the recurrence rate is high. But this person is out 15 plus years. I remember at one point, now it's probably much more. And they would re-review this case in one of the conferences at Johns Hopkins as sort of a learning teaching case. Now, what happened whereby that patient beat the odds? Well, it turns out that that patient had an infection after the tumor was resected.

Starting point is 01:06:44 And that infection bed got the standard treatment that we do for an infected area. it was, the infection was relieved in that case. They removed the skull plate, evacuated the bacteria or the infected tumor resection bed, and then bring the patient back in another stage procedure to put the skull plate back on. The patient did find from that. That's sort of a standard complication management strategy and surgery. Now, something happened.

Starting point is 01:07:15 I don't know what it is, but we can learn from that case. Maybe the bacteria ate into the tentacles of the tumors. Maybe it activated an immune response that fought that cancer even harder and longer than somebody who didn't have that infection. Maybe it was the evacuation. Maybe it was some molecules or interleukins that were increased from the stress of the second and third operations. I don't know. But those are data points that we can learn from. And when you talk about whether or not petroleum-based food dies alter the behavior of children,

Starting point is 01:07:53 yes, we can do it, a randomized control trial, and that's been done. But we can also listen to parents that say when we removed these petroleum-based food dies, their aggressive abnormal behavior improved. And then a year later, when the kid got back into those artificial food dies, we noticed their behavior regressed to that bad behavior. We can listen to parents and learn. is data also. And also, you look at the risk of potential harm that comes from removing food dies. What's the worst thing that could happen? Because nobody is dependent upon them. You know,

Starting point is 01:08:29 this isn't an essential fatty acid or an essential amino acid. And you're like, well, let's just see if they can survive without these essentials. And then you have this catastrophic outcome. I mean, when the risk that is that it doesn't work, but it does no harm, those seem like viable. risks, right? I mean, when the risk is that it doesn't work and it causes harm, I mean, that's where I would think the FDA needs to step in and say, because, you know, I have firsthand knowledge of clients of mine, and I'm not a physician, so I don't treat them, but I just help direct them to the people that can give them care that have done, that have had late-stage cancers, one of particular is late-stage lung cancer that was inoperable because of the size

Starting point is 01:09:17 the tumor, and went to Cabo, Mexico with U.S. physicians and got a dendritic cell vaccine. Actually, cultured the tumor, grew it in the lab, cultured their own natural killer cells, their dendritic cells, grew those in the lab, introduced these two, had the dendritic cell identify the cancer as a foreign antigen, it created an antibody, they re-infused that patient's own antibodies into their system and it ate the cancer leicotermine. And I've watched this happen. I'd be happy to give you the data. And I look at the risk of taking a patient's own natural killer cells out of their body, introducing them in vitro to cancer, creating this immune response, and then re-infusing those back into the body. The risk of rejections, obviously very low

Starting point is 01:10:11 their own natural killer cells, and seeing in multiple cases that this, you know, was a miracle for these patients, those are the kinds of things I would love to see the FDA at least have an open eye to and say, look, we know that intrarticular stem cells have actually avoided joint replacements. We know that they've accelerated wound healing. We've actually accelerated the post-surgical time frame to full recovery. And there's a promising frontier here, but whether it's pharma or medical dogma that's standing in the way of a lot of these technologies that are being widely used outside the United States, blood filtration technologies, biologic filters, plasma filtration, dendritic cell vaccine, natural killer cells. I've seen these therapies work in front of

Starting point is 01:11:02 my own eyes for people that are going outside of the country and having them done. Are you saying that the FDA is open to looking at that data and helping potentially advance those therapies. We have to be. We have to use common sense. I mean, if somebody, you know, and this is the case of this PD1 inhibitor where the rectal cancers have shrunk to nothing, no detectable. They've even resected the mucosal lining of where the tumor was, and they can't find a single cancer cell. Wow. Now, that's, I guess you can call it a conventional therapy. PD1, it's going through the process. But how do you look at that and say, you know what? There's a lot of people suffering with debilitating rectal cancer surgery where you become incontinence or a claustomy

Starting point is 01:11:49 bags. I mean, very debilitating stuff. And there's this amazing therapy, but, and we see it just eliminate cancers that melt away. But you know what? Let's just give it the standard five years to run through the process. Like, what are we protecting people from? Many of these therapies we know are safe. We have to get away from a paternalistic mindset. And we have to let people respect them and their judgment and their decisions. And you saw that sort of paternalism surface during the COVID years. Now, it's been there for a long time when home pregnancy tests were technically feasible, the medical establishment blocked them. They didn't want them, right? Women can't handle this information. Right, right. They can't handle this. We have to tell them, right?

Starting point is 01:12:45 We've got to be there to catch them if they fall. Same thing with HIV testing. Same thing. You could only get it done. You can only get your results by coming in and meeting with a physician. You couldn't just look up your results or, or so when COVID hit, it was the same thing. We wanted COVID home testing and the medical establishment blocked it. Well, people, they might not know how to use the information. They might, we have to tell them what precautions to take. So you see this medical paternalism rear its head up, hormone replacement therapy and postmenopausal women. Right. Right? Well, you know, they should not take it because there is a risk that we believe exists, even though the data didn't really support it.

Starting point is 01:13:31 And therefore, we don't think it's wise for them to take it, and therefore a lost generation of 50 million women missed out on this incredible opportunity. And you can't really start it more than 10 years after the onset of menopause. Right. Because the risk-benefit ratio went from- Right. It's very sure. According to many doctors who do a lot of- We saw that too. Yeah, yeah. We saw late 60s women not have the same kind of massive turnaround. So we have to get away from this medical paternalism. I love that. I love that.

Starting point is 01:14:00 So what are the biggest headwinds that you face right now? Is it the medical establishment, not necessarily being anti your agenda, but just being so dogmatic in their belief? Is it political opposition? Is it pharma and food not wanting to take their grips out of these agencies? What's the biggest headwin that you're facing at the chairman? the FDA. Well, I think one of the cool things. Yeah, absolutely. Yeah. I mean, I'm unfiltered and I'll tell you exactly. That's what I like about you. But it may not be a polished answer, but it's honest and unfiltered. So we are at an amazing time when people from all political persuasions are aligned

Starting point is 01:14:48 on healthier food for kids. We want to see more cures and meaningful treatments for Americans faster and more safely delivered. And so we think we can deliver on those. And so there's a lot of tailwinds. The biggest headwind is it's hard to work in government. Just to get anything done. Yeah. 10 people will tell you 15 reasons why you can't do it.

Starting point is 01:15:14 And it could be, oh, there's this language and this regulation. And you realize the regulation was created by the agency itself. So these are like self-imposed policies. So I'll typically, you know, say, hey, let's socialize this reform around the agency. And then I might get feedback that says, well, this is not how we typically do things around here. Oh, yeah. Marty, let me tell you how we do things around here. I know you're new to this.

Starting point is 01:15:46 You're so full of hope. Right, right. But this isn't how it goes. I could see that. I mean, this is a big, bloated, bureaucratic machine. I mean, we've got 370 million people here, and it's been dysfunctional for decades, you know. And I think it's commendable that you're coming in with, first of all, I commend the administration as a whole and the FDA and some of these other departments for the level of transparency. That, I think, the American people appreciate no matter what side of the political aisle you're on.

Starting point is 01:16:20 The second thing is I commend you for not being afraid to ask questions, to question the science, which is the foundation of science. You know, it was for so long that if you ask the question, you were ostracized just because you, you know, were outside of the Overton window, right? McCarthyism. McCarthyism, yeah. So, well, as you know, first of all, I'm actually more proud of you for doing a cold plunge than I am for you. running the Food and Drug Administration. That's where you got my, I mean, that's where you earned my respect. I was like, oh, he's really going to do it.

Starting point is 01:16:59 You got right in there. So, Marty, I, you know, I wind down all my podcasts by asking all my guests the same question. You probably heard me ask this to Kyle so you have a tip off. But what does it mean to you to be an ultimate human? I would say, so I've spent a lot of time at the bedside of people that are dying, and they'll often share words of wisdom. And one thing that I think is profound is that none of us are going to be here in 150 years, none of it, our kids. And so what is our mark going to be? Are we going to be able to look back and say that we did something to contribute to a better?

Starting point is 01:17:44 world. And I think the big need right now in society, with the echo chambers of social media, with the affirming news that people listen to, with the toxic polarization that exists, the need right now is for us to all show some humility and to listen to one another. And so I hope I can do that, and I hope I can be a good dad. And to me, that would be being the ultimate human. Well, you got my vote. You know, I've said many times I've been very impressed by the reception this administration has shown, you know, influencers like myself. And our industry is not maybe not being so rogue and as, you know, deserving a voice and a seat at the table. You know, we're both headed up to Washington after this and thought that I actually have a seat at the table in the White House to come and bring the conjoving.

Starting point is 01:18:40 the consensus of folks that are that are on my platform, you know, and actually have a receptive year, you know, at the level of the White House to me just shows that human beings at the top of these pyramids that really have the right intention, an authentic intention to make a change. So I really want to thank you for that on behalf of my entire audience. You know, I really want to thank you for that. Oh, thanks, like Gary. And thank you for educating not just the public, which is what we do. badly need. But for willing to ask big questions, you are actually educating medical students,

Starting point is 01:19:19 residents, doctors in practice, because we're hungry for the type of stuff that you're an expert in. And so you're doing an amazing service out there. And I've been learning from you. So thank you, Gary. Thank you so much, Marty. I hope you'll be back on the Ultimate Human podcast again. And until next time, that's just science.

The Ultimate Human with Gary Brecka - 229. Dr. Marty Makary: Vaccines, Chronic Disease, Drug Prices & Hormone Therapy

There aren't comments yet for this episode. Click on any sentence in the transcript to leave a comment.