229. Dr. Marty Makary: Vaccines, Chronic Disease, Drug Prices & Hormone Therapy

20:56Gary Brecka:Yeah, you have a behavioral disorder, a mood disorder, you know. Yeah. Impulse 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. Ooh, that's a good one. I mean, what is that? I don't know. A kid disagrees? Yeah. A kid doesn't like the fluorescent light desk for seven hours. Now you have a diagnosis. We've medicalized ordinary life. And when we have a mass societal level of the 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 screen addiction.

21:56and 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 gonna have a dysfunctional system.

22:09Gary Brecka:Yeah. And that's where we are today. And I think that every parent that's listening to this just wholeheartedly agrees. And it's so thankful now that we have Food and Drug Administration that's actually listening and doing things. But 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, National Institute of Health, 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.

22:56Gary Brecka:And can you talk a little bit about specifically where are we going from a nutritional perspective, dietary guidelines, food pyramids, things that the masses can actually begin to rely on to make reasonable choices for 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 that. And I was excited to see you had Kyle Diamantis, our deputy commissioner for food on recently. Yeah, he did.

23:34He's an amazing guy, isn't he?

23:35Gary Brecka: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 and food pyramid with USDA, the United States 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 protein. It's been downplayed. It is very important to the body's physiology.

24:16We are going to talk about the type of grains and the importance of fiber. However, 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 - Whole foods.

25:03Whole 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.

25:14Gary Brecka:And how soon will the new dietary guidelines be out? I think in the next, within the next two months. Within the next two months, okay. And is this going to be, I mean, are we gonna 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 gonna, the grains, which are the big, the base now might become the apex. Cause you said, we're gonna talk about the importance of proteins. 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.

25:53Gary Brecka:These are enormous risks to our elderly population. I watched it happen in my own father. You know, just, you know, he broke his humerus getting into the bathtub here over Thanksgiving last year. He ended up staying here for a couple extra months because he's gotten so frail in older ages. But what are concrete things that you can do? Because there are some big legislative wins. I mean, I wanna give you credit for folinic acid being added as a frontline defense for some of these neurodevelopmental disorders. I love to see nutrients, raw materials, vitamins, minerals, amino acids being used to combat those deficiencies.

26:35Gary Brecka:Yes. Big 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 because as soon as you said estrogen, they thought breast cancer. And you talked 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 campaign?

27:23Gary Brecka:What would be the impetus for something like that? But it's old-fashioned medical dogma. Careers were built on certain ideas. So one hypothesis was that women should not be taking estrogen because it could increase the risk of breast cancer. And the guy who led that study, the famous Women's Health Initiative study that was first published in 2002, had gone on record, I found out, when I looked into this. It got on record saying in a medical journal, we have to stop the HRT bandwagon. In other words, we got to get women off this. Well, you haven't done this study yet. The purpose of science is you evaluate the data as it comes in.

28:07And Albert Einstein had said the sign of an intelligent human being is someone 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.

28:39Gary Brecka: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. At least what's your opinion on that? I think there's a cognitive dissonance involved. 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.

29:21Entire careers were built. This was a$1 billion government funded study, the largest study of any medical study of its kind.

29:30Gary Brecka:Yeah, it was massive. Up until that time. And so they were dead set on proving this association. Ah. And now the numbers, there was a slight increase in the number of breast cancer, nonfatal 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 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 bioidenticals, right?

30:12That'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 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.

30:56They were handed the final publication.

30:58Gary Brecka: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. 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, 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 the American Medical Association and accepted.

31:40And of course, they're like, our names are on it. We didn't review it or have input. Right. And so a shouting match erupted. Wow. 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. He had his NIH funding removed for disagreeing with that party line.

32:25And you realize this was a 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 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, stop taking it. Or women would come in and ask about, hey, I'm having symptoms of menopause. What can I do?

33:08They 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, difficulties sleep - Water retention, you know, all these things. 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%. I mean, that's the number one cause of death in women.

33:53Gary Brecka:Wow. Prevents osteoporosis better than anything else 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 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.

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34:55Gary Brecka: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 theultimatehuman.com forward slash VIP and step into your ultimate potential. Now let's get back to the Ultimate Human podcast. 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 know, is that... Taking away their estrogen. Yeah, you take away their estrogen.

35:28Gary Brecka:Skin 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, that in most cases is covered by their health insurance, that could completely turn their life around. I mean, my wife entered menopause and we've been very transparent about this. We've done podcasts about it.

36:05Gary Brecka: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, 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 a 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.

36:44Gary Brecka:Her sleep started to normalize. And I had seen this for the last 10, 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. She never fell for the dogma. She never fell for the dogma. 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.

37:19Gary Brecka:um in in your view um you know and i i asked this about uh to kyle too in a perfect world because the sun's going to set on your tenure in another three years yeah 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. I want to say she's amazing. She is amazing. I'm glad to hear that. She came into the sauna fully clothed for the record. So Marty and Kyle and I are in there in our bathing suits.

37:58Gary Brecka:We're all sweaty at sauna. She got a text message from one of my clients, and she was like, I got to share this with you. She kept talking and talking. I'm like, how long can you stay in a sauna fully clothed? Fully clothed. Almost like with a sweater on it. I'm throwing water on the hot coals. We're sweating. 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 removed 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 a success.

38:45But we've got very ambitious goals. We are eliminating animal testing that's unnecessary. 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 was stuff on myocarditis and the COVID shot in children. We went fully transparent with that stuff.

39:26Gary Brecka:So you put the data out. I mean, nobody wants to touch the vaccines, but while 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. Is there 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. That is one every year. One every year. And we don't know if it's necessary. Where's the data showing it's necessary?

40:06There'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, masqueraded as evidence-based settled science, when the actual data is very flimsy or non-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, the stuff that Kyle talked about. We're looking at the 1 ,000-plus chemicals that are in the American food supply that are not in the European food supply because of our GRAS regulation that we are changing.

41:04Gary Brecka:Yeah, that's amazing. We took action on pharma ads. Many of these ads can be misleading. And so we're gonna enforce the regulations. We're sending out those warning letters and letting the companies know you cannot create a misleading impression. There's a regulation that says they can't create a misleading impression. And so we plan to enforce those regulations. That's great. They sent out zero letters last year. Yeah, you too. I remember you talking about that at the Maha Summit, zero letters and you had over a thousand that you'd sent out, you know, just warning. I wanna go back to the vaccines for a minute because it's a real hot topic.

41:39Gary Brecka: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. You know, 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.

42:21Gary Brecka:You know, what, 18 vaccines in the first 18 months of life, a lot of which are vaccinating 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're gonna 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?

43:03Gary Brecka: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 does the FDA land and where is the FDA going on its investigation of vaccines, especially mRNA vaccines, which are highly controversial now. So we're gonna return to a gold standard science threshold for approvals at the FDA. We're not gonna be blindly rubber stamping mRNA COVID vaccines every year in perpetuity with no data. That's the path that we've been on.

43:47I 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. And our promise has been that we're not gonna take away anybody's vaccines, but we are going to provide information so that people can make their decisions. 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.

44:38That's our job. It's pretty simple. 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.

44:52Gary Brecka: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 mRNA flu shot. mRNA vaccine technology is being used for other things now. Our philosophy is that's great. 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 corruption.

45:40Gary Brecka: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. 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?

46:28We'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 right, go big, go bold, and don't worry about the corporations and the lobbyists. And that's what I'm going to do.

46:49Gary Brecka:That's fantastic. That'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, 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 from it, but the FDA hasn't really taken a strong position like peptides, for example, which we used in our practice and with astounding results, things like BPC-157 for tissue and wound repair, for healing and sealing the gut for people that had gut dysbiosis, Crohn's disease, diverticulitis, ulcerative colitis, these inflammatory bowel conditions that were not responsive to anything other than high doses of corticosteroids, which just bought you another problem down the road.

48:07Gary Brecka: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. 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.

48:56And so if we want to run a randomized trial for each molecule or component of some probiotic therapy, we're going to 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. The microbiome is the biggest frontier of medicine that we are not talking about 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 tracked them as to what diseases they developed later.

49:50Now, why would antibiotics potentially cause disease? Well, the theory is that we know antibiotics alter the microbiome. It's almost like carpet bombing parts of the microbiome. And you get bacterial overgrowth. We don't know what to do with it. We know overgrowth is associated with inflammation. And so 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.

50:31Gary Brecka:90 % higher rates of asthma in kids that were given multiple antibiotic dosages. 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. Celiac had a 200, nearly 300 % higher risk if a kid took antibiotics. Wow. Crohn's disease, nearly 300. All these diseases are going up. Yeah. Crohn's disease was ultra rare a century ago. Yeah. Right now, it's like - So celiac, I mean, true celiac, you know, gluten allergy. Gluten has been around forever.

51:12Gary Brecka:Now, all of a sudden, everybody's allergic to gluten. So 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 antibiotics, C-sections, and other things. but half of antibiotics at least are unnecessary. That study after study shows that. 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 and result in resistance.

52:03That's exactly what's going on. So we've got to talk about the microbiome.

52:09Gary Brecka: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? 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.

52:52But there is a new KRAS inhibitor molecule that is, for a subset of patients, appears to be miraculous. Appears to be. There is a new PD-1 inhibitor that has 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. 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 mutation.

53:38Gary Brecka:Still, GI cancers are so prevalent and they're absolutely exploding right now. I mean, colorectal cancer is on a parabolic tail 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. Donor islets. Donor islets injected into a human with type 1 diabetes. And traditionally, the body rejects these islets, just like a foreign organ. and sometimes there's been protocols to try immunosuppression.

54:23Well, 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.

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55:15Gary Brecka: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, 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, 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?

56:01And 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.

56:20Gary Brecka: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 New England Journal. Yeah. And 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. Congenital 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.

56:58Well, what are we waiting for? These kids are deaf, right? So we reached out to the company, and 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.

57:11Gary Brecka:And is this national priority review, is this something new at the FDA? Is there like a, can I use this term, fast track system now where we're, you know, companies with novel therapies that have some evidence-based? And, you know, we talked about blood filtration, for example, and non-specifically in-use phoresis, therapeutic plasma exchange, serif blood filtration, and how I certainly am a big believer in these, It's just subtractive medicine of taking things out of the body that could be distracting its normal function. Heavy metals, mold mycotoxins, parasites, viruses, microplastics. Microplastics.

57:52Gary Brecka: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 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, you know, on a stage talk not too long ago about what is the one prevailing theory of aging that everyone would agree on? And there's lots of theories of aging and I don't purport to say that this is the one, but immunofatigue 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.

58:38Gary Brecka:Like how do we empower the immune system to do what it does best, 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 system. It's amazing. I mean, if you want to ask me, that's what got us out of the pandemic. But so, you know, where does the FDA fall on some of these things like that?

59:21Gary Brecka: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 defining benefit. How do you address an industry like that and say, rather than sort of turn a blind eye and just kind of let it quietly do what it's gonna 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. And the peptide world is a very large bucket. 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?

1:00:13What 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 48 weeks or so.

1:00:29Gary Brecka:That's insane for the FDA, man. That's amazing. 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? Yeah, we don't like that word. But we got to try new things.

1:00:56The goal of lowering drug prices is such a major goal 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 hell for those companies to come to market after a biologic drugs patent expires or market exclusivity expires i mean it with humera i think it took five years wow um and the average time 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.

1:01:45And so we're going to see a lot more generic versions. We want to move more drugs to over-the-counter. Why do you need a prescription for naloxone? Right. Right? Who are we protecting?

1:01:58Gary Brecka:Yeah, who's going to abuse that, by the way? Yeah, right. 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, they can have a discussion with their doctor and decide, hey, this may benefit you. And they're not going to abuse it for the creation of something else in society. And you don't need laboratory tests to monitor, say, your liver function when you start a drug. Then what are we doing? What are we doing? So we want to get more drugs to over the counter. So that's where you can widen some of these lanes. Yeah, you can. And also when a drug's over the counter, now it's got a price on the shelf of the pharmacy, right?

1:02:43Because 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. So there's so much to do.

1:02:55Gary Brecka: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. And I'm not throwing shade at any of those countries. Nicaragua. to get therapies that are helping them regenerate their joints, that are giving them promise for neurodegenerative disorders, that are helping them repair tissues, amniotic stem cell injections for type 1 diabetes.

1:03:49Gary Brecka:And is there, 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 PVA's purvey in a reasonable timeframe 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? 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? 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.

1:04:46And I'm being honest, because I was a part of the medical establishment in all of its academic regalia at all the top, you know, I trained at a bunch of the top institutions, Harvard, Johns Hopkins, Georgetown, And let's be honest, when 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. Big data, for example. Big data.

1:05:21Gary Brecka:We talked about parachutes. We've never done a randomized clinical trial on parachutes. Yeah, where's the randomized trial on parachutes? I mean, 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 a parachute? I want to see who signs up for that control group. 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 multiforme brain cancer at Johns Hopkins.

1:05:57I 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. Yeah.

1:06:11Gary Brecka:We have less than ones who are 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. And that infection bed got the standard treatment that we do for an infected area. 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.

1:07:05The patient did fine from that. That's sort of a standard complication management strategy in surgery. Now, something happened. 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 dyes alter the behavior of children, yes, we can do 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 dyes, their aggressive abnormal behavior improved.

1:08:04improved. And then a year later, when the kid got back into those artificial food dyes, we noticed their behavior regressed to that bad behavior. We can listen to parents and learn. That is data also.

1:08:19Gary Brecka:And also, you look at the risk of potential harm that comes from removing food dyes. What's the worst thing that could happen? Because nobody is dependent upon You know, 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.

1:09:13Gary Brecka:One in particular is late-stage lung cancer that was inoperable because of the size of 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 like a termite. 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.

1:10:09Gary Brecka:The risk of rejection is obviously very low. It's their own natural killer cells. And seeing in multiple cases that this 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 intra-articular stem cells have actually avoided joint replacements. We know that they've accelerated wound healing. We've actually accelerated the post-surgical timeframe 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.

1:10:57Gary Brecka:I've seen these therapies work in front of 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 PD-1 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. PD-1, it's going through the process.

1:11:38But 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 clostomy bag. I mean, very debilitating stuff. And there's this amazing therapy, 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. What are we protecting people from? and 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.

1:12:27Now, 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?

1:12:45Gary Brecka:You got to be there to catch them if they fall, right? 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 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 in post-menopausal 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.

1:13:31And 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 because the risk-benefit ratio in first. That's very true. According to many doctors who do a lot of - We saw that too.

1:13:51Gary Brecka:Yeah, 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. 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 headwind that you're facing as chairman of the FDA? Well, I think one of the cool things. If you're willing to say it. Yeah, absolutely.

1:14:31I 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 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. And it could be, oh, there's this language and this regulation, and you realize the regulation was created by the agency itself.

1:15:24So these are like self-imposed policies. So I'll typically 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.

1:15:43Gary Brecka:Marty, let me tell you how we do things around here. I know you're new to this. You're so full of hope, right? Right, 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. 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.

1:16:20Gary Brecka:The second thing is I commend you for not being afraid to ask questions, to question the science, which is the foundation of science. It was for so long that if you asked the question, you were ostracized just because you 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 the 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 gonna do it. You got right in there. So Marty, I wind down all my podcasts by asking all my guests the same question.

1:17:06Gary Brecka: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 100, 150 years. None of 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 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.

1:17:57The 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.

1:18:12Gary Brecka:Well, you got my vote. 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 consensus of folks that are on my platform, you know, and actually have a receptive ear, you know, at the level. 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.

1:19:00Gary Brecka: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 a lot, Gary. And thank you for educating not just the public, which is what we badly need, but for willing to ask big questions. you are actually educating medical students, 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. Wow. So thank you, Gary. Thank you so much, Marty. Great to see you. I hope you'll be back on the Ultimate Human Podcast.

1:19:35Gary Brecka:Would love to. And until next time, that's just science.