← Pod Force One
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- [00:02]
A
Welcome to the Pod Force One podcast. I'm Miranda Devine and today we're joined by FDA Commissioner Dr. Marty Makary. Dr. Marty Makary, thank you so much for joining Pod Force One.
- [00:14]
B
Great to see Miranda, and welcome to the fda.
- [00:16]
A
Thank you. It's wonderful to be at your beautiful Maryland campus with all the fall leaves. I wanted to start off with Anthony Fauci, who I think, you know, we were just joking that he was the patron saint of Wuhan, but really he was given a pardon by Joe Biden in his final days before he left the presidency. Why do you think that was?
- [00:40]
B
Well, I don't think Tony Fauci is going to be sending me a Christmas card this year. We had massive disagreements through the entire course of the last four years. And look, I think he gave a lot of bad advice. I think he was involved, regardless of what you think of his positions. Insisting schools shut down for nearly two years, shutting kids out of school, pushing COVID vaccine mandates, pushing COVID vaccine boosters in young, healthy individuals, not talking about the risks of myocarditis or any other evidence of vaccine injury, censoring Americans, pushing cloth masks, giving people a false sense of security. All the areas where we disagreed. Put that aside. We can have a disagreement. We should have an open discourse on those things. One thing that's extremely obvious that very few people realize, and certainly hardly anyone in the medical establishment where I come from realized, is that he was involved in a massive cover up of the origins of COVID A massive cover up. Whether or not he was involved in the experiments or funding the experiments that led to the origins of COVID he was clearly 100% involved in the COVID up. And that all came out in the film. Thank you, Dr. Fauci, which goes through it all.
- [02:03]
A
And I mean particularly there was the letter in The Lancet which Dr. Fauci's kind of proxy, a man called Peter Daszak, who ran this bizarre little nonprofit called Eco Health alliance, which was sort of the cutout for doing that Frankenstein gain of function research in China, in Wuhan, after it was banned in America for a short time. And Dr. Fauci was, we know now, involved in the writing of that letter and making sure that it was published. What went wrong with the whole medical establishment? And I'm talking about the Lancet, I'm talking about during the 2020, you know, we'd all been locked down. And then suddenly in the summer of 2020, we have 1300 medical people, including epidemiologists, writing an open letter saying, oh, it's quite okay to go and join mass gatherings if it comes to BLM protests because you know, racial equity is so much more important than sheltering in place from COVID which just so of surprised everybody. What went wrong?
- [03:14]
B
Yeah, I'm just smiling because they did be clown themselves when they said a campaign event was a massive super spreader event. But if it was for a different purpose that they believed was noble, that it was entirely okay and safe. Look, I think our society has engaged in a toxic polarization of every issue now. The echo chambers of social media, the affirming news that sort of spins people up into a rage. And that's going on in the broader society now where if you disagree, it's no longer a healthy disagreement, where you can just be frustrated with the other person. It's now censor them, silence them, dismiss them, get them fired, lock them up in jail. That is a very toxic level of polarization we really just have not seen in the modern era. And unfortunately it's crossed over into medicine, into the healthy dialogue we as physicians had, that we had at Johns Hopkins, that Jay Bhattacharya had at Stanford, that my colleagues at Harvard when I was there, we would have these disagreements. But only recently did Anthony Fauci take it to the next level of using science as political propaganda. He commissioned the pieces that lied about the COVID origins. The author who submitted the article said this was commissioned by Dr. Fauci and Dr. Collins. In that cover letter again, you go through the emergency calls he had. So if you think back to the end of January, just before COVID became a thing in the news in the United States, January, February, what was Dr. Fauci doing? He was frantically engaging in a massive cover up with 3am emails and phone calls. He was convening people. And the notes from those meetings reveal that all these virologists he convened had told him, we think it came from the Wuhan lab. And the output was. Days later, those same scientists wrote a letter in the medical journal saying it definitely did not come from the lab. And they went on to receive, some of them, millions of dollars in funding from Fauci's agency. This is not rocket science. It's a no brainer where it came from. The researchers in the Wuhan lab sent a grant proposal in 2008 to the United States government saying, this is what we would like to do. It's called the Diffuse grant. You're very familiar with it, hardly ever covered in the media. And the Diffuse grant said the Wuhan lab researchers we, the Wuhan Lab researchers, would like to take a bat coronavirus and insert a furin cleavage site to enable this virus to infect humans. And you think, well, what a bunch of mad scientists. Why would you do that? And there's this fantasy idea that Collins and Fauci had promoted from the dinosaur age where they thought, oh, if you Frankenstein a terrible virus, then you could maybe help find a cure to it. Well, just stop. Stop doing it. You're more likely to cause a pandemic than you are to prevent one. And unfortunately, that's the lesson.
- [06:23]
A
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- [08:36]
B
Yeah. And this, this gets really dark. I mean, spiritually dark. Miranda is that scientists, after watching an experiment that in part was done overseas and in part in Wisconsin years ago, years before COVID they infected ferrets, a known animal model for viral transmission, and they created a sort of super influenza virus and infected all these ferrets. And they published the article, and the scientific community worldwide read this article, and they basically said, and I'm kind of paraphrasing the response, what the hell did you just do? No one should ever do this. This is extremely dangerous. And so the scientific community lobbied the Obama administration to ban this gain of function research, saying it's extremely dangerous. Well, they created all these rules at the time. And so Collins and Fauci meticulously worked in their bureaucratic ways to water down the power of the Oversight Committee of Gain of Function Research to get grants to go around the research around the committee by saying that it wasn't quite gain of function research, they changed the definition. They did everything you could do bureaucratically.
- [09:50]
A
That you did that in Congress. When he was being asked questions by Rand Paul, he just changed the definition.
- [09:57]
B
He has been. That's right. He parsed his words to basically lie to Congress. And it's so obvious right now. So it's, it's. Look, it's an American tragedy. What I'm shocked by coming from the faculty at Johns Hopkins is none of my colleagues knew any of this. Oh, really? There was propaganda piece published in Lancet that Fauci commissioned. Oh, really? They had emergency meetings. They had the Diffuse grant, and it was received by the US Government. Was the cookbook on how to make Covid. The Wuhan lab sent it over and said, hey, this is what we want to do. And then it happens. And we have no idea. We think it came from some random wet lab, and the epicenter of the world happens to be five miles away. I could not believe that my colleagues had no idea of the origins and the facts surrounding the origins and the massive cover up that Fauci and Collins led. And let's be honest, there's allegiance to them. They are, as you kind of opened, saying they are patron saints. Right. They have achieved sainthood and they have tremendous power. So a lot of money, all the grants. Oh, I had infectious diseases colleagues across the country tell me, gosh, you're so right on all this stuff. I'm glad you're speaking up. And I'd say, why don't you speak up? And they say, well, I get so much funding or I have a grant in front of Fauci's institute. Institute. Or you know, the NIH feeds every university in the United States. It feeds them and sets the research agenda. And the research agenda in American medicine for the last 20 years has been the research agenda of Fauci and Collins and that is Frankenstein. These virus. Why aren't we funding food as medicine and the microbiome and understanding school lunch programs? Why are we funding a lab in China? First of all, doesn't China have enough money to fund their own research? And why are we funding these dangerous experiments?
- [11:52]
A
Your predecessor, I believe, said that the biggest problem facing the FDA was misinformation.
- [11:59]
B
That's right. He said the number one cause of death in the US was misinformation. And he said his number one goal was to fight misinformation.
- [12:05]
A
What did he mean by that? People not taking the MRNA vaccine for Covid.
- [12:09]
B
Oh, he was a staunch proponent of the MRNA vaccine and Covid vaccines every year in perpetuity for all Americans, regardless of your risk. And the ultimate, I think, original sin of Fauci and that whole crew was that they failed to recognize the 10,000 fold risk difference between an older individual with a comorbid condition and a young healthy child. And so schools were shut down while bowling alleys were and bars were open. You couldn't have a funeral or get married even though they were young, healthy individuals. You couldn't do things outside because you were being disobedient.
- [12:50]
A
And also apparently the FDA sat on some pre. You obviously, during the Biden administration, sat on some research that showed that there was a huge risk for teenage boys of taking the vaccine.
- [13:04]
B
Yeah, the heart complications. Yeah, myocarditis. So they, we discovered that after we came here, they sat on data on the myocarditis risk. And the tragedy is thousands of American kids got myocarditis.
- [13:16]
A
That's criminal.
- [13:17]
B
It was entirely avoidable.
- [13:20]
A
Right.
- [13:20]
B
You could have just said, hey, we don't know if you need two doses or space the doses out or one. Or you could have been honest that we don't know if any young, healthy kid has died of COVID We still don't know.
- [13:31]
A
Does the COVID 19 vaccine, MRNA vaccine, does it work?
- [13:36]
B
I think it depends on the time and the risk of the individual. So when it first came out, it was a good match for the circulating strain at the time, and it did reduce the severity of illness in high risk individuals for sure. We saw that, we saw the clinical benefit. But over time, natural immunity became ubiquitous. You saw that it wasn't a good match for other strains that were circulating. But there was this sort of desperation. Rather than talk about obesity as the leading modifiable risk factor, we told people to, you know, stay in their homes. They put on £15 of weight. We said, just get a COVID vaccine. Every Monday morning when you show up at work or something, you know, it's. You cannot keep that transient, transient, marginal, incremental protective effect that lasts maybe three months. Then it goes to a baseline, though you can't keep taking it every three months. And so.
- [14:33]
A
And the psychic damage to kids, especially not being able to go to school. I mean, you're seeing now that cohort that was damaged, that went backwards in learning, but also psychologically, seemed to become very strange.
- [14:48]
B
Our public health officials treated children like a biohazard, not as a beautiful living human being.
- [14:55]
A
Teachers did, too.
- [14:56]
B
Teacher. I mean, all the unions. And the irony is the American Academy of Pediatrics initially said, we got to keep the schools open. It's important for the psychological development of children. And the second President Trump said the same thing. They flipped on their position.
- [15:11]
A
Right.
- [15:12]
B
And. And so Trump Derangement syndrome is a real thing. We're working on a medication for it, but I don't think it will work if it gets Approved for Stage 4 terminal TDS.
- [15:27]
A
Yes, it is really an ailment. And that was how I first learned about you. Obviously not tds, but the opposite. In March. Was it March or May of 2020, you wrote a piece of in the Wall Street Journal, and you said the opposite of what everyone else was saying. You said, we need to keep the colleges open. This virus is not very dangerous to young people or to the faculty. First of all, what gave you the kind of the courage to go public and say that you were one of the first and only. And what kind of feedback and backlash did you get?
- [16:05]
B
So that was a piece I wrote in the New York Times, actually, and it was titled we need to Reopen Safely. And it talked about how we can. How we have to treat children differently from older individuals and the importance of living life and the risk of what we call excess mortality, that is people dying from the nutritional deprivation of not going to school to get their meals. Remember, most of America lives paycheck to paycheck and not like the people in the academic ivory towers of medicine. And so they had. Were totally disconnected from what shutting kids out of school meant in inner city Baltimore now for their kids, because they're wealthy, they go to the country clubs, they break the Rules at the French Laundry. They, they have their, you know, their own rules whereby they have their private tutors. Their kids are still learning.
- [16:59]
A
Kind of lovely, Covid.
- [17:00]
B
Yeah, yeah, it was, you know, go to. Just go to work on Zoom in your pajamas. Right?
- [17:04]
A
It was.
- [17:05]
B
And. But for kids in inner city Baltimore, where I was practicing, it was brutal. It was relentless. Tell a kid in inner city Baltimore where the corners on the streets are very dangerous, hey, just take this iPad and go home. Many kids never came back to school. The dropout rates were already some of the highest in the country. My predecessor was basically just on the bandwagon of the solution to Covid is just non stop, perpetual advocating for vaccines. He said fighting misinformation was his top priority. My top priority at the FDA is more cures and meaningful treatments for the American people and healthier food for children. And we're delivering on that.
- [17:49]
A
So talk about food. What, what have you done? I think you're upending the food pyramid now.
- [17:54]
B
Yeah, the food pyramid. You talk about misinformation. I mean, the food pyramid was some of the most damaging misinformation written by the food industry, not because of the foods were what you should eat, but because it's what they wanted you to buy. The medical profession was entirely corrupted. Nutrition science is one of the most corrupted of all disciplines within the medical science. And so you had things on there like the demonization of natural saturated fats. And all the schools then were on this rampage to remove fat from milk.
- [18:29]
A
Right.
- [18:29]
B
You know, as if that makes it healthier.
- [18:31]
A
And no butter, just margarine.
- [18:33]
B
Yeah, margarine sorts of things. Some, yeah, a crazy chemical combination which is like this fake butter. And so you had schools, ironically, removing fat and then adding sugar to their milk. They had ultra processed foods to the point where 60 to 70% of a kid's calories now are ultra processed foods. No one talked about it. Ultra processes weren't even mentioned in the food pyramid.
- [18:57]
A
And is that directly related to the rise in obesity?
- [19:01]
B
Oh, yeah. The, the, the. When you take fat out of a food, it has zero flavor. So you have to add carbohydrates in. And the modern ultra processed carbohydrates allowed companies to pound a food, be it a snack well or a bar or whatever, somebody with these chemicals. The point, you turn the label and there's 50 ingredients and you're like, what? And what happened was we failed to recognize as a medical profession that all these chemicals are causing an inflammatory reaction in the gut and the body is sort of rejecting It. But not in a sudden rejection like after a liver transplant. You can go into rejection. It was a slow rejection. And when you have inflammation of any tube in the body, be it a gallbladder or a segment of bowel or the ureter. People think kidney stones hurt so much because of the jagged edges of the stones. No, that's not correct. It's because of the stretching of the ureter when it's obstructed. Stretching and inflammation is intense pain. So what are we doing to kids? They take all these chemicals, they get a reaction and they increase their inflammatory state. And the GI tract is inflamed and it manifests as the kids not feeling well, being sad. And what do we do? We drug our nation's kids at scale. We wake them up in the middle of the night, not because it's good for their natural circadian rhythms, but because it's convenient for adults going to work. We hit them with ultra processed foods. Their insulin levels surged to levels never seen before in the human race. Really hit them again. We hit them again. They get snacks during the day that are junk food. I don't never had snacks in classes. Now they have snack lists. They go to lunch. We hit them hard again with refined carbohydrates stripped of their fiber. So they're chopped up, they function like sugar. And then they are drowsy and they can't sit still at a desk for seven hours with less natural light than most inmates in a federal penitentiary. And they're under these fluorescent bulbs and they're sitting in these classes and they can't pay attention. And what do we do as a society? We drug them at scale. And we have got to start talking about the root causes. That is what Maha is all about, talking about the root causes. So part of it is rewriting that nutritional guidance, the food pyramid. We're doing it with Brooke Rawlings at USDA. We're ending the 50 year war on natural saturated fat. We're talking about the types of grains you want. Grains bound to fiber from whole foods, from good soil. You want.
- [21:48]
A
You've got rid of the dyes.
- [21:50]
B
We, yes, we took action to remove the nine petroleum based food dyes from the US food supply.
- [21:57]
A
How could they be in food?
- [22:00]
B
You know, it was cheap and easy. And I think the agency was asleep at the wheel for a long time. And so these vibrant colors made ultra processed foods more attractive to the point where kids would seek them and desire these foods with vibrant colors even though they were full. And so when you chemically engineer foods to be addictive and create these vibrant colors. You have a child chronic disease epidemic where now a third of kids have diabetes or insulin resistance in America. And we can't blame these kids. It's not their fault. This is not a willpower problem. This is something we've done to kids that we can correct. And that's why Republican and Democrat and independent moms showed up in high numbers to vote for President Trump over this agenda that Secretary Kennedy is championing.
- [22:56]
A
I remember when I lived in Australia and I brought my children here for a holiday and, and we had, I think, a four year old and he vomited his way across America. And we were worried about him, took him home, went to our family doctor. He said, there's nothing wrong with him, he's fine. And he'd gotten better. As soon as he got home, he said he was just having an allergic reaction to all the preservatives and additives in American food. And that was the first time I couldn't believe it that, you know, he had such a strong response. None of the rest of the US had that response, but he must have been younger and more susceptible. So what is that? What has that done to a generation of children, but also adults? What has it done to the immune system?
- [23:43]
B
Well, I think we've. First of all, we've never seen this before in human history. Now one in ten children has a peanut or food allergy. We have chemicals now, routine ingredients that occur in the environment and chemically engineered ingredients that are causing these allergic reactions. And what's going on with the immune system? Why is it that 1 in 6 to 1 in 7 girls born today will go on to develop an autoimmune disease? What's triggering those antibodies to then attack the woman's actual organs and cells in their body? This has been a blind spot of modern medicine. And as the NIH is focused on collecting the DNA of LGBT and transgender people at the in the all of Us Initiative and funding the Wuhan Lab, we have said we have got to look at the burden of public health problems in the United States and get answers to these people. Why is it that when a mom comes in with a question, doctors have no idea, how do I lose weight? Should I be eating this food? What can I do to treat my rash? There are doctors who actually change your diet, who can cure you of everything from a rash to certain ailments, and we never talk about it. We've got to talk about food as medicine and school lunch programs, not just putting everybody on insulin. We've got to talk about environmental exposures that cause cancer, not just more chemotherapy. We've got to talk about the quality of one's sleep, not just putting people on antihypertensives when they come in and their blood pressure is high. We are talking for the first time in history about SNAP waivers where states now don't have to use taxpayer dollars for junk food and sugary drinks. We've got to talk about these root causes, not just play whack a mole with disease because we keep throwing good money after bad into our broken healthcare system and we can keep doing that forever and it'll be completely unaffordable as it is now for some Americans. Or we can start talking about health and the microbiome and the gut and.
- [26:09]
A
And because that's where all the immune system comes from, doesn't it? From the gut.
- [26:13]
B
It's probably the biggest frontier in all of medicine that is not talked about, that needs to be talked about. For example, serotonin is involved in mood. It's a very powerful molecule that affects mental health. Do you know 90% of your body's serotonin is made in the gut, that microbiome lining by all the bacteria and bacteria, over a billion different bacteria that live in an equilibrium and it's, you're born sterile but then over time it's colonized with these bacteria and it will live in this equilibrium. And those bacteria are making, they produce vitamins, they break down what you eat, they're involved in estrogen regulation. They're, they're doing more and more things. The more we study, the more we're blown away. And what do we do to that microbiome in the modern era? We carpet bomb them with antibiotics. Right, right. Antibiotics save lives. They're necessary sometimes. But the average two year old has been on two and a half antibiotics already. What is it doing to the microbiome? The lack of breastfeeding changes the microbiome. Now some women cannot breastfeed physically or for other reasons, but let's be honest, changes the microbiome. Ultra processed food. What is that doing to the microbiome? The high glucose level. I mean bacteria love sugar and if you just pound sugar. So we've, we're.
- [27:47]
A
So the bad ones eat it up and the good ones die.
- [27:50]
B
Yeah, we get little sneak peeks of this in the hospital. Somebody comes in with intractable abdominal pain and we order a million dollars tests and they show nothing. And then we give the blanket diagnosis of bacterial overgrowth syndrome. And we don't in other Words we don't know. It has something to do with the changes. Microbiome. And then we hear the kid went to Italy for a year and suddenly feels better because they're eating differently.
- [28:15]
A
Wow.
- [28:15]
B
We have a host of inflammatory diseases that are new in the modern era. This, in the last century. I mean, there may have been rare case reports prior, but they are inflammatory conditions. It is the body reacting to something causing the gut to be inflamed. Inflammatory bowel disease, ulcerative colitis, Crohn's disease, bacterial overgrowth syndrome, irritable bowel syndrome. I mean, maybe 5 or 10% of the population suffers from one of these conditions. And so we're focused on root cause. Great.
- [28:54]
A
For the drug companies.
- [28:56]
B
Yes, probably.
- [28:56]
A
Yeah. And just a little sidebar on peanut allergies. This is something that just seems to encapsulate the whole problem. They never, I mean, when my kids were little, it just started, but now it seems everybody's got a peanut allergy who's, you know, under the age of 10, what's going on?
- [29:17]
B
Most of the world does not have any peanut allergies. But in the year 2000, there was an observation that they were real and they were slightly increasing. And so the American Academy of Pediatrics, in their sort of stupor, decided to say, hey, we're going to tell you how to prevent peanut allergies in your kid. Make sure they avoid all peanut products, including peanut butter in the first three years of life, thinking that would reduce the risk of peanut butter allergies. They forgot about a basic principle in immunology called immune tolerance. That is when your body is exposed to an allergen in the first few years, you become essentially immune to it. And they ignited the modern day peanut allergy epidemic. From 2000 until their correction in 2015, which they did kind of quietly, is embarrassing.
- [30:15]
A
Yeah.
- [30:15]
B
For them, the American Academy of Pediatrics made this.
- [30:18]
A
So for that 15 years, they actually caused the peanut allergies. Really?
- [30:22]
B
They caused the epidemic. They had been present prior, but the rates skyrocketed and it, and it snowballs. Right. Because it's a perpetual cycle. If one kid has a peanut allergy and they avoid all peanut products, then the other kids in the family are not going to get exposed. And then when you have more people who have peanut allergies, the school bands peanuts.
- [30:43]
A
Yes.
- [30:43]
B
And so when the no peanut allergen exposure, guess what, you, you create this perpetual, I don't know what it is. It's like a self licking ice cream cone. You're creating a Problem. Yeah, you're manufacturing an epidemic. And so we now recognize what happened. And that's the danger of groupthink and arrogance in medicine, when you don't know something, you just need to say, I don't know.
- [31:09]
A
If we knew more about our sleep, what would we do differently? Would we go to bed at a consistent time or take steps to reduce interruptions to our sleep? With the all new Sleep score, Apple Watch measures your bedtime consistency, interruptions and sleep duration. Then every morning it combines these factors into an easy to understand score from 1 to 100. So you'll know how to take the quality of your sleep from good to excellent. Introducing the new Sleep score on Apple Watch, iPhone 11 or later required. Hi, I'm here to pick up my son, Milo.
- [31:42]
B
There's no Milo here.
- [31:43]
A
Who picked up my son from school? Streaming only on Peacock.
- [31:50]
B
I'm gonna need the name of everyone that could have a connection.
- [31:52]
A
You don't understand. It was just the five of us. So this was all planned. What are you gonna do? I will do whatever it takes to.
- [32:00]
B
Get my son back. I honestly didn't see this coming. These nice people killing each other.
- [32:05]
A
All her fault. A new series, streaming now only on Peacock. That brings us to autism, which has been a hugely fraught issue. And just recently, the administration has come out and said two things. One is that there's this great new drug that is showing promise, but also, more controversially, that pregnant women should avoid taking Tylenol. And to me, that seems common sense. You shouldn't really be taking things you don't have to, drugs you don't have to when you're pregnant. But for some reason, there's been a huge backlash. Maybe again, it's Trump derangement syndrome. What is going on with the whole Tylenol and autism controversy?
- [32:52]
B
A couple months ago, a review article published by Harvard University and Mount Sinai Medical School described an association between taking Tylenol in the prenatal setting, that is when you're pregnant, and subsequent autism. Now, the article didn't conclude that it was causal, but there is a mixed set of literature on this, where about over a dozen studies have described this association and some studies have described no association. The majority of studies on this topic do point to the association. And so the precautionary principle, if you're going to play it safe, would say, hey, why don't we? When it comes to an expanding epidemic like autism that now affects 1 in 12 boys in California, is that real.
- [33:43]
A
Or is it just more diagnosis?
- [33:45]
B
It's both. But I think there is a real increase. You just didn't see a generation ago, the repetitive tics, the completely non verbal individuals from birth and so.
- [34:00]
A
And why boys more?
- [34:02]
B
I don't know. I don't know. But. So the precautionary principle would say we have this expanding epidemic with no known cause. Here's a body of literature where stuff studies more often than not point to an association. And we had the dean of the Harvard School of Public Health who spoke to us and said very clearly he firmly believes that there was a, is a causal relationship between taking Tylenol in pregnancy and autism. And he's gone on record and there's a statement where he just says that he believes there is a causal association, causal relationship, and not just autism, other neurodevelopmental disorders as ADHD is going up and other things. Well, look, the precautionary principle says when you have the dean of the Harvard School of Public Health waving the flag in the air saying, hey, minimize Tylenol, no one's saying ban it. No one's saying you can never take it. We're just saying be aware of this and if you don't need it, you know, think twice, talk to your doctor.
- [35:07]
A
People went crazy. I mean, there were pregnant women on TikTok taking Tylenol.
- [35:12]
B
Yeah.
- [35:12]
A
You know, what is that?
- [35:14]
B
Well, I'll just tell you personally, that really struck me how severe Trump derangement syndrome could be where somebody would take a bunch of Tylenol tablets. Because as a surgeon, I was involved in liver transplant operations from individuals that went into fulminant liver failure from taking too much Tylenol. It's a well known complication.
- [35:38]
A
How much Tylenol is too much?
- [35:40]
B
Well, I don't know, but we would just hear that somebody had a bottle of Tylenol at their, at their bedside. It's a well known association. It's in all the medical textbooks. So to hear that was particularly distributed. So look, we just said there's some literature you're suggesting this concern. And if you listened to what President Trump and others said, they said, be cautious, but talk to your doctor. Sometimes you have to take it. But you know, if you don't have to take it, we want, you know, we suggest it would be wrong not to warn people. Yeah, absolutely. So that's what we felt. We felt we had an obligate. We do it all the time at the fda. If there's studies that point to an association, we just include it in the package insert. We don't take it off the market. And so we did that, but because the dean of the Harvard School of Public Health is at a very liberal institution with extremely liberal faculty and extremely liberal donors. If I had to guess, the second the administration came out and said, hey, we want women to consider minimizing the use, he went running for the hills and hid behind a fig leaf and had absolutely nothing to say, even though this was his life work. And he had gone on record saying that there is a causal relationship, cause and effect relationship, that is with prenatal acetaminophen and neurodevelopmental disorders like autism.
- [37:06]
A
That is so cowardly. And I mean that all the problems you're talking about, a lot of them could be ameliorated if you had doctors who were in those positions of trust and authority, who were more courageous like you were. Tell us when you first came out during the pandemic and you started saying things that were going against the establishment, you were sort of one of the main dissenters. Just on now you've been proven right on everything. What went through your mind to. You must have known that you were putting your career in jeopardy. And what kind of backlash did you suffer?
- [37:46]
B
Well, and you mentioned that New York Times piece I wrote on we have to reopen safely and think about the risk of each individual. So the School of Public Health at Johns Hopkins, where Michael Bloomberg has a very heavy hand, the school is named after him. They immediately went ballistic, and they did everything they could to distance themselves from me. I was a tenured faculty in the School of Medicine with a joint appointment in the School of Public Health. They gave me a hard time. They felt I was spreading misinformation. They sent nasty wow emails to me. I tried to appeal to the leadership at the university. They had no interest in listening to this. And I. I just calling out censorship at a. At a. In academic medicine. The first thing I said probably where there I had a strong disagreement with Fauci and the gang was that the other. There are only three coronaviruses that cause severe illness in humans. SAR, SARS, MERS, and COVID19. Now the other two that we knew about before COVID19 were both spread, they were airborne, they were respiratory. Why did suddenly we thought she think that COVID 19 was spread from surfaces, Right? And so there are people telling people to pour gallons of alcohol in their mail and, you know, take showers. One thing like what? What? And so that was the first time. And I just realized there's a. There's a sort of a facade that can be put out There, the way Fauci was introduced, as in almost every media outlet, introduced as the nation's leading infectious diseases doctor.
- [39:33]
A
Right.
- [39:33]
B
He had never done an infectious diseases fellowship. He did a rheumatology fellowship.
- [39:40]
A
Wow.
- [39:40]
B
And so when I would see that.
- [39:42]
A
I would think, you know, sabotaging.
- [39:44]
B
Yeah, yeah. Just, you know, why are we all listening to one voice and not multiple voices? And then of course, CNN and a bunch of outlets just curated the same group of Fauci disciple doctors on to agree with him.
- [40:00]
A
Well, the media was just as much to blame, I think, for all the lies.
- [40:03]
B
All of. Yeah, all of it.
- [40:04]
A
And, and all those lies that we're told have really lessened the trust in public health and in doctors and in vaccines. So how do you get around that and try and rebuild that trust? And will it ever happen? Because the lies told about the COVID 19 vaccine, the mandates being shoved down our throats, made people, parents question all the vaccines. You know, the vaccines that have saved lives for eons and, and, but they do have a point, don't they, in terms of the number of vaccines? You know, they're very good vaccines that have been around forever, saved lives. But why does a baby, for instance, need hepatitis B shot?
- [40:53]
B
So first on your question of public trust, it's bad right now. It's bad. I mean, there was study in journal the American Medical association that showed from pre Covid until last year, trust in doctors and hospitals went from 71% of the public trusting to 40%. Wow. That's a 31 point drop in just one administration. And so we have to fix that. I mean, that is part of our, our charge. And I think we do it by just showing humility. And if we don't know something, we need to say we, we don't know. So, for example, the hepatitis B shot, the importance of getting it at birth versus getting it at age 10 or 12. Remember, we're preventing a sexually transmitted infection that is a bloodborne infection that you can also get from working in the hospital if you're exposed to blood. We need to be honest. And we say, look, we don't know the best time for it. We might might say, look, I have an opinion. I might personally recommend if it were me getting it at age 10 or 12. But to say you must get it on the first day of life for a little baby, when the reality is it was. If you look at the FDA approval label for the hepatitis B vaccine, you'll see under the safety section, and this is pre my time, it was approved based on A four or five day study just showing the antibodies took a bump and they watched the babies for a couple days. That was it. So to say that it has, you know, proven to be long term, safe and effective. You know what, we think it's very protective against hepatitis B. We think it's safe. We haven't done the studies.
- [42:41]
A
Right.
- [42:41]
B
You know, I mean, let's be honest. Let's just be honest.
- [42:44]
A
Yeah.
- [42:44]
B
Right.
- [42:45]
A
So are there too many vaccines that babies are being given at birth?
- [42:49]
B
So a kid today, it's not like when we were kids, Miranda. A kid today can get 72 vaccines by the age of 18. Now, what's going on there in Denmark, it's half of those. That number. And as a result they get less than half the cumulative aluminum exposure. Exposure. In Germany, uk, Japan, they all give less total vaccines than we get. Are you seeing mass outbreaks in those countries? No, you're not. And so we have to say, look, these are core essential vaccines that we believe in. And then if you want to get other vaccines, that's a conversation between you and your doctor. If you want to get the COVID vaccine, we have said as an administration, if you want it, you can get it. But we're not going to be pushing Covid boosters every year on young, healthy kids. Look, how many students were dismissed and disenrolled from college. How many soldiers, pilots, teachers, firefighters? Hundreds of thousands. It may be over a million in some estimates. Americans were fired because they failed to be obedient with this broad mandate. And so we've got to be honest with people, just have to be honest with people to rebuild that public trust.
- [44:10]
A
Your father was also a doctor? He was a hematologist, I believe. Tell me about how that he, he must have inspired you to go into the field and just about a bit of your family background.
- [44:23]
B
Oh, thanks. He's an amazing guy. You know, my family's originally from Egypt and my grandfather had a clinical pharmacy in a poor section of Cairo. And a clinical pharmacist was essentially the doctor for the. Really for the community. And he was an amazing man. I never met him. He died of a medical error when I was. Before I was born. Yeah. And that's how I got interested in patient safety and research. I think my family experience really shaped my career at Harvard, at Georgetown, at Johns Hopkins. All these.
- [44:57]
A
Because you wrote a paper about how medical error is the cause of major problem. Thousands of deaths.
- [45:03]
B
Yes, one of the. One of. And we don't talk about it. We never talk about when things go wrong. We talk about sort of the ideal. So my parents grew up with state controlled television. And so the government's just lying all the time. Right? Just not everything you watch on state controlled television, you just know it's a lie. You probably can assume it's the opposite.
- [45:27]
A
Right.
- [45:27]
B
And I even remember watching TV in the United States. I was born in England, but I was raised in Pennsylvania in the United States. And I remember watching TV with my mom and my mom would just sit there saying, you know, the eve watching the even news, that's not happening, that's not real. And I'd be like, mom, it's a hurricane in the Caribbean or this volcano. I remember one time they were showing pictures of the lava volcano in Hawaii and she said, that's not, that's not happening. I'm like, it's right there. And she said, now those are doctored images. They could.
- [46:02]
A
And so the woman before her time.
- [46:04]
B
Yes, she was right. And so they just always knew the government was lying. And governments in general tend to abuse their authoritative position. Right. And tell us that there are reasons to go to war when there are not reasons to go to war, be it weapons of mass destruction or whatever it may be. And so my mom had this healthy skepticism to try to get at the truth, sort of like you do as a journalist. And I think that's why I sort of became a journalist within medicine. I became a researcher. I really focused on Research. Written 300 scientific peer reviewed publications in my career.
- [46:42]
A
And your best selling New York Times books, I've only read the latest one, but I mean they read like investigative journalism. You've done your own work, you've interviewed people yourself.
- [46:52]
B
No, thank you. Yeah, I loved writing those. I think we need more investigative journalism and medicine.
- [46:58]
A
Yeah.
- [46:59]
B
But that sort of healthy skepticism I think really established my interest in being intellectually curious. Curious about every area of medicine. My publications are in ophthalmology and orthopedics and women's health and public health. And so.
- [47:17]
A
Pancreas specialist, aren't you?
- [47:19]
B
Yeah, you know, when you, when you, when you're in medical school and day one, they say, well, what are you going to specialize in? And you're like, I don't know, I just, I'm interested in medicine. I'm interested in the holistic care in the human body. And they press you and press you. And so it's this intention, intense pressure.
- [47:33]
A
So why did you choose pancreas?
- [47:35]
B
Well, I decided I wanted to be a missionary doctor. And I asked people in the mission field what would you, what residency would you do since you have to pick something? Family medicine, general internal medicine. And to my surprise, they said surgery, because you can read about the other treatments, but the surgical skills are technical skills, skills that require technical training. So I went into surgical residency. I'd loved my time in the operating room. And then, you know, the pressure. Well, you need to set, you need to specialize. And I said, okay, well, I'll go in. I'll. I'll do a year. I did an extra year under the chief of surgery. One of the most famous surgeons in the U.S. john Cameron at Johns Hopkins, well, he happened to. To specialize in the pancreas. And so when I got this role to work under him, I said, I guess that's what I'm going to do. And then I do the training and I become specialized in pancreatic diseases, which.
- [48:35]
A
Is quite prescient because that's what a lot of these problems now we have originate, don't they?
- [48:40]
B
That's right. That's what's happening to kids in schools with the school lunches. Their pancreas are surging insulin. So it is central to understanding public health and diabetes.
- [48:50]
A
And, and what is the pancreas? What does it do?
- [48:52]
B
So it's an endocrine organ in the center of the body. It's sort of in the seat of the soul of the body. It's deep and it has no capsule. So it's like a piece of jello. It's a very technical skill set to carve it or change the plumbing. It produces enzymes that are involved in digestion. And so it's very much part of gastrointestinal medicine. And so I specialize in pancreas. And then people say in medicine, you got to specialize even more. You got to subspecialize. Then I subspecialized in minimally invasive pancreatic surgery and pancreas islet transplant operations. And then people said, you got to specialize more.
- [49:32]
A
Really?
- [49:33]
B
And I'm thinking, I don't know how much more there is to specialize. I'm not going to just focus on the left side of pancreas. But. But then the whole time you have these kids, curiosities, informed consent doesn't look right. People don't understand the risks and benefits appropriately. Why are we doing this and not doing this? That has a much bigger impact on public health. Why is it when somebody comes in and talks to me about nutrition, we have literally zero education? Why don't we talk about the microbiome that lines the intestinal Tract. And so these curiosities really would pull at me and my mom. Skepticism, I think, you know, made me curious. And, you know, medicine's an amazing profession. It's an ancient profession. It's one where you have an impeccable lens on the equality of human beings. You're the witness of birth and death. And it's a. So it's a sort of sacred.
- [50:30]
A
Equality is in. Everyone's got kidneys and hearts and livers, and we're all the same underneath. Yeah.
- [50:36]
B
We're all the same underneath.
- [50:37]
A
Yeah.
- [50:37]
B
And I would see patients come up to my dad in the grocery store and give him a big hug. I didn't know what was going on. Some random person hugs my dad and starts crying. And then the patient would look at me, the individual, and say, your dad walked with me through leukemia for 15 years. He means the world to me. And you see that, and it's beautiful, and you want to be a part of it when you're a kid. So that had a big impact on me.
- [51:03]
A
He was a hematologist.
- [51:04]
B
Hematologist. Started in pediatric hematology and then migrated into adult hematology practice at a hospital called Geisinger in central Pennsylvania in the middle of nowhere.
- [51:16]
A
And so you. You grew up in. Or you were born in England. So presumably because your dad was working there and then he moved to America, your whole family moved to America when you were a baby?
- [51:26]
B
Yes.
- [51:27]
A
Yeah.
- [51:27]
B
Yes.
- [51:28]
A
And how did they like being here? You know, what was. They obviously left their home, their parents, their family in Egypt, in Cairo. What was that transition like for them?
- [51:39]
B
There was a time when. When they left, when Egypt was starting to indicate a turn towards communism, and the opportunities were very limited. My father really wanted to be a subspecialist and understand cancer and hematology. They're very grateful to be here, to be Americans, and I'm extremely grateful and to, you know, be able to serve my country, not in the military, but in this role. I am so deeply indebted and grateful for this opportunity.
- [52:10]
A
Well, America's very lucky to have you doing this. And when you could be out making, I'm sure, a fortune carving into people's pancreas. Can I ask you just a question about. Of course, surgery. What. What was it like when you first had to cut open a person? And then, I would imagine it would be very scary. And then the pancreas. What is it like to. To, you know, I mean, you've got someone's life in your hands.
- [52:40]
B
Well, I've had great mentors and the way that it becomes palatable to do something like that is to observe a very controlled setting where the drapes are over the patient, so you're looking at a sort of a window of their skin or their abdomen. And then we talk technically about how to do things in a way that constantly has us reminded of the mission to help them. We're trying to help them. We're trying to get a tumor out of them. We're trying to rework the plumbing in the system. We're trying to implant an endocrine organ through a transplantation.
- [53:20]
A
Right. So it's always about helping. And that's. So what went wrong with medicine when it came to sort of the transgender fad, I guess, where, you know, it seems to be the opposite of the Hippocratic, both that you give children hormones that you carve off healthy body parts. Why did that happen?
- [53:47]
B
I think misinformation. I think groupthink started to dominate. There was a philosophy that was never supported by clinical evidence, but it became popularized, I think, first at universities and then the medical field, which makes a killing. They make a fortune of transgender transition operations. Would say, well, and I would talk to surgeons that do this operation, and I would say, how do you know you're doing the right thing here? I mean, there are high regret rates. You're permanently sterilizing a child, and they. They're going to be different for the rest of their life. And they would often tell me the same thing. Well, they go through a separate psychological evaluation. I have nothing to do with that. If the psychologist or psychiatrist gives a note that they have this gender dysmorphia and they want to do it, I just do it.
- [54:48]
A
Right.
- [54:49]
B
And I thought, this isn't. This is not right. I mean, it is so hard to watch. And now we have the testimonies of kids that wish that they feel that they were tricked into it. What are we doing? What are we doing?
- [55:03]
A
Yeah.
- [55:03]
B
And so we're looking at all of that because this was. This, I think, by and large, has been a dogma that resulted. Has resulted in manipulating parents to consent.
- [55:18]
A
And telling them the child will die.
- [55:20]
B
Your child has a high risk of suicide, and you'd rather have. Have a transitioned child than a dead child. Well, that's manipulation. Show me that data. Yeah, show me that data. So there's been. This is a sacred cow topic in American medicine. You're not allowed to talk about this. We are. But in academic medicine, you are censored, dismissed. There's essentially political apartheid in the medical establishment. If you question this, you are not allowed to attend the same panel discussions, join the same societies. You're dismissed from conversation. And what is the evidence to support this? No real deep dive into the evidence until the UK did it in the Cass Commission.
- [56:05]
A
Yes.
- [56:06]
B
And they concluded that essentially there was no clinical evidence of any high level to support puberty blockers and these transition operations and children.
- [56:21]
A
They closed the Tavistock Gender Clinic as a result, which had been doing most of those transitions for kids. But has that filtered through to America?
- [56:30]
B
There is, I would say, a reduction since the beginning of this administration, when this administration made it clear to hospitals that this is not something that we support support and that we want to see it, we want to get back to evidence based medicine. And so you've seen a massive reduction since Trump was it came to office in this type of stuff. And we're going to keep going, we're going to look at this, we're going to look at the evidence, we're going to point out what's evidence based and what's dogma.
- [57:01]
A
So what's the FDA's role in that?
- [57:03]
B
Well, we, some puberty blockers are FDA approved medications. And so when people are using them off label, we need to understand the lack of evidence or the evidence to support the off label use and bring attention to this issue.
- [57:20]
A
And there are a lot of other sort of dogma, I guess you call it, of medicine that has been proved not to be right. One of those was the treatment of menopause with HRT with hormones, which was said some years ago to cause breast cancer. And that's not the case.
- [57:38]
B
Well, first of all, when you say there's a history of the medical, modern medical field, we're not talking back in the 1700s, but the modern medical field getting things massively wrong. Yeah, I'm thinking, as you're saying that where do we start?
- [57:52]
A
Right.
- [57:53]
B
Opioids are not addictive. We got that wrong for 15 years.
- [57:56]
A
How many lives were destroyed by that?
- [57:58]
B
Maybe a million. Natural saturated fat causes heart disease, but I got that wrong probably 50 years, the peanut allergy epidemic. So one of those major mistakes, maybe one of the greatest mistakes of modern medicine in the last 25 years is the demonization of hormone replacement therapy for postmenopausal women, calling it a carcinogen. We're talking about women taking estrogen or estrogen plus progesterone, when their body stops producing those hormones, it not only now we understand has short term benefits, but tremendous long term health benefits. It doesn't just alleviate the symptoms that women go through when they go through menopause. The night sweats, hot flashes, mood swings, weight gain, painful sex because of the dryness. There are maybe 50 different symptoms of menopause, and every woman experiences menopause differently. Hormone replacement therapy for postmenopausal women not only alleviates those symptoms, but it has long term health benefits that have been massively underappreciated and under recognized. Women feel better and live longer. Hormone therapy when started before age 60, that is, you need to start it within 10 years of the onset of menopause, reduces the risk of heart attacks by 25 to 50% in some studies. Now that's the number one cause of death in women. Why are we not talking about it? Women's health issues have not gotten the attention they deserve. And it's a huge priority in this administration to make women's health issues a top priority. Hormone therapy reduces cognitive decline by up to 64% in one study. Reduces the risk of Alzheimer's by 35%. It prevents osteoporosis, improving bone strength, which means if a postmenopausal woman falls or is in a car accident, they're far less likely to have a bone fracture or have a hip fracture. So the benefits long term are so overwhelming. Arguably, with the exception of vaccines and antibiotics, perhaps, there may be no medication in the modern era that can improve the health of women on a population level more than starting hormone replacement therapy within 10 years of the onset of menopause.
- [60:39]
A
And so one study saying that has since been debunked, denied all those women for a generation.
- [60:47]
B
That's right. Doctors had been prescribing hormone therapy routinely. Many women were enjoying the benefits of it. But then in 2002, an individual from the NIH declared that hormone therapy causes breast cancer. Even though the study was released in the media before it was published.
- [61:08]
A
Right.
- [61:08]
B
The study found no statistically significant increase in breast cancer. That was part was left out, really. Yeah.
- [61:16]
A
And can we blame Anthony Fauci for that as well?
- [61:19]
B
It was a Fauci type individual at the nih, and it became dogma. And the fear machine loomed large.
- [61:29]
A
Yeah.
- [61:29]
B
Doctors on that day of that press announcement called their patients and said, you've got to stop taking this. We now know that if you take estrogen alone in that same study, you had a reduced risk of breast cancer. It lowered the risk of breast cancer in the estrogen only group. And that no subsequent clinical trial has ever found that hormone replacement therapy in perimenopausal women increases your risk of Dying of breast cancer. Wow.
- [61:59]
A
What a travesty.
- [62:00]
B
Dogma. Yeah. 50 to 70 million women may have been denied this. Incredible. And the FDA piled on by putting a black box warning on estrogen products at the time.
- [62:10]
A
Is that still there?
- [62:11]
B
We are remove. We just announced removing the black box warnings. And we will now have a nuanced discussion so we don't promote this fear machine and allow doctors and women to make this decision.
- [62:23]
A
Right now, I have another last question for you, which I'd forgotten to ask you, but it's about actually two of them. One is about C sections. So that I think is another issue that you've been strong on saying there's just too many C sections. And why does that matter? It's not just the cost, but it's also health, isn't it? Of the baby.
- [62:47]
B
Yeah. Look, we have two problems in American medicine. Under treatment and over treatment. But by far over treatment dominates the US Healthcare system. And too many C sections is a classic example. Women who are told while they're in labor, well, a C section might be safer for the baby when it's not necessarily safer for the baby. It's just a way to justify doing a C section, maybe out of convenience. And so if you say that to a woman in labor, that something may be safer for their baby, 100% of people say, yeah, we'll do it.
- [63:25]
A
Yeah.
- [63:25]
B
Well, why do you have C section rates in some high risk populations of 12% with good outcomes and in other hospitals it's 35% or 40% or individual doctors with C section rates over 50%.
- [63:39]
A
But isn't that the. Often the mother like, too posh to put push is a line.
- [63:43]
B
Yeah. There's a lot of techniques, I think, that have resulted in manipulation. Now, C sections save lives. And you want a doctor who does it that does C sections judiciously or recommends them judiciously. But let's be honest, it's different if you have a C section, the baby is less likely to latch. There are they are not going to get the seating of the microbiome necessarily that they will get when the baby passes through the vaginal canal in a natural delivery. Because remember, a baby is sterile. There's no bacteria in the gut when the baby's in utero. So the microbiome begins to form by anchoring bacteria that the baby is exposed to through the birth canal.
- [64:28]
A
Swallows.
- [64:30]
B
Yes. Or so. And some medical centers now, like, I think they have this protocol at Mount Sinai Hospital in New York. If you have a C section, they take a vaginal fluid swab and wipe it on the baby. Yeah. Because they want those healthy bacteria to seed. So. Yeah. So there's a lot of things in medicine where there's room for improvements in quality, and that's one of those areas. And I've written a lot about that topic.
- [64:53]
A
Yeah. Last question, I promise.
- [64:56]
B
Sure.
- [64:57]
A
So many interesting things that come up with you and your books. There's also something about generic drugs being made overseas, primarily I think in China and India, where the FDA knew that there was just horrendous sort of factory problems and dangers, I guess, and yet did nothing about them. This is pre your tenure. Can you tell us a bit about that and how that can be fixed?
- [65:28]
B
Gosh, that was so hard. Hard to read that the fda, years prior to us coming here and as recently as a few years ago, had issued overrides of massive safety violations seen in manufacturing facilities overseas. So a factory that makes medications for the United States would have a sterility violation or egregious safety violations. And individuals here at the FDA who are here no longer said, well, doesn't matter, we're going to accept those medicines anyway in the United States because they were worried about drug shortages. Well, safety is my top priority. We're not going to be doing that. We're not going to be playing games. We're going to be honest with the American people. You know, I'm very clear about what my priorities are here. More cures for the American people and meaningful treatments and healthier food for children. And so part of that is we are going into the pipeline and asking the scientific reviewers, are you seeing anything that looks amazing? Anything in animal studies, early phase one trials? And if so, let's put those at the front of the line. If you're going to move your manufacturing from overseas to the United States, we're going to put your application at the front of the line and we're going to create massive incentives to encourage that. And we're going to do your inspections during the construction phase of your plant so you don't have to wait for the FDA for a year after it's done being built. We're doing everything possible and it's happening. We're seeing an exodus of manufacturing come to the United States pharmaceutical manufacturing, generic drugs. We have a new program to cut the red tape for biosimilars, which are the generic versions of the expensive biologic medications. That's what's the fastest growing area of healthcare inflation. It's driving up healthcare costs. It's these new biologic drugs it's half of all the new drugs. And so we're saying we are going to allow a generic version of that to come on the market faster once the patent expires. No longer is it going to take 7 years or 2.5 years.
- [67:39]
A
And presumably it's cheaper, too much cheaper.
- [67:42]
B
And you have competition then. And so we are going to allow more interchangeability at the state level for some states, so the pharmacists can swap out the generic version of a biologic. Biologic called the biosimilar, if the patient wants. Right now, that's really not allowed. So we're doing a lot.
- [68:03]
A
And you, you said you're going into the pipeline to find research.
- [68:07]
B
Yeah.
- [68:08]
A
Could there be a cure for cancer in your tenure or in our lifetime.
- [68:12]
B
In our term in this administration? You're going to see a powerful treatment for certain types of cancer, I believe for neurodegenerative disorders, some in particular like Parkinson's, Alzheimer's, Parkinson's, als, something. I want to see something meaningful come to market. And so right now we have a process where it takes 10 to 12 years for a drug to come to market. Makes no sense. And so we are challenging that assumption. We have a new program to get decisions out in weeks. We are going into the pipeline searching for powerful cures. I want to see a treatment for ptsd. We have veterans who are still suffering from these wars. I want to see a universal flu shot so you don't come in every year and we guess what the structure strain is. We want to see powerful new treatments. A few weeks ago, a study came out in the New England Journal of Medicine showing that some kids were being cured of child deafness, a certain kind of congenital deafness that affects 1 to 3% of kids with congenital deafness. It was a gene therapy with a device. And these kids were cured, Sometimes cured. Well, what did we do? We contacted the company, we saw the study, we immediately reached out, and we gave them a voucher for a priority review. In weeks, in weeks. That is how we are functional. We cannot take this passive receive only mode that bureaucracies tend to take. We should not be a stingy librarian sending applications back because the margins are incorrect. We need to partner with these drug makers to deliver more cures to the American people and yet keep our review process impeccably independent, scientifically independent. And you may have seen, I. One of my first actions was, well, after we eliminated animal testing requirements.
- [70:08]
A
Yes. Fauci loved testing on beagles.
- [70:12]
B
He loved beagles. Yes.
- [70:14]
A
Very mean to them. Yeah.
- [70:15]
B
For research.
- [70:16]
A
Yeah.
- [70:16]
B
And so we took that big step to.
- [70:19]
A
That's great.
- [70:20]
B
The roadmap to eliminate animal testing. It turns out computational modeling is better in testing drugs than animal testing.
- [70:27]
A
Oh, really?
- [70:27]
B
Yeah. And some drugs get held up in animal testing where they have no toxicity in humans. So we may be missing out on some cures. So we're using better techniques, including organ cell lines where the drugs can be tested in the lab on those.
- [70:42]
A
So you don't need the animals at all. It turns out for a lot of.
- [70:45]
B
Areas of medicine, we don't. And so we're sequentially doing it. We want to do it the right way, safely. But one of the other early actions I took was to remove all pharma and industry members from FDA advisory committees wherever statutorily possible.
- [71:03]
A
Gosh, you'd think that that would have been done a long time ago. That's insane.
- [71:07]
B
The agency has gone through some chapters in its history where it's been captured by the industry it's a supposed to regulate.
- [71:14]
A
Yeah.
- [71:14]
B
And so we don't want that to happen. And I'm very proud of where we are right now.
- [71:17]
A
And the ads as well. I think you've, you've worked on getting rid of ads. I mean, America is one of the few countries that actually has big pharma ads on television.
- [71:27]
B
Yeah. It's getting out of control. It's distorting the doctor patient relationship. These endless pharmaceutical ads. This is something doctors are united on. The FDA had been lax in enforcing the regulations. On pharma ads being misleading. Yeah. On them being misleading. We have regulations that they have to provide a fair balance of information. They can't create a misleading impression. And so we're.
- [71:55]
A
You say the singing, dancing ads.
- [71:57]
B
Always singing and dancing. Or marching, you know, marching from some fake town to I don't know where they're going. But you watch these things non stop and you're like, okay, I'll take it. I don't know what it is. I think I heard sudden death and then a complication, but. So the FDA used to send out over 100 enforcement letters a year in the Biden administration. It went down to one letter really in 20, 23 and 0 last year. So a few weeks ago I sent out 1,500 warning letters and over 100 cease and desist letters to those companies. Companies. And we're going to keep going.
- [72:32]
A
Amazing.
- [72:33]
B
You know, they spend 20 to 25% of their budgets as a pharma company on marketing. They should spend that on lowering drug prices for everyday Americans. We're doing it with our most favored nation status pricing. The president is lowering the price of drugs in one case from $243 to $10. We're not talking a tiny 2 or 5% reduction. We're talking massive reductions. That is a health reform. All the health reforms we hear are just about subsidizing the broken system. We know it's broken. Just keep throwing money at it. How much money do we throw at it? You're seeing in this administration, we are actually lowering the price of services and medications. And that is powerful and I think it's going to translate into real relief for everyday Americans. And drugs now are going to be more expensive, accessible.
- [73:25]
A
Wonderful. Well, well done. You've been doing a brilliant job just in the first few months that you've been here. So we look forward to, to the rest, the cures and all the other improvements. Thank you, Dr. Miranda.
- [73:37]
B
Great to be with you. Thanks for being here at the fda.
- [73:41]
A
Thanks for watching Pod Force One. I'm Miranda Devine. Don't miss next week. Please give this podcast a like and a follow and maybe that'll help other people find these great conversations. Hey, Ryan Reynolds here wishing you a very happy half off holiday because right now Mint Mobile is offering you the.
- [74:02]
B
Gift of 50% off unlimited.
- [74:04]
A
To be clear, that's half price, not half the service. Mint is still premium unlimited wireless for a great price.
- [74:12]
B
So that means a half day.
- [74:15]
A
Yeah. Give it a try@mintmobile.com Switch upfront payment of $45 for three month plan equivalent to $15 per month required new customer offer for first three months only. Speed slow, 135 gigabytes of networks busy. Taxes and fees extra. See mintmobile.com.