
In this special bonus episode of The Megyn Kelly Show, Megyn Kelly is joined by FDA Commissioner Dr. Marty Makary to discuss new information on the short- and long-term health benefits of Hormone Replacement Therapy or HRT, how it can actually help reduce heart attacks and dementia as well as sleep, a 2002 flawed study that scared women about the risks of HRT, new data showing the potential dangers for women of taking antidepressants and SSRIs while pregnant, the potential that it could cause birth defects, shocking information about Chinese gene therapy, the truth about what Makary has uncovered at the FDA about COVID, and more.
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Megyn Kelly
Welcome to the Megyn Kelly show live on Sirius XM channel 111 every weekday at noon East. Hey, everyone, I'm Megyn Kelly. Welcome to the Megyn Kelly Show. Earlier this week, the FDA hosted a panel on menopause and the benefits of hormone replacement therapy for women. For years, women have been scared into thinking that HRT was linked to breast cancer because of a misleading study from 2002. Well, Dr. Marty Makary spoke with us about this back in episode 881. That was before he became FDA commissioner and he was sounding the alarm on that study back then. He's done the same thing to his credit now as the big boss over at fda so he can share his message with women across the country. Dr. Makary joins me now. Mr. Commissioner, great to have you. Welcome back.
Dr. Marty Makary
Great to see you again, Megan, you as well.
Megyn Kelly
And thanks for doing this because there's so much misinformation on this on hrt. And even amongst my friends, they don't know what to do because there is a general belief it's bad for you, you shouldn't do it. And, and then women, there are other women who say, well, I don't have hot flashes, et cetera, so I'm not going to do it. And what I gleaned from your panel and your book for that matter, is there are other reasons it's not going to cause breast cancer in these numbers that we were told in 2002, It's a very, very minimal risk. And secondly, it's got a lot of really good benefits.
Dr. Marty Makary
Well, that's right. Look, women have been confused for a good reason. The medical establishment has doesn't even, they're not even all on the same page. And the misunderstanding around the studies has created a lot of dogma that you should not take hormone replacement therapy because of an increased risk of dying of breast cancer. Now it turns out when you look under the hood, no clinical trial has ever shown that hormone replacement therapy for perimenopausal women increases the likelihood of dying of breast cancer. Now there are importantly two different areas of benefit and I should just point out there are contraindications. Some women cannot take hormone replacement therapy. But the vast majority of women going through perimenopause can have not only short term benefits, but long term health benefits. And often when people talk about how it alleviates hot flashes and night sweats and helps with mood swings and better sleep quality and helps prevent some of the weight gain associated with perimenopause, there really only talking about the short term benefits. Now I'm not here to say they're more important or less important than the long term health benefits. I'm not a woman. But look at the studies on the long term health benefits. Cutting the risk of heart attacks in half in some studies or 25 to 50% reduction in other studies. That's the number one cause of death in women and it may prevent Alzheimer's, reduces the risk of cognitive decline by up to 64%, reduces osteoporosis risk and the risk of bone fractures, cutting that risk in half. Those are some of the serious long term risks that can take the life of an older woman is risks of bone fractures and hip fractures. So there may be no other medication in the history of modern medicine that can improve the health outcomes of women on a population level than hormone replacement therapy when started within 10 years from the onset of perimenopause. Maybe with some rare exceptions, I might cite antibiotics as one of those exceptions. But the incredible health benefits of hormone replacement therapy described by the experts at the FDA expert panel just recently have been in the bucket of things in modern medicine that have been underappreciated, under recognized and underfunded. Probably because it deals with women's health and that it is something that needs to come to the surface. Every woman needs to know about the the real data on this topic and not follow dogma for dogma's sake.
Megyn Kelly
The thing that's great about, I mean preventing dementia Hello. Everybody wants to prevent Alzheimer's or dementia, but the thing about hrt, too, is it's estrogen and progesterone. And progesterone helps you sleep better in the short term, even which if you have terrible sleep. We've talked about this with a number of experts. That actually increases your risk of getting some form of dementia. So it's got, like double protection there, where you start to get better sleep immediately. And then long term, it can have, I guess, maybe for other reasons, the effect of helping prevent some forms of dementia.
Dr. Marty Makary
Yeah, it's pretty cool how the importance of good quality sleep is now being recognized as a central component to so many aspects of health. And poor sleep may help drive some of these chronic diseases, including dementia and perhaps even Alzheimer's, in some studies, including one study I was a part of at Johns Hopkins in my previous career. So we're learning more and more that good quality sleep, a healthy microbiome, and what we eat is so central to health. We have had a healthcare system, Megan, entirely focused on drugs and operations. And we've gotta ask, why is Alzheimer's going up every year? It's not just because we have older people in America, as I was taught in medical school, we have early onset Alzheimer's that has tripled in the last few decades. What's going on here? Two thirds of the cases are in women. What's going on here? Turns out there may be an association with the hormonal access. When a woman takes estrogen starting around the time of perimenopause, that risk of Alzheimer's goes down by up to 3.35percent in some studies. So I'm not. Look, I'm not in the business of being someone's teledoctor or telling them what to do. But the data on this area of medicine has been so massively misunderstood and misrepresented. And you saw the fear machine come out 23 years ago talking about, you know, such a sensitive topic like breast cancer to women demonizing hormone replacement therapy. People need to know the facts. And one place to help get good information, in my opinion, is the FDA expert panel that's available online for women to watch.
Megyn Kelly
Yes. So you talked about this when you came on before your new job, and in your book, you get into this about how all the misinformation was rooted in this 2002 study called the Women's Health Initiative. The lead author was Dr. Jacques Russo. And you, when writing your book, went to him to say, I don't. I've looked at your information I don't see this. The correlation between what you said was HRT and breast cancer, because he came out in the middle of doing that Women's health initiative and said, the risk is so high for breast cancer from hrt, we need to stop the study right now. We need to stop doing this to women. And women all across America said, I'm out, and threw away their hormones, the estrogen and the progesterone. But you actually went to him and found some remarkable. I mean, got some remarkable admissions.
Dr. Marty Makary
Well, the most amazing thing, Megan, was that he acknowledged to me that the little tiny bump in breast cancer cases that they observed in the study was not statistically significant. You have to run statistics in these large trials to know whether or not something is a random occurrence, whether or not it's noise in the data or whether or not it's a true association. If you don't run statistics, then we don't have science. All of a sudden, snake oil works and cures cancer, and we don't have science anymore. So he actually acknowledged to me that the observation of breast cancer in one of the looks of the data was not a statistically significant finding. And by the way, subsequent studies have found no statistically significant increase in and dying of breast cancer. So what does that tell you? It is amazing. It really is amazing because when that announcement hit, and, you know, he feels that the media got ahead of his results when I. When I had talked to him. But when those headlines hit that hormone therapy causes breast cancer, man, women flush their pills down the toilet. Doctors were calling and scaring all the patients in their practice, saying, get off of this. There's been new data, and honestly, I don't even know if some of them had actually read the numbers in the study and noticed there was no statistical significance.
Megyn Kelly
So you. This is from your book. It's amazing. You write, I asked Dr. Russo point blank, was the breast cancer link in his study statistically significant? He answered, quote, it touched on significance but wasn't quite significant. It was nominally significant. It was not significant after being adjusted for multiple looks at the data.
Dr. Marty Makary
What?
Megyn Kelly
And based on this, people ran for the hills. And I know this is personal for you because you feel like your own mom could have benefited from this but didn't.
Dr. Marty Makary
Look, my mom is One of the 50 million women over the last 23 years never offered hormone replacement therapy or the many potential health benefits associated with it because of this study. And it became dogma in the medical field. And, man, they pounded this message into primary care doctors and doctors all over the medical field, it just became this dogma that it causes breast cancer, therefore don't prescribe it. And by the way, medical schools never even taught about menopause because why teach about all the symptoms of menopause if there's nothing you can do to treat them? So you don't even need to teach about menopause. So we didn't, we got almost no education on menopause. There was this dogma, but my mom was one of the 50 plus million women never offered it. She should have been offered it. She would have been a great candidate. And you know, HRT reduces the chance that you're gonna break a bone if you're in a car accident or if an 80 year old woman falls later in life, there's like a 50% increase. The risk of breaking a bone is cut in half if you're on hormone therapy. Well, my mom broke her bones twice in two different falls. You know, in one of them, I remember showing the X ray to an orthopedic surgeon friend of mine and I said, does she really need surgery with screws and pins? And you know, my mom is not, you know, you put an older woman through something like that, it sets them back, it's debilitating. They're non ambulatory. And sometimes that sets up older Americans for a cascade of events that can result in their demise. So I didn't want to see her non ambulatory. Well, the orthopedic surgeon said it's really on the border as to whether or not these fractures require surgery. But in my opinion, I think she does need surgery. Well, if it was that much of a borderline call, certainly hormone replacement therapy would have helped her avoid that bone fracture and all of the cost and pain and debilitation associated with that long, lengthy physical therapy. And that's just my mom. And I'm putting these pieces together from what I've done from my research. Think about the 50+ million women. An 80 year old woman has a 1 in 3 chance of having a hip fracture and a quarter of women die within a year of a hip fracture. So these are real issues that are never talked about. Even if hormone replacement therapy slightly increased the risk of developing breast cancer, as was kind of conjectured, the other massive health benefits would far eclipse any harm from the breast cancer issue.
Megyn Kelly
I'll tell you another piece of this that I've noticed just as a woman there is, and of course all my doctors are in New York City where I've been living for the past 17 years now. I've moved to Connecticut, but my docs are still back in New York, and they're all lefties. So this is not a political thing. But I will tell you, there's a political line that you may not even know about. But some of my top women's health care docs, I'm not going to say who, because I don't want to embarrass anybody, but some of my top women's health care docs have said to me, you know, menopause, it's not a disease. You know, there's no. It's nothing. It's not something to be cured. You don't have to go on drugs to solve menopause. And there was like a sort of a lefty woman's bias of, like, these men who are trying to get us to tap into some fountain of youth so they can enjoy sex with us more don't understand that this is like a normal progression of a. And it's. To me, I was like, wow, that's so crazy. This. You don't have to be looking for a fountain of youth to go on hrt. You can be looking for all these other benefits. But I have heard more than one doctor talk about it like they resent it.
Dr. Marty Makary
Yeah. Look, this issue is polarized in medicine, just like society is polarized around politics. And there's a lot of misunderstanding. Hormone replacement for perimenopausal women is exactly what it says. You're replacing your body's natural hormone production. And there are actually hormone replacement forms that are similar to the exact molecule that your body produces. And there was an observation at the Mayo clinic in the 1950s that when a woman had their ovaries removed in their 20s, that is, young women had their ovaries removed, say for a cancer or some other reason, they were developing early heart disease. And that data showed, including one woman who developed. Had a fatal heart attack at age 28. Well, what does that tell you? It suggests the profound cardioprotective effect of a woman's estrogen level. And so when you remove the ovaries, and basically this happens functionally in menopause, the body's natural production of estrogen goes way down. We're talking about continuing the body's natural levels. And progesterone is recommended to add to estrogen. If a woman has a uterus. A third of adult women do not have a uterus. It's been taken out for some reason. But if a woman has a uterus, it's recommended you take both estrogen and progesterone by doctors out there. Again, the doctors at the FDA expert panel, I thought did an amazing job. Stuff everybody should know.
Megyn Kelly
Yeah. Because you, the progesterone protects you from uterine cancer, so you have to take that too, in addition to the estrogen. And the other thing is, by the way, I've talked about this with women's health doctors who have come on this show. Sometimes when you get older, as a female, your sex drive can start to go down and HRT can help with that too. Getting your levels back up to just sort of normal, for lack of a better term is helpful in that regard. So it can be, you know, can lead to other good things, marital health and all that. I do want to play. Speaking of the doctors are at the panel, Dr. Joanne V. Pinkerton, she was there and she, she's as frustrated as you are about the fact that if you, if you get hormone replacement therapy, there's still what's called a black box warning on it right now, which will scare the bejesus out of most people. Here she is lamenting. That's one.
Dr. Joanne V. Pinkerton
I am begging the FDA and all of us are begging, please remove the box label, put a warning if you bleed. You need to be evaluated for that rare risk of endometrial cancer. If you've had an estrogen sensitive cancer, please include your oncologist and please stop harming women.
Megyn Kelly
Because you see that black box label on anything you're gonna take and you're like, it's a no.
Dr. Marty Makary
Yeah. Look, when I came to the FDA as the commissioner just over 100 days ago and we looked under the hood, I was shocked at some of the stuff. We learned there was still a black box warning on vaginal estrogen cream and systemic estrogen. We learned that the FDA had just approved Americans to have their cells gene edited in China. Literally. Cancer patients having their cells shipped to China where they would manipulate the gene of those cells and then ship them back to be infused back into Americans. We put the halt on that illegal Chinese vaping. I mean there's all kinds of stuff we learned about, but this is something that I had heard about from many women because the, the issues in women's health have long been ignored. Some say it's been a male dominated medical establishment in a prior generation that resulted in this. And some say we've never really recognized what perimenopause is in the medical profession. I was kind of taught. Well, some women go through it and some women have. Or sorry, all women go through it, but some have symptoms, and the symptoms are usually mild. Well, that's not true. 80% of women go through it, and it can last five to eight years or longer. And for many women, those symptoms are severe. You know, things like dryness. Now, dryness can have a lot of implications. Vaginal dryness can make sex much more difficult. There have been divorces stemming from this issue in one's nasal mucosal cavities, eye dryness, skin dryness, hair thinning. So, I mean, things like that were ignored. And instead, when a woman came in with symptoms of perimenopause, be it the mood swings, weight gain, night sweats, or the dryness, whatever the symptoms were, a woman was more likely to be prescribed an antidepressant than hormone replacement therapy.
Megyn Kelly
So typical. That makes perfect sense. Now. Wait, and perimenopause is the period right before actual menopause. Right. Like actual menopause is when you haven't had a period for a year. And perimenopause is a number of years, like, leading up to that, where you're not quite, you know, on the schedule you used to be, but you can feel yourself crossing over the change. The change is coming upon you. So that's like the. But it's all time where you could be getting the hrt, and you're saying you need to be doing it within the first 10 years of what, the onset of perimenopause?
Dr. Marty Makary
Yeah, the. For example, the cardiovascular benefits flip if you start it too late. If you go roughly, and this is just sort of a general rule that some doctors use, if you go 10 years without it, or you start it after age 60, as a rule of thumb, some doctors use. Again, I'm not telling people what to do, but this is what some doctors say. Then you go too long without it. The blood vessels sort of narrow and hardened, and then the cardiac benefit flips into a risk. And because, of course, hormone therapy, as with oral contraception, has an ever so slight risk of blood clots. And so that creates a risk of harm. So that benefit turns to a potential risk of harm if you start it too late. That's why people who are, you know, more than 10 years after the onset of menopause, there's really. I mean, there are really no options that many, you know, many doctors will say there's no options at that point. And of course they. They're angry, and they have a right to be angry. They were misinvented by a medical establishment.
Megyn Kelly
Do you. Do you stay on HRT forever? Like, if you do Start it early.
Dr. Marty Makary
Yeah. You know, I'm learning in this job. I have to be careful what I say here as FDA commissioner. But many doctors do keep their patients on it for life.
Megyn Kelly
Wow. All right, well, this is all very helpful information. Now, I want to ask you about something else that you guys are working on, which is equally important to a lot of women. On the younger side, though, now we're moving from like the 50 and 60 set down to the 20s, 30s, and 40s, and that is women who take antidepressants, SSRIs, while pregnant. You guys are about to have a panel on that? Why? What's the. What's the concern?
Dr. Marty Makary
Yeah, look, we've been busy at the FDA. On Monday, we're gonna have a panel on SSRIs and pregnancy. You know, almost a quarter of middle aged women in the United States take an antidepressant, and many of them take it right through pregnancy. About 5% of pregnant women roughly are taking an SSRI, one of the types of antidepressants, even though one of the antidepressants has been identified by the FDA to potentially be associated with birth defects. And there are also concerns about harm to the mother. So we need to get the experts in the room, get this straight again, update the labels if we need to do that. Do whatever we can to try to address this, because we don't want to see birth defects that are entirely avoidable if people would have had the right information.
Megyn Kelly
That's terrifying. I don't think most people know that, that if they're on antidepressants and they're taking them while pregnant, you could be leading to a birth defect situation for your child. Why isn't that a black box warning?
Dr. Marty Makary
So it is on the label of one antidepressant, and so should it be on the label of more? Even if we don't have data, should we err on the side of safety? That's exactly why we're convening experts on Monday. And look, we just can't. Some people say, look, you should do a six month review and go through the normal government FACA process, which is a long bureaucratic process, to convene experts. We're just inviting them in, state their disclosures and talk passionately about these issues on which they are experts. We cannot work at government speed. We have to work at real person speed.
Megyn Kelly
So how do you do that? Because I played that Joanne Pinkerton, she's a doctor. Sod about. Please, for the love of God, get rid of the black box label. I mean, You're FDA commissioner, so can you just do that or what does that process look like?
Dr. Marty Makary
Yeah, so the process is that we petition, we ask the company for a label change if there's label changes with anything. And we're doing this right now with oxycontin. That label change still does not match the data. Believe it or not, even after all.
Megyn Kelly
The lawsuits against the Sacklers and all that.
Dr. Marty Makary
They made one small modification, but it's not good enough. That drug was approved for chronic pain on the label based on a 14 day study. So look, like I said, we're busy, we're looking at that. And what we do is the process is we tell the companies we'd like to see this change and we propose the change. And then there's a. So it takes a couple months, sometimes six months. But we want in the meantime to let the experts have a platform to talk about these issues from both sides of the issue. I believe in a civil discourse and we should have people who are pro and against come and hash it out. That's exactly what science is. And honestly, we didn't see a lot of that during COVID Right. It was more a homogeneous group of like minded friends that were gathering and all put a rubber stamp on COVID vaccine boosters for 17 year old boys. We need a civil discourse if we're going to win back public trust. That's what we're doing at the fda, at the nih, at cms. And this is the charge we have for radical transparency and restoring gold standard science.
Megyn Kelly
I have to ask you a question in a second about Francis Collins. That's coming, but can I just double back to something you said about Chinese gene therapy where people are sending their what cells over to China and then. And you're stopping this. But what, what was going on there?
Dr. Marty Makary
Yeah, the companies who were offering a gene editing sort of therapy for individuals, something called CAR T therapy, they were drawing the blood cells of Americans in the United States, then shipping them off to outsource the gene editing to labs in China. This is all recent, it was just approved in the last administration and then they're shipped back to infuse into Americans. And I thought, oh my God, do people not understand the potential national security risk? And I wonder if these patients were even informed. What's going on? They just were. They just told, hey, we're going to do this therapy, we're going to draw your blood. Did they even really understand what was happening?
Megyn Kelly
Holy cow. I didn't even consider that national security risk. Like what are The Chinese putting in there.
Dr. Marty Makary
They could. It's possible.
Megyn Kelly
You're right. I'm glad you're thinking about that. I do want to ask you about Francis Collins, who used to have the job at the top of the nih, which our friend Jay Bhattacharya now has. Thank God. He went on late night the other night and said this. Listen to this, Doc.
Francis Collins
Steven. We have other deficits that politics aren't going to solve. Maybe they're making it worse. There's a truth deficit. We're in a place now.
Dr. Marty Makary
Yeah.
Francis Collins
Where seems to be no real penalty for saying something that's demonstrably false. It just. It's okay. No, it's not. We have a trust deficit where, because people don't know if they can be sure somebody's telling the truth, why should I trust that person? So we stop trusting each other most of the time. And that's dangerous also for our future.
Megyn Kelly
There seems to be no real penalty for someone saying something that's demonstrably false. I mean, preacher, heal thyself, is what I think when I hear Francis Collins say that. But what do you think, as somebody who's been very honest about the COVID overreaches and now is in a position of authority?
Dr. Marty Makary
Well, I don't know what he's referring to. Are we supposed to blindly trust whatever the government tells us? I mean, that's kind of what they did. I mean, they were involved in censoring scientific dissent among experts. So I do find it relatively arrogant for him to be out there on sort of the truth bandwagon. We are trying to restore public trust. It was damaged. They lied to us about natural immunity, Covid boosters in young, healthy individuals, myocarditis vaccine mandates in healthy subjects, about schools being closed for 18 months. They lied to us about so many issues. That's why trust is down. We're trying hard to rebuild it. And in order to do that, we have to have civil discourse. So I hope we can get to a better place. My interest is not in sort of rebutting Francis Collins as he goes on the Colbert show. My interest is in delivering at the FDA more cures and meaningful treatments for the American public and healthy food for children. We have a very exciting agenda that Secretary Kennedy has laid out. We are delivering. We've got wins on the board. We're moving fast, and we're just going to keep going.
Megyn Kelly
I love it. It's so great to hear two questions on that. Is there anything to be released? Or, like, are you even looking at that? On what they did to us during COVID That would be potentially at fda, potentially at nih, and then Fauci's subset of nih. You know, I, I would imagine those guys frankly scrubbed the record of what, whatever bad documents there were before they left. But have you guys looked at all to see if there's, you know, evidence of what they were doing?
Dr. Marty Makary
Yes, we have. They were sitting on data on myocarditis from the vaccine and young healthy subjects. And so we found out they were, they were sitting on it and they should have acted on it. The second they had that data, we responded by issuing a strong warning on myocarditis. And as you know, we have told the companies we're not gonna rubber stamp blindly vaccines for young healthy kids every year. Show us a clinical trial because look, 85% of healthcare workers said no to the last Covid booster. So we are, we're taking action. Honestly, I'm not interested in looking back. I'm interested in success. And I think that'll be the best statement on that issue.
Megyn Kelly
You mentioned the wins. You're racking up what's like every company practically is rolling over on the food dyes. We just had an announcement from the ice cream industry. Was it Turkey Hill saying we're voluntarily pulling artificial food dyes out of our ice cream? Another win for our public health, including rfkj. What do you make of that? And do you think more and more companies are now gonna go along with this? We had President Trump with Coca Cola announcing they're gonna get rid of high fructose corn syrup and go to natural cane sugar. Are these significant?
Dr. Marty Makary
Yeah. Pepsi just made an announcement. We've got General Mills, Kraft, Heinz. Turkey Hill is a brand I love because it's a Pennsylvania company and I grew up in central Pennsylvania. This is amazing. You know, this is the first step. We're gonna keep going. We took action to remove the nine petroleum based food dyes and do it quickly. Everyone said we couldn't do it. Here we are several weeks later with almost half the food industry saying that we're going to do this and we're going to keep going. We saw titanium dioxide voluntarily removed from the large. One of the largest candy makers in the United States from one of their products. We want to rewrite the food pyramid. Misinformation. That food dietary guideline information. We're rewriting it right now at FDA and usda. It's not going to demonize natural saturated fat, which has been the dogma and bandwagon effect of the government and the medical establishment, it is going to be evidence based. And we are going to mention ultra processed foods, which is now 70% of the diet of young kids. So we're going to keep going on the drug side. As you know, we're accelerating approvals. We have a pilot program to get answers out in weeks instead of a year. We are reducing animal testing. There's no need for routine animal testing requirements in many instances. When I told you we looked under the hood and found some shocking stuff. We were still requiring animal testing for new drugs even though the drug was approved in Europe and used in tens of thousands of people already. We're going to use computational modeling. We brought in AI. We're moving fast. I want to see a cure for Alzheimer's, for adhd, for ptsd. Our veterans deserve a decision quickly. I don't know if these drugs will provide a cure, but they deserve a decision quickly from the FDA. Type 1 diabetes, some types of stage 4 cancer, and maybe a universal flu shot. That data could look promising whereby we're not guessing every year what strain to pick. It's a universal flu shot with long term protection.
Megyn Kelly
Wow, you're busy. You gotta go. Thank you for giving us this half an hour and updating us on these amazing developments and really important information in there, in particular on Women's Health. Dr. Makary, always a pleasure. Thank you.
Dr. Marty Makary
You too, Meghan. Thanks so much.
Megyn Kelly
Wow, what a guy. Aren't you so happy he's there? I'm so happy. I feel so much better knowing that we've got Dr. Marty Makary running FDA. It's like our public health is being completely revamped. And by the way, it's one department that's just had win after win after win. Bobby Kennedy, Jay Bhattacharya, Marty Makary. They're completely revamping and pushing through the MAHA agenda and, and there's been really like no problems. It's been quite remarkable. These guys are making good on the promises that they and Trump ran on they in service of Trump. And it's something for which he's gotten no credit because people are focused on other things which 99% of which are bullshit made up by the mainstream media. Okay, so There you go, Dr. Marty Makary. And that whole conversation should make you feel good going into the weekend. Talk to you soon.
Dr. Marty Makary
Soon.
Megyn Kelly
Thanks for listening to the Megyn Kelly show. No bs, no agenda and no fear.
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Summary of "Truth About Benefits of HRT For Women, and COVID Lies Uncovered, with FDA Commissioner Dr. Marty Makary"
Episode Release Date: July 20, 2025
Podcast: The Megyn Kelly Show
Host: Megyn Kelly
Guest: Dr. Marty Makary, FDA Commissioner
In this compelling episode of The Megyn Kelly Show, host Megyn Kelly engages in an enlightening conversation with Dr. Marty Makary, the newly appointed Commissioner of the U.S. Food and Drug Administration (FDA). Building upon their previous discussion in episode 881, Kelly and Dr. Makary delve deep into the misconceptions surrounding Hormone Replacement Therapy (HRT) for women, particularly addressing the long-standing fears linking HRT to breast cancer.
Megyn Kelly [01:02]:
"Earlier this week, the FDA hosted a panel on menopause and the benefits of hormone replacement therapy for women. For years, women have been scared into thinking that HRT was linked to breast cancer because of a misleading study from 2002."
Dr. Makary emphasizes that the 2002 Women's Health Initiative (WHI) study, led by Dr. Jacques Russo, erroneously suggested a significant link between HRT and breast cancer. Upon reviewing the data, Dr. Makary reveals that the observed increase in breast cancer cases was not statistically significant.
Dr. Marty Makary [02:39]:
"No clinical trial has ever shown that hormone replacement therapy for perimenopausal women increases the likelihood of dying of breast cancer."
This misinterpretation led to widespread fear and the subsequent avoidance of HRT among millions of women, including Dr. Makary's own mother, who suffered severe bone fractures that HRT could have potentially mitigated.
Beyond alleviating hot flashes and night sweats, HRT offers profound long-term health benefits:
Dr. Marty Makary [05:18]:
"There may be no other medication in the history of modern medicine that can improve the health outcomes of women on a population level than hormone replacement therapy when started within 10 years from the onset of perimenopause."
Despite the substantial benefits, HRT continues to bear a black box warning that deters many women from considering it. Dr. Joanne V. Pinkerton advocates for the removal of this warning to prevent unnecessary fears.
Dr. Joanne V. Pinkerton [16:49]:
"I am begging the FDA and all of us are begging, please remove the box label... please stop harming women."
Responding to this, Dr. Makary acknowledges the outdated warnings and underscores the FDA's commitment to revising these labels based on current scientific evidence.
The debate over HRT is symptomatic of a broader polarization within the medical community. Dr. Makary calls for civil discourse and evidence-based discussions to bridge the divide and restore public trust.
Dr. Marty Makary [15:56]:
"Hormone replacement for perimenopausal women is exactly what it says. You're replacing your body's natural hormone production... we have to have civil discourse. So I hope we can get to a better place."
Transitioning from HRT, the conversation shifts to the FDA's upcoming panel on Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy. A significant portion of pregnant women are on SSRIs, raising concerns about potential birth defects and maternal health risks.
Dr. Marty Makary [21:21]:
"About 5% of pregnant women roughly are taking an SSRI... there's a potential association with birth defects... we need to get this straight again."
The FDA aims to reassess and update SSRI labels to better inform and protect expectant mothers.
Dr. Makary criticizes the handling of COVID-19 by previous administrations, highlighting issues like suppressed data on myocarditis and misleading information about vaccines. He stresses the importance of transparency and truth in public health to rebuild trust.
Dr. Marty Makary [28:34]:
"They lied to us about natural immunity, Covid boosters in young, healthy individuals, myocarditis vaccine mandates... that's why trust is down."
Beyond addressing HRT and SSRIs, the FDA under Dr. Makary is pioneering several initiatives:
Dr. Marty Makary [29:49]:
"We are moving fast. I want to see a cure for Alzheimer's, for ADHD, for PTSD... what's exciting is that we're just going to keep going."
Megyn Kelly wraps up the episode by lauding Dr. Makary's visionary leadership and the FDA's transformative agenda, which aligns with progressive public health goals.
Megyn Kelly [31:55]:
"Thank you for giving us this half an hour and updating us on these amazing developments and really important information in there, in particular on Women's Health."
HRT Misconceptions: The fear linking HRT to breast cancer stems from a misinterpreted 2002 WHI study. Current evidence shows minimal risk and substantial long-term health benefits.
HRT Benefits: Beyond symptom relief, HRT significantly reduces risks of heart disease, cognitive decline, and osteoporosis in women when started within 10 years of perimenopause onset.
Medical Bias and Warnings: Outdated black box warnings on HRT hinder its acceptance despite its benefits. There's a pressing need to update these labels based on recent scientific findings.
FDA's Role: Under Dr. Makary, the FDA is actively revising harmful policies, accelerating drug approvals, and promoting transparency to restore public trust.
Broader Public Health Initiatives: The FDA is tackling issues from artificial food additives to the safe use of SSRIs during pregnancy, emphasizing evidence-based practices and civil discourse in medicine.
Dr. Marty Makary [05:18]:
"There may be no other medication in the history of modern medicine that can improve the health outcomes of women on a population level than hormone replacement therapy when started within 10 years from the onset of perimenopause."
Dr. Joanne V. Pinkerton [16:49]:
"Please remove the box label... Please stop harming women."
Dr. Marty Makary [28:34]:
"They lied to us about natural immunity, Covid boosters in young, healthy individuals... that's why trust is down."
Dr. Marty Makary [29:49]:
"We are moving fast. I want to see a cure for Alzheimer's, for ADHD, for PTSD..."
This episode serves as a crucial resource for women seeking clarity on HRT and underscores the FDA's commitment to rectifying past medical misinformation. Dr. Marty's insights pave the way for informed health decisions and a more transparent healthcare system.