Truth About Benefits of HRT For Women, and COVID Lies Uncovered, with FDA Commissioner Dr. Marty Makary

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1:01Welcome to The Megyn Kelly Show, live on Sirius XM channel 111 every weekday at New East.

1:12Hey 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 McCary 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.

1:56Dr. McCary joins me now. Mr. Commissioner, great to have you. Welcome back. Great to see you again, Megan. You as well. 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 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.

2:32It's a very, very minimal risk. And secondly, it's got a lot of really good benefits. Well, that's right. Look, women have been confused for a good reason. The medical establishment, 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.

3:13And I should just point out that 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. they're 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.

3:51I'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.

4:41maybe 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, underrecognized, 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 real data on this topic and not follow dogma for dogma's sake. The thing that's great about, I mean, preventing dementia, hello, everybody wants to prevent Alzheimer's or dementia.

5:21But 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. 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.

6:00And 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 got to 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.

6:43What'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 35 % 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, So as such a sensitive topic like breast cancer to women demonizing hormone replacement therapy, people need to know the facts.

7:32And one place to help get good information, in my opinion, is the FDA expert panel that's available online for women to watch. 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 Rousseau. 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. Cause 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.

8:18We 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. 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.

8:57If 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 dying of breast cancer. So what does that tell you? It is amazing. It really is amazing because when that announcement hit, and he feels that the media got ahead of his results when I had talked to him. But when those headlines hit that hormone therapy causes breast cancer, man, women flushed their pills down the toilet.

9:40Doctors 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 that there was no statistical significance. So this is from your book. It's amazing. You write, I asked Dr. Rousseau point blank, was the breast cancer link in his studies 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.

10:13What? 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. 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?

10:59So you don't even need to teach about menopause. So we didn't, we got almost no educational 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 going to 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?

11:44And, 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.

12:31And that's just my mom. And I'm putting these pieces together from what I've done for my research. Think about the 50 plus million women. An 80-year-old woman has a one in three 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. I'll tell you another piece of this that I've noticed just as a woman.

13:17There 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 healthcare docs, I'm not going to say who, cause I don't want to embarrass anybody, but some of my top women's healthcare docs have said to me, uh, you know, menopause, it's not a disease. You know, there's no, it's nothing, it's not something to be cured.

13:47You 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 one. And it's to me, I was like, wow, that's so crazy. This you're, 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. Yeah. Look, this issue is polarized in medicine, just like a society is polarized around politics.

14:26And there's a lot of misunderstanding I think 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 cancer or some other reason. they were developing early heart disease. And that data showed, including one woman who had a fatal heart attack at age 28.

15:07Well, 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.

15:51The stuff everybody should know. Yeah, because 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 who are at the panel, Dr.

16:28Joanne 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. That's not one. 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. Because you see that black box label on anything you're going to take and you're like, it's a no.

17:11Yeah, look, when I came to the FDA as the commissioner just over 100 days ago, I was 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 issues in women's health have long been ignored.

17:55Some 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 percent 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.

18:39There 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. That was 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.

19:20And 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, 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? Yeah. 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.

19:56Again, 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 harden, 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 say there's no options at that point.

20:35And of course they're angry and they have a right to be angry. They were misled by a medical establishment. Do you, do you stay on HRT forever? Like if you do start it early. 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. 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.

21:09And that is women who take antidepressants, SSRIs, while pregnant. You guys are about to have a panel on that. Why? What's the concern? Yeah, look, we've been busy at the FDA on Monday. We're going to 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.

21:56So 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. 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? 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?

22:34That'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. So how do you do that? Because I played that Joanne Pinkerton, she's a doctor, that sought 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?

23:14Or what does that process look like? 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 the lawsuits against the Sacklers and all that? 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.

23:52And 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.

24:31And this is the charge we have for radical transparency and restoring gold standard science. 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 you're stopping this. But what was going on there? 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.

25:10This 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. Were they just told, hey, we're going to do this therapy. or you were going to draw your blood, did they even really understand what was happening? Holy cow. I didn't even consider that national security risk. Like, what are the Chinese putting in there? They could. It's possible. You're right. I'm glad you're thinking about that.

25:45I 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. Stephen, 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. Yeah, seems to be no real penalty for saying something that's demonstrably false. It just it's OK. No, it's not. Oh, yeah. We have a 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?