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

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Welcome to the Megan Kelly Show, live on SiriusXM Channel 111 every weekday at Noon East.

Hey everyone, I'm Megan Kelly.

Welcome to the Megan 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.

Dr.

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 glean from your panel and your book for that matter is there are other reasons.

It's not, it's not going to cause breast cancer and 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.

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 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 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 perimenopathy, 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.

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 a 25 to 50 percent 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 percent, 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, 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.

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.

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 got to ask, why is Alzheimer's going up 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?

It 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, such a sensitive topic like breast cancer to women, demonizing hormone replacement therapy.

People need to 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.

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 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.

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 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.

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.

So this is from your book.

It's amazing.

You write, I asked Dr.

Rousseau 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, what?

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?

So 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...

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, and 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 this, 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 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 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.

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 it's not, 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, and I'm not going to say who because I don't want to embarrass anybody, but some of my top women's healthcare 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.

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 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 cardio protective 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.

The stuff everybody should know.

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 who are at the panel, Dr.

Joanne V.

Pinkrenton, she was there and she's as frustrated as you are about the fact that

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 SOT1.

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.

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 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, well, 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.

So typical.

That makes perfect sense.

Now, wait, and perimos is the period, 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

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?

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 is 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 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 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 misled by a medical establishment do you do you stay on hrt forever

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 uh 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.

And 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.

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.

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 that's exactly why we're convening experts on monday and look we we just can't we some people say look you should do a six-month review and uh 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, 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?

Or what does that process look like?

Yeah, so the process is that we petition, we asked the company for a label change.

If there's label changes with anything, and we're doing this right now with OxieContin, that label change has 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.

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.

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 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.

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?

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.

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.

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, where

seems to be no real penalty for saying something that's demonstrably false.

It just, it's okay.

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?

So we stop trusting each other most of the time.

And that's dangerous also for our future.

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?

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 the sort of the truth bandwagon.

You know, 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 and 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.

You know,

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.

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 would imagine those guys frankly scrubbed the record of whatever.

bad documents there were before they left.

But have you guys looked at all to see if there's

evidence of what they were doing?

Yes, we have.

They were sitting on data on myocarditis from the vaccine in 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 going to 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 covet booster so we are wow uh we're taking action i i honestly i'm not interested in in looking back i'm interested in success and i think that'll be the best uh statement on that issue 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 uh from the ice cream industry was it turkey hill um 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 going to go along with this?

We had President Trump with Coca-Cola announcing they're going to get rid of high fructose corn syrup and go to natural cane sugar.

Are these significant?

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 going to 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.

We're going to keep going.

We saw titanium dioxide voluntarily removed from

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 SFDA.

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.

Wow.

You're busy.

You got to go.

Thank you for giving us this half an hour and updating us on these amazing developments and really important important information in there in particular on women's health.

Dr.

McCary, always a pleasure.

Thank you.

You too, Megan.

Thanks so much.

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 McCary 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 McCary.

They're completely revamping and pushing through the Maha agenda.

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 McCary, and that whole conversation should make you feel good going into the weekend.

Talk to you soon.

Thanks for listening to The Megan Kelly Show.

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