FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

Fifty to seventy million women have been denied
the incredible short term and long term

health benefits including living longer, reducing
the risk of heart attacks

which is the number one
cause of death in women,

because of this dogma
that was magnified by the FDA,

Black box
warning the groupthink of modern medicine.

It’s mind boggling to me. Maybe one
of the greatest screw-ups 

of modern medicine in recent time.

Okay, we're doing this.

I am here with Doctor
Rachel Rubin and Doctor Kelly Casperson,

two experts in hormone replacement
therapy who’ve treated

I don't know, thousands of women
that are perimenopausal with hormone

replacement therapy.

And this is around
our new announcement on HRT.

Welcome to both of you.

Great to have you here.
Thanks for having us.

Just out of curiosity,
how many women have you treated

with hormone replacement
therapy in your practices?

So I'm a urologist.

I started with vaginal estrogen
because vaginal estrogen

is incredibly important for the pelvis.

And now it's been thousands,
thousands of thousands.

Yourself, Doctor Rubin, again,
since I graduated fellowship in 

This has been a primary focus of mine.

Thousands and thousands of patients,
but also teaching thousands of clinicians

how to do it.

And I know you're both big
into the education piece of this.

Let's go ahead and start off

by educating our listeners
about what we did today at the FDA.

We took action
following a public comment period,

going through the proper process
of having our subject matter experts

rereview
the entire body of scientific literature

and made the decision to remove
the black box warnings around hormone

replacement therapy for postmenopausal
perimenopausal women, specifically around,

breast cancer warnings and

thromboembolic
events, and the other things

that have really contributed
to the fear machine over the years.

All of those issues are discussed
in nuance,

in detail, in the package
insert on the label.

But we are getting rid of that fear
machine,

black box
warning on hormone replacement therapy

that is estrogen or estrogen
plus progesterone.

It's a really monumental week.

Like this is a very big deal.

And I want people to understand
that this is a long time coming, right?

We had a citizens petition in 

There was a petition for the FDA
to change it.

And Doctor Rubin went back 

So over and over saying, we have data,
we have research.

We have treated thousands
and thousands of women

and published the data
to say that this the sanctity of the box

warning needs to reflect the actual risk
and to adjust that accordingly

now for the safety of the American women
is monumental.

And I think this is just going to be
the next step in

normalizing health
care and safe medications.

So we are I've this is outside

of, my personal health area, right?

I'm not a candidate for,

hormone replacement
therapy around the time of menopause.

This is a women's health issue.

But in my view, people ask me,
why are you so passionate about this?

Women's health issues have not gotten
the attention, the funding,

the education, the appreciation
that, those issues deserve.

And this is like number one,
this is almost like a case study.

What kind of damage?

So first of all, we heard the voices of
all of you and the experts in the field.

We reviewed the literature,
we went through the process.

We took this action today.

But what kind of damage did that
black box warning do?

Doctor Rubin, over the years,
ever since that,

milestone and tragic announcement in 

Yeah.

So in they did a press conference
before papers were even published

that said hormones are dangerous.

They cause breast cancer,
cardiovascular disease.

No one had seen the data.

And now we know the data actually looked
pretty good.

It actually looked really hopeful.

And there's
so much benefits of hormone therapy.

But the cat was out of the bag
and they couldn't put it back in.

And the messaging for years has been
hormones are dangerous.

And the catastrophic event
that happens because of that

is an entire generation of clinicians
have no idea

how to talk to their patients about this
or how to write prescriptions.

There is a handful of brilliant,
pioneering

sort of warriors in the menopause groups
that have done this work for decades.

But you.

But, but but this is over
half the population.

This must be changed.

And we have so much work to do to teach
every clinician who takes care of women

why this is important and how to do it.

So, I think what you're referring to,
just to add a little color,

because I did look into this in detail,
is that when the Women's Health

Initiative, the largest study
ever in the world at the time, $billion

NIH funded study, went to ask
whether or not hormone replacement

therapy causes breast cancer for women
and what the other health outcomes were.

It was tragically flawed in its design.

The average age that it was that women
initiated treatment was, I think, 

There was,

there were a lot of issues in that cohort
and then the inclusion criteria

and then, and it's well recognized
that you need to start at what,

within ten years
of the onset of perimenopause or,

ten years from the onset of menopause
and generally before age 

Is that generally correct?

Is that? That's what the guidelines say.

Okay. So,

they took a very different cohort,
a very different formulation,

that is a drug
that is not commonly recommended

today that I don't think you use it
as first line.

That was. Horse

Estrogen is very different from
the estrogens today that are being used.

And they went to the media with the story
that it causes breast cancer,

even though the study,
which later came out in JAMA,

never showed a statistically significant
increase in breast

cancer rates in the hormone replacement
therapy group versus the control group.

And you remember that
the estrogen only arm.

So if you didn't have a uterus,

if you don't have a uterus,
you don't always need progestins

with your estrogen had a decreased
risk. Lower. Of getting and dying

from breast cancer, not just dying
but getting it was reduce the risk.

And so women don't know this.

Their every day
woman thinks estrogen causes cancer.

It's going to fuel a cancer.

And that is a misconception.

And so we aren't messaging this correctly
because what are the risks of taking

hormone therapy,
which now you're putting in your label

in the packaged inserts
so people can read the risks.

But what are the benefits?
What are the benefits of hormone therapy?

Incredible twist of irony that it reduced

the risk of breast cancer in that estrogen
only subgroup. Reduced

the risk of breast cancer.

All fracture,
not just osteoporosis, colon cancer.

Okay.
We're talking about other long term.

All right. Let's go through the list.
Yeah.

All cause mortality

in between the ages of and 
mostly because of reduced heart disease.

And the other thing
I really want people to know,

because we throw around the word estrogen,
like estrogens, estrogens, estrogen.

This was oral synthetic estrogen
to the currently transdermal estradiol,

what our ovaries naturally make,
that is now a gold standard

first thing to start with.

So we're seeing, risks with apples that
weren't actually that bad are not risks.

The horse estrogen versus the estrogen today,

that's close to your body’s natural estrogen.

So the oranges
got this label on them, right?

And that's
what this is doing is it's clearing up.

These are different medications,
different doses,

different routes of administration.

Clinicians know that.

But the lay population
estrogens, estrogen, estrogen.

And we're here to say
apples aren't oranges.

We need accurate labeling for the oranges.

We studied apples, right?

And the apples ruined the oranges forever.

But the challenge here is clinicians
don't know this.

Your regular clinician,
your family practice doctor,

your primary care doctor,
your neurologist, your orthopedic surgeon,

anyone who they don't know the safety
and the benefits of hormone therapy.

And they've never studied it

because of that Women's Health Initiative
press conference back in the s.

And so now you have a whole generation.

They didn't learn it in medical school.

They didn't learn it in their residency
programs.

Even gynecologists
do not get this training routinely and,

you know, systematically.

And so, again,

you women are hearing my friends
on podcasts, they're reading their books.

They're reading your book
and they're getting excited,

and they go to their doctor
and they said, I read,

you know, I read Doctor Makary’s
book, the chapter two.

Oh, my gosh, this is safe

and they say they look at them
like they have six heads

and it's a ten minute visit.

And so
and they don't know how to help them.

And so they either change the conversation
or they tell them it's dangerous

and that and that they, you know,
and they just dismiss them.

And every day. Easy way to dismiss

somebody is telling them
they could die from something.

Yeah, make them scared, right?

And the box
labeling helped to make them afraid.

They're afraid of,
the doctors are afraid of getting sued.

They're afraid of being not in their lane.

And they don't know how to do this.

Everyone's lane is women's health.

Everyone who takes care of people,
their lane should be women's health.

Black box warning fed the fear machine
that began with that press conference.

The media ran with the story.

HRT became synonymous with breast cancer.

I remember I was a resident.
All of a sudden,

This medication that helps women
feel better,

live longer, improves all kinds of health,
long term health outcomes.

And we'll go through
that list one more time.

All of a sudden,

HRT became a carcinogen on that day,
even though we didn't have the study.

Study comes out later.
Hey, wait a minute. No

statistically significant to increase
risk of breast cancer in that study.

And those who got estrogen alone
had lower rates.

But that fear machine took on a life
of its own, and the FDA piled on

the next year by slapping the black box,
warning across the class of products. Yes.

So when I see patients, I have to say
now what this says, and if you go home

and you read the label, I need you to know
that this part's not true.

Probable dementia
doesn't even say possible dementia.

It says probable dementia,
which is a stronger word, right?

Heart disease, clot risk, stroke.

That's not true.

And what I'm asking you to do is
you have to decide between me

and the FDA on who's truthful here.

And, you know,

we kind of joke about it in the clinic,
but that's what I have to say

is you're going to go read things
that I'm telling you aren't true.

And now we're in alignment.

Now we're a partnership on it.

And I have stories where,

you know, a woman will come in
vaginal estrogen for pain with sex.

Her husband will read the label at home
and he'll say, it's okay, honey,

our sex life is not that important.

It's not worth you dying over.

Will you tell me,

Doctor Casperson about, patients
who are prescribed that

maybe you've prescribed,

estrogen to,

and then they go home
and read the black box warning,

and they're like, “oh
my God, I'm not taking this. This is.

That sounds
just like the scariest thing on earth.”

So there's a published study done
by Doctor Una Lee and her team looking at

if a woman's lucky enough
to get a vaginal estrogen prescription.

Right.

So she goes in, somebody who's trained
in general urinary syndrome,

a menopause, who knows that it's safe,
that knows it's effective.

She's lucky enough to get a prescription.

She then goes home.

% of those women
will then choose not to use the product

because of the incorrect label. Amazing.

And so talk about what this is for.

And I think the revolutionary thing
that your team did is that they changed

the labeling so that vaginal hormones
like local, low dose

vaginal hormones are very different
than whole body systemic hormones.

And those are different,

the transdermal and the oral options
and the synthetic options are different

from each other.

And so what we've been advocating for,
for all of these years,

long before you were in this job,

we've been advocating for
vaginal estrogen, which treats the genital

and urinary symptoms of menopause,
should not have the same warning labels

as an oral
synthetic hormone therapy for hot flashes.

There are different indications,
they're different things.

And so we're so grateful because
our community every day has to warn women.

This is microdosing estrogen.

It is safe for your great grandmother

in the nursing home who has leakage
and urinary tract infections,

and she's going to die
from those urinary tract infections.

And so many women are not being offered

this vaginal estrogen therapy
because they have a ten minute visit.

And how am I possibly going to explain
to grandma that this box labeling

doesn't apply to her?

It's amazing.

You know the sentiment out there.

You talk to doctors, I talk to friends,

they have no idea what the truth is.

They just know about this black box
warning the fear machine, the

the stuff that you're saying
that's not supported by evidence.

That is this black box warning of probable
damage, not supported by any evidence.

Right.

And so you have women
who have come in to their doctor for help,

either not offered

hormone replacement therapy
when they're great candidates, or they ask

and they are dismissed,

or they're the fear
machine is used to dismiss their question

or they, beg for it
because they've listened

to other experts, maybe from social media
or other platforms,

and they're told, well,
we really don't want you to take it.

Take a tiny small of a dose
for a short of time as possible.

to million women have been denied

the incredible short
term and long term health benefits,

including living longer,
reducing the risk of heart attacks,

which is the number one
cause of death in women.

Because of this dogma
that is was magnified

by the FDA black box
warning the groupthink of modern medicine.

It's mind boggling to me.

Maybe one of the greatest screw
ups of modern medicine in recent time.

Yeah, and now what we have to do
is we have to catch the clinicians up.

We have about a million physicians
in this country.

We've got about nurse
practitioners and advanced practice

practitioners, and we have million
women over the age of 

And what we're doing from the grassroots,
we're educating the people, right?

They're hungry for information.

They love body literacy information.

And we have to tell them,
you're going to go in.

You might be more trained
than your physician on this right now.

And I'm sorry, but this is the way
you turn a very large boat, right?

We have to train the clinicians.

The interesting thing, after the
WHI came out,

ten years after, about % of women
in this country are on hormones.

As a back up in the s,
% of women were on hormones,

ten years after, % were. Wow. years
after the WHI, only % were.

It's getting worse.

We're like, why is it getting worse?

Well, there were clinicians
ten years after

who still knew that hormones were good
and that hormones were safe,

and that hormones helped women.

They've all since retired and we're not
teaching it in the medical schools.

Residencies generally don't.

I mean, I only speak for my own,

medical

education, but there
are studies looking at OB residencies, how

they don't even teach about menopause,
let alone hormone replacement therapy.

And this is the lived experience.

So we have been teaching and teaching.

I was Education

Chair of an international society
for the Study of Women's Sexual Health.

We do advanced
training in hormone therapy.

I have spoken at the American College
of Physicians, where you have a conference

of primary care docs,
and there were no, no,

meetings, courses or anything on menopause
and hormone therapy.

I got to talk about sexual health,

which, of course, I talked about hormone
therapy and menopause.

And I got a standing ovation
from the clinicians.

You don't get very many standing ovations,
you know, for giving a medical talk.

And the comments, the comments
all said, oh,

my gosh, I learned something actionable
that I can take to my clinic.

They're starving.

They love.

They loved it.

I've never seen such glowing evaluations.

So when I do things like the Peter Attia podcast,

I got so much, so many clinicians
who showed up and said, thank you.

My practice has now changed.

I really
I can't believe I didn't learn this.

How can I learn more?

And so these clinicians are so hungry
to know not just why hormones are safe.

Because the data is overwhelmingly
showing us the benefits of hormone therapy

and everyone's talking about it.

But how do we actually teach clinicians?

Well, what dose of estrogen
do you start with

and what pharmacy do you use
and what are the tips and tricks?

hormone replacement

therapy in postmenopausal women

relates
to almost every single organ system

and specialty and all of medicine,
all major specialties in medicine.

Almost every cell on the body
has an estrogen receptor.

If I were to,
you know, take a gander at it.

And so,

if I were to have told my colleagues
I was interested in diabetes and pancreas

and public health,

hey, I'm going to be doing some research
on hormone replacement

therapy as it relates to these.
They would have laughed at me.

Why are you doing that?

There's no NIH funding for it.

That's a dead subject.

It's a carcinogen.

Why would you, you know,
look at the possible benefit.

Let's talk about the possible health
benefits from the literature for a second.

Let's look at the list.

Short term and long term benefits.

I would guess it's hormone
replacement therapy is known more

on sort of a

broad scale for the short term benefits.

What blows me away
are the long term benefits.

Well, let's talk about the on label
sort of what do.

So this is really important
because I was very involved

with the development of guidelines
for genital urinary syndrome of menopause.

And there are guidelines
from the Menopause Society sort of about

when we give hormone therapy
and sort of how it's changed and it has

evolved, guidelines evolve
when new data comes out,

just like warning
labels should evolve when data comes out.

And thank goodness
that we're getting there.

So so if we talk, there's the on label
sort of, or on, guidelines.

And then there's sort of what we,
what we see every day.

Right.

I and Doctor Casperson will talk
about sort of the, the,

what the guidelines say.

But as a urologist,
you know, trained in sexual medicine,

I never thought I would treat
so much joint pain in my life.

Patients come to me every day and say,
oh my God, I wake up without feeling

like an old person.

I can move my joints again
because hormones are like brake fluid,

so they help with dryness everywhere
your skin dryness, your eye

dryness, your itchy ears, but your joints,
your Plantar Fasciitis.

You're frozen shoulder, right?

It can help with the lubrication
of your joints.

But but there is sort of the
by the guidelines, you know what?

What do we do? Right?

Yeah.

And I think that's where

where people they rely on
what is FDA approved and what happens

when things get FDA approved is insurance
coverage gets validated.

Right.

There's so much that hormones cover
because it's in every single cell

that is not reflected.

And because you can't have

how do you approve every single organ,
right.

As a use for estrogen.

But if there was a drug
and I joke with my patients, I'm like,

if there is a drug that you could take
in prediabetes, so you're pre-diabetic

and you take a drug

versus a placebo, it decrease the risk
of getting diabetes by %.

And that study has been done. It's
been done.

That's an estrogen patch. Right.

Like they would have two
Super Bowl ads that year. Right.

It's an estrogen patch again
looking at prevention of dementia,

prevention of depression
in perimenopausal women,

placebo versus estrogen patch,
significant decrease

in getting depression by one year
because mental health changes

that not feeling like myself,
which is to % of women in midlife.

This is huge.

This is relationships.

This is jobs. This is how well you parent.

This is how much you feel

like going to exercise this
not feeling like myself, which I joke.

I'm like, you can't X-ray that.

How do I know that

Doctor Makary doesn't feel like Doctor
Makary today? And a woman.

But it's vitally important.

And a woman's
going through the symptoms of,

perimenopause.

They're more likely to get
an antidepressant than they are hormone

replacement.

So, actually, the Menopause
Society meeting is happening right now.

And there was a study that came out
that said, if you go to see an OBGYN, you're

more likely to get a hormone prescription,
but still not. It's not that high.

And if you're likely to go to a primary
care doctor, you're more likely going

to get an antidepressant.

And it's not because,

that the primary care doctors
just don't know how to write the hormone

prescriptions they don't understand.

And there's no
education on even perimenopause.

So they don't realize
that this is starting in the s.

This is all your year
old women who are coming saying, I'm dying

because I wake up with drenched in sweat.

Right? You would think of cancer
as like as a cancer doctor, right?

I'm drenched in sweat.

My weight is changing.

I am so anxious. I'm depressed.

You know, like I'm hot all the time.

Do a $million workup, right?

You don't even think about menopause.
And they tell you you're fine

after your million dollar work up.
And they tell you

you're fine, and they give you
no solutions. Oh, it's just aging.

But this idea of, like,
we have to be having

these conversations in the s,
not after one year of no periods.

Your period doesn't actually matter.

You can be cycling fully
and still need and benefit

from either a contraception
or menopause hormone therapy.

And that is where the nuance discussion of
do you need contraception?

Do you need hormone therapy?

Or, you know, do you need something else?

Like what is it that you do need? Do you need
bleeding control?

And if we don't have people able
to have high level conversations and right?

How many menopause society
sort of specialists are there? Not enough

for the million women who are
having problems but on label, right?

You're looking at prevent
like stopping and treatment.

The best treatment benefits outweigh
the risk for vasomotor

symptoms, which is hot flashes, night
sweats, irritability.

All right.

All of those vasomotor

symptoms hormones benefits outweigh
the risks by the guidelines.

How about osteoporosis prevention.

So that's not a symptom.

So if you go to your doctor and say hey
I'm really afraid of getting osteoporosis.

My grandma was in the nursing home
with dementia and osteoporosis.

My grandfather gave her a hug and broke
all her ribs.

Okay, that's not how I want to age.

I really want to prevent osteoporosis,
but it's not a symptom.

My bones are not telling me
that I have a symptom.

And so and we know the genital
and urinary symptoms of menopause.

And it's not just dryness
and pain with sex, although it is it's

urinary urgency, frequency leakage
and recurrent urinary tract infections.

As urologists, we see daily women have

recurrent urinary tract infections
in their s, in their s and beyond.

And it gets worse and worse and worse
without the very, very safe

local vaginal hormones.

So you're both clinicians.

You have a lot of experience
treating patients,

which is why,
I invited you after the expert panel.

You were both part of the FDA expert
panel on HRT that everybody should watch.

Everybody who is a woman or knows
a woman should watch it.

That should be the universe
of human beings on planet Earth.

By the way, what the U.S. does
sets the standard for the world.

So I'm proud of what the FDA has done
here.

I'm proud of what all of you have said
and voiced in your passion

that came out in the expert
panel. I was moved by it.

I do want to share that.

So first of all, they got it's not a

it's not a one size fits all.

You your periods, stop

and you then you start that,
you've got to sit down with the clinician.

There's laboratory indicators

that are much better indicators
of when you could initiate.

You want to initiate the right type.

You want to ensure
that you don't have one of the

rare contraindications
which some women have.

So that's why it's so important
to talk to a clinician.

That's
why I'm sitting here with both of you.

I remember as a medical student,
somebody came in with symptoms of

menopause, hot flashes, night sweats,
a little abdominal pain, dryness,

mood swings, some of the classic,
classic short term symptoms.

When I say short term is they can
on average I think last eight years.

You know, we were told in medical school
Oh some women have

perimenopausal symptoms,
but they're really short.

They just go a couple of years
and they're very and they're mild.

Well, not true.

% of women plus have symptoms.

Many of them are unrecognized.

The average durations eight years.

And for many women they're severe.

They're severe.

I mean, it destroys
marriages, all kinds of stuff.

Well, we had a woman
come in with the classic short term

symptoms, and nobody
just put the basic pieces together.

And this is like the most basic,

women's Health 

These are classic symptoms of menopause.

Screaming at the docs.

But they didn't see them.

And they ordered a million consultations
and tests and giant workup.

And then a medical student,
a female medical student,

I think it was popped in and said,
hey guys, this is menopause.

These are the symptoms of menopause.

So we talked about the short term
symptoms of of menopause.

Those symptoms are alleviated
by hormone replacement therapy,

maybe not %, but significant relief
for the vast majority of women.

But then there's the long term health
benefits.

You're talking about osteoporosis.
You're talking about heart disease.

Let's enumerate them one by one, reducing

the risk of fatal heart events.

That is, heart attacks
by to % in different studies,

reducing cognitive decline

by up to % in some studies I've seen.

In that percentage point range,
I've seen up to %.

Preventing bone fractures
because it prevents Alzheimer's,

prevents osteoporosis.

By the way, also found in one study
to reduce the risk of Alzheimer's by %.

What else does that?

Nothing.

I mean, statins don't even reduce
your risk of fatal heart attacks

as much as hormone replacement
therapy for women in,

in some of the studies
about reducing cardiac risk.

And then, the bone fracture risk,
a massive reduction in bone fracture, over

% reduction in bone fracture, and women
die of bone fractures later in life.

There's more hospitalizations in America
every year from bone

fracture, hip fracture than stroke
and heart attack combined.

Let that sink in.

Why do we not know about that?

These are older women. They have no voice.

They're not speaking up.

But this is a huge problem.

So when I talk to women,
I say, if men if men had a drug

that they could take between
the ages of and that increase

their life expectancy, said a different
way, decrease the risk of dying.

However you want to say that,
do you think all the men would be on it?

And everybody's like, yeah, all the men...
There would have been billions of dollars..

All the men would be on this.

And I'm like, it's called estrogen.

Yeah. This is so challenging. Right?

Because, it even it's amazing

what the menopause community has been able
to do to really show benefit,

to really to get patients on board
and to help their patients individually.

But it's not enough.

And so we're so proud to be a part

of that community
and all the work they're doing.

And we fight.
We all fight in our communities.

On the little details of wait.

That percentage didn't show that,
and that thing didn't show that.

This is science
and this is how science has always

silenced,
is that you have different camps,

you have different
people who believe different things.

But here's the problem.

This is a tiny community,
and yet it's over half the population.

So this is a wake up call.

Everyone wants to say, it's not my thing.

This is not my lane.
This is not my scope of medicine.

And to have the head of the FDA say,
if you take care of women,

this is your lane

is probably the most impactful thing
that can change future funding,

future research, and our understanding
of menopause and hormone therapy.

But this isn't just about menopause.

This is about perimenopause, which again
happens in your late s and s.

And we need more funding.

We need more research,

and we need more basic science
and smart voices in this space.

So this kind of platform
is absolutely revolutionary

because what it does is both
the patients are watching,

but the clinicians are watching industries
watching, the scientists are watching,

and they can't say anymore well, up
there's a box labeled this isn't my lane.

This is too dangerous to be interested in.

In fact, I love it.

This cures my burnout
because it gives me curiosity

and it's so fun because not
every patient needs the same thing.

Some patients only need vaginal hormones.

Some patients only want progesterone
at bedtime.

Some patients only need, estrogen, you
know, because they don't have a uterus.

So you have to.

But if your clinician doesn't know

the difference between different types
of hormone therapy,

you should choose a different clinician
because you have agency over

who you go see. What percent of docs,

believe in hormone replacement therapy?

They believe the benefits far outweigh
the risks for the vast,

but they just don't know
how to prescribe it.

It's just we don't have the numbers. So

as the social media has really menopause,
everyone says is having a moment.

This is not a moment. It's a movement.

Right? We have this movement happening.

So people are getting on board.

We're doing these podcasts
where people are interested.

But again, there is not enough.

Here's how to write the prescription.

Here's how to counsel your patient.

And here's another big systematic problem
is when I go to

the doctor, it's a ten minute visit
and we were trained.

You get one problem, Mrs. Jones.

Are we talking about your hypertension
today?

Are we talking about your headaches,
or are we talking about your UTIs?

You can't have all because we only have
ten minutes, so you have to pick one.

You just got done

saying that there are hormone receptors
in every cell in your body.

So when you go to the doctor
because you are not feeling like yourself,

you've got a lot of problems,
you've got headaches,

you've got joint pain,
you're not sleeping, you're getting UTIs,

and your doctor says up
patients just crazy or oh, patient

has too many problems
and you can't help them in ten minutes.

But if you understood that
there actually really was one problem,

but again, no one taught you.

So now you're writing different
referral letters.

Go see the neurologist,
go see the urologist, go see.

But no one's putting it all together.

The average woman goes and depending upon
what data you look at.

But the average woman
has to see to different doctors

to get her menopause symptoms.
Treat it. Wow.

And we we women,
we're given a hard time for you.

Consume too many health care dollars.
You're too expensive.

You're utilizing too many resources.

If we treated women in the first place
and didn't have them go from doctored

a doctor to a doctor to actually get help,
that number would come down.

I mean, we had a, a woman
orthopedic surgeon

on the expert panel at the FDA expert
panel on HRT that was showing

X-rays of hip replacements that she did
in women with severe osteoporosis,

where that osteoporosis was likely
preventable had some woman been.

And you think about the expenditure,
you think about the fact that if a woman

reaches age in of them
will go on to have a hip fracture.

I mean, bones, bone strength matters.

It's essential to health.

And then the one year

mortality after a hip fracture,
even with surgery, is like %.

The wins are because we talk about long
term this long term

that all me not dying
doesn't, you know, end of chapter.

Right.

But the short term
I feel like myself again,

which is not an ICD-code
and will never get anything FDA approved

for feeling like myself again. It saves
marriages sometimes. It saves everything.

Can I tell a quick story? Yes.
I take care of veterans.

And this week I had a veteran couple come
to see me and it was about his problems.

And he's he's got some problems, right.

As we get older. Right.

% of year olds have erectile
dysfunction, % of year olds.

And he came to me for his problems.

And what was so cool
is he brought his wife of years,

this gorgeous woman who was with him.
They were in love.

You saw the way they looked at each other.

They had deep connection
and we're talking about his problems.

And I asked her,
I said, I said, well, how old are you?

And she said, oh, I'm, I'm 

And I said, are you,
are you feeling like yourself these days?

And she said, no, I've got hot flashes,
night sweats, I've got brain fog.

Sex feels like razor blades,
I've got dryness.

And every time we have sex,
I get a urinary tract infection.

And I spent the next minutes
talking to them, giving them books,

podcasts, resources, guidelines,
showing them my video at the FDA,

telling them
about how it's actually not his problem.

He just wants to connect with the woman
who he has loved for years,

and he doesn't have the knowledge,
the education, or the language to

understand why they've been disconnected
for all these years.

But it's her biology, right,
that is affecting their bio

psychosocial relationship.

And he cares deeply about her.

He doesn't want to hurt her during sex.

And so once he got that information
and he realized it, you just felt

the ether of the room, just so much more
hopeful and excited of like, wow.

But then it was, well, where do they go?

She wasn't a veteran,
so she couldn't be my patient.

Like, like, where does she go?

Where do I send her for medical care?

Because there aren't that many people
who can have these deeply nuanced

conversations about risks and benefits
and family history.

So it is essential, right, that
we actually pay for all this new education

and knowledge with the clinicians
who can have these conversations.

How many,

docs have we talked to?

Where you say,
do you prescribe hormone replacement

therapy for post-menopausal women?

And they'll say, oh, I worry about that
breast cancer risk.

So no I'm concerned,

so I don't. The damage done
by that press release in 

from the WHI announcement
without any data released.

And, you know, let's it's

maybe the biggest screw up in modern
medicine.

It's had tremendous consequences.

And I'm, you know, I'm
thinking as you're talking,

which I should be talking about these long
term health benefits,

there may be no medication
in the modern era

that can improve the health of women
at a population level

more than hormone
replacement therapy, arguably,

maybe with the exception of antibiotics
or something I'm not thinking of.

But the tremendous public health benefits.

Well, Doctor Rubin published a paper
that said if every woman who receives

Medicare so this is and older,
just got vaginal estrogen, right.

There are a low hanging fruit here.

So that's just for genital
urinary syndrome menopause.

If you mailed everybody on Medicare
who has a vagina tube of vaginal estrogen

and they used it,

which they're more likely to do now
that we have correct labeling,

it will save the government
health care system billion

a year
just in reduced urinary tract infections.

Just in one outcome.

Out of all the outcomes.

Forget about the fewer
hip replacements, fewer

people taken to the cardiac surgery
suite for a heart attack.

Just the one outcome, billion.

So I think also
the point is that we are not suggesting

that every single woman on Earth
gets a hormone prescription tomorrow.

We are suggesting that they are able

to go to their clinician
and get options and see the menu.

And the menu

may just look like vaginal hormone therapy
to prevent urinary tract infections,

which is guideline driven
and every human on Earth can take safely.

Right? I truly believe that.

And the data is only overwhelmingly safe.

We there's data that came out last year,
women with breast cancer,

if they took vaginal estrogen, had less
likely risk of dying than if they didn't.

And so we have more data out there
that shows mortality

benefit from vaginal estrogen
than any harms at all.

So some women may just opt for nothing,
which is okay.

Like if as long as you're
it's all informed consent.

If you know what the risk the benefits are
and the risks are

and you choose to do nothing,
that's a great option.

But you deserve the dignity, the dignity
to get to choose how you live your life.

Because we are all going to die,
every single one of us.

And the question is,
how do you want to live?

Do you want right, like, like,
what are the options

and what do you choose
to put in your body?

Some people choose to smoke,
some people choose to drink,

and they take on those risks,
but they aren't often

sort of given the options.

And that's what we're trying to change.

And this labeling change is
just the first step.

It is the first necessary step to say,
wait a minute now.

Now we have the hard work

of training people to understand
how to do this and how to message it.

I write in my books.

I say, I'm
not here to tell you what to do.

When women are smart,

they once given good information
that they can make excellent decisions.

But I want you to make your decision
based upon education and not fear.

And for too long,
fear has been driving the train. Yes.

Look, you dangle something as sensitive
as breast cancer to women.

That is a powerful fear machine.

And look to the people who might disagree
with us, out there

might say, hey, no, look, there's
this one study that showed,

even though it was not statistically
significant in its first publication in

in 

women would experience
a breast cancer diagnosis.

No subsequent study has ever shown.

No clinical trial specifically
has ever shown an increase in breast

cancer mortality,
and the initial finding was not

statistically significant and a subgroup
had a lower rate of breast cancer.

I'm like you, I'm a regulator now.

I'm a health official.

I I'm I'm part of the government.

I'm not here to tell anybody what to do
with their own health decisions.

But I feel like by removing
some of the black box warning dogma,

we are clearing the air for a conversation
around the evidence

and getting away from the fear
based mindset

that has dominated
this field for years.

A lot of women now are saying, hey,
why have these issues

not gotten the attention they deserve?

It's a very bipartisan discussion,
actually, because everyone loves

a woman in menopause. Everyone.

Everyone has a man, a perimenopausal
or menopausal person in their life.

And that spans beyond politics.

We're living % to % of our lives
post menopause, right?

And people think it's
all about the period.

One third of women
don't even have periods.

Hysterectomy’s, IUDs, Ablations, right?

It's not about the period.

It's about outliving ovarian function.

And this is for decades.

Right? And so when I talk to women, I say,

what do you want to be doing
when you're ?

How functional do you want to be?

What's your ideal day?

Let's build you now
so you can be that person.

And once you get women
thinking about the future,

it actually is a lot easier
to make that decision.

I want to be playing pickleball.

I want to be able to get off the ground
with my grandkids.

I want to be writing my fifth book,
whatever it might be.

Everybody's different.

But when you think,
how do you want to age?

Well, 
hormones are part of that discussion.

I always agree when women are like,
we need more research,

we need more research.

I completely agree, we need more research.

But let's not forget about the research
that we have.

And a lot of this research
that we have is actually old research,

because the iron Curtain came down in 
at the WHI.

Right.
And the box warning. And the box warning.

So we actually do have to go back
and be like, we've been giving women

hormones for years, years.

Let's not forget all the research
that we've done to show decrease

in diabetes, in prediabetics, decrease
in depression in people

you know who are in perimenopause.

We've got all these amazing studies.

Yes, we need more.
I will always say we need more.

But let's not forget about what we have
and then be able to make safe,

wise decisions.

You know what students will sometimes
ask me

what higher or advanced degree
should they get?

And almost invariably, regardless
of what they want to go into, I tell them

to get a degree that allows them

to have a command of the skill

set of critically appraising a study,
something that's, almost a lost art

now. We find studies

that give us conclusions that we like
and we latch on and

We site them, regardless of if the study is
flawed, methodologically or weak

or and vice versa.

A study gives us an answer we don't like,
even though it's methodologically solid.

We dismiss it and, that is sort of falling

for this cultural trap
that we have going on all the time.

We have to, as physicians, objectively

evaluate data with the same,

appraisal of methodology, whether or not

the results show it,
tell us what we expected or didn't expect.

So here's what's crazy.

The paper that was published in 

in JAMA, the first WHI paper.

It is free online, no paywall.

It is available now.

Anybody’s been able to read it
ever since

we've had an internet connection
and they put it up.

So it's like because of the boxed warning
and because of this fear

that's in the ether, and people
can't even see where it's coming from.

The actual paper is free online for
anybody to read and interpret at any time.

I was a medical student,
third year medical student,

doing my general surgery rotation,
and the chief resident said,

I don't know what we're talking about, but
he said something that changed my life.

He said, nobody is more in charge
of your education than you.

Yeah.

So it's like,

listen to the thought leaders listened to,
you know, what people are saying.

But at the end of the day,
go read the paper if you if you want to.

And the the crazy thing is
the paper is frickin free online.

And we still have so much work
to undo the damage.

Well, the boxed warnings
that the FDA slapped on in the groupthink

bandwagon
pile on that happened in 

are now gone, and the only boxed warnings
that are going to remain

are the basic warnings
around systemic estrogen,

being given alone without progesterone
and women who still have a uterus,

which is an important principle that most
clinicians should be, giving guidance on.

But the fear machine is,
is hopefully going to

and and we are going to now usher
in a new era of education and research.

And so thank you

to both of you for coming in
for what you do, taking care of patients.

I wanted to have just sort of

an open conversation with both of you,
and this has been wonderful.

So thanks. Thank you. Thank you. Great.

All right, folks,
thanks so much for listening.

We'll do it again.