FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

I think sometimes there may
be no other medication in the modern era

besides, say, antibiotics or vaccines
that can improve the health

outcomes of women at a population level

more than hormone replacement therapy.

Okay. Welcome, folks.

I'm here today with, Gloria Bowles-Johnson
and with Heather Hirsch.

Thanks so much for being here.

And really excited to have you here to
talk about HRT for postmenopausal women.

Exciting topic.

Tell us a little bit
about your background.

Do you want to start, Heather? Yeah, sure.

So I am board certified
in internal medicine, and I completed

my internal medicine residency
from Case Western in 

And I was always so interested
in women's health.

So I ended up doing a two year

fellowship at Cleveland Clinic,
and I trained under Dr. Holly Thacker.

And during those two years, she saw women

just for menopause, perimenopause
and hormone therapy replacement.

And, you know, I had come out of my
seemingly topnotch residency,

and I really didn't learn anything
about menopause or hormone therapy.

If I learned anything,

it was really to use it as last resort
for menopausal symptoms.

So to 

I pored over the research,
the Women's Health Initiative, and more.

There's lots more studies,
but the Women's Health

Initiative is the biggest one
and saw hundreds of patients with her.

And I saw women from all over the globe.

She's a legend.
To Cleveland.

She really is.  She taught me
everything I know.

And really say to me over and over again,
I feel like you saved my life.

I feel like you've saved my life.

And, you know,
they had spent years trying to figure out

what was this weird thing
that was happening to them,

and it was really menopause
or perimenopause.

And so that two years really allowed me

to see how effective and safe
menopausal hormone therapy was.

And really, that's what I've been doing
with my career ever since my training.

That's cool.
And where are you practicing now?

Yeah, so I went on to a first practice at,
Ohio State Wexner Medical Center.

Then I went to the Brigham and Women's
Hospital and, while I was

there, founded the first midlife
and menopause

clinic at the Brigham.
And then now I have my own private

telemedicine practice
called The Collaborative.

That's awesome. Yeah.

That's great.

You can meet reach a lot of patients
that way. Exactly.

Great.

So, awesome to have you, 
Doctor Bowles-Johnson.

So do you do a lot of podcast?

I know you do a lot of podcasts, Heather. 

Not as much as Heather,
but I do some podcasts.

You've done some podcasts.

Menopause and maternal health actually
did a big thing on maternal health.

Tell us about your background. Yeah.

Tell us.

So I, let's see.

Start from the very beginning.

Sure. Med school.

Med school.

So med school was Boston University. Okay.

And then my residency was at the Brigham
and Women, and,

and then, my four years of training

where we actually learned quite a bit
about hormonal replacement therapy.

And this was actually in the s,
the early s.

And part of it, I think, is because

we had our chair of our department.
Obstetrics and Gynecology.

Yeah, who had done a lot of work on like, DES,
some of the hormonal stuff background.

So that was kind of known
for a lot of like

research in their REI department.

And so we learned a fair amount actually,
during that time.

But it was a different time because HRT
was acceptable actually during that time.

And then I went on, after my training
and I actually was in the Navy.

I was a Navy officer at Bethesda
Naval Hospital, served three years.

I was an HPSP scholar.

And so they helped
pay my education for medical school.

And I served back.

And then from there,
I've always been an academic medicine.

So from there

I went on to work at Sinai Hospital
in Baltimore for about or years.

And then I've been at Georgetown
for the last years. 

Great.  And you're a professor there?

Great. Awesome to have both you guys here.

And this is such, a great topic
because there are

so many questions
that are still looming out there.

I invited each of you because you have
slightly different approaches in your,

practice style
with HRT and postmenopausal women,

but you, both see
so many things alike in the field,

and you are actually on the frontlines
treating women who are walking in

and asking these big questions.

And you've been doing it for a long time.

Doctor Bowles-Johnson,
so tell us about the early days

of hormone replacement
therapy and postmenopausal. So

early days.

And I would say during our training,

we learned to write prescriptions
for hormone replacement therapy.

We were kind of taught during that era
that actually

when a woman became menopausal,
you gave her a prescription

kind of like, you know, prophylactic
preventive medicine.

Routine.
Yeah, it was routine.

It was literally said the vitamin of your life.

And we really focused on the decrease
of Alzheimer's disease,

the decrease of osteoporosis.

We actually didn't even really focus
mostly on like quality of life issues

because it was mostly geared
towards osteoporosis and for Alzheimer's,

which was a big deal, big thing out
about women as women actually age,

even though we knew that it
definitely improved one's quality of life.

You mean the short term symptoms?

Yes, the hot flashes.

So even if women weren't, like,
asking for hormones.

But once we learned,
you know, their last menstrual period

and they were a year out
from that last menstrual period,

we were writing the prescription
and saying, you need to take this

for the rest of your life.

Wow. And and pretty much, you know,
I can't say there was % compliance

because there were patients
who obviously we're not asking for it, but

we were trying to convince them
that this was really important

for you, for longevity of your life
and to give you quality of life as well.

And so and that all changed.

Obviously, you know, when the Women's
Health Initiative study came out.

So I finished residency in 

The Women's Health Initiative
study came out like the end of the s, 

And it was a degree turn.

We stopped writing prescriptions.

We when women
started to complain about symptoms,

we said we were, you know,
talking about other alternatives.

We never pooh poohed because obviously
those symptoms are significant.

And of course,
I was a young attending at the time.

So when women would come and talk
about hot flashes, night sweats, insomnia,

I was like, oh my God,
I hope I never get to that stage of life.


So you have a very different perspective
when you're living through

some of the things that you deal with
with your patients, actually.

But we talked about other alternatives.

Right.

So those alternatives
being herbal supplements, you know, black

cohosh, estroven, things over-the-counter
that really were not,

you know, FDA approved, but,
you know, may have a placebo effect.

Talking about meditation, you know,
the conservative thing, loose clothing,

because most things
that women complain about,

if you really want to talk about
it, is really hot flashes

and not being able to sleep,
the libido issues becomes secondary.

The vaginal dryness becomes secondary.

But the main thing that really, really
interferes with a woman's quality of life

when she comes in complaining is really
hot flashes, night sweats and hot flashes,

and then those other things
become cumulative.

On top of that.
This is gold.

I'm learning so much right here.

I want to make sure Bigfoot we're catching
all this.

Is she close enough to the mic?
Are you hearing it?

He’d like you to get a little closer
because what you're saying

is fascinating.

And that is that before 
when you came out of residency for years,

you were part of a broader
prescribing pattern,

which was put every woman
on hormone replacement therapy

when they would start going through, 
perimenopause.

And it was
I mean, it sounds like you're saying

it was considered a vitamin for life,
and it was really prescribed.

If I'm understanding you correctly,
for the long term benefits

of reducing osteoporosis risk
and preventing the cognitive decline and,

maybe cardiovascular benefits,
that's fascinating.

Yeah.

You know, the American College
of Physicians, in 

at their annual meeting,
strongly recommended

the use of menopausal hormone therapy
for most women.

And really sort of
what we were seeing back then, although,

you know, it was hard to know
at the time, was prospective,

you know, people were watching women
prospectively. Yep.

So you were administering hormone therapy

around the time of menopause
and watching them in the s and s

that women lived longer and had less heart
disease, better bones, less dementia.

And then they thought, oh, why don't we do
a randomized controlled trial,

which they set up in the late s?
And then, of course,

you've got the Women's Health Initiative
that ended in 

Now my lunch,
my my menopause lecture was a voluntary

lunch and learn in 
when I was a first year medical student.

You could come and learn about menopause.
You didn't have to.

It was voluntary.
You got pizza if you came.

And in I remember learning,
you know, this clinician stood up.

She'd come in from out of town
and she said, look,

we used to think hormone
therapy was great.

We learned not so much.

So now we don't prescribe anymore.

That was the main takeaway
that I took in and luckily

I ended up going to that

because I probably didn't
bring any money for lunch that day.

Well, I don't think that we do a great job
even today with training our residents.

I mean, there's so much for our residents
to actually to learn.

And I'm an ObGyn, so I mean, this is real.

The meat and butter of women's health
and all the stages.

We spent a lot of time on obstetrics
and we spent a lot of time

we're trying to, you know, get the keep
the numbers up from a surgical standpoint.

You know, all of the main things
fibroids, abnormal bleeding.

We're coming out with technology for that.

But when it comes
because when you think about menopause

and the symptoms and all that, it's
really like primary care.

And although we're kind of looked at,
we don't always like to be looked

at as primary care because we're surgeons.

But we because there's so much
that is encompassed

in the four years of our residence to,
to learn obstetrics and gynecology.

And there's and honestly,
even when you look at fellowships,

I mean, they're not necessarily like,

you know, board certified fellowships
that are actually for midlife crisis.

So a lot of centers, and Hopkins
is one that announced it

setting up like menopausal clinics.

But because people have become interested
in it. Right.

You've done your research on your own.

You, you,
you seek out to read the studies, etc.

but it's a lot and there's a lot there.

So our young residents
that come out as attendings,

which we have many of them
in our practice, don't know about HRT,

but when you start out, you're,
you're taking care of young women.

You're taking care of them
in the baby years. Right?

So they're not talking
about perimenopause, all that.

It's a happy time.

It's about having babies and whatnot
until all of a sudden you hit your s

and in your s, and then you're really
talking about issues that impact

your ability to function as a female day
to day in all the things you do parenting,

working, you know, being a wife
and all of those kind of things.

So it really becomes a big deal.

And we as people who are treat
are training the next generation

need to figure out how in our training
that we can actually get more

training for our future doctors.

Yes.

You know, that are going to be out there

and taking care of like,
you know, the next generation

of women that are going to be going
through perimenopause and menopause.

It's a big problem.

It's a big I mean, tragically, to 
million have been denied.

Yes.  
The potentially life changing, life

extending benefits of hormone
therapy post menopause because of a dogma

that it,

had a very high risk of
of increasing your death,

risk of breast cancer
when no clinical trial has ever found.

We can talk about the nuance
in the small details of,

not to minimize the but the the,

in increased risk.

in women in the Women's Health

Initiative had a non-fatal breast
cancer diagnosis.

It never translated into a risk,
increased risk of breast cancer mortality.

It was not statistically significant
in the initial study.

Hardly anyone noticed
could follow the statistics.

It hit that media first.

It was broadcast around the world.

And the reason we're talking about this
today is that

the FDA piled on to that bandwagon

thinking and issued a black box
warning, slapping

this scary warning across
all estrogen products.

And so today,
we are announcing that the FDA

is initiating action
to remove the black box warnings

of a breast cancer of cardiovascular
disease, of possible dementia

on estrogen products,
all of them systemic and local

and there will still be a warning
that if you are taking estrogen alone with

and you have a uterus,
there's an increased risk of,

endometrial hyperplasia,
which can cause endometrial cancer.

And that's why the progesterone
is recommended to go with estrogen.

If you still have a uterus.

And so we're going to preserve
that important thing.

But that other scary warning is now
we're just going to go

in the text of the insert.

That's why we're talking about this today.

It's a big decision by the FDA.

It comes after our expert panel
that you were on.

And it comes after an intense review
of the scientific literature

by our subject matter experts at the FDA,
including OB doctors and OB doctors

have had sort of an eye and expertise
on women's hormones for a long time.

And, Heather, you've been close
to this issue because you actually read

that Women's Health Initiative study
and called out

the fact that it was misleading at
I mean, I'm being

I think it's at best,
I mean, at minimum, it's misleading.

Yeah.

You know, when you look at the Women's
Health Initiative,

it's a very interesting study.

And really, you have so much information
in the original findings

that were published in that really
it took a lot of post-hoc analysis

to be able to kind of review
and really kind of see what was going on.

And the important thing that we really now
know is, well, there's two.

But the first was really that the time
that a woman initiates menopausal hormone

therapy is distinctly important,
especially when it comes

to those long term benefits

that the prospective studies were seeing
that you were seeing in the s.

So originally,
the study was women aged to 

In fact, only a small percentage of women
were within five years of menopause.

And actually it was excluding women
with severe symptoms

because it was a primary prevention trial.

Looking at does estrogen
reduce the risk of chronic diseases?

Well.
Specifically cardiovascular diseases, yes.

As part of the Framingham Heart Study. 
Exactly.

And so what they actually got in
the study was women

who are on the 
who were on average age or 

So therefore they were about 
or years out of menopause

when they initiated hormone therapy.
Too late to initiate. 

You know, you could say that but
definitely different physiologic states.

Right. 
You have a different view.

You've had some okay.
So let's talk about that later.

But keep going.

I'm sorry to interrupt. Yeah.
Yeah a little slightly different.

Yeah.

Well, you know,
the thing is, is women often kind of hear

this age of but let's kind of say
ten years from menopause

is really if you were menopause was at 
that means 

If it was at that means 

So I really find the ten year window
for getting the benefit

of heart disease, bone health and etc.

that really we see
within the first ten years.

Initiating it within ten years
of the onset of menopause,

that's when you see the those long term
long term benefits. Yes.

So and let's let's just summarize.

Yeah.
Fifty to sixty percent reduction in osteoporosis risk.

And in the risk of fractures,
something like a % reduced

or reduced risk.
Significant which is, which has so many long term

implications
into the economics of just broken bones

and etc., and women dying
after having a fracture.

So yes, significant.
Mortality increases.

Yeah. With all Cosmo.

Yeah.

With a major with a major fracture,
a hip fracture.

I mean, when you think about, you know,
being immobile and pulmonary

emboli and all of those things
that become like the death sentence.

Yeah, % really
big deal, % one year mortality.

And then in those women
who are within ten years from menopause,

you saw reductions
in cardiovascular disease, death

from all causes, 
and death from heart attacks.  And then

also, as you said,
that group was split into two.

If you didn't have a uterus, you took
estrogen only, which was Premarin.

And if you did have a uterus,
you took Prempro

and then the women who did not have
a uterus and only took estrogen,

they had reductions in breast cancer,
which didn't get publicized at all.

Yeah.

So it was really.
The irony, deep irony.

I mean, what a twist of irony.
But it came out later.

It did come out, but it came but it yeah.

Started to see. Yeah.

And it was, it was more the progesterone
that was the biggest risk

as far as the HRT for the potential risk
of breast cancer compared to the estrogen.

Just because of that, that they did
separate the women actually out.

So yeah

very very and I mean again
that came out years after we had already,

you know, done the deed in the sense
of taking hormones away from women

or scaring them half to death, that
they didn't ask for it or did not want it.

Even the women with severe osteoporosis,
where oftentimes the bone

specialists will say you might benefit
from going on some estrogen, right?

You mean you may need estrogen

plus progesterone, but be a part
of that cocktail for osteoporosis?

We were you know, many women
were kind of pointed towards the SERMS,

the selective estrogen receptor modulator
drugs, actually for osteoporosis.

But there were women

that really benefited from like estrogen
for severe osteoporosis.

Yeah. So you're right.

The damage was done in despite
even what they had at the time,

which was probably a lot of information
because you had, you know,

tens of thousands of women
in both randomized arms

plus an observational arm,
which wasn't randomized to HRT.

And so it was really hard for them

to look through all that data,
and then those post hoc analyses

that have come out every couple of years
since then have really solidified the

benefits of hormone therapy for women,
especially if they start within ten years.

And they use a slightly different
formulation with Prometrium

as a progesterone with their
Instead of MPA medroxyprogesterone with progesterone.

Progesterone acetate.

MPA. Does that come from horses by the way?

No the Premarin comes from.

Yes okay.

So MPA now that blip that we talked

about of again
I'm not minimizing it by calling it.

But we're talking about one per thousand
nonfatal diagnosis for breast cancer

per year has been since attributed
by many doctors to be the progesterone

due to the MPA,
that type of progesterone that was used

that is not commonly used today
for hormone replacement therapy.

Fair enough.

And even actually the Premarin in which
of course is a different derivative of,

of estrogen
compared to the more contemporary methods

of giving estrogen the patch,
which tends to be less thrombo-

genic compared
to oral products of estrogen.

So we've learned a lot.

I mean, yes, the label had yes, increased
risk of, you know, VTE,

thrombotic stroke, you know, heart attack,
those kind of things on it.

But we've learned a lot that just having
to do with the formulation of the estrogen

makes a difference. Right.

So the patch seems to be a little bit
more protective in VTE risk

compared to actually oral agents
of estrogen itself.

Right.

And actually I think it's kind of
closing that loop again.

When they first

put those studies out, they really took
all those women who were from to 

put them all together and said, well,
not only do we see, you know,

you know, two out of four women,
out of a thousand over five years on oral

Prempro having a slight increased
risk of, diagnosis

of breast cancer, although didn't end up
having increased mortality.

But, you know, gosh, we also see increased
risk of maybe cardio thrombotic events,

which were mostly in the women
who started HRT

really years
since their last menstrual period.

And that was the basis,
the genesis of of the FDA's black box,

warning that this could increase
the risk of cardiovascular disease.

So the irony is
you start it earlier, let's say ten years.

With the onset of menopause,
there might have been protection.

I mean, the the numbers
that have been described in different

studies are a to % reduction
in fatal cardiovascular events.

Now, those
some of those are observational studies.

There was a great review article
that I just saw published.

I think it was circulation. Yep. Yeah.

And so you talk about in 

risk of a non-fatal breast cancer
diagnosis with a formulation of estrogen

that is not commonly used today
in the past.

And people are extrapolate extrapolating
that to say I shouldn't take it

when the number one cause of death
in women is cardio disease.

Yeah.

I mean,
and you look at the numbers, right?

You look at the reduction in risk in bone
fractures and cognitive decline

in heart attack risk.

I mean, I think sometimes
there may be no other medication

in the modern era
besides, say, antibiotics or vaccines

that can improve the health
outcomes of women at a population level

more than hormone replacement therapy
when started

at the right time in the right
candidate women.  I agree,

I absolutely agree and, you know, spend
a lot of time around clinicians who are

studying longevity, not just clinician
entrepreneurs and scientists.

And they're always floored when I say, you
know, while everyone's thinking of these

in incredible interventions and wearables

and devices,
you know, estrogen is the one intervention

that's been shown to increase
healthspan in women by years.

And that data comes from the Women's
Health Initiative. Wow.

It's amazing.

Tell me, you know,

we can geek out on these studies for hours

at least I, I can do that and do that.

In case you're wondering what I do
in my free time.

That's what I love doing.
You know, my friends.

Yes. And, but, tell me more about how

that scare that was, again, bannered.

And I've talked to some of the authors
of that study and they'll say,

well, it wasn't statistically significant
in this study.

The media ran with it.

And, you know, kind of like
it was the media's fault.

Well, you know, we can debate

it was fed to the media
and the publication was not out.

And so why did the media run with it
without the data?

But, tell me what it looked like
on the ground when talking to patients.

When the when the Women's Health
Initiative study came out in the media


Yeah.

So, women were scared.

You had certainly less,

less women coming in and asking for HRT.

So you have to remember,
when I trained, like, it wasn't that women

were coming in all ways to initiate
to want a prescription for HRT.

We were giving it
part of the preventive health.

Right.

But now you had women that were afraid,
right, to even ask the question

because they're dealing

with their symptoms and they are afraid
because if you hear the word cancer,

and I think for a woman, cancer more
than a heart attack is a big deal, right?

Nobody wants cancer.
And particularly breast cancer.

You have women that fear
getting a mammogram

every year because they're afraid

that they're going to come back
with the diagnosis of cancer.

It's a very sensitive,
very sensitive topic.

In fact,

as I was driving here today, I got a call
from my nurse of one of my patients

who I just delivered a third baby two
years ago who had a mammogram, in April.

That was suspicious, and 
a follow up in June that wanted a biopsy.

And it's now five months later, and she's
not had the biopsy because she's afraid.

She's afraid to be given
the diagnosis of cancer

as opposed to trying to pick up
something early to treat it.

So the word
C is a scary thing for a female.

Okay.

And that was enough to scare women
to say, I'm not.

I'm not even going to talk about my like,
you know, vasomotor symptoms.

I'm not, you know. Yeah.

Just as my mother said,
you just lived through it

because that's kind of how the generations
before they didn't talk about it.

You just lived through it.

And we didn't have social media
the way we have it today.

So we're talking about the early s

where, you know, the internet
was just exploding coming about,

I think about search engines
back in the middle s and whatnot.

But it was the news, right?

It was your it was your nightly news
that was like giving you the information.

And so, so let's talk about it.

And when women did come to say,

I want hormones, we,
the clinicians would talk them out of it.

The majority because the way we interpret
it, what came out that even scared us,

you know,

and for the prescriptions
that I have may have written,

if the patient had not stopped
the medication, I was for sure

saying, you need to stop the medication
because of that fear.

But one of the things that was a take away
was that, and we learned from that.

So that's why women kind of some
who decided to continue

it was to give it for the shortest term,
the lowest dose for the shortest term.

Okay.

Because after
because the Women's Health Initiative

said, after five and a half years,
we knew that date to the T.

That's where you started

to see the increase of the risks
associated actually with the estrogen,

you know, that was being prescribed
the progesterone, the estrogen

and progesterone related to the VTE.

Yeah, yeah.

You know, when you read the label because
it didn't really kind of differentiate

out estrogen versus progesterone,
it was the information that came

after as people
started to extrapolate the data.

So when it first came out,
it was like hormone replacement,

regardless whether it was estrogen alone
or estrogen plus progesterone.

That's significant. Yeah.
And that is significant.

So that that information didn't
come about until several years after that.

I want to say maybe like eight years
after the Women's

Health Initiative study in 
when people started to question it,

and then we started saying, oh, yeah,

okay, maybe it's more of the progesterone
as opposed to the estrogen.

But it was enough to scare women.

So now there's a resurgence, though.

Women are coming in and they're talking,

yeah, social media women are, you know,
we're we're we're talking a whole lot.

The medical field has I mean,
the medical field gets groupthink.

All right.

So I mean ob I think out of all fields,

saw through the fear

machine and set
and because they I think the field of OB

is very knowledgeable
and expert on women's hormones.

I know of a couple OB doctors
who immediately saw

through the statistical, non significance
and the design flaws of the 

and kept prescribing
through and supposedly, you know,

you go back a year ago

most doctors would not prescribe
hormone therapy for post-menopausal women.

Fair enough.

And that was the remember
the liability side of it too.

Sure.

I mean, the whole
I mean, the whole machine.

I mean, it was, again,
a community groupthink

and but of the different specialties
in medicine, I would say

OBs were more likely to be prescribing
because they they were comfortable.

They knew that, medication.

Well, you were running an, a menopause
clinic at the Brigham and Women's

Hospital, and you're still very much
on the front lines of this whole field.

I mean, what's your take on this?

Yeah, I mean, I think it's such
a interesting field of medicine.

One, it's so satisfying.

Patients really are looking for answers
and support and they're so confused.

This damage that was done over 

almost years ago like still lingers today.

And as you mentioned it, a lot of this
stems from not having any education

in the last two decades,
because after I received that lunch lesson

that was voluntary, that menopause hormone

therapy was dangerous
that was really all that I got.

But I think there is a resurgence
and a re interest

that really probably started,
you know, a couple of years ago

when women were at home,
they were on social media more.

And while there's pros

and cons to being on social media,
that's that's definitely true.

They started really talking about what
their options were,

and there were few doctors along the way,
like my mentor, Doctor Thacker,

who also were reading the studies
and still prescribing hormone therapy

through, and what I really found
is that the more you learn to prescribe

hormone therapy
and the more you actually do it,

the more that fear and those biases

actually start to dwindle,
because patients do really well.

You know, as an internist,
there's a lot of scary medications.

I learn how to prescribe, you know,
antibiotics, anti-seizure medications,

all sorts of things
that can really impact,

you know, that
have box warnings on them as well.

But nothing seemed to scare clinicians
more than hormone therapy in the last

two and a half decades.

So training clinicians is so important.

There was a study that came out in 

Back to geeking out on studies
where they asked OB

and I think it was ten true
or false questions

about hormone therapy,
and gave them clinical vignettes.

And they also did this
for internal medicine clinicians as well.

And the hypothesis
was the more knowledgeable

you were about the randomized
controlled trials

on menopausal hormone therapy,
the more likely you were to prescribe it.

And that actually was true.

So the ObGyns scored a %

and the internal medicine scored,
I think a %.

So we and we still have a long way to go,

because circling back to what you said,
data comes out every year.

That residents in ObGyn
and the internal medicine specialties

family medicine are not getting trained
on this information,

but yet now we have women
asking a lot of questions

and also doing their own research
and reading the WHI by themselves.

Right. You know, challenge
it because it's available.

Yeah,
challenging for sure. Well, you know,

when I think

back, one of my mentors was Isaac
Schiff, Doctor Isaac Schiff. Yes.

And actually the Menopause Society
was just kind of

being creative,
actually, towards the end of my residency.

And and Veronica Ravnikar was one of also

one of the,
the trailblazers back in the day as well.

She wrote a book on like, menopause.

I remember it's like on my shelf.

Yeah. You know, the whole the whole thing.

You know,

it was very few people as gynecologists
that were like,

looking at that phase of life.

But because of, like,
the Menopause Society is a big deal now.

And we're getting certified to say
we're a menopausal specialist,

which is what you can do

post, you know, residency
to be to to learn a little bit more

about hormones and about women's
health in the midlife, for sure.

So those are things
that can actually be done.

But we were not afraid at the Brigham.

I feel like very blessed, you know,
and Doctor Schiff was at Mass General.

So we were the Brigham Mass General,

which is where we trained
and did our stuff.

And we are among really the greats,
honestly, when it came to that.

But I must say that
that mentality did shift.

And I can tell you,
even personally, for me,

when it came time for me to make decisions
personally for myself as I started

going through that phase of life,
which was not a pleasant phase of life,

you know, I pooh poohed away from hormones
myself.

You know, not all physicians can say that
for the various reasons, you know,

because at the end of the day,
we're all human, despite being clinicians

and all of that.

When it comes to you personally,
you have to make

your own personal decisions as well.

And so, but I think about it
very differently, and I counsel

very differently

today as well, since the new information
has come out to say it's okay.

And I've, I've actually never really
deprived anyone who asked unless it was,

you know, real major contraindications
that they couldn't do it.

But I definitely hound on the lowest
dose for the, the, you know, the,

the length of time,
which is just the right time to get you

through that phase of life to get you,
you know, relieved of those symptoms.

That's your practice style today.

I think it's changing a little bit,
but I must say I still kind of guide

by that, honestly.

And again, because the course is
just more than just hormones.

So again, even though it's
the vitamin of life, there's

so much more
to living a full life of longevity.

So educating women about exercise, diet,

I mean, it's not just take a pill
and think that you're going to do fine.

You know, it's not promised

that you're going to live years
even if you're doing okay. Right.

But there's more to it.

It's more than just that HRT.

And so we're doing
a whole lot more education

in the sense of like,
you know, vitamin D, calcium,

you know, weight bearing exercises,
you know, self breast awareness,

you know,
making sure you get your mammograms

and all of those things in addition to,
yes, you might need or want to take HRT

for its protective effects
or to just get you through the phase

that you're going through
that you can't focus on right now.

Right.

So I, I'm a little bit of both. Gotcha.

Yeah. Interesting. Yeah.

Tell me about your personal practice,
style, when it comes

to a woman who comes in, they're dealing
with symptoms of perimenopause and.

Yeah. What do I do, doc?

Yeah, again,
we're not promoting any any product here.

We're not telling people what to do.

I'm certainly not you.

You're welcome to say whatever you want.
It's a free country.

But what is your practice pattern or style

or approach when it comes to women
going through her menopause?

I would love to talk about my approach,
because I've gotten to refine this over

the last years, and I % agree with you.

You know, there is no magic bullet.

And, certainly I,
I really while we're talking on the topic

of menopausal hormone therapy, it's
always important, I think, to acknowledge

that there's no one right answer or one
right way there really, really isn't.

But I spend a lot of time, you know,
talking about menopausal hormone therapy

to still break down
some of those myths and misconceptions

because they're still so deeply rooted,
so when patients come to see

me, oftentimes I'm asking them,
if they're menopausal status,

are they in perimenopause or menopause?

Because in my practice,
I prescribe, menopausal

hormone therapy,
even if women are still in perimenopause.

And then I find out,
you know, their medical history,

if they have any what we call
red flags for hormone therapy.

Can you mention those real quickly? Yeah.

So if we're looking at the textbook,
which I think we should

look at the textbook
and the red flags for menopausal hormone

therapy will be, undiagnosed
abnormal uterine bleeding.

So we want to make sure
your uterus is healthy.

So that needs to be worked up first.

There's, history
or active breast cancer,

which while there are clinicians
who do treat patients after breast cancer,

let's say for the textbook purposes right
now, that's

we're going to call that a red flag.

Patients with a history of a stroke,
specifically with residual deficits,

a lot of women have something called
transient ischemic attacks or TIAs,

which actually I put in the yellow flag
category

because they're not having residual
deficits.

And actually,

we know some of these TIA events
are actually just abnormal migraines.

And so we don't want women to be unfairly.

Uncategorized.

You could have end stage liver disease.

That's going to be another red flag for,
menopausal hormone therapy.

And then it's a good general idea
to look at cardiovascular risks.

Not that anything in particular
is a red flag,

but you just want to look
at their cholesterol levels, their blood

pressures, their
AC's and risk for metabolic syndrome.

And just kind of put

that also in your mind, although none of
those are strictly contraindications,

but you just want to do a good general
thorough

look of the patient and treat somebody
holistically.

Yeah. In the middle.

Then, I really have my patients list out
the symptoms that are bothering them

the most. They do tend to have a lot.

And lately, instead of hot flashes,
interestingly, I see a lot of brain fog.

I see a lot of
I have that two trouble concentrating.

Of course I see the usual hot
flashes and night sweats.

I think it's a good time to also say
the indications for menopausal hormone

therapy still really are hot
flashes, night sweats,

genital urinary syndrome of menopause,
and osteopenia and bone loss.

But I look at all their symptoms.

And then one thing I do with my patients,
which I found really interesting

over the last decade, is

I say, you know, do you have any guesses
as to what might help you?

And back
when I was, a fellow at Cleveland Clinic,

they used to say, I don't know,
I probably need a neurologist

in to write a will, and I can't remember
anything, and I have no idea.

Doctor. Help me.

And, you know,
now they'll say, well, a patch,

mg of progesterone badgered them twice
a week and maybe a dab of testosterone.

I think that's what might help,
which is fascinating because we have seen

this education of women,
be it on social media or elsewhere.

So that helps for me
to guide the conversation

as to if hormone therapy is kind of their
first choice in their first option,

because for many women
it is, a really great option for them.

And then we kind of start hormone
stacking, which is my way of starting,

maybe with the progesterone,
then maybe adding the estrogen later

and really helping them see, 
you know, what they're going to do

well on, there's
lots of different formulations.

There's certainly ones that we tend
to prefer to use as first line.

The Prometrium as opposed to

the medroxyprogesterone acetate,
different transdermal options.

And then.
We have them putting in the IUDs now to for your protection.

And there's lots of different.

So the progesterone is delivered through
the IUD for some women that you recommend.

Yeah. Yeah. Interesting.

Yeah.

So short term and long term health
benefits.

Yeah.

How are what is the popular perception
that hormone therapy

is primarily for short term
or for long term

health benefits among physicians?

I think it's very mixed.

And again, I think it's really about who
you might ask.

Yeah, I was going to say
you're talking to an internist here

and you're talking to an ob gyn. Okay.

And I think, I think we have
a little bit of differences there.

Yeah.

How do you how do you see it?

I, I well, again, I think it's evolving.

Let's be fair.

Okay.

You heard me in the beginning,
when I was a young attending,

that it was like the vitamin for life.

So you took it until you died, right?

I think it's
probably somewhere in the middle.

And I think when more data comes out
to show that there are still these

protective effects beyond a certain point,
that and no negative effects, then

I think we can talk about longer, longer,
longer and prescribing the medication.

Right.

So I'm really like into this really
that ten, ten year protective

kind of we know that now to be true,
that there is that ten year

protective period of time from the time
a woman becomes menopausal.

And that varies between average age
being and to up to 

So you may have somebody that's on it
til she's years old,

and you may actually have a woman
that may come to you who's been on it

and says, I'm sorry,
even though my ten years,

whatever you decide is up,
I like how I feel.

My skin is beautiful, my hair is luscious,
my joints are not clicking

anymore, and I feel great
and I want to continue it.

Okay.

And as long as
there is no contraindications

and when you talk about those red box
contraindications,

then you know I respect that actually.

And so I think it's evolving.

And okay.

So that's what
that's my point.

And you know to that point too,
we really see a potentiation.

So even if women do use hormone
therapy for, you know, five years,

which is again, they only got to years
before the study stopped.

But we do see, even if you do use it
for just a few years,

you do get these benefits
that last, a while.

That last actually a really long time.

That's actually where the data comes from,
from the Women's Health Initiative.

So, you know, similarly,
I say that, you know, every visit

we do at, once a patient kind of find
if they want to be on hormone therapy

and then it works well for them.

Every year we do,
you know, their their menopause visit

and we ask the same questions.

Any new diagnoses,
any red flags that are new.

How are you feeling on it?
Is it still covered?

You know, you still,

are you still feeling positively
about using your hormone therapy?

We do tend to continue it.

And it was in 
the Menopause Society's

position statement was that you no longer
have to stop hormone therapy.

Just because
just because a woman turns or 

But we have that idea in green
from the Women's Health Initiative,

because that's kind of where they started
to draw those lines.

The difference really was,

is that's the age at which
they started their hormone therapy versus

if you did start earlier,
ideally within the ten years,

that's really
where you can continue it longer.

So ideally that would be if if you started
within ten years and you you shared

decision making and the patient's
doing well and there's no new red flags.

You know, I say you can continue your
hormone therapy for as long as you need.

So you can continue it.

What do you recommend for somebody who,
you know, I had two types of patients,

those who walk in
with a stack of Google printouts

and they say, you know,
I've got some questions

and you spent an hour
going through all their questions,

and then you have other patients
that come in and say they just stopped.

You don't need to stop explaining.
Just tell me what to do.

Exactly. Right.

So you have two types of patients
and everybody in between.

So what would you recommend for
somebody who

they've had symptom alleviation
of the perimenopausal symptoms.

Yeah.

And they're on hormone therapy and doing
well on it.

Yeah.

You know so I have this

this method I have this
like there's three things I look for

when women are starting
and, you know, continuing hormone therapy

one that they continue
to feel to % better.

Two, that it fits into their lifestyle
because sometimes

we're giving people patches
and they forget to change that.

I would for sure.

But three I want patients to feel
really confident in their HRT regimen

because of the reason we're sitting here
today.

There's still a lot of myths
and misconceptions.

So even if a patient's
really feeling well,

I might want,
you know, sort of personally, I think

continuing it would be fine,
but I want her to have that confidence,

so that if another clinician
or a best friend or neighbor asks her,

gosh, you know, you're 
why are you still on hormone therapy?

She really has the knowledge to say why.

And I think increasing that education
for my patients is something I take.

So, so, you know,
I really value that so highly.

So we make sure they have
educational videos and all the things

at their fingertips so that, you know,
they really make the decision.

I know even if they say

you make it for me, Doctor Hirsch,
I really want them to feel really involved

because it'll be very easy for them
to get scared and then be confused. And

I don't want to be a part of, you know,
having anyone create more confusion.

Well, most patients that feel good on it

and know that it's them, it's the medicine
that's making them feel good

are going to be at least
for this medication, going to be compliant

and are usually going to want
to not go backwards for the most part.

Yeah, yeah.

So patients say yeah
put it on one I'm great.

Yeah.

But we you know we do have conversations
because it does come up about

should I come off of it
I don't think I want to take it forever

because there's still that fear
that is never going to go away.

Right.

So we talk about tapering

and there are some patients that taper
that don't do well on tapering and say,

you know what,
I think I just want to go back on it.

And that's fair, right, that you allow her
to be a part of that decision process.

And she kind of helps you help her,
but she guides you towards what she

actually wants to do.

So I think,

to answer that question about forever,
I don't think, in my personal opinion

that I would want an year
old to stay on HRT.

At least right now, where I am
a little bit biased by the past history.

And although medicine
is constantly evolving, right,

we learn new things and right now
it's looking really good for HRT.

And I'm so happy for that because
we can do so much more for our patients.

But, you know, ten years down the line,
we may discover

something
that may be a little bit different

and we may have to hold back
just a little bit. Right.

And so

we don't want to deprive our patients
because quality of life is very important.

But we need to stay abreast
of like the science

because the science
is constantly changing. Yeah.

We don't have we don't have randomized
controlled trials like that long.

Right.

Yet hopefully,

hopefully they'll keep following women
though who are in some of these trials,

not just the WHI study.
The prospective studies, some prospective.

Yeah.

There have been prospective studies
that, ended

and you would hope
that there's resources there to follow.

What happens
even observational data people,

if you take a cohort of women who are on,
you know, sort of the modern,

regimen of hormone therapy,
we can learn from that data.

Now, it may not be as good
as randomized controlled trial data,

but we can learn from data.

We can learn from individuals.

We can learn from listening to
to patients. Yeah.

The WHI back story is something
I researched and had have previously

written about.

And it was an amazing back story
of an internal meeting

before the announcement where there were
there were dissenting doctors.

Yeah.

Who said in sort of a shouting match,

you can't put this out there
if you dangle something as sensitive

as breast cancer
associated with this medication

in front of women, you may never be able
to put that genie back in the bottle.

That's true.

And I think it was. Words were prophetic.

I mean, these were scientists
who one of whom appears

to have been retaliated against
for his dissenting view.

It's a fascinating back story.

But when, when you said,
you know, some women

just want to stop because of the fear
and you think about that,

this the propagation and the life
this fear machine has taken on.

And again, we're not I don't think
any of the three of us are saying

all women should be on it
or no women should be on.

We're just saying there it's nuanced.

This is a conversation with your doctor.
Yeah.

And the kind of perceptions out there
sometimes

don't matched match the evidence
and the nuance of the topic.

Yeah, exactly.

Well, as you know, as women age
and we think about our mortality rate.

And when we think about our mortality,
we think about in women will develop

breast cancer in a lifetime.

And that increases actually with age.

And so when you start thinking about that,
and then you've got this bias

in the back of your mind about hormones,
that now sound like we can give it.

It's all good.

There are women
who are still thinking that, yeah,

you know, there was that cancer risk.

And although and it's, you know,
may not be a black box label anymore, but

it's still going to be some information
there that might be saying that

the way we talk to patients nowadays

is usually like there's some things
that we just don't know, right?

We can't say it does increase,
but we can't say it decreases either.

Right. That's kind of the way to say it.

So there's that unknown.

And as women start to get older,
they start to worry about cancer

and particularly breast cancer because
it affects more women than men for sure.

And so I think that's the reality
when we start

talking about long term
use of hormone replacement therapy

and I do think it's individualized
because it is right.

We're all different in the way
that we have our symptoms and how we feel.

And at some point it becomes
less of an issue as those hot flashes

become less of an issue, you get older,
you start to get more cold and hot,

and you know, all all of those things
that come about what the aging process,

you know what I'm seeing?

Actually a lot to kind of on the flip side

is I see a lot of women who are coming
to me in perimenopause in their,

you know, s, late s, early s,
and they're watching their parents

age and they're thinking,

Oh no.

You know, and they're kind of actually
thinking, gosh, I'm looking at my mom

and she's hunched over,
she's got osteoporosis.

She you know is, is memory
lost her memory.

She's wearing her diaper
because she's got incontinence

and they're thinking,
I don't want to end up like that.

And so as they're kind of looking through
and thinking about what can they do,

I think this is also a place

where hormone therapy has interestingly,
entered the chat.

And this goes back to what we're saying
at the beginning of the podcast,

which is what about these long term
benefits when it comes to bones?

And we can talk about brain health,
although that one is still being studied.

Right.

We definitely can't say that
there is definitive

data that it's going to prevent dementia,
but the impacts on the brain

are probably there's likely to be some
when women start early.

And so I think this sort of resurgence of
I want to build generational health,

I want to be fit and active and playing
tennis and playing with grandchildren.

When I'm in my s and s,

especially as they're now sandwich
taking care of their, their parents,

they're they're helping their daughter
have their first period.

They're thinking, wait,
you know, menopausal hormone

therapy has entered the chat
for that reason.

And I think this is
really interesting as well.

It also seems like

half of more than half of medical students
are women now. Yes.

And so you have a whole generation
of female doctors now who are saying,

hey, wait a minute, these women's
health issues, we're experiencing them.

We're close to them.
We're proximate to them. Oh, yes.

And it does not have its proper place
in the medical textbooks

or the curriculum
or the residency programs.

So it does appear
as if this is a driving force

to bring attention to women's
health issues that have been massively

under-recognized, underappreciated,
underfunded over the years.

It seems like that is part of the trend.

I mean, let's be honest,
it's been a male dominated profession

for decades, maybe centuries even.

Yeah, yeah.

And so only in the last couple of decades
have we had this now

enlightenment, where,

you know,

maybe we're now recognizing
these are major issues of health.

I mean, you probably have had,

women can just come to their doctors.

And this topic has been entirely blown off
because,

like, if you have perimenopausal symptoms,
the only treatment is a carcinogen.

We can't do that.

So I even teach the students
about menopause.

Well, and you also have to think
about the generations before.

So if you're a product of the generation
before and the generation before,

first of all, women
didn't live as long, right?

And if they did live through
that transition of life, of perimenopause,

they just didn't talk about it.

They weren't
they weren't told to talk about it.

They didn't talk about it
with their mothers,

and they didn't talk about it
with their sister.

It was just a part of life.

If you will hear that from women

that are in their s now,
it was just a part of life.

You just dealt with it,

you know, and as I said before,
we started talking on our podcast,

I was telling you about a family member
who is like now and she said her male

doctor told her
he wouldn't give estrogen to a dog

and no way that he would prescribe it
to her.

Just suck it up.

And so she said, I sucked it up and I did.

So her daughter, who's now menopausal,
who's suffered from the symptoms,

she's like, my mom says, just suck it up
because she sucked it up.

And I'm like, no, no, no, no,
you don't have to suck it up.

We're living in a different era,

and there are things that we can do
to help you, but that has been kind of,

you know, sort of the history
for women, right?

That we couldn't complain
and that if your mom didn't talk about it

and teach you about it,

you didn't talk about it.

It was just the phase of life,
the change of life that you had to deal

with.

And so we're a different generation now
and absolutely having more women

in the field of medicine
that can address women issues to women

is going to change the footprint
of medicine in the future, hopefully.

Yeah. You know, it's been amazing.

At the last annual Menopause
Society meeting, membership

and certification has gone
up, you know, from about 

health care professionals,
because it's not just doctors.

There's pelvic floor physical therapists,
social workers, psychologists.

But to now over Wow.

And interestingly,
I also train a lot of clinicians I train

on, you know, the FDA approved, science
behind menopausal hormone therapy.

And even now I'm getting younger
and younger clinicians.

It used to be, as you said
at the beginning, you know, a very few,

you know, clinicians, maybe after their
years of delivering baby or doing surgery.

And now I'm seeing young women's
health nurse practitioners,

emergency room physicians
who don't want to do that anymore.

They're excited about menopause
because they've seen so many urinary

tract infections and panic attacks
coming into the emergency room.

And we're actually seeing younger
and younger clinicians and health care

professionals getting excited about this.
And tying those symptoms together more.

Right?
So we're not isolating those symptoms.

We're taking menopause out of its and,
you know, now with more pelvic floor

physical therapists,
even urologists who are into like,

you know, genital urinary syndrome,
I think that they're writing you know

HRT and certainly, vaginal estrogen
like water in the emergency room.

That would be amazing given a little bit
of, you know, testosterone, you know,

addressing things that was not traditional
even in the field of urology.

Right.

And so that's
why you're seeing the explosion,

because it's not just the clinicians
that are part of it.

And just like an internal medicine,
I mean, you know, you're

you're a generation
also because back in not long ago,

there was no going internal medicine
and doing special training

and actually like midlife crisis and HRT
and whatnot.

It was unheard of.
It was only the gynecologists.

Yeah, that was actually doing that.

So it is changing.

Yeah. For the good.

And it is a demand driven. Is it.

So there's an awakening in the field.

Obviously you're describing
but I assume with social media

women are describing their
I mean, I, I've had a couple friends

tell me that it has changed their life
dramatically.

Saved marriages, I mean, dramatic results.

There's not a lot of things in medicine
where you get those that sort of result.

Yeah.

It's one of those times of just satisfying
career.

It it just tells you
the importance of ovaries.

I mean, really, yes.

I just really I mean, it just really tells
you the importance of it.

Well, that's, you know,
I got in first intrigued by this.

Because there was a mayo clinic study

that women had there who had their ovaries
removed in their s,

went on to have cardiovascular disease
in their s and s,

suggesting
there was a profound cardioprotective

benefit to the hormones
produced by the ovaries.

And that study in a male
dominated culture,

I think, just got ignored or blown off.

I mean, that's like a massive clue. Yeah.

And we we spent how much money studying
arteriosclerosis, right?

I mean, that's like a treasure
trove of information that got blown off

for almost a century.

Yes. And so, 
which thus you could understand

why it was felt
that it was the vitamin of life, right?

You saw this change that suddenly happened
and you start you even saw it

in young women who shouldn't have
those diseases happening.

But when they were oophorectomised,

they were dying of cardiovascular disease,
like, you know, prematurely.

Right.

And so thus it must be the estrogen, you
know, you know, it must be the estrogen.

So let's give the estrogen back.

And, wouldn't that be great
if we really felt like that?

Right.
That we could have estrogen forever?

And there were no really downsides
to that.

And there's just more to evolve.

And that's where kind of
when you ask that question, you know,

what is the practice
and how long would you do it?

I think it's continuing to evolve.

It really it's going to be very different
from my daughters

and hopefully my grandchildren one day, 
you know, to kind of see the evolution

if I live long enough to see that
evolution, because there's a lot to learn.

There's a reason why we have our hormones.

Yeah. And it's not all about reproduction.
Right.

You know,

Doctor Makary,
I think the way you felt about that

study is the way I feel about
the fact that women

who are in the estrogen
only arm had reductions in breast cancer.

Like, why was nobody talking about this?

Right. Exactly.

It's so fascinating and so important.

And, and these studies on women, they do
they tend to really kind of get brushed

under or, you know, not really thought of
or taken seriously for some reason.

Now, I do think it's important,
you know, here like my,

my doctor brain is like,
if anyone has premature menopause

or early menopause, which is menopause
before age or before age 

the gold standard of care is to replace
those hormones for that reason.

But even those women,
they are still getting missed.

I can't tell you how many women I've had,

who I've seen that said
menopause was at 

Maybe they're now 
maybe they're and they say

nobody gave me hormone therapy.

And now we've really put these
younger women who have menopause

before age at massive risk.

And we said something at the beginning
of the podcast that's so important,

is that we lumped all hormone therapy

in all different kinds of menopause
together under one umbrella, right?

Whether it was, you know, from the Women's
Health Initiative and it was Prempro

or it's vaginal estrogen suppositories,
or it's women with premature

surgical menopause,

you know, it's really important
that we individualize

we get the right definitions
for both the kind of

menopause women experience
and then the formulations

and the doses of the hormone therapy
that they're going to be on.

So you're basically prescribing,
you're treating or seeing women

with, menopause
and perimenopausal symptoms all the time

when they come to you
because you're, you're a sub specialist.

Yeah.

What were they told by other doctors
before they come to you?

Oh my goodness.
The things that they tell me.

Honestly, I wish I used to write them down
in a notebook.

I had a patient
who told me, her clinician told her,

because she wasn't feeling well,
that she should garden.

I don't know why,
but that was something I remember

telling premenopausal
something that's to garden.

Maybe it came from, you know, move
or exercise or get some vitamin D.

A lot of them have, said,
you know, my doctor doesn't

believe in hormone therapy,
sort of this idea, you know,

you'll see memes on this that, you know,
your doctor isn't Santa Claus.

It's not something you believe in
or you don't.

It's a FDA approved treatment
that's indicated for some women.

So I hear a lot of that,
you know, that it wasn't.

It's it's it's, I don't believe in it
or certainly there's I don't do it.

And I hope that we're going to get

to a point where you know,
maybe it's all about education, right?

Right. Maybe they say I'm not.

I'm not, you know,
I'm not trained in how to prescribe.

I'm not.

You hear that?

But then I don't know how to.

I wasn't trained in it.

Well, well, also, if they're asking

their primary care doctor
before they're asking the gynecologist,

but also they could be asking,
you know, again,

training is very different
in different parts of the country.

Right? It's not yeah.

We have a standardization
to a certain degree.

What you get in
some places is not the same elsewhere.

And also if you're patient practice
depending on where you're practicing

in rural area
versus basically in the city,

you know, your patient population
you know varies.

You kind of practice
where you are in the setting

and also based on the education
that you've actually received.

I mean, coming out of med school,

I think the only thing I knew about
hormone replacement therapy for probably

looking at the pharmacologic steroid, I'm
not even sure I was that sophisticated.

It's just that
it causes breast cancer. Right?

So it's like it's bad.

So it's like it was that kind of.

And then you, you peel back the layers
and you learn it's a, it's a,

it's a topic
where we like a lot of things in medicine.

The nuance and the evidence
is under appreciated.

And you know, to that end,
I think it's really important to also say,

you know, I think
especially when it comes to breast cancer,

we still should really work on this idea
that estrogen causes breast cancer.

I don't know that that's necessarily
reduce the risk of breast cancer

and the estrogen only arm. Right.

And you know, yes, certainly
if there is a, breast cancer or cancer

cell that grows
because it has estrogen receptors on it

that can cause there to be growth.

But the idea, I think, is
that, you know, it's not actually

that estrogen has ever
been shown to cause cancer.

And I think if we could actually start

speaking more about that,
it would also help to eradicate the fears.

Again, it could help to, you know,
say it could cause a tumor to grow,

which we think one of the hypothesis as to
why women actually had a lower mortality

in the

in the treatment arm

was because that actually got it
caught faster, because maybe it did grow.

So they finally saw it on a mammogram.

Well, the other thing too

was that women that were getting
hormones were seeing a doctor.

And part of seeing that doctor

was also making sure that they were
getting annual mammograms. Right.

So they weren't.

So there were bias
actually in that. Right?

So we were picking up things, you know,
that may have not gotten picked up

because the patient had to come for her
refill of her HRT, to see the doctor.

And the doctor

was going to make sure that she, you know,
sometimes hold them hostage, actually,

to not give them

a prescription of a refill
until they actually got their mammogram.

Interesting.

I've also heard some physicians,
believe that the,

the type that you're going to detect
these

non-fatal breast cancers
that were found in those study

are if they if that is

a, breast cancer that blossoms, it's

also going to be hormone sensitive,
which has a very high cure rate.

So it may be a subgroup of breast cancers
that have.

And maybe that's why there is no
association with breast cancer mortality

among those who had that slight increased
risk of non-fatal

breast cancer diagnoses.

Yeah. They got treated faster.
Yeah. Interesting.

But so that unfortunately
that challenging population

is that patient that has an estrogen
sensitive, breast cancer.

And she's in her s
and she actually goes through

chemo and radiation,
and she's now menopausal.

And some made prematurely menopausal.

And she's miserable. Right.

But she's scared at the same time because
she has a diagnosis of breast cancer,

and you cannot give her hormones.

And that's a really difficult
patient population to deal with.

Can, I petition
this is not in my official capacity.

Someone in the medical

field to rename triple
negative breast cancer.

It sounds like
the scariest thing on Earth.

And it's it's just like,
why are we, you know,

creating a super scary

sounding name around an already
difficult diagnosis?

I know, I actually,
I always thought about that.

I still think, I mean, our PR
positive is still scary as well.

But you know, we're naming negative.

Yeah, we're naming cancers
after their receptors. Right.

Which is which.

You know,
we need, scientifically it makes sense.

It's very logical.

But sometimes, you know, the
the way it's received by patients, it's

not something we think about. Yeah.
I mean, we're not better.

And some of our, terminology
and gastroenterology with,

fecal transplants, I mean,
I don't know who came up with that,

but that's not I don't know,
you know, where that came from?

Yeah. Yeah.

I'm right.
I do know where that came from. Yeah.

So, any closing thoughts?

And I just want to make a note
for the record

that gardening is good and bad,
but the effect size.

And that's a new statistical term
we're trying to.

Okay. Yes.

Our using the effect size is probably much

smaller than hormone replacement
therapy in candidate women.

Yeah. Yeah.

Well, I just want to thank you, you know,
for all that you've done to really,

put this topic, back on the spotlight
where it should have been, because, again,

with that
lumping of all the different formulations

and kinds, of menopausal hormone therapy,
be it local,

vaginal, estrogen or systemic, but what,
you know, the different formulations,

this is going to change
millions of women's lives.

And this is going to hopefully also help
clinicians feel less,

scared or nervous or apprehensive
about life saving treatment for many,

many women,
especially even just the low dose

vaginal estrogen, which can prevent
recurrent and tract infections.

And, you know,
I really think that, we, you know,

the, the, the, the data that we have

on the safety of hormone therapy
based on the timing of when a woman starts

the formulations and which she uses,
you know, to encourage right now

is still studies say only five,
maybe % of women

use systemic menopausal hormone therapy
when we know the vast majority of women

are still good candidates,
we still have a long way to go.

And nobody wants to harm any patients.

Of course.

But we want women to have the
facts without the fear.

Yeah.

And we live in a sort of

very polarizing partisan time

where people now dig in to their view,
they want to shut up their

whoever disagrees with them, censor them,
cancel them, take them off the internet.

And so do
you see a bit of a sort of polarization

around this topic in medicine or you do
you see a field that is evolving?

I always would tell my residents, 
the mark of a great physician

is evolving
your view as new information comes in.

Yeah. And that's good.

That's good.

It's not like I'm in this camp
and I'm in that camp.

And, you know, like you said, one of
the doctors said, like, I don't do that.

And it's like, well,
you can be open to reevaluating this.

Yeah.

Well, you know,
I think that having when I think

about like some of these things
that we have to do for recertification

and, and particularly my board,

you know,
ABOG, American Board of ObGyn, we,

we come up with like the relevant topics,

you know, so maintenance of certification

articles and different things
is like the state of the art research

that we as board certified
obstetrician gynecologist need to know

so that we can learn, you know,
along the path and educate our patients.

And I think that there's something
to be said about that, particularly

in internal medicine for the oncologists
that treat women with breast cancer,

for the urologist, with, you know, dealing
with, urogenital genital,

genital urinary syndrome of menopause,
you know, all of that

to stay abreast of the changing data
and the science.

And that's really, really important.

It's okay to like, be at this level
and have an opinion

at this phase of your life,
in your career. Right.

But as science evolves
and you stay abreast of it,

you should be changing along with it.

Otherwise, you're doing a disservice
to your patients.

And so that's really, really important.

And that's not something
that when you come out of residency

and you finish your residency
and you get you're just,

you know, really anxious
to practice medicine,

that's something that evolves
as you become a mature physician

and understand
that medicine is not stagnant.

It's basically evolving.

It's a science
that is constantly evolving.

And as long as we understand,
can interpret the data and make decisions

in the way that we feel
is the right way to practice,

and that we don't do a disservice to our
patients, that's like really important.

I couldn't agree more.

Yeah. So well said.

Yeah. Amazing.

Well, I'm so impressed by both of you.

One for you

what you do in your practice is, two,
because you're evidence driven

and open minded, and three you’re,
we have been willing to come here

and have an open, honest dialog
around a topic that's not an easy topic.

And there's a lot of views out there
and opinions.

And it's good that we have slightly
different approaches sometimes to,

have this dialog in front of people
so they can see here are amazing

experts in the field
who are practicing and treating women,

and they can have slightly different
practice styles or approaches.

And we are maturing as a field
as the evidence comes in.

And we're very honest
about what we know and don't know

and what we hope to know soon
with more studies.

So, so thank you for doing this.
Thank you.

Thanks for making the effort. Yeah, yeah,
such an honor. Yeah.

Great to be a game changer for women
I hope so.

This is an effort to really,
stop the fear machine

that has prevented
so many women from taking hormone therapy

that are candidates to take hormone
therapy post menopause.

And this is an effort
to also send a message

to the medical community
that the evidence now is clear

and that, it is time, based on the data
that's out there,

to remove the black box warnings around,

hormone replacement therapy
for post-menopausal women,

specifically for,

breast cancer, cardiovascular disease,
and for the possible dementia

label that is currently
on all estrogen products.

And we are going to let people know
in that box warning

that they shouldn't take
on a post estrogen if they have a uterus

because of that risk.

of endometrial hyperplasia
and endometrial cancer,

that is standard practice.

I think % of doctors agree
that is good practice,

but we are going
to, move the nuance and some of that,

warning

into the package inserts
so that people can,

I think, have a more fair impression
of what's out there.

So, thank you for saying that.

And thanks, folks, for listening. It's
been a great conversation.

I've enjoyed it.
I like geeking out on this stuff.

So hopefully there's been some
interesting information for everybody.

And, it's good to garden.

So please do garden.

And you can do that in combination
with other medical interventions

when indicated.

And so we believe in treating people
holistically.

So that's a good tip.

All right.

Thank you.
And thanks for doing this. Yeah.

Thank you, thank you, thank you.