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Okay.

Oh, that's so good.

.
Um, one more time.

Look towards me.

And action, Cindy.

I took on the government
for women's sexual pleasure,

and I won.

Let me tell you why I did it.

The single biggest crisis
in women's health is

that you are not
taken seriously.

Why at your age should you
still be concerned about sex?

.
Ladies and gentlemen, stand up on your feet

and give a wild 10X welcome

to Cindy Eckert!

How many of you,
before this very moment,

knew there was a little
pink pill for women?

Not so many of you.

So I have to ask the
obvious question:

How many of you knew there was
a little blue pill for men?

.
Oh, all of you know that.

Okay.

.
It's known as Viagra for women,

a tiny tablet that could have
a huge impact in the bedroom.

.
This quest to get a female sex pill

has been going on

for years and
years and years.

The drug comes
with side effects.

The FDA has
rejected it twice.

This whole fight has been about

getting women what we deserve.

Addressing low desire
and sexual health in women

is very similar to the
fight that's happening

in reproductive health.

It's all the same message:

We don't deserve to
control our own bodies.

.
A new study released today raises big questions

about whether or not it should
have been approved for women

to use at all.

.
I've heard every single thing.

I've been told
not to wear pink,

pull your hair back,
take the makeup off.

No one will take
you seriously.

.
Will the FDA approve

the so-called female
Viagra drug for women

with unhappy sex lives?

Our very first
meeting with the FDA,

a gentleman in the room said,

"What do we need a bunch of
horny women running around for?"

What?

If there were clear evidence of
a clinically meaningful benefit,

which I don't believe there is,

approval might be appropriate.

.
All of that fed the frenzy.

But at the heart of
that is really our bias.

In every scenario we're
gonna talk about here today,

you can just
think to yourself,

but what if the
pill had been blue?

.
Clamour for Viagra worldwide.

.
For men suffering from impotence

Viagra has
been hailed

as a miracle drug.

.
It's the first pill ever developed

to treat impotence.

Pfizer estimates

there are 140 million
men worldwide

who have trouble
achieving erection.

.
Understand that we're really dealing with

a worldwide
medical problem.

This has been of
interest to men,

you know,
from time immemorial.

.
As fast as pharmacists count them,

men are buying them.

.
After two weeks on pharmacy shelves,

this little blue diamond
is the fastest selling

prescription pill ever.

.
A US internet provider can hardly keep up.

In Saudi Arabia, men pay as
much as $100 for a single pill.

But in Japan where
it's not approved yet,

a travel agency offers four
day tours to Hawaii to get it.

Airfare, hotel
and prescription

all included.

.
We're discussing the treatment of impotence

and the use of Viagra.

In Washington,

we have former
presidential nominee,

Bob Dole.

.
I did not have sexual relations

with that woman.

I mean,
President Clinton's cock,

Bob Dole's cock.

Now you know you don't want
to hear about Bob Dole's cock,

you know?

* Huh? What? Right Uh

* Huh? Right

Viagra may wind up creating
a sexual revolution for men,

but what about women?

- Camera's rolling.
- Mark it.

Alpha roll. Colour mark.

.
Okay, so first question,

can you tell me what you
learned in medical school

about women's sexual health?

So when I was a
medical student,

we had
pretty robust

sexual health
lectures,

but mainly centred
around male sexual health.

And I realized very quickly
the gaps that existed,

including simple as,

learning how to
examine a clitoris.

So you learn
absolutely nothing

in medical school

about sexual
medicine

at all for anybody.

In fact, in the
OBGYN residency,

the word clitoris
doesn't appear anywhere

in what they have to learn.

In fact, they tell you
don't touch the clitoris

as to not make the
patient uncomfortable.

Can you imagine me as a
urologist if I was taught

don't touch the penis

'cause you would make
the man uncomfortable?

In my experience,

unfortunately female
sexual health

was all about
delivering babies,

doing women's well visits,

a little bit on
gynaecological cancers,

but that's really it.

And I went to Columbia.

I mean, that's one of the best
medical schools in the country.

What I didn't learn
about sexual medicine

is pretty much
everything.

The only memory I have

of sexual medicine coming
up in medical school

was this like
weird film they showed

of like, hippies having sex.

It was really cringey,

and a lot of people just
like kind of walked out.

.
We often will define sex

really in
terms of

how the male
engages in sex.

Men get an erection,

ejaculate, feel pleasure.

But unfortunately, a much
larger number of women

don't experience that.

That's the orgasm gap.

The orgasm gap is,

it's maddening because in
order to have an orgasm,

there are a number of
different parts of the vulva

that need to be stimulated.

The brain needs
to be stimulated.

There's a lot of
pieces that go into it

and people then suddenly
say it's complex

and that it's unattainable.

But when it comes to a penis,

it's just assumed that if
that penis can't have an orgasm,

there's a serious problem
with that individual.

The gap starts
when we realize

that society doesn't
really care whether or not

someone with a
clitoris has an orgasm.

And once you realize that,

you recognize where all
these balls get dropped.

.
No one is talking about pleasure and orgasms.

No one is talking
about libido at all.

It really doesn't
matter to our society

whether people like
sex or don't like sex

as long as they have
sex to make babies

and we procreate as a society.

And so we've ignored
it completely.

* One thing on my mind

.
When Viagra was approved in 1998,

it was deemed to meet such an
important unmet medical need,

it was literally fast
tracked for approval.

It received the kind of
rare status we reserve

for lifesaving cancer
drugs or rare diseases.

So literally a
national emergency

if men can't get it up.

This is a subject you will
not see discussed much

on television.

Were you embarrassed?

Yeah, I was- still am.

I mean, it's something you
don't run around, you know,

sit around talking
about in a coffee shop

or particularly in a
public television program.

I just really have to comment
on to Dr, uh, to Senator Dole.

What he just did was
just truly amazing to,

to discuss in-in public,

in a public forum what it's
like to have this problem.

The-the humiliation,

the embarrassment,
the frustration.

My name is Irwin Goldstein
and, uh, I love sexual medicine.

There are so many sufferers
with this condition.

They stay in closets.

They do not talk about this
and it's just wonderful.

Okay, let me answer
your question.

Impotence means
you're not a man.

Being a male,

you're supposed to
have an erection,

uh, on demand.

So in the days prior
to the oral pill,

it was considered,

I don't want to
talk about it.

Divorce
happened commonly,

uh, depression happened.

.
Irwin Goldstein is the godfather of sexual medicine.

I mean, he was the key
investigator on the trial

that got Viagra approved.

Irwin really did something
spectacular, um, with Viagra.

And I think once he solved
that problem for men,

he said...

women.

.
May 14th, 1998,

a day I will never forget.

The New England
Journal of Medicine

published finally
all the data on Viagra.

I was the first author

and all the phone calls

from people who
had any concerns,

came to our office.

And guess what the gender was?

.
Hi Dr. Goldstein,

happily married lady
here for over ten years.

My husband's not the issue.

And we used to have
a great love life,

but I just don't find myself
wanting to have sex.

.
Dr. Goldstein,

calling about this Viagra pill,

not for my boyfriend.

He's got no problem.

.
Congratulations on getting my husband a boner.

What do you have for me?

.
They're off the planet!

I don't know where they
think these men on Viagra

are gonna stick all
those erections.

.
I said, Hey, we're very busy.

I'm a urologist.

I do the men's sexual problems.

There's gynecologist,
they deal with women.

And I said, "If you have any,
any issues, come back to me

"and let me tell
you what's going.

"You know, tell me
what's going on."

And to a T,

everyone called back.

"Gynecologists
aren't doing this.

"The gynecologist said,
'Go see Dr. Goldstein.'"

So I was like, okay.

I finally learn that we
need to take care of women

with sexual health problems.

.
I first learned about sexual medicine as a career

when I was in medical school.

And realized

that there was this whole
world of information

that I did not know even
existed about sexual health,

about pain,
about orgasm, arousal,

and realized I wanted it to
be a part of my practice.

Women's sexual health,

and vulvas in general,

have never been a
priority of our society.

We can see that as deep
as the terminology used

for the innervation
of the vulva.

The pudendal nerve

is the nerve that provides
most of the sensation,

particularly in regards
to sexual function,

to the vulva, the clitoris,

the labia, the vestibule.

And pudendal literally
means "shame."

Often patients don't feel
like they deserve sex,

they don't deserve intimacy,

they don't deserve
pleasure or connection.

And when that is lost,

I think that a piece of
them is really broken.

More often
than not,

women will
just say,

"Oh yeah, I,
you know,

"I haven't
orgasmed in years,

"but it's fine, whatever.

"I mean, I just gave up."

Not that it's someone
who's like okay

with not having
sexual pleasure,

it's just that they didn't
think that they deserved it.

And a lot of my job is
actually normalizing

that it's okay to want
more for yourself

when it comes to sexual
pleasure and desire,

which is very different than
society's approach to men,

where it is a right.

Your genitalia affects

how you're treated in
the healthcare system.

You know, I trained
as a urologist

and I was very used
to objective data,

and objective evidence,

and really listening
to our patients.

And I didn't realize

that was something very
unique to the fact that

I was working with
predominantly men,

'cause when I started working
in the women's health space,

I was oftentimes
listening to my patients

telling me the consistent
medical gaslighting

that they were experiencing

when it came to their vulva,
vaginal healthcare.

A lot of times when
people come in with problems

and are previously told,
"It's all in your head,"

okay, basically getting
medically gaslit,

the default sometimes
is to blame the patient

when you as the provider
don't know how to help them.

Uh, your name, uh,
is Mrs. Martin,

is that right?

That's correct.

.
Well try and tell me for starters if you can,

what is the current dilemma?

What's going on that troubles?

.
The idea of it's all in your head

is a tale as old as time.

"Have a date night,
drink a glass of wine,

"read Fifty Shades of Grey.

"Here's a good therapist,
go to this therapist.

"It's all trauma."

Well, I-I don't have
climaxes anymore at all.

And I feel like I'm
just submitting now,

that I'm not, I'm not giving
anything or getting anything.

.
In general,

people don't like talking
about sexual problems.

Um, most providers don't
do sexual medicine.

Have you ever been to a doctor
who does sexual medicine?

There's so few of them.

Your sexual experiences,

which are very
important to you,

you're not willing to share and
they're not willing to hear,

but they should be.

They should be as,

if they're bothering you
and it's affecting your,

your yourself, your, your, your
relationship with someone else,

your ability to be a parent,

your ability to be a
good worker at work,

uh, you should have the
opportunity to discuss this.

.
Irwin Goldstein is a mad scientist

who loves discovery

and does it for the
care of his patients

through and through.

.
I'll take you back to 2010.

I'm in Miami

at the Sexual Medicine
Society Conference,

and it's the best researchers
in the world on sex.

So here's Irwin chasing
me around with his MacBook

and he said, "You
have to watch these,

"you have to watch these,
you have to watch these."

So today is 10 21 10.

It's, uh, Thursday.

There was a drug
company in Germany

that was studying an
alternative drug for depression.

And of course,
just like Viagra,

it was found to be
amazingly successful

in helping women who had
low libido or low desire.

We have patient 24163

of the flibanserin
open label trial.

I had patients on this.

I filmed them saying,
"Oh my God,

"after taking flibanserin
I'm smiling and I'm happy

"and I stare at my partner and
I just want to be with them."

And why we're filming this?

This is really cool,
her results.

So I'm gonna turn this
around and patient 24163.

How are ya?

I'm fine.

.
So this is a little weird, but you know, I, you know,

this is your really
last chance to,

to document this to humanity.

So you're on, tell us
side effects, benefits.

How did you do
with this drug?

I did phenomenal
on this drug.

I feel like a new
woman on this drug.

.
At that conference,

this company presented
this brain scan imaging

of a women struggling
with their libido.

And it was like
lightning struck!

Holy shit!

It's biology!

.
HSDD or Hypoactive Sexual Desire Disorder

is the name.

It was first characterized
in the literature in 1977.

And it basically is this like
absence of spontaneous thoughts

or interest.

And we realize it's in the
sex centre of the brain.

You know, we're
hardwired to procreate

and for, you know,
millions of people,

something goes off
kilter in that wiring.

I had no sexual desire.

Libido was almost zero.

.
It was such a common thread.

And, you know, what happened
is I saw those videos,

I completely saw myself
in those videos.

I was in a place
in a relationship

where I was
deeply disconnected.

I was in the
exact same place,

really struggling
with this issue.

I just never think about it,

like it's gone.

It used to be there,
but it's gone.

Go talk to hundreds of women

who have nothing in common
other than this one issue,

and listen to them all give
you the exact same words:

It's gone.

And they had been
conditioned to not even

sort of fight for it

because, well, your
pleasure doesn't matter.

"Just go along.

"This is what it is.

"Relax, honey, have a bath.

"Schedule date night.

"Buy sexier lingerie.

"Do better."

You do better.

Fuck you.

.
I had never talked about libido.

I think that's another
thing where I thought,

after you have a kid that
goes away, you know?

That was kind of
the narrative from

my elders, right?

And the women
around me,

that you're a mother now

and you focus on these
things and that's behind you.

So no discussion about it.

.
I went from a scale of one to ten on the libido,

I was eleven.

Uh, and then when
menopause hit,

I became
a negative three.

Um, it was devastating.

As a woman, we, we
love to feel desirable

and happy with
their relationships

and things like that.

And for me,

I felt like someone
had just slayed me.

I, I tell people I, I lost
touch with my inner goddess.

.
My husband likes to practice what he preaches.

And one day he came home
from work and he said,

we've just developed
a new questionnaire.

It was basically the
beginning of testing

for Addyi.

And he says, just take
the test for fun.

And I took it and he
goes, holy, you've got HSD!

When you have Hypoactive
Sexual Desire Disorder,

which is what I had,

you're not aware that
it's in your cognition.

Well, everybody has
it differently.

It may mean that, you know,

when your partner
walks through the door,

you used to wanna jump
his bones or her bones

and that's not of
interest anymore.

It may be that while
you're in bed having sex,

you're thinking about, ugh,

I have to put the
wash in the dryer,

I have to buy milk for the
kids before school tomorrow.

Or it may be that you don't
want your partner to touch you

because you have,

you've developed,
you know, aversion.

It couldn't mean
a lot of things.

But for me, I was having
essentially duty sex.

When I had sex, it was good,

but I had no reason to
want to have sex again.

.
I met my husband at a party at his uncle's house

and in our early relationship
there was no problem

with desire with sex.

One time there was a
construction site

and we decided that

this would be a
great opportunity.

I mean, it was just spur of
the moment all the time.

Spur of the moment,
just boom, we're ready to go.

Um, and then we had children

and there was absolutely
no problem whatsoever.

And then all of a sudden,

it was like somebody
pulled the plug.

I had zero desire.

.
When I first met her I,

I thought she was a,
a real hottie.

No, we were a
young, healthy,

- sexually active-
- Amorous.

Couple. Yeah,
and, uh, yeah,

and it, it was, it was
good for a long time.

When it became evident
that she wasn't responding,

I almost got angry.

Is she mad at me
about something?

Did I do something?

Uh, does she think
I'm cheating?

I never did.

Never have, never will.

Um, so yeah, it was tough.

.
So that's why I decided

that when I heard of
this clinical trial,

I would definitely
give that a try.

And oh my gosh,
it was just amazing.

Your whole
relationship with your,

or at least mine
with my husband,

was stressed or strained.

.
And on the medication?

On the medication
I chase him.

.
Awesome.

It is, it is unbelievable.

I love my husband
tremendously,

but with this drug I
love him even more.

And our, our sexual
experiences were,

were incredible.

It was, it was like
I was a new woman.

.
Will the FDA approve the so-called female Viagra?

A drug for women with
unhappy sex lives.

I'm at the FDA
meeting right now.

I'll have more in this hour.

Boehringer Ingelheim be
applied for approval by the FDA.

Today's agenda involves
discussion related

to new drug application.

NDA 22526 Flibanserin
hundred milligrams tablets.

Because I was doing
a lot of work

with antidepressant associated
sexual dysfunction,

I was an advisor.

I appreciate the opportunity to
be able to speak with you today.

For male
erectile dysfunction,

and what they had
used a measure,

was this sexual event
successful for you?

Meaning the penis was rigid
enough to penetrate a vagina.

They decided to try to
apply that to women.

And we said,

what is a successful
sexual event in women?

Do you think that it
might be having an orgasm

'cause that's really
not related to desire.

And that was the
sort of first real foray

into them not really
understanding women's sexuality.

These are the numbers
that you see,

so these are women
who have HSDD.

They do not have depression.

You can see that HSDD
is the most common

sexual dysfunction

as compared to effects
on arousal or orgasm.

The studies were positive

and it showed that people's
sexual functioning improved

over time when they
were on this drug.

But ultimately Boehringer
Ingelheim had it turned down

for approval by the FDA.

.
At that meeting in Miami,

the German company went to all
the researchers in the world

and said, we're not
gonna develop it.

And you could feel the
air leave the room.

.
I am so, so upset that this is terminating

because this Flibanserin
can change people's lives,

they can change relationships,

they can, um, make a
person whole again.

And she is patient 24174.

And she, uh,

because closed up,
we had to close out the trial.

.
What was surprising is that a company

that had found this kind
of spectacular discovery

was not going to pursue it

'cause they didn't want to
take on women and sex, right?

No thank you,

we're not getting
into this debate.

And I think Irwin
knew that too,

which is why he said you need
to do something about this.

The science was there,
it required a champion.

I said, please just
get on an airplane,

fly to this place.

For one dollar they'll probably
give you the medicine.

I sort of almost begged.

I mean, you have to develop it.

Irwin chose me,
it spoke to me,

this is what I was
struggling with

and I was gonna fight
for what I deserved

and I was determined.

And so I bought the drug.

* Gimme what I want,
what I want, what I want *

* want, want, want,
what I want *

.
And so, what do you do when you get a drug through the FDA?

You sit down with the FDA

and you say, okay,
here's this product,

what is the roadmap?

* Gimme what I want,
what I want, what I want

* what I want, what I want

* Like a Spice Girl *

.
They tell you what endpoints you have to meet

in clinical trials.

They define success for you

and you have to prove it with
statistical significance.

So that's what we really
spent our first year doing

is all the things that
the FDA had asked of us,

good stewards of science,

we went out,
we did all that work.

And I remember being
just so excited.

Like we've done it,
we did it,

it works!

This drug was about women
living life on their own terms,

so I wanted a woman's name.

A character that I loved
was actually Addison

on Grey's Anatomy.

I like that she lives
life on her own terms,

so we called it Addyi.

Our very first
meeting with the FDA,

there was a tension
in that room.

You can imagine you walk in
like company sits on one side,

FDA sits on the other side,

it's like a face off.

And there was just this sense

that this was not gonna be a
straightforward conversation.

Here I am running a company,

totally a woman
in a man's world.

When I left college I worked for
Fortune's most admired company,

but I left Big Pharma because
it wasn't the fit for me.

And I found this incredible
testosterone product for men

and built my first business
out of that called Slate.

And so, I had brought a
product to market for men

that was FDA approved.

So when all the
questions were different

on a product for women,

I knew something was up.

And I asked this question,

why are we being reviewed

by the urology division
of the FDA

when this is a drug that
works on neurotransmitters?

And the answer was,

"We review all the sex drugs."

I said, "Yeah because
they've all been for men."

And that was it,
like I stepped in it.

I knew it as soon
as I said it,

I could feel that
tension in the room,

like how dare you,

we are the experts on sex,
and yet they weren't.

I walked out of that
meeting and I thought,

science cures bias, right?

Science always
knows the answer.

I knew we'd actually
achieved all the results

that they'd asked
us to achieve.

And so, I was getting
ready to launch,

and I had been in New York

and I flew back to
Raleigh where I'm based.

The whole company
is like waiting

with the champagne chilling.

The minute the plane landed,
my phone's blowing up.

I got a call from my assistant.

She's like, Hey, we
heard from the FDA,

they came back and said no.

And it was just like, pow!

I thought, oh my God.

I didn't know what
I was gonna say.

My board knew
this was the day,

my shareholders
knew this was the day,

the patients knew
this was the day,

Irwin knew this was the day.

I'm like, gotta go in,
gotta face the music.

I got everybody around
the table and I said,

"We just heard from the FDA
and we were turned down."

And it was silence.

I remember sitting in the office
until the last person left.

I was looking out the window
until I started to cry

and I'm like, what the
hell are you doing?

Like pick yourself back up,
we're going back into battle.

And I thought not on my
fucking watch, no way.

It was time to take 'em on.

.
Viagra for women.

It's a little pink pill

that's supposed to
increase a woman's desire.

And the FDA has already
said no to the drug.

But the company is
appealing that decision.

.
I had never heard of HSDD.

I had never heard
of Flibanserin.

There was a meeting
on my calendar, um,

to meet with a
company called Sprout

who was coming
to us for help.

And so I went to the meeting

and I met Cindy
who was a very,

very different from
most of my clients.

Ooh, what's coming?

Hey, hey, hey.

I remember that first meeting,
you know,

this spectacular woman
came into the room.

I was watching
her body language

and I thought,
I think this is my soulmate.

Theodore, I can't
believe you're not even

paying attention, buddy.

The plan is to make a plan.

So how do you take
on the government

for women's sexual pleasure?

I was working
primarily in oncology,

so trying to get cancer
drugs through the FDA,

and I hadn't done much in the
reproductive health space.

And Cindy walked in
with so much energy

and started telling me
about HSDD and Flibanserin

and the challenges that
FDA had given them.

My first reaction honestly
in that moment was, oh these,

these seem like great people
and an energized team,

but I don't think I'm
gonna be able to help them.

I didn't understand
the condition.

You know, I thought of
it's, it's a sex drug,

that sounds like something
that's not necessary.

Oncology drugs are
saving people's lives

and I didn't think
it was as important.

The reason I decided to take
the case was Cindy showed me

some real documented evidence

of things FDA was
saying and asking for

that pointed out to me
that FDA had a real bias

rooted in maybe hangups
about women and sex and,

and that FDA wasn't
thinking about this, um,

in a truly scientific way.

And I decided to take
it because as a lawyer

it sort of rubbed my fairness
button the wrong way.

.
When the drug first went up for FDA review in 2010,

the FDA did not feel
that there was enough data

to support its effectiveness.

.
The FDA advisory panel voted ten to one,

that flibanserin was not
significantly better

than a placebo,

and unanimously
that the benefits

did not outweigh side effects
like dizziness, nausea,

and fatigue.

.
When the German company took it forward,

they got a list of issues that
said go do one more study

where you show desire

and then also go do
a number of studies

on healthy volunteers
looking at interactions

with other drugs.

And that's when Sprout took
it and did all that work.

Then they brought
that back to FDA

and now they get
rejected again,

having done everything
FDA asked for.

.
The FDA gave a red light

to a drug meant to rev
up a woman's sex drive.

The agency rejected a little
pink pill called Flibanserin

saying it had
modest effectiveness.

We've had biological solutions
and treatments for men.

I think it's time for women.

.
Erectile dysfunction was seen as an unmet physical ailment.

Addyi was evaluated as an
unmet psychological ailment,

which immediately triggers
a higher standard of review

and additional safety measures.

.
They said it had to be ultra safe

because women were
taking it every day.

And so, they generated a lot
of concerns about things like

use with alcohol.

Addyi is alleged to have this
shocking alcohol interaction

that we can't accept,

when the data are almost
exactly the data of Cialis.

And when you look at Cialis,

it essentially says men
should not binge drink.

.
"You shouldn't consume if you've had more than five

"alcoholic beverages."

So women can't have any
and men can have five

and still take it.

Well it's probably not
gonna work very well

in that circumstance for
an erection, but okay.

.
Another example is that flibanserin makes you sleepy.

That is a labelled side effect,

we know that that's why you
take it right before bed.

And we had shown

that there were more sex,

satisfying sexual events
when you were on flibanserin

than when you weren't.

And one of the FDA
reviewers said,

"Well couldn't that be because
the women are just too sleepy

"to fight off their husbands?"

First of all, I don't believe
we have husband rapists

at large in this country.

But, but beyond that,

you know, I just thought,

if everybody could just think
about their personal situation

for a moment,

the wife is sleepy,

are we having more
sex or less sex?

The notion that
the wife is sleepy

so we must be
having more sex,

like you're refusing to
accept that this is real data.

Like so when you see data
that answers the question,

yes, they're having more sex,

you immediately are looking
for a way to discount it.

Their concern with
sedation was,

and they literally said this,

that a woman might take
flibanserin the night before

and get up in the morning

and fall asleep driving
her kids to school.

It was very much like,

well, we need to sort
of protect women

because they might
not remember,

they might not make good
choices about taking this,

and it's so dangerous.

So we did a driving
study and lo and behold,

women drove better
taking Addyi than placebo.

And that's not surprising

'cause if you have a better
deeper night's sleep, um,

your reaction time in
the morning is improved.

You know, the driving study
was over a million dollars,

which we have so many drugs,

all the anti-depressants
cause sedation.

And no one said,

go make sure,
you know, you're,

you're not gonna be
impaired the next morning.

The reason here was,
well these are women

who could be driving
their kids to school.

And it's that paternalistic
lens over women's health, right?

That it's, it's not
about the woman,

it's about the people
she touches in her life

and also protecting them.

And that's inappropriate, right?

A drug is, is approved
as safe and effective

for the people who take it.

.
It's the little pink pill.

And this one is
for the ladies.

It works on key chemicals in
the brain to increase desire.

They, they had a desire
before and they've lost that

and it's really causing
pretty profound distress,

either for them personally or
in their relationship dynamic.

.
Enter the pink pill known as flibanserin.

Cindy Whitehead bought
the rights to it

and has been working for three
years to get FDA approval.

The last trial of a thousand
women showed promising results.

.
FDA insisted that we measure satisfying sexual events.

We had to show an improvement

in how many satisfying
sexual events we were having,

and we showed it, right?

That was, I think it
was one more per month

and FDA's like oh,
one more per month.

And in essence, the
FDA had said to us,

well, we feel the
effect is only modest

and therefore no risk
would be worth it.

So we said to the FDA,
hold on,

what do you mean that
the effect is modest?

It is true

that Addyi doesn't take you
from being having no sex

to being a nymphomaniac.

Actually, that would be bad.

We have to measure for that
in clinical trials, right?

It takes you from
a place in which

you're not thinking about sex

to where you are
thinking about sex.

Society thinks of sex
as a performative act,

there's a destination.

And really what
this was addressing

was the brain being
in the right place

to have spontaneous interest

to respond to a
partner's advance,

to want to initiate something.

So like everything being
so performance driven

was really a male metric.

.
The studies show that there's an increase in, on average,

one sexually satisfying
encounter a month.

And a lot of folks
will hear that and say,

one encounter a month,
that's very little,

but how is that even worth it?

And my response to
that typically is,

when we're treating
somebody who has HSDD,

they'll be lucky
if they have sex

once or twice a
year typically.

Once a month is a monstrous
change for some of these, uh,

these couples.

.
We've always prioritized our sex life

and it's something
we don't wanna lose.

- We met in college.
- Yeah.

- Um...
- Grad school.

Grad school.

Both studying
the same subject,

and we didn't hit
it off right away,

but, um, once we, uh, got
together we've been inseparable

and, um, well our
relationship was fine, um,

but our sex life had,
had dwindled, um,

and it was frustrating
of course,

but then, um, you know,

I was going through
a change too.

And so, every month I was
going and getting tested,

um, for testosterone levels.

And I think we were both
experiencing our own versions

of menopause, um,

and our libidos seemed
to be out of sync.

Um, David got involved in some
treatment that increased his,

and mine was still
laxing there behind.

And, um, I had one,
um, gynecologist, um,

but she didn't try to
educate me beyond, um,

I think she said
something to the effect of,

um, you're at a approaching
a period of time

where hormones probably wouldn't
make more sense for you.

.
So clearly you can see,

despite the wonderful
job with my makeup,

that I'm a menopausal woman.

And for those who think

that after your hot
flashes are gone

menopause is over,

no, you're in menopause
for the rest of your life

until you die.

But just because
you're menopausal

doesn't mean you don't
have a right to great sex.

My whole life and
my whole training

menopause was treated
as a footnote.

In my field it was like,

use lube as though that would
solve all the solutions

to do with your shoulder,

to do with your brain fog,

to do with the way
alcohol affects you,

the fact that you
can't sleep at night.

And now we're in this moment

where we're talking about
perimenopause and menopause

and it's pissing
some people off.

They're wondering why are
you being so loud about it?

Well, the real question is,

why were we forced to be so
quiet about it for so long?

Postmenopausal patients
are considered irrelevant

when it comes to sexual
health in our society.

It is not only by our society,

but patients within themselves

don't feel like
they deserve sex.

They don't deserve intimacy.

They don't deserve
pleasure, connection.

I had a patient come in
just the other day who said,

"I shouldn't even be having
sex anymore, right?"

And I mean, my, my
mouth is open for them

because I'm just like,

I don't understand how
this can be so ingrained

in everything that we do

that even patients feel
that they don't deserve it.

And I think that's what's
so heartbreaking, um,

is to see that people don't
even value themselves

because our society has
so clearly told them

that they are no longer a
valued part of the society.

.
When you look at women:

premenopausal,
postmenopausal,

transgender individuals,

the conversation of what
is available for you

is not dictated by you.

If you are a
cisgendered white male,

the healthcare in
the United States

is pretty darn good

and your healthcare experience
can be a uniquely personal one.

.
Twenty-six to zero,

that represents how
many drugs are available

to treat male
sexual dysfunction,

compared to those
that treat women's.

.
When I started, there were 25 FDA approved drugs for men.

When we were going through this,
and in our appeal,

the 26th drug for
men came to market

and it's for curvature
of the penis

that interferes with
your enjoyment of sex.

Okay, so that typically had
to be corrected surgically

and now there was a
different and simpler option.

Great.

So the studies were on
around a thousand or so men

and it had a pretty important
but rare side effect,

and that was penile rupture.

So let me get this straight,

we can give men a product
and their dick can explode,

but women can't have the
seven dwarfs of side effects

like sleepy, dizzy, nausea.

Twenty-six times we
had done that for men.

So guys, it's just
you and your honey.

Setting is perfect.

But then erectile
dysfunction happens again.

.
Viagra at that point had done so many commercials

and, you know, we laughed
about the Viagra ads at the time

that were basically
conditioning women

to let men know all
their choices, um,

while not asking the
question, where's mine?

You know what?

Plenty of guys
have this issue,

not just getting an erection,

but keeping it.

Well Viagra helps guys with
ED get and keep an erection.

I'm a beautiful woman
laying in a bed talking about

your erection.

Erection.

Now that they're distracted,

let's do something
to change this.

Women deserve better.

Let's even the score.

Stop!

Sprout initiated something
called "even the score."

This was a advocacy campaign

to try to get people
to understand

that this is a critical issue
for 10% or more of women.

Are we really so behind

that we don't think women have
the right to sexual desire?

Yet again we come second.

.
Men who take erectile dysfunction medication

may find it entirely useless

if their partner does not
have any sexual desire.

Options for women have been
through rigorous trials

and show less
serious side effects.

Safe and effective
sexual health medication

could help thousands of
women and their partners

enjoy a healthy sex life.

Men have a little blue pill,

so why not a little
pink pill for the ladies?

.
Sprout really helped in bringing the conversation

into the media

and into the living rooms
and awareness of people.

- Flibanserin.
- Flibanserin.

Flibanserin.

.
Now it is expected to be marketed under the name,

Addyi-1.

.
It became a very public conversation.

Here's this little
private company

in Raleigh, North Carolina,

and all of a sudden Nightline
shows up at my door.

They're like, who are you
and what's happening here?

.
It's known as Viagra for women,

a tiny tablet that could have
a huge impact in the bedroom.

I think this is
absolutely an evolution

in the female
sexual revolution.

.
But you won't be able to get the pink pill just yet

because the drug is
locked in a heated battle

for FDA approval.

.
Once that happened, you know,

the public was
all weighing in.

.
There's a pill that's in development

not FDA approved yet.

Woo! For women? Like Viagra?

There you go.

People are like, aw,
the little pink pill.

So it's the little pink pill.

That little pink pill.

It's a little pink pill.

Oh the little pink pill.

It is the sing song
in their voice

and the pat on the shoulders.

It assumed weakness.

It assumed that
it was trivial.

Is there something to fix?

No, not at all.

.
And it was so dismissive.

.
Some doctors say flibanserin was rejected

for a very simple reason,

it's an ineffective drug
for a non-existent problem.

It's a classic
marketing technique

to first create a problem
and then sell the solution.

And that's what's
going on here.

What is this advocacy group?

Is it a Sprout PR campaign?

.
It looks like a Viagra ad,

but this parody is mocking
all those male pills

and their big
budget commercials.

Even the Score made the video,

a group backed by nonprofits
and pharmaceutical companies,

including the one
that makes Flibanserin,

the so-called
"Little Pink Pill."

.
You can make two choices in that moment, right?

You either let it set you
back and you lean back from it

or you lean right into it

and say, this is the
conversation we're gonna have.

I took my pink stilettos
and I started going to DC.

And I was knocking on the
doors of these giants

in women's rights
and women's health

and I was like, hi, I'm Cindy,

I have this company and here's
what this condition is.

And I went with Dr. Goldstein

so that they could ask an expert
any questions they might have.

And at the end of this meeting
a woman named Susan Scanlon

who ran the National Council
of Women's Organizations,

came over and she's like,
we're gonna fight this.

When we called it on
a double standard,

this group started
to come together.

Here were giants of
Women's Health and Rights,

Black Women's
Health Imperative,

Nurse Practitioners
in Women's Health,

Nurse-Midwives,

National Organization
for Women,

National Council of
Women's Organizations,

National Consumers League,

incredible like women
that were my heroes.

The FDA themselves
had deemed this

one of their top ten
areas of unmet need.

This issue is so prevalent
it affects so many women

that it was on
their top ten list,

and yet here we were
in this conversation.

So for all these
women's rights groups,

with Dr. Goldstein,

chartered a bus and demanded
a meeting with the FDA,

.
An FDA advisory panel today

hearing the pros and
cons of Flibanserin,

also known as the
female Viagra.

.
When we fought, other women fought.

.
Good morning, thank you for letting me speak.

I'm Susan Scanlon,
I'm Chair Emerita

of the National Council of
Women's Organizations.

I'm also chair of
Even The Score.

.
You know, I give all credit to Susan Scanlon,

who I'm so sad is
no longer with us.

She was larger than life,
with a voice to match,

and, you know, also a huge
mentor of mine in that she said,

"We're gonna call a
spade a spade here."

.
We're tired of hearing that female sexual health is complex

as if there would be no
answer if we didn't study it.

Make no mistake,

men are equally complex

and there's been no
shortage of medications

to address their
sexual dysfunction.

In 1960,

the birth control pill
precipitated a societal shift

to recognize women's rights
as reproductive beings.

In 2014, let's shift to
recognize women's rights

as sexual beings.

Thank you very much.

.
I would challenge anybody,

what is better than
to have advocacy?

The best things have happened

when patients have
taken the mic

and demanded
what they deserve.

My name is Judith,
I'm 66 years old

and I've been
dealing with FSD

on and off for 17 years.

Hi, I'm Katherine,
I'm from Indianapolis, Indiana.

I learned in high school sex
ed that a woman's sexual prime,

so to speak,
is in her thirties,

yet here I am.

.
It is amazing how many women of all ages I talked to

that have some
degree of HSDD,

this disorder is real
and we need a solution.

At that time, there was
a lot of feeling that

we were medicalizing HSDD.

And finally we have Susan.

Hi, I'm Susan.

I stopped having desire
for sex about two years

into my now 11-year
partnership with my husband.

My partner and I had
done work on ourselves

in a therapeutic setting.

We learned that our sexual
problems were a co-created

problem in our relationship.

.
Their idea was really that

it was saying
you have a condition

that they didn't have
because they were normal.

.
Clinical psychologist Leonore Tiefer

says Sprout has concocted
a women's rights issue

to guilt the FDA into
approving flibanserin.

It's just a mishmash
of politics and science

and sex and money.

Money, money, money.

.
The FDA's ruling is due later this month.

.
Some people felt like women's desire was more complicated

and we shouldn't be
medicating women

because oftentimes their
desire can get better

if they're working
with a therapist

or you know, seeing a couple's
therapist with their partner.

.
This busy mom of four, Amanda Parrish,

says she used to have
a smouldering sex life

with her husband.

.
This drug isn't necessarily going to treat the fatigue

that might be giving
you a low sex drive

or you know, the kids that
you have running around

or the partner who
isn't helping you out

with the chores
around the house.

.
That's totally true.

But why shouldn't we
offer a medication

that has been shown,
clinically proven,

to help increase desire?

Not to say that it's
one or the other.

In fact, I think most people
that prescribe this medication

would say,

keeping that
therapy stuff around

is really important, right?

But if you can provide
a medical solution

in conjunction with
psychological treatments,

why would we deny women that?

Women don't need treatments
with real side effects

for imaginary diseases
invented by marketers.

.
If you've never experienced HSDD,

you don't understand
what it is.

.
It is a thinly veiled,

profit-driven marketing
campaign filled with bias,

misleading,
unsubstantiated information.

I think it's a scam.

To have a community fighting
and saying we were medicalizing

and claiming this wasn't
a biologic problem.

Well I will tell you it's
a, it's in your brain.

The language I like to use when
they say it's all in your head,

well, your brain is
up in your head.

This is your brain.

We live in a world

where women should have
a choice for their body

and they should
be able to choose

if they wanna take a a pill,

an injection, sex therapy,

or all of them.

But who is anyone
else to tell me?

And that's what angered me.

Who is that anyone else to tell
me I have a biologic problem?

I know that I was
functional before.

I know it's not in
my relationship.

I know something's changed.

Who is gonna tell me I
can't do something about it?

So the mood of the FDA
was very much a combative

that either you believed
in a biologic treatment

or you believed

that you shouldn't have
a biologic treatment.

.
A major medical headline tonight involving women,

the drug nicknamed
the Little Pink Pill.

A key decision today.

.
FDA advisors will once again consider

whether to approve a drug that's
already been rejected twice.

.
Women now once step closer

with joining their
frisky male counterparts

who've enjoyed the benefits of
pills to help their sex lives

for years.

.
I arrived at FDA when the doors opened

and then as people started
to come, they were like,

you know, there's people on the
road, um, leading into the FDA

with signs and banners

and like, I think it's
gonna be a tough day.

I was in my urology
training at Georgetown

and so I was in the
Washington DC area

and it just felt important.

I can't describe it,
but it felt historical.

.
Good morning.

We have a very full agenda.

Welcome to the
Drugs Advisory Committee.

.
It was straight out of a movie.

FDA's never seen
crowds like this.

The press were showing up,
everybody was in this room

and it feels a little bit like
you're at the Supreme Court.

.
The first FDA meeting I went to with Cindy,

you know, I had at that point
met her a number of times

in person.

She was oddly always
wearing pink.

And so I had this concern

that she was gonna
wear pink to FDA,

and so I got up my nerve
to tell her, so don't,

don't wear pink to FDA
because you won't be credible.

And she really didn't
say yes or no,

but she showed up
the next day in pink.

.
When I showed up at FDA meetings

and my pink got brighter
and brighter and brighter

until you could see
it from outer space.

To me it was about
being unapologetic

and actually what
was at the root of that

was the conversation
we needed to have.

.
I will tell you that the morning of the advisory committee,

I mean, it was very tense

and I was in my black
suit and my beige shirt,

and I just went up to her and
I knelt down right next to her

and I just said,

"I'm wearing pink underwear."

Like just to like,
lighten the mood,

which was like also
happened to be true.

Thank you Dr. Lewis
and good morning.

I'd like to take a moment.
I'm Josephine Torrente,

Executive Vice President

of Corporate and
Regulatory Affairs

at Sprout Pharmaceuticals.

The first statement
by FDA was a defence

that they are not
in fact biassed.

So, uh, some have claimed
gender bias on the part of FDA

when it comes to treatments
for female sexual dysfunction.

The FDA firmly rejects
this assertion.

FDA is always concerned
with unmet needs,

whether this is in women,
men or in children.

.
The fact that FDA felt the pressure to say,

"We are not biassed
against women's health,"

just tells you the impact
that these women were having

by going to FDA and saying,
we need a drug for this.

Don't diminish the benefit.

Good afternoon.
My name is Barbara.

I'm a nurse.

This is my daughter Vicky,

and we are patients
of Dr. Goldstein

and we have no interest in
the outcome of this meeting.

I'm Amanda Parrish.

I am one of the
lucky 11,000 women

that was a patient on the
Flibanserin clinical trial.

I'm here with my husband Ben.

We funded our own trip and
we have no financial stake

at the outcome of this meeting.

Hi, my name is
Katherine Campbell.

My travel expenses are
being reimbursed by Sprout.

I hope everyone understands
that my husband and I

do not have money set aside
to fly back and forth to DC

so that I can talk about how
much sex we're not having.

.
Here you are with women who've taken time off work,

had somebody
babysit the kids,

potentially fly
across country

to reveal their most
private struggle

behind the closed doors of their
bedroom at a federal agency.

My name is Kelly Stapp

and I have no financial
things to disclose,

but I will disclose the fact
that I'm a bit scared to death

to stand up here and
talk about this.

.
Can you imagine like how just awkward, uncomfortable,

brave it was for
them to do that?

They're the heroes
of this story.

Hello, my name is
Erica

and I hate public speaking,

but I'm here anyway.

I am here today to tell
you HSDD is not a figment

of a woman's imagination.

It's not a fiction invented
by the drug companies

and it's not a disease
forced upon women

by the medical community.

HSDD is real.

I know because I had it

When I was 24 years old

I was diagnosed
with breast cancer.

I was clearly informed

of many of the potential
negative consequences

of surgical menopause.

But no one ever advised me
that I was at an increased risk

for HSDD.

There was so much
emotion in the room.

A television doctor suggested
on an interview just last night

that maybe my libido
is low sometimes

because I've had a bad day.

An anchor on a morning
show yesterday said

that she doesn't need
treatment because a housekeeper

and time away from the kids
would solve her desire issues.

If your sexual desire issues
can be cured with a good day

and a babysitter,
then congratulations,

you do not have HSDD,

but the rest of us would
sure appreciate it

if you would stop
dismissing our concerns

and making a complete
mockery of the issue.

Hi, my name is Vicky Loftus.

I was on the patient
panel in October, 2014

and told my story
about how HSDD

has negatively
affected my life.

My mother was on
the panel as well.

We both shared our
individual struggles,

which were sadly
very similar.

Since my appearance
on the panel,

my marriage has
suffered greatly.

So much so that the
conversation of divorce

is on the table stemming
from my low sexual desire.

My husband has a difficult
time understanding

my struggle with
this disorder.

He still takes my
avoidance of sex personally

thinking I don't
love him anymore

and there is something
wrong with him,

which is farthest
from the truth.

.
As a mom standing next to your daughter

who is going through
a divorce at that time,

for her to get in
front of an FDA panel,

it took a lot of
courage on her part.

It was a very traumatic
thing for her.

So to listen to
those hecklers it,

it was heartbreaking
to watch that.

It was just heartbreaking.

Thank you.
Speaker 31, please.

There was a woman
who stood up and said,

let me give you some options:

read erotica,

find a different partner,

get a better shower head.

.
Here are some things that have helped me with periods

of low libido:

switching boyfriends,

chocolate, coffee,

certain episodes
of Grey's Anatomy

pornography,

upgrading my vibrator,

reading 50 Shades of Grey,

a removable shower head,

and an acceptance of myself
and the libido I came with.

.
Excuse me, Alexandra, sorry, your two minutes is up.

.
That's all saying you're doing something wrong

and it's your fault.

And you just watched
the faces of women

who were brave enough
to say the thing

they were struggling with

and then others mock them,
be cruel to them.

And that was hard to watch.

Sprout's lobbying effort
called Even The Score

has used deception to mobilize
women with real sexual concerns

to lobby for their
questionable product.

They've tried to
distract the public,

bully the FDA,

and they have hampered
real sex research.

But make no mistake,

Even The Score reveals
the methods and values

of Sprout Pharmaceuticals.

Reject this drug
once and for all

and let's move on to
really help women.

Thank you.

Speaker 32, please.

There was so much politics.

There was so many people
there angry about the idea

that a medicine could
help with sexual health.

If there were clear evidence

of a clinically
meaningful benefit,

which I don't
believe there is,

significant but not
clinically meaningful,

accompanied by
manageable risks,

approval might be appropriate.

Flibanserin is a
mediocre aphrodisiac

with scary side effects.

Its effects may be due to
non-specific sedating effects,

apparently equivalent
to four drinks.

One of the fears the FDA had

was that this was
like an aphrodisiac

and it might be slipped into
somebody's drink in a bar

and then they'd have
sex with some stranger.

One thing I worry about is

because of the
indication of this drug,

could it be thought of
as like a date rape drug?

I think that's an
excellent point

and that is something certainly
that we have thought about.

But it doesn't work
like that at all.

Anything that you
have to take daily,

I will tell you that

you have to have taken it
for a certain number of days

before it really has an effect.

My name is Dr. Irwin Goldstein.

I serve on
Sprouts Advisory Board.

And I'm Sue Goldstein.

We're here for San Diego
Sexual Medicine today,

and we have no financial
interest in today's outcome.

.
It was very distressing

that colleagues
would take this view

that we were harming people,

and we had a lot of
evidence that wasn't true.

It's an embarrassment,
it's a humiliation.

It's a evil against women.

It's crazy. It's just crazy.

To the experts who
do not manage women

with sexual health problems,

give these women the
right to choose,

vote yes to approve,
and thank you.

.
Thank you.

.
Some of this, I think,

is an attempt to
control women,

and that's been going
on for millennia.

It's going on now.

There really is a whole sense

of not hearing women and
not trying to help them,

or trying to block something
when help is available.

And that's
unconscionable to me.

I'm Dr. Anita Clayton.

I'm gonna get
straight to the point.

Stop moving the goalposts.

The efficacy, safety,

and clinically meaningful
effects of Flibanserin

are clear.

Maybe the message is that you
don't trust women with HSDD,

or you just don't trust women.

At the core of this
whole thing was really,

does it matter?

And do women deserve.

I think that's
really what it was.

Like all this other
was just noise.

It was just noise to distract

from the bias at
the centre of it,

which is, we don't
think it really matters

if women have a more
satisfying sex life.

That's the truth.

We literally heard
this from the FDA

is that women do not
have to desire sex

to have sex.

Yeah.

.
So with that said,

we will now turn to
the voting process.

.
I think about the stakes

because I knew what
we were up against.

Ooh. Because we had
done everything we could

and the team was nervous.

We felt immense pressure
to win it for women.

All the women that showed up,

all the women's health
and rights advocates,

all the doctors,

Okay, we ready?

Okay, let's go.

.
The emotions are just up and down all day,

and then they vote sort
of secretly, right?

They all press a button

so that they can't
influence each other,

and the number just
comes up on the screen.

That process probably
took a minute and a half,

it felt like twenty minutes

before that number
came up on the screen,

and then the room
just erupted.

* Never believed I
could feel like this

* Got me feeling so high

.
The FDA approving the controversial Little Pink Pill.

.
The FDA approved the new drug

designed to boost
the female libido.

* And there ain't
nobody can blame me

* They can't blame me now

* 'Cause everything you doing,
yeah that's how I like it

* You know what
you're doing, yeah *

.
We got an 18 to six positive vote.

It just tells you the
strength of the data

and also the strength of
the people who spoke to say,

this is meaningful and
I do need this drug.

.
That day in the room when my hand was shaking

as the score went up,

I don't know that the FDA's
ever had a whole room

erupt into cheers over an
approval of a medication.

It was so validating.

And I was on the last
flight out to New York

to do press the next morning.

* I hope that you,
you were talkin' 'bout me *

.
Yesterday science won and so too did women.

Finally, women have the ability

to make the choice with
their healthcare providers

whether or not
they want treatment

for the most common form of
female sexual dysfunction.

And it's been a long time
to get to this moment.

What about the reality
of money raising

when it comes to
now marketing this,

and Cind, you're a small
company, privately held.

We are small, yes.

How are you going
to pay for all this?

.
We were the largest news story in the world.

And then the phone
started ringing.

In August 2015,
we got the approval.

Two days later, we sold the
company for a billion dollars.

*

.
Up until about 4:00 AM in the morning the night before,

we were still going
back and forth.

And I can remember sitting
in the seat at Squawk Box

next to the CEO,

and they wanted
confirmation of the signature.

And they were like 5, 4, 3.

We got it!

And it just happened
right there on air.

To be sure, science
has won the day here.

So this is a condition that
we've known about medically

since 1977.

We have four decades of
medical literature on it.

The opportunity's quite large.

You know, and certainly in the
hundreds of millions for us.

But we're hope, hopefully
it's in the billions

in terms of, uh,
what this could do

from a, from a
revenue standpoint,

.
This whole fight has been about getting women,

myself included,

what we deserve and
knowing our worth.

And I wasn't gonna
take something

that wasn't what
this was worth.

Let me ask you about
the Valeant acquisition

and sort of what
that did for you

because you've got a lot
more marketing muscle,

a lot more oomph
behind this product now.

What kind of a game
changer was that for you?

Game changer.

We're a 34 person company

who managed to get this
across the finish line.

So this is the ability to make
good on the mission, right?

This is gonna be
accessible to women

every corner of the globe

because we needed
a global player

to be able to do that in a
way this tiny little company

with 35 people couldn't do.

But again, no one
takes you seriously.

I think this sounds like
a great holiday gift.

Tonight we'll take a
look at the pros and cons

of female Viagra.

.
Pro: When ingested

Flibanserin increases
a woman's sex drive.

Con: you might know
it by its old name-

"wine." Yeah.

.
The media,

they picked up on the people
saying "this is dangerous."

This pill is not for everyone.

Dizziness four times greater,

sleepiness, nausea, fatigue.

There's an interaction
with alcohol.

.
They splashed it all over

because they like a story,
they like a conflict

and it was detrimental.

But your critics
remain this morning.

The critics have
not gone away.

Charlie Rose asked
me like, "Hey Cindy,

"could you not have invented
a drug with no side effects?"

.
Is there no way to have created a drug

without the side effects?

Uh, no.

No drug comes
without side effects.

I think that's very
important, right?

Addyi is no different than
countless other drugs.

It was so obtuse.

Again, you can't have any risk

'cause this thing
doesn't really matter.

The challenge with this
drug is that it is limited

to a very strict
subpopulation of women

who have a sudden or
new onset of low desire

and no other explanations.

And it's a reproductive
age population too,

and we should be thinking
about and concerned about

the reproductive
safety of this drug.

It just shows up over
and over and over again.

.
The Addyi comes with a black box warning from the FDA,

the strongest
warning it can give

because it's loaded
with side effects.

A box warning literally is a
box in the medical information.

They said you couldn't
drink alcohol at all.

And their warning for Viagra
was you shouldn't take it,

not that you couldn't,
but you shouldn't take it.

So putting something
in a boxed warning

that is not a legitimate
safety issue is a real problem.

.
Doctors had to take a test to write it.

Pharmacists had to take
a test to dispense it

and women had to sign
a piece of paper

promising they wouldn't
drink if they were on it.

.
They put it in a classification with things

that are very harmful,

and Addyi is not harmful.

I took alcohol,

I didn't, I
wasn't even told

that I couldn't
take alcohol.

And everybody that I know
had a drink before dinner.

You take this
medication at night,

you're not supposed to get
behind the wheel of a car

or take it in the morning.

.
The other thing is that men can take it from

basically any age,

and that includes people
up to 70, 80, or whatever.

Women though had
to be between 18

and where they entered
the perimenopause.

So there's real problems
there in a discrepancy

between men and women.

And there was a very
paternalistic attitude.

.
Addyi is not approved for use in postmenopausal women.

The FDA says more
studies are needed

to determine whether it's
safe and effective for them.

.
They just made it impossible to get the drug.

And with all the restrictions
on the pharmacists,

they weren't selling it.

.
It's been on the market now for three or four weeks

and the demands so far has been
really, really, really low.

And frankly, you know,

Valeant been in the news
for a lot of other reasons

for some of the troubles
that they've had.

.
For Valeant to jack the price up the way they did

is I think criminal for women.

.
Valeant's a very controversial company.

A lot of stuff came out
about its business model,

particularly the business model
of buying other drug companies

then jacking up the
prices of those drugs.

Well then it was
cost prohibitive,

so they stopped taking it.

And that was the end of it.

.
And then, of course,

the next thing that happened
is they shelved it.

The intention was
I was gonna stay.

You know, that was
part of the deal.

I would stay and build their
entire women's health franchise,

and within three months
of that deal closing,

I got a phone call that
invited me to leave.

And not long after that,

they got rid of
the entire team.

I've never been more depressed
in my life than that period.

To have won one and then
them to not launch it,

and the women who had
shown up at those meetings

to not be able to get it.

That felt the
worst of anything.

It was, it was,
that was brutal for me.

.
Women that are struggling with HSDD should have the option

to choose a safe and
approved treatment

with guidance from their
healthcare provider.

Thank you.

.
How can you possibly pass something

that is so
wonderful for women

and then have it ripped out?

After all of this work,

and after all of this emotion,

we're down to square one
again and we still are.

.
We just got new metrics in,

Donald J. Trump

is the President of the
United States Elect.

.
The past five to ten years really calls into question

where the state of
women's health is going.

.
The last year has been incredibly difficult for women.

We have seen major
attacks on Obamacare,

protections for birth control.

And we know that
on the state level

there are a number of courts

that are working to roll
back our right to choose.

.
Tonight we remember an American icon,

Supreme Court Justice
Ruth Bader Ginsburg

died today.

.
Ginsburg was seen as a champion of women's rights.

Her passing now gives
President Donald Trump

the chance to shore up the
conservative majority

when choosing a replacement.

.
Confirmation brings a major shift to the court

and it will have an
impact for years to come.

.
One of the tipping points in the conversation that we're having

requires us to look back to what
happened just a few years ago

with the overturning
of Roe v. Wade.

I don't accept this ruling!
We're not going to go back!

What changed since 1973?

What changed?

.
To be at a time in my life

that the rights
that my generation

fought so hard to have

see them taken away.

What right does anybody have
to say what I do with my body?

Why does any right
and men have a right to,

to, to control any of that,

whether it's sexual health,
reproductive rights, uh,

who, who you're married to,

none of that is
anybody's business

if you're not harming
anybody else,

and I will stand up and
support and hope to God,

like I have two
granddaughters, teenagers.

I hope that they live
in a world better

than the world we're
looking at today.

.
Today the story of Josseli Barnica,

a young mother pregnant
with her second child

who died of sepsis
just one week

after Texas's abortion
ban went into effect.

Despite being diagnosed with
a miscarriage in progress,

doctors said they
could not treat her,

meaning provide an abortion,

until her fetus no
longer had a heartbeat.

.
People are literally dying

as a result of these
horrible political changes.

We have to get all of
this reversed back

to the where it once was,

where-where people
have rights.

And-and reproductive
and sexual rights

are just as important
as cardiac rights,

as orthopedic rights,
as any other right.

I'm scared to have a daughter

because I don't know how the
world is going to treat her,

'cause you could be the
best parent in the world

and you could teach that girl

to be the strongest
possible person,

but you have no idea when
she goes out into the world

how the world is gonna
receive and treat her.

It's also a scary time
with what is happening

to traditionally
marginalized groups.

Trans people are the most
marginalized in our society

and they've been
scapegoated in a way that

they are sort of being used as
this smoke and mirrors vehicle

in this all out assault
on personal autonomy.

And it's scary how quickly
that has escalated.

You know, back in the
twenty late teens,

it was this discussion
around bathrooms

and then very quickly it
was trans people in sports.

It is a hot topic in
American politics,

whether or not
transgender people

can compete in categories
in which they identify.

.
And then very quickly it was

trying to ban care
for trans youth,

and now there's multiple
states actually trying to

limit care for trans adults.

So what happened with
Roe is a direct extension

of what's been happening
with trans rights.

At the end of the day,

if like we collectively
as-as a society

are not standing up and
protecting trans rights,

then we're not
protecting our rights.

Regardless of what's going on
in Washington politically,

people are still suffering.

So all the games that
people are playing,

all the rights that are
being stripped from people

regardless of who they are,

at the end of the day,

my patient in my room
is still suffering

because I will be honest right
now as a gynecologist,

it's a little bleak.

Patients are feeling it too

when they come into
the exam room as well.

If our reproductive rights,

our rights to bodily
autonomy are threatened,

we almost can't even get to
the conversation of pleasure

because we're fighting
for basic human rights,

those fundamental
rights to exist

to have control
over our bodies.

And that's very scary.

But I don't wanna lose the
conversation around pleasure

as we focus on rights itself

because pleasure
is a part of that.

And in fact, if we focus on
everybody's right to pleasure,

men, women,
folks of all genders,

if we talk about pleasure,

then we have more support
to talk about rights.

And I think that they
go hand in hand.

.
You need people yelling and screaming,

and you need coalitions,

and you need
people getting loud.

You need advocacy,

you need research,
you need mentorship,

you need awareness,
you need communicat-

You need all of those things.

.
We need a seat at the medical school tables.

Who's coming up with
the curriculum?

How many hours need to be
devoted to this subject?

We need a seat at
the FDA in terms of

what medications are
getting FDA approved.

What roadblocks are they
putting up in place

trying to protect women
and keep us safe,

which actually just create
huge barriers to care.

We need to hold insurance
companies responsible.

And our patients
need to speak up

and demand from
their congressmen,

from their legislators

that these are important
issues that they deserve.

.
The most important way

in which any individual

could make an impact on this
fight for bodily autonomy

and the right to
equal amounts of care,

would be to educate ourselves
and to remain curious.

And when we hear something that
doesn't quite seem the same

as what we were
trained to think,

to push back a little bit

and realize that the truth
is actually something

that's been hidden from
us for a very long time.

.
I think the key is to not be discouraged by the losses.

There will be losses and you
can't just take that and go,

well there's no point
in fighting this fight

'cause we just lost that fight.

And I think right now
that's what we have to do,

is we keep having to
push for the right answer.

*

.
In the dark days after the CEO fired me,

no one was feeling
sorry for me, right?

I had really the
entrepreneur's dream come true.

I exited the business.

It was an incredible outcome
for all the shareholders,

and yet I found myself
really unfulfilled

because it's not what
I'd set out to do.

.
Well the drama isn't over for the drug maker,

Valeant Pharmaceuticals,

the CEO just recently back
from medical leave is now out.

.
So when the new CEO came,

I asked him if he'd have
breakfast with me in New York

and I sat down with him
and I said, "Give it back."

He said, "No thank you.
Go away."

So I issued a lawsuit.

They'd made commitments to
me on what they would do.

You know, how much they would
put toward the marketing,

the education of
physicians on it.

And they were in breach
of all those obligations.

And ultimately in exchange
for dropping the lawsuit,

they gave the product back.

Just give us the history
of this female Viagra drug

because it was bought,
wasn't it,

by Valeant and
went nowhere fast.

And now she's bought it back.

.
Yeah, Cindy successfully settled with Valeant a lawsuit

that allowed them to get the
drug back at no cost to them.

And they're taking this
back to the market

for the second time.

And so it's basically the,
the drug's second shot.

.
The minute we got it back,

we went to back to work

and we invested all of
these dollars back into

all the scenarios that we
could show back up to the FDA

and actually got that black
box warning contraindication

removed.

It has an entirely
different label today.

No doctor has to take a
test to prescribe it.

Eli does what he calls pharma
or farm P-H-A-R-M to table.

That's right.

So he's making sure all
these pills are coming off

the manufacturing line.

Kristen, our chief of staff,

Margaret in finance here.

Chrissy Newbauer, who runs
customer service for us.

Michelle, who's working in
customer service as well.

When we got approved,

we were confined to only
premenopausal women.

So we've submitted for our
postmenopausal expansion of use.

.
I don't even like to say

that we've submitted
for postmenopausal.

We've submitted for approval
in women with HSDD.

It, it's not for approval of
postmenopausal women, right?

It's women with HSDD

'cause that's who it should
always have been approved for.

And so,

after we disprove the
alcohol contraindication,

if you Google
Addyi and alcohol,

what comes up is Addyi is
contraindicated with alcohol.

That's still out there,
that narrative.

Like even though
we proved it,

that narrative, six years,
is still out there,

and it's still
out there in part

because FDA keeps
it out there.

So the first order of
business was science,

and then I think the
second order of business

has been demystifying
all of the garbage

that's been out
there about this.

Women are like,

what do you mean there's
a pink pill for me?

I've never heard of it.

And that is now
the real problem.

You guys know

that I've been fighting
for years on this issue,

that I fought to get the first
FDA approved treatment option

for women's libido.

All the while hearing
the same excuse,

"Mmm, women's libido
is complicated."

Is it complicated or is
it just not prioritized?

I had nothing on social media,

but you know what?

Somebody had to speak up

and once I spoke up,
it just never stopped.

When doctors
dismiss our pain,

downplay our symptoms,

or essentially tell us
it's all in your head,

we learn to be our
own advocates.

That's not empowerment,
that's survival.

Cindy, welcome to the show.

Thanks for having me.

The truth is, I knew that
you were gonna be wearing

pink today.

I know, it's shocking.

I think Addyi has parallels to
all of these other conversations

we're having right now

that I'd like to think
we've had a hand in

because when you fight back,
you can win.

Dr. Blair Peters here,

full-time gender
affirming surgeon.

Hi everybody, uh,

Rachel Rubin, urologist
and sexual medicine specialist.

We're live on
Instagram right now.

* I don't want to
want when I wanna

* Anything I want cuz
I like it like that *

.
So this person asked,

I pee after sex and yet
I'm still getting UTIs.

What am I doing wrong?

Just wanted to give you guys
a walkthrough to this device.

Um, it is for
erectile dysfunction.

Here are things I would do
to have a better sex life.

.
It is so fun

to watch these badass
younger physicians.

Hi everybody,
it's your education share,

Sarah Cigna.

.
Whether they're on Instagram breaking barriers

or they're in the room
challenging conventional wisdom,

I love it.

* I'm a rebel *

* I'm a rebel

I am not a magician,

but my batting average
is really fricking good.

And in our practice
we take a lot of time

to get to know you,

to figure out what's
bothering you,

and to figure out how do we
optimize your quality of life.

Stacey, David,
it's great to see ya!

Good to see you.

One of the things we
often ask people is,

what does sex look like
for you right now?

And compare that to what
you want it to look like.

Why is that important?

Because I can't assume what
kind of sex you're having

or even what you want
it to look like,

and the more I understand
you and what your goals are,

then we see magic.

When you really take
the time with people,

that's when the magic happens.

That's why I think
it is so important

during an annual exam
to encourage women

to hold a hand mirror

while I go through their
external vulvar exam.

I feel like most of the
time when I do that

women are so
shocked and happy

that somebody took
the time to show them

really who they
are down there.

And that's just one step in
the process of empowering women

to take more ownership over
their own sexual function.

.
Patients and we as clinicians,

need some sense of community,

especially in the current
political climate.

Without people who
are banding together,

creating community,

creating safe spaces,

and pushing the needle forward,

we're never gonna get anywhere.

.
We should be able to stand up for our rights

and say, "I want more."

I want something better
out of this relationship.

I want something
better outta sex.

I want something
better out of my job.

I want something
better from, you know,

from the, from my family,

but you, but if you
don't tell somebody,

then how can you expect
somebody else to help you?

.
The underlying theme of whether it's sexual health

to reproductive
health is choice.

So whether it's
having an orgasm

or having an abortion,

women should have the
ability to choose

what is the best
thing for them.

.
A lot of the culture in medicine

is still very anti
speaking out

and it's because we don't
speak up for things

that the narrative has
become very warped

and very much straight
away from science.

So I think there's a huge
need more than ever

for a lot of us to
really be out there.

.
I'm hopeful because I'm seeing more women come into this field.

I'm seeing more queer
people enter this space

and saying like,

we need to really rethink
how we talk to people about sex

so that we include
all types of people.

I think that the more
pleasure and orgasms

and fun people can
have that is safe,

that is consensual,

I think when we focus
on pleasure and joy,

then the hatred and the
trolling and the nastiness

and the focus on
all the negative,

I think it kind of
starts to go away.

So I think by focusing on joy,

I think we can make
a lot of progress.

The magic that happens after
someone reclaims their sexuality

just knows who they are,

takes full ownership
of their existence,

their bodies,

their birthright of pleasure.

You get to literally
witness this person

step into their power.

I have seen so many
of my patients

go on to sign a book deal,

go on to like run for office,

to go on to do so many things

because they had the audacity

and the audaciousness to
chase their pleasure,

which then opened up doors to
chase all their other dreams,

and it is so fun.

Story alert.
I have a story alert.

I saw a patient very recently,

she's in her sixties,

twenty-five years ago
in her late thirties

she lost her ability to have
her three magical orgasms.

She used to orgasm three
powerful magical times.

Well, I just saw her and
she said, "Dr. Rubin,

"they're back!"

* Love heavy but I
gotta let you go

* Mind steady and I got
a way to let it go

* Love came here but
it never left so

* The way we look be
supervised by a pen stroke

* In the high note
crying in my throat

* Love heavy and I think
its time to let it go *

* Way of love but it weighs too
much and you weigh too much

* Staying out of touch
looking suss, huh *

* Put our love on a layaway

* Paying for it every time
I have a piece for you

* Peach that's sweet

* Bon appetit, bon appetit

* Just miss me... *