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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... *