Okay, now could
you just move down?
Go ahead
and move down.
Okay, move down
a little more.
There you go.
Okay.
Now just make yourself
comfortable, relax.
I'm going to
leave now.
What's an orgasm
like for you?
I'm going to say that
it's like a blooming flower.
It comes from the roots
and grows up
until it spreads beautiful aroma
around the room.
It's like coming down
from the highest
and the best
rollercoaster ride.
I think it's
different sound.
It's definitely
a different sound.
It would be like "ahhh"
with the rollercoaster
but with the orgasm
it would be "ohhh. "
Is there something
that comes to your mind
when you think about
having an orgasm?
War.
That's what I think about
is the war in my head.
I'd like to.
I hope I do.
What's wrong with me...
I can't?
And so by the time
I get through
having this conversation
in my head,
I am not involved
anymore in the now
and in the activity
that's going on.
Why does it hurt you?
It's vey frustrating.
It's vey, vey frustrating
to enjoy sex
and to never get to
have that release.
I don't want to be hurt
anymore about this.
In this morning's "Healthy Woman"
something new to deal with.
An astonishing statistic.
Forty-three percent
of women aged 18 to 59
have some kind of
sexual dysfunction.
Female Sexual Dysfunction.
Symptoms include
lack of desire,
lack of pleasure,
painful intercourse.
This is a vey new
field of medicine
but there's a good chance
the problem can be tackled.
The FDA has only
approved Viagra for men
but some doctors
such as Jennifer Berman
believe Viagra might
help women too.
As many woman
hold their breath and wait
for the cream or spray or pill
that might work for them,
the race is on
to be first.
The prize: Undoubtedly
billions upon billions of dollars.
Vivus was a pharmaceutical company
that was busy developing
an Of9aSM CfeaM
for women.
Your name?
My name is
Liz Canner.
Okay, iust a moment.
I'm a documentay filmmaker
and Vivus contacted me
because they needed
some help
with the clinical trial
of their new drug.
Vivus is a company
that develops drugs
for male erectile
dysfunction
and we're currently
getting into
the female sexual
dysfunction arena.
We're doing some
early phase clinical trials.
What we want
people to do
is they're going have to
come into a doctor's office
and they're going to
have to apply this drug
and then we are going to have
to measure a sexual response.
What we intend on using
is visual sexual stimulation
which is visually
explicit material.
Well, we need some help with
the actual production of the video.
Vivus wanted me to
put together erotic video
for use during the testing
of their new drug.
I thought, "How could
I take this job?"
How could I not
take this job?
I was curious
about the latest
scientific thinking about
women and pleasure.
So, I gained permission to film
Vivus for my own documentay.
Little did I know that I
would spend nine years
documenting the medical
industy's attempt
to change our understanding
of the meaning of health,
illness, desire, and that
ultimate moment: Orgasm.
What's the name of
the company mean?
It's Latin for "alive"
and I just had the feeling
that our obiective was to put life
back into dead penises.
Twelve years ago today,
I incorporated the company.
And as you can see it's
a real joyous, boisterous crowd.
Vivus 12th Anniversay April 16,
Celebrating 12 Years of Sexcess.
Why did you
found Vivus?
After a radical prostatectomy
for cancer
my privy organ was
no longer alive.
And that's when I focused
on what could be done
in the field of
sexual dysfunction.
All the drugs that we developed,
all of them started on me.
In 1996, Vivus was one
of the first companies
to win FDA approval for a drug
to treat Erectile Dysfunction.
It was on the market
It was heady days though.
You really... you watched
the stock price go up evey day.
Our market capitalization
was over $1.5 billion.
But for only a few days.
Then Viagra was
launched, obviously,
of the product
actually started
to deteriorate.
When Vivus was no longer
the market place champion for men,
they started testing their
erection drug on women.
This new treatment
was called Alista.
How does Alista work?
What happens
when you add Alista,
our product,
with sexual stimulation,
what affect does it have
on cyclic A and P?
In this case it increases
it pretty dramatically.
That, in turn, decreases
intercellular calcium,
which in turn causes
increased blood flow.
How will you know if a woman
has been cured by Alista?
The endpoint in the male
is rather straightforward,
an erection occurs
or it doesn't.
The female doesn't have that
same type of a vertical indicator.
So we're dependent upon
a diay or on questionnaires
rather than doing
a measurement
of the amount of engorgement
of the penis.
What about orgasm?
Well, an interesting equation
here that increased blood flow
hasn't conclusively been
shown to cause orgasm.
How many drug companies
do you think there are
out there right now
developing drugs for FSD?
There's probably
at least 12,
developing all different
types of things.
We're all in a race to see
who can be first to market.
The top four contenders for FDA
approval are approaching the start.
My work with Vivus began
with a meeting with Kim Airs.
Vivus hired her to curate the erotic
footage for the clinical trial videos.
Oh, hi Liz.
How are you?
She was a nationally
recognized expert
on women's taste
in pornography.
Well, I think when we're
going to select videos
that I'm assuming that woman
are going to enjoy watching,
I've really found that
women do go for plot.
They do go for videos
that are well-shot.
People go "porno, plot?"
It's really kind of funny.
Porno is so subiective.
It's like, what gets me off
might not get you off.
Now, I'm a little
worried about
if it's not the right porn
for the majority of women
then this will have an
effect on their result.
The only thing we
can do is guess
because that's the whole
tough thing about it.
If you're making something as
standardized as a testing protocol
you have to assume
that most women
are going to like
what you give them.
That's why I don't want to
have "Babes Ballin' Boys"
or "Butt Man's
European Vacation. "
Oh look they're
wearing condoms.
That's good.
So this, I mean this is
definitely, this could...
Ohhh!
That's... I know.
See, she's got a little
birthmark there.
I can make
the sound effect.
So, I don't know which ones
were tape 1 and tape 2.
Isn't it strange the way
Female Sexual Dysfunction
was only recently
discovered?
Right, to medicalize stuff
that's been around since histoy.
You know, what is
Female Sexual Dysfunction?
Is it you're
withholding sex
because you know
your husband's cheating on ya?
Is it wants and desires
that are unfulfilled?
I mean, it's so complex.
The erotic videos would
soon be screening
in exam rooms
across America.
It was time to visit my doctor,
Susan Bennett.
She teaches a class on human
sexuality at Harvard Medical School.
I usually visit her
when I need a checkup.
Is eveything
okay with sex?
It's okay.
Today, I was checking up
on Female Sexual Dysfunction.
Were there any new
medical discoveries
that could have prompted
this newly named disorder,
Female Sexual Dysfunction?
No new medical discoveries
regarding women's sexual problems
that I know have been
reported in literature.
We as a society think
that we should be able
to fix eveything
by just taking a pill.
If women think that they
should be having an orgasm
evey time they
have intercourse,
a lot of women
are going to think
there's something
wrong with them.
If women think that
they should be
as libidinous at 60
as they were at 25
a lot of women
are going to think
that they need medication
to feel better.
But if in fact we say,
"This is normal.
This is a normal
part of aging.
You can still enioy sex. "
It's not a disease.
And you don't need
a pill to fix it.
How did Female Sexual Dysfunction
come to be seen as a disease?
How did that happen?
We don't know.
How did you're company ever start
working on a drug for FSD.
What's sort of the stoy
about how that came about?
I don't want
to go there.
So is there anything
organically wrong
with these women
that you can find,
that you can locate,
that Alista will address?
Well, that's not, uh...
I can't answer that question.
How we ended up
developing a drug for FSD...
We'll wait for the sun
to go away.
Saved by the sun.
I don't know that
I can say that.
A little bit after the time that
Viagra had been launched,
one of the local
N stations
had come to Vivus
and were interviewing people.
In the foreplay
process you apply
a small amount of cream
in the vaginal area
topically to
the sex organs...
One of the things that Lee
said during an interview is,
"We're developing drugs not only
for male erectile dysfunction;
we also have drugs in development
for female sexual dysfunction. "
The cream would be available
by prescription only
to women who are
sexually dysfunctional.
But somehow that
got picked up as,
"We've got drugs
for Female Sexual Dysfunction. "
The market went wild.
We didn't even know
what the disease was.
We just knew that we had something
that treated erectile dysfunction
and could probably be used
in females as well.
That's why we're in FSD.
Let me attempt to lay out what
I see as one of the freshest,
clearest examples
of the corporate sponsored
creation of disease,
Female Sexual Dysfunction.
The key meetings... through
the mid-to-late 90s and onwards...
the key medical
and scientific meetings
where this new condition
called Female Sexual Dysfunction
was being debated
and defined and refined,
all of them were sponsored
by the drug industy.
Who defines whether
or not FSD is a disease?
Why is it now a disease
where maybe it wasn't before?
That's a really interesting
aspect to what it is that we do.
In order for us
to develop drugs,
we need to better
and more clearly
define what
the disease is.
We, the drug company,
define the disease.
We've been able to
get thought leaders
involved in Female
Sexual Dysfunction
and really work
closely with them
to develop this
disease entity.
Why on earth would
we want a drug company
involved in developing
or defining a disease?
Clearly they have
a vested interest
inmaximizing
thenumbersofpeople
they target
with their drugs,
so they'll define
the disease as big
and broad and wide
as possible.
There's been estimates
on the average
of 40 million women
in the United States alone
may be affected by
psychological disorders...
Sory, no, sexual disorders,
Female Sexual Dysfunction.
If they can transform vey common
female sexual difficulties
into Female Sexual Dysfunction
and treat it with a pill
then that's a bonanza
for their shareholders.
We at one point in this company
we had five secretaries
that had a net worth of well
over a million dollars in paper
in the stock
of the company.
But Jane was one
of the smart ones.
Jane was able to sell her shares
for well over a million dollars
and so she retired
at an age of 34.
So, those things happen
when you're on a roll going up.
Well, it's a vey
positive year.
Health costs are already
exploding in the United States
and generally across
the western world.
One of the biggest
increasing costs
is coming from
pharmaceuticals
and there is a whole line
of argument that says
we are medicalizing more
and more ordinay life.
Certainly in the last
drug companies and the thought
leaders that they're close to,
have been involved
in some way in defining
and redefining
and designing conditions.
Expanding old ones,
creating new ones.
Because there's a lot
of money to be made
telling healthy people
they're sick.
One of the reasons
the pharmaceutical industy
was involved with
developing diseases
was that in order to create
a prescription drug or treatment,
the FDA requires that it
treats an actual disorder.
So when the FDA
said yes...
Yes.
...Female Sexual Dysfunction
is a legitimate disorder;
it started a gold rush as
inventors searched for cures.
We're going to call the device
the Orgasmatron.
Essentially what is
done is an electrode
is threaded up
the spinal cord.
And then by adiusting
the electrical parameters
you will have
an orgasm.
Leaving it on
at a low level
you would have a pleasurable
sensation there
for as long
as you wanted.
All day, waiting in traffic,
shopping,
all the sort of boring chores
of eveyday life.
Yes.
The potential market includes
the one third of women
over the age of 25
in the United States
who have problems
with orgasmic dysfunction
so I could see having clinics
in major metropolitan areas
and other areas overseas would be
Amsterdam, Berlin, and Sydney.
I hope to make
money off this.
And what do you want
to call your clinics?
Well, I'd thought of
a vey simple sign
that says, "Orgasmatron,
Inquire Within. "
This is a symbol
of marital happiness.
And so we have the two
ducks kissing each other.
They're salt
and pepper shakers.
Like I said,
people give me things
and I stick them up there
and they know I like this stuff.
This is Randle, my husband,
and this is me.
We're two old goats,
you see.
I am in a loving relationship
and my husband
has unconditionally
accepted me where I am
because he does know this not
about him, this is about me.
All of my life I have had
difficulty achieving orgasm.
This box will actually accommodate
a total of eight electrodes.
Charletta and ten other
women were enrolled
in a clinical trial
of the Orgasmatron.
Basically, you have the ability
to adjust the sensation
no matter what
position you're in.
So, I'm going to
turn it up again...
It's taken me a long time
to get to the place
where I wasn't
humiliated so that
I could come here and do this
and even talk to you like this.
So I'm really
excited about it.
I feel like I'm well on
my way to being healed
and being more
healthy and normal.
Female Sexual Dysfunction, per se,
probably runs 80... 83 percent.
Orgasmic Dysfunction
is a subset of that.
I think that's
vey interesting
and I think there is
a tremendous need then
to do this for women,
to help women.
I'm not from the South
but I got here as quick as I could
and one of the sayings
they have around here is that,
"If momma ain't happy,
nobody's happy. "
That's right.
Each time you use
the device,
and if it does work,
we'd like you to fill this out too
please grade your
orgasmic experience.
If you need more pages
give me a call,
and I'll get
some to you.
Okay!
We have high
hopes here, huh?!
Yes ma'am.
Yes we do.
I'm in this to
heal myself.
Not only am I not normal,
I'm diseased.
That feels real bad.
Coming from the religious
background I came from
there was a lot of mixed
messages about do and don't
and this is wrong
and that's right.
Well, the flesh was evil.
The flesh was wicked.
And so you didn't want to
indulge yourself in the flesh,
or g ive over
to the flesh.
They typically can be accomplished
within about 20 minutes time.
And how long
did this one take?
About 40?
About 40 minutes.
A new article in the British Medical
Journal by Ray Moynihan,
launched a debate
about whether
Female Sexual Dysfunction
was an actual disease.
So, what got you
writing this stoy?
A friend of mine sent me
a press release
that she'd got from
a company called Vivus.
"Alista: New Hope for
Sexual Healing for Women"
and it's from the Investor
Relations Group.
Is this about money
or medicine?
There's talk here of 430/o of women
suffering from this dysfunction
and that really, you know,
that triggered alarm bells.
It is a secret epidemic...
experience some kind
of sexual dysfunction.
suffer from
what is now called
Female Sexual Dysfunction.
Here's the actual
paper that was
in the Journal of the American
Medical Association
that first launched this
It's based on a survey
from the early '90s.
Women were asked
a series of questions
about common sexual difficulties
that they might experience.
If they answered "yes"
to any of these problems,
they were put into a box that
said Female Sexual Dysfunction
and that's how you
get to the 430/o figure.
Ed Laumann, the sociologist
from Chicago who did this survey,
he himself says that a lot
of these 430/o of women
are "perfectly normal,"
that's his words,
and that "a lot of
their problems arise
out of perfectly
reasonable responses
of the human organism
to challenges and stress. "
A correction appears in
a subsequent issue of the Journal
disclosing that those authors
had financial ties to Pfizer.
The pharmaceutical industy,
through a whole range
of vey sophisticated PR
and marketing strategies
is actually changing
how we all think about
our bodies, about our health,
and about our diseases.
Essentially you're turning
healthy people into patients.
How does one effectively protest
against the existence of a disease?
New York University professor
of Psychiaty Leonore Tiefer
was tying to
figure that out... fast.
I'm going after
the pharmaceutical industy
because I iust got really upset
with the hunt for the pink Viagra
and I thought, well,
over my dead body,
and, I'm iust going to
do something about this.
We know the truth,
there isn't a pill for eveything.
What I'm concerned about is
that there is a shift going on
in the meaning of
sexuality in the culture
towards this commodified,
individualized thing
that has
a normal level,
and that if you don't
experience it in that way
there is something
wrong with you
and you need
medical help.
I just want to say
it ain't so simple.
It's different for
different people.
I like the idea that desire is
a co-created phenomenon
rather than it being
an internal thing.
It's kind of like friendship.
You don't walk around,
how many times in the last month
did you have
the friendship feeling?
You know, friendship is something
that happens between people
and I think sex is something
that happens between people.
Leonore Tiefer runs
the New View Campaign,
with its hundreds
of members,
from her small apartment
in Manhattan.
How is your campaign
going to stop
the FDA from approving
a drug for FSD?
The FDA hearing, the public
is going to hear from us,
hopefully, as well
as from others,
that you need to prove
that there is a disorder
and you need to prove
that your drug is safe
and you need to prove
that your drug is effective.
And we're going
to go down there
and ty to throw a roadblock
in front of their steamroller.
What's wrong with drug that helps
women achieve a better sex life?
It's not iust the drug.
It's the drug in the context
of the advertising,
of the lack of education,
of the lack of regulation.
I think that it's a manufactured
term to create a market for drugs.
While Leonore used the airwaves
to spread her message,
medical experts pushed the concept
of Female Sexual Dysfunction.
Actually there are more
sexual dysfunctions in women
than there are
in men.
This is Viagra, this is actually
a sample pack, but these... tada!
Most of the medical experts
had financial ties
to the pharmaceutical industy
but did not disclose them.
Viagra is useful in a smaller
subsection of women
but it can improve blood flow
and lubrication
to women who have
that as a problem.
Now there was
a movement.
Our proposed indication,
as you've heard,
is for the treatment of Hypoactive
Sexual Desire Disorder.
And a counter movement.
Assessing sexual experience
is subtle and complex.
Evey study must be closely
examined for what they leave out.
The two sides were
really duking it out.
And it remained to be seen
who would define
woman's sexuality
in the 21 st centuy.
Ladies and Gentlemen, we'd like
to welcome you to Salt Lake City.
The local time
here is 11:06.
In the midst
of the battle,
Vivus arranged a luxurious
ski trip in Utah
for the doctors who ran
their clinical trials.
There they planned
to announce
the long-awaited results
of the clinical trial of Alista.
The same one that featured
the erotic videos that I edited.
You know, they come
and they relax.
They get an opportunity
to do some skiing.
The one good thing,
though that you do establish
at a meeting like this, is you
establish the relationships.
And so once you have
the relationships in place,
you can play
on those.
Come on,
sing with me now.
The words, the words!
There just are no words
for how good this drug will be
...once it becomes
on the market!
The best.
These are the people
that make it happen.
Yay!
I get up at 6:30 evey morning
and I work until 9:OO evey night
all for the bettering of
Female Sexual Dysfunction.
We gotta go.
It's time.
It's show time.
At the last minute
a senior executive
banned my camera
from the meeting.
I managed to attend anyway
and discovered that Alista
was not doing nearly
as well as they'd hoped.
It was interesting what
we found in this study
was that even when you
gave patients placebo,
when you showed
them visual stimulation
So you basically discovered
women like porn.
Yeah, so, so porn works.
Porn works.
It's not, you know, the panacea
for solving all your sexual troubles
but it does elicit
sexual responses.
Despite the high success rate
with the placebo
and the plain fact
that porn works,
Vivus decided to continue
their clinical trials of Alista.
You can ask questions
of patients
that are vey simple questions
on the surface of things,
but small changes in
how you ask a question,
can lead to sometimes
vey significant changes
in the answers that
you get to a question.
It's just that improvement is
different than enhancement.
And, and there is
a little difference.
We knew there might be
some sort of a small difference
but that looks like
a big difference.
The data never lies.
Back in North Carolina,
Dr. Meloy was wrapping up
the clinical trial
of the Orgasmatron.
I'm waiting for my second visit
with Dr. Meloy.
It's not working
for me vey well
and if you want
to come closer,
I'll demonstrate for you.
It's working in
this leg watch.
I said I'm not much good unless
you like to be kicked in the behind.
I had a feeling they were
going to take it out today.
Were you able
to get close?
Uh-uh.
Not even.
And I tried evey position
you can imagine on that.
I'm disappointed.
In your clinical trial
how many women
did the Orgasmatron
work on?
We've, ah, succeeded
in stimulating eight out of nine,
but we've not been able to
maintain the electrode in but six,
and of those six
it's worked in four.
We're able to stimulate 91 O/o
of the women, 1 O out of 11.
But at this point
I just give up.
I mean it's okay.
I accept myself
the way I am.
There are lots of ways
to achieve orgasm
other than just to have
sexual intercourse.
And...
Can I just ask
you a question?
Can you achieve orgasm
through other means?
Yes, I can.
Yes, I can.
So I'm not
without orgasms.
I can have orgasms but it's
just not the normal situation
where two people
get together
and they have sexual intercourse
and each has an orgasm.
And that's what I say,
maybe that's not real.
Maybe that's just what
the movies tell us is real.
Exactly.
Most women would
not have orgasms
from the kind of sex
you see in the movies.
Seventy percent
of us need
direct clitoral stimulation
in order to climax.
So that's what
you were hoping,
that this device would allow you
to have orgasms during sex?
Yes, during sexual
intercourse,
and just, again, in what
I think is a normal way.
But you have absolutely
washed that out of my mind.
I no longer know
what's normal.
So that's wonderful because
that's a brand new start.
Charletta was enrolled
in a clinical trial
for women with FSD despite
the fact that she was healthy.
To heck with that
disease stuff.
How many women risk
being taken advantage of
because of a lack of
comprehensive sex education?
What about sex education
in America?
Seems to me there's an
interesting double standard there.
Vey soon we'll see
some sort of orgasm pill
or orgasm nasal spray
and we're teaching people
abstinence only
in our schools.
Did any of you get abstinence
only sex ed training?
You did.
Well, it was... the woman
who was teaching the class
first of all divided the guys
up in one room
and the girls
in the other.
She was about 80 years old,
vey, vey traditional and was like,
"Sex is bad so don't have it
until you're married".
Our health teacher evey time
she told us about
another form of contraception
or STD prevention,
she would just say,
"Well, you don't need to know this
because you're not having
sex till you're married,
and then when
you are married
you're not allowed to
use birth control anyway.
Because if you
use contraception
while you're married,
you'll go to hell. "
Do you think that
affected you at all?
Oh no,
not at all.
I...
I was going to college
and my godfather
had a talk with me
saying, you know,
"Wait until you finish college,
after college,
then go ahead
and have sex. "
But my same godfather had
a conversation with my brother
and said, "Have as much sex
as you can possibly in college. "
So what would you
all say has been
your primay source for sex
education or information?
Peers.
Peers.
Peers?
So your peers have
shaped you the most
and given you the most
information?
Yeah.
Women come into Good Vibrations,
now, not just young women,
older women, women
the age of their mothers,
women the age of
their grandmothers,
and they're not sure
where their clitoris is.
How are those women,
who can't find the parts of their body
that might help them
feel the best,
supposed to
function sexually?
Is a drug going
to help them?
Maybe if has a map of
the clitoris on the box.
I hope nobody
steals my idea.
I'm Dr. Carol Queen,
and I'm the curator of the vibrators.
One of the reason I love
these antique vibrators
is because my first vibrator
was an antique vibrator,
a Stimulax Junior,
vey much like this one.
And I read in a women's magazine
in about 1973 about vibrators,
and thought,
isn't that what
my parents have
in the hall closet?
I ran down.
I dug it out and then I snuck it
back up to my room.
I turned it on.
It was my vey
first orgasm.
After that I was not going
to put the thing back
and sory to say
that my parents
never asked me
for it back.
So clearly, I was getting a lot more
out of it than they ever did.
The reason we have
vibrators today
is because over
a hundred years ago,
in the late 19th centuy,
doctors were using vibrators
to treat a disease in women
called hysteria.
When a woman who
had hysterical symptoms
would go and see
her doctor,
and her doctor would
apply vibration,
and she would have a hysterical
paroysm of relief,
something that today
we would call an orgasm.
And by the end of
the 19th centuy,
some sources estimated
that three quarters
of women suffered
from hysteria.
Those of them who
could afford to do so
went to their doctors
on a weekly,
sometimes more
frequent basis,
and it was
a big business.
We no longer call hysteria
a disease at all
and what it probably was
was a combination of stress,
and women's hard work
plus sexual deprivation
and inability to get all the way
through sexual response cycle.
In a lot of ways,
female sexual dysfunction
is the hysteria
of this centuy.
It's a new way of putting a lens
on women's sexual experience
from a distinctly
medical perspective.
Woman need to feel entitled
to their sexual response.
They need to go to their doctors
and demand to be heard,
and demand treatment,
because it is available.
Urologist Jennifer Berman
and sex therapist Laura Berman
were the first to really brand
the condition of FSD.
They have become
the pseudo celebrities
associated with this
particular dysfunction.
In 2001, they wrote
the first popular book on FSD
and used it to launch a huge
marketing campaign.
This is a device
that was developed
to enhance genital
blood flow.
What Viagra does is it increases
the blood flow to the genital area.
You crave sex.
You can't stand sex.
Within a vey short time,
they had their own N shows...
...a call in radio
program,
a syndicated newspaper column
and sex clinics.
From the Berman Center
in downtown Chicago,
it's time to talk about
your love life.
The Dr. Laura Berman show...
no men allowed!
This is all about women.
Hi, welcome to
the Berman Center.
My name's Neyla
and I'm the patient concierge.
I just wanted to
introduce myself.
If you want
to follow me...
...you'll meet with
the sex therapist.
The sex therapist will be
looking to determine
if there is any emotional
or relationship issues
that may be
contributing
to the patient's problem
for coming in today.
Do you want me to talk to
you or talk to the camera?
Talk to the camera.
The Berman Center is
really sort of a culmination
of my professional dreams
over the past 1 O to 15 years
I've been working
in this field.
Well, my husband,
he's the one
who raised the money
to open the Center
but also he wears
a business hat,
in a way that I as
a clinician don't,
so it's really a nice marriage
literally and professionally.
If vibrators were
recommended,
if lubricants were
recommended,
it would be at the patient
concierge point
that we would go through them,
and talk about them,
and answer any questions
that they had.
So you were
really involved
at the beginning
of this weren't you?
Mm-hm.
How did it all happen?
Yeah, from the beginning,
when all of the focus started
on female sexual dysfunction,
the medical piece of it,
there have been
a lot of companies
that have been tying
to develop drugs
or medications or medical devices
for sexual dysfunction,
and I've been involved
with just about all of them.
I was one of the principal investigators
of Viagra in women.
At the halfway mark, Viagra,
the favorite, is bringing up the rear.
There's trouble
on the track.
Viagra is not working any better
in clinical trials than sugar pills
so Pfizer yanks her
from the competition.
So would you recommend
that doctors continue
to prescribe Viagra
for women?
I still feel really strongly
that Viagra and drugs like it,
the vasodilators in general
which improve blood flow
to the genital area,
definitely have a role
as part of a comprehensive
treatment plan for women.
The initial...
Laura Berman is playing
a dangerous game here.
She's promoting the use
of Viagra even after Pfizer
has found it does not
work in women
and the health risks
are unknown.
Once a drug has been FDA approved
for a particular condition,
doctors can legally prescribe it
for any disease.
It's called off label use.
That said, it's illegal
for pharmaceutical companies
to promote off label use
of their drugs.
So would you recommend
that doctors continue
to prescribe Viagra
for women off label?
I do recommend
it for women
who have arousal problems,
loss of sensation...
Here is a senior figure, Dr. Berman,
suggesting that doctors
prescribe Viagra off label
and yet Pfizer has called off
the trials for Viagra
in women.
They can't show that Viagra has
a meaningful benefit over sugar pills.
It's a vey subtle way to get
around the approval process.
The Berman sisters are key
characters in the development
of female sexual
dysfunction.
The trouble is that
with such influential figures,
they are so close to
the pharmaceutical industy,
on occasions working directly
with drug companies,
paid by drug
companies.
And our topic
is Viagra.
It does a bing
for men.
It does sort of the same thing
for women.
Our patient takes Viagra.
Viagra.
Viagra.
Viagra.
And I have no vested
interested in, in Viagra.
Our goal is to, whatever drug,
whatever hormone,
is to help women, but...
Does Viagra work?
Viagra works.
Now you'll be going to
the Sensoy Testing Room
where the physician will monitor
blood flow to the genitals.
If you'd like to go ahead
and have a seat,
she'll be with
you shortly.
This piece of equipment is
going to test your nerve function
at your clitoris and right inside
the vaginal opening,
to warmth, coolness,
and vibration.
And how that's done is
I'm going to give you this button.
Here's the first probe
that we are going to use
and the metal tip on this is going
to be placed against your clitoris.
So would you hand that to me
or would you hold it?
No.
At $50,OOO I don't want
anyone to drop it.
It'd be an awfully
expensive visit.
Okay.
Um, then you're going to
depress your button
to indicate to me
that you have felt something.
Okay?
Are there articles that I could read
about the tests that you run
in terms of what
the norms are?
Medock, the name of the manufacturer
for this piece of equipment,
Medock has the information
that determines the normal ranges
that we look for
in these patients.
You'll wear these
You'll be watching
an erotic video
and the whole idea again,
is to get yourself excited.
Bring some blood flow
to your genital area.
Your total today
is $1,500.
We take cash,
check, or charge.
Television in the United States
wasn't always full of doctors
and ads pushing pharmaceuticals
and diseases.
If you just say
no to drugs,
you'll be saying yes
to a whole lot more.
While Nancy Reagan was telling us
to just "say no to drugs,"
her husband was signing
a bill that would make us
the pill-popping nation
that we are today.
President Ronald Reagan
opened the floodgates
for direct to consumer
advertising of pharmaceuticals.
In 1997, thanks to
further deregulation
the pharmaceutical industy started
advertising like crazy on N.
This is the age
of Fosamax.
Oh no!
I live deep under
your nails.
They aren't kidding.
And I've been
on it for years.
And ya gotta
love that!
Even our pop culture heroes are
dependent on prescription drugs.
Well son, your uncle Homer
is like 800/o of America,
whacked out on
prescription drugs.
But users are losers.
You're confusing drugs
with DRUUUGS.
For now, the United States
and New Zealand
are the only countries
in the world that allow
direct-to-consumer advertising
of pharmaceuticals.
But the drug industy
is putting pressure
on other nations
to change their laws.
What we do is
we prescribe.
That's what we do
as a profession.
We're not paid
for counseling.
We're paid for action,
writing prescriptions,
seeing a certain volume
of people per unit time.
I think doctors
want a pill too.
Doctors want to be able
to write a prescription
for something that is going
to help a woman
feel better about
her sex life.
It's the easiest part
of what we do
and is kind of what patients
have come to expect.
Deep into the race the key players
are quickening their stride.
But wait!
From out of nowhere,
over on the sidelines,
comes what could be
a real game changer.
Sex surgey.
Ow!
Some of the new inventions
to treat FSD
were starting to hit
the marketplace.
At a trade show
for doctors,
medical companies were
marketing new extreme treatments.
It's a bloodless surgey.
I'm here to speak to physicians
that are interested
in incorporating a new procedure
into their practice.
It's a procedure that
gives women additional choices
for regaining sexual gratification
that they maybe have lost
as they've aged
or had children.
You use the laser
to make an incision,
you're able to push
the bladder back up
to where normally
in a young person it would be
and then bring the muscles
back together making it tighter.
Do you think
there's a chance
that some of the nerves
of the clitoris could get cut?
Well with any surgey
there are going to be risks.
We also train them to do
something that's called
Designer Laser
Vaginoplasty.
A lot of women feel
like they're unhappy
that their labia
are abnormally long.
And it really is in
a sense plastic surgey.
What is an abnormally
long labia?
I think that's up to the women
to decide, and, so again,
this is all about giving
women choices.
You're feeling uncomfortable
about this?
I am, I'm hating
this part of it.
You are?
Yes.
Why?
Hmmm.
See now I might have to ask
for the tape back.
Yeah, you don't want
to talk about this?
No, just because this part of it,
I am ambivalent about.
The plastic surgey part?
Mhmm.
I think that our culture has
made women feel vey self conscious,
and uncomfortable
with who they really are
and so there's
always this attitude
of feeling like they
need to be perfect
and really I think people should
be happy with who they are.
These magazines
have published articles
promoting cosmetic
genital surgey.
One of the things that really
motivates gynecologists
to start offering
these procedures
is they went into gynecology
to deliver babies,
to help women,
all of those good things,
but after a while they find that
they're tired of being on call,
tired of running out and delivering babies
in the middle of the night.
And it just gives the surgeon
or gynecologist
a better quality of life
for himself or herself.
I asked Lisa to show me
before and after photos of women
who had undergone
the surgey.
I would be more comfortable
if you wouldn't film the pictures.
So this is actually the presentation
as part of the training course.
See you asked for it.
Oh.
Okay.
I think I'm going
to be faint.
They want to look
like little girls.
This is all making them
look just like little girls.
I hadn't thought of it in
those terms, but you're right.
That's really disturbing.
So, yes, at least give me
enough time
to find a new job
before you air this.
You're going to go
job hunting now?
I am.
I'm going to go home
and go job hunting
so I don't have to feel
conflicted any more.
I don't blame you.
Yeah.
The procedures that I had done
were a labial reduction and a...
...I don't know how
to phrase it,
I, I, guess it would be
a clitoral hood reduction as well.
I did think that this would help me
achieve orgasm with sex
and my gynecologist did have
hopes that it would help.
The surgey itself
went well.
When I got home I actually got
a mirror to look at the surgical site
and there was a huge gush
and a huge splurt of, of blood.
And then at that point I knew
a suture had popped.
By the time I got to
the emergency room
it was dripping down my leg
onto the emergency room floor.
They had to do
emergency surgey.
The tissue in the genital area
is vey vascular.
If it does bleed,
it's gonna bleed a lot and fast.
My doctor said that I lost
about a third of my blood volume.
And had I not sought
emergency treatment
as quickly as I did it could
have gotten a lot worse.
And, yes, there was
the possibility of me dying.
I was hoping that after this procedure
I would be able to achieve orgasm
with just intercourse
but that did not happen.
Due to intense marketing,
eight cosmetic genital surgey clinics
opened up in
New York City.
More research,
less marketing.
More research,
less marketing.
More research,
less marketing.
More research,
less marketing.
More research,
less marketing.
More research,
less marketing.
More research,
less marketing.
Say no to designer vaginas.
No two alike,
all are beautiful.
Teenagers are
having this done.
And there's the sense
that the labia minora
needs to be sort of
symmetric and tidy.
Labia minora are a vey important
part of erotic genital tissue.
Eveybody's different.
Some people have
vey small labia,
some people have
asymmetric labias,
some women have
vey long labia.
It's all normal.
Any kind of cosmetic surgey
to the external genitalia
is a form of
genital mutilation.
I can't think of any
rational reason for it.
One of the main
reasons not to do it
is that women can end up
with chronic pain syndromes.
And it, we shouldn't be allowing it
and we are in fact allowing it.
It's eight years into the race
and it shows.
Uh-oh.
Vivus can't get Alista work
any better than a placebo.
So that cream
is out of the race.
With Alista and Viagra
dropping out of the race,
it was becoming clear
that the drugs
that have been made
to give men erections,
were not working
On WOMen.
It seems that it takes more
than increased vaginal blood flow
to give women orgasms.
Hi, Craig.
This is Liz Canner calling.
I'm calling just to
check in with you
about the filming
that we discussed.
Still tying to reach you
because I wanted
to check in with you
about filming.
Still tying to reach you.
Perhaps because
they were failing,
Vivus did not want to be interviewed
anymore about Alista.
The creams, pills, and vaginal
surgeries, and the Orgasmatron
were not providing
the quick fix
that the industy
had been hoping for.
Maybe, this is because
most of women's sexual problems
are not purely
physiological.
I was working full time
and taking care of the kids
and taking care of the house,
taking care of eveything.
I was physically tired,
I was mentally tired,
and I was
emotionally tired.
The last thing that I wanted
at night or any time
was for someone
to touch me
in a sexual manner
because it was just,
I felt like all day long I had
been pulled at and touched
and I had little hands
On Me.
You know, taking care of kids all day
and then still tying to work.
Sex was just
not important.
I was abused sexually as a child
by a relative of mine.
I do realize that men
of my culture specifically,
that I have a much more fearful
reaction towards physically.
I've had experiences
where I've felt like um,
my whole body sort of closing off
to a certain type of person
and I'm sure that has
to do with the past.
My first few years of sexual experience
were not that enjoyable.
It was as though
I felt the urge to,
but I couldn't let go
into enjoying it.
I had an idea of what
sey was and I wasn't it.
Can't even really lose myself
in the moment 'cause I'd be like oh,
well, I have to, you know,
be, you know,
don't look at me from
that angle kind of thing.
Ya know, not in the middle of the day
when all the lights are on.
I'm, you know,
I'm not in that relationship.
I'm in another relationship
but I still have kids,
and I still work full time,
and I still have a life,
and it's still busy
and it's still crazy
and it's still hectic
but it's different.
And now the workload around
the house has been lessened
because there's
more equal sharing.
I'm not as exhausted
as I once was
so intimate and emotional
needs are being met
and so I do feel like a sexual being
and I do want sex.
I do desire it.
My partner right now who's like one
of the most caring, sensitive people
in the world, is of
the same culture as me.
And when we initially started
seeing each other,
I was vey, vey,
vey, vey afraid.
Memories don't
go anywhere.
They just physically
stay with you.
I see a therapist.
I think it's something that's
really, really important to realize
that most sexual health problems
are all, a lot related to things
that therapists or psychiatrists
needs to talk to you about.
So I definitely feel that
things have changed,
but I mean I'm
getting there.
I wouldn't say that I'm like,
I've reached full sexual liberation.
But I really learned
how to love myself
and give myself
what I needed
and to be able to make myself
feel beautiful and sey
or not even make myself
feel that way
but just allow myself
to feel that way.
Maybe I feel that
way naturally
if I'm not tying to
judge it or confine it.
Okay.
I'm gonna leave now.
Attractiveness, actually, is like
a feeling that comes from within,
not how good your thighs look
in fluorescent lighting.
Dude.
The whole thing with
taking drugs for this or for that,
my belief is living for
a drug free America.
I mean,
don't take drugs.
Sex expert Kim Airs invited me
to meet up with her
at a pharmaceutical sponsored
conference on FSD for doctors.
Kim was planning to train
doctors in her non-medical,
pleasure-based approach to helping
women with sexual problems.
But the organizers would
not allow Kim to speak.
So she crashed
the conference
and booked her own room
in the same hotel.
I'm completely thrilled
by the turnout
and I'm so honored
to be able to do this today.
I don't have
a clinical background.
I have a pretty active sex life
and always have.
And I combined two
of my favorite loves
with my career which
is sex and retail.
I tend to use things to teach women
about their own anatomy.
And fortunately, there are
some great tools out there.
This is one that you may
or may not have seen.
It's called the wondrous
vulva puppet.
Now, it's pretty accurate
as I like to point out,
except for the fact
that it's satin and velvet.
So something like this
is just really unobtrusive,
not scay and kind
of nice and comfy.
I've done a lot of workshops
that women have like held this
and have actually cried because
it's so intimate to them.
Now, getting into
the realm of sex toys.
There's quite
a few out there
but these pertaining more
to FSD symptoms.
This is the coolest
thing out there.
All right, pretty simple.
Now when you squeeze this,
you squeeze it with Kegels.
And it'll make the...
Ooh, I love that.
Isn't this something!
You get the white
lights going.
Bingo.
I tried this with a pal
and it was so much fun.
He's like, "Go on, go on,
get more lights, get more lights!"
I'm like hrrrrr,
you know?
Yeah.
I think this was
absolutely priceless.
It was wonderful, and,
especially when we
have been exposed to
so much scientific data.
This is the kind of meat
and potatoes stuff we need.
And uh, maybe I shouldn't have
said meat and potatoes.
I would hope that each year
she can continue to do it.
And I don't know, maybe we can
even begin to integrate it
into the program because this
is incredibly important stuff.
So I really want
to thank Kim.
Just when the world
of sexual medicine
seemed like it
was improving,
Procter & Gamble announced
that they had a drug that worked.
Intrinsa shoots
out in front.
She's picking up
the pace.
Wow.
Look at her go!
It looks like she will be the first
FSD drug to win FDA approval
and claim the billion
dollar prize.
A new female sex patch
called Intrinsa
is on the fast track
to FDA approval.
It is said to significantly boost
sexual desire in women.
There's an update in the news now
about the search for a treatment
for sexual dysfunction
in women.
Low doses of testosterone
delivered through a skin patch.
Let's just say the next thing
we're doing in this campaign
is that the FDA is going to
evaluate the testosterone patch.
Now, I don't know
if the FDA is expecting...
well, never mind
the FDA.
I don't know if P&G is expecting
a lot of opposition.
They are expecting me.
And I'll do
the best I can
but it would be nice to
have some other people.
And whatever happens,
sex is acquiring a different meaning.
We have to
be prepared.
Thank you.
Vivus was a pretty small company
but Procter and Gamble sure wasn't.
Leonore and the New View
Campaign were up against
one of the biggest
companies in the world.
Procter & Gamble
was so confident
that their drug was going
to be approved
that they began a $1 OO million
marketing campaign for Intrinsa,
months before
the FDA Hearing.
Women getting the hormone,
not a fake patch,
said they had four times more sex
than usual and were happier.
These are highly statistically
significant results.
Most women who
have low libido
or even other kinds of
sexual function complaints
may have low testosterone
and don't realize it.
Procter and Gamble and
a lot of these other companies
are banking on
a simplistic notion
that sexual desire
is just testosterone.
It's iust hormonal.
Most of the news stories
on the patch failed to mention
some of the likely causes
of a diminishing libido.
Why did P&G decide that they wanted
to start looking at testosterone?
P&G has been vey committed
to women's health.
And we have tried to take care
of the full woman.
When they first became interested
in the testosterone patch,
they felt that this would add
to the whole gamut
of taking care of
the whole woman.
So when you did
your clinical trials,
who did you test
the testosterone on?
The clinical trials were
in women who've had surgey
and had their
ovaries removed.
Were they also
taking estrogen?
Yes.
In fact all the trials we've done
so far, surgical and natural,
all the women have
been on estrogen.
So it's not gonna necessarily be
the miracle drug for eveybody?
Personally, I believe
it's going to help most
because it does
improve desire.
It does improve arousal.
It does improve orgasm.
Right now,
in clinical practice,
there really is no normal
for testosterone levels.
And when you actually
ask somebody, well,
"If the level's high
what will you do,
if the level's low
what will you do?"
And people, physicians
really can't say what is normal.
In order to learn more
about testosterone,
I met up with behavioral
neuroendocrinologist
Kim Wallen of
Emoy University.
From a vey early age,
I had this sense that sex
was something that was
extremely powerful
and I also had
this sense
that we didn't know
vey much about it.
So when I discovered in college
that you could actually study sex
that was really I think,
what I was most interested in
and most
committed to.
He has devoted his life
to studying the effects
of hormones
on sexuality.
It just turned out that I ended up
working with monkeys
and I think they're actually
an ideal system.
It's clear that hormones are probably
not even the biggest factor
that influences
sexual motivation.
Context is much
more important.
If I see a young couple on
their honeymoon in the Caribbean,
I actually don't need to know what
the woman's hormone level is,
or what the man's
hormone level is,
to know that they're
likely to engage in sex.
And it really has nothing to do
with hormones in that situation at all
because the social context
of their relationship,
and the context of where
they are in a relaxed atmosphere
may be actually much more important
in influencing sexual behavior.
So why is this testosterone patch
thought to work?
I think there are a couple
of reasons why testosterone
is being pursued so actively
by drug companies.
I think that there's this
vey strong notion that testosterone
is a hormone that
affects sex drive.
We certainly know that
that's the case in men.
I think it's easy
for people to sort of feel,
well, it must do
the same thing in women.
It must affect
sex drive also.
But we really still don't know
exactly how these hormones
interact with each other
to affect female sexual desire.
So what are they
doing there?
So she's saying, "These are
my genitals, don't they look good?"
She's going to actually start
tying to turn this guy on.
So what do you think
you've learned
over all these years
about sex?
To pay more attention
to females.
That was my first
great insight,
was that females were
actually telling males a lot
that males weren't
paying any attention to.
You know, we need to talk
a little bit about it
but I'm not sure what
we're going to do about it,
is this FDA Meeting
on December second.
You know, I've started collecting
the original research on these tests.
These women are not being tested
for a testosterone patch.
These women
are being tested
for estrogen plus
a testosterone patch
and nobody's
talking about that.
And it is my belief that
they tried without estrogen
and the patch
didn't work.
It's, of course the question is
what have they not included?
The success will not be measured
by stopping this drug
because there are...
Andrasorb and Alista,
and Estracin
and Estratest,
and Avista, and Femprox,
and Intrinsa,
and Liveal,
and NM1870,
and Steronorestocine,
and testosterone creams,
and Tostrel,
a gel and...
Do you think that there's a chance
you could have an effect?
Well I always think there's
a chance we can have an effect.
I'd like to first remind the audience
and committee members
to please put your cell phones
on silent or vibrate.
The FDA hearing was
set up like a debate.
Procter and Gamble
presented their data.
Then the FDA reanalyzed
that same data.
The public had a chance
to weigh in as well.
The judges were a panel
of expert doctors.
Finally, at the end
of a ten hour day,
the panel voted on whether to
recommend Intrinsa for approval.
This new drug will be
requested by many people
on whom it has
not been tested.
Believing that it's safe,
these women may well become
the guinea pigs
of the twenty-first centuy.
I would urge the committee
to not approve this
because I think it is a premature drug
that simply does not solve
what is a vey important
and critical problem,
but this is not
the answer.
The next presenter
is Leonore Tiefer.
My name is
Leonore Tiefer.
No money,
no way.
As a psychologist with over
awards and publications
in sexuality,
I see today as
a perilous moment
in the histoy of
women's sexuality.
Intrinsa is not a glass
of Chardonnay
and yet we have
already seen
that it may well be promoted
with a giggle and a wink
as the female Viagra.
Not so.
This is a steroid hormone
women must continuously take
for weeks before
getting an effect.
Patients treated with testosterone
also experienced
significant increases in numbers
of sexual episodes
and in numbers
of orgasms.
The key issue for us,
there was a strong placebo effect
that persisted throughout
the trials.
And the difference of placebo
compared to testosterone treatment
is not clear to
the division.
It looks to me like about 360/o
of the placebo patients
would really like
to continue the therapy
and about 500/o
of the treated patients
would really like
to continue the therapy
and I want the sponsor to consider
marketing the placebo.
The testosterone transdermal patch
is both safe and efficacious.
There do not
appear to be
any major hormone safety
issues with Intrinsa.
Testosterone was vey strongly
actually related to breast cancer risk,
of developing breast cancer.
This was highly significant.
In addition to being concerned about
the side effects of testosterone,
the FDA was also alarmed
by the health risks associated
with the long-term use of estrogen
as found in the WHI study.
In reality there was
a 240/o increase
in the risk of coronay
heart disease.
There was a 31 O/o
increase risk in stroke.
Venous Thromboembolism
was doubled.
There was an increase
in breast cancer.
There was a doubling
in the rate of dementia
if one was assigned
to active hormones.
Just because the WHI studies
were disappointing,
we're not debating
the safety of estrogen here.
It's only the patch.
I'm not so sure if
we are or are not.
I don't understand this.
I mean you know, if they're
mandating these patients
have to go on long term estrogen
and then use the patch,
then basically aren't you
back to where you are
with the discussion
of the safety of estrogen?
You're putting a product on top
of a base that already has warnings.
The risk that was seen
with Vio was vey modest
but when you translated that
to 105 million prescriptions
and 20 million Americans,
it represented an enormous burden.
The potential for this agent
to increase the risk
of cardio vascular morbidity
and mortality is substantial.
I also don't want to expose several
million American women
to the risk of heart
attack and stroke
with their devastating
consequences
in order to have one more sexual
experience per month increase.
So we now reach our fourth
and final question
and that is are the efficacy
and safety data adequate
to support approval
of TTS?
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
I want to thank the committee
for their hard work
and also our participants
in the open public forum.
This now concludes our
Advisoy Committee Meeting.
Thank you.
Don't you think there's a need
for a product like this
even though this one
didn't measure up?
No.
I don't feel that
there's a disease.
That is a point that I'm
not sure is widely shared.
If one episode a month
makes people happy,
then I can help people get
one episode a month.
I mean, it's a homework assignment
when you come to see me.
Here we go.
It's up next.
...A testosterone patch
designed to help women.
Its maker:
Procter and Gamble.
It could be a huge
money-maker for them
but an FDA Advisoy Panel today
had some other ideas.
This is not a drug like Viagra
where you take the pill
and 24 hours later
it's out of your system.
Sex is a vey important part
of our lives and to do without it
is something that we
think we can resolve
through pharmaceutical
agents today.
Amazing.
What a come back.
After failing to receive FDA approval
in the United States,
Intrinsa wins authorization
in the European Union
for use in women who have
had radical hysterectomies
and are taking
replacement estrogen.
Sex sells and so that's
where you follow the money.
Follow the money.
Yeah.
Down there.
This drug will probably fail
because it's not effective enough
and not safe enough
to be unleashed on the world.
I'm normal,
I'm normal.
That word.
Yeah.
I'm not diseased.
I'm iust normal, honey.