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00:00:19Okay.

00:00:43I took on the government for women's sexual pleasure and I won.

00:00:48Let me tell you why I did it.

00:00:52The single biggest crisis in women's health is that you are not taken seriously.

00:00:59Why, at your age, should you still be concerned about sex?

00:01:05Ladies and gentlemen, stand up on your feet and give a wild 10X welcome to Cindy Eckert.

00:01:12How many of you before this very moment knew there was a little pink pill for women?

00:01:17Not so many of you, so I have to ask the obvious question.

00:01:21How many of you knew there was a little blue pill for men?

00:01:25Oh, all of you know that. Okay.

00:01:27It's known as Viagra for women, a tiny tablet that could have a huge impact in the bedroom.

00:01:34This quest to get a female sex pill has been going on for years and years and years.

00:01:40The drug comes with side effects. The FDA has rejected it twice.

00:01:44This whole fight has been about getting women what we deserve.

00:01:48Addressing low desire and sexual health in women is very similar to the fight that's happening in reproductive health.

00:01:56It's all the same message. We don't deserve to control our own bodies.

00:02:00A new study released today raises big questions about whether or not it should have been approved for women to

00:02:06use at all.

00:02:16I've heard every single thing. I've been told not to wear pink.

00:02:21Pull your hair back. Take the makeup off. No one will take you seriously.

00:02:24Will the FDA approve the so-called female Viagra, a drug for women with unhappy sex lives?

00:02:31Our very first meeting with the FDA, a gentleman in the room said,

00:02:36what do we need a bunch of horny women running around for? What?

00:02:40If there were clear evidence of a clinically meaningful benefit, which I don't believe there is, approval might be appropriate.

00:02:47All of that fed the frenzy, but at the heart of that is really our bias.

00:02:54In every scenario we're going to talk about here today, you can just think to yourself, but what if the

00:03:00pill had been blue?

00:03:03Clamor for Viagra worldwide.

00:03:07For men suffering from impotence, Viagra has been hailed as a miracle drug.

00:03:15It's the first pill ever developed to treat impotence.

00:03:18Pfizer estimates there are 140 million men worldwide who have trouble achieving erection.

00:03:23Understand that we're really dealing with a worldwide medical problem.

00:03:28This has been of interest to men, you know, from time immemorial.

00:03:37As fast as pharmacists count them, men are buying them.

00:03:42After two weeks on pharmacy shelves, this little blue diamond is the fastest selling prescription pill ever.

00:03:48A U.S. internet provider can hardly keep up.

00:03:51In Saudi Arabia, men pay as much as $100 for a single pill.

00:03:56But in Japan, where it's not approved yet, a travel agency offers four-day tours to Hawaii to get it.

00:04:01Airfare, hotel, and prescription all included.

00:04:04We're discussing the treatment of impotence and the use of Viagra.

00:04:07In Washington, we have former presidential nominee Bob Dole.

00:04:10I did not have sexual relations with that woman.

00:04:14I mean, President Clinton's cock, Bob Dole's cock, you know, you don't want to hear about Bob Dole's cock, you

00:04:20know.

00:04:33Joe, go ahead.

00:04:37Viagra may wind up creating a sexual revolution for men, but what about women?

00:04:47Cameras rolling.

00:04:48Mark it.

00:04:48Alison Brown, Common Market.

00:04:53okay so first question can you tell me what you learned in medical school about women's sexual

00:05:02health so when i was a medical student we had pretty robust sexual health lectures but mainly

00:05:11centered around male sexual health and i realized very quickly the gaps that existed including

00:05:19simple as learning how to examine a clitoris so you learn absolutely nothing in medical school

00:05:24about sexual medicine at all for anybody in fact in the ob-gyn residency the word clitoris doesn't

00:05:31appear anywhere in what they have to learn in fact they tell you don't touch the clitoris

00:05:35as to not make the patient uncomfortable can you imagine me as a urologist if i was taught

00:05:42don't touch the penis because you would make the man uncomfortable in my experience unfortunately

00:05:48female sexual health was all about delivering babies doing women's well visits a little bit

00:05:54on gynecological cancers but that's really it and i went to columbia i mean that's one of the best

00:05:59medical schools in the country what i didn't learn about sexual medicine is pretty much everything

00:06:03the only memory i have of sexual medicine coming up in medical school was this like weird film they

00:06:11showed of like hippies having sex it was really cringy and a lot of people just like kind of walked

00:06:18out

00:06:18we often will define sex really in terms of how the male engages in sex

00:06:29men get an erection ejaculate feel pleasure

00:06:35but unfortunately a much larger number of women don't experience that that's the orgasm gap the

00:06:41orgasm gap is it's maddening because in order to have an orgasm there are a number of different parts

00:06:49of the vulva that need to be stimulated the brain needs to be stimulated there's a lot of pieces that

00:06:54go into it and people then suddenly say it's complex and that it's unattainable but when it comes to a

00:07:00penis it's just assume that if that penis can't have an orgasm there's a serious problem with that

00:07:05individual the gap starts when we realize that society doesn't really care whether or not someone

00:07:12with a clitoris has an orgasm and once you realize that you recognize where all these balls get dropped

00:07:19no one is talking about pleasure and orgasms no one is talking about libido at all it really doesn't

00:07:27matter to our society whether people like sex or don't like sex as long as they have sex to make

00:07:31babies and we procreate as a society and so we've ignored it completely

00:07:43when viagra was approved in 1998 it was deemed to meet such an important unmet medical need

00:07:49it was literally fast-tracked for approval it received the kind of rare status we reserve for

00:07:55life-saving cancer drugs or rare diseases so literally a national emergency if men can't get

00:08:00it up this is a subject you will not see discussed much on television were you embarrassed yeah i still

00:08:06am i mean it's something you don't run around you know sit around talking about in a coffee shop or

00:08:10ticket in a public television program i just really have to comment on to doctor to senator dole

00:08:16what he just did was just truly amazing to discuss in in public in a public forum what it's like

00:08:22to have

00:08:22this problem the the humiliation the embarrassment the frustration my name is erwin goldstein and

00:08:29uh i love sexual medicine there are so many sufferers with this condition they stay in closets

00:08:35they do not talk about this and it's just wonderful okay let me answer your question impotence

00:08:41means you're not a man being a male you're supposed to have an erection uh on demand so in the

00:08:48days prior

00:08:49to the oral pill it was considered i don't want to talk about it divorce happened commonly uh depression

00:08:56happened erwin goldstein is the godfather of sexual medicine i mean he was the key investigator on the

00:09:07trial that got viagra approved erwin really did something spectacular um with viagra and i think once

00:09:14he solved that problem for men he said women may 14 1998 a day i will never forget the new

00:09:23england

00:09:23journal of medicine published finally all the data on viagra i was the first author and all the phone

00:09:30calls from people who had any concerns came to our office and guess what the gender was

00:09:37hi dr goldstein happily married lady here for over 10 years my husband's not the issue and we used to

00:09:44have a great love life but i just don't find myself wanting to have sex dr goldstein calling about this

00:09:49viagra pill not for my boyfriend he's got no problem congratulations on getting my husband a boner

00:09:56who do you have for me we're half the planet i don't know where they think these men on viagra

00:10:01are

00:10:01going to stick all those erections i said hey we're very busy i'm a urologist i do the men's sexual

00:10:09problems they're gynecologists they deal with women and i said if you have any any issues come back to

00:10:15me and let me tell you what's going you know tell me what's going on and to a tee everyone

00:10:19called back

00:10:20gynecologists aren't doing this the gynecologist said go see dr goldstein so i was like okay i

00:10:27finally learned that we need to take care of women with sexual health problems i first learned about

00:10:34sexual medicine as a career when i was in medical school and realized that there was this whole world

00:10:40of information that i did not know even existed about sexual health about pain about orgasm arousal

00:10:48and realized i wanted it to be a part of my practice women's sexual health and vulvas in

00:10:53general have never been a priority of our society we can see that as deep as the terminology used for

00:11:00the innervation of the vulva the pudendal nerve is the nerve that provides most of the sensation

00:11:06particularly in regards to sexual function to the vulva the clitoris the labia the vestibule and

00:11:12pudendal literally means shame often patients don't feel like they deserve sex they don't

00:11:19deserve intimacy they don't deserve pleasure connection and when that is lost i think that

00:11:25a piece of them is really broken more often than not women will just say oh yeah i you know

00:11:32i haven't

00:11:32orgasmed in years but it's fine whatever i mean i just gave up not that it's someone who's like okay

00:11:37with not having sexual pleasure it's just that they didn't think that they deserved it and a lot

00:11:43of my job is actually normalizing that it's okay to want more for yourself when it comes to sexual

00:11:49pleasure and desire which is very different than society's approach to men where it is a right

00:11:56your genitalia affects how you're treated in the healthcare system you know i trained as a urologist

00:12:01and i was very used to objective data and objective evidence and really listening to our patients and

00:12:09i didn't realize that was something very unique to the fact that i was working with predominantly men

00:12:16because when i started working in the women's health space i was oftentimes listening to my patients

00:12:22telling me the consistent medical gaslighting that they were experiencing when it came to their vulva

00:12:28vaginal health care a lot of times when people come in with problems and are previously told it's

00:12:34all in your head aka basically getting medically gaslit the default sometimes is to blame the patient

00:12:39when you as the provider don't know how to help them uh your name is uh mrs martin is that

00:12:44right

00:12:45that's correct well try and tell me for starters if you can what is the current uh dilemma what's

00:12:50going on the troubles the idea of it's all in your head is a tale as old as time have

00:12:55a date night

00:12:56drink a glass of wine read 50 shades of gray here's a good therapist go to this therapist it's all

00:13:02trauma well i don't have climaxes anymore at all and i feel like i'm just submitting now that i'm not

00:13:10i'm not giving anything or getting anything in general people don't like talking about sexual problems

00:13:18most providers don't do sexual medicine have you ever been to a doctor who does sexual medicine there's

00:13:24so few of them your sexual experiences which are very important to you you're not willing to share

00:13:30and they're not willing to hear but they should be they should be as uh if they're bothering you and

00:13:37it's affecting your your yourself your your your relationship with someone else your ability to be

00:13:44a parent your ability to be a good worker at work uh you should have the opportunity to discuss this

00:13:49irwin goldstein is a mad scientist who loves discovery and does it for the care of his patients

00:14:00through and through

00:14:04i'll take you back to 2010 i'm in miami at the sexual medicine society conference and it's the best

00:14:11researchers in the world on sex so here's irwin chasing me around with his macbook and he said you

00:14:18have to watch these you have to watch these you have to watch these so today is 10 21 10

00:14:25it's uh

00:14:27thursday there was a drug company in germany that was studying an alternative drug for depression

00:14:35and of course just like viagra it was found to be amazingly successful in helping women who had low

00:14:42libido or low desire we have patient two four one six three of the flibantrin open label trial i had

00:14:50patients on this i filmed them saying oh my god after taking flibantrin i'm smiling and i'm happy

00:14:57and i stare at my partner and i just want to be with him and why we're filming this is

00:15:01this really cool

00:15:02her results so i'm going to turn this around and patient two four one six three how are you so

00:15:09this

00:15:09a little weird but you know i you know this is your really last chance to to document this to

00:15:14humanity

00:15:15so uh you're on tell us uh side effects benefits how did you do with this drug i did phenomenal

00:15:22on

00:15:22this drug i feel like a new woman on this drug at that conference this company presented this brain scan

00:15:30imaging is of women struggling with their libido and it was like lightning struck holy it's biology

00:15:44hstd or hypoactive sexual desire disorder is the name it was first characterized in the literature in 1977

00:15:53and it basically is this like absence of spontaneous thoughts or interest

00:15:58and we realized it's in the sex center of the brain you know we're hardwired to procreate and for

00:16:07you know millions of people something goes off kilter in that wiring i had no sexual desire libido

00:16:14was almost zero it was such a common thread and you know what happened is i saw those videos

00:16:22i completely saw myself in those videos i was in a place in a relationship where i was deeply disconnected

00:16:30i was in the exact same place really struggling with this issue

00:16:36i just never think about it like it's gone it used to be there but it's gone

00:16:42go talk to hundreds of women who have nothing in common other than this one issue and listen to

00:16:49them all give you the exact same words it's gone and they had been conditioned to not even sort of

00:16:57fight for it because well your pleasure doesn't matter just go along this is what it is relax honey

00:17:04have a bath schedule date night bisect your lingerie do better you do better fuck you

00:17:15i had never talked about libido i think that's another thing where i thought

00:17:20after you have a kid that goes away you know that was kind of the narrative from

00:17:26my elders right and the women around me that you're a mother now and you focus on these things and

00:17:32that's behind you so no discussion about it

00:17:38i went from a scale of one to ten on the libido i was at 11. uh and then when

00:17:47menopause hit i came became

00:17:49a negative three um it was devastating as a woman we we love to feel desirable and happy with their

00:18:00relationships and things like that and for me i felt like someone had just slayed me that i tell people

00:18:08i i lost touch with my inner goddess

00:18:13my husband likes to practice what he preaches and one day he came home from work and he said

00:18:19we've just developed a new questionnaire it was basically the beginning of testing for abby

00:18:26and he says just take the test for fun and i took it he goes holy you've got hst when

00:18:32you have

00:18:32hypoactive sexual desire disorder which is what i had you're not aware that it's in your cognition

00:18:37well everybody has it differently it may mean that you know when your partner walks through the door

00:18:42you used to want to jump his bones or her bones and that's not of interest anymore it may be

00:18:46that while

00:18:47you're in bed having sex you're thinking about i have to put the wash in the dryer i forgot to

00:18:51buy milk

00:18:52for the kids before school tomorrow or it may be that you don't want your partner to touch you

00:18:55because you have you've developed you know aversion it can mean a lot of things but for me i was

00:19:00having

00:19:01essentially duty sex when i had sex it was good but i had no reason to want to have sex

00:19:07again

00:19:11i met my husband at a party at his uncle's house

00:19:16and in our early relationship there was no problem with desire with sex one time there was a

00:19:26construction site and we decided that this would be a great opportunity i mean it was just spur of the

00:19:33moment all the time spur of the moment just boom we're ready to go um and then we had children

00:19:41and

00:19:41there was absolutely no problem whatsoever and then all of a sudden it was like somebody pulled the plug

00:19:48i had zero desire when i first met her i i thought she was a real hottie

00:19:55you know we were a young healthy sexually active

00:20:02yeah and uh yeah and it was it was good for a long time when it became evident that she

00:20:09wasn't

00:20:09responding i almost got angry right did she mad at me about something did i do something does she

00:20:16think i'm cheating i never did never have never will um so yeah it was tough so that's why i

00:20:27decided

00:20:27that when i heard of this clinical trial i would definitely give that a try and oh my gosh it

00:20:34was just

00:20:35amazing your whole relationship with your at least mine with my husband was stressed or strained and

00:20:43on the medication the medication i chase him awesome it is it is unbelievable i love my husband tremendously

00:20:54but with this drug i love him even more and our our sexual experiences were were incredible it was it

00:21:05was

00:21:05like i was a new woman will the fda approve the so-called female viagra drug for women with unhappy

00:21:15sex lives i'm at the fda meeting right now i'll have more in this episode berger ingelheim applied for

00:21:22approval by the fda today's agenda involves discussion related to new drug application nda

00:21:2722526 flabanstrin 100 milligrams tablets because i was doing a lot of work with antidepressant

00:21:34associated sexual dysfunction i was an advisor i appreciate the opportunity to be able to speak with you

00:21:42today for male erectile dysfunction and like they had used a measure was this sexual event successful

00:21:50for you meaning the penis was rigid enough to penetrate a vagina they decided to try to apply

00:21:57that to women and we said what is a successful sexual event in women do you think that it might

00:22:03be

00:22:03having an orgasm because that's really not related to desire and that was the sort of first real foray

00:22:10into them not really understanding women's sexuality these are the numbers that you see so these are women

00:22:18women who have hsdd they do not have depression you can see that hsdd is the most common sexual

00:22:28dysfunction as compared to effects on arousal or orgasm the studies were positive and that showed

00:22:36that people's sexual functioning improved over time when they were on this drug but ultimately

00:22:43beringer ingelheim had it turned down for approval by the fda at that meeting in miami the german company

00:22:55went to all the researchers in the world and said we're not going to develop it and you could feel

00:23:02the

00:23:03air leave the room i am so so upset that this is terminating because this flabanstrin can change

00:23:13people's lives they can change relationships they can make a person whole again and she is patient

00:23:22two four one seven four and she uh because lancering closed out she had to close out the trial what

00:23:29was

00:23:29surprising is that a company that had found this kind of spectacular discovery was not going to pursue

00:23:35it because they didn't want to take on women and sex right no thank you we're not getting into this

00:23:41debate

00:23:41and i think erwin knew that too which is why he said you need to do something about this the

00:23:46science was

00:23:47there it required a champion i said please just get on an airplane fly to this place for one dollar

00:23:55they'll probably give you the medicine i sort of almost beg i mean you have to develop it erwin chose

00:24:00me

00:24:01it spoke to me this is what i was struggling with and i was going to fight for what i

00:24:05deserved

00:24:06and i was determined and so i bought the drug

00:24:15and so what do you do when you get a drug through the fda you sit down with the fda

00:24:19and you say okay here's this product what is the roadmap

00:24:26they tell you what endpoints you have to meet in clinical trials they define success for you

00:24:31and you have to prove it with statistical significance so that's what we really spent

00:24:36our first year doing is all the things that the fda had asked of us good stewards of science we

00:24:42went

00:24:42out we did all that work and i remember being just so excited like we've done it we did it

00:24:48it works

00:24:49this drug was about women living life on their own terms so i wanted a woman's name a character that

00:24:58i

00:24:58loved was actually addison on gray's anatomy i liked that she lived life on her own terms so we called

00:25:05it addie

00:25:13our very first meeting with the fda there was a tension in that room you can imagine you walk in

00:25:20like company sits on one side fda sits on the other side it's like a face-off and there was

00:25:27just this

00:25:29sense that this was not going to be a straightforward conversation here i am running a company totally a

00:25:38woman in a man's world when i left college i worked for fortune's most admired company but i left big

00:25:47pharma

00:25:47because it wasn't the fit for me and i found this incredible testosterone product for men

00:25:53and built my first business out of that called slate and so i had brought a product to market for

00:26:00men

00:26:00that was fda approved so when all the questions were different on a product for women i knew something

00:26:06was up and i asked this question why are we being reviewed by the urology division of the fda when

00:26:15this

00:26:15is a drug that works on neurotransmitters and the answer was we review all the sex drugs i said yeah

00:26:22because they've all been for men and that was it like i stepped in it i knew it as soon

00:26:29as i said it i

00:26:29could feel that tension in the room like how dare you we are the experts on sex and yet they

00:26:36weren't

00:26:37i walked out of that meeting and i thought science cures bias right science always knows the answer

00:26:45i knew we'd actually achieved all the results that they'd asked us to achieve and so i would get

00:26:51ready to launch and i had been in new york and i flew back to raleigh where i'm based the

00:26:58whole company

00:26:59is like waiting with the champagne chilling the minute the plane landed my phone's blowing up

00:27:06i got a call from my assistant she's like hey we heard from the fda they came back and said

00:27:12no

00:27:13and it was just like

00:27:17i thought oh my god i didn't know what i was gonna say

00:27:21my board knew this was the day my shareholders knew this was the day the patients knew this was the

00:27:27day

00:27:27erwin knew this was the day i'm like gotta go in gotta face the music

00:27:35i got everybody around the table and i said we just heard from the fda and we were turned down

00:27:42and it was silence

00:27:47i remember sitting in the office until the last person left i was looking out the window until i

00:27:53started to cry and i'm like what the hell are you doing like pick yourself back up we're going back

00:27:59into battle and i thought not on my watch no way it was time to take them on viagra for

00:28:10women it's a

00:28:11little pink pill that's supposed to increase a woman's desire the fda has already said no to the drug

00:28:17but the company is appealing that decision i had never heard of hsdd i had never heard of flavancerin

00:28:26there was a meeting on my calendar to meet with a company called sprout who was coming to us for

00:28:31help and so i went to the meeting and i met cindy who was very very different from most of

00:28:36my clients

00:28:43i remember that first meeting you know this spectacular woman came into the room i was

00:28:49watching her body language and i thought i think this is my soul mate theodore i can't believe you're

00:28:55not even paying attention buddy the plan is to make a plan so how do you take on the government

00:29:02for

00:29:03women's sexual pleasure i was working primarily in oncology so trying to get cancer drugs through the

00:29:09fda and i hadn't done much in the reproductive health space and cindy walked in with so much energy

00:29:15and started telling me about hsdd and flavancerin and the challenges that fda had given them my first

00:29:22reaction honestly in that moment was oh these seem like great people and an energized team but i don't

00:29:28think i'm going to be able to help them i didn't understand the condition you know i thought of

00:29:37it's it's a sex drug that sounds like something that's not necessary oncology drugs are saving

00:29:43people's lives and i didn't think it was as important the reason i decided to take the case

00:29:50was cindy showed me some real documented evidence of things fda was saying and asking for

00:29:57that pointed out to me that fda had a real bias rooted in maybe hang-ups about women and sex

00:30:06and

00:30:06and that fda wasn't thinking about this um in a truly scientific way and i decided to take it because

00:30:12as a lawyer it sort of rubbed my fairness button the wrong way when the drug first went up for

00:30:19fda review

00:30:20in 2010 the fda did not feel that there is enough data to support its effectiveness the fda advisory

00:30:29panel voted 10 to 1 that flavancerin was not significantly better than a placebo and unanimously

00:30:35that the benefits did not outweigh side effects like dizziness nausea and fatigue when the german company

00:30:43took it forward they got a list of issues that said go do one more study where you showed desire

00:30:47and then also go do a number of studies and healthy volunteers looking at interactions with other

00:30:54drugs and that's when sprout took it and did all that work then they brought that back to fda and

00:30:59now

00:31:00they get rejected again having done everything fda asked for the fda gave a red light to a drug meant

00:31:06to rev up a woman's sex drive the agency rejected a little pink pill called flabanserin saying it had

00:31:12modest effectiveness we've had biological solutions and treatments for men i think it's time for women

00:31:19erectile dysfunction was seen as an unmet physical ailment addi was evaluated as an unmet psychological

00:31:29ailment which immediately triggers a higher standard of review and additional safety measures they said

00:31:38it had to be ultra safe because women were taking it every day and so they generated a lot of

00:31:46concerns

00:31:46about things like use with alcohol addi is alleged to have this shocking alcohol interaction that we can't

00:31:55accept when the data are almost exactly the data of cialis and when you look at cialis it essentially

00:32:02says men should not binge drink you shouldn't consume if you've had more than five alcoholic beverages

00:32:10so women can't have any and men can have five and still take it well it's probably not going to

00:32:16work

00:32:16very well in that circumstance for an erection but okay another example is that flabanserin makes you sleepy

00:32:23that is a labeled side effect we know that that's why you take it right before bed and we had

00:32:30shown

00:32:30that there were more sex satisfying sexual events when you were on filbanserin than when you weren't

00:32:34and one of the fda reviewers said well couldn't that be because the women are just too sleepy to fight

00:32:40off

00:32:40their husbands first of all i don't believe we have husband rapists at large in this country but but

00:32:45beyond that you know i just thought if everybody could just think about their personal situation for a

00:32:50moment the wife is sleepy are we having more sex or less sex the notion that the wife is sleepy

00:32:56so we

00:32:57must be having more sex like you're refusing to accept that this is real data like so when you see

00:33:04data that answers the question yes they're having more sex you immediately are looking for a way to

00:33:09discount it their concern with sedation was and they literally said this that a woman might take

00:33:17flabanserin the night before and get up in the morning and fall asleep driving her kids to school

00:33:24it was very much like well we need to sort of protect women because they might not remember

00:33:30they might not make good choices about taking this and it's so dangerous so we did a striving study and

00:33:37lo and behold women drove better taking addy than placebo and that's not surprising because if you have a

00:33:45better deeper night sleep your reaction time in the morning is improved you know the driving study

00:33:52was over a million dollars which we have so many drugs all the antidepressants cause sedation

00:33:59and no one said go make sure you know you're not going to be impaired the next morning the reason

00:34:05here was well these are women who could be driving their kids to school and it's that paternalistic lens

00:34:11over women's health right that it's it's not about the woman it's about the people she touches in her

00:34:16life and also protecting them and that's inappropriate right a drug is is approved as safe and effective

00:34:22for the people who will take it it's the little pink pill and this one is for the ladies it

00:34:29works

00:34:29on key chemicals in the brain to increase desire they they had a desire before and they've lost that

00:34:36and it's really causing pretty profound distress either for them personally or in their relationship

00:34:42dynamic enter the pink pill known as flibanserin cindy whitehead brought the rights to it and has

00:34:48been working for three years to get fda approval the last trial of a thousand women showed promising results

00:34:55fda insisted that we measure satisfying sexual events we had to show an improvement in how many

00:35:01satisfying sexual events we were having and we showed it right that was i think it was one more

00:35:06per month and fda's like oh one more per month and in essence the fda had said to us well

00:35:11we feel the

00:35:12effect is only modest and therefore no risk would be worth it so we said to the fda hold on

00:35:19what do you

00:35:19mean that the effect is modest it is true that addy doesn't take you from being having no sex to

00:35:26being

00:35:26an infomaniac actually that would be bad we have to measure for that in clinical trials

00:35:30right it takes you from a place in which you're not thinking about sex to where you are thinking

00:35:35about sex society thinks of sex as a performative act there's a destination and really what this was

00:35:42addressing was the brain being in the right place to have spontaneous interest to respond to a partner's

00:35:50advance to want to initiate something so like everything being so performance driven was really

00:35:57a male metric the studies show that there's an increase in on average one sexually satisfying

00:36:03encounter a month and a lot of folks will hear that and say one encounter a month that's very little

00:36:08what how is that even worth it and my response to that typically is when we're treating somebody who

00:36:14has hsdd they'll be lucky if they have sex once or twice a year typically once a month is a

00:36:20monstrous

00:36:21change for some of these uh these couples we've always prioritized our sex life and it's something

00:36:29we don't want to lose we met in college yeah um grad school grad school yeah both um studying the

00:36:37same

00:36:38subject and um we didn't hit it off right away but um once we um got together we've been inseparable

00:36:47and um well our relationship was fine um but our sex life had had dwindled um and it was frustrating

00:36:59of course but then um you know i was going through a change too and so every month i was

00:37:05going and

00:37:05getting um tested um for testosterone levels i think we were both experiencing our own versions of menopause

00:37:12um and our libidos seemed to be out of sync um david got involved in some treatment that increased his

00:37:22and mine was still laxing there behind and um i had one um gynecologist um but she didn't try to

00:37:34educate me beyond um i think she said something to the effect of um you're at approaching a period of

00:37:42time where hormones probably wouldn't make more sense for you so clearly you can see despite the

00:37:48wonderful job with my makeup that i'm a menopausal woman and for those who think that after your

00:37:53hot flashes are gone menopause is over no you're in menopause for the rest of your life until you die

00:37:59but just because you're menopausal doesn't mean you don't have a right to great sex

00:38:03my whole life and my whole training menopause was treated as a footnote

00:38:07in my field it was like use lube as though that would solve all the solutions to do with your

00:38:13shoulder to do with your brain fog to do with the way alcohol affects you the fact that you can't

00:38:17sleep at night and now we're in this moment where we're talking about perimenopause and menopause and

00:38:23it's pissing some people off they're wondering why are you being so loud about it well the real

00:38:28question is why were we forced to be so quiet about it for so long postmenopausal patients are

00:38:34considered irrelevant when it comes to sexual health in our society um it is not only by our

00:38:41society but patients within themselves don't feel like they deserve sex they don't deserve intimacy

00:38:46they don't deserve pleasure connection i had a patient come in just the other day who said i

00:38:52shouldn't even be having sex anymore right and i mean my my mouth is open for them because i'm just

00:38:59like i don't understand how this can be so ingrained in everything that we do that even patients feel

00:39:05that they don't deserve it and i think that's what's so heartbreaking um is to see that people

00:39:11don't even value themselves because our society has so clearly told them that they are no longer a

00:39:19valued part of the society when you look at women premenopausal postmenopausal transgender individuals

00:39:29the conversation of what is available for you is not dictated by you if you're a cisgendered white male

00:39:39the health care in the united states is pretty darn good and your health care experience can be

00:39:45a uniquely personal one 26 to zero that represents how many drugs are available to treat male sexual

00:39:53dysfunction compared to those that treat women's when i started there were 25 fta approved drugs for men

00:40:00when we were going through this and in our appeal the 26th drug for men came to market and it's

00:40:07for

00:40:07curvature of the penis that interferes with your enjoyment of sex okay so that typically had to

00:40:14be corrected surgically and now there was a different and simpler option great so the studies were on

00:40:19around a thousand or so men and it had a pretty important but rare side effect and that was penile

00:40:28rupture

00:40:29so let me get this straight we can give men a product and their dick can explode but women can't

00:40:34have the seven dwarfs of side effects like sleepy dizzy nausea 26 times we had done that for men

00:40:42so guys it's just you and your honey setting is perfect but then erectile dysfunction happens again

00:40:52viagra at that point had done so many commercials and you know we laughed about the viagra ads at the

00:40:58time that were basically conditioning women to let men know all their choices um while not asking the

00:41:04question where's mine you know what plenty of guys have this issue not just getting an erection but keeping

00:41:10it well viagra helps guys with ed get and keep an erection i'm a beautiful woman laying in a bed

00:41:20talking about your erection erection

00:41:29now that they're distracted let's do something to change this women deserve better let's even the score

00:41:37stop sprout initiated something called even the score this was a advocacy campaign to try to get

00:41:45people to understand that this is a critical issue for 10 percent or more of women are we really so

00:41:53far behind that we don't think women have the right to sexual desire yet again we come second

00:42:01men who take erectile dysfunction medication may find it entirely useless if their partner does not

00:42:06have any sexual desire options for women have been through rigorous trials and show less serious side

00:42:11effects safe and effective sexual health medication could help thousands of women and their partners

00:42:16enjoy a healthy sex life men have a little blue pill so why not a little pink pill for the

00:42:23ladies

00:42:24sprout really helped in bringing the conversation into the media and into the living rooms and awareness

00:42:33of people lebanserin lebanserin now it is expected to be marketed under the name addy one it became a

00:42:41very public conversation here's this little private company in raleigh north carolina and all of a sudden

00:42:47nightline shows up at my door they're like who are you and what's happening here it's known as viagra for

00:42:54women a tiny tablet that could have a huge impact in the bedroom i think this is absolutely an evolution

00:43:00in

00:43:01the female sexual revolution but you won't be able to get the pink pill just yet because the drug is

00:43:07locked in a heated battle for fda approval once that happened you know the public was all weighing in

00:43:13there's a pill that's in development not fda approved for women like liagra there you go

00:43:19people are like oh the little pink pill so it's the little pink pill that little pink pill it's a

00:43:24little pink pill oh the little pink pill it's the sing song in their voice and the pat on the

00:43:30shoulders

00:43:30it assumed weakness it assumed that it was trivial is there something to fix no not at all and it

00:43:37was

00:43:38so dismissive some doctors say flibanserin was rejected for a very simple reason it's an

00:43:44ineffective drug for a non-existent problem it's a classic marketing technique to first create a

00:43:50problem and then sell the solution and that's what's going on here what is this advocacy group

00:43:56is it a sprout pr campaign it looks like a viagra ad but this parody is mocking all those male

00:44:02pills

00:44:02and their big budget commercials even the score made the video a group backed by non-profits and

00:44:08pharmaceutical companies including the one that makes flibanserin the so-called little pink pill

00:44:20you can make two choices in that moment right you either let it set you back and you lean back

00:44:26from

00:44:26it or you lean right into it and say this is the conversation we're gonna have i took my pink

00:44:33stilettos

00:44:34and i started going to dc and i was knocking on the doors of these giants in women's rights and

00:44:40women's

00:44:40health and i was like hi i'm cindy i have this company and here's what this condition is and i

00:44:48went with dr goldstein so that they could ask an expert any questions they might have and at the end

00:44:54of this meeting a woman named susan stanlin who ran the national council of women's organizations

00:44:59came over and she's like we're gonna fight this

00:45:07when we called it on a double standard this group started to come together here were giants

00:45:15of women's health and rights black women's health imperative nurse practitioners and women's health

00:45:20nurse midwives national organization for women national council of women's organization national

00:45:25consumers league incredible like women that were my heroes

00:45:32the fda themselves had deemed this one of their top 10 areas of unmet need this issue is so prevalent

00:45:40it affects so many women that it was on their top 10 list and yet here we were in this

00:45:46conversation so

00:45:47all these women's rights groups with dr goldstein chartered a bus and demanded a meeting with the fda

00:45:58an fda advisory panel today hearing the pros and cons of plebanserin also known as the female viagra

00:46:06when we fought other women fought good morning thank you for letting me speak i'm susan scanlon i'm

00:46:14chair emerita of the national council of women's organizations i'm also chair of even the score

00:46:21you know i give all credit to susan scanlon who i'm so sad is no longer with us she was

00:46:27larger than

00:46:28life with a voice to match and you know also a huge mentor of mine in that she said we're

00:46:36gonna call

00:46:36a spade a spade here we're tired of hearing that female sexual health is complex as if there would

00:46:42be no answer if we didn't study it make no mistake men are equally complex and there's been no shortage

00:46:49of medications to address their sexual dysfunction in 1960 the birth control pill precipitated a societal

00:46:56shift to recognize women's rights as reproductive beings in 2014 let's shift to recognize women's rights

00:47:04as sexual beings thank you very much thank you i would challenge anybody what is better than to have

00:47:13advocacy the best things have happened when patients have taken the mic and demanded what they deserve

00:47:20my name is judith i'm 66 years old and i've been dealing with fsd on and off for 17 years

00:47:26hi i'm

00:47:27catherine i'm from indianapolis indiana i learned in high school sex ed that a woman's sexual prime

00:47:33so to speak is in her 30s yet here i am it is amazing how many women of all ages

00:47:39i talk to that

00:47:40have some degree of hsdd this disorder is real and we need a solution at that time there was a

00:47:50lot of

00:47:50feeling that we were medicalizing hsdd and finally we have susan hi i'm susan um i stopped having desire

00:48:00for sex about two years into my now 11-year partnership with my husband my partner and

00:48:06i had done work on ourselves in a therapeutic setting we learned that our sexual problems were

00:48:10a co-created problem in our relationship their idea was really that it was saying you have a condition

00:48:17that they didn't have because they were normal clinical psychologist leonore tiefer says sprout has

00:48:23concocted a women's rights issue to guilt the fda into approving flibanserin it's just a mishmash

00:48:30of politics and science and sex and money money money money the fda's ruling is due later this month

00:48:38some people felt like women's desire was more complicated and we shouldn't be medicating women

00:48:45because oftentimes their desire can get better if they're working with a therapist or you know

00:48:50seeing a couple's therapist with their partner this busy mom of four amanda parish says she used to

00:48:55have a smoldering sex life with her husband this drug isn't necessarily going to treat the fatigue

00:49:01that might be giving you a low sex drive or you know the kids that you have running around or

00:49:06the

00:49:06partner who isn't helping you out with the chores around the house that's totally true but why shouldn't

00:49:13we offer a medication that has been shown clinically proven to help increase desire not to say that it's one

00:49:21or the other in fact i think most people that prescribe this medication would say keeping that

00:49:26therapy stuff around is really important right but if you can provide a medical solution in conjunction

00:49:34with psychological treatments why would we deny women that women don't need treatments with real

00:49:40side effects for imaginary diseases invented by marketers if you've never experienced hsdd

00:49:46you don't understand what it is it is a thinly veiled profit driven marketing campaign filled with

00:49:52bias misleading unsubstantiated information i think it's a scam to have a community fighting and saying

00:50:01we were medicalizing and claiming this wasn't a biologic problem well i will tell you it's a it's in your

00:50:06brain the language i like to use when they say it's all in your head well your brain is up

00:50:11in your head

00:50:12this is your brain we live in a world where women should have a choice for their body and they

00:50:16should be able to choose if they want to take a pill an injection sex therapy or all of them

00:50:23but who

00:50:24is anyone else to tell me and that's what angered me who is that anyone else to tell me i

00:50:29have a

00:50:29biologic problem i know that i was functional before i know it's not in my relationship i know something's

00:50:34changed who's going to tell me i can't do something about it so the mood of the fda

00:50:40was very much a combative that either you believed in a biologic treatment or you believed

00:50:48that you shouldn't have a biologic treatment a major medical headline tonight involving women

00:50:53the drug nicknamed the little pink pill a key decision today fda advisors will once again consider

00:51:00whether to approve a drug that's already been rejected twice women now one step closer will

00:51:06joining their frisky male counterparts who've enjoyed the benefits of pills to help their sex

00:51:10lives for years i arrived at fda when the doors opened and then as people started to come they were

00:51:16like you know there's people on the road leading into the fda with signs and banners and like i think

00:51:22it's going to be a tough day i was in my urology training at georgetown and so i was in

00:51:30the washington

00:51:31dc area and it just felt important i i can't describe it but it felt historical good morning

00:51:39we have a very full agenda welcome to the drugs advisory committee it was straight out of a movie

00:51:46fda has never seen crowds like this the press were showing up everybody was in this room and it feels

00:51:53a little bit like you're at the supreme court the first fda meeting i went to with cindy you know

00:51:59i had

00:51:59at that point met her a number of times in person she was oddly always wearing pink and so i

00:52:05had this

00:52:05concern that she was going to wear pink to fda and so i got up my nerve to tell her

00:52:10so don't don't wear

00:52:11pink to fda she won't be credible and she really didn't say yes or no but she showed up the

00:52:18next day

00:52:19in pink when i showed up at fda meetings my pink got brighter and brighter and brighter until you could

00:52:25see it from outer space to me it was about being unapologetic and actually what was at the root of

00:52:31that was the conversation we needed to have i will tell you that the morning of the advisory committee

00:52:36i mean it was very tense and i was in my black suit and my beige shirt and i just

00:52:40went up to her

00:52:41and i knelt down right next to her and i just said i'm wearing pink underwear like just to like

00:52:47lighten the mood which was like also happened to be true thank you dr lewis and good morning

00:52:53i'd like to take a moment i'm josephine torrenti executive vice president of corporate and regulatory

00:52:58affairs at sprout pharmaceuticals the first statement by fda was a defense that they are not in fact

00:53:05biased so some have claimed gender bias on the part of fda when it comes to treatments for female

00:53:13sexual dysfunction the fda firmly rejects this assertion fda is always concerned with unmet needs

00:53:21whether this is in women men or in children the fact that fda felt the pressure to say we are

00:53:30not

00:53:30biased against women's health just tells you the impact that these women were having

00:53:36by going to fda and saying we need a drug for this don't diminish the benefit

00:53:49good afternoon my name is barbara i'm a nurse this is my daughter vicky

00:53:53and we are patients of dr goldstein and we have no interest in the outcome of this meeting

00:54:00i'm amanda parish um i am one of the lucky 11 000 women that was a patient on the phlobanserin

00:54:06clinical trial i'm here with my husband ben um we funded our own trip and we have no financial

00:54:12stake at the outcome of this meeting hi my name is katherine campbell my travel expenses are being

00:54:18reimbursed by sprout i hope everyone understands that my husband and i do not have money set aside

00:54:23to fly back and forth to dc so that i can talk about how much sex we're not having here

00:54:29you are

00:54:30with women who've taken time off work had somebody babysit the kids potentially fly across country

00:54:38to reveal their most private struggle behind the closed doors of their bedroom at a federal agency

00:54:45my name is kelly staup and i have no financial things to disclose but i will disclose the fact

00:54:49that i'm a bit scared to death to stand up here and talk about this can you imagine like how

00:54:55just

00:54:56awkward uncomfortable brave it was for them to do that they're the heroes of this story hello my name

00:55:03is eric of halam and i hate public speaking but i'm here anyway i am here today to tell you

00:55:08hsdd is

00:55:09not a figment of a woman's imagination it's not a fiction invented by the drug companies and it's

00:55:14not a disease forced upon women by the medical community hsdd is real i know because i had it

00:55:21when i was 24 years old i was diagnosed with breast cancer i was clearly informed of many of the

00:55:26potential negative consequences of surgical menopause but no one ever advised me that i was at

00:55:32an increased risk for hsdd there was so much emotion in the room a television doctor suggested on an

00:55:39interview just last night that maybe my libido is low sometimes because i've had a bad day

00:55:44an anchor on a morning show yesterday said that she doesn't need treatment because a housekeeper and

00:55:49time away from the kids would solve her desire issues if your sexual desire issues can be cured

00:55:55with a good day and a babysitter then congratulations you do not have hsdd but the rest of us would

00:56:02sure

00:56:02appreciate it if you would stop dismissing our concerns and making a complete mockery of the issue

00:56:09hi my name is vicky loftus i was on the patient panel in october 2014 and told my story about

00:56:16how

00:56:16hsdd has negatively affected my life my mother was on the panel as well we both shared our individual

00:56:23struggles which were sadly very similar since my appearance on the panel my marriage has suffered

00:56:29greatly so much so that the conversation of divorce is on the table stemming from my low sexual desire

00:56:35my husband has a difficult time understanding my struggle with this disorder he still takes my

00:56:41avoidance of sex personally thinking i don't love him anymore and there is something wrong with him

00:56:46which is farthest from the truth

00:56:50as a mom standing next to your daughter who is going through a divorce at that time

00:56:56for her to get in front of an fda panel it took a lot of courage on her part it

00:57:02was a very traumatic

00:57:05thing for her so to listen to those hecklers it was heartbreaking to watch that it was just heartbreaking

00:57:18thank you speaker 31 please there was a woman who stood up and said let me give you some options

00:57:26read erotica find a different partner get a better shower head here are some things that

00:57:32that have helped me with periods of low libido switching boyfriends chocolate coffee certain episodes

00:57:41of gray's anatomy pornography upgrading my vibrator reading 50 shades of gray a removable shower head

00:57:48and an acceptance of myself and the libido i came with excuse me alessandra sorry your two minutes is up

00:57:56that's all saying you're doing something wrong and it's your fault and you just watch the faces of

00:58:03women who were brave enough to say the thing they were struggling with and then others mock them

00:58:09be cruel to them and that was hard to watch sprouts lobbying effort called even the score has used deception

00:58:18to mobilize women with real sexual concerns to lobby for their questionable product they've tried to

00:58:25distract the public bully the fda and they have hampered real sex research but make no mistake even the

00:58:34score reveals the methods and values of sprout pharmaceuticals reject this drug once and for all

00:58:41and let's move on to really help women thank you speaker 32 please there was so much

00:58:50politics there was so many people there angry about the idea that a medicine could help with sexual

00:58:56health if there were clear evidence of a clinically meaningful benefit which i don't believe there is

00:59:02significant but not clinically meaningful accompanied by manageable risks approval might be appropriate

00:59:09blubanserin is a mediocre aphrodisiac with scary side effects its effects may be due to nonspecific

00:59:15sedating effects apparently equivalent to four drinks one of the fears the fda had was that this was like

00:59:22an aphrodisiac and it might be slipped into somebody's drink in a bar and then they'd have sex with some

00:59:28stranger one thing i worry about is because of the indication of this drug could it be thought of

00:59:36as um like a date rape drug i think that's an excellent point and that is something um certainly

00:59:45of that day we have thought about but it doesn't work like that at all anything that you have to

00:59:50take

00:59:51daily i will tell you that you have to have taken it for a certain number of days before it

00:59:56really has

00:59:57an effect my name is dr erwin goldstein i serve on sprouts advisory board i'm sue goldstein we're here

01:00:03for san diego sexual medicine today and we have no financial interest in today's outcome it was very

01:00:08distressing that colleagues would take this view that we were harming people and we had a lot of

01:00:15evidence that wasn't true it's an embarrassment it's a humiliation it's a evil against women it's

01:00:21crazy it's just crazy to the experts who do not manage women with sexual health problems give these

01:00:28women the right to choose vote yes to approve and thank you thank you some of this i think is

01:00:36an attempt

01:00:36to control women and that's been going on for millennia it's going on now there really is a whole

01:00:46sense of not hearing women and not trying to help them or trying to block something when help is

01:00:53available and that's unconscionable to me

01:01:00i'm dr anita clayton i'm going to get straight to the point stop moving the goal posts the efficacy

01:01:08safety and clinically meaningful effects of phlobanserin are clear maybe the message is that you don't

01:01:15trust women with hsdd or you just don't trust women at the core of this whole thing was really

01:01:23does it matter and do women deserve i think that's really what it was like all this other was just

01:01:29noise it was just noise to distract from the bias at the center of it which is we don't think

01:01:37it

01:01:37really matters if women have a more satisfying sex life that's the truth we literally heard this

01:01:42from the fda is that women do not have to desire sex to have sex

01:01:53yeah so with that said we will now turn to the voting process i think about the stakes because i

01:02:03knew

01:02:03what we were up against because we had done everything we could and the team was nervous

01:02:12we felt immense pressure to win it for women all the women that showed up all the women's health and

01:02:18rights advocates all the doctors okay we ready okay let's go

01:02:29the emotions are just up and down all day and then they vote sort of secretly right they all press

01:02:35a button so that they can't influence each other and the number just comes up on the screen

01:02:42that process probably took a minute and a half it felt like 20 minutes before that number came up on

01:02:51the screen and then the room just erupted the fda approving the controversial little pink pill

01:03:06the fda approved the new drug designed to boost the female libido and there ain't nobody can blame me

01:03:13they can't blame me now because everything you're doing yeah that's how i like it you know what you're

01:03:18doing yeah we got an 18 to 6 positive vote it just tells you the strength of the data

01:03:23and also the strength of the people who spoke to say this is meaningful and i do need this drug

01:03:32that day in the room when my hand was shaking as the score went up i don't know that the

01:03:38fda's ever

01:03:39had a whole room erupted to cheers over an approval of a medication it was so validating and i was

01:03:46on

01:03:46the last flight out to new york to do press the next morning yesterday science one and so too did

01:03:55women finally women have the ability to make the choice with their health care providers whether or

01:04:01not they want treatment for the most common form of female sexual dysfunction and it's been a long time

01:04:06uh to get to this moment what about the reality of money raising when it comes to now marketing this

01:04:12and son you're a small company privately held uh how are you gonna pay for all this

01:04:21we were the largest news story in the world and then the phone started ringing

01:04:27in august 2015 we got the approval two days later we sold the company for a billion dollars

01:04:36and then we got the approval two days later we got the approval two days later we got the

01:04:42up until about 4 a.m in the morning the night before we were still going back and forth and

01:04:48i can

01:04:48remember sitting in the seat at squawk box next to the ceo and they wanted confirmation of the signature

01:04:55and they were like five four three we got it and it just happened right there on air to be

01:05:01sure science

01:05:01has won the day here so this is a condition that we've known about medically since 1977. we have

01:05:07four decades of medical literature on it the opportunity is quite large you know certainly

01:05:11in the hundreds of millions for us but we're hope hopefully it's in the billions in terms of uh

01:05:15what this could do and from a from a revenue standpoint this whole fight has been about getting

01:05:21women myself included what we deserve and knowing our worth and i wasn't going to take something that

01:05:27wasn't what this was worth let me ask you about the valiance acquisition and sort of what that did

01:05:32for you because you've got a lot more marketing muscle a lot more oomph behind this product now

01:05:38what kind of game changer was that for you game changer we are a 34 person company who managed to

01:05:43get

01:05:43this across the finish line so this is the ability to make good on the mission right this is going

01:05:48to

01:05:49be accessible to women every corner of the globe because we needed a global player to be able to do

01:05:55that

01:05:55in a way this tiny little company with 35 people couldn't do but again no one takes you seriously

01:06:02i think this sounds like a great holiday gift

01:06:08tonight we'll take a look at the pros and cons of female viagra uh pro when ingested uh flibanserin

01:06:15increases a woman's sex drive con you might know it by its old name wine yeah don't need no

01:06:25the media they picked up on the people saying this is dangerous this pill is not for everyone

01:06:31dizziness four times greater sleepiness nausea fatigue there's an interaction with alcohol they

01:06:37splashed it all over because they like a story they like a conflict and it was detrimental but your

01:06:45critics remain this morning the critics have not gone away charlie rose asked me like hey cindy could you

01:06:50not have invented a drug with no side effects is there no way to have created a drug without the

01:06:54side effects uh no no drug comes without side effects i think that's very important right addy is

01:07:04no different than countless other drugs what we it was so obtuse again you can't have any risk because

01:07:11this thing doesn't really matter the challenge with this drug is that it is limited to a very strict

01:07:19subpopulation of women who have a sudden or new onset of low desire and no other explanations and

01:07:26it's a reproductive age population too and we should be thinking about and concerned about the reproductive

01:07:31safety of this drug it just shows up over and over and over again addy comes with a black box

01:07:38warning

01:07:39from the fda the strongest warning it can give because it's loaded with side effects a box warning literally

01:07:45is a box in the medical information they said you couldn't drink alcohol at all and their warning for

01:07:54viagra was you shouldn't take it not that you couldn't but you shouldn't take it so putting something

01:08:01in a box warning that is not a legitimate safety issue is a real problem doctors had to take a

01:08:09test to

01:08:10write it pharmacists had to take a test to dispense it and women had to sign a piece of paper

01:08:14promising

01:08:15they wouldn't drink if they were on it they put it in a classification with things that are very harmful

01:08:22and addy is not harmful i took alcohol i didn't i wasn't even told that i couldn't take alcohol and

01:08:30everybody that i know had a drink before dinner you take this medication at night you're not supposed to

01:08:36get behind the wheel of a car or take it in the morning the other thing is that men can

01:08:42take it

01:08:42from basically any age and that includes people up to 70 80 or whatever women know had to be between

01:08:5218

01:08:53and where they entered the perimenopause so there's real problems there in a discrepancy between

01:09:01men and women and there was a very paternalistic attitude addy is not approved for use in post

01:09:08menopausal women the fda says more studies are needed to determine whether it's safe and effective

01:09:13for them they just made it impossible to get the drug and with all the restrictions on the pharmacists

01:09:22they weren't selling it it's been on the market now for three or four weeks and the demand so far

01:09:28has

01:09:29been really really really low and frankly you know valiant been in the news for a lot of other

01:09:34reasons for some of the troubles that they've had for valiant to jack the price up the way they did

01:09:42is i think criminal for women valiant's a very controversial company a lot of stuff came out about

01:09:49its business model particularly the business model of buying other drug companies then jacking up the

01:09:54prices of those drugs well then it was cost prohibitive so they stopped taking it and that was the end

01:10:02of it

01:10:06and then of course the next thing that happened is they shelved it

01:10:18the intention was i was going to stay you know that was part of the deal i would stay and

01:10:22build

01:10:23their entire women's health franchise and within three months of that deal closing i got a phone

01:10:29call that invited me to leave and not long after that they got rid of the entire team

01:10:36i've never been more depressed in my life than that period to have one one and then them to not

01:10:44launch

01:10:44it and the women who had shown up at those meetings to not be able to get it that felt

01:10:53the worst of anything it was it was that was brutal for me women that are struggling with hsdd

01:11:00should have the option to choose a safe and approved treatment with guidance from their health care

01:11:05provider thank you how can you possibly pass something that is so wonderful for women and then

01:11:14have it ripped out after all of this work and after all of this emotion we're down to square one

01:11:24again and we

01:11:25still are we just got new metrics in donald j trump is the president of the united states elect

01:11:37in the past five to ten years really calls into question where the state of women's health is going

01:11:48the last year has been incredibly difficult for women

01:11:51we have seen major attacks on obamacare protections for birth control and we know that on the state

01:11:57level there are a number of courts that are working to roll back our right to choose

01:12:03tonight we remember an american icon supreme court justice ruth vader ginsburg died today

01:12:10ginsburg was seen as a champion of women's rights her passing now gives president donald trump

01:12:14the chance to shore up the conservative majority when choosing a replacement

01:12:19confirmation brings a major shift to the court and it will have an impact for years to come

01:12:26one of the tipping points in the conversation that we're having requires us to look back to what

01:12:33happened just a few years ago with the overturning of roe v wade i don't accept this ruling we're not

01:12:39going to go back what changed since 1973 what changed

01:12:45to be in a time in my life that the rights that my generation thought so hard to have

01:12:52see them taken away what right does anybody have to say what i do with my body why does any

01:13:00right and

01:13:00men have a right to to control any of that whether it's sexual health reproductive rights uh who you're

01:13:08married to none of that is anybody's business if you're not harming anybody else and i will stand

01:13:13up and support and hope to god right i have two granddaughters teenagers i hope that they live in a

01:13:18world better than the world we're looking at today today the story of joselly barnica a young mother

01:13:25pregnant with her second child who died of sepsis just one week after texas's abortion

01:13:31ban went into effect despite being diagnosed with a miscarriage in progress doctors said they could

01:13:38not treat her meaning provide an abortion until her fetus no longer had a heartbeat people are

01:13:44literally dying as a result of these horrible political changes we have to get all of this

01:13:50reversed back to the where it once was where people have rights and reproductive and sexual

01:13:55rights are just as important as cardiac rights as orthopedic rights as any other right i'm scared

01:14:02to have a daughter because i don't know how the world is going to treat her because you could be

01:14:07the

01:14:07best parent in the world and you could teach that girl to be the strongest possible person but you have

01:14:14no idea when she goes out into the world how the world is going to receive and treat her

01:14:19it's also a scary time with what is happening to traditionally marginalized groups trans people

01:14:28are the most marginalized in our society and they've been scapegoated in a way that they are sort of

01:14:35being used this as the smoke and mirrors vehicle in this all-out assault on personal autonomy and it's

01:14:41scary how quickly that has escalated you know back in the 20 late teens it was this discussion around

01:14:48bathrooms and then very quickly it was trans people in sports it is a hot topic at american

01:14:53politics whether or not transgender people can compete in categories in which they identify

01:14:58and then very quickly it was trying to ban care for trans youth and now there's multiple states

01:15:03actually trying to limit care for trans adults so what happened with roe is a direct extension of

01:15:10what's been happening with trans rights at the end of the day if like we collectively as a

01:15:15society are not standing up and protecting trans rights then we're not protecting our rights

01:15:20regardless of what's going on in washington politically people are still suffering so all

01:15:28the games that people are playing all the rights that are being stripped from people

01:15:33regardless of who they are at the end of the day my patient my room is still suffering because

01:15:39i will be honest right now as a gynecologist it's a little bleak patients are feeling it too when

01:15:44they come into the exam room as well if our reproductive rights our rights to bodily autonomy

01:15:50are threatened we almost can't even get to the conversation of pleasure because we're

01:15:54fighting for basic human rights those fundamental rights to exist to have control over our bodies and

01:16:01that's very scary but i don't want to lose the conversation around pleasure as we focus on rights

01:16:09itself because pleasure is a part of that and in fact if we focus on everybody's right to pleasure

01:16:14men women folks of all genders if we talk about pleasure then we have more support to talk about

01:16:23rights and i think that they go hand in hand you need people yelling and screaming and you need

01:16:27coalitions and you need people getting loud you need advocacy you need research you need mentorship

01:16:33you need awareness you need communicate you need all of those things we need a seat at the medical

01:16:37school tables who's coming up with the curriculum how many hours need to be devoted to this subject

01:16:43we need a seat at the fda in terms of what medications are getting fda approved what roadblocks

01:16:48are they putting up in place trying to protect women and keep us safe which actually just create huge

01:16:54barriers to care we need to hold insurance companies responsible and our patients need to speak up in

01:17:00demand from their congressmen from their legislators that these are important issues that they deserve

01:17:07the most important way in which any individual could make an impact on this fight for bodily autonomy

01:17:15and the right to equal amounts of care would be to educate ourselves and to remain curious and when

01:17:23we hear something that doesn't quite seem the same as what we were trained to think to push back a

01:17:30little

01:17:30bit and realize that the truth is actually something that's been hidden from us for a very long time

01:17:35i think the key is to not be discouraged by the losses there will be losses and you can't just

01:17:42take

01:17:42that and go well there's no point in fighting this fight because we just lost that fight i think right

01:17:47now

01:17:47that's what we have to do is we keep having to push for the right answer

01:18:07in the dark days after the ceo fired me no one was feeling sorry for me right i had really

01:18:13the

01:18:13entrepreneur's dream come true i exited the business it was an incredible outcome for all

01:18:18the shareholders and yet i found myself really unfulfilled because it's not what i'd set out to

01:18:24do well the drama isn't over for the drug maker valiant pharmaceuticals the ceo just recently back from

01:18:30medical leave is now out so when the new ceo came i asked him if he'd have breakfast with me

01:18:35in new york

01:18:36and i sat down with him and i said give it back he said no thank you go away so

01:18:42i issued a lawsuit

01:18:45they'd made commitments to me on what they would do you know how much they would put toward the

01:18:49marketing education of physicians on it and they were in breach of all those obligations and ultimately

01:18:56in exchange for dropping the lawsuit they gave the product back just give us the history of this

01:19:02female viagra drug because it was bought wasn't it by valiant and went nowhere fast and now she's

01:19:08brought it back yeah cindy successfully settled with valiant a lawsuit that allowed them to get

01:19:13the drug back at no cost to them and they're taking this back to the market for the second time

01:19:18and so it's basically the the drugs second shot

01:19:25the minute we got it back we went back to work and we invested all of these dollars back

01:19:29into all the scenarios that we could show back up to the fda and actually got that black box warning

01:19:34contraindication removed it has an entirely different label today no doctor has to take a

01:19:40test to prescribe it eli does what he calls pharma or farm p-h-a-r-m to table so

01:19:47he's making sure all

01:19:48these pills are coming off the manufacturing line kristin our chief of staff margaret and finance here

01:19:56chrissy neubauer who runs customer service for us michelle who's working in customer service as

01:20:04well when we got approved we were confined to only pre-menopausal women so we've submitted for our

01:20:11post-menopausal expansion of use i don't even like to say that we've submitted for post-menopausal

01:20:17we've submitted for approval in women with hstd it it's not for approval of post-menopausal women right

01:20:24it's women with hstd because that's who it should always have been approved for and so after we

01:20:29disprove the alcohol contraindication if you google addy and alcohol what comes up is addy is

01:20:37contraindicated with alcohol that's still out there that narrative like even though we proved it

01:20:44that narrative six years is still out there and it's still out there in part because fda keeps it

01:20:50out there so the first order of business was science and then i think the second order of

01:20:54business has been demystifying all of the garbage that's been out there about this women are like

01:21:01what do you mean there's a pink pill for me i've never heard of it and that is now the

01:21:07real problem

01:21:08you guys know that i've been fighting for years on this issue that i fought to get the first fda

01:21:14approved treatment option for women's libido all the while hearing the same excuse

01:21:19women's libido is complicated is it complicated or is it just not prioritized i had nothing on social

01:21:25media but you know what somebody had to speak up and once i spoke up it just never stopped when

01:21:32doctors dismiss our pain downplay our symptoms or essentially tell us it's all in your head we learn

01:21:38to be our own advocates that's not empowerment that's survival cindy welcome to the show thanks

01:21:43for having me the truth is i knew that you're going to be wearing pink today i know it's shocking

01:21:47i think addy has parallels to all of these other conversations we're having right now

01:21:52that i'd like to think we've had a hand in because when you fight back you can win

01:22:01dr blair peters here full-time gender-affirming surgeon hi everybody uh rachel ruben

01:22:06neurologist and sexual medicine specialist we're live on instagram right now

01:22:13so this person asked i pee after sex and yet i'm still getting utis what am i doing wrong just

01:22:19wanted to give you guys a walk through through this device um it is for erectile dysfunction here are

01:22:24things i would do to have a better sex life it is so fun to watch these badass younger physicians

01:22:31hey everybody it's your education chair sarah signa whether they're on instagram breaking barriers or

01:22:38they're in the room challenging conventional wisdom i love it

01:22:48i am not a magician but my batting average is really freaking good and in our practice we take a

01:22:55lot of time to get to know you to figure out what's bothering you and to figure out how do

01:23:00we optimize your

01:23:01quality of life stacy david it's great to see you good to see you one of the things we often

01:23:06ask

01:23:06people is what does sex look like for you right now and compare that to what you want it to

01:23:11look like

01:23:12why is that important because i can't assume what kind of sex you're having or even what you want it

01:23:18to look like and the more i understand you and what your goals are then we see magic when you

01:23:23really

01:23:23take the time with people that's when the magic happens that's why i think it is so important

01:23:29that's why i think it is so important to encourage women to hold a hand mirror while i go through

01:23:33their

01:23:33external vulvar exam i feel like most of the time when i do that women are so shocked and happy

01:23:39that

01:23:39somebody took the time to show them really who they are down there and that's just one step in the

01:23:45process of empowering women to take more ownership over their own sexual function patients and and we as

01:23:52clinicians need some sense of community especially in the current political climate without people

01:23:58who are banding together creating community creating safe spaces and pushing the needle forward we're

01:24:06never going to get anywhere we should be able to stand up for our rights and say i want more

01:24:12i want

01:24:12something better out of this relationship i want something better out of sex i want something better out

01:24:16of my job what i want something better from you know from from my family but you but if you

01:24:22don't

01:24:23tell somebody then how can you expect somebody else to help you the underlying theme of whether it's sexual

01:24:30health to reproductive health is choice so whether it's having an orgasm or having an abortion women

01:24:35should have the ability to choose what is the best thing for them a lot of the culture in medicine

01:24:41is

01:24:41still very anti-speaking out and it's because we don't speak up for things that the narrative has

01:24:48become very warped and very much straight away from science so i think there's a huge need more than

01:24:55ever for a lot of us to really be out there i'm hopeful because i'm seeing more women come into

01:25:02this

01:25:02field i'm seeing more queer people into this space and saying like we need to really rethink how we talk

01:25:08to

01:25:08people about sex so that we include all types of people i think that the more pleasure and orgasms and

01:25:16fun people can have that is safe that is consensual i think when we focus on pleasure and joy then

01:25:22the

01:25:22hatred and the trolling and the nastiness and the focus on all the negative i think it kind of starts

01:25:29to

01:25:29go away so i think by focusing on joy i think we can make a lot of progress the magic

01:25:35that happens after

01:25:37someone reclaims their sexuality just knows who they are takes full ownership of their existence

01:25:44their bodies their birthright of pleasure you get to literally witness this person step into their power

01:25:51i have seen so many of my patients go on to sign a book deal go on to like run

01:25:57for office to go on to

01:25:59do so many things because they had the audacity and the audaciousness to chase their pleasure which then

01:26:06open up doors to chase all their other dreams and it is so fun story alert i have a story

01:26:12alert i saw

01:26:13a patient very recently she's in her 60s 25 years ago in her late 30s she lost her ability to

01:26:20have

01:26:20her three magical orgasms she used to orgasm three powerful magical times well i just saw her and she said

01:26:27dr ruben they're back love heavy but i gotta let you go mine's steady and i gotta let it go

01:26:36love came

01:26:37here but i never left so the way we never said goodbye until the pen stroke in the high note

01:26:42crying in my

01:26:43throat love heavy and i think it's time to let it go wait on love but it way too much

01:26:48and you're way too much

01:26:49stayin' stayin' out of touch lookin' sus i got love on layaway payin' for it every time i get a

01:26:55piece

01:26:56a bit of a peach this sweet long what a petite bon appetit just miss me

01:26:59crossin' and in the sea peace i'm on this way

01:27:07i'm on the way now

01:27:12i'm on the way

01:27:31and there's no one back home and they all know you're gone and the sadness isn't and it's just

01:27:35halfway love and the faucets are dry call i gets dry they always circle it hurt fireflies you saw me

01:27:42then

01:27:42knock the corner of the eye my heart maybe i still feel like a painting swirling like whiskey that

01:27:48night it was raining dancing alone a hook that was well laughing like children strumming my pain like

01:27:54it could be all i need this could be all i need this could be all i need this could

01:28:00be all i need

01:28:12to be all i need this could be all i need this

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