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What One Doctor Wants Women to Know About the Little Pink Libido Pill

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What One Doctor Wants Women to Know About the Little Pink Libido Pill

Aug 27, 2015

Will it work for me? What are the side effects? Why did the FDA reject it twice? Addyi, the woman’s sex-drive drug, should be available sometime in October 2015. We asked Dr. Kirtly Jones what she would say to a woman asking if this treatment is right for her. When you’re done listening to this 15-minute interview, you will have a very good understanding about what is being called–inaccurately–the female Viagra.

Episode Transcript

Interviewer: The little pink pill that helps women's sex drive. We're going to ask Dr. Kirtly Parker Jones to tell us more about that next on The Scope.

Announcer: Covering all aspects of women's health. This is the "Seven Domains of Women's Health" with Dr. Kirtly Jones, on The Scope.

Interviewer: Dr. Jones, we've been reading much, as I would imagine our listeners have and seen the news coverage on the little pink pill, it's being called "the female Viagra" which is probably not accurate and we'll talk about that in a second as well. How would you decide whether or not you would recommend it or not recommend it to a patient? There are benefits, there are drawbacks, the FDA didn't approve it twice and now they've approved it, just a lot of questions. So first of all what is this pill and what does it do?

Dr. Jones: Sure, what's the pill? Some years ago a drug company in Europe was looking for a new, better anti-anxiety and anti-depressant drug that wouldn't have sexual side effects. A lot of the drugs in the SSRI group can cause problems with libido. So they have this drug called flibanserin and they rolled it out, looking at it as an anti-depressant and they found that in men it didn't change their libido one way or the other and it didn't work that great as an anti-depressant. But in women it wasn't that great as an anti-depressant, but it actually had a little boost in sexual interest.

So they then went on to say, "We'll take this drug which works on the neurotransmitters in the brain," so this works on dopamine, it increases dopamine, the reward center. It increases norepinephrine, another rewards center and it decreases serotonin. So they decided they'd work on it and see how it really worked in women who complained of hypoactive sexual desire disorder.

Now, what is this? Is this a disease or do women, when they get to a certain part of life, is not having much of a sex drive perfectly normal and the answer is it's so common, that yes, it's normal. It's been suggested that as many of 40% of women at some time in their life have a period of time of two weeks when they're not interested in sex. So if I ask women, "Has there been a time in the last year for longer than two weeks when you weren't interested in sex?" Most women are going to respond, "Oh shoot yeah. My kid was sick" or whatever.

Not being interested in sex isn't a disease. But then the question you ask is, "How much does this distress you?" and you say, "Well I don't care, it's fine by me. My husband is a little tweaked about it, but fine," or, "This has really destroyed our relationship. My husband is looking forward to the kind of closeness we had early in our relationship, the intimacy, frequency, and now, it's not there."

So although not having desire is normal for women, if it was a change in desire and if it causes distress, should we medicate that? My feeling for a patient who comes to me with this complaint, and about 10% of women have this condition, where they have a decrease in their desire and it causes them distress. Those are the two things you have to have. And for women for whom it causes distress, we have not had anything that works. "Take a couple of drinks and see how you feel." Or, we tried testosterone patches and that's a whole separate issue and that didn't make a big difference, so we really didn't have anything.

Guys had a whole menu of things that could work on erectile dysfunction. Now, erectile dysfunction is not desire disorder. It means you've got desire and it doesn't work and the purple little, blue pill, Viagra, is one of a series of drugs which increase blood flow to the penis, and when you give those kinds of drugs to women, nothing happens. They get more blood flow down there but they're not excited. So to call this female Viagra is way wrong.

Interviewer: Because Viagra solves a mechanical problem.

Dr. Jones: Exactly, and in women it's an internal desire problem.

Interviewer: It's in the brain.

Dr. Jones: Right. So they had this drug and they did a randomized trial where women were given placebo versus this drug at different doses and lo and behold, there was a little difference. Now I want to talk about, if I were going to counsel a patient, what kind of difference was there with flibanserin?

It turns out about 10% of women respond. So if you give this drug to 100 women, and you give placebo to 100 women, 34 out of 100 of women with placebo will get better, they'll have more interest in sex and they'll have more sexually satisfying sexual activity. If you give flibanserin, 46% will feel better. So out of 100 people, about 10 will actually be responding because of the drug, and we don't know when I'm sitting in the office, which 10% those are. It's a drug that you have to take every day and it has side effects.

But what can you expect if you are one of those 10%, what can you expect to see in terms of difference? Well the other reason the FDA was not excited was the fact that the average number of satisfying sexual activities was 2.8 in the study group and when they took placebo it went to 3.7 per month, 2.7 happy times in bed per month. And then with placebo, it went to 3.7. So about one extra happy time when you just took placebo, and it went from 2.8 on flibanserin before they started, to 4.5 on flibanserin. So that was about two extra happy times a month. So that's one over placebo, per month. So the FDA didn't think that was very impressive.

What happened was the drug company that originally started flibanserin gave up the drug, and another small start up company called Sprout Pharmaceuticals took it on and they actually started a media campaign called Even the Score. They went to the FDA and said, "Women have nothing. Men have all these things to help them, women have nothing. We need to even the score." So the FDA originally didn't think that one extra happy time per month was adequate given the side effects, which I'll talk about in a second.

Then I think they got some pressure and they decided okay, we'll just put it out, and it's going to be available under the brand name Addyi, with a funny spelling A-D-D-Y-I, Addyi, on the middle of October. It should be available in drug stores. You have to take it every day, you have to take it at bedtime and so different from the Viagra style drugs for men, they only take it when they think they're going to be interested in sex. Women have to take this every day, so they're taking a pill every day for an event that might happen three or four times a month.

What are the side effects and why do you take it at bedtime? You take it at bedtime because the side effects include low blood pressure, hypotension, fainting, dizziness, headache and sleepiness. About 10% of women are going to have that effect. So 10% of women are going to have a benefit, 10% of women are going to have a side effect. We don't know if it's the same 10%. So they recommend taking it at bedtime so that you're less likely to be dizzy or to pass out, so I think that's the issue.

I'm glad that women have something that might work for them, and like birth control methods, not all methods are right for everyone. They recommend that if a woman takes it for eight weeks and she doesn't notice a difference, remember that half the difference that she notices is going to be placebo effect. So if she doesn't notice a difference then she shouldn't take it anymore. It's going to be moderately expensive. It's going to be $30-$75 per month and we don't know whether insurance companies are going to cover it. But you can bet your booties that if insurance companies cover the Viagra type drugs and they don't cover Addyi, there's going to be some ladies marching on your insurance company's front door.

Interviewer: So there are a lot of pills for men, as you mentioned, this is really the only one for women. Is there a medical reason for that? Is it more difficult to create a drug, or is it what a lot of people claim that it's a man's world and I don't even know the words, but that argument.

Dr. Jones: Well it's been unfortunate that we've considered men so simple. All they need is something to make their switch go up instead of down and that should be very easy. Whereas women, desire is a complicated thing. What do women want? Isn't that what Freud said? What do women want?

We don't know how flibanserin works, if it does, and why it only works for 10% and not on the others, because we don't know where desire comes from in women. Why do some women have a lot? Why do some women have none? Why is it common, 50% of women don't have desire until they're already in the middle of being stimulated, so they only have responsive desire? So we're not very smart about where desire comes from, and there aren't very many good animal models for desire.

Interviewer: What would you recommend to a patient asking you about this medication?

Dr. Jones: I think I'm a fan of the 5 Ts, so when a woman says I'm just not that interested in sex anymore and this bothers me, remember those are the two things. They have to be not as interested, they have to have had interest at least once, so taking a 50-year-old who's never been interested in sex and thinking a pill is going to work, it's not going to work.

"So I had interest and now I don't." I say the 5 Ts are, Time - we are over extended. If you think you're going to have fast food sex the way you did when you were 20 you're not going to. You need to go for gourmet sex which means you have to plan it, you have to think about it, you have to tell your partner what makes you get in the mood. You need some time.

I think touch is important, the kind of quick sex where you didn't have that much time together physically, that's not going to work as you get older, so the right kind of touch.

Tenderness, try a little tenderness. There's a song about that. Women need emotional and physical tenderness before they're going to get in the boat and row with you.

Then trust. A lot of women say "I'm not interested but I haven't been interested since my husband had an affair with that woman down the street," well I can't blame you. So is there trust? Are you angry with your partner? Do you have some inner hostilities and you just don't want to have sex with them? So what are the reasons going on?

What I often hear is "I just am not that interested anymore." "Well tell me about your relationship with your husband." "Well we've been together for 20 years and he's my best friend." Well you know, you just don't have sex with your best friend. So having that kind of relationship evolve is great for the marriage, that they're now best friends, but it's not great for sex. The sex needs something a little bit different.

Interviewer: So if it doesn't bother your patient, then there's not a problem?

Dr. Jones: No.

Interviewer: And before you would recommend this pill you might recommend the 5 Ts that you've talked about.

Dr. Jones: Right, and I usually recommend taking some time out for each other. I ask them, what kind of pattern of intimacy do you have when you and your partner go on vacation? "Oh yeah, when we're away we have great hotel sex." Well, there are no kids around, there are no dishes, and definitely no bills, you're in a brand new bed, it's a new place. So that's a suggestion. But if women say, "I don't want to do all that thing," it's like dieting and exercise, "Just give me a pill doctor so I can lose weight, just give me a pill."

What I am afraid of is that I will get calls from husbands, "I want you to fix my wife. I want you to give her that pill." So if this is being driven by the partner, I need to get buy-in by my patient that she's really interested, because she may have some side effects. And if she's really not interested in becoming interested, then this is not for her. If she's interested in becoming interested, I think it's worth a try for a couple of weeks. And if she doesn't have significant side effects and it improves her intimate life, just thinking about sex makes people have sex more often, so the placebo effect can be significant.

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