In this 2013 file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals. The FDA recommended  approval of the "female Viagra," though critics aren't convinced the pill will actually work.

In this 2013 file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals. The FDA recommended approval of the "female Viagra," though critics aren't convinced the pill will actually work.

Last week, an FDA panel recommended the approval of the first drug to treat low sexual desire in women. The FDA has rejected the drug – called flibanserin – multiple times, in part due to concerns over severe side effects like fainting and nausea. Now, the drug could be available within months. Some doctors insist flibanserin is a long-overdue solution for the many woman struggling with low libido. But questions persist about the drug’s effectiveness, and whether a pill is even the answer for women who feel something is wrong with their level of sexual desire. We look at the risks and benefits of so-called Viagra for women.

Guests

  • Dr. Adriane Fugh-Berman director of PharmedOut, a research and education project at Georgetown University Medical Center; associate professor of pharmacology and physiology, Georgetown University
  • Dr. James A. Simon clinical professor of obstetrics and gynecology, The George Washington University School of Medicine; sexual dysfunction expert
  • Dr. Jennifer Berman urologist and sexual health expert; co-host of the Emmy Award-winning talk show "The Doctors"
  • Emily Nagoski director of wellness education at Smith College; author of the new book “Come As You Are: The Surprising New Science That Will Transform Your Sex Life”

Transcript

  • 10:06:53

    MS. DIANE REHMThanks for joining us. I'm Diane Rehm. Prescription medication for male sexual dysfunction has been available for years, but there's no FDA approved drug available for women who complain of low libido. Many suffering from a lack of sexual desire are hoping a new little pink pill will be the answer. Some doctors rejoice at the possibility. Others say the risks are too high and the benefits too little.

  • 10:07:27

    MS. DIANE REHMHere with me, Dr. Adriane Fugh-Berman of Georgetown University and Dr. James Simon of the George Washington University School of Medicine. Joining us from the studios of NPR West in Culver City, California, urologist and sex health expert, Dr. Jennifer Berman and from Minneapolis, Minnesota, Emily Nagoski of Smith College.

  • 10:07:56

    MS. DIANE REHMAnd throughout the hour, I'm sure many of you will want to join us. Feel free to call us at 800-433-8850. Send an email to drshow@wamu.org. Follow us on Facebook or send us a tweet. And thank you all for being with us.

  • 10:08:17

    DR. JAMES A. SIMONThank you for having me.

  • 10:08:18

    DR. ADRIANE FUGH-BERMANThank you.

  • 10:08:18

    DR. JENNIFER BERMANThank you, Diane.

  • 10:08:20

    REHMGood to have you all. Dr. Jennifer Berman, let me start with you. Tell us about the condition we're dealing with. Describe for us hypoactive sexual desire disorder.

  • 10:08:37

    BERMANGood question to start with. Hypoactive sexual desire is a persistent or recurring lack of sexual interest, lack of desire to be sexual, lack of motivation or initiative to be sexual, lack of sexual thoughts, lack of sexual fantasies, lack of desire to be -- to engage in sexual activity of any kind. Oftentimes women will avoid any form of intimacy with their partner, touching, holding hands, kissing for fear that it will ultimately lead to the expectation of sex.

  • 10:09:13

    BERMANIn this case, the patients were determined to have secondary hypoactive sexual desire disorder, meaning -- and this is one of the things that's a little bit confusing and concerning to me, meaning that at some point in time in their lives, they were satisfied with their level of sexual desire, that they did have sexual interest, desire and fantasies, but for some reason, and what they've identified in the criteria of the study, not due to medical reasons that they can be identified, they are now not experiencing or suffering, with distress, from low sexual desire.

  • 10:09:57

    REHMAnd how many of your patients would you say are suffering from this problem? What percentage?

  • 10:10:08

    BERMANWell, 43 percent of American women at the time the initial study was done suffer from some form of sexual functioning complaints. Low sexual desire is, in my clinical practice and in clinical studies, is the most common sexual function complaint that women have. And it is disabling and it is distressing and it does affect a lot of women. So I see this frequently in my practice and I would say, at least in my experience, low desire and pain are the two most common sexual function complaints that I see.

  • 10:10:42

    REHMAnd turning to you, Emily Nagoski, you're director of wellness education at Smith College and you're the author of the new book, "Come As You Are: The Surprising New Science That Will Transform Your Sex Life." Why do you think this condition is so distressing for women?

  • 10:11:10

    DR. EMILY NAGOSKII think the reason it's distressing is that all of us have grown up being told that the normal way to experience sexual desire is spontaneous, out of the blue anticipation of pleasure. And so when that goes away, we feel like we're broken, like we must be doing something wrong. It must be something wrong with our bodies. We start to criticize ourselves. It disrupts our relationships and it can be really disabling. And it turns out, over the last 20 years of research, what we've found is that there's another normal, healthy way to experience desire, called responsive desire, that emerges in response to pleasure, rather than in anticipation of pleasure.

  • 10:11:55

    DR. EMILY NAGOSKIAnd some of the women who are participating in the drug trial had intact responsive desire, but because they didn't know that was normal, they were really self critical. They didn't know what to do.

  • 10:12:09

    REHMI'm not sure I understand the distinction you're making here. Are you saying that their sexual desire comes as a response to stimulation and does not simply arise within themselves?

  • 10:12:29

    NAGOSKIRight. So you're in a sort of neutral state of mind, but you've set up a date night with your certain special someone and you put yourself in that situation and the pleasure of touching your partner's skin when you both love, trust and respect each other causes the desire to emerge in response to the pleasure, which is complicated if it doesn't...

  • 10:12:49

    BERMANBut Emily, would you call that...

  • 10:12:51

    REHMOkay.

  • 10:12:52

    BERMANWould you call that -- this is Jennifer speaking, sorry. Would you call that hypoactive sexual desire disorder, the responsive desire, if it's secondary to...

  • 10:12:59

    NAGOSKINo. Well, so according to the definition of HSDD, yes, it is, which is why, in the American Psychiatric Association's diagnostic and statistical manual, they changed the diagnosis to female sexual interest and arousal disorder, which does exclude responsive desire and recognizes that it's a normal variation on the ways people can experience desire.

  • 10:13:22

    REHMAll right. I want to hear about the drug, flibanserin, from you, Dr. Simon. Talk about how it works to treat hypoactive sexual desire disorder.

  • 10:13:36

    SIMONSo, Diane, first, we need to make sure that we aren't mixing our metaphors here. The women in the studies did not have responsive desire. Responsive desire, as Ms. Nagoski said, is a normal variant. The women in the study had no desire, no spontaneous desire, no reactive desire, no spontaneous desire, no sexual thoughts and fantasies. They were -- those issues were excluded if the investigator correctly identified the patients.

  • 10:14:09

    SIMONAnd that's an important distinction. These women just did not have it. And it couldn't be explained by anything else, drugs, the relationship, all of those secondary issues were examined in detail. And if there were relationship issues or medications or situations that cause them not to be interested in sex, they were excluded from the studies. It's an important point. HSDD is a relatively narrow definition and that's what was investigated with flibanserin.

  • 10:14:49

    REHMSo how is success with this drug measured?

  • 10:14:54

    SIMONSo the success was measured, in the most recent studies, in three ways. First, the number of sexual events that the women engaged in, second, their measure of desire on a validated scale called the FSFI, the Female Sexual Function Index, and third, a decrease in their distress over having low desire as measure by a different validated scale on distress. So increasing desire, decreasing distress resulting in more sexual events.

  • 10:15:36

    REHMAnd to you, Dr. Fugh-Berman, you've been vocally opposed to the approval of this drug. Tell us why.

  • 10:15:46

    FUGH-BERMANWell, hypoactive sexual desire disorder was actually created by pharmaceutical companies and certainly some women have low libido and may even be distressed by that, but what is low libido? There actually is not a scientific norm for what is normal sexual feelings, desire or behavior that -- these trials -- the women in the trials actually were having two to three sexual satisfying events per month. There was one woman who was having 34 of them. So how can someone be diagnosed with a disease if they're having 34 sexual satisfying events a month?

  • 10:16:32

    BERMANWell, you just said it's a continuum so for every woman, it's different. And for that woman, that may be lower. But I just have...

  • 10:16:39

    FUGH-BERMANBut this isn't a disease at all.

  • 10:16:39

    REHMExcuse me, Dr. Berman. Let's let Dr. Fugh-Berman continue because I want to ask you, Dr. Fugh-Berman, about a piece on the op-ed page of this morning's Washington Post by two doctors at the Dartmouth Institute For Health Policy. They say -- the headline says, "Sell The Disease To Sell The Drug." Are you saying we are creating a disease to be treated with a pill out of a normal condition?

  • 10:17:23

    FUGH-BERMANThat's absolutely true. This is one of many diseases that have been invented by pharmaceutical companies in order to sell targeted drugs. So other ones include social anxiety disorder, for example, premenstrual dysphoric disorder, osteopenia. There have been a variety of diseases, gastroesophogeal reflux disorder, that have been created by pharmaceutical companies to sell drugs.

  • 10:17:46

    REHMAnd as I understand it, this drug was originally created for depression and it was found that it created a greater sexual desire in woman and that is why it's now being marketed this way. Short break here, more comments and your calls, emails when we come back. Stay with us.

  • 10:20:02

    REHMAnd in this hour, we're talking about flibanserin, the new drug that the FDA has given tentative approval toward helping women who feel that they are not active sexually, that their sex desire is low and flibanserin is said to help stimulate that desire. However, there are concerns about both nausea and fainting. Interesting to me that more than a year ago The Washington Post published a story that said couples who share housework have the most sex and the best sex lives. It turns out, using recent data, that couples who split the housework fairly are the happiest between the sheets. They have the most sex, are the most satisfied with their sex lives and express the highest level of sexual intimacy.

  • 10:21:23

    REHMWe have an email from Washington, D.C., from Judy, who says, "Viagra and similar male pills address a physical inability to get or maintain an erection. That to me is very different from increasing one's desire. Does the female pill increase feelings? Or does it correct a physical disorder? Or is desire being used to describe something physical?" Dr. Jennifer Berman.

  • 10:22:07

    BERMANThat's a very, very, very good question and a profound question at that. And that -- in that, lies the root of all the challenge that the FDA and physicians and all of us are having in terms of objectifying and quantifying a subjective feeling. What -- desire is a individualized feeling or emotion linked to a thought. And that is -- and we're trying to quantify that in a lab. So that is part of the challenge. And we've developed validated instruments and questionnaires and diaries and retrospective diaries and daily diaries and indices and distress scales to try and measure that. But therein lies the challenge. And that's why it's cost, you know, it's cost time and effort and a huge amount of money just to get to that point.

  • 10:22:56

    REHMSure. So -- so today, Dr. Berman, in the absence of flibanserin, what are you able to do for your patients?

  • 10:23:08

    BERMANI'll tell you that. But I do want to make one comment about a -- the pharmaceutical companies' allegedly developing this disease. That's not necessarily true because I was on the consensus panel in 1998 where a group of physicians passionate about this field sat in a room for hours, if not days, developing the criteria for female sexual function complaints, HSDD being one of seven. So it wasn't the pharmaceutical companies that created, it was doctors out of the need who saw this in their patients, who believed that sexual function complaints are not all in women's heads. It's not all because they're stressed or crazy or don't like their husbands. There are real medical, physical reasons why women experience these complaints.

  • 10:23:53

    BERMANIn terms of what we have available now, there is nothing that's FDA approved for low libido at this time. However, there, you know, in my patients, the reasons why women experience low desire, assuming that they're not emotional or relational issues -- history of sexual abuse or trauma or whatever, their medications that patients take, hormonal imbalances...

  • 10:24:16

    REHMSure.

  • 10:24:17

    BERMAN...changes in fluctuating hormone levels...

  • 10:24:19

    REHMAll right.

  • 10:24:20

    BERMAN...prior pelvic surgery or removal of the ovaries. But I want to say, what's challenging to me about this very, very select group of women -- and I've been doing this for 20 years and I know those women -- those women tend to be very self-critical, less resilient, they don't bounce back quickly, they're worriers, they're anxious. So we're -- so the low libido is the tip of the iceberg in this...

  • 10:24:46

    REHMAll right.

  • 10:24:47

    BERMAN...in this group of women, in my opinion.

  • 10:24:48

    REHMDr. Fugh-Berman, I know you want to make a comment about that meeting.

  • 10:24:54

    FUGH-BERMANYeah, the meeting that Dr. Berman refers to is actually an industry-funded meeting with people who are taking money from the industry. And in fact, marketing for a drug starts seven to ten years before a drug comes on the market. Because it's not illegal to sell a disease before a drug is marketed but it is illegal to sell a drug before it's marketed. And in this case, with flibanserin, they created a PR campaign called Even the Score and have convinced some congresswomen and consumers to come before the -- to write letters to the FDA and come before the FDA.

  • 10:25:32

    FUGH-BERMANBut really, this is a public relations campaign. They've co-opted the language of feminism, even though this is not feminist at all. Not only is Sprout's board of directors entirely male, but it's really not -- this is a couples problem. And it's being cast as something that's wrong with a woman, when really this is a couples problem. And I think that what Dr. Berman just said about this being the tip of the iceberg is really true. That there are women who suffer, for example, from depression or anxiety or medical problems that can lower libido. A very big contributor is drugs -- antidepressants, some blood pressure medications, antipsychotics can lower libido. So in those case, medication management is the most important thing, or counseling.

  • 10:26:24

    REHMAnd, Dr. Simon, I gather you were involved in the clinical trials. You are very pro flibanserin.

  • 10:26:34

    SIMONThe record is a mess on your show today, Diane. HSDD has a very specific definition. The definition has been codified for 40 years, long before Dr. Berman and I came on the scene. It was originally described by a psychiatrist in New York because, as many of your listeners know, Masters and Johnson, who described the female sexual response, were only in the lab looking at how women responded. Desire was not part of their study. So Dr. Kaplan, Helen Singer Kaplan, added this to the normal female sexual response cycle. And that's where it came from. And it's been in the DSM long before the changes, most recently, in the DSM-5.

  • 10:27:33

    REHMAll right. Let's go to Emily Nagoski.

  • 10:27:37

    NAGOSKIYes. And it was removed from the DSM because the science in the 40 years that followed the definition of HSDD showed us that we were wrong, in the same way that we used to have homosexuality in the DSM. And it turns out we were wrong about the way -- about that being a disease. So the science changes. And I know for sure that people with responsive desire were not ruled out in a systematic empirical way, because there is not a survey instrument or questionnaire that can effectively do that. I was talking to a researcher yesterday morning, Kristen Mark at the University of Kentucky, who's working on developing such an instrument. But until we have that, we don't have a consistent way of ruling them out of the drug trials.

  • 10:28:20

    NAGOSKIAnd also I've talked to one of the women and I've read interviews with several of them and they, themselves, say, once I got there, it was great. But it was getting there that was the hard part.

  • 10:28:32

    REHMDr. Fugh-Berman.

  • 10:28:34

    NAGOSKIOh, also, it's Dr. Nagoski, just for the record.

  • 10:28:37

    REHMOh, forgive me. Okay.

  • 10:28:39

    FUGH-BERMANThat's a great point, that the questionnaires that have been used have been developed by industry, including the FSFI. And the standard in the FSFI for sexual desire, if you only feel sexual desire for 50 percent of your waking hours, you only score a three out of five on that scale. It seems like an unreasonable standard. Scoring any higher or even scoring a three seems kind of inconsistent with having a job.

  • 10:29:09

    REHMSo, Dr. Simon, how do you treat women who come to you with this complaint: low feelings of sexual energy?

  • 10:29:23

    SIMONSo it really depends what they have. If they have a bad relationship, we send them for relationship counseling or individual therapy. If they're on a medication, as Dr. Fugh-Berman suggested, like an antidepressant, certain antihypertensives -- these are some of the most commonly prescribed medications to women -- we either try and wean them off or modify which ones they're on. Certain of those antidepressives, for example, have much greater sexual side effects than others and some have few or no sexual side effects. Once we're gotten rid of all the wheat, all the chaff and are down to the wheat of a woman who just does not have sexual desire, no...

  • 10:30:12

    REHMWhat percentage would that be?

  • 10:30:15

    SIMONI think it's around 4 to 7 percent. And the literature would agree with me. These are women for whom there is no other explanation. A switch went off in their brains and there is no spontaneous, no reactive sexual desire. And this is causing distress. It has to cause distress in the couple or has to cause distress for that woman. If it's just a relationship issue, then the answer is relationship counseling. But this is, as was said, a relationship issue and it has to be handled on its root cause. If it's a root cause of HSDD, right now we don't have anything that's FDA approved to treat them.

  • 10:31:04

    REHMDr. Fugh-Berman.

  • 10:31:05

    FUGH-BERMANWell, therapy has really been shown to help and psychosexual education. So seeing a sex therapist can be extremely helpful.

  • 10:31:13

    REHMHow so?

  • 10:31:15

    FUGH-BERMANWell, there's different -- I mean, you do have to deal with relationship issues, certainly.

  • 10:31:20

    REHMOf course.

  • 10:31:20

    FUGH-BERMANBut sometimes people just actually need some tips on...

  • 10:31:27

    REHMSome education, perhaps.

  • 10:31:28

    FUGH-BERMANSome education, adding some creativity.

  • 10:31:31

    REHMYeah.

  • 10:31:31

    FUGH-BERMANYeah. So the...

  • 10:31:34

    REHMI can certainly understand that. Dr. Nagoski.

  • 10:31:38

    NAGOSKISome of the most evidenced-based interventions for helping women who are experiencing low desire are mindfulness interventions. Lori Brotto's research is really, really great around this. That FSFI instrument that was mentioned previously, the increase in those scores from doing mindfulness and psycho-educational interventions are much higher than the FSFI outcome scores for flibanserin. So it's actually more effective. And the reason it's effective is because it teaches people to put pleasure, sensation at the center of their definition of sexual wellbeing, instead of wanting or craving.

  • 10:32:17

    REHMSo, Dr. Simon, flibanserin on a test basis?

  • 10:32:26

    SIMONSo the studies on flibanserin have completed. They're not currently being done. We are currently investigating some other medications for this disorder. But I want to correct something. Nagoski said, mindfulness works better than...

  • 10:32:44

    REHMDr. Nagoski.

  • 10:32:45

    SIMONDr. Nagoski said mindfulness works better than flibanserin. It's never been directly compared. So let's be very careful with our metaphors here.

  • 10:32:56

    REHMAre you...

  • 10:32:56

    SIMONI believe that mindfulness...

  • 10:32:57

    REHM...are you disagreeing with that, Dr. -- excuse me.

  • 10:33:00

    FUGH-BERMANIt should be compared to therapy. There were almost no patients in the flibanserin trials, of thousands of women, there were a couple of dozen who had even tried therapy. They were excluded if they were on therapy, if -- within the last 12 weeks, so they couldn't even enter the study. Anyone in individual therapy, couples therapy, any other form of therapy within the last 12 weeks, if they just started, were excluded.

  • 10:33:21

    REHMAll right. And you're listening to "The Diane Rehm Show." Go ahead and finish, Dr. Simon.

  • 10:33:29

    SIMONSo the reason they were excluded was that someone, a health professional, made the judgment that psychotherapy or sex therapy or sexual education was the problem. Those people who needed medication because they didn't need psychotherapy, their relationships were fine, their sexual function had been fine in the past and now it's not, those were the people that were in the trials. We keep mixing up all kinds of stuff here. The people in the trials were a very selected group where no other explanation could be found for their low sexual desire.

  • 10:34:19

    REHMDr. Nagoski, do you want to add to that?

  • 10:34:23

    NAGOSKIYes. So even the women in the trial, though they were selected for -- in a very specific way, were brought up in a culture that tells us that how much you want or crave sex, spontaneously, out of the blue, how much you anticipate pleasure is the definition of what it means to be a sexually healthy person. And what therapy does, what all of the other treatments do, especially sexuality education, is asks people to consider what would happen if we let go of the idea of desire outright and just considered pleasure, what feels good inside your body, and let desire emerge from the pleasure.

  • 10:35:05

    REHMDr. Fugh-Berman, do you want to add. Yeah, that's really good. I mean, I think that they excluded therapy because it works. It would be a confounder to the study if they actually included women -- there are many studies showing that psychosexual education and therapy does help with low libido. And, you know, it's such a great point about flibanserin not working very well, either -- that if you look at women who even had a minimal response, there was only a 10 percent difference between women on placebo and women on flibanserin. Libido is a very placebo-responsive condition. A lot of women will respond to placebo. And flibanserin doesn't work much better than that.

  • 10:35:46

    REHMWhat about that, Dr. Simon? Only a 10 percent difference?

  • 10:35:51

    SIMONSo the question really is, do women respond to flibanserin or do they respond to placebo? And they respond to both. And that's not different than in studies of depression, anxiety, any other central nervous system disorder, has a high placebo effect. This is built into the studies that are approved by the FDA because it's well known and well characterized.

  • 10:36:21

    REHMBut it does make me wonder whether, if I were a woman seeking a greater response, a greater sexual initiation, whether flibanserin and a placebo are going to be much different, if there's only 10 percent.

  • 10:36:44

    SIMONWell, let's do some simple math. As was said, the women in the trials were having two to three events -- sexual events a month, without any desire. And that's because women have sex for a variety of reasons, notwithstanding low desire. They keep the peace -- we even have a name for it in the scientific literature, we call it mercy sex or duty sex, but they weren't interested. Remember, these are women who have no desire to have sex. So they're having it two to three times a month. So let's just take an average of 2.5. If it's 2.5 and then placebo adds another event a month, and we told them they should have one extra event a month, that's 3.5.

  • 10:37:39

    REHMAll right. Short break. And your calls when we come back. Stay with us.

  • 10:40:02

    REHMWe're talking about the drug flibanserin, which the FDA is considering putting onto the market. There's been lots of discussion, lots of concern expressed on both sides. The FDA has been reluctant in the past to market this drug, to allow it to go on the market because of nausea, fainting, other side effects. Here's a tweet from Carol, who says, I was frigid while I was married. I didn't like my husband. Normal function after my divorce. How much, Dr. Nagoski, do you think this is relational and how much do you think a pill like flibanserin might help a woman who calls herself frigid while married?

  • 10:41:07

    NAGOSKII think context might be the single most important factor, and by context, I mean the external circumstances and the person's internal state. It's the trust in the relationship, the level of affection, the individual's mental health, whether or not she has positive body image. Having had a kid changes your whole relationship with your body and it you have to relearn what it means to live inside that body. The brain mechanism that governs sexual response has two parts. There's the sexual excitation system, the gas pedal and the sexual inhibition system, the brake.

  • 10:41:43

    NAGOSKIAnd when people struggle with sexual desire, it's usually because there's too much activation of the brake. So, when people can figure out what it is that's hitting the brake, they can change their context and take control of it. And increase their sexual arousal. Not liking your husband is a pretty big brake hitter.

  • 10:42:01

    REHMAll right. And here's an email from Jaime in Arlington, Virginia. She says, I'm only 30, getting married to the world's most wonderful man this summer. I've ruled out all medical, medication related issues, yet I still suffer from this condition. I feel intense guilt from my complete lack of desire. In order to have intercourse, I have to just force myself to do it, despite really not wanting to. After it's over, yes, I experience responsive sexual pleasure, but it's not okay that I have to force myself into intercourse. This should not be acceptable, in my opinion. Dr. Simon, do you think flibanserin would help Jaime?

  • 10:43:06

    SIMONNo, I'm not clear. I would need much more information to make a recommendation or a decision about a particular patient. The patient you spoke of before who was texting and who had a bad relationship and was getting divorced. A, flibanserin wouldn't help her, and B, she would have been excluded from the studies as having a bad relationship.

  • 10:43:33

    REHMAnd Dr. Berman, this for you from Mitch in Unison, Virginia. He says, I'm very concerned that this new drug is ripe for abuse. It sounds to me like the companion drug to Viagra. Men take Viagra and then either pressure or trick women into taking this drug. What do you think?

  • 10:44:03

    BERMANWell, the issue is that this is a medication that's taken on a daily basis, so it's not on an as needed, you know, pop a few pills and then go expect your libido to change. So, it is something that's taken daily. The concern is if -- my concern was for people that had taken too much or don't take it as prescribed and what happens is that the side effects increase. So, hopefully, the motivation to abuse or overuse or slip someone this drug is going to be extremely low, because the side effect profile's going to increase.

  • 10:44:35

    BERMANSo, it's not, we're -- that said, when we're altering brain chemistry, and this drug not only decreases serotonin levels, but allegedly activates dopamine levels in the brain. We've seen what's happened with people on the Parkinsonian drugs that increase dopamine, increase compulsive behavior, sexually addictive behaviors, gambling behaviors. I mean, I'm not saying that's what's going to happen here, but that is my -- one of my concerns when we're altering brain chemistry.

  • 10:45:00

    REHMInteresting. Dr. Fugh-Berman.

  • 10:45:03

    FUGH-BERMANYeah, great points. And also, you know, could this actually inhibit communication if there is a pill that can be taken for this and this pill causes heavy sedation. I have a great quote from Cosmo in 1956 that said about Milltown, that it helped frigid women who abhorred marital relations. They reported they responded more readily to their husband's advances. How much of the benefits of this pill is really due to sedation, which is equivalent, according to what the FDA said, to about four drinks.

  • 10:45:35

    FUGH-BERMANAnd by the way, it's dangerous to combine it with alcohol, and there are more adverse effects in women who are taking birth control pills or many other commonly used medications, like migraine medications, for example.

  • 10:45:48

    REHMDr. Nagoski.

  • 10:45:51

    NAGOSKIA less sketchy way of thinking about that, there was a paper that was just published that showed that one extra hour of sleep per night increased your odds of having sex the following night by 15 percent. So, I have wondered if we can attribute the efficacy of flibanserin to people getting better sleep.

  • 10:46:09

    REHMInteresting. The op-ed piece I referred to earlier in today's Washington Post, by two professors of medicine at Dartmouth, begins this way. Seven years, at least 25 million prescriptions and 9.7 billion in sales. Too late, the FDA is finally pushing back against the overprescribing of testosterone. Last month, in response to new FDA rules, testosterone manufacturers released new instructions for doctors, making it clear that testosterone is not approved for low T, a marketing term developed by drug companies to describe men with low testosterone levels caused by aging.

  • 10:47:17

    REHMCompanies must now warn doctors about a possible increased risk of heart attack and stroke in men who take these drugs. Seven years from now, Dr. Simon, are you at all concerned that we might find use of, whatever it is, flibanserin, really causing certain problems?

  • 10:47:48

    SIMONSo, flibanserin has been studied in more than 11,000 women. This makes it one of the better studied drugs that have ever come through for women. It's a large database. While it's always possible that after perhaps millions of women are exposed to any medication that a new side effect will emerge, it's less likely when you have a very robust development program.

  • 10:48:16

    REHMWhat do you think, Dr. Fugh-Berman, and you had your mouth wide open when he used the figure of 11,000.

  • 10:48:25

    FUGH-BERMANWell, we don't need more information on the adverse effects. This drug caused so many adverse effects in the clinical trials that I'm not sure that the FDA would have approved it if it cured cancer. That especially combined with alcohol. For example, 92 percent of the people in the alcohol study, most of whom were men, by the way. 23 out of 25 of them were men, had an adverse effect. When they did some drug interaction studies, they actually couldn't finish the studies because the adverse effects were so high. And while some people have characterized the fainting as being minor, it is not.

  • 10:49:00

    FUGH-BERMANPeople have fallen unconscious. One person had a concussion. People have had to be taken to the hospital with extremely low blood pressure and required medical intervention. And that's in a healthy population, that clinical trials populations tend to be the healthiest. When we start using this in a general population with some medical problems. Women taking drugs, we are going to see an epidemic of adverse effects.

  • 10:49:23

    REHMAll right, let's open the phones. We'll go first to Venice, Florida. Hi Nancy, you're on the air.

  • 10:49:32

    NANCYHi Diane. Thank you so much for taking my call.

  • 10:49:34

    REHMCertainly.

  • 10:49:35

    NANCYLoved listening to your show when I lived in the D.C. area.

  • 10:49:38

    REHMThank you.

  • 10:49:38

    NANCYAnd at that time, I participated in one of the clinical studies. The first one. It was with the first company that was developing this medication. The study had to end prematurely because of funding and after the study was all over with, I happened to come across the person that I had been dealing with. And she let me know that interestingly enough, they knew who was taking the real medication and who was not. And I had always been reporting that my sex life and my marriage had improved tremendously. Now, I was around 52 at the time that this had happened and I had only been married for five years.

  • 10:50:24

    NANCYSo, I was still in the honeymoon stages of my relationship when my libido just died. I had no desire whatsoever, and that's why I participated in this study. I had no ill side effects, I was very disappointed that I wasn't allowed to take home any samples to continue using this because it did work for me. And it didn't make me sick. It didn't make me, in any way, shape or form, feel different except desire. I was physically ready to accept a sexual intercourse when it was initiated, either by myself or my husband.

  • 10:51:02

    REHMAll right, and Nancy, Nancy, tell me how you are now.

  • 10:51:08

    NANCYNot good. I've reverted back to having no desire and I've reverted back to performing what the one doctor said was mercy sex. It's very painful, it's something that I really don't get much enjoyment out of, and I'm so looking forward to this drug coming back on the market.

  • 10:51:29

    REHMAll right. Dr. Nagoski.

  • 10:51:32

    NAGOSKIWe have lived much too long in a culture that tells women that they need to put the -- sacrifice themselves on the altar of sex for their partners. When I talk about responsive desire, it's response to pleasure, what feels good. And if that is just skin to skin contact with your partner without intercourse, let that be what happens. If the other stuff doesn't feel good, it's not about doing what other people want and performing to other peoples' expectations. It's about noticing what sensations feel like in your body, which ones are pleasurable and doing more of that stuff.

  • 10:52:09

    NAGOSKILetting go of the expectations and the cultural narratives and just letting it be two people in a bad with their bodies loving each other.

  • 10:52:18

    REHMAll right. To Jane in Durham, North Carolina. You're on the air.

  • 10:52:24

    JANEThank you for taking my call. I would pay anything for this pill. I consider myself a feminist and as a feminist, I feel I deserve the right to define my sex life. I have little to no sexual desire. It may be related to anti-depressants. I've switched from SSRIs to SNRIs. If it is those, I'm not gonna stop taking them. And I want to be a sexual person.

  • 10:52:59

    REHMWhat do you say to her, Dr. Simon?

  • 10:53:00

    SIMONSo, there may be alternative medications that can take care of your depression, if that's what you're on. That may have a positive effect or a differential effect on your interest in sex. Women like you, who are on anti-depressants, were likewise not included in the study in an effort to keep the population that was under study, focused on HSDD as I've defined it. I also want to make sure that it's very clear that when we talk about mindfulness or education or sex therapy or whatever, the brains of women with HSDD are different from the brains of women who are normal.

  • 10:53:44

    REHMHow do we know that?

  • 10:53:46

    SIMONIt has been tested with functional MRI and pet scanning and they respond differently to erotic stimuli.

  • 10:53:56

    REHMAll right, and you're listening to "The Diane Rehm Show." Want to comment, Dr. Fugh-Berman?

  • 10:54:04

    FUGH-BERMANThere are a lot of problems with F-MRI, but emotions can effect brain chemicals. It's not clear where the direction of causation lies.

  • 10:54:14

    REHMAll right. To Andrew in Fort Meyers, Florida. You're on the air.

  • 10:54:20

    ANDREWThank you so much for taking the call.

  • 10:54:22

    REHMSure.

  • 10:54:22

    ANDREWMy wife and I, when we got married, we experienced some chemistry issues that was related to treatment that she has for bi-polar depression. She's on numerous medications and it has really suppressed her libido. Now, we've since gone back to sex therapists and relationship counseling and her physician's adjusted medications and stuff. And we've done all that stuff. But, you know, the mindfulness, and all these other coachings, sometimes they don't work, and I think that it's important that we look at medications in the aspect of it's not just a problem of the mind.

  • 10:55:03

    ANDREWIt's not just a problem of lack of arousal. Because, I mean, we've tried pretty much everything, and the first trick in the bag is always well, have you tried being mindful, have you tried these exercises? And there is an actual physical component. In her case, it's chemical, and I realize that this drug may not help, but, you know, it's a step in the right direction.

  • 10:55:23

    REHMDr. Fugh-Berman.

  • 10:55:26

    FUGH-BERMANYeah, that sounds like a bad medication, bad situation, but it's also, clearly, this is due to medication. And unfortunately, often, doctors are only aware of the newest branded medications. They don't necessarily think about older medications like Lithium, that are very effective for bi-polar disorder and may not have this effect. But I think it's important to note that this drug has a very high level of drug interactions. It actually should not be used with anti-depressants, antibiotics. There is a higher level of adverse effects, even with the birth control pill.

  • 10:55:58

    FUGH-BERMANThis drug is a big interactor, so it's not at all clear that it would be a good idea. In fact, it sounds like it would be a very bad idea to mix it with other medications.

  • 10:56:04

    REHMDo you agree, Dr. Simon?

  • 10:56:06

    SIMONSo, the human body metabolizes drugs in very predictable ways. And when multiple drugs are used, whether it's birth control pills or alcohol, or drugs that directly interact, sometimes, one of those drugs is metabolized slower and there may be more side effects. That's not new, that's not unique to flibanserin, and I'm positive there will be warning labels, as suggested by the FDA advisory committee, about the use of flibanserin with alcohol and other drugs where it's known to interact.

  • 10:56:44

    REHMDo you, Dr. Fugh-Berman, believe the FDA will approve this drug?

  • 10:56:52

    FUGH-BERMANWe're hoping it doesn't. They usually take the advice of their advisory committees, but not always. The FDA's very concerned about the safety hazards of this drug. They've already turned it down, and we're hoping that they turn it down for a third time.

  • 10:57:07

    REHMAll right. We'll have to leave it at that. Dr. Adriane Fugh-Berman of Georgetown University Medical Center. Dr. James Simon of George Washington University. Dr. Jennifer Berman, she's co-host of the Emmy award winning talk show, "The Doctors." And Dr. Emily Nagoski at Smith College. Thank you all. Thanks for listening. I'm Diane Rehm.

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