August 19, 2015

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desire ›   FDA ›   flibanserin ›   HSDD ›  


Celebrating the First FDA-Approved Treatment for HSDD

The FDA’s announcement yesterday that they’ve approved flibanserin is huge for women. This is the first medication approved for treatment of hypoactive sexual desire disorder (HSDD), also called female sexual dysfunction (FSD) and, more recently, female sexual interest/arousal disorder (FSIAD—a new abbreviation!).

The multiple names for the condition we’re treating tell a story all by themselves. It’s been a long road to get sexual arousal issues for women the same attention as has been paid to erectile dysfunction in men, perhaps because the symptoms are less visible. The media coverage of the process, I’m hopeful, has had some educational effect, endorsing FSIAD as a real medical condition with real potential for treatments. I have new reason to be optimistic that this decision will lead to further developments in the field—because it’s been proven that it is possible to get a medical treatment in this arena through the FDA approval process.

This approval is great news for women who suffer from this specific medical diagnosis, for whom I, as a menopause care specialist, have had nothing to offer. It’s great news for their partners, who, along with the women, have some hope and optimism that the desire and passion they once shared may be restored to their relationships. I’ve heard from women in my practice about the double-whammy of their loss of desire: Not only do they miss their sexual selves, they regret the unintentional messages they’ve sent their partners.

I’m hopeful that hearing about this development will encourage more women to be frank with their health care providers. At least half of women will have sexual difficulty at some point, but far fewer of them will bring it up to their doctors. If they know there’s a possible treatment, perhaps women will have more motivation to ask. I haven’t seen a study, but I’d be willing to bet that more men asked doctors about erectile dysfunction when they’d heard Viagra was available.

Together with my patients facing the FSIAD diagnosis, I can have a conversation about the potential benefits and side effects of this medication. We can make a plan of action. The women I serve aren’t expecting miracles; any possibility of even a modest improvement will be life-changing for them.

As a doctor, I'll now have something to say after "no, it's not all in your head" and "I'm sorry." I can't wait.

August 13, 2015

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desire ›   FDA ›   flibanserin ›   HSDD ›  


Watching for Herstory to Be Made

Even though I’m a medical doctor, I’m not accustomed to watching the Food and Drug Administration’s actions as closely as I have the past few months. If you’ve followed this blog, you know that last October, I traveled to Washington DC for a public hearing and then a workshop of women’s health experts. The FDA sponsored the events to hear about women’s sexual health and to examine how they might respond.

And then in June, an advisory committee to the FDA recommended the approval of flibanserin, a medical treatment to address hypoactive sexual desire disorder (HSDD). The FDA is poised to announce its decision next week.

It’s been a long road. I first wrote about flibanserin back in 2010, when the company that had developed fibanserin shelved it, saying that it didn’t have sufficient “potential to make it to market.” There’s been controversy about the HSDD diagnosis, although it was first medically characterized in 1977 in the Journal of Sex and Marital Therapy and is listed in the International Classification of Diseases.

More important to me than those scientific listings are specific women I’ve seen in my practice. They’ve had satisfying sex lives. They love their partners. They want to want intimacy. They don’t have psychological problems, relationship issues, social hang-ups, or a medical problem—beyond HSDD. Brain scans show different activity and structure in women with HSDD, proving the biological component.

As their doctor, I want to offer them options to reclaim the life they want, which includes intimacy. It’s up to each woman to decide which of the options she’d like to try, and then to determine whether each option is working for her.

Beyond the approval of this one pharmaceutical product, the FDA’s action is, I hope, a signal for a bright future. When I was there in October, I heard that the agency “recognizes that this [female sexual dysfunction, or FSD] is a condition that can greatly impact the quality of life,” and that “the FDA is committed to supporting the development of drug therapies for FSD.”

As a physician, I’m committed to the least invasive, simplest solution for each woman. But when that simplest solution doesn’t work, I’m deeply grateful for well-tested, thoroughly researched pharmaceutical options that help women restore the fullness of their lives.

June 08, 2015

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fda ›   flibanserin ›   hsdd ›  


Taking a Moment to Celebrate

Last week, an advisory committee to the Food and Drug Administration made history. Or, as the Even The Score folks have been hashtagging, Herstory.

They recommended that the FDA approve flibanserin, which is a pharmaceutical product intended to address hypoactive sexual desire disorder (HSDD). There were a number of concerns voiced, and some cautions will likely be recommended, including caution with interactions with alcohol and while driving.

Sally Greenberg, National Consumers League executive director, was quoted in The Washington Post as saying, “I think this is a huge moment for women’s sexual health, in the way that the pill was for women’s sexual health and ability to control their own destiny.” The Wall Street Journal article on the FDA panel said “… the panel’s vote marks a turning point in women’s health.”

I’m celebrating. This particular drug will not be the silver bullet for all women with HSDD, but I’m hopeful that we have turned the corner that the Wall Street Journal reporter envisioned. HSDD has been recognized as a legitimate health problem, and this panel of the FDA has accepted evidence that brain chemistry is a factor (as it is with depression and other mood disorders).

As a medical practitioner, I know that every woman is different, and no treatment will be perfect for everyone. Each woman has her own medical history, her own values, her own desires, her own trade-offs, her own attitudes toward medical treatments—and, for that matter, toward sex. Having options to choose among helps each woman to navigate challenges as she prefers.

The FDA is expected to take action on flibanserin in August. I’m hopeful that after that, I’ll have an option to offer women who have lost desire. And I’m hopeful that having seen this hurdle overcome, other researchers will add to our armorarium so we have even more choices to offer.

The Flibanserin Decision: Is the FDA Condescending to Women?

I have had women in my office, losing sleep, depressed, miserable, because the lack of intimacy where it is wanted can have a domino effect, destroying communication, trust, a couple, a family. For these women, overcoming our ancient biological responses to stress — in a modern world where stress is constant — is what they want and need, and as a doctor, I would like to be able to help them. View full article →