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.

Loss of Desire Is Real

The conversation about women’s sexual health has continued, sometimes with heat, sometimes with light. For the first time I can remember, the International Society for the Study of Women’s Sexual Health, of which I’m a member, responded directly to a New York Times op ed piece, calling it false and demeaning (The New York Times published a number of responses this weekend).

I’m grateful to my colleagues who are setting the record straight.

As a practicing physician, I have conversations every day with women who are navigating changes in and challenges to the intimacy they want.

Some women have no problem wanting sex. They may encounter pain with intercourse, diminished capacity, or more difficulty experiencing orgasm. As a doctor, I have plenty of treatments options I can recommend and see what works best. Many of the options are neither prescription-only nor pharmaceutical: moisturizers and lubricants, dilators, and vibrators can do a lot. If those don’t work, there are some drugs that could.

Other women, though, come to me because while they love their partners, they no longer get the sexual urge. They find it difficult to respond when their partners initiate. If I close my eyes, I can see their faces, hear the grief in their voices. They’ve told me about their own sense of loss, of incompleteness; they’ve told me their concerns about the unintended messages their partners are receiving; they’ve told me about their fears for their relationships.

And of course I do the obvious assessments, ask them the obvious questions, make the obvious suggestions. I check their overall health to see if there’s an underlying condition that could explain their loss. I check out—and ask them about—medications they’re taking, which sometimes have unintended consequences. I probe for signs of depression. I inquire about their relationships, alert to any clue that it may not be a healthy one.

And sometimes, I do find an underlying cause. I’m able to treat a medical problem, make a referral for counseling, provide compassion to a woman who acknowledges that a relationship is over.

But other times, there’s no apparent reason for a loss of desire. And for those women, it doesn’t occur to me to say “Nothing is wrong with your sex drive,” which is what the New York Times op ed piece asserted. If nothing were wrong, they wouldn’t be in my office, asking—sometimes pleading—for help.

There’s not a lot in my toolkit to respond to those women. And I’d like some options, because I think #womendeserve them. There have been very few silver bullets in my line of work—solutions that work all the time for every woman. I don’t expect that. I do firmly believe that women—with support from their health care providers—can make decisions about what might help them and the trade-offs that affect their quality of life.

Each woman can decide. For herself. From among options not limited by lack of priority or double standards at the FDA. And not limited by the opinions, however well-intentioned, of other women or men.

Repurposing Pharmaceuticals: “New” Drugs for Menopausal Symptoms

Low-fat mocha or chai tea latte? Caramel-cashew delight or plain vanilla?

Everyone likes choices. As a physician, I really like to have options in my toolkit. If one drug doesn’t work or causes unpleasant side effects, it’s nice to be able to offer my patients something else.

Recently, the FDA approved two new drugs for treatment of menopausal symptoms. Of course, they come with caveats, including questions on how truly effective they are, but I love having relatively safe options for my patients with unpleasant and sometimes difficult menopausal symptoms.

The ironic part is that both drugs are old friends in new packaging—one combines estrogen with a new non-hormonal compound; the other is an antidepressant that happens to be good at alleviating hot flashes.

The first, Duavee, was developed by Wyeth, a subsidiary of Pfizer, and came on the market last year. This drug takes a different approach to the traditional estrogen/progestin combo for women who still have their uterus. The estrogen part, Premarin in this case (called “conjugated estrogen”), eases the menopausal unpleasantness, while the progestin protects endometrial hyperplasia—the overgrowth of endometrial cells. (That’s why women who have undergone a hysterectomy can take estrogen-only drugs—they no longer have a uterus.)

Duavee replaces the progestin with bazedoxifene, a nonhormonal drug with the cumbersome classification of a selective estrogen receptor modulator or SERM. A SERM acts like estrogen in some tissues and it acts just the opposite in others, so bazedoxifene is also called an estrogen agonist/antagonist. It “selects” a tissue to either promote estrogen effects or block estrogen effects.

Yeah. Confusing. I know.

Here’s how Dr. Seibel, a well-known specialist in menopause and reproductive health, puts it, “The excitement about this medication is that bazedoxifene acts like a progestin, meaning it blocks the potential negative side effects of the Premarin [the estrogen component], but lets the Premarin continue to do its good stuff.”

The bazedoxifene component in Duavee does some other good stuff as well: It also protects against postmenopausal bone loss and “significantly increases bone mineral density,” according to Pharmacy Times.

So, according to the FDA, it can be prescribed for prevention of osteoporosis for at-risk women after other options without estrogen have been considered.

There are still risks to taking hormones, and the FDA still advises that, like any estrogen compound, Duavee be used at a low dosage for the shortest possible time for relief of menopausal symptoms.

For women who want to get away from hormones altogether, now there’s Brisdelle. Developed by Noven Therapeutics, Brisdelle is another old friend in new dress-up clothes—paroxetine, better known as Paxil. The “new” part is the very low dose.

Gynecologists have been aware for a while now that antidepressants can be helpful in relieving menopausal hot flashes, night sweats, and the sleeplessness associated with them. So sometimes we’ve prescribed antidepressants off-label.

The problem with that approach has been that the dosage for depression is higher than the dosage required for relief of menopausal symptoms (10 mg. rather than 7.5 mg.). The side-effects of that higher dosage can be weight gain and, god forbid, loss of libido. “The last thing a menopausal women needs is a drug that might sabotage her diet or an already waning sex drive,” says Dr. Streicher in this article.

Amen to that, sister.

With a dedicated drug like Brisdelle, you not only get the correct dosage to douse the flames of hot flashes, but you also avoid the confusion of being diagnosed with a completely different condition. A generic prescription for paroxetine would still be cheaper, but Brisdelle provides the right dosage for the right problem (hot flashes, not depression).

No drugs are perfect, but these two “new” drugs at least have a track record. They’re relatively safe and effective, and they add a couple of good options to the arsenal.

Nothing wrong with more choices, after all.

We Can Each Decide

In October, I traveled to Washington DC to participate in a public meeting and scientific workshop on female sexual dysfunction. The meetings came about because questions had been raised about whether the FDA was paying enough attention to women’s sexual health, and whether they’d set the bar higher for products for women than for comparable products for men (think Viagra or the 25 other prescription drugs for erectile dysfunction [ED]). ABC’s 20/20 found the meetings newsworthy enough to do a segment on the pursuit of “pink Viagra.”

I’m a pragmatic, Midwestern menopause care provider. I see women who are at all points of the spectrum from mild discomfort to despair. I make recommendations and write prescriptions for quite a range of options—from use of lubricants and vibrators to off-label testosterone. I certainly know that there’s no one-size-fits-all solution, no silver bullet, no magic pill that’s going to make every woman’s sexual experience legendary—or even comfortable.

As we’ve said before, women’s sexual desire, arousal, and response are complicated. Emotional security and intimacy, sexual history, and relationship satisfaction can make an already-complex reality even more difficult to untangle. Every woman deserves an individual approach. Every woman deserves a health care provider who can capably represent the options for treatment, when that’s needed—including describing the benefits and drawbacks. Every woman deserves to make her own choices to govern her quality of life—including her sex life.

So I watch with interest the discussion that’s transpired since the October meetings, reinforcing the messages I heard there. Sexual dysfunction is as real for women as for men. Yes, it’s true that some women find relief without pharmaceuticals. Yes, it’s true that there’s a profit motive for pharmaceutical companies. Yes, there’s a hazard in “medicalizing” women’s sexuality; we are not only biological systems. Yes, it often seems “pharma” is marketing out of control; I know I’ve seen enough ED commercials to last me the rest of my life.

And yet—if the FDA is charged with looking out for all of us, why wouldn’t that include women? And if they’re concerned with all health conditions, why wouldn’t that include sexual health? And if a pharmaceutical option is developed, and found by fair and rational standards to be both effective and healthful, why shouldn’t that option be made available to women who might choose to take advantage of it?

The FDA is accepting comments from the public—especially seeking insight from women who’ve suffered from sexual dysfunction—until December 29. You can read the questions in the FDA’s document online, and then submit your comments by clicking on the blue button at the right on this page on Regulations.gov.

Your story can help make clear what #WomenDeserve.

Think about What #WomenDeserve

This summer, in a blog post on the absence of pharmaceutical options for my treatment of women with hypoactive sexual desire disorder (HSDD), I said “I’m not in the room for the FDA discussions.” Thankfully, that’s about to change.

I’ve written here a number of times (as early as 2010 and as late as earlier this year) about the progress with the pursuit of “pink Viagra” and its frustrating setbacks. My message has consistently been that women’s sexuality is complicated, and no pill is going to fix everything for everyone.

But because of that very complication, as a physician, I value having options available. For one woman, simply thinking about intention and follow-through is enough to change the equation. For another, a combination of moisturizer, lubricant, and a powerful-enough vibrator is restorative. A third may require localized estrogen to rejuvenate tissues and restore comfort. You get the idea.

What that means is that the more options I have, the more likely I am to be able to work with a woman to maintain or restore the level of physical intimacy and sexual activity she wants. And I’m increasingly aware that while there are 26 drugs approved by the FDA for men’s erectile dysfunction, there is nothing that’s been approved for women facing comparable issues.

It’s not for want of trying. From the outside, it looks as though the bar is set higher for drugs for women than drugs for men. The side effects noted for drugs recently considered seemed more mild than that list we can all recite from hearing Viagra commercials since 1998. It doesn’t matter whether this is an intentional bias; what matters is that the FDA assure that it’s even-handed and supportive of women and their sexual health moving forward.

And that’s where the change comes in. Later this month, I’ll be traveling to Washington, DC, to attend a public hearing and then a workshop of women’s health experts, both intended to establish the reality of women’s experience (43 percent of us suffer from some sexual dysfunction!) and how the FDA can productively respond.

You can lend your voice to the proceedings. There’s a consortium of us who are concerned with women’s sexual health. We’re gathering signatures to a petition so that it’s clear to the FDA when we meet that this is a real problem, suffered by real women who seek a range of solutions. Add your voice at EvenTheScore.org or sign the #WomenDeserve petition at Change.org. Follow the discussion at the WomenDeserve Facebook community.

And I’ll keep you posted on the progress your voice has supported!

Still Seeking Options

We’ve been following the development of Flibanserin, also called “pink Viagra,” since 2010, when its developer shelved it after hitting a bump in the road to FDA approval. Several years later, we were talking about alternatives, Librido and Lybridos, which were moving forward with clinical trials (and have not yet been approved).

We’ve just learned that the manufacturer that now owns Flibanserin has filed an appeal of the FDA denial, saying that other drugs have been approved with less data and more extreme side effects. And that’s reignited discussion about whether pharmaceutical products targeting women’s sexual disorders are evaluated on a level—or relevant—playing field.

Flibanserin, Librido, and Lybridos (and a small handful of others) are all drugs designed to play a part in awakening libido for women. They counter hypoactive sexual desire disorder (HSDD), in physicians’ terminology (the rest of us call it “not tonight—or tomorrow night, either” syndrome). There are, for context, a couple of dozen FDA-approved drugs for the comparable problem among men, including Viagra.

I don’t have the insider information I’d need to assert a double standard, although people I know and respect—like my colleague Sheryl Kingsberg—suggest there is one. Women’s health psychologist at University Hospitals MacDonald Women’s Hospital, Sheryl said, “There’s a double standard of approving drugs with a high risk for men versus a minimal risk for women.” The side effects for Flibanserin, for example, were reported as dizziness and nausea; Sheryl compares those to side effects of penile pain, penile hematoma, and penile fracture—all from a drug that was approved.

That does sound like some extra protectiveness of women. Given my focus on sexual health for women, I run into a lot of cultural expectations and hesitations; we Americans are still just a bit prudish when it comes to, especially, older women having sex. That’s in spite of what I see in my practice every day: Women themselves want to live whole lives, which means being physically active, emotionally engaged, and sexually active within their relationships.

I recognize that sexuality for women is complex, and there won’t be a “magic bullet.” For women, arousal and desire is a mix of emotional intimacy, biological responses, and psychological responses; a drug won’t address all of the components. But because I’m often working with patients to untangle interlocking causes of problems with sex, I’m eager for as many tools as possible, including pharmaceuticals.

As a physician, I also see the need to evaluate trade-offs and risks. I’ve talked before about the pros and cons of hormone therapy. For some women, living longer doesn’t really count if they’re not able to be active—including being actively sexual. “Pink Viagra” drugs may well require the same kind of close collaboration between women and their doctors to evaluate risks and benefits. Again, Sheryl: “Give women a chance to decide for themselves, within reason. There is no drug out there that has no risk.” In the case of Flibanserin, only 8 percent of testers said the side effects were bad enough to make them want to drop the drug.

These decisions by the FDA are also important because pharmaceutical research is done by businesses, businesses that can decide that one problem or another is too expensive or too complicated to take on. Sheryl sees this, too, saying, “My worry is that research in this area will dry up and will leave many women without a pharmacological option.”

One way to make your voice heard about the importance of continued research is by signing the International Society for the Study of Women’s Sexual Health (ISSWSH) WISH petition. Our sexual health is integral to our overall health, and we need more investigation and even-handed, common-sense consideration of therapies for women.

Nonhormonal Drugs for Menopausal Symptoms Nixed by FDA

So much for WISHes.

Following the approval of Osphena, a nonhormonal drug for vaginal pain, or dyspareunia, an advisory panel for the Food and Drug Administration (FDA) just voted against approving two nonhormonal drugs for the treatment of hot flashes.

Hot flashes, night sweats, and the sleep disturbance that accompanies them affect about 75 percent of perimenopausal women. Often, they are merely inconvenient, but for some women, they are severe enough to affect sleep, sex, and overall well-being. And they may continue for years—long after menopause is over.

However, based on the results of several rounds of clinical trials for gabapentin, a drug already used to treat seizures and nerve damage from shingles, and other trials for paroxetine, an antidepressant (the active ingredient in Paxil), the FDA panel voted overwhelmingly to deny approval.

The panel’s objection to both drugs was that their effectiveness didn’t outweigh the risks and side effects associated with their use. The most common side effects of gabapentine are dizziness and drowsiness. The most common side effects of paroxetine are nausea, sweating, drowsiness, and headache.

According to a recent New York Times article, women in the gabapentine trial experienced an average of 11 hot flashes a day. At the end of 12 weeks, they were down to about 4 per day. But the women on placebos saw almost as much relief—their hot flashes had dropped to about 5 per day. Thus, “women taking placebos in the trials experienced a substantial reduction in hot flashes that the drugs could not beat in any pronounced way.”

Women in the paroxetine trial fared slightly better, but the FDA panel decided that it still hadn’t cleared the bar for approval.

Voices on both sides of the debate are intense.

“They don’t work and cause dangerous side effects,” the consumer advocacy group Public Citizen testified before the FDA panel.

On the other hand, Linda Keyes, one of the panel members who voted to approve the drugs, said that the need for nonhormonal treatment “is high enough that I feel that a very modest reduction [in hot flashes] is still acceptable, assuming the risks are known and carefully watched, which I believe they can be,” according to an article on WebMD.

Obviously, these results are disappointing for women who are looking for a safe, federally approved, nonhormonal treatment for hot flashes and sleep disturbance. Currently, the go-to treatment for these menopausal symptoms is hormone therapy, and many women either can’t take hormones or choose not to because of the risk of stroke and breast cancer.

Both gabapentine and paroxetine are available off-label, and doctors have been prescribing them for menopausal symptoms for years. They, and other off-label options, can still be considered for treatment of menopausal symptoms—yet another reason for a detailed discussion with your health care provider so you’re making the best—and best informed—choices for you.

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 →