March 14, 2016

3 comments

HSDD ›   libido ›   testosterone therapy ›  


Testosterone Therapy: Another Set of Socket Wrenches

I love options. Moose Tracks or Mackinaw Island Fudge? Mocha or machiatto? Phillips screwdriver or allen wrench?

Mostly, I like having options for my patients. At this awkward middle-age time of life, issues are complex and solutions are rarely straightforward. So I like to have a toolbox of treatment options to choose from. If one method doesn’t work, maybe another will.

To be clear, I always start with the most natural, straightforward treatment possible, postponing pills, prescriptions, and hormones. To this end, a healthy lifestyle is the first and most important contributor to a good sex life. Along with lavish use of moisturizers, lubricants, toys, and imagination.

But when these things fall short, it’s nice to have options.

Healthy lifestyle first and most important contributor to good sex lifeThat’s what testosterone therapy offers—another tool. Another treatment regimen that might fan a faltering libido and fading intimacy in an otherwise healthy relationship. Like any treatment, this isn’t a silver bullet or a magic pill. In fact, it’s controversial. There just isn’t a lot of research on long-term use or even on how testosterone functions in women. (Spoiler alert: a lot different than in men.) It isn’t FDA-approved, although it’s been prescribed “off-label” for decades in the US and is prescribed legally in Europe and elsewhere.

In women, testosterone is produced at much lower levels than in men, mostly in the ovaries and adrenal glands. As we age, and especially if our ovaries have been removed, testosterone levels drop sharply. This isn’t the only reason for diminishing sexual desire but it may be part of the picture. (In medicalese, a distressing loss of libido is called hyposexual desire disorder—HSDD.)

Since declining testosterone levels, menopause, and HSDD tend to happen in tandem, maybe a causal link exists among them, so the thinking goes. Obviously, it’s more complicated than that, but for some women, a little testosterone boost just seems to work. As a recent bulletin from Harvard Medical School states: “…in some but not all studies, testosterone therapy has been shown to be an effective treatment for HSDD in carefully selected postmenopausal women.” In my clinical experience, testosterone therapy improves libido, desire, and/or the ability to orgasm in about 60 percent of the women who take it.

So, what are those “carefully selected” qualities that make a patient a good candidate for testosterone therapy?

First, testosterone won’t cure difficulties in a relationship that may be contributing to intimacy problems. Other libido-killers include depression, fatigue, anxiety, certain medications, and the usual menopausal suspects: loss of estrogen, night sweats.

In the absence of physical or psychological factors, women who are distressed by their lack of libido (the classic definition of HSDD) might find relief with a little extra testosterone in their system. I monitor blood levels during treatment with the goal of restoring testosterone to the level you probably had when you were 25 years old.

Some women (about 20-30 percent of my patients) experience some added benefits, such as improved mood and more energy, while another 10 to 15 percent have less positive side effects, like unwanted hair growth or acne. And for about 40 percent of my patients, testosterone therapy isn’t helpful at all.

Testosterone can be safely applied topically; I usually prescribe a gel, the same FDA-approved topical gel that is used by men, but at one-tenth the dose, which I find offers a safe and consistent delivery of the medication.

For some women, testosterone is a game-changer and for others, not so much. Since the potential benefit is so positive and the detriment is minimal, in my opinion, testosterone therapy is a solid treatment option. A woman who’s tried it will tell her story in our next blog post.

November 30, 2015

2 comments

addyi ›   desire ›   hsdd ›   women's sexual health ›  


A Watershed Moment for Women's Sexual Health

It may surprise you to hear a practicing doctor readily admit that there are vast fields of uncharted forest in human medicine.

I knew that when I began my studies, and now, many years later, I still find the constant learning that the discoveries my scientific sisters and brothers bring to my field my greatest hope and challenge. And sometimes it’s a source of frustration too, but today I’m focused on hope.

For quite a few weeks now I’ve been able to offer my patients something new. Addyi, the trade name for Flibanserin, the much talked-about prescription drug designed to treat Hypoactive Sexual Desire Disorder (HSDD), a disorder that I’m all too familiar with in my practice, a heartbreaking condition faced by so many of my patients and their loved ones.

But back to the question of advancements in medicine. When I think of this moment. I think of a parade of watershed moments in medicine. I know it may not seem like this to many people on the surface of it, but the approval of this drug, to doctors who serve women with sexual disorders, is HUGE. In my field it’s up there with, say, the dawn of anti-septic operating procedures. Think: we’ve only been washing our hands carefully before surgery since the 1860s. In the scheme of things, not that long ago! Or another watershed moment for women, the publication of Our Bodies, Ourselves by the Boston Women’s Health Collective in 1973, a book that changed everything, utterly. Or the Public Health Service Act of 1975, which made gender inequality in medical education illegal for the first time and propped open the doors for my own education… Finally.

And when I think of my ability to write Addyi prescriptions for my patients, that’s mainly what I think. I think…Finally! As hard as it was to get this one single drug for female sexual dysfunction (compared with 26 for men?) approved, and with all of the weight of its warnings and the hoops of physician training and the cost of it — despite the weight of all of that, through all of that — the FDA heard us. THEY HEARD US. 

And that is the win. 

So. Addyi is my new septic procedure. The one that will start saving lives immediately, one way or another. I can’t tell you what it means to me to have at least one arrow in my quiver for the women, LOTS of women, suffering, in my practice, because they WANT to want to feel the fullness of their sexual selves come alive. A basic human right, says the World Health Organization. A basic human right. 

(By the way, did you know that Joseph Lister, the inventor of septic operating procedures was ridiculed widely and run out of this country, had to work extra hard and fought a difficult uphill battle to convince people that, really, anti-septic procedures in surgery would save lives? True story… If people had only believed him right away…. )

The outcome of the past few years is a watershed, a turning point because through the process of approval, the FDA has gotten the message: They now completely understand that this previously misunderstood disease — or the complex of Female Sexual Dysfunction, is very real. These women are suffering. So are their partners. They deserve focus, research, discovery, and treatment. And judging by the most recent news that the FDA has recognized Female Sexual Dysfunction as one of the 20 key unmet medical needs in the United States, they will be getting it. 

HUGE.

Meantime, Addyi will help some of these women. Maybe your sisters or daughters. Some with Hypoactive Sexual Desire Disorder will improve with this treatment. At least they will know within a month or two of trying, and for those suffering, the option is available to them right now. 

These women will need to talk to their doctors about Addyi. Women who don't think they need it can help their sisters by asking their doctors about it, showing that it matters. Doctors will need to complete a short online training course to familiarize themselves with the new drug. It’s very short, and found right here. The sooner doctors get their training in, the sooner they can start prescribing the drug, the sooner women can at least try it, to see if it will work for them. I started prescribing in October, so expect to hear in December, after the recommended two months, whether it’s been beneficial.

If it works, happier lives. Fuller, happier lives. The medicine will keep getting better. Have hope!

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

2 comments

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

2 comments

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.

Fingers Crossed, Minds Open

This week Thursday, there’s a dry-sounding meeting that is a big event on an issue of enormous interest to a relatively small number of us. I’m talking about the joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA. Snoozing yet?

This meeting will hear presentations about Flibanserin, a drug developed to address loss of sexual desire, which is a real issue for some women. I’ve been following the prospects for Flibanserin (and other pharmaceuticals) for some time, as you may know if you’ve followed this blog. There’s been controversy—in medical, regulatory, and sociological circles. Some said the original studies were inconclusive. Some said the side effects were too significant. Others said that loss of desire isn’t an issue at all—that, variously, couples therapy, a romantic dinner, or more chocolate was the answer.

As a physician, I have conversations with women about their sex lives every day. Some women are clear about relationships that are no longer satisfying. Some have emotional issues—some from past sexual trauma, others from life’s over-abundance of stress—that affect their attitudes toward intimacy. Some have physical symptoms of discomfort or pain or loss of sensation that we can address.

But there are some who have simply lost desire. They love their partners, they have no physical symptoms or obstacles to overcome, they have no complications in their lives that would explain away the change. The overwhelming emotion they share with me is sadness. They are experiencing a loss. And my overwhelming response is frustration. Because as many options—over the counter and by prescription—as I have for vaginal dryness and pain and loss of sensation and even depression, I have no options for treating loss of desire.

Here are the things I hope the members of the advisory committees are keeping in mind when they hear the presentations this Thursday:

  • Loss of desire—for insurance code purposes, Hypoactive Sexual Desire Disorder (HSDD)—is real. Women and their doctors are smart enough to figure out when there’s another issue of physical or emotional health. And one in 10 women has HSDD.
  • Women are as deserving as men of treatment for conditions that affect their quality of life. There are 26 drugs for male sexual dysfunctions; surely a healthy and satisfying sex life can be as important to women as to men.
  • Women and their doctors are capable of deciding for themselves what trade-offs they’d like to make with their health. We’re already doing it with hormone therapy; for some of us, the benefits to our overall health and quality of life outweigh potential risks or side effects.
  • No blanket rules are required. Whatever treatments are available will be choices, subject to the insight of health care providers and individual patients’ health histories, values, and priorities. We’re hungry for options.

And I recognize that this week’s meeting is only one step down what has already been a long road. The advisory committees will make recommendations, but they won’t make a decision. That’s the work of another day. The pharmaceutical industry has to retain interest and commitment actually to bring drugs to market. Health care providers need to educate themselves and their patients about the options and the trade-offs.

So it’s a long road, still. Please, let’s just take one step. With open minds and fingers crossed.

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.

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!

Stuck without Solutions

If you’re a regular reader of the MiddlesexMD blog, you might think I’m a broken record on the topic of the dearth of pharmaceutical tools to address hypoactive sexual desire disorder (HSDD). That’s because I am. I don’t know how else to respond to where we are, except to keep talking about it, to make sure we’re all sufficiently aware—so we can all be clear, when the subject arises, about what we want and need.

As I encourage us all to recognize, women’s sexuality is complicated from the start, and becomes more so as we enter perimenopause and menopause. Our sexuality is an intermixing of the physical, psychological, and emotional. It often takes some experimentation for women to get back on sexual track, sometimes because it’s not clear whether a physical problem is in the lead or it’s really stress or a relationship issue that’s diminished desire.

In that experimentation, I prefer, as a physician, to start with the simplest steps first. That may mean adding a lubricant or a vibrator to a woman’s bedside table; it may mean using dilators for a time. But also as a physician, I appreciate knowing that there are pharmaceutical options in my repertoire, too, to help a woman get unstuck.

So I follow the news about drugs in development, and about their progress in getting approved for use by the FDA. Earlier this summer, I received an update from the Board of Directors of the International Society for the Study of Women’s Sexual Health (ISSWSH). They wanted to be sure that we’d seen an ABC News story on Flibanserin, which is still stalled out on appeal, subject to additional study.

“No single drug will ever be a cure-all in sexual or most other conditions, let alone effective for 100% of appropriate patients,” the ISSWSH statement read. “But that is never the standard by which biopsychosocial drugs are approved.” The news story also questions whether the standards for drugs for women’s sexuality are different from those for men. It compared side effects of dizziness, sleepiness, and anxiety to those listed in “iconic Viagra commercials, such as nausea, diarrhea, and the risk of erections lasting over four hours.” The reporter suggests that the bar seems higher for drugs for women.

I’m not in the room for the FDA discussions, so I don’t pretend to know whether there’s bias at play. I simply point out that there are 25 FDA-approved medications for men’s sexual dysfunction, and none that address HSDD for women. None. As a physician, I’m conscious of that void whenever I’m talking to a patient who misses her sexual self.

What do we do? Keep talking about it, even if we sound like broken records. And, if you haven’t already, you can sign on to the ISSWSH Wish Petition. The number of names listed does help to communicate the importance of this issue to women and the men who love them—as well as to the health care providers who serve them!

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 →