Pink Viagra or Pink Elephant?

On October 27 – 28 the FDA held a “Patient Focused Drug Development Meeting” on the issue of Female Sexual Dysfunction (FSD). It’s one of about of a dozen such meetings they’re hosting over the next two years in what’s billed as an effort to be more responsive to patients. Most will focus on conditions that are life-threatening (sickle-cell anemia, Parkinson’s, breast cancer) or at least debilitating (fibromyalgia, irritable bowel syndrome).

But “female sexual dysfunction” or “hypoactive sexual desire,” stands out. After all, who decides how much sex is “enough”? And is “not enough” a disease?

A number of women testified at the hearing that it was a disease, and they desperately wanted a drug that could help. Journalists noticed, however, that most of them had had their way paid by drug companies. And of thirteen experts on the scientific panel, eight had served as paid consultants to various drug companies developing FSD treatments. For an account of the hearings see Evening the Score.

Leonore Tiefer saw things differently. As a committed feminist, and a professional sex therapist and researcher, she firmly believes women have as much right to sexual satisfaction as men. But she seriously doubts the answer is a “Pink Viagra” sex pill for women. And she was outraged at a campaign launched by drug companies to label the search for such a pill a “feminist cause.”

Dr. Tiefer wrote a guest column last month on RxISK about the New View Campaign, which she organized to rally women against efforts to medicalize this aspect of women’s lives. Here is some of the testimony they collected for the FDA hearing from experts and ordinary women alike. (Readers can still offer the FDA their opinion at this link until December 29. You’re invited to share it with the New View Campaign and RxISK as well!)

Iona Heath, MD

Dr. Heath is a past president of the British general-practitioners’ association, the RCGP. She also has 35 years’ experience as a family doctor in inner-city London:

All my experience tells me sexual dysfunction is situated within relationships rather than individuals. The medicating of women merely serves to stigmatize them as lacking libido or even frigid and excuses the other partner within the relationship from any responsibility. This is extremely destructive of dignity and self-respect, and all too often serves to perpetuate problems rather than resolve them.

The clinical trials for Female Sexual Dysfunction drugs have repeatedly failed to show safety and efficacy not because companies haven’t tried hard enough, involved enough thought leaders or developed enough questionnaires. The reason stems from the complexity and diversity of women’s sexual problems and experiences, which often occur in the context of difficult relationships all too often involving elements of coercion, fear and exploitation. The high placebo rates in all the trials are further evidence against simplistic analyses.

In contrast, there is clear evidence to show that many nonmedical interventions for sexual problems are both safe and effective, including sex education, counselling, careful attention to relationship dynamics, and changes in lifestyle and sexual technique. Drug treatments should be compared with these nonmedical interventions in clinical trials before being approved.

Dorian Solot and Marshall Miller

Sex educators and co-authors of I Love Female Orgasm, Solot and Miller have spent the past ten years giving public lectures and talking to average people about their sexual issues:

We couldn’t agree more passionately that women deserve to have their sexual issues taken as seriously as men’s … But this is precisely why the FDA should continue to use caution before approving any female sexual dysfunction drugs. In the meantime, here are a few things that we definitely know do work, and that truly can help “even the score”:

Sex education that teaches about women’s sexual pleasure – Most high school sex education in this country fails to teach about the clitoris, the primary organ for sexual pleasure and orgasm for most women. While most boys learn at an early age the pleasure their penis can provide, girls are taught about fallopian tubes and ovaries. As a result, many adult women simply never acquire the information about what works sexually for their bodies. Widespread, high-quality information would be far more effective, less expensive, and involve fewer side effects than any pharmaceutical solution.

Creating realistic expectations about sex and orgasms – We live in a culture that bombards us with depictions of how people can and should have more sex, better sex, multi-orgasmic-swing-upside-down-from-the-chandelier sex. As a result, many people are left with deeply unrealistic expectations of what sex between what two real, live human beings looks like. It’s common for women to expect to have orgasms from intercourse alone (the norm in movies but possible for only a minority of women) or to think there’s something wrong with them if it takes their bodies longer to reach orgasm than their male partners. Women we work with are often enormously relieved to learn how normal and common their sexual experiences are.

Ending sexist double standards – We live in a culture where men are valorized for having lots of sex and knowing a lot about sex. That same culture often shames women – and labels them derogatory names like slut and and whore – for daring to learn about, desire or enjoy sex. The solution to this isn’t going to be found in a drug, unless there’s a drug that cures sexism.

Consumer, aged 57

“My personal drug-therapy breakthrough for sexual dysfunction turned out to be stopping a drug, not starting one.”

I have wrestled with a lack of sexual interest and desire for most of my adult life. I have also struggled with depression for even longer. For years I blamed the depression for all my problems with sex, and hoped I could overcome them with the help of antidepressant treatments. In the end, however, what helped me more than anything else was simply getting off the antidepressants, and realizing the effects they’d had on my sexuality for years.

Many of you may think that the “sexual side effects” of antidepressants are a well-recognized problem, easily dealt with, and not in need of much further attention. I beg to differ. For a number of years doctors were told this particular side-effect affected only five or ten percent of patients. (We now know it’s more like fifty percent.) Patients were left with a great deal of guilt, bitterness and conflict in their relationships as a result – I know I was.

By the late 1990’s there was considerably more awareness of “sexual side effects.” But the discussion was largely limited to “performance” problems – erectile dysfunction in men, and perhaps difficulty having orgasms in women. I was not made aware of the larger effects of my meds on sexual interest and desire as well as “performance”, or their potential to expand past sex to affect any caring, passion or interest in other people. I continued to believe that I was not only sexually impaired by nature, but perhaps even a rather cold, unfeeling person. This made my depression even worse.

It wasn’t until I was fifty that a crisis brought on by a strong negative reaction to the latest “miracle” antidepressant led me to attempt what had seemed impossible to me and my doctors alike – going off the damn things altogether. Within a month I was amazed to find myself experiencing not just more physical sensation, but more interest in sex in general – along with a lively interest in life that I thought had finally faded out for good. My personal drug-therapy breakthrough for sexual dysfunction turned out to be stopping a drug, not starting one.

I think women are far more likely than men to suffer in silence without realizing the role of their meds. With close to 20% of adult women on antidepressants, this problem likely affects millions of us. It’s one reason why I’m particularly uneasy to hear that flibanserin, which began its career as an antidepressant, is being proposed as a sex aid.

Consumer, aged 23

For this young Turkish woman, now a graduate student at Yale, books rather than pills were the key to overcoming her sexual difficulties:

I had my first sexual experience when I was 17. I was very excited about being in a long-term relationship and my boyfriend was asking me to have some sort of sexual interaction, but I was not ready for it. However, I was very afraid of losing the relationship, so we ended up having sexual intercourse, but it was definitely not enjoyable for me and I was really disappointed that the intercourse gave me no pleasure. He told me that his ex-girlfriends were having pleasure and it is the only time he has been facing with this issue and pressured me to see a doctor.

It was too much pressure for me and affected my mental health in a very bad way. As time passed, I discovered the pleasure I take from clitoris and we shaped our sexual interaction accordingly, but I was still expecting to have pleasure and orgasm through coitus. We broke up after 3 years. Six months later I saw the feminist article from the 70s ‘Myth of Vaginal Orgasm’ by Anne Koedt. It was a relief and it started my self-education period about female sexuality. Shere Hite was the next author that has changed my life through her reports, followed by Leonore Tiefer, Paula Caplan and others. Now I know what my sexuality is, what I need and what are the misconception and myths about female sexuality. It’s empowerment.

There should be more sex education for women, especially about the body and the clitoris. We do not have this in Turkey but I think that you do not have too much of this in the US, either. I believe that this is needed more than pharmaceuticals.

Colleen Derkatch, Ph.D, critical health studies researcher

“Transforming everyday problems of life into medical problems with pharmaceutical treatments also transforms the people who experience those problems.”

The business of the FDA, according to its website, is “Protecting the public health by assuring that…human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.” To date, clinical trials for FSD drugs have shown no evidence of efficacy, and their high placebo rates indicate that anticipation effects alone may be as effective as any pill. Approving such a product puts women at unnecessary risk.

Transforming everyday problems of life into medical problems with pharmaceutical treatments also transforms the people who experience those problems. For women whose sexual problems stem from untreated depression or anxiety, thyroid or hormonal conditions, poor communication with partners, stale or abusive relationships, or stress due to unequal distribution of household and parental labor, treating problems of sexual desire as simply mechanical does little to promote or protect their health. Further, it threatens to mask those other factors that, left unattended, could carry far greater consequences than those posed by the drug itself. That would be a profoundly anti-woman, anti-equality position for the FDA to take.

I urge the FDA to resist pharmaceutical companies’ deceptive and opportunistic efforts to cast female sexual problems as a matter of gender equality. Approaching FSD as analogous to erectile dysfunction assumes not that women and men are equal, but that women are functionally the same as men. The underlying principle of this perspective is not equality but its opposite, using a male standard against which to measure and manage female sexuality.

Kari Christianson, DES Action

“DES Daughters are living proof that good intentions and poor research lead to disaster, potentially for generations to come.”

DES Action USA advocates for individuals who were prenatally exposed to diethylstilbestrol (DES), an ineffective and harmful non-steroidal estrogen given to millions of pregnant women in the U.S. and around the world with the erroneous idea that it prevented miscarriage. Their prenatally DES-exposed daughters have much higher rates of reproductive tract problems, including ectopic pregnancies, miscarriages, infertility and cancer. And this drug disaster may continue to harm future generations.

Because several drugs have been approved for male sexual dysfunction, groups have asked whether the FDA is holding women’s sexual satisfaction to a different standard. As a population already harmed by an FDA-approved drug, we wonder if political and media attention is the reason for considering and reconsidering drugs for any female health or disorder issue, rather than attention to safety and efficacy.

The gender equity argument ignores the real safety difference between any drug under consideration for female sexual disorder and the drugs approved for men. All but one of the drugs approved for men are taken on an as-needed basis, whereas a drug for women, like flibanserin, is a central nervous system serotonergic agent and requires daily, long-term administration. This raises toxicological concerns that make it appropriate for the FDA to subject this drug or any similar drug to elevated safety scrutiny.

DES Action’s online community of DES Daughters has shared information about non-drug hormone-free alternatives and natural remedies to deal with vaginal dryness. And it has been the sharing of our ongoing health and sexuality experiences that itself is a remedy. By learning what others are experiencing, we learn about ourselves, what is common, what is normal, and what we can do to relieve symptoms safely and inexpensively without pharmaceutical intervention.

No one, particularly the FDA, should be in a rush to “fix” women’s bodies via drugs. DES Daughters are living proof that good intentions and poor research lead to disaster, potentially for generations to come.

Leonore Tiefer, New View Campaign

Dr. Tiefer’s comments focused on her many years as a sex therapist, and on what she found has worked for women and their partners:

Most patients acknowledge that they’re ill-prepared by their limited knowledge about sex to deal with the problems they are confronting. We all live in a hyper-sexualized world of stimulation and chatter, but one with little opportunity to understand the mental and physical details of sexual experiences. In sex therapy patients are intrigued by being taken seriously as having unique sexual lives and being able to set aside simplistic, reductionistic ideas about hormones or gender differences. They’re relieved to back off from blame and shame and acknowledge our cockeyed sexual world, where much is expected but little preparation is offered.

The most valuable intervention, couples will say in retrospect, is often the commitment to spend time together – over a period of weeks – talking about their sexual life in an intimate, cooperative way, and touching each other in non-demanding but intimate and cooperative activities. None of them has ever done this before and the results are a revelation! The couple may think at first that the important interventions are the new technical things they try, but gradually they realize that more important is the intimacy and the communication. This cannot be done in one appointment or even in 2 or 3. Like any process of learning and change, some time is required.

The FDA has posted testimony submitted by experts and organizations (22 so far) at this link. They welcome consumer testimony as well, although they don’t appear to be posting it.