Sex Matters: The FDA Seminar on Female Sexual Dysfunction

By on December 4th, 2014 Categories: Sex Matters

I decided to delay our jump into the topic of libido since I want to update you on a very important meeting that recently took place at the Food and Drug Administration (FDA) in Washington, DC in late October. On the 27th and 28th, the FDA convened a 2-day seminar to discuss the issues of the unmet medical need for treatment for the most common form of female sexual dysfunction (FSD).

The theme of the two days was optimism. Day one focused on the impact of FSD on daily life, and patients and patient advocates shared their stories and views on current approaches to treatment in the absence of an FDA-approved solution. Women who suffer from hypoactive sexual desire disorder (HSDD) were accompanied by their husbands and told poignant stories filled with emotion and sadness about how loss of libido (sex drive) had been distressing and had impacted their lives well beyond the bedroom.  Sally Greenberg, executive director of the National Consumers League, held up a binder of over 51 unapproved concoctions that women desperate for treatment might choose, given the lack of safe and effective treatments for this medical condition. The FDA acknowledged this and recognized that desire and arousal are different entities, which are part of a legitimate condition, as we heard many women articulate their experiences with such striking similarity.

A small group of opposition was present at the seminar, and it seemed as though they were blocking their ears to drown out expert comments.  Opposition statements at the microphone were insulting to women with HSDD. This group suggested that getting new boyfriends, watching “Grey’s Anatomy” episodes, eating chocolate, or using a self-stimulator would help improve libido. I believe these are outrageous things to say to women with this medical condition.

Opposition aside, the overall tone at the seminar was one of fierce support for women who deserve a medical treatment when neurochemistry is the root cause of their lowered libido.  Many organizations joined forces in this message including the American Health Association, EmpowHer, Healthy Women, National Council of Women’s Organizations, and Even the Score.

Experts in sexual medicine took the stage on day two with a 13-expert panel assembled by the FDA to discuss challenges associated with clinical trials for medications that could potentially treat female sexual dysfunction. Clinical experts had to arrive early to get 2 minutes at the open public commentary microphone – I arrived at 6:30 a.m. to sign in at position 12 out of a possible 15 slots. I’ve included my commentary below. (Please note these comments reflect my personal voice and do not in any way represent Breastcancer.org.)

Hello, my name is Michael Krychman, sexual medicine gynecologist, sex therapist, and clinical researcher. I have been here for two days and heard the word “complex” many times — I stopped counting at 20. WE have oversimplified men and overcomplicated women.  WE have agreed here that sexuality is multifactorial and multifaceted.

I am the sole financial provider for a family of four — a father of 8-year-old twins — and plan to take a night flight to teach educational rounds at a major university — so please do not minimize my fatigue.

WE have heard today that women respond and implement treatments to address their libido symptoms. As a clinician, I can provide ingredients so we can uniquely provide a safe, effective recipe for individual women who are impacted by this medical issue.

I believe in women. Women will choose pills or not, counseling or not, mindfulness or not, hormones or not. Having NO medically approved option hurts women.

I am cautiously concerned that the FDA is now scrutinizing and getting involved in healthcare professional prescribing behavior.

I believe in women. Let us learn from history. WE did not think women were smart enough to vote. WE denied them that right. WE have been taught wrong.

WE did not think women were strong enough to defend our country. WE have been taught wrong.

Allow the philosophy of the sanctity of the therapeutic alliance between the healthcare professional and the patient. 

Healthcare professionals want to help and women want to be helped. Women will not remain on treatment if it’s not effective or if they experience adverse events.

Allow women their constitutional autonomy to be STRONG and SMART.

Regulate medications, approve safe and effective medications, but PLEASE do not regulate my prescription pad by imposing judgment on whether or not that treatment is worthy.

Now that voices have been heard, the FDA will likely develop a new guidance document that can help improve the clinical trial process so that medications to treat low libido can more easily become available. Stay tuned.

Next month, we will focus on specific ways to address low libido. Women deserve treatment options.

Do you struggle with low libido? Please share your concerns in the comments below!

Michael L. Krychman, M.D.C.M., is the executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, California. He is the former co-director of the Sexual Medicine and Rehabilitation Program at Memorial Sloan-Kettering Cancer. Dr. Krychman is also an American Association of Sexuality Educators, Counselors and Therapists (AASECT) certified sexual counselor. He is an associate clinical professor at the University of California, Irvine, Division of Gynecological Oncology, and the medical director of Ann’s Clinic, a high-risk program for breast and ovarian cancer survivors. His special interests include menopausal health, hormone therapy, sexual pain disorders, loss of libido, and chronic medical illness and its impact on female sexual function as well as breast cancer sexuality. Dr. Krychman is also a member of the Breastcancer.org Professional Advisory Board.

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