A Door Opens for Women's Right to Sexual Pleasure, Let's Hope the FDA Doesn't Close It
When a woman or man suffers from a form of sexual dysfunction, their ability to have a satisfying sex life is curtailed and personal relations with a partner or spouse also can be damaged. The global community's response to sexual dysfunction should be equal for women and men, but it is not. This year marks 16 years since the introduction of Viagra. Today, the market includes more than 20 drugs to address male sexual dysfunction -- and not a single one for women.
The Food and Drug Administration (FDA) has approved 24 drugs to treat some form of male sexual dysfunction (low testosterone, erectile dysfunction, Peyronie's disease), yet they continue to hold up the approval of just one drug for women -- flibanserin. Flibanserin would treat the most common form of female sexual dysfunction -- low sexual desire (Hypoactive Sexual Desire Disorder or HSDD).
In the coming weeks, women's health advocates are awaiting a decision on a dispute taken to the FDA that objects to delays in approving a first-of-its-kind treatment for low sexual desire with accompanying distress in women.
Twenty years ago, 180 countries gathered in Cairo, Egypt for the groundbreaking International Conference on Population and Development (ICPD) -- here nations made commitments to advance the sexual and reproductive health and rights (SRHR) of women, men, and young people throughout the world. The Center for Health and Gender Equity (CHANGE) emerged from this conference as an advocacy group to ensure that U.S. commitments to the SRHR agenda were translated into U.S. policies.
Both the ICPD Programme of Action and the Fourth World Conference on Women and Girls Platform for Action (Beijing, 1995) articulate that individuals should be able to have safe and satisfying sex lives. Sexual health services, according to these two global consensus documents, should be more than just counseling and care related to reproduction and sexually-transmitted diseases. Understanding sexuality to be a critical human need, the international consensus aims higher: sexual health includes the enhancement of life and personal relations.
A drug that addresses HSDD would enhance life and personal relations for women who suffer from low sexual desire. Without a doubt, there is a need for safe and effective treatment for female HSDD, yet none has ever been approved. But now, we have a product before the FDA and the application must be taken seriously.
CHANGE is not endorsing any one product under pending application for female sexual dysfunction. However, we believe that a thorough review and re-consideration of flibanserin is due. Certainly the fact that numerous treatments have been approved by the FDA and made available for men, while none have ever been approved for women, should raise questions.
No single drug will ever be a cure-all for any condition, and will not be the choice for all women. It is only fair that women have choices to address sexual dysfunction as men do.
The FDA should remember the commitment made by the U.S. government to the global community -- and to the women of the world -- to support the ability of individuals to have a satisfying sexual life. The FDA should closely examine the extensive data package that has been submitted and make a decision that would be in the best interest of women, thereby keeping the door open for women's sexual health, pleasure and life enhancement.
In their efforts to treat female sexual dysfunction, the
pharmaceutical company who makes Flibanserin, a drug referred to as
“female Viagra,” is running into issues trying to get approval from the
U.S. Food & Drug Administration (FDA).In a Flibanserin study conducted nearly three years ago, 1,900 women were given the drug for 24 weeks. Researchers discovered an 18 percent increase in libido and sexual drive with the only side effects reported being nausea and dizziness. The drug is considered an antidepressant and is non-hormonal, but the FDA fears further safety issues and would like further testing, which may delay the release of the pharmaceutical.
Changing the way urologists practice medicine, Viagra is celebrating 15 years of continued treatment for men with sexual dysfunction. For males, sexual dysfunction is considered a mechanical or plumbing issue that can be easily treated. Men who are diagnosed with erectile dysfunction/sexual dysfunction can take Viagra with approval from their physician, and may have overall improved blood flow to genitalia.
With women, the mechanics are quite different. A diagnosis of hypoactive sexual drive disorder (HSDD), means that the woman’s libido isn’t there or she has difficulty with arousal, and it’s much more complex than the male form of the condition. There is an unbalance in the brain between the serotonin and dopamine. Taking into consideration that this is more than a mechanics issue, it should be looked at from a psychosocial standpoint.
Roughly 33 percent women complain of low libido and symptoms can include:
A loss of interest in sex
Pain during intercourse
Sexual dissatisfaction: Some people with signs of HSDD find sex aversive, traumatic, painful, or boring
Having HSDD is relatively common among women and causes considerable distress as well as interpersonal difficulties. It can have a serious effect on emotional well-being and interpersonal relationships and it occurs in pre- and post-menopausal women. Nevertheless, many women with HSDD remain untreated because they are reluctant to discuss sexual issues with their physicians and have low expectations concerning the prospects for help.
Overcoming libido lossIf you’re suffering from loss of libido, and think there is a medical basis for your problem, here are some solutions to consider:
Talk to your doctor about testosterone, especially if you have had your ovaries removed and are taking estrogen or if you are under severe stress. Get your testosterone level evaluated and if it is below 20ng/dL, this may be an option for you. Testosterone is so central to a woman’s sexual function, that no amount of sexual stimulation can make up for its absence.
Switch to medications known to have less effect on sexual function or lower dosages. The antidepressants Prozac, Zoloft and Paxil, of which women are major consumers, cause loss of libido in as many as 60 percent of patients. Medications with less side effects can help curb the problem.
Viagra, the little blue pill may help jump-start your sex life as long as you have the desire to engage in sex and have been stimulated enough for it to take effect. It’s especially helpful if your lack of desire is related to hysterectomy or menopause. Physicians aren’t exactly sure how Viagra helps rekindle lust, but it is known to help women achieve arousal by increasing blood flow to the vagina, clitoris and labia.
So before making any quick decisions, make an appointment to speak to your physician to see what will work with your body chemistry.
Dr. David B. Samadi is the Chairman of the Department of Urology and Chief of Robotic Surgery at Lenox Hill Hospital in New York City. He is a board-certified urologist, specializing in the diagnosis and treatment of urological disease, with a focus on robotic prostate cancer treatments. Dr. Samadi joined Fox News Channel in 2009 as a medical contributor. To learn more please visit his websites RoboticOncology.com
and SMART-surgery.com. Find Dr. Samadi on Facebook