The Food and Drug Administration's recent approval of Addyi, the first drug to increase sexual desire in women, could lead to some new and complicated conversations in doctors' offices across the country.
Many have touted the little pink pill as a victory for gender equality, but some say it could mask a disorder that has often been overlooked and is still viewed by some as not being a medical condition at all.
The prospect of treating a woman for what's known as hypoactive sexual desire disorder, or HSDD, may present a challenge for those physicians who have had little or no experience with the condition prior to Addyi's approval, said Dr. Lauren Streicher, noted women's health expert, author and an associate professor of clinical obstetrics and gynecology at Northwestern University's Feinberg School of Medicine.
She said such unfamiliarity might lead some providers to overprescribe Addyi instead of engaging in patient discussions that yield a proper diagnosis.
“If Addyi didn't exist, this is a conversation that's supposed to be happening anyway,” Streicher said. “The reason for the conversation isn't to see if you are a good candidate for Addyi, the reason for the conversation is because we know that 40% of the general (female) population and 60% of the post-menopausal population have sexual dysfunction.”
Even among gynecologists, studies show conversations with patients about sex rarely focus on satisfaction. Findings from a survey of more than 1,100 practicing obstetrician-gynecologists published in 2012 in the Journal of Sexual Medicine revealed that, despite a majority of doctors reporting that they routinely assessed patients' sexual activity, only 29% asked about sexual satisfaction, while 14% discussed whether sexual activity was pleasurable.
“You have to ask the question,” said Dr. Alan Altman, an Aspen, Colo.-based obstetrician-gynecologist and noted specialist on menopause and women's sexual medicine. “If you don't ask the question, the door won't be open because many women are too embarrassed to talk about it.”
To guide physicians toward that discussion, the drug's manufacturer, Sprout Pharmaceuticals, released a diagnostic screener with five questions doctors can ask patients to determine their likelihood of having HSDD, which affects about 15 million women in the U.S.
The disorder is characterized by low sexual desire over a prolonged period that causes distress, and cannot be attributed to other factors, such as a co-existing medical or psychiatric condition, or another prescription's side effects.
Treatment for HSDD, which some doctors even dismiss as a medical problem, has been limited. Some physicians prescribe testosterone creams to boost libido. Unlike medications for men such as Viagra that increase blood flow, Addyi works by fixing the balance of neurotransmitter impulses in the brain that can affect mood and appetite.
An FDA advisory panel recommended the drug—generically called flibanserin—for approval in June by a vote of 18-6, despite clinical trial results that found women who took it reported having an average of 0.5 to 1 additional sexually satisfying events a month, with between 8% and 13% experiencing improvement over those who took a placebo.
But Streicher said the results represented the entire pool of subjects tested, including those identified as having a low response to the drug. The 55% of women studied who had a high response to flibanserin reported having an average of six to seven additional sexual satisfying events a month.
Sex educator Emily Nagoski noted in a blog post following Addyi's approval that the women in the trial experienced “responsive desire,” or the desire that is felt only after a partner initiates sex, as opposed to “spontaneous desire,” defined as sexual desire that sparks the woman herself to initiate sex.
One of the FDA panel members, University of Pennsylvania urologist Dr. Philip Hanno, who voted against approving Addyi, reportedly asked why women in the study were having, on average, two to three “sexually satisfying events” a month at all, if they lacked desire.
Those are the questions specialists say need to be addressed to fully acknowledge Addyi's approval as a victory for women's health and happiness. Streicher sees Addyi as an opportunity to get to the heart of any problem involving female intimacy.
She said part of the reason why many physicians don't ask women more specific questions about sexual activity is because they would not know how to formulate a clinical response once they got answers.
“One of the reasons why I am personally so glad that Addyi has gotten approved is because that means that doctors are going to need to have this conversation, and hopefully become more informed and arm themselves with information,” Streicher said. “It's not just about libido, it's about all the other sexual dysfunctions that have largely been ignored.”