We’ve been following the development of Flibanserin, also called “pink Viagra,” since 2010, when its developer shelved it after hitting a bump in the road to FDA approval. Several years later, we were talking about alternatives, Librido and Lybridos, which were moving forward with clinical trials (and have not yet been approved).
We’ve just learned that the manufacturer that now owns Flibanserin has filed an appeal of the FDA denial, saying that other drugs have been approved with less data and more extreme side effects. And that’s reignited discussion about whether pharmaceutical products targeting women’s sexual disorders are evaluated on a level—or relevant—playing field.
Flibanserin, Librido, and Lybridos (and a small handful of others) are all drugs designed to play a part in awakening libido for women. They counter hypoactive sexual desire disorder (HSDD), in physicians’ terminology (the rest of us call it “not tonight—or tomorrow night, either” syndrome). There are, for context, a couple of dozen FDA-approved drugs for the comparable problem among men, including Viagra.
I don’t have the insider information I’d need to assert a double standard, although people I know and respect—like my colleague Sheryl Kingsberg—suggest there is one. Women’s health psychologist at University Hospitals MacDonald Women’s Hospital, Sheryl said, “There’s a double standard of approving drugs with a high risk for men versus a minimal risk for women.” The side effects for Flibanserin, for example, were reported as dizziness and nausea; Sheryl compares those to side effects of penile pain, penile hematoma, and penile fracture—all from a drug that was approved.
That does sound like some extra protectiveness of women. Given my focus on sexual health for women, I run into a lot of cultural expectations and hesitations; we Americans are still just a bit prudish when it comes to, especially, older women having sex. That’s in spite of what I see in my practice every day: Women themselves want to live whole lives, which means being physically active, emotionally engaged, and sexually active within their relationships.
I recognize that sexuality for women is complex, and there won’t be a “magic bullet.” For women, arousal and desire is a mix of emotional intimacy, biological responses, and psychological responses; a drug won’t address all of the components. But because I’m often working with patients to untangle interlocking causes of problems with sex, I’m eager for as many tools as possible, including pharmaceuticals.
As a physician, I also see the need to evaluate trade-offs and risks. I’ve talked before about the pros and cons of hormone therapy. For some women, living longer doesn’t really count if they’re not able to be active—including being actively sexual. “Pink Viagra” drugs may well require the same kind of close collaboration between women and their doctors to evaluate risks and benefits. Again, Sheryl: “Give women a chance to decide for themselves, within reason. There is no drug out there that has no risk.” In the case of Flibanserin, only 8 percent of testers said the side effects were bad enough to make them want to drop the drug.
These decisions by the FDA are also important because pharmaceutical research is done by businesses, businesses that can decide that one problem or another is too expensive or too complicated to take on. Sheryl sees this, too, saying, “My worry is that research in this area will dry up and will leave many women without a pharmacological option.”
One way to make your voice heard about the importance of continued research is by signing the International Society for the Study of Women’s Sexual Health (ISSWSH) WISH petition. Our sexual health is integral to our overall health, and we need more investigation and even-handed, common-sense consideration of therapies for women.
Dr. Barb DePree, M.D., has been a gynecologist and women’s health provider for almost 30 years and a menopause care specialist for the past ten. Read more about and from her here.