Seeking answers and treatment for female sexual dysfunction
When Sheri Mike met her husband more than a decade ago, her attraction to him was instant.
Sheri, then 21-years-old, had driven from her home in Winnipeg to Grand Forks, North Dakota for a weekend out with her girlfriends. It was there she met Brandon, a college student who was bartending part time, and the two hit it off.
“We ended up talking that night and we exchanged phone numbers and pretty much ever since then we’ve been together,” Sheri recalled in an interview with W5.
Fifteen years later, Sheri and Brandon are married with two young kids. Settled down in the suburbs of Lafayette, Louisiana, they present the picture of a strong, loving couple. But there’s one thing that’s missing from their marriage – Sheri’s sex drive.
“I have no desire for sex,” she says. “No libido. There’s just nothing there.”
Sheri has Hypoactive Sexual Desire Disorder, more commonly referred to as HSDD. Researchers believe 10 percent of women have this condition.
“HSDD is the persistent of loss of all sexual interest, fantasies, or hunger for sexual activity,” explains Sheryl Kingsberg, a clinical psychologist.
In order for a woman to be diagnosed with HSDD, her lack of sexual desire must be causing her distress, or interpersonal difficulty. Sheri Mike says her low desire has affected her relationship with her husband.
“I feel a lot of guilt,” she said. “He feels a lot of rejection. And so we go through this cycle of guilt and rejection, frustration.”
Doctors must also be able to rule out any other factor that could be causing low sexual desire, such as a co-existing medical or psychiatric condition, problems in the relationship, or side effects from other medications or drugs.
Sheri tried a variety of different things to get her libido back, including vitamin supplements, hypnotherapy, counselling and testosterone. Nothing worked.
But in August 2015, a new option became available for Sheri and other women with HSDD living in the United States. The U.S. Food and Drug Administration approved flibanserin, known under its brand name as Addyi. Flibanserin is the first pharmacological drug ever approved to treat female sexual desire, though this milestone is not without controversy.
Prior to being approved in August 2015, flibanserin had been rejected twice by the FDA.
Flibanserin was originally designed to be an anti-depressant. While it didn’t work as such, researchers noticed that some women in the clinical trials reported an increase in sexual desire after taking it. The pharmaceutical company behind flibanserin, Boehringer Ingelheim, shifted gears and began looking at flibanserin’s effects on desire.
Researchers believe flibanserin decreases serotonin levels in the pre-frontal cortex of the brain, which is thought to dampen sexual desire, while at the same time boosting dopamine and norepinephrine, the chemicals linked to increasing sexual excitement.
Clinical trials for flibanserin showed that on average, women taking it experienced 0.5 to 1 more sexually satisfying events a month than women taking a placebo. Of the women taking flibanserin, one in 10 reported meaningful improvements in sexual desire.
“In terms of increasing women’s desire or in terms of increasing their experience of sexual satisfaction, the drugs just don’t work very well,” said Dr. Jonathan Huber, an Ottawa gynaecologist.
“I see a lot of women who come in with low libido,” said Dr. Huber. “And I would probably say that I have not identified that woman, for whom we’ve ruled out every single possible contextual factor, be it biological, psychological, social, cultural, political, that hasn’t in some way influenced their experience of their sexuality or their sexual problem that we can’t improve upon.”
Critics of the drug also believe that the possible side effects of flibanserin, which include nausea, dizziness, and loss of consciousness, are too dangerous considering the drug’s minimal effectiveness.
That’s partly why the FDA did not approve flibanserin when it was previously submitted, citing among other things, that the drug’s impact was “not robust enough to justify the risks.”
After it was rejected by the FDA in 2010, Boehringer Ingelheim sold flibanserin to Sprout Pharmaceuticals. Sprout submitted flibanserin to the FDA a second time in 2013 and the FDA again denied its approval.
Following that second denial, several women’s health groups and pharmaceutical companies, including Sprout, formed a marketing campaign called “Even the Score” -- which lobbied the FDA to approve a pharmacological treatment for women’s sexual dysfunction.
“I really think that there has been a double standard in our willingness to approve treatments for women’s sexual problems,” said Kingsberg, who supported the campaign.
After the FDA requested more studies on the safety of the drug, flibanserin was approved on its third submission in August 2015. It was approved with aboxed warning highlighting the severe side effects, and physicians and pharmacists mustcomplete specific training before being able to prescribe and dispense it.
Canadian pharmaceutical company Valeant bought the drug from Sprout for $1 billion shortly after the FDA’s approval. Valeant says it filed a new drug submission with Health Canada for flibanserin in November 2015. Health Canada has yet to approve the drug.
Proponents of the drug feel the FDA’s approval is at least a step forward in offering pharmacological treatments for women with low sexual desire.
“Flibanserin will work for many, for millions of women, but it won’t work for everybody,” said Kingsberg. “We need more options.”
For Sheri Mike however, she wasn’t part of that 10 percent who benefit from the drug. She took Addyi for 30 days and didn’t notice an increase in her libido. She’s since stopped taking it.
“Unfortunately it didn’t work for me,” she said. “And it was disappointing. But I know that it’s helping so many other women and it’s an option.”