Washington/New York: As American women get closer to having access to the first-ever drug to treat low sex drive, the hope of a “magic pink pill" for women is crashing into the complex and little-understood reality of female sexuality.

Doctors and drug experts are already sceptical, and worry that if the pill does rack up big sales, it will be because of marketing, not science.

“If there was a great product ready to be approved, I’d be all for it," said Susan Wood, former women’s health director of the US Food and Drug Administration. “This is not it."

Flibanserin is made by closely held Sprout Pharmaceuticals Inc., and would be sold as Addyi. An FDA decision on approval is supposed to come by mid-August. With it would come a long list of not-very-sexy side effects.

Not only can it cause fainting and extreme sleepiness, but the risk is exacerbated by things that sometimes go hand-in-hand with sex: alcohol and birth control medicine. Drugs that treat yeast infections are also on that list.

“Would you take this medicine if you couldn’t take birth control and couldn’t drink? I think the market for the medicine is going to be pretty limited," said Richard Jenet, an obstetrician-gynaecologist in Woodbridge, Virginia. “I’m thinking there are a lot of people who won’t sign up."

Doctors may also be required to get special training to prescribe the pill. For patients, those restrictions may not be a great trade-off for a drug that, in clinical studies, only offered one more “satisfying sexual event" a month than a sugar pill.

Sprout will work with the FDA on monitoring the drug’s risks, if approved, the company said Thursday. The company didn’t immediately respond to questions on Friday.

Symptom or disease

Low libido “is a troubling symptom—that doesn’t make it a disease," said Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center group that calls for thoughtful use of drugs and looks at industry marketing. Sex drive might be hurt by other factors, like a bad relationship, she said.

“What I worry about is that it’s already being called ‘the pink Viagra,’" Wood said in an interview. “There may be societal pressures, marketing pressures to overprescribe."

Treating the lack of desire for sex in women is very different than sexual problems in men. Pfizer Inc. has sold millions of Viagra pills since the drug’s 1998 approval. The treatments have been blockbusters—Viagra and Eli Lilly & Co.’s Cialis had sales of $3.98 billion last year.

The treatments help men who can’t get an erection by increasing blood flow to the penis. Their dysfunctions are a case of a willing mind and a weak body.

Mysterious desire

Flibanserin, on the other hand, affects a far more complicated and mysterious organ—the brain. It targets neurotransmitters such as dopamine and norepinephrine—similar to antidepressants—that communicate information throughout the mind and body and can affect mood. While men take Viagra just before sex, flibanserin would be taken every night before bed.

On Thursday, a panel of outside experts recommended the FDA approve the drug in an 18-6 vote.

“The suffering of these women is real," said the panel’s acting consumer representative, Michele Orza, who voted against recommending approval. “The question I felt we had to answer is whether this is the treatment that they need. I felt that they deserve better."

Rejected twice

The medicine has been rejected twice by the FDA, most recently in 2013 when the agency said the drug’s small benefit didn’t outweigh its risks.

This time, Sprout mobilized a lobbying campaign, called Even the Score.

“There are 26 FDA approved drugs to treat various sexual dysfunctions for men (41 if you count generics!), but still not a single one for women’s most common sexual complaint," Even the Score says on its website.

Wood, the former FDA official, disagreed that sexism had anything to do with the rejections, and called the effort “inappropriate and misguided."

“The reality is that millions of women suffer" from the disorder “without a single FDA-approved medical treatment option," Susan Scanlan, chairwoman of Even the Score, said in an email. “Yesterday’s decision by the FDA Advisory Committee was a validation of both this very real need, and of the clear science that supports flibanserin’s approval."

Starting a conversation

Yet even if the drug doesn’t work very well, it will get the medical community talking about women’s desire, said Laura Berman, a relationship therapist and assistant clinical professor of obstetrics and gynaecology at Northwestern University in Chicago.

“Doctors don’t want to talk about something that there isn’t a cure" for, Berman said in an interview. “Just getting something through and approved, there will finally be a conversation about what can be done."

Viagra, for example, started a conversation about sexual health in aging men. More drugs followed.

“I think the same thing is going to happen now for women," Berman said. Bloomberg

Close