A pill for the ‘not tonight, honey’ crowd
Critics of the ‘female Viagra’ say the risks are too high for a drug that’s not needed
Men have a little blue pill. And now women have a little pink pill.
In a landmark decision, the U.S. Food and Drug Administration on Tuesday approved the use of a controversial drug, commonly called “female Viagra,” to treat low sex drive in premenopausal women.
It’s the first time the agency has given the green light to a drug that treats sexual desire disorders in men or women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The drug flibanserin, sold under the brand name Addyi, is approved for use only in the U.S., but North Carolina-based Sprout Pharmaceuticals hopes to make it more widely available.
The firm is “committed to working closely with other regulatory bodies outside the U.S.” On Wednesday, Health Canada said it has not authorized any applications for drugs to treat female hypoactive sexual desire disorder (HSDD).
But it may be just a matter of time before the company seeks approval here and Addyi ends up on the shelves of Canadian pharmacies, says Alan Cassels, a drug policy researcher at the University of Victoria.
“If the manufacturer really wanted to get it to the market in Canada they would do it,” Cassels said. “If they’ve been able to overcome the hurdles of the FDA, Health Canada is going to be a cakewalk.”
According to Sprout, HSDD affects up to one in 10 American women.
It’s characterized as an unexplained persistent lack of sexual thoughts, fantasies, responsiveness and desire to engage in sex, which causes personal distress.
Addyi, which is taken daily, can cause severely low blood pressure and loss of consciousness — risks that increase if consumed with alcohol or certain medicines.
Common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth.
FDA approval was, in part, based on three randomized trials involving about 2,400 premenopausal women with HSDD.
On average, Addyi boosted the number of “satisfying sexual events” from 0.5 to one additional event per month, as compared with those who took the placebo. The drug has overcome numerous hurdles, opposition and criticism.
It was rejected by the FDA as a desire drug in 2010 and 2013. Then Sprout and other drug companies with sexual pharmaceuticals in the pipeline sponsored the campaign Even the Score. It resembled a grassroots, social media campaign accusing the FDA of sexism for not having approved this drug for women, while claiming men had similar drugs to help them treat male sexual dysfunction.
“Even the Score . . . It’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction,” reads the campaign’s website.
Thea Cacchioni, an assistant professor of women’s studies at the University of Victoria who testified before the FDA in 2010 and was critical of the drug, suspects public pressure influenced the agency’s most recent decision.
In addition to Even the Score, there was compelling testimony at the most recent FDA hearing.
“There were many patients and doctors, who were sponsored by Sprout, and they gave very emotional pleas and spoke a lot about the demand for the drug,” Cacchioni said in an interview. “The FDA panel members barely had anything positive to say about the drug.”
Cacchioni has been studying the race by pharmaceutical companies to launch a sexual drug for women for years and recently published the book Big Pharma, Women, and the Labour of Love.
She doesn’t believe that the benefits of Addyi, when weighed against its risks, have been proven, particularly when compared with the benefits of sex therapy, sex education and sex counselling.
Cacchioni is also concerned that the drug was tested on a young and healthy population — the average age of the participants in the trials was 36 — saying “we don’t know what a drug is really going to do until it goes out into a wider population.” Her comments are echoed, in part, by Cassels.
“When you take a drug and give it to healthy people, you have to be absolutely certain that drug is not going to have any adverse effect. And, in the clinical studies of this drug, we’ve seen that there are people being harmed by it.”
Cassels, who co-wrote Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients with Ray Moynihan, believes that the industry has created disorders, such as HSDD, in an effort to market drugs.
“The main hurdle (for approval) was to try and define the disease,” Cassels said. “And I think (Sprout) bamboozled the FDA into considering this a disease.”
Cassels said it’s a misnomer to refer to Addyi as the female Viagra or pink Viagra because Viagra has nothing to do with desire. Rather, it’s aimed at increasing blood flow to the genitals for men.
At the extreme end, he believes there are women who aren’t interested in having sex.
But Cassels suspects that’s not who the drug maker will be targeting.
“This drug will be marketed to everyone who doesn’t want to have sex, for whatever reason — the ‘Not tonight, honey, I have a headache’ market. “The market has been shaped around turning lack of desire into a disease and I think it’s highly problematic,” Cassels said.
“This idea that you can tamper with and increase sexual desire with a pill — this is the brave new world.”