The drug flibanserin, marketed by Sprout Pharmaceuticals as a pink pill called Addyi, was thrust under the media spotlight last week when it finally secured FDA approval on Aug. 18 after two previous failed attempts.
Sprout was acquired by Valeant Pharmaceuticals for $1 billion just two days later.
The highly controversial drug is designed to treat women who experience a low sex drive that causes them distress or anxiety, a condition sometimes known as hypoactive sexual desire disorder (HSDD). Unlike Viagra, which is a purely physiological drug taken only as needed, Addyi is a daily pill meant to increase women's psychological desire for sex; it changes the levels of certain chemicals in the brain over time.
Addyi has faced widespread criticism since clinical trials have shown it's only marginally more effective than a sugar pill and comes with serious side effects, especially when taken with alcohol. Sprout Pharmaceutical's aggressive public relations campaign to get the drug approved has also come under fire. Some have even accused Sprout and the women's group that helped it rally support of "inventing" the condition of HSDD just to market a new drug.
The approval of this little pink pill has become as much a political issue as a scientific one.
Tech Insider spoke with Cindy Whitehead, the CEO of Sprout, as well as two independent experts, about some of the key arguments critics have made against Addyi.
The surprising path to FDA approval
Addyi failed FDA approval twice. The effectiveness of the drug was too slight and the side effects too severe, the agency said.
So what changed?
Sprout has been accused of using feminism to push the drug onto the market. It joined forces with a group called Even the Score (which is partially funded by Sprout) and spun the approval of the drug into a feminist issue. The core argument in their aggressive campaign was that men have access to many drugs to treat sexual dysfunction while women have none.
But Whitehead told Tech Insider that the drug's approval has always focused on data and scientific understanding. "The FDA rules on science, and on Tuesday they ruled on science," Whitehead said.
Others aren't so sure.
"The drug was approved on the same science that it was twice rejected on," Lisa Schwartz, a professor of medicine at The Dartmouth Institute for Health Policy and Clinical Practice, told Tech Insider.
Schwartz also pointed out that despite what appeared to be feminist forces helping the approval along, the drug could be considered anti-feminist. "The strongest advocate for women would want good safe drugs that will really help them," she said.
Finally, some have argued that the FDA's approval rates have gone up in general — the agency has approved the vast majority of drugs it's reviewed so far this year — and that flibanserin's approval is just a symptom of a larger issue.
Limited effectiveness
Women taking the drug every day during clinical trials had, on average, between 0.5 and 1 more satisfying sexual encounters per month than women taking a placebo. That limited effectiveness has made some question whether Addyi is worth approving at all.
Such people are too caught up in the absolute numerical difference between the pill and a placebo, Whitehead argued: Even a small improvement can make a big difference for patients.
"Talk to a woman with HSDD and ask her what's meaningful," Whitehead said. "For HSDD patients, one more time per month can be significant," she said.
Serious side effects
The benefits Addyi has shown in trials may not be worth the risks of side effects.
Sex and alcohol often go together, but Addyi's side effects are worsened when women take it with alcohol, studies have found.
When women took the pill after drinking two to four shots of alcohol, some experienced low blood pressure and fainting. That's why the pill will come with an FDA warning not to take it with alcohol.
"But are people really not going to drink and take this medicine?" Schwartz asked. "Can we really make that happen?"
Addyi will be put through more rigorous trials to test the effect of alcohol, including one where women drink two glasses of wine with dinner, take Addyi before bedtime, and then have their vitals monitored overnight. That could help the FDA determine whether certain amounts of alcohol might be acceptable for Addyi users.
For now, there is no amount of alcohol that's considered safe. "Counsel patients prescribed ADDYI about the importance of abstaining from alcohol," the FDA advises clinicians.
Potentially high cost
There is no set price yet for Addyi.
Sprout has said it will try to make a month's supply of pills equal to what most men pay for a month's supply of Viagra — about $400. About 70% of men taking Viagra pay between a $30 to $75 out of pocket, Whitehead said. The hope is that Addyi will cost roughly the same.
Others still question whether a daily pill can realistically be priced the same as a drug like Viagra that's only taken on demand. It's also unclear whether insurance will cover Addyi.
Pathologizing normal behavior?
In an essay published in June in the Journal of Medical Ethics, a team of doctors accused Sprout and Even the Score of "inventing" the condition of HSDD or at least making it seem more common than it is in order to cash in on a new drug.
"There is no scientifically established norm for sexual activity, feelings or desire, and there is no evidence that hypoactive sexual desire disorder is a medical condition," the team wrote. "Hypoactive sexual desire disorder is a typical example of a condition that was sponsored by industry to prepare the market for a specific treatment."
Whitehead insists that's a baseless accusation. "I would have been five years old then when the condition was first in the medical literature," she said. "So look, I think that's so out of step with scientific understanding." (The oldest reference to HSDD we found in PubMed, a database of medical journals, was in 1989.)
Still, the condition is a highly controversial one. The American Psychiatric Association doesn't list HSDD in its manual of mental health disorders anymore. It's now included in the broader category of female sexual interest/arousal disorder.
Part of the controversy comes from the fact that there's no medical or scientific norm when it comes to sex drive. What sounds like not very much sex to one person might sound like a lot of sex to another. We're all different — and pathologizing those differences can be dangerous, as Emily Nagoski argued in The New York Times.
"Is there really an underlying disease being treated here or is this just about the normal underlying variations in desire that people experience in life?" Schwartz asked.
For women whose sex drive takes a nosedive, there's also a risk of seeing that dropoff as a problem that needs to be treated, rather than as a symptom of something else that should be addressed. Relationship problems, stress, and even other medical conditions and medications can all lead to low sex drive. A sleep-deprived mother of young children might notice her sex drive waning, said Stanley Althof, director of the Center for Marital and Sexual Health of South Florida, and that's perfectly normal.
People who aren't actually bothered by their low sex drive would never be prescribed Addyi, Whitehead argued. "The hallmark characteristic, the only reason you would ever be considered to be treated for [HSDD], is if it is causing you distress," she said.
Yet some research suggests that this kind of diagnostic criteria would exclude most people experiencing "low desire."
A large study in the UK found that while as many as 50% of women reported problems with their "sexual response," only 11% said they had any distress about their sex lives. In fact, the authors concluded, the majority of people not having sex didn't seem to care — or at least they told researchers they didn't: "Most participants who did not have sex in the past year were not dissatisfied, distressed, or avoiding sex because of sexual difficulties."
Some experts think the drug could change that, making women who weren't previously bothered start thinking they have a medical condition when they don't. Others argue that there is indeed a narrow set of women that could be helped by Addyi.
"Where there is a clear biological basis, this drug may be helpful," Althof said. "Nobody wants to shame or embarrass anyone into using the drug" — especially when there might be other things going on.
Careful analysis of factors like relationship quality, mood, stress, kids, and sleep deprivation are all critical in determining whether the drug might be appropriate for a patient, according to Althof.
Looking forward
Evidence so far suggests that Addyi won't make a significant difference in the world. But it could fast track other, more effective drugs down the road, Althof argued. Viagra opened the floodgates to a host of other drugs designed to treat male sexual dysfunction.
But Schwartz said that argument doesn't hold up: "Why do we need a bad drug in order to get good drugs?"
