A controversial new drug designed to treat low sex drive in women secured FDA approval on Aug. 18 after a five-year battle and two previous rejections.
The drug is called flibanserin, marketed by Sprout Pharmaceuticals under the name Addyi. It will hit pharmacy shelves on Oct. 17, and it's being touted as "female Viagra."
First of all, it's important to know that Addyi doesn't work anything like Viagra. It's a daily pill that women take to treat hypoactive sexual desire disorder (HSDD) — a condition where women experience a low desire for sex that causes distress and anxiety. (Even the diagnosis, potentially pathologizing what may be within the range of normal behavior, is controversial.)
The drug is meant to increase women's psychological desire for sex. If taken long enough, Addyi can alter levels of chemicals in the brain, much like some antidepressants. Viagra is simply designed to treat erectile dysfunction by increasing blood flow to the penis.
Unfortunately it seems like Addyi isn't going to have anywhere close to the impact on sexual dysfunction in women that Pfizer's Viagra did on sexual dysfunction in men, and there are a lot of reasons why:
For many women, Addyi doesn't really do what it's supposed to do.
The biggest problem is Addyi has barely made any difference in women's sexual desire in clinical trails.
In one clinical trial, women took a pill, either Addyi or a placebo, every day for a month. Women taking Addyi reported an increase in the number of times they had satisfying sex from about 2.8 times a month to an average of 4.5 times. That's an increase of about 1.7 satisfying sexual experiences per month. But the women taking the placebo also saw a similar increase. They reported going from about 2.7 times a month to 3.7 times — an increase of about 1 time per month.
Sprout has offered more data to support a median increase of 0.5 to 1.0 satisfying sexual experiences per month, with a slightly larger impact on a small subset of women.
But the generally marginal increase has caused many experts to question the pill's effectiveness.
Addyi comes with side effects.
The pill has a whole host of side effects including dizziness, low blood pressure, fainting and sleepiness, especially when it is taken with alcohol.
That's a problem because Americans drink a lot. Heavy drinking in the US in up over 17% since 2005, and that number is rising even faster among women. It seems unlikely that women will stop drinking to take a pill with such a limited effect.
Addyi may also interact poorly with other medication that women take like birth control or yeast infection medication.
It's probably going to cost more than Viagra.
As Forbes points out, drugs like Viagra are only taken on demand while women will have to take Addyi daily. Sprout has said it plans to charge about the same amount for Addyi as for erectile dysfunction drugs: perhaps around $400 a month, according to a rough estimate by The New York Times. But the costs for Addyi will be fixed, while men can choose how much they want to spend on Viagra. And "it is not clear," The Times notes, "if insurance companies will pay for Addyi."
Doctors may also hesitate to prescribe a pricey pill with very limited effectiveness and side effects that are exacerbated by alcohol.
How did Addyi get FDA approval then?
The short answer: a smart and aggressive public relations campaign. (The history of that campaign is detailed in a story by Azeen Ghorayshi of BuzzFeed News.)
After the drug's second failed attempt to get FDA approval, Sprout joined forces with a women's rights coalition called Even the Score (which, according to The New York Times, is at least partially funded by Sprout).
Somehow Sprout and Even the Score turned Addyi into a women's rights issue. They centered the conversation around feminism, not whether or not the drug actually works, and made blocking it seem anti-women.
"I’m hopeful not only for what it could mean for women in which it could work, but also for women at large," Cindy Whitehead, CEO of Sprout Pharmaceuticals, told Buzzfeed News. "This marks a real shift in our conversations around women’s sexuality."
Even the Score played a pivotal role in rallying feminist support. It called in HSDD patients for testimony, and lobbied Congress members to write letters to the FDA.
The organization's name comes from its assertion that there are dozens of drugs on the market to treat male sexual dysfunction, but none on the market for women. Even the Score wants to "even the score," and has gone as far as to say the FDA is sexist.
The problem is that Even the Score's position is fundamentally flawed. None of those male drugs on the market treat low sexual desire. Viagra and drugs like it only increase blood flow to the penis — the effect is purely physiological, not psychological. Even the Score's argument is also something of a strawman: Most people are not arguing that treating women's sexual dysfunction is a waste of time, only that this particular drug does not seem up to the task.
Other women’s groups, including the National Women’s Health Network and Our Bodies Ourselves, have criticized Even the Score for distracting people from the actual data and turning a serious scientific issue into a political one.
The FDA has recommended strict measures to make sure women are aware of the risks, which includes a warning to not drink alcohol with the drug.
Is low sexual desire really an illness that needs medication?
The American Psychiatric Association doesn't list HSDD in its manual of mental health disorders anymore; it's now folded into a broader category called female sexual interest/arousal disorder. In any case, there's little scientific evidence that a "normal" level of sexual desire exists; it can vary within a large range depending on many factors. And many women with a low sex drive are not actually troubled by it.
Some experts think Sprout and Even the Score tried to establish that HSDD is common among women (there's not much evidence for this — estimates on HSDD prevalence range from 5% to 19% of women) and that many women may not know that they have it but can easily be diagnosed with a simple questionnaire.
A letter published in the Journal of Medical Ethics goes as far to say that Sprout's marketing campaign almost amounted to inventing a disease just to sell a low libido drug. There are laws against marketing a drug before it gets approval, but there are no laws against marketing a disease.
"In fact, 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 authors write in the letter. "Hypoactive sexual desire disorder is a typical example of a condition that was sponsored by industry to prepare the market for a specific treatment."
Women who are distressed by what they see as low sexual desire deserve options to manage that. But it seems clear that Addyi will fail to meet the needs of many women when they take a pill that has a high chance of not working and could lead to unpleasant side effects.
Sprout did not immediately respond to a request for comment on these issues; we will update this post if we hear back.
