Addyi is a new libido-boosting pill for women.
But the drug is expensive and has scary side effects.
So is Addyi worth it?
Addyi wasapproved amid controversyin August and went on sale in October.
The FDA had rejected it twice before, due to its small benefit and serious risks.
But the downsides could be forgiven in a drug that truly works.
Addyis maker,Sprout, has backed amarketing campaignthat argues drugs like Addyi are desperately needed.
Meanwhile, critics say Sprout is unfairlypositioning normal sexuality as a diseaseto create demand for its pills.
Flibanserin works more like an antidepressant, which once upon a time it was intended to be.
(That didnt work out.)
This is pretty standard for new drug applications.
The studies havent all been published in journals, butthis briefing document includes the key results.
On average, the effect size was small.
For example, in BEGONIA, the women had 2.5 more satisfying sexual events per month, on average.
But those are averages.
Some women responded well to Addyi, addingan extra satisfying sexual event each week.
On the other hand, most women who took it saw no improvement at all.
Only a few responded to the drugbetween 7 and 13 percent.
Heres what that means.
That placebo effectisnt bogusit includes things like the effects of thinking about your sexual feelings on a daily basis.
The Risks of Addyi
Whats more concerning are the risks.
The drug can cause sedation, sleepiness, and dizziness, so Sprout recommends taking it at bedtime.
This only happened to a few people in the studies, but regulators were, understandably, extremely concerned.
Youre more likely to experience this effect if you drink alcohol.
In terms of the alcohol study, we didnt have the foresight to require only women, their spokespersonsaid.
Nonetheless, women taking the drug are expected to abstain from alcohol.
Not just on occasion, but completely.
Can Low Libido Be Treated With Medication?
There are definitely women who feel they have a sex drive low enough that it interferes with their lives.
The condition Addyi was designed to treat is known as HSDD:Hypoactive Sexual Desire Disorder.
Instead, most people experience spontaneous desire sometimes and RESPONSIVE desire other times.
Having a similar attitude toward sex is healthy and normal, she argues.
Women who feel this way arent broken and dont need a drug.
And women will choose to have sexual events that eventually are satisfying for a variety of reasons.
What they miss is the reward system that then wants them to want it again.
[O]nce they engage in activity, its pleasurable.
As psychiatrists learned more about the different ways people experience sexual desire, the APA considered HSDD obsolete.
Itsbeen replaced by Female Sexual Interest/Arousal Disorder, which incorporates the idea of responsive desire as normal.
Flibanserin is potentially helpful for women who dont haveanytype of desire.
(That number comes from a study that judged things like not looking at porn to be aproblem).
Sprout nowuses a 10% numberin their marketing.
Nagoski guesses the truth is closer to 6%.
So were the women in Sprouts trials actually experiencing a real problem that medication should be able to fix?
Its also not clear if increasing those events meant that women were enjoying sex more.
In other words, the obligation she feels to her husband.
A key component of HSDD is that it causes distress to the patient.
But the weakness of this approach is that theres no reality check on whatshouldbe considered a problem at all.
The trial data dont give us enough information to tell the difference.
Whats even more shocking: only a few dozen out of the thousands had ever tried therapy.
Were they seeking medication when what they really needed was a better understanding of their own sexuality?
Will It Work for Me?
Addyi can probably benefit some people, but its still not really clear who or by how much.
Thats in addition to the concerns about side effects.
But theres one other important question about taking this shiny new pill: Can you afford it?
What Does Addyi Actually Cost?
Their customer service people wouldnt tell me either.
At that pharmacy, a Walgreens, a months supply out of pocket would cost $971.09.
But Addyis maker doesnt intend for you to pay for it out of pocket.
They have a different business model in mind, one that is getting theminvestigated by federal prosecutors.
It involves semi-secret prices, co-pay assistance, and a connection of pharmacies that they directly control.
Valeanthas a habitof buying smaller drug companies and jacking up their drugs prices.
But Valeant deployed its other two trademark moves on Addyi: assistance programs and a captive pharmacy.
Heres how the assistance program works: you download a coupon to bring to the pharmacy.
The offer is good for your first seven monthly prescriptions.
They are probably also planning to use the time toconvince more insurers to add coveragefor Addyi.
The assistance programs sound backwards (why would they buy their own drug from themselves?)
until you realizethe whole point is to encourage you to fill prescriptions that your insurance has to pay for.
You love it because you get the drug for cheap.
Your doctor loves it because you dont complain about the drug being expensive.
The drug company loves it because they still make a ton of money.
But Valeant is still screwing you overjust belatedly and indirectly.
And even while Valeant is paying, your insurance company is wasting money on an overpriced drug.
Many private insurance companies put up with these assistance programs, although they areprohibited under Medicare.
Hidden drug costsare a major factor behind rising premiums.
(Addyi doesnt have a generic equivalent, but many of Valeants other high-priced drugs do.)
The pharmacy that ran Addyi Direct, calledPhilidor, is at the center of the accusations.
So is Addyi worth the risks, cost, and uncertainty?
For most women, probably notbut only time will tell.
Illustration by Tara Jacoby.
