Is “female Viagra” Worth It?
Addyi is a new libido enhancer pill for women. According to the manufacturer’s research, it may restore healthy sex drive to some (but not all) women who take it daily. But the drug is expensive and has dire side effects. So is Addy worth it?
Addie (pronounced “Addie” like adoll ) is a brand name for flibanserin, manufactured by Sprout Pharmaceuticals , a division of Valeant . Addyi was approved amid controversy in August and went on sale in October. The FDA has rejected it twice because of its small benefits and serious risks.
But in a drug that actually works, the shortcomings can be forgiven. Low libido is a real problem for many women, although experts disagree on how best to treat it. Addy’s creator, Sprout , has backed a marketing campaign that claims drugs like Addy are desperately needed. Meanwhile, critics say Sprout is unfairly positioning normal sexuality as a disease in order to create demand for its pills.
What Addie Can and Can’t
First things first, although it is called “female Viagra,” Addyi has nothing to do with Viagra. Flibanserin is more like an antidepressant than it was once conceived. (It didn’t work.)
Like antidepressants, flibanserin does not work overnight: you need to take it for weeks or months to change the chemistry of your brain. This is the first difference between Addie and Viagra: men take Viagra on the days they want to have sex, and it increases blood flow to the penis for an hour. Women take Addie every day indefinitely in the hope that in a month or two they will want more sex.
The FDA approval decision was based on research conducted and funded by the drug manufacturer, but developed in accordance with FDA requirements. This is fairly standard for newer drug applications. Not all studies are published in journals, but this white paper includes key findings .
In three trials named by Sprout —DAISY ,VIOLET, andBEGONIA — women who took flibanserin for six months ended up having “satisfactory” sexual experiences (including sex and masturbation) more often than before the trial. On average, the size of the effect was small. For example, in BEGONIA, women per month had an average of 2.5 more pleasant sexual experiences per month. But women in the control group also had sex more often – in this case, 1.5 more, that is, the drug was added one per month.
But these are average figures. Some women have responded well to Addie by adding an extra pleasurable sexual experience each week . On the other hand, most of the women who took it did not notice any improvement. Only a few responded to the drug – from 7 to 13 percent. Sprout recommends that women try the drug for two months and stop taking it if they see no benefit.
Only this small percentage will be due to a biological response to the drug, but many more women will appear to be improving. This is what it means. In BEGONIA, 46% had more sex than before the trial when they took Addie, but 36% did so in the placebo group, the inactive pill used for comparison. We can say the drug added an extra 10%, but it is impossible to know which of this group benefited from the drug and who owes their extra sexual time to the placebo effect.
This ” placebo effect ” is not fake – it includes things like the effects of thinking about your sexual feelings every day. The women in the studies were required to answer a few questions about their sex lives every night and talk about it with the researchers and possibly their partners as well. Something similar happened inthis trial of oxytocin for the treatment of sexual dysfunction, published in Fertility and Sterility : Oxytocin didn’t work better than placebo, but women in both groups had more sex and better. Mikaela Beierle-Eder, lead researcher, told Think Progress that the trial really showed the power of partnership.
Addie’s risks
What’s more worrying are the risks. The drug can cause sedation, drowsiness and dizziness, so Sprout recommends taking it before bed. Sprout’s latest statement from the FDA included research on how safe women can drive in the morning after taking Addy before bed, and luckily they were able to drive normally.
Addie can also cause women to have low blood pressure and (rarely) fainting at seemingly random times. This only happened to a few people in the studies, but regulators were understandably worried. You are more likely to experience this effect if you drink alcohol. Sprout has done research to see what happens when flibanserin is combined with alcohol … and somehow managed to do it mostly in men .
“When it comes to alcohol research, we were not careful about requiring only women,” said their spokesperson. And no, this is not from the depths of the history of flibanserin as a drug for men and women; The FDA requested a study when they rejected flibanserin as a female libido pill in 2010. Walid Gellad, a member of the FDA’s advisory panel, called the 23: 2 sex ratio in the study “a huge disappointment.” Women metabolize alcohol differently than men, which means we know little about this interaction with the people who will actually take it.
However, women taking the drug are expected to abstain from alcohol. Not only from time to time, but completely. This means that if you’re used to a glass of wine to relax or get in the mood – or if you just enjoy a drink because, hey, that’s okay – this option is now out of your reach. …
Can low libido be cured with medication?
There are definitely women who believe that they have a rather weak sex drive, and it prevents them from living. What’s less clear is whether it is appropriate at all to treat the condition with medication, and if so, whether Addy has been studied in such a way that we know if it will actually help these women.
The condition Addy was developed to treat is known as HSDD: Hypoactive Sex Drive Disorder . The name implies that women should experience some normal level of desire, and that it is a medical problem if they feel that their desire is low.
But “desire” as a prerequisite for sex may be based on outdated and male- centered models of how sexuality works . Emily Nagoski , sex educator and researcher, explains it this way:
Basically, the drug maker assumes that spontaneous, “unexpected” desire for sex is the only “normal” way to experience desire, and that is, according to the accumulated scientific research over the past 20-30 years, not true. Instead, most people sometimes have a spontaneous desire and sometimes a RESPONSIVE desire.
Responsive desire means that desire can be an effect and not just a cause of sexual pleasure. Nagoski likes the analogy of going to a party : maybe you’re not sure what you want to go – there are traffic jams, you have to put on your pants and get out of the house – but as soon as you come to the party, you already have a great time. She claims that this attitude towards sex is healthy and normal. Women who feel this way are not broken and do not need drugs.
Doctors and patients who spoke at an FDA meeting earlier this year described HSDD in terms that sound like a textbook definition of responsive desire:
“[We] we know that women [with HSDD] can have a satisfying sexual experience … what [these] women lack is desire, desire, appetite for sexual activity. And women will choose sexual experiences that are ultimately satisfying for a variety of reasons. They lose sight of the reward system, which then wants them to want it again. “
“[When] they do something, it’s fun.”
While HSDD is recognized by the FDA as a disorder worth treating, it is no longer listed in DSM-5 , the American Psychiatric Association’s premier directory of psychiatric disorders. As psychiatrists learned more about the different ways that people experience sexual desire, the APA found HSDD obsolete. It has been replaced by Female Sexual Interest / Arousal Disorder , which involves the idea of responding normally to desire.
Flibanserin is potentially beneficial for women who have no desires. It is not known how many women could fall into this category, but it is likely much less than the 43% of women who are reported to have “sexual problems.” (This number came from research that showed that things like quitting porn are a problem .) Sprout now uses a 10% figure in their marketing. Nagoski believes the truth is closer to 6%.
So did the women in Sprout’s studies really have a real problem that drugs should have corrected? Before they started taking the drug, they had “satisfactory sexual experiences” 2.5 times a month, which is actually quite the average for married women their age. It is also unclear whether the increase in the number of such events meant that women enjoyed sex more. As Sprout researcher David Portman explained:
“[E] even if a woman reports SSE, a satisfactory sexual experience, we heard here in a patient-centered meeting last October that women often said, ‘I am happy because I have fulfilled my obligations.’
In other words, the “obligation” she feels towards her husband.
A key component of HSDD is that it hurts the patient. On the one hand, it’s great that the diagnosis leaves it up to the woman to decide when lack of desire is a problem. But the weakness of this approach is that there is no real test of what should even be considered a problem.
Many of the women who spoke at FDA meetings said their “distress” was often caused by feelings of guilt for disappointing their partners. This adds even more confusion to the question of effectiveness: does the drug actually help women have better sex, or does it just make them have more sex? The test data doesn’t tell us enough information to tell the difference.
Addie’s research also failed to answer an important question: if low sex drive is a problem for you, should Addie choose other treatment options? Researchers tested the drug only against an inactive placebo, not against other treatments.Sex therapy can be an effective treatment for low libido, but subjects from Addie’s trials were effectively excluded if they had any type of talking therapy in the past three months. Even more shocking, only a few tens of thousands have ever tried therapy. Did they seek medication when they really needed to better understand their sexuality?
Although there is no real female equivalent of Viagra, doctors who see patients with low libido prescribe several off-label treatments that help some women. Medications used in this way include the antidepressant bupropion , which appears to enhance reward mechanisms in the brain, and testosterone.
Obstetrician-Gynecologist Alyssa Dweck says she sees Addy as a “welcome addition” to current treatment, lifestyle, therapy, and counseling options.
Will this work for me?
Addie can probably benefit some people, but it’s still not entirely clear to whom and to what extent.
There’s a lot we don’t know about Addy’s effects in real life, such as whether the placebo effect will continue to be strong and how well the drug will work in women who do not fit the population tested in the trials.
All of these women were premenopausal, heterosexual, mostly white, and all had stable monogamous relationships that were otherwise happy. These women were excluded from trials if they had depression or any other conditions that might affect their sexuality, or if they were taking other medications, such as antidepressants, that might have sexual side effects.
The decision to take Addie (or, in fact, try any of the current low libido treatments) is a bit of a gamble – you are betting that you have the type of low libido that Addie can treat and that you are one of the them. answered. This is in addition to concerns about side effects. But there is another big question about taking this shiny new pill: can you afford it?
How much is Addie actually worth?
Shortly before the drug hit the market, I contacted the manufacturer, Sprout Pharmaceuticals, to ask a few simple questions, including the price of the drug. Their public relations specialists refused to let me know before launching the product, but instead offered a help program to help people get Addyi for “just” $ 20 a month.
Their customer service specialists didn’t tell me either. The representative I spoke to on 1-844-PINK-PILL said she did not know the price of the sticker but could tell me all about the assistance program. So I called one of the pharmacies that had the paperwork ready to be able to dispense the medicine (this consists of up and down vows that they would advise patients never to drink alcohol while taking Addy ).
You know, it’s bad when a pharmacist – who of all people should be immune to the shock of stickers – pauses for a couple of seconds and says, “Oooh, this is expensive.” This pharmacy, Walgreen’s, will have a monthly out-of-pocket supply of $ 971.09.
But Addie’s manufacturer doesn’t want you to pay out of pocket for it. They have a different business model by which the federal attorney’s office is investigating them . It includes semi-secret prices, co-payment assistance, and a network of pharmacies that they directly control.
Two days after the FDA approved Addyi , pharmaceutical company Valeant announced it was buying Addyi’s manufacturer, Sprout , for $ 1 billion. Valeant has a habit of buying smaller pharmaceutical companies and overpricing their drugs. Sounds familiar? This is the same strategy that Pharma-bro Martin Shkreli used when he raised the price of Daraprim by 5000% and pissed off the whole Internet .
In this case, Addy is a completely new drug, so we don’t know what the price would have been prior to absorption. But Valeant applied two of its other proprietary steps to Addyi: relief programs and a dependent pharmacy.
This is how the help program works: you download a coupon to bring it to the pharmacy. If you have insurance that covers the drug, you pay $ 20 in your co-pay and Valeant will cover the rest. Offer valid for your first seven recipes of the month. If you have insurance that doesn’t cover Addyi, you only pay $ 20 anyway, and Valeant pays for the rest, essentially buying itself the drug. (The fine print limits Valeant’s contribution to $ 780, which suggests the price at my local pharmacy is not random – the sticker price must be $ 800 or more)
By the time the deal is completed, you will have the opportunity to decide if it works for you – remember that it takes a month or two to see the effect, and that almost half of the women received some kind of positive response (although all but 10 % would have had the same response to an appropriately advertised tic-tac-toe). They are also likely planning to use this time to convince more insurers to add coverage for Addyi.
Assistance programs sound the other way around (why would they buy drugs from themselves?) Until you realize that it’s all about getting you to write the prescriptions your insurance has to pay for . The company subsidizes your expenses by helping with co-payments and deductibles, but still charges the insurance company as much as they can get away with.
You like it because you get the drug cheap. Your doctor likes it because you don’t complain about the high cost of the medicine. The pharmaceutical company loves this because they still make tons of money. But Valeant is still cheating you – only belatedly and indirectly.
First, the support program will expire after a few months and Valeant reserves the right to cancel the program without prior notice at any time. This means that within a few months of starting this long-term therapy, you will find that it will cost you the full cost.
And even while Valeant pays, your insurance company is wasting money on the overpriced drug. Many private insurance companies have put up with these assistance programs even though they are prohibited by Medicare . In order to pay for your (and all other) Addyi prescriptions, the insurance company will eventually have to charge you more for coverage. The hidden cost of drugs is a major driver of premium growth . So, while it seems like you are not paying the full price for the drug, in the end you still feel constrained.
Until this week, Valeant had an even more ridiculous program: they urged everyone to fill out their prescriptions not in the Walgreen’s neighborhood, but in a “captive pharmacy”: a mail order pharmacy controlled by a drug manufacturer. These pharmacies help keep prices high by writing relief prescriptions whenever possible and selling only the company’s drugs and not competitors’ drugs or generics. (Addy does not have a generic drug, but many other high-value Valeant drugs do.) There is also a real benefit to Addie that he gives patients easy access to a certified pharmacy in case there is no pharmacy in their area.
In the case of the pharmacy, the assistance program offered even better conditions: there was no time limit if you had insurance, and even people who were not insured could get the medicine for as little as $ 150. But Valeant has recently been accused of fraud, and federal prosecutors are investigating whether its pharmacy scams and price gouging are legal – because everything described so far is surprisingly legal – or they’ve added a few more layers of criminal offenses. The pharmacy that ran Addyi Direct, called Philidor , is at the center of the charges.
So far, a coupon scheme has been in effect, and rumors circulate that Valeant will likely team up with another pharmacy to replace Philidor .
In a few months, the first patients to use Addyi outside of clinical trials will be able to decide if it worked for them (and if they can still afford it after the Valeant grace period). In a few years, we will find out if the safety issues are more or less serious than the tests suggested. We’ll also get the post-approval research that the FDA is asking Sprout to do , including a repeat of the alcohol study, but this time with women.
So is Addy worth the risk, cost and uncertainty? For most women, probably not, but only time will tell.
Illustration by Tara Jacoby.
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