Apparently there's some kind of big marketing push right now for flibanserin, the decade-old, remarkably shitty "female Viagra" sold under the brand name Addyi in the US. Every podcast I've listened to in the last two weeks has featured an Addyi commercial.
So, friendly reminder those who forgot: while there are definitely women and other humans with vaginas who experience sexual dysfunction and would love to take a pill about it, Addyi is almost certainly not that pill.
A few facts:
Flibanserin was officially approved to treat hypoactive sexual desire disorder, a diagnosis removed from the DSM before the drug hit the market. As far as I can determine, Addyi is not currently approved to treat HSDD's replacement diagnosis, female sexual arousal/interest disorder (FSAID).
One of the major differences between HSDD and FSAID is that HSDD could be diagnosed on the basis of a partner's report of insufficient sexual desire, while FSAID must be diagnosed based on patient reports. Basically, you can get diagnosed with HSDD if your boyfriend doesn't think you're putting out enough, whereas you can only get diagnosed with FSAID if YOU, the patient, think there's a problem. And Addyi claims to treat the boyfriend version.
Side effects of flibanserin include dizziness, nausea, tiredness, sleepiness, and (ironically) trouble sleeping. Those are not the kind of side effects anyone would put up with from Viagra, but hey, apparently they're fine in a "little pink pill".
When flibanserin was first released in 2015, it included a "Don't drink alcohol ever" warning on the bottle because mixing the two substances could torpedo blood pressure. Apparently that's been downgraded to "either sober up before you take your daily pill, or skip it for the day if you've had 3 or more drinks".
Daily pill? Daily pill. Unlike Viagra, which can be taken more or less at the moment of need, flibanserin is supposed to be taken daily if it's to be effective.
And how effective is it? Not very! The most recent published studies are vague (or at least their publicly accessible summaries are), but the studies released with the initial marketing push in 2015 were touting effects like one whole additional satisfying sexual event per month, and the more recent ones are vague about everything except "it's totally better now". That's not a lot for an expensive daily med with serious side effects.
So if this med doesn't really work, it has serious side effects, and it claims to treat a disorder that hasn't been on the books since two years before it was released, how the hell did it get FDA approval? The answer is a massive marketing campaign, including an astroturf group called Even The Score that was put together by the pharma company Sprout Pharmaceutical after the FDA initially denied approval.
But don't worry! Sprout was acquired by a bigger pharma company, Valeant, for $1 billion right after Addyi hit the market. So there's a happy ending after all. 🫠
I realize griping about the marketing of a decade-old drug is kind of off-brand for me, but I'm frankly creeped out that someone decided to follow up The Misogyny Election with a massive ad buy for a daily roofie that can be prescribed if a woman's partner wants more sex than he's getting. It's very "your body, my choice".
Oh, and it'll run you $400 a month.
Anyway, talk to your doctor about literally anything other than this shitty drug.
So I just learned that female Viagra exists (Addyi and Vyleesi), and there is something called "Hypoactive Sexual Desire Disorder". The more research I do the more conflicted I am about the whole thing. Primarily females are diagnosed, and it is when they are in distress over their low sex drive. As a therapist who is getting more comfortable with their asexuality and a niche in mental health/trauma, I just don't know how to process this. It bothers me and I don't really understand why.
I was going to delete this ask because it’s in the FAQ and that’s the rule. However, you are an asexual therapist?
Q: What’s wrong with flibanserin/addyi/“female Viagra”
A: You can see a collection of articles here. There’s a bunch in that tag from my favorite article on the matter to mentions of an asexual task force 4 years ago that was like whoa whoa why are targeting us with your marketing here?
If you’d like to learn the history of this beyond just Addyi there is a documentary called Orgasm Inc on Netflix. It’s from 2009, but it gives you backstory long before the Addyi problem. The documentary is sexual in nature so beware of that, but does have some gems like the following. The clearest example of corporate sponsored creation of disease is female sexual dysfunction. - Ray Moynihan, British Medical Journal.
Addyi at least (I’m not versed with Vyleesi) was a once a day pill, that had a high bar of don’t do other things while on this and a very low bar of added sexual encounters while on it. (I think it was +2 every month) It was also only to be used on a young population and when loss of sex drive is reported and not linked to another problems is most often reporter older people which this was not made to help.
I’d also like to link you to the asexual related DSM post I have that mentioned how in 2013 “*If Asexual Does Not Apply” marker was added. Which even the phrasing makes me worry “What if they don’t know the label? What if they hate their asexuality?” But you’d know the common phrasing of it better than me.
I think it is you absolutely your place and your due diligence as an asexual therapist to be bothered by this until you know acephobia isn’t being spread in the name of mental health.
I wasn’t on the task force, but I know people who were so let me know if you want to discuss it more with me or with you want me to reach out to them to connect you.
Some of you might remember me talking about my loss of libido. Well I have finally gotten a prescription for Addyi, which is sort of like the female version of viagra but not quite. You have to take it daily.
I also just saw an ad for Vyleesi, which is similar but in EpiPen form. You have to inject yourself with the medication 45mins before you think you may have sex. So there are options out there for me!!
Will update with a review of how Addyi is working for me once I feel any effects or have finished the two months worth of medication.
@draegaa and anyone who is curious about why we get so mad about Addyi/Flibanserin:
I saw your questions about addyi/flibanserin and why it gets so much criticism - it’s got a bit of a complicated history but here are a couple of initial links that can give some additional background:
Rotten Zuchinnis has posts about it here and here, and I have some scattered thoughts about the latest campaign and their previous campaign (with many of the same problems). You can also see posts from the ace flibanserin taskforce (which unfortunately is no longer active).
For more mainstream criticisms (that are less focused on implications for ace communities), the NWHN also has a summary and the CNN article in the original post has a decent summary of some points as well.
The most common critiques are that it barely works, if at all (they had to try a bunch of different testing measures until they found one that didn’t indicate that it was almost all placebo effect); that it has dangerous side affects that may outweigh any potential benefits; and that the marketing blatantly targets groups who are completely contra-indicated for a diagnosis of HSDD* and who the drug has not been approved for.
( *technically speaking, as of the DSM-5 updates in 2013, [M]HSDD is only used to refer to low sexual desire in men, and the equivalent low desire disorder for women is classified as FSIAD. Which is another reason I would be hesitant to trust that site as an appropriate medical information provider. )
With regard to the new campaign in the post:
The first thing to know is that the ad campaign in question is funded entirely by Sprout Pharmaceuticals, the company that sells the only HSDD* drug on the market, so they have a vested interest in getting people diagnosed and on pills, whether it’s appropriate or not. They have no interest in actually giving accurate information about HSDD/FSIAD or women’s health in general.
Unfortunately “you should take this drug to make your husband happy / save your relationship” is pretty much one of their main selling points:
Also, technically speaking, HSDD is only supposed to be diagnosed when:
1. It is causing clinically signficant distress to the patient
2. The patient is not post-menopausal
3. The loss of desire cannot also be explained by much more common causes like relationship troubles, stress, pregnancy, menopause, pain during sex, other medical issues, etc.
However, if you take the quiz, even if you check every single contra-indicator and state that you have no distress, it will still recommend that you talk to your doctor about HSDD.
The wording of the quiz questions is also explicitly framed in such a way that long term low libido is positioned as if it’s always a bad thing - even if in previous questions you indicate that you have no problem with low libido and see it as a healthy state for yourself:
Anyway, that’s just touching the surface. I have a longstanding grudge against Addyi and the way it’s marketed so I’m happy to elaborate if anyone has more questions about it or why so many of us are mad about.
(Also: While I criticism Sprout a lot for indiscriminately trying to apply HSDD* to situations that don’t fit the DSM-5 criteria, I don’t want to necessarily endorse the DSM diagnoses either - they also tend to be overly broad, have poorly defined etiology and questionable assumptions that should be critiqued and carefully considered. The marketing of Addyi is just taking an already fraught issue and making it even more unfounded).
Thank you for all your research on addyi. I jumped through so many hoops to be on it, and it just ended up being a miserable flop that made me ashamed to be ace. Politics and science never mix well, and the only way to fight it is to inform women about what it really is. Also, the black box alcohol warning is bs. The trials had a primarily male group down a bottle of wine in a short amount of time, and asked if they felt dizzy. It was a sabotage attempt by the FDA
I’m glad you found the information useful. ( These [ text ] are my FAQ’s to which you might have been referring. )
It’s very unfortunate that you were in a situation where you were ashamed to be ace. I look forward to a world where nobody is ever made to feel that way. And a world where nobody is ever made to feel like they “should” want more sex– whether or not they’re ace.
In terms of the other stuff ( e.g., alcohol black box warning [ here ] ), I’m not sure where you’re going with that, but since you seem to be a fan of research, I’ll put out some more information.
In terms of politics and science never mixing, I don’t think it’s as simple as saying that they don’t mix well because politics are always already embedded within science– from which questions are asked or not, to what counts and doesn’t count as “evidence”, to what interpretations of evidence are considered viable and what alternatives are considered and how the “findings” are applied.
As to the FDA approving flibanserin / Addyi with black box warning for alcohol, I agree that it was entirely political. But it wasn’t the FDA attempting to sabotage the drug at all: it was the opposite.
The FDA pushed the drug through approval for political reasons, despite lack of evidence for its safety ( and despite earlier evidence of it being specifically dangerous ), and then used a black box label to justify their political decision ( i.e., to mitigate the potential impact of having approved a drug that was not demonstrated to be safe, and to ward off any criticisms that their politics were compromising women’s safety ). Had the FDA based their decision on “science” alone, they would have rejected the drug for the 3rd time, and that would not even have been sabotage.
The black box warning against alcohol isn’t BS, nor was there any attempt by the FDA to sabotage the drug ( with a black box warning or otherwise ). Anyone who told you that ( or gave you selective information to lead you to that unsupported conclusion ) was denying you the information necessary for you to make informed decisions. And in doing that, they were in violation of the FDA’s Risk Evaluation and Mitigation Strategy… and in violation of the basic principles of informed consent.
Here’s a lenthy discussion below the cut of:
of the FDA’s purpose ( and the goal of evidence-based medicine )
why the FDA approved Addyi / flibanserin ( i.e. for political reasons ),
information about the dangers of mixing alcohol and flibanserin ( *not* just from that 1 mostly-male study )
the Risk Evaluation and Mitigation Strategy including the black-box warning… ( i.e., as something pretty reasonable given the evidence for risks and lack of evidence for safety )
The FDA and the goal of evidence-based medicine:
The FDA makes decisions about whether to approve drugs in a context where all medical treatments are *supposed* to be “evidence-based”. Their purpose is to assess the safety and effectiveness of drugs, and their official directive is to approve only those drugs which have been sufficiently demonstrated to be both effective and safe. They also specifically have a public health mandate.
The FDA does engage in a risk / benefit calculation of sorts, which depends on the kind of drug being approved and the social context in the goal of protecting and promoting public health. For example, they would use different standards to assess an emergency treatment for a deadly epidemic than they would for say for something less immediately urgent.
Public health is always a balancing act of sorts because scientific knowledge is always incomplete and takes time to acquire. Sometimes life and death decisions need to be made quickly. There are always politics that guide these decisions. The higher the “cost” of no action ( i.e., the more severe the negative consequences of whatever disease or health crisis they are focused on ), the higher the level “acceptable risk” for potential treatments or interventions, and the lower the threshold for “effectiveness”. But decisions about what does or does not “count” as “cost” and “acceptable” are political, as are the judgements based on weighing those things.
The FDA’s ( political ) reasons for approving Addyi / flibanserin
The people on the FDA committee who recommended Addyi / flibanserin for approval shared publicly about how their recommendation was based on factors *other* than the drug’s ( seriously questionable ) safety or its ( very limited ) effectiveness. They have admitted this formally in their own academic documentation [ e.g., text ] and been quoted by journalists [ e.g., text ] ).
Basically, the FDA approved the drug ( even though it was neither effective nor safe ) because they decided that:
it’s so terrible for women to have low sexual desire that even an unsafe drug that does not much to help is better than nothing ( i.e., they used much less strict standards of acceptable risk and benefit than they usually use, for political reasons ) and
since there are no other drugs approved, and if they rejected this drug for the 3rd time, then pharmaceutical companies would decide it’s not profitable to develop drugs aimed at increasing women’s low sexual desire and that would stop people from trying to develop these drugs ( which they viewed as a negative outcome )
The committee that recommended the drug for approval was clear that if other drugs to “treat” low sexual desire had already existed, they would have recommended that Addyi / flibanserin be rejected. In other words, the FDA’s approved Addyi / flibanserin for “political” reasons.
Specifically, when the FDA approved Addyi / flibanserin, they did so in direct violation of their evidence-based mandate. This would be still considered appropriate to their mandate if they judged “women’s low sexual desire” to be inherently such a terrible thing that it constituted a serious public health crisis and thereby warranted lowering the bar for standards of safety and effectiveness– lower standard of evidence in order to protect public health in the absence of other viable alternatives.
Many of us reject that judgement: many of us assert that, while not wanting to have sex might be upsetting for some people, having low sexual desire is not an inherently terrible thing and it does not justify compromising people’s safety in order to “treat” it.
re: safety and alcohol ( adopting a “Risk Evaluation and Mitigation Strategy” instead of rejecting the drug outright )
When the FDA rejected flibanserin in 2013 ( for the second time ), some the main concerns were that it was not demonstrated to be safe with alcohol ( or for that matter with CYP3A4 inhibitors, including oral contraceptives [ source1 ; source2 ; wikipedia source ). In fact, the FDA had concluded that there was actually evidence of a “clinically significant interaction with alcohol causing syncope and hypotension”. ( Long *before* the study with 23 men and 2 women was done. )
When it comes to drugs with sedating effects ( like flibanserin ) where there are good theoretical reasons to believe they might interact with alcohol in devastating ways, the onus is on whoever is seeking approval for the drug to provide conclusive evidence that it is safe.
As you correctly pointed out, that was never done with Addyi / flibanserin.
Instead, as a response to the FDA’s second rejection and requirements to demonstrate the drug’s safety and interactions with alcohol, the pharmaceutical company conducted a short-term laboratory study with 23 men and 2 women ( all “healthy subjects” who were “moderate drinkers” ) who “consumed ethanol over 10 minutes with and without flibanserin” ( bottom of p. 5 of the FDA briefing document for flibanserin from June 4, 2015 ] ).
Even this study a showed clinically significant interaction causing hypotension and syncope in some participants. ( The details of the study and results are outlined beginning on p. 59 of that FDA briefing doc. ) Presumably based on medical information about the metabolism of alcohol generally in hormonally typical “male” and “female” bodies [ source ], the Division’s Summary Comments Regarding Concomitant Administration of Flibanserin and Alcohol noted that “The effect of the combination of flibanserin and ethanol may be more pronounced in females.” ( p. 61 ).
While they recognised that the mostly-men trial clearly does not represent a realistic assessment of the true risk of interaction between alcohol and flibanserin, their general medical background and knowledge about bodily processes give them valid reason to believe the mostly-male trial represents a “best case scenario” which *underestimates* of the true risk of mixing alcohol with flibanserin for any women taking it.
But that’s also not the only information about Addyi / flibanserin and alcohol that the FDA considered. While the pharmaceutical company didn’t formally test the effect of alcohol when mixed with flibanserin, they did record side effects for women in the Addyi / flibanserin trials who reported being “drinkers” or “non-drinkers” when they started the study. ( Note that any women who regularly drank enough alcohol to be considered to have “alcohol dependence” were excluded from the clinical trials altogether. )
Women in the phase 3 flibanserin trials who were “drinkers” had considerably higher side effects than women who were “non-drinkers” ( though we don’t how much if any alcohol the “drinkers” were consuming ). The full table is on p. 61 of the FDA background doc.
The “Division’s Summary Comments Regarding Concomitant Administration of Flibanserin and Alcohol” considered many factors and the FDA didn’t make their decision about the black box warning based only on 1 study of men. ( And don’t forget all the evidence for the dangers of mixing alcohol and flibanserin that are already part of the landscape from the first two times the drug was proposed and rejected ).
The Risk Evaluation and Mitigation Strategy as reasonable ( but based on your comments, apparently not necessarily being effectively executed )
The FDA had many reasons to believe there might be an interaction between Addyi / flibanserin and alcohol– information from the first 2 rejected FDA applications; the side effect profile of the phase 3 Addyi / fliansering trials; the mostly-male 1-time alcohol study; and the rarely-discussed theory based on the not-clearly-understood mechanism of action ). Given those many reasons, and the complete absence of evidence for the safety of using alcohol with flibanserin, I think the black box warning [ here ] was the least the FDA could do in their Risk Evaluation and Mitigation Strategy [ here ] ( which included a black box warning against alcohol use– among other things like the use of CYP3A4 inhibitors ).
( Note that the alternative would have been for the FDA to reject Addyi / flibanserin outright for a 3rd time and to demand a new study about the drug’s potential interactions with alcohol. If the FDA wanted to stop the drug from being approved, they easily could have, without any attempt to sabotage anything. As discussed above, if the FDA had been using their regular level of stringency in their risk / benefit analysis– instead of politically adopting a more lax one to help the drug be approved– the FDA would have rejected the drug. )
Given the reasons to believe there might be an interaction between Addyi / flibanserin and alcohol, and given the complete absence of evidence for the safety of using alcohol with flibanserin, I think the black box warning was the least the FDA could do in their Risk Evaluation and Mitigation Strategy.
Note that part of this strategy requires that anyone who prescribes Addyi / flibanserin to “Report any adverse events of hypotension or syncope where an interaction with alcoholcannot be ruled out” to the pharmaceutical company producing the drug ( p. 2, point II A 1. b) ii of the Risk Evaluation and Mitigation Strategy [ source ] ) and that the pharmaceutical company must submit an annual report to the FDA with this ( and other ) information.
The REMS is much more than a black-box warning. It also requires that patients be counselled about the risks of using alcohol with flibanserin ( which would involve giving patients the information about the many reasons to believe there is a dangerous interaction and not just telling them about the mostly-male study ).
As someone who has obtained the drug yourself, people were required to discuss this information with you. It doesn’t seem like they did. Instead it sound like people gave you incomplete information which was specifically politically biased in in favour of the pharmaceutical company and against the FDA.
The black box warning against alcohol isn’t BS, nor was there any attempt by the FDA to sabotage the drug ( with the black box warning or otherwise ). Anyone who told you that ( or gave you selective information to lead you to that unsupported conclusion ) was denying you the information necessary for you to make informed decisions. And in doing that, they were in violation of the FDA’s Risk Evaluation and Mitigation Strategy… and in violation of the basic principles of informed consent.
The public ostensibly believes these groups are speaking for patients, but in reality they could be the mouthpiece of a pharmaceutical company, she said.
She pointed to the pharma-funded patient advocacy groups who were mute when price-gouging sent the cost of Epipens skyrocketing in the US, and a drug company-funded patient advocacy campaign helped push through the approval of a controversial female sex drug that had been rejected three times.
Patient advocacy groups should disclose pharma sponsors, say experts (Sydney Morning Herald, 18 January)
I haven’t had the time or energy to keep up as much as I’d like with developments with flibanserin/addyi (yay burnout!), but I was curious and decided to do a quick little search today – look…
Not a real fleshed out post, but I spent 30 min or so doing some googling and here’s some of the more recent developments I was able to find.
