So for those of you who remember Addyi (aka Flibanserin, the anti-HSDD drug that went through a lot of controversy over it’s FDA approval and has been warily watched by the ace community), the company that produces it (Valeant) just launched a new marketing campaign called “find my spark” - and this is definitely something the ace community should keep an eye on.
You can read my initial commentary here, or investigate the new addyi-funded “FSD” campaign website here.
(Content warnings for compulsory sexuality, dubious medical advice, and blatant marketing shilling. Take all claims made there about FSD, HSDD, or anything else with a grain of a salt, as a lot of it is not necessarily scientifically or medically supported, and it’s very much twisted to make Addyi seem like the answer even if they don’t say that explicitly.)
This is the kind of the think the ace community should definitely keep a careful eye on, because the entire profit plan of this drug is based on convinving as many people as possible that lack of sexual desire is a disease that can be cured by giving them money for their drugs - which understandably leads to increased pathologization of asexual people and others who may naturally have lower sexual desire.
Have your say (until Dec. 27th): FDA guidance for industry developing drugs for women’s low sexual desire
Kind of short notice, but:
The FDA put out a draft document about how the clinical trials should proceed for pharmaceuticals to “treat” or “cure” low sexual desire in women.
Check out a post about some parts of the FDA’s guidance document that might be of particular interest to aces.
The FDA has invited public feedback until Tues, Dec. 27th, 2016 at 11:59pm EST. Comments can be submitted here.
About a year ago, the FDA approved the first ever drug to treat low sexual desire. This drug was approved largely based on the argument that it’s so terrible to have low sexual desire that even an unsafe and minimally effective drug is work the risk. (More info below the Read-More cut).
While this drug was under review, pharmaceutical companies arranged for the FDA to be flooded with comments from people about how it’s so terrible to not want to have sex, entreating them for a drug. Chances are, they’ve continued this tactic.
It would be very useful for people to write comments on the guidelines document from other perspectives-- particularly perspectives where having low or no sexual desire is perfectly okay! And particularly if they have comments that might speak to concerns about the research context or what “counts” as evidence.
For context, in August 2015, the FDA Addyi / flibanserin as a treatment for low sexual desire in pre-menopausal women whose low sexual desire was *not* due to a side effect of another drug and *not* due to another medical condition. The drug was the first drug ever to be approved to treat low sexual desire in anyone (of any gender). It needs to be taken every day, has very serious side effects and interactions with other substances, and is at best minimally effective (i.e., the increase in desire for less than 1 sexual interaction per month more than a placebo). More information about that in this post.
Even doctors on the FDA advisory committee that recommended that the drug be approved had publicly acknowledged that their decision was based on factors *other* than its (very limited) effectiveness or its (questionable) safety, both in their own academic document and when speaking to the press), namely that if they rejected it again for a third time, then pharmaceutical companies would likely move on to more lucrative-seeming drugs. The decision to approve this drug was essentially based on the argument that it’s so inherently terrible to have low sexual desire that even a dangerous and minimally effective drug is worth the risk (and that rejecting the drug again even if it’s neither safe nor effective would halt development of future drugs that might eventually be safe and effective).
So far, the drug has not sold well. The company developed the drug (Sprout) was bought out shortly after the drug was approved by another company (Valeant). Former Sprout investors are actually suing Valeant, accusing them of fumbling the marketing and depriving them of the profit they otherwise would have made.
Quebec-based Valeant Pharmaceuticals has a friendly deal to buy a U.S. company that recently received approval to market a drug that claims to improve sexual satisfaction.
A Canadian company is buying Sprout pharmaceuticals and trying to bring Addyi / flibanserin to Canada.
Apparently they’re expected to submit their application to Health Canada within the next few months asking them to approve the drug, and that Health Canada’s decision would be expected within a year of their application.
*Now* the mainstream news coverage of flibanserin & asexuality begins. Kind of upset at the basic factual inaccuracies here. I submitted a correction saying Flibanserin only increased the number of satisfying sexual events by 0.5-1 per month compared to placebo.
theasexualityblog is quoted as referring to a grassroots campaign claiming there are many drugs for sexual dysfunction in men. But Even The Score is an astroturf group not grassroots campaign. Furthermore, the article fails to mention this claim is misleading. There are no drugs for low sexual desire in men.
That’s actually a misquote, and I’ve sent an e-mail to the writer of the article about it. I specifically explained to her in the interview that the claim that there were options for male sexual dysfunction was false which was why the gender-bias claim is baseless.
I also don’t recall referring to Even The Score as a grassroots organization, but I may have given that’s what they’re commonly referred to as in other sources.
Newsweek article looking at some ace community responses to the FDA’s decision to approve Addyi/flibanserin and what this might mean to the ace community.
The articles includes a statement from Sprout:
“Asexual individuals are not distressed, and therefore would not be a candidate for treatment with Addyi. Sprout is committed to educating healthcare providers about Addyi to help facilitate informed, educational conversations with their patients. With the five question screener, called the Decreased Sexual Desire Screener (DSDS), doctors can effectively rule out women who would not be considered for medical intervention.”
Here’s the problem:
Unfortunately, some aces are distressed about being ace and/or about having low sexual desire. That distress is very often because of anti-ace hostility and social expectations and pressures around sex and sexuality and “being normal”, but that doesn’t make it less real: that distress is still distress.
Regardless of what Sprout is claiming, the FDA approved Addyi/flibanserin to treat women whose low sexual desire “causes marked distress or interpersonal difficulties”. And a lot of ace women who don’t want to have sex face “interpersonal difficulties” when they’re in romantic partnerships with (non-ace) people who do want to have sex. So even if ace women with low sexual desire aren’t distressed, they still might be part of the “target population” for this drug. (And they’re probably especially likely to be targeted for it if their libido hasn’t always been low.)
Dispelling myths and misinformation re: the Addyi / flibanserin situation
There is an overwhelming sea of misconceptions and misinformation surrounding the drug Addyi / flibanserin and the FDA’s August 2015 decision to approve it.
Mostly, people can learn the basics from reading the FDA’s Addyi / flibanserin label ( or get a brief overview from the PharmedOut factsheet ).
Here’s a breakdown of some common misconceptions around what Addyi / flibanserin is, who it is and is not approved for, and why many people are justifiably upset about it:
The daily pill, called Addyi, modestly increased women's interest in sex in clinical tests. The approval was praised by some women's advocates as a milestone and condemned by others as irresponsible.
Last chance to sign the petition to the FDA about flibanserin!
The FDA is expected to make its decision about whether or not to approve flibanserin on August 18, 2015. We put together a petition to bring the FDA awareness of ace, so that they will have something to counteract the powerfully pro-flibanserin lobbying that has already influenced their advisory committee’s recommendation about the drug. But time is running out: there are only a few more days days left!
For the many of you who support the petition but haven’t gotten around yet to signing it yet, please sign it now. The ace-related petition is here.
There’s also a petition unrelated to the ace community (started by Leonore Tiefer, PhD) opposing the pro-flibanserin PR campaign and urging the FDA to stick to the science. You can find that petition here.
More info on flibanserin and the FDA’s advisory committee’s recommendation below (because that was missing when the petition was first posted):
The FDA is currently expected to make a decision by August 18, 2015 about whether or not to approve the drug flibanserin to “treat” women’s low sexual desire. We’ve put together a petition to bring awareness to the FDA of how this will affect aces and ace communities.
Please take a moment to view and sign this petition and consider forwarding it/signal boosting it. It takes only a few moments of your time and will cost you no money.
This is vital to the ace community and your participation is greatly appreciated.
The petition itself doesn’t include much info about the context or what it’s responding to. So this might help clarify a few things:
Flibanserin is being proposed by Sprout Pharmaceuticals specifically to treat pre-menopausal women diagnosed with HSDD (not FSIAD)– that has to do with the DSM changing part-way through the process. (They did some trials in post-menopausal women and even they recognised the side effects were so bad that they didn’t even bother trying to get it approved for that.)
Edit because a sentence was missing from the original post: Groups of scientists have already sent letters asking the FDA not to approve flibanserin for scientific reasons of its lack of effectiveness and its side effects (e.g.,the PharmedOut letter and the New View letter .)
This is the 3rd time the FDA is being asked to consider this drug. The FDA already rejected it twice based on lack of effectiveness and safety. (And as the petition mentioned, there are groups of scientists opposing it now on that basis.) The doctors at PharmedOut have put together a couple factsheets (here and here) that might be useful. And you can check out the FDA briefing document with in-depth summaries of the clinical findings but they are in medical language.
The Scientific Advisory Committee recommended that the FDA approve this drug with measure beyond labelling to mitigate the substantial risks. But they have been clear (both in formal in academic writing as well as newspaper quotes) that they based this decision largely on factors of pro-flibanerin advocacy (and *not* on factors of the drug’s effectiveness or safety).
The very powerful pro-flibanserin advocacy has argued that the not wanting to have sex with anyone is so inherently terrible that it’s worth approving the drug just so women will have *any drug option* (even if it is hardly more effective than a placbo and has risky known side effects and potentially dangerous unknown drug and alcohol interactions).
This petition is to give the FDA a counter-point to the powerful pro-flibanserin lobbying– it emphasises that “not wanting to have sex” is *not* inherently terrible.
Note: Robert Whithead one of the co-founders of Sprout Pharmaceuticals (i.e., the company putting forward flibanserin). Shortly before they formed Sprout, the FDA issued a warning to Robert Whitehead to withdraw misleading marketing and inaccurate medical information about another drug (aimed at treating sexual stuff in men).
Last chance to sign the petition to the FDA about flibanserin!
The FDA is expected to make its decision about whether or not to approve flibanserin on August 18, 2015. We put together a petition to bring the FDA awareness of ace, so that they will have something to counteract the powerfully pro-flibanserin lobbying that has already influenced their advisory committee’s recommendation about the drug. But time is running out: there are only a few more days days left!
For the many of you who support the petition but haven’t gotten around yet to signing it yet, please sign it now. The ace-related petition is here.
There’s also a petition unrelated to the ace community (started by Leonore Tiefer, PhD) opposing the pro-flibanserin PR campaign and urging the FDA to stick to the science. You can find that petition here.
More info on flibanserin and the FDA’s advisory committee’s recommendation below (because that was missing when the petition was first posted):
Right now, the FDA is considering whether to approve the drug flibanserin– a psychoactive drug with sedating effects that women would need to take every day and which is supposed to increase sexual desire. The drug company is trying to get it approved for premenopausal (cis) women formally diagnosed with HSDD. HSDD is a diagnosis from the previous version of the DSM (i.e., the DSM-IV; APA) that’s defined by low sexual desire accompanied by “distress or interpersonal difficulties” and when the low sexual desire cannot be explained by a side-effect of medication.(1)
The doctors at PharmedOut put together a FactSheet on flibanserin which is a good basic introduction. (The clinical trials show that flibanserin really doesn’t work much better than a placebo, and it has a whole bunch of nasty side-effects. Also it was only tested on cis women in heterosexual monogamous relationships who were *not* taking any medications from a very long list, and the interactions between flibanserin and alcohol were largely tested on men.) You can read up on the clinical trials themselves from the FDA report to the scientific advisory committee.
There’s also a huge pro-flibanserin narrative exploiting the language of “gender equality” or “choice”(2) with pro-flibanserin people claiming that the FDA has approved a bunch of drugs to treat men’s sexual problems but not women’s even though there are no drugs approved to treat *anyone’s* low sexual desire. None. Despite what the pro-flibanserin narrative would have people believe. In fact shortly before co-founding Sprout Pharmaceuticals, Robert Whitehead– one of Sprout’s current Vice Chair and past Chief Executive Officer– has already been warned by the FDA to withdraw its misleading marketing and incorrect medical information around another drug (including falsely promoting it as a treatment for low sexual desire in men).
The FDA has already rejected the drug twice previously, but this time the pro-flibanserin tactic is to focus on a narrative about how terrible, shameful and un-liveable life is for women who don’t want to have sex (with their husbands)… because (apparently) wanting to have sex is a necessary part of any full and happy life and/or marriage and part of what a “wife should do”. These themes were central in the FDA's Open Public Hearings voiced by supporters of flibanserin (many of whom had received money from Sprout Pharmaceuticals, e.g., for travel, accommodations, expenses).
This time, the FDA’s Scientific Advisory Committee recommended for the FDA to approve the drug with additional steps beyond labeling to help mitigate the risks. However, doctors on the FDA advisory committee have publicly acknowledged that their decision to recommend that the drug be approved was based on factors *other* than scientific evidence about the drug's (very limited) effectiveness or its (questionable) safety.
They were also clear that they would not have recommended that the FDA approve flibanserin if they had been making their decision solely on the basis of clinical evidence of the drug’s effectiveness or safety as they might have been if there were already other similar drugs approved. (i.e., Instead of using the usual FDA standards of safety and effectiveness in their risk/benefit assessment, the FDA’s scientific advisory committee lowered their standards for these things based on misleading pro-flibanserin narrative-- a narrative of how inherently terrible or shameful it is for anyone to not want to have sex with anyone that it is better to have something even if that something is minimally effective and comes with considerable risks).
The FDA is expected to make its final decision on August 18, 2015.
Many scientists oppose the approval of flibanserin already on the basis of its lack of safety and effectiveness. And scientists and clinicians have already submitted 2 mass-signed open letters urging the FDA to reject flibanserin on the basis of the drug’s poor performance in clinical trials. And there is a petition started by Leonore Tiefer (the psychologist who founded the New View Campaign) urging the FDA to disregard the (misleading) pro-flibanserin marketing and instead to use the same high standards of safety and effectiveness the FDA requires for other drugs..
But so far, there has been nothing to challenge the damaging and influential pro-flibanserin narrative that not wanting to have sex is inherently horrible.
That is where the Ace Flibanserin Taskforce petition comes in: urging the FDA not to approve flibanserin and explicitly challenging the dangerous idea which seems to be influencing the FDA's considerations (namely the incorrect assumption that it is inherently horrible to not want to have sex).
You can find the ace-related petition here. You do not need to be either American or live in the USA for your signature to count.
Notes:
(1) In the DSM-5 (APA, 2013), the diagnosis was changed around and while women can be diagnosed with HSDD because their partners are upset about their low sexual desire, they cannot be diagnosed with FSIAD for that reason. But flibanserin is being proposed to treat pre-menopausal women diagnosed with HSDD and not FSIAD.
Even if flibanserin is approved, any other usage of the drug would be “off-label” (as in, not what the drug would have been approved for-- and not what the FDA would have decided is “worth the risk”). So even if the FDA does approve flibanserin, it would *not* be approved to treat women who experience low sexual desire as a side effect of some medication, or to treat post-menopausal women with low sexual desire, or for that matter to “treat” asexual women who don’t want to have sex who are dating non-asexual partners who do... But many drugs are prescribed “off-label” and there’s a good chance that if the FDA approves flibanserin that it would be prescribed “off-label” even though it has *not* been shown to be safe.
(2) People, especially in the open public hearings were making a lot of arguments about how women should be given options (even if they’re not safe and don’t work very well) and then trusted to make their own informed choices with their doctors. But they neglected to mention how the available clinical trial research does not provide the information that women (and doctors) would need to make these decisions.
For example, the research tools measuring sexual desire are suspect and there isn’t enough info about interactions between flibanserin and alcohol or almost any prescription drugs the additional safety trials about the interaction between flibanserin and alcohol were conducted mostly with men and because of how the other clinical trials were done, there’s no information about how flibanserin interacts with most other drugs. (On the other hand, the outcomes of the clinical trials do suggest that flibanserin doesn’t work the way the researchers thought it did). The in-depth summary of the trial results are public, but they’re in medical-researcher-speak.
Furthermore, apparently in all the pro-flibanerin statements to the FDA emphasising giving women choices, pro-flibanserin advocates managed to miss the part where women should be given the choice *not* to be shamed for not wanting to have sex. They also managed to conceal the therapeutic options that do currently exist to for women to increase their sexual desire-- specific therapies mentioned in the petition which are already the recommended best practice by the International Consultation on Sexual Medicine, e.g., Basson, Wierman, van Lankveld & Brotto, 2010).
Several people in ace community discussions around this issue have already talked about how choice and coercion play out for women and-or aces (e.g., here, here, here and here).
'Female Viagra' Foes Denounce PR Campaign to Win FDA Approval
Some 200 researchers, clinicians, and sex therapists are urging the US Food and Drug Administration (FDA) to withhold its approval of flibanserin (Addyi, Sprout Pharmaceuticals), or the "female Viagra," in the face of what they say is an unprecedented "manufacturer-funded public relations campaign that accused the FDA of sexism."
The FDA is currently expected to make a decision by August 18, 2015 about whether or not to approve the drug flibanserin to “treat” women’s low sexual desire. We’ve put together a petition to bring awareness to the FDA of how this will affect aces and ace communities.
Please take a moment to view and sign this petition and consider forwarding it/signal boosting it. It takes only a few moments of your time and will cost you no money.
This is vital to the ace community and your participation is greatly appreciated.
The petition itself doesn’t include much info about the context or what it’s responding to. So this might help clarify a few things:
Flibanserin is being proposed by Sprout Pharmaceuticals specifically to treat pre-menopausal women diagnosed with HSDD (not FSIAD)– that has to do with the DSM changing part-way through the process. (They did some trials in post-menopausal women and even they recognised the side effects were so bad that they didn’t even bother trying to get it approved for that.)
Edit because a sentence was missing from the original post: Groups of scientists have already sent letters asking the FDA not to approve flibanserin for scientific reasons of its lack of effectiveness and its side effects (e.g.,the PharmedOut letter and the New View letter .)
This is the 3rd time the FDA is being asked to consider this drug. The FDA already rejected it twice based on lack of effectiveness and safety. (And as the petition mentioned, there are groups of scientists opposing it now on that basis.) The doctors at PharmedOut have put together a couple factsheets (here and here) that might be useful. And you can check out the FDA briefing document with in-depth summaries of the clinical findings but they are in medical language.
The Scientific Advisory Committee recommended that the FDA approve this drug with measure beyond labelling to mitigate the substantial risks. But they have been clear (both in formal in academic writing as well as newspaper quotes) that they based this decision largely on factors of pro-flibanerin advocacy (and *not* on factors of the drug’s effectiveness or safety).
The very powerful pro-flibanserin advocacy has argued that the not wanting to have sex with anyone is so inherently terrible that it’s worth approving the drug just so women will have *any drug option* (even if it is hardly more effective than a placbo and has risky known side effects and potentially dangerous unknown drug and alcohol interactions).
This petition is to give the FDA a counter-point to the powerful pro-flibanserin lobbying– it emphasises that “not wanting to have sex” is *not* inherently terrible.
Note: Robert Whithead one of the co-founders of Sprout Pharmaceuticals (i.e., the company putting forward flibanserin). Shortly before they formed Sprout, the FDA issued a warning to Robert Whitehead to withdraw misleading marketing and inaccurate medical information about another drug (aimed at treating sexual stuff in men).
(Ace-unrelated) Petition to FDA to “end deceptive PR about women’s sexual health” re: flibanserin
So I already listed this petition in my post about the history of progress of flibanserin, pathologising discourse… and ace community, but I forgot to mention that it was actually a petition.
Leonore Tiefer (the feminist psychologist who founded the New View Campaign) started a petition urging the FDA to “end deceptive PR about women’s sexual health” when it comes to their decision about flibanserin.
You can find that petition here.
That petition is still open and in need of more signatures.
The female libido pill doesn't react well to alcohol or birth control pills
More than two hundred scientists are calling on the Food and Drug Administration to reject the so-called “female Viagra” pill, labeling the drug ineffective and unsafe.
