NORTHAMPTON, Mass. — LAST week, Sprout Pharmaceuticals resubmitted its drug flibanserin to the Food and Drug Administration for approval. Flibanserin, in case you haven’t heard, is a drug intended to treat low sexual desire in women. The F.D.A. has rejected it twice already, and will most likely reject it a third time because (if you’re Sprout) the F.D.A. is sexist or (if you’re the F.D.A.) the drug doesn’t work and isn’t safe.
But the biggest problem with the drug — and with the F.D.A.’s consideration of it — is that its backers are attempting to treat something that isn’t a disease.
Flibanserin purportedly treats a condition called hypoactive sexual desire disorder in women. But H.S.D.D. was removed from the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders in 2013, and replaced with a new diagnosis called female sexual interest/arousal disorder, or F.S.I.A.D.
Why the change? Researchers have begun to understand that sexual response is not the linear mechanism they once thought it was. The previous model, originating in the late ’70s, described a lack of “sexual fantasies and desire for sexual activity.” It placed sexual desire first, as if it were a hunger, motivating an individual to pursue satisfaction. Desire was conceptualized as emerging more or less “spontaneously.” And some people do feel they experience desire that way. Desire first, then arousal.
But it turns out many people (perhaps especially women) often experience desire as responsive, emerging in response to, rather than in anticipation of, erotic stimulation. Arousal first, then desire.
Both desire styles are normal and healthy. Neither is associated with pain or any disorder of arousal or orgasm.
The new diagnosis is intended for women who lack both spontaneous and responsive desire, and are distressed by this. For these women, research has found that nonpharmaceutical treatments like sex therapy can be effective.
But I can’t count the number of women I’ve talked with who assume that because their desire is responsive, rather than spontaneous, they have “low desire”; that their ability to enjoy sex with their partner is meaningless if they don’t also feel a persistent urge for it; in short, that they are broken, because their desire isn’t what it’s “supposed” to be.
What these women need is not medical treatment, but a thoughtful exploration of what creates desire between them and their partners. This is likely to include confidence in their bodies, feeling accepted, and (not least) explicitly erotic stimulation. Feeling judged or broken for their sexuality is exactly what they don’t need — and what will make their desire for sex genuinely shut down.
Apparently we still haven’t learned our lesson about what happens when we pathologize normal sexual functioning.
In one extreme example, medical professionals once took seriously the idea that homosexuality was a disease in need of a cure.
In a 1972 issue of The Journal of Nervous and Mental Disease, the neurologist Robert G. Heath reported that he had recorded the brain activity of a young man suffering from epilepsy and “severe mental illness,” including “a five-year history of overt homosexuality.” Continue reading the main story Continue reading the main story Continue reading the main story
The patient had electrodes implanted in his cortex, which was then thought to control pleasure. He was given a “three-button self-stimulating” device, with which he could zap his own brain for three hours at a time — which he did, about once every 10 seconds. Researchers showed him stag films (read: porn), introduced him to a female prostitute and measured his brain activity during heterosexual intercourse. Dr. Heath said the treatment was effective.
A year later, homosexuality was voted out of the Diagnostic and Statistical Manual. Now, of course, only a fringe minority of the medical community would suggest that sexual orientation is anything other than a normal aspect of human sexuality.
This analogy between desire style and sexual orientation is imperfect: There is no reason to suspect that responsive or spontaneous desire is innate. In fact all desire is somewhat responsive, even when it feels spontaneous. But Dr. Heath and Sprout are both part of the long history of trying to call “diseased” what is simply different.
When a woman experiencing responsive desire comes to understand how to make the most of her desire, she opens up the opportunity for greater satisfaction. Outdated science isn’t going to improve our sex lives. But embracing our differences — working with our sexuality, rather than against it — will.
But I can’t count the number of women I’ve talked with who assume that because their desire is responsive, rather than spontaneous, they have “low desire”; that their ability to enjoy sex with their partner is meaningless if they don’t also feel a persistent urge for it; in short, that they are broken, because their desire isn’t what it’s “supposed” to be.
I don't know any of the data. But I'm assuming that whatever benefit the company demonstrated wasn't balanced by the safety risks, or the risk of approving an unnecessary therapy for an unproven condition. And the fact that the company was willing to spend millions of dollars to file three times shows that they're expecting to recoup A LOT of money on sales if it's approved. They're not doing this out of the goodness of their heart. At first glance, I'm with the FDA on this one. Pharma is known for this move. Create a problem and sell a solution.
Hmmm, I'm not entirely sure how I feel about this. Certainly I don't think rushing a drug to market is a good idea, I imagine we can all agree on that, as well as the importance the brain plays sexual desire. However I'd be shocked if every man that has a prescription for or uses Viagra needs it because of pure mechanical dysfunction. Yet no one ever said men should be working on communicating with their partners to prevent episodes of impotence or erectile dysfunction and that a pill wasn't really necessary.
Post by open24hours on Feb 27, 2015 14:57:20 GMT -5
I can see both points of view.
If lack of drive causes distress for one women then I am all for a safe pill to allow her to experience more desire if that is what she wants.
But, there are so many societal rules that govern women's sexuality. If you don't follow those rules you get labeled as frigid if you don't want sex "enough" or a whore you want sex "too much" or a slut if you have sex with "too many people". We should be ready and willing for sex for any man that wants it from us, but if we have an unwanted pregnancy we should have kept our legs together.
So, I think this pill can be good for individual women, but not necessarily women as a whole.
I want the choice as to whether or not to take medication. I do not want society telling me I need a pill if I don't want sex "enough."
How is female sexual interest/arousal disorder, or F.S.I.A.D different than just being asexual? This is where I worry that many women won't be able to see a difference between just accepting themselves as they are, and taking a pill to become who they think their partner wants.
I'm getting a divorce largely because of my complete disinterest in sex so this is an interesting thing to think about.
Hmmm, I'm not entirely sure how I feel about this. Certainly I don't think rushing a drug to market is a good idea, I imagine we can all agree on that, as well as the importance the brain plays sexual desire. However I'd be shocked if every man that has a prescription for or uses Viagra needs it because of pure mechanical dysfunction. Yet no one ever said men should be working on communicating with their partners to prevent episodes of impotence or erectile dysfunction and that a pill wasn't really necessary.
The difference is that the mechanical dysfunction was what was used to demonstrate the efficacy of the drug. The question was, "does Viagra give you an erection?", and the answer was yes. Approved.
Now whether a Dr. chooses to follow those strict guidelines put forth by the FDA when prescribing is up to him or her. What Pfizer and other Viagra-like drug makers will never be able to do is go back to the FDA and say that Viagra will improve your quality of life or make you live longer on account of your having more sex, even if you don't have a mechanical problem. It may be true, and there may be some amount of evidence to suggest it; but that's just not how it works. That's kind of what this other company seems to be trying to do. They just put a fancy term around "quality of life" and are hoping someone buys it.
To be fair, I'm all for a pill if it works. Even if it's a band-aid for a larger societal issue. But FDA approval is a high bar to clear, so they need to generate the appropriate data. Otherwise they can hawk it as an unregulated supplement like everyone else does.
ETA: Phun Pharma Phact (omg, I hate myself). Viagra was originally studied as cardiac medication. The investigators got suspicious when many of the male subjects failed to return their study drug, and a star was born! The same thing happened with Rogaine.
How is female sexual interest/arousal disorder, or F.S.I.A.D different than just being asexual? This is where I worry that many women won't be able to see a difference between just accepting themselves as they are, and taking a pill to become who they think their partner wants.
I'm getting a divorce largely because of my complete disinterest in sex so this is an interesting thing to think about.
While I understand and agree with this idea to a point - I'm not sure it's as simple as just accepting yourself and not being concerned about what your partner wants if it's not what you want. I mean, sex is important to a lot of people. If you find another person with a similarly low sex drive, I wouldn't see a point in taking a pill to change that because you're both happy with the way things are. But if your partner wants more sex, and you love your partner and want to have a relationship where the needs (sexual or otherwise) of both partners are met - why is it a bad thing to want to change something to better fit what your partner wants? I don't think women (or men) should feel forced to do something they don't want to do, but if there is something that will help them WANT to do it - great!
To be fair, I'm all for a pill if it works. Even if it's a band-aid for a larger societal issue. But FDA approval is a high bar to clear, so they need to generate the appropriate data. Otherwise they can hawk it as an unregulated supplement like everyone else does.
ETA: Phun Pharma Phact (omg, I hate myself). Viagra was originally studied as cardiac medication. The investigators got suspicious when many of the male subjects failed to return their study drug, and a star was born! The same thing happened with Rogaine.
It was for low blood pressure right?
Rogaine was for high blood pressure and Viagra was for angina.
Hmmm, I'm not entirely sure how I feel about this. Certainly I don't think rushing a drug to market is a good idea, I imagine we can all agree on that, as well as the importance the brain plays sexual desire. However I'd be shocked if every man that has a prescription for or uses Viagra needs it because of pure mechanical dysfunction. Yet no one ever said men should be working on communicating with their partners to prevent episodes of impotence or erectile dysfunction and that a pill wasn't really necessary.
The difference is that the mechanical dysfunction was what was used to demonstrate the efficacy of the drug. The question was, "does Viagra give you an erection?", and the answer was yes. Approved.
Now whether a Dr. chooses to follow those strict guidelines put forth by the FDA when prescribing is up to him or her. What Pfizer and other Viagra-like drug makers will never be able to do is go back to the FDA and say that Viagra will improve your quality of life or make you live longer on account of your having more sex, even if you don't have a mechanical problem. It may be true, and there may be some amount of evidence to suggest it; but that's just not how it works. That's kind of what this other company seems to be trying to do. They just put a fancy term around "quality of life" and are hoping someone buys it.
I'm not arguing whether or not this drug should or shouldn't be approved. I honestly just don't really like the tone of the article, even though I get that it's focusing on the routine pathologicalization (probably not a word, but you get my meaning) of a normal range of sexual function and how unhealthy that is to women. And I don't disagree. I just think the way this article seems to dismiss the potential need for a pill for women feels condescending.
Not every man who has an episode of impotence has a chronically dysfunctioning (malfunctioning?) penis just as not every woman who experiences reactive arousal more often than spontaneous arousal has a malfunctioning libido. But that doesn't mean that they're wrong for wanting a pill that would address that for them, if it's something they want to change.
And it is ostensibly more difficult to create a desire pill, because so much of what makes up that concept is complicated and frankly fairly difficult to pin down. So I definitely get that the burden to prove efficacy of a drug that addresses this has a bar that is set pretty high. I don't think that should change. The last thing I want is drugs approved without proper oversight. But I don't think it's wrong for women to want a pill, just as I don't think it's wrong for others to not want one and decide not to take it when/if it's available.
I think a lot of it is do you WANT to want sex. If you don't want sex and you're ok with that, awesome! No pills for you. But if you don't want sex, but want to want it and don't understand why you don't want it and want a solution, this could be one. Along with sex therapy or other solutions. I'm certainly not saying "pills for everyone!" or that anything should be rushed to market OR that the pharm companies want to help women just out of the goodness of their hearts.
But then again, I wonder how much of the reason you want to want it is because of societal pressure? LIke you feel weird because you don't want it?
This is where my train of thought was going. I think it will boil down to whether it has been a lifetime issue like mine, or maybe something that has changed recently due to age or other factors. I just have to hope doctors are willing to ask good questions before handing out any future approved medication to make sure they are solving the actual problem and not just masking something deeper.
The difference is that the mechanical dysfunction was what was used to demonstrate the efficacy of the drug. The question was, "does Viagra give you an erection?", and the answer was yes. Approved.
Now whether a Dr. chooses to follow those strict guidelines put forth by the FDA when prescribing is up to him or her. What Pfizer and other Viagra-like drug makers will never be able to do is go back to the FDA and say that Viagra will improve your quality of life or make you live longer on account of your having more sex, even if you don't have a mechanical problem. It may be true, and there may be some amount of evidence to suggest it; but that's just not how it works. That's kind of what this other company seems to be trying to do. They just put a fancy term around "quality of life" and are hoping someone buys it.
I'm not arguing whether or not this drug should or shouldn't be approved. I honestly just don't really like the tone of the article, even though I get that it's focusing on the routine pathologicalization (probably not a word, but you get my meaning) of a normal range of sexual function and how unhealthy that is to women. And I don't disagree. I just think the way this article seems to dismiss the potential need for a pill for women feels condescending.
Not every man who has an episode of impotence has a chronically dysfunctioning (malfunctioning?) penis just as not every woman who experiences reactive arousal more often than spontaneous arousal has a malfunctioning libido. But that doesn't mean that they're wrong for wanting a pill that would address that for them, if it's something they want to change.
And it is ostensibly more difficult to create a desire pill, because so much of what makes up that concept is complicated and frankly fairly difficult to pin down. So I definitely get that the burden to prove efficacy of a drug that addresses this has a bar that is set pretty high. I don't think that should change. The last thing I want is drugs approved without proper oversight. But I don't think it's wrong for women to want a pill, just as I don't think it's wrong for others to not want one and decide not to take it when/if it's available.
I will have to do some more research for sure, but as someone coming to terms with my asexuality at age 34, it worries me, though I think ultimately the bigger issue isn't with the medication itself but the thought that people would go on it not even realizing that it's ok to not want sex. It doesn't have to mean something is wrong.
I think I get what you're saying btay. That if a desire pill is produced, society may "normalize" a sort of hyper-libido or desire, when that isn't actually normal for most people. And certainly, potential drug abuse concerns are legitimate - are people using medications for the right reasons - but I'd argue you could say that about many pills on the market currently.
I just feel like there are aleady a lot of treatments that will fix the various physiological and psychological problems that lead to sexual dysfunction in women. So there are targeted "solutions", just like Viagra. Maybe they're not all approved, but they work to varying degrees. So if you have a good doctor (which many women don't), then a lot of the problems are fixable with what we already have. The problem with the article is that it was arguing against a flawed, baseless premise to begin with, so I think it's hard to do that without being condescending. I'd be far more in favor of comprehensive guidelines and education for prescribers so that they can really help and manage their female patients with sexual issues. And I'm talking about medical management with drugs and stuff that have a snowball's chance of working. Women's health should be taken more seriously overall, and I am pretty annoyed at this company that really doesn't seem to be doing that. Despite what they say or present as their evidence.