Clinical Studies on Women's Health Medications

An erection can be easily managed with drugs, creating a situation in which a penis can be used for sexual intercourse. But what if desire—for both (or all) sexes and genders—is more complicated than something as easily measurable as an erection? These questions raise other important queries about what we want from sexual medicine more broadly.

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How do we currently assess sexual problems? How do we know if a treatment is working?

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Or, is it for her purportedly more virile partner (who in many cases, is male)? In a recent article in the New York Times published immediately following the FDA approval of Addyi, Dr. Irwin Goldstein, a sexual specialist based in San Diego, similarly stated that women might be willing to put up with the side effects in order to garner the benefits: “Some women might find the risk of side effects acceptable if their relationships are in jeopardy because of a lack of desire.” It seems ironic that the very cost-benefit analyses or interest schemas that women are thought to “naturally” or “biologically” engage in when it comes to sex are here being prescribed to women by doctors in the sociopolitical sphere fildena tablet (of which conceptions of the “natural” and “biological” are arguably a part). These prescriptions also raise important questions about gender, sexuality, and health: Why should a woman put her health at risk just to please her partner? Why is her own sexual desire so sorely lacking from this representation?

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Why is it assumed that what she would (or should) desire most is to make her partner happy and thus to improve her “jeopardized” relationship? What type of—and whose—health are we most concerned with here? Further troubling is the way medical treatments for women’s low desire have been supported by financial stakeholders who brandish their arguments under the banner of “feminism.” For instance, Sprout Pharmaceuticals-funded “patient advocacy” campaign Even the Score helped catapult the drug through the FDA evaluation process, in large part by amassing a number of groups to apply pressure to the federal advisory board based on the flawed notion that the FDA’s prior reticence to approve a sexual dysfunction drug for women constitutes blatant sexism. The campaign—which includes groups such as the National Organization for Women (NOW), Sprout Pharmaceuticals itself, and a variety of so-called “women’s health” groups who received grants and other funding incentives from Sprout—has argued that women deserve access to a drug to treat their most common sexual problem (low desire), seeing as men have had a drug to treat their most common dysfunction (erectile disorder) for over fifteen years now (hence, the argument to “even the score”). Even the Score released a short “thank you” video after the FDA approval of Addyi in August 2015 (titled “#ThankYouFDA: Our First Step Towards Sexual Health Equity” on YouTube), expressing support and gratitude to the FDA for finally moving beyond their “sexist” ways and approving a drug for women.

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In this short clip, the male partner in an assumedly heterosexual relationship quips that the federal approval and release of Addyi might give “new meaning to his four-hour erection.” To this, his blonde, white, female counterpart responds, “I know what to do with it!” The video ends with an image of a “Treatment Score Board,” with the text “Men = 26, Women = 1.” An image created and distributed by Even the Score, a “patient advocacy” campaign funded by Sprout Pharmaceuticals which makes Addyi and pushed for its approval by the US FDA. The number on the left represents available pharmaceutical treatments for men’s sexual dysfunction while the number on the right indicates Addyi, the first drug approved to address sexual dysfunction in women. Such imagery implies that FDA approval is a “win” for some variant of gender equality. However, not a single one of the “26” drugs for men affect neurochemistry or attempt to influence sexual desire. Instead of targeting men’s desire, they target men’s ability to maintain an erection. These are questions that are generally not attended to by pharmaceutical companies or even the psychologists running these companies’ drug trials, and all of their answers depend on what kind of sex we believe to be most optimal—for men, and women, to be engaging in (usually—and importantly as our sexual culture is so deeply rooted in heteronormativity—with each other). Images on a Google search for “women’s sexual dysfunction” show either sad women alone, or women with men in a situation indicating their relationship is damaged by the changes to sexual intimacy. The editor could not readily find images from this search that involved women with other women as their partners. The history of Addyi illuminates what pharmaceutical companies and the medical industry more broadly appear to think of these questions (or rather, not think), and attests to how stakeholders in these realms have continued to implement rigid ideas about sexual difference in regards to dysfunction and desire, making broad, sweeping claims about men’s and women’s sexuality in the process. In the earliest years of the twenty-first century, a German company, Boehringer Ingelheim, owned the patent to the generic version of Addyi—called flibanserin. After flibanserin was shot down for approval by the FDA in 2010 and then again in 2013 (both times because the drug’s side effects appeared to outweigh any benefits to low-desiring women in clinical trials), Boehringer Ingelheim sold the rights to the patent to a U.S.-based pharmaceutical company—Sprout Pharmaceuticals. After running new clinical trials that showed slightly lower side effects but only a marginal improvement in satisfactory sexual encounters for women with low desire, flibanserin was finally approved by the FDA in August 2015. The drug was to be made officially available for public consumption in October 2015. In the interval between approval and release, before Addyi hit the shelves last fall, Valeant—a much larger, Canadian pharmaceutical company—bought Sprout Pharmaceuticals, in a $1 billion deal. Valeant is the current owner of the rights to Addyi. So, we know that Addyi has the potential to make a lot of money for big pharmaceutical companies, but what does it actually do? Addyi is considered a norepinephrine-dopamine disinhibitor, or NDDI, when compared to other antidepressants (it was initially formulated as an antidepressant before being vigora spray remarketed as a sexual dysfunction drug). This means that its mechanism of action involves allowing for more uptake of norepinephrine and dopamine, while decreasing levels of serotonin in the brain. Dopamine in particular has been found to be associated with sex drive and pleasure[5]. According to studies conducted prior to FDA approval in 2015, women who were taking Addyi reported that the average number of times they experienced “satisfying sexual events” rose from 2.8 to 4.5 times per month. It is important to note that women receiving a placebo in the same study also reported a significant increase in “satisfying sexual events,” though—an increase of 2.7 to 3.7 times per month. Side effects were also experienced by many women who took Addyi in the study, including dizziness, nausea, fatigue, sleepiness, insomnia, and dangerously low blood pressure, particularly when combined with alcohol consumption (even just two glasses of wine). This image shows the highlighted side effects of Addyi (flibanserin). While more are listed in the full packet, this so-called “Black Box” Warning indicates that whatever benefits Addyi may have, they certainly do not come without cost. It is not to be taken lightly. Despite these very real side effects, many clinicians and practitioners have vocalized their support for the drug, stating that the potential benefits may outweigh the potential harms. Bat Sheva Marcus of the Medical Center for Female Sexuality (MCFS) in New York City, “Drug trials have shown those women who take the drug are more receptive to sexual stimulation and have more satisfying sexual activities. I like to think of it as helping you feel your sexual hunger.” It is remarkable that Dr. Marcus makes reference to women being “more receptive to sexual stimulation” in the above quote. This again raises the question of who this drug is actually for—is it for the woman who lacks desire, and suffers because of this lack? Or, is it for her purportedly more virile partner (who in many cases, is male)?

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In a recent article in the New York Times published immediately following the FDA approval of Addyi, Dr. Irwin Goldstein, a sexual specialist based in San Diego, similarly stated that women might be willing to put up with the side effects in order to garner the benefits: “Some women might find the risk of side effects acceptable if their relationships are in jeopardy because of a lack of desire.” It seems ironic that the very cost-benefit analyses or interest schemas that women are thought to “naturally” or “biologically” engage in when it comes to sex are here being prescribed to women by doctors in the sociopolitical sphere fildena tablet (of which conceptions of the “natural” and “biological” are arguably a part). These prescriptions also raise important questions about gender, sexuality, and health: Why should a woman put her health at risk just to please her partner?

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Why is her own sexual desire so sorely lacking from this representation? Why is it assumed that what she would (or should) desire most is to make her partner happy and thus to improve her “jeopardized” relationship? What type of—and whose—health are we most concerned with here?

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Further troubling is the way medical treatments for women’s low desire have been supported by financial stakeholders who brandish their arguments under the banner of “feminism.” For instance, Sprout Pharmaceuticals-funded “patient advocacy” campaign Even the Score helped catapult the drug through the FDA evaluation process, in large part by amassing a number of groups to apply pressure to the federal advisory board based on the flawed notion that the FDA’s prior reticence to approve a sexual dysfunction drug for women constitutes blatant sexism. The campaign—which includes groups such as the National Organization for Women (NOW), Sprout Pharmaceuticals itself, and a variety of so-called “women’s health” groups who received grants and other funding incentives from Sprout—has argued that women deserve access to a drug to treat their most common sexual problem (low desire), seeing as men have had a drug to treat their most common dysfunction (erectile disorder) for over fifteen years now (hence, the argument to “even the score”). Even the Score released a short “thank you” video after the FDA approval of Addyi in August 2015 (titled “#ThankYouFDA: Our First Step Towards Sexual Health Equity” on YouTube), expressing support and gratitude to the FDA for finally moving beyond their “sexist” ways and approving a drug for women. In this short clip, the male partner in an assumedly heterosexual relationship quips that the federal approval and release of Addyi might give “new meaning to his four-hour erection.” To this, his blonde, white, female counterpart responds, “I know what to do with it!” The video ends with an image of a “Treatment Score Board,” with the text “Men = 26, Women = 1.” An image created and distributed by Even the Score, a “patient advocacy” campaign funded by Sprout Pharmaceuticals which makes Addyi and pushed for its approval by the US FDA. The number on the left represents available pharmaceutical treatments for men’s sexual dysfunction while the number on the right indicates Addyi, the first drug approved to address sexual dysfunction in women. Such imagery implies that FDA approval is a “win” for some variant of gender equality.

IN THEIR WORDS

Addyi, by contrast, targets women’s desire, an aspect of which is purported to be their “receptivity” to their partner’s advances. Even the Score has consistently emphasized the number of sexual dysfunction drugs on the market designed for men and compared this to the number available for women, in order to suggest that the disparity reveals a pervasive lack of concern for women’s sexual problems. Thinking back on Even the Score’s ““#ThankYouFDA!” video—which now haunts me—I am deeply concerned about the false equivalences[7] being made so casually about the two drugs. Just because there are drugs already on the market to treat men’s “most common sexual problem,” does that mean it will truly “even the score” to create and market drugs for women? How did we decide what men’s and women’s “most common sexual problems” are in the first place?

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Why do we assume they are so different from each other? Let us not forget the assumptions that are being made about men’s and women’s sexualities in each of these drugs’ design and mechanisms of action, and also in the corresponding gender-distinct disorders they require for prescription, compliance, and widespread societal endorsement. Sexual desire is not divorced from the domain of the political—how we have sex, with whom, and with what technologies (including drugs and other treatments), are all political choices. If we really cared about women, maybe we’d focus more on their pleasure, and try to dismantle some of the barriers to pleasure that women experience so regularly in our world—including childhood and lifelong sexual trauma, other forms of gendered harassment and violence, low pay, antiquated divisions of labor and disproportionate burdening with carework, with housework, with sex work, all types of exploitation, and all the other pressures that exert themselves on women (and other sexual and gender minorities) disproportionately in everyday life.

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However, not a single one of the “26” drugs for men affect neurochemistry or attempt to influence sexual desire. Instead of targeting men’s desire, they target men’s ability to maintain an erection. Addyi, by contrast, targets women’s desire, an aspect of which is purported to be their “receptivity” to their partner’s advances. Even the Score has consistently emphasized the number of sexual dysfunction drugs on the market designed for men and compared this to the number available for women, in order to suggest that the disparity reveals a pervasive lack of concern for women’s sexual problems.

i have little to no sexual desire

An erection can be easily managed with drugs, creating a situation in which a penis can be used for sexual intercourse. But what if desire—for both (or all) sexes and genders—is more complicated than something as easily measurable as an erection? These questions raise other important queries about what we want from sexual medicine more broadly. How do we currently assess sexual problems? How do we know if a treatment is working?

Drug Interactions

These are questions that are generally not attended to by pharmaceutical companies or even the psychologists running these companies’ drug trials, and all of their answers depend on what kind of sex we believe to be most optimal—for men, and women, to be engaging in (usually—and importantly as our sexual culture is so deeply rooted in heteronormativity—with each other). Images on a Google search for “women’s sexual dysfunction” show either sad women alone, or women with men in a situation indicating their relationship is damaged by the changes to sexual intimacy. The editor could not readily find images from this search that involved women with other women as their partners. The history of Addyi illuminates what pharmaceutical companies and the medical industry more broadly appear to think of these questions (or rather, not think), and attests to how stakeholders in these realms have continued to implement rigid ideas about sexual difference in regards to dysfunction and desire, making broad, sweeping claims about men’s and women’s sexuality in the process. In the earliest years of the twenty-first century, a German company, Boehringer Ingelheim, owned the patent to the generic version of Addyi—called flibanserin.

How can I get more information about Addyi?

After flibanserin was shot down for approval by the FDA in 2010 and then again in 2013 (both times because the drug’s side effects appeared to outweigh any benefits to low-desiring women in clinical trials), Boehringer Ingelheim sold the rights to the patent to a U.S.-based pharmaceutical company—Sprout Pharmaceuticals. After running new clinical trials that showed slightly lower side effects but only a marginal improvement in satisfactory sexual encounters for women with low desire, flibanserin was finally approved by the FDA in August 2015. The drug was to be made officially available for public consumption in October 2015. In the interval between approval and release, before Addyi hit the shelves last fall, Valeant—a much larger, Canadian pharmaceutical company—bought Sprout Pharmaceuticals, in a $1 billion deal. Valeant is the current owner of the rights to Addyi. Thinking back on Even the Score’s ““#ThankYouFDA!” video—which now haunts me—I am deeply concerned about the false equivalences[7] being made so casually about the two drugs. Just because there are drugs already on the market to treat men’s “most common sexual problem,” does that mean it will truly “even the score” to create and market drugs for women?

The Big Pink Fight for the Little Pink Pill

So, we know that Addyi has the potential to make a lot of money for big pharmaceutical companies, but what does it actually do? Addyi is considered a norepinephrine-dopamine disinhibitor, or NDDI, when compared to other antidepressants (it was initially formulated as an antidepressant before being vigora spray remarketed as a sexual dysfunction drug). This means that its mechanism of action involves allowing for more uptake of norepinephrine and dopamine, while decreasing levels of serotonin in the brain. Dopamine in particular has been found to be associated with sex drive and pleasure[5]. According to studies conducted prior to FDA approval in 2015, women who were taking Addyi reported that the average number of times they experienced “satisfying sexual events” rose from 2.8 to 4.5 times per month.

Drug information

It is important to note that women receiving a placebo in the same study also reported a significant increase in “satisfying sexual events,” though—an increase of 2.7 to 3.7 times per month. Side effects were also experienced by many women who took Addyi in the study, including dizziness, nausea, fatigue, sleepiness, insomnia, and dangerously low blood pressure, particularly when combined with alcohol consumption (even just two glasses of wine). This image shows the highlighted side effects of Addyi (flibanserin). While more are listed in the full packet, this so-called “Black Box” Warning indicates that whatever benefits Addyi may have, they certainly do not come without cost. It is not to be taken lightly.

Keys to patient success

Despite these very real side effects, many clinicians and practitioners have vocalized their support for the drug, stating that the potential benefits may outweigh the potential harms. Bat Sheva Marcus of the Medical Center for Female Sexuality (MCFS) in New York City, “Drug trials have shown those women who take the drug are more receptive to sexual stimulation and have more satisfying sexual activities. I like to think of it as helping you feel your sexual hunger.” It is remarkable that Dr. Marcus makes reference to women being “more receptive to sexual stimulation” in the above quote. This again raises the question of who this drug is actually for—is it for the woman who lacks desire, and suffers because of this lack? How did we decide what men’s and women’s “most common sexual problems” are in the first place? Why do we assume they are so different from each other? Let us not forget the assumptions that are being made about men’s and women’s sexualities in each of these drugs’ design and mechanisms of action, and also in the corresponding gender-distinct disorders they require for prescription, compliance, and widespread societal endorsement. Sexual desire is not divorced from the domain of the political—how we have sex, with whom, and with what technologies (including drugs and other treatments), are all political choices. If we really cared about women, maybe we’d focus more on their pleasure, and try to dismantle some of the barriers to pleasure that women experience so regularly in our world—including childhood and lifelong sexual trauma, other forms of gendered harassment and violence, low pay, antiquated divisions of labor and disproportionate burdening with carework, with housework, with sex work, all types of exploitation, and all the other pressures that exert themselves on women (and other sexual and gender minorities) disproportionately in everyday life.