Money can’t buy happiness, but evidently is instrumental in gaining FDA approval for controversial drugs with low efficacy and significant side effects.
On Tuesday, the U.S. Food and Drug Administration (FDA) approved Addyi (Flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, after denying approval in 2010 and 2013 because the risks of the medication did not outweigh the benefits.
The side effects, which include dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth, are not only more prominent than the low levels of efficacy reported in the clinical trials, but are also exacerbated by the consumption of alcohol to such an extent that the FDA granted approval only with a risk evaluation and mitigation strategy (REMS) and a Boxed Warning – the strongest kind.
Why did the FDA decide to approve Addyi this time? The drug did not become any safer or more beneficial; the difference came from a lobbying group largely funded by the pharmaceutical company behind Addyi called Even the Score. Coopting feminism to sell pills under the guise of equality, Even the Score casts Addyi as one small step towards sexual equity, finally giving women a means to medicate what society has deemed to be a low sex drive.
What exactly is Addyi treating? The FDA specifies that HSDD is “characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.” In other words, very broadly applicable and lacking the potential for a straightforward diagnosis.
Moreover, the FDA specifies that the drug was approved for women with sexual problems resulting from illness or as side effects of other medications, yet also causes significant side effects. This cyclical nature of side effects is clearly problematic, but profitable for pharmaceutical companies.
During the 24-week randomized, double-blind, placebo-controlled trials, approximately 2,400 premenopausal women with HSDD were asked to count the number of vaguely named “satisfying sexual events” and report their sexual desire and any distress related to low sexual desire over the course of each month.
Ultimately, approximately 10% percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. It should also be noted that Addyi “has not been shown to enhance sexual performance.”
For ease of reference, the media has been referring to Addyi as “female Viagra” – a misnomer that is detrimental to the current discussion surrounding the medical treatment of low sexual desire. To begin with, Addyi – originally developed as an antidepressant – affects levels of dopamine and serotonin, whereas Viagra’s effect is physical, increasing blood flow to the penis.
This presents a psychopharmacological drug as being the medical equivalent of a treatment for a physical condition, assigning what is perceived to be typical male sexual desire as the norm; anything less is deemed a disorder, and is cause for medication.
In reality, there is no singular norm for sexual desire – in males or females – and this pathologization of women’s sexuality is detrimental to anyone not exhibiting what society deems to be a “normal” libido.
Another stark difference between the two drugs is that Viagra is taken as needed, whereas Addyi, like many long-term psychopharmacological treatments, must be taken daily in order to be effective.
The FDA specifies that “health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.” In other words, in addition to existing power imbalance between physicians and patients, doctors now have been granted the task of judging a woman’s ability to refrain from drinking alcohol.
In fact, the alcohol-related side effects are serious enough that the FDA is requiring the company that owns Addyi “to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.”
While it is undoubtedly beneficial to have an ongoing dialogue about varying levels of sexual desire, and for women to be able to speak openly about sexual dissatisfaction, it is unfortunate that it had to take place in this context.
The FDA’s approval of Addyi grants ethically problematic weight to the influence of pharmaceutical lobbying, as well as disregarding the standard of having the benefits outweigh the risks of a medication, and the importance of efficacy.
Dr. Elizabeth Yuko is a bioethicist at the Center for Ethics Education at Fordham University, editor of Ethics & Society, and coordinates the HIV and Drug Abuse Prevention Research Ethics Training Institute. You can follow her on Twitter at @elizabethics.
Written By Fordham University Center for Ethics Education
The FDA, Finances, & Feminism: Why the third time was the charm for so-called “female Viagra” was originally published @ Ethics and Society and has been syndicated with permission.
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