Opposition to the “Pink Pill” –  New View Campaign Has an Old View (Part 1 of a 4-Part Series)

During the public hearing portion of the advisory committee meeting, most of the testimony came from women seeking approval of the drug. However, there were some naysayers. Their arguments against approval boiled down to 4 perspectives. In my opinion, the arguments against the drug miss the mark.

The view is presented that development of flibanserin represents “medicalization” of a disorder that can be treated effectively with psychotherapy and education. This perspective is best embodied by an organization called the New View Campaign.

Refuting this perspective, however, is research in animal models that clearly demonstrates that HSDD (or its equivalent in animals) is the result of an imbalance between dopamine and norepinephrine on the positive end and serotonin on the negative end. These findings are supported by functional magnetic resonance imaging (MRI) and positron emission tomography (PET) scans of the brains of women with HSDD who are shown erotic stimuli. The scans demonstrate that their brains respond differently from those of normal women. So if it’s all about education and counseling, why are the brains of women with HSDD functioning differently?

I would argue that, if depression and HSDD are both abnormalities of the serotonergic system (flibanserin is essentially an SSRI), then how can depression be a biologically based disorder but HSDD can’t? In my opinion, the New View Campaign isn’t new at all.

Continue reading “Opposition to the “Pink Pill””

The “Pink Pill”-Who Is It For?

Pink PillsThe “pink pill”, flibanserin, was developed for premenopausal women. Although preliminary data on flibanserin use among postmenopausal women are available, the drug was studied primarily in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD), the indication sought at this time.

In the premenopausal population, problems such as pain with intercourse or hyperestrogenism aren’t typically present, simplifying the identification of HSDD. In clinical trials of the drug, HSDD was secondary, generalized, and acquired—that is, it followed a period of normal sexual function. And it didn’t come and go but was present regardless of location and circumstance.

Study participants had had a normal sex drive before their desire “turned off,” an occurrence they found distressing.

Clinicians, myself included, have been frustrated by our inability to prescribe an effective treatment for this common problem. The recent recommendation of an FDA Advisory panel to approve flibanserin for the treatment off HSDD in premenopausal women brings us a step closer to having additional options for treatment.
(Excerpted from an editorial by Dr. James Simon published in OBG Management, July 2015)

 

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