Opposition to the “Pink Pill”

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.

Opposition to the “Pink Pill” –  Over Influence to Prescribers (Part 2 of a 4-Part Series)

Second in our review of arguments presented against approval of the drug, flibanserin, for treatment of HSDD is represented by an organization called PharmedOUT. Their position is  that marketing by pharmaceutical companies overly influences prescribers, ultimately medicalizing problems that don’t require medication or overselling medications for problems that may require drug treatment for a short time only. While the goals of this organization are worthwhile, their antagonism against pharmaceuticals, in general, is generic, rather than specific. This organization is headed by an academic physician who has not seen patients in many years and has never treated women for HSDD.

Opposition to the “Pink Pill” –  Lack of Safety Profile? (Part 3 of a 4-Part Series)

Third in our series of arguments against approval of the drug flibanserin is the view, represented by the Public Citizen Health Research Group, that the safety profile of flibanserin is lacking. This organization argues not just against flibanserin but against pretty much any drug. In its view, there are never enough safety data. I would argue that, when it comes to flibanserin, there are more safety and efficacy data than there are for almost any other women’s health drug. Most drug companies test their medications in 1,500 to 2,000 people, as the FDA requires. Sprout Pharmaceuticals tested flibanserin in almost 8,000 women. The total number of individuals who have been studied, in fact, exceeds 11,000.

Opposition to the “Pink Pill” –  Do the Risks Outweigh the Benefits? (Part 4 of a 4-Part Series)

The final opposition opinion is the view, represented by the National Women’s Health Network, that the drug’s risks outweigh its modest benefits. As I have pointed out, however, the benefits of flibanserin have been downplayed in data analysis, and the body of safety data for the drug is substantial.

There is also the sociological view that HSDD is a normal variant of healthy sexual function. Its adherents argue that women with HSDD feel distressed because their male partners are forcing them to feel inadequate. But I have yet to hear a single critical voice from a physician who actually treats women and who can prescribe drugs. The opposition to flibanserin, such as it is, flows from people who don’t see patients and can’t prescribe medications.

These naysayers are negative in a theoretical vacuum. It’s very easy to fall into that trap when you don’t have to look across the consultation desk to a patient who is asking you for a remedy—a woman who’s been suffering for 25 years, say—and have to tell her you have nothing to offer. You might mention testosterone, explaining that it was approved for men, but you’ll try to prescribe an appropriate dose. But be sure to include discussion of its many side effects.

 

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Contributed by

James A. Simon

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