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08/28/2015

Marketing Trumps Science, or How the Pink Pill Does Not Even the Score

This month’s blog is going to be a bit of a rant. I don’t
generally consider myself a rant-y person, but some of the commentary
surrounding the recent
FDA
approval
of the sexual desire disorder drug Addyi has proven too much for
my delicate constitution.

First, what I am NOT doing: I am NOT denying the existence
of hypoactive sexual desire disorder (HSDD), or that for women who are so
afflicted it can cause serious distress or otherwise negative consequences. I
am NOT challenging the notion that HSDD is a medical problem that warrants seeking
a medical treatment or medical solution. I am NOT arguing against
pharmaceuticals in general, or here specifically, as a potentially viable
medical treatment for HSDD. I am NOT saying all pharmaceuticals should have
absolutely no risks or side effects, or should be required to produce overly
substantial benefits for it to be appropriate for them to be FDA-approved and
released to the market. I am NOT calling into question the claims that there
are very real sex and gender disparities in medicine, human medicalization, and
medical treatment. And I am NOT disputing the value of empowering women with
greater control over their own bodies and their own healthcare.

So what AM I doing? I’m questioning the approval and
impending market release of this specific drug, Addyi, based on its known
and unknown risks and benefits
both from a medical perspective and from a
feminist perspective. A few of my concerns:

Is it counter-intuitive to have a drug aimed at increasing
female libido that is shown to have increased side effects when a woman is also
taking hormonal birth control? And given its contraindications with hormonal
birth control, is it appropriate to approve the drug without a clearer
understanding of what, if anything, being on Addyi will do if a woman becomes
pregnant?

Will the medicalization of a concept of “normal libido”
potentially become a stigmatizing description for those women whose natural
libido falls below that conceptual threshold? And will the presence and possible
widespread use of Addyi pressure women who through natural human variation have
“lower” libidos into taking the drug under the guise that their normal libido
isn’t “normal”?

If one of the goals of making Addyi available is to help some
couples achieve greater match in their respective libidos, why should the
presumption be in favor of increasing a woman’s libido rather than, e.g.,
decreasing the libido of her partner? Is it appropriate to ask women to incur
the sorts of risks that are, and that may be, associated with long-term use of
Addyi for the sake of a more matched libido?

What is the appropriateness of referring to Addyi as “the
female Viagra”, when unlike Viagra, which only needs to be taken at time of use
for near immediate effect, Addyi requires consistent, long-term use in order
for its benefits to be experienced? And should such phrasing actually be
considered unethical, because it draws an unfair association between the two
drugs and might paint Addyi in a more appealing light than its research to date
warrants?

Will the availability of the drug potentially exacerbate the
problem of HSDD for the women who receive limited to no benefit from taking it?
And will drug use capitalize on a sort of patient desperation, pushing some
women to incur a higher level of risk just in the hope of some remote benefit?

Given what is both unknown and known about the risks and
benefits of Addyi, has the FDA insisted on sufficient evidence and research caliber
supporting it before their approval, especially since it enters a market with
no competition? And since having a monopoly on this share of the drug market
might be thought a very lucrative
business opportunity
, should the evidentiary threshold perhaps have been
held even higher to ensure adequate safeguards?

I think perhaps what bothers me most about much of the
dialogue supporting Addyi is the presumption that the FDA’s former position of
rejecting Addyi was sexist, and that their new approval of Addyi is a definite
triumph for women and for feminism. I have a couple of questions for those who
want to support Addyi on the grounds that it is “for women”: If this drug were
being marketed for men and offered the same level of benefits, had the same
amount of known side effects and unknown risks, and required the same dosing
schedule and long-term use, would the FDA have approved it, hailing it as a
major breakthrough? If not (and my inclination is that it would not), what does
it say that for women we are either unwilling or unable to demand the same?

Perhaps there is something wrong with my understanding of
feminism and I am deeply misguided in the matter, but I don’t think it’s
feminist to celebrate the FDA-approval of Addyi (almost) simply in virtue of it
being a drug for women; for the sake of all women I think it’s feminist to
demand better medicine and more rigorous science.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.

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