Flibanserin, 'female Viagra,' distracts from real causes of low libido: critics

The U.S.approval of apill to treat low libido in women has whippedup a whirlwind of debate andraised questions about whether theso-called female Viagraaddresses the real reasons for lack of sexual desire.

The U.S.Food and Drug Administration last weekapproved flibanserin, tobesoldunder thename Addyistarting in October, for the treatment of hypoactive sexual desire disorder (HSDD)among premenopausal womensome two decades after Viagra was approvedfor thetreatment ofmale erectile dysfunction.

• Drug designed to boostfemale libido approved by U.S. FDA
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Sprout Pharmaceuticalspitched flibanserin asa drug that would finally give women with sexual dysfunction similar treatment options to men andbused dozens of womento FDA hearings in Maryland to attest to itsbenefits and pleadfor its approval in what some saw as a heavy-handed and misleading public relationscampaign.

The FDA gaveflibanserinthe OK after twice rejecting it and despite concerns about its risks and modest efficacybecauseit said women suffering distressfrom low libido havean"unmet medical need." Days after it did, Canadian pharmaceutical company Valeant offered to buy Sprout for $1 billion US and said it will apply togetflibanserin approved in Canada and other countries.

Taking pill vs. talking it through

Althoughoften likened toViagra, flibanserin was created as anantidepressant and works on the brainwhileerectile dysfunctionmedicationsstimulateblood flow to the penis. It must be taken dailyunlike Viagra, which is taken up to four hoursbefore sex.

Criticsargueit'san ineffectual pharmacological solution fora problembetter treated with relationshipcounselling, sex therapy and behavioural changes.

"Their suffering isreal, but the womenwho testified had a lot ofdifferentstories,andsomeofthosestorieswere verygoodreasonsfor havinglowlibido, including having sixchildren,having a one-year-old, having had breast cancer treatment ," saysAdriane Fugh-Berman, associate professor of pharmacology and physiologyat Georgetown University in Washington, D.C.,and director of PharmedOut, a pharmaceutical marketing watchdog group.

Fugh-Berman's view is echoed byCynthia Graham, a Canadian psychologist currentlyworking as aprofessor of sexual andreproductivehealth at theUniversity ofSouthamptonand aresearchfellow at theKinseyInstitute atIndiana University.

"We know that a lot of sexual problems are related to relationship issues, stress, contextual issues. For these, I don't think medication is the answer," she said.

Most people are "inhibited and tongue tied" when it comes to sex, says sex therapistLeonoreTiefer. She tries tohelp patients unravelthe relationship and personalissuesat the rootof their sexual problems, but that kind of work is much messier than popping a pill, she says.

"In a society where it's your fault if you don't get sex right, and you have to have a lot of it and you have to do it right but nobody teaches you how ... you're looking for a way to excuse yourself from your problems, and biology offers that excuse," saidTiefer,a clinicalassociate professorof psychiatry at New York University School of Medicine.

Desire, arousal intertwined

Tiefer, who campaignedagainstapproval offlibanserin,felt most members of the expertcommittee advising the FDA were not familiar enough with the latest research on sexual dysfunctionand too swayed by patients'emotional testimony.

Scientific thinking about sexual desire has changed, and,in fact, HSDDno longer appears in theDiagnostic and Statistical Manual of Mental Disorders, widely used to diagnose patients but also to assessinsurance claims.

It's beenreclassified as female sexual interest/arousal disorder because scientists don'tviewdesire and arousal as separable any more, saysGraham.

Absence of sexual thoughts or fantasies used to be a key part ofdiagnosing a desire disorder in women, but "there'sa lot ofresearchnow that suggests not all women even reportfantasies," she said. "Somefantasizealot,and otherssay they don'tfantasizebut theyfeel very sexually satisfied."

Desire is also no longer thought of as "this spontaneous, horny thing that just comes out of nowhere, which is pretty much how HSDD views it," Tiefer said.

'Compelling testimony' about pill's impact

Tiefer and Graham fearflibanserin feeds into the unrealistic expectations people have about sex.

"The approval of this drug is going to encourage that ideathatweshouldallalwayshavethesame level ofsexualdesire, that itshouldnot really beaffectedbyhavingkids, bystress, byfatigue,byrelationshipproblems," Graham said.

Clinical trial subjectswho wereon flibanserinreported having only an average of 0.5 to one more "satisfying sexual events" a month compared with the placebo groupand a modest alleviation of distress and increase in desire. Eight to 13 per cent were"much improved"on at least one of thethreemeasures.

"Most committee members felt theseeffectswere small,"saidCaleb Alexander, co-director of the Center for Drug Safety and Effectiveness at JohnsHopkinsBloombergSchool of Public Health, andone of six committee members (out of 24) to vote against the drug. "On the other hand,we were hearing from individuals who provided compelling testimony that theproduct made an important difference in their lives."

Eventhose who recommendedapproval ofthe drugexpressedreservations, becauseof its modest benefits and serious side-effects, which includelow bloodpressure, drowsiness and fainting.

"[I] believe that it should be used by almost no one," saidWalidGellad,associate professor of medicine at the University of Pittsburgh and co-director of the Center for Pharmaceutical Policy and Prescribing.

Gelladsays he has no regrets about recommending approval of flibanserinbutadvises women to "try everything" before they use it.