Pol­i­tics and the lit­tle pink pill

Los Angeles Times - - OPINION -

There’s noth­ing fem­i­nist about a drug that isn’t very ef­fec­tive and can have neg­a­tive side ef­fects in the women who take it. That’s some­thing for the U.S. Food and Drug Ad­min­is­tra­tion to keep in mind as it re­con­sid­ers the so-called lit­tle pink pill or women’s Viagra — a phar­ma­ceu­ti­cal in­tended to in­crease sex­ual de­sire in pre­menopausal women trou­bled by low li­bido.

The FDA al­ready has re­jected the ex­per­i­men­tal drug flibanserin twice, on the grounds that its down­sides out­weigh its ben­e­fits. Now Sprout Phar­ma­ceu­ti­cals is back with more re­search and a re-anal­y­sis of previous data show­ing stronger out­comes. Ac­cord­ing to an FDA anal­y­sis, the drug pro­vides bet­ter re­sults than a placebo — but not by much. Over­all, the drug led women to have one more sat­is­fy­ing sex­ual ex­pe­ri­ence per month than they had with­out it.

A few women’s groups have called on the agency to ap­prove flibanserin this time, say­ing it’s un­fair that there is no drug for women’s sex­ual-de­sire prob­lems, while men have a choice of for­mu­la­tions for erec­tile dys­func­tion, in­clud­ing that fa­mous blue pill, Viagra. One cam­paign on be­half of the drug is called “Even the Score.” Other women’s health groups say the drug shouldn’t be ap­proved. A joint FDA panel is meet­ing on the is­sue Thurs­day.

The list of flibanserin’s com­mon side ef­fects in­cludes low blood pres­sure and faint­ing, as well as headaches, nau­sea, dizzi­ness and fa­tigue. Its sup­port­ers point out that Viagra has a much longer list of side ef­fects. True, but drug ap­proval is a bal­anc­ing act be­tween ben­e­fits and risks. Viagra is a far more ef­fec­tive drug than flibanserin. It also is taken only when needed; flibanserin must be taken ev­ery day, in­def­i­nitely, for women to reap any ben­e­fit, in­creas­ing the dan­ger of the side ef­fects.

Many in the med­i­cal estab­lish­ment ob­ject to the very idea of a drug for low de­sire in pre­menopausal women, say­ing that, un­like with erec­tile dys­func­tion in men, it is pri­mar­ily caused by psy­cho­log­i­cal prob­lems and re­la­tion­ship is­sues. The FDA takes a dif­fer­ent, more rea­son­able view: If there is a safe phar­ma­ceu­ti­cal so­lu­tion to this dis­tress­ing prob­lem, great. It’s far from clear, though, that flibanserin fits the bill.

The most dis­turb­ing as­pect of the pink-pill de­bate is the at­tempt to make this de­ci­sion po­lit­i­cal rather than sci­en­tific. Whether a drug treats peo­ple of a par­tic­u­lar age, gen­der or eth­nic­ity, it must pro­vide sub­stan­tially more ben­e­fit than risk. That is the only “score” the FDA ad­vi­sory panel should be tot­ing up in re­con­sid­er­ing flibanserin.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.