An investigation by ThinkProgress reveals that the drug's public relations campaign is highly misleading and its effectiveness is modest at best. Read the full transcript below.
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August 14, 2015
WOMAN 1: I wanted my sex life back
WOMAN 2: I had a wonderfully loving husband and no sexual feelings.
WOMAN 3: A silent wall of shame grew between us
IGOR VOLSKY: These women suffer from lack of sexual desire and now a new pill developed by Sprout Pharmaceuticals could help jump start their libido.
JAMES SIMON: This has been under the radar, hidden, most women are just sucking it up, so to speak.
IGOR VOLSKY: After years with no FDA-approved solutions, Flibanserin -- popularly known as “the female Viagra” -- may finally provide women with treatment. In fact, women’s health groups have joined with the pharmaceutical company to create a new campaign called Even The Score. That campaign is lobbying the FDA to approve Flibanserin. It's about time, right?
CINDY PEARSON: Even The Score is full of lies, knowing willful lies.
IGOR VOLSKY: One such lie, the campaign strongly implies the drug is similar to Viagra, but that's not true at all. Men take the little blue pill when they want to have sex to increase blood flow to the penis. Women would have to take Flibanserin daily -- and that pill works to convince the brain to desire sex. Also, as one of the doctors advising the FDA told us, this drug isn’t for nearly any women.
CALEB ALEXANDER: In general medicine, in my clinical practice of 15 years, I’ve never met a woman that fulfills the formal diagnostic criteria for this disorder.
IGOR VOLSKY: And for the few pre-menopausal women who do qualify, they would have to make some major life changes. The only way I could take this product as a woman is: I have to stop drinking, I have to get off my prescription birth control, contraception pill...
CALEB ALEXANDER: No anti-fungal medicine for vaginal yeast infections.
IGOR VOLSKY: Ok, stop that. And I have to take it at night and over a six month period I might, during some point in that six months experience a slightly heightened desire to have sex.
CALEB ALEXANDER: Right.
IGOR VOLSKY: In fact, the few participants who made such a small increase in their sexual activity that we had trouble characterizing it. And many participants experienced adverse effects that the expert panelists feared would only increase in the general population.
CALEB ALEXANDER: If you faint while you drive a car, you may kill yourself or someone else. These safety concerns in light of the very modest effectiveness benefit together don’t present a favorable package.
IGOR VOLSKY: The FDA previously rejected Flibanserin twice and this third time around, they requested an additional study of how the drug interacts with alcohol. The company enrolled 25 people: 23 men and only 2 women -- and later claimed it didn’t have the ‘foresight’ to enroll more women.
CINDY PEARSON: Sprout Pharmaceuticals set off to do the right thing, I believe, but they then went astray. When the FDA said, we’re still not convinced, you still haven’t answered all the questions about safety, then they started advancing pretty significant amounts of money into this marketing campaign
IGOR VOLSKY: After a full day of hearings, the panel voted 18-6 to approve the drug, though not without conditions and some serious reservations.
PANELIST 1: Women suffering from HSDD deserve better than this.
PANELIST 2: I think we all wish it was a drug that was a better one.
PANELIST 3: There are serious safety concerns, so my yes is conditional.
PANELIST 4: If this were the 7th drug in the class, I think it would be a very different discussion.
IGOR VOLSKY: So will this drug really help women?
JAMES SIMON: It is not perfect. The drug is not perfect, the FDA is not perfect. We accept certain imperfections to move progress.
CINDY PEARSON: If the FDA approves flibanserin, I will be convinced forever that it came about as a result of a brilliant marketing campaign and not the result of good science and I’m afraid women will suffer as a result.