Hey everybody, in about two hours, I’ll spend 12 minutes at Chicago Ideas Week explaining responsive desire and why Flibanserin is bogus. Hilariously, I go on about two hours after Cindy Whitehead, (BRILLIANT) CEO of the company that shepherded the drug through FDA approal, who spoke in a “Medical Breakthroughs” session. Chicago Ideas Week tweeted her talk this way:

 

Well.

My job is to bring the science, free of any profit motive.

 

I’ll be mentioning some Sciencey Facty-Facts, so I’m taking this opportunity to post the reference I’d be citing if I were citing reference in my talk:

 

1. Flibanserin accumulates in the system over 4-8 weeks

fda onset

 

2. The potential for serious side effects is so high that the FDA is requiring proiders to participate in a training and certification process before they’re allowed to prescribe it.

Here is the complete REMS (PDF) (Risk Evaluation and Mitigation Strategy)

 

3. Only about 10% of women in the drug trial experienced “at least minimal benefit” above placebo (which, of course, means that the remaining 90% experienced not even minimal benefit.

The number to notice is the one under “Trt. Diff.” That’s the real effect, after placebo.

fda minimally improved fda improved

 

4. Women on the drug experienced approximately one additional sexually satisfying event per month above placebo.

FDA sses

For more info, all of the FDA’s slides are here, and information sbout viewing the archived FDA hearing here (PDF)

 

 

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