Boehringer Ingelheim Gets No Satisfaction From the FDA

Manufacturing Consent

An FDA panel last week rejected Boehringer Ingelheim's application for flibanserin, a drug the company claims treats "hypoactive sexual desire disorder" (HSDD) in women. Boehringer's studies showed that low libido women who took the "film-coated, 100mg tablets" had on average ".8 more satisfying sexual events (SSE) per month (hey, it's statistically relevant) than the control group. But the drug caused side effects such as nausea, dizziness, and fatigue. The panel said the company did not prove that the drug increased desire despite Boehringer's claim that an SSE was an adequate "downstream" measure of desire.

The drug is controversial for reasons other than efficacy and side effects. Boehringer says research shows HSDD affects 6-10 percent of women. But half of that study's researchers were company consultants and employees, and speakers attending the hearing disagreed that the low libido occurred that often. Nevertheless, the Boehringer crafted an intensive marketing strategy to build buzz around flibanserin. In Australia, the marketing firm Ethical Strategies Pty Ltd invited influential sex experts to Sydney on behalf of Boehringer to "discuss a common yet relatively unrecognized medical condition". The company offered payment of $1,000, airfare, food, and accommodation. The experts discussed the important "research" and strategies to increase awareness of HSDD, and their participation, promised Ethical Strategies, was "confidential".

None of this is too shocking, but doctors and researchers voiced their disapproval of Boehringer's approach calling it a "thinly veiled marketing campaign filled with bias, misinformation and celebrity endorsement". One noted that "women don't need treatments with real side effects for imaginary diseases designed by a marketer", and others offered their opinions that the research was a "scam" and not of "clinical meaningful benefit".

Fear of Flying?

HSDD itself is a disputed diagnosis. The American Psychiatric Association recently proposed that HSDD be subsumed into another disorder. That the condition once solidly in the realm of the psychiatric field is being labeled a biochemical disorder may ruffle some feathers. One psychiatrist said: "a women's desire for sexual emancipation is very worthy. I fear that it's being hijacked by a profit-oriented industry that doesn't really try to understand women and their sexuality." Another doctor said: "The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.

Both these statements are odd. If you're speaking on behalf of women, isn't it a little patronizing to characterize the company's marketing as "preying" on women's "insecurity"? The research may be sketchy and the mechanism is not like Viagra. But should the pill work, aren't women sophisticated enough to balance risks of fatigue and nausea with ".8 more sexually satisfying episodes" per month? Horrifying side effects have been streaming alongside pharmaceutical ads on TV for years, many of them far more disconcerting than "nausea". Now that women are out of the kitchen, voting, graduating from college in higher numbers then men, etc., do women really need "emancipating"? I don't know. But doesn't it all sound so, I don't know, 1970's?

And That Name!

And my thoughts on naming: Next time around Boehringer may want to reassign the detail. "Flibanserin" is just weird. Others agree. NYPost called it "unsexy", and one Nature blogger prefers "pink viagra", which he said "rolls off the tongue so much more easily than filba... filiba... flibasero..." The proposed trade name "Girosa" really doesn't cut it either. Hard "G" in organism? Or soft "G" in gender? Eeewww....but what do I know?

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