ACT III: NOW THEY’RE PAYING PATIENTS TO GO TO THE FDA

14 October 2014

Here’s the third installment of the saga about PR tactics on the “female sexual dysfunction” front as we get closer to the October 27/28 meeting on FSD and Patient-focused drug development. (opens in a new tab)

I (L.T.) first wrote here in April 2014  about the efforts Sprout Pharmaceuticals and the professional organization ISSWSH were undertaking to promote approval of flibanserin, a serotonergic/adrenergic drug twice FDA rejected (2010, 2013) for the treatment of low sexual desire in women. Their first step was to claim the FDA was sexist in approving drugs for men’s sexual problems but not women’s. The “gender equity” ploy was at first supported by most media (opens in a new tab) but fortunately received some critical press (opens in a new tab) as well. However, a letter (opens in a new tab) from four congresswomen  and several feminist groups created the appearance of grassroots activism. Needless to say, other feminist groups also wrote opposing letters. Duelling feminisms, one wag said.

Then, over the summer, a second tactic emerged:  a glossy PR campaign called “even the score” recruited the public to sign a petition and “get informed” about the injustices at the FDA on the topic of women’s sexuality drugs. This time, the press (opens in a new tab) was less charitable and there was grumbling heard about pressure on the FDA.

So now we are in the autumn, preparing for the special two-day “female sexual dysfunction” event (opens in a new tab)at the FDA as part of the “Patient-focused Drug Development” initiative (opens in a new tab) called for by PDUFA 2012.  And what interesting new tactic do we see emerging at the 11th hour?

ISSWSH and Sprout have been distributing a fancy flyer (opens in a new tab) online and at their various fancy lunch meetings inviting all and sundry to attend the October meeting in Maryland , but that's no surprise. A new (opens in a new tab) campaign website emerged with a new petition (claiming 15,000 signers) with the familiar messages, except for one brand new claim, “A biological lack of desire to have sex negatively impacts 1-in-10 American women.” That IS a surprise. No footnote, reference, or citation is provided, and in fact it is totally absurd because there is no biological marker, assay or sign for sexual desire that anyone has identified. So, science has been thrown to the winds, it seems.

But that’s not all! What you won’t find on line is the letter ISSWSH sent to its members in early October encouraging them to recruit their patients to attend the October FDA meeting and offering to pay patients’ travel and expenses (see below) WHOA! Now how low can you go? This is professionally highly inappropriate - even unethical. One simply doesn't put patients under that kind of pressure.

I hesitate to say this is the final step in the saga, so we'll just wait and see. A full page ad in the NYTimes? When there's billions to be made, why not?