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.
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 but fortunately received some critical press as well. However, a letter 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 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 at the FDA as part of the “Patient-focused Drug Development” initiative 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 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 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?
| Dear ISSWSH member, As per our prior e-blast, the FDA is holding a public meeting on FSD October 27-28, 2014 (information available on the FDA website at http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm). It is important that the FDA understands how having a sexual dysfunction impacts a woman, so we are encouraging not only your attendance (online or in person), but also urging you to share this information with your patients.Your patients have several ways to have a voice and make a difference. We need to encourage them to have this voice:
1) If your patients are passionate about this issue and are able to attend the FDA patent panel, funding is now available (money is from multiple sources) to help support travel and hotel costs for patients to attend the meeting. Patients can request a travel grant by writing to email@example.com.
* Please note that If they cannot attend in person, the FDA has explained that those participating on line can still vote and write comments to be included in the final FDA report.
2) For women (and men) who believe that women deserve better care, better treatment, better options etc, please ask them to go to http://womendeserve.org. From this page they can sign the letter to the FDA currently on change.org (more than 15,000 respondents to date). From this page women (and men) can also click through to the #women deserve Facebook page to share a selfie holding a sign “#women deserve” and any specific message they want to write down.
As members of ISSWSH, it is imperative that we send the message to the FDA that sexual dysfunctions are real, that they affect our patients, and that this is something that deserves their attention. We can make a difference and our patients can make a difference!
Global Program Chair, ISSWSH