Serotonin Drug for Low Desire in Premenopausal Women
The FDA has announced a June 18 committee hearing to consider a new serotonin (!!!) drug for low desire in PREMENOPAUSAL women. I am organizing speakers and letters and lots of this appears on the listserv of the New View campaign (newviewcampaign.org) which some of you I know are already on.
The clinical trial data have not been published but are dribbling out, e.g., in abstracts at the ACOG meeting currently going on in SF. Here is a pretty balanced report from WebMD - I talked the guy's ear off yesterday!!
One of the arguments will be about HSDD - Hypoactive sexual desire disorder - the DSM indication for the drug because the DSM-V proposes to drop HSDD and merge it with arousal disorder. Hard to know if you can have a drug for a nonexistent condition.
For the past year, Boehringer-Ingelheim has been paying a group of sexologists to help them with their marketing materials. You can see the resultant campaign on http://www.sexandahealthieryou.org/ and you can read how it was developed over the past year on http://www.arhp.org/uploadDocs/SHF_meetingreport.pdf
For the past 2 months, Boehringer-Ingelheim has been pushing their celebrity campaign for HSDD, http://www.sexbrainbody.com/ featuring actress Lisa Rinna and celebrity sex therapist Laura Berman. Lisa was on CBS-TV this morning. This campaign softens up the public to welcome a brain drug like Flibanserin. Here is an example of the kind of media they are getting http://weblogs.wpix.com/news/local/morningnews/blogs/2010/05/lisa_rinnasexual_desire.html
The worrisome thing, though, is about the serotonin angle - this is a big gun.
If you are interested, you're more than welcome to write to the FDA
Please send LETTERS to the FDA contact person below before June 3. Be brief and to the point. If you need help with your letter contact me, and if you want to speak at the hearing, please contact me. You will have to register to speak before May 25.
FDA contact person:
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093)
Rockville, MD 20857
Leonore Tiefer, PhD