Tomorrow sees the FDA Committee Hearing on Flibanserin, the drug created by Boehringer Ingelheim (BI) to address ‘hypoactive sexual desire disorder in women’. In advance of the meeting you can see the hearing’s list of materials here, BI’s submission of their research on Flibanserin to the FDA here, and my summary of the story/science of this case to date here.
For the past few years while BI have been developing Flibanserin there have been numerous concerns raised by scientists, therapists, educators and activists. Their concerns have included the measures used to assess sexual satisfaction, the trials undertaken to assess the product, safety/efficacy questions, marketing strategies aimed at practitioners and the public, and the fact the research has not been made available within a peer reviewed journal.
It is now possible to review the research (see above) and, as critics have already indicated, it seems there are problems with the method and measures used and particularly issues around side effects and the effectiveness of the drug.
These issues are part of a wider anxiety over the increasing medicalisation of reduced female sexual desire and have been discussed in advance of the FDA hearing by Leonore Tiefer and Liz Canner and challenged via groups such as the New View Campaign.
Over recent months press coverage has not been particularly critical. Numerous stories have run about the promised ‘Pink Viagra’, despite practitioners like myself consistently urging journalists to check the science, the ethics of marketing and the general backplot on medicalisation.
Overall the media coverage is reporting the FDA as raising issues about the safety and efficacy of Flibanserin. Fewer discussions have focused on the equally troublesome aspect of the marketing of the product, though after the hearing tomorrow this may be raised.
It is a pity that journalists covering this story could not have perhaps applied a more critical lens when the story was being flagged up back in April/May. Particularly since they were actively advised by practitioners to ask core questions which have now been raised by the FDA.
More positively, it is worth noting that at least the media have kept up with this story and followed up discussions of the hearing and the drug. Previously when the drug Intrinsa (Proctor and Gamble) was being assessed by the FDA the media applied little critical coverage to the event and failed to follow up what happened at the FDA hearing – despite being encouraged to do so.
Certainly the role of blogs, twitter, and activists challenging poor science and misleading media coverage have undoubtedly ensured core questions that should have been asked about the drug have been addressed somewhere – even if not always in the mainstream media.
So, what may the hearing decide? It’s hard to tell. Previously with the Intrinsa hearing it was assumed they would approve the drug, but this didn’t happen. Early indications seem to be suggesting the FDA won’t approve Flibanserin but we cannot assume this just yet. Even if the FDA do turn it down we can expect BI to then approach the European Medicines Association (EMEA) for approval (as happened with Intrinsa).
The media often tends to suffer with memory loss on such cases so it’s very important if the FDA do not approve Flibanserin that journalists remember this. Because if BI then goes for EMEA approval and relaunches their ‘Pink Viagra’ PR drive journalists need to remember the problems already highlighted with the drug.
You can keep up with the discussions at the FDA tomorrow by following The New View Campaign on Twitter who will be tweeting live from the event. Do follow them and keep watching and asking questions about science and medicalisation. Tomorrow is a very important day for the future of women’s sexual wellbeing, but the quest to find a pill to fix our sexual problems without looking at wider social/cultural issues is not going to end there.
FDA Committee hearing on Flibanserin tomorrow (18 June) – how you can keep up with the meeting
Tomorrow sees the FDA Committee Hearing on Flibanserin, the drug created by Boehringer Ingelheim (BI) to address ‘hypoactive sexual desire disorder in women’. In advance of the meeting you can see the hearing’s list of materials here, BI’s submission of their research on Flibanserin to the FDA here, and my summary of the story/science of this case to date here.
For the past few years while BI have been developing Flibanserin there have been numerous concerns raised by scientists, therapists, educators and activists. Their concerns have included the measures used to assess sexual satisfaction, the trials undertaken to assess the product, safety/efficacy questions, marketing strategies aimed at practitioners and the public, and the fact the research has not been made available within a peer reviewed journal.
It is now possible to review the research (see above) and, as critics have already indicated, it seems there are problems with the method and measures used and particularly issues around side effects and the effectiveness of the drug.
These issues are part of a wider anxiety over the increasing medicalisation of reduced female sexual desire and have been discussed in advance of the FDA hearing by Leonore Tiefer and Liz Canner and challenged via groups such as the New View Campaign.
Over recent months press coverage has not been particularly critical. Numerous stories have run about the promised ‘Pink Viagra’, despite practitioners like myself consistently urging journalists to check the science, the ethics of marketing and the general backplot on medicalisation.
However, with the release of data by BI for the FDA hearing the press have become more critical of the research and finally have begun to raise questions about ethics, science and marketing. Some example coverage includes:
FDA Staff question female sex drive pill (Reuters)
Flibanserin Failure: Female Viagra Drug Disappoints (US News)
Female Viagra fails in clinical trials, or so male partners claim (TrueSlant)
Push to market pill stirs debate on sexual desire (New York Times)
Overall the media coverage is reporting the FDA as raising issues about the safety and efficacy of Flibanserin. Fewer discussions have focused on the equally troublesome aspect of the marketing of the product, though after the hearing tomorrow this may be raised.
It is a pity that journalists covering this story could not have perhaps applied a more critical lens when the story was being flagged up back in April/May. Particularly since they were actively advised by practitioners to ask core questions which have now been raised by the FDA.
More positively, it is worth noting that at least the media have kept up with this story and followed up discussions of the hearing and the drug. Previously when the drug Intrinsa (Proctor and Gamble) was being assessed by the FDA the media applied little critical coverage to the event and failed to follow up what happened at the FDA hearing – despite being encouraged to do so.
Certainly the role of blogs, twitter, and activists challenging poor science and misleading media coverage have undoubtedly ensured core questions that should have been asked about the drug have been addressed somewhere – even if not always in the mainstream media.
So, what may the hearing decide? It’s hard to tell. Previously with the Intrinsa hearing it was assumed they would approve the drug, but this didn’t happen. Early indications seem to be suggesting the FDA won’t approve Flibanserin but we cannot assume this just yet. Even if the FDA do turn it down we can expect BI to then approach the European Medicines Association (EMEA) for approval (as happened with Intrinsa).
The media often tends to suffer with memory loss on such cases so it’s very important if the FDA do not approve Flibanserin that journalists remember this. Because if BI then goes for EMEA approval and relaunches their ‘Pink Viagra’ PR drive journalists need to remember the problems already highlighted with the drug.
You can keep up with the discussions at the FDA tomorrow by following The New View Campaign on Twitter who will be tweeting live from the event. Do follow them and keep watching and asking questions about science and medicalisation. Tomorrow is a very important day for the future of women’s sexual wellbeing, but the quest to find a pill to fix our sexual problems without looking at wider social/cultural issues is not going to end there.
FDA Committee hearing on Flibanserin tomorrow (18 June) – how you can keep up with the meetingRelated posts