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FDA advisory panel rejects Flibanserin

June 21st, 2010

Dr Petra

Last Friday drug company Boehringer Ingelheim presented evidence to the FDA’s advisory panel on their drug Flibanserin. This product, designed to tackle Hypoactive Sexual Desire Disorder (HSDD) in women had already been given plenty of media coverage focusing on ‘Pink Viagra’, and raised concern from scientists, healthcare staff, therapists and activists. You can see a summary of the case up until the hearing here. Meanwhile Neuroskeptic has an excellent discussion on the problems with the drug while the New View Campaign (who gave evidence at the hearing) have produced a number of really helpful fact sheets to help you understand the research behind Flibanserin.

Why did the FDA Advisory Panel say ‘no’?

The FDA rejected the application to approve Flibanserin for several reasons. They were concerned about the materials used in trials to measure sexual response, the trial outcomes (which suggested Flibanserin did not perform much better than placebo) analysis of the data, and overall management of the trial. The FDA did not, however, dismiss HSDD generally and indicated it was a problematic condition they recognised.

Those who have raised concerns about Boehringer Ingelheim’s marketing of Flibanserin, it’s attempts to increase focus on HDSS within medical education and the quality of the research on the drug were relieved to hear the FDA’s decision. However, critics of the concept of medicalising women’s sexuality were concerned the FDA accepted the diagnosis of HSDD which is seen by many as problematic.

Boehringer Ingelheim have since issued a press release detailing how they will continue to research HSDD and continue their trials on Flibanserin. The result from the FDA, although fair, comes as very bad news to the company who have already invested heavily in the drug in the hope of making millions from sales if they can get it approved.

The FDA Advisory Panel’s decision will be formalised in the coming months. What seems very obvious is concerns raised about the drug have been heard but only in part and certainly there is no sign Boehringer Ingelheim will discontinue trials of Flibanserin at this stage.

How about the press coverage of this case?

The media have handled this case better than previous drugs aimed at treating HSDD. Although in the run up to the hearing there has been a lot of coverage for ‘Pink Viagra’ there has been some more accurate and critical reporting. Certainly since the FDA decision has been released there has been some particularly excellent coverage such as this report for CNN by Jennifer Terry.

There are, however, lessons to be learned from the media’s approach to this case. Journalists in the main did not investigate the claims made by scientists such as myself about the marketing of Flibanserin, the approaches by Boeringher Ingelheim took to medical education, or the quality of the research. Indeed many journalists said they couldn’t find the research – and that’s because Boeringher Ingelheim did not publish it in any peer reviewed journal. This alone should have rung major warning bells for journalists but generally didn’t. So we need to be aware that while there is now some critical coverage about the medicalisation of sexuality there is also a long way to go to get journalists to ask basic questions about drug company funded research in this area. It’s important the media gets better at this because, aside from getting better stories to cover, the focus on finding a pill to fix female sex problems won’t go away.

What should we be aware of now?

Boeringher Ingelheim have indicated they will continue with their trials of Flibanserin, they may well reapply to the FDA with new trial data or may apply to the European Medicines Agency (EMEA) for approval.

Debates about the diagnosis of HSDD (and sexual problems) will also continue as the DSM V is developed.

Journalists, healthcare providers, therapists and the public need to be aware of the problems with the research that led to the FDA’s decision and further scrutiny needs to be applied to the company and the drug in the coming months. It would certainly be helpful if healthcare staff challenged the medical education for HSDD awareness funded by the company and the media applied a critical lens. We will also need to be alert to other drug companies also working on similar products.

We also need to be careful to avoid getting into debates about whether a pill is needed or whether women have sexual problems, as has been the case in the current coverage of Flibanserin. This has missed the wider aspects of marketing, poor trial design and other research questions that really needed to be talked about. Instead we’re often left with an argument that in questioning medicalisation of female sexual functioning we’re somehow denying women have problems.

So as this latest chapter in the medicalisation story closes, let’s be very clear. Women do experience sexual problems that cause them distress, discomfort and dissatisfaction. These are often linked to other factors and do need attention, but they are not a clinical condition or a dysfunction, and they do not require a new and separate diagnosis. A summary of common reasons women experience problems with sex can be found here.

Helping women involves highlighting the wide range of reasons they may experience problems with sex, the different solutions to those problems and to focus on educating women and their partners about the wide range of sexual experiences they may enjoy. It also means continually challenging anything that may restrict and pathologise female sexual desire.

The FDA decision is good news for science, healthcare, activism and for women’s sexual lives. However the push to find a medical solution to female sex problems is not going away and I will continue to question, challenge and update you on what’s happening. Although I hope you’ll also be doing this too!

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