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Is low sexual desire in women a disease? No it’s not. But drug company are seeking FDA approval for a drug to ‘cure’ women nonetheless

June 1st, 2010

Dr Petra

On June 18th pharmaceutical company Boehringer Ingelheim will be seeking approval from the Food and Drug Administration (FDA) for their drug Flibanserin (which may be traded under the names of Ectris and/or Girosa).

This is an antidepressant style drug which Boehringer Ingelheim claim is a treatment for low/lack of sexual desire in women (aka Hypoactive Sexual Desire Disorder or HSDD). It must be taken every day and for up to a month before any benefits may be noticed. How long it should be taken for after that is not clear.

It has been difficult to judge the efficacy/effectiveness of this drug because to date no trial data has been published in a peer reviewed journal. Instead data was presented at a conference last November based on combined data from a number of trials. This combined data indicated a significant difference between the drug and placebo although it was only one more sexually satisfying experience per month on Flibanserin as compared with placebo. There is little information available about how long the drug must be taken for, potential side effects and what happens during/after withdrawal. A summary of activity on this product to date can be found here.

Despite a lack of clear data about the product, its effectiveness or how it has been evaluated, Boehringer Ingelheim has already focused on marketing to the public with activities including a glossy website aimed at women called Sex Brain Body. Messages outlining the prevalence of HSDD and related issues are also shared frequently via @SexBrainBody on Twitter. They have also been approaching practitioners to put their name to pre-written pieces to go into journals. These detail the prevalence of HSDD to be aimed at GPs and other healthcare staff along with hosting numerous ‘training events’ (described as ‘round table discussions’) for practitioners to learn more about HSDD and CME activities for medics such as “Female Sexual Health: Recognizing the Impact of FSDs on Patient and Partner and Implementing Clinical Strategies for Overcoming Communication Barriers”. In addition for the last 12 months the company has also paid a number of sexologists to design marketing materials.

What is HSDD and does it exist?
Women do experience psychosexual problems, as well as relationships difficulties or dissatisfaction with sex/relationships. You can see these summarised in an answer I recently wrote for NHS Choices.

Obviously with many potential causes of problems there are many potential solutions/responses. This might include basic health information, adequate reproductive health care, improved communication with a partner, healthcare for other problems or relationships counselling.

Concerns have been raised by the suggestion that not wanting sex or experiencing low sexual desire is a clinical problem requiring a pharmaceutical solution as a first port of call.

It was all about your hormones, now it’s all in your head

In the past five years we’ve seen some interesting (and worrying) developments in the area of drug development for HSDD. For several years the general view was women’s lack of desire was linked to hormonal deficits (specifically Testosterone) with hormonal patches designed to ‘treat’ the problem. These performed poorly at trial and were not approved by the FDA (although did get approval for use in Europe). A systematic review of all trial data indicated the Intrinsa patch was not effective at dealing with low desire in women.

The focus has now shifted to seeing women’s lack of desire as a neurological problem, with Flibanserin working in a similar way to an antidepressant (indeed it was developed as an antidepressant but was not fit for purpose). The naming of the promotional site as ‘Sex. Brain. Body’ particularly shifts attention towards female desire problems as being psychological, complex and emotional.

Intrinsa was only designed for women who had low desire following surgical menopause, whereas Flibanserin can be taken by any woman diagnosed with low sexual desire. Already we have seen practitioners associated with Boehringer Ingelheim working on Flibanserin also suggesting the contraceptive pill reduces desire which is one market which may benefit from having a pill to boost arousal.

Challenging the medicalisation of female sexual problems

There have been a number of efforts to challenge the medicalisation of female sexual dysfunction and to ask questions about Flibanserin. These include the New View Campaign, journalist Ray Moynihan’s forthcoming book Sex, Lies and Pharmaceuticals and Liz Canner’s documentary Orgasm Inc. While Paul Joannides has used humour to focus on problematic aspects of the drug.

The response by the Boehringer Ingelheim has been to focus on presenting high levels of female sexual dysfunction to practitioners and the media, and reinforcing the message HSDD is extremely prevalent and highly distressing. Those who have criticised the company or the drug have been accused of ignoring women’s plight or dismissing problems.

This is unfair and inaccurate. It is perfectly reasonable to question any drug that is being marketed, particularly in terms of its effectiveness, safety, marketing and purpose. Rather than denying women’s problems those questioning Boehringer Ingelheim are mostly long term activists for women’s health and sexual wellbeing.

What can you do?

Write to the FDA
This needs to be done by 3 June (can do this via email or fax). Contact details are:
Kalyani Bhatt
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
Phone: 301-827-7001
Fax: 301-827-6776
E-mail: Kalyani.Bhatt@fda.hhs.gov

In particular you may wish to focus on the following in your feedback via the New View Campaign
“Please write to the FDA before June 3 about Flibanserin. All the information you need is on the FDA website. Write about side effects worries, poor efficacy in the trials, your concerns about the target population of young women, the outrageous marketing campaigns now underway with actress Lisa Rinna and others, the poor efficacy in the European trials that is never mentioned, the emphasis on HSDD (a soon to be extinct designation), etc. Be specific and be personal!!”


Sign the petition

The petition against Flibanserin and the medicalisation of female sexual functioning is hosted at Change.org. Please share this widely on twitter, your blog, forums, through health groups and listserves. It will be presented to the FDA at the hearing on the 18th June.

Encourage the media to focus on this as a women’s health issue, rather than a pro/con debate on whether HSDD exists or whether women should/shouldn’t get help.

If you work within healthcare encourage colleagues to look critically at this drug, ask questions about why trial data hasn’t been published/subjected to peer review, and consider wider ways we can enable women and their partners.

This is a very important issue in sexual and reproductive health. It is extremely worrying the FDA are being asked to approve a drug which has not performed particularly well at trial, and which has not been published in any peer reviewed journal to allow the scientific community to investigate it. It is also concerning that female sexual responses which may be distressing are being reclassified into a clinical condition.

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