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New trials of female sexual dysfunction drug (Flibanserin) will be reported this week

November 15th, 2009

Dr Petra

Brief background – female sexual dysfunction

Over the past 10 years the race has been on with pharmaceutical companies to find the ‘female Viagra’ – a drug to treat female sexual dysfunction (FSD).

At the same time, concern has been growing within healthcare, therapy and education about the medicalisation of sexual functioning. FSD in particular is a diagnosis with a controversial heritage, with concerns expressed that common (but often upsetting) female problems around lack of desire and difficulty experiencing orgasm have been repackaged within a illness-based model.

[You might also find this discussion held a couple of years ago on Woman’s Hour that addressed FSD useful (includes links to support organisations relating to sexual difficulties). Plus this special issue of the journal Sexualities tackles the problem of medicalising sex for women and men, and Liz Canner’s amazing documentary Orgasm Inc provides a thorough backdrop to the topic]

Over the years several drugs have been developed, although many did not get past early trial stages. Of those that did, testosterone patch Intrinsa was heralded as being the answer to lack of sexual desire in women, although was later found not to be clinically effective (and was never approved for use in the US). Another drug – PT141 – aimed at boosting desire (and aimed at men and women) also failed to meet safety standards and wasn’t developed further (although that wasn’t before the media promoted it as the sex wonder-drug of the future). Alongside these promised medications there’s been a whole slew of herbal products and ‘super foods’ (usually fruits, seeds and berries) promoted in the media and all guaranteed to boost desire or enhance orgasms.

Latest trials – Flibanserin
Flibanserin is a centrally acting anti-depressant type drug made by Boehringer-Ingelheim who have been developing it over the past few years. It is aimed at a condition referred to as Hypoactive Sexual Desire Disorder (HSDD) – or a lack of/no desire for sex in lay terms. Reports suggest the latest trials of the drug are about to be announced, and it’s likely the product will be promoted for public use within the six to eighteen months (pending FDA and EMEA approval). Early trials claim the drug boosts sexual desire, but (as with other SSRIs) this drug must be taken every day for 3-6 weeks before any effects will be noticed and continuously thereafter.

What’s interesting about this drug is it indicates a shift around how we conceptualise and ‘cure’ female sexual problems. Previously the message from drug companies was FSD was a hormonal problem and could be managed with additional testosterone. Flibanserin reframes FSD as a ‘desire is in your head’ model, working on neurotransmitters to increase libido. Moreover, previous drugs tended to focus on women who were approaching or had gone through the menopause (naturally or surgically). Flibanserin is being targeted at all women (so a far larger market share than products just for post menopausal women).

Aside from the wider worries about medicalising female sexual problems (which are caused by numerous factors), critics of Flibanserin question how an antidepressant can boost desire given a common side effect of such drugs are to reduce desire. There are also worries from healthcare workers and therapists around the long term safety of using such drugs and potential problems with withdrawal.

Those defending Flibanserin (and drugs like it) argue that therapists are only criticising the products as they want to promote talking cures over medical ones (and thus have a conflict of interest). They also have reappropriated feminist discourse to talk about women being left out or needing the same access to sex drugs as men (although the products available for men are actually limited and mostly only for erectile dysfunction).

The difficulty with discussing this area is that women do experience sexual problems for a variety of reasons. Many of these can be helped with education, better contraception, improving (or leaving) a difficult relationship, therapy, addressing psychological or physical health problems, or better sexual communication between a woman and her partner. These issues should be tackled as a first port of call, rather than recommending a pill or patch. However, given the embarrassment women experience over sex problems, plus additional pressures from the media and partners to be good in bed (and a desire for pleasure and intimacy), it’s easy to see why someone would prefer a magic bullet than having to work through what’s causing their problems.

Sadly drug companies (and practitioners allied to them) exploit this by making out anyone who questions the FSD diagnosis is anti-women or out to stop women enjoying sex.

What you can expect from media coverage

At each stage of development Flibanserin has already been promoted via the media as a forthcoming drug that will transform women’s sex lives. No doubt coverage over latest research on the drug will follow this format. It’s a dream for health writers and particularly glossy men and women’s magazines as you can discuss sex (and the stereotypical ‘women don’t like it’ angle) with a mix of science and the promise women who’re not sexy enough can be fixed.

You can expect plenty of headlines promoting a wonder drug to boost sex – and reinforcing the idea that women’s sex problems are ‘all in her head’.

What you won’t see is questioning about the drug, safety and long term effects. Nor will you see any critical reflection on the construction of FSD as a medical condition, nor any practical advice on the many reasons women may not experience the sex life they expect – and what they might do about this.

What journalists probably don’t know – behind the scenes of marketing Flibanserin

While Flibanserin has been developed, there has also been a systematic approach from Boehringer-Ingelheim to promote the product before it has been developed. In 2008/9 I’ve had two invitations to attend two two-day long ‘training days’ at top London hotels (with an honorarium of £1000 per session). This invitation has been extended to other practitioners within sexual health.

My understanding of the aim of these events were to highlight FSD (or more specifically Hypoactive Sexual Desire Disorder) as a problem and inform practitioners about treatment approaches. From that, key advisors who’d attended training days could speak further and influence colleagues to also promote FSD as a problem and recommend future treatments as they came on board. Here’s a copy of the agenda for one of the events to give you an idea about what was covered.

I did not attend these events. However, this did not prevent Boehringer-Ingelheim from trying to engage me in other ways. On 1 April this year I was sent an unsolicited invitation to write a paper for their journal British Journal of Sexual Medicine. You’ll see from both the letter and instructions for writing the paper that they had clear instructions about what they wanted me to say and how this would set the scene that HSDD was a prevalent and distressing problem doctors ought to be aware of – presumably so they could be alerted to a problem and be more willing to prescribe a pill when said medication became available.

This may not seem like a major issue, but it’s worth noting that such activity is frowned upon by reputable academics as really all you are doing is marketing a product, not engaging in true peer reviewed science. So obviously I didn’t accept this offer either.

[Since writing this Boehringer Ingelheim’s Medical and Scientific Affairs Manager contacted me and requested a right to reply. You can read their response here].

I’m raising this here as journalists and the public need to know this may be considered a case where the market for the product is being worked upon at the same time the product is being developed.

Nobody is denying women have problems, but there are many ways to approach these without slapping a clinical diagnosis on women who don’t feel sexy.

Questions you should be asking about FSD and sex drugs
If you’re a journalist, healthcare provider or member of the public you should think about what may cause women’s problems with sex and solutions to those. Question whether a clinical intervention is the best option, and research how the category of FSD (and related diagnoses like HSDD) have been created (and who by). In particular you should ask the question whether taking SSRIs on a long term basis is the best answer to women who aren’t feeling desire.

Update 16/11/09

The press release for Flibanserin is now available. If you’re a journalist covering this story you may want to ask questions about efficacy, safety and medicalisation (as outlined above). You may also want the drug company to clarify exactly how many ‘satisfying sexual events’ (their term) were classed as significant as compared with placebo. The press release states a significance, but in lay terms how much more satisfying sex per month can a woman expect if she’s taking her daily dose of Flibanserin?

Update 17/11/09

Cory Silverberg has a clear and thoughtful analysis of the Flibanserin studies, reflecting particularly on how sexual experiences were measured. This blog highlights how Flibanserin is still an experimental drug (not quite how the media are reporting it). Also, it’s worth noting from Cory’s appraisal of the research how not all women in the study did experience significantly better ‘satisfying sexual events’ compared with placebo. Well worth a read for an appraisal of both the research and marketing approaches from Boehringer-Ingelheim.

Also, Neuroskeptic has a fantastic blog that tackles in depth the trials for Flibanserin and the interpretation of the findings.

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