It’s been a while since I’ve written about medicalisation. Which seems as good an excuse as any to revisit this issue and reflect on some of the developments in this area in healthcare, therapy and media.

A few months ago I took part in the 41st Maudsley Debate entitled ‘Love is a Drug’. Ben Goldacre and I spoke for the motion, Sandy Goldbeck-Wood and John Dean against it.

In fairness the title of the debate ‘This house believes that female sexual arousal disorder is a fabrication’ was somewhat misleading since it could be construed as saying there was no such thing as women having problems with desire and arousal. Obviously that’s a ridiculous idea for anyone to support, so Ben and I kept our focus more on the way female sexual problems have been medicalised, and what implications this can have (particularly in healthcare).

You can hear the debate and subsequent discussion here. Ben and I won the debate, although the discussion certainly indicated this is a complex area and one that is not always fully understood in terms of gender, politics and ‘bad science’. I think Ben’s points about teaching medical students (and healthcare staff more widely) to read and think critically about pharmaceutical research is important – particularly in relation to the area of sexual functioning which is heavily medicalised but often not taken seriously. Because it’s about sex.

Additional reviews of this debate can be found here, here and here.

This event follows a debate last year hosted by the British Medical Association which was also attended by John and Sandy, who discussed issues around female sexual dysfunction with Ray Moynihan (author of Sex, Lies and Pharmaceuticals) and Iona Heath.

Both of these discussions were focused towards a medical audience (with the Maudsley debate particularly aimed at medical students and trainee psychiatrists, and the BMA event at practising clinicians and therapists). While the Maudsley debate was open to the public the BMA event was invitation only, so there is a remaining problem of making discussions around medicalisation open to a wider audience.

One way this is being achieved is through screenings of Liz Canner’s amazing documentary ‘Orgasm Inc’ which have been taking place across the US, Canada and UK. Media coverage of this movie has also helped raise the profile of female sexual problems (examples here, here, here and here). Although unfortunately not all journalists covering this area ‘get’ all the issues surrounding this topic, particularly around medicalisation, evidence based practice, and endorsing largely untrialled/untested interventions).

This leaves us with some stubborn problems which still need tackling. These include:

Critiquing FSD = women don’t have problems
One of the most frustrating aspects of challenging the medicalisation of female sexual problems is the inevitable response from some journalists, medics, researchers and members of the public who interpret what you are actually saying as – ‘women don’t have sexual problems’. Clearly women who are experiencing sexual difficulties don’t want to be told they’re inventing their problems, and do want a solution. Those who are challenging medicalisation of sexual function are not saying women don’t have problems. They’re not saying sex isn’t important. What they are saying is that there are many reasons women experience problems, and an equal number of possible solutions to them (see here for more on this). And that it are the many causes and solutions that require exploring rather than assuming a woman who isn’t desiring sex is ill and requires a clinical solution (we unpack this to some degree in the Maudsley debate podcast linked above).

Discussing women’s problems = denying men have problems
Another real problem around talking about this topic is the focus on women. The media ignored the medicalisation of sex for a long while. Then did a lot to write and broadcast in ways that promoted pharmaceutical company agendas. Some media outlets have more recently decided to focus on the medicalisation problem, but generally in terms of focusing on women. This can partly be attributed to activism in this area, and partly due to rehearsing comfortable stereotypes – that women are not particularly sexual or are more likely to have problems with sex. This has led to criticisms that men’s sexual functioning has been ignored, or is not an issue. In terms of research that’s not really true. The challenging of medicalisation of male sexuality came before campaigns against the medicalisation of female sexual functioning. You can read some examples of that work here, here and here (It’s an area I’ve also researched and published on, as well as given advice to men about e.g. here and here).

What may be a more accurate statement is there is concern over men’s sexual functioning and the medicalisation of men’s sexual lives, but a lack of interest in the mainstream media in really taking this up. Other activist and sceptic groups you’d expect to challenge this problem seem reluctant. Witness the general apathy to helping men affected by the actions of the Advanced Medical Institute as a prime example. It is difficult to get journalists to focus on this in terms of medicalisation of sexual functioning per se, rather than simply seeing it as a ‘woman’s issue’.

Media lack of awareness of/complicity in this area
One of the main issues in this area is the media often doesn’t ‘get’ medicalisation. Indeed promises of wonder drugs that will boost our sex lives attract editors like moths to flames. The result has been uncritical pickup of pharmaceutical research on psychosexual problems, either promoting products that aren’t all that effective, or showcasing drugs that aren’t even available for public use. Even where drugs for desire problems have been identified as ineffective media coverage continues to write about them as if they are – for example with media’s ongoing obsession with testosterone therapy as a sex drive booster for women. This parallels problems within medicine where practitioners simply don’t understand the influence of Big Pharma in this area, can’t access (or understand) the diverse literature about medicalisation and critical sexology, and remain unable to identify and appraise literature on this topic.

Where to next?
The problem of medicalisation and poor media coverage of sexual problems is not going away. So encouraging and recognising good quality reporting in this area is vital. Supporting screenings and discussions of documentaries like Orgasm Inc can help, as can more public events tackling this topic. Moving away from a debate style format (i.e. do problems exist or not) would also allow for perhaps a more nuanced discussion on medicalisation, how it happens, and how to recognise and respond to it. Focusing on this as an issue affecting cis and trans women and men, as well as different sexualities is important. As is reflecting on how we view psychosexual issues for different age groups (and what age groups, genders, sexualities do we seem most keen to pathologize). Helping medics, therapists, journalists and the public to understand core issues around medicalisation as well as critiquing research on treatments in this area would also be useful. As would challenging any suggestion that critiquing medicalisation equals denying people have psychosexual problems.

You may also be interested in responding to the classifications of psychosexual issues in the revised DSM (deadline 15 June), or learning more about the Medicalisation of Sex from this recent conference in Vancouver.

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.

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.