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.

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.

The Diagnostic and Statistical Manual of Mental Disorders (DSM) is a classification system created by the American Psychiatric Association to enable those working in healthcare to research, diagnose and treat mental health problems. It is not without controversy with critics arguing over each iteration of the manual more and more behaviours are medicalised and the DSM is tainted by the influence of drug companies with a vested interest in creating disorders in order to provide treatments. Supporters argue having a system of managing our understanding of mental disorders improves our approaches to research and care for those experiencing mental distress.

Today sees the launch of the draft version of the latest incarnation of the manual – the DSM5. It’s been worked on over the last decade and you can now see how mental disorders are being conceptualised (including what disorders have been amended, removed or added to). The whole draft is available here although I am most interested in how sexual functioning, gender identity and paraphilias are being approached.

In particular hypersexuality appears to be moving towards supporting diagnostics around sexually addictive/compulsive behaviours, which requires close attention as we already know this is one area full of very poor science, political and faith based ideology and a whole slew of homespun (but largely unevaluated) therapies.

If this is to be included in the DSM5 there needs to be a strong evidence base underpinning anything we want to label as ‘hypersexuality’ and robust reflections on how we classify problematic behaviour to ensure we don’t pathologise certain forms of sexuality (ie adultery, masturbation or alternative relationships) that particular faith based and neo conservative groups/professionals disapprove of.

The classifications around gender identity have proved controversial with critics questioning whether such guidance should be developed – particularly given a weak evidence base in this area. You can see how it is being approached in children here (approaches for adults also outlined in this part of the DSM5 draft). Mainly the debates around the classification in children have focused less on the issue of identifying problems and more about evidence based evaluations of treatment interventions for young people.

Sexual interest/arousal disorder in women is also an issue requiring close attention as we know this is an area where there’s been an ongoing issue about medicalising female sexual behaviour, suggesting women who don’t want sex for practical, relationship or health based reasons require hormonal or SSRI-type interventions.

You can expect to see discussions of this particular classification on sex blogs in the coming weeks, although it’s worth also looking at the additional classification aimed at men, and compare how these are new classifications as distinct from existing categories of orgasmic disorder aimed in women and men.

The existing DSM classifies difficulties in experiencing orgasm as a dysfunction, while the proposed new version would add to this lacking in desire for sex. Some people will welcome this seeing the lack of desire as the barrier to orgasm, others may conclude that there are many reasons women and men don’t feel desire or experience orgasm and classifying them as a mental disorder may be overmedicalising a range of normal human sexual responses.

If you’re interested in how we understand sexuality and human sexual behaviour I’d recommend reading through the entire list but focus your attention particularly on what’s being proposed as now needing classification, what’s being subsumed into existing categories and what established diagnostics look set to remain.

From this you should consider the evidence (shown by each category) and see whether you feel this is fair, balanced and whether it comes with any conflict of interest (you may need to track down the cited papers to do this). You could also reflect on what categories are being added, who is suggesting them and who might benefit or face discrimination from them should they be classed as a mental disorder. You may also want to think about what happens if any categories are added to or removed from the DSM – in terms of how we’ll be approaching research, therapy, drug treatments or surgery for sexual dysfunctions, and gender identity disorders and how those plus legal sanctions may be applied to the classification of paraphilias.

I’m not arguing here that all the items listed in the ’sexual and gender identity disorders’ aspect of the DSM should be overlooked (for example nobody’s going to dispute paedophilia is a problem, although we need to be sure the way we classify this means those anxious about being potential abusers can get help and treatment). Yet we do need to cast a critical eye over some of the definitions activities that might come under the umbrella of fetish and kink, and also problematise those who apparently have too much or too little sex (or interest in sex).

No doubt colleagues far better versed in understanding mental health classification will be discussing the ramifications of the DSM5 draft in the coming weeks and I’ll add their reports to this blog.

In the meantime you have until 20 April 2010 to respond to this or any other aspect of the DSM5 draft. I would recommend we all do this as individuals or collective groups of practitioners or activists as this process will be used to inform how we define, research and treat mental disorders. If you feel there are particular areas which should be included or excluded from the DSM now is the time to have your say.

This week BBC2’s Horizon series continues with ‘Pill Poppers’, an investigation into our use of drugs. From the programme’s website

Over your lifetime you are likely to be prescribed more than 14,000 pills. Antibiotics, cholesterol lowering tablets, anti-depressants, painkillers, even tablets to extend your youth and improve your performance in bed… These drugs perform minor miracles day after day, but how much do we really know about them?

Drug discovery often owes as much to serendipity as to science, and that means we learn much about how these medicines work, or even what they can do, when we take them. By investigating some of the most popular pills we pop Horizon asks – how much can we trust them to do what they are supposed to?

I was invited to participate in the programme to discuss sex drugs and the medicalisation of sexuality. This covers a wide area, not all of which was possible to cover in the programme, so here’s an overview of this issue.

Medicalisation of sex has a long history – explained thoroughly here, and while we undoubtedly welcome the benefits of antibiotics for sexually transmitted infections, the more recent phenomena of medicalising sexual functioning is more worrying.

The best known sex drug is, of course, Viagra. Aimed at tackling erectile dysfunction in men it has morphed from a drug for a chronic clinical condition to a ‘lifestyle drug’ often wrongly understood to be an aphrodisiac. Other drugs for ED soon followed – Cialis and Levitra, with more in development. A discussion of the 10 year history of Viagra can be found here.

Given the huge profit made from erectile dysfunction drugs, the race was on to find additional sex drugs and over the past few years we’ve seen a lot of hype about sprays that would boost desire, Viagra’s use in women, and testosterone treatments for women. Which either did not proceed past trial stage (in the case of the first two examples), or was licenced for public use but not found to be clinically effective (in the case of the latter example). There’s also the growing market of herbal sex products mostly sold online but also stocked in high street stores. Not to mention the private clinics using bullying tactics to persuade men to buy their ‘cure’ for premature ejaculation.

Over the past 15 years there’s also been a major shift to categorise a lack of desire in women as a clinical disorder requiring medical treatment, the most recent development being the ‘desire drug’ Flibanserin.

For Horizon’s ‘Pill Poppers’ I was keen to outline how some sex drugs (such as the contraceptive pill or antibiotics for sexually transmitted infections) have undoubtedly enhanced our lives. But the medicalisation of sexual behaviour is another matter. While I agree men with chronic erectile dysfunction as a result of a health problem such as MS or diabetes benefit from an erectile dysfunction drug, attempts to classify a lack of desire have proved highly problematic.

There are many things that can cause sexual problems for women and men (gay or straight), including:
- Physical or mental health problems (such as diabetes, heart disease or depression, cancer)
- Gynaecological or urinary problems (including thrush, cystitis, sexually transmitted infections)
- Relationship problems (such as arguments, jealousy or communication difficulties)
- Stress (from too much work or workplace problems, being overloaded with housework, a lack of partner support, or financial worries)
- Not knowing or being able to effectively explore or communicate what turns you on
- Lack of privacy for sex
- Concerns over pregnancy (worries about getting or not getting pregnant)
- Past or current physical, emotional or sexual abuse
- Body image or confidence issues
- Lack of sex education or holding negative beliefs about sex

These can be short or long term problems and may resolve themselves or require the assistance of a therapist or healthcare practitioner. The idea that a lack of interest in sex should be immediately approached with a pill means the multiple contributory factors to sexual problems may well be missed – resulting in any medication being largely ineffective.

It’s worth noting, as Pill Poppers airs, that despite the media hype we only currently have drugs legally available to treat erectile problems. Although from the media hype around drugs in the pipeline (at trial stage) you’d be forgiven for thinking there’s more products available. You’d also be forgiven for thinking no drugs means no support or help for psychosexual problems, which isn’t true. Therapy and other healthcare interventions can do a lot to help.

So my advice is if you are worried about your sex life, identify what the cause of any problems might be before thinking you’ve a clinical condition. Of course if you’re in pain or distress you should speak to a doctor or therapist, but it may well be that while you have a problem it isn’t necessarily one a pill would fix.

After all they’ve yet to make a pill that makes your partner romantic, or keen to share all the household chores.

Link to Pill Poppers, BBC2, 21.00 (GMT). Available on iplayer via link.

First off, after blogging about Flibanserin I was contacted by Boehringer Ingelheim wanting a right to reply. So their letter is now added to that blog, which you can read here.

More 4 ran a short piece about the drug, featuring the very excellent Katherine Angel. This piece ran to the standard format that many media outlets took. It was presented as the ‘fun’ piece at the end of the news, and didn’t explain the drug completely. Interestingly within the piece one interviewee (the features editor for Woman magazine) described a scenario of a wife feeling pestered into sex by a husband – an upsetting situation and one that could be addressed through better communication. But not one that a drug might fix. And yet this was presented within the report in the context of a female libido problem that scientists should be working to ‘fix’. And sadly, as with countless other reports on this issue, the More 4 piece ended with a typical jokey response, with the anchorman describing Flibanserin as ‘the cure for creeping hands’.

Christine Ottery wrote a fantastic piece for The Guardian outlining the drug but with a focus on the wider issues of women’s sexual functioning. Meanwhile blogger Laurie Penny took up the political aspects of what the drug might mean to women in her piece (simultaneously published for Morning Star and Liberal Conspiracy). Both Christine and Laurie’s pieces are well worth a read – and particularly the responses. It’s interesting to me if you frame this debate within a health or sexual rights issue people tend to listen more than if you place it within a more feminist account.

The New York Times ran two pieces about medicalising female desire generally which you can read here and here. While Cory Silverberg returned to the debate and referenced a couple of fantastic blogs he’d spotted on Flibanserin.

The San Diego Union Tribune focuses on medics involved in consulting on female sexual dysfunction products, while Scottish paper The Herald compares male and female sex drugs. I wanted to like the Herald’s piece but a quick glance suggested the writer hadn’t really researched the area and seemed to have relied on a poorly written piece about ‘what women want’ to argue sex researchers can’t agree about what excites women, and ends with the statement “comparatively little research goes into combating killers of the developing world such as malaria” – which is just not true. It’s very annoying when you’re requiring journalists to write intelligently about the marketing of drugs if they don’t get basic public health information correct.

In more helpful coverage Agony Aunt and medic Miriam Stoppard wrote a helpful lay summary of female desire problems – along with some practical solutions.

And on a similar note, today I discussed Flibanserin and more specifically issues of female desire on BBC Radio 4’s Woman’s Hour, with veteran Agony Aunt and writer Katharine Whitehorn. You can hear that discussion here.

One thing that has been brought to my attention during the period of time Flibanserin’s been in the news, is the lack of awareness about the development and marketing of the drug by many therapists or those working in sexual health. Journalists have told me they’ve had a struggle to find people who can talk about the drug in any informed way. They’ve had no shortage of therapists and others able to talk about women and desire, but they’ve noted that either therapists/educators hadn’t heard of Flibanserin, or hadn’t followed its recent progress, nor were able to interpret or understand the clinical data from the trials.

In fairness to those working in therapy/education the drug trials haven’t been reported in any peer reviewed journals, but some parts of the data were released to the public (see my original blog linked above). It is worrying that those working in this area are not keeping up to speed with the development of drugs, the debates around medicalisation, and the ability to read trial data. It’s one reason that drug companies can unduly influence practitioners – if said practitioners are not aware of wider political debates or able to critically evaluate evidence. So a big take home message from this is about better education for those involved in therapy/sexual health – and particularly those willing to talk to the media.

It’s also worth correcting a few errors that have appeared in the media following launch of the Flibanserin trial data. Flibanserin is not the ‘female Viagra’ (despite the lead researcher for the Flibanserin trials using that term). Viagra works on the circulatory system and it increases blood flow to the penis. Flibanserin works on neurotransmitters and promotes feelings of desire.

Some media reports have suggested the drug will be on sale in two years time. This is also inaccurate. At this stage the drug is still undergoing trials and has yet to be approved for safe use. So there will be a period of time (unknown) before it becomes publicly available, and we have seen other drugs fall at this point if the FDA or EMEA don’t pass them for public use. If/when Flibanserin is made available it won’t be on sale or an over the counter product, but will be on prescription only. And in the UK this will be limited based on cost.

I’ve seen media coverage stating you take the drug when you want sex. This is also incorrect. Flibanserin is an anti-depressant style drug and to get any effects you have to take it daily for a set period of time. We don’t yet know what the side effects are from withdrawing from the drug, or long term use. But we do know it’s not a ’sex smartie’ to take when you want to have sex.

Obviously a lot of the coverage of the drug has raised concerns women have about desire and arousal. I’ve noted these worries and I’ll be creating blogs and handouts for the new year that address these issues. After all, there are many reasons women go off sex, and while a lot of them can’t be fixed overnight, many of them can be sorted effectively.

Let’s wait and see what happens with the development of Flibanserin. I’ll keep you updated on it, and I’ll be letting you know what other research on women and desire is coming out.

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.

Without further ado, let’s find out the answers to the questions I posed as part of the Science Late evening of sex event on Wednesday. How did you score?

1. What are the most common methods sex researchers use to study sex?
a. By looking – watching people have sex in a laboratory or on film
b. By measuring – assessing sexual behaviour via brain scanning, blood tests or heat sensors
c. By listening – recording answers from surveys or interviews
d. By participating – having sex with the people they are studying
e. Not sure

Correct answer = C

The most commonly used methods in contemporary sex research globally are surveys or interviews/focus groups. Brain scans, heat sensors or blood tests can be used, as can observational studies (where people have sex within laboratory settings). However, these latter two methods are used less as they’re often more difficult to recruit representative participants for studies. With the internet the opportunity for people to film their sexual activities and share those with researchers, and methods where participants film or document their own lives may become increasingly popular in the future. One thing we don’t do, but which people often assume happens, is have sex with the people we’re studying and then write about it. This would be considered unprofessional and unethical in research nowadays, and would focus the study on the researcher rather than a wide range of participants.

Want to find out more?
Check out the Kinsey Institute and the Magnus Hirschfeld Archive for Sexology who provide information about sex research being undertaken and provide answers to your frequently asked questions about sexual behaviour.

You might also find these guides helpful too:
Want to be in a sex study? Tells you about how sex research is conducted and how you can get involved

Sex research since Kinsey’s day – explains the different methodological approaches that can be used to study human sexual behaviour.

What’s it like to be a sex researcher? answers the frequently asked questions I’ve received about studying sex.

How to run a sex study outlines the steps you’d undertake to carry out a scientific study.

2. How often does the average UK couple have sex per week?
a. 7-10 times
b. 4-7 times
c. Once a week or less
d. Not sure

Correct answer = C

Robust and reliable research indicates that younger people do have more sexual encounters annually than older people. You can see links to research where frequency has been addressed here. The UK Natsal study found the average for heterosexual sexual activity per month was around 6 times. If you account for sexual behaviour over a wide range of ages the average is once a week or less. However, reputable sex research focuses more on quality rather than quantity. We would usually ask people for a range of sexual behaviours they engage in (masturbation, oral sex, intercourse) and whether they enjoyed them. That way you might find someone doesn’t report much ‘sex’ (as in intercourse) but they enjoy masturbation on a regular basis and are happy with this.

This contrasts with the media’s description of sex where ‘sex’ is usually only considered in terms of intercourse and quantity is taken as a measure of ‘great sex’.

Want to find out more?
Set yourself an experiment. Look at magazine or newspaper coverage of sex/relationships over the next month and see how ‘great sex’ is described. Is it written about in terms of exploration, variety and pleasure, or described in terms of quantity and penetration.

3. The average penis size is 5 inches long
a. True
b. False
c. Not sure

Correct answer = B

Many studies do give the average erect penis length as 5 inches. However, there are numerous problems with studies on penis size as they vary in the methods used to collect data. Some studies relied on self report, others on a researcher either measuring an erect or flaccid penis. Critical reflection on penis size studies suggest there are problems with the inconsistency of measuring penis size (summarized here). Interestingly research in this area suggests men (gay and straight) are more worried about length than girth, although women seem to be more interested in girth. And partners of men (male or female) are usually most bothered about their partner’s technique and the way they treat them. With anecdotal evidence suggesting men with larger penises don’t try so hard to please their lovers.

4. Women and men are equally stimulated by visual images of sex
a. True
b. False
c. Not sure

Correct answer = A

Women and men are just as likely to be turned on by visual images of sex. This may run counter to common knowledge of this issue, particularly since the media often repeats the idea that men are visual creatures and provide various evolutionary and biological explanations for this. What science is now discovering is that women, like men, do get aroused by sexual imagery. There is a diverse range of what turns women on – as with men. There is often the myth that women prefer erotica and men like porn, or women need their sexual imagery served up with a warm slice of romance. Yet studies where women have been asked about or shown sexual imagery suggest they do respond to a variety of arousing stimuli.

Interestingly many of the studies assessing response to visual images of sex (usually done through showing a series of images or sexual film clips and measuring genital response) did not include women. These were conducted on male participants (often undergraduate students) who were tested in response to viewing sexual images to see if exposure to said imagery had led to them feeling more hostile towards women.

More recent studies of women show they report enjoying a range of sexual imagery but do often worry more than men about the content of materials and how they’re made. Debates around the impact of porn, and whether the content is sexist, can often make women feel guilty for looking at/enjoying sexual imagery. Interestingly we’ve focused more on asking women critical questions about how they respond to porn than we have inviting men to reflect on their porn use.

Want to learn more?
Violet Blue’s written a fascinating book called The Ultimate Guide to Adult Videos which discusses how to pick porn to view, and answers some of the common concerns people have about content.

Alternatively there is a vigorous debate about porn/sexual imagery that’s ongoing. Some view porn as innately sexist and degrading to women, others feel it’s a symptom of a sexist culture but not a direct contributor to sexism/abuse. While some believe porn could help improve relationships, or at least has no harmful effects. You can find debates ongoing across different websites (particularly those with a feminist/political focus). Read up on the issues and see where you fit in.

5. Men can fake orgasm
a. True
b. False
c. Not sure

Correct answer = A

Men can, and do, fake orgasm. We don’t know exactly how many do this, but therapists and educators are increasingly hearing from men who are worried about faking orgasm. Reasons for doing so include being tired, sore, wanting to bring sex to an end, and not wanting to let a partner down. Men report feeling the need to fake because of pressure to perform sexually. It is unclear whether this pressure is experienced more or less acutely by straight or gay men. Interestingly, we tend to respond to women faking orgasm as being an inevitable (partly linked to the stereotype of women being less sexual). We tend to respond to the idea of men faking with disbelief or humour. This does little to help either gender if they feel the need to fake.

Want to find out more?
Comedian Richard Herring has written a great book called Talking Cock which although based on humour is a useful survey on male sexual behaviour and includes some discussion about faking orgasm.

If you’re a man and find it consistently difficult to orgasm it might be you have delayed (or retarded) ejaculation. More information about this condition and treatment options available here.

6. Men reach their sexual peak at 17 years old, women at around 40 years old
a. True
b. False
c. Not sure

Correct answer = B

Although this is often quoted in the media it doesn’t make sense in social research terms. The data seems to have come from surveys in the first half of the 20th century on sex where young men could record an interest in sex, but young women couldn’t. Culturally young women weren’t supposed to be sexual (particularly before marriage) and so either were unable to report on sexual behaviour, or were too afraid to disclose what they may have done. Older women who were married and had experienced sex were in a stronger position to report on their experiences. So early surveys measured behaviour and found younger men were able to report sex positively, as were older women. This is not the same as hitting a sexual peak during lifespan.

Although studies do still about that reinforce this myth or suggest particular ‘peak’ times for sex, reliable research suggests that rather than their being specific peak times for sex, there will be times when people enjoy, desire, and have sex more or less. This will be influenced by many factors including health, parenthood, financial security, relationship quality, and lifestyle factors (such as work stress).

Sexual activity may reduce as people age, and certainly we do see young people reporting having more sexual encounters. However, this does not mean the same thing as pleasure or desire or exploration. Older people do also report they may not have as much sex as in their youth, but the sex they have remains important and pleasurable.

Part of the misrepresentation of sexual behaviour across lifespan as having one off peaks is linked to the quantity over quality. A more accurate way of looking at this issue would be to see sex intertwined with other factors (listed above) and to expect points in your life when you’ll have no sex (with a partner), lots of sex, and occasional sex – with quality differing also.

Want to find out more?
Keep a diary for the next year and record when you had sex. Note periods when you enjoyed different sexual activities (masturbation alone, oral sex, intercourse), who you were intimate with, and when you were or were not enjoying sex to identify what else was happening. It might be something negative like being made redundant, or something positive like starting a new job where you put your energy into that activity.

7. Animals (other than humans) can be gay
a. True
b. False
c. Not sure

Correct answer = A

Homosexuality has been observed in numerous species from dolphins to monkeys, dogs to sheep. We have only recently begun to learn more about this topic as science has in the past often misrepresented homosexuality in animals, describing it as ‘immature sexual behaviour’ or reporting it as something that only happens because no other sexual partners are available. Or simply not discussing it at all.

Want to find out more?
The question of sexuality is one that fascinates people – and can be a reason for concern or celebration. If you want to find out more about your own sexuality why not try the Kinsey scale which gives you a score from heterosexual through to entirely homosexual. You can even get a t-shirt to proudly display your rating.

Within the scientific community we’re still debating homosexuality and for two differing takes on this issue you might consider Queer Theory which sees sexuality largely as a social construct or contrast this with Qazi Rahman and Glenn Wilson’s excellent book Born Gay.

There’s also widespread discussion about whether homosexuality can be ‘cured’. Evidence shows it cannot (because it’s not a disease or dysfunction). You might find these papers interesting – they feature interviews with psychiatrists and patients who were part of treatment programmes to ‘cure’ them of homosexuality.

8. Where do most people get their sex information from?
a. Friends and family
b. School/college sex education
c. Self help/sex experts
d. The media (magazines, films, television, internet)
f. Pornography

Correct answer = D

Most people do use the media, and particularly the internet (where available to learn more about sex). Friends can be highly influential, although more for young people than older adults. The self help/sexpert market (which often influences media content) is worrying given that many sex experts are not adequately qualified to discuss sex and relationships issues. Porn is not the first place people look for information, however evidence suggests it is somewhere people will turn to if they can’t find answers elsewhere.

Want to learn more?
If you want to find useful places to get quality sex information (aside from the links above), I’d recommend:
Paul Joannides – author of Guide to Getting it On
Cory Silverberg – who writes Sexuality About
Good Vibrations magazine
Dodson and Ross – sex tips, advice and information
DIY sex education from All About My Vagina
Susie Bright gives great sex advice over at Jezebel

9. What’s the most popular area in sex research currently?
a. Desire and pleasure
b. Sexual problems
c. Sexuality
d. Sex addiction
e. Love, romance and courtship

Correct answer = B

The most funded and most prolific research globally focuses currently on sexual problems. That’s things like sexual dysfunctions and sexually transmitted infections (particularly HIV). While these are issues requiring investigation, there are problems about other issues such as love and romance, desire and pleasure receiving far less attention. In particular concerns have been expressed about the ‘medicalisation of sex’ (for women and men) and the way sex research has been influenced by pharmaceutical funding.

Campaigners working within sex research are working to try and broaden the range of topics studied in this area, but limitations around funding and academic priorities do still influence what gets studied. This is a problem since many members of the public have many unanswered questions about sex which are currently not being addressed.

Interestingly, the area of sex addiction is hyped up a lot in the press but is not being researched to the same degree within academia/therapy. That’s because the concept is not agreed upon by practitioners. You can find out more in this great discussion between Susie Bright and Leonore Tiefer on the topic, or see just how problematic the diagnosis of sex addiction is in my blog ‘Help! I’m a sex addict and I didn’t even know it’.

10. Why do sex researchers study sex?
There are numerous reasons why we study sex. To find out more about human sexual behaviour, to get people answers to questions they have. To reduce problems – STIs, anxieties, fears. To promote sexual pleasure. Or to encourage abstinence (not all sex researchers are sex positive). Some sex researchers are motivated to research sex because they want to offer help, to share pleasure, or to learn more about themselves. Some may have had a personal experience (positive or negative) that’s motivated them to study a particular area of sex.

As part of the Science Museum event I asked guests to share why they thought we studied sex and I’ll blog all their ideas next week – along with some updates from real life sex researchers about their motivations.

So, are you a sexpert? You may have scored well or badly on this test. It doesn’t really matter. Many of the questions were deliberately tricky. Hopefully what the test has revealed to you is that there’s a lot more to sex research than you may have imagined, it’s an area that spans many academic areas (science, medicine, history, anthropology and zoology to name a few). It’s a growing subject area and one with a real application to human life. By continuing to read up on sex (using some of the links above) and ask questions about all the sex stories you read in the press (and anyone who calls themselves a ‘sexpert’) you’ll be well on the way to sexpertise.

If you work in science communication, sex research or sexual health you are welcome to use this quiz (and answers) in your own activities (with acknolwedgement). Please do research all answers before presenting to ensure you fully understand topics, and perhaps you can bring in questions and resources of your own to add to the quiz.

Last night the Science Museum in London hosted one of its fabulous ‘Lates’ events. The theme of the evening was ’sex and science’ and there was a great range of things to do. From learning more about yourself in the ‘who am I?’ tour, through to speed dating, finding out about the history of sex toys, salsa dancing, an experiment in ‘dance, hormones and sexual selection’ and some sexy punk science. Condoms were available to all guests, just in case things got extra fruity, and judging by the amount of drink and giggling going on I think people had a good time

I hosted a talk called ‘So you think you’re a sexpert?’ where we took 10 commonly asked questions about sex or commonly quoted sex ‘facts’ and put them to the test with some interactive voting to find out how smart our audience were about sex.

I’d like to give a great big thank you to everyone who came to Science Lates last night. I thought it was a novel way to share science, and the range of talks/events going on ensured we could create a balance between the fun and frisky and the serious and scientific.

For those of you who weren’t able to make it, I’ve reproduced the ‘So you think you’re a sexpert?’ quiz below, and I’ll give you the answers tomorrow, along with incorporating questions from the audience last night.

1. What are the most common methods sex researchers use to study sex?
a. By looking – watching people have sex in a laboratory or on film
b. By measuring – assessing sexual behaviour via brain scanning or heat sensors
c. By listening – recording answers from surveys or interviews
d. By participating – having sex with the people they are studying
e. Not sure

2. How often does the average UK couple have sex per week?
a. 7-10 times
b. 4-7 times
c. Once a week or less
d. Not sure

3. The average (erect) penis size is 5 inches long
a. True
b. False
c. Not sure

4. Women and men are equally stimulated by visual images of sex
a. True
b. False
c. Not sure

5. Men can fake orgasm
a. True
b. False
c. Not sure

6. Men reach their sexual peak at 17 years old, women at around 40 years old
a. True
b. False
c. Not sure

7. Animals (other than humans) can be gay
a. True
b. False
c. Not sure

8. Where do most people get their sex information from?
a. Friends and family
b. School/college sex education
c. Self help/sex experts
d. The media (magazines, films, television, internet)
f. Pornography

9. What’s the most popular area in sex research currently?
a. Desire and pleasure
b. Sexual problems
c. Sexuality
d. Sex addiction
e. Love, romance and courtship

10. Why do sex researchers study sex?
This was an open-ended question we gave to the audience last night. I’ve got all their answers to sort through and I’ll be posting those in a blog next week, along with some answers from real-life sex researchers and educators.

Come back tomorrow and you can find out whether you’re a sexpert, and learn more about each question.