Does women's sexual dysfunction really exist? And would female Viagra make any difference?
According to some accounts almost half of all women suffer from sexual dysfunction. But does it really exist? And would a female Viagra make any difference?
In 2001, filmmaker Liz Canner was asked by American pharmaceutical company Vivus to help with trials of a new drug. Alista was a topical cream designed to remedy sexual dysfunction in women. It was branded, breathlessly, as an "orgasm cream". Canner was commissioned to edit a series of erotic videos which would be shown to women participating in early clinical trials. She was perplexed, enthralled, a little appalled. "How could I take this job? How could I not take this job?" she says. Ultimately, she agreed. She was interested in the nature of female desire, and a little weary of making films about genocide and human rights violations. She had also gained permission from Vivus to make a film study of the process.
Through the course of her involvement with the Alista trials, Canner became confused about the nature of female sexual dysfunction (FSD). She hadn't really come across the term before she began working with Vivus and yet the more she heard it invoked the more confused she became. Canner extended the lines of her enquiry beyond Vivus, and ended up devoting much of the next nine years to her film Orgasm Inc – a jewel of a documentary intended, Canner says, to: "Document the medical industry's attempt to change our understanding of the meaning of health, illness, desire and that ultimate moment – orgasm." In it, Canner meets the CEOs and marketing heads of different drug companies, and she meets doctors, scientists and therapists, all of whom are working frenziedly toward producing and flogging the key to the ultimate female sexual experience. She meets the campaigners who rage against the attempts to control and medicalise women's sexuality. Most effecting of all, Canner meets the women who suffer – or who think they suffer – from FSD. She meets Charletta, a middle-aged woman – who says that when she thinks about orgasms, she thinks in terms of "the war – the war inside my head…" adding, "Not only am I not normal, I am diseased." Canner accompanies Charletta on an appointment to see a doctor who inserts electrodes into her spine. This is a device Stuart Meloy MD calls his "Orgasmatron", once it's in place he promises Charletta will orgasm spontaneously any time she wants. It doesn't happen. The Orgasmatron does, however, make her left leg twitch wildly.
The world's pharmaceutical companies have been consumed by the race to find a remedy for female sexual dysfunction ever since the late 1990s when Pfizer gained FDA approval for Viagra. Viagra – so very effective in the treatment of erectile dysfunction in men – has proved to be a "blockbuster" drug: a billion-dollar-generating marvel of a product. It worked, it changed lives; it was a sexy drug, in every sense of the term. It became clear that there was a great deal of money and power in the field of sexual dysfunction. Money and power that could be multiplied, if the market were expanded – which it would be, if pharmaceutical companies could sell drugs to women, as well as men.
Vivus had a particular interest in tapping the market. In 1996, 14 months before Viagra launched, Vivus gained FDA approval for Muse – a suppository which, when inserted into the male urethra shortly before sex, improved blood flow to the penis thus alleviating the symptoms of erectile dysfunction. Muse did extremely good business, until Viagra launched. It had sales of $130m before Viagra, and $59m in the year afterwards; these figures have dwindled ever since. Men preferred a pill to a suppository and abandoned Muse en masse.
Around the same time, Leland Wilson, president and director of Vivus, gave a TV interview about sexual dysfunction and mentioned in passing that his company was working on concepts for drugs for female sexual dysfunction. The stock price of Vivus went wild in response; Vivus begun working in earnest on Alista. Pfizer, meanwhile, began working hard on discovering whether Viagra might work for women as well as men; Procter & Gamble began working on a testosterone patch called Intrinsa. Darby Stephens, Vivus's manager of clinical research, estimated that at the time her company was working on Alista some 12 pharmaceutical companies in total were developing alternative cures for FSD. "We are on a race to see who can be first to market," she said. Canner called it a gold rush.
All of which would be fine if anyone knew exactly what FSD was, whether or not it truly exists and what curing it might entail. At the beginning of Orgasm Inc (subtitled The Strange Science of Female Pleasure), Virgil Place MD, the founder of Vivus, addresses a meeting of his employees. "What does the name of the company mean?" he asks. "It's Latin for 'alive'. I had the feeling that our objective was to put the life back into dead penises."
Place is playing for laughs – but he draws attention to a significant issue. We know what a "dead" penis looks like – and so we know what male sexual dysfunction looks like. We equally know an erect penis when we see one, and so we have a decent measure for the efficacy of a drug designed to treat erectile dysfunction. But it's much harder to quantify FSD. What is sexual dysfunction as far as women are concerned? Really? It's categorised medically as a lack of arousal or desire to have sex; dyspareunia (pain or discomfort during intercourse), diminished blood flow to the vagina, and an inability to achieve orgasm.
It first began appearing in medical dictionaries in the 1970s, but started garnering serious attention and press in the late 1990s. Nothing obvious provoked the ratcheting up of activity around FSD – there were no major new discoveries regarding women and sexuality. All that had happened was Viagra – Viagra, and a 1999 survey which claimed that 43% of American women suffered from FSD. FSD was, Oprah Winfrey declared on learning of the survey: "A secret epidemic!" But really? Could 43%, almost half of American women, and by extension almost half of us, actually be suffering from a disease without realising it?
What do we even mean by a "lack of desire"? How do we know that lack of desire is a medical condition, as opposed to a condition relating to the fact that we just don't fancy our partners any more? Or that we're not feeling especially sexy temporarily, for any number of other reasons. How we feel about our bodies, or how tired we are, how stressed, how anxious, how fat we feel… Between 80 and 90% of women, after all, are believed to have body-image issues. And if FSD equates to a lack of arousal – how much arousal is normal arousal? What's the end goal for medication? Loads of orgasms? Constantly desiring our partners, feeling constantly available to them?
What's a normal sex life, anyway? Anyone? Three times a week, three times a month? Three orgasms, each and every time? Who has the right to tell us we're not measuring up? How do they know? Are the attempts to treat FSD about helping women; about a woman's right to a fulfilling sex life? Or are they about the drug companies' attempts to medicalise female sexuality for financial gain?
These are the issues at the heart of the battle to cure FSD; the issues with which Canner collided when she began working with Vivus.
Canner was genuinely surprised Рshe didn't set out to make a raging polemic of a film. "I didn't want to do an expos̩ on a drug company," she tells me in a phone call from her home in Vermont. "Orgasm Inc wasn't the film I'd planned to make. I wasn't trying to catch these guys out. It's just that when I started watching the footage back, I realised their discomfort."
Canner is no Michael Moore. She doesn't rage or scoff or mock. She doesn't condemn. She isn't fuelled with self-righteousness and fury. She doesn't contrive showy stunts to make her point. The Vivus portrayed in Orgasm Inc doesn't seem craven, or cynical and money-minded. It is laid back and boisterous, the walls of its light, cheery offices in Mountain View, California, are covered with line drawings of rhinos in profile. Its employees are affable, self-effacing and fun. They eat ice-cream sundaes at their meetings and are truly convinced that they're working for the greater good of womankind.
Yet Canner does expose Vivus, along with the rest of the pharmaceutical industry. She does this simply by asking reasonable questions of the right people. "How will you know if a woman has been cured by Alista?" she asks Virgil Place. "Er… we're dependent on… a diary, or questionnaires," he responds. "And how did female sexual dysfunction come to be seen as a disease?" "We don't know." "What about orgasm?" she asks of Leland Wilson. "Er… well, interesting equation here, that increased blood flow [Alista's function] hasn't been conclusively shown to cause orgasm," he replies. "How did your company come to start working on FSD?" to Craig Peterson, director of clinical research. "I don't want to go there," he says. "And is there anything organically wrong with these women, that Alista will address?" to Virgil Place, again. "I er… I can't answer that question."
"I do believe that this is not a completely made-up condition," Canner tells me. "I think a small figure are genuinely affected and I think it's a debilitating, difficult thing. I think there are also hard medical conditions that affect sexual function. Hysterectomies, diabetes, antidepressants… But as for this 43% figure – I think that's a marketing term. It's nowhere near that much. Nowhere near."
Last month, the Royal College of Obstetricians and Gynaecologists held its first ever conference on FSD at its glossy headquarters off Regents Park in central London.
The day-long event is entitled "Female Sexual Dysfunction: Myth or Reality?" and is attended by some 200 healthcare professionals – and me. A series of 18 speakers from different relevant fields presented their ideas on, and experiences of, treating the condition.
I sit in and gain a variety of terrifying and funny insights into the world of gynaecology: among them, gynaecologists are endlessly amused by ongoing evolutions in bikini waxing (as I always suspected). I also get some background on the history of attempts to medicalise female sexual function. According to Professor John Studd of Imperial College London, 19th-century middle-class women believed to be suffering from anything from PMT to nymphomania were routinely subject to clitoridectomies. Later, Professor Linda Cardozo will compare genital mutilation and the contemporary craze for vaginal rejuvenation, elective surgical procedures often performed in the interest of improved sexual response.
Along with the rest of the auditorium, I complete a questionnaire intended to determine whether I am suffering from FSD Рthe kind of survey researchers have used to establish how widespread the condition is Рand I realise how limiting the questions can be. For example, many of them relate to the degree of desire a patient is feeling (or not feeling) for their partner; rather than asking, for example, how much desire the patient is feeling for Jos̩ Mourinho or Robert Pattinson; or the bloke she fancies at work. "Who are these questionnaires designed by? For whom? With what aim?" asks Claudine Domoney, chair of the Institute of Psychosexual Medicine, London.
I learn that in the UK, doctors are not super-keen to treat FSD. There's a sense that they would be opening a can of worms; there's concern over the financial implications to the NHS (current estimates suggest FSD would cost around £472 per patient). Every fifth presentation features illustrative images of a simple on/off switch intended to represent male sexual function, and a complex control panel of slides, nobs and buttons for women. I find myself becoming annoyed at the implication women are just so complex sexually, really – what can we expect other than to fail to be adequately turned on from time to time?
After lunch, gynaecologist Dr Nick Panay speaks in glowing terms of the potential of Intrinsa – a testosterone patch developed by Procter & Gamble which is, to date, the only medication to have gained approval for use in Europe (nothing, not Alista nor Intrinsa, nor any other drug, has gained FDA approval for use in the US) – and is designed specifically to treat women who have had an early menopause as a consequence of hysterectomies.
I leave the conference with a sense that, generally, British healthcare professionals believe in FSD, and are keen to see it more widely recognised and treated in this country, although they're as invested in couples therapy and psychosexual treatment as they are the pursuit of a female Viagra.
Perhaps Liz Canner and Orgasm Inc has it wrong, then. Perhaps not.
The British Medical Journal suggests I speak to an investigative journalist named Ray Moynihan about his research into the treatment of FSD. Moynihan published his first article on the subject in 2003 in the BMJ. It was entitled "FSD, The Making of a New Disease" and it caused uproar internationally, sparking the debate on whether or not FSD exists. Moynihan was inspired to write the article after a friend sent him a press release on Alista. Like Liz Canner (who interviewed him for Orgasm Inc), Moynihan discovered he couldn't easily move on from the subject; seven years later, he has just completed a first draft of a book devoted to FSD. "Its working title," he tells me, "is Sex, Lies and Pharmaceuticals."
Moynihan is at home in Byron Bay, Australia, when we speak. He's just come in from a salsa class. I ask him if FSD exists, and he laughs.
"That's the $1bn question. That's the question the book asks. Let's just say: it's a good question to be asking at the moment. It's a good question for as many people as possible to ask – and particularly women."
Moynihan explains that while researching the 2003 article, he was "stunned, shocked, surprised, bewildered by the intimate involvement of the [pharmaceutical] industry in every aspect of the science. We're not just talking about funding clinical trials. We're talking funding surveys of how widespread this thing is. We're talking funding questionnaires that help diagnose whether you have the disease or not. This is a classic case of medicalisation, of the medical profession expanding its empire, if you will."
So these kinds of sexual problems simply aren't real, medically speaking? I ask him. They've been manufactured to enable the invention of a cure?
"No. Of course they exist. Many sexual problems are utterly debilitating and can benefit from medical help and medication. My sense after having looked closely at this stuff… I'd say there would be a cohort of women for whom a medical label and medication would be absolutely appropriate."
So FSD exists, but just in a much smaller way than we are led to believe?
"Correct."
And the 43% figure?
"It's absurd and it's utterly wrong. If it's used to suggest that that many women have a medical dysfunction that would require treatment then that is absurd and that is wrong."
It should be said that so far, no one's come all that close to finding a drug, or nasal spray, or electrode insert, or topical cream or whatever else that might be compared to Viagra in terms of treating FSD. Procter & Gamble's "sex patch" Intrinsa, as I have mentioned, is approved for use in Europe only, and even then, only to treat premenopausal women who have had hysterectomies. Apart from that, no medication has got beyond clinical trial stage. Furthermore, none of them seem – to me – to do great business at trial. Efficacy of the drugs is measured in terms of increases in SSEs (Significant Sexual Events) which are defined as: "sexual intercourse, oral sex, masturbation or genital stimulation by the partner… [that] was satisfying for the individual, defined as gratifying, fulfilling, satisfactory and/or successful for the individual". At best, results obtained during trial represent a doubling of SSEs: a woman who takes a pill or attaches a patch to herself every day for weeks might go from experiencing one to two SSEs in a month. This is, it strikes me, not terribly impressive. As Dr Leonore Tiefer, founder member of campaign group The New View (strapline: Sex for our pleasure, or their profit?) points out: "One extra episode a month? I can help you with one episode a month! Come to one of our meetings. One extra episode a month is a homework assignment."
Yet drug companies persist in trying to find a cure for FSD. German pharmaceutical company Boehringer Ingelheim is currently working on clinical trials for Flibanserin, an antidepressant which seems to improve the sex lives of female patients. Participants in a trial reported an increase from 2.8 SSEs to 4.5 in a 24-week trial period; although participants who were taking a placebo reported an increase from 2.8 SSEs to 3.7, which would suggest that Flibanserin is responsible for delivering less than one extra SSE.
Pfizer's British outpost in Kent, meanwhile, has just released details of a prototype drug which aids blood flow to female genitalia, alleged to increase lubrication and sensitivity. Early press reports referenced the 43% of women who cannot get aroused during sex – and I found myself angry at how routinely those discredited stats are referenced.
I ask Canner and Moynihan what their biggest fears are for FSD. They both voice a concern that any drug will ever gain FDA approval. Because the United States allow pharmaceutical companies to market directly to the public through TV ads, once a drug gets approved for use in America, once marketing budgets, and by association general awareness of FSD is increased, then we'll potentially all be in the grip of a female sexual dysfunction epidemic, wherever we live. Beyond that: "The entanglement between the pharmaceutical industry and the medical profession is a serious threat to public health," Moynihan says. "There's no doubt about that. There's strong evidence that that relationship can harm the way doctors behave."
Because they prescribe unnecessarily?
"Because the closeness can lead to inappropriate prescribing, and a bias towards the latest and most expensive drug, when a non-drug therapy or an old cheap drug might be better. So you've got implications for individual health and you've got very serious implications for the health of the system, if we're wasting money on the latest product when something else might be more appropriate."
On the plus side, Moynihan says, the difficulties with FSD are provoking a larger debate about how entangled drug companies and doctors have become. "It's happening in Britain, it's happening in the US and Australia. It's slow and it's just getting started, and there's much more focus on disclosure rather than disentanglement, but I think one is going to lead to the other. We're not talking about separating the two spheres so that no one talks to each other. We want and need [them to talk to each other]. But the problem is that too often, when a group of doctors gets together, the drug companies are paying for the wine."
Canner, meanwhile, is concerned that cures for FSD focus on drugs that need to be taken every day on an on-going basis and consequently will affect our overall being. "And why?" she asks. "Because there's more money that way." Her "nightmare" is that a drug is released that ultimately proves harmful to women. And she's worried that the more we focus on fixing women medically, the less attention we'll give to their context, their relationships (which might be abusive), or their past (ditto); we should, she says, be thinking in terms of fixing society and not distributing pills to individual members. But "am I worried that they'll produce a pill that will turn us all into Stepford Wives?" Canner asks. "No, because I don't think they'll ever come up with anything that good."
In February 2010, a British helpline previously named the Sexual Dysfunction Association Helpline changed its name to the Sexual Advice Association. Subsequently, they experienced a steep increase in women ringing in. "It's an incredible range," says Ilaria Primoni, a helpline advisor. "These women can be in their late teens and early twenties. They can be thirtysomething women who have just had a baby. They can be post-menopausal women in their sixties. We hear from them all."
Primoni thinks increased awareness of FSD is inspiring these women to call in, which troubles me. How many of these women might think they were "just going through a bit of a phase" – a phase from which they'd surely recover, as opposed to suffering with an illness, if it weren't for the international branding of lack of desire as a disease?
Does Primoni think FSD is a real problem? "If people are calling me, then yes, it's a problem. It's a problem for them."
It turns out that it's also a problem for a friend of mine. S is a women in her early thirties who confides that she thinks she has FSD. I was beginning to wonder if it exists, I say. "It does!" she says. "For the past eight months, I haven't felt any desire. Nothing." She is, she says, happy with her husband. She's experienced work-related stress over the same period which she assumes is a contributing factor, but she is still profoundly unsettled by her lack of desire.
"It is as if my body isn't mine any more," she says. "It's been awful."
What did you do, I ask. "I Googled." She discovered, among other things, that desire can sometimes arrive for women after sex has been initiated. A woman might start having sex with her partner despite not feeling desire, because she doesn't want him to feel rejected, and discover that she gets turned on anyway. "Like when you think you don't want pudding; then you see someone else tucking into some cake, or ice cream, and you try a bit of theirs, and realise you really do want pudding after all," S explains. Furthermore: "I feel like I'm finally coming out of it. It's a massive relief."
So would S have taken a pill to reignite desire, had one existed, I ask. "Oh hell, no!" she says. "No way!"
It does seem that investigating alternative, non-medical treatments for FSD might be the best way forward. There has to be a place for vibrators, new lovers, S's pudding approach, porn, doesn't there? For better sex education in schools. Even for more realistic portrayals of the messy, unglamorous truth of sex on film and on TV.
Perhaps not thinking of FSD as a disease, not labelling it "FSD" even, might be our starter for 10 – unless we're dealing with those hard medical conditions that Liz Canner spoke of, or Ray Moynihan's "cohort of women".
Canner herself performed better than both Alista and Dr Stuart Meloy's Orgasmatron in remedying FSD through the making of Orgasm Inc. Participants in the Alista trials responded as well to Canner's erotic videos and a placebo, as they did to Alista. ("Yeah, so porn works," says Vivus's Darby Stephens, drily, shortly before an FDA panel did not approve Vivus's "orgasm cream" for use.)
And Charletta of the Orgasmatron and the twitching leg experience, is also somewhat "cured" by Canner. Charletta eventually explains to Canner that the orgasms she struggles to achieve are orgasms through penetrative sex. Canner asks her if she can orgasm in other ways. "Yes," says Charletta. "But that's not the normal situation where two people get together and have sexual intercourse and both orgasm." Canner explains that few women orgasm through sex alone. "Well then, you have absolutely washed the idea of what is normal out of my mind!" says Charletta. "And to heck with that disease stuff!"
To heck with the disease stuff, indeed. I am no kind of sexpert, but I'm pretty confident that whatever else may be going on with you sexually, thinking of yourself as diseased is not going to put you on a fast-track to orgasm.
