Sex, Lies, and Pharmaceuticals Ray Moynihan and Barbara Mintzes Greystone Books (2010) "We're hoping to be able to expedite the process. . . of disease development. . . " -- Drug company manager Darby Stephens The woman looking confidently into the camera lens must be in her late twenties or early thirties, her long black hair falling over strong shoulders, a slip of striped blue material tied into a bow around her neck. Her red lips and good looks are striking, but it's her words that are most captivating. Her name is Darby Stephens, and she's a research manager at a California-based drug company called Vivus. The company is testing a drug for women said to suffer from a new condition called female sexual dysfunction or FSD. As Darby Stephens explains in an extremely candid on-camera interview for a documentary, FSD is so new that the drug company itself has had to help work out what the condition actually is: 'In order for us to develop drugs, we need to better and more clearly define what the disease is,' she said. The frankness of the comments may be unusual, but the marketing activity being described is becoming commonplace. Pharmaceutical companies now assist in shaping the very diseases their drugs are targeting. Through its close ties to the medical profession and its influence over public debate, the industry is now helping to determine whether we see our sexual problems as every day difficulties or medical dysfunctions, and whether female sex drugs become a permanent feature in the bedrooms of our future. The Californian company where Darby Stephens was manager of clinical research had started testing a pharmaceutical cream for women to rub on their genitals, to see whether it could enhance blood flow and boost their level of sexual arousal. First you have to have a disease Before the drug testing could go into full swing, however, there was a problem that needed to be addressed. As Stephens tells it, in order to get a drug formally approved and have insurance companies pay for its use, it has to be shown to work against a specific medical condition: 'The whole thing is kind of complicated because you have to have a disease before you can treat it.' The difficulty with FSD was that no one was really certain exactly what the condition was, and some people even questioned whether it existed at all. So part of Vivus's role, Darby Stephens explained, was to sit down with the experts, the 'thought leaders' in the field, and work with them directly on developing this new dysfunction in order to be clearer about what it was. During her frank interview, she revealed that in the 'process of defining the disease, we've been able to get thought leaders involved in female sexual dysfunction, and really work closely with them to develop this disease entity, so that it makes sense'. Her comments were made at a time when drugs for male sexual dysfunction had already been approved, and billions of dollars' worth were set to sell every year. So from the industry's perspective, there was no time to waste in developing the sister condition for women. "We're hoping to be able to expedite the process of drug development and of disease development," she told film-maker Liz Canner during the interview for Canner's documentary Orgasm Inc. 'Condition branding' Bizarre as it may sound, the idea that a drug company would play a role in 'disease development' is backed up by observations from another industry insider, this one with expertise in the practice known as 'condition branding'. The advertising expert Vince Parry famously revealed how drug companies are sometimes involved in 'fostering the creation' of medical disorders, giving a little known condition renewed attention, helping redefine or rename an old disease, or sometimes assisting in the creation of a whole new one. The branding expert has said that as part of his high-level work for drug companies he will sit down with medical experts to try to 'create new ideas about illness and conditions'. As the Canadian writer Naomi Klein told us in her classic No Logo, corporations are no longer just selling products, they are selling brands, and brands are about lifestyles and concepts, not commodities. These revelations about drug company plans to accelerate the development of a disease, in order to test and sell drugs for it, herald the opening of a new chapter in the story of the modern medical marketplace, where the corporate sector now works together with leading medical experts to help tell us who's sick and who's in need of the industry's latest cures. But to what extent are women's problems of desire and arousal really the signs of dysfunctions, or rather common sexual difficulties being portrayed as diseases in order to sell drugs? One place to start answering the question is to take a closer look at the actual technical definitions of this new sexual dysfunction and its four sub-disorders. Just as some infectious diseases are technically defined by the presence of particular levels of antibodies in the blood, so too dysfunctions and disorders are defined by certain behaviours or characteristics considered abnormal. While we might imagine these medical definitions to be solid and certain, nothing could be further from the truth. This condition is poorly defined and its definitions are constantly shifting and moving—a fact readily acknowledged even by those who write them. Dr Sandra Leiblum, the high-profile psychologist from the Robert Wood Johnson Medical School with first-hand experience of revising the definitions, has eloquently described these shifting sexual sands: 'the classification of female sexual dysfunction', she wrote, 'is somewhat arbitrary, imprecise, and changeable'. One of the first things that strike you about this technical definition is that it comes from the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is produced by the American Psychiatric Association, the professional body representing psychiatrists. An accretion of maladies When it was first released in the 1950s the Diagnostic and Statistical Manual of Mental Disorders was a small book, but it has become a giant text running to almost 1,000 pages, full of many different disorders. While it was an American creation, it is now highly influential around the world. As some readers will already know, the DSM is seen as something of a bible of diseases by many doctors; however, it is also regarded as controversial, coming under heavy criticism for turning the experiences of ordinary life into the signs of medical illness. In its pages, severe pre-menstrual pain has become 'pre-menstrual dysphoric disorder', a set of common children's behaviours re-packaged as 'attention deficit hyperactivity disorder' and extreme shyness has been transformed into 'social anxiety disorder'. The DSM has also been criticised for the closeness between the expert committees who write the definitions of diseases and the pharmaceutical companies that sell the drugs prescribed to treat them. One study that looked closely at the affiliations of the men and women on those committees found that more than half of them had ties to drug companies. On the committees revising mood disorders, including depression, the figure was closer to 100 per cent. It was only as recently as the 1980s that the term 'sexual dysfunction' first appeared in the DSM though sexual 'disorders' had been previously listed. Since then, the definitions have changed a number of times, as the manual has been updated and new editions have been published. The details of the most recent definitions now run to many pages, but in simple terms the condition known as female sexual dysfunction, or FSD, has been divided into four sub-disorders: desire, arousal, orgasm and pain. The disorder of low desire is defined as a deficiency in sexual interest or fantasy, and technically described as 'hypoactive sexual desire disorder', or HSDD. Arousal disorder is described as inadequate genital lubrication and swelling, in response to sexual excitement. It is termed 'female sexual arousal disorder', or FSAD. 'Female orgasmic disorder' is the label attached to a woman whose orgasms are delayed, or who is unable to reach them. Pain disorder involves pain associated with sex, problems also known as dyspareunia or vaginismus. One of the criteria for each of these disorders is that women must be distressed or bothered by their situation in order to qualify for a formal diagnosis from a doctor. Using these definitions as a foundation, different groups have revised and rewritten their own versions, as researchers struggle to find the words that accurately describe what goes wrong for women sexually. As to the causes of this 'dysfunction', the conventional medical view readily acknowledges that psychological and social factors play a big role in sexual difficulties. A woman may, for example, lose interest in sex when she's grieving the loss of a loved one, or if she's been sexually assaulted. Couples can also grow apart over time, and it may be difficult to talk about what’s happening in a relationship. But the medical view is also highly interested in what are regarded as possible biological causes: problems with blood flow to the genitals, low testosterone levels or chemical imbalances in a woman's brain. Many researchers have been content to work with the existing definitions of the four sub-disorders in the DSM, and to tinker with them occasionally to try to make them more accurate. Some have suggested the need for a major overhaul of the way the condition is defined. Others claim FSD and its four sub-orders simply don't exist as they are defined, and the DSM approach to classifying women's sexual problems is fundamentally flawed. The 'New View' Sex therapist and academic Dr Leonore Tiefer and other experts have argued that the definitions in the psychiatrists' manual are unhelpful because they're far too narrowly focused on problems relating to 'function'. They say the definitions fail to place a woman's sexual problems in the broader context of her life, her relationships, and the wider society and culture in which she lives. The grass-roots campaign Tiefer has helped create, called the New View, has proposed and published an alternative approach, complete with books, a website and an active global list-serve. According to the New View definition -- written by a group of psychologists, academics and experts in women's health -- women identify their own difficulties, which are defined as 'discontent or dissatisfaction with any emotional, physical, or relational aspect of sexual experience'. Unlike the definitions in the DSM, this approach puts more emphasis on trying to understand the causes of a woman's sexual dissatisfaction, and on attempting to prevent them if possible. The differing approaches reflect a longstanding tension in the world of psychiatry and psychotherapy between those more interested in uncovering the root causes of problems, and those with an emphasis on describing and classifying the symptoms. In sharp contrast to the more medical view favoured by drug companies, Leonore Tiefer doesn't generally see sexual problems as individual dysfunctions that can be fixed with medications—though she and her colleagues are not opposed in principle to the idea of drugs, if safe and effective medicines emerge. Under the New View's alternative approach, the causes of women's sexual difficulties are divided loosely into four categories. The first includes the broad factors at play in a society that impact on sexuality. These are the religious taboos that breed shame about our bodies, the cultures that help create our inhibitions and the economic factors that leave many women exhausted after combining work and family obligations. The second category of causes includes factors relating to partners, including the common mismatch in the level of desire between partners and other relationship difficulties. The third category is when sexual problems arise from psychological issues, like past abuse or depression. The fourth and final category is when sexual difficulties arise from medical causes, like nerves being damaged in surgery, or the harmful sexual side-effects of anti-depressant drugs, which can impair a person's ability to orgasm. These four categories are not mutually exclusive, and an individual woman's difficulties may well be caused by a complex interaction of more than one factor. While it rejects the idea of a widespread dysfunction, there is no sense that this approach plays down the distressing or debilitating nature of these problems for some women. The tune the New View is singing is clearly not music to the ears of drug companies, whose pills can do little to change religious taboos or relationship woes. Portraying a sexual problem as an individual woman's failure to 'function' makes a drug solution much more appealing. A perspective that puts women's difficulties firmly in the context of their life and loves, their cultures and societies is far less valuable to those trying to promote new medicines.