Female Viagra sounds like the answer to our prayers: a little pink pill to put you in the mood, just as the little blue pill does for men.
The drug looks set to be approved for women suffering from low libido, clearing a major hurdle with the US medicines regulator earlier this month.
But it’s not the first time the pharmaceutical company that makes the little pink pill has tried to get its likely-lucrative pill approved (Flibanserin was rejected in 2010 and 2013 because the benefits were not deemed to outweigh the health risks) – and questions remain about potentially over-medicalising female sex drive, which is far more complicated than that of a male. Clair Weaver reports.
Belinda’s sex life has dried up.
It’s not that the vivacious 32-year-old marketing executive is no longer attracted to husband Matthew – rather her libido has waned since the birth of baby Oliver eight months ago, as she juggles a new life of feeds, nappy changes and interrupted nights.
“This probably sounds terrible but I’m just not interested in sex anymore,” Belinda says. “Once my head hits the pillow, all I want to do is sleep.”
Before their wedding two years ago, the couple enjoyed an active sex life with compatible levels of desire. Post-honeymoon, however, they sank into a more predictable routine and lost some of their spontaneity.
During her pregnancy, Belinda’s sexual urges declined as her belly grew so the couple put passion on the backburner as they awaited the birth of their first child. Nine months later, sex is the proverbial elephant in the bedroom.
This sudden loss of libido has taken both of them by surprise.
So is Belinda normal? Or is she suffering from a medical condition known as female sexual dysfunction (FSD) that should be treated with a pill?
The latter is the multi-million dollar question to which pharmaceutical companies would undoubtedly reply with a resounding yes. For they are locked in a fierce battle to create the first clinically-proven and government-approved female version of the blockbuster drug Viagra.
But first they must do one thing: convince a large proportion of the female populations that they have a problem.
It is this almost paradoxical strategy that has engrossed Ray Moynihan, author of Sex, Lies and Pharmaceuticals ($27.99 Allen & Unwin). “The drug companies see [female sexual dysfunction] as the new billion dollar market,” he says.
“But a lot of women are really cynical about this very corporate attempt to turn a very common sexual difficulty into a medical condition.”
Among unsuccessful contenders so far have been Pfizer’s Viagra, which was no more effective than a placebo in women; Procter & Gamble’s testosterone patch, which relied on weak evidence and risked side-effects like hair growth, voice deepening and heart disease; and Boehringer Ingelheim’s Flibanserin, which proved unconvincing and left some feeling dizzy, nauseous and anxious (rejected in 2010 and 2013 – but looks set to be approved in 2015 after a controversial positive recommendation by the US medicines regulator’s expert panel).
Whether our medicine makers can produce this elusive female sex pill – and it’s by no means certain given the many complex factors at play in determining a woman’s libido – remains to be seen. In the meantime, we are likely to be administered a continuing flow of “education” about a condition that allegedly afflicts nearly half of the female population.
“Female sexual dysfunction can become a problem for almost any woman at any age,” booms an online hormone prescribing firm. “With over 50 per cent of women never achieving climax and a high percentage having a severe lack of libido, the focus has now been shifted [from men to women].”
The creation of new diseases by pharmaceutical companies isn’t new. Back in 1921, a leading mouthwash manufacturer introduced the term “halitosis” in a bid to medicalise bad breath, thus fuelling demand for its antiseptic product.
What has changed is the scale and sophistication of the phenomenon dubbed “selling sickness” (also the title of an earlier book by Moynihan, published in 2005). These days, the pharmaceutical industry is constantly coming up with innovative new ways to inflate the size of its market for drugs by publicising conditions you may have otherwise have never realized you had, while simultaneously broadening their definitions to include more people.
“It’s endemic really,” says Professor Jon Jureidini, of the Adelaide-based global advocacy organisation Healthy Skepticism. “I would have thought it’s on the agenda for every disease group or drug group that a pharmaceutical company has an interest in.”
Because pharmaceutical companies are forbidden from advertising drugs directly to consumers in Australia, he explains, they spend their budgets on “raising awareness” of the conditions they are designed to treat instead through public campaigns. At the same time, they are permitted to target doctors with branded advertising for the supposed cure to these conditions and entertain them at lavish information events. Even the medical profession is not immune to clever marketing.
Take pre-menstrual dysphoric disorder (PMDD), for example, a relatively new illness described as a severe form of PMS. After the monthly malady controversially secured official recognition in the psychiatric bible the Diagnostic and Statistical Manual of Mental Disorders (DSM), drug company Eli Lilly won approval for its top-selling antidepressant Prozac to be used as a treatment. But instead of marketing it as Prozac for women with PMDD, the firm renamed it Sarafem and put it into a female-friendly box.
Inside, the pill – fluoxetine – was exactly the same.
“By changing the brand name from Prozac to Sarafem – packaged in a lavender-coloured pill and promoted with images of sunflowers and smart women – Lilly created a brand that better aligned with the personality of the condition for a hand-in-glove fit,” comments pharmaceutical marketing specialist Vince Parry in Selling Sickness.
The move backfired, however, when Lilly was reprimanded by the US drugs regulator for an over-zealous advertising campaign, depicting a woman struggling with a shopping trolley, that asked: “Think it’s PMS? It could be PMDD.” Sarafem was eventually sold off to another drug company, where sales have slumped.
Today in Australia, women diagnosed with PMDD may be treated with antidepressants under the brand names Prozac, Zoloft and Lovan or with the contraceptive pill Yaz.
The problem with PMDD is that many of us experience uncomfortable symptoms such as bloating, moodiness and cramping before our periods.
And this may have a varying impact on our everyday lives. Some may forgo a swim, while others might argue with their partner or need a day off work to hibernate with a hot water bottle. But does this make it a medical condition? Or is it simply a normal part of our reproductive cycles?
Indeed, whether PMDD even exists is still under debate. In the US and Australia, it is recognized as a genuine condition. In Europe, however, it hasn’t been widely accepted as a diagnosis because of concerns women with less severe symptoms could be inappropriately prescribed anti-depressants.
Jureidini describes it as “spurious” at best, warning the severe premenstrual symptoms suffered by some women may in fact indicate a more serious problem that could be masked by drugs for PMDD.
Yet the pharmaceutical industry insists PMDD is a genuine condition that can be treated effectively, rather than letting severe symptoms mar women’s lives every month.
“It’s a severe form of PMS that affects about 9 per cent of Australian women,” a drug company says. “It’s debilitating.”
According to Moynihan, however, the line between what is normal and what is sick is being blurred with conditions like PMDD. “The emotional ups and downs preceding your period are no longer a part of normal life – they are now a telltale sign you could have a psychiatric disorder,” he says in Selling Sickness. And taking a pill for it is not without risk. “The antidepressants like Prozac that are being prescribed for PMDD carry many side effects, including serious sexual difficulties, and for teenagers an apparent increase in the risk of suicidal behaviour,” he adds.
It is these same anti-depressants that are being used to treat the phenomenon formerly known as shyness: “social anxiety disorder” (SAD). It used to be that shy people would avoid uncomfortable situations, take an assertiveness class or seek counseling. Today, though, they may instead be diagnosed with SAD and prescribed a pill.
When an overly-enthusiastic PR firm claimed one million Australians were suffering from social phobia or SAD in a bid to boost the market for Roche’s anti-depressant Aurorix at the dawn of the 21st Century, the campaign backfired spectacularly.
Official government estimates put the figure at a third of that or less. Embarrassingly, Roche was unable to recruit enough genuine sufferers to conduct a clinical trial.
The Australian Government’s National Prescribing Service recommends doctors first try non-drug strategies for SAD if available before introducing anti-depressants for six to 24 months.
But it notes: “Up to 40 per cent of patients relapse 6 to 12 months after stopping drug therapy”, potentially creating future need for more pills.
Further boosting demand for this top-selling group of pharmaceuticals is depression, which affects one in five Australians, according to the national depression initiative beyondblue.
But Moynihan fears the definition of sickness is being moved too far into the realm of ordinary blues. In Selling Sickness, he recounts a father named Tom Woodward telling how his daughter Julie was diagnosed with depression and prescribed Zoloft after a normal bout of teenage troubles following her final school exams. A week after starting on the drug, she hung herself in the family garage.
“Instead of picking out colleges for our daughter, my wife and I had to pick out a cemetery plot for her,’ Woodward said, his voice full of sadness and anger. ‘Instead of looking forward to visiting Julie at school, we now visit her grave.” In Australia, meanwhile, the volume of anti-depressants prescribed for young people increased tenfold between 1990 and 2000 alone.
Nevertheless, a simple chemical solution may seem more appealing than months of talking and behavioural therapy. “There certainly is a kind of quick fix mentality and that comes from a deep sort of love affair we have with technology, science and innovation,” says Moynihan. “The idea of someone handing us a panacea in the form of a pill is an attractive one – but for many problems, the idea that a pill can fix it is absurd.”
It also means taking a problem out of its all-important context, where the root causes may well be hiding. Giving a woman a drug for FSD, for example, means looking at a sexual problem in physical isolation – when the real issues and answers may lie in her relationship, body image, hormonal cycle or past.
For some people, having a named disorder and a pill may be reassuring and make them feel special or validated. “If people are hurting or suffering, they don’t necessarily want to be told that’s just ordinary life, you will be fine,” says Moynihan. “I think some people like the idea that their problem could be described with a medical label because that brings attention, sympathy and the recognition of the medical world. It legitimizes their pain and suffering – they don’t feel it’s in their head or they are making it up.”
Such may be the case for some sufferers of stomach problems who are diagnosed with irritable bowel syndrome (IBS), which some drug companies estimate affects up to 20 per cent of the population. In reality, it is likely to be a far smaller minority that suffers the most severe gastrointestinal symptoms. Soberingly, Moynihan reports GlaxoSmithKline’s IBS drug Lotronex has two potentially fatal side-effects: severe constipation that risks perforating the bowel wall and ischaemic colitis, which is like “a heart attack happening in the bowel”. This has led to doctors being urged to use even the reduced-dosage version with “great caution”.
“A common problem is the way in which risk factors are turned into diseases,” says Moynihan, citing osteoporosis as “a risk factor for a fracture” rather than a brittle bone disease in itself. As we get older, our bones inevitably become thinner but not everyone’s will break. With public awareness campaigns warning us one in three women will get osteoporosis, many of us will pop calcium supplements or end up taking strong drugs with significant side-effects in a bid to stave off this dreaded disease. But the benchmark against which women’s bone density is being measured against is hardly realistic: it’s that of a 30-year-old. “There’s been a marketing of fear in relation to osteoporosis,” says Moynihan, condemning it as “pharmaceutical propaganda”.
Moynihan says he doesn’t deny some of our modern conditions are genuine and drugs can be useful – but he does continually question where the cut-off lines for diagnoses are.
Despite his concerns about FSD being promoted as a 21st Century epidemic, Moynihan is optimistic that many women have a self-awareness that will prevent them unquestioningly swallowing drug industry bait. “A lot of women realize the sexual changes, difficulties or dissatisfactions in their lives are a lot broader and more complex than a medical label and that the solutions are a lot more complex than a simple pharmaceutical,” he says.
On a more general front, Moynihan wants the Federal Government to crack down on doctors who accept funding and hospitality from the pharmaceutical industry. And he urges us as patients to feel empowered to question whether a diagnosis or prescription is appropriate. “I think we would all be a lot healthier if we were a bit more skeptical about labels our GPs and pharmacists give us,” he says.
The publication of his latest book may be a headache for the pharmaceutical industry, which is nevertheless in no danger of collapse. “Moynihan is a sensationalist – he’s overblowing it,” says the drug company source. “When you are talking about medication, it’s a competitive industry and with pharmaceutical companies, there are a lot of ‘me too’ drugs. But we really are trying to meet medical need.”
As for Belinda, although she remains worried about her diminished sex drive, she isn’t yet convinced she has a medical disorder either.
“My friends have told me it’s normal after having a baby,” she says. “Hopefully my libido will come back as our life settles down.”
And if it doesn’t? There’ll be a pill for that.
This story was originally published in The Australian Women’s Weekly magazine.
