Millions of us may now be deceived into taking a drug that doesn't work much better than a glass of wine or two. Photo / iStock.
In 1998 I hosted a lunch for Erotic Review magazine, where an ebullient barrister (now judge) turned up rattling a bottle of bright blue pills. "Black market Viagra!", he announced, with a glint in his eye. "Who wants one?" Most of the men present accepted this gracious offer, while the women said no. As my colleague Annie said drily, "It doesn't really get the lasses going, does it?"
Viagra was, of course, tested on women, but there was no significant increase in erotic va-va-voom. Male and female genitalia may both have increased blood flow during arousal, yet Viagra's ability to dilate blood vessels in the penis and enhance erectile function, leading to more "sexually satisfying events", has not been shown to have a corresponding benefit for women. Why? Because, to the surprise of pretty much nobody at all, it was found sexual function, or dysfunction, in female patients has as much to do with the mind, as the workings of the body.
Fast-forward to this month, however, and the US Food and Drug Administration (FDA) looks set to follow its advisory panel's lead in approving Flibanserin - dubbed "female Viagra" by the press - making it the first officially sanctioned drug for the treatment of hypoactive sexual desire disorder, or HSDD (the natty new terminology for female sexual dysfunction), and paving the way for its arrival in the rest of the world.
Likening the pill to Viagra is misleading, however, as the little blue rhombus has a measurable effect on the body's hydraulics, while Flibanserin tinkers with the chemistry of the brain.
Hardly surprising, as it was originally developed as an antidepressant. Then some of the women who were subjects of clinical trials reported slight increases in "sexually satisfying events" - in other words, any form of sexual act deemed gratifying by the participant, regardless of whether they reached orgasm or not. So the parent company, Boeringer Ingelheim (who later sold the drug to the drug company Sprout, after failing to get it past the FDA), started concentrating its efforts on these supposedly sexy side-effects.
No one was completely certain how this enlivening effect was produced, but researchers surmised the drug modified the effect of the neurotransmitters dopamine and norepinephrine (key agents in the process of arousal), while curtailing the sexually inhibitory effect of serotonin.
So shouldn't we women be high-fiving one another and saluting this magic, new aphrodisiacal pill that may restore our mojo? Sadly, it's not that simple.
Unlike Viagra, Flibanserin needs to be taken on a pill-a-day basis and is only suitable for pre-menopausal women whose levels of dopamine and norepinephrine could benefit from a little recalibration.
Furthermore, in clinical trials women only reported 0.5-1 extra sexually satisfying events in a given month than those taking the placebo (which also made participants feel a wee bit more frisky).
More worryingly, unlike the placebo, Flibanserin has some unpleasant side-effects, such as dizziness, nausea, fatigue, fainting, insomnia and worrying drops in blood pressure when combined with alcohol. Nor has the drug's effects on pregnant women been thoroughly monitored yet.
It's also hard to see why the FDA's drug safety advisory committee approved the drug in June, having turned it down twice since 2010 precisely because of its lack of effectiveness, frequent side effects and long-term safety concerns.
Until, that is, you factor in a vocal pro-licensing lobby, comprising a coalition of women's groups backed by the drug's current manufacturer, Sprout, campaigning under the banner "Even the Score". They say "institutionalised sexism" has stopped sexual dysfunction in women getting the same medical attention as that in men. They also argue a "moderate" benefit for women whose sex lives have floundered is better than none at all.
Which seems reasonable, until you look at the history of this whole crusade. This takes us right back to the 1990s and the staggering profits made by Pfizer when Viagra was licensed for use by the general public.
Within two years, Viagra accounted for 92 per cent of the global market for pills remedying erectile dysfunction. Soon it was earning Pfizer a billion pounds a year. In Britain alone, around six million prescriptions for the miracle drug were written every year. Inevitably, the quest for "Female Viagra" became the next gold rush.
But to cure a sexual disorder, you have to have a widespread condition that's easy to recognise and diagnose in the first place. This helps explains why, in the 1990s, the term female sexual dysfunction (FSD) began to be bandied around in the press. The condition had appeared in medical dictionaries as early as the 1970s, but was something of a catch-all disorder, used to describe one or more of the following symptoms: recurrent inability to feel desire or achieve sexual arousal, pain during intercourse, diminished blood flow to the vagina, and the inability to achieve orgasm.
Quite frankly, what woman hasn't felt recurrent lack of desire after, say, the birth of a child, or a taxing time at work, only to find pleasure return after sustained rest? Stress, shame, depression, repression, sexual boredom, exhaustion, anti-depressants, the contraceptive pill, diabetes, lack of imagination, a partner who's a poor communicator (or just not keen on foreplay) can all also play their part in an absent libido.
Undeterred, a dozen or so pharmaceutical companies entered a drugs race, putting resources into trying to remedy the condition with a tablet, cream or hormonal patch. Just as the corporations desperately needed women to start recognising their own supposedly burgeoning erotic dysfunction, a headline-grabbing survey surfaced. "Sexual dysfunction in the United States" was published in 1999, announcing to a credulous world that 43 per cent of women suffered from FSD. Oprah Winfrey duly called the findings "a silent epidemic".
However, the figures seemed to be based on whether a woman had ever suffered a period of low libido, or failure to achieve orgasm, rather than the sustained and persistent disorders that typifies true FSD - now reborn as HSDD. And, according to Roy Moynihan, writer of the British Medical Journal article "FSD, The Making of a New Disease" (who went on to write the book Sex, Lies and Pharmaceuticals), two of the authors of the report had links to the drugs industry. He also said: "When you look at the proportions of women experiencing these sexual difficulties 'frequently', the numbers collapse."
Nevertheless, that mythical "43 per cent" became and remained the most quoted statistic whenever FSD - or HSDD - was mentioned.
Another spirited opponent of the drive by big pharma to cure supposed widespread sexual dysfunction is the film-maker Liz Canner, director of Orgasm Inc. In 2001 Canner was asked by the drugs company Vivus to make some erotic films as part of the trials of a new topical cream, Alista, which the company hoped would help remedy HSDD in women.
The more Canner worked with the company, the greater her worries that the ebb and flow of female libido was being pathologised to an alarming degree.
After all, no one could begin to say what "normal" female sexuality entailed. How many orgasms should any woman have a month and how strong should your desire be? Can you expect libido to be as fierce 10 years into a marriage as in the honeymoon period? Would they feel plenty of lust if Brad Pitt whisked them off to a luxury hotel suite? Had anyone tried relationship counselling with the research subjects, before they were offered a pill?
Canner was at the FDA hearing in June and remains as sceptical as ever. In an email exchange, she pointed out, "It's interesting to note that 69 per cent of the patients on Flibanserin stayed in the study while 78 per cent on placebo remained. Sprout [should] consider selling the placebo ... "
Of course, it's easy to crack cheap jokes about the subject, bringing to mind, as it inevitably does, visions of the Orgasmatron in Woody Allen's Sleeper. But Canner is clear that the FDA's decision is no laughing matter: "Millions of us may now be deceived into taking a drug that doesn't work much better than a glass of wine or two, [and] could potentially seriously harm us."
I fear few will hear her warnings for the drug company's deafening cry: "We've struck gold."
- Canvas, Telegraph
The average age of patients in the study was just 38, highlighting risks for younger adults.