IT’S being dubbed the ‘pink Viagra’, a daily pill that women can pop to increase their flagging sexual desire.
And in an era when millions of women already routinely use birth control drugs, it appears that gender equality and sexual liberation is being elevated to a whole new level — or is it?
With Viagra launched by Pfizer for men 17 years ago, it’s argued that women have so far been left out in the cold, but female sexual desire is a much more complex issue — if only low libido could be sorted as easily, with a little pill, regardless of colour.
Nevertheless, the equality card was one of the main arguments put forward by a pressure group, a coalition of women’s groups and healthcare companies, called Even The Score, included in the application process before the US-based Food and Drug Administration (FDA), for the approval of Flibanserin.
But the drug, which recently got the thumbs up, was previously rejected twice by the FDA when it was first marketed as an antidepressant by a German conglomerate, Boehinger Ingelheim.
It has been shrouded in controversy since it was bought over by US-based Sprout Pharmaceuticals.
Owned by a husband-and-wife team, they were accused of mounting a powerful PR campaign, which included Even The Score, to get it passed as a libido pill for pre-menopausal women, on the sexual equality ticket.
Sprout repackaged it as Addyi, after putting it in clinical trials for hypoactive sexual desire disorder (HSSD), a condition recognised by the Diagnostic and Statistical Manual of Mental Disorders (DSM), the bible of the American Psychiatric Association.
The rebranding meant the failed antidepressant metamorphosed into a drug offering a solution to women’s low libido.
Sprout Pharmaceuticals points out that Flibanserin has been studied in more than 11,000 women.
According to the company’s website, research on Addyi, “has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events”.
Furthermore, Sprout has developed “a comprehensive Risk Evaluation and Mitigation Strategy (REMS) programme, including prescriber and pharmacist certification”, to ensure the safe use of the drug.
Critics argue that the gender equality political campaign was an emotional one, which overshadowed the independent scientific facts.
Trials of Flibansarin — which, like antidepressants, targets brain chemicals, releasing feelgood dopamine and norepinephrine, and reducing the stress-inducing serotonin — saw the improvement in female libido as minimal, compared to the placebo, and taking the pill brought a trail of potential side-effects.
Ironically, some of the side-effects include drowsiness, nausea, fatigue, and dizziness — not a far cry from the common excuse ‘I have a headache, dear’.
And the fact that it cannot be taken with alcohol — arguably one of the most commonplace relaxants women use to enhance sexual desire — is a definite disadvantage.
Regardless, two days after the FDA approved Addyi on August 18, the owners of Sprout Pharmaceuticals, Cindy and Robert Whitehead, sold the company for around $1bn to a Canadian corporation called Valiant.
The deal was seen as a vote of confidence in the potential of the drug worldwide and evidence of how pharma companies are willing to cash in on a chemical remedy for a complex condition.
Meanwhile, many experts point out that the variety of reasons for a woman’s lack of sexual desire can be psychological, emotional and situational — not so easily solved by a daily pill.
Mark Murphy, chairman of communications at the Irish College of General Practitioners, says the causes for reduced libido in women can include physical (such as hormonal or endocrinological problems), psychological (such as depression), or as a side-effect of certain medications.
“However, for all human behaviours, such as sexual desire, there are a range of normal responses and it is very common in society to have a wide distribution in sex drive and libido,” says Dr Murphy.
“Differences in libido does not mean there is ‘disease’ and a worrying phenomenon of modern medicine and the pharmaceutical industry has been to ascribe medical diagnoses to certain normal behaviours and to expand diagnostic criteria of illness to reflect this.
“Over the past 20 years, the role of GPs has shifted to protecting patients from the harms of this concept of ‘over-diagnosis’ and over-treatment, so I think this trend will continue with this new medication, Flibanserin, if it is ever licensed for use in Ireland.”
Dublin-based sexologist Emily Power Smith agrees.
“The idea of pathologising a female’s subjective experience of her own sexuality was invented by the pharma industry,” she says.
“What is ‘normal’ libido from which we can judge another as ‘abnormal’? When does it become a ‘disorder’ or ‘dysfunction’?
"The pharma industry has finally managed to get a drug approved by the FDA to ‘treat’ this ‘problem’ that they invented in the first place.”
The search for a pill to treat women’s sexual desire disorders has up to this been notoriously difficult — precisely because of its complexity.
The goal was pursued and later dropped by Pfizer and other big-name pharmaceutical companies, because drugs that act on blood flow, hormones and other biological functions did not boost libido.
“The idea that women should be ‘cured’ by this one drug is ludicrous,” says Power Smith.
“In my experience of clients, there are myriad causes that affect women’s sexual urge — including fatigue, stress, poor body image, culture, religion, hormonal imbalance, relational issues, expectations, children, lack of confidence, lack of skills, and illness.
“If a man wants to be sexual and needs an erection for this, he can pop a little blue pill at the time and have his result — because there is a mechanical dysfunction.
"This [new]drug works on the brain and is supposed to increase desire in a woman, not functionality.”
Power Smith argues that if, for instance, a woman no longer feels desirable or interesting or valued, or if the sex isn’t satisfying, in that case then her lowered desire is normal — an issue that a drug can’t, or shouldn’t address.
“As the levels of Flibanserin’s efficacy are poor, I fear that there will be a number of women and their partners expecting great results but experiencing no meaningful change.
"For example, from the side effects alone, if you are feeling dizzy and sick, that will probably knock any sexy ideas on the head.”
The fact that Flibanserin targets the neurotransmitters, like antidepressants, is a disadvantage in itself, says Andrew Rynne, a medic who deals with sexual dysfunctional issues through testosterone-based therapy, at his Kildare-based clinic.
“Desire is different to the physical response — you need to have desire first off,” says Dr Rynne.
“I would be wary of this so-called pink Viagra because antidepressants are notorious for messing up people’s sexuality.”
Even if Flibanserin did give a woman a kickstart in sexual desire again, the issue as to why she lost it in the first place has to be addressed, says Anne Mathews, a psychosexual therapist, at Body and Mind Works in Dublin.
“In my opinion, if you take the drug as the only way of dealing with the condition then it’s going to have a limited outcome,” says Mathews.
“Because of the complexity of the disorders of desire for women, talk therapy has to be part of it. It’s only through working with somebody who is qualified and understands that complexity, that outcomes can be good and maybe the drug has a part to play in that, but I’m not sure, because of the outcomes and contraindications.”
Mathews says she sees many women, particularly in their late 30s and 40s who are usually in a committed relationship, attending the clinic with issues around disorders of desire and there is often a biopsychosocial background to their problems.
“People think they can manage it for a while and tell themselves that it’s going to change when the children get older, or they go on that holiday — but actually when they realise that nothing is changing and it’s getting worse, they present, because it affects the whole relationship,” she says.
Quite often, religious and cultural influences, such as how their own parents dealt with sex and how women perceive themselves as sexual beings, still persist, despite Irish society’s apparent growth on this matter, she says.
Mathews quotes a leading American theorist on sexual issues, Barry McCarthy, who says that if sex is working it’s about 20% of the relationship; if sex stops working, it tips into about 80% of the relationship.
“Though the dysfunction is being held by women in the relationship, the problem is a couple issue, so it’s very worthwhile and I consider it as an investment in the couple’s relationship, for both of them to attend and to come to an understanding as to why things are the way they are,” she says.
A woman’s sexual difficulties need to be addressed in a compassionate understanding manner and, if in a relationship, put in context with her partner, not magically solved by the swallowing of a pill. Real equality in other words.
HOW MALE AND FEMALE DRUGS DIFFER
While the drug Flibanserin – or Addyi as it is branded, is being called the new ‘pink Viagra’ there are clear differences between it and the male sexual performance booster, Viagra (right).
Viagra works by increasing blood flow to the penis. Addyi works on the neurotransmitters, or brain chemicals.
Viagra aims to boost the man’s sexual response (he is already aroused). Addyi aims to boost the woman’s sexual desire (not her physical response).
Viagra is taken on a need-to-use basis by men. Addyi has to be taken daily by women.
The effects of Viagra can be experienced within 15 minutes and can last up to four hours. Addyi is taken daily for up to four weeks before any effect can be seen.
The side effects of Viagra are headache, flushing, upset stomach, abnormal vision, blurred vision, stuffy/runny nose, back pain, muscle pain, nausea, dizziness and rash.
Due to the side effects of Addyi there is a ban on taking alcohol and the pill must be taken at night. Side effects include: dizziness, drowsiness, nausea, fatigue, insomnia, dry mouth, low blood pressure and loss of consciousness.