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A pill, not a victory for women


addyi, FDA, daily dose, not with alcoholThe USA’s Food and Drug Administration has approved Addyi, the so-called ‘Female Viagra’.

Anyone who has watched Liz Canner’s excellent documentary Orgasm, Inc. will know that the pursuit of an equivalent to the multi-billion dollar Viagra industry for women has long been the holy grail of pharmaceuticals.

To give it its due, the Food and Drug Administration (FDA) has fended off  various gels, electrodes, pills and patches with uncertain benefits and all-too-certain side effects for years, but now the time has arrived: something has finally been approved – albeit by a split vote – 18/6.

However Addyi, the brand name used by the pharmaceutical company Sprout which has steered this treatment to victory, is far from a new drug.

Since Hypoactive Sexual Desire Disorder  (HSDD) was included in the Diagnostics and Statistical Manual of Mental Disorders (DSM) in the USA in 2004, there have been numerous attempts to find a treatment.

HSDD is classified as a “deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty”.

In October 2010, Addyi – at that time only called flibanserin – was rejected by the FDA as a treatment because there was little evidence of benefits but clear evidence of unacceptable side effects.

The drug was then sold to Sprout Pharmaceuticals for further development.

In October 2013, the drug was again put forward for FDA approval by Sprout, and again rejected because of concerns about side-effects.

Now, in August 2015, it has been approved, under its new guise ‘Addyi’.

What has changed, you might ask?

Critics are saying the approval is a win for the lobbying carried out by Even the Score, which tried to re-frame the lack of treatment for HSDD as a gender equality issue, given the proliferation of treatments for male erectile dysfunction.

Which could almost sound reasonable, until you look at their list of sponsors, which include Sprout Pharmaceuticals and a whole host of other organisations with a vested interest.

In a statement, Sprout’s chief executive Cindy Whitehead spoke of the FDA’s approval as a ‘victory for women’, telling the Guardian: “We applaud the FDA for putting the patient voice at the centre of the conversation and for focusing on scientific evidence.”  .

But this is no safe, woman-centred breakthrough in science.

The results of the latest – and by no means only – trial of Addyi showed that daily doses of the pill may give women between half and one more sexually satisfying experience per month, however with a high risk of side-effects such as low blood pressure and loss of consciousness.

Unlike the medication for men’s erectile dysfunction Viagra, which is taken shortly before sexual intercourse, this has to be taken every day. So presumably it has a permanent or semi-permanent effect. And what happens if you want to quit?

It is not recommended for post-menopausal women, women with liver problems, and it should not be taken with alcohol.

Indeed the FDA has strongly recommended further testing of the interactions between Addyi and alcohol.

But if the benefits are still low and the risks still arguably unnecessarily high, what is this but a PR win?

“I am concerned about the expectations that women have,” Cynthia Graham, Professor in sexual and reproductive health at the University of Southampton was quoted as saying in the Guardian.

“Among women who spoke at the FDA, there were expectations that you can have sexual desire that is at a high level and nothing is going to affect it – that it will be right back where it was when you met your partner.”

Of course there is an agenda behind pharmaceuticals raising women’s expectations of the drug and framing it within a gender-equality perspective.

But the real science doesn’t support the need for a panacea drug, because women’s sexual function is much more complicated than just biology.

Even the first journal article about HSDD, published in the USA in 2002, argued that female sexual function is affected by all manner of life experiences from hormonal contraception and menstrual cycles to marital problems and lifestyle decisions.

The treatment for HSDD should be tailored to the woman in question, the author argued, and such treatment could include lifestyle changes, hormone therapy, marital therapy, treatment of other mental health disorders, or switching/discontinuing medications which may be affecting that person’s libido.

In the latest National Survey of Sexual Attitudes and Lifestyles for the UK, published in 2014, low sexual function in women and men was associated with a variety of factors.

These ranged from increased age, depression, poor health, ending of relationships, poor communication with partners, being unhappy in a relationship, having less than four sex acts in as many weeks, and high numbers of partners, as well as experiences such as non-consensual sex and STI diagnosis.

One or more problems with sexual response in the last year were reported by 41.6 per cent of men compared to 51.2 per cent of women, however far fewer reported distress about this – just 9.9 per cent of men and 10.9 per cent of women.

In other words, it was the norm for women to have had one or more problems with their sexual response in the last year because of a myriad of factors in their lives, but for only 10.9 per cent of women was this actually viewed as distressing, or what we might choose to label a ‘disorder’.

Compare this to the oft-quoted figure of 43 per cent of women in the USA suffering from loss of sexual desire, taken from the results of a 1999 survey which forgot to ask women if this was in fact a problem for them, and you start to realise the ‘science’ behind this ‘breakthrough’ is more than a little shaky.

No one is denying that there are women with low libidos, perhaps even unrelated to events in their lives, which they feel seriously impacts them and their relationships.

And as Boyd Tonkin wrote in the Independent recently, it may be utopian and heartless to steer “unhappy women, or men, away from pills” which may allow them to get by.

But we must ask, as he pointed out, why talking treatment, such as Cognitive Behavioural Therapy, is never promoted as much as quick-fix drugs are?

The answer, of course, is there is just no profit in it.

If there was any more proof needed that the Addyi ‘breakthrough’ was about profit and not about women, it comes in the form of Sprout Pharmaceuticals being bought by Valeant Pharmaceuticals International just over 24 hours after the FDA approval, ostensibly to help the company help more women by using Valeant’s extensive resources.

Nothing to do with the USD1 billion in cash, then.

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