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Tuesday, September 28, 2010

The madness of the quest for female Viagra

 

By Jerome Burne

Drug firms claim four in ten women have low libido - and hope to make a killing with pills to treat it. But experts say their products are ineffective, risky and pointless...

'Sex has been difficult for most of the 12 years of my marriage,’ admits housewife Samantha Lane, 30.

‘At first my husband worshipped me, but now he makes demands on me, then he sulks and I feel guilty, but I just don’t have any interest in making love.

‘He works hard and often comes home in a bad mood. If I try to bring up emotional issues he gets annoyed and says I am boring. Now I don’t even bother. We don’t kiss any more, we rarely even touch.’

Couple in Bed

Researchers and pharmaceutical - companies are accused of 'medicalising' female sexual problems in order to sell drugs

Samantha’s problem is far from unusual. Experts claim that millions of British women suffer from sexual difficulty such as low libido and discomfort.

One widely quoted study ­calculated that 43 per cent of women have problems with sex, or female sexual ­dysfunction (FSD) as it’s known.

The question is: what is the best way to help these women?

The ­pharmaceutical companies have spent ­millions to find an effective drug solution - hoping for similar returns to ­Viagra, the male impotence pill which is worth an ­astonishing $500 million (£316m) in sales every year.

Some companies have looked at how to ­target blood flow, others the hormones or chemicals that affect mood.

Already women can be prescribed a ­testosterone patch to boost low libido; other treatments waiting to be licensed include an anti-depressant-type drug that affects the feel-good brain chemical serotonin and one containing the hormone DHEA that the body can turn into testosterone. It seems millions of women - and their ­partners -could soon rejoice. 

 

But now a new book suggests they’d be wrong to do so. Not only is the effectiveness of such ­treatments questionable, says its author, but the claim that nearly half of all women have a problem is deliberately ­misleading and a wild exaggeration.

Worse, researchers and pharmaceutical ­companies are accused of ‘medicalising’ female sexual problems in order to sell drugs.

Of course, this is not unique to female ­sexual problems - critics point to other recently ­discovered ‘conditions’ such as ­shyness, which in the past might have been put down to a personality trait but for which there are now prescription drug treatments.

The difference is the potential size of the ­market for female sexual dysfunction drugs - a business report from Datamonitor in 2003 ­predicted it could soon approach $1 billion a year.

As leading health journalist Ray ­Moynihan puts it, it’s all part of the drive by drug ­companies to ‘expand the patient pool’ by ‘creating ­markets for ­lifestyle drugs’ for both men and women.

Couple in bed cartoon

Research is finding that women's sex problems are not about mechanics (unlike much male impotence)

‘Companies no longer just sell drugs,’ says Moynihan in his book, Sex, Lies And Pharmaceuticals: How Drug Companies Are ­Bankrolling The Next Big ­Condition For Women.

‘Increasingly they create a ­disease like female sexual dysfunction and then spend a fortune “educating” doctors to prescribe strong drugs to women that they don’t need and that are unlikely to help them.’

Furthermore, these drugs, which are marginally effective at best, come with a nasty raft of potential side-effects. These include nausea, dizziness and a raised risk of heart disease. One drug currently ­applying for a licence can cause depression and even loss of consciousness.

Moynihan reserves particular ire for the claim that 43 per cent of woman suffer from a sexual ­problem, calling it ‘one of the most pervasive medical myths, as extreme as it is absurd’.

This figure is important because drug companies frequently use it to indicate the scale of the problem they are trying to treat.

The faulty figure dates back more than ten years to a ­survey ­published in the ­prestigious Journal of the ­American Medical Association.

The study involved giving a long questionnaire to 3,000 Americans with the aim of finding out more about their sexual habits to fight the spread of AIDS.

The questionnaire included a very short section about ­sexual ­difficulties tacked on the end which asked women if they had ever ­suffered any ­difficulties with sex - such as lack of interest in sex, ­anxiety about performance or pain - for more than a few months over the previous year.

Any woman who answered yes to just one of them was classified as suffering from sexual dysfunction. Adding all the yeses up gives the ­figure of 43 per cent.

‘There was no attempt to ­determine how serious the problem had been or if the women had been distressed by it,’ says Moynihan.

Even the author of the study says the figure has been wrongly used.

‘There’s a lack of understanding of what really drives these ­numbers,’ Ed Laumann, professor of sociology at Chicago University told Moynihan.

‘What drives them is stress - ­physical and social stress, ­exhaustion and not being in a relationship with somebody you care about so you are not sexually interested.’

In other words, their sex problems were not about mechanics (unlike much male impotence).

In fact, later surveys have reported far lower figures. For instance, researchers at the Royal Free ­Hospital in London reported three years ago that only 6 per cent of women thought they had a problem and were distressed enough about it to want help. And when they do seek help, the problem is rarely just ­physical.

‘All sorts of things can result in a woman having a low libido,’ says Dr Sandy Goldbeck-Wood, ­associate specialist in psycho­sexual medicine at ­Camden and ­Islington Mental Health Trust in London.

‘She may have had a traumatic experience or been seriously ill or just be feeling generally unhappy in her wider life. But the reason they affect her libido is because they have an impact on her ­relationship with her partner and how she feels about her body.’

Pile of Viagra

Viagra, the male impotence pill which is worth an ­astonishing $500million (£316m) in sales every year

Researchers into sexual disorders all agree that some women have ­genuine sexual problems that may involve anxiety, pain or difficulty that might respond to medical treatment. But many others might be better helped with counselling.

Yet there is an awful lot of money and ­expertise invested in ­persuading both the medical ­profession and patients that ­popping a pill to revive a flagging libido is the ­quickest and easiest route to go.

Moynihan’s book describes in impressive detail just how this is being achieved.

For instance, 95 per cent of the experts who hammered out the ­medical definition of female sexual dysfunction that’s widely used in ­promotional literature had ­financial ­relationships with the ­company making a drug to treat it.

As an example of the kind of ­tactics some drug ­companies employ, he tells the story of a top salesman who ­persuaded doctors to ­prescribe large ­quantities of ­Viagra by ­taking them to strip clubs.

This blurring of the line between commercial ­interests and doctors’ ­independence is something that ­worries one UK expert, Dr John Dean, ­clinical director of ­Sexual and Gender Medicine with Devon ­Partnership NHS Trust, who ­admitted to Moynihan: ‘Perhaps we are a little too cosy, a little too comfortable.’

There are serious questions about how effective the drugs are. In the summer, a product called ­flibanserin, which works by ­boosting the feel-good brain ­chemicals ­serotonin and dopamine, had its ­application for a licence turned down by the U.S. Food and Drug Administration.

The company claimed it boosted the number of ­satisfactory sexual encounters in a month by an ­average of just under one. The rate for those on the drug went up from 2.8 a week to 4.5 compared with 2.7 to 3.7 for those on a placebo.

The regulator said this wasn’t enough given the possible side-effects, which include loss of ­consciousness and depression. ­Flibanserin is not yet licensed ­anywhere; however, the company has said it will keep trying to obtain a licence.

The trial results aren’t very ­impressive. But if the drugs were used in the real world, they may not have even that small result.

A new study found that ­people who take part in these drug trials end up ­having relationship therapy (to ­participate, you have to be in a ­relationship, agree to have sex three times a month for four months, fill in detailed ­questionnaires each time, keep diaries etc).

As the study’s author, Professor Cindy Mason, of the University of Texas, points out: ‘Trying to find a solution to a sexual problem by ­participating in a study seems to make couples feel closer, ­communicate more and even act ­differently towards each other ­during their ­sexual encounters.’

What all this means is that even if a pill did come up with good results, you couldn’t know for sure that it would do the same for ­people who hadn’t been filling in ­questionnaires, agreeing to regular sex for months, filling in diaries and all the rest.

Perhaps, then, counselling and other therapies could help women who are having difficulties. Talking to a ­therapist certainly helped Samantha.

‘My therapist pointed out how ­unemotional I was, even when I was telling her about how far we had drifted apart,’ says Samantha.

‘My husband was drinking and I felt depressed.

‘I wanted to leave him because he thought I was stupid, but at the same time I was guilty because it was all my fault.’

During therapy, Samantha was able to face the much deeper anger. Her husband had had an affair a few years earlier, but she’d bottled up her feelings about it.

‘Once I’d admitted to the therapist how furious I was, I felt I could talk to my husband about my fear and tension much more honestly.’

Her relationship improved and her libido increased.

‘We’re hoping to have a child now,’ she says.

But while therapy certainly works for some people, it is not widely ­available on the NHS and there haven’t been enough big trials to show exactly how effective it is.

‘If a fraction of the money that’s been spent on drug research had been spent on running trials for sex therapy, we’d be able to deliver much more targeted packages,’ says Dr Goldbeck-Wood.

So what should be done to ensure patients get an unbiased ­opinion about the best treatment for them? Dr Dean believes in keeping ­pharmaceutical companies out of the picture.

‘In an ideal world, doctors’ learning would be funded through entirely independent sources without drug company money,’ he says.

Worth bearing in mind when your doctor brings out the prescription pad . . .

Dr Dean, Ray Moynihan and Dr Goldbeck-Wood will be ­discussing these issues at a debate organised by the BMJ on Monday.

Ray ­Moynihan’s book is available from raymoynihan.com

Read more: http://www.dailymail.co.uk/health/article-1315720/Viagra-The-madness-quest-female-version.html#ixzz10qnvfk7I

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