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Don’t believe the testosterone hype

February 11th, 2005

Dr Petra

Newspapers and radio shows have yet again been led by the nose by the pharmaceutical PR machine. Only recently, Ray Moynihan criticised the media in the British Medical Journal for its wholesale acceptance of Procter and Gamble’s attempts to get their ‘Intrinsa’ hormone patch into the headlines.

Moynihan argued journalists had neglected their core skills by not asking questions about who was funding the Intrinsa research, conflict of interest of researchers, and the lack of transparency about the product.

Intrinsa, uncritically reported by most media outlets as a wonder drug to boost female libido, involved delivering testosterone to post menopausal women’s stomachs via a patch.

Journalists were told, and unquestioningly reported, that the product was marvellous – even though it hadn’t been granted FDA approval. On the 2nd December last year, the FDA rejected the application by Proctor and Gamble to market the Intrinsa patch, given concerns about the robustness of the research into the product, and possible harmful side effects of the drug. You can find detailed criticisms of the Intrinsa research here.

You’d have thought journalists might have learned to start being a bit more critical, given they were shown up by the Intrinsa case. But no. This week they’re at it again, praising the virtues of ‘orgasm in a spray’ – another testosterone based product for female sexual dysfunction.

Acrux Ltd, an Australian company, have developed a testosterone spray in partnership with a US company Vivus Inc. This spray is supposedly for post menopausal women, although appears to have been tested on pre menopausal women. The drug, like Procter and Gamble’s Intrinsa, is delivered to the stomach on a daily basis via a spray.

In their promotional material, Acrux claim they’ve completed a ‘large phase 2b clinical trial’, but then go on to say they only studied 261 women, which many people feel isn’t enough to draw conclusions about the effectiveness of a drug. The trial lasted 16 weeks, with three different dosages being delivered over this time. Again, a 16 week trial doesn’t tell us anything about the long term effects of using such medication.

One of the major criticisms of Intrinsa was there wasn’t any data on long term effects of the drug, and that in order for postmenopausal women to get any benefits they also had to be on Hormone Replacement Therapy – a treatment not recommended for long term use. Acrux don’t detail whether their product needs to be used in conjunction with HRT.

Acrux mention they measured sexual satisfaction, but they don’t make it clear how, and although they report a ‘significant’ increase in sexually satisfying events, they don’t detail what ‘significant’ means. For the Intrinsa study, the increase in sexually satisfying events was one extra sexual encounter per month!

Although the Acrux study’s been in all the papers, it’s not yet got FDA approval even to take it to stage three of testing, and it certainly isn’t anywhere near being on the commercial market yet.

However, if journalists continue to be lazy and don’t ask questions about the quality of the research, side effects, conflict of interest etc, it’s likely more and more testosterone based products will be discussed – whetting the appetite of people for a sex drug in many cases they probably won’t need.

What these drug companies don’t tell women is if their sexual problems aren’t linked to testosterone deficiency, and they start taking testosterone, they could experience side effects including increased growth of facial hair, losing head hair, deepening voice, and acne.

Most women don’t have a clinical sexual dysfunction. They may report being dissatisfied with their sex lives. But that’s not the same thing. It could be their sexual difficulties are linked to a lack of body confidence, the fact they don’t get to enjoy masturbation, or haven’t dealt with other (nonsexual) health or emotional problems. They may have partners who aren’t able to turn them on, or have little idea of what excites them.

Looking at the sort of sex the media describes – exciting, gadget fuelled, multi position, and porn inspired – makes people feel they’re missing out. Which is why pharmaceutical companies can take advantage and label people as dysfunctional, making lacking libido into a disease – something requiring medical intervention.

Anyone who has concerns about their sex life needs to look at lifestyle, social and cultural issues first. If it seems the cause may be linked to physical or psychological problems then they should consult with their GP, or if it’s down to relationship difficulties a therapist may be able to help.

We’re being conned into thinking all our sexual problems are hormonally based and require medical treatment. We need to ask in whose interest is it for us to think that?

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