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What’s going on with the Intrinsa patch?

December 29th, 2006

Dr Petra

Next year you can expect a lot of articles in women’s media about female sexual dysfunction and more specifically the Intrinsa patch.

In case you didn’t know, the Intrinsa patch is a testosterone patch produced by Procter and Gamble (P&G). It was created for a very specific market – women who have had a hysterectomy who have also lost their sex drives. This doesn’t apply to women who had poor sex lives pre-operatively, but is aimed at women who previously had good sex lives but develop a lack of sexual desire post-surgery and where their sexual problems cannot be attributed to other factors or treated with education, support or counselling.

When P&G applied to the FDA (Food and Drug Administration) in late 2004 they were turned down by the organisation due to concerns over the research that underpinned the patch and the target audience. Despite testing the company can only guarantee the patch works safely for a one-year period – after that time it is unclear about how it works. And as with any hormonal treatment there are risks of side-effects. For more information about the FDA decision and challenges to the research behind the patch click here.

It seems P&G have no future plans to try again for FDA approval to market their patch, but they have applied for approval from the European Commission to develop and sell it. The patch is due to become available next spring across Europe (although not everyone appears to agree on this). And that’s where things get interesting.

As mentioned, the patch is aimed at a specific group of women. It is not a desire booster and it is not designed for women who are pre-menopausal or who have not had a hysterectomy. It is unclear whether women who use the patch will also have to use hormone replacement therapy (one of the concerns expressed at the FDA hearings). It is also unclear how the products will be made available to the public and how the drug will be marketed.

Technically the patch should only be available on prescription after a full assessment from a doctor and only after all other forms of treatment and therapy have been explored (for example counselling, education, lubricant provision, relationship therapy etc). However it is unclear whether the patch will be sold in other outlets, and concerns have been expressed that it could be sold online with few checks made on those buying the product.

The company to promote the product will target journalists. In fact we know this is already happening. There is a lot of confusion around the relationship between the media and P&G since the official line from the pharmaceutical company is the patch is for a specific group of women with a health problem and not for anyone else. However journalists are saying they are not being told this message clearly and instead are being led to believe the drug could work for all women who need a desire boost. Sources tell me P&G have counter claimed that they have not done this at all; it’s all journalists fault for misunderstanding and overhyping a product. It would be interesting to know what’s going on here – what are journalists being told and who is being targeted?

So if I were a journalist I think I’d start sniffing a story at this point. Women’s media are being approached to promote the Intrinsa patch with varying versions of how this is happening and for what purpose. If I were an investigative journalist I’d start asking questions like…

Will P&G ensure that online sales of the Intrinsa patch are banned? If the patch becomes available for all to buy online who will be responsible for this?

What health messages will women be given? Will it be made clear that the patch is only for a minority of women with a specific health need? Will it be made equally clear that the patch is the last point of treatment after a physical exam, life assessment and psychological care if appropriate – not the first point of call.

Why, if the FDA did not grant approval for the patch because of safety concerns did the European Commission grant approval? Where different standards of assessment and evaluation employed? What does it mean if certain countries regulatory bodies see the product as unsafe to approve but other countries approve it? Does this create double standards that could place women at risk?

What messages are being given to the media? Those journalists already investigating the case seem to be being given a much stronger party line version of the patch than those being sent information by the company. Is that really happening, and if so, why?

Although the market for the Intrinsa patch is a very small percentage of Western women it seems to be being presented as a potential cure-all for all women who’ve gone off sex. Where are these messages coming from and what’s going to happen where women and their partners have their interest raised about desire problems? The company has been accused of hyping up a disorder to tailor a product and increase sales. What do they have to say about this accusation and what plans do they have to address it?

Already we’ve seen numerous press reports claiming the patch can boost the sex lives of all women. If P&G are clear that their product is for a specific target group but these messages are not being reported in the media. What plans does the company have for ensuring correct messages are provided? Where these messages are not being challenged could it be because the company actually wants a different message to be given to women and their partners?

We have seen drugs like Viagra do not work for everyone with sexual dysfunction. What disclaimers are P&G giving the public to warn the drug may not work for all women (particularly if they have other underlying problems in their relationship or body image)?

Although P&G have a product they want to promote theirs is not the only view of female sexual dysfunction. Within the medical profession concern has been expressed about the medicalisation of female sexual behaviour, particularly making dissatisfaction with sex into a full-blown disease requiring hormonal treatment. Other research suggests numerous factors influence women’s sexual problems and hormonal deficits are not the major cause of women’s sexual difficulties. Why are these messages not finding its way into the public domain even though it is the most widely held view within the medical profession?

These questions and more could form the basis of a number of interesting and useful features that would help women decide what treatments (if any) they need for sexual problems. All we need now are some journalists willing to try some old-school reporting and to find out more about the questions the marketing of the Intrinsa patch in Europe raises.

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