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Another testosterone drug trial for female sexual dysfunction launched

November 9th, 2012

Dr Petra

Recently Trimel Pharmaceuticals have announced they are enrolling women into a drug trial to test a ‘use as required’ testosterone nasal spray for women with anorgasmia.

This drug trial forms part of a lengthy history of similar trials (some focusing on testosterone, some not) to ‘treat’ either a lack of desire in women, a lack of orgasm, or both. Examples that got as far as seeking FDA approval include Flibanserin (see here and here), and Intrinsa. Other drugs that didn’t make it that far include Alista, Bremelanotide (aka PT141), Tostrelle, Vasofem. And countless others that were discontinued during early trial phases.

In order to focus on the launch of this latest trial it’s worth unpacking some of the things they claim they are trying to test and treat.

First off – anorgasmia. Anorgasmia is what it says on the tin. The ‘absence of orgasm’. It is not something that’s gender specific. Anyone can experience an absence of orgasm. It’s defined as a clinical problem if the absence of orgasm happens while someone is already aroused (so you feel turned on but you can’t come). That this is a problem that consistently occurs over weeks or months. And that it causes a person distress. A reflection on the diagnostic criteria for Female Orgasmic Disorder by Cynthia Graham can be found here and is well worth a read if you want to know more about the history, definition and diagnosis of this condition.

Secondly – women. This trial (as with many others) focuses on the sexual problems of women. Not in itself unreasonable. Some women do have sexual problems and researching the many causes and solutions (if needed) to those could help. Just as researching men’s sexual problems in a similarly nuanced and critical way can be beneficial. The problem within much of the research in this area is it is medicalised, reductive, and focuses on desire and orgasm as if they occur in isolation from social, cultural and personal influences. They suggest problems are more prevalent than they are, but can be fixed with a pill, patch or spray. And they define ‘women’ in a very specific way. In the majority of trials conducted in this area the ‘women’ recruited are cis women, not Trans women. They are heterosexual. Partnered (usually married or with a long term cohabiting partner). They are middle aged (40-60 age bracket). They are Western and predominantly white. It might be more appropriate to argue drug trials on women’s sexual problems have, to date, focused on a narrow view of sexual problems in a narrow sample of women.

Thirdly I’d like to think about what ‘use as required’ means. Presumably it refers to having a spray that you inhale when you feel like having an orgasm. But it isn’t clear if this is used when you’ve been intimate already but aren’t experiencing orgasm and would like to. Or if you use it before any intimacy begins. Thinking about this is important in terms of what additional ‘stimulation’ women might require.

Which brings us to a fourth issue with these kinds of trials. Their focus on drug vs placebo. Rather than the drug versus something else that might help. If you are struggling to experience orgasm it may well be rather than sniffing a spray you might reach for a sex toy. Or perhaps reading a book on sexual possibilities might mean you know there could be something else that might arouse you more. Maybe drugs could be trialled against talking therapies to identify if there’s a psychological barrier preventing a woman experiencing orgasm. Or couples therapy where you might help people better communicate sexual needs and feel more confident to explore pleasure together? This is not denying a woman (or man) can be distressed and frustrated by being turned on but not being able to experience orgasm. Just to say if we are looking for a solution, why simply focus on drug vs placebo. If, as drug companies claim, there is a genuine interest in helping women find ways to experience more pleasure, why aren’t we fully exploring what those many possibilities might be?

Could the reason be because trials consistently show drugs to ‘treat’ female sexual problems often fail to make the grade because they are either problematic in terms of side effects, or do not demonstrate much in the way of superior performance as compared with placebo. That comparing them with other (non medical) interventions might prove better than the drug being tested? If that could be the case, the question is then why would this be a problem for drug companies and what might their agenda in medicalising sexual problems be?

In terms of the latest drug being tested we have to wonder why there seems to be no learning from existing evidence, which is pretty conclusive that testosterone therapies are not effective in ‘treating’ female sexual problems. The answer, of course, is commercial. If we convince women that they’re sexual difficulties are dysfunctions and these are actually a medical problem that can be fixed with a clinical solution – and then we provide that solution – then this could represent a very lucrative market. Though of course drug companies dress this up in the language of concern, of prevalence of undiagnosed problems, of a lack of research, reclaiming feminist discourses of neglected women suffering in silence. A powerful narrative the media are happy to further reinforce.

It is right to ask questions about this ongoing procession of drug trials, what they are aiming to achieve and how they are being conducted. This does not mean we are dismissive of those who have psychosexual problems, are distressed or experiencing relationship difficulties. Indeed, questioning such trials is a response to creating distress in those who perhaps do not have the problems they’ve been led to believe they are suffering with. While offering self help solutions to those who’re able to make use of them and further research (that goes beyond just pills and patches) for those who do have sexual problems.

Whenever a drug trial like this comes out the media are keen to cover it. The seductive mix of sex and science and the Brave New World-ish ideas of popping a pill in order to feel sexy is hard to resist. Add to that time constraints, and a lack of skills to interrogate claims made in press releases or scientific papers, means little critical attention is given to what is being tested or the wider historical context of the medicalisation of sexual dysfunction in women and men. It does not occur to journalists to check what other drugs may have already been promoted via the media, nor to follow up what happens with trials. So you get regular fanfares for proposed wonder drugs as trials or early data from them are announced. But little or no attention given when trials are abandoned or approval to market said drugs is not forthcoming.

You can expect for this drug, as for all those before it, there will be uncritical media coverage. In fact some of it has already begun with the usual misunderstandings of gender, misleading ideas about sex, the obligatory reference to ‘female viagra’ and of course the ‘mark of the muppet’ – telling your readers 43% of women have a sexual dysfunction. You can also expect that journalists will not research the background to this topic. The challenge remains regarding how we might enable them to ‘get’ what is going on, or more importantly encourage their editors to see they are consistently missing health stories while misleading readers and providing free advertising for drug companies on products that are most likely never going to get past trial or approval stages.

If you are interested in this topic information in the links above should bring you up to speed. You may also find Cory Silverberg’s recent blog post on the same issue helpful, along Ben Goldacre’s new book Bad Pharma, and Leonore Tiefer’s New View Campaign, plus the forthcoming conference Selling Sickness.

Update 19/11/2012
The European Medicines Agency (EMA) announced the withdrawal of the marketing authorisation for the Intrinsa (testosterone) patch in July 2012. This came from Warner Chilcott (UK Ltd) who are the Marketing Authorisation Holder responsible for the product. They withdrew authorisation for commercial reasons. Full statement available here. This means as of 2012 there are no Female Sexual Dysfunction medications available for prescribing (although there are rogue products still on sale online). If you see any journalist writing about FSD and medication without taking into account this fact or the wider history around medicalisation you might want to point them in the direction of this post ;-)

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