Drugs for low libido raise concerns over industry 'construction' of new diseases

Researching his new book 'Sex, Lies and Pharmaceuticals' Ray Moynihan, journalist and lecturer at the University of Newcastle in Australia, discovered that drug industry employees have worked with paid key opinion leaders to help develop the disease entity; they have run surveys to portray it as widespread; and they helped design diagnostic tools to persuade women that their sexual difficulties deserve a medical label and treatment.

He believes that "drug marketing is merging with medical science in a fascinating and frightening way" and he asks whether we need a fresh approach to defining disease.

He quotes a company employee saying that her company was interested in "expediting the development of a disease" and he reveals how companies are funding surveys that portray sexual problems as widespread and creating tools to assess women for "hypoactive sexual desire disorder."

Many of the researchers involved in these activities were drug company employees or had financial ties to the industry, writes Moynihan. Meanwhile, scientific studies conducted without industry funding were questioning whether a widespread disorder of low desire really existed.

Industry is also taking a leading role in "educating" both professionals and the public about this controversial condition, he adds.

For example, a Pfizer funded course designed for doctors across the United States claimed that up to 63% of women had sexual dysfunction and that testosterone and sildenafil (Viagra) may be helpful, along with behavioural therapy. And he points out that German drug company Boehringer Ingelheim's "educational" activities "went into overdrive" as the planned 2010 launch of its desire drug, flibanserin, approached.

In June, flibanserin was rejected by advisors to the US Food and Drug Administration and Pfizer's sildenafil was also pulled after studies showed virtually no difference from placebo. But although the drugs have so far failed, Moynihan warns that "the edifice of scientific evidence about the condition remains in place … creating the impression that there is a massive "unmet need" for treatment."

And with more experimental drugs in the pipeline, "the drug industry shows no signs of abandoning plans to meet the unmet need it has helped to manufacturer," he says.

"Perhaps it's time to reassess the way in which the medical establishment defines common conditions and recommends how to treat them," he suggests.

"Perhaps it is time to develop new panels to take responsibility for defining treatable illness, made up of people without financial ties to those with vested interests in the outcomes of their deliberations and much more broadly representative of the wider public … and start the slow process of untangling the marketing from the medical science." he concludes.

"Faced with a woman in tears whose libido has disappeared and who is terrified of losing her partner, doctors can feel immense pressure to provide an immediate, effective solution," says Dr Sandy Goldbeck-Wood, a specialist in psychosexual medicine, in an accompanying commentary.

She says Moynihan's research clarifies both the conflicts of interest at work and the relative paucity of good quality evidence for pharmacological solutions to women's sexual problems. However, she argues: "his argument that female sexual dysfunction is an illness constructed by pathologising doctors under the influence of drug companies will fail to convince clinicians who see women with sexual dysfunction, or their patients."

Women who have struggled to overcome the psychological and cultural barriers to requesting help with their sexual difficulties will not welcome the argument that they are to be "left alone," she writes.

She believes the problem is one of oversimplification and believes that more studies are needed that reflect the complexity of sexual life. "It's time to invest in more research into the most realistic, respectful and evidence based treatments, rather than narrow biological ones founded on poor evidence," she says.