Viewpoint J Med Ethics: first published as 10.1136/medethics-2014-102596 on 29 June 2015. Downloaded from Hypoactive sexual desire disorder: inventing a disease to sell low libido 1 1 2 Editor’s choice Antonie Meixel, Elena Yanchar, Adriane Fugh-Berman Scan to access more free content ▸ Additional material is ABSTRACT The three strategies for ‘fostering the creation of published online only. To view Condition branding is a marketing technique in which a condition and aligning it with a product’ are: please visit the journal online ▸ (http://dx.doi.org/10.1136/ companies develop conditions concurrently with elevating the importance of an existing medethics-2014-102596). developing drugs; examples include gastro-oesophageal condition; reflux disease, premenstrual dysphoric disorder, social ▸ redefining an existing condition to reduce a 1University of California, San Diego, California, USA anxiety disorder, erectile dysfunction and hypoactive stigma; 2Department of Pharmacology sexual desire disorder. Although it is illegal for ▸ developing a new condition to build recognition and Physiology, Georgetown pharmaceutical companies to market drugs prior to for an unmet market need.2 University Medical Center, regulatory approval, there are no restrictions on Examples follow: Washington DC, USA marketing diseases, and industry seeks to establish a Elevating the importance of an existing condi- Correspondence to disease state in the minds of clinicians years before an tion: from heartburn to gastro-oesophageal reflux Dr Adriane Fugh-Berman, expected drug launch. Continuing medical education disease Department of Pharmacology (CME) courses are an important part of promotion prior The metamorphosis of heartburn to gastro- and Physiology, Georgetown to drug approval and have become a key marketing tool oesophageal reflux disease (GERD) is a recent University Medical Center, ‘ 3900 Reservoir Rd. N.W., for increasing clinician receptivity to new products. We example of elevating the importance of an existing Med-Dent SE 402, Washington systematically identified 14 free, internet-based, industry- condition’. Heartburn, a benign condition most DC 20007, USA; funded, accredited CME modules on hypoactive sexual commonly caused by eating too much or drinking [email protected] desire disorder in women which came out before a new too much alcohol, was renamed and condition- fl Received 24 November 2014 drug, ibanserin, was being considered for regulatory branded as GERD by the manufacturers of Zantac Revised 22 May 2015 approval in the USA. Common themes in these modules (ranitidine). To ‘raise the bar of seriousness’ of Accepted 2 June 2015 included the following: (1) Hypoactive sexual desire GERD, Glaxo created the Glaxo Institute for Published Online First disorder is common, underdiagnosed and can have a Digestive Health, which conferred research awards 29 June 2015 profound effect on quality of life. (2) Women may not be in gastrointestinal health; involved the American aware that they are sick or distressed. (3) Simple College of Gastroenterology; and launched a public questionnaires can assist clinicians in diagnosing the relations effort called ‘Heartburn across America’.2 disorder. (4) It is problematic that there are medicines Redefining an existing condition to reduce a available to treat sexual problems for men but not stigma: Viagra women. In fact, there is no scientifically established To sell Viagra (sildenafil), the condition previ- norm for sexual activity, feelings or desire, and there is ously known as impotence was rebranded as erectile http://jme.bmj.com/ no evidence that hypoactive sexual desire disorder is a dysfunction (ED).2 The condition branding of medical condition. Hypoactive sexual desire disorder is a Viagra involved renaming the condition in a way typical example of a condition that was sponsored by that reduced social stigma and casting it as a highly industry to prepare the market for a specific treatment. prevalent, chronic condition that had a serious impact on quality of life. It was important to cast ED as a medical condition, rather than a psycho- Disease branding or condition branding is a mar- logical condition, or a normal effect of ageing. To on September 26, 2021 by guest. Protected copyright. keting technique in which a company adopts—or help medicalise the condition, a questionnaire tool invents—a condition and then develops the was created that subdivided the condition into mild, so-called disease state prior to or concurrently with moderate and severe versions.1 Researchers paid by marketing therapies for that condition. According Pfizer published studies about the high prevalence to industry articles, while product branding pro- of ED, the importance of treating it and the avail- motes a specific solution, condition branding ‘edu- ability of questionnaire tools.3 Physicians paid by cates consumers, physicians and other stakeholders Pfizer were used to promote both the drug and the 1 about the problem’. For example, when the block- disease;3 efforts were made to expand the market to buster drug Prozac (fluoxetine) was nearing the end include even men with rare or transient episodes of of its patent life, the company sponsored the cre- failing to achieve or maintain an erection.4 One ation of the condition premenstrual dysphoric dis- Pfizer-paid physician even suggested that Viagra order, depicted as a more serious form of should be taken on a regular basis to prevent ED.3 premenstrual syndrome, before marketing Sarafem The runaway success of Viagra, an effective treat- 2 (fluoxetine), which was simply repackaged Prozac. ment, launched a race to create a drug for women. The condition previously known as shyness was Although there is no female equivalent to ED, a condition-branded as social anxiety disorder, coalition of pharmaceutical companies, with the designed to provide a marketing edge for Paxil help of paid key opinion leaders, funded pro- To cite: Meixel A, (paroxetine), a serotonin reuptake inhibitor that grammes to increase awareness of ‘female sexual Yanchar E, Fugh-Berman A. otherwise risked being sidelined as just another dysfunction’ among both physicians and consumers J Med Ethics 2015;41: 1 859–862. ‘me-too’ antidepressant. in the late 1990s.5 Meixel A, et al. J Med Ethics 2015;41:859–862. doi:10.1136/medethics-2014-102596 859 Viewpoint J Med Ethics: first published as 10.1136/medethics-2014-102596 on 29 June 2015. Downloaded from Developing a new condition to build recognition for an unmet ‘CME’ or ‘Continuing Medical Education’. We examined the first market need: hypoactive sexual desire disorder 100 hits (10 Google pages) for each search and then excluded Hypoactive sexual desire disorder was established by industry duplicate modules, modules pertaining to hypoactive sexual desire in 2004 to prepare the market for a testosterone patch for disorder in men and modules that were webcast-only with no text women.67According to the Diagnostic and Statistical Manual of component. No other exclusion criteria were applied. Mental Disorders (DSM), hypoactive sexual desire disorder is Fourteen CME modules on hypoactive sexual desire disorder – characterised by ‘persistently or recurrently deficient (or absent) in women were identified.15 28 All were fully accredited CME sexual fantasies and desire for sexual activity’ that causes ‘marked modules, approved by a provider accredited by the distress or interpersonal difficulty’.8 Hypoactive sexual desire Accreditation Council of CME. All 14 CME modules disclosed disorder was recently dropped from the latest edition of the funding through educational grants by Boehringer Ingelheim. DSM-5; disorders of desire and arousal have now been combined Additionally, 12 of 14 modules had at least one author with in the term ‘female sexual interest/arousal disorder’ (FSI/AD).9 financial ties to Boehringer Ingelheim which was revealed under Treatments developed to enhance female libido, including the faculty disclosures (see online supplementary appendix for the testosterone patch, Viagra (sildenafil), Libigel (a testosterone gel) list of CME courses assessed and financial ties of authors). and flibanserin, have all failed to obtain Food and Drug All authors reviewed all modules and identified themes and Administration (FDA) approval.10 messages common to the modules by consensus. To our knowl- Of these three, only flibanserin is still in the running. Flibanserin edge, this is the first analysis of marketing messages in a subject- has been rejected twice. A failed antidepressant developed by specific set of CME modules. Boehringer Ingelheim, flibanserin was recast as a treatment for Marketing messages often focus on how a condition is under- hypoactive sexual desire disorder.6 In October 2010, after an FDA diagnosed, widespread and affects quality of life, and how current advisory committee concluded that there was little evidence that fli- treatments are absent, inadequate or problematic.29 CME messa- banserin increased libido and that the drug caused an unacceptable ging about hypoactive sexual desire disorder fits this template: level of adverse effects, Boehringer Ingelheim abandoned develop- hypoactive sexual desire disorder was cast as a common, underdiag- ing the drug and sold it to Sprout Pharmaceuticals in 2011. In nosed problem that has a profound adverse effect on quality of life October 2013, the FDA denied Sprout Pharmaceuticals permission and the lack of treatments for women’ssexualproblemswaspre- to market flibanserin.10 The company has resubmitted its applica- sented