• Drugs and Drug Industry
• Education for Health Care Professionals
• Women
• Feminism

Disease branding or condition branding is a marketing technique in which a company adopts—or invents—a condition and then develops the so-called disease state prior to or concurrently with marketing therapies for that condition. According to industry articles, while product branding promotes a specific solution, condition branding ‘educates consumers, physicians and other stakeholders about the problem’.1 For example, when the blockbuster drug Prozac (fluoxetine) was nearing the end of its patent life, the company sponsored the creation of the condition premenstrual dysphoric disorder, depicted as a more serious form of premenstrual syndrome, before marketing Sarafem (fluoxetine), which was simply repackaged Prozac.2 The condition previously known as shyness was condition-branded as social anxiety disorder, designed to provide a marketing edge for Paxil (paroxetine), a serotonin reuptake inhibitor that otherwise risked being sidelined as just another ‘me-too’ antidepressant.1

The three strategies for ‘fostering the creation of a condition and aligning it with a product’ are:

• elevating the importance of an existing condition;

• redefining an existing condition to reduce a stigma;

• developing a new condition to build recognition for an unmet market need.2

Examples follow:

Elevating the importance of an existing condition: from heartburn to gastro-oesophageal reflux disease

The metamorphosis of heartburn to gastro-oesophageal reflux disease (GERD) is a recent example of ‘elevating the importance of an existing condition’. Heartburn, a benign condition most commonly caused by eating too much or drinking too much alcohol, was renamed and condition-branded as GERD by the manufacturers of Zantac (ranitidine). To ‘raise the bar of seriousness’ of GERD, Glaxo created the Glaxo Institute for Digestive Health, which conferred research awards in gastrointestinal health; involved the American College of Gastroenterology; and launched a public relations effort called ‘Heartburn across America’.2

Redefining an existing condition to reduce a stigma: Viagra

To sell Viagra (sildenafil), the condition previously known as impotence was rebranded as erectile dysfunction (ED).2 The condition branding of Viagra involved renaming the condition in a way that reduced social stigma and casting it as a highly 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 psychological condition, or a normal effect of ageing. To help medicalise the condition, a questionnaire tool was created that subdivided the condition into mild, moderate and severe versions.1 Researchers paid by Pfizer published studies about the high prevalence of ED, the importance of treating it and the availability of questionnaire tools.3 Physicians paid by Pfizer were used to promote both the drug and the disease;3 efforts were made to expand the market to include even men with rare or transient episodes of failing to achieve or maintain an erection.4 One Pfizer-paid physician even suggested that Viagra should be taken on a regular basis to prevent ED.3

The runaway success of Viagra, an effective treatment, launched a race to create a drug for women. Although there is no female equivalent to ED, a coalition of pharmaceutical companies, with the help of paid key opinion leaders, funded programmes to increase awareness of ‘female sexual dysfunction’ among both physicians and consumers in the late 1990s.5

Developing a new condition to build recognition for an unmet market need: hypoactive sexual desire disorder

Hypoactive sexual desire disorder was established by industry in 2004 to prepare the market for a testosterone patch for women.6 ,7 According to the Diagnostic and Statistical Manual of Mental Disorders (DSM), hypoactive sexual desire disorder is characterised by ‘persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity’ that causes ‘marked distress or interpersonal difficulty’.8 Hypoactive sexual desire disorder was recently dropped from the latest edition of the DSM-5; disorders of desire and arousal have now been combined in the term ‘female sexual interest/arousal disorder’ (FSI/AD).9

Treatments developed to enhance female libido, including the testosterone patch, Viagra (sildenafil), Libigel (a testosterone gel) and flibanserin, have all failed to obtain Food and Drug Administration (FDA) approval.10

Of these three, only flibanserin is still in the running. Flibanserin has been rejected twice. A failed antidepressant developed by Boehringer Ingelheim, flibanserin was recast as a treatment for hypoactive sexual desire disorder.6 In October 2010, after an FDA advisory committee concluded that there was little evidence that flibanserin increased libido and that the drug caused an unacceptable level of adverse effects, Boehringer Ingelheim abandoned developing the drug and sold it to Sprout Pharmaceuticals in 2011. In October 2013, the FDA denied Sprout Pharmaceuticals permission to market flibanserin.10 The company has resubmitted its application and the drug will be reconsidered by the FDA in 2015.

After the FDA’s second rejection of flibanserin in 2013, Sprout launched a public relations campaign, persuading several women’s groups, female Congressional representatives and a group of clinicians to complain to the FDA that the agency is ‘sexist’ for having approved drugs only for male, but not female, sexual dysfunction. A coalition of non-industry-funded advocacy groups supported the FDA’s decision.11

Marketing a drug begins many years before a drug is expected to be approved. Although it is illegal for pharmaceutical companies to market drugs prior to regulatory approval, there are no restrictions on marketing diseases. It is important that what industry terms a disease state is established in the minds of clinicians in the ‘pre-launch’ stage of drug development, prior to the availability of a drug.12

Key opinion leaders, also called KOLs, are influential physicians or researchers who may be paid by industry to provide promotional talks or continuing medical education (CME) courses. CME events are an especially important part of pre-launch disease state promotion. CME is not regulated as promotion and has become a key marketing tool for increasing clinician receptivity to new products, expanding existing markets, positioning products against competitors, mitigating concerns about adverse effects and promoting unproven off-label uses of marketed drugs.12

We decided to examine CME materials on hypoactive sexual desire disorder near the time that flibanserin was first being considered by the FDA to see whether there were any common themes in these modules that could support marketing purposes. Although the invention of female sexual dysfunction and hypoactive sexual desire disorder has been well-documented in medical journal articles5^–7 ,13 and Sex, Lies, and Pharmaceuticals, a book by Australian journalist Ray Moynihan and Canadian researcher Barbara Mintzes,14 no previous publication to our knowledge has examined themes in CME materials prior to regulatory consideration of a drug.

In 2010, the year flibanserin first came before the FDA, we identified free, internet-based CME modules that focused on hypoactive sexual desire disorder in women by searching Google for ‘Hypoactive Sexual Desire Disorder’ or ‘HSDD’ combined with ‘CME’ or ‘Continuing Medical Education’. We examined the first 100 hits (10 Google pages) for each search and then excluded duplicate modules, modules pertaining to hypoactive sexual desire disorder in men and modules that were webcast-only with no text component. No other exclusion criteria were applied.

Fourteen CME modules on hypoactive sexual desire disorder in women were identified.15–28 All were fully accredited CME modules, approved by a provider accredited by the Accreditation Council of CME. All 14 CME modules disclosed funding through educational grants by Boehringer Ingelheim. Additionally, 12 of 14 modules had at least one author with financial ties to Boehringer Ingelheim which was revealed under faculty disclosures (see online supplementary appendix for the list of CME courses assessed and financial ties of authors).

All authors reviewed all modules and identified themes and messages common to the modules by consensus. To our knowledge, this is the first analysis of marketing messages in a subject-specific set of CME modules.

Marketing messages often focus on how a condition is underdiagnosed, widespread and affects quality of life, and how current treatments are absent, inadequate or problematic.29 CME messaging about hypoactive sexual desire disorder fits this template: hypoactive sexual desire disorder was cast as a common, underdiagnosed problem that has a profound adverse effect on quality of life and the lack of treatments for women’s sexual problems was presented as an urgent unmet need. Specific marketing messages that we identified within the CME modules included the following:

1. Hypoactive sexual desire disorder is very common and underdiagnosed.

2. Hypoactive sexual desire disorder can have a profound effect on quality of life.

3. Women may not be aware that they are sick or distressed.

4. Hypoactive sexual desire disorder and distress can have other names.

5. Clinicians should initiate conversation with their patients about their sexual health.

6. Clinicians find it difficult to discuss their patients’ sexual concerns and lack training and confidence in the diagnosis of sexual problems.

7. Clinicians need tools and resources to help them diagnose hypoactive sexual desire disorder.

8. Simple tools, including the decreased sexual desire screener (DSDS) and Female Sexual Function Index (FSFI) can assist clinicians in diagnosing hypoactive sexual desire disorder.

9. A major barrier to clinicians talking about hypoactive sexual desire disorder/female sexual dysfunction is the lack of medications.

10. It is problematic that there are medicines available to treat sexual problems for men but not women.