Disease mongering and low testosterone in men: the tale of two regulatory failures

Currently, direct-to-consumer advertising of prescription-only medicines is legal in only two industrialised countries, the United States and New Zealand. However, in countries where direct-to-consumer advertising is not allowed, including Australia, Canada and countries in the European Union, pharmaceutical companies have found ways to sidestep this prohibition through intensive use of the internet, social media and print and broadcast media — for example, by running “help-seeking” or “disease-awareness” campaigns.1 These unbranded promotional campaigns feature a condition treated by the manufacturer’s product, and often encourage viewers or readers to ask their doctor about a newly available treatment. However, there are many examples of drug company-funded disease-awareness campaigns that exaggerate disease risks and prevalence, and misrepresent treatment effectiveness.2 Aspects of ordinary life (such as menopause or unhappiness) are “medicalised”, and conditions that are often mild (such as irritable bowel syndrome and restless legs syndrome) are portrayed as serious illnesses. Disease-awareness campaigns can affect consultation and prescribing rates, with potential negative effects on public health if they encourage inaccurate health beliefs and incite consumers to request inappropriate treatments from health care providers.3,4

In Australia and Canada, drug manufacturers have run disease-awareness campaigns warning that symptoms as diverse and vague as “lack of vitality” and “feeling grumpy” could result from low testosterone levels. In Australia, Bayer, which sells Testogel, a testosterone gel, ran an advertisement in The Weekend Australian Magazine in August 2009 claiming that “low testosterone can take the life out of you” (and that symptoms may include mood swings, poor concentration and reduced strength).

In Canada, Abbott, which sells AndroGel, a testosterone gel, ran an advertisement in a national newspaper, The Globe and Mail, in June and July 2011 with the headline “Has he lost that loving feeling?” (highlighting symptoms such as lack of energy and low sex drive).

The Australian and Canadian advertisements encouraged readers to contact their doctors and ask for a testosterone test if they experienced these symptoms, and the advertisements were linked to websites that included a quiz that called on readers to test their testosterone levels if they exhibited only such non-specific symptoms as “falling asleep after dinner”.5

As men age, testosterone levels gradually decline at an average rate of about 1%–2% per year. No sudden shift in hormone levels occurs, as is the case with the menopause in women. There is no consensus on a threshold for age-related testosterone loss that would be considered pathological, and late-onset male hypogonadism does not feature as a diagnostic code in the International Classification of Diseases (10th revision).6,7 Low libido is a poor predictor of testosterone levels; age alone plays a larger role. Questionnaires used to evaluate the likelihood of androgen deficiency through self-assessment of symptoms such as lack of energy and libido have low specificity and should not be used as screening tools.6

Symptoms displayed in Bayer and Abbott advertisements are non-specific and widespread in the ageing male population, and low testosterone is an unlikely cause of these symptoms. In addition, testosterone treatment has not been shown to improve libido and sexual function, depression and cognitive function, or quality of life in men with age-related testosterone loss.6 Testosterone therapy may expose men to many unwanted adverse effects, including progression of subclinical prostate cancer.6,8 A meta-analysis of trials of testosterone therapy has shown non-significant increases in cardiovascular risk, but trials were limited by small numbers of participants, short duration and inadequate reporting of adverse events.9 A recent study of testosterone replacement in older men was stopped early because of increased rates of cardiovascular adverse events over a 6-month period in men on testosterone versus men on placebo (21.7% v 4.9%, P = 0.0004; 16.8% absolute risk increase).10 Results of ongoing larger-scale trials have not yet been reported.

Australia and Canada have different regulatory systems for advertising of prescription products. In Australia, advertisements for prescription products must comply with the requirements of the Therapeutic Goods Act 1989 (Cwlth) and other relevant laws and, in practice, all communication to the public about prescription products (including disease-awareness campaigns) is regulated by the Code of Conduct operated by Medicines Australia, the representative body of the drug industry. This code does not require preapproval of promotional campaigns. In Canada, advertising for prescription products is regulated by the Food and Drugs Act. A multistakeholder body, the Pharmaceutical Advertising Advisory Board (PAAB), administers a voluntary preclearance program for pharmaceutical advertisements and had pre-approved Abbott’s low-testosterone campaign. Complaints about the low-testosterone campaigns run by Abbott and Bayer alleged that the campaigns were advertising a prescription medicine to the general public and that the promotion of testosterone products for ill defined symptoms of ageing was misleading and potentially harmful.

In both cases, the complaints were unsuccessful. In Australia, the Medicines Australia Code of Conduct Committee found that Bayer’s advertisement was not in breach of the section of the Code of Conduct that prohibits any activity directed towards the general public (section 9.4 of Edition 15 of the Code of Conduct)11 — because the advertisement did not encourage patients to seek a prescription for a specific testosterone product.12 However, the advertisement was found to be in breach of section 9.5.1 (“the educational material must be current, accurate and balanced”) as it implied “that low testosterone was the most prevalent cause of the symptoms described” and “that there is a high incidence of low testosterone whereas this is not an accurate reflection of the incidence across all ages”.12 It was also found to be in breach of section 9.5.6 (“The tone of the message must not be presented in a way that unnecessarily causes alarm or misunderstanding in the community”) as the “tone and imagery were alarmist”.12 Bayer was fined $10 000, less than half the cost of placing one advertisement in The Weekend Australian Magazine. In Canada, Health Canada dismissed the complaint on the basis that Abbott’s advertisement was not a drug advertisement according to the definition in the Canadian Food and Drugs Act because the brand name, AndroGel, was not mentioned; therefore, this was not deemed to be “promotional material in disguise” (unpublished material). Health Canada also stated that Abbott’s low testosterone website provided “fairly balanced information about the various testosterone treatment options available in Canada” (unpublished material).

These disease-awareness campaigns are classic examples of disease mongering. In both cases, the companies market testosterone products that have been approved for testosterone replacement therapy in male hypogonadism, a condition that is often congenital or linked to pituitary tumours. By expanding the boundaries of this disease to common symptoms in ageing males, such as fatigue and reduced libido, drug companies seek to increase their markets and boost their sales. In our opinion, this (a) places an unjustifiable burden on publicly funded health care systems, by advising consumers to consult their doctor and request testosterone testing; (b) raises undue anxiety; and (c) encourages use of testosterone products in healthy men, implying broad effectiveness and exposing men to possible severe adverse effects. In Australia, Pharmaceutical Benefits Scheme statistics show a 115% increase in use of testosterone products following the marketing of Bayer’s testosterone gel, from 28 706 testosterone prescription products dispensed in 2005 to 61 791 dispensed in 2010.13 In Canada, Abbott promoted its testosterone gel to physicians during May and June 2011, in the lead-up to the consumer campaign. The number of monthly prescriptions dispensed rose steadily during 2011, from an estimated 12 400 in January to about 15 900 in December, based on pharmacy dispensing data (unpublished material). In the absence of data on efficacy in older men, increasing testosterone use for male ageing may be the most prevalent form of androgen misuse.7

Unlike Health Canada, the Medicines Australia Code of Conduct Committee determined that the low-testosterone advertisement and website provided unbalanced and alarmist information and that the company should pay a fine. It is worth noting that the Medicines Australia process seems fairer and is more transparent than that of Health Canada, as it involves a multistakeholder committee and allows appeals. However, both the Australian and the Canadian advertising regulatory bodies did not agree with the complainants that these campaigns were disguised advertising of testosterone products because no specific product had been named. We believe that Medicines Australia and Health Canada are not adequately enforcing the prohibition of advertising of prescription medicines to the public in national laws. These permissive attitudes towards disease-awareness campaigns seem to stem from the perception that industry activities to “educate” the public about diseases provide a legitimate public service. However, research conducted in Australia calls this paradigm into question. A recent study found that most disease-awareness campaigns, instead of providing unbiased and comparative information, used emotive messages and techniques to build brand loyalty, such as campaign names, logos and symbols.14

In Australia and Canada, the regulatory responses to low-testosterone campaigns highlight the need for changes to current approaches to enforcing the legislative ban on direct-to-consumer advertising. Like independent consumer and health professional organisations in Europe, Australia and Canada, we call for stricter limits on the role of drug companies in providing health information to the public because of the companies’ inherent conflicts of interest.15 Regulatory bodies should adopt and enforce the World Health Organization’s Ethical criteria for medicinal drug promotion, which states that

In particular, unbranded product advertising, and the use of pseudo-branding or similar techniques, should be explicitly prohibited. Pharmaceutical companies should be discouraged from illegal direct-to-consumer advertising through meaningful penalties, rather than non-prohibitive sanctions such as the symbolic fines imposed in Australia.