Authors Baillargeon J, Urban RJ, Ottenbacher KJ, Pierson KS, Goodwin JS.
Review Date June 2013
Citation JAMA Intern Med 2013: doi:10.1001/jamainternmed.2013.6895 (published online June 3)
Increases in testosterone prescribing without accompanying changes in proven medical indications or diagnosis of pathological androgen deficiency have been documented in Australia (Handelsman, MJA, 2010). Data from the USA have recently been published that support the Australian data and again raise questions about marketing and promotion of testosterone to men as a cure-all for a variety of ailments, particularly to ageing men with declining testosterone levels. This US paper was accompanied by an article (Braun, 2013) describing the conflict of interest issues around drug company sponsorship of ‘consensus panels’, continuing medical education and development of patient materials related to testosterone. A related commentary (Schwartz & Woloshin, 2013) discusses the so-called “Low T” disease awareness campaign and the techniques used to lead men to think their symptoms are due to low testosterone and can be treated with testosterone therapy.
To examine androgen prescribing patterns in the United States over 10 years (2001-2011).
Data from a large US commercial health insurance population was used to examine androgen prescribing patterns over 10 years. Prevalence of use was calculated as the number of men receiving a prescription for androgen replacement therapy (ART) in one year divided by the number of men covered in that year. Incident users were men prescribed ART who had not received a prescription in the 12 months prior. Total days of ART in the 12 months following the first prescription for androgen comprised an incidence cohort from 2010. Total days represented all filled prescriptions and number of days covered by prescription.
During 2001-2011 a total of 10,739,815 men aged 40 years or older were included in the overall study population, with a minimum of 1,270,812 men in any year. From 2001 through 2011, androgen use among men 40 years or older increased more than 3-fold, from 0.8% in 2001 to 2.9% in 2011. In 2011 2.3% of men in their 40s and 3.8% of men in their 60s were taking ART with topical gel preparations used the most and also showing the greatest increase over time.
Among all new androgen users (2001-2011), only 35.9% had testosterone level measured in the previous 12 months. Common diagnoses in the year prior to ART initiation were hypogonadism (50.6%), fatigue (34.5%), erectile dysfunction (31.9%), psychosexual dysfunction (11.8%).
The authors concluded that the finding that most men did not have clear evidence of an indication for ART suggests that the clinical reasons for initiating therapy are complex and more research is needed to determine the extent to which men with normal testosterone levels and ambiguous symptoms seek and are prescribed ART.
Points to Note
- The study again highlights the increasing trend in testosterone prescribing without an accompanying trend in better diagnosis of clinical androgen deficiency.
- The use of testosterone in men without a clear clinical indication is a concern given the possible cardiovascular and other side-effects of testosterone treatment.
- The study group included members of an employment health insurance organisation 40 years of age or older and may not be representative of the general population.
- The study found 36% of men had testosterone levels measured but the results of the tests were not known.
- The commentaries accompanying this paper highlight i) the potential conflict of interest issues arising from drug companies who manufacture testosterone products supporting consensus committees and medical education; and ii) the marketing strategies used to make ‘Low T’ a medical condition in need of treatment.