Androgen misuse is systematic over-prescribing of testosterone or its synthetic analogs for unproven, “off-label” medical indications. Misuse is the grey zone between legitimate androgen use for physiological replacement or pharmacological therapy and outright abuse, the illicit use of androgens for non-medical cosmetic, recreational or occupational (including sports doping) purposes. Inevitably, the boundary between enthusiastic advocacy for novel but unproven use and misuse is necessarily vague although either end of that spectrum is readily recognizable. Distinguishing valid but unproven indications from unjustified and/or unsafe prescribing driven by commercial gain or evidence-light enthusiasm is made difficult by the formidable cost of the necessary clinical trials. As a result many potentially useful – as well as worthless, wasteful and harmful - clinical applications of androgens dwell in the limbo of “off-label” use and prone to misuse. As androgens are already marketed and relatively cheap, bypassing the need for evidence in favor of “off-label” mass marketing is attractive. This often involves suborning Key Opinion Leaders and Regional Influencers, undermining incompatible existing guidelines and/or creating new elastic guidelines catering to ill informed and manipulated consumer demand. Areas of androgen misuse in Australia include male and female ageing, where safety and efficacy of androgens remain unproven, as well as in HIV, where androgen usage far exceeds the limited proven indication of treatment for AIDS wasting. The most prudent approach remains to promote evidence-based use of androgens. This requires both professional and public education as well as timely regulatory responses, notably restrictions on PBS subsidy of testosterone to deter over-prescribing. Pharmaco-epidemiological monitoring of PBS androgen prescribing can help monitor the effectiveness of interventions aiming to minimize androgen misuse. So far Australia has largely avoided the dramatic escalation in evidence-free testosterone prescribing in the USA over the last 2 decades.
Conflict of Interest: None disclosed
Financial Support/Funding: None disclosed
Recorded: Sydney, Australia, April 2007
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