Marketing, not evidence based arguments, has probably increased testosterone prescribing

Abstract

We strongly disagree with the British Society for Sexual Medicine's "reflections" on testosterone. 1 Firstly, there is no consistent evidence that hormone replacement provides clear health or patient oriented benefits in most men with low testosterone values. The Endocrine Society therefore recommends against a general policy of offering testosterone to all older men with low testosterone values. 2 Secondly, the safety of testosterone treatment is not entirely clear. Hackett and colleagues state that treatment reduces cardiovascular mortality, citing data from an observational study plagued by limitations and bias. 3 Instead, a recent randomised clinical trial was stopped early because of an increase in deaths in the testosterone arm. 4 A tendency towards increased mortality was also shown in a earlier meta-analysis that didn't include this trial. 5Testosterone replacement in older men has been associated with a significantly higher risk of prostate events (odds ratio 1.78, 95% confidence interval 1.07 to 2.95), 6 and to date no long term placebo controlled trials have evaluated the risk of prostate cancer.Long term placebo controlled studies with hard endpoints are needed before this treatment is used. The increase in testosterone prescribing is probably due to marketing forces rather than evidence based arguments. Competing interests: None declared. 1 Hackett G, Kirby M, Jackson G, Wylie K; On behalf of the British Society for Sexual Medicine. Evidence based medicine inevitably increases testosterone prescribing. BMJ 2012;345:e6167. (24 September.) 2 Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010;95:2536-59. 3 Wu FC. Caveat emptor: does testosterone treatment reduce mortality in men? J Clin Endocrinol Metab 2012;97:1884-6. 4 Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, et al. Adverse events associated with testosterone administration. N Engl J Med 2010;363:109-22. 5 Haddad RM, Kennedy CC, Caples SM, Tracz MJ, Boloña ER, Sideras K, et al. Testosterone and cardiovascular risk in men: a systematic review and metaanalysis of randomized placebo-controlled trials. Mayo Clin Proc 2007;82:29-39. 6Calof OM, Singh AB, Lee ML, Kenny AM, Urban RJ, Tenover JL, et al. Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials.

Population‐based patterns of prescription androgen use, 1976–2008

“…Although we had supplemental aggregate data results for non‐benefit use in the province for two of our study years, we are unable to capture the use of androgen products not listed in the Formulary in all study years. It has been suggested that observed increases in prescribing in other countries are related to pharmaceutical company promotional campaigns that may reach the public through websites regardless of the legality of direct‐to‐consumer advertising in that country . Direct to consumer prescription drug advertising is not legal in Canada, and the timing and impact of pharmaceutical company marketing to Canadian prescribers, or campaigns to increase ‘disease awareness’ among potential patients in Canada over the study period, are difficult to determine.…”