A leading endocrinologist has delivered a scathing condemnation of the global rise in inappropriate prescribing of testosterone for the non-existent disease of ‘age-related hypogonadism’.
Professor David Handelsman says the increasing use of testosterone for its alleged anti-ageing properties in older men has come to rival that of prescription drug misuse from benzodiazepines and opioids.
In a lengthy review, published in Frontiers in Endocrinology, Professor Handelsman says the trend has been driven by a disease-mongering expanded definition of hypogonadism promoted by commercial interests that exploits ‘internet-driven patient fantasies’ about testosterone as a rejuvenating agent and sexual dysfunction tonic.
The reality is that there is little evidence for the efficacy of testosterone in treating sexual dysfunction in older men for whom the natural course of ageing has been transformed into an invented ‘disease’ given quasi scientific terminology such as ‘andropause’ and ‘(partial) androgen deficiency in the ageing male’.
In his article, Professor Handelsman of the ANZAC Research Institute, University of Sydney, says there are also serious concerns about the long term adverse cardiovascular effects and prostate safety of testosterone, and also unanswered questions about androgen dependence.
Despite this, testosterone is too readily prescribed based on flimsy criteria for ‘androgen deficiency’ and non-specific symptoms in an older male.
“It is not easy in the present environment for endocrinologists to avoid being drawn, however reluctantly, into testosterone misuse. Many endocrinologists are referred patients with a single, marginally low blood testosterone measurement seeking testosterone treatment for ‘hypogonadism’,” he writes.
The demand is driven by concerted marketing and papers emanating from pharma companies, upscale single-issue men’s health clinics and academic enthusiasts, he adds.
Endocrinologists therefore need to reassert the proper definition of hypogonadism as a clinical diagnosis with a pathological basis, confirmed by hormone assays and specific symptoms, he suggests.
There is no basis for treatment based on a single low level of testosterone not for population or individual patient screening (“case finding”) by measuring blood testosterone “without a genuine clinical suspicion of underlying male reproductive pathology based on the clinical presentation including examination of testes.”
“When measurement of blood testosterone is justified by the clinical presentation including physical examination, it should be accompanied by blood LH, FSH and SHBG to clarify interpretation and assays should be performed multiple times. Pathologists should be encouraged to switch to more accurate LCMS-based measurements of testosterone and stop reporting the misleading imaginary fractions of testosterone (“free”, “bioavailable”), a numerical artifice signifying nothing for clinical guidance,” he writes.
The article notes that in 2015 Australia took steps to curb the inappropriate use of testosterone through PBS reimbursement restrictions that required a specialist to initiate new testosterone treatment. However this resulted in a switch to private, non-subsidised testosterone prescribing, maintaining the same overall rate of testosterone usage.
“Testosterone prescribing for men without pathological hypogonadism is a therapeutic illusion in search of a definition,” he concludes.
Professor Handelsman says that with the exception of replacement therapy for authentic hypogonadism, testosterone therapy should be restricted to use in clinical trials “geared to determining the efficacy and safety of testosterone prescribing for functional states, including but not limited to, age-related hypogonadism.”
“In the meantime, doctors need to be supported resisting the popular but misguided demand for testosterone. In many respects this is an educational challenge like smoking cessation, which was equally driven by clever advertising confecting public demand for the product without health benefit.”