Monkey Business and the UK epidemic of testosterone prescribing

Earn Gan1, Stewart Pattman3, Simon Pearce1,2& Richard Quinton1,2
1Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom; 2Endocrine Unit, Newcastle-upon-Tyne Hospital NHS trust, Newcastle upon Tyne, United Kingdom; 3Clinical Biochemistry, Newcastle-upon-Tyne Hospital NHS Trust, Newcastle upon Tyne, United Kingdom.

Male hypogonadism is characterised by sexual dysfunction, loss of muscle bulk, central obesity, fatigue, mood and sleep disturbances, osteoporosis and anaemia. Although these features are associated with low serum testosterone concentration, not all men with a low serum testosterone are definitively hypogonadal, and there is a large symptom overlap with obesity and non-endocrine illness. Importantly, testosterone replacement therapy may not be appropriate for men with mild, functional and/or transient hypotestosteronaemia.

As Delamothe points out,1 pharma companies have run aggressive marketing campaigns (including ‘restore the man’) that have sought to equate hypogonadism with low serum testosterone, despite the lack of long-term safety data and inconsistent improvement in symptoms. We collated data about the use of testosterone preparations from the Departments of Health Prescription Cost Analysis for community pharmacies 2000–2010, for England, Scotland and Wales. Community requests for serum total testosterone assay in males to the Biochemistry Department at the Newcastle upon Tyne Hospitals Trust were also examined over the same period.

Prescriptions for testosterone increased by nearly 90% from 157,602 to 298,134 items annually, over the last 10 years. In particular, prescriptions for transdermal testosterone have increased 5-fold since testosterone gels were introduced in 2003. The cost of this medication showed a 267% escalation, from £3.2 to £11.7 million yearly over the same period, with more than half being spent on transdermal testosterone. Local requests for serum testosterone measurement in males from primary care also increased, from 347 requests in 2000 to 823 requests in 2010. However, the number of men with unequivocal hypogonadism (testosterone less than 6.0 nmol/l) remained roughly constant at 5.2% in 2000 and 6.3% in 2010. We believe that many men in the UK are receiving unnecessary testosterone replacement therapy. Similar trends have been observed in Australia and Switzerland.2,3 Regulation of industry advertising to primary care is inadequate. National guidance on the indications for testosterone replacement is urgently needed.

References:
1. Delamothe T. Monkey business: reflections on testosterone. BMJ 2012; 345:e4967
2. Handelsman DJ. Pharmacoepidemiology of testosterone prescribing in Australia, 1992-2010. MJA 2012; 196:642-645.
3. Nigro N, Christ-Crain M. Testosterone treatment in the aging male: myth or reality? Swiss Med Wkly 2012; 142:w13539

Competing interests: None declared