PBS Regulation Struggles to Overcome Fountain of Youth Wishful Thinking
Testosterone prescription for older Australian men has increased since 1991 largely due to promotional activity rather than clinical need, according to research published in the current issue of The Medical Journal of Australia.
Researcher, Professor David Handelsman, Director of the ANZAC Research Institute at the Concord Hospital, University of Sydney, says there's no convincing evidence of any quality of life benefit to justify testosterone therapy for older men without overt androgen deficiency.
The MJA study, funded by Andrology Australia, analysed testosterone prescribing over 11 years according to products and regions, determined by Pharmaceutical Benefits Scheme (PBS) expenditure.
The study measured patterns of monthly PBS expenditure on injectable, oral and implantable testosterone products from 1 January 1991 to 30 December 2001.
"There were two periods from 1993-1994 and 1998-1999 of striking upsurge followed by declines in national total prescribing of testosterone," Professor Handelsman said.
"These changes were more prominent for oral than injectable testosterone products, and patterns were similar in all regions, apart from a disproportionately higher peak in Western Australia in 1998.
"On a per-capita basis, Western Australia showed a dramatic increase in prescribing of oral and implantable, but not injectable, testosterone coinciding with the opening of a franchised men's sexual health clinic in Perth," Professor Handelsman said.
The study shows increased testosterone prescribing in Australia during the 1990s coincided with changes in Pharmaceutical Benefits Scheme (PBS) regulations.
The surge in the early 1990s in prescriptions for oral testosterone and to a lesser extent injectable testosterone, probably reflects marketing for the product.
"This early surge appeared to be partly reversed by the 1994 change to 'authority required' status for androgens. This change, requiring a phone call to authorise each prescription, may have deterred poorly justified prescribing," Professor Handelsman said.
Professor Handelsman said the surge in the late 1990s reflected the successful marketing of transdermal androgens and testosterone gel, chiefly targeted at older men suffering 'male menopause'.
Additional PBS restrictions had a small impact on prescribing habits but may have encouraged more private prescriptions despite the financial disincentive to patients.
Professor Handelsman said regulatory barriers are only partly successful in counteracting the commercial and populist pressure driving excessive testosterone prescribing. "Professional and community education is needed for appropriate diagnosis of genuine androgen deficiency in younger men, which is significantly under diagnosed, while discouraging unproven testosterone treatment for ageing men," Professor Handelsman said.
CONTACT Professor David HANDELSMAN 02 97679100 (week days only)
Judith TOKLEY, AMA Public Affairs, 0408 824 306 / 02 6270 5471