Driven by commercial interests rather than science, testosterone prescribing is escalating at startling rates around the world.

It now constitutes an annual market of almost $2 billion in which the raw drug costs only 1 per cent of the total, representing huge profits for the industry.

This total does not include the informal market where steroids are bought from compounding chemists and gyms or are illegally imported via the internet.

Although testosterone has been available for 70 years, its complexity is not understood and it has never been subjected to the rigour that current drugs have to undergo before being released to the public.

This is a major concern because millions of men are taking it without understanding the ramifications of doing so.

In Australia, regulatory authorities are now analysing the criteria for the use of testosterone, which has risen dramatically here since new products became available some seven years ago.

NOT AN ANTI-AGING TONIC
Contrary to popular belief, testosterone is not a magic tonic that lifts lethargy and supplies energy for the rest of the day. Nor is it an anti-ageing elixir.

Although promoted by the industry as safe to use, its risks in relation to accelerating cardiovascular disease and prostate cancer have not been ruled out and there are still good reasons for caution.

A couple of years ago a trial of testosterone supplementation in frail older men was halted because of the high incidence of adverse cardiovascular effects.

And another study suggested cardiovascular hazards have been systematically underestimated because industry-sponsored research has found fewer hazards than independent research.

Now a new study in the New England Journal of Medicine has shown just how complex its action is and indicated how supplementation can go wrong.

JUST A CHEAP OLD OVERUSED DRUG
In an editorial in the journal, Australia’s leading expert in the area, David Handelsman, describes testosterone as a cheap old drug suffering from “surging overuse from off-label prescribing for diverse unproven indications including use in older men as an anti-aging or sexual tonic and in younger men for bodybuilding or doping”.

Handelsman, who is director of the ANZAC Research Institute in Sydney, writes that rather than occupying a stable niche after so many years, the international prescribing market is now close to $2 billion.

He told The Australian Financial Review that Australia is a relatively high user of prescription testosterone and that the progressive rise has been driven by promotion without any new indications.

He believes taxpayers shouldn’t be subsidising it, just as they don’t subsidise anti-impotence drugs or cosmetic medicine. Hobby users should pay for it themselves.

“We are in the midst of an epidemic of over-use driven by the internet, rejuvenation fantasies and a professional and public misunderstanding of what testosterone does.”

TOO LITTLE LOVING CAN CAUSE REDUCTION
For instance, he says there is a fundamental misunderstanding of the role of testosterone in sexual dysfunction.

Recent research has shown sexual inactivity of itself reduces testosterone levels.

This mild reduction in blood testosterone levels is not a true deficiency state itself – as is widely and naively assumed among many doctors.

When a sexually inactive man goes to his family doctor about his condition, he’ll be given a routine blood test that will measure his testosterone.

When results show it is mildly low, doctors who are unaware of the latest research will think the easy solution is to prescribe testosterone.

This is a classic misunderstanding because the low testosterone is a consequence of low sexual activity, not a cause of it.

“Giving a supplement in this case is pointless and possibly harmful and it is helping to fuel the overuse of testosterone,” says Handelsman.

A $17M INDUSTRY
He says Australia’s prescription criteria for testosterone, introduced in 2000 as a world first, are being evaded and should be tightened to prevent potential harm and public money being spent fruitlessly.

“However industry lobbying has led to Australia’s once world-leading professional societies surrendering their lead in regulating testosterone over-use.”

Last year, Australia spent an estimated $17 million on testosterone prescriptions.

In August 2013, the Pharmaceutical Benefits Advisory Committee considered clarifying restrictions on the use of testosterone. Its conclusions are not yet public.