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DRUG companies are side-stepping direct-to-consumer advertising bans through branded consumer campaigns about low testosterone that researchers describe as “disease mongering”.
The criticism comes at the same time as research showing a surge in PBS-subsidised testosterone, which was likely to have been fuelled by drug promotion and off-label prescribing.
In an article in the latest MJA, Dr Agnes Vitry, from the University of SA, and Dr Barbara Mintzes, of the University of British Columbia, Canada, said disease-awareness campaigns linking vague symptoms such as low libido and lack of energy to low testosterone levels were classic examples of disease mongering. (1)
“By expanding the boundaries of this disease to common symptoms in ageing males, such as fatigue and reduced libido, drug companies seek to increase their markets”, they wrote.
Research in the same issue of the MJA by Dr David Handelsman, of the University of Sydney’s ANZAC Research Institute, found a 4.5-fold rise in PBS expenditure on testosterone since 2006. (2)
Dr Handelsman said the rise was likely to be due to “new product launches for speculative, non-approved indications such as ‘andropause’ and male sexual dysfunction”.
Dr Justin Coleman, a GP and author of Crikey blog the Naked Doctor, which focuses on overdiagnosis and overtreatment, told MJA InSight the increases in testosterone prescribing showed “beyond doubt” that disease mongering was a significant problem.
“The cleverness of marketing to the public is that if a drug rep comes to your office and says ‘you must prescribe this’, you’re on high alert”, Dr Coleman said. “Whereas, if a patient comes in saying ‘I feel tired all the time, my sex life isn’t as good, and I’ve read that this really helps’, there’s a lot more pressure on the GP to prescribe.”
Dr Coleman said there were dangers in widening disease definitions. “[If] you broaden the spectrum to 10 times the number of people — many of whom won’t have a significant, true testosterone deficiency … the risk of harm becomes much more significant, in this case potentially prostate cancer harms or cardiovascular risk harms.”
An article published last week in the BMJ has also highlighted the problem of overdiagnosis, particularly in older people. (3)
“Changing diagnostic criteria for many conditions are … causing virtually the entire older population to be classified as having at least one chronic condition”, the BMJ authors wrote.
Drs Vitry and Mintzes criticised the regulatory response to complaints about low-testosterone “disease-awareness” campaigns in Australia and Canada, and called for Australia to adopt stricter limits on the provision of health information to the public.
They highlighted a case in Australia involving Bayer, which manufacturers a testosterone gel and which ran an advertisement in The Weekend Australian Magazine in August 2009 stating that “low testosterone can take the life out of you”.
The company was fined $10 000 — less than half the cost of placing the ad — for implying that testosterone was the most prevalent cause of the symptoms portrayed and for using an “alarmist” tone, the authors wrote.
However, Medicines Australia found that the advertisement did not breach the section of its code of conduct that prohibits activity directed to the public.
Medicines Australia chief executive Dr Brendan Shaw told MJA InSight the organisation had a strong code of conduct and complaints were examined by an independent committee of experts.
“The code has a strong matrix of provisions covering communications with consumers”, Dr Shaw said. “These include prohibiting promotion to consumers and ensuring educational information developed for consumers is current, accurate and balanced and does not focus on a particular product. They also require that raising awareness about medical conditions and their management is done in a way that does not promote or emphasise particular treatment options.”
– Nicole Mackee
1. MJA 2012; 196: 619-621
2. MJA 2012; 196: 642-645
3. BMJ 2012; Online 29 May
Posted 4 June 2012
Good point Chris, we sometimes need to remind ourselves normal ranges are based on +/- 2 x std deviation from the mean, and for individuals, they may not be adequately served with what passes for being inside that range. I think the LH is more useful in assessing this. We have no trouble assessing someone with a raised TSH, and marginal T3 & 4, as being probably clinically hypothyroid for them, and worth considering low level top-up, as recent papers now endorse the fact that patients like that are at increased risk of co-mobidities – why would you treat testosterone differently..?
Don’t think we should get too carried away with “normal range”. I’s a range of normality, says nothing about the individual. The HIC wants a total testosterone level under 8. Why 8? Could be a third of the normal level in a particular male. I tend to use the Mass study of lowest quartile. I see a lot of patients referred by psychiatrists who have lowish testosterone. They feel better on treatment.
Like Sue says. That’s what I was getting at. An area ignored or largely neglected until relatively recently.
I can see the analogy with hormone replacement for menopausal women – but only insofar as a deficiency is shown. If a man has symptoms specific to testosterone deficiency, and a measured level outside the normal range, then replacement seems to make sense. The use of testosterone as some sort of “tonic”, however, does not.
If we do not oppose this rogue behaviour, we will be seen as complicit and reinforce the perception some people have of a conspiracy between Big Pharma and doctors..
As a genetics specialist I was recently referred a 35 year old woman who was given testosterone injections and testosterone cream by a GP because of tiredness and low libido. She was married, not using contraception, and became pregnant. She was concerned about a possible teratogenic effect from testosterone. If the fetus is female, and could have virilisation of the external genitalia, do you think her GP is at risk of being sued?
Peter, In the case of HRT there is evidence for its use. I don’t have an issue, nor would most endocrinologists I presume, with prescribing of testosterone to patients with low serum levels. But to advocate it for everyone who has libido issues, or is just tired, without medical input, is a nonsense.
Is this scare, or disease-mongering, or is it really the ‘becoming aware of something just overlooked until now’ phenomenon. As someone above posted, we give HRT to women soon enough for symptoms of hormone lack – why not men? As yet these are the only anti-aging meds we have. Hands up anyone who wants to age faster than they have to and suffer how it feels…?…and I’ll show you a liar…
It’s pleasing to know Medicines Australia has such a strong Code of Conduct.
No problem with companies targeting segments of the population with scaremongering tactics should they not use a particular product, but it’s OK to demonise doctors who may have a pen with a drug company logo on their desk.
The hypocrisy is amazing.
The Mass Male Ageing Study showed that males in the lowest quartile had an increased all cause mortality. The relationship between prostate cancer and testosterone remains unclear despite decades of study. We prescribe hormone replacement to females so I don’t see a problem with giving it to males if it helps symptomatically- even if these are placebo responses. (I don’t have access to an injection labelled “Good for old blokes”, containing no active ingredient)