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Observations Yankee Doodling

BMJ 2014; 348 (Published 10 January 2014) Cite this as: BMJ 2014;348:g182
1. Douglas Kamerow, chief scientist, RTI International, and associate editor, BMJ
1. dkamerow{at}rti.org

Big pharma creates a new disease: low testosterone

I’ve been seeing a lot of TV commercials for testosterone replacement therapy (TRT) recently. It must be because the manufacturers like the demographics of the two main types of programs I watch: network news and sports. That’s where you find the middle aged and older guys, as well as their wives, who can actually get them to see their doctors. Pushing through the ads for overactive bladder, arthritis pain, and, yes, erectile dysfunction treatments are now numerous questions about whether I have “low T” or not.

It used to be that TRT was reserved for clear cases of hypogonadism, either primary (due to testicular failure) or secondary (such as from pituitary tumors). Because oral testosterone is largely ineffective, these patients would be treated with regular testosterone injections, at considerable cost and inconvenience, resulting in widely varying blood concentrations. Now we have several non-injectable ways to deliver stable testosterone levels: patch, gel, subdermal pellet, buccal tablet, and even an underarm roll-on.

Until recently, however, TRT was a relatively small market. In 2002 only about 0.8% of US men were receiving testosterone prescriptions, and sales were just $324m (£197m; €240m) a year.1 2 Clearly what was needed was creative marketing. Enter the low T campaign: the medicalization of symptoms of everyday life in the service of pharmaceutical sales. Schwartz and Woloshin recently described the three part strategy of the low T and similar programs perfectly: “lower the bar for diagnosis, raise the stakes so that people want to get tested, and spin the evidence about drug benefits and harms.”3 In addition to their standard promotional strategies of advertising directly to consumers and physician sampling and promotion, drug companies now create disease awareness campaigns. When you go to the website recommended in the low T advertising (www.isitlowt.com) you don’t see anything about a specific drug. It is, seemingly, a straightforward presentation of the science behind low testosterone, including celebrity case histories, a list of symptoms, and a “quiz” you can take to “help you find out if you have symptoms of low T and if you should talk to your doctor.” Do you have a lack of energy and decreased endurance, and have you noticed that you fall asleep after dinner? Your symptoms may be caused by low T. How about decreased libido? Ditto. Or the combination of feeling grumpy, decreased sports performance, and loss in height? If so, you pass (or is it fail?) the quiz. Answering yes to these questions qualifies you for the recommendation to “talk to your doctor about your symptoms and ask if you should be tested for low testosterone.” This quiz, a preposterous screening test called ADAM (androgen deficiency in aging males), was created “in 20 minutes” by the endocrinologist John Morley of St Louis University for a Dutch drug company. Morley himself described it as a “crappy questionnaire.”2 No expert group recommends screening healthy men for hypogonadism, so this questionnaire turns everyday symptoms into a proto-disease requiring medical attention. The clear message is that testosterone therapy will help men who have these symptoms by giving them more energy and endurance, better sports and sexual performance, and improved libido. Sounds pretty terrific. Of course, nowhere on the low T website is there evidence supporting the claims that testosterone therapy is an effective treatment for the symptoms in the quiz. Such evidence largely does not exist, according to published systematic reviews and guidelines.4 More importantly, nowhere on the low T website is there a list of adverse effects of testosterone therapy, which would be required if it were an advertisement for the drugs themselves. No mention of exacerbation of congestive heart failure, polycythemia, decreased sperm production, benign prostatic hypertrophy, or increased risk of prostate cancer. The goal here is to equate common symptoms with a disease that is benignly called low T, which obviously could be easily and completely treated by a prescription for testosterone. Unsurprisingly, the campaign has worked very well indeed. Annual US sales of testosterone preparations have grown 10-fold in the past 10 years to$3bn, with almost three million men filling prescriptions.1 2 Do all these men have clear primary or secondary hypogonadism? It seems unlikely.

What is upsetting about this scenario? Firstly, a lot of money is being wasted on unnecessary drugs. Secondly, other treatable diseases with similar symptoms (depression, for example, comes to mind) are being ignored in favor of testosterone treatment. And, of course, thousands if not a million men are being exposed to the risk of serious side effects to treat a “disease” that actually may just be normal aging.

Doctors are not blameless in this fiasco either. Baillargeon and colleagues recently published an analysis of 10 years of prescribing and clinical data concerning more than 10 million men aged 40 years or older who were in a large employer based health plan.1 Of those men to whom testosterone was prescribed, over 25% had had no measurement of testosterone concentrations in the preceding year. Barely half of these men carried a diagnosis of hypogonadism. In some ways, this may be the most upsetting finding of all. The whole low T marketing strategy would collapse if doctors refused to play along and prescribe testosterone for questionable indications.

## Notes

Cite this as: BMJ 2014;348:g182

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