'Low T' and the peril of medicating grumpy old men

Could you have low testosterone?

Thats the question Abbott Laboratories (now AbbVie) has been urging men to consider with its Is It Low T? awareness campaign, a highly effective effort to change how doctors and the public think about managing aging in men.

Since 2008, this massive marketing endeavor has targeted middle-age men who have put on some weight, sometimes feel grumpy or get sleepy after meals, encouraging them to have their testosterone levels tested and to consider treatment if levels are low. It has helped persuade legions of men to take a drug that may not help and may actually do harm for a condition they probably dont have.

In a recent article in JAMA Internal Medicine, we described the tactics such campaigns use to sell disease. Since the start of the campaign, testosterone sales, which had been stable for years, have risen more than 1,800 percent, exceeding $1.9 billion in 2012.

By targeting men worried about weight, muscle tone, energy levels, mood and sexual satisfaction, the campaigns imply that treatment will help them become thinner, more muscular, more energetic, less grumpy and more sexually satisfied. But theres a big problem: We really dont know if diagnosing and treating low T does any good. More important, there is some evidence it may cause harm. Last month, a new study of men found that older men taking the drug were more likely to have heart attacks. Soon after the studys release, the Food and Drug Administration announced a new investigation into the possible harms of testosterone.

Testosterone drugs were initially developed for a narrow use: treating men with a reduced ability to produce testosterone because of such things as trauma, chemotherapy, genetic abnormalities or undescended testicles. For these men, testosterone replacement provides a clear quality-of-life benefit, permitting normal sexual development or restoring male appearance and sexual function. In the years since the drug was first developed, the FDA has approved a whole medicine cabinet of testosterone products gels, pills, patches and even an underarm roll-on.

But who should be getting the drug? Drug information approved by the FDA is ambiguous about which conditions testosterone drugs are approved to treat. This matters because pharmaceutical companies can promote drugs only for on-label FDA-approved uses. Years ago, the Institute of Medicine, the nations premier medical advisory group, described prescribing testosterone for low T as an off-label use. Last month, the FDA seemed to agree. In announcing its new investigation, the agency specifically mentioned that testosterone is approved only to treat hormonal problems caused by medical problems. So why has the FDA tolerated six years of aggressive marketing of the drug to a much wider range of potential patients?

One reason is that the FDA only regulates advertisements that mention drugs by name. Strictly speaking, the disease awareness campaign does not mention any brand names. But this seems like sophistry since the campaign does specifically mention testosterone and lists the variety of ways it is available patches, injections, tablets, etc.

And the Is It Low T? website links to a direct-to-consumer website for the testosterone gel Androgel. Websites for the gel and other testosterone products use tactics very similar to the Is It Low T? website except they explicitly mention the brand-name drug. Doesnt this bump up against FDA regulations about off-label promotion?

Its time for the FDA to rein in these kinds of disease awareness campaigns and branded advertising, because they are misleading: They imply unproven benefits and ignore possible harms.

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'Low T' and the peril of medicating grumpy old men

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