Television ads for testosterone products were highly successful, leading to dramatic increases in the number of men taking testosterone drugs, according to a new study published in the Journal of the American Medical Association.
J. Bradley Layton (University of North Carolina, Chapel Hill) and colleagues analyzed the relationship between ratings in 75 television markets and data on testosterone initiation and use based on commercial insurance claims. Within the study area, which contained more than 17 million commercially insured men, more than 1 million had a new serum test and more than a quarter million initiated testosterone treatment during the study period between 2009 and 2013.
Although testosterone is approved only for men with pathological hypogonadism, the pharmaceutical industry spent years promoting its much broader use as a "lifestyle" drug in men despite an absence of evidence for either safety or efficacy. The authors wrote that existing studies "offer little support for widespread use of testosterone outside the narrow approved indications."
Testosterone uptake correlated closely with advertising intensity. The authors calculated that each commercial resulted in an increase in new testosterone testing, new initiation of treatment, and even new initiation of treatment without a recent test. Each individual television ad was associated with an increase in 0.14 tests, 0.05 new initiations, and 0.02 initiations without a recent test per 10,000 men exposed to the ad.
Although the increase associated with each individual advertisement was small, the cumulative effect was quite large, since "advertisements were widespread and frequent during the study period; with cumulative ad exposures of close to 200" in some markets, the researchers said.
"This study confirms both the pros and cons of direct-to-consumer advertising of pharmaceutical products, a practice allowed only by the U.S. and New Zealand among high-income economies," commented Joe Ross (Yale University). "On the pro side, DTCA works – men who were exposed to the ads were more likely to seek out testing and treatment. But on the con side, DTCA likely motivates overuse of a treatment that has been associated with increased risk and without strong evidence of benefit."
Ross continued, "Many men who were exposed to ads received treatment without being appropriately tested, and thus may not have even had the disease for which the treatment is indicated. DTCA can play an important role in disease awareness for less common or stigmatized conditions, but there are accompanying risks in over-testing and over-treatment, potentially leading many patients to receive treatment who are unlikely to benefit, exposing them only to the risks of therapy."
In an accompanying editorial, Richard Kravitz (University of California, Davis) wrote that the industry's campaign was "startlingly effective" and that "physicians were ill prepared to respond, as practice guidelines at the time were ambiguous."
Kravitz continued: "As learned intermediaries, physicians are supposed to protect consumers from the potential adverse effects of drug advertisements. However, when clinical indications are weak or uncertain, signals of harm are suggestive but unproven, and patient demand is strong, physicians may not be able to provide that protection."
It is worth mentioning here that there are some physicians who played, and continue to play, an active role in promoting the benefits of testosterone (and other unproven products and tests) to enhance lifestyle.