Televised direct-to-consumer advertising for testosterone therapies increased across U.S. metropolitan areas between 2009 and 2013, and exposure to these ads was associated with greater testosterone testing, new use of testosterone therapies, and use without recent testing, according to a study led by Dr. J. Bradley Layton, research assistant professor of epidemiology at the UNC Gillings School of Global Public Health.
[Photo: Dr. Bradley Layton]
The study was published online March 21 in the Journal of the American Medical Association (JAMA).
Testosterone therapies originally were approved to treat hypogonadism (a condition in which the body does not produce enough testosterone) resulting from the disruption of the pituitary-hypothalamus-gonadal axis. Now, many men take or are prescribed testosterone for age-related reduced testosterone levels or nonspecific symptoms without pathological hypogonadism.
Testosterone initiation increased substantially in the United States from 2000 to 2013, especially among men without clear indications. Direct-to-consumer advertising also increased during this time.
Dr. Layton and colleagues examined associations between televised advertising and testosterone testing and initiation in 75 designated market areas (DMA) in the United States. They derived monthly testosterone advertising ratings from commercial insurance claims and linked those ratings to 2009-2013 testosterone-use data in the market areas.
The authors then estimated associations between television advertising and testosterone testing, initiation and initiation without recent baseline tests. They defined “initiation” of testosterone gels, patches, injections or implants as being newly dispensed by a pharmacy or by an in-office receipt (identified through procedure codes) of testosterone, following six months without having received testosterone.
Of 17,228,599 commercially insured men in the 75 market areas, 1,007,990 (average age, 50 years) had new serum testosterone tests, and 283,317 (average age, 52 years) initiated testosterone treatment.
Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States. Monthly data showed a range between no ad exposures to an average of 13.6 exposures per household.
Non-branded advertisements were common prior to 2012, with branded advertisements becoming more common during and after 2012. Each household advertisement exposure was associated with a monthly increase in rates of new testosterone testing, initiation and initiation without a recent test.
“Testosterone advertisements were associated with increased testosterone testing and use in the time period we surveyed,” Dr. Layton said. “This all occurred during a time when there was rapidly increasing use, but with unresolved safety concerns and little evidence of benefit for treating men with normal, age-related testosterone-reductions or non-specific symptoms.”
Dr. Layton said previous studies had shown that patients’ specific requests for treatments can influence physicians’ prescribing – and that many men starting testosterone therapy were not following guidelines for assessing and treating hypogonadism.
“If advertisements increased patients’ demand for testosterone, it could have contributed to large amounts of testosterone use in men without there being sound reasons for taking it,” he said.
The authors reported that “[a]lthough the average increase in testosterone rates associated with a single ad exposure was less than 1 percent, advertisements were widespread and frequent during the study period. With cumulative ad exposures of close to 200 in some [market areas], direct-to-consumer advertising was associated with substantial overall increases in testosterone testing and initiation.”
Other studies had demonstrated associations between advertising and increasing medication use, the authors reported, but the new study demonstrated increasing initiation and potentially inappropriate use.
“[The increase in initiation occurred] during a time when most testosterone use was of questionable value for age-related testosterone decreases without strong evidence of benefit,” the researchers wrote. “This study complements many others that suggest the contribution that direct-to-consumer advertising may make in the early adoption of recently approved treatments whose risk-benefit profile may be quite unclear.”