Direct-to-Consumer Advertising of Androgen Replacement Therapy

[Michael Scally MD]

Kravitz RL. Direct-to-Consumer Advertising of Androgen Replacement Therapy. JAMA. 2017;317(11):1124-1125. Direct-to-Consumer Advertising of Androgen Replacement Therapy

Ads promoting androgen replacement therapy for testosterone deficiency emphasized the high prevalence of subnormal testosterone values in men older than 45 years and implicitly promised better quality of life and improved performance “in the boardroom and the bedroom.”

Until 2012, direct-to-consumer advertising (DTCA) of androgen replacement therapy emphasized nonbranded “disease awareness” spots urging middle-aged men to consult their physicians for common symptoms (eg, fatigue) that might be the result of “low T.” After that time, ads for branded products, such as for Androgel and Axiron, became more common. The industry’s campaign was startlingly effective.

In this issue of JAMA, Layton and colleagues provide evidence that in the period between 2009 and 2013, DTCA of androgen replacement therapy was associated with an increase in new testosterone testing, new testosterone initiation, and, in a departure from existing guidelines, testosterone initiation without prior testing. Direct-to-Consumer Advertising and Testosterone Testing and Initiation

If anything, nonbranded “condition awareness” ads for “low T” were more powerful motivators than ads promoting Androgel and Axiron. By merging data on DTCA exposure (using Nielson ratings in 75 communities) and a large commercial claims database, the authors estimated that 1 additional exposure to an androgen replacement therapy television advertisement was associated with 14 new tests, 5 new initiations, and 2 initiations without testing per 1 million men exposed.

The study used an ecological time-series design, and the results were sensitive to the length of the “lag period” imposed between exposure to androgen replacement therapy–related DTCA at the regional level and testosterone testing and initiation. Nevertheless, the data are consistent with what is known about DTCA in general: patients respond to DTCA and physicians respond to patients.

Whether DTCA improves or worsens the health of the public depends on the balance among 4 factors:
(1) prevalence of the condition in the population targeted by advertising;
(2) diagnostic accuracy in community practice;
(3) prognosis (expected clinical course of the target condition, either with no treatment or with the best available alternative treatment); and
(4) effectiveness and safety of the advertised product.

 

[Michael Scally MD]

Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation

Question - Is there an association between televised direct-to-consumer testosterone advertising and testosterone testing and initiation in the United States?

Findings - In this ecological study of 75 US designated market areas, each exposure to a testosterone advertisement was associated with monthly relative increases in rates of new testosterone testing of 0.6%, new initiation of 0.7%, and initiation without a recent baseline test of 0.8%.

Meaning - Regional exposure to televised direct-to-consumer advertising was associated with greater testosterone testing, new initiation, and initiation without recent serum testosterone tests.

Layton JB, Kim Y, Alexander GC, Emery SL. Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013. JAMA. 2017;317(11):1159-1166. Direct-to-Consumer Advertising and Testosterone Testing and Initiation

Importance - Testosterone initiation increased substantially in the United States from 2000 to 2013, especially among men without clear indications. Direct-to-consumer advertising (DTCA) also increased during this time.

Objective - To investigate associations between televised DTCA and testosterone testing and initiation in the United States.

Design, Setting, and Population - Ecologic study conducted in designated market areas (DMAs) in the United States. Monthly testosterone advertising ratings were linked to DMA-level testosterone use data from 2009-2013 derived from commercial insurance claims. Associations between DTCA and testosterone testing, initiation, and initiation without recent baseline tests were estimated using Poisson generalized estimating equations.

Exposures - Monthly Nielsen ratings for testosterone DTCA in the 75 largest DMAs.

Main Outcomes and Measures - (1) Rates of new serum testosterone testing; (2) rates of testosterone initiation (in-office injection, surgical implant, or pharmacy dispensing) for all testosterone products combined and for specific brands; and (3) rates of testosterone initiation without recent serum testosterone testing.

Results - Of 17 228 599 commercially insured men in the 75 DMAs, 1 007 990 (mean age, 49.6 [SD, 11.5] years) had new serum testosterone tests and 283 317 (mean age, 51.8 [SD, 11.3] years) initiated testosterone treatment.

Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States and with months ranging from no ad exposures to a mean of 13.6 exposures per household. Nonbranded 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 (rate ratio [RR], 1.006; 95% CI, 1.004-1.008), initiation (RR, 1.007; 95% CI, 1.004-1.010), and initiation without a recent test (RR, 1.008; 95% CI, 1.002-1.013). Mean absolute rate increases were 0.14 tests (95% CI, 0.09-0.19), 0.05 new initiations (95% CI, 0.03-0.08), and 0.02 initiations without a recent test (95% CI, 0.01-0.03) per 10 000 men for each monthly ad exposure over the entire period.

Conclusions and Relevance - Among US men residing in the 75 designated market areas, regional exposure to televised direct-to-consumer advertising was associated with greater testosterone testing, new initiation, and initiation without recent testing.