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. 2017 Mar 21;317(11):1159-1166.
doi: 10.1001/jama.2016.21041.

Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013

Affiliations

Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013

J Bradley Layton et al. JAMA. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Alexander is chair of the FDA’s Peripheral and Central Nervous System Advisory Committee, serves as a consultant to a mobile startup to improve patient pain management, serves as a paid consultant to Quintiles IMS Health, and serves on a Quintiles IMS Health scientific advisory board. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. No other disclosures were reported.

Figures

Figure 1
Figure 1
Mean Testosterone Testing and Initiation Rates Among Adult Men in the 75 Largest Designated Market Areas in the United States, January 2009–December 2013 Shaded areas are interquartile ranges. Vertical dotted lines in all panels indicate 3 key events that may be associated with overall use: (1) May 2009, US Food and Drug Administration warning of transfer of testosterone gel from men to women and children; (2) April 2011, release of new testosterone gel formulations; and (3) August 2012, increased concern about cardiovascular safety of testosterone products as evidenced by the National Institutes of Health funding safety studies of testosterone in older men.
Figure 2
Figure 2
Mean Household Testosterone Advertisement Exposures From Nielsen Television Ratings Across the 75 Largest Designated Market Areas in the United States, November 2008–October 2013 Shaded areas are interquartile ranges.
Figure 3
Figure 3
Geographic Distribution of Cumulative Testosterone Advertisement Exposures From Nielsen Television Ratings (Total Summed Ratings, November 2008–October 2013) in the 75 Largest US DMAs Monthly advertisement exposures were summed across the entire study period within designated market areas (DMAs), and DMAs were stratified into 7 strata of cumulative advertising exposures containing approximately equal numbers of DMAs. The borders between exposure strata were defined empirically; thus, there are gaps between strata where no DMA had measures in that range.

Comment in

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