Barbara Mintzes1. 1. Charles Perkins Centre and Faculty of Pharmacy, University of Sydney, Sydney, New South Wales, Australia.
Abstract
PURPOSE OF REVIEW: To summarize the research evidence on promotion of testosterone for 'Low T', or age-related hypogonadism. RECENT FINDINGS: Marketing of testosterone for 'Low T' has relied on strategies that are inadequately regulated to prevent off-label promotion, such as unbranded 'disease-awareness' advertising campaigns targeting the general public, sponsored continuing medical education (CME) and ghostwriting. A recent US analysis of television advertising exposure levels versus insurance claims found that both unbranded 'disease-awareness' advertising and branded ads were associated with increased rates of testosterone testing, treatment initiation, and treatment without prior testing. Exposés of sponsored CME and ghostwriting indicate misrepresentation of the research evidence on the sequelae of untreated low testosterone and on treatment efficacy. In the United States, advertising to the general public ceased in 2014 after the Food and Drug Administration changed product labeling to clarify that testosterone is only indicated for pathological hypogonadism. Unbranded 'disease-awareness' advertising to the general public and 'Low T' messages for health professionals have continued elsewhere. SUMMARY: The review of the experience of promotion of testosterone for 'Low T' and research evidence on effects of advertising targeting the public highlights the need for improved regulation of unbranded 'disease awareness' advertising to ensure adequate protection of public.
PURPOSE OF REVIEW: To summarize the research evidence on promotion of testosterone for 'Low T', or age-related hypogonadism. RECENT FINDINGS: Marketing of testosterone for 'Low T' has relied on strategies that are inadequately regulated to prevent off-label promotion, such as unbranded 'disease-awareness' advertising campaigns targeting the general public, sponsored continuing medical education (CME) and ghostwriting. A recent US analysis of television advertising exposure levels versus insurance claims found that both unbranded 'disease-awareness' advertising and branded ads were associated with increased rates of testosterone testing, treatment initiation, and treatment without prior testing. Exposés of sponsored CME and ghostwriting indicate misrepresentation of the research evidence on the sequelae of untreated low testosterone and on treatment efficacy. In the United States, advertising to the general public ceased in 2014 after the Food and Drug Administration changed product labeling to clarify that testosterone is only indicated for pathological hypogonadism. Unbranded 'disease-awareness' advertising to the general public and 'Low T' messages for health professionals have continued elsewhere. SUMMARY: The review of the experience of promotion of testosterone for 'Low T' and research evidence on effects of advertising targeting the public highlights the need for improved regulation of unbranded 'disease awareness' advertising to ensure adequate protection of public.
Authors: Adithya Balasubramanian; Nannan Thirumavalavan; Ashwin Srivatsav; Justin Yu; Larry I Lipshultz; Alexander W Pastuszak Journal: J Sex Med Date: 2019-02 Impact factor: 3.802