American men aged 40 years or older tripled their use of androgen replacement therapy (ART) between 2001 and 2011, including a greater than 5-fold surge in use of the hormone testosterone as a topical gel, according to a recent analysis.
Jacques Baillargeon, PhD, from the Department of Preventive Medicine and Community Health and the Sealy Center on Aging, both at the University of Texas Medical Branch in Galveston, and colleagues report their findings in a research letter published in the August 12/26 issue of JAMA Internal Medicine.
Dr. Baillargeon and colleagues studied prescription drug claims data from Clinformatics DataMart, which tracks employment-based commercial health insurance plans. Some 10.74 million men aged 40 years or older were included in the study population.
During the study period, androgen use rose among men 40 years or older from 0.81% in 2001 to 2.91% in 2011. "By 2011, 2.29% of men in their 40s and 3.75% of men in their 60s were taking some form of ART," Dr. Baillargeon and colleagues write. Androgen use was higher among men who lived in the South (3.77% in 2010 for all men aged 40 years or older) and lower among men who lived in the Northeast (1.60%).
"Our findings that almost 20% of all new users received treatment for 30 days or less and that most men did not have clear evidence of a potential indication for ART suggests that the clinical reasons for initiating therapy are complex," Dr. Baillargeon and colleagues conclude. "More research is needed to determine the extent to which men with normal testosterone levels and ambiguous symptoms seek and are prescribed ART, particularly given the concerns about cardiovascular and other toxic effects from such treatment."
Indeed, in 2 accompanying commentaries, the authors suggest that the rise in prescriptions was driven by pharmaceutical companies' subtle (and sometimes surreptitious) marketing efforts to consumers.
In an editorial by Stephen R. Braun, from Braun Medical Media, Amherst, Massachusetts, explains how he was paid to "trumpet the party line" in ghostwritten articles he authored for a leading endocrinologist that ran in Life After 50, Woman's Day, Business Week, and other magazines. Braun describes a consumer-friendly booklet he wrote on behalf of Solvay, the original maker of AndroGel testosterone gel, as "a shill for the sponsor — an uncritical, unbalanced presentation of 'facts' that serves primarily to drive people to their physicians seeking the holy grail of 'energy, positive mood, and sexuality' in the form of testosterone."
Moreover, he notes that a recent market analysis of sales of testosterone replacement therapies to treat low testosterone, available as gels, transdermal patches, oral formulations, and injections given in a physician's office, have more than doubled since 2006 and are forecast to triple to $5 billion by 2017.
In an invited commentary, Lisa M. Schwartz, MD, and Steven Woloshin, MD, from the VA Outcomes Group, Department of Veterans Affairs Medical Center, White River Junction, Vermont; the Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice; and Norris Cotton Cancer Center, in Lebanon, New Hampshire, write that the "Low T" campaign follows a familiar script: medicalize ordinary life experiences, "raise the stakes" to trigger testing, and "spin the evidence" about benefit and harm.
"Whether the campaign is motivated by a sincere desire to help men or simply by greed, we should recognize it for what it is: a mass, uncontrolled experiment that invites men to expose themselves to the harms of a treatment unlikely to fix problems that may be wholly unrelated to testosterone levels," Dr. Schwartz and Dr. Woloshin write.
Support for the study was provided by the National Institutes of Health. The authors, editorialist, and commentators have disclosed no relevant financial relationships.
JAMA Intern Med. 2013;1458-1460, 1460-1462, 1465-1466.
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Cite this: Low Testosterone: Medical Problem or Marketing Tool? - Medscape - Aug 12, 2013.