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Editor's Correspondence
January 12, 2009

Men, Androgen Deficiency, and Pharmaceutical Promotion—Reply

Arch Intern Med. 2009;169(1):87-89. doi:10.1001/archinternmed.2008.539

In reply

Dr Finucane suggests that symptomatic androgen deficiency was arbitrarily defined in the Boston Area Community Health (BACH) study1 and seems to imply that the study was a “disease creation” effort related to pharmaceutical marketing. This study was sponsored by the National Institutes of Health, with additional financial support from GlaxoSmithKline for these analyses, as we disclosed in our article. Our disease definition was not arbitrary but based on published clinical practice guidelines from the Endocrine Society, the medical authority on this topic.2 We used a combination of low total testosterone level + low free testosterone + the presence of symptoms (both specific [eg, low libido, osteoporosis, and erectile dysfunction] and nonspecific symptoms). We recognize that there is significant debate over what threshold constitutes low testosterone level. In our publication examining the prevalence of symptomatic androgen deficiency in this study population, our cut points of lower than 300 ng/dL for total testosterone and lower than 5 ng/dL for free testosterone level were empirically superior to others tested insofar as they best corresponded with the prevalence of low libido, which is considered the hallmark symptom of a low testosterone level.3 We chose to consistently define symptomatic androgen deficiency when turning to estimate treatment patterns. In our “Comment” section, we specifically noted that we do not know whether it would have been clinically appropriate to give testosterone to the untreated men but that it is important to monitor treatment patterns in the general population for change, given the marked increase in sales of prescription testosterone in the United States.4

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