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Disease Mongering of Age‐Associated Declines in Testosterone and Growth Hormone Levels

T. Perls,David Handelsman

Published 2015 in Journal of The American Geriatrics Society

ABSTRACT

A combination of direct-to-consumer product advertising (DTCPA) and lax consensus guidelines for testosterone prescribing have, over the past decade, led to 10and 40-fold increases in testosterone prescriptions in the United States and Canada, respectively, with Internet pharmacies playing a major role in the latter’s increase. U.S. pharmaceutical sales of testosterone increased from $324 million in 2002 to $2 billion in 2012, and the number of testosterone doses prescribed climbed from 100 million in 2007 to half a billion in 2012, not including the additional contributions from compounding pharmacies, Internet, and direct-to-patient clinic sales. On September 17, 2014, the U.S. Food and Drug Administration (FDA) convened a meeting to address concerns that many men are receiving testosterone who should not and because of reports of adverse cardiovascular events in men using testosterone. We join others who characterize the mass marketing of testosterone coupled with the permissive prescribing of testosterone for common, nonspecific, agingrelated symptoms as disease mongering of declines in testosterone with advancing age. Disease mongering is defined as “the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments.” The prescribing of growth hormone for “antiaging” or “age management” is another example of disease mongering. DTCPA is the mass marketing component of disease mongering of age-related declines in testosterone. With advertising directed primarily at baby boomers, age-related complaints such as “slowing down” and low libido are attributed to catchy medicalized sounding syndromes like “low T” and “andropause.” These syndromes are likened to menopause, which is a false and misleading analogy because middle-aged men do not experience any universal or sharp decline in serum testosterone. The pharmaceutical industry asserts that DTCPA is an important service to the public that helps people and their doctors become aware of treatable medical problems. However, when sophisticated mass marketing is directed toward people lacking the technical expertise to critically evaluate the deceptively simplified medical science claims that such advertising makes, there is ample opportunity for disease mongering. Because doctors are the prescription gatekeepers, these advertisements can effectively pit patients against their doctors, pressuring them for compliant prescribing on demand and distorting clinical judgment. As a result, recognizing the dangers, nearly all countries prohibit DTCPA, except Canada, New Zealand, and the United States. The other enabler of disease mongering of age-related declines in testosterone is lax professional consensus panel prescribing guidelines. Guidelines created over the last decade, some sponsored by manufacturers of testosterone products, have stretched the definition of hypogonadism, a clinical disorder of the hypothalamus–pituitary–testicular axis that has a pathological basis, to include functional disorders so as to include men with an unexplained low serum testosterone level (without any underlying reproductive pathology) accompanied by complaints that are commonly associated with classical hypogonadism but also many age-related comorbidities. Marketers of “low T” have capitalized upon the nonspecificity of these agerelated symptoms by encouraging men to take questionnaires of equally low specificity focusing on common complaints such as low energy, feeling sad, sleep problems, decreased physical performance, or increased fat. Notably, in middle-aged and older men who report excellent health, aging is not associated with a decrease in serum testosterone, highlighting the effect of age-associated comorbidities rather than age itself upon testosterone levels. These nonreproductive disorders, such as obesity, may invoke adaptive responses of an intact reproductive system, the net effects of which, a priori, may be beneficial, neutral, or adverse. The appropriate treatment for such functional declines in serum testosterone is not testosterone but reversing the underlying condition. Because unselected aging men with comorbidities will display a gradual decrease in serum testosterone with age, using any fixed serum testosterone threshold, the proportion of men with a “low” serum testosterone will automatically increase with age and be mislabeled as “late-onset hypogonadism.” This has led to claimed prevalences of agerelated hypogonadism of up to 40%, representing an almost 100-times larger market size over the estimated age-invariant prevalence of 0.5% of men who have testosterone deficiency due to a pathological disruption of the hypothalamus–pituitary–testicular axis. In an attempt to define a more-specific syndrome of “late-onset hypogonadism,” the latest medicalized term for “low T” or “andropause,” Wu and colleagues compared men with low serum testosterone with those with normal levels and found no difference in the prevalence of 23 of 32 potentially associated symptoms or in clusters of physical or psychological symptoms. They reported a cluster of DOI: 10.1111/jgs.13391

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