Call to Ban “Low Testosterone” Ads as “Disease-mongering”

An editorial in the Journal of the American Geriatrics Society has called for a ban on advertisements about testosterone replacement therapy in the wake of massive increases in inappropriate and potentially dangerous prescribing of the hormone for a wide variety of physical and psychological conditions. The FDA also recently issued warnings about the practice.

“A combination of direct-to-consumer advertising and lenient professional prescribing guidelines has led to a 10-fold increase in testosterone prescriptions in the United States and a 40-fold increase in Canada during the past decade,” reported MinnPost. “Under the new, expanded definition, any middle-aged or older man with somewhat lower testosterone levels and common age-related complaints, such as fatigue, sleep problems, weight gain, feelings of sadness and decreased libido or physical abilities, can receive a hypogonadism diagnosis — and a prescription for testosterone.”

“Testosterone is FDA-approved as replacement therapy only for men with low testosterone levels due to disorders of the testicles, pituitary gland, or brain that can cause hypogonadism,” stated the FDA. “However, FDA has become aware of testosterone being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established. Additionally, based on the available evidence from published studies and expert input from an advisory committee, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use… Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment…”

“We applaud the FDA’s recent joint committee meeting and labeling changes to address what we and others view as disease mongering of age-related declines in testosterone for ‘age-related hypogonadism’ or ‘antiaging’, stated the editorial in the Journal of the American Geriatrics Society. “We call upon Health Canada, the U.S. FDA, and the Federal Trade Commission to ban educational and product advertising of testosterone for these contrived ‘indications’.”

‘Low T’ marketing is disease mongering and should be banned, say experts (MinnPost, March 30, 2015)

FDA Drug Safety Podcast: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use (FDA Drug Safety Podcast, March 5, 2015)

Perls, Thomas, and David J. Handelsman. “Disease Mongering of Age-Associated Declines in Testosterone and Growth Hormone Levels.” Journal of the American Geriatrics Society, March 1, 2015, n/a – n/a. doi:10.1111/jgs.13391. (Full text)