Researchers say testosterone ads amount to disease mongering

Researchers have had enough with DTC advertising that promotes testosterone drugs and said so in an editorial published Tuesday in the Journal of the American Geriatrics Society.

Dr. Thomas Perls of Boston Medical Center and researcher David Handelsman of the University of Sydney wrote that misleading advertising fueled the prescription testosterone business, which saw US sales jump from $324 million in 2002 to $2 billion in 2012.

The doctors blame pharmaceutical marketers for exploiting the FDA's decision to approve testosterone products “without proof of clinical efficacy” to normalize serum testosterone levels in patients with hypogonadism, which is when the body does not produce enough testosterone. Low testosterone levels can impact growth and typically peak during adolescence and early adulthood, according to the Mayo Clinic. Testosterone is also associated with maintaining muscle mass, blood cell production and sex drive. Mayo and the study's researchers noted that testosterone naturally declines with age, but a natural decline does not necessarily warrant a prescription. 

The researchers wrote that the ads latch on to symptoms, such as fatigue, that can be associated with hypogonadism but are often the result of conditions like obesity.

They also wrote that this efficacy loophole allowed advertisers to sell prescription testosterone for conditions that do not exist. The doctors took issue with “catchy medicalized sounding syndromes like ‘low T' and ‘andropause' ” that liken waning testosterone levels to menopause. They wrote this is misleading “because middle-age men do not experience any universal or sharp decline in serum testosterone.”

They also said medical groups have failed to create a consensus around prescribing guidelines but at the same time they are using industry-created ones that have “stretched the definition of hypogonadism” and are so inclusive that a general list of complaints could result in a prescription.

The doctors are not alone in their criticism. The FDA announced label changes for these products earlier this month. The regulator's changes include alerting patients that the drugs may be associated with a cardiovascular risk and it said “the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone.”