The marketing of testosterone drugs for either “low T” or “andropause” (so-called male menopause) — is disease mongering and should be banned, according to an editorial published last week in the Journal of the American Geriatrics Society by two experts on aging and men’s health.
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, point out the editorial’s authors, Dr. Thomas Perls, a geriatrician at Boston University, and David Handelsman, a professor of endocrinology and andrology at the University of Sydney in Australia.
In the U.S. alone, annual sales of testosterone jumped from $324 million in 2002 to $2 billion in 2012.
Yet the vast majority of those sales are inappropriate, say Perls and Handelsman.
Stretching the definition
Testosterone drugs are supposed to be used only by men whose low testosterone levels are due to hypogonadism — a relatively rare medical condition caused by a disorder of the testicles, pituitary gland or brain.
But, as Perls and Handelsman explain, testosterone manufacturers have taken advantage of regulatory loopholes in recent years to broaden the definition of hypogonadism, an effort aided by “lax” prescribing guidelines from professional medical groups (guidelines often sponsored by the drug manufacturers).
No longer must a man’s low testosterone levels be caused by an established medical disorder for him to be diagnosed with hypogonadism. 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.
That’s a classic case of disease mongering — “the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments,” say Perls and Handelsman.
The drug companies — and some doctors — have even come up with a new medicalized name for this more encompassing condition: “age-related hypogonadism.” Yet, as Perls and Handelsman stress, “there is no convincing evidence that testosterone treatment of ‘age related hypogonadism’ is beneficial or safe.”
As the two men also note, middle-aged and older men who are in excellent health tend not to experience drops in testosterone — a finding that strongly suggests that lower levels of the hormone are caused by underlying health issues rather than age.
Doctors should be treating those health issues rather than the testosterone levels, they add.
More action needed from FDA
Earlier this month, the U.S. Food and Drug Administration (FDA) announced that companies advertising prescription testosterone drugs — those “low T” products ubiquitously on TV and elsewhere — must make it clear to consumers that the drugs should be used only by men with lab-diagnosed hypogonadism and not by men with low testosterone levels associated with aging.
The FDA also ordered the companies to make sure the products’ labels include a warning that the drugs are associated with an increased risk of heart attack and stroke.
Those cautionary steps are welcomed — but they don’t go far enough, according to Perls and Handelsman.
To discourage further disease mongering of low testosterone levels, the two men are calling on the FDA, along with the Federal Trade Commission, to ban the advertising of testosterone products for “contrived” conditions, such as “low T” or “andropause.”
They are also asking Health Canada to do the same. The U.S. and Canada, along with New Zealand, are the only countries in the world that allow direct-to-consumer pharmaceutical advertising.
Perls and Handelsman also want the FDA to require physicians to show evidence — through lab and other test results — that a patient has a legitimate testosterone deficiency before he is given a prescription for the drug.
“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,” they write. “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 judgement.”
The editorial can be read in full on the Journal of the American Geriatrics Society website.