The FDA prides itself on taking an active role in protecting consumers from the risks associated with direct-to-consumer testing. Yet the FDA has been notably restrained on the pharmaceutical marketing saturating the media and Internet concerning “Low T”, a condition that might be a “disease” or simply just a slick advertising strategy to generate drugs sales.
Low T is the term for the decreasing blood level of the male hormone testosterone in most men over the age of 30. While extreme testosterone deficiency is an actual inherited or acquired hormonal disease in a small number of men, a gradual drop in testosterone occurs in normal aging men (in contrast to the precipitous drop in sex hormones experienced by women at menopause). Although Low T is a campaign to diagnose patients with “below normal” values of testosterone, this is problematic because the “normal” range for testosterone in the blood for males varies widely from age 30 through age 80.
The ostensible purpose of diagnosing Low T appears to be to create a market to sell testosterone supplements to a significant segment of middle-aged American and Canadian men. And it’s working – in both countries testosterone use has increased exponentially in the past decade. In a 2012 Colbert Report, Stephen Colbert facetiously, but accurately, described the billion-dollar industry, “A man on TV is selling me a miracle cure that will keep me young forever…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.”
The pharmaceutical marketing of testosterone supplements avoids the scrutiny of the FDA by exploiting loopholes in the advertising laws. The FDA closely monitors prescription medication advertising - witness the fast talking fine-print patter on television - but a company can circumvent that by creating a “disease-awareness” campaign. Low T advertising becomes part of disease-awareness, or in the industry jargon, having men take a proactive approach to their overall health. Commercials advise men to see their doctor for a checkup and get tested for blood pressure, cholesterol - and testosterone. The unstated message being that Low T is now a risk factor comparable to high blood pressure or elevated cholesterol. That’s what is meant by disease-awareness.
Of course, a disease usually has symptoms, especially if a specific treatment is being marketed to the public. So according to the advertising, symptoms of Low T include occasional fatigue, weight gain, mood swings, and decreased sex drive. Basically, symptoms endemic in aging baby-boomer males. In this way, Low T is essentially transformed into a “quality of life” disease.
None of this means that testosterone supplements in patients with low testosterone levels have no benefit; testimonials to its effectiveness are not hard to come by. But testimonials are not the same as a proven scientific benefit; there is simply insufficient clinical literature on that count. A recent article in the Journal of The American Medical Association said, “Testosterone therapy results in only small improvements in lean body mass and body fat, libido, and sexual satisfaction, and has inconsistent (or no) effect on weight, depression, and lower extremity strength. Whether these effects are big enough to matter to patients is unknown.”
At the same time, there is no guarantee treating Low T is completely safe. Some cardiologists worry that one important side effect of testosterone supplement may be accelerated coronary heart disease. As with the benefits of testosterone supplementation, the risks have not received enough scientific scrutiny to date. Since the Low T advertisements are careful not to refer to any specific medicine, there is no obligation to mention any downsides to treatment, unlike warnings that must be included for prescription drug advertising.
Today middle-aged men find themselves in a similar position to women of a generation ago. Then, the medical community pushed for estrogen and progestin supplementation in women during and after menopause, on the theory that hormone supplementation would confer protection against heart disease. It was not until that a 2002 Women’s Health Initiative long-term study of hormone replacement in 160,000 women failed to demonstrate such protection. In fact, it was suggested the treatment might have increased the danger to women of heart disease and cancer.
If there is a difference between then and now, it is that the pharmaceutical industry has wholeheartedly embraced the modern direct-to-consumer marketing approach that bypasses the physician. While there are undeniably public health benefits to the direct-to-consumer approach in terms of promoting health awareness, there is a fine line between that and a manufactured campaign for a pseudo-disease. And as the case of Low T illustrates, there is lots of money to be made straddling that line. That straddle may not be illegal, or even unethical. But it’s close, and until greater study is done on the risks and benefits of testosterone supplements in Low T, the FDA should be paying special attention to this new disease.
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