For those who go through all the testing anyway, whatever the costs and hassle, and turn up positive for LowT, there's still the question of what happens next. Should we hold a 70-year-old male to the same testosterone standards as a 35-year-old male? Experts disagree on whether the “normal” levels should be scaled back in an age-dependent manner, but their debate raises a central question: Are falling testosterone levels a “mistake” of aging, like arthritis—a complication that should be treated? Or are they a natural, wholesome change, and one not to be tampered with?
We have some prior clinical experience with this, and it’s called hormone replacement therapy. For years we badgered menopausal women to prop up their sagging hormone levels, only to find out—shucks—that doing so increased their risk of breast cancer, heart disease, and stroke. Granted, male andropause isn’t the hormonal free-fall that menopausal women experience, but the concerns about unintended consequences of testosterone therapy are just as real, and include the risk of accelerating heart disease and prostate cancer. There are seasons of life, and the bikini you wore in summer may not work for you in the dark of winter. Hormones critical to our younger life may well have different consequences as we grow older.
The risks of hormone replacement therapy for aging women didn’t become clear until the completion of a very large study called the Women’s Health Initiative. But there have been relatively few studies on testosterone therapy in older men, and those that have been done suffer from small sample sizes and a lack of long-term data, or from not having a placebo arm (which is critically important when you're dealing with subjective symptoms like energy level and sex drive). In 2004, the Institute of Medicine completed a systematic review of these trials and found no clear evidence of benefit for any of the health outcomes examined, and that includes machismo. Since then there haven’t been any new studies powerful or definitive enough to draw a different conclusion. From the IOM findings came the impetus for “The T Trial,” a large, multicenter study on treating low testosterone levels in older males that began in 2009 and should be finished by 2015. (Interestingly, Solvay Pharmaceuticals, an Abbott Laboratories subsidiary, is one of the trial’s sponsors, providing the testosterone gel.)
While we await results from The T Trial, Abbott’s LowT campaign appears willing to ask men to bravely go where few men have gone before. Why are we seeing ads for a treatment that has unproven benefits and real safety concerns? It started with the broad approval assigned to Abbott's testosterone replacement product, Androgel, by the Food and Drug Administration. The government gave Abbott permission to sell its product as a treatment for male hypogonadism (i.e. "LowT"), without specifying exactly what constitutes the condition in the aging male. (That's left up to individual physicians.) But even if the FDA hadn't approved the drug for this use, the "Is It LowT?" ads would still be kosher, since they're not directly promoting the treatment. These spots are classified by the FDA as "Help Seeking Ads," which describe a disease or condition but don't recommend a specific drug.
If Abbott is really looking to deliver help to the help-seeking—aging males lurking in the shadows—it might buy airtime to encourage older men who’ve lost the hots for hoops to enter The T Trial. That would help us find out whether testosterone therapy for the aging male is good medicine, or just wishful thinking.