A couple days ago I wrote about the discrepancy between the levels of research into men’s health and into women’s health. As it turns out, there are areas in which we know less about men’s health than about that of women. One of those areas is hormone replacement therapy.
If you were still watching broadcast TV a couple years ago, you couldn’t escape the ads for prescription testosterone therapy. Products were available as pills, as gels, as injections, even as an underarm roll-on. The marketers came up with a condition they called “Low T,” which is just what it sounds like—low blood levels of the hormone testosterone. The ads have pretty much disappeared as prescription testosterone therapy comes under increased scrutiny by the FDA.
The Testosterone Controversy
Testosterone replacement therapy has been around for many years. At one time it was recommended strictly for men who for medical or surgical reasons were unable to manufacture testosterone on their own. The promise of restoring youth was too powerful to resist, though, and doctors began prescribing the therapy to older men who felt their “vitality” slipping away. Low levels of testosterone are associated with loss of skin tone and muscle mass, loss of energy and “drive,” and declining sexual interest. The idea was that restoring levels of testosterone would rejuvenate the patient, making them look and feel like a younger man again.
But a 2002 report from the Institute of Medicine cast doubt on the effectiveness of testosterone therapy—as well as on its safety. More recent clinical trials have reported benefits for certain groups, at least convincing enough that the FDA approved testosterone replacement therapy for a broader population. But concerns still linger about how tightly prescribing should be controlled, and about the overall safety of the therapy.
Ignorance Is Definitely Not Bliss
In 2002 researchers halted a major clinical study because results showed the therapy, hormone replacement therapy for women, increased the risk of heart disease and some cancers. There was a huge outcry at the time. How could it have taken more than 50 years for these risks to become known?
We’re at a similar stage with men’s hormone therapy. Our FDA is getting its act together, although a little late. In March of this year the agency required changes to labeling for all testosterone products to highlight the increased risk of heart attack and stroke in users of the products. And just this week the agency said it is encouraging manufacturers to work together on a large after-market trial to determine the true risks and benefits of testosterone replacement therapy.
I’m not a big fan of the FDA, because I believe they’re generally more responsive to the interests of industry than to those of the American public. I am glad to see that they’re finally “encouraging” such research, even though it should have been done 20 years ago. It’s too bad that the push comes after more than 2,000 lawsuits have been filed by people who believe their use of testosterone replacement therapy caused a heart attack or stroke. We’ll see how those suits turn out; the first one isn’t scheduled to come to trial next year. In the meantime, docs will go on prescribing testosterone for men even without a complete understanding of the risks.