![\"\"](\"http://distractible.org/wp-content/uploads/2010/10/mr-T.jpg\" "\\"mr-T\\"")
I\’ve been tired lately. I\’ve been gaining weight and feeling unmotivated as well. I thought that maybe it was because I wasn\’t sleeping enough and was eating too many donuts.
Then my life changed.
I saw a commercial that talked about \”Low T\” being associated with ALL OF MY SYMPTOMS!!! It seems obvious that my sleeping and donut-eating habits aren\’t the culprit. What luck! I just need to rub a gel on my body and everything will be great. I am going to get checked for \”low T.\”
Play this scenario (sans hyperbole) 100 times, and that is what I\’ve been hit with. Multiply that times the number of PCP\’s in the US, and you see evidence of very good marketing. Testosterone replacement for men has become the new magic bullett, a counterpoint to the request for thyroid tests by my female patients – with one big difference: it\’s clearly safe to replace a thyroid hormone deficiency, but not so clear with testosterone.
Today\’s NY Times addressed this very issue, comparing testosterone replacement to one-time dogma of estrogen replacement in women:
Despite beliefs based on observational evidence that estrogen therapy enhanced the health and well-being of menopausal women, when a definitive study was finally done, clinicians and researchers were shocked to discover that the risks of long-term hormone replacement could outweigh its benefits.
Would a similar study of testosterone therapy for men experiencing “andropause” likewise reveal more hazard than help? The answer would be welcomed by an estimated four million men in the United States who have subnormal levels of this important hormone, a common result of advancing age.
Yes, I lived through the estrogen replacement therapy about-face caused by the landmark study, The Women\’s Health Initiative. The medical community was convinced that estrogen replacement gave a good enough heart disease and osteoporosis risk-reduction that it would easily offset any slight increase in breast-cancer risk. There was even a retrospective study supporting this hypothesis. The WHI not only didn\’t show a cardiac benefit, it showed an increase in risk. Wyeth pharmaceuticals, the company who makes Premarin and other estrogen replacement drugs (and the company who funded the study) was devastated, and never really recovered.
So now we have commercials for \”low T\” blasting the airwaves, suggesting a treatment that may not be safe. Is that ethical? Again, from the NY Times:
Late last year, for example, a six-month federally financed study of a testosterone gel put a surprising hitch in efforts to improve the lives of aging men who experience a decline in energy, mood, vitality and sexuality as a result of low testosterone levels. The study, conducted among 209 men 65 and older who had difficulty walking, was abruptly halted when those using the hormone had an unexpectedly high rate of cardiac problems.
The article goes on to point out that the evidence is unclear at this point, and that the study mentioned had flaws. Still, it stirs up the ghosts of hormones past, with the strong possibility that treating \”low T\” will cause harm. And at least estrogen therapy had clear benefits (osteoporosis) and studies that supported the replacement therapy. Unanswered too is if the therapy increased prostate cancer risk (one of the main treatments for prostate cancer is castration, which is cutting the body\’s production of testosterone almost completely – no pun intended).
So how should I respond to these men who just want a little \”get up and go?\” Why is it that I have to fight against a potentially harmful advertising campaign? What is the service (aside from that to investors) the drug companies perform by educating men about \”low T?\” It puts doctors like me in a situation where we could potentially harm our patients.
So what are the limits to advertising by drug companies? Most people are not in favor of any of such advertising, but the government has so far allowed it. Are there ethical guidelines? Consumers assume these ads are being vetted. I really wonder about this in light of the \”low T\” campaign that is allowed to go forth despite lack of proven health benefit (\”get up and go\” doesn\’t qualify as a health benefit) and significant potential risk. I had a man with known coronary heart disease recently insist on getting checked for \”low T.\” I told him that the no matter the lab result, I would not prescribe it for him. He insisted, and yes, the level was low.
Now his doctor is standing in his way to a better life.
Thanks a lot, drug companies.
The problem is that, like many other treatments, the [alleged] benefits are immediate, but the consequences have a double whammy of being both not “guaranteed” (corollary: “I’ll probably be fine,”) and in most cases, dealt with later if at all. Can’t really compete against that. :/ That said, I do think that low testosterone is not taken seriously enough, but it needs to be in context with a realistic expectation of benefit (HRT in women isn’t about making them feel 20 years younger) and expected serum levels of free T adjusted for age.
Dr. Rob,I am a urologist who dabbled a bit in the world of andrology before settling in on a fellowship in GU onc. I too felt very uncomfortable with testosterone replacement. . .I was just unsure what the end point wa supposed to be. I think most urologists would agree that there is no true “normal” T value, at least no exact cutoff. Additionally, levels have to be collected appropriately (am values) using a good assay. Most of the time T is prescribed based on vague symptoms, and a response correlated to an improvement in those same vague symptoms. Lots of placebo effect, it always seemed.
As for the prostate cancer correlation, that is much less strong. Actually, most hypogonadal men have worse prostate cancer than eugonadal men. Normal testosterone (using the current ranges) is probably better for your prostate than less testosterone. They are even using T replacement (in Canada, mainly) in men with a positive prostate biopsy on active surveillance (ie, where therapy is deferred for the time being).
Good article. I also had chance to read the one on PSA testing–don’t agree with you 100% but interesting to have a PCP’s point of view.
J
Dr. Rob,I am a urologist who dabbled a bit in the world of andrology before settling in on a fellowship in GU onc. I too felt very uncomfortable with testosterone replacement. . .I was just unsure what the end point waa supposed to be. I think most urologists would agree that there is no true “normal” T value, at least no exact cutoff. Additionally, levels have to be collected appropriately (am values) using a good assay. Most of the time T is prescribed based on vague symptoms, and a response correlated to an improvement in those same vague symptoms. Lots of placebo effect, it always seemed.
As for the prostate cancer correlation, that is much less strong. Actually, most hypogonadal men have worse prostate cancer than eugonadal men. Normal testosterone (using the current ranges) is probably a predictor for less aggressive disease than decreased levels. They have even reported using T replacement (in Canada, mainly) in “symptomatic” men with a positive prostate biopsy on active surveillance (ie, where therapy is deferred for the time being).
Good article. I also had chance to read the one on PSA testing–don’t agree with you 100% but interesting to have a PCP’s point of view.
J
Thanks. I think anyone who thinks a little about this will be uneasy. The problem is, some don’t think.
Many folks, and even some of us physicians, believe that low levels of any lab result should be remedied. While this makes sense with thyroid hormone levels, sometimes it leads to sillyness. Testosterone and female hormones may be examples of this. Should we give IV albumin to patients with low albumin levels? What if the WBC count is low? Hey, your AST and ALT values are low, have a liverwurst sandwich!
Amen. Who knows what to do with all these low testosterone levels. This fellow with CAD and “low T” is much like the breast cancer survivor with hot flashes. You don’t give her estrogen.