Clinical hypogonadism and the urologist’s role: Primum non nocere

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I consider urology to be a very unique field, one that I am lucky to be part of. We deal with conditions and talk to patients about problems that are not often discussed in “polite” conversation.

Professionally, we take this responsibility very seriously. We constantly push the field forward, taking full advantage of advances in both technology (ESWL, robotics, and ureteroscopy, for example) and pharmacology (PDE-5 inhibitors and beta-3 agonists, to name two), even when using them sometimes decreases our own surgical volume. Recently, though, I have begun to wonder whether the medical community (not necessarily the urology community) has been too quick to embrace the widespread use of testosterone replacement therapy.

Testosterone replacement therapy is not new. Some of the early work came in 1889 from Brown-Sequard, when, at the age of 72, he injected himself with a combination of dog and guinea pig testicular extract and reported increased vigor. I’ve often wondered if Brindley had that article in mind during his famous 1983 AUA presentation on the effects of penile self-injection of phenoxybenzamine. (Click here if you’re not familiar with that bit of urology lore.) 

Within 50 years, Butenandt (1931) had isolated androgen and Rizica (1935) had synthesized it. By the 1950s, injectable testosterone esters were available and oral testosterone undecanoate was on the market by the 1970s. Twenty years later, a transdermal patch was available, and the gels were introduced in 2000.

The clinical use of testosterone, however, did not significantly increase until the last few years. According to data from Bloomberg, sales of Androgel increased from $874 million in 2011 to almost $1.14 billion in 2013, and Axiron sales increased from $24 million to $168 million over a similar time period). Another Bloomberg article shows that prescriptions for testosterone replacement have increased fivefold between 2000 and 2011 and forecasts that sales of testosterone should triple by 2017.

The trend toward increased use of testosterone replacement is not confined to the United States. A graph in a recent article from the BBC shows that Sweden has also had a dramatic increase in testosterone use.

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Before anyone starts sending me unkind emails, I understand that these data, while undoubtedly proving that use of testosterone replacement therapy is becoming more common, in no way show that this treatment is being prescribed inappropriately or that the increase in use is not justified. All of us are aware of the data on the prevalence of androgen deficiency in the aging male and likely all have patients with symptomatic hypogonadism who have had a remarkable response to testosterone replacement therapy.

With that in mind, I do believe it’s fair to ask why the use of testosterone replacement therapy has become so popular over the last 10 years or so. Studies as far back as 1944 correlate low testosterone levels with what we would now describe as clinical hypogonadism (termed back then “male climacteric,” which has fallen out of favor for obvious reasons [JAMA 1944; 126:472-7]), but it took 60 years for testosterone replacement therapy to become common.

Why now? The optimist in me likes to believe that over the last few years, the combination of better pharmacologic methods to dose and deliver testosterone combined with the educational effort of the pharmaceutical industry have combined to create a situation where a condition that used to simply be considered a part of aging can now be easily and safely treated. The pessimist (realist?) in me looks at the money that is being made both by the medical community and the pharmaceutical industry and worries. Anyone who doubts that there is money to be made in testosterone replacement should simply Google “Low T Centers” or check out lowtcenter.com.

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What does this mean for us as a urology community? I was thinking about this last week while I was in the OR working on a 4-cm bladder stone. The patient preferred a minimally invasive approach, so while I could have had the stone removed in 45 minutes with a small suprapubic incision, I slowly lased away at it. It was during that case that I remembered a line from the original Hippocratic Oath, a line that I think holds the answer to the proper use of testosterone replacement:

“I will not cut for stone, even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art” (my emphasis added).

I think the same is true for clinical hypogonadism. Who besides us, with the possible exception of endocrinologists, better understands male hormonal health? Aren’t we the specialists that Hippocrates was referring to? Clinical hypogonadism is real and needs to be treated. I believe that if someone is going to treat this condition, it should not be some PA-in-a-box working out of a strip mall but should be a specialist.

While we all have patients with dramatic improvement after treatment, we are also aware of the numerous side effects and potential complications of this medicine. I think this is especially true given the FDA’s recent investigation of testosterone replacement and the three studies-in PLOS ONE, JAMA, and the New England Journal of Medicine (each of which I know has its own significant methodologic problems)-regarding the apparent correlation between testosterone replacement and cardiovascular risk. (More recently, the FDA issued a warning about the risk of venous blood clots associated with testosterone products, even in men without polycythemia.)

In summary, while I understand that many urologists have reservations about the patient population that seeks testosterone replacement therapy, I believe that we as urologists have a responsibility to ensure that the appropriate people are treated and that those who do not need treatment, despite seeking it, are told so.

As always, I look forward to hearing your comments or thoughts on this topic. My hope is that this simple blog starts a conversation that leads the urology community to take a more proactive role in the diagnosis and treatment of this common condition.

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More blog posts from Henry Rosevear, MD

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