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The Business of Testosterone

Published: May 11, 2012

“Surge in testosterone treatments raises alarm”

That headline on a Bloomberg News item grabbed my attention. The first paragraph of the piece got right to the point. Noted author Shannon Pettypiece (no, that really is her name) “In what may become one of the most sought-after sex enhancement treatments since Viagra 14 years ago, new testosterone drugs are in hot demand”.

The trouble is that in the entire article, no justification is provided for speaking of testosterone in the same sentence as Viagra. Bloomberg is a business publication not one devoted to medicine, but I’d have expected that after an opening implying that hormone supplementation is in hot demand for “sex enhancement,” at some point the reader would learn why that was stated in the first place. But no luck.

We do learn business-related facts; prescriptions for testosterone have doubled over the past 6 years to 5.6 million/year in the US. We learn that over the next five years sales are expected to triple to 5 billion dollars. We learn that Abbot and Lilly are increasing their advertising budgets.

Thankfully, we also learn that medical experts are very dubious about all of this. Checking the levels of testosterone involve a notoriously unreliable test, and a Cleveland Clinic doc takes pains to note he only prescribes it for patients with a medical need. What a concept!

The issue of testosterone supplementation comes up weekly in my clinic. A while ago I decided that we would not be supplementing people unless they could a) produce lab tests showing they really were low and b) their doctor would simply not write a prescription for hormone replacement. So far exactly one person met the criteria, and after starting them on a gel we turned the management of that over to his primary care physician. We are not much into the testosterone business.

The reason for this is that despite the popularity of using testosterone to help erectile dysfunction it rarely works. We see many, many patients who have tried it, for example. Had it actually worked, they would not be coming to us.

There is no good reason why it should help most patients. If a man’s levels are in the normal range, boosting the levels above normal (or to the high end of the normal range) does not help him. Ask your local urologists. We certainly did and they were explicit about this logic. Everything I’ve seen supports their reasoning. Testosterone has more to do with desire than the actual mechanisms that produce erections. Oddly, this is true for females too! When the occasional man comes in with genuinely below-normal testosterone levels they have usually noticed a drop in libido, prompting testing.

No libido will produce a certain failure to achieve an erection. That I don’t dispute. The occasional man with this problem can (and should!) be supplemented. When this happens, their condition usually improves. The thing is, we are talking perhaps 3-4% of the ED patient population. The vast majority of ED patients have testosterone levels that are within the normal range.

So where do people (and Bloomberg writers) get the idea that male hormone is an ED treatment? Well, sex sells. Some men find that they feel improved energy levels on testosterone. Body builders in particular (as noted in the article) are pretty big on the subject. The same guys who fill out the pages of muscle magazines, who abuse anabolic steroids, are all for it. Hmmmm.

The drug companies are not going to quibble over this. It is claimed that 13.8 million Americans have low levels. Seems high to me! Men’s levels do tend to drop after age 45, as the ads on late-night TV keep reminding us, but five billion dollars in sales by 2017 looks pretty good to them. Note: Viagra sales last year totaled 2 billion, with Cialis is right behind at 1.9 billion. But both these medicines are effective for most men with ED. The class of medication (phosphodiesterase inhibitors) to which they belong will help perhaps 60% of men with ED. Compare that to maybe 4% for testosterone.

Testosterone, like any potent hormone, can have drawbacks. While no studies have ever shown (at least none so far) that extra male hormone can produce an increased risk of prostate cancer that remains a theoretical risk. As for BPH (Benign Prostatic Hypertrophy) standard therapy for men with enlarged and troublesome prostates is to LOWER their most potent forms of testosterone.

A former competitor (thankfully now out of business) used to supplement everyone seeking treatment for ED with testosterone cream. Everyone! Shameless staffers would tell patients it would add 30 yards to his golf drive. Steroid misuse can enhance athletic performance as anyone who follows sports knows. Some improvement of energy levels and/or athletic performance probably does take place with many men on testosterone.
But how much comes from the placebo effect? I sure do not know.

I will grant that some men surely think they do better with their ED from testosterone, but considering only 3-4% of those being treated actually have a need for testosterone supplements, I would say that most of these men are experiencing a placebo effect. After all, rich Chinese consumers are paying top dollar for powdered rhino horn (and helping wipe out the last of these mighty beasts) even though rhino horn is chemically identical to powdered fingernail clippings. But they swear it works, because when they tried it they felt better. We must do better than that as we have millions of men starting supplementation.

As I finished typing this, a clipping fell out of one my files that was remarkably appropriate. It noted that 9 years ago a panel had been being convened to examine the ever-growing issue of hormone supplementation. At the time Science magazine noted that the Institute of Medicine in Washington concluded that the efficacy of the treatment needed to be established, the adverse effects needed to be examined more closely and that in the meantime “men and their doctors shouldn’t consider testosterone preventative medicine against age-related symptoms”.

Although this all remains true today testosterone has climbed in the back door to become a billion dollar industry in no small part due to the matter of erectile dysfunction being a major “age-related” symptom. There is much to discuss before millions line up for $250 a month injections or Barry Bonds-like gels. We will have more to say about this in the future.