Is testosterone therapy the fountain of youth? If so, WWWD? (What Would WADA Do?)
As a retired lawyer and long time cyclist, I thoroughly enjoy your column.
Here’s one that might be arising more in the Masters’ ranks, which have had their share of doping positives, recently.
Doctors are increasingly treating below normal testosterone levels with (and Big Pharma is increasingly promoting) testosterone replacement therapy for older men. The therapy is based on research that tends to show that below normal T levels lead to various premature aging symptoms, low energy levels and low sex drive.
For those who race in the masters’ classes, is a TUE available for this therapy, with or without limitations? If not, is there any effort by WADA to consider it?
Given the threshold method of triggering tests, the ratio of epitestosterone to testosterone, would it even come up in testing if the therapy resulted in levels in the “normal” range?
Your hypothetical for the day.
First off, let me thank you for your kind words. Given my relatively short time as an attorney (I’m just three years out of law school), I am always nervous when other lawyers – especially the experienced ones – read this column. Like anyone, I appreciate the kudos, but I do want to encourage anyone to send me a note if they notice a bone-headed mistake. I will correct those and make note of them.
Now, to your questions. The quick and simple answer regarding testosterone is yes. The World Anti-Doping Agency does make an allowance for the therapeutic use of testosterone. However, before we see the entire middle-aged masters’ peloton veer off to the doc’s office, you need to keep in mind that according to the rules, a Therapeutic Use Exemption (TUE) for testosterone is issued under the narrowest of circumstances. Most of us would probably not qualify.
Under the current WADA Code, a national doping agency is permitted to issue a TUE for testosterone only after an athlete has been diagnosed with primary or secondary “hypogonadism.” In other words, the testes are not producing enough of the hormone to bring the level of what is considered “normal.” (NOTE: While testosterone replacement therapy is offered to women in rare cases, WADA has concluded that there are more effective alternatives, so no TUE for testosterone will be granted to females under current rules.)
The definition of “normal” is based on several factors, chief among them age. Measured in nanograms per deciliter (ng/dL), normally blood testosterone levels in the general population of adult males run anywhere between 300ng/dL and 1000ng/dL. Of course, a 24-year-old with blood levels of 300ng/dL would be a cause of concern for his doctor. That same level in his 85-year-old grandfather might be considered to be within normal parameters.
Generally in a healthy and relatively young male, a serum testosterone level below 350ng/dL is considered to be a cause for concern and would make the patient a candidate for treatment.
However, it’s important to note that low testosterone levels due to the normal aging process are usually characterized as “functional” hypogonadism and would not qualify for a WADA-issued TUE. What would qualify is hypogonadism that is the result of a medically defined cause.
Rather than get into an analysis of each contributing factor recognized by WADA, I am simply including the causes of primary and secondary hypogonadism for which the agency says it would consider a TUE:
Klinefelter syndrome, bilateral anorchia, cryptorchidism, Leydig cell aplasia, male Turner syndrome, Noonan’s syndrome, congenital adrenal hyperplasia.
panhypopituitarism, idiopathic hypogonadotropic hypogonadism, Kallmann’s syndrome, constitutional delay of puberty, LH deficiency, Prader Willi syndrome
That’s the general list and there are other contributing factors for which WADA – or a national anti-doping agency – could consider a TUE request. The bottom line, though, is that anyone seeking a TUE for testosterone must submit a detailed diagnosis, with supporting medical evidence, to justify the claim that his low serum testosterone levels are due to one of the medically recognized causes.
In the words of the U.S. Anti-Doping Agency (USADA), “It is extremely unlikely that a Therapeutic Use Exemption will be approved for ‘functional’ hypogonadism (a diagnosis of hypogonadism based on low testosterone levels but without a defined etiology).”
Getting old sucks. Is there a cure?
So let’s assume that the members of our hypothetical field of masters racers are not suffering from any of the aforementioned afflictions, but merely “functionally” hypogonadistic. The theory is that these men, too, would benefit from testosterone replacement therapy and you’re right, Larry, there has been an increase in interest (and marketing) in recent years, especially as we Baby Boomers get older.
Aging is a key factor in reduced testosterone levels in men. According to one study (Vermeulen A and Kaufman JM  “Ageing of the hypothalamo–pituitary–testicular axis in men.” Hormone Research 43, 25–28) about seven percent of men between the ages of 40 and 60 have serum testosterone levels below 350ng/dL. That number increases to 21 percent for men between 60 and 80 and 35 percent for men 80 and older.
The symptoms of low testosterone levels – even those due to aging – are not pretty. There is the whole diminishing libido thing. (Of course, if that’s a problem, then the other common symptom, erectile dysfunction, probably won’t bother a guy as much.) But beyond those, there is a decrease in muscle mass, fatique, increased abdominal fat, loss of bone mass, frequent urination, high cholesterol and depression (probably caused by all of the other symptoms).
Like the Stones said, “what a drag it is getting old.”
So, would restoring those levels back to the way they were when you were 25 help reverse some of the symptoms of the normal aging process? Some studies say yes … and some studies say no. There is a big study going on right now, sponsored by the National Institutes of Health, which involves tracking 800 men over the age of 65 who are using a gel-based testosterone supplement. So, we may have a more definitive answer once all of the data is reviewed in the next year or so.
One thing is for certain, though. While there may be benefits that accompany testosterone replacement therapy for functional hypogonadism, there are risks, too. One key concern is the effect testosterone supplementation will have on the reproductive system, especially the prostate.
Exogenous testosterone can contribute to an enlarged (but non-cancerous) prostate, a problem known as benign prostatic hyperplasia (BHP) and some studies indicate that it can also contribute to the growth of cancer cells in the prostate.
Exogenous testosterone can also result in a decline in the production of natural testosterone, as the body adjusts in response to unnatural increases in serum levels of the hormone. That can also result in decreased production of sperm to the point that fertility may be put at risk.
The natural conversion testosterone to estrogen can also contribute to the growth of the much feared “man boob,” with men experiencing enlarged and tender breast tissue.
Indeed, the aforementioned side-effects are to be considered so potentially serious that any male with high risk factors for prostate or breast cancer (hey, it does happen) is automatically off the list of potential candidates for testosterone replacement therapy.
There are other side-effects, including liver toxicity, sleep apnea, fluid retention and increased risks of other cancers.
On a somewhat positive note, doctors also warn of one side-effect that would actually play pretty well with our little peloton of aging cyclists, though: Polycythemia. Yup, that’s an increase in the production of red blood cells. Unfortunately, that is also accompanied by an elevated risk of heart attack and stroke, not something you want to toy with in an age group whose cardiac risk factors are already on the increase.
Gee … this “therapy” sounds appealing, doesn’t it?
Since we’re in hypothetical mode, though, let’s assume that the NIH study comes back with stellar results and all of the 800 test subjects emerged from their two years with the strength, energy and looks of a 25-year-old. As a result, our masters all opt to take the chance and go with the therapy …. USADA be damned.
You asked if they might test positive in the rare event that USADA’s testers show up to request samples from the men’s 55+ field. The simple answer is yes. The initial test is based on the famed T/E ratio, the same test that caught Floyd Landis at the Tour de France. That test, for all of its flaws, is based on the assumption that the body produces testosterone and epitestosterone at about the same levels. WADA allows for some wiggle room, and the Dope-O-Meter™ isn’t tripped until the T/E ratio exceeds four-to-one (Landis, by the way, was 11-to-1).
Further study – using the Carbon Isotope Ratio test – would show that the elevated ratio is due to the presence of exogenous testosterone and that could result in a two-year suspension. In other words, that lucrative masters’ racing career could be at risk.
So in conclusion, testosterone therapy should probably be considered by a relatively small number of those for whom it might prove beneficial, especially if you want to live by the rules of our sport.
For the rest of us … well, I always like to remember the words of Mark Twain, who observed that “age is an issue of mind over matter. If you don’t mind, it doesn’t matter.”
The Explainer is now a weekly feature on Red Kite Prayer. If you have a question related to the sport of cycling, doping or the legal issues faced by cyclists of all stripes, feel free to send it directly to The Explainer at Charles@Pelkey.com. PLEASE NOTE: Understand that reading the information contained here does not mean you have established an attorney-client relationship with attorney Charles Pelkey. Readers of this column should not act upon any information contained therein without first seeking the advice of qualified legal counsel licensed to practice in your jurisdiction.