Problems With This Testosterone TUE

File:Depo-testosterone 200 mg ml crop.jpgLet’s stipulate there’s a racer out there who feels tired.  He blames it on his work.  But when he changes his job, he’s still tired. He goes to a doctor.  The doctor comes up with a diagnosis and prescribes a drug regimen.   The racer does the regimen.  After a while is feeing better.  “Normal” even.
Only the drug is testosterone, a banned drug in all Olympic sports.  He decides to apply for a Therapeutic Use Exemption, or TUE, from the United States Anti-Doping Association (USADA).  He doesn’t get it.
This is the story of Jeff Hammond as profiled on VeloNews.com. 
Here’s some more from the story. “The diagnosis was hypogonadism, and now he takes supplemental testosterone to raise his levels to average for a man of his age, 58. He also takes the medication to combat low bone density.”
Hammond didn’t get the TUE.  Here’s what USADA wrote him, “Testosterone is an anabolic steroid and has been shown scientifically and medically to improve muscle strength, recovery, and performance. As such it is included on the WADA Prohibited List as a substance prohibited at all times… Justification for the use of testosterone must meet the standard of demonstrating an organic cause of androgen deficiency/male hypogonadism. A diagnosis based simply on a functional disorder does not meet this standard … rather, functional diagnoses often focus solely on low testosterone levels and generalized symptoms.”
The author of the piece, Matthew Beaudin interviews Matthew Fedoruk, USADA’s Science Director.  Federuk reports, “There has to be more than just generalized symptoms, or a single low blood test, a single low value. They have to be able to show a diagnosis and pinpoint a reason for why they have hypogonadism. So without that, it’s impossible for us to grant a TUE. Then you would be opening up, essentially, a Pandora’s box if you lowered the bar on the TUE criteria.”
Interestingly, Fedoruk claims that the denial of the TUE is not the end of the process.  “I feel very strongly about allowing the athlete to come back with more medical information,” he tells Beaudin.
Despite this, Hammond, rather than looking deeper into his diagnosis, appears to be instead trying to rally public officials to his side by writing elected representatives.  And the public as well—the VeloNews piece probably reflects him flacking for himself.  The denial of the TUE was a signal to Hammond that he needs to change USADA’s rules, move the lines, so his doping is no longer doping. 
What isn’t written about is what matters
The VeloNews article leaves me with more questions than it answers.
Discussing someone’s medial conditions often feels wrong.  At the same time, Hammond is publicizing his case presumably because he hopes to change things enough so he can use testosterone and still race.  My feeling is that not nearly enough is revealed to make sense of his claims.  USADA, quite wisely, doesn’t publicly disclose their thinking, so it’s up to the public to figure out what’s really going on.
Starting from the end, it seems that Hammond was not interested (no idea if he was unwilling or unable) in proving an “organic cause” of his diagnosis.  According to USADA’s Federuk, denial of a TUE isn’t necessarily the end of the process.  It’s a notice to the applicant to dig deeper.  And the letter they sent explicitly states what USADA is looking for: “organic cause of androgen deficiency/male hypogonadism.” 
Why Hammond didn’t take this step is something he’s not telling.  Maybe he wasn’t asked.  Perhaps his doctor was unwilling or unable.  His physician, Michelle Cassara, appears to have an expertise in diagnosing low testosterone.  From her web page, “Specializing in the field of Endocrinology, Dr. Cassara is prepared to treat patients for a variety of hormonal diseases and disorders. Dr. Cassara can diagnose and create treatment plans for conditions such as growth disorders, obesity, low testosterone, osteoporosis and various thyroid disorders, among others.”  It’s hard to tell from her site what her specialty really is.  Does she look for these disorders and happily treats patients with performance-enhancing drugs, or is it but one course of treatment she offers?  At the very least, it would be good to know if Cassara is Hammond’s primary care physician or if he was referred to her, or if he went shopping for a doc who is quick to dispense drugs. 
Getting a second opinion is certainly a good idea.  But we should know if he was looking for an answer to his problems or he had an answer in mind and was looking for a doc who agreed with his assessment.  Perhaps it was somewhere in the twain, he was intrigued about testosterone and was open to a doctor who had experience prescribing it.  It’s fine if he believes in better living through pharmacology, it’s fine if he wanted a doc that believed in the same, but that strikes me as another discussion entirely.
“Low-T,” a coinage for low testosterone, is an increasingly popular diagnosis. NBC news has a feature here.  It could be from an aging population.  It could be because Big Pharma is advertising heavily.  One testosterone drug, Androgel, was the 36th best selling drug in quarter two of 2013. In 2012, BusinessWeek asked if testosterone drugs were the next Viagra.  In 2013, Androgel is ahead of Nasonex, ahead of Viagra.  AbbVie, makers of Androgel, spent over $80 million on advertising Androgel in 2012 and even subsidized patient co-pays.  Sales of testosterone drugs are in the billions of dollars annually.
Problem is, there’s little proof it works to help men with the problems they are hoping to solve.  The NBC story cites several trials that were halted because the observed negative effects to participants were deemed too great a risk for the remainder of the participants.  A New York Times story cited increased risk of coronary artery disease, which others have characterized as a greater risk for heart attacks, as well as an enlarged prostrate and the increased risk of prostate cancer.  Infertility is also a risk, but for many who are considering the drug, that hardly seems like a risk.  There of plenty of other side effects as well—many of which anyone who has paid even marginal attention to steroid use probably already knows.
There are also no long-term studies examining the effects of use.  Even an AbbVie representative admits as much and seems to be calling for more studies.  There is a long-term study in progress and isn’t sent to finish for at least a year.  But one doesn’t seem like enough considering the risks already found.
The New England Journal of Medicine recently published a study that casts serious doubt on the idea what low-T is a fixed number, or if it matters at all. Here’s what they conclude “The amount of testosterone required to maintain lean mass, fat mass, strength, and sexual function varied widely in men. Androgen deficiency accounted for decreases in lean mass, muscle size, and strength; estrogen deficiency primarily accounted for increases in body fat; and both contributed to the decline in sexual function. Our findings support changes in the approach to evaluation and management of hypogonadism in men.”
 
Skinny Bones
The low bone density problem Hammond reports seems strange in some respects.  Osteopenia and osteoporosis has been reported in cyclists in many places. There are some indications that being extra lean for a long time and engaging in non-weight bearing activities might lean out the bones.  Yes, ultra-lean pro cyclists are at risk.  Yes, so are many others.  It’s potentially a serious problem.  And if his bone density is really low, Hammond probably should have avoided racing until his bones thickened up.
But how low?  What’s his T-score?  Is it from heredity, a drug he was taking at one time, or some other cause? 
Yes, it appears that testosterone can help build bone mass.  But according to WebMD, it’s not clear how much is needed and there are plenty of limitations and concerns.  Interestingly, cortisone use, as well as smoking, drinking alcohol, drinking caffeine, and high salt intake can lead to thinning of bones.  And solutions include weight bearing exercise, weight-lifting, calcium, and vitamin D.  Of the several osteoporosis drugs WebMD lists, only one appears to be on the World Anti-Doping Association’s (WADA) prohibited list.
There’s a second reason the assertion is strange. A less charitable explanation of the claim is that by getting a diagnosis for  low bone density, an athlete could be trying to find a way around the ban on testosterone.  Kind of like Lance Armstrong’s claim of using enough cortisone in a topical crème for treating saddle sores.  Kind of brilliant in a way—lots of cyclists can probably state to be suffering from osteopenia and their doctor’s recommended treatment is testosterone. 
You’re tired, everyone’s tired
What is wrong with being tired?  Tired is what makes us fall asleep at night.  Tired is a signal to take it easier.  I don’t know what makes Hammond’s fatigue unusual or worthy of doping.  When a three year-old starts melting down, their parents usually don’t think about doping her, they think about putting the kid to bed.  When a teenager sleeps all morning, their parents don’t usually pour coffee down his throat. 
Likewise, work and life can make you tired.  Mental exertions have been shown to reduce endurance, even if muscles are relatively fresh and can still manage maximal exertions.  Not exactly a surprise, but it is a reminder that mental state can have a real effect on performance.  
The claim that Hammond’s levels are low and he’s just trying to get back to “normal” is suspect for other reasons.  For all we know, every 58 year-old he’s racing against have lower levels of testosterone than he.  Even if there’s a number for “normal,” we don’t know the variation of what normal is and how normal will play out with the rest of his body.  His claim treats testosterone level as a single, standalone factor in health, but there’s no proof of this, nor is there knowledge to know how artificial testosterone plays with the rest of the body.  As with any stimuli processed by humans, there are high responders and low.
The guy is old and slow
There always seems to sympathy for a guy who doesn’t seem to be a threat to anybody.  He’s old, he’s not an elite racer, he’s not going for big prize money or medals or national championships.  He just wants to compete in local crits. 
Unless he’s last every time, he’s beating somebody.  And the people who are already finishing behind him are racing without resorting to doping.  Yes, there’s fun in racing and people ought to be having fun, but people are training, buying stuff, altering their lives to plunk down money at some race nobody has ever heard of.  They’ve agreed to follow the WADA code.  And here comes a guy with a questionable condition who wants his doping to pass muster.  If the standard becomes whomever’s doctor is the arbiter of what is doping and not for their patient, there is no standard at all. 
Maybe Jeff Hammond really has a condition that merits a TUE.  Maybe he doesn’t.  But USADA doesn’t think his condition does, and what VeloNews reported of his condition adds nothing to the discussion.  And while his story could be more common in the future, TUE applications for stimulants, which could be for people who want to take drugs to combat attention deficit disorder (ADD), were more than twice as common in 2012.  Considering how common that diagnosis already is, granting TUE’s for that kind of condition might be a far larger concern.  
It’s just bike racing, of course.  But Hammond takes the matter seriously.  As should we.  The article closes with a statement from him. “If I can’t race, I won’t cheat. I just won’t. I’ve thought about it and I won’t. My health is too important. The reputation of my team and our sponsors is too important, too. I’ll try to find alternative ways of riding my bike, live with it, and move on.” What’s left unsaid by him and unwritten in the article is the name of his team.  RealD-Amgen Masters Cycling Team.
 



2 thoughts on “Problems With This Testosterone TUE”

  1. You know, the worst part is that USADA doesn't care about the health of individuals. So what do they want Jeff Hammond to do? Have his doctor take him off of the medication to watch his testosterone fall and not only feel sick, but possibly began to experience medical fallout from the cascade of events of a failure of a portion of the endocrine system? When it was discovered I had low testosterone, I had to wait 6 weeks to get an endocrinologist appointment. My endocrinologist ordered a repeat testosterone, along with LH and FSH (pre-sex hormones) and my testosterone had fallen even further. He was so taken aback by the plunging of my testosterone in that 6 week period that I was sent for a brain MRI to make sure I didn't have a pituitary tumor. Luckily, I didn't but the end diagnosis- primary hypogonadism. I had the proper amounts of LH and FSH, but my family jewels were not taking that message from the LH and FSH to produce testosterone. I don't know how USADA to find it in the standard of medical practice to make a doctor STOP a medication that is proving itself to treat the condition, just for the sake of "having more proof" that the TUE is justified.

  2. In other sports where there are a lot of TUEs for Testosterone, the biggest guess for why athletes have low testosterone is because previously using testosterone illegally they overdid their cycles and consequently their testosterone production never recovered.

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