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Treating or Cheating? The Therapeutic Use Exemption Question

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article by Joe Harris and Steve Maxwell of The Outer Line 

Recent fallout over the hacking of the World Anti-Doping Agency’s athlete medical data files has been far-reaching. Most of the world now knows which champion athletes have competed using a therapeutic use exemption, or TUE; the use of doctor-prescribed medication in and/or out of competition. Despite this unfair invasion of the athletes’ privacy by a hacking group called Fancy Bears, the old ethical question has again been raised – as to whether the TUE is a progressive development to preserve health and equitable career opportunities, or whether it is simply another loop-hole which can be exploited by certain athletes to win at any cost.

Cycling, like many other sports overseen by the WADA codes, allows athletes to receive TUEs from their respective national anti-doping organizations, but only after rigorous medical testing and diagnosis confirmation. The most recognizable examples of TUEs in elite cycling involve athletes with asthma being allowed to use an inhaler or similar medication, insulin for diabetes, (or as WADA’s data breach confirmed) exemptions for corticosteroids to treat bronchitis or allergies.

Even without the recent revelations surrounding the Sky pro team and various individual star athletes, the TUE has been one of the most polarizing topics in competitive cycling. International federations like the UCI have the discretion to impose even tougher TUE approval standards for their respective sports. As a result of this, and the removal of some over-the-counter medications and more benign substances from the WADA banned list, the number of TUEs issued at the top-level of pro cycling has actually declined in recent years, despite the recent news and high-profile athletes named.

TUEs and Amateur Racing: TUEs are not only a factor at the elite strata of the sport; the issue is becoming particularly troubling in U.S. amateur Masters racing as well. There are numerous and potent medications geared to treating various common ailments which are increasingly being abused as performance enhancing drugs at the amateur level. Examples include medications prescribed for thyroid conditions, or the increasingly popular testosterone replacement therapy (TRT) for hypogonadism (low testosterone, or “Low T”) in men. Testosterone – which can be synthetic testosterone, or one of many different steroid analogues for testosterone – is one of the most potent and widely abused doping substances and is at the center of U.S. cycling’s TUE debate. Several Masters racers have recently been issued a special type of exemption called a Recreational Competitor TUE for TRT, and as a result many amateur Masters racers are asking if competition in that category will really be fair in the future.

The U.S. Anti-Doping Agency (USADA) and other national anti-doping bodies oversee more than just pro athletes, including amateur racing in age ranges all the way from Juniors to the Masters level competitors. The age range of most Masters-level competitors sits right in the primary population for hypogonadism. In fact, this demographic segment of USA Cycling’s licensed racers has grown significantly as the U.S. population has aged. Almost predictably, there have been an increasing number of “hits,” where older, non-elite cyclists on physician-prescribed TRT have tested positive for their medication in the past few years.

USADA was criticized over its handling of some of these cases, and hence – in an effort to deal with this situation – it launched the Recreational Competitor TUE (or RCTUE) on April 10, 2015. Defining this new category was an attempt to differentiate casual racers from elite professional athletes, although USADA continued to place considerable requirements and focus on the medical testing, the physician/patient relationship, and the legal definition and criteria for a confirmed diagnosis. In fact, the procedural challenge of obtaining a RCTUE was so significant that the process itself might constitute a deterrent to even requesting one. The athlete must submit an exacting and comprehensive medical history, which is then reviewed by an independent USADA TUE committee comprised of experts in that specific condition or disease. (USADA has a network of more than twenty highly-qualified medical experts from around the country, in different disciplines, from which individual TUE review committees are convened.)

This review committee can approve a RCTUE if it meets the four key criteria in the international WADA-established TUE requirements, and comes to the same conclusion as the athlete’s physician – in terms of the medication need, dosage and duration. In short, the process is expensive, time-consuming, not covered by medical insurance as an elective action, and potentially exposes private medical information to many parties. Even though the introduction of the RCTUE has been perceived as potentially lowering the bar for a certain segment of the sport, USADA in fact rejects the vast majority of all TUE applications. Hence, the apparent perception – based on early media reports – that RCTUEs are “rubber stamps” or easy to obtain, is simply not true.

However, on the other hand, USA Cycling’s (USAC) Master’s men’s category contains some of the most affluent and litigious demographics in all of U.S. sports. Many of these aging weekend warriors have demonstrated their willingness to take on USADA in the courts. And complicating the issue from a social perspective, the pharmaceutical industry has continued to popularize testosterone replacement programs with ubiquitous mass media advertising and the catchy hook phrase – “Low T.” While TRT has undoubtedly helped improve the lives of many men who otherwise might never have sought diagnosis and treatment for hypogonadism, it has also desensitized the public and created the popular belief that testosterone is a readily-available magic elixir – as ubiquitous as caffeine, Ibuprofen, or Viagra.

This explosion of testosterone prescriptions over the last ten years has created a $2 billion market, not including the influx of dubious over-the-counter testosterone “boosting” supplements. TRT is unfortunately no longer perceived as a complex medical treatment, and in the process has been recast as something more like cosmetic surgery. However, instead of fixing a scar or a crooked nose, Low T redefines feeling weak or fatigued as an “ailment” – a medical condition rather than a natural progression of the human condition.

Potential Risks With the RCTUE: The Outer Line reached out to medical experts in endocrinology, cardiology, family practice, laboratory testing and oncology to discuss how the Recreational Competitor TUE for testosterone could be diverted from legitimate patient treatment into the realm of cheating in the amateur ranks. Several key factors were pointed out as potentially increasing the risk of abuse in sports.

The goal of TRT is to return a patient to a normal level of testosterone and restore their baseline level of health – not to extend an athlete’s performance beyond what it would otherwise be in the absence of the disease. However, that “normal level” could be manipulated to improve the effects. A healthy 35-55 year-old’s testosterone level sits in a specific range, and TRT could potentially increase it up to the limit for a specific age without fear of a positive test – similar to the UCI’s “speed limit” of a 50% hematocrit during the EPO era. Increased testosterone is proven to decrease recovery time and improve lean muscle mass, but it can also raise the hematocrit in some patients by up to 10% – similar to the supercharging effects of blood doping.

Physicians also have more leeway to prescribe testosterone for a condition it is not explicitly approved to treat – an “off-label” prescription – than ever before. This shift in physician discretion means that more prescriptions for testosterone are being dispensed, and not always for patients diagnosed with diseases for which the FDA has approved it as a treatment. This indirectly affects RCTUE policies by directly increasing the accessibility of testosterone to athletes, and the amount which can be diverted for cheating.

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Several of the physicians we spoke to believe that a RCTUE for TRT could be abused through an ulterior strategy of “gaming” the system. For example, suppose that a Masters athlete dopes himself with a testosterone analogue like the designer steroid tetrahydrogestrinone (THG), a week or so before going in for a physician’s lab test. It is scientifically proven that the presence of excess testosterone creates a negative feedback effect on the pituitary gland, causing a rapid decrease in the production of natural testosterone – and this phenomenon would occur during the timeframe prior to the lab work. The testosterone analogue would not be detectable by a standard hospital laboratory, while the test results for overall testosterone levels would be deceptively low. Hence, the analytical results would tilt the RCTUE request in the athlete’s favor.

This potential TRT abuse example highlights a key policy alternative for USADA to consider: perhaps its accredited labs should do at least some of the physician-ordered diagnostic tests, or that tests should be performed by higher-sensitivity “reference” labs – with more sophisticated analytical equipment which can identify the chemical traces of different artificial testosterone types from that of natural testosterone. USADA could perform a targeted test on that applicant at any time, but of course this begs the vexing question of who would pay for any additional and more detailed tests. This method of gaming the system has allegedly already been used by some in the U.S. to obtain TRT and to fool insurance companies into reimbursing the considerable long-term medication, physician and lab testing costs.

The Way Forward: The general concept behind the TUE is a vital component of a strong and healthy anti-doping strategy, even at the highest levels of pro cycling. It is a kind of containment policy which permits the medical community to actively treat patients for real issues while allowing them to pursue professional competitive careers, have normal lives, or just enjoy the camaraderie that comes with sports participation. However, it also just so happens that some of these athletes may be your local Masters weekend racing arch-enemies.

Those Master’s categories are among U.S. competitive cycling’s most important demographics, providing the National federation with much of its financial stability in recent years. So, USAC must continue to meet the needs of these constituents, even as it moves to expand membership in the Women’s and Juniors ranks. But when some weekend warrior with a Recreational Competitor TUE suddenly transforms himself from “criterium pack-filler” into a consistent winner, how should the USAC, USADA or other Masters athletes react?

USADA recognizes that it must balance the oversight and policing of this issue, with its more significant mission of monitoring elite athletes. But USADA is also an organization with limited resources trying to oversee a huge population of amateur athletes, and it is almost certainly feeling the strain as it stretches to cover more and more non-elite competitors. USADA admits that it can’t possibly test or track all amateur events. “We’re trying to utilize the resources we have as efficiently as possible,” says Ryan Madden, USADA’s Communications Manager. “We’ve heard the voice of the athletes, and we’re working with local cycling associations to try to create and preserve a level playing field, the best we can.”

USA Cycling should work with USADA to impose a more balanced, or perhaps more restrictive, overall TUE policy. But in the bigger picture, physician governance bodies – not just the ad-hoc and established physician TUE review committees – need to devise a consensus for how to protect the health of patients who are competitive athletes, and make this a standard against which future sporting policy can be weighed.

The question, “How sick is too sick to compete?” now begs for a definitive answer at all levels of sanctioned competition, not just the elite level of the Tour de France. Hypogonadism, for example, is a serious medical condition. Like many diseases, it should not be viewed as a simple athletic handicap to be quickly corrected, especially as increases in testosterone can worsen pre-existing medical conditions, accelerate the progression of many cancers, and in some cases even trigger new and serious illnesses. Other conditions eligible for a TUE or RCTUE should be viewed in the same light. And it may be time for cycling to start prescribing enforced rest as freely as some professional teams apparently prescribe potent corticosteroids.

Pro cycling has tended to focus on what is best for its economics rather than what is best for the affected or ill individual, and this in turn tends to push TUEs in the direction of sanctioned doping. Global TUE reforms must focus on athlete health, to reinforce sporting integrity and uphold competitors’ rights – not just the rights of athletes with legitimate medical conditions, but also those of healthy athletes around them. As long as there is a gray area between a doctor’s dedicated care and a consensus legal opinion, TUEs will represent a thin line between “treating the athlete” and potentially “a cheating athlete.”

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