Therapeutic Use Exemption: Gray and Grayer

Mark Heinicke is the Associate Editor of Road Race Management and is responsible for most of the statistical surveys that appear in the newsletter. Mark has followed the sport as a participant and a writer for over 40 years. With gimpy knees forcing him on to a bicycle in recent years, he observes running in a frequently more detached but analytical manner, which provides a fresh perspective for those of us who spend most of our waking hours in the trenches.

Does the Therapeutic Use Exemption (TUE) for competitive athletes enable legalized cheating, or is it just a complicated means to “level a playing field?”

It may depend on a specific situation, the drug in question, or whom you ask. Case in point is the furor that erupted last fall in the pro cycling community, when the mischievous Russian hackers “Fancy Bears” released records showing the use of the steroid triamcinolone by Sir Bradley Wiggins prior to his competing in the Tour de France in 2011 and 2012 (which he won), and the 2013 Tour of Italy. (The records were hacked via the World Anti-Doping Agency (WADA) database; WADA has been scrambling to improve its security ever since.)

In all three cases, Wiggins was granted a TUE for triamcinolone to treat asthma and hay fever.  Triamcinolone belongs to the group of glucocortisoids (a class of corticosteroids), all of which are on the WADA banned list.

Prominent members of the cycling community pounced on the news with opinions ranging from absolutist (no use of banned substances whatsoever), to calls for reevaluation of the rules by which TUEs are granted (one of those calls came from former Sky teammate and three-time Tour de France victor Chris Froome, himself the beneficiary of a TUE in the 2014 Tour de Romandie ). No one seemed willing to stand up for the TUE procedures as they now exist. For a report on the controversy last fall, check out the following link:

http://www.cyclingnews.com/news/uci-defends-tue-use-after-russians-hack-wiggins-froome-medical-records/

Black-and-White versus Shades of Gray

The absolutist position—call it the Black-and-White position—is the easiest to understand and simplest to implement. A banned substance is banned for a reason. The reason may be performance enhancement, ill health effects, or both. The reason should hold for all. Using a banned drug? You’re out. Asthma or no asthma. End of story.

On the face of it, the absolutist position is the best way to go. Why? The basis is as follows.

The counterargument is, that if the drug, in the judgment of medical experts, does no more than “level the playing field” by undoing the effect of a disease such as asthma, without conferring any other competitive advantage, then its use should be permitted for certain sufferers under special conditions.

Every TUE requires review by a panel of medical experts—minimally three doctors/scientists by the rules of the WADA. Each panel is chosen by the governing body of a particular sport: in pro cycling, the Union Cycliste International (UCI).  So we’re already into a gray area: the qualifications of the experts themselves, and the qualifications of who is choosing them.

This is not to say that anyone is operating in bad faith. But the ambiguities surrounding the qualifications of doctors in the panels, compounded by the incomplete understanding of how many of these drugs work, undermine the credibility of the process.

The language of the IAAF on this issue does not inspire confidence: the panel consists of  “at least three independent and experienced physicians with sound knowledge of clinical, sports, and exercise medicine.” Sound knowledge?  It is a purely qualitative judgment.  There’s no requirement that, for example, each physician show proof of having kept up with the latest developments in a rapidly changing field. Whoever chooses them may insist on it, or not, but there is no requirement under the rules.

The IAAF language mirrors that of the WADA “International Standard for TUE,” which you can find at https://www.wada-ama.org/sites/default/files/resources/files/WADA-2015-ISTUE-Final-EN.pdfat in section 5.2a.

As for the confusion as to how these drugs work, we need look no farther than the triamcinolone that was injected into Bradley Wiggins.

Doctors Weigh in on Triamcinolone: the Catabolic and the Anabolic

Interestingly, in the case of triamcinolone, three doctors in the field of respiratory illness, quoted by journalist Tom Cary in last September’s  Sport Cycling section of The Telegraph, all doubted that triamcinolone, could enhance performance. Furthermore, its side effects—such as cataracts, high blood pressure, diabetes, bone-thinning and Achilles tendon rupture—raised health risks that would make it a drug “of last resort” for the treatment of asthma. For details see: http://www.telegraph.co.uk/cycling/2016/09/20/sir-bradley-wigginss-last-resort-drug-was-utterly-bonkers-say-me/

Dr. Brian  Lipworth of the Scottish Centre for Respiratory Research, pointed out that triamcinolone is a catabolic steroid that breaks down muscle, as opposed to anabolic steroids that add muscle. He said there was “no scientific reason” why the drug would be performance-enhancing. Would it relieve asthma? Yes, but that’s only leveling the playing field for a player such as Sir Bradley Wiggins.

Lipworth brushed off anecdotal accounts of the performance-enhancing benefit of triamcinolone, such as the pronouncement of pro cyclist David Millar (banned for doping in 2004) that the drug was the most potent thing he took in his career. Said Lipworth,  “the fact that [Millar] was taking EPO and testosterone at the same time” meant that “the anabolic effect of the testosterone probably counteracted the triamcinolone.”

Incomplete Sports Medicine Knowledge

Probably counteracted? Dr. Lipworth is careful with his words. He is an expert on airway allergy and COPD, but he is not an expert on sport. For example: Glucorticoids (or corticosteroids) can bring about weight loss, and weight affects performance.  For pro cyclists faced with the immense climbs in the European grand tours, muscle mass imposes a weight penalty, and a catabolic steroid that breaks down muscle just might provide the lift to make you fly. The trade-off between gaining muscle and losing weight creates a delicate fine-tuning act for a pro cyclist in a stage race with big mountains.

Muscle mass aside, the reddest flag with triamcinolone, as well as other glucorticoids, is that it suppresses inflammation (in the case of asthma, inflammation of the airways). And minimizing inflammation is key to recovery from strenuous exercise. Who is to say that a drug that reduces inflammation to any degree is not a performance enhancer? Do we know that triamcinolone affects only the airways?

For a deeper shade of gray, you might look at the part of the IAAF rule that expands on what I quoted above: “The chairman of the IAAF TUESC may decide in appropriate circumstances to delegate responsibility for reviewing TUE applications to a single experienced physician.” (Emphasis mine.) When you add to the vagueness of “appropriate circumstances” the possibility that the decision could be in the hands of just one physician, you increase the potential for misjudgment.

(The language for the IAAF rule is taken from the “IAAF Medical and Anti-Doping Department Advisory Note – Therapeutic Use Exemptions, 2013” downloadable from the IAAF site as a .pdf. )

Numbers Game: the BADTUEC.

For a model of what a TUE Committee should look like, we might take a page from The Bahamas Anti-Doping Therapeutic Use Exemption Committee (BADTUEC). You can find it at http://www.bahamasadc.com/Therapuetic-Use-Committee.aspx

The BADTUEC has the least ambiguous language regarding a TUE committee that I could find through a web search. The committee should consist of six members, each of whom is appointed for at most three years (they can be reappointed). The exclusions cover such conflicts of interest as connection with an athlete or a sporting organization.

As specific as the rules are, there remain (at least) three questionable aspects of the BADTUEC. One, there are no specifications as to qualifications other than the term “duly qualified.” Second, there is nothing in the conflicts of interest clause that excludes members with interests in a pharmaceutical company. Third, the means by which the committee reaches a judgment is not specified. Unanimity could be a tough nut with six members. Majority rule leaves open the possibility of a 3-3 stalemate.  Could the committee chairman, appointed by the commission, have the final say, whatever the breakdown between the six members?

The deeper you look into the TUE process, the more fraught it is with ambiguity. It’s hard to avoid the inference that the principle of the TUE itself is flawed. It seeks to level a playing field which is already warped with the uncertainty and complexity of what individual drugs do, compounded by interactions with other drugs both legal and illegal. Moreover, the experts reviewing a case are not explicitly required, at least in the case of the IAAF, to show proof of current expert knowledge.

The most level playing field is where everyone follows the same rules, and prohibiting the use of banned drugs altogether gets it about as level as you could hope for.

Breaking2: Science or Stunt?

Mark Heinicke is the Associate Editor of Road Race Management and is responsible for most of the statistical surveys that appear in the newsletter. Mark has followed the sport as a participant and a writer for over 40 years. With gimpy knees forcing him on to a bicycle in recent years, he observes running in a frequently more detached but analytical manner, which provides a fresh perspective for those of us who spend most of our waking hours in the trenches.

Nike’s project, Breaking2, to help a man break two hours in the marathon by spring of 2017, has been getting heaps of media attention. And that, I believe is the point of it—since failure of this attempt is virtually guaranteed, the best explanation for the project is that it gets a big media splash, I mean swoosh. Why bother with an extraordinary but vain effort, except for the hoopla?

It is being billed as a science project of sorts—testing the limits of human physiology. That makes sense for a clothing manufacturer, presenting the latest in electronic wearables, as the runners—for scientific purposes—will have their vital signs and other key stats monitored, and where else to have monitoring gadgets but embedded in Nike plumage?

Adidas has its own two-hour project under way and under wraps. They announced it to the Wall Street Journal four days after Nike’s announcement, but released no details. One wonders how much Adidas rues letting Nike upstage them. Or how much they might chortle with glee if and when Breaking2 breaks bad.

Nike’s project has been described as “bold,” “audacious,” “wildly ambitious,” and “a moon shot.” Nike executives are eating up this rhetoric like holiday candy.

OK, you think I’m deriding Nike for sensationalism on the basis of the near-impossibility of breaking two hours in the next six months. What’s my reasoning?

Is breaking two hours possible? Sure, sometime. Physiologists have calculated it’s doable, eventually. Definitely if we were to breed runners like racehorses, which might be not so farfetched. By the end of this century, if we haven’t destroyed civilization, a physical specimen will come along who will be to marathoning as Secretariat was to horse racing, and could even get under 1:58:00.

Then again, by that time there may be competitors so augmented by genetic engineering as to make records meaningless. (At least, meaningless to us living in the Dark Ages of high-tech. With disruptive technologies jabbing the body politic on a daily basis, by the year 2100 norms, standards, and values may have evolved into forms unrecognizable to us.)

Back to Breaking2. Is success possible for the spring of 2017? Well, it depends.  As experts have been pointing out, it will depend a LOT on the conditions in which it is run. Optimizing it for temperature, humidity, road surface, and minimal and soft turns, all seem fair (although who knows what psychological effect it might have on runners to be waiting around for that Perfect Day). But, if the course has an elevation drop or start-finish separation outside of IAAF rules for records, it won’t go in the record books. It will look like the science project that Nike is advertising—oh no, it was never about the time, it was about discovery. Once the result gets run through the Nike spin machine, it’s a triumph either way.

But, say the course falls within the IAAF rules for records, and the athletes are not chased by a pack of wolves, what’s the chance of success?

Just about zero. Here’s why:

Consider first, how much the world 1500 meter record on the track has changed since 1998, the 5000 record since 2004, the 10,000 since 2005. In each case, not. Those records delineate the near-limits of the possible. It’s the area of diminishing returns, a few seconds gained from years of advances in training and equipment. The records will be broken, but not by much, and they will come slowly, barring the arrival of a superman.

During that same period, the marathon record has dropped six times, from 2:05:08 in 2002, to 2:02:57 in 2014, sometimes by increments of 20-30 seconds. Striking! Makes you think 2:00:00 is nearly within our grasp. But where does that trajectory actually take us? There’s a cool graph in Runner’s World online that gives you an idea at: http://www.runnersworld.com/marathon/nikes-audacious-plan-break-the-2-hour-marathon-barrier-in-2017

Runner’s World’s graph implies that, even if the record continued to drop in a straight line, it won’t hit 2:00:00 until around 2030. But the advances won’t continue in a straight line, because the athletes are entering a phase where the line begins to flatten out toward an asymptote, just as has happened with the shorter distances on the track.

Instead of looking at the world record progression starting in 2002, let’s look at the stats in another way. Fourteen marathons have been run under 2:04:00. The fastest, 2:02:57 in 2014, is separated from the fourteenth, 2:03:59 in 2008, by 62 seconds. Sixty-two seconds in six years = 10.3 seconds per year.  Also, seven of those fourteen performances belong to just three guys: Wilson Kiprotich Kipsang with three, and two each for Emmanuel Mutai and Dennis Kimetto (WR holder). You can look it up at marathonguide.com: http://www.marathonguide.com/history/records/alltimelist.cfm?Gen=m&Sort=Time

Add to this picture the fact that there’s been no progress in the last two years, and you get a sense of diminishing returns as runners gasp in the rarefied atmosphere beyond two hours, three minutes. Which makes the idea of a three minute gain in six months on a record-eligible course kind of outlandish.

Of the three runners picked by Nike—Eliud Kipchoge, Lelisa Desisa, and Zersenay Tadese—only Kipchoge (2:03:05) has come close to the current WR.  It was razor close, indeed, eight seconds off in London this year. Tadese did run a WR 58:23 half marathon, but that was back in 2010.

From all appearances, Kipchoge is the Chosen One, to be spurred on by the other two. He won London last spring, was untouchable in Rio, and he’s won seven of the eight marathons he’s run, the exception being second in Berlin 2013. He’s mentally tough as nails, having won Berlin 2015 in 2:04:00, even though his shoes (made by guess-who) were coming apart. See (with a photo) at Wall Street Journal: http://www.wsj.com/articles/kenyan-marathoner-falls-short-of-record-after-nike-shoes-fail-1443375160

Perhaps it’s on the basis of that performance that Nike has chosen Kipchoge as its Two Hour standard bearer. (They ought to make sure he gets a better pair of shoes for that attempt.)

At age 32, Kipchoge’s at the zenith of his career. Another of his strengths is his comfort with running alone, as Rio attested to. He’ll have to do a lot of running alone to break two hours.

Sociability, Race Numbers, and Side Shows in Road Races

Mark Heinicke is the Associate Editor of Road Race Management and is responsible for most of the statistical surveys that appear in the newsletter. Mark has followed the sport as a participant and a writer for over 40 years. With gimpy knees forcing him on to a bicycle in recent years, he observes running in a frequently more detached but analytical manner, which provides a fresh perspective for those of us who spend most of our waking hours in the trenches.

Running USA’s CEO Rich Harshbarger, observing the rise in participation in turkey trots, noted “the sport of running is increasingly social. . . .”

Part of what attracts runners to turkey trots—even in thirty-degree weather—is that Thanksgiving is inherently a very social occasion all in itself. Even if the uncles get to bickering about politics before they sit down to dinner.

The “increasingly social” aspect has been implicit in what’s going on in road racing, but Harshbarger’s making it explicit as a draw for races got me to thinking about the concern for numbers. You may have heard that the Madison Marathon has boasted a one percent increase in participation, touting that it bucks the trend of declines in participation that have been “as much as nine percent.” If a one percent increase can be celebrated as a big achievement, then the sport really has fallen upon hard times.

The “as much as nine percent” drop between 2013 and 2015 comes from Running USA’s aggregation of all races, including ones that don’t belong in the category of “traditional” events. For the latter, we recently published in the RRM newsletter our findings that for traditional races, at least those with fields over 4,200, that drop was more like three to four percent. Unfortunately, based on recent results, the trend has not seemed to level off in 2016. Stay tuned.

Back to social. You can’t beat Thanksgiving for sociability, but what big race now is not packed with electronic social thingamajiggies to enhance the race experience on the social side?  Can there be anything new in this domain? Say, a Pokemon-Go of road racing? (Inadvisable on the race course, but as a sideshow.) If you can’t run the race distance, or you can’t even get into the race, maybe you could have a treasure hunt, an informal competition on the side. Something for spectators, friends, and family to indulge themselves in while their loved ones toil through the big miles. “Hey, Dad, you came in tenth in your age group, but I won a stuffed Donald Trump doll in the treasure hunt.” The treasure hunt would be captured on cell phone cameras of course, to be enjoyed over dinner (by those not texting through dinner).

Of course some races with lotteries and waiting lists have little need to boost their numbers—applications always beat the cap—but a sociable semi-competitive sideshow might work for some events that have been in decline and have the kind of infrastructure convenient for such an addition.

If this all sounds a bit facetious, let’s dwell on a more serious topic in which we can be truly thankful: no terrorist attacks on any Thanksgiving event just past, running or otherwise.  There are so many kinds of misery the that terrorists can inflict. Is race participation falling off on account of terrorism? What impact might the Boston Marathon bombing have had on participation numbers?

Gee, here I thought I’d be writing about a light topic!  So it goes in 2016.