Response to Grigory Rodchenkov and Vladimir Putin on Russian Doping Debacle

Beijing Olympics Opening Ceremony – Photo by Oliver Catlin

We welcomed reading the Sept. 22 New York Times opinion piece from Grigory Rodchenkov on Russia’s state-sanctioned doping and the response to date by the Olympic community. Vladmir Putin has now added his voice to the discussion.

Grigory’s comments clarifying the direct involvement of the Russian sport minister in the country’s nefarious doping activities are very important, as that has been difficult to prove. Grigory also shares what our position has been for some time, that as a result of its state-directed doping Russia should be sanctioned and not allowed to compete as a nation in the upcoming 2018 Winter Olympics in PyeongChang but demonstrably clean Russian athletes should be allowed to compete under a neutral flag.

While we appreciate much of the perspectives Grigory shares, and also his apology to those he disappointed since we fall into that group, we still have some questions regarding his explanation and reasoning. The biggest question remains: Why did he participate in Russia’s fraudulent state-directed doping for so long without trying to expose it earlier on ethical grounds, and exactly how long was the activity going on?

Grigory begins his piece saying he escaped Russia to expose to the world the Russian doping activities in hopes of leading to change. He laments that his hope for change is fading due to a lax response. He notes that Russia has yet to admit to supporting the doping activities or provide evidence to demonstrate the specifics of what occurred, part of the recommended reforms the Olympic authorities have requested. He points out the oddity that none of the commissions investigating the case had sought comment from him until September. This is certainly unfortunate if true.

He then goes on to unequivocally explain that Vitaly Mutko, a deputy prime minister and former minister of sport, and other government officials were directly involved in the doping activities, saying Mr. Mutko “knew about, and was critical to the success of, Russia’s doping program.” The involvement of the state and the ability to demonstrate it has been debated by some to date and has made it easier to support a less stringent response for those so inclined. Grigory, as a key witness, adds important clarity as to the direct involvement of government authorities in the Russian doping agenda.

Grigory goes on to describe himself as the witch in the witch-hunt, and we agree with that notion in part as he was most likely not the mastermind behind this affair. Yet we are not ready to accept his absolution of guilt. After all, from an ethical standpoint there are still many questions remaining as to why Grigory did not come forward earlier to expose the truth behind the Russian doping activities and halt his own involvement in them. There are also big questions as to how long the state-sponsored doping has been ongoing that are of significant concern.

Grigory describes himself as a victim of the system suggesting that he did not have a choice but to be involved in the doping activities. He compares this to the clean athletes that also do not “have much choice but to cheat, even if some did so enthusiastically.” He suggests that the Russian system demands compliance and that people face serious consequences if they do not comply with directions from superiors or the state. He recounts the sudden, mysterious deaths of two of his colleagues that were involved in Russia’s doping system, saying that they were not coincidental.

We do not doubt, nor discount, the need to comply with the demands of the state in Russia or face dire consequences. We understand that careers, and in fact lives in certain circumstances, are at stake for non-compliance.

For Grigory, or for Russian athletes, a sad choice is suggested: Follow the directions of the state, sacrificing your ethics in the process, if you want to be successful in your career. The other option seems to be to leave the country to pursue your trade, whether it be science or athletics. Leaving ones country and life behind is perhaps a more difficult choice to make than sacrificing ones ethics, but that is a choice that some people in similar circumstances have made. What a horrible decision to have to make.

We noted recently in our commentary on the documentary “Icarus” that there are allegations of state-sponsored doping in the Soviet Union and Russia going back to 1988 and before, when Victor Uralets was the laboratory director from 1980 to 1992. Elliott Almond reminded us of this on May 13, 2016 in The Monterey Herald in his interview with Victor the week following the revelations of Russian doping in The New York Times. Grigory was hired by Victor and eventually succeeded him as director of the Moscow anti-doping laboratory.

A Russian magazine Smena had revealed allegations of 1988 pre-testing occurring on the ship ‘Mikhail Sholokhov,’ docked 60 kilometers from Seoul in an effort to explore whether Russian athletes would pass drug tests during the Olympics. As Elliott writes, this was “one of the most startling revelations that attracted little attention… after the 1988 Summer Olympics in Seoul, South Korea.” An L.A. Times piece from March 24, 1989 describes the Smena article and recounts a startling story told by the young anonymous Soviet athlete interviewed by the youth magazine.

“They knew what kind of ‘vitamins’ these were,” said the athlete, who asked not to be identified. “And that if you refused, you’d be thrown off the team. . . . Now I’m practically an invalid . . . constant pains . . . my whole hormonal system is destroyed, my health is ruined . . . and my life is still ahead of me. I would have liked to become a mother.” For those who question why we should fight against doping, this one personal story should provide a powerful answer.

Victor verifies the veracity of the pre-testing claims and the apparent purpose, in Elliott’s article and also importantly noted that he left his position and came to the United States because he did not believe what he was being asked to do was ethical or safe. “By the time I realized it is not ethical or safe, I decided to leave,” Victor is quoted as saying. “I have a similar job here but without that embarrassment involved with cheating.” He goes on to say, “It is repeating itself. It is a huge embarrassment. It is an embarrassment on a global scale.”

Is it repeating itself or did it never end?

As we pointed out in our earlier discussion on “Icarus,” Don, and others had concerns that doping activity was occurring going back to the Soviet era. Manfred Donike, one of the greatest anti-doping scientists in history, had become suspicious in 1988 of Soviet pre-testing during the Olympics in Calgary where on the street he ran into Victor, who was there unbeknownst to his international doping control lab colleagues. Later, Don and other colleagues became aware of the Smena allegations of pre-testing of Soviet athletes; Don even recalls a photo of Grigory coming off the boat.

While there was suspicion that these activities could be part of a larger Soviet doping strategy there was never anything actionable to address. There had been no proof presented that we can recall that could clearly demonstrate state-sanctioned doping was occurring in the 1980s, or in the years since. As Grigory points out, that proof has yet to be provided by Russia even for the most recent endeavors.

But Grigory, we must ask, why did you not opt to do the same thing that Victor did? Why did you not come out earlier to expose the scandal for the benefit of clean athletes? Why did you wait until your life was threatened? You could have come to us at any point and we would have done everything possible to help you expose whatever was occurring in the right way–and do what was possible to protect your family in the process. You chose not to take that path, and that is unfortunate. Now you want to wash your hands of any responsibility?

The New York Times article of May 12, 2016, “Russian Insider Says State-Run Doping Fueled Olympic Gold” by Rebecca Ruiz, described your activities as “the apex of a decade-long effort to perfect Russia’s doping strategy at international competitions.” You have admitted to not only allowing your testing to be used as a tool in the state-directed doping activities, but to actually providing the drugs involved! We would really like to know the extent of what was going on back to the 1980s and how you were involved since then.

For us to consider that you were complicit somehow in Soviet and Russian doping from the 1980s through recent years makes our spine tingle. We were your friends, your colleagues. We even worked on collaborative anti-doping efforts with you including a groundbreaking U.S. – Soviet partnership in 1988 described in the New York Times at the time as “the first major attempt by each country to eliminate the use of performance-enhancing drugs like anabolic steroids.”  All that seems like a fraud now, sadly.

In “Icarus,” Grigory briefly alludes to challenges we have faced in the United States with doping athletes. In the 1980s the USOC’s now infamous “education” program was used to explore how to dope athletes and beat the drug tests. When Don uncovered the reality behind the program, for which he was doing the testing, he immediately stopped the work and demanded change.

His career was potentially on the line, but thankfully his life was never threatened. We understand the ethical dilemma Grigory faced, but we can’t profess to truly understand the circumstantial dilemma that the threat of the state adds to the equation.

Courageous whistleblower athletes Yuliya Stepanova and her husband, Vitaliy, did understand the risk and nonetheless elected to come forward. They are to be lauded for helping to expose the sordid Russian doping affair. As we noted in our earlier statement on “Icarus,” the athletes courageously stepped forward to demand change themselves and took action. Their strength is a powerful force in confronting state corruption and impelling the system to change.

We share the opinion that the Olympic family must adequately respond to this demand for change and that it has yet to do so. Prohibiting Russia from achieving glory at the 2018 Winter Olympics in PyeongChang as a penalty for its involvement in the establishment of a doping program seems justified. We advocated for that step to be taken before Rio. Fines are not adequate and set a dangerous precedent. Allowing Russian athletes that are proven clean to compete under a neutral flag reinforces support of clean athletes while a Russian ban would enforce a deservedly harsh penalty on the state.

We remain hopeful the exposure of the Russian doping scandal will result in positive changes that will reinforce the protection that clean athletes deserve. Grigory could help further by explaining what was happening before Sochi and the mouse holes were drilled and the bottles tampered with and the positive test results covered up and the clean athletes denied their victories. He could help shed some light on the historical realities of the Soviet and Russian doping program going back to the 1980s and 1990s. This information might help us to avoid state-sponsored doping in the future, by Russia or some other country willing to ride roughshod over the integrity of Olympic sport.

Russia is now requesting that Grigory be returned home to face trial for his actions. If he is sent back he will surely be imprisoned, or worse, and his knowledge of what really happened will be lost. What he knows is important to the future of clean sport and he should be given the opportunity to finish telling his story.

On Nov. 9, Russian President Vladimir Putin commented on the Russian doping allegations, suggesting among other things that the doping scandal is a U.S. plot aimed at swinging the upcoming Russian presidential election against him. He is quoted in part as follows:

“Here is what worries me: the Olympics start in February, and when are our presidential elections? In March. There is a strong suspicion that this is all happening in order to create a situation useful to some, one of disappointment for sports followers and sportsmen in which the state allegedly participated in violations. Therefore, there is strong suspicion that in response to our alleged interference in their election they want to create problems in the election of the President of Russia, which, if so, is very bad, as it undermines the very meaning of the Olympic movement.”

President Putin, the eyes of the world have already been opened to the reality that there was high-level support for the doping that occurred in your country. Independent international parties under the auspices of the World Anti-Doping Agency carried out the process of investigating and reporting the reality of the abuses that occurred. The exposed Russian doping scandal is not a U.S. plot and the good people of the Lausanne laboratory were not part of the subterfuge. It is clear this was a systemic scheme perpetuated on sport by Russia to subvert Olympic competition. The worldwide reaction to this affront represents a global fight for the integrity of Olympic sport, led in part by Russia’s own athletes.

Indeed, part of the beauty of Olympic sport is that it transcends politics, which is all the more reason to protect it. In your own words, “sport as well as culture should be beyond politics, because it is a bridge that unites people”–yet you seek to politicize it. Doping degrades and destroys sport, it ruins the lives of talented athletes, and it undermines the unity and goodwill that international sport generates. As you point out, “a sports match should be honest, otherwise it loses all meaning. Interest in it disappears.”

President Putin, we appreciate your passion for sport and your aim to ensure Russia remains a global leader in sport. We hope you realize that in order to accomplish that goal a true embrace of the Olympic ideals and a real commitment to support clean sport are required.

Catlin Perspective on Netflix Documentary ‘Icarus’ and Russian Doping

By Oliver Catlin

Icarus coverWith the high-profile “Icarus” documentary now available on Netflix and in selected movie theaters, I wanted to take a moment to provide perspective on some points my father, anti-doping pioneer Dr. Don H. Catlin, and I have considered in regards to “Icarus” and Russian doping in general.

We offer a warning to those who have not yet seen the film that the following contains some spoilers.

Participation in ‘Icarus’ Documentary

When a documentary maker contacts my father looking for help for an anti-doping piece, he tries to lend his support and expertise whenever possible. He did so with Bryan Fogel, even though he was unfamiliar with Fogel’s previous work. In his request for participation, Fogel stated that the primary aim of his film would be a historical review of anti-doping scientific developments and a discussion of my father’s many achievements in the field and anything else my father wanted to discuss. Fogel also mentioned an interest in doping himself prior to riding in a top amateur cycling race to hopefully demonstrate he could beat the anti-doping system. “You are the expert on the subject—I am the filmmaker… let’s discuss and formulate a schedule and a plan and hopefully be aligned!” he wrote in his pitch.

As a key expert at the highest levels of sports drug testing for more than three decades, Don was excited to have an opportunity to share his historical insights about a myriad of professional experiences and developments in the field. Though he hesitated at the thought of helping someone to dope or attempt to game a system he had helped to build, he found himself curious how doping might impact someone in a real-world race environment. Fogel, however, was eager to discuss how difficult it was to evade detection and where the current holes in the system might be and how they could be exploited. Don shared some discussion with Fogel about the filmmaker’s ideas, but orchestrating the doping activity or trying to demonstrate that the current anti-doping system could be thwarted was not something my father was interested in doing.

About Grigory Rodchenkov

Over the years, my father has crossed paths with many other capable, dedicated scientists in the anti-doping field. He has enjoyed working with this committed group to help build the best anti-doping system possible for the protection of sport and the athletes. When Fogel asked if there was anyone he knew who might be able to help with his doping agenda, my father believed his dedicated colleagues, especially those in WADA-accredited labs, would decline as he did. Without question, most of them have high ethical standards and scrupulous laboratory practices, and take pride in their anti-doping work. He could think of only one person who might be willing to assist Fogel: Grigory Rodchenkov, then the director of Russia’s anti-doping laboratory in Moscow.

My father had known Rodchenkov for many years and respected his scientific work but over time was less certain of his ethics. While my father could never have imagined how extensive the Russian state-sponsored doping and its cover-up were at the 2014 Sochi Winter Olympics under the direction of Rodchenkov, he did believe Rodchenkov was operating in a different realm than the rest of his colleagues.

My father and others in the anti-doping community had been suspicious of Russia’s doping activity for many years. Prior to the airing of the earth-shattering ARD exposés in Germany in 2015 and 2016, allegations of widespread malfeasance in Russian track and field were publicly reported in 2014 with the help of courageous athletes by the ARD’s award-winning journalist Hajo Seppelt.

Some Context About Russian Doping

Russian state-sponsored doping of its top athletes has likely been going on for years. At one point in “Icarus,” Fogel raises the possibility that it goes all the way back to 1968. Thanks to the Russian magazine Smena, we know that in 1988, prior to the Summer Olympics in Seoul, South Korea, the Soviet team was pre-tested aboard a ship offshore. The Soviets purportedly wanted to ensure their doped athletes could pass the IOC tests. Victor Uralets, the director of the Moscow anti-doping laboratory from 1980 to 1992, essentially corroborated this story publicly in 2016 and indicated that he left the lab because he did not believe what he was being asked to do was ethical or safe. He now works at a testing lab in Northern California where he no longer has to deal with what he described as the embarrassment involved with cheating. We commend Victor for having the courage to leave a corrupt system.

In 2002, at the Winter Olympics at Salt Lake City, two Russian cross-country skiers, as well as a Spanish cross-country skier, were suspended after testing positive for darbepoetin alfa, a new form of the blood-booster EPO, or erythropoietin. It was the first time the test, developed by the French scientist Dr. Françoise Lasne, had been employed successfully. My father, who oversaw the drug testing at these Olympics, martialed the introduction of this new test that produced these historic positive results. Perhaps these early findings were merely the tip of the iceberg in the larger scheme of Russian doping that has been unveiled.

A Silver Lining

One small bit of silver lining loosely discussed in “Icarus” is the actual effects of doping on Fogel’s cycling performance, which decreased the year he rode dirty. By originally dedicating himself to training, proper nutrition, and riding clean, Fogel came in 14th place in the Haute Route Alps in 2014, 4th in his 40 – 49 age class. With a focus on doping, beating the system, and riding with a dirty mentality the following year, he came in 27th place and 12th in his age class. While a mechanical issue impaired a direct comparison of the two performances, we are left to wonder what the real effect of his doping might have been. Did it improve performance or did it hinder it, as Fogel’s results appear to show?

Fogel described it being easier to train and recover when he was doping, that the banned substances made it mentally easier to perform at a high level. When you are in a race situation and constantly challenging your maximum capability, however, is such an effect really beneficial? Or could the mental strength necessary to overcome suffering exhibited by clean riders sometimes actually enhance performance more than banned drugs? The mental capacity to deal with suffering and pain is vital in the grueling sport of cycling, and we wonder if that is actually diminished if one makes the sport easier by doping.

Many people will probably view “Icarus” and be dismayed as we were by its sordid tale of Russian doping, but we are also buoyed by the larger picture. We must remember it was not Rodchenkov or Fogel who were responsible for unveiling the ugly truth of state-sponsored Russian doping; it was the courageous athletes caught in its web, such as Yuliya Stepanova and her husband Vitaliy, who at great risk to themselves came forward to expose what was happening. The athletes themselves are driving change and endorsing clean sport more and more, and that is extremely powerful.

Oliver Catlin is President of BSCG (Banned Substances Control Group), a leading dietary supplement testing and certification provider since 2004. A graduate of UC Berkeley’s Haas School of Business, he has worked as an executive in the anti-doping and dietary supplement industries for nearly fifteen years.

The Rio Olympics, the Russian Doping Scandal, Dietary Supplements and Banned Substances in Sport

DSCN0492A Discussion with Dr. Don H. Catlin and Oliver Catlin

Don H. Catlin, M.D., a renowned longtime sports anti-doping researcher, is considered a father of drug testing in sport. He founded the UCLA Olympic Analytical Laboratory prior to the 1984 Los Angeles Summer Olympics and served as its director for 25 years, growing it into the world’s largest lab testing for performance-enhancing drugs. Today, among other things, he is Chief Science Officer at BSCG (Banned Substances Control Group), a leading provider of analytical testing and certification programs for dietary supplements, natural products, ingredient suppliers and manufacturing facilities.

Oliver Catlin is president of BSCG. A well-respected executive, he has been working in the arenas of sports anti-doping and dietary supplements for more than a decade.

Catlins

Dr. Don Catlin, left, and Oliver Catlin

In the interview that follows, Dr. Catlin and Mr. Catlin discuss the upcoming summer Olympic Games in Rio, the Russian doping scandal and dietary supplement issues related to drugs in sport.

 

Q. Dr. Catlin, as a former longtime member of the IOC (International Olympic Committee) Medical Commission, how do you feel about the IOC’s recent decision not to ban all Russian athletes at the Rio Olympics?

Dr. Catlin: I was not happy to wake up a few days ago to the news that the IOC did not ban Russian athletes from competing at the Summer Olympic Games in Rio. I was hoping to see a serious statement made against the practice of state-sponsored doping. Instead the IOC turned the decision over to International Federations and an IOC executive committee. Several high-level recent reports (McLaren, WADA report 1C, German television ARD) established that the state of Russia was clearly involved with directing doping activities in an operation that included,Russian lab director Dr. Grigory Rodchenkov, the state ministry of sport, and the FSB security forces (renamed from the KGB). The extent of the activities warranted a ban in my view. This decision presented an opportunity for the IOC to show its dedication to anti-doping ideals and make a serious statement in support of clean sport, but sadly they failed to make that statement

Mr. Catlin: If we don’t stand up for anti-doping in this instance, when will we? I think that perhaps the consideration of a complete ban was challenged by a lack of precedence for banning an entire country as a result of anti-doping as well as liability concerns. Clean athletes were going to be harmed whether a total ban was enacted or not; arguably more clean athletes are impacted by not proceeding with a ban. Although I don’t believe there is a precedent for keeping an entire country out of the Games due to systemic doping, there is perhaps a precedent for systemic doping factoring into whether a sport is allowed to remain an Olympic sport. It was not long ago that the status of baseball and softball as Olympic sports were affected in large part due to concerns over systemic doping in baseball. Surely a number of clean athletes were affected by the decision to remove these sports, and for a longer period of time than the Russian ban was being considered. Liability is also perhaps a concern. With gold medals being worth upwards of $10 million or more, the risk of Russian athletes suing for damages may have been a factor in the IOC’s decision.

 

Q. What do you make of Sochi Olympics lab director Dr. Rodchenkov’s claims that he helped to oversee the systematic doping of Russian Olympic athletes at the behest of the Russian government?

Dr. Catlin: I was deeply disappointed to learn that Grigory Rodchenkov, someone I had called a friend and a colleague, had become a central figure in the Russian doping scandal that has spanned many years. In an in-depth interview with the New York Times in May, Dr. Rodchenkov revealed his role in doping Russian athletes. He did this by providing cocktails of drugs that were designed to clear the system quickly, aiding Russian agencies in a scheme to cover up positive test results, and in the case of Sochi testing he participated in an elaborate sample switching scheme enabled by the FSB. Dr. Rodchenkov remained in the lab from midnight to dawn. He knew which samples were positive. He passed those through a hole in the wall to an FSB agent, who used a new technique to open the tamper proof bottles and replace the positive urine with a clean sample. The bottles were closed and passed back to the lab for testing. It is hard for me to stomach that kind of deceit from someone I had known for many years. Thankfully, most of the lab directors in the WADA system are dedicated and ethical scientists who work hard to defend anti-doping and clean sport.

Mr. Catlin: I think most observers of the Russian doping scandal realize that Russia presents a very different environment. There is often no option other than to follow state directives. Ramifications of challenging the state can be severe. The recent McLaren report noted that the Russian laboratory personnel did not have a choice in whether to be involved in the state-directed system; their employment required participation. We are focused on the current scandal but I think it is fair to say that this is not the first occasion that my father, or the larger anti-doping community, have been suspicious of Russian doping. Nor is Russia alone in having issues, we have seen problems previously with Chinese swimmers, East German athletes, and even in the U.S. with result shredding scandals and ‘educational’ testing in the 80’s.

 

Q. Some have gone so far as to suggest that systematic doping threatens the very existence of the Olympics. How concerned are you that we could actually reach a tipping point where the general public might no longer believe the Olympics is a fair competition?

Dr. Catlin: The Olympics have been involved with controversies for many years, including doping scandals. I think back to the Ben Johnson affair at the 1988 Summer Olympics at Seoul, South Korea, and what that did to shake up the system at the time. The Olympics have survived all such controversies in the past and will likely survive this one. It is true that each drug scandal takes its toll, and this one is pretty gross. But a scandal can also help expose systemic weakness, which if addressed, can improve anti-doping efforts for the future.

Mr. Catlin: It’s sad that the Russian doping scandal has cast a pall over the Rio Olympics. The silver lining is that it has put the anti-doping issue on center stage, as it should be given its importance to the Olympic family. Years ago, my father helped to create the International Olympic Charter against Doping in Sport, and hopefully commitment to those ideas will help lead us past the current situation. The important thing is for us to recognize the problems and find real solutions.

 

Q. What changes or solutions do you think are necessary to protect against these kinds of concerns at the Olympics in the future?

Dr. Catlin: One thing we need to evaluate is the process involved in reviewing and reporting positive results and to create more oversight when it comes to results management. For years we have put result management largely in the hands of stakeholders without adequate independent review. In WADA’s review and criticism of its own activities a year or two ago, they suggested they needed more commitment and participation on behalf of stakeholders. If we continue to allow results decisions to be managed by state sport agencies or federations like IAAF, we face the risk of result manipulation. Decision-making is not always in the hands of the experts anymore. Twenty years ago the IOC doping control system was largely managed by a group of lab directors and scientific experts. Today the IOC has abdicated much of the responsibility and expertise and put it on the shoulders of WADA, an administrative body. In its zeal to conduct its mission, WADA has at times created an adversarial relationship with lab directors, which can diminish their impact and value. I would like to see the system return to a more collegial process in the future.

Mr. Catlin: In addition to added oversight, I think we need to review the resources available to the pursuit of anti-doping. The world expects a lot out of anti-doping forces, and rightly so, but the resources also have to be there to support the task at hand. The worldwide budget for anti-doping is perhaps $300 million. That sounds like a lot until you consider that we have to test a pool of 100,000 or more athletes around the globe, staff and maintain more than 35 laboratories, and must create methods to find clandestine and evolving doping agents and improve detection capabilities. The resources dopers have to thwart the system have been shown to far exceed the resources we have available to fight for clean sport.

 

Q. Russian media outlets and others in Russia have asked you what can be done to legitimize the participation of their athletes in this summer’s Olympics. What do you tell them?

Dr. Catlin: It is hard to evaluate things on an athlete-by-athlete basis with the extent of the Russian doping now exposed. Some may have been effectively tested outside of the Russian system and perhaps those athletes could be allowed to participate legitimately. Ultimately, Russia needs to replace all the agencies that have been involved and put a new person in charge, someone who is clearly not involved with doping, and then build from there. The process will not be quick or easy. The international community needs to ensure oversight in the process in order for us to trust the new system.

Mr. Catlin: The big question is what percentage of Russian Olympic athletes were involved in the state sponsored doping; 5%, 20%, 50%? It spanned many athletes and sports based on the report statistics, but I don’t know if we really have all the necessary facts to answer that question. Were other undetectable drugs being used that we don’t yet know about that might still be in use? I am not aware of any consistent guidelines being used to consider whether Russian athletes should be allowed to participate, and without those how do we come to consistent decisions?

 

Q. What are your thoughts about the retesting of samples from the 2012 London Summer Olympics and the 2008 Beijing Games that have led to a number of positive test results?

Dr. Catlin: This is a marvelous idea, and one that I supported over the years. It puts the doper at risk of being penalized for activities that may have been undetectable at the time.  The testing methods are always improving and sometimes it takes anti-doping science a few years to develop an effective test for drugs that we know are being abused. This is a great mechanism for dissuading athletes from pursuing clandestine doping strategies.  The IOC has shown that retesting is a potent addition to the process.

Mr. Catlin: Retesting has certainly proven to be valuable. Historically there are usually only a handful of positive results that occur during an Olympic Games. The retesting has exposed three times as many results per Olympics, sometimes even more. The added deterrence is certainly significant. The shame is that the doper benefits for several years to the detriment of the clean athletes that get elevated in placement years later.

 

Q. Dr. Catlin, you voiced concerns in media interviews about WADA’s closure of the Rio Olympic laboratory weeks before the Olympics were about to begin. Are you glad the lab has been reaccredited and will now handle the drug testing after all?

Dr. Catlin:  Yes, I am very pleased that the lab has been reaccredited. There is much secretiveness about WADA’s actions so we never, if ever, know what the extent of the problem was that led to the loss of accreditation. While it is possible to send the samples to another lab, doing so is difficult and expensive and has many complications. Whenever the Olympics come to town the home country’s lab receives support from experts from around the globe and I have faith that the group assembled will do a great job of conducting the testing during the Rio Games.

Mr. Catlin: Some people have considered the loss of accreditation to be a flaw in the system, when in fact it is evidence of the system working. If deficiencies are found, they are identified and addressed.

 

Q. The drugs meldonium and oral-turinabol/dehydrochlormethyltestosterone (DHCMT) have been in the news lately. What impact, if any, do you think these substances might have at the Rio Olympics?

Dr. Catlin: I don’t think that either drug will have a major impact on the Games. The lack of consideration of meldonium withdrawal times was embarrassing and certainly resulted in a lot of wasted money and effort, but we are mostly beyond that at this point. As for oral-turinabol, or DHCMT, I do not know why there have been so many positive cases recently. The testing method for DHCMT was improved in the last few years with the detection of long-term metabolites extending the detection window from several days to several months. Perhaps that is one reason. Unfortunately, the drug remains prevalent online and has been seen as a contaminant in dietary supplement products as well. If the drug infiltrates the raw material supply for supplements, it could lead to trace amounts of contamination that the new urine-testing methodology would be more likely to expose.

Mr. Catlin: I think some athletes continue to claim they were affected by discrepancies in meldonium findings before or after the cutoff dates for withdrawal time to be considered a valid reason for a positive finding. This might impact which athletes get to participate in the Rio Games. In the case of meldonium, the WADA system addressed a substance that athletes were apparently using for performance enhancement. In the case of DHCMT, the system is now using an improved method that has a longer window of detection. In either case, additional loopholes were closed, which would seem to be good for the system overall.

 

Q. As key figures in both overseeing the testing of Olympic athletes and helping to protect them by providing quality supplement information, testing and certification, what general advice do you offer Olympic athletes about consumption of supplements?

Dr. Catlin: There have been numerous examples where athletes have been harmed by supplements that were spiked with drugs on the WADA Prohibited List. Over the years I helped a number of athletes fight cases against supplement companies after they had tested positive. That is one reason we created BSCG. Athletes should be cautious when considering supplements and should only take those that have been tested to make sure they are ‘clean.’

BSCG_FNLMr. Catlin: We have worked on a number of cases over the years where supplements have been involved in a positive drug test in some fashion and have impacted careers or health. Athletes like Kicker Vencill, Jareem Gunter, and Jessica Hardy. The issues involved are complex. Some supplements include active ingredients that may be banned substances in disguise. That was the case with the Superdrol product Gunter used; it contained the powerful anabolic steroid methasterone, which also contributed to his liver failure. Other products can be contaminated with trace amounts of banned substances that can still result in a positive drug test. This was the case with Hardy, who, as a result of using a supplement, lost out on her chance to compete in the 2008 Olympic Games in the prime of her career. We started our company BSCG to test and certify products to be free of banned substances so that athletes could have confidence when using them, and to give responsible supplement manufacturers a way to distinguish themselves from others in the industry. If athletes elect to use supplements—as many do, surveys have shown—we recommend they only consume products that have been certified by a reputable third party.

Colabello, Oral Turinabol and the MLB Positive Drug Tests

turanabol_j500Intrigue continues to swirl after a recent article in SportsNet brought up potential questions surrounding Chris Colabello’s Major League Baseball positive drug test for Dehydrochlormethyltestosterone, otherwise known as DHCMT or Oral Turinabol. The article quoted statements by our Chief Science Officer, Don Catlin, M.D., apparently questioning the test results and also exploring a common point source of DHCMT. We wished to provide additional clarity as to Dr. Catlin’s views on the test results and add some thoughts on Colabello, oral turinabol and the MLB positive drug tests.

First we wanted to clarify the comments made as to the test results and laboratory data. Dr. Catlin was quoted in the article in the excerpt below:

“The one (DHCMT) case where I looked at the laboratory data, I didn’t think it was very good,” he said in an interview with Sportsnet.

Asked what that meant, Catlin, who has overseen drug testing at multiple Olympics and years ago received a grant from Major League Baseball to help develop a test for HGH, replied: “There’s a long process involved and I just didn’t think the laboratory did a very good job in demonstrating that the (DHCMT) metabolite was present in the urine. But I didn’t want to get into it because of a whole bunch of other issues.”

While that doesn’t necessarily exonerate the players, from a scientific perspective, isn’t that an issue?

“It’s a huge issue, yes.”

Enough of an issue that a player can use it in appeal process?

“Sure.”

And present a reasonable case, and perhaps even win?

“Yes. But that would be a huge concern for baseball and (the testing lab in) Montreal.”

Because it would call into question the results of other tests and open the door for multiple athletes to contest their doping sanction?

“Right. I did not wish to get into it. But I was interested not so much in the chemistry, but in the source. The three baseball players I talked to were all adamant that they had never used it, didn’t know what it was. And that’s fairly typical, but it also suggests that there’s a source of it somewhere, and my view of it was that it was probably coming from a supplement that they all took.”

Please allow us to distill the intended meaning behind those comments in relation to Colabello, oral turinabol and the MLB positive drug tests. Before we begin, please consider that Dr. Catlin has been reviewing laboratory documentation packages for more than three decades, both those from his own UCLA Olympic Analytical Laboratory, as well as those from other laboratories in the WADA system. He is regarded in the anti-doping arena not only as one of the most renowned scientists but as one of its most frank individuals.

In this situation, Dr. Catlin was taking issue with the way in which the data in the documentation package was presented, not the underlying chemistry involved. This should not come as a surprise to our friend and dedicated colleague Christiane Ayotte, Ph.D., director of the respected Montreal laboratory; it is probably not the first time she has heard Dr. Catlin gripe about her doc packs (Madame Ayotte, malheursement le Don reste inchangé). Gripes aside, it does not mean the results were wrong.

Is it, “Enough of an issue that a player can use it in appeal process?” In Dr. Catlin’s view, if a documentation package is not presented in a clear fashion, it can leave room for athletes or their representatives and experts to attempt to construct a reasonable case to refute the finding. That is what he was alluding to in his response.

As for the chemistry, Dr. Catlin said he did not want to get into it, but wanted to focus instead on the possible source of the issue. As for Colabello, oral turinabol, and the MLB positive drug tests the results ultimately indicated the presence of a long-term metabolite of DHCMT. No parent drug was found and no other metabolite was identified, which is common when relying on the recently identified DHCMT long-term metabolite to detect long-term use of the drug. The finding was considered to be a trace finding for the long-term metabolite of DHCMT.

Before exploring potential sources of DHCMT, we wanted to comment on the DHCMT test itself, and the chemistry involved. Oral turinabol is an old drug that became infamous when it was the primary drug fueling the East German state-sponsored doping from 1968-88. The testing for the drug initially had a short window of detection of a few days. As research expanded on the drug and additional metabolites were identified, the retrospectivity of the testing improved to about 20 days.

In the last several years, a new long-term metabolite, referred to as the M4 metabolite, was identified that increases the window of detection to at least 40-50 days, perhaps longer. The chemistry of DHCMT, however, appears to be such that after 20 days only the long-term metabolite would be detectable, while the parent and other identifying metabolites would no longer be detectable. While not many drugs in the WADA system rely on the presence of a single metabolite to demonstrate the presence of a drug, doing so is certainly acceptable.

When validating such methods, it is commonplace to verify that there are no ‘false positives.’ Whether there could be a genetic anomaly that may produce a ‘false positive’ circumstance that did not present itself during the validation process remains a remote possibility that presents a difficult theory to explore. Many of the athletes in question have been tested before and did not produce positive results. Chasing an inconsistent anomaly could prove to be an endless pursuit. Cody Stanley’s circumstances certainly heighten the intrigue behind the theory, but it has yet to be considered or proven.

Unfortunately, limited research dollars are available to the anti-doping community and labs rightfully use those to validate and demonstrate new testing methods, as they have in the case of DHCMT. However, the community is certainly not afforded the resources to research all the theories on how a ‘false positive’ might occur. As you can imagine, we hear a lot of theories in that regard. If such a possibility does exist, we know our dedicated colleagues in anti-doping like Dr. Ayotte, the experienced folks at Kings College, Cologne, the UCLA Olympic Analytical Laboratory and others will be working diligently to evaluate it and further improve the testing platform for DHCMT.

As for the potential sources of DHCMT, unfortunately it is not hard to find. A quick google search for supplements that contain DHCMT or oral turinabol brings up at least ten different websites where you can buy the drug in pill form. It is clear that oral turinabol remains available, likely through raw material providers in China or elsewhere. Unfortunately, many of these raw material providers also offer legitimate and legal supplement ingredients to the supplement marketplace, leaving open the real possibility for inadvertent contamination of benign products.

In that regard, we recommend that athletes take supplements that have been certified to be free of banned substances by an independent third-party—through programs like ours at BSCG Certified Drug Free® or the others you can explore on our comparison chart. Make sure to evaluate the technical details of such programs to ensure they provide adequate protection against banned substances. Athletes should verify that a particular lot number has been certified to ensure a representative sample of what they consume has been cleared of prohibited drugs.Osta Rx

Since DHCMT remains prevalent online and as a raw material, it is plausible that a contaminated supplement could have been responsible for the rash of recent DHCMT positive drug tests. Several supplements included on the USADA High Risk List present oral turinabol concerns, like Alpha-4D, OrlaTEST, and Osta RX. Osta RX was labelled to contain the banned substance ostarine, a selective androgen receptor modulator (SARM), but instead testing revealed the presence of oral turinabol.

However, since multiple athletes are involved, who use a variety of different supplements, the possibility of a single point source of DHCMT being a single supplement product common to the athletes is unlikely. The players say they were using only certified supplements, so that possibility is further diminished. Whether there could be widespread trace contamination of a single ingredient that may have resulted in multiple supplements being contaminated with trace amounts of DHCMT seems like a slim possibility but still in the realm of consideration.

Ultimately, the following scenarios remain plausible in regards to Colabello, oral turinabol and the MLB positive drug tests: The athletes in question took oral turinabol after purchasing it online as part of a doping regiment that had worked in the past, believing the window of detection was still narrow. There could be contamination coming from dietary supplements, or their ingredients, that resulted in trace findings for the long term DHCMT metabolite in the various athlete urine samples. Finally, there is the theory that a common genetic anomaly, or another substance related to DHCMT that is present in the environment, could produce the same long-term DHCMT metabolite used for detection in trace amounts in some athletes—remote possibilities that have yet to be demonstrated.

A few questions remain open, but none seem to present a significant possibility of providing an explanation. Nonetheless, we will certainly be watching with great intrigue to see if the burgeoning list of DHCMT positives continues to grow in MLB and elsewhere.

Two Female Sports Reporters Among the Best in the Business

We were saddened to learn last week of the abuse female sports reporters frequently endure via social media forums such as Twitter and in e-mails. The hate-filled messages, usually from men, include such things as wanting to see the women murdered, raped, or beaten by their boyfriends. Vile doesn’t seem a strong enough word to describe these taunts.

The video of the words being read aloud by uninvolved men to some of the female sports reporters in question is heartbreaking and infuriating. Who do the men behind these messages think they are? Besides lacking common decency, we know one thing they are not: informed.

Over the past three decades, journalists from print, radio, and television have interviewed our esteemed anti-doping guru, Dr. Don Catlin, countless times. Sometimes it relates to his experience directing the first sports anti-doping lab in the United States, the UCLA Olympic Analytical Laboratory, or about the many tests he’s developed to detect performance-enhancing drugs such as the first designer steroid, norbolethone; the T/E ratio test used to distinguish natural from synthetic testosterone; or THG. More recently, it often regards his experience overseeing the testing of dietary supplement products for the trusted third-party supplement certification program BSCG Certified Drug Free® or includes his insights about the use of drugs in the headlines such as meldonium, hGH, or FG-4592.

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Interview with Dr. Don Catlin in 2008. Photo by Oliver Catlin.

Throughout this span of time, Dr. Catlin has been interviewed by hundreds of journalists of every stripe. Among just a handful who have stood out and risen to the top are Amy Shipley, formerly with the Washington Post, and The New York TimesJuliet Macur, who wrote the newspaper’s story about the misogynistic messages. He has worked with both women on multiple stories over the years, and found both to be exceptional professionals.

In their own ways, Shipley and Macur have demonstrated themselves to be consistently fair, perceptive, thorough, and undaunted in asking a range of questions, doing extensive research, and covering subjects others might have overlooked or been intimated by. Their stories have been accurate, smart, and well written. In our eyes, these two women have helped lead the field of sports reporting.

Juliet Macur’s reporting of the doping challenges facing cycling outpaced others in the field and didn’t come about via conjecture, rumor, or bias as did some others’ work. Her subsequent book on Lance Armstrong’s fall demonstrated the breadth and depth of her reporting and writing skills.

Nearly 30 years ago in the 1980s, Amy Shipley contacted Dr. Catlin, wanting to know what his lab did and how they did it. He suggested she fly out to see how it all worked—and she did. The result was an extensive, in-depth piece on the science of anti-doping testing, including the use of gas chromatography mass spectrometry—not a typical topic for a daily newspaper.

In 2005, when Dr. Catlin discovered a performance-enhancing drug, the designer steroid methasterone, masquerading as a dietary supplement product, he reached out to Shipley to warn athletes. She broke the story that November, which reverberated through the industry, leading to a focus on pro-hormone supplements and ultimately an FDA raid in 2009 of Bodybuilding.com, which remains as one of the largest enforcement actions to date in the supplement industry. Methasterone was soon added to the WADA Prohibited List, and Superdrol and other similar supplement products containing the substance were eventually pulled from the marketplace.

The article prompted a loud response on the muscle boards and discussion sites, many of which included hate-filled messages and even death threats directed at Ms. Shipley and Dr. Catlin. A perfect example of the kind of vitriol that can come from journalism that pushes the envelope and exposes issues of concern to sport that also has larger impacts on the general public.

In 2006, two years before the first positive test result in sports, Shipley wrote of Dr. Catlin’s analysis of the new designer stimulant methylhexaneamine, which was being used as an ingredient in dietary supplements. Her exposé led to further evaluation of this dangerous compound, which was added to the WADA Prohibited List in 2009 and has since become the third most reported drug in the WADA system.

These are just a few examples of contributions female journalists have made to sport. Those who seek to offend and hurl scorn at female sports reporters need to be aware of the impact these dedicated, hardworking, and talented women have made in the sports realm. Shipley, Macur, and others like them, have more than earned a right to work in the field of sports reporting and deserve nothing less than our praise and our thanks for their fortitude and great work.

Gordon Adds Another Dee to PED Discussion – The Steroid Dilemma Continues for MLB

Baseball Stadium - 2000 Sydney Olympic Games, Photo by Oliver Catlin

Baseball Stadium – 2000 Sydney Olympic Games, Photo by Oliver Catlin

While most people were waking up to a wonderful Friday morning, baseball fans were discovering some more depressing news in the announcement that Dee Gordon, infielder for the Miami Marlins, has been suspended 80 games due to test results revealing two performance-enhancing drugs (PED) in his system. Gordon had originally appealed the decision, but decided against appealing Friday morning.

Thursday night, Gordon revealed to his teammates, after a 4-game sweep of his former team in Los Angeles, that he tested positive earlier this year for synthetic testosterone and Clostebol, an anabolic steroid. He released a statement this morning through the MLB Players Association saying the following:  “Though I did not do so knowingly, I have been informed that test results showed I ingested something that contained prohibited substances. The hardest part about this is feeling that I have let down my teammates, the organization and the fans. I have been careful to avoid products that could contain something banned by MLB and the 20+ tests that I have taken and passed throughout my career prove this. I made a mistake, and I accept the consequences.”

Responses to the statement have been coming faster than Dee Gordon stealing second. Players, from all teams, are showing concern and making comments on the news about Gordon’s suspension.

Figure 1 Tweets by MLB players in response to Dee Gordon's PED suspension

Figure 1 Tweets by MLB players in response to Dee Gordon’s PED suspension

Justin Verlander’s Twitter response adds powerful perspective to the issue and shows how personal it is to the players, the majority of whom love and respect our national pastime.

Figure 2 - Twitter post made by Justin Verlander from the Detroit Tigers

Figure 2 Twitter post made by Justin Verlander from the Detroit Tigers. 

Why was Gordon Allowed to continue playing when these test results came in?

Gordon won the National League batting title in 2015 and was an All-Star player while with the Dodgers and the Marlins. Having him on the field obviously makes him a valuable asset to a team. You can ask anyone who was at Dodger Stadium Thursday night when Gordon “delivered the game-tying RBI single for the Marlins in the seventh inning,” which more or less solidified the series sweep.

Gordon had originally appealed the test results, meaning that nothing was going to be released publicly until the situation had been decided, which is in accordance with MLB policy. He was allowed to continue to take the field while the case was going through the appeal process. The news became public Friday morning, because Gordon decided to no longer appeal the results. But his answer just leads to more questions.

Should the punishment be more severe for players who cheat?

The topic of performance-enhancing drugs in the league has been trending lately due to the recent announcement of the Chris Colabello doping violation a week ago, Taylor Teagarden’s suspension earlier this month, as well as allegations of Chicago Cubs’ pitcher, Jake Arrieta, cheating after his recent successes on the field drew attention. Gordon’s suspension has further catalyzed conversations already in motion about what to do with his test results as well as the punishments associated with them.

The USA Today summarized the MLB penalties as of March 28, 2014 as follows: “Players and owners announce penalties will increase to 80 games for a first testing violation and to 162 for a second, and a season-long suspension will result in a complete loss of that year’s salary, rather than 162-183rds. A player who serves a PED suspension during the season will be ineligible for that year’s postseason.”

Even with these changes made, is it enough to incentivize players to not cheat? Many aren’t so sure. In an article released on April 21, by Fox Sports, the opinions players have about the MLB drug-testing program were discussed. Ever opinionated on the topic, Verlander discussed a potential way to clean up the league. “Maybe more severe punishments,” he said. He also mentioned that “It’s too easy for guys to serve a suspension and come back and still get paid,” which is what will happen with Gordon.

Another player, Matt Holliday from the St. Louis Cardinals, gave his take on punishments for cheating players in the article. “If you’re caught taking something where they prove that you’re trying to cheat,” he said, “that it’s a legitimate steroid or testosterone. I’m all for a year, two years, to keep guys from trying to cheat…for as harsh a penalty as possible. I’m all for second chances. But if you make the penalty super, super stiff, guys will think twice. They’ll look at 80 games and think, ‘That’s not that big a deal.’ But if you start taking away two years, that’s a lot of money. That might be different.”

We can all speculate that harsher punishments would make it a more difficult decision for players to take banned substances. They would also make it even more of a priority to be aware of what is in dietary supplement products or other medications athletes use. Lack of knowledge in this area can lead to problems, just ask Maria Sharapova, who tested positive at the Australian Open for the banned substance Meldonium. Thankfully, in the case of supplements, third-party certification programs like the BSCG Certified Drug Free® program are available that evaluate and test supplements to ensure they are free of banned substances to help mitigate the risks for athletes.

Is there incentive for players to cheat, regardless of the current punishments?

Gordon was traded to the Miami Marlins at the end of his best season with the Los Angeles Dodgers in 2014. Flash Gordon looked great in Dodger blue. Many fans in Chavez Ravine were sad to see him leave, especially having seen his stats soar after leaving. Of course, now that Gordon added another Dee to the PED discussion opinions have changed as we don’t need another superstar turned PED poster boy in L.A.

Last season, Gordon won the National League batting title with a .333 average. That was a big deal, due to the fact that he was neck-and-neck with Washington Nationals outfielder, Bryce Harper. He also led the league in stolen bases, with 58, a number not seen since JACKIE ROBINSON (yes, that guy) did it in 1949. Dee Gordon ended 2015 with the label “Big Deal” associated with his name and, as a result, was given a five-year, $50 million contract extension with the Miami Marlins.

Interviews were conducted before the 4-game series against the Dodgers on April 25th, prior to Gordon’s announcement. It was there, when Don Mattingly, who you might know as Donnie Baseball or the manager of the Los Angeles Dodgers from 2011 to 2015, discussed being the new manager of the Marlins and his thoughts of Gordon as a player, “What I always liked about him was his swing. You have to remember he was 140-something pounds when he started and now he’s brought it up to about 170. This is a kid that’s put on a lot of mature strength and his speed tools aren’t going away. That’s something that makes you feel really good about what he can do.”

As his manager ironically noted, Gordon was getting bigger, stronger, and better. The pressures that come with playing at this level include maintaining his skills in order to prove he is deserving of that label “Big Deal”. It isn’t unfathomable for a player to resort to taking performance-enhancing drugs in order to keep oneself at that professional level. It has been done before!

Gordon’s current punishment, aside from the 80-game suspension, includes a fine of $1.65 million. One might think that is a lot of money, until you realize it doesn’t even touch the $48.35 million he is still guaranteed on his contract. This being said, one could conclude that Gordon fought hard to earn this big paycheck, at any means possible, because cheating was worth close to fifty million dollars for him.   

Did Gordon use performance-enhancing drugs with mal intent? Did he cheat to gain weight and strength throughout his career? Was he trying to keep that “Big Deal” label while in Miami, or make it even bigger? Could this be something that happened unknowingly as his public statement claims?

While those questions linger, a single theme seems to resonate in professional baseball; even though a player’s failed test leads to a tarnished reputation, or demotion to the minor leagues, or retirement, or 80 game sanctions, he still makes millions of dollars. This is perhaps one reason why the issue of abusing banned substances in professional sports can be rationalized by players. Buster Olney’s statement about Gordon’s suspension puts it well, “the incentive to cheat will far outweigh the risks involved in being caught. Whatever the intent, whatever the justification, PED crime in baseball pays well.

If we can learn anything from the past two days, it is that the PED discussion is far from over in MLB. Those who thought the steroid era was over may need to reconsider. We also need to reconsider how the system can be improved and made stronger for the sake of the players and the fans who love our nation’s pastime. For now, Gordon is just another name added to the list of MLB players that have tested positive for PEDs. He isn’t the first, sadly–he won’t be the last.

Maria Sharapova and Meldonium – Consideration of a Therapeutic Use Exemption After a Positive Drug Test

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Maria Sharapova – London 2012 – Photo by Oliver Catlin, http://www.bscg.org

The coverage of Maria Sharapova’s announcement of her positive drug test for meldonium, or mildronate, has been astounding. Her case is yet another amazing example of a great champion falling victim to performance-enhancing drugs in one way or another. We wrote an immediate blog post about it an attempt to consider the two potential sides to a doping issue. That post still provides an interesting view of the perspective we were aiming to provide and we stand behind the bulk of the content.

In our haste to give Ms. Sharapova the benefit of the doubt in the situation, however, as we did in our conclusion and in the suggestion that perhaps her therapeutic use would be considered retrospectively, we did not fully consider the realities behind Ms. Sharapova’s claim of therapeutic use. Thankfully our friends in the anti-doping doping community have elegantly expounded on this element of the case.

The expert analysis below on therapeutic use and application in World Anti-Doping Agency (WADA) doping control is important to consider. It corrects the notion that a TUE could be granted retroactively and impact a pending sanction, which would be extremely rare if not completely unique in the field of anti-doping.

The information below was written by Dr. Ken Fitch and distributed by Jim Ferstle, both valued friends and colleagues who care deeply about clean sport and anti-doping and have spent their careers fighting for the cause as we have. The points of primary interest: retroactive TUEs would be unlikely to be considered from a standpoint of sanction relief, and the defined timeframe and clinical guidelines for use of a drug should always be scrutinized when evaluating potential therapeutic use. Thank you, Ken, for providing an insightful explanation of the criteria involved in the consideration of therapeutic use exemptions and the potential application to meldonium.

Dr. Ken Fitch is an Australian doctor and Professor, School of Sports Science, Exercise and Health, Faculty of Life Science University of Western Australia. Dr. Fitch wrote the original rules for TUEs in 1991 for the IOC, chaired the IOC’s TUE Committee for 20 years, chaired WADA’s interim committee (2001-2003) that established the initial International Standard for TUE (2004) and chaired Australia’s national TUE Committee for 22 years.

Maria Sharapova’s lawyer exploring a possible TUE to exempt a sanction
by Ken Fitch, M.D.

The ludicrous suggestion by Sharapova’s lawyer that she might seek a retroactive Therapeutic Use Exemption (TUE) to avoid a sanction for testing positive to meldonium demands a response. Ignoring whether the 2016 World Anti-Doping Code and the 2015 International Standard for TUEs does or does not make a retroactive TUE a possibility in her circumstances, if anybody examines the criteria that must be met to grant a TUE, he/she would understand that no respectable TUE Committee could approve any such application.

WADA states that there are four criteria, all of which must be met to grant a TUE.

  1. The drug is necessary to treat an acute or chronic medical condition and the athlete would experience a significant impairment to health if it were to be withheld.
  2. The therapeutic use of the prohibited drug is highly unlikely to produce any additional enhancement of performance beyond what might be anticipated by a return to the athlete’s normal state of health following the treatment.
  3. There is no reasonable therapeutic alternative to the use of the prohibited drug.
  4. The necessity to use of the prohibited drug is not a consequence of prior use of a prohibited drug or method.

Would Sharapova’s health be significantly impaired if she was denied a TUE? The Latvian makers of meldonium advise that it should be taken in intermittent courses of 4-6 weeks and for what period of time Sharapova administered meldonium during the past ten years, has yet to be disclosed. As the only acceptable medical indications are for ischemic cardiac and ischemic cerebral conditions, it is unthinkable that Sharapova has either. Hence any claim that should she be denied the right to take meldonium would impair her health is simply fanciful. Any TUE application must fail criterion 1.

The second criterion was introduced because some athletes had an essential need to take a prohibited drug. For example, an insulin dependent diabetic would die if denied insulin which has been prohibited in sport since 1998 and their daily insulin injections that are permitted with a TUE do not enhance performance. Whether meldonium actually enhances performance in humans has yet to be demonstrated. That WADA has advised that in less than two months since it was added to the Prohibited List, 99 athletes have tested positive for meldonium would appear to indicate that many athletes and their advisors believe that it does. No athlete could claim that meldonium was essential to restore their health back to normal levels. To claim that without it, a person’s health would be less than normal is surely fictitious. Fails criterion 2.

There are many drugs that have been demonstrated in scientific trials to be valuable in cardiac ischemia and the vast majority would be far superior to meldonium. The few meldonium studies performed in humans have been on persons who recently had experienced a myocardial infarction or an acute coronary syndrome. That the makers of meldonium recommend that it be administered only in intermittent courses in contrast to most of the widely acceptable, prescribed alternatives that are to be taken daily, is further evidence of the non-essential status of meldonium to treat cardiac ischemia. As the drug is marketed in only ten countries globally and Sharapova has lived in the USA for much of her life where meldonium is not approved for human use, this poses further questions for the tennis player.

Drug therapy for cerebral ischemia is generally ineffective and less frequently used than for cardiac ischemia but those patients on whom meldonium was trialled had had either a recent stroke or evidence of deteriorating brain function. As Sharapova could not possibly demonstrate that she has either of these or indeed significant cardiac or cerebral ischemia, and if she could, alternative permitted drugs are at least as effective if not more so, she fails criterion 3.

Hence Sharapova fails 3/3 and the fourth criterion has no relevance. Finally, should an unscrupulous or ignorant TUE Committee happen to grant Sharapova a retroactive or even a prospective TUE for meldonium, WADA would be certain to appeal to CAS and the decision would be or should be overturned.