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.

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.

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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.

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.

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.

Maria Sharapova and Meldonium – Consideration of a Positive Drug Test

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Maria Sharapova – 2012 London Olympic Games – Photo by Oliver Catlin, www.bscg.org

Before jumping to conclusions and lambasting Maria Sharapova as a deliberate doper over recent revelations, we should attempt to educate ourselves and arrive at an informed decision based on the circumstances at hand. There is much to consider when reviewing Ms. Sharapova’s recent positive drug test at the Australian Open for the drug Meldonium.

First, we start with the drug, Meldonium, also known as Mildronate. You can review the pubchem listing for mildronate if you are interested. Other synonyms for the drug include “Quaterin; 76144-81-5; Kvaterin.” The long IUPAC chemical name is 3-[(trimethylazaniumyl)amino]propanoate.

In medicine, Meldonium is used to treat cardiac conditions like angina and vascular disease. It was developed by a Latvian company Grindeks and is approved in the Russian Federation and other countries but not in the Unites States. The description on Drugs.com describes it in two therapeutic categories; “treatment of cardiac disorders” and “inhibitor of carnitine synthesis.” Drugs.com includes 11 brand names across the Russian Federation, Latvia, Georgia and Lithuania: “Cardionate, Meldonium Olainfarm, Meldonium-MIK, Mildronat, Mildronat Grindeks, Mildronats, Mildroxyn, Vazomag, Midromax, Mildronate, Milkor.” There are 189 publications to explore via PubMed if you want to want to spend the time perusing them.

It appears Ms. Sharapova tested positive for the drug in an ITF (International Tennis Federation) drug test on Jan. 26 at the Australian Open. This information comes from her own accounts and the various media summaries of her case, including one from the New York Times that includes a video of her press conference in which she disclosed the positive test results. She explains the details saying, “I was legally taking the drug for the last ten years. I was getting sick very often, I had a deficiency in magnesium. I had irregular EKG results, and I had a family history of diabetes.” She added she had used the drug since 2006 based on treatment advice from her doctor.

Meldonium was added to the World Anti-Doping Agency (WADA) Prohibited List for 2016 under the category ‘S4. Hormone and Metabolic Modulators’. Prior to 2016, Meldonium was on WADA’s monitoring program list, meaning they were watching to see if it was being abused by athletes. The notes from WADA’s 2016 Prohibited List – Summary of Major Modifications and Explanatory Notes that came out on September 16, 2015, says that “Meldonium (Mildronate) was added because of evidence of its use by athletes with the intention of enhancing performance.”

More specifically, an abstract from a publication on Meldonium in Drug Testing and Analysis from December 2015 mentions, “the anti-ischemic drug Mildronate demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of central nervous system (CNS) functions.” A good explanation on the logic and research leading WADA to prohibit of Meldonium is included in a blog from March 3, 2016, noting the positive drug tests of runners Abebe Aregawi and Endeshaw Negesse, who also recently tested positive for Meldonium.

According to a Roidadvisor.com article, “Performance-enhancing Drugs Used by Athletes That Are Surprisingly Common,” (Oct. 17, 2015),“Meldonium has generally been used by athletes in various sports for its mild stimulant-like properties.” The piece goes on to say, “Of interest to athletes is the finding that it consistently and significantly improves exercise tolerance. Some pharmaceutical companies have recently marketed it explicitly as a performance-enhancing drug. It’s also used as a ‘smart drug’ by non-athletes. Athletes have been using it for over 5 years.” Of additional concern, the article mentions other similar drugs “telmisartan (Micardis) and T3 liothyronine (Cytomel) – are currently being used by numerous elite athletes particularly in endurance sports.”

So, on the one hand there appears to be a plausible and legitimate medical reason for Ms. Sharapova to have used Meldonium. It could have simply been a mistake that she continued to use it in 2016 without realizing it had become prohibited or seeking a therapeutic-use exemption for the drug, which presumably she could have and still might receive if her account holds true. It’s possible that will be evaluated retrospectively. It would appear there was enough time to consider the potential concern as Meldonium was on the WADA monitoring program list since January 1, 2015 and notification of it being added to the Prohibited List came out more than three months before the start of the year. It is not known if the ITF provided any notification to its players in addition to the information WADA provided.

Now, the cynics will probably look at the message board information and say it appears clear that athletes have known about the doping potential of drugs like Meldonium for years now. They may conclude that Ms. Sharapova has come up with a convenient explanation of what happened after the fact. Sadly, that explanation is also plausible.

This issue is the perfect example of a primary challenge we face when confronting the need to conduct anti-doping testing to keep sport clean. All we have is the test results that indicate a positive or negative finding in a urine sample. The results do not speak to the motivations or intentions of the athlete. In situations like this one, or in cases that involve dietary supplement use, it is hard to know whether the athlete is being truthful in their explanation or if they have developed a convenient explanation for their use of the substance involved.

We will see how things conclude in this case. Given what we know about the character of Ms. Sharapova, we have to think this is accidental doping. Of course one can never be certain and the rules of strict liability still apply as they always do in the anti-doping realm, and as she herself notes in her statement. Sadly, she is now subject to a possible two years of sanctions and has had a pall pulled over the culmination of a fabulous career. Tennis will miss her and her the game. This case is the perfect illustration of the need for drug tested athletes to take it upon themselves at the end of each year to be vigilant and review changes in the WADA Prohibited List to ensure their medications and dietary supplements are compliant with the drug testing rules for the next year.

By Oliver Catlin, President, Banned Substances Control Group, www.bscg.org

For a Growing Number of Athletes and Consumers, Supplement Certification is Key

banner10bA new survey published recently in the New Zealand Medical Journal reveals 93 percent of elite New Zealand athletes consume dietary supplements. That an overwhelming majority of elite athletes use supplements shouldn’t come as a surprise to anyone. A 2013 survey from the National Marketing Institute in the United States revealed that supplement usage among U.S. adults at large increased from 62 percent in 2009 to 73 percent in 2013.

For competitive athletes, the pressure to be in top physical form is often especially intense. Some supplements can help optimize performance and nutrition without leading to positive drug tests. Supplements can help improve hydration and oxygen levels, support protein and carbohydrate intake and other baseline needs, and maximize key nutrients.

The caveat is that not all dietary and nutritional supplements are safe or free of problematic performance-enhancing drugs. Some products—especially those aimed at muscle-building, pre-workout stimulation, male sexual performance, and weight loss—are often contaminated with pharmaceutical drugs or designer drugs that could be harmful or may be banned in sport. Ingredients lists on supplement products cannot always be trusted, as problematic substances are often hidden in the product and do not appear on the label. These issues put athletes and general consumers at risk

According to WADA (World Anti-Doping Agency) on its website, “A significant number of positive tests have been attributed to the misuse of supplements.” Sporting authorities will not tolerate inadvertent doping, or doping via supplements, as an excuse for a positive drug test. Because every athlete is responsible for every substance found in his or her body, they must take great care in choosing which supplements to consume.

The traditional approach sporting authorities have espoused to athletes is to avoid taking supplements altogether. “The use of dietary supplements,” one common refrain goes, “is not recommended or encouraged as such products can lead to positive drug tests or other health concerns.”

As longtime experts in the field of sports drug testing, we at BSCG (Banned Substances Control Group) do not believe such a rigid approach today is realistic—or necessary. Many supplements can help athletes achieve their goals without risking their health or disqualification.

Today the supplement quandary for athletes and consumers is being solved through certification. Third-party administrators such as BSCG offer rigorous, independent, ISO-accredited supplement certification focused on the protection of athletes, consumers and even animals. A searchable database is provided for supplements that meet the established certification criteria.

Supplement certification helps the growing numbers of athletes and consumers to effectively navigate the supplement marketplace and identify supplement products that have been tested for their security. For more information about supplement certification for athletes, consumers, or animals or to search for BSCG Certified Drug Free® supplements, visit www.BSCG.org.

Banned Sports Doping Agents and Illegal Drugs Marketed as Dietary Supplements on Amazon.com

Designer steroids and prohormones, Selective Androgen Receptor Modulators (SARMs), growth hormone secretagogues, and new blood doping agents like FG-4592 all available to athletes and consumers through the online retailer, often under the guise of dietary supplements

The media has been swarming over possible concerns about Amazon’s poor treatment of its employees. Apparently there is less scrutiny on the products the retpillsailer has available for sale. Those interested in anti-doping and drugs in sport wonder how athletes manage to get their hands on banned doping agents to enhance their performance. One simple answer, products masquerading as dietary supplements on Amazon.com.

For years we have marveled at the easy access to steroids and other drugs via Amazon.com, and have written blog posts about it in 2010, 2011, 2013 and assisted with a Slate article in May 2014. Anabolic steroids like methasterone, new drugs like the SARM Ostarine, prescription drugs, and more have all been available. Ever since we realized the prevalence of doping agents on the site, some of which were on the list of DEA Controlled Substances, we have tracked the issue further.

We recently circled back again to see how Amazon has responded, especially after the passage of the new Designer Anabolic Steroid Control Act in December 2014 (DASCA). We applaud our friends at the United Natural Products Alliance (UNPA) for promoting this bill and the government for finally enacting stronger regulations in this arena.

So what is still available at Amazon.com in the way of sports doping agents, or designer drugs? Plenty. This week, a search for prohormones brings up 94 items. When we were here a week ago there were 96, and it went up to 97 while we were exploring, so the list is constantly in flux. Having reviewed the offerings before, and being reasonably familiar with the products, we focused our review on a few items of interest. It is good that we are familiar, because for some of these potentially dangerous products, which presume to be dietary supplements, no information is provided about the ingredients.

Real problems remain. Take Blackstone Labs Alpha-1 Max, the product description on Amazon merely says, “Great product.” Visiting Strong Supplement Shop online, you find the product, label information and the ingredient, 20mg of Methyl-1-Etiocholenolol-Epietiocholanolone. This drug is otherwise known in the vernacular as Alpha One, Methyl-1-AD, or Methyl-1-Alpha. PubChem lists it as Epietiocholanolone with 43 depositor-supplied-synonyms, so the naming conventions are broad for this one compound, which is part of the challenge in tracking it and others like it.

If you Google the drug name, many links come up. Just pick one and an explanation like the following appears: “Methyl-1-Etiocholenolol-Epietiocholanolone, aka Methyl 1-AD, M1A, or Alpha One is one of the strongest designer steroid/prohormone compounds on the market.” Alpha-1 Max is not alone, Xtreme Alpha-1 contains the same drug, according to the Amazon product description.

XtremeShedThe list of steroidal products available on Amazon continues with Xtreme Shed. Strong Supplement Shop has a version of the same product which is no longer available due to the prohormone ban in 2014. According to the Amazon product description Xtreme Shed includes: “(3,3-azo-17a-methyl-5a-androstan-17b-ol) 20mg (6a-Chloro-androst-4-en-17b-ol-3-one) 30mg”. The first ingredient is known as methyldiazirinol, the second hexadrone. Both are prohormones or designer steroids. The StrongSupplementShop listing for Xtreme Shed says the product contained 4-chloro-17a-methyl-androst-4-en-17b-ol3-one, otherwise known as methylclostebol.

Methylclostebol is a steroid that was added to the DEA Controlled Substances list under the DASCA legislation, probably why Xtreme Shed was discontinued at Strong Supplement Shop. The two compounds in Xtreme Shed on Amazon are not listed by name in the DASCA language. Perhaps the one on Amazon is a new version with the ingredients adjusted in hopes of getting around the DASCA legislation? If you thought the prohormone and designer steroid era was over, think again.

It doesn’t stop there. SARMs, a new category of developing drugs that aim to mimic the effects of anabolic steroids, remain available on Amazon.com in offerings like EPG OstaLean, or Osta, or Osta Laxogen. The names and product information suggest they contain the drug Ostarine, which appears on the WADA Prohibited List. Its scientific name is Enobosarm with a long name, (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(Trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide). In the case of Osta and Osta Laxogen, the Amazon product descriptions include the long name, the same way it is written in an FDA warning letter from December 11, 2014 addressing the sale of the SARM by another company.

Interestingly, if you purchase Osta the order is fulfilled by Amazon. What does it mean to be fulfilled by Amazon? According to the site, “Fulfillment by Amazon (FBA) is a service we offer sellers that lets them store their products in Amazon’s fulfillment centers, and we directly pack, ship, and provide customer service for these products. Something we hope you’ll especially enjoy.” So, in the case of Osta, fulfilled by Amazon apparently means that the product is currently inventoried in an Amazon warehouse, with Amazon shipping and providing customer service, all for a product described to contain a drug that the FDA has issued a warning letter against previously.

The FDA wrote the following in its warning letter, “androgenic modulator products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) [21 U.S.C. §§ 352 and 331(a)] of the FDCA”. It goes on to say that SARMs, “are not dietary supplements.”

A Maxim magazine article focused on the popularity of SARMs, secretagogues and other unapproved drugs sold as supplements earlier this year. The DEA’s position on SARMs after the passage of DASCA is represented as follows in the article: “The way the statute is written, we have to be able to demonstrate a substance is chemically and pharmaceutically similar to testosterone,” says DEA spokesman Joseph Moses. “That makes them incapable of being controlled under the term anabolic steroid.” Nonetheless, SARMs certainly don’t qualify as legal dietary supplement ingredients, hence the FDA’s warning letter.

Unfortunately, the list of doping agents available at Amazon.com does not stop with steroids and SARMs. Blackstone Labs MK Ultra contains the drug Ibutamoren, also known as MK-677, according to the label and product information found elsewherefg-4592. Ibutamoren is in development for the treatment of growth disorders; in the doping realm it is known as a growth hormone secretagogue. Growth hormone secretagogues are listed generally on the WADA Prohibited List, but this specific drug does not appear yet by name. Even the new blood doping agent FG-4592 can be found on Amazon.com, although it is not currently available from the listed supplier nor is it clear if it is offered as a dietary supplement.

Athletes don’t need any kind of clandestine network to get sports doping agents; all they need is Amazon. The reality is banned and unapproved new drugs are at our finger tips often pretending to be dietary supplements. If you don’t believe this is a problem, picture a 16-year-old kid unknowingly buying a potent anabolic steroid on Amazon that can cause serious health issues, like Alpha-1 Max, and it might change your thinking. From the anti-doping perspective, we have a tough fight ahead if new doping drugs appear as supplements on Amazon.com as quickly as we can create the tests to detect them.