Russian Doping of a Different Sort: Russian and Eastern European Drugs Hiding in Plain Sight as Alternative Doping Agents

Russian doping has been at the forefront of people’s minds as the 2020 Tokyo Olympic Games fade in our memories and we prepare for the 2022 Beijing Olympics to begin in February. The state-sponsored doping that culminated at the 2014 Sochi Olympics continues to cast shade over Russian sport–excuse me, the Russian Olympic Committee (ROC)–and indeed global competition, as the ensuing discussion and veiled accusations mar the Olympic spirit. But perhaps people should also be concerned about Russian doping of a different sort, one that is not often considered but should be. History has shown that athletes use Russian and Eastern European drugs as doping agents and yet few are prohibited today.

The World Anti-Doping Agency (WADA) Prohibited List outlines the substances that are banned in international competition including the Olympics. The 2021 WADA Prohibited List consists of 333 compounds listed by name, but the inclusion of catch-all language also prohibits related substances in many product categories. To be found, however, drugs have to rise to a level of concern and be targeted first and the WADA list primarily focuses on drugs of Western origin. Only four drugs of Russian or Eastern European origin appear to be included. Certainly there are others out there that would be attractive as doping agents.

Let’s take a look at the four drugs on the WADA Prohibited List that are of Russian or Eastern European origin and explore alternatives that athletes may be using today.

The story starts with bromantan, which was developed in the 1980s at the Russian Academy of Medical Sciences in Moscow. It can be found under the brand name Ladasten and is technically an actoprotector. Research out of Korea in 2012 explored bromantan in The Pharmacology of Actoprotectors: Practical Application for Improvement of Mental and Physical Performance. The writers described actoprotectors as “synthetic adaptogens with a significant capacity to improve physical performance.” The literature noted, “Bromantan was first found in an athlete sample at the 1996 Atlanta Olympics and was officially banned in 1997 as a stimulant.” There have been 11 adverse findings for bromantan in the WADA system since 2006.

Perhaps this is not surprising as a perfect alternative, bemitil, also known as metaprot, is described in the literature above and remains widely available online today, often at sites that offer Russian medicines or nootropics. The paper above explains that “nowadays, bemitil is manufactured in Ukraine (commercial name: Antihot) and is widely used in preparing Ukrainian national sport teams for international competitions.” It also notes, “Bemitil was successfully employed in preparing the athletes of the USSR’s national team for the 1980 Olympic Games held in Moscow.”

“Bemitil was successfully employed in preparing the athletes of the USSR’s national team for the 1980 Olympic Games held in Moscow.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3762282/

Bemitil was added to the WADA monitoring program list in 2018, 38 years after the Moscow Olympics you will note, but is not yet prohibited. If it does get prohibited, fear not there are alternatives for it, too. A site that sells Eastern European drugs like bemitil, MOSPharma.com, suggests four related products including noopept (see below) and trekrezan “from Russian pharmaceutical company Usolye-Siberian CPP,” with activity that “increases endurance during physical and mental stress.”

Next on the list of Russian doping agents is mescocarb, a central nervous system (CNS) stimulant and a dopamine reuptake inhibitor patented originally in Russia in 1970 by Vni Khim Farmatsevtichesky. Also known as Armesocarb, it is currently in clinical trials as an antiparkinsonian drug from Melior Pharmaceuticals. It has been sold under the brand name Sydnocarb with a nod to the technical chemical category in which it fits, mesoionic sydnone imine. Mesocarb does not appear to be widely available today online. It has been prohibited in sport since at least 1996 based on references to it at that time, but it has only been responsible for two adverse analytical findings since 2006.

There are also Russian alternatives to CNS stimulants with semax as one option. A poster on black market products with suspiciously doping relevant ingredients – annual report from the 2016 Manfred Donike Workshop discussed that semax “acts as a nootropic agent on the central nervous system and regulates dopamine and serotonine levels.” MOSPharma.com describes semax as “100% original from the Russian CJSC INPC Peptogen,” and notes it is used “to stimulate the central nervous system and enhance memory, focus, mental and physical performance, analytical skills.”

Carphedon, otherwise known as phenylpiracetam, is the next on our list and one of a family called racetams that are generally considered nootropic drugs. In 2019, researchers from the Czech Republic considered Carphedon at the Crossroads: A Dangerous  Drug or a Promising Psychopharmaceutical? They explain this substance was “developed in Russia as a stimulant to keep astronauts awake on long missions, and occasionally used in Russia as a nootropic prescription for various types of neurological disease.” Carphedon “was synthesized in 1990 by Russian chemists as a combination of two drugs, nootropic piracetam and amphetamine stimulant.” A 2012 review of Piracetam and Piracetam-Like Drugs describes them as “modulators of cerebral functions,” used for, “various therapeutic interventions relating to the CNS, including (i) cognition/memory; (ii) epilepsy and seizure; (iii) neurodegenerative diseases; (iv) stroke/ischaemia; and (v) stress and anxiety.”

Handwritten notes from 1997 show carphedon was considered by my father, sports drug-testing guru Dr. Don H. Catlin, and colleagues at the IOC Medical Commission for addition to the prohibited list at the time. The notes describe carphedon as, “adaptogenic, registered in 1994 in Russian pharmacopeia that might help with space travel and improve workload.” The drug has caused 122 adverse analytical findings since 2006.

If you peruse the piracetam review highlighted above, you will find nine other racetam options that may be considered as doping agents. None is listed by WADA today. Neither is noopept, otherwise known as omberacetam, which has become one of the most popular nootropic agents on the market today. The National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) notes that “noopept was patented by Russian-based pharmaceutical company JSC LEKKO Pharmaceuticals in 1996.” The information cites that the “research shows Noopept has similar effects, but works differently than other nootropics in the racetam-family.” A number of sites compare the effects of phenylpiracetam to noopept with nootriment.com, suggesting that “both are purported to have benefits for memory, concentration, mood and alertness.”

From a banned substance standpoint, phenylpiracetam is on the WADA Prohibited List while noopept is not listed nor is it targeted. A synthetic drug, noopept, is widely available in supplement form despite it not qualifying as a dietary supplement ingredient according to the Dietary Supplement Health and Education Act of 1994 (DSHEA), which defines legal supplement ingredients in the U.S. It shows up in 32 dietary supplement products in the NIH Office of Dietary Supplements Dietary Supplement Label Database. In 2016 a BSCG blog post I wrote considered noopept could be the next big doping agent hiding in plain sight. That still remains the case today.

Last but not least of the four Russian doping agents is meldonium, otherwise known as mildronate. One will remember the maelstrom that ensued when meldonium was added to the WADA Prohibited List in 2016. There were 515 positive drug tests for meldonium in 2016, making it the most common substance found that year in Olympic sport. Tennis star Maria Sharapova was among them. There were 269 more positives from 2017 to 2019 for a total of 784. Meldonium is included on the WADA Prohibited List as a metabolic modulator in category S4.

Scientists from the University of Latvia and the Latvian Institute of Organic Synthesis that created meldonium, described it as “an anti-ischemic drug.” Its performance-enhancing potential has been the subject of much debate likely because it is a complex substance that has a variety of effects. An excerpt from a 2005 paper written by the aforementioned scientists, Mildronate: An Antiischemic Drug for Neurological Indications, describes it as follows.

“Mildronate was designed to inhibit carnitine biosynthesis in order to prevent accumulation of cytotoxic intermediate products of fatty acid oxidation in ischemic tissues and to block this highly oxygen-consuming process. Mildronate is efficient in the treatment of heart ischemia and its consequences. Extensive evaluation of pharmacological activities of mildronate revealed its beneficial effect on cerebral circulation disorders and central nervous system (CNS) functions. The drug is used in neurological clinics for the treatment of brain circulation disorders. It appears to improve patients’ mood; they become more active, their motor dysfunction decreases, and asthenia, dizziness and nausea become less pronounced.”

The meldonium saga more than demonstrated athletes around the world had recognized an obscure anti-ischemia agent as a doping option and had started to use it. When it was prohibited, Russian scientists boasted they already had alternatives. As reported in USA Today from Moscow, “Federal Medical-Biological Agency head Vladimir Uiba says Russia has found ‘several drugs which are not banned and work significantly better than meldonium.’”

You don’t have to look far. Mexidol is broadly available on sites that cater to Russian medicine as well as on a site called DrDoping.com; very subtle. It is also available on Amazon from Pharmasoft at $21 for 50 tablets with a label that suggests it be used for “Anxiety Relief, Anti-Stress, and Ischemic Condition.” Mexidol, an anti-oxidant, was patented in 2002 in Russia with the patent describing the “invention relates to preparations used for prophylaxis and treatment of different forms of cardiac ischemia disease, atherosclerosis and acute circulation disturbances, cerebral insults.” With indications for ischemic conditions, it certainly appears similar to meldonium.

In a 2007 paper, Mexidol effects in extreme conditions, T.A. Varonina with the Institute of Pharmacology, Russian Academy of Medical Sciences notes, “Mexidol can be prescribed to humans to maintain efficiency in all kinds of extreme situations.” Could hundreds of Olympic athletes be using mexidol as an alternative to meldonium today?

A 2019 review from Russia of Pharmacoeconomic analysis of the neuroprotective medicines in the treatment of ischemic stroke compares mexidol to actovegin, which gained some notoriety as a potential doping agent around 2009 as explored in the Daily News. Actovegin, which DrDoping.com carries in pill form, is an extract from calf blood and is not on the WADA Prohibited List. In the article Olivier Rabin, WADA’s science director, suggests, “Actovegin could be used as a component of sophisticated blood doping methods, in which athletes withdraw, manipulate, and re-inject their blood to boost their endurance, or in conjunction with the use of erythropoietin, or EPO.”

When we ran independent drug-testing programs for several leading cycling teams in the peloton years ago, a key member of a team said to me after an event, “You know, Oliver, we aren’t doing anything that is over the line but we are doing everything we can up to the line.” That simple philosophy likely rings true across sport today.

People often ask if the Olympics or sport in general is clean today. To answer that simply, the system is very good at finding drugs that are currently defined as prohibited substances. None of the Russian or Eastern European drugs we note here–bemitil, trekrezan, semax, noopept and other racetams, actovegin, or mexidol–is on the WADA Prohibited List today. These Russian or Eastern European drugs certainly seem to be potential alternatives to prohibited drugs, but if they are not yet defined as such then using them is not yet considered doping. If sites like DrDoping.com has found them, who else might have them?

Oliver Catlin is the longtime president and co-founder of BSCG (Banned Substances Control Group), an international third-party certification and testing provider. With a background in sports anti-doping, he is widely regarded as a thought-leader in the field of sports nutrition and dietary supplements.

Lives in the Balance: Why Doping Control Matters

As the Tour de France rolls onto stage 7, few in the general public know of the story of 21-year-old Linas Rumsas, but they need to consider it. Especially on this day, July 13, 2018, the 51^st anniversary of cyclist Tommy Simpson’s death.

People ask us all the time why doping control matters. Some argue that it doesn’t and that we should just let folks use what they want. A doping free-for-all. Cynics might say that plenty of dopers have already escaped through the net in sports, at least for a time: Lance Armstrong, Tim Montgomery, Marion Jones, to name a few.

Linas Rumsas was an up-and-coming cyclist whose life was cut short after he abused performance-enhancing drugs. Photo: Team Altopack-Eppela

The story of young Linas, a promising cyclist whose life was cut short after abusing performance-enhancing drugs, reminds us that doping can kill. We would be wise to remember that it has happened before. Linas’ story is one of the saddest we have come across and it powerfully demonstrates why many of us who have chosen to pursue anti-doping continue to do so. This one story illuminates in no uncertain terms the realities of what we all face with the scourge of doping, and yet outside of Italy and frequent readers of Cycling News, few sports fans have probably heard of it.

There have been others who have perished from doping. According to ProCon, which provides a comprehensive historical timeline of doping in sports, the first modern athlete chronicled to have died from doping was the Danish cyclist Knut Jensen at the Summer Olympics in Rome in 1960. Heat was the initial culprit but his autopsy found traces of Ronicol. ProCon describes Ronicol as an amphetamine, but Ronicol would be described more accurately as a vasodilator and can be used as an anti-ischemia drug. Though it is not on the 2018 WADA Prohibited List, it is similar to meldonium in many ways.

Stop to consider that the first drug to have been implicated in the death of an athlete in the Olympics in 1960 is not banned today! Ronicol, otherwise known as nicotinyl alcohol, is not prohibited as confirmed by the Global DRO. Its cousin meldonium wasn’t prohibited by WADA until 2016, when it caused hundreds of athletes to test positive. Some might like to think that doping is behind the peloton, but we fear it may still be in the middle. Just in a form we don’t currently define as doping, like Ronicol.

Fifty one years ago today on July 13, 1967, Tommy Simpson infamously died on the slopes of Mount Ventoux during Stage 13 of the Tour at the age of 29. His death was one of the central moments in anti-doping history. Shortly thereafter that same year the International Olympic Committee (IOC) created the IOC Medical Commission and the first drug testing began at the Olympics in 1968, with narcotics and stimulants making up the initial prohibited list. Steroids were not added until 1975.

There have been other examples of athlete deaths that have been seminal. MLB pitcher Steve Bechler, of the Baltimore Orioles, died during drills in 2003. Ephedrine was indicated as a contributing cause in his premature death, which played a role in the regulation of ephedrine as a dietary supplement ingredient in the United States.

Steroids have played a role in the demise of many young athletes, including Taylor Hooton, Efrain Marrero, and just two days ago, a young 18-year-old Irishman in Limerick. Numerous stories exist of athletes who went too far with blood doping, or performed transfusions the wrong way, leading to dire consequences. Many stories are out there but few are known to the broader sporting public.

Linas Rumsas’ story reminds us that the scourge of doping is still present and that it is just as deadly today as it was in 1967 when amphetamines derailed the promising life and career of Mr. Simpson.

Linas Rumsas is the son of Raimondas Rumsas, who himself was a professional cyclist and took third place in the 2002 Tour de France. After Raimondas’ wife Edita was caught with a van full of drugs on the way home from that Tour, they both received four-month suspended sentences in 2006. Raimondas later tested positive for EPO during the 2003 Giro d’Italia. Sadly, this experience did not seem to deter them from apparently assisting their two children with doping.

Linas rode for the Altopack-Eppela squad in Italy and had already been a national road race champion. But in May 2017, he died at age 21 of a heart attack. It was nearly 50 years to the day after Mr. Simpson had died.

Upon Linas’ death, police searched his family’s home and seized a number of banned substances and medications. In September 2017, his older brother Raimondas Jr. tested positive for the prohibited substance GHRP-6, a peptide that produces natural growth hormone. It seems a cocktail of banned substances and other medications were being used at the family home.

The result of all this has been one family torn apart, again, from doping. Perhaps doping didn’t matter to the Rumsas family either until their son died. But Linas didn’t just die, if the allegations in this case hold true. He died as a result of family support and encouragement to dope.

It gets worse. In the course of the investigation, six people have been arrested in an apparent team-sponsored doping program including the team owner, directeur sportif, pharmacist, and trainer, who stand accused of providing drugs to riders. Seventeen other people are being investigated. Sadly, however, it is too late for Linas.

Unfortunately, the recent decision to allow Chris Froome to ride again with no sanctions after testing positive for elevated levels of salbutamol has called into question the validity and utility of the anti-doping system, again, at least in some people’s eyes. WADA has tried to explain the reasoning now, including clarifying the levels (1,428 ng/ml of urine, when adjusted for specific gravity, which is above the decision limit of 1,200 ng/ml). The reasons may not satisfy everyone, or anyone, but Froome’s case is certainly not a reason to give up on anti-doping.

Linas’ story personifies why giving up on anti-doping is simply not an option and should remind us all that doping is a significant matter. In fact, it is all the more reason to recognize that the failures of the anti-doping system are largely due to a lack of resources and money. For that to change, more people will need to truly understand what is at stake when athletes dope and to demonstrate the will to do more to combat the problem.

– Oliver Catlin

2018 PyeongChang Winter Olympic Games Review

Don Catlin, M.D., at Vancouver 2010 Opening Ceremony – Photo by Oliver Catlin

We watched with the rest of the world as the 2018 PyeongChang Winter Olympic Games unfolded. In the face of tense politics, doping scandals, and other controversy, the Olympic ideals still shined through, sometimes in unexpected ways. Having been fortunate to attend six amazing Winter Olympic Games (Don got to go to seven, I think), we figured why not provide some perspective on these. Here is our 2018 PyeongChang Winter Olympic Games Review.

Most Amazing Victory – Ester Ledecka. Who knew someone could win a gold medal in snowboarding and skiing! Some people don’t think that the two sports are compatible, some don’t even want both sports on the same mountain. This woman just went out and ripped it up, twice, however many planks were strapped to her feet. Well done, Ester.

Clean Athlete Awards – Jessica Diggins and Kikkan Randall. In an Olympics marred by the Russian doping scandal, we always appreciate it when you can literally see that athletes are clean. Not that we advocate that a visual determination replace anti-doping testing, but some people you can just tell are not doping. We thoroughly enjoyed watching these ladies win clean, and with amazing smiles! We also appreciate the other courageous cross-country skiers who signed the letter in 2016 demanding a stronger stance on doping, including notably the four Russian women who signed. Thanks to all of you for working to defend your sport from the scourge of doping.

Classiest Athlete – Yevgenia Medvedeva. OK, we admit we watched the ladies figure skating final and it was pretty amazing. The talent and class displayed by all the young ladies is unbelievable. However, one shined above the rest. Despite missing the gold medal by a heartbreaking 1.31 points that even experts could not decipher, this woman took disappointment with amazing class for an 18-year old. She genuinely embraced her younger upstart Alina Zagitova and accepted her silver medal with a smile. She could be overheard saying she “did everything she could.” That statement represents what Olympic athletes are all about. We don’t know much about this Russian athlete otherwise, but in PyeongChang this little Anna Karenina showed enormous class.

Most Notable Olympic Farewell – Lindsey Vonn. Although you leave the 2018 PyeongChang Olympic Games with a bronze medal, which most people could only hope for, you will always be the golden girl of American skiing. You took yourself to the pinnacle of your sport and beyond, and you brought your country with you. Along the way you’ve inspired generations of Olympians for years to come. We wouldn’t be surprised to see a woman like you one more time in Beijing four years from now, but if not thank you for all the amazing Olympic moments.

Strangest Doping Incident – Doping in Curling, really? We thought people drank beer during curling, but doping? Of course it would be an Olympic Athlete from Russia with meldonium as the offending substance, such perfect irony.

Ugliest Controversy – The ugliest controversy in these Olympics goes to the argument between Dick Pound and others in the IOC over whether or not to allow the Russian delegation to be permitted to fly the state colors during the closing ceremonies. It took long enough to finally get some kind of ban enacted and the corresponding statement made that state-sponsored doping is unacceptable, and it was going to be overturned during the Games? Way to go Dick Pound for sticking up for clean sport, as always! Or should we thank the second Olympic Athlete from Russia for doping and closing the door on that argument.

Most Inspiring Olympic Athlete – One athlete that epitomized the ideals of the Olympic movement and displayed them proudly in every fiber of his being by bringing athletes from all nations together sadly was not present in PyeongChang, but he was there is spirit. And his spirit we know will continue to inspire generations of Olympians for years to come. The Olympic Family lost Steven Holcomb, a beloved member of the bobsled community, in May 2017. But in the true spirit of the Olympic movement he went down the track many times in PyeongChang in the form of tribute bracelets on the wrists of many of his sliding colleagues, his parents cheering with tears in their eyes in the stands. Despite not being present, this man, and his spirit, made for the most inspiring Olympic athlete of this Games. We wish we could have known him and been inspired by his spirit.

Most Amazing Olympic Moment – It was hard to miss the unity demonstrated at the Opening Ceremonies with South Korea and North Korea marching together as one. This was a powerful symbol of the peaceful celebration of sport that the Olympics represent. We appreciate that this unity was achieved during the Games, and I think we all hope the peace was more than just for show and lasts.

The Olympics are truly an amazing gathering of athletes from all different countries, politics, races, sizes, sexes, orientations, faiths, and more. For all these moments and more, the Olympic Games remain one of the most amazing spectacles of human interaction and accomplishment in this world. They deserve to be truly appreciated, celebrated, and protected. We can’t wait for the years to pass to see what amazing feats and memorable moments Tokyo, Beijing, Paris, and Los Angeles will produce.

WADA EPO Testing Methodology Remains Sound and Strong Despite Colvert Case Discussion

My father, Dr. Don Catlin, has always been one of the most frank and open experts in the anti-doping industry. That is in part what attracts media to him still today. Yet, this style poses challenges as intents and comments can sometimes be misused. His comments have been used recently to suggest that there are flaws with the EPO drug-testing process in place today. To clarify, the WADA EPO testing methodology remains sound and strong despite the Colvert case discussion.

The case of Steven Colvert has been discussed as a potential example of a case that demonstrates the flaws in the WADA EPO testing methodology, but really it is an example of the complexity of the EPO test and why thorough analysis is needed to establish solid results—which the results in this case appear to be. Confusion can arise when visual analysis is considered alone, or when results are not considered in their entirety or without the benefit of scientific tools. To understand the realities of the Colvert case, one must first gain an understanding of the science involved.

Erythropoietin (EPO)

EPO testing today includes the use of three primary methods; IEF, SDS-PAGE and SAR-PAGE. All three methods have been carefully validated and peer reviewed across multiple laboratories and they have been in use for many years. There is an array of research showing the breadth and capability of the methods. We have published papers based on the seminal methods Dr. Francoise Lasne and other colleagues in the doping control industry have created in this complex realm of science. We certainly would not have based our own research on these techniques if we did not believe the methods to be valid and strong.

The EPO testing methodology is outlined in the WADA Technical Document – TD2014EPO. We recommend that those who wish to completely understand the methodology review the document. The harmonized methodology outlined is designed to create consistency in results between laboratories. There is an image on page 11 that is useful in evaluating Colvert’s results.

This complexity of EPO sport drug testing stems from the reality that EPO is a naturally present substance in the human body. This requires methods to be able to distinguish natural EPO from synthetic, or exogenous, forms. The three EPO testing methods evaluate band patterns with variable shading that migrate from a natural EPO pattern when a drug is used.

It is pretty easy to see a positive when therapeutic quantities of a drug are used as there are large migrations in the band patterns. The results are much more difficult to visually determine when an athlete has microdosed, or when an athlete has stopped using in an attempt to clear the drug from the system, as these situations present band migration patterns that can be very subtle and difficult to distinguish visually from negatives.

It is important to realize that EPO testing does not rely on subjective visual analysis of band migration patterns. There is underlying science applied in the data review process to take visual subjectivity out of the equation. Densitometry, defined as the quantitative measurement of optical density in light-sensitive materials, is performed to scientifically evaluate the shading of bands. GASepo—a software solution for quantitative analysis of digital images in EPO doping control, has been developed to present a “method of robust calculation of the cut-off line, band segmentation and classification algorithms.” So, there is sound quantitative science applied beyond visual review of results.

The recent documentary Troubling Science – Steven Colvert Doping Conviction, as well as the October 26, 2016 article that preceded it, did not adequately consider the underlying science in our view. The response from our esteemed colleague Dr. Christiane Ayotte, Laboratory Director at the WADA-accredited laboratory in Montreal, outlined the scientific conclusions made and included references to the densitometry and software applications used to produce the results such as this image.

The Norwegian authors of the 2016 article suggest that Colvert’s SAR-PAGE results are not indicative of EPO drug use based on his lane being “not much different from other lanes.” They discuss the diffuse staining above the blue line, which was used to determine a positive result for Colvert, as a standard staining anomaly that PAGE testing is subject to with different sample conditions. That conclusion discounts the fact that sample conditions are standardized prior to analysis and it also fails to consider that the staining that appeared in Colvert’s lane did not appear for other negatives in the sample group run at the same time under the same conditions.

Having performed the EPO testing methods in our own labs, we are certainly familiar with staining challenges. Indeed, the 2-3 day tests that are performed are highly sensitive and require extremely skilled analysts in order to create bands that are consistently free from what WADA describes as, “spots, smears, areas of excessive background or absent signal in a lane that significantly interfere with the application of the identification criteria.” In such circumstances, the WADA technical document calls for “invalidating the lane.” The SAR-PAGE results that include Colvert’s sample appear to be an excellent model of results that are free of any staining anomalies.

When the documentary was filmed, Don was asked to visually evaluate Colvert’s SAR-PAGE results, with the filmmaker pointing and asking if Colvert’s looked negative. Don ultimately agreed with that assertion, going on to say that he has seen 20 like it and that the lab must not know what it is doing. A rather astounding statement on its own.

When I was shown Colvert’s SAR-PAGE results, I was able to visually determine the positive sample. To me the slight diffuse staining above the blue line is visually different than the other negative samples. Perhaps my 40-year-old eyes are better than Don’s as he approaches the 80-year milestone later this year. This shows that two people with expertise in evaluating EPO testing results can come to different visual conclusions, which reinforces the importance of the underlying science used to properly determine a positive or negative result.

Colvert’s SAR-PAGE results are an example of the subtle migration patterns that make EPO testing complex and difficult to properly evaluate visually. The peaks laid over SAR-PAGE results by the software application help in the results review process and take subjectivity out of the equation as this image shows with Colvert’s sample on the left, a positive control in the middle, and a negative at right.

Furthermore, the IEF results in Colvert’s case are also indicative of the presence of exogenous EPO. This test requires the two densest bands to be above the line and in Colvert’s sample there are actually three above the line making the visual results easy to recognize. So, two separate validated testing methodologies were used to establish Colvert’s results.

It should also be noted that two different laboratories confirmed these results. This is in fact required under the WADA technical document in order to avoid the reporting of false positives that could be subject to intra-laboratory differences. Both laboratories came to the same positive conclusion.

Some paranoid theorists might point to laboratory malfeasance painting pictures of scandalous anti-doping scientists purposefully contaminating samples. That notion is absurd as our colleagues in anti-doping laboratories are among the most ethical scientists we know. The recent Russian doping debacle and the gross ethical transgressions of our old friend, former Russian laboratory director Grigory Rodchenkov, have called into question the ethics of the anti-doping industry as a whole, one of the most unfortunate ramifications of his actions. Yet we would point out that even Grigory considered it anathema to purposefully taint an innocent athlete’s urine and he refused to do so despite direct orders from above.

What does bother us about Mr. Colvert’s case is not the results, but rather the vehement and passionate defense Mr. Colvert has lodged on his own behalf. His words, and his strong statements in defense of clean sport, are certainly convincing. But we have seen such convincing statements before, from both innocent and guilty athletes. Even stars like Alex Rodriguez and Lance Armstrong told convincing tales once. These stories are one of the most difficult elements we confront in anti-doping.

The Colvert case discussion demonstrates the complexity of the EPO test and data review process. Even well-meaning, qualified scientists, including Don, can be critical of it in certain circumstances. Yet at its core, and through the complexity, the WADA EPO testing methodology remains sound and strong.

Don and I would like to extend our apologies for the remarks about the Cologne WADA accredited laboratory, which were not intended to be disparaging. The Cologne laboratory and staff are some of the most capable, ethical and committed partners in the global fight against doping, and we very much respect their undeniable work as leaders in the industry.

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

With 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 14^th place in the Haute Route Alps in 2014, 4^th 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 27^th place and 12^th 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

A 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.

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.’

Mr. 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.

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 Times’ Juliet 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.

New Sports Doping Agent FG-4592 Not the Only HIF Drug Available to Athletes

What drugs are athletes using to dope? This is one of the most commonly asked questions in the realm of sports anti-doping. Recently the answer has been provided in glaring form. During the week of July 29, Dr. Don Catlin, BSCG’s chief science officer and former longtime director of the UCLA Olympic Analytical Laboratory, was interviewed by the New York Times regarding a new drug called FG-4592, which was detected in tests of at least two elite cyclists.

AstraZeneca, one of the drugs’ developers, summarizes FG-4592 as “a small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein that responds to oxygen changes in the cellular environment and meets the body’s demands for oxygen by inducing erythropoiesis, the process by which red blood cells are produced.”

FG-4592 is available in pill form and is orally active, unlike its cousin, recombinant erythropoietin, or EPO, which must be injected. Some have dubbed FG-4592 as oxygen in pill form. This new drug is a breakthrough for anemia treatment and other similar blood ailments.  Unfortunately, an effective blood boosting drug in pill form is also the Holy Grail for endurance dopers. Though FG-4592 remains in third-stage clinical trials around the world, it is widely available as a research chemical on the Internet. Its apparent arrival in elite sport is troubling, yet predictable.

Similar to EPO, HIF drugs like FG-4592 help increase oxygen carrying capacity by spurring the production of red blood cells. Some researchers believe HIF stabilizers might be even more effective than EPO as they can help stimulate iron absorption and suppress the inflammation of cytokines.[1] FG-4592 was recently added to the WADA (World Anti-Doping Agency) Prohibited List for 2015, as have cobalt and other HIF stabilizers and activators in general.  No other HIF drugs are named though they would be prohibited if they are detected.

According to PubChem’s listing of Chemical Vendors, there are 18 suppliers of FG-4592 worldwide . One of the vendors, the Houston-based company APExBIO, has eight HIF-related biochemicals available on its website including BAY 87-2243, 2-Methoxyestradiol, PX 12, ML 228, KC7F2, Chetomin, DMOG, and its top seller, IOX2 (Glycine). On PubChem, there are 251 Related Compounds with Annotation to explore.

Recent positive drug tests of two elite cyclists suggest athletes have managed to obtain FG-4592 for use as a performance-enhancer. Though the chemical vendors listed on PubMed are not marketing the drug to athletes, another site does not seem as scrupulous, as it sells research peptides like FG-4592 alongside an array of “performance enhancers.”  Some research peptides at www.superhumanstore.com overlap the list of performance enhancers. Numerous drugs on the WADA Prohibited List are available on this site including Aicar, CJC-1295 (a growth hormone secretagogue), Erythropoietin-mimetic peptide 17 (EMP17), GHRP-2, Sermorelin, Thymosin Beta- 4 and more. Similar drugs are available that are not included on the WADA Prohibited List by name, like BAY 87-2243 and Follistatin 344 (a myostatin inhibitor).

The average professional cyclist in the UCI Tour makes $142,000, according to Ernst & Young.  Top riders can earn up to $5 million. Currently, the average dose of FG-4592 is recommended at 1-2mg/kg, 3 times a week, so $780 for 500mg will buy a two- week’s supply. An athlete could buy a year’s supply for around $20,280. This is a relatively affordable rate, even to an average Tour rider. With the difference between the average salary and the top salaries in elite cycling so significant, the financial incentives to use this new drug, or its cousins, remains high.

The good news is FG-4592 is detectable with drug tests. Similar developing drugs will undoubtedly be pursued and tried by athletes in the not-too-distant future. Whether these other options, particularly those not specified on the WADA Prohibited List, are detectable only time will tell. One thing history has proven, these will not be the last athletes to test positive for a new sports doping agent.

By Oliver Catlin and Joe Taylor

[1] Medscape  (http://www.medscape.org/viewarticle/548667)

BSCG CERTIFIED DRUG FREE® CERTIFICATION PROGRAM ADDRESSES UNMET SUPPLEMENT ADULTERATION CONCERNS, AN ANALYSIS OF FDA STATISTICS CONFIRMS

FOR IMMEDIATE RELEASE

April 16, 2015

BSCG CERTIFIED DRUG FREE^® PROGRAM ADDRESSES UNMET SUPPLEMENT ADULTERATION CONCERNS, AN ANALYSIS OF FDA STATISTICS CONFIRMS 

BSCG is the first to offer protection against drugs not banned in sport

(Los Angeles) – In broadening its services to include a range of new protections against supplement adulteration, including an expanded drug-testing menu for the protection of general consumers, BSCG (Banned Substances Control Group), a highly regarded independent dietary supplement certification provider, is filling important unmet needs in the realm of supplement quality control.  An analysis of the FDA’s Tainted Supplements List reveals that 76% of the hidden drugs found in supplements are not banned in sport—substances that only BSCG’s pioneering program covers.

The FDA’s testing has shown that products may contain harmful compounds falling outside the scope of those banned by the World Anti-Doping Agency (WADA) and elite and professional sports leagues including antihistamines, muscle relaxers, pain killers, weight loss drugs, PDE-5 inhibitors like sildenafil, and more dangerous agents. As the FDA warns, “this list only includes a small fraction of the potentially hazardous products with hidden ingredients.” BSCG is the only certification provider to focus on this concern.

“We knew that the FDA was finding a lot of prescription and over-the-counter drugs not banned in sport in the course of their testing,” said Oliver Catlin, BSCG President. “Recognizing the associated risks, we added those drugs and related compounds to our menu. We’re proud to take the lead in offering additional protection against these substances that are important for the protection of the general consumer.”

BSCG’s industry-leading drug testing menu includes more than 392 compounds, of which 185 are prescription or over-the-counter drugs and 207 are drugs banned in sport. BSCG not only has become the first certification program to safeguard against drugs not banned in sport but also offers the broadest and most finely tuned protection available in the supplement certification industry against substances prohibited by WADA, NFL, MLB, PGA, LPGA, NHL, MLS, ATP, WTA, NCAA, NASCAR and other sporting groups.

Founded in 2004 in Los Angeles by renowned sports anti-doping pioneer Don Catlin, M.D., his son, industry leader Oliver Catlin and respected attorney Ryan Connolly, BSCG grew out of the desire to protect elite athletes and professionals from ingesting hidden substances in supplement products that could lead to health concerns and positive drug tests. No product BSCG has certified has ever led to a positive drug test. In late 2014, the third-party company released its new BSCG Certified Drug Free® program.

In addition to security against drug contamination, the BSCG program includes annual testing for label claims and toxic contaminants and a Good Manufacturing Practices (GMP) audit. With fervent recent regulatory actions in New York and other states and added scrutiny on compliance with FDA’s 21 C.F.R. 111 – GMP quality control guidelines has come a renewed focus on ensuring that supplement products meet ingredient and finished product specifications for identity, purity, strength and composition and have been appropriately tested for potential contamination.

“Supplement consumers deserve assurance that products are not only drug free but that they meet label claim and contamination specifications and standards,” said Catlin. “BSCG recognizes the importance of these quality control elements and is pleased to include them as part our supplement certification services.”

The BSCG Certified Drug Free^® program represents the gold standard in dietary supplement certification and can be applied to finished products, raw materials or manufacturing facilities. The Athlete Assurance Program offers protection directly to teams, leagues or individuals. BSCG’s certification allows clients to establish products and brands as reputable and drug free and offers assurance on product integrity to consumers and athletes. Look for the BSCG Certified Drug Free^® seal.

For more about BSCG and the BSCG Certified Drug Free^® program, call 1-800-920-6605 or e-mail info@bscg.org, visit its website at www.bscg.org and download its free brochure. Join Banned Substances Control Group on Facebook and @BSCGCertified on Twitter.

================================================================

For press inquiries, contact info@bscg.org or 800-920-6605, or Joseph Taylor, BSCG Public Relations Consultant, at joseph.taylor.pr@gmail.com.