Trimetazidine Russian Doping Affair in Beijing has Olympic Movement Doing a Twizzle

Is the World’s Best Figure Skater another Example of Russian Doping or an Innocent Victim of Contamination?

By Oliver Catlin

Halfway through and the 2022 Beijing Olympics are spinning thanks to the latest Russian doping affair surrounding the world’s best figure skater. The future of the Olympic movement now hangs in the balance. This is the last thing the Olympic movement needed after the worst doping scandal ever perpetrated during the 2014 Sochi Olympics. It is easy to have a knee jerk reaction to the current case, where 15-year old figure skating sensation, Kamila Valieva, tested positive for the drug trimetazidine on a Christmas Day drug test that was finally reported on February 7. Now the entire Olympics awaits a decision to be made this weekend after the Court of Arbitration for Sport (CAS) was called in to sort out the matter. Most people probably think she is a doper given the scandalous history in Russia, but as we have learned over our years in anti-doping the answer may not be that straight forward in the end.

Let’s start with what trimetazidine is so we can get a foundation. Trimetazidine (TMZ) is a heart medication that has been used in medical practice to treat angina or stroke. It is not approved for use in the U.S. One paper describes that as an “orally administered antianginal agent trimetazidine increases cell tolerance to ischaemia by maintaining cellular homeostasis.” In simple terms TMZ can increase blood flow and stabilize blood pressure and can have endurance benefits. In 2012 the European Medicines Agency, “recommended restricting the use of trimetazidine-containing medicines in the treatment of patients with angina pectoris to second-line, add-on therapy.” It is banned in sport as a metabolic modulator in category S4.4 alongside another now infamous doping agent meldonium, also an anti-ischemic agent. Overall, the WADA system reported 57 trimetazidine findings from 2014 when it was first banned to 2020.

To most people it would seem unlikely that Valieva has a heart condition at age 15 that would justify medical use of TMZ. It is now recommended only as a second line therapy perhaps making legitimate treatment even less likely. Even if there was a medical need if she didn’t get a therapeutic use exemption (TUE) and disclose the use of TMZ in advance that would be a violation in itself.

The Valieva situation is framed by several trimetazidine cases. Sun Yang, the Chinese swimmer now notorious for a string of doping concerns, tested positive for trimetazidine in 2014. Yang claimed he had been prescribed it for chest pains but he did not declare it on his collection form. Yang received a three-month ban, his Chinese doctor was banned for a year. Valieva joins fellow Russian bobsledder Nadezhda Sergeeva who tested positive for trimetazidine two days prior to her race and was banned from competition at the 2018 Pyeongchang Olympics. Sergeeva served an eight-month ban after it was considered that she had used a contaminated supplement.

A third case in 2018 also points to the concern of supplement contamination. U.S. swimmer Madisyn Cox was positive for trimetazidine and originally thought it had come from water contamination. Cox eventually had her sanction reduced to six-months after testing discovered TMZ as a contaminant in a supplement. At BSCG our business revolves around protecting athletes from nutritional supplement contamination through our industry leading Certified Drug Free program, which verifies supplements are free of banned substances. These cases illustrate how important it is for athletes to protect themselves from the risks of supplement contamination.

Sergeeva’s is an illustrative case when it comes to the timeframe of action as she was banned from the Olympics two days after testing positive. Yet we still have no answer on Valieva? It is now five days past the result being announced, 49 days since the sample was taken, and we still don’t have an answer? This stinks of politicking to us, and surely many others.

Why did six weeks pass before a final result was issued? The laboratory in Sweden that did the testing explained the confirmation of the result was delayed due to COVID issues, something we can sympathize with and understand. We don’t believe anything nefarious happened at the lab. This isn’t a lab issue unlike the debacle in Sochi.

In a powerful article, Yahoo Sports reported that the Russian Anti-Doping Agency (RUSADA) evaluated the Valieva situation and decided on February 8 to issue a provisional suspension. Then in classic fashion RUSADA turned around the next day and overturned it with no reason provided, clearly heightening suspicion. The Russian Olympic Committee released a statement Friday saying she had “passed numerous doping tests” before and after Christmas Day.

Travis Tygart, head of the U.S. Anti-Doping Agency (USADA) is not happy. Surely there is another Russian doping fiasco afoot. In the Yahoo Sports article Tygart called the excuse, “classic diversion by the Russians.” Tygart goes on to say, “This drug doesn’t just show up in your water somehow, my guess is … there is likely someone else behind how she got this drug. Again, I don’t know the facts. But clearly you have enough to ask those kinds of questions and demand answers to them.”

We don’t know the facts either but the theories are flying. Could a rogue doctor or trainer have been responsible for giving her something? The Russians are investigating and I don’t think anyone would want to be one of the targets of that investigation. Looking for a scapegoat perhaps? There have certainly been cases where support personnel have doped athletes, both purposefully and accidentally.

Tygart’s comments to Yahoo Sports are quite interesting as they allude to another possible reason Valieva, or any other athlete for that matter, could test positive for trimetazidine or other drugs. That is contamination of food, prescription drugs, and yes maybe even water.

The research has actually proven that water, and even crops, could be contaminated with drugs banned in sport, even trimetazidine. A 2021 summary by Polish researchers explored the concern that pharmaceuticals may appear in water and pointed to 826.7 ng/L of trimetazidine that was found in raw wastewater in Poland with 457.8 ng/L in treated wastewater. Other banned substance categories like stimulants, hormones, diuretics and beta-blockers were also found in variety of water samples. A U.S. Environmental Protection Agency poster presentation demonstrated how drugs banned in sport could infiltrate crops irrigated with treated wastewater. This highlights the unfortunate reality that not all drug residues are removed during water treatment and that irrigation with treated wastewater can result in contamination of crops.

I wrote an article on, “Differentiating adulteration from natural or environmental presence in dietary supplements,” for Natural Product Insider in late 2020. The article noted the many challenges we face with compounds banned in sport that surround us every day in items like whey protein, deer antler, plant extracts, or sometimes our water and food.

The possibility of contamination causing positive drug tests is well noted both in World Anti-Doping Agency (WADA) regulations and also in prior doping cases that have established a precedent for innocent sources like meat to be considered a likely source of a positive. WADA has now accounted for meat contamination in a technical letter outlining, “Minimum Reporting Level for Certain Substances Known to be Potential Meat Contaminants.” The document explains special thresholds to avoid innocent positives from clenbuterol, ractopamine, zeranol and zilpaterol. But are those the only potential meat contaminants?

A patent application filed in 2016 for ‘Extended Release Formulation of Trimetazidine’ describes in the abstract that, “The present invention relates to a dry ready to use modified release dosage formulation for Trimetazidine dosage forms and its salts and derivatives thereof,… also use thereof as additive to animal feeds, foods and food supplements and also cosmetic and pharmaceutical compositions.” With use in animal feeds outlined this would seem to establish a possibility that trimetazidine could not only show up as a water contaminant in the environment but also as a possible meat contaminant.

Trenbolone is a commonly used anabolic steroid implant used in the livestock industry today and yet there are no thresholds to account for it as a possible meat contaminant. This was a primary concern in the case of Alex Wilson, a Swiss sprinter who tested positive in March of 2021 for epitrenbolone, a metabolite of trenbolone.

The Sports Integrity Initiative suggested a review of meat contamination was needed after the Swiss Olympic Federation was rebuked by WADA and the Athletics Integrity Unit of CAS for considering meat contamination in Wilson’s case and voiding a provisional sanction. The sanction was reinstated by CAS and it kept him out of the Tokyo Olympics. The article notes, “when trace amounts of known meat contaminants are involved and a proffered explanation has already been accepted as likely, it seems a little perverse for anti-doping to celebrate ending an athlete’s Olympic dream.”

Meanwhile, Carl Grove, a 90-year old American cyclist, set a world record in his age group in the Masters Track National Championships in 2018 only to test positive for the same drug epitrenbolone. USADA investigated and in their statement relieving him of any sanctions they noted, “Grove provided USADA with information which established that the source of his positive test was more likely than not caused by contaminated meat consumed the evening before competing on July 11, 2018. Prior to consuming the meat, Grove had tested negative for prohibited substances during an in-competition test on July 10, 2018.” Grove was allowed to keep his result and world record.

This crazy case prompted The New York Times to delve deeper in a 2019 review that included an interview with USADA’s Tygart. “Cases like this make us bang our head against the wall,” said Travis Tygart, the agency’s chief executive. “They’re not right.” He goes on, “I don’t think the meat industry has changed significantly,” Tygart said. “The issue is now that the labs can see so much farther down that the likelihood of capturing something increases.” In conclusion the article notes, “Tygart and Usada are pushing for changes when the World Anti-Doping Agency revises its rules in November. Tygart said he backed putting in minimums for some substances that don’t have them to help ensure that tests were not merely finding environmental contamination. He also said he believed that “no fault” cases, like when tainted food, water or medicine is ingested accidentally, should not be a violation or be publicly announced.” “It absolutely breaks my heart to see a case like this with Carl,” Tygart said.

The article notes a key fact, that any amount of a substance that has no thresholds, like epitrenbolone and trimetazidine, is a violation. “Usada is confident the positive test occurred because of the meat. Sophisticated modern testing methods showed that Grove had less than 500 picograms of trenbolone, “an extremely low level,” Tygart said. But there is no established legal minimum level of trenbolone; any amount is considered a positive.”

It appears that USADA made an exception to the rules in Grove’s case based on their investigation of the circumstances and the conclusion that the most likely reason Grove tested positive was innocent consumption of contaminated meat. Similar to what the Swiss Olympic Committee considered in Wilson’s case. Could similar reasoning be the reason why RUSADA overturned their initial provisional suspension of Valieva? Likely not since the RUSADA investigation appears to have only taken one day, but it is possible.

The case also highlights one of the challenges we face with the advancement of anti-doping testing capabilities. Today we can detect down to a fraction of a picogram (part per trillion) whereas a decade ago we were only able to see down to the low nanogram (parts per billion) level. With a thousand fold increase in the sensitivity of drug tests the timeframe of detection has drastically expanded. However, this also increases the possibility of finding miniscule amounts of substances that result from inadvertent and in many cases unavoidable ingestion of contaminated supplements or food.

Shelby Houlihan, one of America’s premier distance runners, tested positive for nandrolone metabolites before trials for the 2020 Tokyo Olympics and is now serving a four year ban. Her case put the meat contamination concern in the spotlight in The Washington Post as she blamed the finding on a pork burrito she got from an Oregon food truck. The contention was rejected by CAS, hence the ban, despite research from the WADA community in 2020 that actually demonstrated the possibility that eating pork from random sources in Germany had a 16.7% chance of making a clean person test positive for up to 24 hours for nandrolone metabolites according to current WADA thresholds. That explanation was simply not believed in Houlihan’s case.

In 2019 The Athletic reviewed several low level positive drug tests in the UFC for Nate Diaz and Neil Magny noting that we live in a ‘contaminated world.’ Both Diaz and Magny had tested positive for tiny amounts of Selective Androgen Receptor Modulators (SARMs) in the double digit picogram realm. When we say tiny we mean tiny, as in an amount equivalent to a grain of salt sliced into 50 million pieces then chopped in half. Both tested positive as a result of supplement contamination and they were relieved of any sanctions after investigation of the circumstances. Article excerpts below note some fascinating considerations that could be relevant in the Valieva case.

“Over-the-counter medicine and prescription medicine may have been contaminated for a long time, but we’re now picking them up,” said Dr. Daniel Eichner, head of the World Anti-Doping Agency (WADA) accredited Sports Medicine Research and Testing Laboratory (SMRTL) in Salt Lake City.

Jeff Novitzky, the UFC’s senior vice president of athlete health and performance who works hand in glove with the promotion’s anti-doping program that is administered by the United States Anti-Doping Agency, believes the problem of contaminants is “getting worse and worse.” This is one reason the UFC’s anti-doping program will fully enact significant changes in the coming weeks.

Novitzky said in Los Angeles during a stakeholder meeting held by the California State Athletic Commission on Oct. 15 to address “common sense” disciplinary guidelines and minimum thresholds pertaining to certain prohibited substances. “But we have seen more and more commonly what I would call benign supplements being positive for prohibited substances. We’ve seen a couple of occasions where a women’s multivitamin having a SARM — ostarine — in it. We’ve seen creatine have prohibited substances. We’ve seen pure protein powder have prohibited substances. We’ve seen prescription medication from legitimate pharmacies be contaminated with prohibited substances. And we’ve seen contaminants at compounding pharmacies, both here in the U.S. and abroad where they’re mixing their own drugs and other drugs they’re mixing getting into a different drug.”

Of the approximately 13,000 individual tests that have been administered under the auspices of the UFC Anti-Doping Program since it began 2015, USADA and the UFC have announced sanctions on 100 athletes. A little fewer than half of them have come with “either definitive evidence or evidence tending to show that those positive tests were results of contaminants and not purposeful doping,” Novitzky told the California commission.

The UFC experience mirrors others with multi-vitamins, creatine, protein, medicine and other benign products often resulting in inadvertent positives. In nearly 50% of UFC doping cases investigations unearth an inadvertent source of the drug in question. This statistic was supported by John Ruger, U.S. Olympic Committee Athlete Ombudsman, who said, “between 40% to 60% of positive test doping results were inadvertent (non-deliberate) cases,” as quoted in a swimmingworldmagazine.com article in 2014. Imagine if that holds true across the spectrum of sport drug testing. So, did Valieva really dope or is it contamination? Flip your coin.

In a progressive move, the UFC now has reporting thresholds for SARMs set at 100 picograms and epitrenbolone set at 200 picograms. As of now, these thresholds only apply in the UFC anti-doping program and have not been adopted in the Olympic movement. There are no reporting thresholds for trimetazidine in the Olympic movement or elsewhere and any amount found is still a positive despite potential sources of contamination existing as noted herein.

Things are not always as simple as they may appear in the doping or anti-doping realms. There are many innocent and inadvertent reasons why an athlete could test positive. The problem is those same reasons also give accused athletes who really doped many excuses to point to other than cheating. Sadly, testing alone can’t distinguish between purposeful use that has faded away to miniscule levels over time and accidental use of something that could have been eaten or consumed yesterday.

Nonetheless, sprinter Sha’Carri Richardson tested positive for marijuana at the U.S. Olympic Trials just before Tokyo and lost her chance to compete at the Games while serving her one-month ban. Shouldn’t something like that have happened to Valieva? We are now at 49 days and counting since the positive sample was collected and Valieva is still on the ice with a possible gold medal in hand and likely more to come if she is allowed to continue in individual competition that starts Tuesday. That is simply outrageous regardless of whether she is the next poster child of Russian doping or an innocent victim of contamination called out by advancements in testing capabilities. Purposeful, accidental, or a mistake not declaring therapeutic use, all deserve some kind of sanction.

Sadly we may never know the real reason Valieva tested positive but we will all be witness to how the Olympic movement handles the case, and so far it is not looking good. The CAS decision is due Monday morning Beijing time. The world will be watching.

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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.

In a Victory for Clean Sport, David Guttenplan Takes the Orange Jersey as USA CRITS 2018 Season Champion

USA CRITS 2018 season champion David Guttenplan of the Support Clean Sport/Guttenplan Coaching Team earlier in his remarkable season. Photo by Lee McDaniels, USA CRITS.

On Sunday at the Gateway Cup in St. Louis, professional bike racer David “Gutt” Guttenplan finished with the orange Colavita Overall Leader Jersey on his back after becoming the USA CRITS 2018 season champion. Though Gutt and many observers had expected such an outcome due to his commanding lead going in to the final race, the victory nonetheless resonated with him and all those who care about clean sport.

“With the series, you just never know how it’s going to go,” said Gutt in a post-race interview. “I just have to give a big thanks to (teammate) Tyler Locke. He’s really stepped up, and he’s been getting up there every single time. It’s been great.”

Locke took sixth place overall and their Support Clean Sport/Guttenplan Coaching Team placed second in the team competition. The excellent results cemented their reputation as one of North America’s premiere cycling teams and delighted sponsor Support Clean Sport.

“We’re thrilled for Davey and these guys and all they represent,” said SCS Executive Director Oliver Catlin. “They faced some serious obstacles and have shown that it is possible for clean athletes to reach the podium. The team as a whole worked really hard to help get Davey to this point, and as a sponsor we couldn’t be more proud.”

Many find the personal stories of both Gutt and Locke compelling. Gutt suffered a serious accident while cycling in 2016 that left him in a coma for five days and in need of surgeries. Some wondered whether he would ever compete again. Locke has had to face his own personal obstacles, notably going sober with the help of the bike. He said that when he made a conscious choice to channel his energy into his riding his racing performance skyrocketed and turned him into the capable lieutenant he is today.

Catlin says he hopes the results help to diffuse the naysayers who don’t think clean athletes can compete in cycling. “We’ve never stopped believing that athletes who chose not to dope can still succeed in their sports, whatever those sports might be,” he said. “And when they do best their competitors, they can hold their heads high.”

As the team coach, Gutt echoed these sentiments in an interview prior to the season’s final race. “Doping takes the fun out of it,” he said. “I tell my guys that if you can’t be proud of your results, what’s the point?”

Catlin hopes to build on the success of the 2018 season by expanding Support Clean Sport’s involvement with the Guttenplan team and investing in other teams. With SCS having sponsored Team California Juniors and 706P, Catlin hopes the concept can grow and expand into new endeavors. “We will be fundraising in the coming months to raise money to support these worthy athletes and to help others follow in their paths.”

One new idea Support Clean Sport is considering in the coming year, says Catlin, is a program that helps addicts of various types find a new path through cycling. Such a program would likely include an addiction management campaign and cycling clinics specifically designed for people to combat their addiction problems.

As with Locke, participants in such a program would have a new avenue in which to put their energies and hopes. Gutt and Locke, as well as Coach Sean Wilson of Team California Juniors, have already signed on as willing instructors for such clinics.

“I’m excited about this concept and continuing to grow Support Clean Sport,” said Catlin. “But we can’t do it alone. We need people who care about cycling and clean sport, as well as those wanting to fight addiction, to step up and donate, in whatever amounts that they can, and to show their support for healthy and clean competition.”

Please consider donating what you can to this worthy cause; simply click on the Donate button in the upper right-hand corner of the Support Clean Sport homepage. Donations will go directly to team support and to the launch of our addiction clinics. Join SCS foundational sponsor BSCG (Banned Substances Control Group), a leading supplement and natural product testing and certification provider, in expanding the SCS concept. To learn more about SCS, visit the Support Clean Sport website, like Support Clean Sport on Facebook and follow SCS on Twitter.

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.

FDA’s significant action is already reducing the number of steroids at some retailers

The Food and Drug Administration’s letter to industry sent Dec. 15 is one of the most important and commendable actions against the proliferation of anabolic steroids in the United States since the Anabolic Steroid Control Act of 2004, as it comes with the promise of significant enforcement action.  Unfortunately, the Anabolic Steroid Control Act did not stem the widespread availability of steroids it merely ushered in a new era of designer steroids.  By providing a list of those that were “illegal,” it pushed the prohormone manufacturers to find new compounds or name old ones using obscure nomenclature to confuse the authorities.  This recent forceful FDA action has the potential to change the landscape and it is already seeing evidence of its effect, but there is a great deal of work to do.

The letter began as follows: “This letter addresses the significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”

It goes on to commit to serious enforcement. “Manufacturers, ingredient suppliers and distributors should not expect that a warning letter will be issued if FDA discovers potentially harmful violative ingredients in products marketed as dietary supplements. FDA recognizes that active ingredients at meaningful levels do not appear by accident in a product marketed as a dietary supplement – somewhere in the supply chain, the active ingredient is incorporated into the ingredient or the finished product. Actions that pose a risk to public health should expect a swift and strong agency response.”

The threat of significant and immediate action without any warning is what is needed to finally control the flow of these dangerous products.  This action is just in time as the situation was truly getting out of control.  An example using one retailer of such products demonstrates the problem and the effect of the FDA action.

When we first mentioned nutritionarsenal.com on Sept. 15 in our blog post, Despite numerous efforts to the contrary, prohormones remain widely available today, we found 84 products listed as prohormones.  As we noted on Dec. 12 in our blog post, New designer steroids appearing at an alarming rate, 15 new products in two months!, the explosion of such products was astounding as the number of prohormones listed had ballooned to 99!  We visited nutritionarsenal.com again today and were quite pleased to see the evidence of the FDA activity.  Today the number of prohormones offered is at 75 and dropping three weeks after the FDA letter, a clear sign that it is being taken seriously.

As we say, however, much work remains.  One of the most blatant examples comes in Competitive Edge Labs M-Drol product.  Although it was included in the FDA’s action against Bodybuilding.com in late 2009, it has remained for sale at a number of retailers since that time.  At nutritionarsenal.com, a new label has been added on the sales page for M-drol: “This item has been discontinued. All sales are FINAL,” another sign that the FDA letter, and perhaps our posts, have been effective.