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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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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Amazon.com: An unfettered marketplace for banned and illegal drugs masquerading as dietary supplements

Banned and illegal drugs, by definition, should be hard to get, shouldn’t they? Unfortunately, the reality is quite the opposite; just explore Amazon.com, one of the largest marketplaces for banned or illegal drugs masquerading as dietary supplements.

Need steroids?  There are plenty of options.  New stimulant compounds that the FDA and other international authorities consider illegal and have proven harmful; no problem those are in stock.  What about new drugs that have yet to be approved for human consumption?  Sure you can get those too.  We explore a few startling examples of the illegal and potentially dangerous compounds available today at Amazon.com.

Steroids have been a concern for consumers and athletes for decades.  Pharmaceutical steroid development reached a pinnacle in the 1960’s with a handful of steroids like stanozolol and nandrolone approved for human use, after being evaluated for safety and toxicity. 

Since then a proliferation of prohormones, designer steroids or steroids in disguise, appeared in the dietary supplement marketplace and in positive drug test results in sport.  Unlike approved steroids, the safety, toxicity and approved dose of such compounds are unknown, and some, particularly 17-alpha-methylated steroids like Superdrol, have proven to be toxic and dangerous.  The drug caused liver failure and a positive drug test for an NCAA athlete Jareem Gunter in 2005.

With the BALCO scandal in 2003, that unearthed the doping escapades of Marion Jones, Tim Montgomery and Barry Bonds, came attention.  Steroids like ‘THG’ and ‘Madol’ were at its heart.  President George W. Bush focused on steroids in his 2004 State of the Union Address.  Later that year, Bush signed the Anabolic Steroid Control Act of 2004, which was enhanced with the passing of the Anabolic Steroid Control Act of 2012.

The FDA took prominent action in a highly publicized raid of Bodybuilding.com in November 2009.  In one of the largest regulatory actions to date, the FDA found 65 illegal steroid products for sale that contained five steroid compounds, “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.”  In 2012, as a result of this case, a fine of $7 million dollars was levied against Bodybuilding.com.

Unfortunately, Amazon did not heed the president’s 2004 State-of-the-Union message, nor the legal regulations in the Anabolic Steroid Control Acts, nor the prominent FDA enforcement action against Bodybuilding.com.

Amazingly, in January 2011 we noted in a blog post that products the FDA had raided Bodybuilding.com for in 2009 were still available at Amazon.com, namely CEL M-Drol, which contained ‘Superdrol’ (Superdrol, also known as methasterone, has the scientific name 2α, 17α-dimethyl-5α-androstane-3-one-17β-ol).  The Washington Post reported the story on January 19, 2011, numerous other news outlets followed with their own coverage.  We at The Catlin Consortium had hoped that by publicizing the issue Amazon would be put on notice allowing the company to address the issue responsibly.

That has not happened.  Instead, CEL M-Drol remained available at Amazon.com on September 10, 2013.  It has since mysteriously disappeared from the site after we
included the link in a supplement industry presentation in late September.  ‘Superdrol’, however, continues to appear in another product called M-Stane, which lists the compound on the label under the name 2a-17a-dimethyl-5a-androst-3-one-17b-ol.

M-Stane is only the tip of the iceberg.  As of October 20, Amazon.com still had two products available that were named on the FDA raid list in 2009; Kilo Sports Trenadrol and Purus Labs Nasty Mass.   A search for ‘prohormones’ on Amazon.com returned 125 products on October 20.  Many likely contain steroids or related substances. 

But the concern doesn’t stop with steroids.  Dangerous new stimulants like methlyhexaneamine and methamphetamine analogs, appearing as pre-workout supplements, remain available at Amazon.com.  Of particular concern is the original version of Jack3D from USP Labs and Craze from Driven Sports.

Jack3D grew to be one of the most popular pre-workout supplements on the market over the last several years.  The original version contained the now infamous stimulant methylhexaneamine, otherwise known in the industry as DMAA, geranamine, geranium oil extract and other names.  Patrick Arnold, the BALCO chemist, filed a patent for the compound under the name geranamine and included it in his own pre-workout product.

The drug has become a huge concern for athletes.  Astonishingly, more than 758 positive drug tests for methylhexaneamine have been reported by World-Anti-Doping Agency (WADA) labs since 2008, when the first positive was called.  The drug was not banned in 2008.  It was added to the WADA Prohibited List in 2009.  In 2012 alone there were 320 positive test results representing 7.1% of the 4,500 total WADA findings that year, placing behind only testosterone (T/E, 1,202 findings) and marijuana (398 findings). 

Some manufacturers defended methylhexaneamine, claiming it was geranium oil extract and thus of natural origin and present in the food supply prior to 1994, which would make it legal according to the definition of an ingredient in the Dietary Supplement Health and Education Act of 1994.  However, the natural origin of the DMAA used in supplements proved unfounded and the FDA has challenged its legality and safety for several years and considers the synthetic compound to be an illegal ingredient. 

Of primary concern is the potential for the compound to cause serious harm, and even death.  Sadly, Jack3D was implicated in the death of Claire Squires, a runner in the 2012 London marathon.

USP Labs has since reformulated the product and removed DMAA  as have other manufacturers.  Despite the significant attention and health risks, the original version of Jack3D continues to be available at Amazon.com.  The reformulated Advanced Formula Jack3D is also available, marketed differently, suggesting that the distinction between the two products is known.  Neither includes ingredient information on the site.

Craze is one of the second generation pre-workout products that began to proliferate when methylhexaneamine was addressed by authorities.  It was Bodybuilding.com’s New Supplement of the Year in 2012.  The Craze label says it contains Dendrobex™, a trademarked extract of dendrobium, an orchid.  The label suggests that several suspicious compounds are components of Dendrobex™: N,N-Diethyl-B-Phenylethylamine and N,N-Dimethyl-B-Phenylethylamine, a CAS registered compound that is .004 mass units away from methamphetamine.  Eventually, the compound present in Craze was shown to be a methamphetamine analog, N,α-diethylphenylethylamine, with no known natural presence.

USA Today, in its exhaustive reporting on Craze and its manufacturer Driven Sports, elicited a significant response from retailers in the dietary supplement industry.  Giants like Wal-Mart, eBay, and Bodybuilding.com have recently pulled the product, but not Amazon.com. As of October 20, Craze remained available from 8 Amazon sellers.

We conclude with perhaps the most amazing example of all, involving a new category of developing drugs called Selective Androgen Receptor Modulators, or SARMs for short.  SARMs are drugs that act like steroids by activating androgen receptors in the body.  SARMs are a relatively new category of drugs and thus many compounds are still in development and clinical trials where toxicity and safety are being evaluated.  One such drug is Ostarine, being developed for muscle wasting disease associated with cancer by a company called GT-X, under the name Enobosarm, GTx-024 and MK-2866. 

No need to wait for approval, it appears Ostarine is already for sale in dietary supplements at Amazon.com, IronMagLabs OstaRx and Cutting Edge Labs OstaMax are names that suggest the new SARM is an ingredient.  The label for OstaMax, included on Amazon.com, is astounding, stating, “FOR RESEARCH PURPOSES ONLY, NOT FOR HUMAN CONSUMPTION”, and yet there is a serving suggestion of one capsule daily!  The scientific name of Ostarine is on the label as is the MK-2866 naming convention used by GT-X.  Positive drug tests have already been seen with a female cyclist testing positive for Ostarine in June, and WADA reporting five SARMs as a whole in 2012.

The Amazon mission statement is “to be Earth’s most customer-centric company, where customers can find and discover anything they might want to buy online.”  Steroids, stimulants, drugs not approved for human consumption, and other potentially dangerous drugs, we hope, were not the intended aim of that mission.  Providing a marketplace for illegal compounds masquerading as dietary supplements in the face of international attention, consumer health concerns, and serious adverse events seems contrary to the customer-centric focus.  At the very least it is dangerous and irresponsible.

Global marketplaces like Amazon.com help set preferences across a variety of products, including dietary supplements.  We hope that Amazon becomes a real part of the solution by making the choice to eliminate these dangerous products instead of continuing to perpetuate their distribution.

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Athletes, Drug Testing, and Deer Antler – The Real Story

The sporting media is up in antlers with reports that allege Ray Lewis used a deer antler spray in his injury comeback.  The questions as to whether deer antler is banned and whether its use could lead to a doping violation are indeed complex.  We felt it was time to peel back the velvet to answer those questions and review the facts on deer antler.

Deer antler has a long history of use in Chinese medicine and is used ‘to decrease fatigue and improve sleep and appetite. In animal tests, deer antler has been shown to increase oxygen uptake in the brain, liver and kidneys, and increase red and white blood cell production.’  Traditionally it is available in the form of antler slices, powders, and extracts.  In its natural form, it is likely a legal dietary ingredient under the 1994 Dietary Supplement Health and Education Act (DSHEA); it has been sold at herbologists and various natural product stores for some time.

Deer antler has gained popularity as a dietary supplement over the last few years.  Some manufacturers, like LuRong Living Essential, grind the actual antler into powder form and encapsulate it in ingestible capsules.  (For the record, our company Banned Substances Control Group has certified LuRong Living Essential to be free of methyltestosterone [see below] and other contaminants.)

Other manufacturers sell the deer antler as a concentrated extract in a spray form.  The sprays, often with names like IGF-1+, are marketed as anti-aging and/or performance-enhancing agents and are offered with different dosages of IGF-1.  The sprays carry claims that the IGF-1 is delivered to the body through liposomal absorption, meaning it would be absorbed through membranes, such as those in the mouth, as opposed to having to enter the body through digestion.

Whether the spray forms are legal under U.S. law is unclear.  If deer antler is chemically altered to standardize the amount of IGF-1 present or to make it absorbable, then the spray form of deer antler is likely illegal under DSHEA.  However, we will let the FDA sort that out; we are here to examine issues related to drugs in sport.

In the realm of sport, the hoopla started with a spray form of deer antler called The Ultimate Spray, marketed by Sports with Alternative to Steroids (SWATS), that was involved in David Vobora’s NFL positive drug test for the steroid methyltestosterone in 2009.  During the course of the civil action following Vobora’s suspension, Vobora had the spray he used tested and it was found to be contaminated with methyltestosterone.  Vobora won a $5.4 million ruling as a result.

As the article notes, we tested the spray at our nonprofit/NGO Anti-Doping Research for The Post Game in 2011 and did not find methyltestosterone.  This highlights an important point: that one batch of a product can be contaminated and another batch clean, something that athletes need to consider.

All this attention prompted MLB and NFL to issue warnings to players regarding the use of deer antler.  Interestingly, the MLB warning did not focus on the IGF-1 issue but rather on the issue of methyltestosterone contamination.  The NFL warning meanwhile concentrated more on the IGF-1 issue and questioned the appropriateness of its players or coaches representing such a product.

Confusion has swirled ever since culminating in Super Bowl fashion with allegations that Ray Lewis used the very same SWATS spray in his triceps recovery.  ESPN ticker reports are now alleging that the Alabama football team may have used the spray as well.

Whether deer antler is banned in sport and whether its use would be considered a doping violation comes down to whether it is ingested or absorbed and whether it has been certified to be free of potential contaminants like methyltestosterone.

Is deer antler a banned substance?

No, deer antler is not listed as a banned substance today in any sport.  It is true that deer antler naturally contains IGF-1, a substance banned in sport.  However, so do animal food products like red meat, eggs or milk and other common dietary supplement ingredients like colostrum.  Many food products contain IGF-1 or other growth factors that are banned in sport yet consuming them does not constitute or lead to doping violations.  The World Anti-Doping Agency (WADA) supports this notion but does not exactly provide clarity with their confusing note on colostrum: “Colostrum is not prohibited per se, however it contains certain quantities of IGF-1 and other growth factors which are prohibited and can influence the outcome of anti-doping tests. Therefore WADA does not recommend the ingestion of this product.”

Would using deer antler be considered use of a banned substance in sport?

In our opinion, the answer comes down to the form used.  Scientific publications agree that when IGF-1 is ingested in the form of colostrum it is not absorbed by the body and would ‘not elicit positive results on drug tests.’  Assuming the same is true of the IGF-1 in deer antler or other food products, ingesting the IGF-1 is unlikely to be construed as a violation of drug testing regulations since no banned substance is absorbed by the body.  Therefore, ingestible deer antler products should be acceptable for athletes to use under current rules.  Conversely, using a spray form of deer antler concentrated to contain certain amounts of IGF-1 that is delivered through liposomal absorption would likely constitute a doping violation, because if the product works as claimed the banned substance IGF-1 would be absorbed by the body.

Is IGF-1 detectable in the current sport drug testing system?

As the abstract of a recent publication states: “Currently, there is no test for the detection of IGF-1 introduced worldwide”.  This is not to say that the anti-doping community can not detect it as there are numerous publications that demonstrate the ability to do so.  IGF-1 is used as an important marker in the Sonksen test for human growth hormone that has been slowly gaining traction in the WADA community.  That said, we are not aware of a complete detection method for IGF-1 in use in sport drug testing today that can unequivocally determine if exogenous, or foreign, IGF-1 has entered the body.  So, if the deer antler sprays work as intended and IGF-1 is actually absorbed by the body, that may be a violation of drug testing policies but we do not believe it would result in a positive drug test in the current system.  Unfortunately, IGF-1 in general remains a major challenge for anti-doping authorities and is a huge potential loophole in the current doping control system.

Is there a way for athletes to protect themselves against the potential for methyltestosterone or other contamination to occur in deer antler products?

As with all dietary supplements, we would recommend that athletes only use batches or lots of products that have been certified by a reputable independent testing body to be free of banned substances.  We operate a program called BSCG Certified Drug Free® that offers testing services to manufacturers, teams and athletes to ensure that products are safe and free of banned and dangerous substances.

It is our view that if you are an athlete using a spray form of deer antler be aware that you are likely in violation of drug-testing rules even though the IGF-1 at issue may not be detectable currently.  If you want to use deer antler without violating drug-testing policies, you should be careful to use only an ingestible product that has been tested for potential contaminants like methyltestosterone.

This is a perfect example of the extremely complex issues we all face when considering the connections between dietary supplements and banned substances in sport.  We feel it is the responsibility of the leagues, the players associations, the anti-doping authorities, the FDA, supplement industry representatives, and scientific organizations like ours to come together to address the broader issues in some fashion.  As deer antler does not wander the forests alone, we owe it to the athletes to provide a concrete yes or no as to whether something is prohibited, as their careers and reputations are at stake.  We have the ability and the knowledge; we just need to make the effort.

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Amazon sellers trafficking steroids, some classified as Schedule III Controlled Substances

With the attention paid to anabolic steroids and the threat they pose to sport and public health, it is amazing to discover that such products are for sale today at Amazon.com.  We focus here on Amazon.com and on methasterone and madol, two drugs that appear in two products for sale there, but it is important to realize this marketplace is only the tip of the iceberg.  Although some suggest that we should continue to allow free access to these products, our contention is that products like these that can cause liver failure and other significant harm should not be a mouseclick away from unsuspecting consumers, especially our youth where the harm can be greatly magnified.

The first drug is methasterone, otherwise known as methyldrostanolone, which became known under the name Superdrol in late 2005. Don helped expose it as a new designer steroid in an article by Amy Shipley published by the Washington Post Nov. 2005. Methasterone has been connected to cases of liver failure in several publications.  The chat rooms on the topic provide the user accounts and hammer home the issue; check out this graphic example, if you want.  The FDA issued a warning and took action against marketers of the product in March 2006.  The World Anti-Doping Agency added the compound to the Prohibited List for 2006.

Despite inclusion on the FDA and WADA lists, the DEA does not yet have methasterone on its list of Controlled Substances as of Sept. 15. M-Drol caught the eye of the FDA in late 2009 when the product was included on a list of 65 steroid products that Bodybuilding.com was distributing.  The FDA took action against some of the products and against Bodybuilding.com resulting in voluntary recall of the products from the site.  Nonetheless, methasterone appears to be widely available in the marketplace today in many forms including Competitive Edge Labs M-Drol.

This dangerous non-FDA approved drug can still be purchased from many mainstream retailers including through 7 Amazon Sellers at Amazon.com, as of Jan. 17.  Included in the marketing heading for the product is, “M-Drol-Anabolic Muscle Building Formula, 90ct (Compare To Superdrol).”  We decided to go ahead and do the comparison.

Competitive Edge Labs M-Drol was purchased through Amazon.com on Nov. 15 in an order fulfilled by Amazon Seller Surplus-Supplements.  We analyzed it in our ISO 17025-accredited lab and compared it to a reference standard of methasterone, or Superdrol, and in fact M-Drol does still contain methasterone.  The sale of methasterone or a drug like it would likely qualify as sale of an unapproved new drug, according to the FDA’s recent letter to industry from Dec. 15: “These products are illegal because they are unapproved new drugs under 21 U.S.C. §§ 321(p) and 355(a) and/or adulterated dietary supplements under 21 U.S.C. § 342.”

There is more clarity in the case of the second product, Competitive Edge Labs P-Plex, which contains the anabolic steroid Madol.   Madol is classified as a schedule III controlled substance by the DEA under the name desoxymethyltestosterone (no other names listed).

Madol was the second of two designer steroids discovered during the BALCO doping scandal in 2003. During the federal BALCO investigation, vials of the seized drugs were analyzed and characterized by Don and his team, then at the UCLA Olympic Analytical Laboratory.  The drug that received the most notoriety was THG, short for tetrahydrogestrinone, a modified version of the already prohibited anabolic steroid gestrinone.  Madol was characterized later in 2004 and received much less publicity.  Madol was added to the Controlled Substance list Jan. 4. 2010 after a nearly two year process.

Madol has a proper scientific name of 17α-methyl-5α-androst-2-en-17β-ol.  The compound can be found under the following names; Madol, DMT, desoxymethyltestosterone, 17a-methyl-5a-androst-2-ene-17b-ol, 17a-methyl-etioallocholan-2-ene-17b-ol and other variations.

Despite its involvement in a high-profile case such as the BALCO investigation and inclusion on the controlled substance list, Madol appears in the dietary supplement marketplace in many forms.  It became popular under the name Phera-Plex and continues to be marketed in many products today.  Numerous options can be easily purchased on the Internet, including through Amazon.com.

Today at Amazon.com you will find Competitive Edge Labs P-Plex.  P-Plex was also included in the FDA action against Bodybuilding.com, yet it remains in stock and available through two Amazon Sellers as of Jan. 17. The marketing headline for P-Plex on Amazon.com reads, “P-Plex-Anabolic Muscle Building Formula 10mg, 90ct (Compare To Phera-Plex).”  We purchased the product on Jan. 6 through Amazon.com in an order fulfilled by Amazon Seller MMMPower and have identified Madol in the product.

The FDA considers this a serious matter and in a powerful letter to industry on December 15, 2010 wrote, “Responsible individuals and companies should be aware that the government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act (the Act) and endanger the public health. Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted under the Act, pursuant to 21 U.S.C. § 331. See United States v. Park, 421 U.S. 658 (1975). When the evidence warrants, felony charges may be appropriate.”

Knowingly or not, Amazon does appear to be providing a marketplace for selling steroids, some classified as controlled substances.  Amazon was willing to withdraw the pedophile’s guide in three weeks, as we pointed out in our blog post Nov. 12.  Hopefully, Amazon will hear the FDA on this matter and also voluntarily withdraw these steroid products from their website, sooner rather than later.  We stand ready to help Amazon or other retailers in maintaining a safe marketplace for dietary supplements in the future.  ##

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.

FDA warns that tainted products marketed as dietary supplements are potentially dangerous – Anti-Doping Research’s Dietary Supplement Survey – A strategy in response

The Good, the Bad, and the Dirty in the Dietary Supplement Industry – Anti-Doping Research’s (ADR) Dietary Supplement Survey

Despite being widely available today, dietary supplements can contain unsafe and illegal substances that pose significant health risks to consumers.  Novel designer steroids, stimulants like ephedrine, pharmaceutically active ingredients like sibutramine, and other untested or unsafe ingredients continue to slip into the dietary supplement marketplace.  The FDA has responded with a significant and laudable new effort to work with the industry to combat the issue as described in, “FDA: Tainted Products Marketed as Dietary Supplements Potentially Dangerous.”  We would like to assist the effort through ADR’s Dietary Supplement Survey, for which we are currently raising financial support.

In ‘Tainted Body Building Products,” the FDA issued a warning that, “FDA cannot test all products on the market that contain potentially hidden ingredients.  Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”  The numbers of tainted products are vast and the problems real.  According to the press release, “In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.”  Yet this is just a small fraction.  We would like to use our experience to help test and expose more, one of the primary goals of our Dietary Supplement Survey.

In the words of the FDA Commissioner, Margaret A. Hamburg, “These tainted products can cause serious adverse effects, including strokes, organ failure, and death.”  The dangers, as we know first-hand, are all too real, as we have dealt with numerous cases of acute liver injury in young adults who have used such products.  Colleagues such as Don Hooton have had lives forever changed by the suicide of a son using steroids to pursue athletic advancement.  Unfortunately, the issues are not isolated to body-building products as they span other categories like weight loss and sexual enhancement as well.  If such products are manufactured in the same facilities as legitimate supplements, the potential for contamination is also a concern.

In the FDA Letter to Industry, a fine point is made. “These products not only pose risks to consumers,” it states, “but undermine confidence in legitimately marketed dietary supplements in these and other categories.”  The majority of the dietary supplement industry produces products that do not contain illicit ingredients or contaminants and that should also be showcased.  In the letter, the “FDA is also seeking continued input and collaboration from the trade associations to educate the industry about this problem and to develop strategies to combat it.”

We believe that ADR’s Dietary Supplement Survey initiative could be such a strategy.  To sum up our goals:  We aim to explore which products are good, which products are bad, and which products exhibit contamination with low but potentially harmful levels of illicit ingredients.

More specifically, we will perform focused testing on problem categories to expose dangerous new products.  We will also conduct testing on a variety of randomly selected products to evaluate the prevalence of contamination and to demonstrate that the majority of products are indeed clean.  In the process, we will help audit the current retail environment to assist with enforcement and will characterize new supplement ingredients that have the potential to cause harm or lead to a positive drug test.  The results of our work will available via an interactive website portal complete with testing data, public service announcements and more.

As a public charity, Anti-Doping Research, a leader in performance-enhancing drug and toxicology research and testing, is working to raise $1.5 million to conduct the Dietary Supplement Survey.  We hope to gain broad support from a variety of sources to provide for a collective solution.  We have reached out to our friends in the dietary supplement community, the sporting community, anti-doping, collegiate and high school athletics, sporting sponsors, pharmaceutical companies and others in pursuit of support.  We would also welcome the involvement of the general public through volunteer activity or small contributions.  All donations are tax deductible.

If you have any questions, please contact us at 310-482-6925 or by e-mail at dcatlin@antidopingresearch.org or ocatlin@antidopingresearch.org.

Consumers, athletes and other elite professionals deserve a marketplace offering legitimate and safe dietary supplements.  With your help, we are confident that we can help make this happen.   Please join us and help support this important initiative with your contribution today.