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

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

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

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

Catlins

Dr. Don Catlin, left, and Oliver Catlin

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

Colabello, Oral Turinabol and the MLB Positive Drug Tests

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

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

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

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

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

“It’s a huge issue, yes.”

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

“Sure.”

And present a reasonable case, and perhaps even win?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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April 16, 2015

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

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

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

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

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

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

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

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

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

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

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

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

Dietary Supplement Certification – BSCG Certified Drug Free®

BSCG_FNLDear friends, colleagues and fellow professionals in the anti-doping and supplement industries,

A decade ago our company Banned Substances Control Group (BSCG) helped found a nascent industry focused on dietary supplement certification to provide assurance that products are free of banned substances in sport.  We are pleased to have been a leader in the field since 2004 working with more than 40 companies to certify more than 100 products. As we look to the future, BSCG is leading the industry forward once again with our gold standard BSCG Certified Drug Free® program.

Our foundational supplement certification program was designed for the protection of elite athletes and professionals targeting drugs prohibited in sport—and this still remains a primary focus. We also realized that athletes are not the only consumers facing risks of drug contamination, nor are banned substances in sport the only culprits.  BSCG has responded by broadening our testing menu to focus on drugs of concern not only to athletes but to general consumers and also animals.

The BSCG Certified Drug Free® standard testing menu covers more than 392 drugs, including 207 banned in sport and 185 prescription and over-the-counter drugs not banned in sport. Our optional equine and canine screen includes more than 1,200 drugs banned by the Federation Equine International (FEI) offering protection to racing animals and against feed contamination concerns. With this expanded menu the BSCG Certified Drug Free® program not only offers the best protection available to athletes and sport nutrition products but is the first to safeguard against additional drugs relevant across the spectrum of consumers and products.

Protection against adulteration with drugs is only one element of the BSCG Certified Drug Free® program. With a growing focus on quality control in general, athletes, consumers, nutritionists, doctors, trainers, sport regulators, among others, are starting to demand assurances that products meet quality specifications and are free of toxic contaminants. Recognizing the importance of these elements, BSCG includes annual contaminant and label verification testing and an audit for 21C.F.R.111 – GMP compliance in its program.

The BSCG Certified Drug Free® program, which can be applied to raw materials and manufacturing facilities as well as supplement products, is the most complete quality control solution available in the dietary supplement industry. Our mission is to ensure products and ingredients are free of drugs and other harmful agents that can lead to health concerns or positive drug tests and that quality control specifications are met. Our certification allows clients to establish their products as reputable and drug free and provides athletes and consumers with trusted supplement options.

To explore our program further please download the BSCG Certified Drug Free® brochure. We are always happy to provide further education and support on supplement or anti-doping topics.  Please contact us at 1-800-920-6605, e-mail us at info@bscg.org, or explore our website at www.bscg.org. Thank you in advance for your consideration, we welcome your feedback and comments.

Sincerely,
Oliver Catlin
BSCG President

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,Superdrol 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-MDrolDrol, 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.

MStaneTranadrol Image Purus Labs Nasty Mass

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.

Jack3dJack3D 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.

Jack3d

USP Labs has since reformulated the product and Jack3D Advanced Formularemoved 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.

CrazeCraze 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 supplementsOstamax label - MK2866 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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