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.

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.

DRUG TESTING RULES FOR NARCOTIC PAINKILLERS IN THE NFL, MLB, NCAA AND OLYMPIC SPORT

The world is focused once again on the NFL, after a DEA investigation into the possible illegal use of prescription painkillers in the sport, as first reported Sunday by Sally Jenkins and Rick Maese of the Washington Post.

The issue centers on how such drugs are used and dispensed within pro football. According to DEA regulations, controlled substances like narcotic painkillers, known as analgesics in the medical field, can only be monitored and prescribed by licensed medical personnel and only within states where the license applies.

Controlling the use and abuse of analgesics is not an isolated issue faced by the NFL. The problem is prevalent across sport and society. Alarmingly, the CDC reported deaths from prescription drug overdose had risen steadily through 2008 reaching the same level as deaths from vehicle accidents. Thankfully, the CDC reports this trend has slowed in recent years, but the issue remains present and acute.

To understand the issue better one needs to know what drugs we are talking about. Most of the concern is centered on narcotic opioid analgesics, substances that can be dangerous and addictive. These include morphine, heroin, codeine and their synthetic derivatives and analogs. Fentanyl, tramadol, meperidine (demerol), hydrocodone (vicodin), oxycodone are common examples of drugs in this category. Narcotic analgesics are to be distinguished from other drugs used to treat pain like muscle relaxers or non-steroidal anti-inflammatory drugs.

While controlled substance laws dictate how narcotic analgesics are managed in society, drug-testing programs in sport dictate how these drugs are treated within the sport in question.  We look deeper into the drug-testing policies and banned substance lists in sport to see how these drugs are governed and managed.

The World Anti-Doping Agency (WADA) Prohibited List governs international Olympic sport and is often used as a model by other sporting groups when considering what to ban. Some narcotic analgesics are on the WADA Prohibited List in the S7. Narcotics category, but not all the common ones mentioned above would be included.  The language for narcotics is shown below.

S7. NARCOTICS

The following are prohibited: Buprenorphine, dextromoramide, diamorphine (heroin), fentanyl and its derivatives, hydromorphone, methadone, morphine, oxycodone, oxymorphone, pentazocine, pethidine.

The language does not include the ‘similar chemical structure or similar biological effect’ language or the ‘including but not limited to’ language used in other categories to cover additional substances not listed. In the case of narcotics, the only substances not listed that are covered are fentanyl and its derivates. Codeine and derivatives like hydrocodone and tramadol are not covered by the WADA language. WADA prohibits the use of narcotics in-competition, but these agents are not tested for out of competition.

Interestingly, the language included on the WADA Prohibited List is different than that used by Olympic sport prior to WADA. In 2000, Olympic sport was still governed by the International Olympic Committee (IOC) and the rules in the Olympic Movement Anti-Doping Code. At the time, the narcotics section included ‘and related substances’ but a specific list of narcotic analgesics was permitted, as shown below.

  1. NARCOTICS

Prohibited Substances in class (B) include the following examples: buprenorphine, dextromoramide, diamorphine (heroin), methadone, morphine, pentazocine, pethidine, … and related substances

NOTE: codeine, dextromethorphan, dextropropoxyphene, dihydrocodeine, diphenoxylate, ethylmorphine, pholcodine, propoxyphene and tramadol are permitted.

The issue is different when one evaluates how narcotic analgesics are treated in professional sport leagues and college. We review the NFL, MLB and NCAA policies here. A review of how other sport groups might deal with these drugs is more difficult as drug-testing policy language is not always publicly available.

The NFL covers narcotic analgesics under its Policy and Program on Substances of Abuse. The policy says that, “Players shall be tested only for the following substances.” Narcotic analgesics are covered as follows: “Opiates (total morphine and codeine) ≥ 300 ng/mL, Opioids (e.g., hydrocodone, oxycodone) ≥ 300 ng/mL.” The language is somewhat vague but it should broadly cover narcotic analgesics depending a bit on how the testing provider interprets the listing of opioids (are only hydrocodone and oxycodone included or all opioids?). Looking at how the testing policy is applied in the NFL, one discovers that testing for drugs of abuse only occurs Pre Season, Pre-Employment, during an Intervention Program or by Agreement. During the season, when narcotic analgesics would be expected to be used, the drugs are not typically included in the drug-testing parameters.

In the MLB, narcotic analgesics are covered under Drugs of Abuse in Major League Baseball’s Joint Drug Prevention and Treatment Program. The MLB language describing the compounds covered is broader and more inclusive than WADA’s or the NFL’s and includes: “Opiates (e.g., Oxycodone, Heroin, Codeine, and Morphine),” “…and their analogs,” and “any and all drugs or substances included on Schedules I and II of the Code of Federal Regulations’ Schedule of Controlled Substances.” However, the application of the testing in the MLB is more restrictive as testing is only done for drugs of abuse in the case of reasonable cause or if a player is in a treatment program. No other testing for drugs of abuse is allowed.

In college sport narcotic analgesics are covered still differently in the NCAA Drug Testing Program. The 2014-2015 NCAA Banned Drugs list includes one opiate, heroin, under Street Drugs. The entire list is governed by language stating, “any substance that is chemically related to the class, even if it is not listed as an example, is also banned!” In the case of narcotic analgesics it is unclear if this would be interpreted narrowly to include only drugs chemically related to heroin or whether it would be interpreted more broadly to include opiates or opioids. This language leaves it vague as to the analgesics that are or are not approved. Use of banned substances can be allowed by medical exception, but “no medical exception review is available for substances in the class street drugs.” As for application, testing for street drugs, and any narcotic analgesics interpreted to be included, can occur year round for selected athletes.

It is fascinating to review the treatment of narcotic analgesics and see the lack of consistency between sport drug-testing programs as to the substances that are banned and the application of the testing. This is an example of the challenges faced when considering what to ban and how.

Perhaps the realization that significant differences exist in the treatment of narcotics will prompt a larger review of other categories of banned substances and the differences that exist across sport in the management of performance-enhancing drugs in general. After more than three decades of modern drug testing, we should be able to achieve greater consistency and clarity in drug-testing policy and the protections afforded therein to the sports and the athletes represented.

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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The Monetary Gap – One Reason for the Lance Armstrong Affair

LA photo from TVYesterday much of the world had to watch Oprah to see Lance Armstrong confess his doping for the first time.  Even Lance agrees that should have happened long ago. 

One of the most troubling elements of all of this is that drug testing began in the Olympics in 1968 more than 44 years ago and yet the system is still unable to distinguish who is a clean athlete.  Every decade we are faced with a groundbreaking scandal, and multiple times a year we are faced with an ordinary scandal resulting from doping in sport.  Just last week we finished a baseball hall of fame vote where a whole generation of players got snubbed largely because of doping, and yet it seemed ordinary. 

Lance Armstrong, Ben Johnson, Marion Jones, Tim Montgomery, Barry Bonds, Roger Clemens… the list is long and spans all sports and generations when it comes to sport heroes and champions who have fallen, some even sacrificing their lives like Tommy Simpson, from using performance-enhancing drugs.  The question facing us all is why and what should we do about it, in much the same way we ask why and what to do about gun violence after witnessing the Newtown disaster. 

Now some may say hold on, you are way out of line.  There is no way to compare innocent children dying in a horrifying massacre to the performance-enhancing drug problem.  While we would agree with that in large part, we also point out that children are tragically affected by performance-enhancing drugs, figuring they have to use them to compete.  Sadly, some of our children even sacrifice their lives in pursuit of steroids and other drugs.  Just ask the Hooton’s, or the Garibaldi’s, or the Marrero’s or the other parents that have paid the ultimate price in losing a child to the use of performance-enhancing drugs. 

We consider the annual budget of the World Anti-Doping Agency at ~$28 million annually and the United States Anti-Doping Agency at $14 million.  We assume UK Sport and Australian Sports Anti-Doping Authority are equivalent to USADA for another $28 million.  The NFL spent $10 million in 2011.  We will put MLB at $10 million as well although their updated new program likely will come with additional cost.  The sport of cycling was estimated to spend $4.7 million and tennis (ITF) $1.3 million per year in 2011 for another $6 million.  If we assume there are 150 other countries and sporting bodies spending an average of $1-2 million annually on anti-doping, that adds another $150-300 million.  All said we estimate the total annual anti-doping budget worldwide to be $246-396 million, which compares to the budget of a small pharmaceutical company – and our estimate is probably on the high side. 

At the same time, you consider that Lance Armstrong made an estimated $17.5 million in endorsements alone in 2005.  Alex Rodriguez, another previous doper, makes $29 million per year in salary alone.  Annual budgets for professional cycling teams range from several million up to $25 million for a team like Sky.  The median team payroll in Major League Baseball is around $90 million while the total payroll for the league is a staggering $2.94 billion.  The total payroll in the NFL is even higher at almost $3.4 billion.  Finally consider the $3.2 billion in endorsement contracts for Nike athletes alone over the next 5 years.  All told, professional and Olympic athletes and teams have easily more than $10 billion in annual resources. 

When Lance Armstrong’s endorsements plus A-Rod’s salary alone totals more than $46.5 million, eclipsing the WADA and USADA annual budgets by $4.5 million.  When the drug-testing programs for MLB and NFL represent 0.3% of annual player salaries.  When the estimated annual amount spent worldwide on anti-doping testing, legal matters and research at ~$246-396 million represents 2-4% of the more than $10 billion in resources available to athletes perhaps we begin to see the scope of the problem.  Those who want to dope can afford to beat the system; at present the monetary gap is simply too great for the system to overcome. 

Now we consider the response.  There have already been countless hours of media content alone dedicated to Lance Armstrong.  We tried to estimate the dollars spent and considered 500 media outlets spending an average of $10,000 each on the coverage.  That would be $5 million alone spent covering the issue worldwide, by the end of this whole affair it is likely to be 10 or 50 times that amount, and our estimate is likely conservative. 

Those of us in the anti-doping community don’t expect $6 billion to be dropped off anytime soon, but it would be nice to see the resources available to anti-doping double or triple at least.  If we can’t afford to give anti-doping a fighting chance by providing the movement with the financial resources needed to effectuate change, then we are part of the problem and we can settle in for a continuing parade of scandals. 

It is up to sport and those that care about it to ensure adequate resources are available to establish and maintain a reality of clean competition.  The athletes, sport, and the next generations of athletes and sports fans deserve a drug testing system that can deliver to the world clean sporting champions, ones we can believe in and trust.  With an outmatched system that can’t expose dirty athletes, even athletes who want to compete clean feel they have to dope to win, and we simply can’t accept that reality.  The risks are too great to sport and the individuals who dedicate their lives to it. 

But it is not just about the money, it is about finding real solutions that can improve the drug-testing system and approach in place today, with or without more resources.  Stay tuned as our dinner conversations have been generating some interesting ideas….

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Methylhexanamine information: Where can you find it?

Methylhexaneamine

The world is awash with more and more news about methylhexaneamine and positive drug tests related to it.  We have already written a couple blog posts about the compound.  Yesterday we noted an article in The Herald Sun in Australia entitled: Athletes warned of supplement risk: FRESH warnings have been sent to Australia’s elite athletes outlining the risks of taking dietary supplements containing the banned substance methylhexaneamine.

The article describes an e-mail from the Australian Anti-Doping Authority (ASADA) warning athletes against taking dietary supplements containing methylhexaneamine…

“Athletes need to be aware that, under the policy of strict liability, they are responsible for any substance found in their body,” the ASADA e-mail reads.

“Athletes using supplements do so at their own risk. This substance is classed as an S6 stimulant on the Prohibited list and is prohibited in-competition.  ASADA is advising all Australian athletes subject to in-competition doping control to carefully consider their use of supplements and products containing methylhexaneamine.”

The article then goes on to quote track star Tamsyn Lewis’ response to the warning:  “There is simply not enough information and for younger athletes coming up through junior ranks, including the football codes, they’re driving blind,” Lewis said.  “They haven’t been educated or informed about this banned substance and the specific supplements to avoid.”

So, where do you find information on methylhexaneamine if you’re an athlete and want to avoid positive tests related to the compound?  Given all the attention on the compound recently we thought we would explore ASADA’s website to see what kind of information they have.  We found four listings after putting ‘methylhexaneamine’ into the search box on the site, all in the last month.  We also went to the USADA and WADA websites to see if information was available through their search boxes; surprisingly neither site returned any matching items.

Digging into the second link on the ASADA site, you can find ASADA’s formal advisory on methylhexaneamine that contains some very good information about the compound including a list of the various synonyms.

What seems to be missing is a listing of the various supplement products and label names, which hides the reality that methylhexaneamine is present.  Many products, for example, contain geranium oil extract, a seemingly benign ingredient.  In reality, geranium oil extract is a common label name for methylhexanamine in supplement products.  Mistaken use of methylhexanamine can easily result.

We have responded ourselves to the methylhexaneamine issue by creating ADR’s Searchable Database of Banned Stimulants.  The database includes banned stimulants, their synonyms, label names, and also brand names that contain this and other banned stimulants.  With the hope of providing a simple tool for athletes and other drug-tested professionals to help avoid similar issues in the future, we are working on raising financial support to further develop the database and expand it to other categories of drugs.  Please contact us at 310-482-6925 or info@antidopingresearch.org if you would like to help.

Comment on title: Perhaps you have noticed that we have spelled methylhexanamine in the title without the extra ‘e.’  This is because the compound is more commonly listed on internet sites without the ‘e’ even though the scientific name includes it, as a PubChem search demonstrates.  The Wikipedia page is found by searching without the ‘e,’ yet the first line of the article includes the ‘e.’  This example further demonstrates the confusion that swirls around this compound….

Methylhexaneamine, the recent positives, and the larger issues

pillsMethlyhexaneamine is back in the news again, this time after 14 Indian athletes tested positive for it. This is not the first time this substance has caused a problem with positive drug tests.

Methylhexaneamine is a weak stimulant that was added to the WADA list of banned substances in 2010. It is very similar to the banned substance tuaminoheptane, which was added to the WADA list of banned substances in 2008. In 2009, five Jamaican athletes returned positive drug test results after using methyhexaneamine. Although methylhexaneamine was not banned at the time, sanctions were pursued based on the rarely invoked “and related substances” clause in the WADA rules. Methylhexaneamine is chemically similar to tuaminoheptane. It was added to the WADA banned list largely in response to this situation.

Methylhexaneamine has an interesting history. It was first trademarked under the name “Forthane’ by Eli Lilly in 1971 as a nasal decongestant. That trademark has since expired. Patrick Arnold of BALCO fame and the creator of THG and other designer steroids, was part owner of Proviant Technologies until recently. Proviant Technologies currently holds a patent on Geranamine, a synonym for methylhexaneamine. You can also find it under the synonyms Forthan, Forthane, Floradrene jack3d, DMAA, shizandol A, 1-3 dimethylamine and Geranamine. It is often used as a “party pill” in New Zealand. It is included in many dietary supplements around the world using synonyms that may not be recognizable as banned substances. Methylhexaneamine has been shown to be naturally present in geranium oil at amounts less than 1%. This natural presence is why it is argued that the drug should be allowed to be used in dietary supplements. Given all the confusion it is certainly plausible that the Indian athletes were unaware that they were taking a banned substance.

The larger issues here are why is methylhexaneamine banned in sport and still legal in dietary supplements. If it is a stimulant then it should be banned in sport but should it not also be considered a controlled substance and thus not be allowed as an ingredient in dietary supplements? If the reason it is allowed to be in dietary supplement is that the drug is present naturally in geranium oil in small amounts, then why is androstenedione not legal? Androstenedione too can be derived from plants. Anyone who takes dietary supplements, vitamins, minerals or anything in this category should be vitally interested in the question, what is actually in my dietary supplements?