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

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

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

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

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

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

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

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

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

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

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

Is deer antler a banned substance?

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

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

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

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

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

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

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

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

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

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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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Catlins launch new Support Clean Sport campaign

SUPPORT CLEAN SPORT

HOSTS NATIONAL LAUNCH PARTY

(Los Angeles) – Support Clean Sport, a new athlete-driven grassroots campaign dedicated to fostering clean sport, is hosting its national launch party on Sunday, May 22 from 10:00 a.m. – 6:00 p.m. at the downtown City Park in Woodstock, Georgia.  Sponsored by Banned Substances Control Group and presented by Star 94.1FM and host DJ Crazy Mike, the all-day event will feature educational seminars on training, diet, and supplements, a bench-press contest presented by Hickory Flat GNC, high-intensity functional fitness exercises by The Garage and CrossFit, speed and agility measurements by XCelerate Sports Development, and physiological testing by Life University Sport Health Science.

“We’re very excited about bringing together athletes, coaches, parents, sports fans, fitness enthusiasts and health experts to not only help foster clean sport, but to embrace and celebrate it,” says Oliver Catlin, co-founder and Vice President of Anti-Doping Research and Executive Director of Support Clean Sport.  “Over the years, we’ve heard from many athletes, sponsors and others that they would like to do something positive to help promote integrity in athletic competition.  Support Clean Sport provides that opportunity to any person or company that shares our passion.”

Support Clean Sport combines education and outreach by top experts with commitments from athletes to stay clean and active participation of coaches, parents, alumni and sport enthusiasts.  The SCS Team of Professionals provides information on banned substance regulations so athletes can stay clean, and it shares tips on diet, training, supplementation and other topics that allow athletes to reach their highest potential and win clean.  Support Clean Sport also provides people an opportunity to Join SCS, our social networking community for those passionate about clean sport.

“I think many athletes and fans long for a time when you know the person on the podium deserves to be there, and the victory can be celebrated without a hint of suspicion,” says Don Catlin, M.D., co-founder and President of Anti-Doping Research & Support Clean Sport and founder and former longtime director of the UCLA Olympic Analytical Lab.  “Athletes who have invested so much time and effort into their training deserve that, as do sports fans.  Ultimately, we believe that working together, it’s possible to get there.”

Among the educational speakers at the SCS national launch party on Sunday in Woodstock will be drug-testing experts, dietary supplement experts and doctors.  Up-and-coming R&B artist Candy Nicole will be singing the national anthem and “Should Have Been Me.”  Also performing will be four-time national champions Kennesaw State University’s competitive cheerleading squad.

Support Clean Sport is an initiative organized by the nonprofit organization/NPO Anti-Doping Research, a leading sports research institute based in Los Angeles.  Proceeds from Support Clean Sport go toward supporting the vision of clean sport and ADR’s efforts to generate new initiatives and approaches that are conducive to clean sport.  Current Xterra Triathlon World Champion Shonny Vanlandingham is among those athletes who have joined Support Clean Sport.

For more information, visit Support Clean Sport’s website at www.supportcleansport.com, check out its page on Facebook, and follow it on Twitter
Video: Are you a Real Athlete?

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Egregious error in high-profile Sports Illustrated story by Selena Roberts & David Epstein exposed

Los Angeles,  March 29, 2011

Egregious Error in Sports Illustrated Story by Selena Roberts & David Epstein Exposed

USOC Committee Meeting Notes Reveal Truth

Anti-Doping Research (ADR) has obtained a copy of meeting notes of the United States Olympic Committee (USOC) meeting of March 2000, referenced as “the minutes” in the misleading Jan. 24 Sports Illustrated Lance Armstrong story by Selena Roberts and David Epstein.  Attorneys at Time, Inc. finally provided an excerpt of the notes after repeated requests.

As suspected, the notes show that contrary to Roberts and Epstein’s claims, the committee, with Dr. Catlin often leading the way, was not only trying to do everything it could within the existing framework to ensure an effective doping system in the United States, it was attempting to raise the testing standards and make them more stringent for athletes.

The meeting notes are crucial for providing the appropriate context and demonstrate that Roberts and Epstein’s written and press interview statements charging that Dr. Catlin and officials discuss in the meeting how “to informally test athletes–not to sanction them but to help them avoid testing positive at the Olympics” are patently false.  Indeed, the writers and editor(s) either do not understand or willfully ignore the context of the discussion.

To help shed light on the situation and be as transparent as possible, Dr. Catlin and ADR are taking the step of releasing the USOC meeting notes.  Because the discussion is complex and difficult to follow, Dr. Catlin is offering a statement on the context of the meeting and an annotated version of the notes that adds helpful and insightful comments.  You may click the following links to pdfs of Dr. Catlin’s Statement and Annotated Notes as well as the Raw Version of the Notes.

The primary issue at hand was how to apply Dr. Catlin’s new, complex, and, at that time, legally untested Carbon Isotope Ratio (CIR) test to confirm testosterone use in U.S. athlete samples prior to the Summer Olympics in Sydney.  For his part, Dr. Catlin wanted to see his test implemented in the United States and was doing what he could to advance it.

“I want to see better and better doping (control),” he said.  “And it’s (the CIR test is) ready to go… and I submit that there’s tons and tons of political and legal reasons not to do it and to do it.  I’m making a statement that I’m willing to go to court to defend the test, and I wouldn’t have made that statement until very recently.”

The group was reviewing the rules for screening for testosterone use by applying the testosterone to epitestosterone (T/E) ratio to see how the follow-up CIR confirmation test could be applied.  A key issue discussed was what constituted an initial positive T/E finding.  According to the IOC, the relevant governing body at the time, only a sample with a T/E ratio of 6:1 or higher was an initial positive.  The IOC rules included the ability to use CIR for follow-up testing while the USOC protocol under discussion did not mention CIR use.

Dr. Catlin and others on the committee considered implementing tougher standards than the IOC rules allowed, by applying the CIR test to samples in which the T/E ratio was in the more stringent 4:1 to 6:1 range.  In fact, Dr. Catlin had lobbied the IOC to adopt the more stringent T/E range, a point he mentions in the meeting.  The meeting notes reveal the group struggling with how to use CIR for sanctioning purposes given the concern that prosecution of testosterone doping offenses in which the T/E ratio was less than 6:1 would be unsuccessful under the current IOC framework.

The members discussed if and how U.S. athletes should be introduced to the new test, with some wanting to warn athletes and others not wanting to warn them.  Those who argued for warning athletes were doing so out of a desire to compel as many of them as possible to clean up—the point of doping control—and for a time the IOC required such warnings.  Again contrary to Roberts and Epstein’s claims, Dr. Catlin argued that alerting the USOC, so that they could warn athletes, was not necessary.  “I don’t (care) whether you guys are alerted in advance,” he said.  “If we want to put a test in before the Games, we’ll do it.”

As a potential compromise, a committee member floated the idea of doing an informal study applying the CIR test to a group of 50 samples in which the T/E ratio measured in the more stringent 4:1 to 6:1 range.  The purpose of this proposal was to assess the potential of doping prevalence, as good, credible science-based anti-doping programs do.  Research studies are, by proper protocol, anonymous, as Dr. Catlin told the group.

Although Dr. Catlin believed in the science behind the CIR test and was pressing to use it for sanctioning purposes, he was open to the idea of a compromise because he believed that the results would help push the IOC to adopt the more stringent standard.  A precedent had been established with similar research conducted by the IOC at the 1998 Nagano Winter Olympics, he noted, though he remained, as always, opposed to “no-penalty testing.”

In the end the motion to conduct the research study was withdrawn, and no such study was conducted.  Five years later, in 2005, the World Anti-Doping Agency lowered the benchmark for an initial positive testosterone test result to a T/E ratio of 4:1.

The CIR test is considered revolutionary and has proven highly effective; despite many challenges by athletes testing positive, the Court of Arbitration for Sport has never found any fault with it.

The blatant mischaracterization of the USOC meeting is merely one of several egregious errors Anti-Doping Research has found in the Jan. 24 Sports Illustrated feature story by Selena Roberts and David Epstein.

Amazon steroids not on Texas high school steroid testing lists

Many people have been discussing high school steroid testing and the effectiveness of the programs to control steroid use.  The largest such example, in fact one of the largest drug- testing programs in the world, is the University Interscholastic League (UIL) testing program in Texas.  

According to Jeff Miller’s article in the Dallas Morning News, “the Legislature initially funded the effort in 2007 with an annual budget of $3 million, but the allotment for the current school year is $750,000 – after a cut to $1 million a year earlier.” The statistics show 51,635 tests conducted from February 2008 through May 2010 with 21 positives for a positive rate of less than 0.0005% of the total.  The discussion over effectiveness, and indeed the utility of the money, rages and rightfully so. 

As the discussion continues, we reviewed the policies and the testing menu for potential sources of the issue and in hopes of addressing the problem that many believe remains.  Surprisingly, there are only ten steroids included in the testing panel according to information we reviewed from an Open Records Request, we will not list them here as we do not want to deleteriously impact the program.  Meanwhile, the UIL Anabolic Steroid List for 2010-11 is posted on its website and contains 36 anabolic steroids (33 actually as two are duplicate listings and one is not a known steroid under the name listed).  It lists those compounds “contained in section 481.104 of the Texas Health and Safety Code.”  

Unfortunately and of significant concern is that neither of these lists include steroids that until recently were available on Amazon.com.  A drug like methasterone, otherwise known as Superdrol, is not on either list.  It was for sale under the name CEL M-Drol on Amazon.com until we exposed it early this year.  After we helped break the story with Amy Shipley in the Washington Post on January 19, the product was removed from the site.  So too were CEL’s X-Tren and P-Plex, which contain the steroids ‘Tren’ and Madol as we described in our post on the topic.  Again, neither appears to be included on the lists governing UIL testing.  

For a program to be effective, it needs to test for the steroids that remain widely available, as they are one click away from the students.  If we are correct in our analysis of the lists and the program coverage then you could take any of the three products above and not test positive in the UIL program, and that is simply not acceptable.  Unfortunately, the options do not end with the CEL products.  Many other steroids remain for sale on Amazon.com and other online retailers today with names that are not included in the UIL program or other high school testing programs.  

We are certainly supporters of high school drug-testing programs and believe that they can be effective, even given the more limited per person high school testing budget.  The first step to that aim is to ensure the menu covers the new steroid options that continue to appear online daily.

Don Catlin, M.D., responds to Sports Illustrated story by Selena Roberts & David Epstein on Lance Armstrong

Los Angeles, January 27, 2011

Statement of Anti-Doping Research (ADR) on recent Sports Illustrated story by Selena Roberts and David Epstein:

A high-profile feature story on Lance Armstrong in the Jan. 24 issue of Sports Illustrated has led to NPR and CNN interviews for its writers, Selena Roberts and David Epstein.  Unfortunately, both their story and their interviews contain innuendo and mischaracterize key elements, including perhaps most notably, urine tests performed by Don Catlin, M.D., back in the mid-1990s.

Dr. Catlin, a widely respected pioneer in the field of anti-doping in sport, wishes to set the record straight.  In the detailed statement that follows, he demonstrates his respect for the truth as he knows it as well as his commitment to transparency.

As he states, he was not aware that the A samples allegedly testing high for testosterone in 1993, 1994 and 1996 were Lance Armstrong’s, if, in fact, that is the case.  We have seen no evidence to suggest that it is.

Sports drug-testing laboratories are required to use codes, not names, for samples to protect all parties and the sanctity of the process.  Dr. Catlin and his team followed those rules during his tenure as director of the UCLA Olympic Analytical Lab.

Further, during the years in question, Dr. Catlin and the world at large did not even know who Lance Armstrong was.  Mr. Armstrong had not yet established himself as a champion cyclist and Tour de France winner.

We find that the elements of Ms. Roberts and Mr. Epstein’s story that involve Dr. Catlin lack credibility.  The reporters have delivered a story that misrepresents the truth.

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Statement of Don Catlin, M.D.

Background:

I was the founder and Director of the UCLA Olympic laboratory from its inception in 1982 until I left UCLA 25 years later (2007).  The lab was accredited by the International Olympic Committee (IOC) in 1983 and it was the first sport testing lab in the United States.  The laboratory performed the testing for the 1984 Los Angeles Olympic Games, the steroid testing for the 1996 Atlanta Olympic Games, and the testing for the 2002 Salt Lake City Olympic Games.  During those years the sample numbers grew from 2,000 to over 50,000 samples per year making it the largest sport-testing lab in the world.

During my tenure, I performed drug testing on behalf of the United States Olympic Committee (USOC), the United States Anti-Doping Agency (USADA), the National Football League (NFL), the National Collegiate Athletic Association (NCAA), Major League Baseball (MLB), the World Anti-Doping Agency (WADA), the U.S. federal government and many other organizations.  I have spent my whole career dedicated to building the ethos and system of anti-doping that we have today.  Violating that system in any way would be anathema to everything I believe in.

As a laboratory director, I often responded to legitimate requests for information about the results.  Guiding those requests and the whole testing process are the cardinal features of all sport testing contracts: 1) samples are identified only by a code number, 2) only the testing agency (for example USADA) can connect the name of the athlete to the code number, and 3) nobody at the laboratory knows the name of the athletes.  The testing is anonymous.

For as long as I can remember, laboratory directors and their staffs have been forbidden by anti-doping agencies from discussing cases with the media.  Today, this is formalized within the World Anti-Doping Agency’s Code of Ethics of the International Standard for Laboratories.

On Wade Exum:

Wade Exum was the Director of Drug Control at the USOC from 1991 through 2000.  The article refers to Exum’s lawsuit against the USOC upon his termination and also to Exum’s allegations of “letting positive drug tests slide.”  As the article mentions, “Exum’s lawsuit was dismissed for lack of evidence.”

Later in the article, Wade Exum is quoted as saying “Out of tens of thousands of tests purchased during my tenure as Director of Drug Control at the USOC, I can remember only one T/E ratio being called positive.”

I have reviewed my records and they reveal that the UCLA Lab reported more than 25 urine samples with T/E values greater than 6 to the USOC between 1992 and 2000.  As the lab director, reporting to the USOC fulfilled my obligations I had no authority or ability to take further action against the athlete; the authority to take action against the athlete rested solely with the USOC or other appropriate agency.  I would not have the ability to take further action against an athlete as I only work with sample codes and would not know the identities of those testing positive or negative.

On the minutes of USOC anti-doping committee meetings:

I spoke with the co-author of the Sports Illustrated article, David Epstein, in a telephone conversation between January 13-19, just before his article was published.  During the conversation, I asked for a copy of the meeting minutes to which the article refers.  It is important to understand the context of the meeting to appropriately comment.  Mr. Epstein told me that he either could not or would not provide the meeting minutes.  Since the publication of the article, I have asked the USOC for a copy of the minutes but have not yet received one.  I have also formally requested a copy from the editors of SI through counsel and am awaiting a response.

I have attended hundreds of meetings in my career and cannot recall all of the topics discussed.  It is impossible to comment on the context of a meeting after being read a few lines from minutes that are almost eleven years old.  I am confident that if provided with the context I could easily explain any statements in the minutes and their relevance to the advancement of the anti-doping system in general as that has always been my creed.

On the USA Cycling letter to Catlin from May 1999:

The article describes a May 1999 letter from USA Cycling to me asking for the testosterone-epitestosterone (T/E) ratios “for a cyclist identified only by his drug-testing code numbers.”  Allegedly, “a source with knowledge of the request says that the cyclist was Lance Armstrong.”

The article suggests that the letter referred to one cyclist, but the letter is not directly quoted.  It is unclear if the letter in fact requested results for one cyclist or whether it was a general request for results on a group of lab codes not tied to any individual.  Again, I have asked David Epstein for a copy of the letter.  As of January 26, it has not been provided.

The article makes it clear that the request included only code numbers.  As a result, I could not have known the identity of the athlete or athletes included in the request.  Regardless of the specifics, such requests were very common and routine; I had numerous such requests in the course of my career.

Catlin’s letter to USA Cycling dated June 4, 1999 (see 4 numbered comments):

An excerpt of the article describes my response to USA Cycling:

“In a letter dated June 4, 1999, Catlin responded that the lab couldn’t recover a total of five of the cyclist’s test results from 1990, 1992 and 1993, adding, ‘the likelihood that we will be able to recover these old files is low.’ The letter went on to detail the cyclist’s testosterone-epitestosterone results from 1991 to 1998, with one missing season: 1997, the only year during that span in which Armstrong didn’t compete. Three results stand out: a 9.0-to-1 ratio from a sample collected on June 23, 1993; a 7.6-to-1 from July 7, 1994; and a 6.5-to-1 from June 4, 1996.”

Again, I have asked for a copy of this letter, but it has not been provided.

1 – Background necessary to understand the testing methods and reporting:

The urine samples are collected at the testing site by trained collectors who follow a detailed protocol and do not work at the lab.  Each sample is split into two portions (A and B) while the athlete observes.  Samples from one athlete are labeled, for example: 123456A and 123456B.  At the lab, the A samples are screened and the B samples are stored intact.  If the A screen is negative, the lab reports a negative result to the agency.  If the A shows evidence of a drug, the laboratory performs an A confirmation.  If the A confirmation is positive, the laboratory reports an adverse result to the agency.  The agency informs the athlete, who may choose to make an appointment for a representative to come to the laboratory to watch his or her B sample confirmation.  If the B confirmation confirms the adverse finding, the laboratory reports an adverse result to the agency that requested the test, the relevant national governing body, and an international body such as the IOC or WADA (The details of the reporting pathway changed over the years).

2 – On the request for data from five samples from 1990, 1992 and 1993:

In 1990, 1992 and 1993 we did not have the consistent electronic archive options that are available today.  The data was stored on magnetic tape and other similar media that were not always consistent in their performance.  When older data could not be found it was usually because the storage medium had deteriorated and the data was no longer in archive directories.  In the 1990s, WADA did not exist and the labs were managed by the IOC.  The IOC-accredited laboratories were not required to retain the data on samples declared negative, although it was our practice to retain all electronic data while I was at UCLA and respond to requests similar to the alleged request from USA Cycling if the data still existed.

3 – On the three T/E results from 1993, 1994 and 1996 discussed in the article:

When the laboratory would have originally received the samples in question, identified only by a number, not only did no lab employee, including myself, know the name of the athlete, but nobody knew whether the athlete had ever been tested before or would ever be tested again.  All three were reported long before Armstrong won his first Tour de France and became famous; I had no idea who he was at the time.  In a response letter of the sort described from June 4, 1999, I would merely be describing results that had been obtained and reported independently from one another several years earlier.

It was not an unexpected occurrence to have samples with screen T/E ratios between 6.0 and 7.5 not confirm.  It would be less likely, however, that a sample that screens at 9.0 does not confirm.

4 – Background necessary to understand T/E ratio results:

To determine whether a sample’s T/E is greater than 6, the lab must measure it.  Inherent to any and all kinds of measurements is a certain amount of “measurement uncertainty.”  To confirm a T/E greater than 6, statistical analysis of the measurements obtained for the sample and standards must meet certain criteria.  Sometimes those strict criteria are not met by samples whose T/E is above 6.  In addition to these mathematical criteria, a host of other requirements must be met in order to confirm a positive T/E result, which would be described in the Standard Operating Procedure (SOP) relevant at the time.  In other words, the lab, accreditation, and drug-testing system require the lab to report positive results only when the data meet the strict standards laid out in the SOP.

The T/E ratio is a very complicated test and the interpretation of the test results are equally difficult.(3,4)  A ratio greater than 6 does not prove that the individual used testosterone.  It does mean that additional tests are necessary.  Nowadays, thanks to research conducted by a handful of scientists, many of which I have had the pleasure of working with, laboratories perform the Carbon Isotope Ratio test to help clarify the results.  However, before the CIR test was available starting in the late 1990s, one approach was to collect three more samples from the athlete at least several weeks apart and study the results.  Exactly how to do this is explained in a peer-reviewed paper that I wrote with colleagues and published in 1996.(4)  Reading these papers today will provide the serious student of this issue with considerable insight.

On Mark Levinstein’s visit to the UCLA Olympic Analytical Lab in 2005:

As a doping-control lab director and anti-doping scientist, a key element of my mission is to educate students, attorneys, journalists, and the public about relevant issues surrounding drugs in sports.  This includes educating attorneys about how lab testing is done.  I have done this countless times over the years, sometimes one on one, sometimes in small groups and occasionally with very large groups.  Examples include delivering a two-day educational seminar to some 30 North American arbitrators in 2001.  In addition, I have conducted numerous lectures and broadcasts for hundreds if not thousands of attorneys in my career.

I do recall Mark Levinstein asking to visit the lab in 2005 for a tutorial on EPO.  At first, I delayed because I was busy and I knew that he also represented Lance Armstrong on some matters.  I asked if this was on behalf of Lance Armstrong or any other athlete.  The answers were ‘no’.  In addition, he added that he knew I had educated groups of attorneys and that was all he was looking for.  Eventually I consented to his visit.

On the appointed day, I introduced Levinstein to my EPO staff, which included Andreas Breidbach.  I did not monitor the conversations.  Although employees are not allowed to discuss cases, it seems from Breidbach’s quotes that he spoke in general of the quality of the testing in the Paris lab.  Obviously, Breidbach did not heed the rules.  As far as I know, no harm came from that incident.  I would not have had any discussions with Levinstein about the case.

I will also point out that during the course of B-confirmations athlete representatives, including attorneys, are allowed to witness the entire testing process.  It was hardly the first time an attorney had been educated on these matters.

Philosophy Behind 2009 Lance Armstrong Monitoring Program:

I was approached to help develop a monitoring program for Lance Armstrong’s comeback in 2009.  As initially conceived, it would have been the first time that any testing organization would be allowed to sample and test Armstrong every three days or even more often and make the analytical data available online for anyone interested to see.  My laboratory would have had unrestricted ability to perform any test we wanted.  Under those circumstances, I did not believe that anybody could get away with cheating.  I was interested to proceed.

Clarification on the intended Armstrong monitoring program:

We were aiming to collect from Armstrong on average every three days throughout the cycling season.  Such a program would be very challenging logistically and would be quite expensive.  It would also likely impact the activities of the international doping control process.  We did not want to impede or interfere with the sanctioning bodies’ ability to test Armstrong, which we knew they would do frequently.

As negotiations were wrapping up, we did perform one collection prior to abandoning the program.  The logistical and cost realities became immediately apparent.  In addition, there were difficulties with the publicity surrounding the program.

The article says that “In its months of overseeing Armstrong’s testing program, Catlin’s lab had collected only one urine sample from him, … and it is clean.”

It is correct that only one sample was collected, however we had only overseen the program for one day, not months.  The results were free of any blood profile abnormalities, the urine was negative for EPO analogues and had a T/E ratio below 4.

References:

While preparing this response I relied on my general knowledge of doping, personal files, specific publications and the following articles:

1) Roberts S and Epstein D.  The Case Against Lance Armstrong.  Sports Illustrated.  January 2011.

2)  Catlin DH, Murray TH.  Performance Enhancing Drugs, Fair Competition, and Olympic Sport.  J American Medical Association 1996;276:231-237. (describes doping control and the system)

3)  Catlin DH, Hatton CK, Starcevic S.  Issues in detecting xenobiotic anabolic steroids and testosterone by analysis of athletes’ urine. Clinical Chemistry 1997;43:1280-1288. http://www.clinchem.org/cgi/reprint/43/7/1280.  (explains the TE ratio in detail)

4)  Catlin DH, Cowan DA, de la Torre R, Donike M, Fraisse D, Oftebro H, Hatton CK, Starcevic B, de la Torre X, Norli H, Geyer H, Walker CJ.  Urinary testosterone (T) to epitestosterone (E) ratios by GC/MS.  I.  Initial comparison of uncorrected T/E in six international laboratories.   J Mass Spectrometry 1996;31:397-402.  (measurement of the TE ratio)

5)  Essay dedication: Coleman DL and Coleman, JE.  The Problem of Doping.  Duke University School of Law.  Duke Law Journal, 2008.

6) Anonymous, Current Biography®, March 2010 issue, 2010. The H.W. Wilson Company (www.hwwilson.com). (Catlin’s career)

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