Testosterone therapy, hGH therapy, anti-aging products and the potential for doping in sports: “Is it low T?”

Testosterone

We have noted with great interest the influx of testosterone therapy products that are spreading throughout the market.  This is one of the largest segments of growth seen in anti-aging medicine and indeed in general medical treatments.  All it takes is to watch TV and see commercials like the ‘Is it Low T’ campaign to see the prevalence of such treatments in the world today. 

Now certainly, there are legitimate purposes for treatment with testosterone as the campaign highlights.  In fact, the list is long and the treatment can be effective. 

Nonetheless, the potential to abuse the availability of testosterone treatments or use them for doping purposes is high.  It is not dissimilar to the use of another popular so-called anti-aging medicine, human Growth Hormone (hGH).  The use and abuse we describe is simple to comprehend. 

In both cases a patient can come to a clinic and get tested for testosterone or hGH and be compared to a ‘normal’ scale.  If the patient is below optimal in the scale then a treatment would likely be offered.  But what exactly is normal and how is it determined?  Perhaps more importantly, if you come in as a normal 35-year-old male athlete and your testosterone is measured at 75% of normal, should you be offered treatment to bring you up to 95%, maybe 99%?  Why not 150% and return you to your prime?  What is the limit? 

The point is exacerbated when applying it to hGH, a human hormone that is secreted by the body in cycles.  Once again, if your hGH level is measured to be low, should you be offered treatment, and how much?  How do you know if you were tested at a low or high point in the cycle? 

In a recent conversation we came across someone who works for such a clinic, which shall remain nameless.  During the course of the casual discussion the topic turned to the clientele.  The question was asked, off the cuff, “Surely you must have some athletes as clients?”  The answer not surprisingly was, “Yes.” 

The potential for doping with these natural hormones remains high.  While detection methods are in place, the game is getting complicated.  People we speak to who are close to the anti-aging industry describe claims of bioidentical testosterone that can thwart current testing methodologies.  Now, we know that such claims have been made before, many have been proven to be a farce, but others have shown to be all too true.  After all, when the now infamous BALCO chemist Patrick Arnold got out of prison he said he planned not to pursue further work in the dietary supplement industry, but rather he was turning to anti-aging. 

We are interested in exploring some of these issues further, and hope you are too.

Controlled substances in dietary supplements and the potential threat to public health

Anti-Doping Research – Dietary Supplement Survey Initiative

Controlled Substances in Dietary Supplements and the Potential Threat to Public Health

October 2010

Current Dietary Supplements May Contain Harmful Ingredients

According to the U.S. Food & Drug Administration, over-the-counter dietary supplements available today are increasingly unsafe.  The FDA recently issued the following warning: “FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for bodybuilding, weight loss and sexual enhancement.  Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”[1]

With more than half the population of the United States consuming dietary supplements, according to a recent Nielsen survey[2], the current situation represents a serious risk to public health.  It also threatens the integrity of sport and the livelihoods of elite professionals and others who are subject to strict drug testing.  The Los Angeles-based nonprofit organization Anti-Doping Research, Inc., a leading performance-enhancing drug and toxicology research organization, is moving to help tackle this problem with its Dietary Supplement Survey and is seeking financial assistance to fund its work.  Please consider joining ADR in this important effort.

Background

The passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) led to a remarkable expansion of the dietary supplement industry.  Today, the industry has reached more than $25 billion in annual sales with over 29,000 products[3].  DSHEA qualified dietary supplements as a special category excluding them from the stringent requirements for safety or efficacy that the FDA has for food and drugs.  Vitamins, minerals, herbs, amino acids, protein powders, weight loss products, muscle building or performance aids, and more are classified as ‘dietary supplements’.

It is generally agreed that DSHEA was an important legislative advance, yet ongoing issues remain with interpretation of certain provisions and enforcement.  Of greatest importance, as the FDA clearly warns, it does not have the capacity to keep hidden, undeclared active ingredients out of the dietary supplement market.  Consequently, some complicated and dangerous issues have become apparent.

Specific Examples of the Problems

Prohormones – Steroid alternatives still widely available over-the-counter today

Prohormones are a loosely defined group of compounds that are anabolic steroids in disguise or work like anabolic steroids through body metabolism.  Androstenedione, which appeared around 1996 and was made famous by Mark McGwire, was the first ‘successful’ prohormone.  Other options soon followed with names like Madol, Tren, Turinabol, Superdrol, Halodrol 50 and THG, the drug at the center of the infamous BALCO[4] sports scandal.  Not surprisingly, these compounds, known under hundreds of synonyms and brand names, became very popular and sales exploded.  Finally, in 2004 the government revised the Anabolic Steroid Control Act[5], officially classifying these drugs and their chemical cousins as controlled substances making them illegal to sell in dietary supplements.

Despite the new legislation, the sports supplement industry continued to sell and create new options.  In late 2009, the FDA stepped up efforts to curtail sales by approaching one of the largest retailers, Bodybuilding.com, and informing the company that they were selling 65 products classified as steroids resulting in a voluntary recall[6].  In a laudable step, Bodybuilding.com appears to have adopted a commitment to keep prohormones off its site as none are found on the site currently.

One might think this was the end for these products but a quick Internet search today demonstrates otherwise.  Amazon.com is still selling Competitive Edge Labs X-Tren [7] and more like M-Drol and H-Drol.  Nutrition Arsenal has Competitive Edge Labs M-Drol and H-Drol today as well as 84 other prohormone options[8].  Another, BuySupps.com has 6 prohormones[9] listed including new clones of old favorites like Halodrol and Superdrol.  These are mere examples of the dangerous products that remain widely available and more brands and products appear monthly.

Drug alternatives sold as dietary supplements – Example: Ephedra and other herbal stimulants

The herbal stimulant craze became widespread with Ephedra, a popular Chinese remedy known also as Ma Huang.  FDA started attempts to regulate it around 1995 as it became associated with harmful side effects and health concerns.  They were finally successful in 2004, prompted in large part by the death of Major League Baseball pitcher Steve Bechler in February 2003.

Since then, the supplement industry has created a variety of ‘legal ephedra’ alternatives such as bitter orange.  Bitter orange, or citrus aurantium, is known to contain octopamine, an analog of ephedrine that is banned in many sports.  The National Center for Complementary and Alternative Medicine has found that “there is currently little evidence that bitter orange is safer to use than ephedra.[10]“  Nonetheless, it remains a popular ingredient in dietary supplements.

Methylhexanamine is a weak stimulant that has become popular in supplement products.  It was first trademarked under the name “Forthane’ by Eli Lilly in 1971 as a nasal decongestant and has been used as a ‘party pill’ in New Zealand.  In 2009, the use of methylhexanamine caused five Jamaican athletes to return positive drug tests.  Although methylhexanamine was not named as a banned substance by the World Anti-Doping Agency (WADA) at the time, it was banned as a “related substance” on page 7 of the WADA Prohibited List, therefore sanctions were imposed.  Methylhexanamine is chemically similar to tuaminoheptane, which was banned in 2009.  Methylhexanamine was explicitly added to the WADA 2010 List of Banned Substances, largely in response to this situation.

Despite its addition to the list, methylhexanamine continues to cause positive drugs tests, including the recent announcements of nearly a dozen positives among Indian athletes.  This is largely due to the confusing network of synonyms and brand names.  For example, methylhexanamine is also known as  Forthan, Forthane, Floradrene, Jack3d, DMAA, shizandol A, 1-3 dimethylamine, geranamine, geranium oil extract and more.  This is of primary concern as it results in unknown use of these drugs by consumers and athletes alike.

Purposeful contamination with pharmaceutical drugs – StarCaps

Sometimes nefarious manufacturers spike their supplements with drugs.  Lay persons are at risk for serious adverse reactions while athletes and elite professionals who consume these tainted products may return a positive test jeopardizing their careers.

StarCaps is a weight loss supplement that was proven to contain an undeclared potent diuretic, bumetanide, in amounts indicating that it was not a contaminant but rather was likely added to achieve a desired effect.  In 2008, several NFL players tested positive for bumetanide after using the StarCaps product.  Unfortunately, StarCaps is not an exception.  A survey performed by the FDA in 2009 found that 72 products sold as weight loss supplements contained unlisted pharmaceutical medications[11].  Sexual performance enhancers and testosterone boosters also raise similar concerns.

Raw material impurities and accidental contamination of products   – AdvoCare

During the 2008 Olympic Trials, a swimmer, Jessica Hardy, tested positive for clenbuterol.  She alleged that the positive came from a product by AdvoCare, one of her sponsors.  ADR’s testing showed the presence of clenbuterol in very small amounts.  The amount of clenbuterol was so low that it is highly improbable that it was deliberately added to the supplement.  The issue was likely due to raw material contamination as opposed to purposeful contamination.

Vitamins too are susceptible to contamination as the Kicker Vencill case demonstrated.  Vencill lost a chance at the 2004 Olympics due to a positive drug test, later proven to have come from a multi-vitamin[12].  Amazingly enough there are no requirements to test raw materials for banned or controlled substances prior to their inclusion in supplements.  Impurities are often the culprit behind adverse reactions and positive drug tests in sports-persons, police, fire and other elite professionals.

Actions

Through our Dietary Supplement Survey, Anti-Doping Research aims to do more to protect the public and athletes through product testing, research and information dissemination.  Our survey encompasses the following objectives:

1. Randomly select products from across the industry and subject them to broad screening for a variety of controlled substances or those banned by sport.  We aim to analyze  250-500 products annually to obtain an adequate and representative sampling.
2. Target test for certain compounds in high-risk categories.  We will focus on steroids in muscle building products and pharmaceutical drugs in weight loss supplements and sexual performance/testosterone enhancers.
3. Categorize ingredients that are banned in sport or in professional drug testing programs and index the many synonyms and brands that contain them.  Distribute the information through searchable databases similar to ADR’s Searchable Database of Banned Stimulants.
4. Scan for new ingredients or brands appearing on the market that could be potentially harmful or lead to a positive drug test. Make public service announcements to provide information.
5. In the process of scanning the marketplace and purchasing products, ADR will track where illicit products are promoted in efforts to help audit the current retail environment and assist with enforcement.
6. Operate the ‘Dietary Supplement Survey’, an interactive website portal that makes results available to the public and athletes, and conveys accurate and up-to-date information.

Needed Resources

We are seeking $1.5 million dollars annually to support the project.  The budget would be used as follows:

Operating Expenses	Annual $
Laboratory Equipment	$      50,000
Equipment Maintenance	$      45,000
Laboratory Consumables (Chemicals, Glassware)	$    240,000
Supplement Purchases	$      30,000
Website Support and Development	$      75,000
Consulting/Professional Services	$      70,000
Building Operations	$    115,000
Office Expenses	$      75,000
Scientific Payroll	$    565,600
Administration and Office Payroll	$    194,400
Miscellaneous	$      40,000
TOTAL	$ 1,500,000

About Anti-Doping Research, Inc.

Anti-Doping Research has a great deal of experience working on various sides of these issues.  We have worked on medical cases supporting doctors whose teenage patients have suffered liver failure from inadvertent use of powerful designer steroids such as Superdrol or 4,9-Estradiene-3,17-dione, also known as ‘Tren.’  We have worked on legal cases for athletes whose use of products resulted in a positive drug test severely impacting their career and reputation.  We have worked with the media to expose new designer steroids.  We also perform testing on behalf of Banned Substances Control Group on a variety of supplement products to determine if they contain banned substances.

Anti-Doping Research, Inc. (ADR) is a non-profit organization founded in 2005 by anti-doping pioneer Don Catlin, M.D., and colleagues as a dynamic new paradigm dedicated to creating novel solutions to modern-day issues related to banned substances in sports, toxicology and public health.  Its focus is on research, analytical testing, education, program development and collaboration.

ADR is grateful to the following major contributors whose generous support during the last six years have made ADR’s work possible: Amgen, Anti-Doping Sciences Institute, Grayson-Jockey Club Research Foundation’s Equine Drug Research Institute, Major League Baseball, the National Football League/National Football League Players Association Research & Education Foundation and the United States Anti-Doping Agency.

Please join us and help support this important public health project with your contribution today.

Sincerely,

Don H. Catlin M.D.                                                           Oliver Catlin

CEO and President                                                          Vice President and CFO

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[1] http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm207647.htm

[2] http://en-us.nielsen.com/content/nielsen/en_us/insights/consumer_insight/issue_16/half_of_americans.html

[3] http://www.crnusa.org/CRNRegQandA.html

[4] http://www.usatoday.com/sports/balco-timeline.htm

[5] http://www.govtrack.us/congress/billtext.xpd?bill=s108-2195

[6] http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm188929.htm

[7] http://www.amazon.com/Competitive-Edge-Labs-CEL-tren/dp/B002W2X8BM/ref=pd_sim_hpc_6

[8] http://www.nutritionarsenal.com/Prohormones-C33.aspx

[9] http://www.buysupps.com/categories/Prohormones/

[10] http://nccam.nih.gov/health/bitterorange/

[11] http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm136187.htm

[12] http://sports.espn.go.com/oly/news/story?id=2059714

Anti-Doping Research and Don Catlin pursue support for new Dietary Supplement Survey initiative

Dear Friends and Colleagues,

Anti-Doping Research (ADR) has been working in and around the realm of dietary supplements for some time.  Over the course of our history, we have worked on product contamination cases, medical issues stemming from dietary supplement use, characterization of new ingredients that have doping potential, media projects exposing new concerns, product testing for the Banned Substances Control Group Certification Program and more.  Our activities to date have dealt effectively with specific issues yet we have always sought a broader mechanism for evaluating the industry and the potential for controlled substances to contaminate dietary supplements.

There have been a few isolated studies on contamination in dietary supplements, but there has never been a fair and impartial industry-wide survey that examines this issue on an ongoing basis.  Surprisingly, there are no requirements today for the supplement industry to test raw materials or finished products for controlled substances, so the scope of the issue is unknown.  Through random sampling of dietary supplement products, analytical testing, and information dissemination, our Dietary Supplement Survey aims to differentiate the reputable players in the supplement industry from those that continue to introduce nefarious products, and to provide a network of information to consumers and athletes who seek safe supplementation.

Please take a few moments to explore our Dietary Supplement Survey.  We have announced the project in a recent press release and are currently in the process of generating the support and resources necessary to move forward.  Please contact us if you would like further information or if you are interested in supporting the project in some way.

Thank you kindly for your consideration.

Don & Oliver

About Anti-Doping Research, Inc.: Founded in 2005, Anti-Doping Research, Inc. (ADR) is a world-class center of analytical excellence and knowledge.  ADR’s mission is to utilize research, analytical services and education to identify dangerous and banned substances wherever they may be found and help halt their use.  ADR’s laboratory is an ISO 17025-accredited facility with a broad range of analytical capabilities.  ADR is a 501(c)(3) public charity/nonprofit/NGO; donations are most welcomed and are fully tax deductible.

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….

Strict liability rules in doping violations for clenbuterol: the Ovtcharov, Contador and Hardy cases

Clenbuterol

The recent news reported by Associated Press on September 22 that German Olympic Table Tennis medalist Dimitrij Ovtcharov was suspended over a positive doping test was likely missed by many in the United States, but it was certainly not missed in Germany.  What should be notable to all is that this is yet another violation due to clenbuterol, the same drug that Tour De France Champion Alberto Contador tested positive for a few months ago.  Also at the core of this case is the long-held rule of strict liability that has been a core tenet of the anti-doping system and is undergoing a series of tests currently due to the influx of recent clenbuterol positive drug-test reports.

This core tenet, described on page 19 in section 2.1.1 of the World Anti-Doping Code – 2009 says that athletes are responsible for any substance found in their body.  The comment provides a good history of the rule and describes that “in the exceptional circumstance where a Prohibited Substance entered an Athlete’s system through No Fault or Negligence or No Significant Fault or Negligence on the Athlete’s part” modified sanctions may be considered.  The consideration of fault or negligence has been adopted over the course of time based on experiences similar to that of American swimmer Jessica Hardy, who also tested positive for clenbuterol back in 2008 and lost her opportunity to compete in the Olympics because of it.

In her case, our laboratory found that the supplements she was taking were contaminated with clenbuterol.  After a long legal fight, she did receive a reduced sanction of one year based on this consideration, though she has to continue to fight to be allowed to compete in the next Olympic Games as drug test violations in today’s system are supposed to keep you out of the next Olympics.

Apparently as of October 15, 2010 news indicates that Ovtcharov’s doping suspension has been lifted after the report by Cologne doping expert Wilhelm Schaenzer noted that “the intake of clenbuterol through contaminated food was the likeliest explanation for the finding.  A doping related use of clenbuterol is highly unlikely.”

We are not surprised by the notes of our friend and colleague Dr. Schaenzer, as we have had similar musings ourselves in regards to the Contador case.  We do note that nothing in the comments quoted from his report in the article above seem to definitively state where the source of clenbuterol originated.  It is also noteworthy that the Ovtcharov suspension seems to have been lifted after only three weeks based on the statements that he was ‘likely’ not at fault.  Comparing this situation to Jessica Hardy’s one-year sanction and two-year-plus legal battle is perhaps most striking.

Now, we have no inside knowledge or information regarding this matter and we suspect that Dr. Schaenzer would not make such statements without data to demonstrate that the likelihood of doping does not exist in this case.  We would like to find out more information.  We are also curious about the hair test noted in the article, how it was done and what it demonstrated.

Meanwhile we have to wonder about the Contador case as he too has blamed contaminated meat for the clenbuterol finding, according to an article in The New York Times on September 30, 2010.  According to the article, Contador’s hired expert, Dutch scientist Douwe de Boer, “has already generated a paper concluding that ‘it is extremely likely and would be only fair’ to say that the existence of clenbuterol in Contador’s system was from an accidental ingestion of contaminated meat.”  The article goes on to note, “An expert in clenbuterol contamination in meat, however, characterized Contador’s explanation as almost impossible.”  Certainly, the swirling rumors surrounding placticizer tests and blood transfusion possibilities do not help his cause.  Perhaps a hair test will exonerate him as well, we will see.  Meanwhile, Contador must move on to month two of his fight; time will tell if it is as long as Jessica Hardy’s.

Once all is said and done, it will be interesting to examine how the strict liability rules are applied in these cases and the others that are out there.

Welcome to The Catlin Perspective

Today we are excited to formally launch our blog, The Catlin Perspective.  We are pleased to have this new forum to share our thoughts with our friends, colleagues and the general public.  We hope that the ideas we share can inspire fresh thinking and action and can lead to cleaner competition and improved safety of over-the-counter products.

In addition to the blog, we encourage you to explore our new website for The Catlin Consortium.  We are also excited to unveil the ADR Dietary Supplement Survey, a non-profit initiative, which aims to do more to protect the public and athletes from supplement contamination concerns through product testing, research and information dissemination.  The survey also provides enormous benefit to the supplement industry as it finally creates an objective way of differentiating reputable products and manufacturers from the nefarious ones.  We encourage you to join us in supporting this new project.

We hope you enjoy the blog and welcome comments and feedback that can inspire further discussion.

Best regards,

Don and Oliver

More methylhexaneamine positives. Why was the compound’s presence not addressed earlier?

Methlyhexaneamine

Sadly, the rash of positive drug tests related to methylhexaneamine continues.  Yesterday, it was reported by Velonation.com that the cyclist brothers Rui and Mario Costa both tested positive for methylhexaneamine in the past year.  This is merely the latest example of a string of high-profile positive drug tests related to methylhexaneamine that have surfaced in the last two years.

Our previous blog post (of Sept. 10) explains how the many synonyms and brand names that surround methylhexaneamine create confusion and can result in inadvertent use of the drug.  We also briefly looked into the interesting history of the compound.  We posed the question, ‘why is this drug banned in sport yet legal in dietary supplements’, and that question remains.

What we did not examine is why it took so long to address this compound, as it was exposed as a potential problem in the Washington Post on May 8, 2006.   Patrick Arnold, the chemist mastermind behind the infamous BALCO steroid scandal, was awaiting his sentencing at the time.  Meanwhile, his company was marketing methylhexaneamine under the trademarked name Geranamine.  The father of designer steroids, as many consider Arnold to be, had shifted his focus to methylhexaneamine.  The writing was on the walls, or at least in the Washington Post, that this substance would become a problem in sport.

Methlyhexaneamine was added to the World-Anti-Doping Agency Prohibited List for 2010.  In the U.S. supplement industry, the argument continues as to whether or not the compound should be allowed as an ingredient.  For now, it continues to be legal to make supplements that contain the compound.

Contador is not alone; clenbuterol positives are not uncommon

The international sport media has been thrown into a fervor again today over the announcement of Alberto Contador’s positive drug test for clenbuterol.  Unfortunately, he is not alone, as clenbuterol positives have been a recurring problem.  The table below summarizes some of the other cases.  We also highlight some of the things we have learned about clenbuterol and the realities of detecting it through drug tests.

What we have learned:

1) The best way to know if clenbuterol was deliberately used for doping purposes is to evaluate the amount present in the athlete’s urine.

2) Labs can detect minute amounts of clenbuterol on drug tests.  As a result, even very small amounts of contamination in a supplement product can cause a positive drug test.  The Jessica Hardy case is a perfect example.  She was pulled out of the Beijing Olympics at the last minute and was sanctioned because very low levels of clenbuterol were found present in her urine.  Clenbuterol contamination was discovered in a supplement she had been taking.

3) Athletes from China account for the most cases, but Spanish athletes have also been involved.   Twenty years ago there was an epidemic of serious clenbuterol toxicity in Spanish persons – non-athletes.  It was thoroughly investigated and traced to a farm that was using huge doses to bulk up cattle.  Athletes were not involved.   The Spanish authorities responded by establishing new controls, which remain in effect today.

Below is a table of clenbuterol drug test violations as summarized by Zack Bilgake on SportsNickel.com, http://sportsnickel.com/2010/09/30/contadors-clenbuterol-positive-and-what-it-really-means-for-tour-champ/:

ATHLETE	NATION	SPORT	EVENT/DATE OF POSITIVE	RESULT OF POSITIVE
Djamolidine Abdoujaparov	UZB	Cycling	1997 Tour de France/Stage 2 (July 6)	Retired
Xiong Guoming	CHN	Swimming	out of competition test in 1999 (March 8 )	3-year suspension
Wang Wei	CHN	Swimming	out of competition test in 1999 (March 8 )	3-year suspension
Mariano Puerta	ARG	Tennis	2003 ATP Viña del Mar (February 12) *ARGUED FOOD CONTAMINATION	9-month susp. + $5600 fine
Zhou Jie	CHN	Swimming	out of competition test in 2005 (Sept 6) *ARGUED FOOD CONTAMINATION	2-year suspension
Karol Beck	SVK	Tennis	2005 Davis Cup semi v. Argentina (Sept 25)	2-year suspension
Anzhelika Gavrilova	KAZ	Speed skating	positive test before 2006 Olympics (Jan 4)	1-year suspension
Mitchil Mann	AUS	Weightlifting	2 positive samples in 2006 (Oct 30, Nov 3)	2-year suspension
Ouyang Kunpeng	CHN	Swimming	tested positive before 2008 Olympics (July 1) *ARGUED FOOD CONTAMINATION	lifetime ban
Jessica Hardy	USA	Swimming	2008 U.S. Olympic trials (July 4) *TAINTED NUTRITIONAL SUPPLEMENT/ADVOCARE	voluntary Olympic withdrawal/1-year suspension
Reni Maitua	AUS	Rugby	positive test by ASADA (May 20/2009)	2-year suspension
Tong Wen	CHN	Judo	stripped of 2009 world title (May 10/2010) *ARGUED FOOD CONTAMINATION	2-year suspension
Li Fuyu	CHN	Cycling	In-competition test at 2010 Dwars Door Vlaanderen (March 24)	2-year suspension
Callum Priestley	GBR	Hurdles	tested positive February 2010 (Sept 5) *ARGUED FOOD CONTAMINATION	2-year suspension

Another positive drug test related to dietary supplement contamination

Sadly, another positive drug test related to use of a dietary supplement surfaced yesterday, this time in equine sport, http://www.horseandhound.co.uk/news/397/302201.html.  Don’t let this situation happen to you; there are ways to protect yourself.

According to the story, a British endurance rider, Christine Yeoman, had her horse test positive for ractopamine, a potent beta agonist, at an event on August 9, 2009.  She had been giving the animal Neigh-Lox, used to prevent gastric ulcers.  Neigh-Lox was manufactured in the United States by Kentucky Performance Products.  Traces of ractopamine were found in the product in subsequent testing, and the company has admitted to the contamination.

For those who are not aware, drug testing usually works according to strict liability, meaning if a drug is detected resulting in a positive test, the individual is responsible for the presence of the substance in the body regardless of where it might have originated.  If the issue is related to a contaminated supplement, the athlete or rider still faces possible sanctions.  The human sport system considers supplement use to be voluntary, and thus even if supplement contamination is the source of a positive drug test the athlete is usually held responsible.

In this equine case, the rider had to spend more than €200,000 to clear her name and win an unprecedented ruling from FEI.  The ruling stated: “Even ordinary feed is often mixed and includes several additives which may be contaminated. Even feed without additives may be contaminated.  Equestrian sport on a high level can be said to require the use of feed supplements to care properly for such elite horses.  In the tribunal’s opinion, PRs [persons responsible, i.e. the rider] are not the proper party to bear the risk of supplements contaminated at the manufacturer level.”

Unfortunately, testing for banned substances in dietary supplements is not mandatory and the risk of contamination remains an issue.  Testing options that can protect against these issues are available to the general public, athletes, and the dietary supplement industry.  We operate our own such program at Banned Substances Control Group.  For more details, please explore http://www.bscg.org/.

Despite numerous efforts to the contrary, prohormones remain widely available today

The supplement industry, sporting groups, the FDA and more have been combating the issue of prohormones, or steroid precursors, for years. Prior to 2004 these substances were available at practically all retailers. They were available in many forms and made by many different manufacturers. This grew to be quite a concern and forced additional regulatory action to be taken.

In 2004, the Anabolic Steroid Control Act was passed, which added many prohormones to the list of controlled substances illegal for sale in the dietary supplement industry. The language included in the act stated, “The term ‘anabolic steroid’ means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone).” It goes on to name more than 43 drugs by name that were now controlled and illegal to put in dietary supplements.

Enacting new regulations is one thing but enforcing them is a different story. Even after the act passed in 2004, prohormones remained widely available for years to come. These products continued to have controlled substances boldly listed on the label. These were things like Superdrol, Halodrol 50, Madol, Turinabol, Androstenedione and more.

At Anti-Doping Research, we helped expose the sales of several designer steroids in a story for ESPN.com in September of 2007, http://www.shaunassael.com/pdf/made-in-china.pdf. Again, in March of 2009, we worked on a two-part story for CBS that exposed a new designer steroid, ‘Tren’, that was being unknowingly used by high school athletes, http://www.cbsnews.com/stories/2009/03/18/earlyshow/health/main4874182.shtml. These examples demonstrate the harsh reality that despite the new legislation, the pipeline of designer steroids and prohormones was still healthy long after 2004.

In late 2009, the FDA finally began to get more assertive in their attempts to curtail the sales of these products. They approached one of the largest retailers of supplement products, Bodybuilding.com, and informed the company that they were selling 65 products that were currently classified as steroids. This resulted in a voluntary recall of the products http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm188929.htm.

You might think that his was the beginning of the end for these products, but a quick Internet search today demonstrates that this is not the case. Amazon.com, in fact, is still selling several of the products that were part of the Bodybuilding.com recall, http://www.amazon.com/Competitive-Edge-Labs-CEL-tren/dp/B002W2X8BM/ref=pd_sim_hpc_6. A quick glance at the bottom of the page shows that more like M-Drol and H-Drol are also for sale. The problem doesn’t stop with Amazon. Nutrition Arsenal is also selling Competitive Edge Labs M-Drol and H-drol today, with a note that the manufacturer has discontinued the product and supplies are very limited, http://www.nutritionarsenal.com/Search.aspx. There are 84 products available on this site listed as prohormones. Another site where prohormones are widely and publicly available is BuySupps.com. They only have six prohormones listed, one CEL’s H-drol is at least no longer available. The five other products, however, are marketed as new clones of old favorites like Halodrol, Superdrol, Tren, and more.

More time spent searching the Internet will find more of the same issues. Certainly, the efforts of the FDA to curtail the sales of these products at major retailers should be applauded and the voluntary response by the retailer to recall products is commendable. That several of these products are still available at a retailer like Amazon.com, however, demonstrates that huge holes remain. Why is it not possible to stem the sales of these products at all retailers? If it is a resource issue then hopefully the resources can be found to address this concern. If not, then we must continue the process of clearing these products from the marketplace completely.

Unfortunately, it is not only products labeled with prohormones or steroids that cause problems. At Banned Substances Control Group (BSCG), we test products on behalf of manufacturers for banned substances to assure that they are not contaminated. The products we test do not have any banned ingredients on the labels but at times we do find contamination of these products. Even manufacturers that try to make products responsibly fall victim to raw material contamination that leads to finished product contamination. There is no requirement to test raw materials for banned substances so it is not surprising that this occurs. The reality is that prohormones and steroids continue to be present as contaminants in supplement products and this too must be addressed and curtailed.

We will continue to work on such pressing supplement issues. They are not only important to elite athletes and professionals such as police and fire people, but also to the general public who use these products widely and with more and more frequency.