Colabello, Oral Turinabol and the MLB Positive Drug Tests

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

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

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

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

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

“It’s a huge issue, yes.”

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

“Sure.”

And present a reasonable case, and perhaps even win?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Maria Sharapova and Meldonium – Consideration of a Therapeutic Use Exemption After a Positive Drug Test

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Maria Sharapova – London 2012 – Photo by Oliver Catlin, http://www.bscg.org

The coverage of Maria Sharapova’s announcement of her positive drug test for meldonium, or mildronate, has been astounding. Her case is yet another amazing example of a great champion falling victim to performance-enhancing drugs in one way or another. We wrote an immediate blog post about it an attempt to consider the two potential sides to a doping issue. That post still provides an interesting view of the perspective we were aiming to provide and we stand behind the bulk of the content.

In our haste to give Ms. Sharapova the benefit of the doubt in the situation, however, as we did in our conclusion and in the suggestion that perhaps her therapeutic use would be considered retrospectively, we did not fully consider the realities behind Ms. Sharapova’s claim of therapeutic use. Thankfully our friends in the anti-doping doping community have elegantly expounded on this element of the case.

The expert analysis below on therapeutic use and application in World Anti-Doping Agency (WADA) doping control is important to consider. It corrects the notion that a TUE could be granted retroactively and impact a pending sanction, which would be extremely rare if not completely unique in the field of anti-doping.

The information below was written by Dr. Ken Fitch and distributed by Jim Ferstle, both valued friends and colleagues who care deeply about clean sport and anti-doping and have spent their careers fighting for the cause as we have. The points of primary interest: retroactive TUEs would be unlikely to be considered from a standpoint of sanction relief, and the defined timeframe and clinical guidelines for use of a drug should always be scrutinized when evaluating potential therapeutic use. Thank you, Ken, for providing an insightful explanation of the criteria involved in the consideration of therapeutic use exemptions and the potential application to meldonium.

Dr. Ken Fitch is an Australian doctor and Professor, School of Sports Science, Exercise and Health, Faculty of Life Science University of Western Australia. Dr. Fitch wrote the original rules for TUEs in 1991 for the IOC, chaired the IOC’s TUE Committee for 20 years, chaired WADA’s interim committee (2001-2003) that established the initial International Standard for TUE (2004) and chaired Australia’s national TUE Committee for 22 years.

Maria Sharapova’s lawyer exploring a possible TUE to exempt a sanction
by Ken Fitch, M.D.

The ludicrous suggestion by Sharapova’s lawyer that she might seek a retroactive Therapeutic Use Exemption (TUE) to avoid a sanction for testing positive to meldonium demands a response. Ignoring whether the 2016 World Anti-Doping Code and the 2015 International Standard for TUEs does or does not make a retroactive TUE a possibility in her circumstances, if anybody examines the criteria that must be met to grant a TUE, he/she would understand that no respectable TUE Committee could approve any such application.

WADA states that there are four criteria, all of which must be met to grant a TUE.

  1. The drug is necessary to treat an acute or chronic medical condition and the athlete would experience a significant impairment to health if it were to be withheld.
  2. The therapeutic use of the prohibited drug is highly unlikely to produce any additional enhancement of performance beyond what might be anticipated by a return to the athlete’s normal state of health following the treatment.
  3. There is no reasonable therapeutic alternative to the use of the prohibited drug.
  4. The necessity to use of the prohibited drug is not a consequence of prior use of a prohibited drug or method.

Would Sharapova’s health be significantly impaired if she was denied a TUE? The Latvian makers of meldonium advise that it should be taken in intermittent courses of 4-6 weeks and for what period of time Sharapova administered meldonium during the past ten years, has yet to be disclosed. As the only acceptable medical indications are for ischemic cardiac and ischemic cerebral conditions, it is unthinkable that Sharapova has either. Hence any claim that should she be denied the right to take meldonium would impair her health is simply fanciful. Any TUE application must fail criterion 1.

The second criterion was introduced because some athletes had an essential need to take a prohibited drug. For example, an insulin dependent diabetic would die if denied insulin which has been prohibited in sport since 1998 and their daily insulin injections that are permitted with a TUE do not enhance performance. Whether meldonium actually enhances performance in humans has yet to be demonstrated. That WADA has advised that in less than two months since it was added to the Prohibited List, 99 athletes have tested positive for meldonium would appear to indicate that many athletes and their advisors believe that it does. No athlete could claim that meldonium was essential to restore their health back to normal levels. To claim that without it, a person’s health would be less than normal is surely fictitious. Fails criterion 2.

There are many drugs that have been demonstrated in scientific trials to be valuable in cardiac ischemia and the vast majority would be far superior to meldonium. The few meldonium studies performed in humans have been on persons who recently had experienced a myocardial infarction or an acute coronary syndrome. That the makers of meldonium recommend that it be administered only in intermittent courses in contrast to most of the widely acceptable, prescribed alternatives that are to be taken daily, is further evidence of the non-essential status of meldonium to treat cardiac ischemia. As the drug is marketed in only ten countries globally and Sharapova has lived in the USA for much of her life where meldonium is not approved for human use, this poses further questions for the tennis player.

Drug therapy for cerebral ischemia is generally ineffective and less frequently used than for cardiac ischemia but those patients on whom meldonium was trialled had had either a recent stroke or evidence of deteriorating brain function. As Sharapova could not possibly demonstrate that she has either of these or indeed significant cardiac or cerebral ischemia, and if she could, alternative permitted drugs are at least as effective if not more so, she fails criterion 3.

Hence Sharapova fails 3/3 and the fourth criterion has no relevance. Finally, should an unscrupulous or ignorant TUE Committee happen to grant Sharapova a retroactive or even a prospective TUE for meldonium, WADA would be certain to appeal to CAS and the decision would be or should be overturned.

Maria Sharapova and Meldonium – Consideration of a Positive Drug Test

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Maria Sharapova – 2012 London Olympic Games – Photo by Oliver Catlin, www.bscg.org

Before jumping to conclusions and lambasting Maria Sharapova as a deliberate doper over recent revelations, we should attempt to educate ourselves and arrive at an informed decision based on the circumstances at hand. There is much to consider when reviewing Ms. Sharapova’s recent positive drug test at the Australian Open for the drug Meldonium.

First, we start with the drug, Meldonium, also known as Mildronate. You can review the pubchem listing for mildronate if you are interested. Other synonyms for the drug include “Quaterin; 76144-81-5; Kvaterin.” The long IUPAC chemical name is 3-[(trimethylazaniumyl)amino]propanoate.

In medicine, Meldonium is used to treat cardiac conditions like angina and vascular disease. It was developed by a Latvian company Grindeks and is approved in the Russian Federation and other countries but not in the Unites States. The description on Drugs.com describes it in two therapeutic categories; “treatment of cardiac disorders” and “inhibitor of carnitine synthesis.” Drugs.com includes 11 brand names across the Russian Federation, Latvia, Georgia and Lithuania: “Cardionate, Meldonium Olainfarm, Meldonium-MIK, Mildronat, Mildronat Grindeks, Mildronats, Mildroxyn, Vazomag, Midromax, Mildronate, Milkor.” There are 189 publications to explore via PubMed if you want to want to spend the time perusing them.

It appears Ms. Sharapova tested positive for the drug in an ITF (International Tennis Federation) drug test on Jan. 26 at the Australian Open. This information comes from her own accounts and the various media summaries of her case, including one from the New York Times that includes a video of her press conference in which she disclosed the positive test results. She explains the details saying, “I was legally taking the drug for the last ten years. I was getting sick very often, I had a deficiency in magnesium. I had irregular EKG results, and I had a family history of diabetes.” She added she had used the drug since 2006 based on treatment advice from her doctor.

Meldonium was added to the World Anti-Doping Agency (WADA) Prohibited List for 2016 under the category ‘S4. Hormone and Metabolic Modulators’. Prior to 2016, Meldonium was on WADA’s monitoring program list, meaning they were watching to see if it was being abused by athletes. The notes from WADA’s 2016 Prohibited List – Summary of Major Modifications and Explanatory Notes that came out on September 16, 2015, says that “Meldonium (Mildronate) was added because of evidence of its use by athletes with the intention of enhancing performance.”

More specifically, an abstract from a publication on Meldonium in Drug Testing and Analysis from December 2015 mentions, “the anti-ischemic drug Mildronate demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of central nervous system (CNS) functions.” A good explanation on the logic and research leading WADA to prohibit of Meldonium is included in a blog from March 3, 2016, noting the positive drug tests of runners Abebe Aregawi and Endeshaw Negesse, who also recently tested positive for Meldonium.

According to a Roidadvisor.com article, “Performance-enhancing Drugs Used by Athletes That Are Surprisingly Common,” (Oct. 17, 2015),“Meldonium has generally been used by athletes in various sports for its mild stimulant-like properties.” The piece goes on to say, “Of interest to athletes is the finding that it consistently and significantly improves exercise tolerance. Some pharmaceutical companies have recently marketed it explicitly as a performance-enhancing drug. It’s also used as a ‘smart drug’ by non-athletes. Athletes have been using it for over 5 years.” Of additional concern, the article mentions other similar drugs “telmisartan (Micardis) and T3 liothyronine (Cytomel) – are currently being used by numerous elite athletes particularly in endurance sports.”

So, on the one hand there appears to be a plausible and legitimate medical reason for Ms. Sharapova to have used Meldonium. It could have simply been a mistake that she continued to use it in 2016 without realizing it had become prohibited or seeking a therapeutic-use exemption for the drug, which presumably she could have and still might receive if her account holds true. It’s possible that will be evaluated retrospectively. It would appear there was enough time to consider the potential concern as Meldonium was on the WADA monitoring program list since January 1, 2015 and notification of it being added to the Prohibited List came out more than three months before the start of the year. It is not known if the ITF provided any notification to its players in addition to the information WADA provided.

Now, the cynics will probably look at the message board information and say it appears clear that athletes have known about the doping potential of drugs like Meldonium for years now. They may conclude that Ms. Sharapova has come up with a convenient explanation of what happened after the fact. Sadly, that explanation is also plausible.

This issue is the perfect example of a primary challenge we face when confronting the need to conduct anti-doping testing to keep sport clean. All we have is the test results that indicate a positive or negative finding in a urine sample. The results do not speak to the motivations or intentions of the athlete. In situations like this one, or in cases that involve dietary supplement use, it is hard to know whether the athlete is being truthful in their explanation or if they have developed a convenient explanation for their use of the substance involved.

We will see how things conclude in this case. Given what we know about the character of Ms. Sharapova, we have to think this is accidental doping. Of course one can never be certain and the rules of strict liability still apply as they always do in the anti-doping realm, and as she herself notes in her statement. Sadly, she is now subject to a possible two years of sanctions and has had a pall pulled over the culmination of a fabulous career. Tennis will miss her and her the game. This case is the perfect illustration of the need for drug tested athletes to take it upon themselves at the end of each year to be vigilant and review changes in the WADA Prohibited List to ensure their medications and dietary supplements are compliant with the drug testing rules for the next year.

By Oliver Catlin, President, Banned Substances Control Group, www.bscg.org

New Sports Doping Agent FG-4592 Not the Only HIF Drug Available to Athletes

fg-4592 What drugs are athletes using to dope? This is one of the most commonly asked questions in the realm of sports anti-doping. Recently the answer has been provided in glaring form. During the week of July 29, Dr. Don Catlin, BSCG’s chief science officer and former longtime director of the UCLA Olympic Analytical Laboratory, was interviewed by the New York Times regarding a new drug called FG-4592, which was detected in tests of at least two elite cyclists.

AstraZeneca, one of the drugs’ developers, summarizes FG-4592 as “a small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein that responds to oxygen changes in the cellular environment and meets the body’s demands for oxygen by inducing erythropoiesis, the process by which red blood cells are produced.”

FG-4592 is available in pill form and is orally active, unlike its cousin, recombinant erythropoietin, or EPO, which must be injected. Some have dubbed FG-4592 as oxygen in pill form. This new drug is a breakthrough for anemia treatment and other similar blood ailments.  doping-271623_640Unfortunately, an effective blood boosting drug in pill form is also the Holy Grail for endurance dopers. Though FG-4592 remains in third-stage clinical trials around the world, it is widely available as a research chemical on the Internet. Its apparent arrival in elite sport is troubling, yet predictable.

Similar to EPO, HIF drugs like FG-4592 help increase oxygen carrying capacity by spurring the production of red blood cells. Some researchers believe HIF stabilizers might be even more effective than EPO as they can help stimulate iron absorption and suppress the inflammation of cytokines.[1] FG-4592 was recently added to the WADA (World Anti-Doping Agency) Prohibited List for 2015, as have cobalt and other HIF stabilizers and activators in general.  No other HIF drugs are named though they would be prohibited if they are detected.

According to PubChem’s listing of Chemical Vendors, there are 18 suppliers of FG-4592 worldwide . One of the vendors, the Houston-based company APExBIO, has eight HIF-related biochemicals available on its website including BAY 87-2243, 2-Methoxyestradiol, PX 12, ML 228, KC7F2, Chetomin, DMOG, and its top seller, IOX2 (Glycine). On PubChem, there are 251 Related Compounds with Annotation to explore.

Recent positive drug tests of two elite cyclists suggest athletes have managed to obtain FG-4592 for use as a performance-enhancer. Though the chemical vendors listed on PubMed are not marketing the drug to athletes, another site does not seem as scrupulous, as it sells research peptides like FG-4592 alongside an array of “performance enhancers.”  Some research peptides at www.superhumanstore.com overlap the list of performance enhancers. Numerous drugs on the WADA Prohibited List are available on this site including Aicar, CJC-1295 (a growth hormone secretagogue), Erythropoietin-mimetic peptide 17 (EMP17), GHRP-2, Sermorelin, Thymosin Beta- 4 and more. Similar drugs are available that are not included on the WADA Prohibited List by name, like BAY 87-2243 and Follistatin 344 (a myostatin inhibitor).

The average cyclists pictureprofessional cyclist in the UCI Tour makes $142,000, according to Ernst & Young.  Top riders can earn up to $5 million. Currently, the average dose of FG-4592 is recommended at 1-2mg/kg, 3 times a week, so $780 for 500mg will buy a two- week’s supply. An athlete could buy a year’s supply for around $20,280. This is a relatively affordable rate, even to an average Tour rider. With the difference between the average salary and the top salaries in elite cycling so significant, the financial incentives to use this new drug, or its cousins, remains high.

The good news is FG-4592 is detectable with drug tests. Similar developing drugs will undoubtedly be pursued and tried by athletes in the not-too-distant future. Whether these other options, particularly those not specified on the WADA Prohibited List, are detectable only time will tell. One thing history has proven, these will not be the last athletes to test positive for a new sports doping agent.

By Oliver Catlin and Joe Taylor

[1] Medscape  (http://www.medscape.org/viewarticle/548667)

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

BSCG Header imageFOR IMMEDIATE RELEASE

April 16, 2015

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

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

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

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

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

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

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

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

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

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

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

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

Dietary Supplement Certification – BSCG Certified Drug Free®

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

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

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

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

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

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

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

Sincerely,
Oliver Catlin
BSCG President

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

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

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

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

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

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

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

S7. NARCOTICS

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

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

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

  1. NARCOTICS

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

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

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

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

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

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

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

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