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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Amazon sellers trafficking steroids, some classified as Schedule III Controlled Substances

With the attention paid to anabolic steroids and the threat they pose to sport and public health, it is amazing to discover that such products are for sale today at Amazon.com.  We focus here on Amazon.com and on methasterone and madol, two drugs that appear in two products for sale there, but it is important to realize this marketplace is only the tip of the iceberg.  Although some suggest that we should continue to allow free access to these products, our contention is that products like these that can cause liver failure and other significant harm should not be a mouseclick away from unsuspecting consumers, especially our youth where the harm can be greatly magnified.

The first drug is methasterone, otherwise known as methyldrostanolone, which became known under the name Superdrol in late 2005. Don helped expose it as a new designer steroid in an article by Amy Shipley published by the Washington Post Nov. 2005. Methasterone has been connected to cases of liver failure in several publications.  The chat rooms on the topic provide the user accounts and hammer home the issue; check out this graphic example, if you want.  The FDA issued a warning and took action against marketers of the product in March 2006.  The World Anti-Doping Agency added the compound to the Prohibited List for 2006.

Despite inclusion on the FDA and WADA lists, the DEA does not yet have methasterone on its list of Controlled Substances as of Sept. 15. M-Drol caught the eye of the FDA in late 2009 when the product was included on a list of 65 steroid products that Bodybuilding.com was distributing.  The FDA took action against some of the products and against Bodybuilding.com resulting in voluntary recall of the products from the site.  Nonetheless, methasterone appears to be widely available in the marketplace today in many forms including Competitive Edge Labs M-Drol.

This dangerous non-FDA approved drug can still be purchased from many mainstream retailers including through 7 Amazon Sellers at Amazon.com, as of Jan. 17.  Included in the marketing heading for the product is, “M-Drol-Anabolic Muscle Building Formula, 90ct (Compare To Superdrol).”  We decided to go ahead and do the comparison.

Competitive Edge Labs M-Drol was purchased through Amazon.com on Nov. 15 in an order fulfilled by Amazon Seller Surplus-Supplements.  We analyzed it in our ISO 17025-accredited lab and compared it to a reference standard of methasterone, or Superdrol, and in fact M-Drol does still contain methasterone.  The sale of methasterone or a drug like it would likely qualify as sale of an unapproved new drug, according to the FDA’s recent letter to industry from Dec. 15: “These products are illegal because they are unapproved new drugs under 21 U.S.C. §§ 321(p) and 355(a) and/or adulterated dietary supplements under 21 U.S.C. § 342.”

There is more clarity in the case of the second product, Competitive Edge Labs P-Plex, which contains the anabolic steroid Madol.   Madol is classified as a schedule III controlled substance by the DEA under the name desoxymethyltestosterone (no other names listed).

Madol was the second of two designer steroids discovered during the BALCO doping scandal in 2003. During the federal BALCO investigation, vials of the seized drugs were analyzed and characterized by Don and his team, then at the UCLA Olympic Analytical Laboratory.  The drug that received the most notoriety was THG, short for tetrahydrogestrinone, a modified version of the already prohibited anabolic steroid gestrinone.  Madol was characterized later in 2004 and received much less publicity.  Madol was added to the Controlled Substance list Jan. 4. 2010 after a nearly two year process.

Madol has a proper scientific name of 17α-methyl-5α-androst-2-en-17β-ol.  The compound can be found under the following names; Madol, DMT, desoxymethyltestosterone, 17a-methyl-5a-androst-2-ene-17b-ol, 17a-methyl-etioallocholan-2-ene-17b-ol and other variations.

Despite its involvement in a high-profile case such as the BALCO investigation and inclusion on the controlled substance list, Madol appears in the dietary supplement marketplace in many forms.  It became popular under the name Phera-Plex and continues to be marketed in many products today.  Numerous options can be easily purchased on the Internet, including through Amazon.com.

Today at Amazon.com you will find Competitive Edge Labs P-Plex.  P-Plex was also included in the FDA action against Bodybuilding.com, yet it remains in stock and available through two Amazon Sellers as of Jan. 17. The marketing headline for P-Plex on Amazon.com reads, “P-Plex-Anabolic Muscle Building Formula 10mg, 90ct (Compare To Phera-Plex).”  We purchased the product on Jan. 6 through Amazon.com in an order fulfilled by Amazon Seller MMMPower and have identified Madol in the product.

The FDA considers this a serious matter and in a powerful letter to industry on December 15, 2010 wrote, “Responsible individuals and companies should be aware that the government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act (the Act) and endanger the public health. Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted under the Act, pursuant to 21 U.S.C. § 331. See United States v. Park, 421 U.S. 658 (1975). When the evidence warrants, felony charges may be appropriate.”

Knowingly or not, Amazon does appear to be providing a marketplace for selling steroids, some classified as controlled substances.  Amazon was willing to withdraw the pedophile’s guide in three weeks, as we pointed out in our blog post Nov. 12.  Hopefully, Amazon will hear the FDA on this matter and also voluntarily withdraw these steroid products from their website, sooner rather than later.  We stand ready to help Amazon or other retailers in maintaining a safe marketplace for dietary supplements in the future.  ##

FDA’s significant action is already reducing the number of steroids at some retailers

The Food and Drug Administration’s letter to industry sent Dec. 15 is one of the most important and commendable actions against the proliferation of anabolic steroids in the United States since the Anabolic Steroid Control Act of 2004, as it comes with the promise of significant enforcement action.  Unfortunately, the Anabolic Steroid Control Act did not stem the widespread availability of steroids it merely ushered in a new era of designer steroids.  By providing a list of those that were “illegal,” it pushed the prohormone manufacturers to find new compounds or name old ones using obscure nomenclature to confuse the authorities.  This recent forceful FDA action has the potential to change the landscape and it is already seeing evidence of its effect, but there is a great deal of work to do.

The letter began as follows: “This letter addresses the significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”

It goes on to commit to serious enforcement. “Manufacturers, ingredient suppliers and distributors should not expect that a warning letter will be issued if FDA discovers potentially harmful violative ingredients in products marketed as dietary supplements. FDA recognizes that active ingredients at meaningful levels do not appear by accident in a product marketed as a dietary supplement – somewhere in the supply chain, the active ingredient is incorporated into the ingredient or the finished product. Actions that pose a risk to public health should expect a swift and strong agency response.”

The threat of significant and immediate action without any warning is what is needed to finally control the flow of these dangerous products.  This action is just in time as the situation was truly getting out of control.  An example using one retailer of such products demonstrates the problem and the effect of the FDA action.

When we first mentioned nutritionarsenal.com on Sept. 15 in our blog post, Despite numerous efforts to the contrary, prohormones remain widely available today, we found 84 products listed as prohormones.  As we noted on Dec. 12 in our blog post, New designer steroids appearing at an alarming rate, 15 new products in two months!, the explosion of such products was astounding as the number of prohormones listed had ballooned to 99!  We visited nutritionarsenal.com again today and were quite pleased to see the evidence of the FDA activity.  Today the number of prohormones offered is at 75 and dropping three weeks after the FDA letter, a clear sign that it is being taken seriously.

As we say, however, much work remains.  One of the most blatant examples comes in Competitive Edge Labs M-Drol product.  Although it was included in the FDA’s action against Bodybuilding.com in late 2009, it has remained for sale at a number of retailers since that time.  At nutritionarsenal.com, a new label has been added on the sales page for M-drol: “This item has been discontinued. All sales are FINAL,” another sign that the FDA letter, and perhaps our posts, have been effective.

FDA warns that tainted products marketed as dietary supplements are potentially dangerous – Anti-Doping Research’s Dietary Supplement Survey – A strategy in response

The Good, the Bad, and the Dirty in the Dietary Supplement Industry – Anti-Doping Research’s (ADR) Dietary Supplement Survey

Despite being widely available today, dietary supplements can contain unsafe and illegal substances that pose significant health risks to consumers.  Novel designer steroids, stimulants like ephedrine, pharmaceutically active ingredients like sibutramine, and other untested or unsafe ingredients continue to slip into the dietary supplement marketplace.  The FDA has responded with a significant and laudable new effort to work with the industry to combat the issue as described in, “FDA: Tainted Products Marketed as Dietary Supplements Potentially Dangerous.”  We would like to assist the effort through ADR’s Dietary Supplement Survey, for which we are currently raising financial support.

In ‘Tainted Body Building Products,” the FDA issued a warning that, “FDA cannot test all products on the market that contain potentially 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.”  The numbers of tainted products are vast and the problems real.  According to the press release, “In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.”  Yet this is just a small fraction.  We would like to use our experience to help test and expose more, one of the primary goals of our Dietary Supplement Survey.

In the words of the FDA Commissioner, Margaret A. Hamburg, “These tainted products can cause serious adverse effects, including strokes, organ failure, and death.”  The dangers, as we know first-hand, are all too real, as we have dealt with numerous cases of acute liver injury in young adults who have used such products.  Colleagues such as Don Hooton have had lives forever changed by the suicide of a son using steroids to pursue athletic advancement.  Unfortunately, the issues are not isolated to body-building products as they span other categories like weight loss and sexual enhancement as well.  If such products are manufactured in the same facilities as legitimate supplements, the potential for contamination is also a concern.

In the FDA Letter to Industry, a fine point is made. “These products not only pose risks to consumers,” it states, “but undermine confidence in legitimately marketed dietary supplements in these and other categories.”  The majority of the dietary supplement industry produces products that do not contain illicit ingredients or contaminants and that should also be showcased.  In the letter, the “FDA is also seeking continued input and collaboration from the trade associations to educate the industry about this problem and to develop strategies to combat it.”

We believe that ADR’s Dietary Supplement Survey initiative could be such a strategy.  To sum up our goals:  We aim to explore which products are good, which products are bad, and which products exhibit contamination with low but potentially harmful levels of illicit ingredients.

More specifically, we will perform focused testing on problem categories to expose dangerous new products.  We will also conduct testing on a variety of randomly selected products to evaluate the prevalence of contamination and to demonstrate that the majority of products are indeed clean.  In the process, we will help audit the current retail environment to assist with enforcement and will characterize new supplement ingredients that have the potential to cause harm or lead to a positive drug test.  The results of our work will available via an interactive website portal complete with testing data, public service announcements and more.

As a public charity, Anti-Doping Research, a leader in performance-enhancing drug and toxicology research and testing, is working to raise $1.5 million to conduct the Dietary Supplement Survey.  We hope to gain broad support from a variety of sources to provide for a collective solution.  We have reached out to our friends in the dietary supplement community, the sporting community, anti-doping, collegiate and high school athletics, sporting sponsors, pharmaceutical companies and others in pursuit of support.  We would also welcome the involvement of the general public through volunteer activity or small contributions.  All donations are tax deductible.

If you have any questions, please contact us at 310-482-6925 or by e-mail at dcatlin@antidopingresearch.org or ocatlin@antidopingresearch.org.

Consumers, athletes and other elite professionals deserve a marketplace offering legitimate and safe dietary supplements.  With your help, we are confident that we can help make this happen.   Please join us and help support this important initiative with your contribution today.

Dietary supplement manufacturing and why designer steroids should matter to the general public

Perhaps you might think that you are far removed from the issues related to designer steroids.  Some see it as a problem for professional or Olympic sport to deal with but don’t see the issue influencing their daily lives.  Well, if you take dietary supplements on a regular basis, as more than half the population of the United States does, according to a recent Nielsen survey, designer steroids should matter to you.

Why, you might ask; I only take vitamins or herbs?  Well, the answer comes from the manufacturing process, which often occurs in co-packing facilities in the case of dietary supplements.  Co-packers simply mix and package the formulas provided by various supplement manufacturers and turn them into final products.  If your vitamin, protein powder, amino acid supplement or other product is processed in the same facility as one of the many designer steroids that continue to be produced you may have a problem.

A quick tour of a co-packer manufacturing facility illustrates the potential for contamination…

First, the raw materials are obtained and are warehoused for use.

The raw materials

The ingredients for a particular formula are then gathered and sent for measuring.

Gathering raw materials on pallet

The ingredients are weighed out according to the formula for the product.

Weighing the ingredients

The ingredients are combined in a huge blender to be mixed for hours.  If the blender is not completely cleaned and sanitized between mixes of different products, one can see how cross-contamination between products can occur.

The giant blender

If your protein powder is produced just after a designer steroid, one can see how cross-contamination might occur.    Many co-packers in the industry make an ethical choice not to participate in the manufacturing of dangerous products like designer steroids, but not all.  O.K., so there are regulations in place to protect against possible contamination of the finished products with potentially harmful unlabelled ingredients right?  Wrong.  (In fairness to the many competent and capable co-packers we should mention that we test products regularly from the facility shown above and have yet to find any contamination)

Certainly dietary supplement industry regulations have come a long way.  The phase-in of the Current Good Manufacturing Practice (CGMP) for dietary supplements over the last few years is likely to significantly improve quality of products as manufacturers are held to the new standards that CGMP dictate.  All manufacturers are now subject to CGMP, although the industry recognizes that the benefits will only be as good as the enforcement and auditing of the CGMP.

The new CGMP requirements, however, DO NOT include the need to test finished goods for contaminants such as designer steroids.  This is surprising given the prevalence of such compounds still today, even though they should be illegal to put in supplements.  CGMPs do require raw materials to be tested for purity prior to being formulated in the product and they also require testing for adulterants like arsenic or lead.

Some argue that purity checks will ensure that contaminants like designer steroids do not enter the marketplace.  However, if you explore the concept of purity testing and you realize that purity checks are often done at the microgram level, the problem is exposed.  Microgram testing is done at parts per million, testing for contaminants like designer steroids is usually done at the parts per billion level (nonograms).  Say you do a purity check on an ingredient and it comes back 99% pure after testing at the microgram level.  Well, how do you know the other 1% does not contain a hidden steroid, stimulant or otherwise unlabelled pharmaceutical ingredient? 

Is it O.K. if your protein powder, amino acid, or vitamin contains microgram quantities of a steroid or stimulant?  How does that magnify itself in your body with daily use of a protein powder where a serving size might be 100 grams, three times daily?  We don’t think that such contamination is acceptable as it could reach levels significant enough to lead to harm for a consumer.  Certainly, such levels of contaminants could cause positive drug tests for elite professionals like athletes or police officers; in fact, even contamination in the low parts per billion can lead to positive drug tests.

We would like to evaluate how prevalent contamination is in today’s supplement marketplace.  Nobody knows the scope of the issue since there are no requirements to test.  We want to survey the industry to characterize the issue through random sampling of a variety of products.  We also want to work to expose the bad products in the industry, like the new designer steroid options that continue to pop up daily.

If you are interested in such issues and would like to support our efforts to conduct a survey of products from the industry, please reach out to us at info@antidopingresearch.org or explore our Dietary Supplement Survey concept, which we are currently raising funding to conduct.  All contributions to our 501c3 public charity Anti-Doping Research are tax deductible.  We would welcome your support of this public-health initiative as we believe it will lead to improved consumer protection, better regulations, and much-needed improved quality control of dietary supplements.

New designer steroids appearing at an alarming rate, 15 new products in two months!

First, thank you to our friends, colleagues and all of you who have been reading our new blog.  We have enjoyed writing it and sharing some of our thoughts on important topics in a new and exciting forum.  We were not sure what to expect when starting this concept but have been pleasantly surprised by the readership.  We hope to keep you interested and inspired with our thoughts, and perhaps make a small impact on the relevant issues in the process.

We have noticed that many of you appear passionate about dietary supplements as we are.  We have worked for many years on issues related to such products and continue to do so today.  While the majority of manufacturers produce reputable supplements, there is a subset that continues to work around the current regulations and produce potentially dangerous products.

We have dealt first-hand with the dangers, which include numerous cases of serious liver failure caused by the uneducated or unintended use of powerful steroids.  Most of these occur in our youth, college or high school students looking for the body beautiful quick fix who stumble upon the wrong supplement on the Internet and cause serious harm to themselves.  Many of these come from methlyated steroids, which sadly remain widely available on the Internet today, despite the fact they are well known.

We focused on the issue in a previous post, Despite numerous efforts to the contrary, prohormones remain widely available today.  At that time one of the sites we visited, http://www.nutritionarsenal.com/Search.aspx, was selling 84 products listed as prohormones.  We visited the site again recently and found 99 products now listed as prohormones.  Amazingly, 15 new products that are likely illegal steroids or aromatase inhibitors in disguise have appeared on one website in two months time.  Sure, this is the holiday season of retail but this explosion seems ridiculous.  In a quick review, at least 75% of the 99 products appear to contain active ingredients that are likely powerful steroids.  That’s right: 75% contain steroids.

Some of these appear to be new compounds altogether, which we are exploring, but others are simply old steroids with new and confusing nomenclature.  A simple example with the compound methasterone, also known under the name Superdrol and Methylmasterdrol, explains the situation well.

Methasterone became popular several years ago.  The FDA deemed the compound to be a synthetic steroid and warned one of the companies that produced it.  The following is an excerpt from the March 8, 2006 FDA warning letter:

“This letter relates to your product Anabolic Xtreme Superdrol, containing the synthetic steroid methasteron. The product label and your Internet website, http://www.anabolicx.com, state that this product is “anabolic” and list methasteron as an ingredient. Further, your website includes statements about this product such as the following:

• “Many people have packed on pounds of lean mass and increased their strength while using this potent supplement . . . .”
• “The average user will gain between 6-10 pounds in as little as three weeks.”

Although Anabolic Xtreme Superdrol is not currently available on your website, where it is marked “Discontinued,” it is still being distributed in interstate commerce with a label that lists your firm name and website. The product label and your website represent this product as a dietary supplement. However, the product cannot be a dietary supplement because the active ingredient used in the product, methasteron, is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, nor is it a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient described above. Rather, it is a synthetic steroid. Consequently, methasteron is not a “dietary ingredient” as defined in Section 201(ff)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 USC 321(ff)(1)], and your product is not a dietary supplement because it does not contain a dietary ingredient.”

The active compound present was 2a, 17a-Dimethylandrostane-3-one-17b-ol.  The compound on the label was written as 2a, 17a di methyl etiocholan-3-one-17b-ol.  The difference in terminology on the label can help to disguise the ingredient.  Interestingly, the compound does not seem to be on the DEA’s Controlled Substance list. 

One might think that this was the last we had seen of the compound methasterone in dietary supplements; afterall, the FDA considers it a synthetic steroid.  But, alas, this is not the case.  A quick look through the available products on nutritionarsenal.com finds many products that contain this compound on the label such as Competitive Edge Labs M-Drol, Extreme Performance Group Dianavar, Methastadrol and more.  It is rather shocking that although the FDA acted against one company in 2006 for selling the synthetic steroid methasterone, multiple other companies still appear to sell the same synthetic steroid today more than four years later.  Unfortunately, this is only the tip of the iceberg.

Sadly, although many perhaps thought the era of designer steroids was behind us, the opposite seems true as the creation of new options only seems to be gaining ground.  While some, such as methasterone products, are well known, others will require resources to explore, characterize and regulate.  We look forward to participating in that process.

Pedophile’s guide and steroids at Amazon.com: The guide has been removed, what about the steroids?

Competitive Edge Labs - M-Drol

It has been hard to avoid the recent coverage regarding the sales of “The Pedophile’s Guide to Love and Pleasure” on Amazon.com.  The story has grown to some significance in the last week getting much airtime on CNN and other outlets and resulting in a litany of media articles and commentary on the topic.

According to a Los Angeles Times article, “Amazon dumps pedophile book,” on Nov. 12, “the book was published for the Kindle, Amazon’s popular e-reader device, Oct. 28.”  So, in approximately two weeks the book has garnered enough attention and resulted in enough pressure on Amazon that it has been pulled.

Now arguments abound as to whether the book should have been allowed on the site in the first place.  Amazon issued a statement Wednesday that said it “believes it is censorship not to sell certain books simply because we or others believe their message is objectionable.”  Others cite free speech right as reasons the book should remain available.  We believe, as many do, that the heinous instructions for proper pedophilia are offensive and obviously that argument won out.  Nonetheless, the book is not illegal, it is merely fiercely objectionable and that is what got it pulled.

Meanwhile, despite their being illegal, steroids remain available on Amazon.com today.  We pointed this out in a previous post, “Despite numerous efforts to the contrary, prohormones remain widely available today” (Sept. 15).

In the post, we recounted the Nov. 3, 2009 press release Bodybuilding.com voluntary recall of 65 Dietary Supplements that may contain steroids.  According to the notice, ‘the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.”

At the time we wrote our previous post, several of these products remained available on Amazon.com, more than a year after the recall.  Still today, Nov. 12, some of the recalled steroid products remain available on Amazon.com, including Competitive Edge Labs – M-Drol.  We searched for another of the brands that was included in the recall, Advanced Muscle Science, and did not find either of their two recalled products listed on Amazon.com.  What we did find was more than 30 new options available from Advance Muscle Science, several of which appear likely to contain steroids as well.  A glance through the “Customers Who Bought This Item Also Bought” section seems to lead to more options.

We understand how a book that is as offensive as the “Pedophile’s Guide” can be removed within two weeks, not because it is illegal, but rather because it is offensive.  We can not understand, however, why products that are likely to contain steroids, such as those included in the voluntary recall, remain available after more than a year if they are illegal to sell.

The recall should have been a road map to removal of these products from the marketplace, yet some remain on Amazon.com.  Many more remain available elsewhere, from other major retailers.  If we value the protection of our youth and the integrity of sport, we can and should work to get steroids removed from Amazon.com and other retailers as well.  Supporting our Dietary Supplement Survey, a scientific examination of dietary supplements and their ingredients with the results made public, is one way you can help.  For more information, visit the Ant-Doping Research website at http://www.antidopingresearch.org.