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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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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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.

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.


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

Anti-Doping Research – Dietary Supplement Survey Initiative

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

October 2010

Current Dietary Supplements May Contain Harmful Ingredients

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

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

Background

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

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

Specific Examples of the Problems

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

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

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

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

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

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

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

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

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

Purposeful contamination with pharmaceutical drugs – StarCaps

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

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

Raw material impurities and accidental contamination of products   – AdvoCare

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

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

Actions

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

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

Needed Resources

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

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

About Anti-Doping Research, Inc.

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

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

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

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

Sincerely,

Don H. Catlin M.D.                                                           Oliver Catlin

CEO and President                                                          Vice President and CFO


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

Dear Friends and Colleagues,

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

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

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

Thank you kindly for your consideration.

Don & Oliver

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