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.