The Concussion Blog

This blog is devoted to concussions, but there are issues out there that most want to know about.  One being the steroid/HGH issue in sports, heck it was all the talk today prior to the CBA being ratified.  Matt Chaney might be one of the best sources on the subject you have never heard of.  Matt has his own blog but has been busy working at a location where he is unable to blog as often as he likes.  Today he sent over a post that will be on his blog soon but for now we will post it here.  Matt plans on revising some of this with further sourcing and information, but if you are interested in the NFL drug testing issue he is a great source of information.

NFLPA Must Resist Unvalidated Blood Testing for HGH

I. Introduction

I am Matt Chaney, a Missouri-based writer with over 20,000 hours of study and writing in the issue of anabolic substances in American football. My expertise is rooted in my experience of reluctantly using synthetic testosterone as an NCAA football player in 1982, and I authored the 2009 book Spiral of Denial: Muscle Doping in American Football.

My persuasion here is to detail primary reasons why the National Football League Players Association must resist blood testing that remains unavailable for independent scientific review. Never have I advocated the use of muscle drugs in any sport, but I am strictly opposed to faulty detection methods—such as the invalid, unreliable urinalysis that American football has employed since 1986.

Testing for anabolic steroids—established by the International Olympic Committee in 1976 and adopted by National Football League commissioner Pete Rozelle in 1987—is an abject, time-proven failure according to an array of mounting evidence, including scant positive results, documented loopholes, and criticism by experts that include endocrinologist Dr. Don Catlin of Los Angeles, the testing pioneer, researcher and a former associate of the IOC and NFL.

In America, steroid testing violates the individual’s right against unreasonable search while failing to meet the 1994 California court mandate that urinalysis must both protect an athlete’s health and ensure fair competition. So-called anti-doping is a false hope that merely serves to cover and perpetuate an entrenched problem for all of American sport—and athletes suffer consequences.

Meanwhile, ineffective blood testing for recombinant human growth hormone [rHGH], currently proposed by NFL commissioner Roger Goodell and management, developed and marketed solely by the World Anti-Doping Agency, would only exacerbate anti-doping’s miscarriage of health, law, truth, integrity and individual rights in this country.

This brief reviews the controversy of blood testing for athletes, especially in America, through sub-topics such as scientific disputes, false results, costs and logistics, and questions of privacy.

 

II. Allegations of Suspect or Bad Science for WADA’s HGH-isoform Test

WADA does not disclose data on its research and development of the isoform test, defying standard scientific protocol and drawing fire from critics worldwide.

In 2007, union executive director Gene Upshaw stated: “I have no confidence in WADA or their [HGH-isoform test] kits. I have my doubts about WADA and their history. I am not willing to accept them as an authority on this. The league may have some interest, but it will not be done without approval of the players.”

At the time, NFL management essentially agreed with Upshaw on the controversial immunoassay of serum, a WADA creation that attempts to detect synthetic growth hormone by measuring molecular weight of about six isomers—particularly for abundance of the dominant HGH form known as 22K, cloned by biotech companies for their synthetic substance.

The isoform test can only detect rHGH for about a day after use, WADA officials concede, while independent experts like Catlin charge the window may only last a few hours.

And the isomer test is only effective through unannounced or no-notice collections that typically should occur in middle of the night, observers note.

“The current test has had limited use, produced no positive results, and thus has not withstood a challenge,” NFL spokesman Greg Aiello said in 2007. “Reliability encompasses a number of factors, including availability, whether it has withstood attacks, appeal, effectiveness, etc.”

“There is no reliable test for HGH right now,” concurred Roger Goodell, league commissioner. “We are investing money to develop that test. I don’t know if that will be a blood test or urine test. … I do understand… what Gene is raising as far as complications of blood tests. But until that [valid] technology is developed, I think it’s premature for us to make any decisions.”

Last year, however, Goodell and league colleagues inexplicably came to demand blood testing of players for rHGH, claiming “advances” in WADA blood testing like a first positive result for an athlete, long overdue, or a “new” test that amounted to merely a commercial kit for the same old isomer scan.

On the contrary, there has been no major improvement in the isoform test since WADA introduced it at the 2004 Olympic Games, according to endocrinologist Dr. Peter Sonksen of London, a pioneer of rHGH detection whose biomarker test is funded by the anti-doping agencies.

“Nothing significant [for the isoform] other than transfer from university to commerce,” Sonksen wrote in a 2010 email, referring to WADA’s entrepreneurship for its kits.

WADA officials have claimed reliable HGH testing from the start, but they also regularly backtrack over problems, only to end up trumpeting rather insubstantial improvements like gaining scattered informants.

The isoform test didn’t produce a positive result until 2010, with WADA relying on a tip to nab British rugby player Terry Newton, after thousands of assays since the Athens Games produced countless false-negatives. Newton admitted rHGH use and accepted a two-year suspension under WADA guidelines for his sport.

Informed observers weren’t impressed. “Well, if you know the guy’s going to shoot up this morning, and you arrive at noon, OK. Glad it works that way,” Catlin said.

Former BALCO chief and doping expert Victor Conte said: “This rugby player did not challenge the scientific validity of this positive HGH blood test in any way. If an MLB or NFL player ever had a positive HGH test, there would be a team of defense lawyers to challenge every step of the scientific as well as legal processes.”

Catlin, having expected an appeal by Newton, had anticipated revelations on the isoform test. “The WADA test measures the amount of growth hormone activity in human serum and they use a ratio to determine who is a user,” Catlin explained, of what he knew. “The ratio is the amount of 22K hGH activity in the sample to the total hGH in the sample. The recombinant hGH is the 22K and that increases when you inject hGH. The total is the sum of all hGH types in blood. There are about six isoforms.”

“WADA uses a ratio to determine who is a user. They do not disclose what the number is or how it was determined.”

For years, Catlin has publicly requested of WADA to release data on HGH-isomer testing, for sensitivity and specificity, which he trusts do exist. “Of course, I believe they have data,” Catlin said. “I mean, it would be silly not to. But they don’t display it. … They recognize, rightfully, that as soon as they do show the numbers, there could be difficulty.”

Catlin had proposed an open summit of experts to discuss blood testing and other anti-doping issues, but officials of WADA and its American arm USADA did not accept the invitation. “See, in order to do that, they have to show their data,” he said. “They don’t want to do that. The only way you’re going to get that is in a courtroom, if then.”

Legal showdowns on WADA blood testing is inevitable if ever adopted by American sport such as the NFL, given the perspective of critics like biomedical statistician Donald A. Berry, of the M.D. Anderson Cancer Center, University of Texas.

Anti-doping methods and instruments, in general, “I regard not to be science,” Berry said in 2008, after reviewing the practices for a commentary in Nature journal. “If conventional doping testing were to be submitted to a regulatory agency such as the U.S. Food and Drug Administration to qualify as a diagnostic for a disease, it would be rejected,” Berry said.

The Nature editorial board criticized the anti-doping agencies, charging that “by not publishing and opening to broader scientific scrutiny the methods by which testing labs engage in study… the anti-doping authorities have fostered a culture of suspicion, secrecy and fear.”

 

III. HGH-isoform Scan Has Not Faced a Courtroom Challenge

During the past 18 months, four athletes have tested positive for rHGH use under the WADA isomer assay: Newton; Matt Socholotiuk, a college football player in Canada; Patrik Sinkewitz, professional cyclist; and Andrus Veerpalu, Olympic skier.

The four are the only positives in seven years of HGH testing of athletes, and only Sinkewitz has publicly stated he would challenge his finding. “No substance was found in my body,” Sinkwitz said in April. “Instead this deals with one single blood value. This value has never before been detected in me, established in me or analyzed. There is therefore nothing to compare this value to.”

Many observers see legal challenges ahead for HGH testing. Experts cite lingering questions of normal “baseline” and other values for natural growth hormone, which pulsates from the pituitary gland into bloodstream. Numbers among individuals can differentiate because of age, gender, body mass index, and even physical activity. Food and beverage intake, along with medicines like corticosteroids, may affect test results for rHGH.

Berry suggests there could be false-positive results from the isomer assay, among anti-doping scans, and Catlin echoed the point while discussing the WADA test in 2007. “In today’s world you’re going to have to show beyond a shadow of a doubt that a test has no false positives,” Catlin said. “I don’t think anybody’s willing to say it’s right around the corner [for HGH blood testing].”

For athletes, another prime consideration of blood testing should be privacy for information beyond signs of possible drug use. More medical data can be harvested on individuals, for falling into other hands, including genetic indicators of existing or potential maladies. The late Gene Upshaw alluded to the concern in 2006.

“When you start talking about coming in to take a person’s blood, that’s different than taking someone’s urine,” Upshaw said. “I know personally I would have a problem with someone coming in and trying to take the players’ blood. I’m not ready to make that leap.”

And neither should the union and players approve blood testing today.

Terry Newton committed suicide within months of becoming sport’s first positive result for HGH testing and accepting his rugby suspension, and biostatistician Donald A. Berry was disturbed by the circumstances.

“Terry Newton’s plight should be a wake-up call to all,” Berry wrote in email. “As a society we cannot take this issue lightly. What many regard to be a small penalty can be a death sentence.”

“Are we trying to save sport? High-level sport? At what cost? Is it worth it? Quite obviously we’re ruining people’s lives. Perhaps we should be exacting such extreme penalties to save sport so we can be entertained by athletes on what we like to think is a level playing field. But a few people should not be making this decision for the rest of us. And the entire process of labeling people with the stain of cheater should be defensible and not cloistered.”

“Are we trying to save the bodies of young people?” Berry continued. “If so, is the tack we’ve taken even remotely reasonable? And is the trade-off of bodies saved and lives ruined appropriate, even if our tack is eventually successful?”

“I don’t pretend to have the answers to these questions, but they must be debated much more broadly than presently, with the pros and cons of the various approaches clearly delineated and widely publicized.”

“And, oh yes, we must get the science right and we must appropriately and adequately fund research in this area so we have a chance of getting it right.”

 

IV. Blood Testing Is Expensive, Logistically Difficult, Impractical

While the NFL covers the country with 32 franchises, only two WADA-accredited labs exist in the United States and only one handles HGH testing, Catlin said in 2010. “That’s my old lab at UCLA.”

“The lab is controlled by WADA,” Catlin continued. “You can’t get in unless they approve, and they have not gone to any sort of system where you allow some labs to do certain kinds of testing. Everybody has to do everything.”

Catlin said the American anti-doping infrastructure must undergo extensive renovation to properly handle blood testing on a wide scale, and he doesn’t see that happening.

WADA officials concede logistics contributed to early problems in HGH testing, and tests reportedly cost about $600 each.

And while WADA and NFL management claim HGH testing is feasible for professional football, no one is bold enough to claim the detection can accomplish what anti-doping supposedly stands for: “Saving kids,” per the call of sport officials, politicians, testers and media.

While blood testing is likely invalid and unreliable for the NFL, it is undoubtedly impossible for the vast majority of American football entities, thousands of programs in youth leagues, schools and colleges.

 

V. Select References

Alexander, B. (2008, August 6). Shaky science casts doubt on doping results. msnbc.com.

Anti-Doping Problems. (2006, February 17). Problems at World Anti-Doping Agency will ‘drive innocent athletes out of sport.’ University of Bath.

Baseball Responds. (2008, January 16). Major League Baseball responds to WADA. MLB.com.

Berry, D.A. (2010, October 3). Email correspondence to author.

Borges, R. (2007, February 3). Goodell takes safe approach. Boston Globe.

Chandler, C. (2007, March 31). HGH use, testing debate rage on. Charlotte Observer.

Catlin, D. (2007, February 15). Telephone interview with author.

Catlin, D. (2010, March 19). Telephone interview with author.

Gordon, S. (2006, August 5). Labs gain on dopers. Toronto Star.

Growth Hormone. (Accessed 2010, March 10). Growth Hormone. WebMD.

Maske, M. (2006, June 10). NFL questions effectiveness of blood testing for hormone. Washington Post.

Maske, M. (2010, February 24). NFL proposes drug testing players for human growth hormone. Washington Post.

Mehaffey, J. (2010, February 24). USADA chief calls for increased blood testing. Reuters.

Meyer, J. (2008, August 7). WADA to test for growth hormone. Denver Post.

Nelson, A., & Ho, K.K. (2009, August). Demographic factors influencing the GH system. Growth Hormone IGF Research, 19(4).

Quinn, T.J. (2007, September 14). Catlin expects news HGH test by next Olympics. New York Daily News.

Red, C. (2010, February 26). Don Catlin, pioneer of Olympic drug testing, says pro sports leagues not close to testing blood. New York Daily News.

Red, C. (2010, March 8). Commissioner Bud Selig wants more proof that HGH blood test is reliable. New York Daily News.

Red, C., Thompson, T., & O’Keeffe, M. (2010, February 24). Major League Baseball commissioner Bud Selig not likely to implement HGH blood testing anytime soon. New York Daily News.

Scholten, M., & Schoof, R. (2009, December 7). Pechstein’s doping conviction based on ‘deceit.’ NRC Handelsblad.

Slater, M. (2007, November 15). New warning over Olympic doping. BBC Sport.

Slater, M. (2008, April 10). IOC promises tougher drugs policy. BBC Sport.

Sonksen, P. (2010, February 27). Email correspondence with author.

Sonksen, P. (2010, March 17). Skype interview with author.

Statistical Muster. (2008, August 6). Anti-doping tests don’t pass statistical muster: Scientist. Agence France Presse.

Sygall, D. (2010, March 14). Everyone’s at it: Mr. World. Sydney Morning Herald.

Use Science. (2008, August 18). Use the best science. Ottawa Citizen.

Wilson, J. (2007, March 25). Bloody disgrace. Herald Sun.

WADA Detection. (2007, June 4). WADA welcomes drug detection method. www.superxtra.coza .

WADA’s Credibility. (2007, January 21). Upshaw tells newspaper he doubts WADA’s credibility. ESPN.com.

Yesalis, C.E. (2006, September 12). Telephone interview with author.

Yesalis, C.E. (2010, February). Telephone interview with author.