Lives in the Balance: Why Doping Control Matters

As the Tour de France rolls onto stage 7, few in the general public know of the story of 21-year-old Linas Rumsas, but they need to consider it. Especially on this day, July 13, 2018, the 51st anniversary of cyclist Tommy Simpson’s death.

People ask us all the time why doping control matters. Some argue that it doesn’t and that we should just let folks use what they want. A doping free-for-all. Cynics might say that plenty of dopers have already escaped through the net in sports, at least for a time: Lance Armstrong, Tim Montgomery, Marion Jones, to name a few.

Linas Rumsas

Linas Rumsas was an up-and-coming cyclist whose life was cut short after he abused performance-enhancing drugs. Photo: Team Altopack-Eppela

The story of young Linas, a promising cyclist whose life was cut short after abusing performance-enhancing drugs, reminds us that doping can kill. We would be wise to remember that it has happened before. Linas’ story is one of the saddest we have come across and it powerfully demonstrates why many of us who have chosen to pursue anti-doping continue to do so. This one story illuminates in no uncertain terms the realities of what we all face with the scourge of doping, and yet outside of Italy and frequent readers of Cycling News, few sports fans have probably heard of it.

There have been others who have perished from doping. According to ProCon, which provides a comprehensive historical timeline of doping in sports, the first modern athlete chronicled to have died from doping was the Danish cyclist Knut Jensen at the Summer Olympics in Rome in 1960. Heat was the initial culprit but his autopsy found traces of Ronicol. ProCon describes Ronicol as an amphetamine, but Ronicol would be described more accurately as a vasodilator and can be used as an anti-ischemia drug. Though it is not on the 2018 WADA Prohibited List, it is similar to meldonium in many ways.

Stop to consider that the first drug to have been implicated in the death of an athlete in the Olympics in 1960 is not banned today! Ronicol, otherwise known as nicotinyl alcohol, is not prohibited as confirmed by the Global DRO. Its cousin meldonium wasn’t prohibited by WADA until 2016, when it caused hundreds of athletes to test positive. Some might like to think that doping is behind the peloton, but we fear it may still be in the middle. Just in a form we don’t currently define as doping, like Ronicol.

Fifty one years ago today on July 13, 1967, Tommy Simpson infamously died on the slopes of Mount Ventoux during Stage 13 of the Tour at the age of 29. His death was one of the central moments in anti-doping history. Shortly thereafter that same year the International Olympic Committee (IOC) created the IOC Medical Commission and the first drug testing began at the Olympics in 1968, with narcotics and stimulants making up the initial prohibited list. Steroids were not added until 1975.

There have been other examples of athlete deaths that have been seminal. MLB pitcher Steve Bechler, of the Baltimore Orioles, died during drills in 2003. Ephedrine was indicated as a contributing cause in his premature death, which played a role in the regulation of ephedrine as a dietary supplement ingredient in the United States.

Steroids have played a role in the demise of many young athletes, including Taylor Hooton, Efrain Marrero, and just two days ago, a young 18-year-old Irishman in Limerick. Numerous stories exist of athletes who went too far with blood doping, or performed transfusions the wrong way, leading to dire consequences. Many stories are out there but few are known to the broader sporting public.

Linas Rumsas’ story reminds us that the scourge of doping is still present and that it is just as deadly today as it was in 1967 when amphetamines derailed the promising life and career of Mr. Simpson.

Linas Rumsas is the son of Raimondas Rumsas, who himself was a professional cyclist and took third place in the 2002 Tour de France. After Raimondas’ wife Edita was caught with a van full of drugs on the way home from that Tour, they both received four-month suspended sentences in 2006. Raimondas later tested positive for EPO during the 2003 Giro d’Italia. Sadly, this experience did not seem to deter them from apparently assisting their two children with doping.

Linas rode for the Altopack-Eppela squad in Italy and had already been a national road race champion. But in May 2017, he died at age 21 of a heart attack. It was nearly 50 years to the day after Mr. Simpson had died.

Upon Linas’ death, police searched his family’s home and seized a number of banned substances and medications. In September 2017, his older brother Raimondas Jr. tested positive for the prohibited substance GHRP-6, a peptide that produces natural growth hormone. It seems a cocktail of banned substances and other medications were being used at the family home.

The result of all this has been one family torn apart, again, from doping. Perhaps doping didn’t matter to the Rumsas family either until their son died. But Linas didn’t just die, if the allegations in this case hold true. He died as a result of family support and encouragement to dope.

It gets worse. In the course of the investigation, six people have been arrested in an apparent team-sponsored doping program including the team owner, directeur sportif, pharmacist, and trainer, who stand accused of providing drugs to riders. Seventeen other people are being investigated. Sadly, however, it is too late for Linas.

Unfortunately, the recent decision to allow Chris Froome to ride again with no sanctions after testing positive for elevated levels of salbutamol has called into question the validity and utility of the anti-doping system, again, at least in some people’s eyes. WADA has tried to explain the reasoning now, including clarifying the levels (1,428 ng/ml of urine, when adjusted for specific gravity, which is above the decision limit of 1,200 ng/ml). The reasons may not satisfy everyone, or anyone, but Froome’s case is certainly not a reason to give up on anti-doping.

Linas’ story personifies why giving up on anti-doping is simply not an option and should remind us all that doping is a significant matter. In fact, it is all the more reason to recognize that the failures of the anti-doping system are largely due to a lack of resources and money. For that to change, more people will need to truly understand what is at stake when athletes dope and to demonstrate the will to do more to combat the problem.

– Oliver Catlin

2018 PyeongChang Winter Olympic Games Review

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Don Catlin, M.D., at Vancouver 2010 Opening Ceremony – Photo by Oliver Catlin

We watched with the rest of the world as the 2018 PyeongChang Winter Olympic Games unfolded. In the face of tense politics, doping scandals, and other controversy, the Olympic ideals still shined through, sometimes in unexpected ways. Having been fortunate to attend six amazing Winter Olympic Games (Don got to go to seven, I think), we figured why not provide some perspective on these. Here is our 2018 PyeongChang Winter Olympic Games Review.

Most Amazing Victory – Ester Ledecka. Who knew someone could win a gold medal in snowboarding and skiing! Some people don’t think that the two sports are compatible, some don’t even want both sports on the same mountain. This woman just went out and ripped it up, twice, however many planks were strapped to her feet. Well done, Ester.

Clean Athlete Awards – Jessica Diggins and Kikkan Randall. In an Olympics marred by the Russian doping scandal, we always appreciate it when you can literally see that athletes are clean. Not that we advocate that a visual determination replace anti-doping testing, but some people you can just tell are not doping. We thoroughly enjoyed watching these ladies win clean, and with amazing smiles! We also appreciate the other courageous cross-country skiers who signed the letter in 2016 demanding a stronger stance on doping, including notably the four Russian women who signed. Thanks to all of you for working to defend your sport from the scourge of doping.

Classiest Athlete – Yevgenia Medvedeva. OK, we admit we watched the ladies figure skating final and it was pretty amazing. The talent and class displayed by all the young ladies is unbelievable. However, one shined above the rest. Despite missing the gold medal by a heartbreaking 1.31 points that even experts could not decipher, this woman took disappointment with amazing class for an 18-year old. She genuinely embraced her younger upstart Alina Zagitova and accepted her silver medal with a smile. She could be overheard saying she “did everything she could.” That statement represents what Olympic athletes are all about. We don’t know much about this Russian athlete otherwise, but in PyeongChang this little Anna Karenina showed enormous class.

Most Notable Olympic Farewell – Lindsey Vonn. Although you leave the 2018 PyeongChang Olympic Games with a bronze medal, which most people could only hope for, you will always be the golden girl of American skiing. You took yourself to the pinnacle of your sport and beyond, and you brought your country with you. Along the way you’ve inspired generations of Olympians for years to come. We wouldn’t be surprised to see a woman like you one more time in Beijing four years from now, but if not thank you for all the amazing Olympic moments.

Strangest Doping Incident – Doping in Curling, really? We thought people drank beer during curling, but doping? Of course it would be an Olympic Athlete from Russia with meldonium as the offending substance, such perfect irony.

Ugliest Controversy – The ugliest controversy in these Olympics goes to the argument between Dick Pound and others in the IOC over whether or not to allow the Russian delegation to be permitted to fly the state colors during the closing ceremonies. It took long enough to finally get some kind of ban enacted and the corresponding statement made that state-sponsored doping is unacceptable, and it was going to be overturned during the Games? Way to go Dick Pound for sticking up for clean sport, as always! Or should we thank the second Olympic Athlete from Russia for doping and closing the door on that argument.

Most Inspiring Olympic Athlete – One athlete that epitomized the ideals of the Olympic movement and displayed them proudly in every fiber of his being by bringing athletes from all nations together sadly was not present in PyeongChang, but he was there is spirit. And his spirit we know will continue to inspire generations of Olympians for years to come. The Olympic Family lost Steven Holcomb, a beloved member of the bobsled community, in May 2017. But in the true spirit of the Olympic movement he went down the track many times in PyeongChang in the form of tribute bracelets on the wrists of many of his sliding colleagues, his parents cheering with tears in their eyes in the stands. Despite not being present, this man, and his spirit, made for the most inspiring Olympic athlete of this Games. We wish we could have known him and been inspired by his spirit.

Most Amazing Olympic Moment – It was hard to miss the unity demonstrated at the Opening Ceremonies with South Korea and North Korea marching together as one. This was a powerful symbol of the peaceful celebration of sport that the Olympics represent. We appreciate that this unity was achieved during the Games, and I think we all hope the peace was more than just for show and lasts.

The Olympics are truly an amazing gathering of athletes from all different countries, politics, races, sizes, sexes, orientations, faiths, and more. For all these moments and more, the Olympic Games remain one of the most amazing spectacles of human interaction and accomplishment in this world. They deserve to be truly appreciated, celebrated, and protected. We can’t wait for the years to pass to see what amazing feats and memorable moments Tokyo, Beijing, Paris, and Los Angeles will produce.

WADA EPO Testing Methodology Remains Sound and Strong Despite Colvert Case Discussion

My father, Dr. Don Catlin, has always been one of the most frank and open experts in the anti-doping industry. That is in part what attracts media to him still today. Yet, this style poses challenges as intents and comments can sometimes be misused. His comments have been used recently to suggest that there are flaws with the EPO drug-testing process in place today. To clarify, the WADA EPO testing methodology remains sound and strong despite the Colvert case discussion.

The case of Steven Colvert has been discussed as a potential example of a case that demonstrates the flaws in the WADA EPO testing methodology, but really it is an example of the complexity of the EPO test and why thorough analysis is needed to establish solid results—which the results in this case appear to be. Confusion can arise when visual analysis is considered alone, or when results are not considered in their entirety or without the benefit of scientific tools. To understand the realities of the Colvert case, one must first gain an understanding of the science involved.

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Erythropoietin (EPO)

EPO testing today includes the use of three primary methods; IEF, SDS-PAGE and SAR-PAGE. All three methods have been carefully validated and peer reviewed across multiple laboratories and they have been in use for many years. There is an array of research showing the breadth and capability of the methods. We have published papers based on the seminal methods Dr. Francoise Lasne and other colleagues in the doping control industry have created in this complex realm of science. We certainly would not have based our own research on these techniques if we did not believe the methods to be valid and strong.

The EPO testing methodology is outlined in the WADA Technical Document – TD2014EPO. We recommend that those who wish to completely understand the methodology review the document. The harmonized methodology outlined is designed to create consistency in results between laboratories. There is an image on page 11 that is useful in evaluating Colvert’s results.

This complexity of EPO sport drug testing stems from the reality that EPO is a naturally present substance in the human body. This requires methods to be able to distinguish natural EPO from synthetic, or exogenous, forms. The three EPO testing methods evaluate band patterns with variable shading that migrate from a natural EPO pattern when a drug is used.

It is pretty easy to see a positive when therapeutic quantities of a drug are used as there are large migrations in the band patterns. The results are much more difficult to visually determine when an athlete has microdosed, or when an athlete has stopped using in an attempt to clear the drug from the system, as these situations present band migration patterns that can be very subtle and difficult to distinguish visually from negatives.

It is important to realize that EPO testing does not rely on subjective visual analysis of band migration patterns. There is underlying science applied in the data review process to take visual subjectivity out of the equation. Densitometry, defined as the quantitative measurement of optical density in light-sensitive materials, is performed to scientifically evaluate the shading of bands. GASepo—a software solution for quantitative analysis of digital images in EPO doping control, has been developed to present a “method of robust calculation of the cut-off line, band segmentation and classification algorithms.” So, there is sound quantitative science applied beyond visual review of results.

The recent documentary Troubling Science – Steven Colvert Doping Conviction, as well as the October 26, 2016 article that preceded it, did not adequately consider the underlying science in our view. The response from our esteemed colleague Dr. Christiane Ayotte, Laboratory Director at the WADA-accredited laboratory in Montreal, outlined the scientific conclusions made and included references to the densitometry and software applications used to produce the results such as this image.

The Norwegian authors of the 2016 article suggest that Colvert’s SAR-PAGE results are not indicative of EPO drug use based on his lane being “not much different from other lanes.” They discuss the diffuse staining above the blue line, which was used to determine a positive result for Colvert, as a standard staining anomaly that PAGE testing is subject to with different sample conditions. That conclusion discounts the fact that sample conditions are standardized prior to analysis and it also fails to consider that the staining that appeared in Colvert’s lane did not appear for other negatives in the sample group run at the same time under the same conditions.

Having performed the EPO testing methods in our own labs, we are certainly familiar with staining challenges. Indeed, the 2-3 day tests that are performed are highly sensitive and require extremely skilled analysts in order to create bands that are consistently free from what WADA describes as, “spots, smears, areas of excessive background or absent signal in a lane that significantly interfere with the application of the identification criteria.” In such circumstances, the WADA technical document calls for “invalidating the lane.” The SAR-PAGE results that include Colvert’s sample appear to be an excellent model of results that are free of any staining anomalies.

When the documentary was filmed, Don was asked to visually evaluate Colvert’s SAR-PAGE results, with the filmmaker pointing and asking if Colvert’s looked negative. Don ultimately agreed with that assertion, going on to say that he has seen 20 like it and that the lab must not know what it is doing. A rather astounding statement on its own.

When I was shown Colvert’s SAR-PAGE results, I was able to visually determine the positive sample. To me the slight diffuse staining above the blue line is visually different than the other negative samples. Perhaps my 40-year-old eyes are better than Don’s as he approaches the 80-year milestone later this year. This shows that two people with expertise in evaluating EPO testing results can come to different visual conclusions, which reinforces the importance of the underlying science used to properly determine a positive or negative result.

Colvert’s SAR-PAGE results are an example of the subtle migration patterns that make EPO testing complex and difficult to properly evaluate visually. The peaks laid over SAR-PAGE results by the software application help in the results review process and take subjectivity out of the equation as this image shows with Colvert’s sample on the left, a positive control in the middle, and a negative at right.

Furthermore, the IEF results in Colvert’s case are also indicative of the presence of exogenous EPO. This test requires the two densest bands to be above the line and in Colvert’s sample there are actually three above the line making the visual results easy to recognize. So, two separate validated testing methodologies were used to establish Colvert’s results.

It should also be noted that two different laboratories confirmed these results. This is in fact required under the WADA technical document in order to avoid the reporting of false positives that could be subject to intra-laboratory differences. Both laboratories came to the same positive conclusion.

Some paranoid theorists might point to laboratory malfeasance painting pictures of scandalous anti-doping scientists purposefully contaminating samples. That notion is absurd as our colleagues in anti-doping laboratories are among the most ethical scientists we know. The recent Russian doping debacle and the gross ethical transgressions of our old friend, former Russian laboratory director Grigory Rodchenkov, have called into question the ethics of the anti-doping industry as a whole, one of the most unfortunate ramifications of his actions. Yet we would point out that even Grigory considered it anathema to purposefully taint an innocent athlete’s urine and he refused to do so despite direct orders from above.

What does bother us about Mr. Colvert’s case is not the results, but rather the vehement and passionate defense Mr. Colvert has lodged on his own behalf. His words, and his strong statements in defense of clean sport, are certainly convincing. But we have seen such convincing statements before, from both innocent and guilty athletes. Even stars like Alex Rodriguez and Lance Armstrong told convincing tales once. These stories are one of the most difficult elements we confront in anti-doping.

The Colvert case discussion demonstrates the complexity of the EPO test and data review process. Even well-meaning, qualified scientists, including Don, can be critical of it in certain circumstances. Yet at its core, and through the complexity, the WADA EPO testing methodology remains sound and strong.

Don and I would like to extend our apologies for the remarks about the Cologne WADA accredited laboratory, which were not intended to be disparaging. The Cologne laboratory and staff are some of the most capable, ethical and committed partners in the global fight against doping, and we very much respect their undeniable work as leaders in the industry.

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.