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 51^st 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 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

Maria Sharapova and Meldonium – Consideration of a Therapeutic Use Exemption After a Positive Drug Test

Maria Sharapova – London 2012 – Photo by Oliver Catlin, http://www.bscg.org

The coverage of Maria Sharapova’s announcement of her positive drug test for meldonium, or mildronate, has been astounding. Her case is yet another amazing example of a great champion falling victim to performance-enhancing drugs in one way or another. We wrote an immediate blog post about it an attempt to consider the two potential sides to a doping issue. That post still provides an interesting view of the perspective we were aiming to provide and we stand behind the bulk of the content.

In our haste to give Ms. Sharapova the benefit of the doubt in the situation, however, as we did in our conclusion and in the suggestion that perhaps her therapeutic use would be considered retrospectively, we did not fully consider the realities behind Ms. Sharapova’s claim of therapeutic use. Thankfully our friends in the anti-doping doping community have elegantly expounded on this element of the case.

The expert analysis below on therapeutic use and application in World Anti-Doping Agency (WADA) doping control is important to consider. It corrects the notion that a TUE could be granted retroactively and impact a pending sanction, which would be extremely rare if not completely unique in the field of anti-doping.

The information below was written by Dr. Ken Fitch and distributed by Jim Ferstle, both valued friends and colleagues who care deeply about clean sport and anti-doping and have spent their careers fighting for the cause as we have. The points of primary interest: retroactive TUEs would be unlikely to be considered from a standpoint of sanction relief, and the defined timeframe and clinical guidelines for use of a drug should always be scrutinized when evaluating potential therapeutic use. Thank you, Ken, for providing an insightful explanation of the criteria involved in the consideration of therapeutic use exemptions and the potential application to meldonium.

Dr. Ken Fitch is an Australian doctor and Professor, School of Sports Science, Exercise and Health, Faculty of Life Science University of Western Australia. Dr. Fitch wrote the original rules for TUEs in 1991 for the IOC, chaired the IOC’s TUE Committee for 20 years, chaired WADA’s interim committee (2001-2003) that established the initial International Standard for TUE (2004) and chaired Australia’s national TUE Committee for 22 years.

Maria Sharapova’s lawyer exploring a possible TUE to exempt a sanction
by Ken Fitch, M.D.

The ludicrous suggestion by Sharapova’s lawyer that she might seek a retroactive Therapeutic Use Exemption (TUE) to avoid a sanction for testing positive to meldonium demands a response. Ignoring whether the 2016 World Anti-Doping Code and the 2015 International Standard for TUEs does or does not make a retroactive TUE a possibility in her circumstances, if anybody examines the criteria that must be met to grant a TUE, he/she would understand that no respectable TUE Committee could approve any such application.

WADA states that there are four criteria, all of which must be met to grant a TUE.

1. The drug is necessary to treat an acute or chronic medical condition and the athlete would experience a significant impairment to health if it were to be withheld.
2. The therapeutic use of the prohibited drug is highly unlikely to produce any additional enhancement of performance beyond what might be anticipated by a return to the athlete’s normal state of health following the treatment.
   
3. There is no reasonable therapeutic alternative to the use of the prohibited drug.
4. The necessity to use of the prohibited drug is not a consequence of prior use of a prohibited drug or method.

Would Sharapova’s health be significantly impaired if she was denied a TUE? The Latvian makers of meldonium advise that it should be taken in intermittent courses of 4-6 weeks and for what period of time Sharapova administered meldonium during the past ten years, has yet to be disclosed. As the only acceptable medical indications are for ischemic cardiac and ischemic cerebral conditions, it is unthinkable that Sharapova has either. Hence any claim that should she be denied the right to take meldonium would impair her health is simply fanciful. Any TUE application must fail criterion 1.

The second criterion was introduced because some athletes had an essential need to take a prohibited drug. For example, an insulin dependent diabetic would die if denied insulin which has been prohibited in sport since 1998 and their daily insulin injections that are permitted with a TUE do not enhance performance. Whether meldonium actually enhances performance in humans has yet to be demonstrated. That WADA has advised that in less than two months since it was added to the Prohibited List, 99 athletes have tested positive for meldonium would appear to indicate that many athletes and their advisors believe that it does. No athlete could claim that meldonium was essential to restore their health back to normal levels. To claim that without it, a person’s health would be less than normal is surely fictitious. Fails criterion 2.

There are many drugs that have been demonstrated in scientific trials to be valuable in cardiac ischemia and the vast majority would be far superior to meldonium. The few meldonium studies performed in humans have been on persons who recently had experienced a myocardial infarction or an acute coronary syndrome. That the makers of meldonium recommend that it be administered only in intermittent courses in contrast to most of the widely acceptable, prescribed alternatives that are to be taken daily, is further evidence of the non-essential status of meldonium to treat cardiac ischemia. As the drug is marketed in only ten countries globally and Sharapova has lived in the USA for much of her life where meldonium is not approved for human use, this poses further questions for the tennis player.

Drug therapy for cerebral ischemia is generally ineffective and less frequently used than for cardiac ischemia but those patients on whom meldonium was trialled had had either a recent stroke or evidence of deteriorating brain function. As Sharapova could not possibly demonstrate that she has either of these or indeed significant cardiac or cerebral ischemia, and if she could, alternative permitted drugs are at least as effective if not more so, she fails criterion 3.

Hence Sharapova fails 3/3 and the fourth criterion has no relevance. Finally, should an unscrupulous or ignorant TUE Committee happen to grant Sharapova a retroactive or even a prospective TUE for meldonium, WADA would be certain to appeal to CAS and the decision would be or should be overturned.