SII Focus 13th April 2016

Analysis: WADA’s guidance to ADOs on meldonium

The World Anti-Doping Agency (WADA) has offered a potential lifeline to athletes who have tested positive for meldonium. In a guidance note, issued on 11 April, WADA recommended anti-doping organisations (ADOs) should consider a finding of ‘no fault or negligence’ where an athlete can show that they stopped taking meldonium prior to 1 January 2016. WADA has also recommended that following an adverse analytical finding (AAF) for meldonium, results management should only proceed if the athlete admits taking meldonium after 1 January, or if evidence suggests it was taken after 1 January.

If this is the case and the test was taken before 1 March, WADA advises that ADOs have discretion as to whether to lift provisional suspensions if the level of meldonium in the athlete’s sample is between 1 μg/mL and 15 μg/mL, due to the lack of scientific evidence on excretion times. For the same reason, WADA advises that ADOs should not proceed with cases where the concentration of meldonium is less than 1 μg/mL, unless the test was conducted after March 1.

‘In the case of meldonium, there is currently a lack of clear scientific information on excretion times’, reads WADA’s guidance (PDF below). ‘For this reason, a hearing panel might justifiably find (unless there is specific evidence to the contrary) that an athlete who has established on the balance of probabilities that he or she ingested meldonium before 1 January 2016 could not reasonably have known or suspected that the meldonium would still be present in his or her body on or after 1 January 2016. In these circumstances, WADA considers that there may be grounds for no fault or negligence on the part of the athlete.’

Under Article 10.4 the 2015 World Anti-Doping Code, a finding of ‘no fault or negligence’ eliminates any period of ineligibility (i.e. any ban). However, WADA has also clarified that as the presence of meldonium still constitutes an anti-doping rule violation (ADRV), ‘the disqualification of the athlete’s results shall (even where there is no fault or negligence) be dealt with in accordance with the applicable Code provisions’.

WADA’s guidance will come as a huge relief to the huge number of athletes (over 100) that have tested positive for meldonium since the 2016 Prohibited List came into effect on 1 January. However, it may also present another issue for ADOs, who now may have to revisit old cases to ascertain whether an athlete can establish, on the basis of probabilities (to use WADA’s words), that they did not ingest meldonium after 1 January 2016.

Excretion of meldonium

As previously reported by the Sports Integrity Initiative, many athletes were told that meldonium would exit the body after two weeks, however it is now understood to be detectable for much longer. A number of athletes have claimed that they stopped taking the drug before the 2016 Prohibited List came into effect on 1 January, leading to difficult questions as to whether an athlete can be sanctioned for testing positive for a substance they took before it was banned.

WADA’s statement confirms that ‘several’ studies are being conducted into the ‘urinary excretion’ of meldonium, which could be detectable in the ‘low tens of ng/mL for a few months’ (note: 1 μg/mL = 1000 ng/mL). It offers this guidance on the matter:

• The renal elimination of meldonium is expected to vary significantly between individuals, depending on the dosing and duration of the drug administration protocol.
• Preliminary results obtained from single and multiple drug applications indicate that the urinary elimination of meldonium at recommended doses includes an initial rapid excretion phase (estimated half-life 5-15 h), which is followed by a second, longer elimination phase with an estimated half-life of more than 100 h.
• Based on the preliminary results of the aforementioned studies, this translates to urinary concentrations higher than 10 μg/mL up to 72 h (first elimination phase), followed by a persistent long-term excretion (second elimination phase) yielding concentrations up to approximately 2 μg/mL over the following three weeks. Long term urinary excretion below 1 μg/mL down to several hundred ng/mL can persist for a number of weeks and in the low tens of ng/mL for a few months.

Performance enhancing?

Questions have been raised as to why meldonium is on the Prohibited List in the first place. In a statement, tennis racquet manufacturer Head asked WADA to provide scientific studies in support of its decision to ban meldonium, after Maria Sharapova tested positive.

“The evidence around whether it is a performance-enhancing drug is quite thin”,  Mark Stuart, a Pharmacist who is on the medical and Anti-Doping commission of the European Olympic Committees (EOC) told the New York Times. However, its mounting use by athletes suggests that it is considered to have a performance-enhancing effect. On 24 March, WADA confirmed that there have been 123 meldonium positives since 1 January.

https://twitter.com/WADA_BCNichols/status/713075163839995905

Meldonium is a drug that was developed in Latvia by a company called Grindeks in Latvia and is primarily sold under the brand name mildronate to treat heart conditions. As reported by the Sports Integrity Initiative in September last year, studies suggested it was being used for performance enhancing effects by endurance athletes. They found that it ‘demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of central nervous system (CNS) functions’.

WADA has previously argued that it doesn’t have to scientifically justify why a substance is on the Prohibited List. “That’s specifically the way that the Code’s wording has been put so that we would not have to justify why a substance is on the list”, said WADA’s Chief Operating Officer and General Counsel, Olivier Niggli, who spoke to the Sports Integrity Initiative at WADA’s 12th Anti-Doping Organisation Symposium in March. “We have experts who look at it, they have three criteria. It has to meet two of the three and we never disclose nor discuss the specifics of a substance because otherwise, every time you have a positive case, there would be a challenge.”

According to WADA’s guidance note, its inclusion on the 2015 Monitoring Programme in September 2014 ‘revealed a high prevalence of the use of meldonium by athletes and teams of athletes’, which ‘ultimately led to the conclusion that meldonium met two of the three criteria listed in Article 4.3.1 of the World Anti-Doping Code’. Scientific evidence of a performance-enhancing effect is one of the three criteria mentioned.

meldoniumprohibitedlist2

Meldonium

The Monitoring Programme – advertising PEDs?

One issue that has emerged from the meldonium madness is that WADA is advertising substances as potentially performance-enhancing, before they have been banned, without scientific evidence as to why. This is potentially dangerous, and goes directly against the ethos of ‘protecting the clean athlete’, which was the focus of WADA’s March Symposium.

“They have to try to show that it enhances performance, but by banning it they’ve already said it enhances performance and that will make people turn to it”, Don Catlin, Scientific Director of the Banned Substances Control Group told USA Today. “You can find that it has effects, but it’s difficult to link those to performance enhancement. I’ve tried and tried to figure out why so many athletes seem to be taking it.”

WADA’s guidance stated that meldonium was added to its Monitoring Programme on 1 January 2015. The Sports Integrity Initiative knew about meldonium on 29 September 2015, when WADA announced that it had been added to the 2016 Prohibited List. However, we could have known that it had the potential to enhance performance a year earlier. On 29 September 2014, WADA announced that it had published the 2015 Prohibited List. Included at the bottom of that press release is a link to the 2015 Monitoring Programme, which advertises that WADA is monitoring meldonium.

In fact, WADA publishes the next year’s Prohibited List on 29 September each year, with a link explaining the substances that have been added to its Monitoring Programme at the bottom, as the back issues of the Monitoring Programme show. It even provides email updates. Bupropion has featured on the Monitoring Programme since 2009 and Telmisartan since 29 September 2014, to take two examples. Should have meldonium have been advertised as potentially performance enhancing by WADA, given its apparent widespread use?

It is understood that athletes in some eastern European countries have been using meldonium for many years, pre-dating WADA’s addition of meldonium to the Monitoring Programme. However, given what we now know about the systemic doping that has occurred in some sections of sport, is it really that fantastical to suggest that others may have been watching additions to the Monitoring Programme, with better scientific and medical advice about how long it takes to leave the body than appears to have been given to the many athletes now reporting positives for meldonium?

The way forward

As mentioned earlier, WADA’s guidance may put many sports in a difficult position. Will the Russian Ice-Hockey Federation (RIHF), which replaced its entire squad for the men’s U18 World Championship, now face action from the replaced players? Will ADOs have to revisit meldonium cases in order to ascertain whether an athlete should now face a sanction? One international federation that appears to have got things right is the International Biathlon Union (IBU), which suspended all meldonium proceedings last week.

One thing is certain. It will be a busy time for lawyers.

• WADA issued a statement regarding meldonium after this article was published. To view the statement, please click here.

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