Meldonium 2016: 172 Positives and a Rule Change Mid-Stream

Timeline

1. Jan 1, 2015Meldonium is added to WADA's Monitoring Program.
2. Sep 16, 2015WADA's Executive Committee adopts the 2016 Prohibited List, including meldonium.
3. Sep 29, 2015WADA sends the 2016 list and an explanatory note to stakeholders and posts them online.
4. Jan 1, 2016Meldonium becomes prohibited at all times.
5. Apr 11–13, 2016WADA issues a meldonium notice; its president says there have been 172 positive samples since January.

The ethical issues

• Strict liability when the science of detection windows is uncertain.
• Notice and fair warning for newly banned substances.
• Medical use versus performance enhancement.
• Consistency of outcomes across many anti-doping organizations.
• Whether widespread use signals a culture problem.

Stakeholders

Stakeholder	Interests & obligations
Athletes who tested positive	Fair treatment, especially those who stopped before the ban.
Clean competitors	Fair competition and enforcement of the rules.
WADA	Credible, consistent enforcement of its list.
National anti-doping organizations and federations	Clear guidance for results management.
Team doctors	Clarity on medical use and prohibited status.
The drug's manufacturer	The reputation and use of its product.

The case

On January 1, 2016, meldonium, a drug developed to treat heart conditions, became a prohibited substance under the World Anti-Doping Code.^[1] Within about three months, there had been “172 positive samples for the substance, for athletes across numerous countries and sports,” according to WADA’s president.^[2] Tennis star Maria Sharapova was among them. (See Maria Sharapova and meldonium.)

Background

Meldonium was added to WADA’s Monitoring Program on January 1, 2015. The program “revealed a high prevalence of the use of meldonium by athletes and teams of athletes.”^[1] After a process of review from 2011 to 2015, WADA concluded that meldonium met two of the three criteria for listing in the Code; in particular, “claims of performance enhancement had been made by various authors, including the manufacturer.”^[1]

Independent data pointed the same way. Meldonium, a carnitine-synthesis inhibitor sold under brand names including Mildronate, was registered as a medicine in Latvia, Russia, Ukraine and seven other former Soviet states, according to the study’s authors.^[6] It had been put on the Monitoring Program after anecdotal reports of use at the London 2012 Olympics, where five teams declared importing it.^[6] At the Baku 2015 European Games, the European Olympic Committees’ medical commission compared three data sources. Only 23 of 662 athletes tested (3.5%) declared using meldonium on their doping-control forms, but 66 of 762 urine samples (8.7%) contained it, from athletes in 15 of 21 sports, including 13 medalists or event winners. Meldonium was not prohibited at the time, so none of this was a violation. The authors concluded that the findings showed “widespread and inappropriate use and prescribing of this prescription drug in a generally healthy athlete population.”^[6]

WADA’s Executive Committee adopted the 2016 Prohibited List on September 16, 2015. WADA sent the list and an explanatory note to all stakeholders on September 29 and posted them online, so, WADA said, the change “was therefore known by all WADA Stakeholders three months prior” to taking effect.^[1]

The rules and governance

Meldonium is a non-specified substance, prohibited in and out of competition, so its presence in a sample is a violation and provisional suspensions apply.^[1] WADA stressed that athletes “must ensure that no prohibited substance is present in their samples,” and that a substance soon to be banned “should have cleared their system” by January 1.^[1]

Many athletes who tested positive said they had stopped taking meldonium before January 1. The problem was that little was known about how long it remained detectable. WADA acknowledged “a lack of clear scientific information on excretion times.” Preliminary studies suggested an initial rapid elimination phase followed by a long tail, with traces below 1 µg/mL persisting “for a number of weeks,” and in the low tens of nanograms per mL “for a few months.”^[1]

On April 11, 2016, WADA issued a notice to guide results management.^[1] It said that a hearing panel “might justifiably find” that an athlete who established that they took meldonium before January 1 “could not reasonably have known or suspected” it would still be present, which could support a finding of no fault or negligence. Results in the competition where a positive sample was taken would still be disqualified.^[1] It recommended that:

• cases proceed if the athlete admitted use after January 1, if other evidence showed later use, if the concentration exceeded 15 µg/mL, or if it was 1–15 µg/mL in a test on or after March 1;
• cases could be stayed pending excretion studies if the concentration was 1–15 µg/mL before March 1, or below 1 µg/mL after March 1; and
• cases below 1 µg/mL before March 1 were “compatible with an intake prior to January 2016” and could result in a finding of no fault or negligence.^[1]

WADA’s president said: “There is no doubt as to the status of meldonium as a prohibited substance.” He described meldonium as “a particular substance, which has created an unprecedented situation and therefore warranted additional guidance.”^[2]

The Sharapova case

The most prominent case did not turn on excretion times. A sample Maria Sharapova gave at the Australian Open on January 26, 2016, tested positive for meldonium. She waived testing of her B sample and announced publicly that she had committed a violation inadvertently: she had taken Mildronate tablets prescribed by her doctor for many years, and she and her team had not noticed that meldonium, sold as Mildronate, was now on the Prohibited List.^[3] According to the arbitral award, a doctor who treated her from 2005 to 2013 had prescribed short courses of Mildronate as part of a 2006 health plan, and she argued she had delegated checking the list to her agent at a major sports agency, who had missed the change at the end of 2015. She also argued that she and her agent had not realized Mildronate was a brand name.^[4]

On June 6, 2016, an independent tribunal appointed by the International Tennis Federation found a violation, disqualified her Australian Open results and banned her for two years. On appeal, CAS found on October 4, 2016, that she bore “no significant fault” but “some degree of fault,” and reduced the ban to 15 months from January 26, 2016.^[3] The panel said its award was “only about the degree of fault” for her failure to make sure that a product she had taken for a long time remained compliant.^[3] WADA acknowledged the decision.^[5]

Aftermath

The notice left decisions to the anti-doping organizations managing each case, which could keep provisional suspensions in place or lift them while studies continued.^[1] WADA said it would share excretion study results as they became available.^[1][2]

The results arrived in June 2016. On June 30, WADA issued updated guidance for athletes who said they had taken meldonium before January 1. It confirmed that from March 1 to September 30, 2016, a concentration below 1 µg/mL was “compatible with a no fault finding,” and left other cases to the responsible anti-doping organizations.^[7] WADA explained that it does not usually commission excretion studies for newly listed substances, because it can rely on manufacturers or regulators for that information; for meldonium, “no information relating to urinary excretion was available.”^[7] Its director general repeated that the listing had “created an unprecedented situation” that, “during a transitional period,” warranted extra guidance.^[7] The transitional guidance was later withdrawn: WADA now notes that it “is no longer valid,” having been replaced by a 2017 technical document on reporting meldonium.^[7]

The core dilemma

WADA banned meldonium after evidence of widespread use and claims of performance enhancement. But it did not yet know how long the drug stayed detectable, and many athletes who said they stopped in time tested positive. How should a strict-liability system handle a new ban when the science needed to apply it fairly is incomplete?

Competing values

• Strict liability vs. fairness: certainty of rules against individual circumstances.
• Timely prohibition vs. scientific certainty.
• Medical use vs. performance enhancement.
• Consistency vs. discretion across many anti-doping organizations.

Strongest arguments

For the ban and its enforcement: widespread use and claims of enhancement justified listing. The list was published three months in advance, and athletes are responsible for knowing it.

For more leniency: the lack of excretion data meant athletes could not know when meldonium would clear. Punishing athletes who stopped in time would be unjust.

For WADA’s interim approach: guidance based on concentrations and test dates balanced strict liability with fairness while the science developed.

Applying the frameworks

Justice

A justice lens asks whether athletes had fair notice and whether outcomes were consistent. It examines whether staying some cases while proceeding with others was a fair way to manage uncertainty.

Utilitarianism

A utilitarian lens weighs the benefits of banning a widely used, possibly performance-enhancing drug against the harm of penalizing athletes who stopped in time and the cost to the system’s credibility.

Rights

A rights lens focuses on athletes’ rights to fair warning and due process, and the presumption that they are responsible for their own bodies.

Walk it through: the Simple Decision Model

1. Spot the issue. You lead a national anti-doping agency with several meldonium positives. Stakeholders include athletes, competitors and WADA. Less visible are athletes who took meldonium on medical advice. The codes are the World Code and WADA’s notice.
2. Gather facts. What were the concentrations and test dates? When did each athlete say they stopped? Beware assuming that all users were cheating, or that none were.
3. Test options. (a) Proceed with all cases. (b) Stay cases where the science is uncertain. (c) Follow WADA’s guidance case by case.
4. Check codes and law. Check the Code’s rules on strict liability, fault and provisional suspension.
5. Decide and document. Record each decision against the guidance.
6. Communicate and follow up. Inform athletes of the status of their cases and update them as excretion data arrive.

What’s settled and what’s contested

• Settled: meldonium’s prohibition from January 1, 2016; the 172 positives by April; WADA’s guidance.
• Contested: whether the ban should have waited for better science; whether meldonium enhances performance; how fairly individual cases were resolved.

Why this case matters

The meldonium episode shows how strict liability interacts with scientific uncertainty, and how WADA responded with interim guidance. It is a case study in notice, fairness and consistency.

Key terms

Strict liability

The anti-doping principle that athletes are responsible for any prohibited substance in their bodies, whether or not they meant to take it.

Due process

Fair procedures before a sanction: notice, a chance to respond, an impartial decision-maker and a right of appeal.

Controls

Concrete safeguards that make ethics operational: training, disclosure forms, testing, monitoring, hotlines. Ethics needs principles, process and controls.

Therapeutic use exemption (TUE)

Advance permission for an athlete to use a medically necessary substance that would otherwise be prohibited.

Trust

The public’s belief that what they are watching is real. Integrity failures are ultimately failures of trust.

Sanction certainty

The principle that the likelihood of being caught and punished deters misconduct more than the severity of the punishment.

Definitions from the Ethics Cases glossary.

Discussion questions

1. WADA published the 2016 list three months before it took effect. Was that enough notice for athletes using meldonium?
2. WADA said there was 'a lack of clear scientific information' on excretion times. Should it have delayed the ban until the science was clearer?
3. Should medical use of a substance by many athletes affect whether it is banned?
4. Was it fair to stay some cases while others proceeded, based on concentration and test date?

Sources

1. Notice – Meldonium (11 April 2016) — World Anti-Doping Agency
2. WADA statement on meldonium notice — Sports Integrity Initiative (republished WADA release)
3. The Court of Arbitration for Sport (CAS) reduces the ban of Maria Sharapova to fifteen months (Oct. 4, 2016) — Court of Arbitration for Sport
4. Arbitral award, CAS 2016/A/4643 Maria Sharapova v. International Tennis Federation (Sept. 30, 2016) — Court of Arbitration for Sport (via Morgan Sports Law)
5. WADA statement regarding Maria Sharapova CAS decision (Oct. 4, 2016) — World Anti-Doping Agency
6. Meldonium use by athletes at the Baku 2015 European Games (accepted for publication in BJSM, Mar. 7, 2016) — British Journal of Sports Medicine (BJSM blog, authors' manuscript)
7. WADA issues updated Stakeholder guidance regarding Meldonium (June 30, 2016) — World Anti-Doping Agency