The meldonium debate

Till the other day not many people would have known what meldonium was. Now a lot many people apparently know about it. When the world’s highest paid woman athlete appears before a press conference and tells you she has tested positive for the substance it is time to do a Google search.

Meldonium is a cardiac drug. Its inventor, Latvian Ivar Kalvins has said it was not a performance enhancing drug. In fact he is on record stating that athletes would die if they do not use the drug since they push themselves to the limits.

Kalvins was also quoted as saying that he developed the drug for use by Soviet troops in Afghanistan since operating in the mountains meant soldiers could suffer due to lack of oxygen. The drug's capacity to improve blood circulation is being cited as one of the reasons for its use as a stamina-booster among athletes.

Questions have also come up how meldonium had been included in the Prohibited List 2016 and on what basis could a drug meant for cardiac problems be dubbed as “performance enhancer” and banned for use by athletes.

This argument of course is nothing new. A large majority of the banned drugs are used for legitimate therapeutic purposes and in a majority of the instances there is no conclusive clinical research to back up the claim that they are performance-enhancing drugs and thus need to be banned for use by athletes without a therapeutic use exemption (TUE).

In the case of meldonium WADA has stated that there was “evidence of its use by athletes with the intention of enhancing performance” and that was why it was put in the Prohibited List. This argument might not satisfy all but that is the way it is. Unless someone takes legal recourse to question the inclusion of a drug in the banned list such arguments may be of little help.

It is true meldonium was placed under the ‘monitoring programme’ in 2015 and then only brought into the main prohibited list in 2016, as is normally done to include a new substance.

The New York Times has an excellent article to explain how meldonium was tracked at least from October 2014 following a tip-off and then placed in the monitoring programme before being brought into the Prohibited List.

No 'why' after a substance is included

The WADA Director General, David Howman, who is stepping down at the end of June this year, was quoted as saying that once a substance was included in the Prohibited List there was no question of finding “why” it was included. That stage, he explained in various reports, was over when it was being monitored and put through the normal, elaborate process of discussions through the List Expert Group and while getting feedback from stakeholders.

The List panel contains leading scientists and experts in the field of pharmacology, endocrinology, sports medicine, forensic toxicology, clinical chemistry, biochemistry, nutrition etc.

Meldonium was put through a study funded partly by "Partnership for Clean Competition” in 2015. The results from 8300 anonymous urine samples showed 182 (2.2%) positive tests for meldonium. These samples came from the WADA-accredited Cologne laboratory and they comprised samples from a variety of sports. Obviously they were all from active athletes, not people having cardiac issues.

 Another study by a group of scientists to assess meldonium misuse among athletes at the European Games in Baku, Azerbaijan, in June 2015 further confirmed the findings of the PCC-funded study. It showed 66 of 762 samples (8.7%) were using meldonium at the Baku Games. The 'positive' findings were recorded in 15 of the 21 sports contested in the games.

Further proof of the widespread use of meldonium by sportspersons has come from the fact that WADA has reported a century of positive results for the substance so far. It is a huge number for just over two months this year.

Obviously, the Sharapova incident has provided added interest to potential users of meldonium. Internet retailers reported a hike in demand and some of the agencies have displayed either “out of stock” notices or else indicated that there could be some delay in dispatching the stuff.

Some of them provide information about the extra benefits the drug could provide apart from its listed use, though the Latvian company Grindeks which alone originally produced the drug and sold it under the brand name Mildronate has denied that there had been any research to suggest improved performance among athletes after consuming the drug.

Deutsche Welle (DW), Germany’s international broadcaster reported that sizeable amount of meldonium had been purchased by various Russian sports organisations and clubs between 2014 and 2016 for use by athletes. Obviously such largescale purchases cannot logically be tied to “cardiac issues” among young athletes.

The process of including substances in Prohibited List

How does WADA get a substance included in the Prohibited List?

Those who are unfamiliar with the process may read this informative interview published on LawInSport on Jan 27 this year, well before Sharapova sensationally  announced her positive test for the drug at a Los Angeles Press conference.

Problems however continue to persist for anti-doping authorities.

Associated Press reported that Ukrainian athlete Nataliya Lupu had withdrawn from the IAAF World Indoor Championships in Portland after she had tested positive for meldonium. That in itself was no big news since several athletes (100 and counting as per latest WADA announcements) had tested positive for meldonium.

What was of great relevance was Lupu’s claim that she had been using the drug on medical advice for the past 15 years and had stopped taking it last November (unlike Sharapova who missed reading about it), enough, in her opinion, to get rid of it from her body before it was officially banned on January 1 this year.

This is Lupu’s second doping offence she having served a nine-month suspension for a positive test for methylhexaneamine at the 2014 World Indoors.

Talking of methylhexaneamine, its ‘popularity’ in the initial years of its ban was huge. In 2010 the year in which it was introduced in the Prohibited List, 123 MHA cases were reported. Next year the number went up to 283 and still climbed in 2012 to 320. It was only in 2014 that MHA showed signs of abatement with only 76 cases reported. In all these years the substance topped the category of stimulants.

“What is this substance that seems to be there in several daily use stuff and is still banned” was an oft-repeated question those days when MHA hit Indian sports in a big way prior to the Commonwealth Games at home.

Once the theories and claims about MHA being present in soaps and shampoos and even cooking oil faded out without a shred of evidence being presented before hearing panels in India, no one criticized its inclusion in the Prohibited List.

Meldonium looks set to breach the marks set by MHA if the initial flurry is any indication.

'Out of stock'!

Online agencies selling meldonium and showing 'in stock' and 'out of stock' at the same time on their websites have listed certain properties of the drug beyond its known use that may tempt the athletes just as some claims about MHA boosted the sale of certain supplements since 2010.

There is a claim by this retailer that meldonium improves “athletic training and competitive performance.”

Among the indications for the use of the drug on this website is “decreased performance including in athletes.”

The craze for meldonium had clearly started even before the Sharapova episode, it would seem. Otherwise it is difficult to explain the large number of positive results. The drug might have been used for enhancing performance for several years in fact, especially in East European countries.

Another cardiac drug, trimetazidine, brought into the list in 2014 by WADA did not gain such popularity even though it was also an anti-ischemic drug and reportedly had properties similar to meldonium,

Chinese Olympic champion Sun Yang tested positive for trimetazidine in 2014, was given a quiet three-month suspension and only on his return did anyone realise that a champion swimmer had a doping violation against his name

Trimetazidine was placed under ‘specified stimulants’ in 2014 but brought into the new class S4.5 Metabolic modulators in 2015, the class in which meldonium also is included now. There were only 18 positive cases for trimetazidine in 2014.

The S4.5 category which comprises ‘non-specified’drugs, also includes insulin. Of course if an athlete is diabetic he/she would be free to use it. But yes insulin has long been misused by athletes and the International Olympic Committee (IOC) had banned it back in 1998.

Athletes would be able to use banned drugs if they get a therapeutic use exemption. Mere prescriptions won’t do. Doctors constitute TUE panels that can grant or deny TUEs. They should know. If equally effective alternative medicines are available a TUE for a banned drug is denied.

Many have tried to find fault with WADA’s communication methods that they have argued have failed somewhere for meldonium to turn up positive in such large numbers among elite athletes.

'It is like Santa coming on 24th'

WADA officials however differ. "Every year you should have on your calendar, 1st of October, let's look at the (banned) list to see what's happening," WADA Director General David Howman was quoted as saying. "It's not new to athletes, it's not new to administrators, it's not new to athlete advisers. This has been going on now for 13, 14 years."

Similar sentiments were also expressed by Olivier Niggli, Chief Operating Officer and General Counsel of WADA, who is billed to take over as DG in July.

“It’s always the same, at the same date (Oct 1), everybody knows what to expect. Like Santa, you expect him on the 24^th in the evening”, Niggli was quoted in an interview in The Sports IntegrityInitiative.

WADA finalizes the Prohibited List every year by the end of September so as to publish it at least by October 1, providing three clear months for the athletes to stop taking something or to get something out of their system.

The fact that Sharapova mentioned a WADA communication dated December 22 which she did not open might have given the impression to many that WADA informs all athletes around the world or that it is WADA’s responsibility to make sure that everyone, at least the top athletes of the world (how do you define that?) come to know of it.

It is actually the responsibility of the International Federations, National Federations and National Anti-Doping Organizations (NADOs) to publicize the Prohibited List.

Surely athletes could be expected to check it up or get it checked out. Least that could be expected would be for an athlete to check out the drug that is prescribed to him/her to make sure that nothing banned is being consumed. For the leading athletes there is of course their entourage which could do all the research and accordingly provide advice.

Drug Reference Online

 If in doubt there is the Global Drug Reference Online facility available at the UKAD and USADA websites, among others, where an athlete can enter a doubtful drug and get the answers. Unless of course an athlete is actually consuming dozens of tablets and syrups and feels the process might take too long for comfort! Then the task could be delegated to a member of the support staff. Leading tennis players have admitted that they do have doctors or others in their team who do the checking up.

According to Wikipedia, page views for meldonium jumped from 870 in the last two days of pre-Sharapova to 1.57 million post-Sharapova press conference. That shows the enormous interest the drug has created around the world after Sharapova’s disclosure. That may also show athletes could still be interested in finding out its potential to enhance performance.

As more and more top athletes start turning in ‘positive’ results for meldonium_the latest happened to be Russian swimmer Yulia Efimova, breast-stroke world champion and Olympic bronze medallist_there will be further scrutiny of the information flow from WADA to federations and from the latter to the athletes. The fact will, however, remain that for a large majority of the athletes who have been trapped into the meldonium net Rio Olympics might have already started looking ‘out of bounds’.