Monday, April 25, 2016

Were athletes actually robbed of Rio qualification?

Were some of the elite athletes of the country deprived of a chance to qualify for the Olympics because of a power shutdown at the Capital’s Jawaharlal Nehru Stadium on Sunday?
Before the events started in the afternoon, yes surely they were confronted with a fait accompli: “Run your best, no matter what your timings are in the sprints, you won’t make it to Rio Olympics”.
The regulations laid down by the International Association of Athletics Federations (IAAF) for Olympic qualification state: “Hand timing performances in 100m, 200m, 400m, 800m, 110m/100m Hurdles, 400m Hurdles and 4x100m Relay will not be accepted”.
As such the AFI knew, at least the technical officials knew, that there would be little point in athletes gaining any timings in short races without a fully automatic timing system in place. Perhaps the media knew, too, at least those familiar with IAAF regulations, record ratifications etc.
One is not sure whether the athletes knew about the futility of clocking personal bests and Olympic standards when there was no power supply and thus no electronic timing system.

Blame game

 There is little point now in going through the blame game that was expectedly resorted to by the host, Delhi State Athletics Associaion, the AFI and the Sports Authority of India (SAI) for not having provided a back-up for electricity supply for a “qualification meet” of this nature. We can go on and on but it would not be of any use.
Should the sprint events have been cancelled since the AFI knew there could be no qualification? That would have been foolish. Why deprive athletes of a chance to compete? Moreover this meet was a good build-up exercise for the more important Federation Cup starting at the same venue four days later.
The power outage made headlines in the National dailies.  “Power failure robs athletes of Olympic qualification”. That was the crux of the argument in most of the reports.
Before the events started, as I noted earlier, yes it robbed them of a chance. But after the end of the events? Who were all close to the Olympic standards in sprint events? Or was there anyone at all? It may look easy when the difference is 0.2s or 0.4s but place it alongside a 100m timing and then see the difference between 10.1 and 10.3. Better still 10.1 and 10.10s.
It has been reported that both men’s and women’s 100m timings were better than existing National records and both also were better than the Olympic entry standards. But since there was no automatic timing system in place, both would be deprived of both the honours.
This is not a true description of the events or the timings returned by the athletes. In men’s 100m Odisha’s Amiya Kumar Mallick clocked 10.09 seconds. This was hand-timed. This should have been rounded off to 10.1s before it was cleared by the technical officials (chief timekeeper, chief judge etc) and passed onto the recorders and from there to the communications team and onto the media. Same with the timing of 11.23s clocked by Srabani Nanda, also of Odisha. That should have been 11.3s.
Just because modern stop watches provide timings up to a hundredth of a second it should not mean these are equivalent to electronic/automatic timings. Nor should it have meant that the chief timekeeper would pass on a timing measured up to a hundredth of a second and the recorder would also make it look as though this was automatic timing without re-checking.
Once you get 10.09s for a 100m it is taken for granted that this was automatic timing. On the other hand a timing given out as 10.1 would make it clear it was hand-timed.
Now if the media were pre-briefed about the power breakdown and absence of automatic timings and the resultant bar on Olympic qualification and provided these results as 10.1 and 11.3 in the official results sheets things would have been far better and different.

Media could have been briefed

It could have been done with an explanation that though these hand-timings may look to be better than the existing National records they indeed were not since a fully automatic time of 10.30s (National record in men’s 100m) was always superior to a hand-timed 10.1s and an automatic 11.38s (National record in women’s 100m) was clearly above a hand-held timing of 11.3s.
Would anyone have then reported that there were ‘national records’?
Or for that matter an automatic timing of 45.48s (achieved by K. M. Binu in 400m in Athens Olympics) has to be surely rated far above that of a hand time of 45.5 (rounded off to the next lower tenth of a second from 45.41s that was credited initially to Mohammad Anas in the Delhi meet).
In order to compare hand-held timings with automatic ones, athletics statisticians had devised a formula by which 0.24s was added to the 100m and 200m timings and 0.14s to 400m and above.
Though several of the Olympic Games timings were officially recorded as hand-timings, automatic timings, where available were later approved as “automatic” for those events including for example for the 1960 Rome Olympics. (It was not until 1964 that Olympics started using automatic timings but till 1972 Games results were given only in hand timings.)

Milkha's record

Rome was where the great Milkha Singh clocked 45.6s (hand) for the fourth place in the 400m. Later when the IAAF, guided by leading statisticians around the world accepted automatic timings ‘where available” and incorporated them within parenthesis to those results, it became 45.73 (not 45.74 the mark that could have been logical had the 0.14s conversion formula been applied to it).
Why this particular record of Milkha is being mentioned here is because of the controversy the subsequent national records in 400m created thanks to this “revision”. Milkha never accepted the argument that someone could clock 45.7-plus and still claim his record of 45.6 was bettered! Paramjeet Singh did that (45.70s) in Calcutta in 1998 and the AFI ratified that record. Any other dispute related to Paramjeet’s record is a different matter.
Hand-timings are nothing new in Indian athletics. We have had these for longer periods than most developed countries around the world. Sometime in the 1990s the AFI brought in automatic timings. Gradually, all senior national-level meets and then junior national-level meets were mandatorily timed with automatic system.
Hand-timings have inherent deficiencies. The time-keepers are actually expected to look for the flame/smoke from the gun (held aloft by the starter against the background of a black board) and not hear the sound before pressing their stop watches. You are not sure how many of them would be seeing the flame and how many of them would have pressed when they heard the sound. There is a considerable time gap if the sound determines the action of the official in the short sprints.
At the finish, too, there is considerable margin for error.
To have clocked 10.09s (10.1 hand) and then be credited, even if through the mistakes of the technical officials, with a national record, bettering the existing one of 10.30s is something that should not have happened at all. 
For comparison purposes, through the conversion formula, 10.09 will first become 10.1 (adjusted up to the lower tenth of a second) and then if we add 0.24s it will become 10.34s. Not good enough to beat NR of 10.30, and nowhere near the Olympic entry standard of 10.16 if we were to just compare these timings and not presume that hand-timings would be allowed for qualification.
Of course the IAAF does not accept hand-timings for sprints as entry standards for Olympics and World Championships etc, as mentioned above, and it also does not accept hand-timings for races up to and including 800 for the purpose of world record ratification. The AFI follows the IAAF pattern mostly, though there is nothing written down about ratification regulations.
That an explanation was eventually made to the media, despite having been supplied with the timings of 10.09, 11.23 and 45.41 was thanks to the intervention of the AFI Technical Committee Chairman, Tony Daniel, who was away in Kerala and could not make it for this meet in Delhi, but who was alerted about the discrepancy by a journalist, baffled by the news about a flurry of “national records”!

Suriya's record is legitimate

Now, a curious mention was made in several reports about the timing returned by Suriya Loganathan in the 3000 metres. Amidst the confusion created by the sprint timings, national records that were never set, Olympic standards etc it was also reported that Suriya’s 9:04.5 will also not be considered for National record ratification  purposes even though it was better than Molly Chacko’s existing mark of 9:06.42 set at the Hiroshima Asian Games in 1994.
Why should Suriya be denied her legitimate right for this distance, where an auomatic timing system is not mandatory, is not clear. Obviously someone made a mistake in informing the media. Unless there are other issues related to Suriya’s performance, the Tamil Nadu woman has to be credited with the NR in this event run occasionally in domestic meets nowadays. It is an early-season event for the distance runners these days to prepare for the tougher and longer races.
“Suriya robbed of record amidst confusion” would have been an apt headline.
In athletics, unlike say in swimming, there are no pre-designated qualification meets to attempt entry standards for Olympics. Any ‘recognized’ meet conducted by a national federation under the IAAF rules would do provided qualified officials and standard equipment were utilized. Thus there should be no question of either stripping the Delhi meet of the ‘qualification’ tag or informing the IAAF that such a tag has been removed. Had a couple of athletes qualified in say long jump or triple jump or discus would such a tag have been removed? (If it indeed had been removed!)
The participation level in a meet in which individual entries were entertained for the first time was pathetically poor. The standards too remained ordinary if we were to exclude the hyped up sprints and a couple of other events. Hand-timings do provide a rather distorted picture in sprints and that is what happened in the Delhi meet.
Amiya Mallick (previous best 10.51s), Srabani Nanda (11.58s) and Anas (46.66s) will surely be expected to look forward to the Federation Cup from April 28 to 30 to repeat their performances and make the cut for Rio. They will need to clock 10.16s, 11.32s and 45.40s. all through automatic timing system to make the Rio-bound team. It is a tough task.
Hopefully the AFI will have the power back-up this time just in case things go wrong again!

(updated 26 April 2016)



Sunday, April 17, 2016

The meldonium conundrum


Has WADA thrown a lifeline to athletes who have turned in positive tests for meldonium as has been widely reported? Or is there a meldonium-linked amnesty as is being suggested by certain people and being debated in the international media?
Can Maria Sharapova greatly benefit_or benefit at all_from the latest clarification by WADA regarding ‘excretion times’ for the drug that was brought into international focus on March 7 last when the Russian tennis star announced that she had tested positive for the little-known cardiac drug?
These questions are being raised and discussed across the world following WADA’s fresh guidelines for pursuing the meldonium doping cases. The meldonium infractions have risen to 201 as on April 15. The numbers are unprecedented for a single drug within a four-month span of its inclusion in the banned list.

Unprecedented intervention

WADA’s intervention in such a short period of time after a drug being introduced into the Prohibited List, with detailed clarifications regarding thresholds to be pursued or ignored for a non-threshold substance is also unprecedented.
With some of the athletes and organizations questioning the ‘excretion times’ of the drug, perhaps WADA perforce had to step in and issue guidelines which has led to speculation about the basis of its inclusion in the Prohibited List as well as about the “escape route” that the “guidance” may provide to at least some of the athletes. WADA stated that several anti-doping agencies were seeking guidance and because of the “unprecedented situation” created by meldonium it felt the need to provide “additional guidance for the anti-doping community.”
Ukrainian athlete Nataliya Lupu was one of the earliest among the meldonium offenders to claim that even after stopping the drug a good two months ahead of the January 1 deadline, she had tested positive. She stated that she had been taking the drug for the past 15 years for medical reasons and thought she had stopped well in time to prevent a ‘positive’. It was the second doping offence for the former European indoor 800m champion.  She was withdrawn from the World Indoor Championships in Portland, US.
In the third week of March Russian middle distance runner Andrey Minzhulin made the claim that the Prohibited List was translated into Russian only in October 2015 and if the drug was taking as much as 100 days to clear from the system (as was being claimed at that time) then it would be unfair to penalize athletes if they tested positive in January 2016.

Manufacturer's claim

Around the same time, Grindeks, the manufacturer of meldonium, told Reuters that the drug had a half -life of four to six hours but “its terminal elimination from the body may last for several months”. (Half-life means the time it takes to reduce the concentration of a drug in the body by half).
WADA has now conceded in its note to anti-doping agencies that meldonium may remain in the system for “a few months”. It has issued concentration levels that could be considered for different periods. The fundamental rationale is if an athlete is claiming that he or she took the drug in October-November there is still a possibility of a positive test in January and the athlete deserves the benefit of some concession.
The cut-off of 1 to 15 microgram/ml stipulated for samples collected before March 1 may not, however, be too encouraging for those trying to find a way out if they had committed an offence. Nor would the 1mcg/ml (0.000001g/ml) limit given for tests done after March 1.
“In the case of meldonium, there is currently a lack of clear scientific information on excretion times. 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” WADA notice stated.
“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,” WADA said. (1ng=000000001g).
WADA has recommended that proceedings may be continued if the concentration is above 15 mcg/ml since it would suggest recent intake of the drug. 

No blanket amnesty

This is not a blanket amnesty. It may turn out to be a lifeline for some of the offenders. It is difficult to guess what those numbers could be from among the 200-odd meldonium positive cases reported so far. Already at least 14 athletes in Russia and Georgia have had their provisional suspensions lifted because of the guidelines issued by WADA. There could be more that had not been reported.
Those who might have ingested the drug prior to January 1 and concentration levels show below 1mcg/ml would be reprieved when the hearing process begins. Their provisional suspensions would be lifted straightaway. Meldonium being a 'non-specified'drug a provisional suspension was standard. Because of the uncertainty over éxcretion times' WADA has now given anti-doping authorities the right to lift the provisional suspension in case ingestion prior to Jan 1 is firmly indicated.
The final decision on all these cases would be dependent on the outcome of the ongoing ‘excretion studies' which alone would be able to determine with some measure of certainty when the athlete would have taken the banned drug. The studies may well be challenged scientifically and legally.
“Cases where the concentration is below 1 μg/ml and the test was taken before 1 March 2016 are compatible with an intake prior to January 2016. If the anti-doping organization finds that the athlete could not reasonably have known or suspected that the substance would still be present in his/her body on or after 1 January 2016, then a finding of no fault or negligence may be made."
At this point all these could be sounding rather confusing. But once the hearing process begins and news gets out, we would be in a position to understand the implications of this WADA notice in a better way.

Sharapova's case

How much of an advantage Maria Sharapova might have following the latest WADA notice?
None perhaps!
The International Tennis Federation (ITF) has stated that it had taken note of the WADA notice and it would go ahead with a hearing for the superstar. The Russian tennis star’s provisional suspension has not been lifted, an indication as to how the fresh guidelines would have worked in her case.
Sharapova did not say she knew the substance was banned and had made sure that she stopped taking meldonium_prescribed to her by her family doctor for an ostensible cardiac condition 10 years ago_in October or November. On the contrary she told the media that she did not know meldonium was banned. No one had told her and she missed clicking a link in a WADA communication that could have given her the crucial information.
She did not say when she took it last. But as things turned out, one of her sponsors, tennis racquet manufacturer, Head, issued a statement on March 11 which stated, among other things:
“On this basis we conclude that although it is beyond doubt that she tested positive for the use of a WADA banned substance, the circumstantial evidence is equally beyond doubt that the continued use of meldonium after Jan 1st, 2016 in the dosages she had been recommended, which were significantly short of performance enhancing levels, was a manifest error by Maria. In the absence of any evidence of any intent by Maria of enhancing her performance or trying to gain an unfair advantage through the use of mildronate, we further conclude this falls into the category of 'honest' mistakes.”
The Head Chairman couldn’t have visualized how things would turn out when he issued the above statement.
WADA has said that in case an athlete admits that the substance was taken after 1 January or if there is “other evidence” that it was taken after 1 January, the proceedings would continue.
Can Sharapova now disown the statement by Head Chairman and CEO, Johan Eliasch, that the she was taking meldonium in small quantities even after January 1? It looks doubtful whether such an argument could be made convincingly before a hearing panel.
Much would depend on the concentration levels being returned in their urine samples by individual athletes including Sharapova. Also the eventual outcome of the ‘excretion studies’ that the WADA-accredited laboratories are conducting at the moment. 
We should not forget the capabilities of the lawyers who would be representing a majority of the athletes. This is a good season for lawyers, especially those who have the experience in anti-doping rule violation cases.

Efimova fails to get suspension lifted

With the Olympics getting closer there is understandable anxiety among athletes to get out of this “meldonium mess” and get on with competitions and qualification process.
One such athlete, Russian swimmer Yulia Efimova, 100m world breast-stroke champion, had tested positive for meldonium on a sample she provided last February. The US-based swimmer apparently told her coach that she had taken the drug last December.
However, as ill luck would have it (from her perspective) another test in January this year turned up negative, according to Swimvortex.
 Probably based on this evidence International Swimming Federation (FINA) has refused to lift her provisional suspension to enable her to compete in the Russian National Championships. Efimova, world number three, may still have an opportunity to make the Olympic selection if she is cleared of the doping charges. This is her second doping offence, she having served a suspension in 2013.
Just as the debate started about WADA’s wisdom of including meldonium in the Prohibited List immediately after the Sharapova bombshell, the latest WADA notice has triggered another round of arguments about how the agency goes about banning drugs.
People have called for conclusive evidence of performance-enhancement through clinical research before WADA includes any substance in the banned list. Russian President Vladimir Putin has gone to the extent of saying meldonium was never a performance-enhancing substance.
Critics and experts will continue to argue that WADA’s methods are arbitrary.

Inclusion of meldonium in Prohibited List

WADA, in the mantime, has stated: “The inclusion of meldonium on the 2016 Prohibited List concluded a long process conducted by the WADA List Committee between 2011 and 2015. This process, which included a review of the available scientific information and the generation of specific data (in particular via the 2015 Monitoring Program, which revealed a high prevalence of the use of meldonium by athletes and teams of athletes) ultimately led to the conclusion that meldonium met two of the three criteria listed at Article 4.3.1 of the World Anti-Doping Code (Code). In particular, claims of performance enhancement had been made by various authors, including the manufacturer of meldonium.”
The manufacturer, Grindeks, had of course denied when the focus shifted to it following the Sharapova announcement that meldonium was a performance-enhancer. Its inventor, Latvian Ivar Kalvins had also said, however, that he had developed the drug for use by Soviet troops in Afghanistan since operating in the mountains could result in lack of oxygen.
Is that not performance enhancing?
Someone will have to go to court to challenge the inclusion of meldonium or any other drug in the Prohibited List. WADA does not disclose all the selection criteria adopted for particular substances all the time. Nor has there been conclusive research about the performance-enhancing capacity of the hundreds of drugs listed by WADA. But it is always prepared to defend its decisions and in the case of meldonium it seems to have done its homework well enough barring of course the 'excretion' study.
One thing is clear, all of 200 athletes would not have been using meldonium either because they had cardiac problems or because they felt it was fashionable to use it. What could happen to it next year, without the controversy surrounding ‘excretion times’ is anybody’s guess.
*****
Click here for previous piece on meldonium.

(updated 18-04-2016)




Tuesday, March 29, 2016

Same class of substance, two vastly different sanctions


Much as the World Anti-Doping Agency (WADA) has tried to bring uniform anti-doping rules and uniform application of those rules, differing interpretations often lead to contrasting sanctions. These sanctions through the years have differed from country to country and, as we will soon be able to observe, within a country itself.
Hearing panels in India generally tend to take a sympathetic view of the offence when doping cases are brought before them, especially when the substance belongs to the cannabinoids group or the corticosteroids one.  Unless the case is one of steroid abuse, the panels, at least in India, give plenty of room for the athletes to seek a lenient punishment. Perhaps this is a world-wide phenomenon. But in India, quite often the lack of education programme to familiarize athletes with anti-doping measures, prohibited substances, TUE etc plus the background of the athletes, in several cases those from villages with little understanding of English or awareness about anti-doping rules, contribute towards the eventual sanctions.
Two cases that came out of the National Games in Kerala in February, 2015 deserve mention here. Both were disposed of last December.
In both instances the substances involved belonged to the glucocorticosteroids group. One involving a male athlete from Tamil Nadu ended up in a four-year sanction and the other involving a female wrestler from UP in a one-year suspension.
Corticosteroids are steroid hormones produced in the human body. Glucocorticoids such as cortisol are anti-inflammatory drugs. In sports corticosteroids used to be a restricted drug that required advance notice and permission some years ago. Over a period of time the rules changed. It was a permitted drug through certain routes (periarticular, meaning into a joint, for example) but prohibited through some other routes.
Now there is a simple stipulation in the WADA prohibited list. “All glucocorticoids are prohibited when administered by oral, intravenous, intramuscular or rectal routes.” This will mean an injection into a joint is permitted though it is not specified as it used to be in the past.
Corticosteroids are grouped in the 'specified'category of the Prohibited List, thus enabling a reduction in sanctions if the athlete is able to prove certain conditions.
Corticosteroids, we know, are anti-inflammatory drugs and are used to manage painful conditions. They are also supposed to give a euphoric sensation that could probably explain their misuse in sports. But can that be all?
Do corticosteroids enhance performance?
Some studies have also claimed that they also delay fatigue and thereby enhance performance but this is yet to be conclusively proved. In fact there are scientists who want this class of drugs removed from the prohibited list. This is a debate for the scientists and doctors to pursue and we should leave them the task.
The widespread use of these drugs among athletes has, however, apparently prompted WADA to retain glucocorticoids in the banned list.

No credible defence

Coming back to the National Games context, the Tamil Nadu athlete tested positive for betamethasone, used in rheumatic disorders and treatment of allergic conditions, among others. He did not have much of a defence to present when he confronted the disciplinary panel headed by Mrs Gouri Karuna Mohanti.
The medicines that he claimed to have consumed mainly related to bronchial conditions. He also said he had taken some ayurvedic and unani medicines that he had been consuming over a long period of time.
“He apologized that he committed mistake and mentioned that he will accept the decision of the Panel”, stated the order.
The order goes on to say:
“As per the anti-doping rule of NADA 2015: 10.2.1 The period of ineligibility shall be four years where: 10.2.1.1 The anti-doping rule violation does not involve a specified substance unless the athlete or other person can establish that the anti-doping rule violation was not intentional.
10.2.1.2 The anti-doping rule violation involves a specified substance and NADA can establish that the anti-doping rule violation was intentional (emphasis mine).
“In the present case the anti-doping rule violation does involved (sic) a specified substance and the athlete was not able to establish that the anti-doping rule violation was not intentional” (emphasis mine).
The panel expected the athlete to prove his culpability while the rule demanded that NADA prove that he had intentionally doped. Otherwise, for specified substance the sanction should be suspension for two years.

The athlete was suspended for four years on the argument that he was not able to prove that the violation was “not intentional”, something that he was not required to do under the rules. It was NADA’s responsibility to prove that he had intentionally doped and that, even if it was proved by NADA to the satisfaction of the panel, is not explained in the order.

Wrester tests positive for three corticosteroids

Now, let us look at the other case, that of the female wrestler. She tested positive for not one but three different glucocorticosteroids, prednisone, prednisolone and betamethasone.
She argued that she had been prescribed medicines by a set of doctors for “severe back ache”. The prescription that contained tab medrol (which contained methylprednisolone) was issued to her in October 2014. Her sample was collected on 3rd Feb, 2015.
NADA argued, as per the order, that the “presence of glucocorticosteroids cannot be consumed (sic) through the medicines as prescribed in the prescriptions. There is substantial gap between the last prescription and the date of the dope test.”
It was not mentioned in the order how long she had been taking the medicines and whether she took them right into the competition in the National Games. Prednisolone/prednisone (5mg) has a half-life of 18 to 36 hours, and betamethasone (0.75mg) 36 to 54 hours.
(Half-life means the time it takes for the drug in your system to drop by 50 per cent)
It was stated in the order that the anti-doping authorities were aware of the “ongoing condition” of her back just before competition. How this could have been possible has not been explained. Perhaps NADA was told of it at the time of sample collection or else she had written down her course of treatment and medications in the doping control form.
It was also stated that the athlete being of a village background did not have much knowledge of English and was not aware of the NADA rules. She had also never received “any formal anti-doping training or booklet”.

High concentration levels

Even though none of the substances was a threshold substance requiring the laboratory to provide concentration of the drug in the urine sample, NADA presented the following facts to the panel:
“Approximate rough concentration of substances: Prednisolone-191ng/ml, prednisone-317ng/ml, betamethasone-40ng/ml.”
The wrestler apparently claimed that she had applied Panderm Plus, a cream, to relieve pain. The medicine which can also contain clobetasol, a corticosteroid, is used for the treatment of skin rashes.
NADA pointed out that none of the prescriptions that she presented contained Panderm Plus. It need not have put forward an argument since the substances detected did not contain clobetasol.
The panel, chaired by Mr. Rajeev Kapoor, however concluded: “It is admitted case that the substances found in the sample was (sic) specified, therefore as per article 10.2.1 the ineligibility shall be for two years. In this case the athlete submitted that she consumed prednisolone, which contains the prohibited substance but same was prescribed by the doctor for severe back ache and not for performance enhancement. The athlete therefore showed and proved that how the substance entered in her body and therefore she is entitled to have reduced punishment.”
NADA argued in vain that the athlete “must have intentionally consumed the prohibited substance as the laboratory reports show that the sample contained different substances belonging to the same group.”

One medicine caused it all?

Apart from medrol, the drugs given in the prescriptions were Zerodol MR (combination of aceclofenac, a non-steroidal anti-inflammatory drug, tizanidine, a muscle relaxant, and paracetamol, anti-inflammatory and fever-reducing medicine), Rantac (antacid), Tryptomer 25 (anti-depressant) and a cough syrup.
Even if assuming that Medrol, which contained methylprednisolone, did contribute prednisolone (while failing to produce the parent drug methylprednisolone or any of its primary metabolites in the urine sample), how did Medrol and the rest of the medicines either together or singly produce betamethasone?
It was apparently assumed that the class of substances being the same (glucocorticosteroids), the presence of methylprednisolone in one of the medicines was enough to prove that the positive test for prednisone, prednisolone and betamethasone was established.
It has long been accepted, even in India, that a mere prescription is no certificate to consume banned drugs.

No clue what doping control form contained

The order of the panel did not mention whether the drugs claimed to have been prescribed for back ache were mentioned in the doping control form by the athlete.
How the substance entered an athlete’s body is the key clause that determines whether “no significant fault or negligence” (article 10.5.2) could be applied in a case. Though in this case there was no explanation as to how this had been proved, as NADA pointed out, the panel concluded:
“In view of the above, the panel has no hesitation in holding that athlete was successful in proving that (sic) how the substance had entered her body and according to article 10.5.1.1 the period of eligibility (sic) shall be reduced if the athlete re-established that she was not significant fault and negligence (sic). Therefore it is decided that the period of ineligibility in this case will be 1 (one) year which will start from the date of provisional suspension i.e. from 13-04-2015”.
At one stage the order states: “These seems (sic) that the athlete indirectly admits her guilt and nor in the position (sic) to explain which resulted (sic) in prohibited substance entered in her body”

Contradictory

Through the above paragraph, the panel has possibly suggested that the athlete could not explain how the prohibited substance entered her body. Yet the panel also concluded in its final summing up that the athlete was “successful in proving” how the substance entered her body!
Thus we have two cases of glucocorticosteroids use, ending in two drastically different sanctions. The Tamil Nadu athlete did not even know perhaps how to argue that his case came under ‘specified substances’ and it was up to NADA to prove that he had taken the banned substance intentionally. Otherwise the worst that he could have got was a two-year suspension. He got four.
The female wrestler, represented by a lawyer, managed to not only convince the panel that it had to go by the prescriptions she presented, though she did not have a TUE to use any of the medicines (and the prescribed medicines did not account for all the drugs detected in her urine sample), and oral administration of prednisolone/prednisone etc was clearly banned, but also that she deserved further reduction under the “no significant fault or negligence” clause.
The wrestler’s village background and lack of understanding of English and familiarity with NADA rules were cited in the order as mitigating factors. The fact that it was her first doping offence also went in her favour. Strangely the fact that she had not tested positive for a “masking agent” was also mentioned to drive home the point that she was not intending to dope!
It is not the first time that disciplinary panels in India have taken note of the “village background” of an athlete, lack of understanding of English, lack of education material having been made available to the athletes etc in reducing sanctions.
But then the Tamil Nadu 400m runner also confessed that he was unaware of the rules that stipulated application and approval for a TUE in case some prohibited medicines were to be consumed. Mere ignorance of rules and procedures did not provide an alibi for him. He did not even get the concession that the ‘specified substance’ allowed him under the anti-doping rules.
NADA will need to make enthusiastic efforts to counter this argument about lack of awareness regarding the rules by holding more ‘athletes outreach’ programme in the coming months and years if its anti-doping efforts have to prove successful.
WADA and NADA, apart from educating athletes and support personnel about doping and anti-doping measures, about the harmful effects of the drugs etc, will also need to hold workshops and seminars involving legal experts and international arbitrators to make Indian panel members acquaint themselves better with the provisions of the Code.
(updated 01-04-2016)

Monday, March 21, 2016

The Code and the lifetime ban


Amidst the flurry of positive dope tests for the cardiac drug meldonium, the issue of lifetime ban in anti-doping measures has unwittingly been brought into focus.
For the past four-five days the news of Russian swimmer Yuliya Efimova testing positive for meldonium has been reported with almost every report dealing with the multiple world champion and Olympic medallist mentioning that she could face a lifetime ban.
Can she be sanctioned like that under the 2015 Code?

No provision

There is no provision in the Code to impose a life-ban on an athlete who tests positive a second time.
The Russian world champion swimmer, having tested positive for DHEA in 2014 and having undergone a 16-month suspension could also be facing a second charge in case the meldonium offence is established and she is indeed proven guilty.
Almost every report during the past few days has suggested that she could end up with a life-ban, perhaps without checking up whether there is a provision to ban her for life for a second offence in the 2015 rules.
Of course a doping offence, whether the first one or the second or third, will have to be proved before a disciplinary tribunal. It is possible Efimova, a strong Olympic medal contender for Russia in Rio, may get off this melodonium infraction without much damage. At least she has maintained that she would be able to prove that she was completely innocent.
"I categorically reject the accusation of doping," AP quoted Efimova as saying in a statement on Monday.  "At the current time, we are preparing for a hearing into my case. We intend to have the charge completely dismissed and to prove that I didn't break anti-doping rules, and I continue to train with the hope that I will compete at the Olympic Games in Rio."
We are not going to look into the latest doping issue surrounding the four-time world champion and Olympic bronze medallist. But only on the possibility of a lifetime ban should she be found guilty as reports have indicated.
 “Efimova faces lifetime ban” has been a routine headline the past few days. Here is one 
I have been wondering for a few months now why WADA has removed the lifetime ban for a second doping offence and why there had been little debate on the topic for more than a year now. Obviously not many have realized that a life-ban will become rarer from now on.

What the rules say

Just to make sure that the lifetime ban provision was not there for a second violation, I checked up the Code again.
This is what it has to say on a second ani-doping rule violation:
 10.7 Multiple Violations
10.7.1 For an Athlete or other Person’s second anti-doping
rule violation, the period of Ineligibility
shall be the greater of:
(a) six months;
(b) one-half of the period of Ineligibility imposed
for the first anti-doping rule violation without
taking into account any reduction under Article
10.6; or
(c) twice the period of Ineligibility otherwise
applicable to the second anti-doping rule
violation treated as if it were a first violation,
without taking into account any reduction under
Article 10.6.
The period of Ineligibility established above may then be
further reduced by the application of Article 10.6.

Confusing

This sounds a bit complicated if not confusing, but what is clear is there cannot be anything more than “twice the period of ineligibility” otherwise applicable to a particular type of offence. There is no mention of a life-ban for a second offence.
Even if we assume that ‘twice’ can be eight years or more than twice could be 10 years it cannot be “lifetime” ban.
Where does “life ban” come in in the 2015 Code?
10.7.2 A third anti-doping rule violation will always
result in a lifetime period of Ineligibility, except
if the third violation fulfills the condition for
elimination or reduction of the period of
Ineligibility under Article 10.4 or 10.5, or involves
a violation of Article 2.4. In these particular
cases, the period of Ineligibility shall be from
eight years to lifetime Ineligibility.
For violation of articles 2.7 (trafficking) or 2.8 (administration or attempted administration) punishment can go up to a lifetime ban even for a first offence.
A simple reading of the Code thus provides a clear understanding that there is no life ban for a second offence which has been the standard for several years in the past and which got changed to “eight years to life” in 2007.
However, between 2007 and 2014 there were only a limited number of cases where the maximum of life-ban was imposed for a second offence. Disciplinary panels tended to take a lenient view most of the time, resulting in more ‘eight-year suspensions’ than ‘lifetime bans’.

No option of life-ban

That option is no longer there now. It could be eight years if there is only a ‘standard’ violation, meaning the offence had it been first would have been sanctioned with a four-year ban. Depending on how a panel would treat a case under the relevant articles and provide relief as may be available in the rules if a case is properly presented an athlete can hope to get further reduction.
From January 1, 2009, when it came into existence till December 31, 2014, the National Anti-Doping Agency (NADA) of India has been able to get only one verdict of life-ban from nine cases that it successfully argued for sanctions in instances of second anti-doping rule violations. That was of one track and field athlete who walked out of a hearing in 2010, suggesting that the panel may impose any sanction including lifetime ban.
There was one more in which an Indian panel would be shown to have imposed a life-ban, that of weightlifter Shailaja Pujari in November 2010. But that was only a mere formality since by then she had been life-banned by the International Weightlifting Federation (IWF) which had handled a separate ‘positive’ report arising out of a test conducted by it in India. She had undergone a suspension previously in 2006.
The Olympic Movement Anti-Doping Code (OMADC), the precursor to the WADC, had the provision for life-ban for a second offence. So too the 2003 WADC, the first set of anti-doping rules under WADA. By 2007 it got diluted to “eight years to life”, with panels given the authority to determine the degree of fault. From 2009 through to 2014 the provision continued till it got changed again for the 2015 Code.
Between 2007 and 2014 the Code contained a provision for “aggravating” circumstances that could be sanctioned by a suspension up to four years. Not many anti-doping authorities used this provision, though, to punish athletes. Under the ‘aggravated sanction’ clause two such instances could lead to a life-ban or even one ‘standard’ coupled with an ‘aggravated’ one.
The ‘aggravated’ clause could have been utilized to sanction use of multiple drugs, apart from a few other instances, but in India, the clause was rarely, if ever, brought in, with cases involving the use of even three steroids and a stimulant taking the routine course and ending in two-year sanctions.

Demand for stiffer sanctions

Even as some of the countries and several athletes across sports have kept demanding that there be lifetime bans for even first-time offenders, rules do not provide for such bans even for second-time offenders.
Possible legal hurdles, based on the principle of “proportionality” have always been cited as the reason for not pursuing harsher penalties. But with so many clauses that could be utilized to gain lighter sanctions, the ‘clean’ athletes must be getting increasingly frustrated. After all no one would be able to recreate the ambience of an Olympic arena, the feel of the podium and the medal around one’s neck when after protracted legal battles or re-testing of samples during a 10-year period the odd athlete could be stripped of a medal and another one upgraded and bestowed the honour.
With meldonium threatening to breach all records for 'positive' results for one substance in a particular year, and offenders ready to defend themselves strongly against possible sanctions, those who still believe in dope-free sport must be hoping that more deterrent sanctions would be brought in sooner than later to deal with dope cheats.



Thursday, March 17, 2016

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 24th 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’.