wada backpedals on meldonium. hurts its science cred.

[WillemS]

Re: Re:

wada based on its poor science basis would probably lose. the russians were intending to challenge not only the lack of science on the clearance rate but also the very inclusion of meldonium on the banned list, not to mention the wrong section s4.

I disagree with you on the "poor science" part. As has been shown earlier in this thread, all publicized papers indicated that Meldonium clears the body rather quickly. So assuming that wasn't based on "poor science", but actually based on what was considered to be the case in science. Now, in this case, it turned out to be that the clearance of Meldonium is somewhat more complicated, with trace amount lingering longer in the body, but that's the way science works. Revising your earlier conclusions when evidence against it surfaces actually shows a rather good scientific integrity as opposed to stubbornly maintaining your conclusions against objecting evidence.

Now, I can't say anything about the inclusion of Meldonium on the list, although I don't agree that "proven effectiveness" should be a criterion for inclusion. There are probably a lot of products on the list that have no true effect on performance, but as long as athletes think there is an effect and the product is potentially harmful, it should be on the list, regardless of the "objective effectiveness". I think that oddly high number of professional athletes that use Meldonium should be reason enough to prohibit its use without a TUE.

 

[Alex Simmons/RST]

Re: Re:

Now, I can't say anything about the inclusion of Meldonium on the list, although I don't agree that "proven effectiveness" should be a criterion for inclusion.

Read the WADA code.

Proven effectiveness (i.e. ergogenic properties) is not the standard used when considering whether a substance or method is to be included on the prohibited list.

 

[Maxiton]

It was just announced that Sharapova will face a hearing. According to the BBC, the decision was left to the International Tennis Federation and they turned thumbs down.

 

[Merckx index]

Re: Re:

I disagree with you on the "poor science" part. As has been shown earlier in this thread, all publicized papers indicated that Meldonium clears the body rather quickly. So assuming that wasn't based on "poor science", but actually based on what was considered to be the case in science. Now, in this case, it turned out to be that the clearance of Meldonium is somewhat more complicated, with trace amount lingering longer in the body, but that's the way science works. Revising your earlier conclusions when evidence against it surfaces actually shows a rather good scientific integrity as opposed to stubbornly maintaining your conclusions against objecting evidence.

Agreed. WADA normally doesn't need to consider clearance rates, except when estimating how long after an athlete takes a substance he will remain positive (the glow time). But they generally aren’t relevant to whether or how a substance should be prohibited. This was a very unusual circumstance, when a substance that had been allowed was banned. WADA, as usual, is giving a lot of probable dopers the benefit of the doubt.

Read the WADA code.

Proven effectiveness (i.e. ergogenic properties) is not the standard used when considering whether a substance or method is to be included on the prohibited list.

That's not quite correct. It's one of three criteria, two of which have to be satisfied. So, yes, a substance can be banned without any evidence that it has PE properties, but that is still an important criterion. And one of the others is whether taking the substance violates the spirit of the code, and generally, if not always, violation of the spirit involves performance enhancement.

It was just announced that Sharapova will face a hearing. According to the BBC, the decision was left to the International Tennis Federation and they turned thumbs down.

Given that she basically admitted to taking the drug after it was no longer permitted, I don't see how this new ruling can help her.

If you've ever wondered why so many dopers continue to lie when they're caught red-handed, clinging to any possible excuse, here's a good example of why. It's not over till it's over. If Sharapova had denied taking meldonium after Jan. 1, and insisted that there must have been a mistake in the testing, she might have been in position to get off. I'm not sure, but I think her tested level was low enough to satisfy the criterion. Even if it wasn't, now that WADA has admitted that there is this second, slower phase of clearance, the door is opened for arguments based on individual variability.

 

[Maxiton]

Re: Re:

Given that she basically admitted to taking the drug after it was no longer permitted, I don't see how this new ruling can help her.

Apparently the ITF agrees with you.

 

[Alex Simmons/RST]

Re: Re:

Read the WADA code.

Proven effectiveness (i.e. ergogenic properties) is not the standard used when considering whether a substance or method is to be included on the prohibited list.

That's not quite correct. It's one of three criteria, two of which have to be satisfied. So, yes, a substance can be banned without any evidence that it has PE properties, but that is still an important criterion. And one of the others is whether taking the substance violates the spirit of the code, and generally, if not always, violation of the spirit involves performance enhancement.

I'm well aware of the criterion that are needed to be satisfied. There are two streams:
(i) Fail any 2 of the 3 criteria of: performance enhancement, health risk or spirit of sport and it's likely to be added.
(ii) The other stream is prohibition of masking agents or methods, which is a single criteria on its own.

For the performance enhancement criterion, proven performance enhancement is not a necessary requirement to trigger this. The WADA code states:

4.3.1.1 Medical or other scientific evidence, pharmacological effect or experience that the substance or method, alone or in combination with other substances or methods, has the potential to enhance or enhances sport performance;

Likewise, the health criterion is similar:

4.3.1.2 Medical or other scientific evidence, pharmacological effect or experience that the Use of the substance or method represents an actual or potential health risk to the Athlete;

Spirit of sport is defined in the code.

The masking properties criterion likewise are actual or potential.

IOW proven performance enhancement isn't necessary to trigger that criterion. Only potential performance enhancement need be shown, and not necessarily with scientific evidence either.

 

[Merckx index]

Re: Re:

I'm well aware of the criterion that are needed to be satisfied. There are two streams:
(i) Fail any 2 of the 3 criteria of: performance enhancement, health risk or spirit of sport and it's likely to be added.
(ii) The other stream is prohibition of masking agents or methods, which is a single criteria on its own.

For the performance enhancement criterion, proven performance enhancement is not a necessary requirement to trigger this. The WADA code states:

4.3.1.1 Medical or other scientific evidence, pharmacological effect or experience that the substance or method, alone or in combination with other substances or methods, has the potential to enhance or enhances sport performance;

Likewise, the health criterion is similar:

4.3.1.2 Medical or other scientific evidence, pharmacological effect or experience that the Use of the substance or method represents an actual or potential health risk to the Athlete;

Spirit of sport is defined in the code.

The masking properties criterion likewise are actual or potential.

IOW proven performance enhancement isn't necessary to trigger that criterion. Only potential performance enhancement need be shown, and not necessarily with scientific evidence either.

“Potential” and “proven” are not necessarily exclusive, as you imply. E.g., you could have a study that concluded that a certain substance improved performance in some, but not all athletes. This may be the case with beetroot juice. You could then claim that it had proven effectiveness in some athletes, and because of this, was potentially effective in any athlete. That is, unless an athlete actually submitted tests showing that beetroot juice did not enhance his performance significantly, one would conclude that it potentially could. It’s potential to do this was in fact proven.

A different case, one that seems to describe the situation you’re implying, is presented by a substance that has well-established physiological effects that could lead to performance enhancement, but for which studies fail to show actual enhancement. Some might argue that HGH is like this. So one would conclude on the basis of its physiological effects that it is potentially performance enhancing, though (according to some) it’s never been proven to be in actual studies.

The problem I have with this is that if the substance has repeatedly failed to show performance enhancing effects, in what sense can it be said to be potentially enhancing? It’s fine to use the word potential before a substance has been thoroughly studied, but if studies continue to be negative, the label potential begins to lose its meaning. There are many situations in which we use the word potential to describe something that could happen in the right circumstances: this man will do great things with the right teachers and the right environment. But that’s not the sense in which potential is used in the WADA code. A substance either is or is not (significantly) performance enhancing; potential is just a label used to hide our ignorance, and should be considered a temporary designation.

Beetroot juice is not banned, while HGH is. Why? Allowing beetroot juice is presumably justified because it doesn’t trip either of the other two criteria. It has no adverse health effects that we know of, and its consumption would seem not to violate the spirit of sport, given that it’s a nutrient commonly found in many people’s diets.

HGH, on the other hand, trips both criteria. It can have adverse health effects, and it contradicts the spirit of the sport. But in what sense does it do the latter? Mostly, because it’s known physiological effects strongly suggest that anyone taking it is doing so for performance enhancement, even if in fact it may not be performance enhancing.

IOW, as I discussed before, these three criteria are not as independent as they’re assumed to be. The spirit criterion is used, basically, as a prop to support the potential criterion. If a substance can’t be proven to be performance enhancing, the only justification for banning it is because athletes think it is, and will use it for that reason. That is a violation of the spirit criterion. Conversely, if a substance (or a method, like high altitude training) has shown to be performance enhancing, the only justification for not banning it is that it’s not in conflict with the spirit of sport.

The potential criterion appears to me to be superfluous; it can’t stand on its own. By definition, taking any substance that is considered potentially performance enhancing is violating the spirit of the sport (and the same with masking agents). So why even have that criterion at all? It would be simpler just to have the two criteria, with a more detailed explanation of what violates the spirit.

So while you may argue that no WADA criterion requires proven effectiveness, my point is that the distinction between proven and potential is irrelevant. The effectiveness of a substance is not really the issue that WADA is concerned with, proven or potential. It’s the violation of the spirit. WADA is not concerned with the likelihood that some substance is performance enhancing; it’s concerned with the intent of the athlete in taking that substance.

 

[Alex Simmons/RST]

I'm only pointing out that under the WADA code, a substance does not need to have proven benefit for it to be prohibited.

The reasons for that are multifactoral and include the use of the words "has the potential to enhance" in the code, as well as the fact that it's an anti-Meatloaf policy, i.e. 2 out of 3 is bad.

Keep in mind that the words "potential health risk" is used in the health criteria and the words "has the potential to mask" is used in the masking agent criteria as well, so the bar is set relatively low for each of those.

To a degree, decisions on what is prohibited is somewhat subjective but where possible is informed by the available science/evidence.

 

[zigmeister]

Re:

^^ WADA simply don't have the budget to do exhaustive pharmacokinetic clinical studies for every substance included in the prohibited list. They rely on information in the scientific literature.
With meldonium, prior studies suggested a relatively short half-life (of <10 hours). In this context, very protracted periods of retention/excretion would be fairly unusual, so I have some sympathy for them.

^This partially.

With that said, the active half-live of a substance, and the metabolites that could be found still days/weeks or even months later in the body still being excreted related to the main drug are two different areas of pharmacokinetics. There are many drugs, during the metabolism process, will still be bound in the plasma and excreted via feces for a long time after the "half-life" of the main/active drug.