Amgen's unethical practices

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Jul 14, 2009
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DirtyWorks said:
Imagine what would happen if 5 year-old samples were re-tested with today's procedures and WADA could open those cases without the UCI. From that point forward, only the very dumbest of athletes would bother doping.

As long as the UCI and IOC remain in complete control of doping control, doping will be rampant.

Bike racing happens without the UCI. No one needs them.
we are both wrong, for reasons that are not completely clear to me the UCI is necessary. Vaughters has both personally and professionally expressed many ideas, complete break away federation/organization or an independent drug control outside the UCI's management, or some other hybrid setup to exclude or semi-exclude the UCI. JV has a successful program that includes all the elements, great coverage, marketable riders, exciting schedule and stable outlook. What are all the other owners balking at? There must be something, and something big that is making them stick w McDump and his associates at the UCI.

Why just 5 years? come on man!!! I want to see the others really shake. I feel like the Armstrong rattle has only got half of the guys who are going to fess up.
I had to laugh when in Lance's 11th hour Phil Anderson suddenly remembered a bribe! or yah that I totally forgot mate. Armstrong was only the biggest wad in the cycling's litterbox but hardly the stinkiest.
 
Aug 27, 2012
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mastersracer said:
Epidemiology is anything but basic. It is certainly not the simple-minded frequentist inference of the sort you suggest.

Just look at the notoriously difficult history of making causal inferences between smoking and cancer. In the case of PEDs and Armstrong, the associations are weak - in previous posts I have cited what I believe to be the single paper on this subject - the underlying mechanisms are poorly understood, there is no prior information on how to model interaction effects among the PEDs Armstrong took, etc. Besides, causal inference is typically made at a population level, and it is fallacious to infer causation at the individual level from that. A journal would flat out reject the proposed study you suggest for these reasons (and simply for lack of statistical power even if the other limitations were not present).
Well thanks for the Epi 201 lecture.

So where does it leave us readers/fans trying to conclude on PED use and risks to long term health, and Amgen's role in promoting its use? And what do the underlying mechanisms/interaction effects have to do with the epidemiological "proof" of health detriment...? Nice to have but don't need this at all to conclude on the Eddy B cohort...

Can we draw any conclusions from the "remarkably high" incidence of morbidity/mortality in one of the few "controlled setting" environments that we now have outcome data on? Ie. the Eddy B junior program? And the high cluster of EPO deaths in the early 90's?

Is the science (epidemiology) just not yet good enough or what is going on? Like tobacco? Please fill us in with Epi 301. Clinical common sense tells us PEDs are/can be dangerous for your health, you're saying "we can't prove it and therefore it doesn't exist? What's the take away, beyond the methodology into "good clinical practice" recommendations for junior cyclists? Quite aside from the obvious "cheating" and benefits we know they provide.
 
Sep 29, 2012
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mastersracer said:
In the case of PEDs and Armstrong, the associations are weak - in previous posts I have cited what I believe to be the single paper on this subject - the underlying mechanisms are poorly understood, there is no prior information on how to model interaction effects among the PEDs Armstrong took, etc. Besides, causal inference is typically made at a population level, and it is fallacious to infer causation at the individual level from that. A journal would flat out reject the proposed study you suggest for these reasons (and simply for lack of statistical power even if the other limitations were not present).
I have no PhD - just a smattering of stats and programming - but isn't the bolded exactly what Ed Coyle did with his Armstrong study? Or worse, not even find causation at the population level and apply it to an individual, but study only n=1 for 7 years, generating 6 data points and extrapolate wildly?

It was published (just in the SCA nick of time).

The Aussies (scientists with PhDs) disagreed, not that that made one wit of difference.

The study is not only published, but cited and used as a source for further study, according to our esteemed resident expert.

Just askin'.
 

mastersracer

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Jun 8, 2010
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Tinman said:
Well thanks for the Epi 201 lecture.

So where does it leave us readers/fans trying to conclude on PED use and risks to long term health, and Amgen's role in promoting its use? And what do the underlying mechanisms/interaction effects have to do with the epidemiological "proof" of health detriment...? Nice to have but don't need this at all to conclude on the Eddy B cohort...

Can we draw any conclusions from the "remarkably high" incidence of morbidity/mortality in one of the few "controlled setting" environments that we now have outcome data on? Ie. the Eddy B junior program? And the high cluster of EPO deaths in the early 90's?

Is the science (epidemiology) just not yet good enough or what is going on? Like tobacco? Please fill us in with Epi 301. Clinical common sense tells us PEDs are/can be dangerous for your health, you're saying "we can't prove it and therefore it doesn't exist? What's the take away, beyond the methodology into "good clinical practice" recommendations for junior cyclists? Quite aside from the obvious "cheating" and benefits we know they provide.
If you want to draw conclusions from your Eddy B cohort, the place to start would be to find out the outcome of the Greg Strock lawsuit. The last I heard of it (based on a Velonews article) was the defense contesting causality.

(http://velonews.competitor.com/2006/04/news/six-years-later-strock-case-comes-to-court_9763

It's not clear to me that there is in fact a raised incidence of any specific disease/disorder in the Eddie B cohort - there's testicular cancer, autoimmune disorders, heart conditions (most apparently congenital). It seems initially plausible that it is simply a coincidence that they at one time rode for the same team. Besides, they belong to a larger cohort (90's PED using professional cyclists), which should be the group to study.

Getting back to Armstrong, I don’t believe there’s a single peer-reviewed article showing any linkage between PED use and testicular cancer, even among strength athletes and steroid abuse (links are between steroids and liver and kidney cancers). This reflects the broader limitations in terms of epidemiology of testicular cancer in the general population, where causation is extremely poorly understood.

As I said before, the single review I have seen on this is Tentori, L., & Graziani, G. (2007). Doping with growth hormone/IGF-1, anabolic steroids or erythropoietin: is there a cancer risk? Pharmacological research, 55(5), 359–69. You can see there the tentative conclusions (or lack of such) reflecting the relatively current state of knowledge.

Finally, I think it is a mistake to base the argument against PED usage on their potential health risks. First, this makes their prohibition dependent on contingent results of science (what if a PED isn’t associated with a health risk?) and ignores the fact that young people are relatively insensitive to future consequences (high temporal discounting and risk insensitivity). The argument should be based on violating norms of fairness (there are separate arguments for why this also more likely to reduce their use).
 

mountainrman

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Oct 17, 2012
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mastersracer said:
The argument should be based on violating norms of fairness
Another bag of worms!

It is hard to define objective fairness in an absolute way outside the context of a set of rules.

For example - it is well known that if you go to and live at 12000 feet for several weeks, natural cycles kick in to create a massive increase red blood effectiveness. Ask any 8000m peak mountaineer!

So - how is it fair for the ones who cannot afford to do that?

Should money dictate fairness?
Many win the geographic lottery- take some Kenyans and Ethiopians from the rift valley live at high altitude continously, and I their genes have adapted to it, which makes them the best long distance runners in the world.

I have always been surprised that rift valley countries do not generate the best cycling climbers too - perpaps because they are not tall enough! - history says you win more tours at 185cm height than those who are less than 170 - a typical Kenyan runner.

How is it fair on countries such as denmark who are almost below sea level?

Many athletes have to hold down a job to fund them , where some states still fund their athletes to train full time (take china for example). How is that fair?

Many athletes have wonderful climates for training year round and local massive hills to train on. Others don't.

So if EPO can achieve in a few days what living at high altitude, going to high altitude or being able to train full time, or having a lot of big hills - is that really "unfair" on the guys with the advantages that allow them to achieve that by natural means? not everyone has those opportunities.

I am not arguing the case for allowing EPO.

I am simply stating that it is impossible to achieve an objective and absolute "fairness" when life itself is not fair with equal opportunities to all.

So in the end - unfair is not an absolute thing at all - it is relative to a set of rules.
For the present taking EPO is unfair, because the rules say so.
 
May 14, 2010
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mountainrman said:
Another bag of worms!

It is hard to define objective fairness in an absolute way outside the context of a set of rules.


For example - it is well known that if you go to and live at 12000 feet for several weeks, natural cycles kick in to create a massive increase red blood effectiveness. Ask any 8000m peak mountaineer!


So - how is it fair for the ones who cannot afford to do that?


Should money dictate fairness?

Many win the geographic lottery- take some Kenyans and Ethiopians from the rift valley live at high altitude continously, and I their genes have adapted to it, which makes them the best long distance runners in the world.

I have always been surprised that rift valley countries do not generate the best cycling climbers too - perpaps because they are not tall enough! - history says you win more tours at 185cm height than those who are less than 170 - a typical Kenyan runner.


How is it fair on countries such as denmark who are almost below sea level?


Many athletes have to hold down a job to fund them , where some states still fund their athletes to train full time (take china for example). How is that fair?


Many athletes have wonderful climates for training year round and local massive hills to train on. Others don't.


So if EPO can achieve in a few days what living at high altitude, going to high altitude or being able to train full time, or having a lot of big hills - is that really "unfair" on the guys with the advantages that allow them to achieve that by natural means? not everyone has those opportunities.


I am not arguing the case for allowing EPO.


I am simply stating that it is impossible to achieve an objective and absolute "fairness" when life itself is not fair with equal opportunities to all.


So in the end - unfair is not an absolute thing at all - it is relative to a set of rules.

For the present taking EPO is unfair, because the rules say so.
That's really all you need to know.
 
Sep 29, 2012
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BUMP - any response, mastersracer?

mastersracer said:
In the case of PEDs and Armstrong, the associations are weak - in previous posts I have cited what I believe to be the single paper on this subject - the underlying mechanisms are poorly understood, there is no prior information on how to model interaction effects among the PEDs Armstrong took, etc. Besides, causal inference is typically made at a population level, and it is fallacious to infer causation at the individual level from that. A journal would flat out reject the proposed study you suggest for these reasons (and simply for lack of statistical power even if the other limitations were not present).
I have no PhD - just a smattering of stats and programming - but isn't the bolded exactly what Ed Coyle did with his Armstrong study? Or worse, not even find causation at the population level and apply it to an individual, but study only n=1 for 7 years, generating 6 data points and extrapolate wildly?

It was published (just in the SCA nick of time).

The Aussies (scientists with PhDs) disagreed, not that that made one wit of difference.

The study is not only published, but cited and used as a source for further study, according to our esteemed resident expert.

Just askin'.
 

mastersracer

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Jun 8, 2010
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Dear Wiggo said:
BUMP - any response, mastersracer?



I have no PhD - just a smattering of stats and programming - but isn't the bolded exactly what Ed Coyle did with his Armstrong study? Or worse, not even find causation at the population level and apply it to an individual, but study only n=1 for 7 years, generating 6 data points and extrapolate wildly?

It was published (just in the SCA nick of time).

The Aussies (scientists with PhDs) disagreed, not that that made one wit of difference.

The study is not only published, but cited and used as a source for further study, according to our esteemed resident expert.

Just askin'.
sorry, didn't see that first time around. The fallacy I was referring to is known as the ecological fallacy, which involves making an inference about an individual based on aggregate data for a group. Coyle didn't make that mistake - I didn't follow the case closely, but it may have been one of the few mistakes he wasn't accused of making :)
 
May 14, 2010
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I'm pretty sure the rules are written so as to take into account substances that aren't specifically listed but which might confer undue advantage. It's tautological to argue, as mountainrman does, that some riders are advantaged by where they live and that because of this EPO is not inherently unfair. Some riders, by virtue of this or that circumstance, are advantaged by superior aerobic and anaerobic systems, too, but that doesn't make concealing a small motor in your bike any less unfair.
 
Sep 29, 2012
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mastersracer said:
sorry, didn't see that first time around. The fallacy I was referring to is known as the ecological fallacy, which involves making an inference about an individual based on aggregate data for a group. Coyle didn't make that mistake - I didn't follow the case closely, but it may have been one of the few mistakes he wasn't accused of making :)
You were claiming that you couldn't publish same study (with ecological fallacy).

Yet Coyle published a study with a sample size of n=1.

Other studies are based on his study, or citie it as "evidence" to support their protocols or conclusions.
 
Aug 27, 2012
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mastersracer said:
If you want to draw conclusions from your Eddy B cohort, the place to start would be to find out the outcome of the Greg Strock lawsuit. The last I heard of it (based on a Velonews article) was the defense contesting causality.

(http://velonews.competitor.com/2006/04/news/six-years-later-strock-case-comes-to-court_9763

It's not clear to me that there is in fact a raised incidence of any specific disease/disorder in the Eddie B cohort - there's testicular cancer, autoimmune disorders, heart conditions (most apparently congenital). It seems initially plausible that it is simply a coincidence that they at one time rode for the same team. Besides, they belong to a larger cohort (90's PED using professional cyclists), which should be the group to study.

Getting back to Armstrong, I don’t believe there’s a single peer-reviewed article showing any linkage between PED use and testicular cancer, even among strength athletes and steroid abuse (links are between steroids and liver and kidney cancers). This reflects the broader limitations in terms of epidemiology of testicular cancer in the general population, where causation is extremely poorly understood.

As I said before, the single review I have seen on this is Tentori, L., & Graziani, G. (2007). Doping with growth hormone/IGF-1, anabolic steroids or erythropoietin: is there a cancer risk? Pharmacological research, 55(5), 359–69. You can see there the tentative conclusions (or lack of such) reflecting the relatively current state of knowledge.

Finally, I think it is a mistake to base the argument against PED usage on their potential health risks. First, this makes their prohibition dependent on contingent results of science (what if a PED isn’t associated with a health risk?) and ignores the fact that young people are relatively insensitive to future consequences (high temporal discounting and risk insensitivity). The argument should be based on violating norms of fairness (there are separate arguments for why this also more likely to reduce their use).
Thanks for reply. Appreciate the thinking.

What would be the advantage studying the larger cohort if you are going to introduce more noise to the sample? Getting people to confess PED use in that larger cohort is a nightmare, in addition, the amount (duration and cocktail) will be even harder to get a read out on. At least with Eddy B's cohort you have a better idea. It's a relatively homogeneous cohort although you may not get a clear read out on exactly what/how/when it was taken, you know there was serious **** going down. And all of the health outcomes in that cohort are well described in PED toxicology. Occam's razor says obvious.

Your post conclusion for me mixes various elements, and I struggle with that.
Mostly the fact we can't "prove" adverse outcome (yet). This is not rationale for not banning use in sport for health risk reasons. Toxicology, coupled with not having control over dose, co-medication, etc in an out of medical indication environment is sufficient reason for banning in sport, not to mention the legal headache of the prescribed medicines controlled environment. Future consequence insensitivity is a social science construct, and as such not relevant to the "harm" discussion, although I agree it is there. I also do agree with your fairness point with regard to "drug", we have to draw the line somewhere. But its a challenging one as one can argue genetic (VO2Max, etc) and economic (money to buy altitude tent) fairness points aplenty.
 
Jul 4, 2009
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Maxiton said:
I'm pretty sure the rules are written so as to take into account substances that aren't specifically listed but which might confer undue advantage. It's tautological to argue, as mountainrman does, that some riders are advantaged by where they live and that because of this EPO is not inherently unfair. Some riders, by virtue of this or that circumstance, are advantaged by superior aerobic and anaerobic systems, too, but that doesn't make concealing a small motor in your bike any less unfair.
....the question was posed with the US Olympic blood doping scandal in mind...apparently blood doping was not at the time against the rules yet the perps paid a price...

...and what I was also trying to do was start a discussion on how this is a bit of a grey area...not as cut and dried as your response was ( and yes I understand it may have been kinda rhetorical/off the cuff so not trying to start a war but a discussion )...for instance for most of my cycling career I suffered from severe asthma and seasonal hayfever...until recently I refused to take the approved drugs...and it finally got so bad that I was faced with a decision..take the drugs or stop racing.....so I took the drugs and man it was amazing, I felt like superman....being able to breathe properly while racing all out was really unbelievable...sound familiar?

..so...but for some rules and TUE's how are guys like me different from drugged to the gills pros...that was a good question that I couldn't resolve...

...so I quit racing and now just putter around...but man, for a short time it certainly wasn't puttering it was hammering...and as you all know that has a very special charm....and some days, I really miss it...:(

...as for topic at hand and the Amgen perps...easy ...find a wall and so on and so forth...I mean trading lives for market share!?...wtf!?...

Cheers

blutto
 
Aug 27, 2012
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blutto said:
for instance for most of my cycling career I suffered from severe asthma and seasonal hayfever...until recently I refused to take the approved drugs...and it finally got so bad that I was faced with a decision..take the drugs or stop racing.....so I took the drugs and man it was amazing, I felt like superman....being able to breathe properly while racing all out was really unbelievable...sound familiar?
Surely a medical clearance would have cleared you for using these drugs in competition (or indeed daily life)?

Many athletes on asthma meds, at least B2 agonists (Ventolins etc). Not sure of inhaled steroids, ie. whether sports approved.
 
Jul 4, 2009
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Tinman said:
Surely a medical clearance would have cleared you for using these drugs in competition (or indeed daily life)?

Many athletes on asthma meds, at least B2 agonists (Ventolins etc). Not sure of inhaled steroids, ie. whether sports approved.
...sorry but I may not have made myself clear....the meds I was taking were all quite "legal" ( though I did have to get TUE's )...the problem was that I couldn't shake the notion that it seemed that I owed my new found success to some prescriptions...and I really wasn't happy with that so I quit the drugs and the racing...

Cheers

blutto
 
Aug 27, 2012
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blutto said:
...sorry but I may not have made myself clear....the meds I was taking were all quite "legal" ( though I did have to get TUE's )...the problem was that I couldn't shake the notion that it seemed that I owed my new found success to some prescriptions...and I really wasn't happy with that so I quit the drugs and the racing...

Cheers

blutto
the drugs you took had no performance enhancing effect to "normal" athletes. So perfectly state of mind for you to take...
 
Jul 4, 2009
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Tinman said:
the drugs you took had no performance enhancing effect to "normal" athletes. So perfectly state of mind for you to take...
..."no performance enhancing effect" ?....dude I was there when this happened and my performance, to my eyes at least, was greatly enhanced....though I guess that depends on how you define the term "normal" which it seems your point is pivoting on....

Cheers

blutto
 
I'll post what I've said in any other thread about the subject of any drug legal/illegal.

There should be not exceptions for any medication, that includes things that don't need TUEs, like albuterol. Which, I posted a link in another thread about a study that showed albuterol can help the performance of cyclist.

Yet, you don't need to tell anybody you are taking it.

Does this make sense?

If you want a clean sport, everything is banned. You race what you were born with, end of story.

If you have asthma, well, sad to say it, too bad. When we start making inclusions of drugs and others banned, you already blurred the line of a so-call level playing field.

If USADA and any other organization was really serious and wasn't on the LA witch hunt to land the big game animal, that would be the stance. Yet, they say one thing, and turn around and do something entirely different hypocritically.

No race result losses for CVV, Danielson, Big George etc? why? Because they testified on behalf to get Lance. All admitted EPO dopers amongst other banned substances.

Anyway, rant over. Ban everything, test for everything, if caught, lifetime ban...loss of all results, earnings, etc...

Amgen isn't the problem here. That is how the drug company business works. You fund research, go through lengthy approval processes with the FDA, spends $$$$ of dollars. Then get approval hopefully to market/sell the drug to get a return on profit. That is the free market.
 
zigmeister said:
...

If you want a clean sport, everything is banned. You race what you were born with, end of story.

If you have asthma, well, sad to say it, too bad. When we start making inclusions of drugs and others banned, you already blurred the line of a so-call level playing field.

...
If only the world were so simple.

Asthma rates have been surging around the globe over the past three decades... by 2004 Sweden’s asthma cases had increased to 10 percent, according to one international study, while the number of cases in the U.K. had soared to 20 percent.

Sorry, I wasn't born with it.

But, just wait, you could be the next cyclist diagnosed with it. The chances of you getting it get better and better.

If we want to make it a level playing field, then all those cyclists that don't have asthma need to breath through a straw.

For asthma sufferers, asthma medication at best returns you to what you were born with. No more. In my case, my asthma medication also has a beneficial effect with allowing me to exhale better - though not to a 'normal' functioning level. I cannot blow out birthday candles otherwise. Think about that the next time someone like me kicks your **** up a hill.

Now, are there guys in the peloton cheating with Salbutamol? Yes.

Dave.
 
blutto said:
..."no performance enhancing effect" ?....dude I was there when this happened and my performance, to my eyes at least, was greatly enhanced....though I guess that depends on how you define the term "normal" which it seems your point is pivoting on....

Cheers

blutto
One inhale of salbutamol can boost my VO2max from ~150W to ~500W. If my allergy reaction is as bad as to restrict that much. the ~500W would be the same or less than on a perfect winter day without allergens. Even with a TUE, if it would take me 10W higher than that ~500W figure, I'd feel like a cheater. Even on a 2'37 dirt road climb, the asthma would get me down to 3'05, taking all reserves from my blood, muscles, and what have you. All-out effort, world of agony. After one inhale and another 3/4hr of riding, I'd do the 2'37.
In the end, I never did manage to get the TUE (stupid house doc, and not very motivated myself to persue it futher), so I quit racing until the cap was installed, and I would always dose 4x less than allowed maximum.

I do sometimes think that insulin use can help a diabetic athlete beyond natural capacity. Not sure what to think about the ethics of that, tough one.
 
Aug 27, 2012
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D-Queued said:
If only the world were so simple.
I think this captures the issue with drugs used on TUE for genuine athlete morbidities. I am not sure what, if any, procedures exist to check if these conditions are genuine in an athlete asking for a TUE.

Salbutamol is a borderline problem case. Many athletes using it, many likely without a real respiratory condition. But if I truly had a respiratory condition that would affect my performance I would have no hesitation using it.

Cloxxki said:
I do sometimes think that insulin use can help a diabetic athlete beyond natural capacity. Not sure what to think about the ethics of that, tough one.
Agreed. In theory Froome could make a point that his rare condition some years ago required EPO. Would a TUE if he asked for one be granted?

No, because there is a list of allowable drugs for TUE's, as I understand it. I am not sure if insulin is on it, suspect not. Hence not allowed. But salbutamol for sure is on the list. And it's not supposed to be of benefit to those who have "normal respiratory function". But checking the research on that may be interesting because it is widely (ab)used.
 
Jul 4, 2009
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....so what do you do about commonly available substances that can "enhance performance" such as aspirin and anti-acid pills...which fly so far under the TUE powered radar they might as well only exist in a parallel undiscovered universe ...

Cheers

blutto
 
Jun 19, 2009
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blutto said:
....so what do you do about commonly available substances that can "enhance performance" such as aspirin and anti-acid pills...which fly so far under the TUE powered radar they might as well only exist in a parallel undiscovered universe ...

Cheers

blutto
I agree with your approach and practice the same as Ziggy and I agree on that point (not the Witch Hunt nonsense). As for the items like aspirin, anti-acids...this is where personal accountability is the key. Water helps you in strenuous excercise but reasonable people would not exclude it from competition as an "aid". Tyler Hamilton's book documents the creeping justifications that caused him to blood dope...there is a certain amount of bullsh*t in that "disclosure" as USAC junior riders where exposed to stimulants and steroids far before going pro. So a strict ban could minimize the opportunity to begin justifying progressive "aids".
Reasonably honest people would have to deal with any justifications about taking a substance; purely for sport. If your "affliction" requires medication in every day life you should pursue what allows you to live. If we agree on the fact that the same doesn't apply to competition we are drawing an appropriate line IMO. Cycling and other endurance sports don't need to be democratic and extend equalizing factors to the health challenged so all can compete. Life's not always fair. I can't ski downhill like Bode.
 
Jul 4, 2009
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Oldman said:
I agree with your approach and practice the same as Ziggy and I agree on that point (not the Witch Hunt nonsense). As for the items like aspirin, anti-acids...this is where personal accountability is the key. Water helps you in strenuous excercise but reasonable people would not exclude it from competition as an "aid". Tyler Hamilton's book documents the creeping justifications that caused him to blood dope...there is a certain amount of bullsh*t in that "disclosure" as USAC junior riders where exposed to stimulants and steroids far before going pro. So a strict ban could minimize the opportunity to begin justifying progressive "aids".
Reasonably honest people would have to deal with any justifications about taking a substance; purely for sport. If your "affliction" requires medication in every day life you should pursue what allows you to live. If we agree on the fact that the same doesn't apply to competition we are drawing an appropriate line IMO. Cycling and other endurance sports don't need to be democratic and extend equalizing factors to the health challenged so all can compete. Life's not always fair. I can't ski downhill like Bode.
....do like your introduction into this discussion of the term "creeping justification"....certainly played into my thinking when I walked away....it is often the slippery slope that allows for the slow incremental movement that carries well intentioned reasonably good folks to doing some pretty stupid things....

...oh, for the want of a nail...

Cheers

blutto
 

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