HemAssist . What do forumites know?

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http://www.cyclingnews.com/news/experts-call-armstrong-hemassist-connection-unlikely

Yorck Olaf Schumacher, a researcher at the Freiburg University in Germany who was part of the study of a drug similar to HemAssist called Hemopure, said that hemoglobin-based oxygen carriers (HBOCs) showed no performance benefit. "There's nothing up to now that shows or proves that it improves performance," he told AP.
I think this is a little misleading. The results of studies of animals have been described as “increasing tissue perfusion”, which certainly sounds like performance enhancement to me. If more oxygen is delivered to tissues, that by virtually definition is performance enhancement. In fact, before the drug would have even been tried on humans, there would have had to have been strong evidence from animal studies that it increased oxygen delivery. If not, there would have been no point in further testing.

The drug was pulled following the results of Phase III trials, which indicated greater mortality rates than in controls. That does not mean that the drug did not increase oxygen delivery to tissues. Unless they actually measured such parameters, and found that there was no increase in oxygen-carrying capacity, then Schumacher’s statement is meaningless. But since neither Schumacher nor anyone else specifically refers to such data, I rather doubt that it exists, particularly since our circulatory system is not so different from that of other mammals that one would expect an effect in the latter that did not occur in our own species. If there is nothing up to now that proves it enhances performance,that is probably because, after the deaths, no one bothered to conduct carefully controlled studies of this issue.

Not to say LA did or did not ever use this drug.
 
Jun 22, 2009
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Merckx index said:
http://www.cyclingnews.com/news/experts-call-armstrong-hemassist-connection-unlikely



I think this is a little misleading. The results of studies of animals have been described as “increasing tissue perfusion”, which certainly sounds like performance enhancement to me. If more oxygen is delivered to tissues, that by virtually definition is performance enhancement. In fact, before the drug would have even been tried on humans, there would have had to have been strong evidence from animal studies that it increased oxygen delivery. If not, there would have been no point in further testing.

The drug was pulled following the results of Phase III trials, which indicated greater mortality rates than in controls. That does not mean that the drug did not increase oxygen delivery to tissues. Unless they actually measured such parameters, and found that there was no increase in oxygen-carrying capacity, then Schumacher’s statement is meaningless. But neither Schumacher nor anyone else specifically refers to such data, I rather doubt it, particularly since our circulatory system is not so different from that of other mammals that one would expect an effect in the latter that did not occur in our own species. If there is nothing up to now that proves it enhances performance because, after the deaths, it’s probably because no one bothered to conduct carefully controlled studies of this issue.

Not to say LA did or did not ever use this drug.
check out:

http://www.ncbi.nlm.nih.gov/pubmed/17024639

i linked to this just a bit ago but may have been too slick.

it suggests the negative impact on BP may offset performance benefits:

Infusion of Hemopure did not bestow the same physiological advantages generally associated with infusion of red blood cells. It is conceivable that under exercise conditions, the hypertensive effects of Hemopure counter the performance-enhancing effect of improved blood oxygen carrying capacity.
 
May 13, 2009
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Merckx index said:
http://www.cyclingnews.com/news/experts-call-armstrong-hemassist-connection-unlikely



I think this is a little misleading. The results of studies of animals have been described as “increasing tissue perfusion”, which certainly sounds like performance enhancement to me. If more oxygen is delivered to tissues, that by virtually definition is performance enhancement. In fact, before the drug would have even been tried on humans, there would have had to have been strong evidence from animal studies that it increased oxygen delivery. If not, there would have been no point in further testing.

The drug was pulled following the results of Phase III trials, which indicated greater mortality rates than in controls. That does not mean that the drug did not increase oxygen delivery to tissues. Unless they actually measured such parameters, and found that there was no increase in oxygen-carrying capacity, then Schumacher’s statement is meaningless. But since neither Schumacher nor anyone else specifically refers to such data, I rather doubt that it exists, particularly since our circulatory system is not so different from that of other mammals that one would expect an effect in the latter that did not occur in our own species. If there is nothing up to now that proves it enhances performance,that is probably because, after the deaths, no one bothered to conduct carefully controlled studies of this issue.

Not to say LA did or did not ever use this drug.
I think you're right and Schumacher is overstating. There's likely not a single study on the performance enhancing effect of HBOCs on healthy, professional endurance athletes. So to state there's no effect is based on what? Not on data I presume. And it's counterintuitive as well.
 
Feb 21, 2010
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Cobblestoned said:
Thank you !
Some things I wrote now detailed by experts.

http://www.cyclingnews.com/news/experts-call-armstrong-hemassist-connection-unlikely

The holy grale :D
I think you have totally missed the core of the issue and are now moving the goal post to suit your stance.

1. The SI article cites a source who stated the Feds have documentation LA obtained the trial medicine. To question is the accuracy and credibility of the source, though legal vetting would not have permitted this to enter publication if it was not valid. Consequences for obtaining trials medicines are what? Certainly it is criminal but at what level.

2. That an HBOC is a holy grail, it is in the context of field medicine and conditions where viable human blood for emergency situations requiring whole human blood. A room temperature, stable medicine that can rapidly be infused to a severely injured individual is a life-saving revelation, IE, Holy Grail in the Pharma world. A doping Holy Grail? Until proven otherwise (the purpose of the human trials, and God knows what the athletes tried) it certainly looked that way. Hindsight being 20/20, it did not prove out. This is mutually exclusive of whether at the time it was being sought, examined and experimented with in training and racing.

3. Experts now stating it would not have been so beneficial has never been a deterrent from WADA banning substances "thought" to improve performance. Just because it has coem to be realized as something that does not work, or work well, has not removed HBOC's from the banned substance list. If Lance "thought" it was worthy of seeking out and obtaining, the fallback position now cannot be reconciled as "well it wasn't truly banned and, either way, I gained no advantage, so...."

As it is, there is some level of confidence, enough to make the pages of a very major publication, that Lance gained access to this "illegal" medicine. If proven true, the consequential points about "holy grail", it being specifically "banned by name or class", or even it "working" fall by the wayside. It fundamentally illustrates the guy sought to obtain by illegal means a substance he thought would enhance his performance at the time.

The sill assertion by Fabiani that Lance "could not have obtained" the medicine since the clinical trial ended in 1998 fails as well. It fails since we know know that the medicine continued to be tested and examined for up to 6 years later (2004) and that the medicine was intended to have a stable shelf life of years. Stockpiling even a minor amount, enough for him to utilize (again, whether it works or not is immaterial) for his own (perceived) benefit.

The guiding applicable rule would be from the UCI, and downstream to the USA Cycling (USCF), and there is language contained that speaks to blood transfusions, blood manipulations and substances that can enhance oxygen carrying capacities.

Further, testing positive is not even the minimum standard to bring a positive. Attempted use (possession implied, and examples of individuals caught possessing, like Festina) would be sufficient.
 
lean said:
check out:

http://www.ncbi.nlm.nih.gov/pubmed/17024639

i linked to this just a bit ago but may have been too slick.

it suggests the negative impact on BP may offset performance benefits:
Thanks for the link. I've been too busy to go searching for some of this on my own, but now I think I need to see what other literature is available.

Experts now stating it would not have been so beneficial has never been a deterrent from WADA banning substances "thought" to improve performance. Just because it has coem to be realized as something that does not work, or work well, has not removed HBOC's from the banned substance list. If Lance "thought" it was worthy of seeking out and obtaining, the fallback position now cannot be reconciled as "well it wasn't truly banned and, either way, I gained no advantage, so....
To underscore this, here is a link to "A fast screening method for the detection of the abuse of hemoglobin-based oxygen carriers (HBOCs) in doping control", published just last year. Obviously, WADA still takes the use of HBOCs very seriously.

http://www.ncbi.nlm.nih.gov/pubmed/20188917
 
Feb 21, 2010
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TheComeBackKid said:
I did have my doubts about this. I can see why Armstrong often feels unfairly treated by these doping stories. The story that he has some super drug went all around the world the other day, but how many will now see this follow up article revealing it was nonsense? Not many i should think.
How is it non-sense?

Because the drug proved to NOT be as powerful, easy to conceal, higher in risk of side-effects as EPO and/or Blood Transfusions?

At the time LA sought it out, that had not yet been determined.

It also WAS against the rules of the sport to possess (intent to dope, and clearly would have been a problem relative to the USPS contract)and also illegal to acquire outside the trial itself.

I think the only non-sense here is your vapid post.
 
Jul 29, 2010
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Lance does not even know what Actovegin was, even though his team was dumping it by the roadside in 2001, even though guys were still getting busted for it in 2009 Junior worlds, etc.

Hell, he can't even pronounce it. So NO WAY does he know what HemAssist is. Poor guy probably thinks its a hemmorhoid cream.

Or is that "saddle cream"?.... :eek:
 
TheComeBackKid said:
But it's been determined now, that's the point. Why didn't SI do some proper research before putting out the implied idea from their story that he had some super drug that was better than anything else? That's very damaging to his reputation. You'd expect this on the internet but not from a big and respected publication.
If HBOCs are so useless as PEDs, why are anti-doping labs still developing tests for them?
 
Mar 20, 2009
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BotanyBay said:
Word on the street is that Lance scored a huge chunk of the remaining supply after the FDA rejected it. If any of it was floating around in the peloton, Armstrong was likely the source.

Of course, the fanboys are quick to say that it was a failure for its intended indication (Emergency room product to help stem death from massive blood volume loss). But it also seemed to have a reputation as an excellent oxygen vector... it just was never tested as one.
lol -word on the street - source? or STFU you fool
 
Aug 2, 2010
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Come on, guys! See this as Novitsky and the U.S. Feds see it.

They don't care whether HemAssist is effective. They don't care about Lance's TDF wins.

They care whether people have bought unapproved drugs and resold them. That's why the FDA is involved in this case.

If Lance, Thom, Bart, Bill, and the gang go down, they go down as an illegal drug lords, not sports cheats.
 
Feb 21, 2010
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TheComeBackKid said:
But it's been determined now, that's the point. Why didn't SI do some proper research before putting out the implied idea from their story that he had some super drug that was better than anything else? That's very damaging to his reputation. You'd expect this on the internet but not from a big and respected publication.
It does not matter if it was no better than EPO, as it certainly could be. The greater issue is there was never enough research to suggest it was some sort of endurance breakthrough. The point was to illustrate that Lance was seeking out these things, found Hemassist, obtained it because at the time they hoped it would.

This is motivation to cheat. The rules at the time would indicate even obtaining it would have been a doping violation, whether he ingested it or not.

You are right, it is damaging. It shows that the scope and pattern of him looking for illegal means of performance enhancing medicines was far and wide.

Clearly, whatever source they had and "knowledge of the case" passed legal muster, knowing the risk of printing something false or risky exposes SI to massive problems.

Why is LA not suing them? Maybe, because it is true? Perhaps, this is the lynchpin in their case, as there are no full fledged positive tests by the WADA standard.

Keep in mind, it will be the full weight of all these things. 1999 EPO positive, cortisone positive, Hemassist acquisition, eyewitness testimonies (and the corroboration of each being so consistent as to further add weight), plasticizer re-testing, Popo doping cache, Ferrari connection and training logs (and coded doping programs) etc. etc. etc. And these are just the things that are in the public domain, not the things tightly guarded with the Feds.

Will it "prove" to the requisite burden of each venue that they doped?

My guess is yes.
 
May 25, 2009
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Colm.Murphy said:
I think you have totally missed the core of the issue and are now moving the goal post to suit your stance.

1. The SI article cites a source who stated the Feds have documentation LA obtained the trial medicine. To question is the accuracy and credibility of the source, though legal vetting would not have permitted this to enter publication if it was not valid. Consequences for obtaining trials medicines are what? Certainly it is criminal but at what level.

2. That an HBOC is a holy grail, it is in the context of field medicine and conditions where viable human blood for emergency situations requiring whole human blood. A room temperature, stable medicine that can rapidly be infused to a severely injured individual is a life-saving revelation, IE, Holy Grail in the Pharma world. A doping Holy Grail? Until proven otherwise (the purpose of the human trials, and God knows what the athletes tried) it certainly looked that way. Hindsight being 20/20, it did not prove out. This is mutually exclusive of whether at the time it was being sought, examined and experimented with in training and racing.

3. Experts now stating it would not have been so beneficial has never been a deterrent from WADA banning substances "thought" to improve performance. Just because it has coem to be realized as something that does not work, or work well, has not removed HBOC's from the banned substance list. If Lance "thought" it was worthy of seeking out and obtaining, the fallback position now cannot be reconciled as "well it wasn't truly banned and, either way, I gained no advantage, so...."

As it is, there is some level of confidence, enough to make the pages of a very major publication, that Lance gained access to this "illegal" medicine. If proven true, the consequential points about "holy grail", it being specifically "banned by name or class", or even it "working" fall by the wayside. It fundamentally illustrates the guy sought to obtain by illegal means a substance he thought would enhance his performance at the time.

The sill assertion by Fabiani that Lance "could not have obtained" the medicine since the clinical trial ended in 1998 fails as well. It fails since we know know that the medicine continued to be tested and examined for up to 6 years later (2004) and that the medicine was intended to have a stable shelf life of years. Stockpiling even a minor amount, enough for him to utilize (again, whether it works or not is immaterial) for his own (perceived) benefit.

The guiding applicable rule would be from the UCI, and downstream to the USA Cycling (USCF), and there is language contained that speaks to blood transfusions, blood manipulations and substances that can enhance oxygen carrying capacities.

Further, testing positive is not even the minimum standard to bring a positive. Attempted use (possession implied, and examples of individuals caught possessing, like Festina) would be sufficient.
Excellent post Colm - this is it right here.
 
Feb 21, 2010
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TheComeBackKid said:
But if you're from the camp that sees doping like nuclear weapons, where the guys at the top are doing much the same thing so it cancels each other out, then the doping itself is not the issue. But that changes when someone supposedly has a super drug. This is what I suspect will annoy Armstrong more than anything about this story. Remember one day he knows the doping will come out and he will talk about it in rational setting. It's the angle that he had some special advantage other the other team programs that he doesn't like.
Really, this is immaterial to the situation. I realize you are just engaging dialogue, and i am not debating you in adversarial way.

Whether it annoys Armstrong is pointless. To be frank, what is probably annoying Armstrong is that it was ultimately Floyd Landis who crushed his empire. The Amish Assassin. Mennonite Mercenary.

I think lance is quite comfortable talking about why they were better. Let's say they all doped. Yes, accepted. Lance and his crew clearly employed every available technique to maximize their prep and performance.

Course recon, Wind Tunnel, team rider selections, tuning and tweaking all those things better than the rest.

The dope was the same. the playing field may have been level, they won because they beat the rest. Call it "Fair" if you like, whatever eases he pain of accepting it was all fraud.

As such, it does not remove the fraud of it, the deception to the cancer patients, the ripping off the govt. For that, they will answer for their violations. It will be an amazing, almost Greek tragedy-style, fall from grace.
 
Aug 2, 2010
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If Armstrong or Tailwind bought a stash of unapproved clinical trial drugs from some rogue employee at Baxter -- and this can be proven -- we are in felony territory. Doesn't matter whether the drugs worked.

Also, if Novitsky leaked the bit about HemAssist to SI, then you can bet he has has a paper trail and sworn testimonies of Baxter people and possibly Tailwind people.
 
TheComeBackKid said:
They have tests for lots of things that are useless. It doesn't seem to be much of a priority.
Such as? I think a more correct way of putting it is that they sometimes apply or modify tests (e.g., HPLC; mass spec) for known PES to substances that might or not be enhancing. Because it's not that difficult or expensive to do. But this is not the case with HBOCs. They require a very different kiind of test, developed specifically for this kind of substance. I doubt they would go to the trouble or the expense if they really felt these substances were both a) ineffective as performer enhancers; and b) were not being used or considered for use by athletes.

Apparently HOBCs have not been demonstrated to be performance enhancing in tests designed for this purpose (see LMG link above). But they have been shown to substitute for blood transfusions in many studies, and one of them, HemoPure, was approved for use in S. Africa (largely to treat the anemia in AIDS patients), nearly ten years ago. Anemia, one of the major targets that EPO was developed for.

I don't think anyone here knows whether HBOCs have ever been used in the pro peloton. But at this stage, no one can say categorically, as you seem to be coming close to doing, that they are not being used and that there would be no reason to use them.
 
Feb 21, 2010
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TheComeBackKid said:
It annoys me as well. I still say they should have contacted more experts and included this in the story since it's such a significant issue.
What issue? That USPS had a "Super Drug", or that the alleged "Super Drug" really did not work.

Recall, USPS used Actovegin and it is know to not work. It eventually was banned, despite evidence pointing to it having virtually no effect on performance.

Sounds like they were on a mission to find advantages, legal, illegal, and everything in between.

If you are still upset, then contact SI and raise your irritation issue with them. I'm sure that will get you far.

Here is the number 1-800-wah-whah.
 
hear, hear

Page Mill Masochist said:
If Armstrong or Tailwind bought a stash of unapproved clinical trial drugs from some rogue employee at Baxter -- and this can be proven -- we are in felony territory. Doesn't matter whether the drugs worked.

Also, if Novitsky leaked the bit about HemAssist to SI, then you can bet he has has a paper trail and sworn testimonies of Baxter people and possibly Tailwind people.
You have to wonder what Baxter's distribution controls were like. Baxter is a publicly traded company, I'd imagine they do pharma compliance pretty well with publicly traded market capitalization. The comments over at The Science of Sport suggest controls are *tight* on the research side.

Pharmstrong's team will likely throw a drug mule (real or fake) under the bus. but I don't see how he steers clear of the FDA prosecution. This could be good.
 
TheComeBackKid said:
But if you're from the camp that sees doping like nuclear weapons, where the guys at the top are doing much the same thing so it cancels each other out, then the doping itself is not the issue. But that changes when someone supposedly has a super drug. This is what I suspect will annoy Armstrong more than anything about this story.
If it annoys him, then he'll have to deal with it. It was he that was researching the drug allegedly while he was still sick. What would the cancer community think of this, he that preached a healthy lifestyle to combat cancer for those seeking hope on a tightrope?

How will they feel about him ingesting a potentially toxic poison while telling the world he wouldn't do something so stupid after his illness?


TheComeBackKid said:
Remember one day he knows the doping will come out and he will talk about it in a rational setting.
I see him doing so like Marion Jones has done. Once the information becomes public, he will find no audience that will listen to any contrived confession on his part. Not the way he's lied about it, and certainly not who he's lied to-the cancer community.


TheComeBackKid said:
It's the angle that he had some special advantage over the other team programs that he doesn't like.
That apparently isn't an "angle", but the unadulterated truth. Now way does he win even one Tour without such an advantage.
 
TheComeBackKid said:
They have tests for lots of things that are useless. It doesn't seem to be much of a priority.
Apparently they haven't developed such a test yet for Armstrong's witch hunt rhetoric or the absurdity of his fanboy brigade. See the picture in the dictionary under 'useless'.

DirtyWorks said:
Check Science of Sport's post on Hemassist. The comments have good information about the precision involved in distributing test drugs.

If half of what is mentioned works out, it does not look good for the previous owner of the drug whoever that was.

http://www.sportsscientists.com/2011/01/drug-of-2011-hemassist-and-armstrong.html
It would be very interesting to have a list of test sites.

Having gone through some of the press releases and articles in the time period, Baxter was really counting on this one:

With that much investment, you would think they might have done some production trials to prepare for the blockbuster demand.

Dave.
 
Feb 21, 2010
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D-Queued said:
Apparently they haven't developed such a test yet for Armstrong's witch hunt rhetoric or the absurdity of his fanboy brigade. See the picture in the dictionary under 'useless'.



It would be very interesting to have a list of test sites.

Having gone through some of the press releases and articles in the time period, Baxter was really counting on this one:



With that much investment, you would think they might have done some production trials to prepare for the blockbuster demand.

Dave.
Great points.

One to focus on is the last one, tuning up a production facility means making batches of product, and right in the backyard of where these people operated. Also, regarding the deaths of trials subjects, conditions under which they died likely meant they were being given massive amounts of the stuff to overcome near-death blood loss. Add to that a comment I read that stated many would have died anyways, as their injuries were so grave the deaths could not be solely or directly linked to use of the trial medicine.

It is not a stretch to think much smaller, performance enhancing dose levels, would exponentially reduce chances of adverse health reactions. Now, if they determined that the stuff truly didn't work, or making it work required administration of it at levels that would risk an adverse health reaction, it is likely it was abandoned. Nonetheless, the acts of obtaining, possession, and use all individually constitute a doping offense, so this item is a strong piece of evidence from what we know of it right now.
 
Jun 19, 2009
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D-Queued said:
With that much investment, you would think they might have done some production trials to prepare for the blockbuster demand.

Dave.
They would have made large enough quantities to test the production facilities for quality control as well. Baxter, as a responsible company; would have also planned to dispose of the unused product. Whether that happened or an opportunistic employee decided to front it to the sporting market is something that USADA and international pharmaceutical companies would want to know.
 

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