HemAssist . What do forumites know?

Page 2 - Get up to date with the latest news, scores & standings from the Cycling News Community.
Oct 25, 2010
3,049
2
0
Oldman said:
This goes way back but there was a Norcal Masters rider that worked in clinical research for heart/blood supplements. He won alot and was not popular there so I chalked it up to regional jealousy as he was nice enough when I competed against him.
He was on the Weisel Master's squad and while this is all a stretch it would be amazing to see ties go that far back.
These are the kinds of ties we need to keep note of, because these are how these connections happen. They DO go back in this manner.

Look at Arnie Baker. He was just a local SoCal bike racer who happened to also be a doctor. Then before too long, he's the "doc to the pros" (WINK WINK).

Look at Allen Lim. Used to be the "junior down the street" riding for Montrose CC. Gets himself a degree in physiology and he's the "physiologist to the pros" (WINK WINK).
 
Jun 22, 2009
794
0
0
Cobblestones said:
Now, many times in the past, when we brought up HBOCs, the one convincing argument against it was: 'it's easy to detect, because you just spin the blood and the plasma will come out red instead of clear, just as if you had severe hemolysis.' So how on earth can Dario Frigo not see the difference between HemAssist and simple saline? Did someone add food color or what? Or is, for some reason, HemAssist clear which would also prohibit its detection in the plasma based on color? How then can it have functioning heme groups? Does anyone have a serious, scientific answer? I'm genuinely curious and puzzled. Can anybody establish what the color of HemAssist is?
most artificial blood products are designed to have a similar appearance to naturally produced blood but i can't say for certain what HemAssist actually looks like, try a google image search.

good old-fashioned food coloring added to the saline maybe? :confused:
 
Cobblestones said:
Now, many times in the past, when we brought up HBOCs, the one convincing argument against it was: 'it's easy to detect, because you just spin the blood and the plasma will come out red instead of clear, just as if you had severe hemolysis.' So how on earth can Dario Frigo not see the difference between HemAssist and simple saline? Did someone add food color or what? Or is, for some reason, HemAssist clear which would also prohibit its detection in the plasma based on color? How then can it have functioning heme groups? Does anyone have a serious, scientific answer? I'm genuinely curious and puzzled. Can anybody establish what the color of HemAssist is?
This is a very good point. I don't have a definitive answer, but I don't know how obvious the color would be in separated plasma. Keep in mind that only a few % increase in oxygen-carrying capacity is necessary for significant performance enhancement. When you add to that the fact that HemAssist molecules bind more oxygen than native hemoglobin molecules, and give it up more easily, one would probably need at most an amount of HemAssist that was no more than 1% of the total natural hemoglobin present in red cells. So upon centrifugation, the color would not be that obvious, perhaps no more than would appear as the result of traces of red cells that did not spin down.

Moreover, HemAssist is cleared from the circulation very quickly, so any color present as a result of the full dose would decline rapidly.

The stuff you administer would presumably be more concentrated. I don't have an answer to the question about Frigo.
 
Jan 5, 2011
32
0
0
Cobblestones said:
snip

Now, many times in the past, when we brought up HBOCs, the one convincing argument against it was: 'it's easy to detect, because you just spin the blood and the plasma will come out red instead of clear, just as if you had severe hemolysis.' So how on earth can Dario Frigo not see the difference between HemAssist and simple saline? Did someone add food color or what? Or is, for some reason, HemAssist clear which would also prohibit its detection in the plasma based on color? How then can it have functioning heme groups? Does anyone have a serious, scientific answer? I'm genuinely curious and puzzled. Can anybody establish what the color of HemAssist is?
I am pretty sure HemAssist is red. All HBOCs I've seen pictures of have been red. It's likely Frigo had no idea what color it was suppose to be (and I though Frigo thought he had Hemapure?).

I'll throw this out there for no other reason than the thought of it amuses me - Could LA have been pretending to provide this product to other riders, but in actuality been giving them saline, or otherwise watered down, product? I doubt it, but the thought does make me chuckle.
 
Jul 2, 2009
2,394
0
0
Cobblestones said:
Now, many times in the past, when we brought up HBOCs, the one convincing argument against it was: 'it's easy to detect, because you just spin the blood and the plasma will come out red instead of clear, just as if you had severe hemolysis.' So how on earth can Dario Frigo not see the difference between HemAssist and simple saline? Did someone add food color or what? Or is, for some reason, HemAssist clear which would also prohibit its detection in the plasma based on color? How then can it have functioning heme groups? Does anyone have a serious, scientific answer? I'm genuinely curious and puzzled. Can anybody establish what the color of HemAssist is?

Frigo couldn't tell the difference because he's not an expert. He's a sportsman who probably left school at 16 with a basic education. You're treating him as though he's a researcher at SmithKlineBeecham.

He got sold a new, secret product which few people have actually seen. He can't know what it's supposed to look like or even what it actually is, all he knows it will make him go faster. The person who sold it too him told him it was HemAssist, so as far as he was concerned it was. He probably had friends who were duped the same way. It probably happens a lot.
 
Jun 16, 2009
860
0
0
BotanyBay said:
These are the kinds of ties we need to keep note of, because these are how these connections happen. They DO go back in this manner.

Look at Arnie Baker. He was just a local SoCal bike racer who happened to also be a doctor. Then before too long, he's the "doc to the pros" (WINK WINK).

Look at Allen Lim. Used to be the "junior down the street" riding for Montrose CC. Gets himself a degree in physiology and he's the "physiologist to the pros" (WINK WINK).
Lim was on Montrose? When? i guess he was probably a junior when i was there. Baker always cracked me up, i was always a wee bit curious hwo he did so well when he just never appeared to be that strong...
Funny i had a teammate on Montrose on his own version of the "belgian cocktail in the mid 80's, he couldnt ride his way out of a paper bag, but when Mammoth would come up the guy rode out of his gourd. I'm existing on a little Jolt cola and getting my doors blown off I turn to a different teammate and said"what got into him today?"
"trust me, ya don't wanna know"
"Ohhhhhh"
"Yeah"
 
Jun 16, 2009
860
0
0
jraama said:
).

I'll throw this out there for no other reason than the thought of it amuses me - Could LA have been pretending to provide this product to other riders, but in actuality been giving them saline, or otherwise watered down, product? I doubt it, but the thought does make me chuckle.
Shades of 10th graders selling pencil shavings spiked with oregano to seventh graders
"this is some good stuff man"
"it better be, that last stuff didn't do squat"
"No No No this is totally different i swear"
 
Great stuff, TT, thanks for these links. After a quick perusal of the article on testing for HBOCs by size differences, I think it would be problematic to test for them on samples that had been stored long-term. Under these conditions, both hemoglobin and any HBOCs present might be subject to some degradation. The article does mention a slight decrease in HBOCs in blood stored frozen for ten days, suggesting that much longer storage might greatly reduce them.

Also, note the date on the article: 2004. The authors say they obtained HemAssist from Baxter. So it was definitely available at that time for someone with the right connections.
 
May 13, 2009
3,093
0
0
lean said:
i can't say for certain what HemAssist actually looks like, try a google image search.
Believe me I did. The topmost result is a photo of Lance Armstrong :D Further down on the first page of results is Mars Blackmon and my square of cobblestones. No photo of the actual product.

Hm, maybe Frigo got duped, but that means he never before saw the actual product. Should we conclude that only one person had access to the real stuff?
 
Tyler'sTwin said:
From WADA's report on the 2010 TdF.

only a reasonably small number of blood samples were collected for analysis for CERA, HBOC or HBT and it is unknown to the IO Team how many (if any) blood passport samples were later analysed for any of these substances.
http://www.wada-ama.org/Documents/World_Anti-Doping_Program/WADP-Independent-Observer/WADA_IO_Report_TDF2010_EN.pdf
You don't think they would have purposefully avoided testing for these things do you? Like someone may have <ahem> suggested their time and effort could be better spent just watching TV or something? Naah, like totally obvious.

Those guys at WADA have nothing better to do than to point out what the UCI wasn't doing. Can't they get real jobs and go catch the real dopers?

(apologies to Floyd for stealing and reapplying another FFF-ism, which was a not-so-well-concealed theft of an OJ-ism)

Dave.
 
Jun 12, 2010
1,234
0
0
Having pondered this most of the last few hours I think its VERY significant that a HemAsist has been named as aposed to the generic description.
To me it sugests the opening shot in letting Pharmstrong know "this is some of what weve got"..lets watch your response. The specific naming of the product intimates theres a chain of supply been uncoverered. I say this because I dont think SI legal dept would go with naming Baxtors or the product if they didnt have confidence in the info the FEDS or other sources provided.
The timing of the SI article, with lance many miles away but under the media spot light is to much to be pure coincidence. The presure is being piled on.
The ending of the equiry stage and the begining of fileing charges smells pretty close to me.
 
Jun 19, 2009
5,220
0
0
Darryl Webster said:
Having pondered this most of the last few hours I think its VERY significant that a HemAsist has been named as aposed to the generic description.
To me it sugests the opening shot in letting Pharmstrong know "this is some of what weve got"..lets watch your response. The specific naming of the product intimates theres a chain of supply been uncoverered. I say this because I dont think SI legal dept would go with naming Baxtors or the product if they didnt have confidence in the info the FEDS or other sources provided.
The timing of the SI article, with lance many miles away but under the media spot light is to much to be pure coincidence. The presure is being piled on.
The ending of the equiry stage and the begining of fileing charges smells pretty close to me.
It seemed to me early into the USADA investigation that this type of custodial issue could be at the heart of a well funded legal case. That a prototype commercial drug hit the street and could be produced on foreign soil would scare any major pharmaceutical firm. As always, Lance and others won't do time for using drugs but commissioning or distributing a new drug raises the stakes.
 
Jun 22, 2009
794
0
0
Cobblestones said:
Believe me I did. The topmost result is a photo of Lance Armstrong :D Further down on the first page of results is Mars Blackmon and my square of cobblestones. No photo of the actual product.

Hm, maybe Frigo got duped, but that means he never before saw the actual product. Should we conclude that only one person had access to the real stuff?
i willing to wager about 5 bucks that HemAssist has a dark red appearance like most other HBOC's. i'll also drop in a nice link that isn't too technical but does a good job of explaining how artificial blood works:

http://health.howstuffworks.com/medicine/modern/artificial-blood.htm/printable

i've heard of athletes attempting to use these products before but have to say i considered it to be more of a conspiracy than based in reality. maybe i was wrong. these products have yet to be perfected and are probably only to be used in life sustaining emergency measures or highly controlled settings for now. if you're willing to use these to win a bike race - you are an imbecile.
 
May 13, 2009
3,093
0
0
I agree with you guys, the specific mentioning of HemAssist is significant. It was an experimental drug, produced in small quantities and never available outside the testing program.

There's just so very few places you could get a hold of this product. It's not like any crooked physician could write a prescription so you could pick it up at the local pharmacy.

Someone of a very small group of people involved with the drug had to divert a significant amount of this stuff out of the clinical trial to Lance Armstrong. This alone is a serious breach of drug safety regulations. Worse, if this stuff is either sold to or forced on to unwitting domestiques which would not receive the required medical attention connected to a clinical trial, that could land people in jail for quite some time.

Should we assume the Feds have a witness from inside Baxter or the clinical trial who's cutting a deal? Maybe someone who went to medical school together with Lim which might be how the initial contact with the HemAssist clinical trial was established in the first place?
 
Jan 5, 2011
32
0
0
There may have been larger quantities available than some people think. Baxter was banking on this product as a multi-billion dollar drug, so much so that they built a $100+ million dollar plant in Switzerland to make it. This plant would have been able to produce massive quantities of product. Now, I have no idea to what extent they cranked up production before it was canceled, or if the plant was even fully online at that time, but the possibility is there.

Anyway, Baxter likely would have had at least several months supply on hand at the time the project was terminated. They never would have risked running short during those critical Phase III trials.
 
May 13, 2009
3,093
0
0
jraama said:
There may have been larger quantities available than some people think. Baxter was banking on this product as a multi-billion dollar drug, so much so that they built a $100+ million dollar plant in Switzerland to make it. This plant would have been able to produce massive quantities of product. Now, I have no idea to what extent they cranked up production before it was canceled, or if the plant was even fully online at that time, but the possibility is there.

Anyway, Baxter likely would have had at least several months supply on hand at the time the project was terminated. They never would have risked running short during those critical Phase III trials.
As far as I can tell, the European trials included 117 patients. The US trial was likely of comparable size. I don't know how much of the stuff would be produced for those trials or in anticipation of FDA approval. No matter what, the stuff wasn't ready to be distributed. Lance had only one source to go to. The number of people with access to the supplies was quite limited. I would think it might be relatively easy to find who supplied Armstrong.
 
Jul 4, 2009
9,666
0
0
...this use of drugs drawn from clinical trials has an interesting precedent...EPO was being shopped around to interested parties as early as January 1988...it was apparently from clinical trials that were being conducted prior to the drug's European approval in late 1988...the reference to this had been available at the following link ( which unfortunately has now been scrubbed...but probably available to those interested tech savvy board members with time on their hands who could track down the cached info )

http://forum.team-saxobank.com/pop_printer_friendly.asp?TOPIC_ID=5013

Cheers

blutto
 
Oct 3, 2010
14
0
0
Another possibility is that a mole had passed the recipe for the product to a third party and that what was obtained was not produced by Baxter.

There are certain countries, where patents rights are not honored, where moles (in companies like Baxter) are commonly used to obtain (buy) recipes, once the recipe is obtained, arrangements for production can begin.

/h
 
Jan 5, 2011
32
0
0
Cobblestones said:
As far as I can tell, the European trials included 117 patients. The US trial was likely of comparable size. I don't know how much of the stuff would be produced for those trials or in anticipation of FDA approval. No matter what, the stuff wasn't ready to be distributed. Lance had only one source to go to. The number of people with access to the supplies was quite limited. I would think it might be relatively easy to find who supplied Armstrong.
Phase III trials typically involve thousands of patients, but given the unique nature of the product, these studies may have been smaller than is typical. It is harder to find a patient population for a drug which relies on traumatic injuries to test it (although I believe one arm of the study was for scheduled surgeries). The Phase III trials for HemAssist were cut short due to the adverse events reported, thus only a small number of patients actually received the stuff. Based on my experience, there would have been at least hundreds, if not a few thousand units on hand at the end of the study. But you are right, unless Baxter makes some kind of announcement, we will not know exactly how much they had left over.

As for where LA could have got it, the list may be relatively small, but far reaching, including production and packaging personnel, warehousing, transport personnel, clinical staff (across multiple sites), doctors with access or laboratory personnel who conducted the release and stability testing. Clinical supplies are generally tracked pretty well these days, from production through patient use, but someone I know in regulatory affairs at a pharma company told me that in the 90s this was not always the case. In fact, they mentioned that regulations for tracking clinical supplies were reinforced in the late 90s due to some instances of people selling the supplies out the back door. Laboratory staff would have the easiest time of providing small numbers of supplies, as they generally receive 2-3 times as much material as they need for testing, and in general, no one checks to make sure the extras are destroyed.
 
Jan 5, 2011
32
0
0
humble said:
Another possibility is that a mole had passed the recipe for the product to a third party and that what was obtained was not produced by Baxter.

There are certain countries, where patents rights are not honored, where moles (in companies like Baxter) are commonly used to obtain (buy) recipes, once the recipe is obtained, arrangements for production can begin.

/h
I think this scenario is doubtful (but not impossible). To make an oral dosage form, where mistakes in production likely will not end up in death, is one thing. To make a parental drug intended for direct infusion into the blood stream is quite another. Any mistake there can quickly lead to many deaths.
Producing a complex new drug for IV administration is an expensive process (even if you have the synthetic route in hand), and a small number of cyclists would not be able to cover the costs.
 
Oct 25, 2010
3,049
2
0
Cobblestones said:
I agree with you guys, the specific mentioning of HemAssist is significant. It was an experimental drug, produced in small quantities and never available outside the testing program.

There's just so very few places you could get a hold of this product. It's not like any crooked physician could write a prescription so you could pick it up at the local pharmacy.

Someone of a very small group of people involved with the drug had to divert a significant amount of this stuff out of the clinical trial to Lance Armstrong. This alone is a serious breach of drug safety regulations. Worse, if this stuff is either sold to or forced on to unwitting domestiques which would not receive the required medical attention connected to a clinical trial, that could land people in jail for quite some time.

Should we assume the Feds have a witness from inside Baxter or the clinical trial who's cutting a deal? Maybe someone who went to medical school together with Lim which might be how the initial contact with the HemAssist clinical trial was established in the first place?
Lim went to med school? I thought he studied physiology.
 
Apr 28, 2010
1,588
0
0
Cobblestones said:
Maybe someone who went to medical school together with Lim which might be how the initial contact with the HemAssist clinical trial was established in the first place?
I think it's more likely it came from his cancer treatment. I think in his book he says he tried to get the best, new stuff he could? It must be nigh-on 10 years since I read it now though so I might be wrong.
 

ASK THE COMMUNITY