AI
Monday, July 23, 2007 8:24:33 AM
First, do no harm.
Second, don't be stupid.
Biopure would have had labeled packages of the product sitting around if only for use in clinical trials and to conduct stability tests mandated by the FDA for labeling reasons (i.e., determining the expiration date they could use on their product.)
Given that the FDA and others had concerns about the manufacturing quality controls, I'd hate to be one of the first to test this blood substitute. You can argue that using it in very healthy young people under close supervision carries less risk than the trauma care or surgery for which it was originally intended.
People with access to it would include people at Biopure, people running clinical trials, and distributors, including low level employees all along the chain if bags that were meant to be discarded weren't. (And presumably others.) I would rule out routine "dumpster diving" in this case as I assume it would be viewed as a biohazard, thus destined for the incinerator. (Then again, I have no idea what they do with cow blood at slaughterhouses.)
This line from the VeloNews story caught my eye:
'Richards said Rasmussen became very upset when Richards explained he had disposed of it, asking him if he had "any idea how much that shit cost?"'
Pure idle comments on my part. I have no intention to cast aspersions on anyone.
Second, don't be stupid.
Biopure would have had labeled packages of the product sitting around if only for use in clinical trials and to conduct stability tests mandated by the FDA for labeling reasons (i.e., determining the expiration date they could use on their product.)
Given that the FDA and others had concerns about the manufacturing quality controls, I'd hate to be one of the first to test this blood substitute. You can argue that using it in very healthy young people under close supervision carries less risk than the trauma care or surgery for which it was originally intended.
People with access to it would include people at Biopure, people running clinical trials, and distributors, including low level employees all along the chain if bags that were meant to be discarded weren't. (And presumably others.) I would rule out routine "dumpster diving" in this case as I assume it would be viewed as a biohazard, thus destined for the incinerator. (Then again, I have no idea what they do with cow blood at slaughterhouses.)
This line from the VeloNews story caught my eye:
'Richards said Rasmussen became very upset when Richards explained he had disposed of it, asking him if he had "any idea how much that shit cost?"'
Pure idle comments on my part. I have no intention to cast aspersions on anyone.
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