Tour de France

[Biowatch]

>>According to labels, the bags were filled with a hemoglobin-based oxygen carrier (HBOC) known as Hemopure, manufactured by the U.S.-based Biopure Corporation. The product is made from hemoglobin molecules that have been removed from the red cells of cow's blood. Originally designed as an emergency blood substitute that requires no refrigeration, Hemopure has only been approved for human use in South Africa. U.S. clinical trials were recently suspended over safety concerns, but a similar product is currently used for veterinary purposes.<<

The bleeding edge of research...

I'm curious where he got Hemopure in March of 2002. I don't know when it was approved for use in people in South Africa, where concerns about HIV contaminated blood are higher. It shouldn't be that hard to develop a test for it.

I hope the riders get blood that's free of HIV, hepatitis, and other contaminants.

From the Biopure website:
"Biopure introduced Oxyglobin to U.S. veterinary emergency clinics and teaching hospitals in March 1998, and nationally launched the product through distributors to community veterinary practices in October 1998. Since that time, the product has been used by thousands of veterinarians nationwide to treat various critical conditions."
http://www.biopure.com/shared/home.cfm?CDID=2&CPgID=54

"In October 2002, the U.S. Food and Drug Administration (FDA) accepted for review Biopure's biologic license application (BLA) to market Hemopure in the United States for a similar indication in orthopedic surgical patients. This acceptance is the first time a hemoglobin-based oxygen therapeutic for human use has reached this stage in the U.S. regulatory process. On July 30, 2003, the FDA issued Biopure a complete response letter requesting additional information and setting forth all of the agency's questions as of that date."
http://www.biopure.com/shared/home.cfm?CDID=2&CPgID=53


#msg-16098996
>>
Biopure Receives Comment Letter From U.K. Regulatory Body on Marketing Application for Hemopure

Wednesday January 10, 6:30 am ET [2007]

...The letter identifies and captions as "Major" issues relating to toxicology, quality, clinical efficacy and safety, including the product's benefit-risk balance in the proposed indication when blood is readily available. It captions as "Other" several dozen issues primarily relating to chemistry, manufacturing and controls. Unless these issues are satisfactorily addressed, the Commission may be unable to recommend marketing authorization.<<