thedrifter
07-25-06, 03:18 PM
July 31, 2006
Blood-substitute trial put on hold
By Gayle S. Putrich
Staff writer
The military’s search for a battlefield-ready blood substitute has hit some turbulence.
A July 14 closed meeting with a Food and Drug Administration advisory board to discuss the Navy’s proposed clinical trial of Hemopure was canceled after the activist group Public Citizen filed a lawsuit to have the meeting opened.
Hemopure, made by Biopure Corp. of Cambridge, Mass., is a synthetic blood-replacement product derived from cow hemoglobin.
Using real blood to treat trauma victims is difficult, and problems grow exponentially in combat situations. Blood has only a 42-day shelf life, and it must be refrigerated. It has to come from already scarce human donors, be screened for diseases and be type-matched before it can be given to a patient.
Since real blood can’t be easily transported to the scene of a trauma, patients usually get saline first, which prevents a potentially fatal drop in blood pressure but doesn’t carry oxygen.
Hemopure and products like it were designed to be used in out-of-hospital situations where a patient has serious blood loss and blood, or the proper blood type, is unavailable.
Unlike saline, such products are designed to carry oxygen through the body the way blood does. Hemopure does not carry diseases and is not blood-type dependent; it is stable for up to three years at temperatures between 2 and 86 degrees Fahrenheit and can be stored in heat up to 104 degrees for 18 months.
In a statement, Navy medical officials said the postponement of the Hemopure trial “allows the parties to more fully assess the scientific and technical issues to be presented and discussed at the advisory committee meeting, consistent with the desire to build public confidence in the process while continuing to comply with all applicable regulations.”
According to Biopure and FDA officials, it is standard procedure for these types of FDA meetings to be closed. Since the cancellation, Biopure officials have said they did not oppose an open meeting.
Dr. Sidney Wolfe, founder and director of Public Citizen’s Health Research Group, called the claim that such meetings are usually closed “unbelievably misleading.”
“There is no way … that the discussion that was going to take place was going to be confidential commercial information,” he said.
Wolfe said he does not oppose development of a blood alternative.
“If it turns out to be safe and effective, I would applaud it. But that’s why you do these randomized trials.”
In the past year, the FDA has blocked three trials of Hemopure, each time citing safety concerns.
Meanwhile, Brooke Army Medical Center in San Antonio, the military’s only Level I trauma center, has been participating in human blind trials of another substance called PolyHeme.
Developed by Northfield Laboratories Inc. in Evanston, Ill., PolyHeme is a solution of chemically modified human hemoglobin designed to replace lost blood in trauma victims.
Civilian trauma centers in 27 cities have taken part in the PolyHeme trials since 2004. Those trials have been mired in controversy: As of early July, 10 of the facilities suspended their trials or stopped recruiting subjects because of safety concerns or questions about the ethics of using an experimental substance on trauma victims without their consent.
BMAC is still participating in the PolyHeme trial.
Ellie
Blood-substitute trial put on hold
By Gayle S. Putrich
Staff writer
The military’s search for a battlefield-ready blood substitute has hit some turbulence.
A July 14 closed meeting with a Food and Drug Administration advisory board to discuss the Navy’s proposed clinical trial of Hemopure was canceled after the activist group Public Citizen filed a lawsuit to have the meeting opened.
Hemopure, made by Biopure Corp. of Cambridge, Mass., is a synthetic blood-replacement product derived from cow hemoglobin.
Using real blood to treat trauma victims is difficult, and problems grow exponentially in combat situations. Blood has only a 42-day shelf life, and it must be refrigerated. It has to come from already scarce human donors, be screened for diseases and be type-matched before it can be given to a patient.
Since real blood can’t be easily transported to the scene of a trauma, patients usually get saline first, which prevents a potentially fatal drop in blood pressure but doesn’t carry oxygen.
Hemopure and products like it were designed to be used in out-of-hospital situations where a patient has serious blood loss and blood, or the proper blood type, is unavailable.
Unlike saline, such products are designed to carry oxygen through the body the way blood does. Hemopure does not carry diseases and is not blood-type dependent; it is stable for up to three years at temperatures between 2 and 86 degrees Fahrenheit and can be stored in heat up to 104 degrees for 18 months.
In a statement, Navy medical officials said the postponement of the Hemopure trial “allows the parties to more fully assess the scientific and technical issues to be presented and discussed at the advisory committee meeting, consistent with the desire to build public confidence in the process while continuing to comply with all applicable regulations.”
According to Biopure and FDA officials, it is standard procedure for these types of FDA meetings to be closed. Since the cancellation, Biopure officials have said they did not oppose an open meeting.
Dr. Sidney Wolfe, founder and director of Public Citizen’s Health Research Group, called the claim that such meetings are usually closed “unbelievably misleading.”
“There is no way … that the discussion that was going to take place was going to be confidential commercial information,” he said.
Wolfe said he does not oppose development of a blood alternative.
“If it turns out to be safe and effective, I would applaud it. But that’s why you do these randomized trials.”
In the past year, the FDA has blocked three trials of Hemopure, each time citing safety concerns.
Meanwhile, Brooke Army Medical Center in San Antonio, the military’s only Level I trauma center, has been participating in human blind trials of another substance called PolyHeme.
Developed by Northfield Laboratories Inc. in Evanston, Ill., PolyHeme is a solution of chemically modified human hemoglobin designed to replace lost blood in trauma victims.
Civilian trauma centers in 27 cities have taken part in the PolyHeme trials since 2004. Those trials have been mired in controversy: As of early July, 10 of the facilities suspended their trials or stopped recruiting subjects because of safety concerns or questions about the ethics of using an experimental substance on trauma victims without their consent.
BMAC is still participating in the PolyHeme trial.
Ellie