Northfield proposed a new trial of 720 ambulance patients - 360 to get up to 6 units of PolyHeme and 360 to get saline in the ambulance and then red blood cells at the hospital. It meant that since they were using ambulance trauma patients, Northfield would not be able to get consent from the patients since most would be unconscious. Incredibly, the FDA agreed to let Northfield carry out this non-consent trial....
mcmike,
appreciate your comments...have been following your informative posts. This type of "consent" is a real consent...its "community consent" and though a consent is not done before the trial drug is started, one is obtained as quickly as possible from family. There is also a process that must be done at every institution's community or city to inform a community that this trial is being done with "community consent" and if there is a community issue, then the institution's own reveiw board will not allow the trial to be done in that community...
I am not involved in the Northfield trial, but we were indirectly associated with the Baxter one a decade ago.... what you say about blood and polyheme is absolutely accurate, IMO...
blood is necessary, but it also is associated with increasing infections after transfusions due to the immunosuppression of blood (many articles show this in research)......Many hospitals have centers now called "Bloodless Medicine and Surgery" to reduce the mortality and morbidity associated with "too much" blood transfusions.....This is why if blood-substitutes like PolyHeme pan out, they will be well received in the medical community(IMO).
thought I would add my 2 cents to this thread.....now back to my other job.....
TSURGE
INSANITY: Keep doing the same thing over and over hoping for a different outcome!!!
LifeFlight Helicopter landing on Scene after major crash
