WASHINGTON, March 10 (UPI) -- A federal agency has "urgent ethical concerns" about a trial of an Illinois company's blood substitute that has been given to patients without consent.
PolyHeme was developed by Northfield Laboratories Inc. of Evanston, Ill. The Wall Street Journal reports that the U.S. Food and Drug Administration gave the company permission for a 720-patient trial involving badly injured and bleeding patients.
Half the patients are given PolyHeme in the ambulance, while the other half get a saline solution followed by donated blood once they reach the hospital.
Sen. Charles Grassley, R-Iowa, chairman of the Finance Committee, said that the Office for Human Research Protections has concerns about the study. The agency is a little-known one that monitors research using human subjects.
