WASHINGTON, March 14 (UPI) -- U.S. Sen. Charles Grassley, R-Iowa, says the Food and Drug Administration has made patients into "potential guinea pigs" in a blood substitute study.
Grassley says a patient-safety office within the Department of Health and Human Services has been expressing ethical concerns about the study to the FDA for nearly two years, The Wall Street Journal reported Tuesday. The concerns centered on the design and implementation of a study of the blood substitute PolyHeme, made by Northfield Laboratories Inc.
In the 720-patient study being conducted at 31 hospitals in 18 states, PolyHeme was given to half of badly hemorrhaging patients both in an ambulance en route to the hospital and at the hospital. The other half of the study's participants received a saline solution in the ambulance followed by donor blood in the hospital.
In contention is the fact no patient consent is being required and participants are not made aware of the risks and benefits of the blood substitute.
A Feb. 22 Wall Street Journal article reported 10 of 81 patients in an earlier PolyHeme study suffered heart attacks, compared with none of the 71 who got blood.
