NoBlood

HHS division questions ethics of PolyHeme blood-substitute trial

03/10/2006

The federal Office for Human Research Protections (OHRP) is expressing concern about an ongoing study of Northfield Laboratories’ PolyHeme blood substitute, citing “urgent ethical concerns� over its use in trauma patients who have not given their consent to participate, the Wall Street Journal reports. The OHRP, a “little-known� division of HHS that monitors research practices in government trials, today is expected to meet with representatives from the Senate Finance Committee to discuss the concerns. For the study in question, 360 “badly injured and hemorrhaging trauma patients� will receive the blood substitute and 360 control subjects will receive saline solution in the field followed by donor blood upon arrival at the hospital. In a previous study of PolyHeme in patients undergoing aneurysm surgery, 10 of the 81 participants given PolyHeme had heart attacks and two of those patients died, compared with no heart attacks or deaths among the 71 patients given saline and donor blood. Northfield attributed the increased number of heart attacks and deaths to “an excess of total fluids given to PolyHeme patients� and discontinued the trial but failed to disclose the results to most hospitals and communities involved in the current study. Despite the previous results, the FDA authorized Northfield to conduct the new trial without patient consent, saying that trauma care, by nature, is often provided to patients who are unconscious and therefore incapable of providing consent. The FDA maintains that “medical, legal, and ethical safeguards [are] in place for these types of research endeavors,� adding that it will continue to explore methods to improve oversight of such studies. However, a social medicine professor at the University of North Carolina School of Medicine writes in the current issue of Ethics and Human Research that the study of trauma patients does not meet existing non-consent trial criteria because the standard therapy of providing saline in the field followed by donor blood at the hospital has not been “unproven or unsatisfactory.� Meanwhile, Senate Finance Committee Chairman Charles Grassley (R-Iowa) is leading an investigation to determine whether patients in the new study are aware of the increases in risk of heart attack or death among patients in the previous study and whether it is appropriate to allow the trial to proceed without patient consent. A Northfield spokesperson says PolyHeme is being “evaluated as a potential better alternative� to donor blood and maintains that the study currently underway was designed on “strong scientific, legal, and ethical ground� (Burton, 3/10).