Northfield rejects Sen Grassley's concerns over its PolyHeme trial

The USA's Northfield Laboratories has rejected concerns raised by Senator Charles Grassley over its PolyHeme blood replacement study (Marketletter March 20).

Sen Grassley questioned whether the protocol meets the requirements for the US Food and Drug Adminsitration's 21 CFR 50.24 waiver of informed consent. Northfield Labs noted that the most critical stipulation in this regard is that the drug under study must have potential for direct benefit to the patients, adding that the FDA believes PolyHeme could have survival benefit.

The Senator also questioned whether continued infusion with PolyHeme is ethical in the hospital setting where blood is available. Northfield replied that, "although blood is the current standard-of-care, there is a growing body of scientific evidence pointing to the adverse immunomodulatory effects of early blood transfusion in trauma patients, specifically the incidence of multiple organ failure and the resultant associated mortality. There are also published data indicating that these same effects may not occur with PolyHeme. Thus while it is true that blood is available in the hospital, it may not be the optimal treatment."