Blood substitutes- the polyheme trials

Sameer S. Apte McGill University, QC, CAN Email: [email protected] ethical debate (1, 6-15). Opponents say that Northfield Laboratories has inappropriately influenced regulatory decisions and abused the bureaucratic system in order to gain approval for a questionable experimental protocol (7, 10, 13). Conversely, proponents argue that prolonged suspension of informed consent is a necessity for effective characterization of safety and efficacy of prospective emergency therapies (6, 12, 14). This putative necessity is hinged upon the fact that the majority of patients targeted by new emergency therapies are incapacitated at the time of enrollment (24, 16). What is not debated is that the completion of the pivotal phase III clinical trial for Polyheme is surrounded by a cloud of ethical tension...