Data from a trial of a whole blood substitute that was suspended one year ago, has revealed a higher mortality among patients receiving the substitute than those receiving saline. The substitute, HemAssist, made by Baxter Healthcare was administered to subjects admitted to emergency rooms and experiencing severe blood loss, under a controversial 1996 Food and Drug Administration (FDA) protocol that allows testing without the direct consent of patients. Of four studies operated under this rule, two—including the HemAssist trial—have recently been terminated, renewing concern that individuals are being exposed to risk without informed consent. The dropped trials have also caused anxiety among researchers that corporate sponsors will avoid such studies in the future.
The rule was intended to facilitate research in emergency medicine, in which patients arrive unconscious at hospital and decisions must be made rapidly. Under the system, products can be tested without patients' consent, but only if stringent requirements are met to inform the community about a trial taking place at their local hospital before, during and after it is done. Such a trial is said to be run under a 'no-consent' protocol.
This is a preview of subscription content, access via your institution