The FDA has begun to review new rules on how the public is notified of studies on experimental drugs and devices that involve patients without their explicit approval, according to a report in the Chicago Tribune. The review is being done at the urging of Senator Chuck Grassley, who has made it clear that "no-consent" trials may not do enough to notify the public of their possible involvement. The review has been triggered by the controversial "no-consent" study being done in trauma situations with the blood substitute Polyheme, which is being developed by Northfield Laboratories. The Wall Street Journal triggered a firestorm of controversy over the blood substitute when it recently reported that Northfield had quietly shelved an early study after a number of patients in the study receiving Polyheme experienced more heart attacks than the control group. Subsequent studies did not include warnings about safety concerns raised by those results.
- here's the report from the Chicago Tribune
PLUS: The federal Office for Human Research Protections has expressed "urgent ethical concerns" about the Polyheme studies. Article
ALSO: Duke University has renewed its study of Polyheme after the dean of the medical school said he was satisfied that the school had done everything it was supposed to do to notify people in the Durham area of their possible involvement. Report