The Senate Finance Committee will launch a probe into a clinical trial of PolyHeme, a blood substitute manufactured by Northfield Laboratories, after reports surfaced that negative results in an earlier trial were suppressed. The investigation centers on the FDA's decision to allow a second trial. In a letter sent to acting FDA Chairman Andrew von Eschenbach, committee chairman Charles Grassley (R-IA) said he is concerned that the current trial, which involves about 30 hospitals around the country, makes an exception to informed consent laws. The case is likely to be a magnet for agency critics who argue that too much emphasis has been placed on speeding drug development at the cost of patient safety.
- see this WSJ article (sub. req.)