Northfield Laboratories finds itself at the center of a major controversy following a report in The Wall Street Journal that the biotech company "quietly" shut down an early trial for a blood substitute in 2000 after 10 patients suffered heart attacks and two died within seven days of being given PolyHeme. The FDA called the results "alarming" but went on to say that they weren't sufficiently alarming to force Northfield to stop its trial work on hundreds of more patients. The FDA went on to say that it was critical for the U.S. to find an alternative to blood, especially for emergency care and battlefield needs. Northfield execs denied any cover-up of the early trial results and said that there had been no subsequent safety concerns in trials involving trauma care.
"It would have been helpful to publish all of these details sooner," Dr. Steven Gould, Northfield's chairman and CEO, told the Chicago Tribune. "We think we have a plausible interpretation of the data."
- read this report from the Chicago Tribune for more information