Biotech company Northfield Laboratories
A recent 20/20 investigation into Northfield centered on the way that the PolyHeme phase 3 clinical trial was being run. The story focused on the ethics of the trial design, which raised concerns because PolyHeme was usually being given to incapacitated trauma patients who could not give their informed consent to enroll in the trial.
After the story aired, Northfield issued a press release on its website charging that the story "lacked balance" and left out many of the steps that the company took to ensure that the trial was as safe as possible.
While many people may believe the PolyHeme trial protocol is unethical, I don't really have a problem with it. The company has an independent monitoring board reviewing the trial throughout its enrollment to ensure that no statistically significant safety issues or adverse events are occurring. On four different occasions, the board found no problems with the trial and recommended that it be continued.
Today, it is extremely rare for clinical trials to enroll patients without their consent. The Food and Drug Administration only ever allows this type of action to occur when there is no other good standard of care and patients are in a life-threatening situation. Northfield, for its part, also conducted community meetings in the cities where the trial sites were located, in an attempt to inform the communities of the trial.
There have been studies showing that people entering clinical trials tend to live longer than comparable people with a disease who don't enter clinical trials. That may be due to the increased medical care that people in clinical trials receive, or it could be because clinical trials are run by large research institutions that contain the best doctors. Or there could be other reasons. I'm not necessarily saying that any of this is the case for trauma patients being enrolled in the PolyHeme trial, but it couldn't be ruled out.
At this point in the PolyHeme trial, I'm left scratching my head as to why 20/20 ran the story. In the next few weeks, Northfield will have completely enrolled its final patients in the phase 3 trial. The time to have argued the merits of the PolyHeme trial protocol really was two years ago, when the trial was just starting.
But the impending end of the PolyHeme trial probably won't represent the end of criticism of the artificial blood. Only if good clinical trial results are announced later this year will Northfield's critics be silenced.
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