Earlier this year we saw some of the problems with PolyHeme, the artificial blood product of Northfield Labs. Despite poor results in some clinical trials, the FDA approved another trial.
Now it looks like the same thing is about to happen with Hemopure, the artificial blood product of Biopure. The company acknowleges that past studies showed more cases of cardiac arrest, more fluid in the lungs and more hypertension among patients who were given Hemopure rather than blood. Yet, the Navy wants to conduct a study using Hemopure on civilian patients without their consent. Despite the negative results of previous studies, the Navy feels that their study will be different as it will use trauma rather than surgery patients.
In the past year the FDA has denied the Navy's request for the trial. A year ago, the FDA said "subjects would be exposed to an unreasonable and significant risk of injury". But now the FDA has convened an advisory panel to determine whether the trial should proceed. Unlike most advisory panels, the Navy was allowed to recommend panel members. Further, two skeptics of the artificial blood products have been removed from the panel. Has a deal been made somewhere along the line? Is the FDA being responsible to the citizens?
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