The study found that those who were given PolyHeme were more likely to die then those that were given a saline solution.

Across the country, 47 patients who were given PolyHeme died, compared to 35 who received only saline — a difference researchers said was not statistically significant. In San Antonio, two patients given PolyHeme died, with one death in the saline group. Eleven patients nationwide suffered nonfatal heart attacks after being given blood substitute, versus three given saline. In San Antonio, one in each group suffered a heart attack.

The other criticism of this the study was most patients were too badly injured to give consent to participate. The FDA allowed the study to take place if participating hospitals held community meetings to explain the study. San Antonio residents could opt out if they wore a special wristband.

I find both criticisms disturbing.  I believe the research was a noble cause but I strongly disagree that this was proper consent for those who participated in the study.  First participants were unaware of the prior failed studies and I doubt any of them attending these meetings explaining the study.  The FDA needs to do more to protect the citizens who end up being participants in such studies.