Is it ethical to test people with experimental treatments without their knowledge or permission? This is what is in question after the FDA approved the testing of an artificial blood substitute known as PolyHeme.
PolyHeme is a synthetic blood substitute derived from outdated, donated, human blood. Unlike human blood though, PolyHeme does not require blood typing or refrigeration. Another advantage of PolyHeme is that it can carry oxygen to the tissues unlike blood volume expanders such as normal saline. Shelf life is another advantage of the blood substitute. PolyHeme has a shelf life of 12 months compared to real blood, which has a shelf life of about 42 days.
There are some serious safety issues with PolyHeme though. The first study of PolyHeme was started in 1998 and continued to the year 2000. In this study consent was obtained from patients as is required by law. The patients all had aneurysm surgery of the heart arteries. Ten of the 81 patients receiving the blood substitute died within a week while none of the 71 patients receiving real blood suffered any heart attacks. This study was not only halted early because of the deaths, but the company who manufactures PolyHeme withheld the fact that people died during the study from the public.
In their most current study Northfield Laboratories, the maker of PolyHeme, conducted a second study on over 700 patients without their consent. Some patients receive PolyHeme alone, others received PolyHeme then saline. The remainder received saline and blood. The study was conducted in various cities throughout the U.S. The FDA approved the testing without consent based on the 1996 Federal regulation CFR 50.24 waiver of informed consent.
The study started with a total of 722 patients. A total of 126 patients were dropped from the study due to what they called “protocol violations”. This includes patients that were too young or they were excluded for other reasons. Other parameters that excluded patients included patients who have sustained unsurvivable injuries, have severe head injury, are pregnant, have cardiac arrest or have objected to the study. Out of the remaining 586 patients, 279 were in the group receiving PolyHeme and 307 patients were controls. Incidences of death were higher in each of the groups receiving PolyHeme, compared to each of the control groups. Although, Northfield Laboratories claims that the difference in the number of deaths was not significant.
Northfield Laboratories tried to get FDA approval based on previous studies of trauma patients. The other patients they were comparing had not had blood though. They were trauma patients that had not received blood because of religious beliefs.