The study raises questions of administering experimental therapies to accident victims without their consent:
A controversial drug experiment, involving artificial blood given to accident victims without their consent, resulted in a 40 percent higher death rate than the standard treatment given to a control group.Preliminary trial results released yesterday revealed that 46 subjects died after receiving the experimental blood substitute, Polyheme. There were 35 deaths among patients in the control group who received the standard care of saline solution in the field and real blood in the hospital.
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{ 3 comments }
That’s really, well, blood chilling.
I feel terrible for those 35 families, each one questioning if their loved one had to die.
Ummm…
Anonymous, there were 35 people in the control group that received standard care. They ‘had’ to die because their physiology dictated it.
There were some apparent excess deaths in the study group, and the number of excess exceeded a preset threshold for how much difference might have been probably by chance alone. That is, good fortune could have resulted in fewer deaths in the control group merely by chance, more deaths in the study group merely by chance or some of both effect.
Actually, the results for patients who met the conditions for the trial had identical death rates for the first 24 hours and the death rate at 30 days was close enough for Polyheme to get FDA approval (7% Confidence Level). The big difference in deaths was for patients who did not meet the trial protocol, and a lot more of them were given Polyheme than were given saline. The trial protocol excluded patients who had severe head injuries, were pregnant, under age 18, etc. The trial was to establish if Polyheme was as safe as saline for patients who were losing blood, for the time until they could get real blood. Previous trials had already established that Polyheme saved lives for patients losing blood who could not get real blood (Jehovah’s Witness surgery patients who refuse blood for religous reasons). The FDA required this second trial before approving the use of Polyheme.
To summarize, Polyheme saves lives when blood is not available quickly (battlefield, rural settings) and this latest test showed it to be as safe as saline statistically to a confidence level of 7%.
If you were an EMT and you had a patient that you thought was going to die who was losing a lot of blood, and you had an experimental blood substitute that might save his life, would you use it? I would. And I believe that is why more of the patients who did not meet the trial protocol and recieved Polyheme died and among those who did meet the trial protocol, the results were very similar to saline.
The data is going to be reverified (since the people who previously verified the data had the date of death wrong on two patients and who know what other errors they made if they screw up something as simple as a date two times) and it will be analyzed to compare patients with similar injuries and who got similar treatment, then the statistics will be calculated comparing apples to apples and we will know if Polyheme is worthy of FDA approval.
I believe a 7% confidence level indicates that the odds of the results being different could be caused by chance 93% of the time and by a difference in treatment 7% of the time. The actual difference in this trial for deaths within 30 days was a confidence level of 5.8% which is better than the 7% level that was required for approval for patients who were eligible to be included in the trial.
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