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Blood substitute too risky to test - More Health News - MSNBC.com

Blood substitute too risky to test, panel says
But Navy says product is urgently needed for soldiers on the battlefield

Updated: 9:10 p.m. ET Dec 14, 2006
WASHINGTON - A Navy plan to test a blood substitute on civilian trauma victims should remain on hold, federal health advisers recommended Thursday, saying the experiment’s risks outweigh its benefits.

The nonbinding vote appears to be the latest blow to the Navy, which has repeatedly sought Food and Drug Administration approval to test the product, derived from cow blood, on roughly 1,100 trauma victims in emergency situations. It proposes doing so without obtaining the customary informed consent of patients.

Dr. Jay Epstein, director of FDA’s office of blood research and review, told panelists that trials done without consent must clear a higher hurdle. The trials can’t just minimize the harm that might befall participants but should promise them some benefit as well, he said.

I find it interesting that the FDA wants to hold any product in a research trial to a "promise of a benefit". Is this a typical FDA standard? AS to the informed consent issue, yes, informed consent is a patient right; but this particular right is frequently overridden in situations where patients are unable to speak for themselves - such as in trauma, where the life of the patient is considered to be in imminent danger of being lost. In such cases, even the best standard of care is not and should not be guaranteed (promised) to save a life. In this case, though, the Navy seeks to involve civilians - non-combatants - as the test subjects. Perhaps arrangements could be made to test the substance on troops in the field, who could be made aware of the trial, and given the option to consent prior to going into a combat situation. It is hard to see how the FDA could withhold its approval for this to be used in a combat scenario, where the risks are clearly evident from the moment the soldier enlists. The risk of receiving a potentially beneficial experimental substance pales by comparison to the risk of being a soldier on a battlefield. In any medical situation, there just cannot be said to be "promises" of benefit. Of course, no one's life should be viewed as expendable from a research standpoint (nor any other, in my view); but soldiers are placed in the position of being expendable by the very nature of their jobs. Development of products that could possibly benefit them in their very vulnerable situations seems at least to be ethically supportable. Finding willing trauma subjects is the real difficulty, it appears.

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Jan Grossberg, RN, BSN
Editorial Team