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March 23, 1994

More Than a Trickle of Interest in Blood Substitutes

JAMA. 1994;271(12):895. doi:10.1001/jama.1994.03510360015009

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WILL ARTIFICIAL red blood cells one day replace the genuine article? The answer seems to be a carefully qualified yes, and only in certain circumstances.

Also, it seems that the evidence that will convince physicians and surgeons that such agents are practical substitutes for natural, oxygen-carrying red blood cells will be the accumulation of experience rather than data-sweeping, double-blind, placebo-controlled studies. "I don't think we'll come out with a clear criterion for the use of blood substitutes. There are no rigid standards of efficacy," says Robert M. Winslow, MD, Veterans Administration Medical Center, San Diego, Calif. This is the essential conclusion from a workshop held to determine the effectiveness of red blood cell substitutes.

The workshop was the second to deal with the circumstances under which these products might be licensed. From the first meeting, in 1990, the Food and Drug Administration (FDA) developed a guide for manufacturers concerning safety

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