Monday, April 28, 2008

Market intelligence - hematology insights

An artificial blood substitute that has a long shelf life and does not need refrigeration could save untold lives by providing an alternative to trauma patients in emergencies, especially in rural areas and in combat settings.

A new analysis reported in JAMA, however, concluded that the FDA approved experiments with artificial blood substitutes even after studies showed that the controversial products posed a clear risk of causing heart attacks and death.

The review of combined data from more than 3,711 patients who participated in 16 studies testing five different types of artificial blood, released today, found the products nearly tripled the risk for heart attacks and increased the chances of dying by 30 percent. Based on the findings, the researchers questioned why the FDA allowed additional testing of the products to go forward and why the agency is considering letting yet another study proceed.

An FDA official declared that the risks and benefits of each study had been carefully weighed and a two-day meeting had been convened this week to address the new concerns raised by the analysis.

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