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FDA Faulted for Approving Studies of Artificial Blood
Key Excerpts from Article on Website of Washington Post
Posted: May 1st, 2008
http://www.washingtonpost.com/wp-dyn/content/article/2008/04...
A new analysis concludes that the Food and Drug Administration 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 yesterday, found that the products nearly tripled the risk of heart attacks and boosted 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. "It's hard to understand," said Charles Natanson, a senior investigator at the National Institutes of Health who led the analysis. "They already had data that these products could cause heart attacks and evidence that they could kill." 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. But attempts to develop such products have been marred by repeated failures and fraught with controversy, in part because some products have been studied under rules allowing researchers to administer them without obtaining consent from individual patients. After the Washington-based consumer group Public Citizen sued the FDA to gain access to data submitted to the agency, Natanson and colleagues at NIH and Public Citizen pooled data from studies conducted between 1998 and 2007.
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