BAD BLOOD REDUX

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The Detroit Free Press has disclosed troubling information about an already controversial clinical trial comparing the safety and efficacy of artificial blood substitute Polyheme to natural blood. Because of the need for blood in emergency room situations, the FDA approved the research on gunshot and other trauma victims without requiring informed consent. The question is whether the FDA knew the researchers would be drafting primarily minorities as subjects. In Detroit, for instance, 15 of the 16 subjects were African American or Hispanic. Results of the study were less than favorable: 46 of the 349 subjects who received Polyheme nationwide died compared to 35 of the 363 patients receiving standard therapy.

Said the Rev. Charles Williams, president of the National Council for Community Empowerment, a civil rights group: "We are an African-American community that has been treated like guinea pigs." 

 

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This page contains a single entry by Administrator published on December 23, 2007 3:57 PM.

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