WASHINGTON (Reuters) - A key Senate Republican pressed the U.S. Food and Drug Administration on Thursday for details on its role in the clinical trial of an experimental blood substitute being tested on trauma patients in 18 states, in some cases without their consent.
Senate Finance Committee Chairman Chuck Grassley asked the FDA to make a full public disclosure about the clinical trial of Northfield Laboratories Inc.'s PolyHeme blood substitute, after its safety was called into question in a Wall Street Journal article.
"It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential 'guinea pig' without providing a practical, informative warning to the public," the Iowa Republican said in a letter to acting FDA Commissioner Andrew von Eschenbach.
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In his letter to the FDA, Grassley expressed concern that patients could be subjected to the experimental blood product unless they were wearing a wristband that says they decline to participate in the study.
Many people probably do not know how to get the wristband, he added.
"Why should Americans have to wear a bracelet at all times to protect themselves from a government-sanctioned medical experiment if they happen to get into a car accident?," Grassley asked in a statement releasing the text of his letter.
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