SENATOR QUESTIONS FDA'S SANCTION OF BLOOD SUBSTITUTE TRIAL
Sen. Chuck Grassley (R-Iowa), chairman of the Senate Committee on Finance, recently wrote a letter to FDA Acting Commissioner Andrew von Eschenbach questioning why the FDA would allow a company to test a blood substitute on trauma patients in 18 states without meaningful patient consent.
"If you're in a car accident, of course you want emergency doctors to save your life," Grassley said. "But no reasonable person would expect to be treated as an experimental subject without consent. The idea that the FDA would put the burden on the public to opt out of this mass experiment is outrageous."
The senator asked that the FDA provide his committee with a detailed briefing regarding the study of PolyHeme, a blood substitute, no later than March 8. Grassley also requested a detailed list and summary of all clinical trials between Jan. 1, 1996 and Feb. 23, 2006 conducted pursuant to the FDA regulation governing exemption from informed consent requirements for emergency research.