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Tuesday, May 17, 2005EPA on Threshold of Brave New World of Human Testing
Under its new policy, EPA would accept all human chemical dosing studies "unless there is clear evidence that the conduct of these studies was fundamentally unethical… or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted." Since industry is not required to disclose the conditions under which experiments were conducted, it is not clear how EPA will ever learn of "fundamentally unethical" practices. Moreover, EPA is unwilling to define what ethical lapses would disqualify an industry submission from being used for regulatory purposes.
"The Bush Administration is setting the ethical bar so low that only the most sleazy cannot limbo under it," stated PEER Program Director Rebecca Roose. "The basic problem is this: the safeguards that apply to experiments involving development of drugs to help people are far more stringent than EPA's standards for experiments to determine how much commercial poisons harm people."