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Lack of standards plagues drug industry testing

David Evans, Michael Smith and Liz Willen of Bloomberg Markets report on the lack of strong regulation and standards that is plaguing the pharmaceutical industry in the testing of experimental substances on humans, resulting in the death and injury of scores of people. The world's largest drugmakers spend $14 billion each year to test experimental drugs on humans. The subjects, almost always poor or illegal immigrants desperate for money, are often injured or killed. "The U.S. Food and Drug Administration, the principal federal agency charged with policing the safety of human drug testing, has farmed out much of that responsibility to a network of private companies and groups called institutional review boards, or IRBs. " The investigation found that the FDA's own enforcement records portray a system of regulation so porous that it has allowed rogue clinicians — some of whom have phony credentials — to continue conducting human drug tests for years, sometimes for decades. The extensive report includes analysis charts, records and testimonials from some of the victims.

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