The FDA’s oversight, for instance, can be porous: One report found that between 2000 and 2005 the agency had only 200 inspectors to police an estimated 350,000 testing sites. And while there are federal guidelines that cover clinical trials, it’s unclear whether recruitment of mentally ill subjects from homeless shelters and recovery houses violates these rules. Those guidelines require selection of subjects to be “equitable,” and special protection is required for subjects who are “economically disadvantaged” or “mentally disabled,” since these people are “vulnerable to coercion or undue influence.” But the guidelines make no mention of mental illness per se. Nor do they specify what constitutes being “economically disadvantaged.” The FDA declined to discuss the issue with me, but said in a statement that neither federal law nor its own regulations prohibit people living in homeless shelters from taking part in clinical trials. https://medium/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe
Posted on: Tue, 29 Jul 2014 13:24:38 +0000
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