http://www.sciencemag.org/news/2020/10/fda-s-own-documents-reveal-agency-s-lax-slow-and-secretive-oversight-clinical-research

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For nearly a decade, the Food and Drug Administration (FDA) cited osteopath Michael Harris for egregious errors in clinical trials he was overseeing. Agency inspectors found a litany of problems at Harris’s private firm, Aspen Clinical Research in Orem, Utah, which had contracts to evaluate many drugs, including ones aiming to treat postoperative pain, pediatric schizophrenia, and migraines. FDA found there were serious lapses in obtaining informed consent from trial volunteers, unqualified staff made medical assessments, and Harris failed to properly report abnormal lab test results. He also did not disclose that trial participants were taking opioid, antidepressant, or antipsychotic drugs—which could have skewed results or posed safety concerns. The agency said Aspen’s records were disorganized, contradictory, and sometimes backdated in a way that “begs the question of the authenticity and veracity of data collected.”