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FDA’S LAXITY ON QUIZ INTO DUBIOUS CLINICAL RESEARCH SCORED

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, Charles Piller wrote for Science.

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.”


Those “serious, ongoing deviations” might constitute “fraud, scientific misconduct,” and “significant human subject protection violations,” according to FDA documents obtained by Science through the Freedom of Information Act (FOIA). Inspectors told Harris he could be subject to fines, permanent disqualification from clinical research in the United States, and legal prosecution. Repeat problems and a raft of new ones emerged during inspections in 2014, 2015, and 2019. Each time, in responses to FDA, Harris admitted some transgressions, strenuously disputed others, and promised to improve.


Through all that, FDA never formally sanctioned Harris or pursued other penalties. The agency never made public the alleged offenses or told trial participants they might have been put at risk. Nor did it tell companies sponsoring some of the trials that their data might have been compromised. (The documents Science obtained were heavily redacted, making it impossible to know which trials were in doubt and, thus, which volunteers might have been harmed or endangered.) Meanwhile, pharmaceutical and medical device companies continued to contract with Aspen. Since 2011, they have paid the firm millions of dollars for work on at least 65 trials, and Aspen is now recruiting people for nine new trials on Alzheimer’s disease, autism, depression, and other serious disorders.





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