A Science investigation shows that FDA oversight of clinical trials is lax, slow moving, and secretive—and that enforcement is declining

WeR0206

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Apr 9, 2014
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2020evidence.org
Not getting informed consent? You don't say....this is from 10/1/2020 right before everyone had these novel vaccines shoved down their throat. Also note this article corroborates much of what the COVID19 vaccine trial whistlblower said many months ago when they file a $2 billion lawsuit.



"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."

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.

Harris declined to comment on the FDA reports and the agency refused to discuss its dealings with him. Wayne Croft, Harris's business partner at Aspen, also would not reply to questions, but he describes FDA's treatment of Harris as bureaucratic harassment that drove away business. "Anytime he hears about the FDA," Croft says, Harris experiences "post-traumatic stress."

Scrutiny of the agency's clinical trial oversight for the past 11 years suggests its interactions with Harris and Aspen are commonplace. FDA's enforcement of clinical research regulations is often light-handed, slow-moving, and secretive, Science has found in an investigation that included a review of some 1600 agency inspection and enforcement documents for other trials that FDA said violated rules and law. Almost all were acquired via FOIA requests, including many made by FDAzilla, a commercial service that tracks the agency.
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