The U.S. Food and Drug Administration (FDA) has issued a warning letter to Dr. Dayan Goodenowe, founder of the controversial Dr. Goodenowe Restorative Health Center, alleging that a clinical trial of his supplements endangered participants. The trial, which tested ProdromeNeuro on 29 patients with mild to moderate dementia, failed to file an Investigational New Drug (IND) application, bypassing critical safety reviews. The FDA’s letter raises concerns about the validity of the study, prompting the journal Frontiers in Cell and Developmental Biology to flag the published research with an “expression of concern.”
Dr. Goodenowe’s trial, conducted between 2020 and 2021, lacked proper regulatory oversight, including animal testing data and ingredient disclosures required by the FDA. While no adverse outcomes were reported, the FDA emphasized that the omission of an IND application compromised patient safety and data integrity. This incident adds to Goodenowe’s ongoing legal and regulatory challenges, including investigations by Moose Jaw police and Saskatchewan’s consumer affairs regulator.
Research ethics expert Janice Parente criticized the lapse, noting that participants were unknowingly exposed to potential risks due to the lack of regulatory compliance. “They’re under the impression that because doctors are running the trial, that it’s all on the up and up,” Parente said. The FDA’s intervention highlights the importance of stringent oversight in clinical trials to protect vulnerable populations.