FDA Warns Health Center Founder: Supplement Study Risks Patient Health
The U.S. Food and Drug Administration (FDA) has issued a warning to Dr. Dayan Goodenowe, founder of the Dr. Goodenowe Restorative Health Center in Moose Jaw, Saskatchewan. This warning stems from concerns over a clinical trial involving his supplements, which raised issues regarding patient safety.
FDA Warning: Risks in Supplement Study
On January 20, the FDA publicly reprimanded Goodenowe and his company, Prodrome Sciences USA, LLC. The agency accused them of compromising the safety of participants in a clinical trial for the supplement ProdromeNeuro, aimed at treating mild to moderate dementia.
Key Details of the FDA Announcement
Between 2020 and 2021, 29 individuals participated in a trial named “Targeted Plasmalogen Supplementation: Effects on Blood Plasmalogens, Oxidative Stress Biomarkers, Cognition and Mobility in Cognitively Impaired Persons.” The study was later published in the journal Frontiers in Cell and Developmental Biology in 2022.
- The FDA’s warning emphasizes that Goodenowe did not file an Investigational New Drug (IND) application before initiating the study.
- This failure has raised significant concerns about both the safety of study subjects and the integrity of the collected data.
Despite these warnings, no adverse effects have been reported among the participants, according to the FDA. Goodenowe has previously faced scrutiny from authorities, including the Moose Jaw police and Saskatchewan’s consumer affairs regulator.
Investigation Findings
The FDA launched its investigation in December 2024. An IND application requires comprehensive documentation to ensure participant safety. Goodenowe claimed that he did not need an IND because ProdromeNeuro is derived from natural substances.
However, the FDA clarified that products intended for treatment or prevention of disease are classified as drugs, regardless of their natural origins.
Broader Implications for Research Ethics
Experts in research ethics, such as Janice Parente, underline the risks incurred by patients when researchers fail to adhere to ethical standards. She pointed out that patients often trust that trials led by doctors are properly regulated.
The issues with Goodenowe’s research have prompted significant regulatory concerns. Timothy Caulfield, a law professor, noted that FDA warnings serve as critical alerts for healthcare regulators in Canada.
Current Developments and Future Plans
In the wake of the FDA’s scrutiny, Goodenowe has committed to reassessing his research protocols. He is also expanding his business operations, launching initiatives in countries like China and Japan, including a $100 million investment project in Moose Jaw.
Health Canada has yet to grant any licenses for manufacturing Goodenowe’s supplements in Canada, highlighting ongoing regulatory hurdles. As this situation evolves, the implications for Goodenowe’s practices and the broader landscape of supplement research remain to be seen.
