What the FDA Warning Entails

The U.S. Food and Drug Administration (FDA) recently issued a formal warning to Prodrome Sciences USA, LLC, and its founder, Dr. Dayan Goodenowe, a Saskatchewan-based researcher, highlighting serious compliance issues in a clinical study involving a plasmalogen-based supplement. The warning centers on the failure to submit an Investigational New Drug (IND) application before initiating a trial that evaluated the supplement's effects on patients with dementia. This oversight, according to the FDA, raised significant concerns about participant safety, data integrity, and overall study validity.

Plasmalogens, a class of ether-linked phospholipids crucial for cell membrane structure and antioxidant protection—particularly in the brain—have been a focal point of Dr. Goodenowe's work. Deficiencies in these lipids are linked to neurodegenerative conditions like Alzheimer's disease (AD), Parkinson's disease (PD), and multiple sclerosis (MS). The study in question aimed to assess whether supplementation could restore levels and improve cognitive and mobility functions in affected individuals.

Dr. Dayan Goodenowe's Research Background

Dr. Dayan Goodenowe, holding a PhD in neurochemistry and biochemistry, has positioned himself as a pioneer in plasmalogen research. Operating from Moose Jaw, Saskatchewan, he founded Prodrome Sciences and the Dr. Goodenowe Restorative Health Centre. His career spans inventing analytical technologies for metabolomics— the comprehensive study of small molecules in biological systems—and developing plasmalogen precursors derived from natural sources like shark liver oil alkylglycerols.

Goodenowe's hypothesis posits that replenishing plasmalogens can reverse neurological decline. This stems from postmortem brain analyses showing reduced plasmalogen levels correlating with cognitive impairment severity. His independent research, often self-funded, challenges conventional pharmaceutical approaches by emphasizing nutritional restoration over synthetic drugs.

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Details of the ProdromeNeuro Clinical Study

Conducted between 2020 and 2021, the trial—titled "Targeted Plasmalogen Supplementation: Effects on Blood Plasmalogens, Oxidative Stress Biomarkers, Cognition and Mobility in Cognitively Impaired Persons"—enrolled 29 participants diagnosed with mild to moderate dementia. Participants received ProdromeNeuro oil, a dietary supplement containing plasmalogen precursors, for four months.

Key endpoints included changes in blood plasmalogen levels, oxidative stress markers (like malondialdehyde and glutathione), cognitive assessments via tools such as the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and mobility tests. Preliminary results suggested improved mobility in most subjects and cognitive gains in a subset, particularly those with severe impairment. Dr. Goodenowe described it as evidence that "we can rebuild human brains," likening neural recovery to turning a "raisin back into a grape."

The study received Institutional Review Board (IRB) approval from Sterling IRB, which verified regulatory compliance at the time. It was published in 2022, but recent events prompted an expression of concern from the journal Frontiers in Cell and Developmental Biology.

Regulatory Distinction: Supplements vs. Investigational Drugs

The core of the dispute lies in classification. The FDA defines dietary supplements as products intended to supplement the diet, not to diagnose, treat, cure, or prevent disease under the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, when used in a clinical investigation to study effects on disease—especially with endpoints like cognition in dementia patients—it qualifies as an investigational new drug, necessitating an IND.

Step-by-step process for IND submission:

• Preclinical data demonstrating safety.
• Investigator's brochure detailing pharmacology and risks.
• Clinical protocol outlining study design.
• Informed consent forms and IRB approval.
• FDA review (30 days) before dosing.

Prodrome Sciences maintained ProdromeNeuro was a supplement, but the FDA ruled its study use rendered it a drug, voiding the exemption.

Dr. Goodenowe's Defense and Corrective Measures

In response, Dr. Goodenowe attributed the issue to a "procedural concern missed by the IRB," asserting it was a fixable miscommunication. He noted prior FDA experience, including successful INDs, and hired a compliance consultant to retrain staff on supplement-drug distinctions. Prodrome Sciences committed to future adherence but emphasized no adverse events occurred, underscoring participant safety.

This stance aligns with Goodenowe's narrative of regulatory hurdles stifling innovative nutraceutical research. Supporters, including some patient advocates, view it as bureaucratic overreach against promising therapies outside Big Pharma.

Impacts on Research Publication and Peer Review

The journal's expression of concern highlights vulnerabilities in peer review for clinical studies. Publishers rely on IRB attestations, but post-publication scrutiny—like FDA actions—can trigger retractions or corrections. This case prompts questions on verifying regulatory compliance beyond ethics approval.

For Canadian researchers publishing internationally, similar pitfalls exist under Health Canada Natural Health Products Regulations versus U.S. FDA IND rules. Cross-border studies amplify risks, especially with U.S. participants.

Academic professionals can find guidance in crafting CVs for regulatory-compliant research roles.

Stakeholder Perspectives and Expert Commentary

Research ethics expert Janice Parente criticized self-regulation, stating, "Conducting research with an unapproved drug on humans without regulatory approval is not a procedural issue—it's breaking the law." Health law professor Timothy Caulfield called it a "red flag" for Canadian regulators, urging probes into Goodenowe's unregulated centre.

Conversely, Goodenowe frames criticisms as smears from competitors, suing CBC for defamation amid ALS coverage. Patient testimonials praise improvements, though anecdotal.

Broader Controversies: ALS Treatments and Patient Outcomes

Beyond dementia, scrutiny intensified over ALS programs at the Moose Jaw centre. A U.S. patient, Susie Silvestri, paid $84,000 USD for treatment but died alone in December 2024 after deterioration. Goodenowe claims 100% success in halting progression, backed by anecdotes but no peer-reviewed ALS trials.

Saskatchewan authorities, including police and consumer affairs, are investigating. The College of Physicians confirmed Goodenowe lacks medical licensure, operating privately.

Canadian Regulatory Context and Cross-Border Challenges

In Canada, natural health products (NHPs) require product licenses from Health Canada if claiming health benefits, unlike U.S. supplements. Goodenowe's products lack such approvals, raising questions for expansion plans like the $100M Moose Jaw Vitality Project offering free services.

Researchers must navigate:

• Health Canada NHP pathway for supplements.
• Clinical Trial Application (CTA) for drugs.
• Harmonization issues with FDA for multi-site studies.

Saskatchewan's research ecosystem, bolstered by universities like University of Saskatchewan, offers robust support for ethical trials.

Future of Plasmalogen Research and Ethical Solutions

Despite setbacks, plasmalogen science advances. Independent studies confirm deficiencies in AD and potential precursor benefits. Future trials should prioritize IND/CTAs, transparent funding, and diverse endpoints.

Actionable insights for researchers:

• Consult regulatory experts pre-study.
• Use adaptive designs for supplements.
• Partner with universities for credibility.

Explore postdoc opportunities in neurodegeneration or clinical research jobs. For career advice, visit higher ed career advice.

Dr. Goodenowe's expansions into China and Japan signal resilience, potentially validating claims globally if compliant.

Photo by Tandem X Visuals on Unsplash

Implications for Higher Education and Research Careers

This saga underscores ethics training needs in graduate programs. Universities emphasize Good Clinical Practice (GCP) to avert pitfalls. Saskatchewan researchers can leverage provincial funding for compliant nutraceutical studies.

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