FDA Flags Safety Issues in Clinical Trial at Moose Jaw Health Facility

The U.S. Food and Drug Administration (FDA) has formally cautioned Dayan Goodenowe, founder of the Dr. Goodenowe Restorative Health Center in Moose Jaw, Saskatchewan, over meaningful safety concerns linked to a clinical trial involving his supplement products.

Regulatory Concerns Arise from Unapproved Human Study

From 2020 to 2021, Goodenowe conducted a clinical investigation with 29 participants diagnosed with mild to moderate dementia. The trial aimed to assess the safety and tolerability of ProdromeNeuro, a supplement intended to enhance cognitive abilities and physical mobility among those affected.

The findings were published in 2022 under the title “Targeted Plasmalogen supplementation: Effects on Blood Plasmalogens, Oxidative Stress Biomarkers, Cognition and Mobility in Cognitively Impaired Persons” within Frontiers in Cell and Developmental Biology. However, shortly after release, the journal issued an expression of concern due to questions about regulatory compliance surrounding the study.

Lack of Mandatory FDA Authorization Raises Red Flags

An FDA review uncovered that goodenowe failed to file an Investigational New Drug (IND) application before starting human trials-a critical requirement designed to safeguard participants by detailing drug composition,manufacturing standards,and preclinical data.

Although ProdromeNeuro is derived from natural ingredients such as shark liver oil alkylglycerols, its use for treating dementia classifies it legally as a drug. Therefore, conducting clinical research without IND approval breaches federal regulations intended to protect study subjects.

“The absence of an IND raises serious concerns regarding participant safety and reliability of collected data,” stated the FDA warning letter.

Ethical Oversight Deficiencies Endanger Participants

Janice parente, an expert in research ethics, emphasizes that circumventing regulatory protocols exposes patients unknowingly to potential hazards. She explains that when investigators operate without external supervision or proper approvals-especially involving vulnerable groups-it compromises essential protections established for clinical research subjects.

“Patients often place implicit trust in healthcare providers; skipping these safeguards means they may face unassessed risks,” Parente remarked.

A History Marked by Controversial Claims

• This latest development adds scrutiny following prior investigations into Goodenowe’s claims about supplements targeting ALS (amyotrophic lateral sclerosis),Alzheimer’s disease,and autism spectrum disorders-claims lacking robust scientific validation according to health authorities.
• Several American ALS patients reportedly paid upwards of $75,000 USD each for intensive three-month treatment programs promising disease reversal or halting progression; however many families report continued decline despite participation.One South carolina patient sold her home hoping for enhancement but passed away months later while receiving treatment at Moose Jaw facilities.
• Saskatchewan consumer protection agencies along with local law enforcement have launched probes into business practices tied with these health claims amid allegations ranging from deceptive advertising tactics to possible fraud schemes.

The Complex Legal Boundary Between Supplements and Drugs

Goodenowe defended his decision not to submit an IND by claiming ProdromeNeuro qualifies as a dietary supplement rather than a pharmaceutical product because it contains naturally occurring marine compounds. He argued this exempts him from stringent drug regulations enforced by agencies like the FDA or Health Canada.

The FDA firmly rejected this position: any substance marketed or tested explicitly for diagnosing or treating diseases must comply with drug approval processes regardless of its natural origin. This distinction is increasingly important given global efforts addressing unregulated supplements making therapeutic claims without sufficient evidence-a factor contributing substantially toward public health risks worldwide. Recent WHO reports estimate up to 20% of adverse events globally are linked directly or indirectly with such products annually (WHO Global Report on traditional & Complementary Medicine 2023).

Erosion of Scientific Credibility And Public Confidence

this failure also casts doubt on data integrity gathered during unauthorized trials as lack of regulatory oversight can lead researchers toward biased methods or incomplete reporting-issues undermining reproducibility crucial within biomedical sciences today amid growing transparency concerns worldwide.

An Expanding Operation Amidst Regulatory Scrutiny

Despite increasing legal challenges-including criminal investigations triggered after complaints filed by political opposition groups-and consumer watchdog reviews questioning marketing strategies around unproven neurodegenerative therapies-the Dr. Goodenowe Restorative Health Center continues aggressive international expansion.
This includes ventures across Asia:
– in China: Collaborating with Ruiya Group aiming at establishing over one thousand rehabilitation centers nationwide plus specialized blood testing laboratories focused on brain health technologies.
– In Japan: Rolling out similar distribution networks promoting plasmalogen precursor supplements.
– Plans are also underway for relocating production facilities closer domestically within Canada pending licensing approvals which remain unresolved according to statements from Health Canada indicating no current authorization nor applications received related specifically thereto.

Divergent Expert Opinions On Compliance Enforcement

“Conducting human trials using investigational drugs without prior authorization is not just procedural negligence-it constitutes legal violations endangering patient welfare.”,stressed Janice Parente reflecting broader consensus among bioethics professionals concerned about enforcement gaps allowing questionable research outside traditional medical frameworks where practitioners lack formal licensure like medical doctors do under provincial colleges’ jurisdiction.

(Janice Parente – Research Ethics Specialist)

Laws professor Timothy Caulfield from University of Alberta describes such official warnings as urgent signals demanding immediate domestic action given ongoing operations outside regulated healthcare systems where accountability mechanisms are limited primarily because founders like Goodenowe are not licensed physicians subjectable directly through professional colleges’ disciplinary powers:

• “This situation should serve as a wake-up call prompting Canadian authorities overseeing consumer protection & healthcare standards alike.”
• “Either ignorance towards complex regulatory frameworks exists here-or deliberate attempts aim at circumventing rigorous scrutiny.”
• “Neither scenario reflects well upon someone claiming extensive scientific expertise while managing interventions affecting vulnerable populations.”

Poor Oversight By Publishing Bodies Heightens Concerns

The journal responsible for publishing initial results acknowledged reliance upon Sterling IRB-a self-regulating review board tasked with verifying ethical compliance-which later failed adequately vetting necessary regulatory documentation before approving publication submission.
This lapse highlights systemic weaknesses within academic publishing pipelines where responsibility frequently enough shifts ambiguously between journals & IRBs rather than being clearly defined leading sometimes flawed studies entering public domain unchecked until whistleblowers intervene.
Research integrity director Elena Vicario admitted their process assumed all requirements met based solely upon IRB confirmation but pledged ongoing improvements emphasizing stricter verification protocols moving forward.

This case underscores calls among experts urging journals adopt more robust multi-layered checks encompassing registration databases cross-referencing government filings alongside institutional review board approvals ensuring full adherence prior acceptance stages-measures increasingly adopted globally amidst rising awareness concerning reproducibility crises impacting biomedical literature quality overall recently documented extensively across major publishers including Elsevier & Springer Nature since early 2020s trends analysis reports released annually highlighting persistent gaps despite technological advances supporting automated screening tools implementation worldwide .

A Network Of Partnerships And Disengagements

lacking formal medical credentials himself,goodenowe initially collaborated closely with neurologist Dr Sheldon Jordan based out California who co-led some clinical investigations underpinning published work yet reportedly severed ties several years ago distancing himself publicly from ongoing ventures raising questions about continuity & accountability surrounding leadership roles tied directly back onto original study designs influencing current controversies .

Pursuing Growth Despite Obstacles With Local Investment Initiatives

In April ,Goodenowe announced plans injecting $100 million CAD into community wellness infrastructure dubbed “Moose Jaw Vitality Project,” promising free access advanced diagnostics monitoring technologies targeting broad population segments locally aiming long-term impact beyond immediate commercial interests .

Ongoing Regulatory Challenges For Domestic Production Goals

Health Canada has confirmed no licenses have been granted nor applications received specifically related either manufacturing permits nor sales authorizations connected directly back onto Prodrome supplements currently produced overseas but potentially slated soon domestically pending resolution clarifying classification status whether falling under natural health products framework versus prescription drugs category requiring full premarket evaluation .