The Whole View with Stacy Toth, Season 3, Episode 129: Working with the FDA as a Naturopathic Doctor w/ Dr. John Neustadt

Naturopathic clinician, author, and entrepreneur Dr. John Neustadt joins Stacy to share his experiences of working with the Food and Drug Administration (FDA) to find alternative treatments for cancer patients. Dr. Neustadt shares the friction points he’s experienced working within a bureaucracy, the mindset of traditional medical doctors, and the disincentives of funding these trials.

Find Dr. Neustadt:

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Key Takeaways 

Introductions

  • John Neustadt earned a doctorate in Naturopathy (ND) from Bastyr University, where he received the Founder’s Award for academic and clinical excellence.
  • He has also gone on to publish more than 100 medical articles and was recognized by analytics company Elsevier as a Top Ten Cited Author in the world for his work.
  • Furthermore, he has written four books, his most recent book is, Fracture-Proof Your Bones: A Comprehensive Guide to Osteoporosis. Dr. Neustadt was also an editor of the textbook, Laboratory Evaluations for Integrative and Functional Medicine, which was used across the United States to train and educate physicians on using functional medicine with their patients.

Working with the FDA as a Naturopathic Doctor

The FDA is a bureaucracy, and you have to check those boxes. And that’s one barrier within the natural products world to taking this research, which is translational research, taking research from published medical articles and clinical trial data that exists and being able to move it to a wider audience through FDA approval channels into the drug market. – Dr. John Neustadt

  • The FDA approves an orphan drug to treat or prevent an orphan disease. This is a rare disease that affects less than 200,000 people in the US.
  • So there are three main friction points Dr. Neustadt describes as a Naturopath working within the modern medical system:
    • The bureaucracy of the FDA, despite their good intentions and the overall great experience Dr. Neustadt had working with them
    • Within the mental models, mindset, and inertia of the conventional oncology world, even though they are well-meaning and well-intentioned and very smart people
    • Funding mechanisms, especially private equity, because you can’t patent these natural products
  • Dr. Neustadt believes there are lot of integrative ways to approach not just cancer, but also many conditions. This includes diet, lifestyle, and social support, all of which are important and have been shown in research to be incredibly beneficial.

Work with the FDA

  • Dr. Neustadt has worked with the FDA to get supplements and treatments approved:
    • MK4 for Acute Myeloid Leukemia (AML). Myelodysplastic Syndrome (MDS), Hepatocellular carcinoma (HCC, liver cancer) and acute promyelocytic leukemia (APL)
    • MK4 plus vitamin D for myelodysplastic syndrome (MDS)
    • CoQ10 and alpha-tocopherol for Friedreich’s ataxia
    • Cytochrome C, flavin mononucleotide, and thiamin diphosophate for mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes (MELAS)
    • Cytochrome C, flavin mononucleotide, and thiamin diphosophate for Kearns Sayr Syndrome (KSS)
    • Met-enkephalin for pancreatic cancer
    • Vitamin B6 for pyridoxine-dependent seizures

Studies, References, and Products

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Note: Stacy and her guests are not medical professionals. This podcast is for general educational purposes only. It is NOT intended to diagnose, advise, or treat any physical or mental illness. We always recommend you consult a licensed service provider.

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