Neural Pharm Podcast

Make America Healthy Again: the Podcast Edition

References: Psychedelics legislation in Colorado Springs: https://gazette.com/health/fountain-joins-colorado-springs-in-seeking-to-regulate-fledgling-psychedelic-mushroom-industry/article_22a66456-a1da-11ef-a515-57588c741084.html Oregon Psilocybin Ballot Measure Results: https://www.opb.org/article/2024/11/07/psilocybin-ban-mushroom-hallucinogenic-ballot-politics-elections-oregon/ Vermont Psychedelic Working Group Final Report: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://legislature.vermont.gov/assets/Legislative-Reports/The-Psychedelic-Therapy-Advisory-Working-Group_Final-Report.pdf US Life Expectancy Expected to Decline to 66th Globally by 2050: https://www.healthdata.org/news-events/newsroom/news-releases/increases-us-life-expectancy-forecasted-stall-2050-poorer-health#:~:text=Life%20expectancy%20in%20the%20US,2022%20to%2066th%20in%202050 United Healthcare uses faulty AI to deny claims: https://www.cbsnews.com/news/unitedhealth-lawsuit-ai-deny-claims-medicare-advantage-health-insurance-denials/ DEA Funding chart: https://crsreports.congress.gov/product/pdf/R/R44576 See here also, Why is the FDA funded by the companies it regulates?: https://today.uconn.edu/2021/05/why-is-the-fda-funded-in-part-by-the-companies-it-regulates-2/ Other references to topics discussed on this edition of podcast: See Colby’s previous article on Measure 110 in Oregon—which decriminalized nearly all categories of drugs, and has since been overturned: Right to Try bill articles (since this was discussed on this edition of podcast): Trump gave patients “Right to Try” but it hasn’t helped them: https://www.statnews.com/2024/08/02/trump-gave-patients-right-to-try-it-hasnt-helped-them/ DEA says Right to Try doesn’t include substances listed as Schedule I: https://www.marijuanamoment.net/in-case-on-psilocybin-access-for-cancer-patients-dea-says-federal-right-to-try-law-does-not-provide-any-exemptions-from-controlled-substance-act/ Understanding the Right to Try act: https://pmc.ncbi.nlm.nih.gov/articles/PMC7416898/ Get full access to Neural Pharm at neuralpharm.substack.com/subscribe [https://neuralpharm.substack.com/subscribe?utm_medium=podcast&utm_campaign=CTA_4]

Kanna Alkaloids: Nature's MDMA?

Show notes and references: * Please note: This was recorded prior to the election on Nov 5. We will discuss the results and predictions for the future of healthcare policy in America in our next edition.” Kanna references: Bennett, A. C., et al. "Sceletium tortuosum may delay chronic disease progression via alkaloid-dependent antioxidant or anti-inflammatory action." Journal of physiology and biochemistry 74.4 (2018): 539-547. Chiu, Simon, et al. "Proof-of-concept randomized controlled study of cognition effects of the proprietary extract Sceletium tortuosum (Zembrin) targeting phosphodiesterase-4 in cognitively healthy subjects: implications for Alzheimer’s dementia." Evidence-Based Complementary and Alternative Medicine 2014 (2014). Chiu, S., et al. "Exploring Standardized Zembrin® Extracts from the South African plant Sceletium tortuosum in Dual Targeting Phosphodiesterase-4 (PDE-4) and Serotonin Reuptake Inhibition as potential treatment in Schizophrenia." Int J Complement Alt Med 6.5 (2017): 00203. Coetzee, Dirk D., Víctor López, and Carine Smith. "High-mesembrine Sceletium extract (Trimesemine™) is a monoamine releasing agent, rather than only a selective serotonin reuptake inhibitor." Journal of Ethnopharmacology 177 (2016): 111-116. Gericke, N., and Alvaro M. Viljoen. "Sceletium—a review update." Journal of Ethnopharmacology 119.3 (2008): 653-663. Gericke, Johané. Evaluating the antidepressant-like properties of Sceletium tortuosum, alone and as adjunctive treatment. Diss. North-West University (South-Africa), 2020. Louw, Letitia. Investigation into potential endocrine disruptive effects of Sceletium tortuosum. Diss. Stellenbosch: Stellenbosch University, 2018. Reay, Jonathon, et al. "Sceletium tortuosum (Zembrin®) ameliorates experimentally induced anxiety in healthy volunteers." Human Psychopharmacology: Clinical and Experimental 35.6 (2020): 1-7. Reay J., Wetherell M.A., Morton E., Lillis J., Badmaev V. Sceletium tortuosum (Zembrin®) ameliorates experimentally induced anxiety in healthy volunteers. Hum. Psychopharmacol. Clin. Exp. 2020;35:1–7. doi: 10.1002/hup.2753. [PubMed [https://pubmed.ncbi.nlm.nih.gov/32761980]] [CrossRef [https://doi.org/10.1002%2Fhup.2753]] [Google Scholar [https://scholar.google.com/scholar_lookup?journal=Hum.+Psychopharmacol.+Clin.+Exp.&title=Sceletium+tortuosum+(Zembrin%C2%AE)+ameliorates+experimentally+induced+anxiety+in+healthy+volunteers&author=J.+Reay&author=M.A.+Wetherell&author=E.+Morton&author=J.+Lillis&author=V.+Badmaev&volume=35&publication_year=2020&pages=1-7&doi=10.1002/hup.2753&]]    https://pubmed.ncbi.nlm.nih.gov/32761980/ [https://pubmed.ncbi.nlm.nih.gov/32761980/] Schell R. Bachelor’s Thesis. Scripps Colleges; Claremont, CA, USA: 2014. Sceletium tortuosum and Mesembrine: A Potential Alternative Treatment for Depression. [Google Scholar [https://scholar.google.com/scholar_lookup?title=Bachelor%E2%80%99s+Thesis&author=R.+Schell&publication_year=2014&]] [Ref list [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8124331/#B59-molecules-26-02557]]     Terburg, David, et al. "Acute effects of Sceletium tortuosum (Zembrin), a dual 5-HT reuptake and PDE4 inhibitor, in the human amygdala and its connection to the hypothalamus." Neuropsychopharmacology 38.13 (2013): 2708-2716. Van der Walt, S. Development and evaluation of a medicated chewing gum containing Sceletium tortuosum. Diss. North-West University, 2018. Villarreal M.L., Sharma A., Cardoso-Taketa A., Garcia G. A systematic updated review of scientifically tested selected plants used for anxiety disorders. Bot. Targets. 2012;2:21–39. doi: 10.2147/BTAT.S20593. [CrossRef [https://doi.org/10.2147%2FBTAT.S20593]] [Google Scholar [https://scholar.google.com/scholar_lookup?journal=Bot.+Targets&title=A+systematic+updated+review+of+scientifically+tested+selected+plants+used+for+anxiety+disorders&author=M.L.+Villarreal&author=A.+Sharma&author=A.+Cardoso-Taketa&author=G.+Garcia&volume=2&publication_year=2012&pages=21-39&doi=10.2147/BTAT.S20593&]]https://www.tandfonline.com/doi/abs/10.2147/BTAT.S20593 [https://www.tandfonline.com/doi/abs/10.2147/BTAT.S20593] For more detailed information on kanna's safety and how to avoid withdrawals: All You Need to Know About Kanna's Safety, Risks, and Withdrawals [https://www.reddit.com/r/Kanna/comments/n9d298/all_you_need_to_know_about_the_risks_withdrawals/?utm_source=share&utm_medium=web2x&context=3] Psychedelics Today interview with Rick Doblin (Ph.D.), founder of MAPS, cited in the podcast: https://psychedelicstoday.com/2024/10/15/the-fda-mdma-and-public-perception-was-the-fda-fair-to-lykos/ October 15 2024. Get full access to Neural Pharm at neuralpharm.substack.com/subscribe [https://neuralpharm.substack.com/subscribe?utm_medium=podcast&utm_campaign=CTA_4]

Breaking down the FDA Advisory Panel Decision on MDMA

**Note this was recorded the first week of July before President Biden announced he would not run for re-election. I know that feels like a lifetime ago but just jump in your time machine for a bit at the beginning of the podcast please. We will likely start our next episode on the pharmacology of Kanna with a “catch up” on Kamala Harris v Trump** Footnotes, References and corrections: See below to watch the live stream of the FDA advisory panel decision on MDMA Assisted Therapy; a review of the MAPP1 and MAPP2 trial data: To review the MAPP1 and MAPP2 trials, listen to our first episode here [https://substack.com/@neuralpharm/p-126522144] To read about how the FDA is funded, and what “user fees” are here [https://www.fda.gov/industry/fda-user-fee-programs/fda-user-fees-explained#:~:text=To%20support%20its%20public%20health,paid%20by%20certain%20other%20entities.] To read the open letter from the Heroic Hearts Project (referenced by Chris) on the FDA advisory panel’s decision on veterans mental health, click on this link [https://heroicheartsproject.org/exposing-icers-anti-veteran-campaign-against-mdma-assisted-therapy/]: To read a bipartisan letter to President Biden in support of MDMA assisted therapy, click here [https://www.ajmc.com/view/bipartisan-letter-to-president-biden-highlights-promise-of-mdma-therapy-for-ptsd] To listen to an interview in Psychedelics Today referenced by Colby in the podcast with Dr. Amanda Holley, a regulatory consultant and pharmacologist in non-clinical drug development, click here [https://podcasts.apple.com/us/podcast/pt522-an-inside-look-at-the-fda-and-early/id1114398275?i=1000659426670]. To read about GLP1 compounding regulations, and how big pharma is lying about owning exclusivity to semaglutide and tirzepatide, click here [http://chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-11-March-2024.pdf] for a statement from the Alliance for Pharmacy Compounding. FACT CHECKS —Colby erroneously said the FDA advisory panel reviewed only phase 2 trial data from Lykos; in reality it was phase 3 data from the MAPP1 and MAPP2 trials —ICER [https://icer.org/who-we-are/independent-funding/sources-of-funding/], which is referenced several times in the episode stands for the Institute for Clinical and Economic Review, an organization that discusses the pharmacoeconomic utility of pharmaceutical therapies. Chris claimed they were mostly funded by user fees from manufacturers, similar to the FDA, but ICER claims they receive most funding from non-profit sources, with only 14% from manufacturers. To read more about ICER’s letter in regards to MDMA assisted therapy, review my previous article on the topic here [https://substack.com/@neuralpharm/p-143252241]. (Note the Heroic Hearts project uncovered ICER’s potential conflicts of interest not known to me at the time of this publication). —Not necessarily a fact check, as at the time we recorded our information was correct, but as news moves quickly it has been revealed through toxicology testing that some Diamond Shruumz products do contain psilocybin [https://www.statnews.com/2024/07/18/legal-psychedelic-mushrooms-actually-contain-illegal-hallucinogens-study-shows/] despite the manufacturers claims they don’t. The FDA possibly didn’t know this either at the time of their original publication. To our listeners, please do not consume any products from this brand, as they have already been associated with 113 illnesses and 2 deaths nationwide [https://www.cbsnews.com/news/recalled-diamond-shruumz-edibles/]. Get full access to Neural Pharm at neuralpharm.substack.com/subscribe [https://neuralpharm.substack.com/subscribe?utm_medium=podcast&utm_campaign=CTA_4]

Guest Interview with Shuna Morelli, author of "49 Days" and founder of Body Mind Bridge Institute

For more information on Shuna’s work visit: https://www.shunamorelli.com/ Get full access to Neural Pharm at neuralpharm.substack.com/subscribe [https://neuralpharm.substack.com/subscribe?utm_medium=podcast&utm_campaign=CTA_4]

Guest Interview with Danielle Daniel, Founder of Microdosing Humboldt

**To learn more about Danielle and the services she provides, go to the Microdosing Humboldt website: https://www.microdosinghumboldt.com/home or follow her on Instagram at: https://www.instagram.com/microdosinghumboldt/ ** Get full access to Neural Pharm at neuralpharm.substack.com/subscribe [https://neuralpharm.substack.com/subscribe?utm_medium=podcast&utm_campaign=CTA_4]