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

To read about how the FDA is funded, and what “user fees” are here

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:

To read a bipartisan letter to President Biden in support of MDMA assisted therapy, click here

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.

To read about GLP1 compounding regulations, and how big pharma is lying about owning exclusivity to semaglutide and tirzepatide, click here 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, 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. (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 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.