Transcript
This is huge with some caveats. Today I'm pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs. In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression, including our cherished veterans. And I got a call from a number of people, including the great Joe Rogan. And he said, we have to do something about this. suicide epidemic among veterans is a national tragedy. Since 9-11, we've lost over 21 times more veteran lives to suicide than on the battlefield. The executive order I'm signing directs the FDA to expedite their review of certain psychedelics already designated as breakthrough therapy drugs. These treatments are currently in the advanced stages of clinical trials to ensure that they're both safe and effective for the American patients. will clear away unnecessary bureaucratic hurdles, improve data sharing among the FDA and the Department of Veterans Affairs and facilitate fast rescheduling of any psychedelic drugs that become FDA approved. In 2024 study from Stanford University, 30 special operation veterans with traumatic brain injuries underwent. It's called i. Bogain treatment. Ibogan. Remember the name. Is that pronounced road? properly, what you said? I don't want to get it wrong. I'm going because it's so important and experienced an 80 to 90% reduction in symptoms of depression and anxiety within one month. Can I have some, please? I'll take it. This is amazing. And as someone who's been very closely following the psychedelic science world, I'm super excited that they're now a lot closer to being approved. But the focus on iBogaine during this whole press conference was a bit misleading. But to get to that, let's review the five things that this order actually did. 1. The FDA will give national priority vouchers to qualifying psychedelics that have already received breakthrough therapy designation. Basically a VIP pass that shortens FDA approval times from over 10 months to down to maybe only a few weeks. And three will be given next week. But IboGain will not be one of them because it doesn't have breakthrough designation yet due to safety concerns. The most likely candidates are versions of psilocybin and LSD, which we'll get to. a pathway for eligible patients to access psychedelic drugs, including ibogane compounds under the Right to Try Act, which is the 2018 law that lets very sick patients who have run out of other options get access to try certain experimental drugs. But including ibupagin compounds here is pretty controversial, because the law says that the only eligible drugs are the ones for which a phase one trial has been completed. That's an official safety trial which Ibogain doesn't have yet because of some concerns which will cover. Three, the HHS will set aside $50 million towards matching state psychedelic research programs like Texas' recent program for researching iBogaine. But this funding can also apply to other psychedelic research. Four, the Department of Veteran Affairs, the HHS and the FDA need to start working together on psychedelic trials to increase trial participation and to share data, which is underrated a big deal. But again, this prioritizes drugs with breakthrough therapy designation. any drug that has completed phase three trials to bump it down from Schedule 1. Right now, legally, LSD and psilocybin sit in the same legal place as heroin. So, the problem with Ibu gain is that it's been shown to interfere with the heart in a way that has led to multiple reported deaths and emergencies, both within clinical trials and outside of the context of that, but reported in the literature. We might be able to get around this with proper reporting, monitoring, and maybe co-administration of magnesium like this trial did. But we need to figure that out before IboGaine can really benefit from this order. I'll do a full video on safety soon. But right now, the biggest winner here is probably psilocybin, the main pro-drug found in Magic Mushrooms. There's a synthetic formulation called Comp 360 that finished phase three trials back in February for treatment-resistant depression and is currently the furthest along towards approval of any psychedelic. We're also in the middle of phase three trials for CYB-003, which is a modified version of psilocin, which is the actual psychedelic compound that psilocybin turns into in your body. And there's also a phase three trial underway for MM-120, which is a small. synthetic version of LSD used to treat generalized anxiety disorder. This will be good for MDMA and DMT as well, but they've got a bit more work to do still. There's so much to cover here, and I want to show you guys some of the actual data around the effectiveness of these compounds and how they work, but let me know what you want to cover from.
Additional notes
What did the recent executive order on psychedelics ACTUALLY say? Let's look at the 5 key points, which drugs they actually impact, and which ones still need some time, and how Ibogaine is mostly still in the latter category. WHAT IS IBOGAINE? Ibogaine is a naturally occurring psychoactive compound found in the root bark of the West African shrub Tabernanthe iboga, where related plant preparations have long been used in spiritual and ceremonial settings. In recent decades, it has attracted attention as a possible treatment for addiction—especially opioid dependence—because some studies and observational reports suggest it may reduce withdrawal symptoms and cravings after a single session. At the same time, ibogaine is not an approved medical treatment in the United States, and it comes with serious safety concerns, especially dangerous effects on heart rhythm, which is why it remains both promising and highly controversial. Ibogaine is not a “typical psychedelic” from a safety standpoint. The clearest and most reproducible safety signal in the literature is delayed cardiac toxicity: ibogaine and its active metabolite noribogaine block the cardiac hERG potassium channel, prolong ventricular repolarization, lengthen the QT interval, and can precipitate torsades de pointes, ventricular flutter/fibrillation, cardiac arrest, and sudden death. This risk is made worse by three real-world factors: noribogaine persists much longer than ibogaine, the people most likely to seek ibogaine often already have electrolyte problems, polypharmacy, opioid dependence, or other medical vulnerabilities, and product quality and dosing are often poorly controlled in informal settings. #science #ibogaine #learnontiktok #tiktoklearningcampaign #health
References
- Executive order on psychedelic access discussed in transcript; direct source link not listed in workbook.
- 2024 Stanford University ibogaine study in 30 special operation veterans with traumatic brain injury mentioned in transcript; DOI/PMID and source link not listed in workbook.
- Right to Try Act, FDA breakthrough therapy designation, HHS/state psychedelic research programs, VA/HHS/FDA trial coordination, and rescheduling pathway discussed in transcript; direct source links not listed in workbook.
- COMP360, CYB-003, and MM-120 phase-three trial context discussed in transcript; direct source links not listed in workbook.