WHAT A TRIP

This video debunks serious flaws and mis-information in the @FDA Advisory Committee hearing (that recommended against approving MDMA Therapy to treat PTSD) and exposes how a small group of radical anti-capitalist activists called Psymposia hijacked a federal regulatory process. With the FDA poised to determine whether to approve MDMA therapy or not, this coordinated mis-information campaign by a small group of activists and ICER may derail a life saving treatment for millions. Here is how it happened: 1. Psymposia made unverified and sensationalized accusations to portray @Lykos_PBC trial data as systemically flawed. 2. Their unverified claims were then repeated by @ICER_review in a questionable report that was not fact checked, and published before the June 4th AdComm meeting. ICER is a group that helps set drug prices for the insurance and health care industry. Psymposia's unverified accusations of researcher bias, study flaws, and systemic omissions published in the ICER report were then amplified by major media outlets like @NPR and the @NYtimes. This misinformation then derailed the FDA Advisory Committee. Because of the way the hearing was structured, the trial sponsor, Lykos, was not given time to correct the myriad of misinformation discussed by the panel for several hours before the panel voted. The panel voted almost unanimously against recommending approval. The resulting press has created an inaccurate cloud of confusion casting doubt on the science and efficacy of the treatment. Fortunately, the committee's vote is non-binding. Lets urge the FDA to follow the science. #approveMDMAtherapy #MDMA4PTSD film by @nirvan featuring @laurentaus editing @umuima produced by @interconnectd @dreammullick

@jacobsullum This might help break it down. The FDA is a deeply flawed process and was derailed by anti-capitalist activists peddling fear over science: youtu.be/reexvtnGcs8?si…

On Friday, the FDA declined to approved MDMA-assisted psychotherapy as a PTSD treatment. Its concerns about the clinical trials are a bit puzzing, since it approved the research protocol. reason.com/2024/08/12/fda…

@MattForFLHouse youtu.be/reexvtnGcs8?si…

The FDA's refusal to approve MDMA for PTSD treatment is a catastrophic failure. This decision protects Big Pharma's profits by denying a one-time treatment that targets the root of trauma. MDMA has proven to be the most effective PTSD treatment ever studied, with minimal side effects. With suicide as the second leading cause of death among young adults, the FDA's choice will have fatal consequences. This is not just negligence—it's a betrayal of those in desperate need. nytimes.com/2024/08/09/hea…

@joarhalvorsen youtu.be/reexvtnGcs8?si…

This video debunks serious flaws and mis-information in the @FDA Advisory Committee hearing (that recommended against approving MDMA Therapy to treat PTSD) and exposes how a small group of radical anti-capitalist activists called Psymposia hijacked a federal regulatory process. With the FDA poised to determine whether to approve MDMA therapy or not, this coordinated mis-information campaign by a small group of activists and ICER may derail a life saving treatment for millions. Here is how it happened: 1. Psymposia made unverified and sensationalized accusations to portray @Lykos_PBC trial data as systemically flawed. 2. Their unverified claims were then repeated by @ICER_review in a questionable report that was not fact checked, and published before the June 4th AdComm meeting. ICER is a group that helps set drug prices for the insurance and health care industry. Psymposia's unverified accusations of researcher bias, study flaws, and systemic omissions published in the ICER report were then amplified by major media outlets like @NPR and the @NYtimes. This misinformation then derailed the FDA Advisory Committee. Because of the way the hearing was structured, the trial sponsor, Lykos, was not given time to correct the myriad of misinformation discussed by the panel for several hours before the panel voted. The panel voted almost unanimously against recommending approval. The resulting press has created an inaccurate cloud of confusion casting doubt on the science and efficacy of the treatment. Fortunately, the committee's vote is non-binding. Lets urge the FDA to follow the science. #approveMDMAtherapy #MDMA4PTSD film by @nirvan featuring @laurentaus editing @umuima produced by @interconnectd @dreammullick

How can something be declared a breakthrough one minute and not a viable treatment the next? The science was clear: 1⃣ 71% of phase 3 trial participants no longer qualified for PTSD diagnosis after MDMA-assisted therapy. 2⃣ 86% of trial participants experienced a reduction in symptoms. 3⃣ MDMA-AT had almost DOUBLE the efficacy of existing treatments. Today’s FDA decision is disgraceful and is a missed opportunity to embrace groundbreaking science, save countless veteran lives, and honor the sacrifices made by those who served our country. We are undeterred and will continue working to bring MDMA-AT to fruition. In the meantime, 13 million Americans will continue to suffer from PTSD, and more than 17 veterans will continue to die by suicide every day. @US_FDA, @DrCaliff_FDA, shame on you. Read our full statement here: heroicheartsproject.org/response-to-fd…

Important take here. Approval would have been appropriate, and would have allowed development of the very safety knowledge that this decision, paradoxically, actually thwarts.

Actually, the 2nd confirmatory part of Phase 3 trial was over 50% BIPOC and showed no difference in efficacy across race or gender. Lykos wasn’t given time to correct this inaccuracy, which also impacted FDA panel votes. Watch video on our page for a breakdown of disturbing flaws in FDA process.

There were other issues too: a lack of diversity among participants (71% were white), the pharma company not collecting data on feelings of euphoria (which are predictive of MDMA abuse), elevated blood pressure, and a few other things. But those all seem relatively minor.

Yesterday, the FDA rejected MDMA-assisted therapy for PTSD treatment. This came as a surprise to tons of people since the phase 3 trials showed *really* promising results. And a lot of people are pretty angry at the FDA right now. So why did the FDA reject it? A 🧵

FDA rejects use of MDMA assisted therapy for PTSD patients. This is a huge setback and so unfortunate for the millions of people struggling with PTSD. Tough day for the psychedelic ecosystem.

Yup. Also the FDA signed off on the design of the study before Phase 3 began. Lykos worked with the FDA for several months to complete something called a Special Protocol Assessment (SPC) where they negotiated and agreed to the design of the study. For the FDA to then reject a study for a reason they had signed off on as acceptable would undermine all drugs being developed, as no sponsor wants to risk spending tens-of millions of dollars to do a trial that the FDA later decides isn’t robust enough.

@ryangrim The criticism about not having a true control group seems like it could be made of many many drugs that have been approved.

The FDA’s MDMA decision is a total travesty. The study showed extraordinary efficacy but the review panel was just culturally biased against psychedelics. One panelists even said out loud she would oppose it because it would be too costly for providers and there are already treatments for PTSD

BIG DECISION: No legal molly any time soon FDA rejects MDMA-assisted therapy as a treatment for PTSD FDA asks for another Phase 3 study -- a costly, years-long process It's one of the safest psychedelics with great support--and it didn't get through news.lykospbc.com/2024-08-09-Lyk…

Did you know there are people out there who want to see the FDA deny MDMA-Assisted Therapy clearance for Veterans on August 11 and actually see themselves as heroes for doing so?  Join me and psychologist @gbathje, Ph.D. on the latest episode of The Psychedelic Report as we dive deeper into the confusing controversy around MDMA-Assisted Therapy’s approval. Listen to the full episode here: podcasts.apple.com/us/podcast/dis…

“They Can’t Have Met Us” Veterans share a powerful plea urging FDA to listen to the science and approve MDMA therapy. instagram.com/p/C9xj0N2uGxX/

What a fun fundraiser. Thanks everyone who has been sharing and supporting our film about @RickDoblin @MAPS work to legalize psychedelics. @Khaliya @dreammullick @nirvan @RickDoblin @BlakeMycoskie @8snowraven8 #psychedelics #mdmaptsd

Sharing @PrescriptionX trailer at our fundraiser w @RickDoblin @MAPS before the final @GratefulDead show

Yesterday was such a powerful start to #PS2023, with opening remarks from @RickDoblin, former Gov. Rick Perry and Gov. @jaredpolis and too many keynotes and sessions to squeeze into one Tweet. 😊 As we roll into the second full day, we can't wait to keep the conversation flowing!

Aaron Rodgers speaks about psychedelics at #PS2023 and how it 'unlocked that whole world' for him — ⁦@NBCNews⁩ nbcnews.com/news/sports/aa…

We provided the setting, but you brought the 'set. After decades of underground incubation, it's so wonderful to see our psychedelics community fruiting and flowering out in the open once more. Together we grow! 🍄

#LegalizeRickDoblin @PsychedelicSci @RickDoblin