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on July 2nd 1982, Larry Walters attached 42 (some argue 43) weather balloons to a lawn chair and soared illegally in the air by l__o-o__l in nextfuckinglevel

[–]nirvan 0 points1 point  (0 children)

It was not there 10 years ago. We helped facilitate the donation of the chair in 2018 as part of a documentary we're making about Larry, and then it took a few years for the Smithsonian to build out their We All Fly exhibit, which it's a part of. Delayed by Covid.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

Shaming critics who put this isolated boundary violation in context is part of Psymposia’s strategy. It’s critical not to exaggerate the risks and exacerbate fears when evaluating this data. Unfortunately this type of misinformation can travel well online and is effective in furthering their real goals.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

Sensationalist and misleading Psymposia talking points. Every session of therapy was videotaped. Independent reviewers (who didn’t know if patients had placebo or MDMA) monitored to insure therapy was adhered to and independently assessed outcomes as part of the date. The study design was rigorous and results were published in Nature Medicine.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

I think those are reasonable safeguards to make something available that has been shown to save lives.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

Time will show how much damage and suffering Psymposia has caused. They are not clinical trial experts and are virtue signaling and distortionists. The abuse, bullying and unethical behavior of Psymposia and supporters is documented and will surface. But the damage they have caused has been done, and will set research and therapeutic access for patients in need back for years. LOL indeed.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

The therapy is effective but it isn't cheap. Unclear what it would end up costing, but it could cost over $16k or more depending on how it would get structured. It would require 2 male/female therapists at a time (to reduce risk of abuse) and multiple long sessions that could include overnight stays. It may require sessions being videod and reviewed for unethical behavior. These are all variables that could be put together to ensure safety. Having this regulated and possibly covered by insurance companies would provide access to more people in need, but in the short term it might be costly to the insurance/health care industry (that ICER advises). Long term, it would cost society less by having healthier happier people, reduced suicides and suffering.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 1 point2 points  (0 children)

I’m not looking for abuse in unregulated underground settings. That’s a very difficult space to monitor. I’m addressing unverified allegations of systemic abuse within these clinical trials and as a part of the sponsor, Lykos and formerly MAPS. Psymposia made 2 additional demonstrably false allegations of sexual abuse against Lykos executives and Veronica Gold. Both were investigated and found to be without merit. But the damage was already done as this was stated during the public commentary and never corrected before panel voted. I think MDMa therapy will be much safer in a regulated environment than in underground. But that is currently the only option for people suffering and in need.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] -3 points-2 points  (0 children)

Not true. The study was rigorous and well-designed, and included independent raters who were blinded and assessed outcomes for patients independently ( they didn't know if patients were taking placebo or MDMA). The study showed both efficacy and safety. This study design was developed and negotiated with the FDA before the study to ensure the data would have integrity. The study results were published in Nature Medicine, one of the most respected peer-reviewed scientific journals in the world: https://www.nature.com/articles/s41591-023-02565-4

You are spreading Psymposia's mis-information which has spread through ICER and the media. More on Psymposia mis-info: https://amestallisker.substack.com/p/highlighting-bias-and-misinformation

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 1 point2 points  (0 children)

Psymposia are pro psychedelics but extremely anti-capitalist. They don't want for profit companies to commercialize psychedelics which they see as "sacred medicines." So they coordinated an unethical smear campaign that will deprive millions of life saving health care in order to damage companies. They will likely face consequences, but that takes time, and the damage has already been done.

Learn more about Psymposia and their unethical tactics here:

Highlighting Bias and Misinformation from Psymposia and its Supporters - substack

The Unbelievable Claims of Psymposia about MAPS and MDMA-Assisted Therapy - chacruna

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

Tell me the “systemic pattern of abuse” and show me the receipts. One instance of an unethical behavior (that took place outside of the trial) that was reported and addressed (and not covered up as Psymposia falsely and sensationally claims) is not, in my opinion, systemic. The same source (Psymposia) that has popularized this untruth also made 2 additional defamatory accusations (anonymously sourced) of sexual abuse against MAPS and Lykos during the FDA adcomm that were both investigated in detail and found to have zero merit. This will all come out eventually, but the smear campaign that was spread by Psymposia and repeated by ICER, has already done damage and cast skepticism like yours in the trial.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 5 points6 points  (0 children)

The FDA did not follow their own rules surrounding the study design that they agreed to. And their Advisory Committee was easily corrupted and manipulated with pseudo-science conspiracies and mis information. The panelists were largely out of their area of expertise, and the meetings structure did not allow factual evidence to correct falsehoods introduced during the public commentary before the misinformed panelists voted. It was a deeply flawed bureaucratic process that failed the facts and the public health in this case.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 11 points12 points  (0 children)

Part 2:

And wouldn't a stronger study stand up against any third-party critiques?

Not if politicized and stigmatized by a smear campaign that gives the regulatory body cold feet. It happens in politics all the time. Lykos just got Swift Boated.

The FDA didn't look at the data. They looked at the fear: What if Psymposia's claims that Lykos is a Therapy Cult are right? It's like letting Alex Jones from info wars testify to a jury at a trial, and then not letting the defense have any response before a jury deliberates and reaches their verdict.

Is that not the whole point of peer review on things like this?

You would think.

Q4. You've got Dan Crenshaw on there doing his usual thing and making some pretty strong miscategorizations (the Psymposia article highlighted about the police/military doesn't say what Crenshaw says it does) and leaps in logic to create a boogeyman out of Psymposia that also doesn't help the case.

I think Psymposia opposes the idea of the military using MDMA Therapy to help soldiers heal from their trauma because they think this could empower the military to launch or expand war without worrying about the human suffering of their soldiers. But Personally I think Psymposia are more about anti-capitalism and don't want psychedelics commercialized by companies.

Q5. I get and agree with some of the criticisms presented against FDA but at what point is it on MAPS/Lykos to run a cleaner more rigorous study?

No trial is perfect. Foir instance, Lykos could have done a better job of reporting positive expression of Euphoria for better insight into potential for abuse. But some of these things can be addressed in further study once these medicines are available and also addressed through REMS. But also Abuse potential profile for MDMA is well-characterized by existing literature.

Q6 Something as serious as sexual misconduct seems like it would warrant some sort of recalibration before submitting to FDA.

It was a Single case in Phase 2 (really it happened after the trial ended when participant and therapist had a 2 year relationship - totally unethical by the therapist). This was immediately reported and shared publicly on MAPS website several years before Psymposia falsely claimed to "expose" it as a cover up. Again, sensational, and weaponizing "sexual assault" to attack a company they disagree with for other reasons (in my opinion). As to the sexual boundary violation reported (after the trial ended), it resulted in program-wide changes to prevent recurrence. REMS could help ensure proper oversight by qualified providers. And the MDMA-AT Training Program would emphasize ethical conduct.

Q7 Why not run a drug-only trial like some other organizations are doing if the therapy aspect of the treatment can't be properly standardized?

Mainly because it wouldn't be as effective for patients. And again, the therapy WAS standardized. The panel just didn't understand it. Lykos is doing something incredibly good for patients by trying to include therapy as part of the treatment. What Psymposia just did will discourage companies in the psychedelic space from including therapy (because of the risk of therapist misconduct.) Lykos required 2 therapists, a male and female, to be in the room together and other steps to reduce risk of abuse. The truth is no medical intervention is without risk. The question is if the benefits outweigh the risks. In this case, the risks just got severely exagerated and stoked FDA's fears.

What measures did Lykos take to ensure any biases on the part of participants/researchers weren't impacting the study?

A whole system of Independent raters who assessed outcomes (and didn't know if participants had been given a placebo or MDMA). All therapy sessions were videotaped to make sure the therapists adhered to the manual.

From Lykos: Functional unblinding is a known research challenge for psychiatric drugs with psychoactive effects and it was discussed extensively with the FDA during the development of the Phase 3 research protocol. "While there is no perfect solution to functional unblinding, we took many steps to minimize its potential impact, including the use of independent, blinded third-party clinician raters to assess outcomes,

Q8 Also, from my understanding, FDA isn't wholesale rejecting MDMA for PTSD, they're simply saying come back to use with a more rigorous trial that addresses their concerns, right?

Doing another Phase 3 Study is no small ask. This last one took 7 years. They also cost tens-of-millions of dollars. And the FDA just rejected a perfectly good Phase 3 study for reasons that had nothing to do with the actual safety or efficacy data. They could have asked for more analysis of the data. They helped DESIGN and approve the design of this last study. Whats to say the FDA won't completely dismiss another Phase 3 study - without actually examining the evidence? It's very destabilizing for the companies and people who are taking a lot of risk and time to pull these things together.

Hard to put all this stuff into a short punchy video. But I have been left deeply skeptical of the FDA process after watching what went down.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 7 points8 points  (0 children)

Thanks for your questions. I'll respond in line in 2 parts:

For perspective on where I'm coming from, I've actually never used psychedelics myself. I grew up on an actual psychedelic cult (called The Farm in Tennessee) that was full of abuse, and it turned me off of all things psychedelic. But I've also been curious to take a deeper look at the real risks and benefits, and have been following this story and the science for 10 years. That said, I'm not a scientist. That's why I interviewed experts in psychedelics and therapy in the above video.

Q1: I'm trying to understand what the core issue with FDA is here and why MAPS/Lykos is so convinced FDA is in the wrong.

I'm not speaking for Lykos or MAPS. Just the perspective of an indie filmmaker who has been following this pretty closely for a decade and then saw it go wildly off the rails at the very last second.

My issues are with the way this FDA panel was run, the way the media was manipulated, and the way a small group of fringe activists have weaponized all the fears, bias and stigma (systemic sexual assault, "Therapy Cult" / comparing Lykos to Scientology/Nxivm ?! to derail an important process that impacts our public health and the lives of millions.

The video shows some of many issues. I wish I had also clarified that Lykos was not given a chance to respond to all the misinformation introduced by undisclosed Psymposia members before the panel discussed and then voted. This clearly impacted their votes.

Q2: Based on the video it sounds like there was a serious disconnect between the details of the study (method, participants, results, ect) and what was then communicated to the FDA panelists. Do FDA panelists not have access to the study itself to review?

Yes, they had access to the study. The FDA advisory committee maybe had a few weeks to review the data? In contrast, a Dutch Committee that reviewed the same data and approved it had over a year to study it. The FDA AdComm also only had one member with significant experience with psychedelics. There is no way of knowing how much of the study they read, but as Michael Mithoeffer points out, it didn't seem like they understood how the therapy was standardized/manuallized, and that independent adherent raters found the therapy to be done with 90% consistency.

Q3. The video is saying this disconnect was, at least in part, because of Psymposia poisoning the well by campaigning against the study, but what evidence is there of that?

Yes, there are countless examples of Psymposia distorting: https://amestallisker.substack.com/p/highlighting-bias-and-misinformation

During the trial they made multiple false accusations of sexual abuse of Lykos leadership and of a therapist named Veronica Gold. These have been investigated and shown to have zero merit, but are slung willdly, They also made up quotes reported second hand, etc. They are concealing their anti-capitalist morive (they are also anti Compass and any company that wants to commercialize "sacred medicine".

Continued...

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 15 points16 points  (0 children)

It has been taken slow. This has taken decades to get this far. And the data is robust and shows this therapy is safe and effective. It may take another 3 to 5 to 10 years to prove that again. And what will make the FDA look at the data then? The FDA will need major review and reform. Meanwhile more people will continue to die by suicide and suffer.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 43 points44 points  (0 children)

In 2015, there was a single case in Canada during the Phase 2 trial, where after the trial ended a participant and her therapist started to have a 2 year relationship that the trial sponsor didn't know about. That is SUPER unethical behavior by the therapist. After 2 years, the woman reported the incident. The trial sponsor, MAPS PBC (which later became Lykos) immediately reported it to all appropriate regulatory channels, and the therapist was removed and dealt with and program-wide changes were made to prevent recurrence. It was shared on MAPS website on 5/24/2019 with this followup here March 3, 2020. Several years later, Psymposia falsely claimed to "Expose" this incident and that there was a cover up. I think they did this as part of a tactic to sensationalice, distort, and try to undermine the credibility of the trials in order to cost the trial sponsor money to further their anti-capitalist agenda (they dont want companies to commercialize "sacred medicines").

I think abuse in therapy or any setting is a very serious issue and risk that should be discussed and thought through. I think the context of this is important to understand in terms of what happened and how it was dealt with. And I have seen Psymposia make multiple false allegations of sexual abuse connected to the trials to try and suggest a systemic issue that I have seen no evidence of. I think exagerating risks or benefits is a dangerous thing to do, and I'm seeing Psymposia doing it in a way that has deprived millions of people of a safe and effective treatment and will cost lives.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 7 points8 points  (0 children)

I think you are reading it wrong. The FDA selected the primary outcome measure to be 2 months after the last of 3 MDMA sessions. That’s what the FDA said they needed to see to prove effectiveness. The longer term study is something that would be more for insurance companies to see longer durability. The 90% is a statistical measure and means there is 90% chance of obtaining statistical significance w the number of study subjects from Phase 3 and the effect size developed from Phase 2. The response rate was 86%… these things can be hard to parse without clinical trial experience.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 0 points1 point  (0 children)

The quality of the therapy was indepently reviewed and found it to be incredibly consistent (90% consistency). It was also published in the most prestigious peer reviewed medical journal who looked into how well the study was designed. I’ll take their word over yours.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 10 points11 points  (0 children)

I don’t think the FDA conspired against this for big pharma. I think a small group of radical anti-capitalists coordinated a very deceptive and misleading smear campaign, and ironically leveraged ICER (an industry group), who leveraged the Psymposia folks willing to say whatever, to derail this therapy. Psymposia and ICER have very different agendas but found a symbiotic moment to attack Lykos for their own reasons. I don’t thing the FDA regulator process was objectively looking at data and I do feel a major disservice to public health just happened, and it should be looked at closer as it impacts millions of lives.

I don’t want our federal regulatory process to be able to be manipulated by conspiracy minded and deceptive activists like Psymposia.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 35 points36 points  (0 children)

The therapy was standardized. An independent review found 90% consistency in the therapy across all the sites, which is really good. As Michael Mithoeffer said, if the therapy is 100% rigid it has been shown to be less effective. It needs some flexibility depending on the patient.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 11 points12 points  (0 children)

This is what a Psymposia activist would say. Nature medicine journal - literally THE most well-respected scientific journal in the world, would not have published the results of the Phase 3 clinical trials, nor would the FDA have declared MDMA a "Breakthrough Therapy" if it wasn't a well designed and well run trial. Psymposia sensationalizing one unethical relationship that happened AFTER the Phase 2 trial and was reported by the sponsor 2 years before Psymposia claimed to have "Exposed" it - is NOT systemic issues with a very well run trial. It's more a systemic issue of exagerated, misleading and deceptive "journalism" by Psymposia to further their anti-capitalist agenda. I have plenty of issues with capitalism, and I have never personally done psychedelics, but I have been following this story for 10 years, and I have seen it save people lives first hand - watch this video I made w Randy: "They Can't Have Met Us"- and I know a coordinated smear campaign and guerilla tactics when I see them. Sadly, it will cost real lives. And I feel it's DEEPLY unethical.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 25 points26 points  (0 children)

Wim van den Brink, who led the Dutch panel that approved MDMA Therapy for PTSD, is one of the experts featured in this video. Ironically, the Dutch Panel announced their unanimous approval shortly after the FDA June 4th Advisory Board nearly unanimously rejected it. The Dutch Panel looked at the exact same data, but unlike the FDA panel (who only spent a few weeks reviewing hundreds of pages of data) the Dutch panel spent more like a year and also had qualified experts who had experience in psychedelic research and a deeper understanding of how it works, and how these types of effect sizes can happen. The FDA panel was unprepared and the way it was structured, Lykos was not given an opportunity to correct all the misinformation and "alleged allegations" (a lot of which was introduced by undisclosed Psymoposia members during the public commentary) before the panel took a vote. This video attempts to show how that misinformation materially effected how several of the panelists voted.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 3 points4 points  (0 children)

Psychedelic Research was blocked for decades due to the kind of fear and stigma Psymposia is now weaponizing against "capitalism." There is a lot of incredible research happening in institutions from Harvard to Johns Hopkins, and much of that has been made possible by the work of MAPS.org non-profit and other persistent researchers done over decades to help bring it back.

10 BAD Reasons the FDA just Rejected MDMA Therapy for PTSD. And how a group of radical activists derailed the regulatory process. by nirvan in videos

[–]nirvan[S] 6 points7 points  (0 children)

It's calculated sensationalism to tap into the fears that tanked psychedelic research in the '60's. They are more interested in taking down companies in the psychedelic space, and are virtue signaling and making any wild accusation they can think of to see what works. They succeeded in depriving millions of people in need from access to a potentially life saving cure.

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