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# MAPS/Lykos MDMA Application - FDA Public Comment Challengers
- URL: https://ghost.psymposia.com/maps-lykos-mdma-application-fda-public-comment-challengers/
- Published: 2024-06-07T00:02:14.000Z
- Updated: 2026-09-29T01:02:04.000Z
- Description: On June 4, 2024, the United States Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee convened to assess Lykos Therapeutics’ (formerly MAPS Public Benefit Corporation) new drug application (NDA) of MDMA-Assisted Psychotherapy for the treatment of post-traumatic stress…
- Author: Mike Elliott
- Tags: Videos, #youtube, #youtube-transcript

On June 4, 2024, the United States Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee convened to assess Lykos Therapeutics’ (formerly MAPS Public Benefit Corporation) new drug application (NDA) of MDMA-Assisted Psychotherapy for the treatment of post-traumatic stress disorder (PTSD). The committee assessed the intervention’s overall benefit-risk profile, including the potential public health impact and overwhelmingly voted against approval due to concerns with company conduct and clinical trial data.

The open public hearing of this meeting was extended in response to a citizen petition submitted April 28, 2024, which requested additional time to accommodate critical perspectives. The co-authors of the petition included Drs. Neşe Devenot and Brian Pace — who are board members of Psymposia — as well as Meaghan Buisson, an independent researcher and MAPS/Lykos clinical trial participant; Kayla Greenstein, PhD candidate at University of Sydney; and Dr. Alaina Jaster, of Virginia Commonwealth University.

Thanks to the extension of the open public hearing, over 30 public speakers were able to be heard in front of the advisory committee. The following public comments represent the public speakers who challenged Lykos Therapeutics’ new drug application. The full open public hearing can be viewed at the link in the description of this video.

Resources:

Full FDA Psychopharmacologic Drugs Advisory Committee meeting on Lykos Therapeutics’ new drug application for MDMA-Assisted Therapy: [https://www.youtube.com/watch?v=JqQKP8gcY1E](https://www.youtube.com/watch?v=JqQKP8gcY1E&ref=ghost.psymposia.com)

Full Open Public Hearing section: [https://www.youtube.com/live/JqQKP8gcY1E?feature=shared&t=21663](https://www.youtube.com/live/JqQKP8gcY1E?feature=shared&t=21663&ref=ghost.psymposia.com)

Citizen Petition can be downloaded here: [https://www.regulations.gov/document/FDA-2024-P-2148-0001](https://www.regulations.gov/document/FDA-2024-P-2148-0001?ref=ghost.psymposia.com)

## Transcript

*This transcript was generated automatically from YouTube's captions, then cleaned up by removing filler words, repeated words and background sounds. It may still contain errors.*

[\[00:01\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1s&ref=ghost.psymposia.com) Righty I'd like to thank the FDA for the opportunity to provide comment today my name is Russell hosfeld and I have no conflicts of interest here for the last eight years in my capacity as a journalist I have followed the developments of the sponsor organization Leos therapy itics or is it was known until earlier this year map's public benefit Corporation when I initially began covering Leos I thought I was aligned with the goals to legalize and destigmatize psychedelics after years of reporting on Leos however I now fear that it would be irresponsible to endorse this company to roll out a radically new pharmaceutical and therapeutic intervention to the world over the last eight years I've been demonstrably lied to by laos's team on multiple occasions I've fielded disclosures of sexual abuse that happened on laos's watch I've observed

[\[01:03\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=63s&ref=ghost.psymposia.com) Gross mishandling and misrepresentation of clinical trial data I've seen evidence that leadership sexually and financially exploited donors and I've cataloged laos's long-term strategy to mainstream its interventions through appeal to the VA and the dod while simultaneously exploiting its own V volunteer veterans because the political strategies of Leos have largely revolved around centering veterans in public relations I wanted to highlight the words of some of the Vets who volunteered with lyos and whose stories of mistreatment I cataloged during reporting I conducted in 2022 slide change please one military police veteran worked with lyos and told me I watched as lyos and its researchers used veterans up and discarded them as soon as they no longer served a useful purpose regardless of mental health consequences or social implications slide change One navy veteran told me that a number of instance told me of a number of instances in which he felt veterans were paraded around used as props and

[\[02:05\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=125s&ref=ghost.psymposia.com) Exploited for free labor slide change and a marine veteran felt that the company leadership essentially stole his research and kicked him off of his own project saying if this mistreatment by lyos is happening to me it concerns me about the population that lyos will be working with moving forward working with Leos has been very very crushing to me as an individual and as a veteran further details about these stories can be found in my written comment on the FDA website in conclusion I agree with these veterans who worry about the incredible incredibly vulnerable patients that lyos intends to work with if it receives approval for MDMA histed therapy the organization has demonstrated time and time again that it is willing to play fast and loose with data and with people's lives I do not trust Leos to spearhead a new industry of psychedelic Pharmaceuticals and I ask that the FDA think hard on the potential consequences of allowing company to move forward with approval thank you for your time for the record you have three minutes my name is n davo and I'm a

[\[03:07\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=187s&ref=ghost.psymposia.com) Researcher at John's Hopkins University with expertise in psychedelic bioethics I co-authored a citizen petition to extend the open public hearing at this meeting Leos claims its training program will reduce the risk of boundary violations by teaching the specific psychological intervention from its clinical trials but the clinical trials failed in this regard this committee has been misled by Leos to believe that this intervention was non-directive and empathetic next slide lus has obscured its actual intervention and its submissions to the FDA this intervention is acknowledged in this 2015 paper by founder Rick doblin next slide doblin admits that loos's entire therapeutic approach is based on stanislav graph's spiritual teachings and that the essence of that treatment approach is a death rebirth process although this specific intervention isn't in any of the briefing documents that were submitted to the committee it is associated with identifiable patterns of harm across lyos clinical trials next slide lyos intervention is described more fully in

[\[04:09\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=249s&ref=ghost.psymposia.com) The book integral psychedelic therapy two of its three editors were lyos trainers and phase three therapists and it was endorsed by prominent members of laos's inner circle next slide in this book Veronica gold a Leos supervisor trainer and faas therapist describes pinning down a patient as their distress escalated to the point of shouting quote go away get your effing hands away from me end quote but gold did not stop as demonstrated by the many lyos therapists who endorse this abusive practice this is an accepted component of the intervention that Leos presented to this committee as necessary for positive patient outcomes next slide lus would like this committee to believe that significant boundary violations were limited to a single phase two participant although this participant Enlisted the media to draw attention to the dangers of liosis therapy the components of her on camera physical assault are still explicitly taught as part of laos's intervention next slide after submitting my 17 Page

[\[05:09\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=309s&ref=ghost.psymposia.com) Written comments to this committee I was connected with a phase three participant whose PTSD symptoms were exacerbated by lcos clinical trial I learned they were under the care of therapist Veronica gold and they continued to experience flashback Nightmares of the specific intervention that Leos expects this committee to support next slide Leos argues that its training will ensure that boundaries are maintained but its intervention heightens risks for participants by incentivizing boundary violations in addition to gross violations in phase two previously unreported violations include laos's senior leadership having sexual encounters with a vulnerable individual who was then recruited into phase three the most significant harms and liosis clinical trials were not caused by MDMA but by the people who were entrusted to supervise its Administration if the committee would like additional information I'm happy to provide it thank you please state your name and

[\[06:10\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=370s&ref=ghost.psymposia.com) Introduce yourself please state your name and organization for the record you have three minutes thank you good afternoon I'm Dr Michael Abrams from public citizens health research group and I have no Financial conflicts of interest on this matter the committee today is mainly evaluating the treatment Associated experiences of about 170 participants who took part in the placebo controlled efficacy studies and about 470 individuals whose data were used to consider mitom aetam as a Psychotherapy enabling treatment for PTSD the two pivotal randomized clinical trials were functionally unblinded and thus likely biased towards favorable drug effects patients and therapists likely knew who received the drug an anecdote suggests some therapists abused that knowledge to manipulate patient beliefs despite reluctantly greenlighting these trials The fda's Briefing materials for this meeting said this quote the contribution

[\[07:11\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=431s&ref=ghost.psymposia.com) Of the likely expectation bias cannot be discounted while it also cannot be Quantified for the primary outcome in both trials statistical estimates of a ninepoint difference in one trial and a 12o difference in the other favoring the drug treatment did not or only barely achieve the 10-point difference the FDA agreed represents the lowend of meaningful Improvement in PTSD related symptoms moreover the pivotal trials were confounded by the inclusion of imprecisely defined multi-hour Psychotherapy sessions to quote the FDA briefing materials another time quote the contribution of psychotherapeutic support sessions to the overall efficacy results cannot be fully Quantified or understood close quote even as the results show that both the drug and the placebo exposed patients improved

[\[08:13\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=493s&ref=ghost.psymposia.com) Markedly though variably Adverse Events that were markedly more prevalent with the drug treatment compared to placeo included blurry vision gastrointestinal disturbances thermal regulation disturbances acute blood pressure increases headache dizziness Tremor psychiatric symptoms such as insomnia and of course the abuse and dependence potential of the treatment are well established in human and animal studies thus as the FDA briefing materials state it is particularly concerning that quote the applicant did not appropriately document central nervous system related Adverse Events close quote as advised by the agency's control substantive staff based on the available evidence and considering the main deficiencies of this drug application the known benefits of metamfetamine to treat post-traumatic stress disorder those benefits are insufficient to outweigh the many risks thus public citizens health research

[\[09:14\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=554s&ref=ghost.psymposia.com) Group urges this committee to vote no on the voting questions before you and to recommend the FDA to the FDA that mmda not be approved thank you hello my name is C too Harvey I'm the executive director of the people of color psychedelic Collective My organization provides education and community outreach to those interested in learning about psychedelics and ending the War on Drugs I've worked in the broader drug policy reform field for 11 years in those 11 years I worked as Rick doin's assistant at the multidisciplinary association for psychedelic studies for eight months in 2015 despite my poor treatment as an employee I am grateful to maps for pionering a movement around psychedelic healing and clinical settings I believe part of the reason why we're here is the question surrounding the efficacy of MDMA assisted Psychotherapy for people with PTSD but I also think the other part of

[\[10:15\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=615s&ref=ghost.psymposia.com) The reason why we're here is because this is the first time in my opinion that Advocates have had the space to share and have others engage their concerns there is a tendency in the Psychedelic Community to shy away from critique or confrontations this hearing may not have been as bustling had leaders in the field address some of the questions speakers are bringing up today I consider a lot of the speakers colleagues and one common theme between us is that we entered the Psychedelic field as enthusiasts for the movement yet we know when we love something you must critique it for the last few years I've critiqued maps for their lack of inclusion of non-white study subjects I've also witnessed the field and Maps dismiss valid concerns from other critics and a refusal to engage those

[\[11:16\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=676s&ref=ghost.psymposia.com) Concerns while some may see this hearing as a detraction I see it as an opportunity to improve our movement and ensure consumer safety after seeing the evidence of abuses cross boundaries and Buri discrepancies I've concluded that there needs to be more rigorous research on MDMA assisted Psychotherapy before is brought to the public as an advocate for ending the War on Drugs I believe that all drugs should be decriminalized and regulated yet there's a need for research back understanding and guidance on safe effective use of psychedelics rigorous accountability standards and a moral degree of integrity are Central to my commitment I hope that after this hearing the field starts to hold itself to a higher standard hi my name is Kayla Greenstein I'm a psychology PhD candidate at the University of Sydney

[\[12:18\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=738s&ref=ghost.psymposia.com) And I used to work in sexual assault response I have no Financial disclosures it's 4:00 a.m. in Australia and I would rather not be awake right now but I am deeply concerned about the lyos model of MDMA assisted therapy when I started my PhD two and a half years ago I wanted to conduct a psychedelic clinical trial for PTSD but as I looked at the Psychotherapy component I quickly realized there were very serious issues my research now focuses on the theoretical underpinnings and use of touch in psychedelic therapies I have read the lyos therapeutic manual very closely and I've read all of the references cited in the manual the core idea of the therapy is that we all have an inner healing intelligence that can be accessed through MDMA and other non-ordinary states of Consciousness given the centrality of the inner healing intelligence in their therapy manual and as a proposed mechanism of action I'm really surprised we didn't hear more about it today from the

[\[13:18\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=798s&ref=ghost.psymposia.com) Sponsor it was also really concerning to hear the sponsor say that MDMA assid therapy facilitates memory recollection this is a highly controversial idea that sits alongside the idea that MDMA elicits a more authentic version of the self connecting to the inner healer and archetypes in the collective unconscious using touch and bodyw work to clear energy blocks in patients are also in the therapeutic manual much of the backing of the manual is based in New Age psychospiritual Theory it is Rick dolin's goal to have a global spiritualized Society by 2070 controversial New Age psych iatrist danan grath comes up 14 times in the therapy manual he believes all Psychopathology is rooted in traumas in the birth canal here's his book and some of those diagrams this includes homosexuality which grth believes is a disfunction that comes from trauma in stage three of the birth process br's

[\[14:20\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=860s&ref=ghost.psymposia.com) Work is homophobic and misogynistic this is not a safe therapy model these theories were an integral part of the phase 2 trial abuse and we need a different therapeutic manual with contemporary co-designed research supporting it I also recently published on the lack of mention or discussion of coercive control in MDMA couples therapy where one person has ppsd in response Maps Affiliated researchers attempted to have my work removed with baseless accusations after a lengthy process I demonstrated my critiques of their work were entirely accurate there has been no recognition of the role of coercive control and increased vulnerability within couples and families in the treatment process I am still hopeful about MDMA assisted therapy and I greatly look forward to seeing the research coming from Labs that are not associated with maps and lyos I wish I could support this application however I believe approving this model of MDMA assisted therapy would result in substantial further harms I very much hope that if it is approved I'm proven

[\[15:21\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=921s&ref=ghost.psymposia.com) Wrong about that thank you my name is Brian Pace I am a lecturer teaching psychedelic studies in the department of Plant Pathology at the Ohio State University I am also a co-author of the citizen petition which raised serious concerns about the NDA under review I thank the FDA for granting extended time in this response to our petition no conflicts I submit that lyos is a therapy cult that uses the application under review to further mystical and utopian goals this lens explains the mounting allegations against them regarding research misconduct and iCal trial participant Harms in my paper right-wing psychedelia I analyze lyos leadership simply stated aims for institutional instrumentalizing the drug under review to change people's beliefs as part of an ongoing project of global spiritual conversion this spiritual conversion underlies their promise of solutions to

[\[16:22\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=982s&ref=ghost.psymposia.com) More material concerns like bringing about world peace or solving climate change while these are not the first dubious promises to be made by applicants before this agency they are perhaps the most grandiose I'm obligated to State the obvious MDMA assisted therapy for PTSD is not going to result in the quote spiritualization of humanity unquote and such claims are the Prophecies of a therapy cult next Slide the FDA is under no obligation to evaluate these spiritual claims but this agency is tasked with monitoring institutional review board compliance and act when study sponsors confess to Casual human experimentation with the drug under consideration at burningman that Leos leadership felt comfortable admitting this while clinical trials were ongoing betrays a lack of internal accountability and an organizational culture of deep impunity lyos has

[\[17:24\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1044s&ref=ghost.psymposia.com) Exploited this lack of monitoring and sanction from the FDA in fact they setting on it next slide at South by Southwest this year lyos CEO Amy Emerson shared that patients presenting increased suicidal adiation is quote actually part of the process unquote of psychedelic therapy in the same breath she acknowledged that committing instances like these to medical records would be poorly received by Gatekeepers of Public Health omission of Adverse Events is one of the specific allegations leveled against the applicant as I mentioned in my written comment an organization convinced it's on a mission to save the world might find justification of any means to do so next slide but the fda's broadest mission is that of protecting public health patients living with PTSD need rigorously tested care not the faith healing of a therapy cult's latest Rebrand of laying on of hands the concerns I share today aren't

[\[18:25\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1105s&ref=ghost.psymposia.com) About the safety of MDMA but rather the people who have been administering and supervising this medicine harms and misconduct will scale if they allowed to train and certify therapists thank you my name is Joe Welker I'm the pastor of East craftsbury Presbyterian Church in craftsbury Vermont I have no Financial relationships to report I completed chapy training at the Charles George VA Medical Center where I worked with many veterans who suffer from PSD I know that condition is not trivial I fully support and grateful for anyone who has gotten and will get healing from mtma for PTSD including in this trial but I also speak as a former member of the Psychedelic industry before I became a whistleblower on a study at Johns Hopkins University where funders and researchers with intimate ties to lyos then known as Maps Advanced a religious and spiritual agenda that is shared by Leos founder and executive director Dr Rick doblin as Dr Pace has just described I feel compelled to Echo concerns warning the public of what is

[\[19:26\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1166s&ref=ghost.psymposia.com) An openly known secret in the Psychedelic industry that in the words of Dr doblin his long-term desire is a quote spiritualized Humanity politically advancing this Mission using the reputation of science this study has functioned as that first politically Savvy Trojan Horse of that mission as I submitted in written comments while one may argue the legitimacy of psychedelic spiritual beliefs on their own merits how do we trust data when a company not only has Financial conflicts of interest but open spiritual and religious conflicts of interest and like the worst religions including my own what happens when people are abused in the name of a religious Mission as we saw in these trials they are often discarded silenced minimized for political gain and tossed away as inconvenient and so while I support anyone who gets healing from mdate therapy I'm here in support of people harmed in these trials many other victims of psychedelic therapy abuse all of their family and friends former lyos employees academics whistleblowers the many who have spoken anonymously to the

[\[20:28\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1228s&ref=ghost.psymposia.com) Media journalists and others who have concerns about the intermingling of a utopian spiritual movement with science I must also say there is a certain irony in questions earlier about risk assessment and whether participants increase in elicit use of MDMA both the FDA and the public should be aware that this study is run primarily by people with an extensive use of MDMA in illicit settings it would be hard to find a bigger promoter of elicit MDMA use in American history than Dr doblin Dr dolin's public advocacy gives the impression that lyos leadership would think any increase in illicit use would not be a bug but a feature again I am a former psychonaut and I do fully support people who got healing in this trial or elsewhere from psychedelics and I support continuing Research into MDMA therapy but while lyos leadership May Envision a spiritualized Humanity in this very study lyos treated the people who were harmed under their care with a falsely spiritual inhumanity regardless of the decision today and in August the

[\[21:30\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1290s&ref=ghost.psymposia.com) Public deserves to know that thank you thank you hello my name is Bo witka I just want to start off by saying it was very hard for me to join you today and it was equally challenging for me to write the statement that I'm reading since I currently find myself in the midst of what I openly describe as the most terrifying time of my life the frightening state I'm in and a to cope with to the best of my ability began immediately following a single guided MDMA to therapy session on February 19th 2023 in spite of my difficulties and discomfort presenting to you I want to be as candid as possible about my experience since I'm living proof of the dangers of the therapy component of MDMA assisted therapy and I feel like I have a duty to educate and warn others about something I was completely ignorant of prior to my treatment last year that MDMA can cause lasting harm to a client when administered under the guidance of an inep and or inex experienced therapist I'm determined to continue to

[\[22:32\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1352s&ref=ghost.psymposia.com) Share my story publicly so as to not allow what happened to me to happen to others I have nothing against MDMA and in fact I know from personal experience that this drug has tremendous clinical potential for positive outcomes when administered correctly in late 2022 I participated in a group Journey where I was not working with a therapist this experience was extremely positive and changed my life in ways that years of talk therapy could not the MDMA that I consumed with this group came from the same source as the MDMA I was given on February 19th 2023 which proves how impactful the role of a therapist can be speaking of therapists it's important for me to note that the license therapist who guided me is a graduate of the California Institute of integral studies Center for psychedelic therapies and research with trains therapist for maps clinical trials she has a doctorate many years of experience various certificates and claims to specialize in treating trauma this experience has completely

[\[23:34\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1414s&ref=ghost.psymposia.com) Derailed my life I've been able to work for the last 15 months and I've had to live with a family member while I attempt to recover on my own just a few of the symptoms I've experienced on a daily basis with often abrupt inconsistent and unpredictable fluctuations include extreme exhaustion rain fog severe cognitive impairment unrefreshing sleep headaches eye issues and a long list that's too extensive to share with you today I'm 100% Pro MDMA and would like to see the drug legalized for therap to cuse however I cannot support MDMA assisted therapy being allowed to go mainstream until more training and research is conducted to better understand how to avoid outcomes like mine and more importantly how to support people who experience extended difficulties there is zero support for people like me and absolutely no Safety Net in place I want to end by saying two years ago this topic in meeting would have meant very little to me but since February 19th of 2023 it has become an

[\[24:34\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1474s&ref=ghost.psymposia.com) Extremely personal subject and thank you again for holding this hearing distinguished members of the psychopharmacologic drugs advisory committee thank you for your time and attention my name is Sasha Cisco and I have no Financial relationships to disclose today I will highlight four incidents of misconduct that raise significant ethical and legal concerns which Merit your urgent consider ation I speak as a survivor of PTSD I will partially draw upon findings from my pre-print entitled omission of serious Adverse Events within Maps sponsored clinical trial Publications first Maps founder and Leos board director Richard doblin PhD has described the publicly available footage of the physical sexual assault of a Maps Phase 2 trial subject in the treatment room as depicting a quote technique involving quote Psycho Drama that quote can be beneficial in the

[\[25:37\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1537s&ref=ghost.psymposia.com) Context of psychotherapy to it Maps has published a book by Stan gra entitled LSD Psychotherapy which endorses quote sometimes inflicting pain and quote upon patients during quote intense psychodynamic struggles second Dr doin has proposed enrolling ukrainians housed at Refugee centers into a Maps sponsored clinical trial examining MDMA assisted group Psychotherapy in sessions involving upwards of 100 participants although doblin has described such quote humanitarian projects as quote a risk that Maps must take his stated proposal violates the nurenberg code third I have documented dozens of instances of Dr Dalin promoting off Lael use of MDMA assisted couples therapy and

[\[26:39\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1599s&ref=ghost.psymposia.com) Furthermore encouraging the general population to practice MDMA Psychotherapy as detailed in the maps treatment manual despite contacting the FDA and Maps Representatives about this I have not to my awareness received a response to these matters fourth I have reported on footage depicting a Maps trial subject informing multiple Maps researchers that they engaged in suicidal behavior during their clinical trial after their first MDMA treatment session however the relevant trial publication claims that no suicidal Behavior occurred quote during the treatment period after dosing I can provide this footage to the FDA upon request it should be noted that Dr Dr doin famously criticized another psychedelic researcher for omitting a serious adverse event from their Publications stating that quote there is no justification for this Omission no

[\[27:42\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1662s&ref=ghost.psymposia.com) Matter how unfairly the critics of This research may have used this information and no matter how minimal the negative persisting effects reported by the subject in conclusion I urge the FDA and its office of criminal investigations to Al investigate these substantiated allegations to ensure compliance with federal laws and FDA regulations while safeguarding the Public's safety as well as the safety of patients thank you for your attention I yield my time hello my name is Sarah G I am a proxy reading a statement for Megan buison my name is Megan Buon I'm a phase 2 clinical trial participant directly recruited into this study by Leos I was so scared of being touched I initially turned them down they called me again A year later desperate for help I agreed I moved provinces for the trial sponsor failed to obtain full informed consent the day before my first

[\[28:43\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1723s&ref=ghost.psymposia.com) Session they found an admission to my screening which should have excluded me instead lyos broke its exclusionary criteria and kept me in the study regarding the assaults I suffered in the clinical trial I will not be going into detail there is a video clip Ely available online the fact that it and my name are public is extremely difficult it should never have been necessary in September of 2021 I submitted a statement to the FDA as part of a formal complaint in it I made the FDA aware of abusive practices normalized by the clinical framework in these practices included being blindfolded gagged pinned cuddled and caressed all things I specifically indicated I did not consent to prior to MDM made dosing video evidence confirms physical and sexual assaults within those active sessions I became suicidal during the trial near leading to a near Miss attempt Leos was informed and chose not to document it undoubtedly it was an

[\[29:44\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1784s&ref=ghost.psymposia.com) Adverse event and they hit it the clinical trial shattered me overwhelmingly vulnerable I was trafficked by my therapist while still in the clinical trial the first position to treat my wounds after I escaped said I was quote drugged raped blamed and held as a sex slave end quote members of laos's leadership team a principal investigator and several phase three therapists witnessed my abuses firsthand no one did a thing Leo still maintains that quote monitoring of study records throughout the course of the trial and afterwards did not indicate signs of ethical violation end quote this is false even after my assaults Leos insists on employing unlicensed unregulated individuals this raises serious questions about ethics patient safety and informed consent vulnerable patients have no recourse when harms occur what I experienced wasn't just two bad therapist it was a predictable outcome of preventable harms and

[\[30:44\]](https://www.youtube.com/watch?v=PSqotSD6WOg&t=1844s&ref=ghost.psymposia.com) Failures of lyos it is gutting to know that individuals in phase three have suffered similar harms even after I leered the FDA in 2021 I now struggle with new PTSD symptoms alongside my original ones I suffer from crippling anxiety and a pervasive distrust of healthcare providers these harms are magnified by laos's Relentless efforts to skirt their responsibility by pushing a false Narrative of misogynistic rape myths this is disgusting in institutionalized abuse the sponsor lied to the committee about Adverse Events and safety monitoring trial videos must be independently reviewed I urge the FDA to ser seriously consider its responsibility for patient safety and reconsider the veracity of laos's claims thank you thank you