When we see comments like this the alarm bells ring
Susie Sarlo spoke of MAPS’s impact on her father, George Sarlo, who was exploited for MAPS’s financial benefit by MAPS Board Chair and Treasurer Vicky Dulai:
“He was repeatedly fed psychedelics by those claiming to be treating his PTSD, but in reality, they were using these powerful substances to gain control of his mind and finances. By the time our family was able to intervene, his physical and mental health had rapidly declined.”
Will Hall, a PhD candidate at Maastricht University and a former participant in underground MDMA therapy wrote:
“I experienced … increased suicidal feelings, anxiety, and decline in functioning as a result of these treatments, without any acknowledgment … [or] long term follow up… I also experienced and witnessed multiple sexual violations and violations of ethical boundaries including exploiting patient labor and sex with multiple patients.”
Rev. Joe Welker wrote “as someone who used to be involved in the psychedelic industry before becoming a whistleblower on issues in a study at Johns Hopkins University:”
“Regardless of the decision you make, the public needs to be aware of the issues and scrutinize the alignment of a pharmaceutical company with utopian spiritual motives, and take a close look at its treatment of those who do not align with their agenda.”
Psymposia —They write in their latest email update
The window is closed to submit comments for the Psychopharmacological Drugs Advisory Committee to review before the public meeting, but you can still leave a comment for FDA until 6/3, the day before the advisory committee meeting.
Members of Psymposia are scheduled to speak for three minutes each during the open hearing portion of the advisory committee meeting.
The general public (including Psymposia members) submitted comments to FDA expressing both support for and concerns over Lykos’ MDMA-AT.
The ICER Public Meeting on MDMA-AT for PTSD is this Thursday (5/30) and “will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, benefits beyond health, and long-term value for money.”
Dr. Neşe Devenot will be speaking at 12 pm ET on 5/30 during the ICER Public Comments period. View the full meeting agenda here.
Window For Written Comments for FDA’s Advisory Committee Meeting Closed (General Comment Window Still Open)
In advance of the FDA hearing to assess Lykos Therapeutics’ (formerly MAPS PBC) new drug application for pharmaceutical MDMA, 46 people submitted written comments before the 5/23 review deadline. The public can still submit comments to the docket through 11:59 pm ET on 6/3, but these comments won’t be given to the Advisory Committee for review.
(Comments submitted between now and 6/3 “will be taken into consideration by FDA,” but are not guaranteed to be read.)
Though most comments were supportive of MDMA approval, others — including three from Psymposia members — expressed concern over Lykos’ methods and the many accounts of abuse and misconduct against them.
Here are a couple of notable excerpts from others voicing concern:
Susie Sarlo spoke of MAPS’s impact on her father, George Sarlo, who was exploited for MAPS’s financial benefit by MAPS Board Chair and Treasurer Vicky Dulai:
“He was repeatedly fed psychedelics by those claiming to be treating his PTSD, but in reality, they were using these powerful substances to gain control of his mind and finances. By the time our family was able to intervene, his physical and mental health had rapidly declined.”
Will Hall, a PhD candidate at Maastricht University and a former participant in underground MDMA therapy wrote:
“I experienced … increased suicidal feelings, anxiety, and decline in functioning as a result of these treatments, without any acknowledgment … [or] long term follow up… I also experienced and witnessed multiple sexual violations and violations of ethical boundaries including exploiting patient labor and sex with multiple patients.”
Rev. Joe Welker wrote “as someone who used to be involved in the psychedelic industry before becoming a whistleblower on issues in a study at Johns Hopkins University:”
“Regardless of the decision you make, the public needs to be aware of the issues and scrutinize the alignment of a pharmaceutical company with utopian spiritual motives, and take a close look at its treatment of those who do not align with their agenda.”
Psymposia’s Comments
The three comments from Psymposia members highlight a variety of concerns with MAPS/Lykos’ approach to MDMA-AT.
Dr. Neşe Devenot’s comment focuses on the power MAPS/Lykos wields in silencing victims’ voices and indoctrinating therapists, patients, and uncritical supporters into cult-like dynamics:
“I have uncovered substantial evidence that the sponsor organization qualifies as a therapy cult that operates on a principle of indoctrinating its therapists and participants into an ideological system of ‘true beliefs.’ The prospect of a therapy cult guiding a suggestibility-enhancing pharmaceutical through clinical trials highlights unique risks for public health, the implications of which have never been publicly discussed.”
Dr. Brian Pace’s comment discusses MAPS/Lykos’ consistent refrain that FDA approval of MDMA is just a step towards a “spiritualized humanity,” and questions the research quality of Lykos’ New Drug Application (NDA):
“This NDA is unprecedented because leadership of the applicant has been explicit for decades about using the drug under review for the larger purpose of a global spiritual conversion. Falling short of this goal—they have been equally explicit—will have disastrous global consequences. I contend that this pattern of rhetorically framing the NDA under review as a key advancement towards fulfillment of deeply held spiritual beliefs among leadership is crucial to understanding the serious allegations of research misconduct against MAPS/Lykos.”
Russell Hausfeld’s comment reviewed his extensive reporting on MAPS’s instrumentalization of veterans, and he emphasizes accounts from veterans who felt exploited by MAPS:
“Considering how heavily Lykos/MAPS has relied on the positive endorsements of veterans to spread its message to the general public and gain political support, I think it is important for the record to reflect the concerns of veterans who have been harmed by the organization and lessons to be learned from their experiences.”
ICER Public Meeting on MDMA-AT for PTSD on Thursday 5/30
In March, the nonprofit Institute for Clinical and Economic Review (ICER) released a report listing a variety of concerns surrounding MAPS/Lykos’ MDMA-AT research. A full breakdown of this report is available on Psychedelic Alpha. These issues include “substantial concerns about the validity of [trial] results,” and ethical and safety concerns.
Following this report, a team of psychedelic researchers and former trial participants, including Drs. Neşe Devenot and Brian Pace, authored a citizen petition calling for FDA to extend its public comment period for the advisory meeting on MDMA. Over 80 people signed the petition.
The debate around Lykos’ clinical trials continued when following these releases, Psychedelic Alpha published an opinion piece from “therapists and trialists from MAPS/Lykos’ Phase 3” trials refuting some of the points made by critics. ICER responded to numerous comments from the public — including Lykos-affiliated individuals — on May 14 alongside its finalized Evidence Report.
Voices of support and opposition will speak at ICER’s upcoming public meeting on 5/30, including our own Dr. Neşe Devenot. You can register to watch along for free at this link. Dr. Devenot will contribute to the public comments period, which will take place from 11:40 am – 12:15 pm ET. You can view the full meeting agenda here.
FDA’s 6/4 Advisory Meeting Extended to Accommodate Additional Oral Presentations
FDA recently announced they would extend the time for public comment, which the citizen petition argued for. However, speakers will still only have three minutes each, which does not fulfill the petition’s request for parity between industry perspectives and concerned voices.
The FDA Psychopharmacologic Drugs Advisory Committee will host a public hearing on 6/4 to discuss the risk-benefit profile of MDMA and its potential impact on public health. The meeting will take place on 6/4 from 8:30 am – 5:30 pm ET with oral presentations from the public happening from 2 pm – 3:45 pm ET.
Dr. Brian Pace, Dr. Neşe Devenot, and Russell Hausfeld are all approved to deliver a 3-minute comment during this time. The committee will meet in person with Lykos representatives at the FDA White Oak Campus in Maryland but you can stream along on YouTube.
