{"id":3833,"date":"2025-02-04T08:20:11","date_gmt":"2025-02-04T08:20:11","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/how-an-activist-group-helped-torpedo-mdma-therapy\/"},"modified":"2025-02-04T08:20:11","modified_gmt":"2025-02-04T08:20:11","slug":"how-an-activist-group-helped-torpedo-mdma-therapy","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/how-an-activist-group-helped-torpedo-mdma-therapy\/","title":{"rendered":"How an Activist Group Helped Torpedo MDMA Therapy"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">After more than three decades of planning and a $250 million investment, Lykos Therapeutics\u2019 application for the first psychedelic drug to reach federal regulators was expected to be a shoo-in.<\/p>\n<p class=\"css-at9mc1 evys1bk0\"><a class=\"css-yywogo\" href=\"https:\/\/lykospbc.com\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Lykos<\/a>, the corporate arm of a nonprofit dedicated to winning mainstream acceptance of psychedelics, had submitted data to the Food and Drug Administration showing that its groundbreaking treatment for post-traumatic stress disorder \u2014 MDMA plus talk therapy \u2014 was <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2024\/06\/04\/health\/mdma-ptsd-fda.html\" title=\"\">significantly more effective<\/a> than existing treatments.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">At a pivotal <a class=\"css-yywogo\" href=\"https:\/\/www.youtube.com\/watch?v=JqQKP8gcY1E\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">public hearing<\/a> last summer, two dozen scientists, doctors and trauma survivors told an F.D.A. advisory panel how MDMA-assisted therapy had brought marked relief from a mental health condition associated with <a class=\"css-yywogo\" href=\"https:\/\/www.ptsd.va.gov\/professional\/treat\/cooccurring\/suicide_ptsd.asp\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">high rates of suicide<\/a>, especially among veterans.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Then came skeptics with disturbing accusations: that <a class=\"css-yywogo\" href=\"https:\/\/chemicalpoetics.substack.com\/p\/maps-is-an-mdma-therapy-cult\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Lykos was \u201ca therapy cult,\u201d<\/a> that practitioners in its clinical trials had engaged in widespread abuse of participants and that the company had concealed a litany of adverse events.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cThe most significant harms in Lykos\u2019s clinical trials were not caused by MDMA, but by the people who were entrusted to supervise its administration,\u201d Ne\u015fe Devenot, one of the speakers opposed to Lykos\u2019s treatment and a writing instructor at Johns Hopkins University, told the committee.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Devenot and six others presented themselves as experts in the field of psychedelics, but none had expertise in medicine or therapy. Nor had the speakers disclosed their connection to <a class=\"css-yywogo\" href=\"https:\/\/www.psymposia.com\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Psymposia<\/a>, a leftist advocacy group whose members oppose the commercialization of psychedelics and had been campaigning against Lykos and its nonprofit parent, the <a class=\"css-yywogo\" href=\"https:\/\/maps.org\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Multidisciplinary Association for Psychedelic Studies<\/a>, or MAPS.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The critics did not provide evidence to back their claims of systematic wrongdoing, but when the votes were counted that day, the panel overwhelmingly rejected Lykos\u2019s application. Before voting, panelists cited a number of concerns, among them MDMA\u2019s potential effects on the heart and liver, and whether trial results were influenced by the fact that most study participants correctly guessed they had received the drug and not a placebo.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Seven of the 11 panelists mentioned the allegations that Psymposia had raised.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">One of them, Kim Witczak, a drug safety advocate, said in an interview that the allegations of misconduct had dampened her initial excitement about MDMA.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThere were too many things that were red flags for me,\u201d she said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Two months later, the F.D.A. <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2024\/08\/09\/health\/fda-mdma-ptsd-delay.html\" title=\"\">rejected the application<\/a>. It did not mention the allegations of misconduct or abuse.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">In a confidential letter to Lykos, the agency said its decision was based on uncertainty about how long the treatment would be effective; concerns about positive bias, including previous use of MDMA by some participants; and Lykos\u2019s failure to collect data on feelings of euphoria, which is considered an adverse event because it can signal a potential for abuse. The letter was described by people who had read it.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-3\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">An F.D.A. spokesperson declined to comment, saying the agency does not discuss pending applications.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Javier Mu\u00f1iz, the former associate director of therapeutic review at the F.D.A.\u2019s division of psychiatry who helped Lykos design its trials, said the treatment\u2019s talk therapy component was a challenge for the agency because it does not regulate psychotherapy.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He also cited another factor: the cultural stigma of an illegal drug commonly associated with cuddle puddles and all-night raves.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-4\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cIf MDMA was a previously unknown molecule, maybe the burden of proof would be lower, but because these drugs have baggage, the science has to be above reproach,\u201d said Dr. Mu\u00f1iz, who was not involved in the final review.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The significance of Psymposia\u2019s role in torpedoing Lykos\u2019s bid is unclear. But Dr. Mu\u00f1iz and other experts said the group\u2019s incendiary allegations made approval that much harder.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The rejection came as a shock to many in the field. It punctured the air of inevitability about the future of psychedelic medicine and led to a management shake-up and mass <a class=\"css-yywogo\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/lykos-cuts-workforce-by-75-2024-08-15\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">layoffs at Lykos<\/a> and other psychedelic companies.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Some have directed their anger at Lykos and MAPS \u2014 for <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2023\/09\/14\/health\/mdma-ptsd-psychedelics.html\" title=\"\">fostering unbridled optimism about federal approval<\/a> and for failing to submit an airtight application to the F.D.A.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">But in recent months, the story of how a small band of anticapitalist activists helped sink the first psychedelic compound to come before the F.D.A. has captivated scientists, therapists and investors in the field.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-5\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">It has also generated fear.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Buoyed by the F.D.A.\u2019s rejection, Psymposia and its allies have expanded their attacks, including against veterans groups that defended Lykos\u2019s application and psychedelic researchers at Johns Hopkins University.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Lykos\u2019s application for MDMA-assisted therapy is not dead. The company met in mid-January with F.D.A. officials to discuss a path forward. Executives said that would most likely include an independent review of its data and another clinical trial that could add years and millions of dollars to the process.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Some advocates hope that the Trump administration will take a friendlier approach. They note that Elon Musk, a presidential adviser, and Robert F. Kennedy Jr., the nominee for health secretary, are vocal supporters of psychedelic medicine.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Jonathan Lubecky, a retired U.S. Army sergeant and a psychedelic medicine policy advocate, said he believed MDMA would eventually be approved. But he worried about the capacity of Psymposia and its allies to damage a field still in its infancy.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He also worries about people with PTSD who have fallen into despair since the F.D.A.\u2019s rejection.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cI see the consequences in my friends,\u201d he said. \u201cSome, quite frankly, are trying to decide whether they should stick around long enough to see it happen.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-6\">\n<div class=\"css-53u6y8\">\n<h2 class=\"css-13o6u42 eoo0vm40\" id=\"link-5afafc83\">Psychedelic Rifts<\/h2>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Devenot has not been shy about claiming credit for derailing the approval of MDMA-assisted therapy.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cYesterday, beyond my wildest expectations, we made international news in a David and Goliath-scale, \u2018dark horse\u2019 victory,\u2019\u201d Dr. Devenot <a class=\"css-yywogo\" href=\"https:\/\/x.com\/NeseLSD\/status\/1798545475127382340\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">wrote on X<\/a> last June.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Founded in 2014 as a nonprofit media organization offering \u201cleftist perspectives on drugs, politics and culture,\u201d according to its website, Psymposia has been widely credited for bringing attention to sexual abuse, especially in underground settings, within the nascent field of psychedelic medicine.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The group has no paid staff and operates as an informal collective of psychedelic industry watchdogs united by their \u201cdesire to disrupt the status quo,\u201d one of its founders, Brett Greene, said on a podcast in 2016.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In an interview, Dr. Devenot, the group\u2019s most high-profile member, said Psymposia was largely focused on \u201cmaking things safer\u201d for those who use psychedelics and highlighting abuses that others in the field were unwilling to address.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-7\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Dr. Devenot, a self-described expert in psychedelic bioethics who uses gender neutral pronouns, often refers to their experience as a sexual assault survivor whose healing was aided by psychedelics. After being \u201cbullied out of the mainstream\u201d psychedelic movement, Dr. Devenot said they connected with other \u201cvery marginalized\u201d individuals at Psymposia.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Devenot\u2019s writings paint a dark portrait of the field. In a <a class=\"css-yywogo\" href=\"https:\/\/akjournals.com\/view\/journals\/2054\/7\/S1\/article-p22.xml\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">recent article<\/a>, Dr. Devenot argued that \u201cglobal financial and tech elites are instrumentalizing psychedelics as one tool in a broader world-building project that justifies increasing material inequality.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-8\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">For many Psymposia contributors, Lykos is Public Enemy No. 1, in part because of the company\u2019s origins as a for-profit arm of MAPS, an organization whose founder, Rick Doblin, has long promoted psychedelics as a tool for healing humanity.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">For Psymposia, MAPS\u2019s decision in 2014 to create a <a class=\"css-yywogo\" href=\"https:\/\/maps.org\/news\/bulletin\/introducing-the-maps-public-benefit-corporation\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">corporate entity<\/a> betrayed those values. Dr. Doblin has said the organization could no longer rely on philanthropy to fund MDMA\u2019s regulatory review and a <a class=\"css-yywogo\" href=\"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2820562\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">post-approval marketing process<\/a> that can cost hundreds of millions of dollars.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-9\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Despite Psymposia\u2019s modest resources, its members have become feared for their ability to use social media to damage reputations and careers, according to more than four dozen academic researchers, clinicians, industry executives, mental health advocates and former Psymposia members who were interviewed for this article.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Many asked not to be named for fear of retaliation.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cEven the name Psymposia causes a pang of anxiety,\u201d said Robin Carhart-Harris, a leading psychedelics researcher at the University of California, San Francisco. \u201cDoing this interview, I\u2019m worried: Am I kicking the hornet\u2019s nest?\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Another Psymposia activist, David Nickles, describes himself as an underground researcher and an anarchist. Mr. Nickles, whose legal name is David Maliken, according to court documents, <a class=\"css-yywogo\" href=\"https:\/\/www.psymposia.com\/magazine\/acab\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">has written critically about veterans and the police<\/a>.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In an interview, Mr. Nickles declined to discuss the use of a different name.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Ido Hartogsohn, a historian and sociologist of psychedelic science at Bar-Ilan University in Israel, served as a peer reviewer for a <a class=\"css-yywogo\" href=\"https:\/\/www.frontiersin.org\/journals\/psychology\/articles\/10.3389\/fpsyg.2021.733185\/full\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">paper written by members of Psymposia<\/a>. He said that the group early on played an important role highlighting abuses in the field but that he had become disenchanted by its tactics.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cPsymposia makes some valid points,\u201d he said. \u201cBut their work is glaringly political, and biased, and it relies too much on shock effect, bad-faith readings of others and questionable assumptions and assertions.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-11\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">In a 2018 Facebook post that has since been deleted, Mr. Nickles outlined strategies for damaging psychedelic companies and nonprofits through persistent, critical media coverage and sabotaging \u201cbusiness operations in ways designed to raise the costs of operating,\u201d according to a screenshot of the post.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The group has become known for its take-no-prisoners approach.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In 2019, Psymposia activists criticized Beatriz Labate, executive director of the <a class=\"css-yywogo\" href=\"https:\/\/chacruna.net\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Chacruna Institute for Psychedelic Plant Medicines<\/a>, an educational nonprofit, after her organization published a series of interviews about <a class=\"css-yywogo\" href=\"https:\/\/chacruna.net\/ayahuasca-community-guide-for-the-awareness-of-sexual-abuse\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">sexual transgressions<\/a> in the psychedelics community and included a man seeking forgiveness for past violations.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Psymposia accused Dr. Labate of giving a platform to an \u201cabuser,\u201d she said, adding that Mr. Nickles published private emails between them in what she said was an effort to paint her in a bad light.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The fallout was immediate, she said, with speakers and sponsors pulling out of a conference she had been organizing, and disinviting her from other events.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-12\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cI really felt my whole career was finished,\u201d Dr. Labate said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Oriana Mayorga, Psymposia\u2019s former director of community engagement, said she also experienced the group\u2019s wrath not long after leaving the organization.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Ms. Mayorga, who is of Latin American and Caribbean descent, said Psymposia\u2019s leaders sought retribution after she criticized on social media a post by Mr. Nickles that accused MAPS of perpetuating \u201cwhite supremacy, capitalism and imperialism.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Days later, Mr. Nickles, Dr. Devenot and Lily Kay Ross, who is married to Mr. Nickles, sent a 28-page letter to administrators at the university where Ms. Mayorga was enrolled, accusing her of \u201cdiscrimination, bullying and intimidation.\u201d The 2020 complaint included transcripts of Ms. Mayorga\u2019s public talks, screenshots from her social media accounts, and text and email messages between Ms. Mayorga and her former colleagues.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In an interview, Dr. Ross said that they had contacted Ms. Mayorga\u2019s university to provide her an opportunity \u201cfor education and growth.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The letter did not result in disciplinary action, but Ms. Mayorga said the experience was devastating. She largely withdrew from the field and no longer has an online presence.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-13\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cThey\u2019ve hurt people like me 10 times more than the good work they believe they\u2019ve done,\u201d she said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Psymposia\u2019s reputation was elevated in 2021, when <a class=\"css-yywogo\" href=\"https:\/\/open.spotify.com\/show\/7dj2XnCMxGpK8W3tGWjiqw\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">a podcast<\/a> it produced with New York magazine on abuses in the world of underground psychedelic therapy became popular on Spotify.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The podcast highlighted an ethical violation that occurred in an early Lykos trial that was not part of the company\u2019s F.D.A. application, when a husband-wife therapy team in Canada <a class=\"css-yywogo\" href=\"https:\/\/www.cbc.ca\/player\/play\/video\/1.6400496\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">spooned and cuddled a participant<\/a>, Meaghan Buisson, during her MDMA session.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">After the trial concluded, the male therapist, Richard Yensen, began a sexual relationship with Ms. Buisson. In 2018, Ms. Buisson filed a civil claim in British Columbia saying that Mr. Yensen had sexually assaulted her. The case was settled out of court.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">After learning of the violation, MAPS notified health authorities in the United States and Canada and barred the two therapists from its programs. The organization <a class=\"css-yywogo\" href=\"https:\/\/maps.org\/2019\/05\/24\/statement-public-announcement-of-ethical-violation-by-former-maps-sponsored-investigators\/#2019\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">publicly addressed<\/a> the incident in 2019 in a statement.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The podcast did not provide evidence of systemic problems in Lykos\u2019s trials, but it helped fuel rumors of rampant misconduct. Psymposia\u2019s approach had another impact, too: It cleaved the small, close-knit psychedelics community.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-14\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cIf you don\u2019t agree with their view on a particular issue or say anything that deviates from the narrative they\u2019re pushing, you\u2019re automatically labeled as supporting sexual assault or being ethically questionable,\u201d said Manesh Girn, a neuroscientist at the University of California, San Francisco.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Ross said the problem was not Psymposia\u2019s approach, but the psychedelic community\u2019s reluctance to engage with the issues that Psymposia was highlighting.<\/p>\n<h2 class=\"css-13o6u42 eoo0vm40\" id=\"link-5516f492\">\u2018Very Disturbing\u2019 Allegations<\/h2>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-15\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">As the F.D.A.\u2019s advisory panel meeting approached, Psymposia ramped up efforts to thwart Lykos\u2019s application.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">It found an audience at the Institute for Clinical and Economic Review, or ICER, an independent nonprofit that evaluates the clinical and cost effectiveness of new medical interventions.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-16\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The opening pages of the <a class=\"css-yywogo\" href=\"https:\/\/icer.org\/wp-content\/uploads\/2024\/06\/PTSD_Final-Report_For-Publication_06272024.pdf\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">institute\u2019s report<\/a> on Lykos\u2019s application detailed many of the ethical concerns raised by Psymposia.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Days before the committee meeting, Dr. David Rind, ICER\u2019s chief medical officer, emailed several members <a class=\"css-yywogo\" href=\"https:\/\/www.youtube.com\/watch?v=erN6vekEK2k\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">a link to five public testimonies<\/a>, four provided by Psymposia affiliates. He described the allegations as \u201cvery disturbing.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In an interview, Dr. Rind said that the institute had not conducted its own investigation but was hoping that the F.D.A. would follow up.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Around the same time, Dr. Devenot submitted <a class=\"css-yywogo\" href=\"https:\/\/docs.google.com\/forms\/d\/e\/1FAIpQLSf1z9uJAdYxKGgv-pMGUL_e0wHKC_4YrzN33ZYu9E-Ka-8Cfw\/viewform\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">a petition<\/a> to the F.D.A. urging it to extend the public session to accommodate speakers who they said would detail data fraud, systematic misreporting of adverse events and of enabling \u201centrapment, sexual abuse and coercive control\u201d by Lykos.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cIf the F.D.A. again prioritizes industry interests over public health,\u201d the petition said, \u201cthe outcome could mirror the trajectory of OxyContin, which was also once promoted as a wonder drug offering relief from chronic suffering.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-17\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The F.D.A. agreed to extend the hearing.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Of the 32 speakers, 10 opposed Lykos\u2019s application. Seven of those 10 were affiliated with Psymposia, though none mentioned their connection to the group.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">During the daylong meeting, panelists repeatedly raised questions about Psymposia\u2019s misconduct claims.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">One advisory member voted in favor of Lykos\u2019s application \u2014 the sole panelist with expertise in psychedelic medicine.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Even though Psymposia did not provide evidence to back up its allegations of widespread wrongdoing, Amy Emerson, the former chief executive of Lykos, said the speakers succeeded in shaping the narrative.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThey were able to prey on the fears of people in government who care about reputational risk,\u201d she said. Ms. Emerson resigned shortly after the F.D.A. denied approval.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-18\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">In their public testimony, Dr. Devenot repeated an explosive accusation they had shared with ICER: One of the therapists who took part in Lykos\u2019s clinical trials, Veronika Gold, had admitted to pinning down a screaming patient.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">But the incident, detailed in a book chapter Ms. Gold wrote, involved ketamine, not MDMA. And rather than being \u201cpinned down,\u201d Ms. Gold said the patient was consensually pushing against her hands, which were passively raised.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Devenot also testified that Ms. Gold had used a similar practice with a clinical trial participant. Ms. Gold said the incident did not happen, a claim backed up by Lykos, which said it reviewed videos of her therapy sessions.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The accusations, <a class=\"css-yywogo\" href=\"https:\/\/www.vox.com\/future-perfect\/355687\/fda-mdma-therapy-maps-lykos-cult\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">repeated<\/a> in the media, were damaging, she said. \u201cPeople have expressed concerns about my ethics and practice,\u201d Ms. Gold said.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-19\">\n<p><h2 class=\"css-13o6u42 eoo0vm40\" id=\"link-8613f4\">Amplified Messaging and Infighting<\/h2>\n<\/p>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-20\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Concerns about the organization\u2019s ability to disrupt the field have mounted in recent months after a public relations firm began amplifying Psymposia\u2019s and Dr. Devenot\u2019s allegations of malpractice against Lykos. Dr. Devenot declined to say who was funding the group\u2019s work.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Another longtime Psymposia ally, Sasha Sisko, has been pressuring academic journals to <a class=\"css-yywogo\" href=\"https:\/\/x.com\/NeseLSD\/status\/1822615797295976779\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">retract studies<\/a> based on Lykos\u2019s clinical trials. In August, the journal Psychopharmacology <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2024\/08\/12\/health\/mdma-ptsd-retractions.html\" title=\"\">retracted three studies<\/a> that contained data from the session with Ms. Buisson.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Lykos disagreed with Psychopharmacology\u2019s decision, saying a correction to the papers would have sufficed.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mx. Sisko, who uses gender-neutral pronouns, has also criticized Lykos trial participants who have spoken favorably about their experiences.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Becca Kacanda, who posted about her treatment on X, said Mx. Sisko criticized her on the platform and wrote in a direct message that she had undergone a \u201cwhack-a-doodle nonsense \u2018therapy.\u2019\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-21\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Ms. Kacanda said Mx. Sisko seemed to be fishing for information to use against Lykos and trying to \u201cgaslight\u201d her about her trial experience.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cI am not trying to silence cases of abuse or constructive critiques,\u201d Ms. Kacanda said. \u201cBut Psymposia does not have the good faith intentions that they are presenting themselves to have.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mx. Sisko declined to be interviewed on the record for this article.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">After the F.D.A. decision, Mr. Nickles and Dr. Ross made a surprising announcement of their own: They were starting their <a class=\"css-yywogo\" href=\"https:\/\/secondhallway.com\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">own group<\/a>.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The reason: Psymposia, they said, had engaged in undisclosed unethical behavior.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.nytimes.com\/2025\/02\/04\/health\/fda-mdma-psychedelic-therapy-psymposia.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>After more than three decades of planning and a $250 million investment, Lykos Therapeutics\u2019 application for the first psychedelic drug<\/p>\n","protected":false},"author":1,"featured_media":3834,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[934,139,232,1625,1626,1622,1627,1624,1620,1623,1628,219,268,1621,1354],"class_list":["post-3833","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-science","tag-clinical-trials","tag-drugs-pharmaceuticals","tag-food-and-drug-administration","tag-institute-for-clinical-and-economic-review","tag-lykos-therapeutics","tag-mental-health-and-disorders","tag-multidisciplinary-assn-for-psychedelic-studies","tag-post-traumatic-stress-disorder","tag-psychedelic-and-hallucinogenic-drugs","tag-psychiatry-and-psychiatrists","tag-psymposia","tag-regulation-and-deregulation-of-industry","tag-research","tag-therapy-and-rehabilitation","tag-veterans"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - 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