The psychedelics world reacts after a FDA Advisory Committee votes against MDMA for PTSD
Plus: MAPS’ 2022 MDMA patent application, Dutch panel recommends MDMA for PTSD, Colorado psilocybin program adopts new rules, FDA issues warning about Diamond Shruumz
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The psychedelics world reacts after a FDA Advisory Committee votes against MDMA for PTSD
Last week, the U.S. Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee met to discuss Lykos Therapeutics’ New Drug Application to use MDMA-assisted therapy in the treatment of PTSD. The committee’s non-binding votes showed an overwhelming lack of confidence in Lykos’s clinical trial results; 9 of the 11 members voted that they did not think the available evidence showed that MDMA was effective in treating PTSD and 10 of 11 voted that they did not feel the benefits of the drug outweigh its risks. (For more details, read our coverage of the meeting.)
The committee’s vote was not the end for Lykos’s application; the FDA is expected to issue a final decision on the matter in August and is not required to follow the Advisory Committee’s vote. But the committee’s decision surprised many in the psychedelics world and has prompted a wide range of reactions from researchers, advocates, industry, and the general public. Lykos issued a measured response immediately after the meeting, saying that the company was “disappointed in today's vote given the urgent unmet need in PTSD,” but Lykos thanked the committee for their engagement, and reiterated their commitment to working with the agency. Yesterday, the company released a more detailed statement addressing issues raised during the committee meeting, like functional unblinding and investigator bias, heart and liver risks, and therapist misconduct. “We have full confidence in the rigor and thoughtfulness that the FDA will give our application,” they wrote. Meanwhile, at the Open Foundation’s Interdisciplinary Conference on Psychedelic Research in Haarlem last week, Multidisciplinary Association for Psychedelic Studies (MAPS) founder Rick Doblin spoke, telling the audience he still believed the new drug application would be approved in August. (Lykos Therapeutics is a for-profit company founded and part-owned by the non-profit MAPS.)
But others with ties to MAPS and Lykos openly criticized the FDA Advisory Committee. Liana Gillooly, who has worked in fundraising and strategy for MAPS, wrote in a blog post that the committee’s rejection was “a deeply humbling moment,” but noted that she thought the committee “seemed to swirl into group think.” In an interview with BioPharmaDive, Jerry Rosenbaum, director of Mass General’s Center for Neuroscience of Psychedelics, called the committee “close to incompetent.” (Rosenbaum spoke at the meeting on behalf of Lykos and has co-founded two psychiatric therapeutics companies.)
Some researchers criticized the Advisory Committee, calling into question the committee members’ understanding of the data and their credentials to evaluate it. “I am interested in writing a short letter arguing that the FDA advisory committee did not have the expertise to advise on MDMA-AT. I want to make the letter concise and not rebut the points themselves but simply challenge the advisors' expertise,” said University of Exeter lecturer Leor Roseman. Psychedelics researchers Robin Carhart-Harris at UCSF and Fred Barrett at Johns Hopkins also indicated their disagreement with the committee’s assessments of potential bias in Lykos’s clinical trials, and Vermont psychologist Rick Barnett went so far as to question the FDA’s trustworthiness. "Concerns about unblinding are overblown and would apply equally to other drugs such as antipsychotics. So why focus on it here?" Imperial College London neuropsychopharmacologist David Nutt wrote. “Detractors of psychedelics are hiding their prejudice, moral objections, dislike of illegal drugs, behind a sort of pseudoscientific smokescreen."
But other researchers highlighted the concerns the advisory committee raised. In a post on Medium, bioethicist Emma Tumilty wrote about the committee’s concerns about bias and how those go beyond mere unblinding. “While some functional unblinding may be considered acceptable in a space where it is very difficult to achieve blinding; in this case, it’s not just unblinding through a participant realizing they are on the interventional drug but active disclosure and encouragement by study therapists to participants that ‘they are part of history’ and doing something important that is affecting their perceptions in the trial. This goes beyond a normal placebo effect,” she wrote. Leiden University psychologist Eiko Fried put it more bluntly: “Folks shouldn’t be upset with the vote (which is based on the work MAPS did), but the fact that MAPS didn’t do their job properly, didn’t listen to criticism, and conducted low quality studies.”
Additionally, a STAT article published days after the meeting reported that former clinical trial researchers and Lykos employees had misgivings about the company’s results; one told the publication she was relieved the committee asked hard-hitting questions about the trials’ methods and ethics. The piece revealed that clinical trial researchers were not kept in the loop about the FDA’s recommendation that Lykos collect data about “positive” adverse effects, such as feelings of euphoria, so that the agency could evaluate the drug’s abuse potential. Jennifer Mitchell, a University of California San Francisco researcher who was one of the principal investigators of Lykos’s phase 3 trials, stated that she explicitly asked the company whether they should be collecting data on positive adverse effects, but that Lykos did not direct her to do so. As a result, she told STAT that she was “surprised” to learn the FDA had requested Lykos collect such data.
Others were pleased by the advisory committee’s discussion and vote. “Today was a huge victory and validation for those of us in the field who have been trying to raise the alarm,” said Johns Hopkins senior lecturer Neşe Devenot, who during the public comment portion of the meeting raised concerns about the therapeutic approach used in Lykos’s clinical trials and ethical lapses in the research.
Leaders at other psychedelics companies seem to be scrambling to distance themselves from the Lykos research by pointing out clinical trials flaws and emphasizing how their companies are doing things differently. For example, a major point of discussion in the FDA advisory committee meeting was the role of therapy in the MDMA-assisted therapy up for consideration. Kabir Nath, the CEO of Compass Pathways, whose synthetic psilocybin formulation called COMP 360 is widely expected to be the next psychedelic drug up for FDA approval, told the Washington Post that the company is not pairing COMP360 with therapy, but support from a therapist. (The line between support and therapy is currently a topic of heated debate in some psychedelic circles.) Nath also highlighted the company’s use of high, medium, and low doses of COMP360 to compare the drug’s efficacy at these different doses. This approach differs from that of Lykos, which gave participants either MDMA or placebo, a methodological decision that came under fire during the committee meeting. (In their Thursday statement, Lykos emphasized that the issue “was discussed extensively with the FDA during the 2017 Special Process Assessment process to agree on our Phase 3 trial design.”)
Billionaire investor Christian Angermayer, who was a seed funder for psychedelics companies atai and COMPASS, wrote on Substack that “it isn’t MDMA itself that was rejected per se, but the specific poor data set provided by Lykos Therapeutics.” He emphasized the importance of strong data and claimed that his two companies would deliver better data. He also criticized the non-profit model of research funding. “Capitalism is the best system we have, especially for drug development, including psychedelics,” he wrote.
The stock value of some publicly-traded psychedelic companies fell in the days after the meeting. Shares of Mind Medicine Inc, also known as MindMed, a New York-based company developing a formulation of LSD for anxiety, had been holding steady between $8.50 and $9, but by the end of the week, that number dipped to $7.22 a share. Compass’s stock also tumbled from $7.67 on June 4 to $6.39 this week, with smaller dips for atai, Cybin, and Numinus. As of Wednesday, most stocks had seen a bit of a rebound, but none had returned to their pre-FDA meeting values.
Even presidential hopeful Robert F. Kennedy Jr. weighed in on X with his thoughts, speculating that the advisory committee voted against MDMA because a single-treatment model could be a threat to “conventional pharmaceuticals.” He also mentioned that a committee member works for Johnson & Johnson, but he failed to include the information that this person serves as an industry representative on the committee, a position which may come with influence but does not come with voting power.
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MAPS’ 2022 MDMA patent application
Psychedelic Alpha reported Thursday that MAPS PBC (which is now Lykos Therapeutics) filed a patent application in December 2022 for different particle sizes of MDMA. The move gives a glimpse into the widening gulf between Lykos’s business strategy and the MAPS founder Rick Doblin’s long-held values. For decades, Doblin has been outspoken in his anti-patent beliefs and developing anti-patent strategy to prevent companies from patenting information in the public domain. As recently as 2021, Doblin said that “MAPS will not seek to patent any uses of MDMA for specific clinical indications and will actively challenge patents on MDMA-assisted therapy that seek to privatize information already in the public domain that don’t represent actual innovations.”
“Over the past few years, sources at the company have repeatedly told Psychedelic Alpha that it had not filed any patents, to their knowledge, meaning it’s unclear the extent to which portions of its staff were left in the dark regarding its IP strategy,” the site wrote.
Dutch panel recommends MDMA for PTSD
A Dutch committee issued a statement last week to health minister Pia Dijkstra recommending that the government act quickly to allow the use of MDMA to treat PTSD. The State Commission on MDMA was established last year by the Dutch government to investigate the health risks and benefits of MDMA, and was made up of Dutch psychiatry, medicine, and drug experts. The full report details the current state of psychedelic science, and the committee plans to release a policy report in the fall. (A Google-translated version in English is available here.)
Colorado psilocybin program adopts new rules
Colorado’s Department of Regulatory Agencies has formally adopted rules for the state’s psilocybin program. The final rules appear to be unchanged from the draft rules submitted to the agency in February based on recommendations made by the state’s Natural Medicine Advisory Board.
The state’s rules are similar to those adopted by Oregon, with the most notable difference being that Colorado’s program allows for two types of facilitator licenses: a standard license for facilitators who undergo a state-approved training program, as well as a clinical facilitator license, which allows licensed professionals in another field, such as psychologists, social workers, therapists, physicians, and nurses, to incorporate “natural medicine services” within the scope of their professional practice. The rules go into effect June 30, and the agency will begin accepting applications from training programs for state approval.
FDA issues warning about Diamond Shruumz
On Tuesday, the FDA issued a warning to consumers to avoid products from Diamond Shruumz, a company that sells what it claims are mushroom gummies, chocolate bars, and waffle cones that come in ice cream flavors. According to the FDA, 12 people have sought medical care after consuming a Diamond Shruumz product and experiencing symptoms including seizure, nausea, vomiting, abnormal heart rate, and loss of consciousness or sleepiness. Ten of the 12 were hospitalized.
Willamette Week reports that psilocybin training program Myco-Method may be the first to be shut down by the Oregon Health Authority. Last year, the program requested a religious exemption to skip obtaining accreditation through the state’s Higher Educational Coordination Commission. The request was denied, but the program continued admitting students even though it was not accredited. According to Willamette Week, Myco-Method’s founder Shasta Winn has filed a suit against the state over her religious exemption denial: “Winn doesn’t have a lawyer and says Chat GPT has been ‘pretty helpful’ as she prepares legal documents.”
California senators have introduced Senate Bill 803, which would allow public health officers in San Francisco, San Diego, and Santa Cruz counties to “establish and operate psychedelic-assisted facilitation centers” only for veterans and first responders.
The Oregon Capital Chronicle reports on the Psilocybin Assisted Therapy Association’s conference in Portland, where psychedelic industry insiders said that a year into the state’s psilocybin program, they worry about staying in business. “Panelists recalled a year of challenges, red tape and waning interest in guided mushroom trips under Oregon’s pioneering legal model, but also life-changing experiences for clients,” the Capital Chronicle wrote.
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