Massive Lykos and MAPS layoffs amid FDA rejection reactions; Three MDMA papers retracted; and false insights
Plus: The State of Psychedelics and atai completes phase 1b DMT study
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Massive Lykos and MAPS layoffs amid FDA rejection reactions
On Thursday afternoon, Lykos Therapeutics announced it is laying off approximately 75% of its 100-person workforce and that big pharma veteran David Hough has been hired to oversee the company’s clinical development program, including its FDA resubmission for MDMA. Additionally, Rick Doblin, founder of MAPS, the non-profit research organization which spun out Lykos to manage the commercialization of MDMA, has resigned from the Lykos board. “I can speak more freely as a public advocate by resigning from the Lykos Board,” Doblin said in Lykos’s press release. “The FDA delays make it more important than ever that I work at MAPS toward developing global legal access to MDMA and other psychedelics for public benefit through MAPS' multidisciplinary research, education, and drug policy reform.” (Lykos, which is Greek for “wolf,” is a nod to Doblin’s pet wolf.)
Update (8/16/24): MAPS has confirmed to The Microdose that it is laying off 33% of its workforce. “Since May, external events have further exacerbated an already challenging fundraising climate,” MAPS board chair Vicky Dulai said in a statement. “We will continue to support Lykos in its pursuit of FDA approval. However, our organization was staffed for a different outcome from the FDA, and now we must consider which of our programs will best support creating access to safe, legal, equitable psychedelic-assisted therapies for people who are suffering.”
Last Friday, Lykos Therapeutics published a press release announcing that its application to the U.S. Food and Drug Administration to use MDMA-assisted therapy in the treatment of PTSD was not accepted. The company and other advocates maintain that the FDA’s decision is not technically a rejection because the company can submit additional information for consideration. According to Lykos’s press release, the agency has requested a new phase 3 trial, an endeavor that would take years to complete and that suggests the FDA has serious qualms with the evidence submitted by the Lykos in its New Drug Application. Therefore, we have chosen to use the word “rejection” in our headlines and reporting on this matter; it may not be a permanent rejection, but functionally, MDMA was not approved and may not be for years to come.
Until we know more about the FDA’s concerns, it will be difficult to judge the merits of their decision making and what steps Lykos is likely to take next. The complete response letter (CRL) the FDA issued to Lykos is not public, and it remains private unless the company releases it or gives the FDA consent for its release. (We have submitted a Freedom of Information Act, or FOIA request, to the FDA and will report back if it yields anything.) There are people calling for the letter to be made public, including former FDA reviewer Erick Turner who called on Lykos to publicly release the letter “so that we don’t have to speculate.”
The decision has prompted a range of reactions. The nonprofit Heroic Hearts Project, which connects veterans with psychedelic therapy, wrote on X that they “are undeterred by the careless whims of government and will continue working to bring psychedelic assisted therapies to fruition.” Those who have worked for or closely with Lykos and MAPS have expressed disappointment. UCSF researcher Jennifer Mitchell told Scientific American that “I thought we met the criteria that the FDA requested, and I absolutely stand by our data.”
Even people who have previously raised concerns about psychedelics trials expressed mixed emotions about the FDA’s decision. “This summer has been one of grief, not of victory. I grieve for those harmed in psychedelic trials and for those facing the despair that comes when false hopes are crushed,” psychotherapist and former MAPS trial participant Sarah McNamee wrote on X. (McNamee wrote to the FDA alleging inappropriate behavior from her clinicians, including pressure to cuddle and to be a “representative” of the MDMA movement.) “This is MAPS/Lykos’ failure, and the failure of an entire field that has chosen to turn a blind eye to known problems for years.”
Meanwhile, some researchers said they were not surprised by the outcome. “This is the process working as it should,” Yale psychologist Phil Corlett wrote on X. “When there is great promise and great need ,we should maintain our standards, not lower them.” University of Leiden psychology Eiko Fried said the decision was not surprising. “FDA followed the evidence,” he wrote on X. “If you are angry, direct that at Lykos that carried out low quality trials.”
In recent years, advocates have tried a variety of strategies to increase access to psychedelics. Medicalizing psychedelics via FDA approval is one avenue; others include deprioritization of enforcing laws related to psychedelic drugs at the city or state level, and regulated programs in states like Oregon and Colorado. The nonprofit Healing Advocacy Fund has worked to help implement state-regulated programs, and its executive director Taylor West released a statement expressing the group’s hope that such programs might be the future of psychedelics. “The FDA’s failure is our call to action,” West wrote. “By throwing our efforts behind building and expanding thoughtful state-based programs, we can ensure that those who are suffering have a new opportunity to heal.”
And perhaps this will mean that other countries might beat the U.S. to the medicalization of psychedelics, as Australia did in 2023 when it allowed psychiatrists to apply for licenses to administer MDMA and psilocybin to patients. Psychedelic Access and Research European Alliance (PAREA), a psychedelic advocacy coalition, wrote in a newsletter that the group “regrets” the FDA’s decision. “Despite this setback, PAREA remains encouraged by the ongoing investment in research and development of new psychedelic treatments, with 29 clinical trials currently underway in the EU alone,” the group wrote.
Scientific journal retracts three MDMA papers
Last Saturday, the journal Psychopharmacology retracted three papers that analyzed data from MAPS’s phase 2 MDMA clinical trials. The papers were published in 2019 and 2020; one reported on long-term outcomes for trial participants, another explored whether antidepressants like Zoloft or Prozac affected outcomes in MDMA-assisted psychotherapy, and the third explained the design and rationale for what became the subsequent phase 3 clinical trials based on outcomes from phase 2 trials. According to the editors’ notice, the papers were retracted due to “protocol violations amounting to unethical conduct” at a study site in Canada. One of the trial participants later sued two therapists in civil court for sexual assault. The papers’ authors were aware of the violations when they submitted the papers, but did not disclose them, nor did they remove data from the site where the violation occurred. The journal editors also say that the authors “did not fully declare a potential competing interest,” the journal editors write, pointing out that multiple authors did not disclose their affiliation with MAPS or Lykos, who organized and funded the trials.
Allison Feduccia is the only co-author on the papers who agreed to the retractions. In a LinkedIn post, Feduccia explained that the authors offered to remove data from the participant who experienced unethical conduct and issue a correction, but Psychopharmacology would not allow this. Several other co-authors, including MAPS founder Rick Doblin, Lykos Chief Scientific Officer Berra Yazar-Klonsinski, and MAPS-affiliated researchers Michael Mithoefer, Anne Mithoefer, Julie Holland, Lisa Jerome, and Mark Wagner disagree with the retraction. In a statement sent to The Microdose, Lykos says it disagrees with the retraction and that “the identified issues should have been addressed through corrections.” The company acknowledges that while it was aware of the ethical violation, it did not disclose that to the journal — “an additional step we should have taken and regret not doing,” the company wrote. The company has filed a complaint with the Committee on Publication Ethics, a third party nonprofit group, to review the journal’s decision.
The retraction of the three papers from Psychopharmacology came just a day after Lykos Therapeutics, the company MAPS created to oversee the clinical development of MDMA, announced that its new drug application for MDMA in the treatment of PTSD was not accepted by the U.S. Food and Drug Administration. That decision was made on the basis of the company’s phase 3 trials, not to be confused with the phase 2 trials analyzed in these retracted papers.
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False insights
Many people have turned to psychedelics in hopes of having profound experiences and life-altering insights. But just as the drugs may induce helpful changes in beliefs or mindsets, they may also lead to what scholars call “false insights.” False insights might reinforce dangerous beliefs or lead one down conspiratorial rabbit holes, the authors write: “For example, an individual may ‘do their own research’ about what caused the twin-towers to collapse.”
In a paper published recently in Communications Psychology, researchers present neurobiological theories on how psychedelics might lead to false insights and how future studies might test their hypotheses. “While we remain optimistic about the future of psychedelic-assisted-therapy, in the interest of averting unfortunate surprises as psychedelic use increases it is important not to overlook the potential for epistemic harm,” the authors write.
The State of Psychedelics: Colorado program moves forward, Olympia deprioritizes psychedelics prosecution
Colorado’s Department of Revenue (DOR) has approved final rules for the state’s Regulated Natural Medicine program. With the rules finalized, the Natural Medicine program, which is regulated by the Department of Revenue and the Department of Regulatory Agencies, will begin accepting licensing applications in 2025.
On Tuesday, the city council of Olympia, Washington approved a resolution declaring that no city funds or resources would be used to enforce laws related to the possession or use of psychedelics. Olympia is the third city in Washington State to pass such a resolution, joining Seattle and Port Townsend. In a recent newsletter, the advocacy group Psychedelic Medicine Alliance Washington says they are organizing similar efforts in Tacoma and Spokane.
atai completes phase 1b DMT study
On Tuesday, Psychedelics company atai Life Sciences announced the preliminary results from a phase 1b trial to test the safety and tolerability of VLS-01, a form of DMT that dissolves in the cheek, compared to intravenously delivered DMT. The company’s report suggests it has taken two major lessons from Lykos’s failed MDMA FDA application: first, it lists “euphoric mood” among adverse events recorded in the study, a point of contention FDA reviewers brought up with regards to Lykos’s application. Regulators consider side effects like euphoria as potential indicators of addiction risk.
Additionally, in an investor pitch deck, atai emphasizes that treatment with VLS-01 would not involve psychotherapy. Therapy was another major stumbling block for Lykos in their MDMA application because the FDA does not regulate therapy. In the June 4 FDA advisory committee meeting about Lykos’s application, members raised concerns that therapy provided in the company’s phase 3 MDMA trials was not adequately standardized and expressed trepidation about approving a drug administered together with therapy.
Many have sought out ibogaine as a treatment for addiction, but “the sprawling ibogaine treatment ecosystem is in uncharted territory,” writes journalist Mattha Busby in Rolling Stone. Busby follows the story of David, a 49-year-old man he met at the ibogaine clinic Beond in Cancun, Mexico who died days later.
For a new DoubleBlind series, Preeti Simran Sethi interviews activists and leaders about what it means to decolonize psychedelics.
In The New York Times, Ezra Klein interviews famed stats guy Nate Silver, who compares the somatic experience of learning to act in a high pressure, risky environment like a poker game to repeated experiences tripping on mushrooms.
According to the Associated Press, A U.S. attorney has charged five people in the death of Matthew Perry, including his personal assistant and two doctors who allegedly illegally provided Perry with ketamine at highly inflated prices.
Last but not least: please take a moment to vote for my SXSW 2025 panel here! Voting ends Saturday, August 17.
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