MAPS, Lykos and the Wheel of Fortune

Welcome to the Psychedelic '30s.

A lot happened over the weekend in psychedelia.  

• On Friday, the FDA turned down Lykos’ application for MDMA-assisted therapy for PTSD, asking Lykos to redo its Phase 3 trial.

• Lykos has not released the FDA’s Complete Response Letter (it would be very helpful for the field if it did) so we don’t know precisely why the FDA said no, other than it made ‘similar comments to the FDA Advisory Committee’ – I reported on that in June, here.

• Even those close to MAPS, like lead researchers on the trials, don’t seem to know what precisely is in the FDA’s letter. ‘We’re left in the dark here’, says Ingmar Gorman, co-founder of Fluence, which worked on MAPS and Lykos trials.

• An FDA spokesperson told me:

The FDA is responsible for ensuring drugs are both safe and effective. In order to approve a drug, we must determine that the research and data submitted by the sponsor show that the drug is safe and effective for its intended use. As discussed as the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that the drug is safe and effective. The agency recognizes that there is a great need for additional treatment options for mental health conditions such as PTSD. We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs.

• Lykos says it ‘plans to request a meeting with the FDA to ask for reconsideration of the decision [and will] take advantage of agency processes to resolve scientific disagreements’.

• The FDA does have a ‘dispute resolution’ process by which companies can dispute an FDA decision. But it’s an internal FDA process and apparently companies only succeed in overturning a decision about 14% of the time. If the people at the FDA who best understands psychedelics say no, how likely is it that other FDA people not involved in psychedelic research at all will say yes?

• The decision is a bitter blow for Lykos, MAPS, and especially Rick Doblin, who has worked for 40 years to make MDMA a legal medicine. He responded with an email to MAPS supporters.

  

• Public reaction to the news was mixed. Some, like presidential candidate Robert F. Kennedy or New Age guru Marianne Williamson, blamed Big Pharma. Others, like ketamine clinician and friend of MAPS Phil Wolfson, blamed ‘political interests’. Many blamed the FDA. I imagine someone somewhere is blaming interdimensional entities.

• But industry figures were more sanguine. Most psychedelic stocks did not drop much in reaction to the news. One industry analyst said they thought it was good news for the field, as it clarified what other psychedelic companies need to do to get approval. Leading psychedelic investor Christian Angermayer reiterated his point that this was a rejection of Lykos’ dataset, not the entire field.

• MAPS / Lykos’ weekend then got worse, when the journal Psychopharmacology retracted three MAPS-sponsored papers on MDMA therapy.

• Activist Sasha Sisko has contacted the journal repeatedly since 2023 to point out these MAPS papers includes data from the trial centre of Richard Yensen and Donna Dryer, where Meaghan Buisson was abused. The journal editors say the paper authors (Rick Doblin, Michael Mithoefer and other leading MAPS researchers) did not inform Psychopharmacoloy about this incident.

• The researchers apparently offered to remove the data from this research site (four participants) from their papers and resubmit them, but the journal refused, so the papers were retracted.  

• Lykos says it ‘disagrees with this retraction and believes the identified issues should have been addressed through corrections. Lykos has filed an official complaint with the Committee on Publication Ethics (COPE) to review the process through which the journal came to this decision.’ One author - Allison Feduccia - agreed with the retraction.

• So that’s everything that happened this weekend (besides a brutal ayahuasca-fuelled murder in Peru, more on that below). What does the FDA’s decision mean for the psychedelic industry and culture?