Mason Marks writes for Psychedelic Week
Psychopharmacology retracted three papers by Lykos (MAPS PBC) researchers, including a meta-analysis of MDMA trials, a long-term follow up study, and a study on discontinuing SSRIs
Updated August 12, 2024 with information about a third retracted paper
Yesterday, the journal Psychopharmacology retracted three papers reporting the results of studies conducted by Lykos Therapeutics (previously known as MAPS PBC). The retractions came one day after the FDA declined to approve Lykos’ MDMA-assisted therapy (MDMA-AT) for the treatment of post traumatic stress disorder. In a complete response letter to Lykos’ new drug application, the FDA asked Lykos to perform a third phase 3 clinical trial.
The first retracted paper, published in 2019, is a meta-analysis of six phase 2 clinical trials of Lykos MDMA-AT. It has ten authors, including a chief architect of Lykos’ clinical protocols Michael Mithoefer, his research partner and wife Anne Mithoefer, Lykos chief scientific officer Berra Yazar-Klosinski, Lykos CEO Amy Emerson, and MAPS founder and Lykos executive board member Rick Doblin.
The second retracted paper, published in 2020, reports on a long-term follow up study of six phase 2 clinical trials. It has six authors, including Yazar-Klosinski, Michael Mithoefer, Emerson, and Doblin.
The third retracted paper, published in 2021, reported the results of a study that explored the effects of gradually discontinuing treatment with selective serotonin reuptake inhibitors (SSRIs) prior to receiving treatment with MDMA. Its authors include Allison A. Feduccia, Lisa Jerome, Michael Mithoefer, and Julie Holland.
Independent journalist Sasha Sisko sent Psychopharmacology editors a request for retractions in 2023.
Read his full article at
https://www.psychedelicweek.com/p/mdma-maps-lykos-doblin-retract-trial-fda-ptsd
