ICER Draft Report Critiques Lykos’ MDMA Therapy for Insufficient Evidence
The TDR Three Takeaways for Lykos:
- ICER’s draft report on Lykos’ MDMA-assisted psychotherapy labels clinical evidence as ‘insufficient’ for PTSD treatment.
- Concerns over trial design and ethical issues mar Lykos’ MDMA therapy studies, according to ICER’s findings.
- Despite exploratory cost-effectiveness analysis favoring Lykos’ MDMA over placebo, ICER remains skeptical due to evidence gaps.
The Institute for Clinical and Economic Review (ICER) has cast a shadow of doubt over the clinical evidence supporting Lykos’ MDMA-assisted psychotherapy (MDMA-AP) for treating post-traumatic stress disorder (PTSD). In a draft evidence report, ICER, a nonprofit organization dedicated to evaluating the value of health interventions, marked the midpoint of its eight-month review process, stressing that the findings were not yet final.
ICER’s Chief Medical Officer, David Rind, acknowledged PTSD’s severe impact and the insufficiency of current treatments but highlighted significant concerns regarding the design and conduct of Lykos’ clinical trials. The draft report points to “functional unblinding” and other issues that leave unanswered questions about the therapy’s balance of benefits and harms.
The organization’s in-depth analysis, influenced by firsthand and secondhand accounts, indicates that while Lykos’ MDMA therapy could significantly enhance treatment options for PTSD, there are substantial doubts about the validity of the study results. These include criticisms of the primary outcome measure, CAPS-5, and its potential failure to capture participants’ overall response to MDMA-AP, along with concerns about the standardization of assisted psychotherapy within the trials.
Ethical and safety issues also feature prominently in ICER’s critique. Allegations of bias, undue pressure on trial participants to report positive outcomes, and serious ethical breaches, including boundary violations, have been brought to light. These claims, if substantiated, could seriously undermine the credibility of Lykos’ research and its implications for MDMA-AP’s efficacy and safety.
Despite these challenges, ICER’s exploratory cost-effectiveness analysis found MDMA-AP to be less costly and more effective compared to placebo, though this conclusion is tempered by the report’s overall skepticism regarding the robustness of clinical evidence. The report underscores the difficulties in implementing MDMA-AP on a large scale, given the intensive therapist involvement and specialized training required, which could impede adoption in settings like the Veterans Affairs healthcare system.
As the public comment period opens, the healthcare community and Lykos await further developments with keen interest. The final conclusions of ICER’s review will undoubtedly play a significant role in shaping the conversation around the use of psychedelic-assisted therapies for mental health conditions, highlighting the importance of transparency, ethical conduct, and rigorous scientific standards in the development of innovative treatments. Want to keep up to date with all of TDR’s research and news, subscribe to our daily Baked In newsletter.
