In light of the FDA rejection of the Lykos Therapeutics-led New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic syndrome (PTSD), we issue the following position statements.
Key Points:
The medical model may be important for enabling insurance coverage of psychedelic-assisted interventions (PAIs) but it is not the only pathway towards accessibility.
The medical model is likewise not the only means of establishing standards and evidence-based protocols.
A parallel system of complementary interventions, both PAI and psychedelic-adjacent interventions, already exists and provides accessible and in many cases affordable treatments.
That existing parallel system also offers benefits that surpass those provided in the medical model.
Likewise, the parallel system circumvents some of the problems inherent in the medical model.
CTAs:
Bolster the parallel system through increased funding for peer-reviewed studies and pilot projects.
Create and maintain standards for credentialing and certification.
Educate healthcare providers/wellness practitioners on how to safely and legally refer clients to the parallel system.
Educate healthcare providers/wellness practitioners on harm reduction practices for PAI.
Create protocols for self-guided PAI.
Offer pro-bono legal counsel to PAI personnel.
Lobby for full scale drug policy reform.
Create localized, community-based partnerships with law enforcement.
Comentários