Josh Hardman, Psychedelic Alpha: The Bill references “any form of psilocybin or methylenedioxymethamphetamine that is in federal Food and Drug Administration Phase 3 testing for an investigational drug”. Does this mean it would cover generic forms of psilocybin and/or MDMA, or only the forms used in clinical trials conducted by Compass Pathways / Usona Institute or Lykos Therapeutics (fka MAPS PBC), respectively?
Senator Kirk Cullimore: This means that while the bill acknowledges the clinical trials conducted by Lykos Therapeutics (formerly MAPS PBC) and Compass Pathways/Usona Institute, it is not limited to only the specific forms of these substances used in their research. The two designated health systems have the autonomy to decide which form of these substances, whether generic or otherwise, they wish to use in their pilot programs, as long as they are in compliance with the Phase 3 testing criteria set by the FDA.
It is important to note, however, that there is a nuanced approach within the designated health systems towards these substances. For instance, Intermountain Healthcare has shown a particular interest in psilocybin over MDMA. This indicates that while the bill provides a broad framework for these substances’ use in mental and behavioral health treatments, the actual implementation may vary based on each health system’s focus and expertise.
By allowing this flexibility, the bill aims to foster an environment of innovation and comprehensive study, enabling these health systems to explore various therapeutic options within a controlled setting to address mental and behavioral health issues effectively.
The legislation is deliberately designed to offer a degree of flexibility to the participating health systems. The bill allows these systems to choose any form of psilocybin or MDMA that is currently in Phase 3 testing under the Food and Drug Administration’s investigational drug guidelines.
Hardman: Have you received any comments from, or had any discussions with, Intermountain Health or the University of Utah that suggest they intend to launch these pilot programs?
Sen. Cullimore: Yes, I was engaged in productive dialogues with both Intermountain Health and the University of Utah regarding the implementation of these pilot programs and the passage of the bill. Throughout the legislative process, it was imperative to incorporate insights and feedback from these key stakeholders to ensure that the bill not only establishes appropriate safety and regulatory frameworks but also provides the necessary flexibility for these institutions to tailor their programs to their specific clinical and research objectives.
Intermountain Health and the University of Utah have both indicated their intention to initiate pilot programs under this new legislation. Their input was invaluable in shaping the bill to ensure that it aligns with the clinical standards and research goals of each institution. This collaborative approach underscores our commitment to fostering innovation in mental and behavioral health care while ensuring patient safety and program integrity. The interest and proactive engagement of these institutions signify a promising step forward in exploring new therapeutic avenues for addressing mental and behavioral health issues.
Hardman: Why do you think this Bill was successful versus others introduced to the legislature in previous sessions?
Sen. Cullimore: The success of this bill, compared to others introduced in previous legislative sessions, can be attributed to its strategic approach of framing the use of psilocybin and MDMA within controlled, well-respected medical institutions through pilot programs. This structure has played a crucial role in gaining the confidence and support of fellow legislators, who saw it as a legitimate and measured effort to tackle mental and behavioral health issues.
By situating the research within the confines of esteemed institutions, the bill presents a clear, regulated framework for exploring the therapeutic potential of these substances, which helped address and mitigate concerns around the state potentially “endorsing” experimental drugs without sufficient oversight. The focus on pilot programs allows for a systematic, evidence-based approach to assess the effectiveness and safety of these treatments in a controlled environment.
Furthermore, the timing of this bill’s introduction aligns with a growing recognition of the mental health crisis facing our communities. The increasing awareness and urgency to find innovative solutions to this crisis have underscored the need for novel approaches in treatment. The support from well-respected medical professionals and institutions has been instrumental in demonstrating the potential of these programs to provide valuable insights and outcomes in mental health care.
In summary, the bill’s success is a result of its careful structuring, the credibility of the participating institutions, and the broader context of an escalating need for effective mental health interventions. These elements collectively helped neutralize previous reservations and showcased the bill as a responsible and forward-thinking initiative.