Psilocybin

A physician reflects on a patient's admiration for RFK Jr., discussing the FDA's role in public health, the efficacy and safety of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelation, ivermectin, hydroxychloroquine, vitamins, and nutraceuticals. The article concludes with concerns over RFK Jr.'s potential impact on public health if he were to lead the Department of Health and Human Services, emphasizing the importance of evidence-based medicine and regulatory oversight.

Robert F. Kennedy Jr. and other prominent Republicans have recently endorsed psychedelics, despite their historical association with the far-right libertarian crowd. This shift is seen as a potential revival for the psychedelic movement, which has shown signs of losing steam. However, concerns arise over the potential for right-wing leadership to fast-track psychedelics without ensuring adequate mental health and societal supports. Despite setbacks, such as the FDA's rejection of MDMA therapy for PTSD, momentum for psychedelic legalization continues, with states like Oregon and Colorado leading the way. The integration of psychedelics into mainstream politics reflects their growing acceptance across party lines, though the industry's future remains uncertain.

Taylor Michael Fischer found guilty of causing his 11-month-old son's death by leaving fentanyl and xylazine unprotected. He was convicted of neglect, possession of methamphetamine, and other charges. The child's mother, Kaytlen Sha Dossett, was also arrested on neglect charges.

The FDA's rejection of Lykos Therapeutics' NDA for MDMA therapy for PTSD highlights the need for consistent clinical trial outcomes. Psychedelics show potential for rapid-acting benefits but require proof of lasting impact. Future research will refine treatments, focusing on safety and long-term efficacy. The regulatory landscape may shift towards drug-therapy combinations, necessitating collaboration between the FDA and professional organizations. NIDA's funding of a ketamine study signals a positive shift in regulatory attitudes towards psychedelics. Each psychedelic compound has unique properties suited for specific conditions, with MDMA for PTSD and psilocybin for depression showing promise. Further research is needed to determine the longevity of therapeutic effects. Challenges in conducting psychedelic trials include safety screening and regulatory navigation, which can be addressed through rigorous trial design and collaboration.

After years of delays, FDA approves Phase 2 of MAPS' study on smoked medical marijuana for PTSD in veterans, funded by Michigan's cannabis tax revenue.

References discuss psychedelics' therapeutic potential, abuse potential, and psychological effects, focusing on psilocybin's impact on depression, anxiety, and cancer-related distress, with studies exploring predictors of psychedelic response, integration challenges, and the role of set and setting in therapeutic outcomes.

Cybin Inc. announced positive 12-month Phase 2 results for CYB003, showing 100% response and 71% remission in MDD patients. The therapy received FDA Breakthrough Therapy Designation and aims to shift from daily to infrequent dosing, potentially revolutionizing mental health care. Cybin plans to initiate Phase 3 trials by end of 2024.

Colorado finalizes pioneering psychedelic-assisted therapy program regulations, with two facilitator licensing tracks, closely watched as a national model. The state will regulate natural medicines, with DORA overseeing training and licensing, and the Department of Revenue managing cultivation, manufacture, and testing. Local communities are establishing rules for the new industry, with some considering temporary moratoriums. High fees and costs of licensing pose challenges for practitioners.

Investors react negatively to Trump's nomination of RFK Jr. for HHS, causing COVID-19 vaccine stocks to tumble, with Moderna and BioNTech seeing significant losses. RFK Jr.'s criticism of COVID-19 vaccines and potential impact on vaccine policy contribute to investor concerns. Psychedelic drug companies, however, see stock increases due to RFK's support for the field.

CaaMTech received regulatory approval for its functional unblinding strategy in CT-4201 drug trials, addressing a major hurdle in psychedelic medicine development.