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Psychedelic Bulletin: California Decrim. Bill Put on Pause; MindMed Inks Real-World Evidence Collaboration

Yesterday, Senator Scott Wiener announced that SB 519, which would decriminalize psychedelics in the golden state, is to be put on hold until next year. Despite progressing through a number of key Committees, Wiener explained that the next year would be spent gaining support from members of the Assembly, before reintroducing the Bill in 2022.

Elsewhere, MindMed announced a collaboration with data and analytics company Forian, through which it hopes to augment its study of LSD for generalized anxiety disorder by leveraging Real-World Evidence.

Psychedelic Sector News

MindMed Inks Another Real-World Evidence Collaboration

Earlier this week MindMed announced a collaboration with data and analytics company Forian to develop best practices for using real-world evidence (RWE). This is not the first collaboration the New York-based company has struck with regard to RWE.

Specifically, the company hopes to leverage Forian’s expertise to augment its study of generalized anxiety disorders, which it is exploring via its LSD-Assisted Therapy program Project Lucy.

Chief Medical Officer Dan Karlin explained:

“Our goal is to use real-world healthcare data and deep digital phenotyping to achieve in-depth, precise and personalized characterizations of individuals with generalized anxiety disorders and other conditions of interest for our drug development programs. By fully acknowledging each person’s physiology, environment, and behavioral stressors, we ultimately aim for integrated digital deep diagnoses to drive precision psychiatry for drug development and clinical treatment across our target therapeutic areas.”

See our bulletin from early last month for an overview of Real-World Data and Evidence, as well as a brief explainer on MindMed’s partnership with healthcare data platform Datavant.

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Weekend Reading

California Bill to Decriminalize Psychedelics Put on Pause

Senator Scott Wiener’s Senate Bill 519, which would effectively decriminalize psychedelics in California, has been put on pause following his decision to pull the bill yesterday.

The bill will be reintroduced next year,  according to Wiener, who explained that “over the next year [a] coalition of veterans, parents, healthcare professionals and others will continue to work hard to earn the support of Assembleymembers.”

Read more on Senator Scott Wiener’s website.


“FDA’s kratom ban would harm the public and damage the agency’s credibility”

The FDA appears poised to impose a ban on kratom, despite outcry from a diverse cohort with myriad concerns. Many worry about the implications on the opioid crisis, while others are convinced that a ban would make promising research into the plant, and its primary alkaloid mitragynine, much more difficult.

“If the FDA secures a global kratom ban, countless people could die by suicide and unintentional overdose. Many Americans say kratom curbs cravings for opioids, which are frequently obtained on the illicit market and are often laced with synthetic opioids like fentanyl. According to the CDC, synthetic opioids are “the main driver of drug overdose deaths,” responsible for nearly three-quarters of opioid-related overdoses. A ban would criminalize people who use kratom, eliminate legitimate sources of the plant, and cause many users to resort to using more harmful substances.”

As aforementioned, any form of prohibition would likely make research into these plants and their alkaloids much more difficult. As a reminder, atai has in-licensed issued and pending patents from Columbia University on deuterated mitragynine, which it is seeking to develop as a treatment for opioid disorder via its Kures program.

Read the full story, penned by Mason Marks – Senior Fellow at Harvard’s Petrie-Flom Center  and Project Lead of the Project on Psychedelics Law and Regulation – over at STAT.


MIT Technology Review: An MDMA trial participant tells his story

In this piece for MIT Technology Review, a participant in an MDMA trial describes his “life-changing” experience with the psychoactive drug.

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