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Husch Blackwell Authors Amicus Brief in Ninth Circuit’s Psilocybin Rescheduling Dispute

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Husch Blackwell prepared and filed an amicus curiae brief on behalf of nearly 30 end-of-life and palliative care clinicians, urging the U.S. Court of Appeals for the Ninth Circuit to compel the U.S. Drug Enforcement Agency (DEA) to initiate proceedings that could lead to a rescheduling of psilocybin for use in the end-of-life clinical setting.

The amici support the position of Seattle-based physician Sunil Aggarwal, who has been embroiled in long-running litigation with the DEA over the use of psilocybin. Following administrative law procedure, Dr. Aggarwal had asked the DEA to render an opinion on the use of psilocybin—currently a Schedule I drug—for palliative-care patients in light of the federal Right to Try (RTT) Act, passed in 2018, that allows certain patients access to investigational drugs outside of clinical trials. The Food & Drug Administration (FDA) defines Schedule I drugs as those “with no currently accepted medical use and a high potential for abuse.”

In the initial suit, the DEA refused to allow the use of psilocybin under RTT or otherwise condone its use outside of clinical trials, despite the fact that psilocybin has twice been designated by the FDA as a breakthrough therapy, arguably making it eligible for use under RTT laws.

Dr. Aggarwal’s initial efforts ended without a ruling on the merits of the case itself. The Ninth Circuit determined in January 2022 that it lacked jurisdiction to review the matter because the DEA had not yet issued a final agency decision. This ruling touched off a series of back-and-forth administrative law procedures that resulted in Dr. Aggarwal filing a citizen petition directed at the rescheduling of psilocybin itself, rather than the DEA’s regulatory posture toward psilocybin in light of the RTT Act. Dr. Aggarwal’s rescheduling petition was summarily rejected by the DEA in September 2022, leading to the current Ninth Circuit appeal.

In addition to the clinician signatories on the Husch Blackwell-authored brief, there are multiple groups supporting Dr. Aggarwal’s appeal, including medical researchers, professors of law, state legislators, and veterans’ affairs advocates. Additionally, policy institutes spanning the political spectrum, including the Goldwater Institute and the Cato Institute, have endorsed Dr. Aggarwal’s position in a bipartisan show of support.

Dr. Aggarwal and the Advanced Integrative Medical Science Institute—of which Dr. Aggarwal is a co-director—is represented by Shane Pennington of Vicente Sederberg LLP, Matthew C. Zorn of Yetter Coleman LLP, Kathryn L. Tucker of the National Psychedelics Association, and James F. Williams, Thomas J. Tobin, Andrew J. Kline, and Holly Martinez of Perkins Coie LLP.

“We are so grateful to see so many prominent hospice and palliative care clinicians support Petitioners in this important case,” said Tucker. “These clinicians know the suffering their patients endure with unrelieved anxiety and depression and are eager to add psilocybin-assisted therapy to the palliative care toolbox as soon as possible, because it brings immediate, substantial and sustained relief.”

“This case is, appropriately, centered on issues of administrative law, but the amici want to remind the court that there is so much more at stake,” said Husch Blackwell partner Karen Luong. “This is about basic human dignity, recognition of the medicinal use of psilocybin, and the right of dying patients to access valuable therapies that might help them in their last days. The DEA’s action has muzzled the most important voices in this fight—the doctors on the front lines and the patients themselves. We are honored to help these voices be heard.”

The Husch Blackwell team included Luong, Kimberly Chew, Natasha Sumner and Danny Solomon.



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Psychedelics

Lykos In Patent Mode On MDMA

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We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

oh actually we do

 

 

Double Blind

In a shocking move that contradicts its previous stance on intellectual property, Lykos Therapeutics (formerly known as MAPS PBC) — the organization leading the movement to legalize MDMAassisted therapy — has filed multiple patent applications for specific forms and formulations of MDMA. Prior to this revelation, which was first reported on by Psychedelic Alpha, Lykos had long been praised in the psychedelic community and media for its “altruistic stance” in not seeking patent protections as part of its strategy, instead choosing to publish its research findings in scientific literature.

MAPS’s anti-patent stance, which intended to prevent MDMA from being monopolized, stood in stark contrast to the aggressive patent strategies of competitors like Compass Pathways and Atai Life Sciences. Rick Doblins, the founder of MAPS, had been analyzing the non-patentable status of MDMA since the late ‘80s, and in an article titled “MDMA Patentability and Orphan Drug Designation,” published in 1992, he wrote:

“It could be a major setback if MAPS funded MDMA research and secured approval for its medical use only to have someone else control it through an inexpensively obtained use patent.”

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Lykos Therapeutics Quietly Moves to Patent MDMA

 



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Press Release: PsychedelicNewsWire Named Official Media Sponsor of the 4th Annual Psychedelic Therapeutics and Drug Development Conference

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LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024



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individualized treatment

Risks of Psychedelics for People with Personality Disorders

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While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert



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