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Experts call for collaborative policies for psychedelic therapy

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First professional practice guidelines for psychedelic therapy published

An increasing amount of research is showing psychedelics as promising treatments for a variety of mental health conditions, however, a group of experts have emphasised the need for collaborative and creative policies to maximise their potential.

Experts from Baylor College of Medicine, the University of Pennsylvania, American University and Harvard Law School say creativity and collaboration at the federal and state levels is needed in developing policies for the use and oversight of psychedelics.

In their paper published in Science, the experts in bioethics, law and policy also call for a commitment to developing a strong evidence base for efficacy and safety and propose solutions to three regulatory challenges in anticipation of Food and Drug Administration (FDA) approval of psychedelics for medical use in the coming years. 

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Dr. Amy McGuire, lead author and Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor stated: “We are clearly on the brink of a major opportunity to help people legally access psychedelic treatment.

“Therefore, the need has never been greater to anticipate, identify and discuss challenges, regulations and risks. We hope this dialogue helps all parts of the system prepare and coordinate so patients can access these treatments in an ethical, equitable way as soon as they become available.”

Regulations and collaboration

The authors call for regulations to help maximise the potential of psychedelic therapies.

A participant’s mindset and the setting in which they take the medicine are vital components of psychedelic therapy. The authors highlight that, while FDA regulates drugs, the agency does not ordinarily regulate conditions of use. 

They therefore propose that the FDA consider risk evaluation and mitigation strategies specifying conditions for safe use, which also may help promote effectiveness, and work with agencies at the state level to enact practitioner certifications and requirements.

See also  MEPs urge European regulators to move faster on psychedelics

Additionally, they call for collaboration between federal and state governments as well as state licensing boards and professional societies on decriminalising psychedelics for both medical and non-medical use, as well as a need to preserve space for traditional and religious uses of psychedelics.

The authors warn against following the state-by-state legalisation model used for cannabis, which has not provided adequate incentives for the collection of safety and efficacy data necessary for FDA approval.

“Considering psychedelics as medicine will require new ways of thinking about regulation, both for FDA and for the regulation of the practice of medicine by states – we hope to help them set an appropriate course while also respecting long-standing use by indigenous populations,” said I. Glenn Cohen, co-author and James A. Attwood and Leslie Williams Professor of Law and deputy dean at Harvard Law School.

See also  EU bodies provide perspective on regulation of psychedelics

Holly Fernandez Lynch, co-author and assistant professor of medical ethics at the University of Pennsylvania’s Perelman School of Medicine, added: “There is a lot of excitement around the use of psychedelics for therapeutic purposes, and equitable access will be critical, but we have to make sure that allowing these drugs to be used outside FDA’s regulatory pathways doesn’t inhibit the generation of essential evidence about whether, when, and for whom these drugs will serve as strong treatment options.”

Creative solutions

Creative solutions in regulating synthetic and natural psychedelics are needed also, say the authors.

They highlight that naturally occurring psychedelics are heterogenous and therefore harder to study in clinical trials and difficult to produce consistently for commercial use. 

Synthetic psychedelics are easier to produce and patent, making them more commercially profitable, but these drugs made with isolated active ingredients may lack the beneficial effects found in natural psychedelics. 

To tackle this issue, the authors call for funding and support of clinical trials to generate data and ensure a pathway for approval of naturally occurring psychedelics.

Dr Lewis A. Grossman, co-author and professor of law and affiliate professor of history at American University Washington College of Law, stated: “During an age when scholars and policy makers are struggling to adapt FDA’s traditional regulatory modalities to cutting edge technologies, such as gene therapy and machine learning, this paper highlights the comparably daunting regulatory challenges posed by a product from the other end of the spectrum – a naturally occurring botanical product used for millennia.”

The publication is part of the Ethical Legal Implications of Psychedelics In Society (ELIPSIS) programme at Baylor’s Center for Medical Ethics and Health Policy and the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

ELIPSIS aims to address ethical and policy issues surrounding the use of psychedelic medicine. POPLAR, launched in 2021, examines the ethical, legal and social implications of psychedelics research, commerce and therapeutics.

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Policy

Now is the time for psychedelic access, says campaigner

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Now is the time for psychedelic access, says campaigner

Activists in Oakland recently filed a ballot put forward by Dave Hodges seeking to legalise safe and legal access to psychedelics for therapeutic uses. 

In the face of critics, Hodges has said now is the time for safe access to psychedelics.

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

Hodges has said: “Now is the time for safe, controlled medical access for patients in need. The way to solve the problem is not by continuing to ignore it.” 

Hodges’ solution is to create a structure for use that includes proper dosages and access to experts who can help users benefit from appropriate treatment.

The updated initiative language emphasises safety, and gives doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of conditions.

Research by the University of Michigan and Columbia University shows non-LSD hallucinogenic use on the rise and Hodges has stated that increase means that the initiative providing guidelines for use is needed more than ever. 

Hodges said he hopes Californians will read the initiative, share their thoughts about it over the holiday week and offer feedback via the initiative website, PW4CA.com, by 27 November, 2023, the deadline for modifications.

“Now is the time to provide medical and therapeutic access to psychedelics,” Hodges said. “The way to do this is through the initiative.”

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Policy

Transform Drugs releases groundbreaking book: How to regulate psychedelics

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Transform Drugs releases book: How to regulate psychedelics

UK charity Transform Drug Policy Foundation has published a new book ‘How to Regulate Psychedelics: A Practical Guide’ that sets out how psychedelics can be legalised and regulated for non-medical adult use.

While an increasing amount of research is pointing to the potentially beneficial effects of psychedelic treatment on mental health conditions, many people across the globe are using psychedelics outside of the clinical setting.

The book includes a set of proposals for post-prohibition policies, covering psychedelics including psilocybin, LSD, DMT and Mescaline. 

Previously, Transform’s guides on regulating stimulants and cannabis have been used to advise governments around the world on drug policy. This book seeks to inform the debates on psychedelic drug reforms taking place across the world.

Co-author and Public Affairs and Policy Manager at Transform Drug Policy Foundation, Ester Kincová, stated: “Despite psychedelic drugs being illegal, their non-medical use within society has been steadily increasing. 

“Punitive enforcement has not decreased use or eliminated supply, but it has made use more unsafe. 

“Legalising and regulating psychedelics is a pragmatic move to reduce harm. This is no longer a theoretical debate, states in the US are already recognising the need and  making moves to regulate for non-medical adult use.”

Scientific Chair of Drug Science, Professor David Nutt, added: “Once again Transform have come up with a well thought out and practical plan for the regulation of another group of currently illegal drugs – in this case psychedelics. 

“Their ideas would be both easy to implement and to engage with and will, if adopted, radically enhance the safe use of these remarkable agents.”

Proposals for regulation

The book includes a four-tiered regulation model “that attempts to manage the variety of psychedelic preparations and the different ways in which they are used”.

These include:

  • Private use, home cultivation, foraging and not-for-profit sharing.
  • Membership-based non-for-profit associations for plant-based products.
  • Licensed production and retail adaptable to different products and environments
  • Regulated commercial guided or supervised use

Additionally, a decriminalisation model is proposed which suggests that possession for personal use should no longer be an offence of any kind or be subject to any sanctions; Drugs for personal use should not be confiscated; cultivation of small amounts of plant-based drugs for personal use should be decriminalised, among other suggestions.

The book also includes topics such as embedding social justice, equity and human rights into policy design, how to think about psychedelics regulation, why regulate psychedelics and why now, and psychedelics and the UN drug treaties.

To read the book, please visit transformdrugs.org/.

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Policy

Oakland ballot seeks to legalise medical psychedelics

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Oakland ballot seeks to legalise medical psychedelics

Activists in Oakland have filed a ballot that seeks to legalise safe and legal access to psychedelics for therapeutic uses. 

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

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Additionally, it would create a statewide framework for regulating the possession, use, cultivation and production of substances for medical and therapeutic use.

The initiative has been introduced by proponent and founder of the Oakland-based Church of Ambrosia, Dave Hodges, to the California Attorney General’s office for the 2024 ballot, and will need 546,651 valid signatures to qualify.

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The filing follows California Governor Gavin Newsom’s recent veto of Senate Bill 58, the bill that sought to decriminalise the use of certain psychedelic drugs. 

Hodges emphasised that SB58 would have been a step forward, but that it had major flaws concerning its lack of provisions to ensure access, public safety and quality control. That veto, Hodges said, compelled him to move quickly on the initiative filing.

When the California Attorney General certifies the initiative for circulation, backers will have about four and a half months to gather the required signatures for ballot placement. 

Signature collecting will begin in early December.

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