A Federal Psychedelic Strategy?

Psychedelics+sympathetic patient populations = Political Plasticity

“Bipartisan effort” is not something you hear very often these days.

But the much-anticipated rollout of psychedelics through FDA approval and state-level policy seems to be galvanizing such neighborliness.

A series of correspondences between activists, lawmakers, and heads of at least two federal agencies (Health and Human Services and the Substance Abuse and Mental Health Services) reveals plans for an Inter-Agency Task Force for Psychedelic Medicines and Therapy.

As the Intercept reported this week:

“Bipartisan congressional lawmakers, state legislators and military veterans sent letters to the head of the U.S. Department of Health and Human Services (HHS) earlier this year, urging him to consider establishing an “interagency taskforce on the proper use and deployment of psychedelic medicine and therapy.”

Although the headline of the Intercept piece would have you believe the Biden administration is behind this effort, it is instead a small group of advocates, lawmakers, and veterans building this bipartisan coalition.

And their point of leverage is straightforward: military veterans who have extinguished all options shouldn’t have to leave the country or break the law to seek promising treatment.

Retired Lieutenant General Martin Steele highlights this dynamic in a recent letter of support for the Right to Try Clarification Act introduced by Senators Booker and Paul:

“Veterans who exhausted all options are precisely those that our coalition represents: specifically, the thousands of Veterans who nearly lost all hope after struggling through (sometimes double digit) ineffective medications and therapies – which often left them worse off than where they started – before eventually leaving the country they served in a last-ditch effort to receive psychedelic-assisted therapy in Mexico, Costa Rica, Jamaica, and other countries where they could legally access this life-saving treatment…

…we find it morally unacceptable that our nation’s Veterans should be forced to take such extreme, and often detrimentally expensive routes to potentially lifesaving interventions.”

Veterans & the Terminally Ill

Sympathy for veterans is one of two leverage points for modifying current drug policy approaches relevant to psychedelic access.

The other is the terminally ill, for whom psychedelic experiences have been shown to reduce end-of-life anxiety.

This is no accident.

You can draw a causative line from the earliest psychedelic trials in the ‘second wave’ of research to these current policy developments, as PTSD and end of Life Anxiety/Distress were some of the first indications studied.

MAPS has been pursuing regulatory trials of MDMA-AT for PTSD not only because they initially thought it would be an effective treatment but because the growing concern of PTSD among veterans would open doors to those skeptical, dismissive, and scornful of psychedelics¹.

Around the same period—the mid-2000s—Charles Grob(*) at UCLA, Peter Gasser(*) in Switzerland, and Rolland Griffiths(*) at Johns Hopkins all conducted trials on the effects of psychedelics on end-of-life anxiety in subjects with terminal illnesses.

In other words, these recent developments at the highest level of government have been a long time in the making.

Political Plasticity

Psychoplastogens are a class of compounds that “promote structural and functional neural plasticity in key circuits relevant to brain health.” Psychedelics are thought to be part of this class of compounds.

Similarly, the example of veterans and the terminally ill, who engender near universal compassion but are forced to leave the country or break the law to access these compounds, is the source of political plasticity.

In other words, framing drug policy as a matter of access for vulnerable and sympathetic patient populations is an effective strategy for generating bipartisan support and promoting structural and function policy reform in key areas of drug policy.

Highlights of the “Task-Force Letters”

If the strategy of this effort is to leverage sympathy for veterans and the terminally ill, the intended product, the above-mentioned Inter-Agency Task Force for Psychedelic Medicines and Therapy, is put forward to help states and healthcare systems adapt to “perhaps the most significant shift in the delivery of mental health care in modern history.”

This is the phrasing used by lawmakers in a February 11th letter to Secretary Beccera of HHS.

Other excerpts that help us understand what to make of these developments include:

“…the intended result of the inter-agency strategic task force would be to publish national guidelines in the federal register pertaining to issues such as provider training, credentialing, state licensure, dispensing, monitoring, instituting good standards of safe and ethical practice, etc. We are encouraged to learn that states would then receive block grant funding and support from SAHMSA to implement or tailor the guidelines to meet their individual needs.”

In other words, this federal action does not appear to be involved with rescheduling, legalizing, or funding academic research but instead, building the necessary infrastructure for the forthcoming FDA approval and state legalization efforts:

“The time intensive treatment process, generally including preparation, administration, and integration sessions (“psychedelic-assistedtherapy”), does not fit neatly within our current mental health care system. Indeed, we must carefully consider issues of cost, access, infrastructure, and insurance coverage within this newparadigm of care.”

Finally, and most importantly for state legislators and organizers to consider, an extension of this proposed task-force would be SAMHSA block grants for states to implement the guidelines:

Establishing national guidelines through this collaborative process, to be published in the federal register, would significantly ease the burden on individual states attempting to address the myriad of complexissues. Moreover, published national guidelines would be the most effective mechanism in establishing good standards of practice, including provider training, credentialing, state licensure, dispensing, safe and ethical use monitoring, etc. States will be able to then reference these nationalguidelines when implementing their own frameworks that meet their needs and requirements, with support and federal funding through SAMHSA block grants.

The full stack of correspondence can be found here.

Other Developments & Further Reading

From Therapsil and Drug Science: Project Solace

“The objectives of Project Solace are two-fold. The primary objective is to expand legal accessto psilocybin medicine for Canadian patients suffering from conditions such as end-of-life distress, Major Depressive Disorder and other serious conditions for which traditional treatment options have failed. The secondary objective of Project Solace is to develop asubstantial body of evidence, using a real-world data registry, to document clinical effectiveness, safety, and clinician and patient reported outcomes in patients who have received psilocybin-assisted psychotherapy by access to psilocybin through Canada’s Special Access Program (the “SAP”) or under exemptions authorizing possession of psilocybin.”

Psychedelics Alpha Special Report: Inside the Challenge to DEA’s Proposed Scheduling of 5 Psychedelic Tryptamines

“On Friday 22nd July, it became apparent that the DEA was withdrawing its proposed rule, and the hearings. The withdrawal was first noted in a response to a motion forwarded by Panacea Plant Sciences ⁷, and shortly thereafter reflected in the Federal Register.

For now, the DEA has withdrawn its intention to place these five tryptamines on schedule I, and denied the petitioners their day in court.”

American Psychiatric Association: Position Statement on the Use of Psychedelic and Empathogenic Agents for Mental Health Conditions

“There is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies. APA supports continued research and therapeutic discovery into psychedelic agents with the same scientific integrity and regulatory standards applied to other promising therapies in medicine. Clinical treatments should be determined by scientific evidence in accordance with applicable regulatory standards and not by ballot initiatives or popular opinion.”

COMPASS Pathways launches phase II clinical trial of psilocybin therapy in anorexia nervosa

“The phase II clinical trial will compare the effects of 25 mg and 1 mg of investigational COMP360 psilocybin when administered with psychological support, in 60 participants with anorexia nervosa, across four world-leading research institutes in the UK and US (King’s College London, Columbia University Irving Medical Center, University of California San Diego School of Medicine and Sheppard Pratt). Any changes in symptoms after COMP360 psilocybin therapy will be measured using the Eating Disorder Examination (EDE) interview and other measures; the trial primary endpoint is change from baseline in the EDE global score at week 4 after administration of COMP360 psilocybin therapy.”

Stat News: Working with Indigenous allies is the ethical way to develop psychedelic-based pharmaceuticals

“Researchers and companies working on psychedelic medicines do not need to reinvent the wheel. Instead, they can and should engage with Indigenous communities. I believe that the most rigorous, data-informed, and thus safest way to develop psychedelic therapeutics is to embody an inclusive — rather than an extractive — model of development. Doing so requires adopting ethical governance structures in which companies share the earned benefits with Indigenous communities while those communities share their knowledge on how to safely administer these substances.”

Thanks for reading, and have a great weekend!

Zach

1. Have a look at this video of Rick Doblin from 2013 discussing this very issue.