Right to Try; Psychedelics in Defense Spending Bill; Updates from Oregon

Jul 15, 2022

This week we’re looking at the following developments:

Next week, we could see a significant development in the ongoing Right to Try case AIMS et al. Vs. DEA; we’ll look ahead to what this could mean.
Two amendments to a U.S. Defense bill include measures to study psychedelics.
In Oregon, two challenges present themselves in the lead-up to the rollout of the Psilocybin Services Initiative.

I also had the privilege of joining Brom Rector of Empath Ventures on his podcast last week. We touched on many topics, including the tension between drug development and drug policy, how psychedelics are inverting the traditional drug development model and what business models will emerge in psychedelics—have a listen!

Right To Try: A No-Brainer

I spend a lot of time thinking about the several approaches to psychedelic “Routes to Access” and the infrastructure demands of each.

These routes include health system-based delivery upon regulatory approval and local legalization efforts like Oregon’s Measure 109.

But two routes in legal grey areas have significant momentum and interest, which demands legal clarity—religious use under the Religious Freedom Restoration Act and the state and federal Right to Try laws.

As we’ll see, legal access to psychedelics through Right To Try could be the perfect, gradual onramp for creating the clinical infrastructure for Psychedelic Assisted Therapies in a small, specific patient population in anticipation of FDA approval and the deluge of expected demand.

Right to Try

Right to Try (RTT) laws allow terminally ill patients access to investigational drugs that have completed Phase I clinical trials but have not yet been approved by the FDA. Since several psychedelics have cleared this hurdle, they should be available under RTT.

However, as palliative care physician Dr. Sunil Kumar Aggarwal discovered, the schedule I status prevents manufacturers from providing the drug product.

When Dr. Aggarwal sought permission from the DEA, and the agency said “no,” he sued them.

Aggarwal’s attorney, Kathryn Tucker, has written and spoken publicly about the case and offers an excellent summary of the case excerpted here:

“In January 2021, Dr. Sunil Aggarwal, a respected palliative care physician and founder of the Advanced Integrative Medical Science (“AIMS”) Institute in Seattle, sought authorization from the DEA to obtain psilocybin for therapeutic use with his dying cancer patients...
Because psilocybin is a Schedule I controlled substance, no supplier would provide psilocybin to Dr. Aggarwal without DEA’s approval.
In February 2021, DEA rejected Dr. Aggarwal’s request for access.
This decision contravened RTT laws; accordingly, Dr. Aggarwal sought judicial review of DEA’s determination in the United States Court of Appeals for the Ninth Circuit…
Oral argument was heard in September 2021. The court dismissed the petition on January 31, 2022, concluding that DEA’s rejection of Dr. Aggarwal’s request was not sufficiently “final” for purposes of judicial review, hence the court lacked jurisdiction to reach the merits.
on June 28, 2022, the DEA, again, rejected access…
In an abundance of respect to the administrative process, Dr. Aggarwal has asked the DEA to confirm that its June 28 letter is indeed ‘final agency action’ so that there can be no doubt about this when we return to court.”

This final agency action is expected by July 20th.

It will determine if the case will return to court (if the DEA continues to reject access) or if the DEA will create a clear pathway for Dr. Aggarwal to procure and administer psilocybin to his terminally ill patients legally.

If the DEA agrees with the case’s merits and grants Dr. Aggarwal a waiver or exemption to use psilocybin with his patients, it would set a precedent for others to do so as well.

If the DEA doubles down on its decision, the case will go back to court.

A no-brainer

A third possibility, since it is a federal agency and is answerable to federal elected officials, is that someone in power recognizes the growing interest and demand for psychedelics as therapeutics and sees this as a prudent route for onboarding the emerging practice of Psychedelic Assisted Therapy.

Granting access to psychedelic access to terminally ill patients under the supervision of a physician is a no-brainer.

In addition to the legal merits of the case, it is a logical and gradual way to start building the infrastructure for care delivery in medical settings before the FDA approval of MDMA and psilocybin.

Even the most risk-averse stakeholders could get on board with this.

Finally, the attorneys working on the case are not charging Dr. Aggarwal or his patients to represent them in this case. Instead, they are relying on charitable contributions to fund their work. If you are interested in supporting this work, you can make donations through the fiscal sponsor, the Nowak Society.

Psychedelic Amendments Included in Defense Spending

From the Intercept:

“..a pair of amendments that would increase access to psychedelic treatments for veterans and active-duty service members with mental health conditions was adopted by the House of Representatives. The amendments, which were added to the annual National Defense Authorization Act, were offered by Reps. Dan Crenshaw, R-Texas, and Alexandria Ocasio-Cortez, D-N.Y…
While the amendments offered by Ocasio-Cortez and Crenshaw would only modestly relax federal restrictions on a subset of therapeutic studies, they are an acknowledgment of growing momentum to rethink the harsh restrictions imposed on psychedelics during the war on drugs.”

The amendments introduced into the House bill by Crenshaw and Ocasio-Cortez still have to pass the Senate, and given the unfortunate state of political discourse, this is not a slam dunk.

“The disjointed nature of the bipartisan effort could complicate adoption of both measures in the final package. While the passage of amendments from members of both parties is a positive sign, the policies’ fates remain uncertain in the Senate. The Senate’s version of the National Defense Authorization Act is typically more conservative, given that chamber’s freewheeling amendment process and the three-fifths requirement to overcome a filibuster. The current draft of the Senate bill, which has not advanced to the floor, does not include amendments to expand access to psychedelic-assisted therapeutics.”

Regardless of how these particular amendments progress, it seems that we are on the cusp of more involvement at the federal level in psychedelic research and policy. We will be watching this area closely.

Growing Pains in Oregon

Two challenges in the rollout of the Oregon Psilocybin Services have been presented recently.

First, some counties will ask residents to vote to ban service centers in their jurisdictions. From OBP.org:

“Several county commissioners, mostly in rural areas, have recently decided to put psilocybin center bans on the ballot in November. But even Clackamas County, which includes Portland's southern suburbs as well as rural mountain areas, has drafted an ordinance asking voters to prohibit such centers.”

Clearly, the stigma of psychedelics persists.

The second issue coming out of Oregon is related to the accreditation of facilitator training programs. I haven’t seen comprehensive reporting on this yet, but this dispatch from the Synaptic Training Institute newsletter points to potential challenges ahead:

“A little over a month ago the Oregon Department of Justice completed an audit of Measure 109, as is routine for a new law. They brought it OHA’s attention that because training programs are providing education leading to a certification or license required to enter a profession, these program will be subject to the accreditation process of the Higher Education Coordinating Commission. It short, this law is meant to protect students from profit seeking ventures (like a Trump University) that make promises to provide training and then go bankrupt, leaving their students behind. It’s a good law, but not one that any of the programs were prepared to abide by. It will essentially force all programs to become career colleges, going through a lengthy and expensive approval process (in addition to OHA’s curriculum approval). Several exemptions are being considered, for example, the requirement to have insurance which is currently not available to any psilocybin business.”

ICPR 2022 Psychedelic Science, Ethics & Business

This year, the upcoming Interdisciplinary Conference on Psychedelic Research (September 21-24) in Amsterdam has added a day of programming focused on the practical aspects of bringing psychedelics from trials to treatments called The Psychedelic Science, Ethics & Business

“The full day is dedicated to an in-depth and critical discussion about the intersection of psychedelic research, treatments, and investment. We'll discuss how the growing economy around psychedelics impacts science and therapy. Featuring leading experts from psychedelic businesses, academia, non-profit organisations, and investment companies.”

Use discount code TTR100 at checkout for €100 off your tickets.

“Ann pioneered the exploration of the therapeutic uses of MDMA and 2C-B, and of several related compounds during a time when they were not illegal. As a lay therapist, she developed methods of working with these materials, incorporating concepts from Jungian psychoanalysis. She was skilled in doing shadow work with clients and was generous in mentoring other therapists in this process. Ann gave an influential presentation on shadow work at the 2019 Women’s Visionary Congress.”

Mindbloom: At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial

“This is the largest study to date on real world safety and effectiveness of any type of ketamine treatment, and specifically for sublingual, at-home administration of ketamine-assisted therapy (KAT) for depression and anxiety. From a chart review of 4334 cases, 1247 individuals had sufficient data to evaluate baseline characteristics, adverse events, dissociation, and clinical outcomes. These data suggested that KAT offered clinically meaningful improvement and demonstrated a desirable safety and risk mitigation profile.”

UCLA Magazine: The Psychedelic Rx

“designing double-blind, randomized placebo-controlled trials — considered the gold standard in clinical research, wherein volunteers are arbitrarily assigned to receive either the experimental treatment or an inactive substance, and neither the research subjects nor the researchers know who is in which group — can be thorny. “For the most part, people know if they’re on a psychedelic drug as opposed to a placebo,” says Dr. Dunn”

NJ.com What mushrooms can do for N.J.: A Q&A with a psilocybin expert

Dr. Sunil Aggarwal:

“I currently sit on our state’s Psilocybin Work Group with public health experts and government officials from around Washington State, and we’re charged with studying Oregon’s rollout and making recommendations for when our law is ready to go. And I think most of us really don’t want to just have service centers for psilocybin. We want to think about home use, about micro-dosing if we can, and other access options.
Because clinical-only is expensive. There are times where you’d want medical or mental-health professionals in the room, but I don’t think that’s necessarily true for all. If you have a psychiatric issue, you need specialists. But if (supervision) is restricted to people with licenses -- doctors and psychotherapists – it becomes very expensive.”

That’s it for this week. Thanks for reading!

Zach

The Trip Report by Beckley Waves

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