Microdosing: A Major Headache in Oregon-- 9th Circuit on Right-to-Try: Try Again-- January News Review
Annnnnnnd we’re back.
Today, I am excited to be relaunching a weekly news round-up here at The Trip Report!
In the coming weeks, we’ll be announcing some changes and updating readers on plans for the future.
For now, look out for the weekly news round-up on Fridays and long-form articles about the topics, themes, and trends that are defining the future of the field.
Today, we’re looking at how Oregon’s Psilocybin Services will reconcile with the challenge of microdosing in a Supported Adult Use context and why it should be included
Also, the Ninth Circuit Court of Appeals’ decision to punt on the plaintiff’s Right to Try a case indicates showcases the frustration of legal battles.
We’ll also run through some of the notable developments so far in 2022.
Let’s get to it.
🤕 Microdosing a Major Headache in Oregon
In 2022 it’s all eyes on Oregon as the first American state where voters approved a ballot initiative to legalize Supported Adult Use of psilocybin.
Tess Riski’s reporting for Willamette Week described a scuffle at a committee meeting to discuss what should be done about microdosing.
Committee members argued over the attendance of the researcher, author, and microdosing advocate, James Fadiman, to speak about the practice he helped popularize.
The statute offers clearer direction on many aspects of the proposed framework—such as manufacturing, facility standards, and the fact that manufactured products cannot leave licensed premises.
But the authors of the ballot initiative did not consider microdosing when drawing up the rules and regulations.
In fact, microdosing is not even mentioned in the bill.
Tom Eckert, Psilocybin Advisory Board chair, told Willamette Week:
“Microdosing was not a focus of ours during the development of Measure 109, which is why the term is not defined or used in the measure… Our intention was not to create a dispensary-type model…Measure 109 supports science-based services at licensed facilities under the care and supervision of trained and licensed facilitators.”
While the bill does not focus on or mention microdosing, its language does not prohibit it.
Thus, microdosing is becoming the pebble in the proverbial shoe1 for members of the steering committee in Oregon.
This is a thorny subject for two reasons:
The Supported Adult Use framework is intended for onsite consumption and support of therapeutic doses (i.e., trips) and stipulates that psilocybin-containing products cannot leave the licensed premises. This makes microdosing a logistical challenge and probably pretty expensive.
Microdosing—a term that eludes definition2—will divide a room as to whether it is 1. Safe (here too) and 2. Beneficial beyond the placebo effect.
Real-World Research Opportunity
Despite the challenges and questions about safety and efficacy, the advantage of including a microdosing framework is that it creates an opportunity for Real-World Research that could accelerate research and move us closer to answers about the risks and benefits.
As Fadiman points out in the Willamette Week article (emphasis added):
“There is going to be microdosing throughout Oregon regardless of what this committee does…The question is, can it also help people use it more safely and more effectively?… We would automatically get that research done without any work, which I admit I like…I like it when the system allows you to kind of learn something and, in this case, it could.”
Supported Adult Use of microdosing might be cumbersome, costly, and logistically challenging, but if it can support Real-World Research and, importantly, the framework can adapt to the outcomes of that research, then it seems like a reasonable approach.
In The Middle Way: Tech-Enabled Psychedelic Pragmatic Clinical Trials, I wrote:
“In the context of a product (psychedelics) that already enjoys substantial (and growing) use, there is an opportunity to employ a more suitable scientific methodology that can inform physicians, therapists, shamans, guides…
We are in the early days of a digital revolution in healthcare. The tools available to patients, providers, scientists are increasingly applying evolutionary pressure to the institutions, incentives, and processes of care delivery and clinical research.”
Oregon has created a naturalistic research setting and the stipulations imposed by measure 109 can actually support study design and execution, might as well use it.
Further Reading:
Oregon Voters Legalized Psilocybin Use. But What About Microdosing?
No difference between psilocybin microdosing and placebo, trial finds
Microdosing Safety And Recommended Usage Report For Measure 109
🛑 Right to Try? Try Again
A group of patients and their doctor in Seattle are seeking clarity from the DEA on whether the Right to Try Act3 includes schedule I substances like psilocybin.
In the fight for legal access to psychedelics, Right to Try is one method of weakening the regulatory stronghold of the Controlled Substances Act and has received notable legal support through a bevy of amicus briefs from parties across the political spectrum.
In January 2021, the plaintiff’s attorney, Kathryn Tucker, first sought guidance from the DEA for terminally ill patients wanting to use psilocybin under Right to Try laws by letter.
The DEA’s response indicated that Right to Try does not exempt Schedule I substances from the Controlled Substances Act. Therefore, such adaptation would require congressional action.
So, in March 2021, Seattle physician Dr. Sunil Aggarwal sued the DEA to allow his terminally ill patients access to psilocybin under the state’s Right to Try Act.
Plaintiffs then took their case to the ninth circuit court of appeals, who quickly decided it lacked jurisdiction to settle the case.
From Marijuana Moment:
“In short,” the opinion says, “AIMS’s (plaintiff) issue is not with the DEA’s letter, but with the CSA’s criminalization of psilocybin use, subject to narrow exemptions. An advice letter recognizing that Congress has not yet made an exception to the CSA to allow for the legal use of psilocybin for therapeutic purposes is not an agency decision.”
I’m no attorney, but it seems that the two matters heading to the Supreme Court are the use of psychedelics under Right to Try conditions and the use of psychedelics under the religious freedom restoration act.
This is just the beginning.
📰 2022 Developments So Far
NIH Sponsors two-day Psychedelic Workshop
Over two days in January, the NIH hosted a virtual event: NIH Workshop: Psychedelics as Therapeutics - Gaps, Challenges, and Opportunities.
The gaps, challenges, and opportunities under discussion included the mechanistic understanding of psychedelics, the role of set and setting and combination with psychotherapy, the challenges of trial design regarding blinding, ethics, and with an eye towards insurance reimbursement.
Helpful commentary can be found on Twitter courtesy of Eduardo Schenberg and Michael Haichin.
I wonder if such an event signals more federal funding for psychedelics and if researchers in the audience might have gleaned insight into what specific areas NIH is interested in funding.
As The DEA Giveth, The DEA Taketh Away
“The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, as identified in this proposed rule, in schedule I of the Controlled Substances Act” (source)
In December, the DEA increased its quota for legal psilocybin and MDMA production for the second time. Then, in January, the agency announced plans to schedule a handful of tryptamines that appear in Sasha Shulgin’s TIKHAL. At least one of which is the subject of drug development by Field Trip, according to Tactogen CEO Matt Baggot on Twitter.
Health Canada’s Special Access Program now Includes Psychedelics
Health Canada recently amended restrictions to the country’s Special Access Program (SAP) which allows for the sale of unapproved drugs for emergency uses.
From the Dales Report:
“On behalf of patients, healthcare practitioners can request access to psychedelics through the program when there is data to support the safety and efficacy of the treatment, and once other therapies have failed, are unsuitable, or are unavailable.”
However, it seems unclear what the change means for patients, compared to the previously invoked Section 56 exemption, since applications will still be evaluated on a case-by-case basis.
One change that could affect a few companies is the requirement that Licensed Dealers supply the substances—previously patients had to source their own psilocybin. At least a handful of companies have dealer’s licenses for psilocybin, MDMA, and other psychedelics.
One more thought. Based on the following language from the Statutory Instruments via the Canada Gazette, one could interpret this as Health Canada’s foray into establishing a framework whereby manufacturers and prescribers are responsible for collecting outcomes data:
“Practitioners requesting drugs through the Special Access Program are responsible for monitoring their patients and the outcomes of the use of the drug. Pursuant to the Food and Drug Regulations, practitioners must report, to the manufacturer and to Health Canada, the outcome experi-enced by the patient using the drug and any observed adverse drug reactions.”
While this is getting sorted out, the previous means of access for federal exemption, the Section 56 pathway, appears to be a closing door.
MAPS, Small Pharma, and Eleusis Recieve Innovation Passport Designation from UK’s MHRA
In the aftermath of Brexit, the UK’s Medicines & Healthcare products Regulatory Agency has had to redesign itself since regulatory approvals for the country will no longer go through the European Medicines Agency.
One development is the creation of Innovation Passport Designation (IPD), akin to FDA’s Breakthrough Therapy Designation, which enables a special pathway for innovative medicines for conditions with significant unmet needs.
Three psychedelic drug developers have been selected for the IPD; MAPS, Small Pharma and Eleusis.
A statement from MAPS summarizes the benefits of IPD:
“The Innovation Passport does not reduce the burden of demonstrating that a treatment may be safe and effective, but does provide research organizers with expert advice, patient input, and collaboration throughout the clinical trial design and development process through a product-specific Target Development Profile.”
Eleusis Goes Public via SPAC
From Fierce Biotech:
“The London and New York biotech is merging with Silver Spike's second special purpose acquisition company, or SPAC, to rack up nearly $300 million in proceeds at an enterprise value of $446 million.
Eleusis, founded in 2013, will use the proceeds to bankroll its first clinical trial of a psychedelic-based medicine. ELE-Psilo will enter a phase 1 trial in depression next quarter, the company said….
With the deal, Eleusis will also secure funds to expand its psychedelic drug therapy clinics nationwide through its Andala subsidiary. The goal is for Andala to offer patients access to future FDA-approved psychedelic drug therapies.”
Washington Legislators Will Not Pass Psychedelic Bill
From The Stranger:
“A bill that would allow the Department of Health to regulate magic mushrooms and allow adults to use them in controlled settings will not pass this session, according to state Sen. Jesse Salomon (D-Shoreline), who sponsored the legislation.”
The sample size is small, but I suspect that psychedelic frameworks that originate from ballot initiatives passed by voters, such as Oregon 109, will be more successful than bills introduced by legislators such as this failed bill in Washington.
MDMA Trial for Veterans Begins
Finally, some exciting news out of the VA:
Thanks for reading, and see you next week!
Zach
“It isn’t the mountains ahead to climb that wear you out; it’s the pebble in your shoe.” —Muhammad Ali
Does it imply effects that are imperceptible or that the psychoactive are small enough so as not to distort normal cognitive function (whatever that means)?
“This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.” (source)
Happy to see this restarting!