37 | FDA public hearing: The Day the Sacred Was Ruled “Out of Scope”
The FDA's White Oak campus, Silver Spring, Maryland, on ground where the Navy once tested mines. The sign names the inspector. The oaks behind the sign were here first. Photo: U.S. Food and Drug Administration.
On Monday, 14 September 02026, the Food and Drug Administration held Considerations for Potential Future Therapeutic Use of Psychedelic Drugs, docket FDA-2026-N-7542, the first ‘Part 15’ hearing on these medicines as a class. Eighty speakers had been drawn by lottery in advance, each given under two minutes at the podium. Five federal bodies listened from the front of the room: the FDA, NIDA, SAMHSA, the Veterans Health Administration, and ARPA-H, named in full in the FAQs. I watched the stream from start to finish. Sadly, not one asked a question across four hours. The written docket stays open until 5 October, and this letter is my filing.
The FDA, the Agency, asked four questions. How a provider should be trained? How a patient should be kept safe? How the care reaches a patient? What data ought to be collected? Then, before the first speaker stood, the Federal Register Notice ruled five subjects “out of bounds,” among them "religious, ceremonial, or personal (non-medical) use."
So the government asked who should sit beside a patient whose mind comes apart, and ruled out of bounds the experience most likely to happen while the mind is open. This letter is about the gap between those two decisions.
Why you might weigh any of this
For much of my adult life, I was a patient in the traditional mental health system, and for most of those years the system was doing an honest best. Post-traumatic stress after the Marines. Depression the textbooks call treatment-resistant, the polite way of saying the shelf ran out. A stretch where I was planning an exit rather than a week. By the end, my marriage was gone and so was my housing.
Past the end of the shelf, there was no single miracle. Structured MDMA sessions, held by humans who knew the work, gave me the first hours in years where my body believed in safety. Mushrooms lifted the depression. The medicine opened a door, and the years walked me through.
So this letter comes from three seats. The patient the system could not hold. The practitioner who holds others now, close to five hundred ceremonies and thousands of hours of integration after them, offered as harm reduction, and integration partner at a ketamine clinic in Arizona where the medicine is prescribed and the setting licensed. And the operator, fifteen years in healthcare innovation, who has watched a good idea die for want of an owner.
The first time these medicines opened me all the way up, there was nobody present who understood what was happening. I came through. Plenty of people do not, and I have since met some of them. Years later I sat in a different kind of room where what I do was weighed, and nothing anyone could point to said what safe practice here looks like. Both times it was not the molecule. It was the absence of a container. So when the Agency asked what rules should govern this class of drugs, I went looking for a risk strategy written around who sits with the patient and the weeks afterward, could not find one anywhere in the field, and wrote one.
I would rather spend the rest of my working life on the other side of that absence. I have carried this account to a President, to state legislators, to the DEA, and to veterans in parking lots outside VA hospitals. Thousands are doing the same, on their own time. The Agency asked for lived experience. The Notice then ruled the living part out of bounds.
Ground rules. Psilocybin and MDMA sit on Schedule I, the most locked shelf the government keeps. This letter touches veteran suicide. Go gently. With that said…
Public comments to the FDA about this hearing close at 11:59 p.m. Eastern on Monday, 5 October 02026. I am reading them as they arrive, so until then this page keeps changing.
~27 MINS READ · LIVING DOCUMENT, REVISED THROUGH 5 OCTOBER
This essay is my account of the hearing. The next one, Vigil, is the framework for what the hours around a dose require, in any setting. Recommendations for Safe Psychedelic Care is the formal comment I filed to the FDA, applying that framework to the agency’s questions one by one.
A government can rule a subject out of scope. A government cannot rule the subject out of the room.
THIS LETTER WALKS YOU THROUGH WHO SPOKE, WHO COULD NOT RISK SPEAKING, WHAT IT COST ME TO SAY IT OUT LOUD, AND THE NINE HANDS WITH NO GARDENER AMONG THEM. BY THE END YOU WILL KNOW WHICH DESK EACH ASK BELONGS ON, AND WHY PRESENCE IS THE PART NO RULE HAS CLAIMED.
(What a ‘Part 15' hearing is, who ran the room, the full speaker roll, and how to file your own comment are in the FAQs below.)
The Room Named for a Tree
Half past twelve, the hearing streaming onto a borrowed kitchen counter. Four hours of federal listening from the White Oak Great Room in Silver Spring, near Washington, D.C. Strange work, weighing the shape of a life through a laptop speaker, a jar of honey sweating by the sink.
A name drawn, the moderator noted, was not a name endorsed. A lottery fills a room fairly and finds a field poorly.
White oak is the one oak a barrel maker can trust. The tree seals the pores of the wood from the inside. A white oak cask holds whiskey for a decade. A red oak cask leaks.
The ground under those trees was a Navy weapons laboratory from 1944 to 1995, magnetic mines and fuzes. The same acreage now holds a hearing on compounds able to take a mind apart. A laboratory for what detonates, turned into a laboratory for what dissolves. A house raised for one purpose can be turned to another. So can a field. So can a life.
They named the room for the one oak which does not leak.
The hearing asked who holds the patient.
Four hours. Eighty speakers. Two minutes each. No questions.
Two hundred people asked to speak and fewer than half got a slot. About three hundred sat in the room. A thousand more watched from kitchens and offices, and I was one of them.
On the podium microphone there was a colored light. Green while you talk. Yellow at one minute remaining. Red when your time is gone.
The complete recording, unedited. The primary record. If you have the afternoon, watch it instead of reading me. If you do not, I spent it so you would not have to, and everything below is checkable against the tape.
Who Spoke, and Who Could Not
Each speaker had met a limit. I have met mine.
Lieutenant General Marty Steele turned eighty the following day. Thirty-nine years between our enlistments and the same unfinished business. He spent the day before his eightieth birthday in a windowless federal room, in the audience, because the lottery did not draw him. The first speaker of the afternoon opened her own two minutes by wishing him a happy birthday from the podium, which is how his name entered the record of a hearing he had helped make happen.
Few come to this out of curiosity. Brothers and sisters of mine are dying while the file fills. Eric Jansen, a Marine who lost his best friend on Easter morning in 2017, gave the panel a number, and I am a post-9/11 combat veteran so I will be quoted on it. The VA counts 17.7 veteran suicides a day. Operation Deep Dive matched state death records against service records and found roughly forty-four a day once overdose and self-injury are counted in. Call it a platoon, and understand that the argument is about which deaths get counted as what.
A mother said her twenty-one-year-old daughter died following psychedelic use. Her name is Susan Taymor Sagy, her daughter was Shira, and she found other mothers who had lost adult children the same way and built an organization with them. Two minutes for a daughter.
And she is not on my side of this argument, which is the part I have to sit with. She supports the research. What she wants is the thing nobody in this field built: honest, accessible information about risk, contraindications and warning signs, offered without fear and without a sales pitch. She says she does not know whether better information would have saved Shira. I believe her, and I believe she was owed it anyway. Every argument I make for access has to survive her, and the version that survives her is the one where safety and access are the same project rather than opposing teams.
Now, count who was absent. Handing a Schedule I substance to another adult is distribution under 21 U.S.C. 841, up to twenty years, and "distribute" covers a transfer with no money in it. Opening a room for the purpose is a separate offense, reaching any place used "whether permanently or temporarily." No commercial scale required. No profit. No repetition. A living room, one afternoon, one other adult. A state license shields a facilitator from the state, not from Washington.
And understand what Schedule I is, because it is not an opinion. It is a finding of three things at once, in statute: high potential for abuse, no currently accepted medical use, and a lack of accepted safety even under medical supervision. When a British committee scored twenty substances against sixteen measures of harm in The Lancet, alcohol came first and psilocybin mushrooms last. A foreign panel, not binding here, and criticized on method. Hold it beside the third criterion anyway: a lack of accepted safety, under medical supervision, for the substance that scored lowest of twenty.
A schedule is a sentence the government writes once and then stops reading.
The record will not hold the next sentence. I will. I assume most who stood at the podium have taken one of these compounds, and none could say so. The experience which qualifies a witness is the one which, spoken in the wrong room, ends a career or a custody arrangement.
So we speak in the register our families can survive. “The data suggest” where the truth is “this saved my life.” I run the arithmetic before each room: what will the saying cost the ones I love.
Some have already paid. I am a father who lost contact with his children over his use of these medicines. There was no document anyone could point to that said what safe practice in this field looks like, because none exists.
So I wrote one.
It will not bring them back. I am asking anyway, for the people it can still reach.
The cost of freedom is a phrase carved on monuments. A few of us are paying ours in installments.
Roughly eight million Americans took psilocybin in the past year, by the first national survey to ask directly. The use is what desperation does at the end of a shelf, and the support stays underground with the practice. The Psychedelic Bar Association put it to the panel plainly: an overly zealous risk framework pushes patients toward alternatives with no oversight. Lift the exposure and the support steps into view, where a standard can reach.
We gave our lives for freedom. We are asking for the freedom to live.
What Will Not Stay Out of Scope
The exclusion, the five subjects the Notice placed out of scope, is sound as jurisdiction and false as description. The sacred does not leave a room because a Notice says so.
The Agency is not squeamish. A drug office has no lawful way to weigh a church, and a lawyer wrote the Notice to keep the hearing out of court. But a rule of order, read aloud in a room full of the ones who keep ceremony, arrives as a doctrine. A friend who reads these letters before you do put the paradox in one line: to rule the sacred out of scope is an orthodoxy, and orthodoxy is a word religion lent us.
I have read the comments filed so far, and I kept reading as they came. Two hundred and eighty the last time I counted, with the box still open. Better than half name the bond between the one sitting and the one dissolving. A third name the months after. When I first counted, at a hundred and ten, chaplaincy appeared twice, and I wrote that down as the whole of it. Then sixty-seven comments arrived in two days at the end, and the word kept turning up: a chaplain, a pastor, a minister, a firefighter listing who should be allowed to sit with somebody. Ceremony was out of bounds. The ones who keep ceremony wrote anyway, late, the way people do when they are not sure they are welcome.
By sacred I do not mean a temple, a mosque, or a grove of trees. I mean the room we sit in. Love asks no doctrine before arriving.
I have sat with hundreds of clients who wanted no part of the spiritual. Atheists. Agnostics. Engineers who came for a symptom score and said so at intake, in the tone a man uses when he wants the technician to skip the small talk. First responders. Survivors whose bodies had learned to leave the room. A good share came out reaching for words like holy, or forgiven, embarrassed to be reaching.
The trials say the same thing in the Agency's own register. Johns Hopkins found that experience in about two of three volunteers at the highest dose, and a decade later found it predicted who was still well six months on. The hour is not a side effect to be screened out. It is the session's most reliable feature, and a rule written as though the feature were rare leaves the common case unprepared.
The hour did not consult the consent form.
I have sat at bedsides, which is where this field's most-cited trial was run. A diagnosis delivered in the afternoon and absorbed by midnight. A hand held while a body finished the last of the work. Parents whose child took their own life, and the room those parents live in afterward, which holds no furniture. What arrives in such hours is seldom relief from a symptom. What arrives is truth, and a gratitude for a life they had stopped being able to see.
No client arrives asking for a lower score. They arrive asking for peace. Healing and the spiritual are one motion with two names. Take the second name away and the Agency is left holding the symptom. Medicine has the symptom covered.
So the sacred is not a belief the Agency is asked to endorse. It is a clinical event with a high base rate, and the least prepared are the ones who arrived for a number. A patient who meets the enormous with no vocabulary for the meeting is not having a religious problem. He has a safety problem. These compounds open a room with a fire burning. A tended fire warms a house. An untended fire takes one.
So my ask is not to add the spiritual to the docket. It is to write the rule as though healing and the spiritual were one thing, because they are. Medicine learned to fix. The caring was left to whoever happened to care.
Ruled out of the docket. Still in the room, unattended.
The Wound With No Column
There is a word for what I carried home, and the Marines did not teach it to me. I learned it twenty years later, from a paper.
In 2009 a psychologist named Brett Litz and six colleagues named the thing the diagnostic manual kept missing. Moral injury: the lasting harm from perpetrating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs. The damage, they wrote, runs emotionally, psychologically, behaviorally, spiritually, and socially.
Read the fourth word again. It is the one the Notice ruled out of scope, and it is not my word. It is in the founding paper, and the VA's own clinical page goes further, naming self-forgiveness as something trauma-focused care does not reach. Self-forgiveness, in a federal guideline.
Post-traumatic stress asks what happened to you. Moral injury asks what you did. The clinicians I saw treated the fear, carefully, by the book, for years. The fear got better. The verdict did not. What took the verdict apart was intentionally working with mushrooms and MDMA with trained guides, and I offer that as a first-person claim and not as a finding.
Here is why it is not a finding. Nobody has ever measured it. Litz, who named the wound, wrote last year that because no trial has used moral injury as an outcome, there is no evidence any therapy is efficacious for it. A 2025 review of psychedelics and moral injury found no peer-reviewed data at all. Hundreds of us stand up in public and say what I just said, and not one of us has been counted.
So this is my answer to the Agency's fourth question. The Notice asked what data should be collected and whether there should be common elements across sources. Here is one. The Moral Injury Outcome Scale is fourteen items, built with service members, veterans, clinicians and chaplains across five countries, and it takes four minutes.
Fourteen items. Four minutes. I would rather be measured and wrong than believed and unexamined.
“Psychedelic policy often cites centuries of entheogenic practice while excluding living religious and sacramental communities.”
The Competence Already Exists
The lineages who carried this work for centuries were thin in the room. My elders taught reverence before technique: a life is not your own, and you owe yours to the ones who raised you and the ones arriving after.
To name what occurs is not to establish a religion. Medicare has seated a pastoral counselor on the hospice team since the 1983 conditions of participation, at 42 CFR 418.56, and the Veterans Health Administration pairs a chaplain with a clinician in moral injury groups. Neither asked a regulator to rule on a church.
The Notice ruled the subject out of scope, so I will put mine on the record. Psilocybin is my religious practice. Not a metaphor for one. The mushroom is how I pray, how I am corrected, and how I became able to sit with another human through the worst hour of a life. Hundreds of clients have told me a version of the same. A record which excludes the practice hears from few practitioners.
My own schooling came by the hard road, and I would trade none of the road. I am ordained and hold no chaplaincy credential, so I am not asking for my own role. I am asking for the one profession whose code forbids imposing a belief to be available where suggestibility runs high and meaning arrives uninvited.
The competence exists. The credential exists. What is missing is permission.
The Experiment Already Ran
The vacancy has been tested at scale already, and a wave is arriving on top of the result. Compass Pathways is furthest along, with two successful phase three trials of synthetic psilocybin under rolling review and launch guided to 2027. MDMA for post-traumatic stress was rejected in 2024 and resubmitted this August.
The useful fact is older. Ketamine has been federally legal since 1970 and is the one medicine of this class available nationwide. Ketamine clinics now operate across the country. By my count from clinic partners, fewer than one in six offers integration of any kind.
Most tried. A salaried therapist cost more than uneven demand could carry, billing swallowed the front desk, and the weeks after went back to the patient, alone. The industry a regulator knows best is built to manage a symptom well, for years. This class proposes a different errand: to reach the wound under the symptom, then help a human live differently. Management is counted in refills. Healing is counted in the years after.
No Agency chose that outcome. The architecture did. The FDA judged a molecule. The DEA scheduled a molecule. A state licensed a prescriber. A payer priced an infusion. The weeks afterward, where the change is won or lost, sat outside the mandate of each.
I work inside the gap, and the clinics are not lazy. They are unassigned.
Unassigned work does not fail. Unassigned work goes unbuilt.
The split has a birthday. In 1937 a poisoned elixir killed more than a hundred Americans and Congress hired an inspector for the seed. Ninety years on, the inspector is excellent and the soil has a vacancy.
One tool does reach the room. Where a risk needs more than a label, the Agency can attach a Risk Evaluation and Mitigation Strategy (REMS). Esketamine runs on one today, proof of the reach and of the ceiling, since the model gave the room a clock instead of a relationship.
Methadone is the working model, fifty years old. The FDA approves the drug, the DEA registers the clinic, and SAMHSA certifies the program itself under 42 CFR Part 8, staffing and counseling and follow-up included. Congress invented no Agency. One arc was shared out, each hand taking a mandate already held.
The same division is available now. The FDA holds the molecule and the hours, through a label and a REMS written around capability rather than a building. SAMHSA holds the program around the drug and has filled a vacancy like it before. The Veterans Health Administration holds the proving ground, with twenty trials running.
What this arc needs is one table where those hands meet on a schedule, a patient's path as the agenda, and a published note on who holds what. A data scientist put the point to the panel directly: "It's a table that only you, the FDA, can set." A watershed has many streams and one river, and the water pays no attention to county lines.
Nine hands on the seed. None on the soil. The fix is a gardener, not another inspector.
What I Would File
The Agency asked four questions. Four answers, in the order asked. Each one runs into the same wall the Notice built.
Training and credentialing. Trained therapists ask me most weeks to take them on as facilitators, and the request runs the same way: a year-long program completed, no direct experience, a sense the course was unlike the room. A surgeon rehearses on cadavers and a pilot has a simulator. Here the instrument is the practitioner's own nervous system. So write the approval around one trained, sober person present for the whole session, with a second where the person or the dose calls for one, and name which licenses and trainings qualify, since silence on who counts shuts out practitioners the Agency never meant to exclude. Require supervised hours, say where they may lawfully be earned, and name spiritual care as a service a setting can offer. A curriculum unable to name what arrives cannot prepare anyone for the meeting.
Patient safety. Screening runs furthest ahead; Homecoming alone puts forty-three validated instruments into a report a clinician signs. Preparation and integration run furthest behind. So index the watch to the dose, since Oregon has written the table for a drug whose effects run six hours, and require a discharge and transport plan before the session, as Colorado does. Then require documented contact after the patient goes home, because of four serious reactions among 346 people in Oregon's licensed centers, two were invisible to the facilitator who sat the entire session and surfaced only because somebody called later and asked. A patient met by the enormous at hour three is a safety event, whatever the Notice calls the hour.
Access. Many clients flew to Oregon or Colorado and paid out of pocket, because a legal session costs more than most households hold in savings. So certify the room by what happens inside rather than by the building. Colorado already permits a private residence, a hospice, and a home for the dying. Medicare's hospice conditions reach a bed at home, and New Mexico names end-of-life care a qualifying condition. The federal Right to Try Act already lets the terminally ill seek eligible investigational drugs. Let the hospice bed and the home count, and the outdoors too, where the living world is part of the healing. And let groups be groups, with a ratio. Veterans heal in units. Couples arrive in twos. A bed at home is where the sacred is least avoidable and least governed.
Data. By my count, I gather more per client than most trials collect, and the harder question is what the material is for. The client reads the arc of a year rather than a string of unconnected nights. I read my own blind spots, which is how a practitioner improves in a craft with no supervisor in the room. So treat the record as a safety instrument for the practitioner as much as the client, since misconduct hides where no record exists. Say what the states' data is worth, since the Agency already publishes postmarketing studies satisfied with evidence from outside a trial. And standardize a small set before a dozen registries grow apart.
My peers have corrected me more often than I have corrected myself. For years I have sat in consultation through the Psychedelic Guide Network, where Ashley Carmen, who built it because she needed one first, runs circles in which a guide brings a real case and peers ask rather than advise. Her line on the hearing: the FDA can regulate a molecule and cannot regulate a relationship. So write the practitioner standard to teach rather than to remove, and name peer consultation as a condition of practice.
And here is what I cannot see from where I sit. I work with people who found their way to me, which means I have never met the ones this went badly for and who never called anybody. My sample is self-selected and so is my confidence. I have close to five hundred ceremonies behind me and no control group, no supervisor in the room, and no way to know what I have missed. That is not modesty. It is the actual epistemic position of every practitioner in this field, including the ones with a license, and it is the strongest argument for writing a rule that watches rather than one that trusts. I would rather be held to a standard I helped write than keep being right in private.
Four days before this window closed, a bipartisan caucus in the House published the paper it had commissioned on how this work should enter American medicine. It is honest about where its respondents split, and they split on exactly this. Some wanted the credential kept to licensed professionals. Others wanted it opened to spiritual and community practitioners. Nobody resolved it. An unresolved question is not a closed door.
Four asks I am not making. No single template across compounds. No therapy written into a label. No registry which turns into a list. No chaplain assigned to a patient who did not ask.
A rule written for hospitals cannot reach a bed at home. And a rule written on trust cannot catch what trust misses.
The Best Arguments Against Me
I have read the other side closely enough to state it in its own words, because an advocate who cannot do that is not reasoning.
The person in the room is the adverse event. Jim Dodson, a New Mexico patient advocate, filed for a sojourner option, where a patient may be alone with the medicine: "other humans disrupt the trance state and can prevent the patient from gaining confidence by overcoming personal adversity and uncertainties alone" (comment 0102). That is the exact inverse of my letter, and a rule written around my convictions would take something real from him. If I want presence written into care, the honest version of my ask is a floor and not a mandate.
Building the infrastructure creates momentum toward approval regardless of the evidence. The Foundation for Drug Policy Solutions: "The threshold question is not how to implement psychedelic therapies safely; it is whether the current evidence justifies implementing them at all" (comment 0017). The American Psychiatric Association has held since 2022, and restated in April, that clinical treatments should be determined by scientific evidence and applicable regulatory standards and not by ballot initiatives or popular opinion. These are not prohibitionists. They are the people who will have to treat whatever we get wrong.
Oregon's evidence is real and Oregon's evidence is wealthy. The cohort of 346 adults was eighty-seven percent White, three quarters college-educated, and nearly a third from households earning over two hundred thousand dollars. A self-selected, affluent, non-clinical cohort cannot stand in for a patient population. I cite Oregon anyway, because it is the only real-world safety data anyone has, and I should say plainly what it is: the best evidence we have, from the least representative sample we could have drawn.
On the schedule itself, the argument against me is not about mushrooms at all. "No currently accepted medical use" is a term of art with a five-part test behind it that the D.C. Circuit upheld in 1994. Known chemistry, safety studies, efficacy studies, expert acceptance, evidence widely available. That is the examination. And every substance the government has moved out of Schedule I moved after the FDA approved a product, by the DEA's own finding. You do not get the diploma before the exam.
The Act schedules substances one at a time, and psychedelics is not a substance. Ibogaine may be the most powerful thing on this shelf: thirty special operations veterans came back from Mexico with an eighty-eight percent drop in post-traumatic stress, in Nature Medicine. It also blocks a potassium channel, and that result happened because somebody gave magnesium alongside it and watched the heart all night. A rule tight enough for ibogaine is absurd for a mushroom. A rule loose enough for a mushroom leaves an ibogaine patient without the cardiology that made those numbers possible.
Rescheduling would not give us what we are asking for, and I wish more of my own people knew it. A Schedule II substance may ordinarily be dispensed only on a written prescription from a registered practitioner, for a drug the FDA has approved. No approved product, nothing to prescribe. Possession stays a federal offense. And no schedule placement turns a trained facilitator into a DEA registrant. It is a key cut for a door nobody has built.
And one more, which is not an argument but a reader. The California Family Council filed a comment quoting Proverbs. I pray with the mushroom, and I will not be glib about somebody else's scripture. We read the same book and reach opposite conclusions about what reverence requires. They believe the hour I describe is a counterfeit of the thing I claim it is, and that belief is as old as the thing itself. I do not expect to persuade them, and I would not want a rule written to exclude them.
So I land somewhere narrower than where I started. Approve a product. Write the risk strategy around the room rather than the building. The schedule follows, the way it followed twice before, for a reason a court can read out loud.
A letter that survives only the arguments it chose is not a letter. It is a brochure.
Mast Year
The moderator closed by sending the room to the docket, and the docket filled. Two hundred and eighty comments as of the 4th of October, every one of them public and permanent, and the box still open as I write. What never arrived is the hearing itself. The Agency posted its Notice in July and an agenda naming who would speak, and then nothing. Its own event page still reads content current as of the day of the hearing. There is no transcript. Four hours on the FDA's YouTube channel, machine captions and all, is the only account anyone has of what eighty people actually said.
So the written record is thick and the spoken record is a video. Which means the two minutes were weather after all, and the filing is the thing that lasts.
No insurer filed, though an insurer prices the hour. No chaplain spoke from the podium, though four filed in writing: a Veterans Affairs hospital chaplain resident who sits on the board of a Christian psychedelic organization, a senior pastor who used to be an Army intelligence warrant officer, a minister of thirty years, and a counselor outside Fort Bragg who put the words moral injury into a federal record. No state regulator filed at all. Oregon, Colorado and New Mexico ran the only laboratories anyone cites, and not one of them testified about its own data.
Ruled out of scope, and they came anyway. That is what a congregation does.
And there is a part of that caucus paper I have not told you yet, published on the first of October while this box was still open. The people who answered it agreed on something this hearing was not built to hear. That Indigenous and religious rights to ceremony must be preserved, without the government intruding and without anyone being made to hand the knowledge over. One line goes further than I have. It says those traditions hold sophisticated systems of care and delivery, not merely knowledge about particular substances. And its credentialing recommendation names four kinds of practitioner it would open a door to. Licensed clinicians. Trained facilitators. Peer support practitioners. Indigenous experts.
Two documents. One week. One city. Neither one mentions the other.
A tree stakes no century on one acorn. Clients arrive hoping the ceremony is the acorn which lands. What remakes a life is the morning after.
Outside, the oaks kept their own appointment. In a mast year the oaks of a region fruit together, cued by a warm spring and not by a committee, and the season arrives on time. A jay buries an acorn a mile off and forgets. Eighty speakers dropped what they had in one afternoon and the rest of us are filing in writing. Most will be eaten. A few, buried in a docket, will root.
What the jay drops, the ground keeps.
Whose Lives These Are
The decisions are about a father in one of the mental health shortage areas covering most of rural Nevada, with no clinician for a hundred miles, the spouse who drove a veteran to the airport, and a child not yet born who will need a human beside him when he sets the armor down.
I was the neighbor of such a father once, at the end of what medicine knew. I am here because a few humans stayed past the point where obligation ended. A credential proves you studied. Presence proves you stayed. The care I would hold every room to, written out plainly, is in Vigil, my next letter. No Agency can require presence. An Agency can stop leaving presence the part of care with no owner.
My own ceremonies average over ten hours, and nobody has ever asked me to leave early. The dose ends when the chemistry says. The day ends when the person does.
The sacred was ruled out of scope on a Monday in September. The sacred will be in the room on the Thursday after the first approval, whether or not a rule has learned the name. No light on any podium has ever once turned red on it.
We are not the forest. We are the mast year.
Maine, September 02026.
“Veterans should not have to be forced to choose between suffering, going underground or leaving the country and crossing international borders just for standard care.”
Before You Go
If any of this landed on a bruise, go slowly tonight. In the United States, 988.
One practice before the list. Sit with a human this week. Two minutes. Listen to the end.
The podium is closed. The file is not.
Name your chair. I am a veteran who went to Mexico.
Write two hundred words. One story, one ask.
Submit your comment by 11:59 p.m. Eastern, Monday, 5 October. Use the direct link.
Then say as much out loud to one reader who would not have written.
Two minutes spoken, two hundred words filed. The Notice weighs them the same.
The next letter is Vigil, the safety framework this one kept reaching for. My formal comment to the Agency, Recommendations for Safe Psychedelic Care, applies that framework to the FDA’s questions one by one.
Most of my work lives in the stretch this letter keeps pointing at: the weeks and years after the ceremony. A reader standing there can start with living the insight, and with the integration work where I spend my days. No docket governs a single hour of either.
If this named the room you work in, send the letter to whoever was told to leave the country to be healed, and to whoever drove them to the airport.
Questions to Sit With
If you had two minutes in front of the ones deciding, who would you speak for?
Where have you mistaken being processed for being cared for?
Whose two minutes could you stay for this week, without fixing, charming, or explaining?
From my Heart to yours,
Yeshua Adonai
Psychedelic Guide
Yeshua is a trauma-informed psychedelic guide, integration coach, and writer. A Marine Corps combat veteran, former diplomat, and mental health executive, he serves sacred mushroom and MDMA ceremonies, offers integration support in ketamine clinics, supports clinical trials, advises policymakers and organizations, and mentors new guides while building technology for the field. He lives in Scottsdale, Arizona, keeps an office in Gilbert, and travels the country, including monthly to communities around Portland, Maine. Most of his work is remote. He counts himself a fellow traveler, still learning to trust his own experience. Posts arrive every other Monday at aboutyeshua.com.
Frequently Asked Questions
The letter carries the argument. What follows carries the mechanics, the evidence, the record of who spoke, and the letter I am filing. Skip to what you need.
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No. Nothing was approved, scheduled, or rescheduled on 14 September. The Agency judges applications one at a time on trial data, and the hearing gathered opinion on the rules around a future approval. Psilocybin and MDMA remain Schedule I. Ketamine, a related but different medicine, is prescribed off label today.
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A ‘Part 15’ hearing, the rule for an informal public meeting where the Agency listens on the record and decides no question on the day. Held Monday 14 September 2026 from 12:30 to 4:30 p.m. Eastern in the White Oak Great Room, 10903 New Hampshire Avenue, Silver Spring, Maryland, in person and streamed online, titled "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs," with eighty scheduled speakers, under two minutes each, and a written docket, FDA-2026-N-7542, open until 11:59 p.m. Eastern on 5 October 2026. Seventy-five of the eighty spoke. Five federal bodies listened: FDA, NIDA, SAMHSA, the Veterans Health Administration, and ARPA-H. No panelist asked a question across the afternoon.
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Because Congress built the Agency to check pills. In 1937 a poisoned elixir sold for streptococcal infection killed more than a hundred Americans, and the country hired a checker. The law says a medicine may be sold once trials show the medicine works and the label says how to use the medicine. A license to practice belongs to the states, the way a driver's license does, so the Agency cannot give credential to a guide or write a scope of practice.
With one large exception, and the exception is where a practitioner should aim. Where a risk needs more than a label, the Agency can attach a Risk Evaluation and Mitigation Strategy under 21 U.S.C. 355-1. Its strongest elements, called elements to assure safe use, can require certified prescribers, certification of the practitioners or settings which dispense, dispensing in named settings and nowhere else, documented safe-use conditions, monitoring of every patient, and a patient registry. So the Agency can decide who may administer, with what training, in what kind of room, under what watch. The sponsor of the MDMA application said as much in 2024: an approval would carry a REMS, and administration would happen only in certified facilities. When MDMA arrived as a pill plus eight hours of therapy, the Agency could judge the pill, could set conditions on the room, and could not license the human in it. Three different things, and the field usually names only the first.
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Worth knowing before you spend two minutes or two hundred words, because an ask filed at the wrong office is a no on a technicality rather than a no on the merits. Nine asks came up in the room. Here is whose desk each one sits on.
Whether the drug is approved at all. The FDA, through the new drug application, the trial design, and the label.
Who may administer, with what training, in what setting. The FDA first, through a REMS with elements to assure safe use, then the states through licensure.
At least three integration sessions, the first within seventy-two hours, and a named provider for the months after. The FDA, as a safe-use condition and a monitoring element in that same REMS. Then the payers, through the code which pays for the visit.
Whether a nurse, therapist, social worker, coach, or chaplain may hold that role. The states, inside the Agency's ceiling, through practice acts and licensing boards, and the professions a REMS agrees to certify.
Legal access outside a prescription. The DEA and Congress, through the schedule. Then the states, through programs like Oregon's, Colorado's, and New Mexico's.
Whether anyone is paid for the months after. The AMA, CMS, state Medicaid, and insurers, through the CPT code, its valuation, and coverage policy.
Certification of the whole program around the drug. SAMHSA, which has done this before, under 42 CFR Part 8 for opioid treatment programs.
Spiritual care as a required member of the team. CMS, through the hospice conditions of participation.
Care delivered to veterans. The Veterans Health Administration, through its own clinical policy.
The hour before and after the dose, the song, the silence. No office. Practitioners, communities, and whoever keeps showing up.
Read down the list and the audience for each ask becomes obvious. Three of these are the Agency's to write, one is the states' with a federal ceiling above it, one belongs to payers, and the last belongs to nobody, which is the argument of this letter. The handoff is the real hazard: the Agency writes the conditions first, and the states, the payers, and the DEA build on whatever shape it leaves them. A narrow REMS becomes a narrow profession, a narrow profession becomes a narrow code, and a narrow code becomes a patient in Nevada with nobody within a hundred miles. That is why a comment aimed at the Agency is worth writing even when the thing you want most is not the Agency's to give.
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It would certify a setting by what it can do rather than the building it sits in, name who may be present, index the watch to the dose, and say what happens in the seventy-two hours after the room empties. Writing one is not my role. A REMS is filed by the company that holds the drug application. What I can do is set out the standard I would hold any room to, and I have, in Vigil.
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My comment goes to the docket under my name by 11:59 p.m. Eastern on Monday 5 October: a short summary in the comment box and four attachments.
Attachment 1: Recommendations for Safe Psychedelic Care, the formal comment, which answers the Agency's four questions in the order asked, with a precedent for each.
Attachment 2: this page, the account of the hearing.
Attachment 3: Vigil, the safety framework for every setting.
Attachment 4: my Ceremony Readiness Guide, the preparation every person receives before a ceremony.
Once it posts, it is public and permanent at regulations.gov, under docket FDA-2026-N-7542.
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Because the FDA regulates drugs sold as medicine, and churches, state programs, and personal use answer to other agencies and to the states. The exclusion was written into the Federal Register Notice before the day began rather than announced from the podium. The exclusion is jurisdiction, not judgment. The cost, named by an Oregon facilitator from the podium, is a medical model built on evidence from a non-medical ecosystem, with the ecosystem ruled out of scope. Further reading: Beyond Belief, on the post-religious spiritual path.
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No, and the framing as a war costs the field more than either side gains. The medical model is good at what lineage cannot supply at scale: a reproducible dose, a screening protocol, a reachable clinician, a billing code, a way to remove a practitioner who does harm. Lineage is good at what a protocol cannot write: how to be with a human whose self is dissolving, what to do with the material afterward, why the ritual exists. The law keeps the jurisdictions separate, correctly, since a drug agency cannot rule on a church. The competencies do not have to be separate. Medicare already requires spiritual care on a hospice team. New Mexico lists end-of-life care among its qualifying conditions. A New Mexico researcher asked for a formal way to seat veteran peer facilitators beside licensed clinicians. Colorado licenses the cultivator who grows the sacrament. Each is coexistence already written into a rule. A colleague of mine is right that the legal conversations stay separate. My argument is about competencies, a different question wearing similar clothes.
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Both halves deserve a straight answer, and I owe a correction. In an earlier draft I summarized a former drug policy adviser's testimony as asking for ordinary science before access. That sells him short and overstates the gap. His complaints were specific: small samples, expectancy bias, suppressed negative results, researchers who use the drugs they study, therapist misconduct. Each is fair. He also cited rising hallucinogen emergency visits in Canada and California, psilocybin poison-control cases among children under twelve rising eightfold in five years, and more than seventy-one thousand suspected ketamine overdose encounters flagged by a federal early-warning system in July 2026. I have not verified each figure, and they deserve an answer rather than a wince. What the framing misses is that the academic record is substantial rather than preliminary. A 2026 meta-analysis in the Journal of Psychopharmacology pooled the randomized psilocybin trials in major depressive disorder and found a large reduction in depressive symptoms, a standardized mean change of −1.24, 95% CI −1.83 to −0.65, holding against placebo. On safety, a 2024 meta-analysis in JAMA Psychiatry from the Johns Hopkins lab whose researcher spoke at this hearing pooled adverse events across the classic psychedelic trials and found the compounds broadly well tolerated in supervised settings while calling for better monitoring, with serious adverse events concentrated among participants with pre-existing psychiatric conditions. Both papers ask for larger samples and longer follow-up. That is the skeptic's point standing inside the literature rather than outside it, which is where I would rather argue with him.
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Researchers at Oregon Health & Science University followed 346 adults through the state's licensed psilocybin centers and published in JAMA Network Open in August 2026 (OHSU summary). Moderate-to-severe depression fell from 42 to 17 percent, anxiety from 45 to 13, PTSD from 48 to 17. Four serious reactions, all in first-time users, and three of the four surfaced at follow-up rather than in the session. The cohort was 87 percent White, three quarters college-educated, nearly a third from households earning over two hundred thousand dollars. Oregon's evidence is real, and Oregon's evidence is wealthy. Lisa Ginzburg, who brought the study to the podium, drew out what that means: a program which counts only what happens in the session sees one serious reaction in four. The other three arrive after everyone has gone home.
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No change on paper, and a line in the record. The FDA and the VA signed a data-sharing agreement in July; the hearing put nine speakers who identified as veterans and three veterans' organizations into the transcript the Agency will read. Nevada and the Interior West, rural New Mexico, Puerto Rico, and Hampton Roads, Virginia were named from the podium as places where a veteran has no lawful route to this care: no trial, no clinic, no state program within reach. One Marine veteran cited Operation Deep Dive's figure of forty to forty-four veteran deaths by suicide a day rather than the familiar seventeen or twenty-two, and called it nearly an infantry platoon. If you have been sitting on a story, the docket is open, and a veteran's two hundred words weigh more there than mine. Further reading: War After War, a veteran's battle to heal.
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Approval is months away for the first drug and years for wide access. A brain-medicine network executive reminded the panel esketamine took five years to reach scale after approval, and said sales in the first two years were too small to report. Waiting is a reasonable choice. Preparing is another. Preparation and integration do not require a molecule, and a cohort does not require a prescription.
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Nurses and social workers, yes, and well. Columbia's social-work program, NYU's nursing school, a pediatric nurse practitioner, the pharmacists' association, and a nurse practitioner who had run a split trauma team in Afghanistan each asked for room inside existing licenses. Chaplains were named once, in a list. A guide working without a license spoke from a chair marked "No Affiliation Disclosed." If the chair is yours, the docket has a field for you the agenda did not.
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Not as a subject, and in glimpses everywhere. Three women introduced themselves as mothers, and one had lost her daughter at twenty-one. A nurse practitioner told the story of a loved one who moved through four caring clinicians and found none who could explain a treatment approved six years earlier. An inventor described sitting with his mother, blind from a rare Alzheimer's, through high doses of psilocybin. Another described caring for a loved one with a severe brain injury. The kitchen was in the room the whole afternoon and never once the topic. The witness letter and Bend carry what the record does not.
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I first read the 110 comments filed as of 16 September, and the counts below come from that first pass. By 30 September the docket held 280, and I read all of them for the formal comment. Counted by hand, in the first 110: the therapeutic relationship appears in 62, integration and aftercare in 41, cost and reimbursement in 33, state programs in 28, harm reduction in 21, spirituality or ceremony in 20, veterans in 17, indigenous lineage in 15, the underground or going abroad in 15, and chaplaincy in 2. About a dozen are form letters. The rest are clinicians, nurses, facilitators, trainers, companies and a scattering of patients. Nurses arrived organised, at least eight of them making the same argument from different states, and April Bogle, twenty-six years in emergency and trauma nursing, put it best: "Excluding nurses does not make this care safer. It makes it scarcer" (comment 0039). Two pre-licensure Colorado therapists wrote nearly the same comment independently, each describing a client they were the right person for and had to refuse; one of them, Eleanor Medina, adds the line the whole docket turns on: "This is a safety issue, because continuity is how risk gets caught early" (0032). Every comment is public and permanent at regulations.gov by ID.
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Yes, and two of them are worth your time. Jim Dodson, a New Mexico patient advocate, argues the person in the room is itself the adverse event, and wants a "sojourner" option where a patient may be alone with the medicine: "I know experientially that other humans disrupt the trance state and can prevent the patient from gaining confidence by overcoming personal adversity and uncertainties alone" (0102). He may be right for himself and for others like him, and a rule written around my convictions would take something from him. The second is the Foundation for Drug Policy Solutions, whose filed argument is better than the podium version: building reimbursement and training infrastructure before approval creates institutional momentum toward approval regardless of the evidence. Their line: "The threshold question is not how to implement psychedelic therapies safely; it is whether the current evidence justifies implementing them at all" (0017). I disagree on sequencing, since waiting for perfect evidence leaves the underground as the only door, which is its own harm with no reporting attached. But the argument deserves an answer rather than a sneer.
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Start at the Federal Register Notice and click the green button, Submit a Public Comment, which opens the form on docket FDA-2026-N-7542 at regulations.gov. The moderator closed the hearing by asking twice that comments go to the docket rather than to an FDA inbox, because an email is not the record. The box holds 5,000 characters; longer letters go as an attached file. Comments are public and permanent. A template: one paragraph naming your chair and your story, one paragraph with a single ask tied to one of the four questions. Two hundred words. Deadline 11:59 p.m. Eastern, Monday 5 October 2026.
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The full comment, Recommendations for Safe Psychedelic Care, lives on its own page, with a PDF of the version filed. The short text in the docket's comment box summarizes it: my central point, two disclosures and six recommendations. This page and Vigil go with it as attachments.
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Across four hours I heard artificial intelligence named once or twice. The fourth question was about data, and the room answered with registries. I also spent time with state health agencies on open data, and the lesson was plain. Publish the data and entrepreneurs, investors, city government and the neighborhood start building health together. No single office had to be in charge. My own clients complete eight assessments across the arc, and the loop is the point: intake shapes preparation, session data shapes integration, and the protocol improves for the client after. So for a few years now each session and ceremony I hold has produced two artifacts. A plan, and what I call an Inner Snapshot, an infographic of a client's inner world they can return to and read months later. The record lives in a HIPAA-compliant environment, on software built for the purpose, with follow-through the client can see. The aim is a better mirror. A held conversation vanishes. A polished mirror can be looked into twice. I have used AI for years to shape the arc, and I have yet to hear another guide describe doing the same. AI stays out of the room. The room is for humans. AI helps me prepare for the room, and helps a client find the shape of what happened afterward. One day, anonymized and consented, records of this kind will show patterns in how healing moves and how a consciousness develops. Until then I guard each client's privacy fiercely, because a record belongs to the one who lived the hours. Further reading: Technology as a Mirror.
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Hundreds of congregations have formed around this sacrament, some under religious exemption, and I have helped build one and advised others. They formed because the lawful door was narrow. They will continue whatever the Agency writes, and the ones inside them are no adversary of medicine.
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Each name links where the speaker can be found. Thank you to each of them. Two minutes in front of five agencies with a clock running is a brave use of a story.
Session one, training and safety. Heidi Allen, Columbia · Erin Atkinson, Prism Wellness · Rajan Dunne, Sheppard Pratt · Angela Fisher, Bionic Bloom · Lisa Ginzburg, Changa Institute · Lynn Marie Morski, Psychedelic Medicine Association · Valerie Porr, TARA · Mark Rasenick, American Brain Coalition · Simeon Schnapper, JLS · Nikita Tsimmer, Fountain Health · Laura Barrett, University of Maryland · Geoff Bathje, Sana Healing Collective · Christine Caldwell, End of Life Psychedelic Care · Liz Collins · Lida Fatemi, Conscious Physicians Psychedelics Academy · Derek Kozlowski, no affiliation disclosed · Lawrence Leeman, University of New Mexico · Joshua Potocko, Althea NOLA · Sandy Samberg, Psychedelic Education Partnership · Michaela Vogt, NeuroAlchemy · Christina Braddock, Mana Warrior Collective · Eileen Brewer, Marylanders for Beneficial Psychedelics and Clusterbusters · Dennis Chien, Pacific Medical Device Consulting · John Eaton, Wounded Warrior Project · Brigitte Gordon, Journey Clinical · Gregory Hutchinson, Emyria · Lakisha Jenkins-Samuels, Kiona Foundation · Laurel Kilgour, Psychedelic Bar Association · Heather Kuiper, Center for Psychedelic Public Health · Jason Roop, Center for Trait-Based Transformation · Jeremy Rudy, Sabba Collective · Jane Caplan, East West Global Healing · Pedram Dara, Psychedelic Lived Experiences · Caroline Dorsen, NYU Meyers · Peter Hendricks, UAB and Apollo Pact · Genesee Herzberg, Psychedelic Therapy Alliance · Jawed Kalim, Compass Pathways (did not speak) · Michael Lawton, Barrow Neurological Institute · Mark Nicolas, Texas A&M Central Texas · Christian Reed, Mindbloom patient and Special Forces Foundation · Stephanie Seal (did not speak) · Raymond Turpin, The Pearl Institute · Corey Whetzel, American Pharmacists Association · Shasta Winn, Satya Therapeutics and Myco-Method.
Session two, access and data. Tiffany Callis, The Spirit Nurse Psychedelic Community · Jon Dalton, Nevada Coalition for Psychedelic Medicines · Mary-Elizabeth Gifford, Clearmind Medicine · Odette Hauke, Odette Alina LLC · Edward Jacobs, Oxford HOPE and Johns Hopkins · Eric Jansen, Balanced Veterans Network · Melissa Lavasani, Psychedelic Medicine Coalition · Justice Leak, Therapod · Shanetha Lewis, Maryland Task Force and Veterans Initiative 22 · Maksim Tsvetovat, Research Lambda · Amber Barnato, The Dartmouth Institute · Raquel Bennett, KRIYA Institute · Jennifer Bremser, neuroscientist and trial participant · Sammy C, Mindful Health (did not speak) · Jagpaul Kaur Deol, University of British Columbia and MAPS Canada · Rhonda DeSantis, Psylutions · Lawrence Goldkind, Uniformed Services University · James Wilson Green, Rutgers · Sarit Hashkes, Filament Health · James Hosobe, Arizona Department of Health Services · Shraga Israel, Metanoia · Ashley Walsh Kvamme, Inner State · Kevin Sabet, Foundation for Drug Policy Solutions · Susan Taymor Sagy, Coalition for Psychedelic Safety and Education · Joel Stanley, Ajna Biosciences · Jean C. Vélez Rodríguez, PRISMA Puerto Rico · Lynn Watkins, Psychedelics and Pain Association · Amna Aslam, Radial · Kerthy Fix, documentary filmmaker · Daniel Huson, Rose City Laboratories · Nick Kadysh, PharmAla Biotech · Richard Langford, Cy Biopharma · Alia Lilienstein, UC Berkeley Center for the Science of Psychedelics · Jorge Valderrábano, Agora.
The listening panels. FDA: Dayle Cristinzio, director of public engagement and moderator · Marta Sokolowska, deputy center director · Tiffany Farchione, Division of Psychiatry · Bernard Fischer, Office of Neuroscience. Federal partners: Daniel Stimson, NIDA · Neeraj Gandotra and Rick Lambert, SAMHSA · Andrew Gradison and Wendy Tenhula, Veterans Health Administration · Al Bugazia, ARPA-H. Also in the room: Michael Davis, the drug center's new director, for the second half, and Lt. Gen. Martin R. Steele, USMC (ret.), Reason for Hope, whose eightieth birthday fell the day after the hearing.
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The habit comes from the Long Now Foundation, who write five digits so the fifth will mean a fifth digit to whoever reads the date then. Lichen grows by a millimeter a year and some colonies are older than cathedrals. A docket closes in three weeks. Both clocks are running.
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No, and yes. I am not a licensed therapist, I do not treat mental illness, I do not supply any substance, and I say so on first calls. What I offer is preparation, a container, and the months after, which no docket governs. I live in Scottsdale, keep an office in Gilbert, work across Arizona including Phoenix, Sedona, Tucson, Tempe, Mesa, and Flagstaff, and travel monthly to communities around Portland, Maine and through New England. Most of the work is remote, so geography is rarely the obstacle a reader expects. Further reading: Self-Remembering, Hyparxis, and Cancer, the other healer in the room.
If the two minutes go somewhere and you want company for the longer work:
Book a Discovery Call. A complimentary conversation about where you are and whether any of this fits. No obligation.
Ceremony Readiness Guide. Free, and a good first step if a call feels like too much too soon.
Monthly Online Integration Circle. A room of readers in the months after, together.
The ceremony container. The full guided arc, preparation through integration.
Psychedelic integration coaching. Six sessions across a season.
Seekers Circle. Six months, circle calls and an accountability partner. Opens once a year.
The archive. Thirty-seven letters and counting.
And if none of these fit, find your own people anyway. A guide, a circle, a therapist, a friend with a calendar. What I offer is company, discernment, and the willingness to stay. The third chair is not meant to sit empty, and the record is open to whoever fills the chair.
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