Welcome to The Frontier Psychiatrists. This article is Part II of a series on MDMA-AT. This is a flashback, now more potent than ever, to a prior article. In this article, I argued against the stance of Rick Doblin, the founder of MAPS and its associated drug company, MAPS PBC, rechristened Lykos Therapeutics, PBC. The data coming to the fore from the FDA Advisory Committee hearing is worrying. An idea that I was willing to write off as “kooky” and “not in keeping with the culture of medicine previously…seems a bit more sus now.
I will open this article with a comment from the FDA’s Open Comment period:
While one may argue the legitimacy of psychedelic spiritual beliefs on their own merits, how do we trust data when a company not only has financial conflicts of interest but open spiritual and religious conflicts of interest?
And like the worst of religions, including my own, what happens when people are abused in the name of a religious mission? As we saw in these trials, they are often discarded, silenced, minimized for political gain, and tossed away as inconvenient.
Was MAPS founded as a pseudo-spiritual organization by Doblin to promote the mystical healing of MDMA and their specific, theologically motivated “therapy?” I don’t know. I do know that the insistence of Doctor (of political science— not medicine or clinical psychology) Doblin that everyone use drugs? It is much more understandable if you think of the organization as a religious organization first and a pharma company as a distant second.
I will open this piece with a quote and return later to the full quote from the same writer:
The best kind of patient for [the purpose of satisfying their therapist] is one who from great suffering and danger of life or sanity responds quickly to a treatment that interests his doctor and thereafter remains completely well. Still, those who recover only slowly or incompletely are less satisfying.
—Tom Main, The Ailment, 1957
For full disclosure, I am a dual board-certified child and adult psychiatrist.
I have written publicly about my personal experience with:
bipolar disorder
ADHD
withdrawal from Medicine treating restless leg syndrome
inadvertent caffeine intoxication
obstructive sleep apnea
obesity
the side effects of antipsychotic medications
transcranial magnetic stimulation
Psoriatic Arthritis
Taltz
Methotrexate
Cimzia
Humera
Lithium
Cocentyx
And more. I am not shy about personal disclosure when it comes to my experience of treatment for medical conditions. It would be hard to argue I don't go long on gonzo Healthcare journalism. And I've been reading
and other health and psychedelic luminaries. The following points have not yet been made, to my knowledge.
Rick Doblin, founder of MAPS, is an evangelist (from GQ in 2021):
Doblin says the company—which consists of a large team of psychologists and neuroscientists—is now working to help create a society built to capitalize on psychedelics’ reentry.
It is worth noting, concerning my neuroscience and psychology colleagues, that these disciplines are not medical. Not all healing is medicine, but all medicine is legally regulated by the admixture of law and medical practice. Psychedelic Medicine requires Medical licensure.
Rick Doblin thinks the problem with exposing therapists to MDMA is the off-label nature of the prescription, and that is factual. His zeal, like so many psychedelic enthusiasts, is born of personal exposure:
He was 28 years old when he tried MDMA for the first time. It was 1982. “I was just stunned at how profound the experience was,” he said. “It was clear to me how tremendous it would be as an adjunct to psychotherapy.”
—Rick Doblin, Ph.D.
That quote belies what I consider to be a feature and a bug of psychedelic research: they create a sense of faith, which is termed a “mystical experience” in the literature:
“[Mystical experiences are] those peculiar states of consciousness in which the individual discovers himself to be one continuous process with God, with the Universe, with the Ground of Being, or whatever name he may use by cultural conditioning or personal preference for the ultimate and eternal reality.”
Although I would hope I don’t need to explain that bias is a problem for science, I will state: feeling like you’ve seen God? It makes it hard to evaluate if the “God Seeing” part is a necessary part of an experience. It is a problem for subsequent dispassionate inquiry and clinical equanimity.1
It is biasing.
If we imagine that the mystical experience phenomenon was a side effect, which might have nothing to do with the actual biological activity of the drug? One could imagine that the ability to make you believe in magic might make it hard to examine data that might disapprove your life-changing experience?
When Doblin talks about MDMA, he rarely dwells on the data involved2. Rather, he talks up the potential of MDMA to “interrupt generational cycles of conflict and replace them with empathy and understanding.”
This sort of religious or evangelical bias has created all kinds of trouble throughout history, not just with religion but with medicine. A brief reminder from our history of under-regulation in advertising before the modern FDA:
And:
And lest we forget:
We have had compelling, profound, powerful treatments at our disposal before.
We already know what medicine looks like when under the influence of extremely potent pharmaceutical agents, because our modern residency training scheduling was determined by a man who was relentlessly addicted to cocaine.
With that investigative spirit, Halsted had embarked on experiments with cocaine—then touted as a wonder drug—with a group of colleagues in 1884. Submitting themselves as test subjects, they explored the drug's pain-numbing abilities by injecting it into their peripheral nerves. In doing so, they would advance the concept of local anesthetic, a critical leap for medical procedures, including dental work. They also became enslaved to the drug, whose dangerously addictive properties were not yet understood.
80 hour work weeks for Medical residents, 24 hours of wakefulness on call, even the concept that we should be living in the hospital all the time, and thus the name residents? We owe these to the relentlessly energetic because he was hopped up on cocaine Dr. Halsted! Much like the potent ability of MDMA to change your perspective, cocaine—and morphine— changed Dr. Halstead's perspective in ways that we all benefit from—and are biased by— today. He was an innovator, putting both himself and his family under the knife and needle:
Halsted performed what was possibly the first successful blood transfusion in the U.S.—on his own sister, whom he injected with blood from his arm after finding her unconscious from a postpartum hemorrhage. He later performed the nation's first gallstone surgery—on his own mother, saving her life through a 2 a.m. operation on her kitchen table.
All of which is well and good, but it did land Halsted in Butler psychiatric hospital himself. And, much like Doblin’s conviction, it is hard to shake the conviction of a remarkable person when augmented by remarkable compounds.
The disambiguation of the remarkable person from the remarkable method is not simple. The bias is built-in, both to the human, and the compounds that augmented them. It is bias of which we should be endlessly mindful— and suspicious— of accepting blindly.
The medical tradition that I was trained in, which included residency as defined by doctors Osler and Halsted at Hopkins, did not come without lessons of its own.
As someone with a medical degree, who treats patient suffering from medical conditions for a living, I am here to explain something. There is a difference between taking the anesthetic and being under the scalpel.3 What psychedelic medicine enthusiasts seem to miss when it comes to the use of psychedelic compounds for medical purposes is that it's not about tripping. Tripping is an adverse event in this context.
When the decision was made—for political reasons by professor of political science Dr. Rick Doblin4— to pursue a Medical path to legal psychedelics, it was a strategic decision.
When you're leading a company submitting for an FDA label on a molecule to treat a medical condition, frankly, you need to act like it.
This quote, for example, isn’t in the category of “pharma advertising compliant”:
“[we seek] mainstreaming psychedelics into western culture, which will serve as a strategy for the human species to overcome the challenges of globalization and create a global spirituality shared by billions.”
—Rick Doblin, Ph.D.
From a pharma executive, these statements could be understood as disrespectful to those suffering from the medical conditions MAPS product is indicated.
Not every oncologist will need chemo. Not every psychiatrist will have a psychiatric admission to an inpatient setting. Lived experience is not mandatory for the care of others— humility is. Suggesting that all therapists who will administer a treatment undergo that experience themselves is hubris—or…it’s a cult.
If the agenda is for everyone on earth to have a mystical experience, that is not a medical agenda. That is the agenda of psychedelic exceptionalism. It’s also f$cking obnoxious—to doctors and patients alike.
We, in the house of medicine, have traditions. We have oaths. We have laws, too. We learned lessons about all of our senior leadership being on drugs 100+ years ago. Allow me to quote from the brilliant Samuels Bergman classic, the House of God. He lays out the “laws” of the House of God, his archetype of an American Hospital, as follows:
I. Gomers don't die. (GOMER = get out of my emergency room, a pejorative and frustrated term for demented elderly people who came in for repeated and futile medical treatment in the book)
II. Gomers go to ground. (Falls are a risk)
III. At a cardiac arrest, the first procedure is to take your own pulse.[1]
Becoming a physician requires decades of experience and sacrifice. We all experience trauma. By definition, we will experience criterion A of PTSD — exposure to death, dying, and more. Some of us will develop a disorder from it. We learned to be careful of miracle cures and our hopes to cure (quoting from another Amazon link: the ailment by Thomas Main from 1957):
When a patient gets better it is a most reassuring event for his doctor or nurse. The nature of this reassurance could be examined at different levels6… but without any such survey it might be granted that cured patients do great service to their attendants.
The best kind of patient for this purpose is one who from great suffering and danger of life or sanity responds quickly to a treatment that interests his doctor and thereafter remains completely well; but those who recover only slowly or incompletely are less satisfying.
Only the most mature of therapists are able to encounter frustration of their hopes without some ambivalence towards the patient, and with patients who do not get better, or who even get worse in spite of long devoted care, major strain may arise. The patient's attendants are then pleased neither with him nor themselves and the quality of their concern for him alters accordingly, with consequences that can be severe both for patients and attendants.
It is the foolish therapist who privileges the interesting treatment above the interest of the patient. It is the opposite of wisdom. The peril of miracle cure-alls is that sometimes they won’t. Even the most effective treatment is a cure some. The bias created by psychedelic treatments is potent.
To state that all psychedelic therapists need to be exposed to the biasing experience of their compounds is every bit as absurdist as Bergman’s “There is no body cavity that cannot be reached with #14 needle and a good strong arm.”
The difference is that Samuel Bergman knew he was kidding. He was making the opposite of that point. Because he was a physician who understood what Tom Main was getting when he wrote:
Refusal to accept therapeutic defeat can, however, lead to therapeutic mania, to subjecting the patient to what is significantly called "heroic surgical attack', to a frenzy of treatments each carrying more danger for the patient than the last, often involving him in varying degrees of unconscious-ness, near-death, pain, anxiety, mutilation or poisoning. … The sufferer who frustrates a keen therapist by failing to improve is always in danger of meeting primitive human behavior disguised as treatment.
The only thing every therapist needs to be exposed to? It is the failure of their ability to help. And this tincture is universally prescribed by fate.
For those who lack caution, I will cite the most relevant of The Laws of the House of God:
VIII.They can always hurt you more.
I would rather that axiom be true of our quixotic drug developers and hopes for perfect cures, and not of our attitude towards our patients. The more therapists who are exposed to the biasing experience of psychedelic treatment, the fewer of them will have as much doubt as will be useful some of the time. Some of the time, they will not help. We need to remain vigilant for those times, as well. Our compassion will be needed then, more than ever.
I’m a fan of many of the people who have joined the Lykos team, and we all agree— that more treatments for PTSD for patients are needed. But, after the Advisory Committee Meeting this week, MDMA-AT, the culture of medicine—and its ever-present attention to risk, put non-physician Dr. Doblin’s approach in its place. The path to world peace doesn’t begin with the FDA’s regulatory process.
Taking a drug and experiencing its effects is not the same as having a drug administered for an indicated medical condition and receiving its benefits and risks for that condition.
Doblin has an advanced degree, but it’s not in psychology. In 2001, he graduated with a Ph.D. in public policy from the Harvard Kennedy School. “We don’t actually do science,” he says of his work with MAPS. “We do political science.”
One of the reasons he chose MDMA for the clinical trials, he says, is because he believes it is a tamer psychedelic, one that might appear less frightening to the public. In devising his strategy, Doblin also sought out a sympathetic patient pool with bipartisan support: veterans with PTSD. “Most of the people that have PTSD are women who’ve been sexually abused or raped or domestic violence, and they’re sympathetic,” he told Marianne Williamson last year on her podcast, but “not quite as much as the veterans.” “Interpersonal violence and trauma,” he elaborated to us this month, “are uncomfortable subjects for many people, whereas combat-related trauma is widely recognized as a national responsibility to address.”
Leaving aside the FDA approval process and the rules and biases of medicine (I do love me some House of God too, tho the hope of the ending does seem naively of its time now), which are obviously being badly broken here, the key is perhaps the difference between a medical and psychotherapeutic mode here, particularly a rather traditional psychotherapeutic mode.
Because while not every oncologist will need chemo, and not every psychiatrist will need antipsychotics, there are significant branches of psychotherapeutic practice, particularly psychodynamic ones, that not only recommend but REQUIRE the therapist to undergo analysis themselves, and while I'm not aware of any CBT derived approaches that would have such a requirement, I've certainly seen recommendations that practitioners use/try techniques themselves even in for example manuals for WHO's mhGAP scalable, widely tested basic interventions. So perhaps in case of what seems like drug-facilitated psychotherapy rather than the drug as such this proposition isn't as egregious or offensive as it might seem, though obviously it doesn't really make much sense because presumably an experience of person with let's say combat PTSD and a person without it will be different anyway (unless we assume everyone is meaningfully traumatized in a comparable way or other some such Gabor Mateish nonsense).
good critique, especially of the dangers of religiosity - rick's insistence on developing his own therapy manual rather than testing novel drugs alongside existing modalities is both unwise and bad science. agree with you there.
however, to deny the existence of subjectively unique aspects such as what is being termed as "mystical experiences" denies the need to reliably+validly quantify these effects with respects to their potential therapeutic mechanisms of action. taking this further by dismissively claiming "tripping" (already a yet-to-be-well-defined phenotype within present research) is an adverse event seems premature if not just as dangerously naive....
Leaving aside the FDA approval process and the rules and biases of medicine (I do love me some House of God too, tho the hope of the ending does seem naively of its time now), which are obviously being badly broken here, the key is perhaps the difference between a medical and psychotherapeutic mode here, particularly a rather traditional psychotherapeutic mode.
Because while not every oncologist will need chemo, and not every psychiatrist will need antipsychotics, there are significant branches of psychotherapeutic practice, particularly psychodynamic ones, that not only recommend but REQUIRE the therapist to undergo analysis themselves, and while I'm not aware of any CBT derived approaches that would have such a requirement, I've certainly seen recommendations that practitioners use/try techniques themselves even in for example manuals for WHO's mhGAP scalable, widely tested basic interventions. So perhaps in case of what seems like drug-facilitated psychotherapy rather than the drug as such this proposition isn't as egregious or offensive as it might seem, though obviously it doesn't really make much sense because presumably an experience of person with let's say combat PTSD and a person without it will be different anyway (unless we assume everyone is meaningfully traumatized in a comparable way or other some such Gabor Mateish nonsense).
good critique, especially of the dangers of religiosity - rick's insistence on developing his own therapy manual rather than testing novel drugs alongside existing modalities is both unwise and bad science. agree with you there.
however, to deny the existence of subjectively unique aspects such as what is being termed as "mystical experiences" denies the need to reliably+validly quantify these effects with respects to their potential therapeutic mechanisms of action. taking this further by dismissively claiming "tripping" (already a yet-to-be-well-defined phenotype within present research) is an adverse event seems premature if not just as dangerously naive....