Over the last decade, studies have shown ketamine’s effectiveness in treating depression. There is emerging proof of the efficacy of LSD and psilocybin. In addition, MDMA seems helpful in managing post-traumatic stress disorders.

Psychedelics go beneath the cell surface to unleash their potential therapeutic effects. Psychedelics — including LSD and psilocin from magic mushrooms—promote the growth of nerve cell branches known as dendrites. This article will examine how psychedelics may promote health.

“Strangers passing in the street
By chance two separate glances meet
And I am you and what I see is me”
― Pink Floyd

What are psychedelics (hallucinogens)?

Hallucinogens are a class of psychoactive substances that alter an individual’s perception, thoughts, and sensory experiences. These substances induce hallucinations, typically as sensory experiences that seem real but are not caused by external stimuli.

Hallucinogens can produce various effects, including visual distortions, time perception alterations, thought pattern changes, and intensified emotions.

Some commonly known hallucinogens include:

1. LSD (Lysergic Acid Diethylamide). A potent hallucinogen is synthesized from a chemical found in a fungus called ergot. LSD is known for its powerful psychedelic effects and can produce profound sensory and perceptual alterations.
2. Psilocybin. This substance is found naturally in certain species of mushrooms. The body converts psilocybin into psilocin. Psilocybin mushrooms, often called “magic mushrooms” or “shrooms,” have been used for centuries for their hallucinogenic properties.
3. DMT (Dimethyltryptamine). DMT is a naturally occurring substance in various plants, animals, and human brain tissue. Scientists can also produce it synthetically. DMT is known for its short but intense effects, often described as a “breakthrough” experience.
4. Peyote and Mescaline. Peyote is a small cactus native to North America; its primary active ingredient is mescaline. Mescaline is a hallucinogenic compound traditionally used in Native American religious ceremonies.
5. Ayahuasca. Ayahuasca is a plant-based brew made from the Banisteriopsis caapi vine and other plants containing DMT. Indigenous cultures in the Amazon Basin have used it for centuries for spiritual and healing purposes.

Hallucinogens can produce a wide range of effects. Their impact can vary depending on dosage, individual sensitivity, set and setting (the user’s mindset and physical environment), and the specific substance used.

It is important to note that hallucinogens can have profound psychological effects. Please approach their use with caution and respect for their potential risks and the laws governing their use in different jurisdictions.

Psychedelics and mental health

Many prominent universities worldwide are exploring four psychedelics, including LSD, psilocybin, MDMA, and ketamine. Research studies demonstrate that these substances promise to manage various mental health problems. Here is a list of universities researching hallucinogenic agents:

Universities Researching Psychedelics | Psychedelic Invest

As the psychedelics ecosystem develops, educational institutions throughout the world continue to have significant…

psychedelicinvest.com

Of course, The United States Drug Enforcement Agency (DEA) does not recognize most of these drugs as having legitimate medical use:

Schedule I drugs, substances, or chemicals are “drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.”

Psychedelics, thus, are challenging to access legally. Moreover, the drugs can be quite pricey.

Psychedelic or hallucinogenic drugs vary in their mechanisms of action and risks. All create an altered state of consciousness (for example, an “acid trip”). For many, this brain alteration opens the door to an increased awareness of parts of their environment. Solid objects may appear to breathe in or out.

For others, a trip may induce panic or anxiety rather than euphoria, particularly at high doses. Given the varying reactions to hallucinogens, a clinical research trial is the best place for consumption.

Four psychedelics that offer promise

Let’s look at four psychedelic drugs.

1. Psilocybin. Psilocybin (magic mushrooms) are naturally occurring and consumed for their hallucinogenic effects. They are psychedelic drugs that can affect all the senses, altering a person’s thinking, sense of time, and emotions. Psychedelics can cause a person to hallucinate, see or hear things that do not exist or become distorted. When consumed, the body converts psilocybin into psilocin — the psychoactive chemical. Magic mushrooms appear similar to ordinary mushrooms. Psilocybin, taken in pill form, has the potential to help manage substance abuse disorders (such as nicotine addiction and alcoholism) and depression.

2. LSD. Lysergic acid diethylamide, commonly known as LSD (from German Lysergsäure-diethylamide), shows promise for treating alcohol addiction.

Still, the benefits may be limited: A meta-analysis showed that a single dose of LSD had significant benefits at the short-term follow-up, but the benefits were not maintained at longer follow-up times of 12 months after treatment.

Of 536 patients, there were eight acute adverse events, including confusion and agitation, a seizure, nausea, vomiting, and bizarre behavior. LSD users often report feelings of bliss during their trip, seeing sound and having a mystical experience. Many report feeling closer to others. One downside? Some have lasting psychological trauma caused by a bad trip, especially with frequent use or higher doses.

3. MDMA. This drug, also known as ecstasy or molly, remains illegal in the United States. MDMA is often considered the drug of choice in the rave culture and is used at festivals, clubs, and house parties.

MDMA can induce feelings of euphoria and connectedness with others. Researchers are investigating it in clinical trials for conditions such as post-traumatic stress disorder, end-of-life conditions, and social anxiety in autistic adults.

Unfortunately, MDMA can cause chronic kidney damage and heart arrhythmias, particularly for those with related pre-existing conditions. In 2017 the United States Food and Drug Administration (FDA) approved limited research on MDMA-assisted psychotherapy for PTSD, given early evidence that the drug might facilitate psychotherapy effectiveness.

4. Ketamine. Also known as Special K, this drug is used as an anesthetic by veterinarians (sometimes in combat or emergency medicine). Ketamine has not been illegal in the USA, so we have more mental health research on this psychedelic than others. Researchers are exploring ketamine for anxiety, depression, and schizophrenia.

Psychedelics for Depression

Psilocybin is effective for up to 12 weeks in severe depression.

medium.com

Ketamine drug promotes the regrowth of nerve cells in the brain, often leading to near-immediate relief. Researchers are exploring its use for those with suicidal ideations. The US Food and Drug Administration approved esketamine (a ketamine form) for limited use in early 2019.

Ketamine downsides include clumsiness and significant memory issues (forgetting where (or who) you are. Blurred vision or hallucinations are common. Rarely do users enter a “K-hole,” feeling disassociated from themselves and their surroundings, leading to panic or paranoia

Ketamine has a different mechanism of action than other psychedelics. Most psychedelics — including LSD, MDMA, and plant-derived ones — affect mood-regulating serotonin receptors. In contrast, ketamine affects brain receptors central to memory and learning. Both receptor types are in the brain’s prefrontal cortex, explaining their similar effects on mental health.

Psilocybin microdosing

Microdosing psilocybin involves taking small doses (one-tenth the standard) every few days. Some individuals get mental health benefits without the high.

Microdosing is not without potential harm: There is limited evidence that it can cause heart damage over time. Recent research hints that microdosing positive effects might be largely due to a placebo effect.

Is LSD Microdosing a Worthwhile Cognitive Hack?

THE HALLUCINOGENIC AGENT LSD (IN MICRODOSES) improves mood and cognitive function, right? Not so fast: A University of…

medium.com

Key points — Psychedelics and mental health

Question. Do psychedelics (hallucinogenic drugs) improve mental health?

Findings. There is a renewed interest in hallucinogens, especially for psychiatric disorders. The last decade has witnessed several clinical (and laboratory) studies showing the effectiveness of ketamine for managing depression. Other studies suggest the promise of LSD and psilocybin for treatment and to modulate functional brain connectivity. Finally, MDMA appears to help those with post-traumatic stress disorder (PTSD).

Meaning. Psychedelics hold promise for managing mental health problems such as PTSD and depression. Moreover, hallucinogenic agents might become valuable tools to understand better brain neural circuits, how nerve cells communicate with one another, brain signaling outside of mental disorders, and potential pharmaceutical targets.

The post Psychedelics and Mental Health appeared first on Medika Life.

The tip-off started with the impressive staged photos that the NYT commissioned for the article. Each of the photos was formatted to fill the entire screen of a monitor when a reader scrolled through the article on a desktop computer.

The photos in the NY Times article displayed authors of the study and actual patients in contrived settings. The captions of the photos of the patients provided glowing testimonials about how the treatment they received in the study miraculously changed their lives.

Other sources quoted as experts in the article conveyed an enthusiasm for the breakthrough nature of the study. The tone was more consistent with the article being an infomercial for the treatment being evaluated in the study, rather than a detached, open-minded, but skeptical probing of the actual quality of the science of the study.

The NY Times article represented more of an active collaboration between the newspaper and the publicity campaign for the trial than what happened with many other media sources. Lazy journalists simply drew on a press kit provided by the study’s funders. However, there was a remarkable consistency in the adulating, highly redundant coverage of the story.

“Readers, including even experts, are falling for a hard sell job by venture capitalists who launder their funding of the study through a nonprofit foundation and seek not legalization of psychedelics and related illegal drugs but lucrative control over their use for therapeutic and recreational use.”

The actual Nature Medicine paper is available here.

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study

The fog rolls in when the title gets elaborated in the second sentence of its abstract:

We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma.

“Double-blind” is not true of the patients or therapist/coaches for very long.

The study was unblinded within minutes of the administration of the active MDMA or inert pill. The difference in subjective reaction was obvious, especially since the patients’ expectations that they should experience a strong effect have been shaped in the therapist/guides and confirmed or disconfirmed in no more than 20 minutes.

The patients’ reports of subjective reactions continue to be shaped in the coaching during the three administrations of the drug and in “integration” sessions afterward, including one after the last administration of the drug or inert pill, just before the outcome assessment.

“Placebo-controlled” is only true in the trivial sense that the patients receive either MDMA or an inert substance in a capsule carefully constructed to be indistinguishable without the patient ingesting it.

The stronger, more appropriate technical sense of “placebo” is the total of the expectancies and support patients receive in the course of the study and the broader context of the setting and what they are told in advertisements encouraging enrollment in the study.

Patients seeking enrollment in the study have strong expectations of a positive experience with trained experimenters and therapists/counselors unlikely to be available elsewhere legally and with the assurance of the purity of the drug.

That goal may even distort their reports of symptoms in the baseline assessment to ensure that they can get into the study. That is a problem that is familiar to trialists who recruit from the community.

That the trial is “multisite” might seem to encourage confidence in the broad generalizability or validity of the findings, but…

The clinical trial conducted in multiple sites or “nesting” must be taken into account in any analyses of the primary outcome. Analyses should consider whether there was variation between sites in the difference in outcomes obtained by MDMA versus placebo. It is a challenge to ensure that procedures are identical across settings. Sometimes the differences between settings in how the study was implemented can dwarf or explain away any overall differences between active treatment and placebo.

A dive into the details of the article and supplementary materials reveals that there were 15 clinical sites in diverse jurisdictions and cultures. In a study with only 42 patients assigned to MDMA and 39 assigned to placebo, it is impossible to separate the effects of the site from the effects of patients getting MDMA or placebo across those sites.

Unconvinced that this is important? In a devastating commentary on the FDA approval of ketamine for treatment-resistant depression, Erick Turner noted that positive results were entirely due to the inclusion of one outlier site in Poland, where there was 100% relapse in the placebo group.”

The trial has a registration with the US government, but there is another registration of the study elsewhere…

The trial registration number provided in this article (NCT03537014) checks out at ClinTrials.Gov. It identifies the primary outcomes reported in this paper. However, it is unnerving to discover in a press release from the Imperial College, London, that the study is registered elsewhere with neuroscience outcomes. Consent and recruitment to a study involving MRI assessments of the brain present very different nonspecific (placebo) conditions for the subsample of patients participating in the trial who get the brain scans. This is a crucial concern for an area of study with so much hype about MDMA opening or changing the brain. The entire sample is too small to take such factors into account. The study is undoubtedly too underpowered to be talking about effects on the brain, anyway.

This is just a probing of one sentence in the abstract, but it should motivate interested readers to probe further, especially the figures and tables and the strength of evidence for claims made in the discussion.

But I am posing a broader issue. I have growing, nagging concerns that readers, including even experts, are falling for a hard sell job by venture capitalists who launder their funding of the study through a nonprofit foundation and seek not legalization of psychedelics and related illegal drugs but lucrative control over their use for therapeutic and recreational use.

Why are so few “experts” speaking out about a reporting of this study that is so wrong in so many ways? Why the silence?

The post The MDMA-Assisted Therapy for PTSD Study. What You’ll Get Wrong appeared first on Medika Life.

It’s a tip of the hat to faith healers, shamans, and witch doctors. It is also a shameful marketing ploy by medically trained professionals that should know better and it is a seriously dangerous red flashing light for the profession and its credibility.

Drugs have become our fallback for almost everything. Practitioners in general are massively guilty of doling them out as a panacea for socially compromised adults. Adults that possess no life skills or coping mechanisms are simply drugged into oblivion. You don’t need to worry about handling life if you’re too stoned to notice it. Forget therapy or actually trying to provide the necessary life skills. Too time-consuming and really, why cure when you create a lifetime of dependence? 

Medicine is slipping, quitely, intentionally and unnoticed, into a new sideline.

It is becoming the traveling quack show we so despise, prescribing drugs to treat conditions that mostly don’t exist, conditions some practitioners are unqualified to recognize, let alone prescribe for, and unfortunately, when it comes to those who are trained, the fallback (and sometimes go-to)treatment is the ever lucrative cocktail of mind-altering concoctions we now have at our disposal.

I would go so far as to say that 90% of the patients showing up cap in hand at your door aren’t suffering from any condition your medication could possibly treat, let alone cure. Forget management, if that’s where you’re going. That isn’t an out either. Someone who hasn’t been given the tools or strategies to cope with life doesn’t require medication, they need the school of life and real help to develop mechanisms many of us are already fortunate enough to possess. Medicating these patients is CRIMINAL. It is WRONG. It is UNETHICAL.

I would suggest to our modern-day mental health professionals and doctors alike, that unless you are really gullible or simply follow the flock, that you are aware of the failings in your treatment of these individuals. It’s an easy out, isn’t it? We’ve conditioned the patients to expect the pill. The miracle in the bottle, the panacea that will solve all of life’s problems.

Your patient doesn’t want any other form of help. They simply want the easy route and they’ll sit in front of you and bitch till you get out that pad and start writing. Part of you justifies it with a simplistic thought to ease your conscience. If you don’t prescribe, they’ll simply get it somewhere else. So you cave in. It’s quicker, it’s easier and at least, you think to yourself as you start writing, you can keep an eye on them.

WRONG. STOP. What you are doing is unethical. Is it in the patient’s best interest? Are you properly qualified to make that judgment? Do you understand that you are fundamentally changing the course of the person’s life sitting in front of you. Do you REALLY? Those quick, few lines on that script are potentially going to create a life of addiction and dependency. Was that why you joined the medical profession. For some doctors and many psychiatrists, it clearly seems to be.

Your flashing lights, new age mumbo jumbo, and cutting edge designer drugs are simply complex rituals you’ve designed to cover your snake oil shows. The best interests of the patient ceased being at issue years ago and the danger now, as even universities get involved in the medical mystery tour routine, is that people will start to perceive this as being real medicine. It isn’t and every effort must be made to ensure it never becomes that.

 It is a marketing farce, quackery, and pseudoscience wrapped up in what you assume to be a professional presentation to fool the public We see you. We see the lives you are destroying and you better believe we aren’t going to let it go.

It’s time to clean up your sad acts. Revert back to your core principles and HELP the patient, stop helping yourselves. Why Treat when you can Cure? By all means, assist your patients, but do so ethically. Treat them humanely and help them to address the shortcomings in their lives by providing them with lasting skills to cope with their existences. None of this involves any need to get your local pharmacist involved.

You’ll find the rewards from this difficult and lengthy process to be far more rewarding than all the time you currently spend arranging your mirrors and putting on the makeup. 

Where are your facts?

Oh, they’re coming. Don’t fret. This is simply a warning shot, fired across the bows, to encourage those with sense to pause, stop, and re-assess their current practices. Most will ignore it, but it may hopefully reach a few professionals. Medika will be publishing a few in-depth articles in the coming weeks on the disgraceful practices that are now becoming almost routine within the mental health community. Medication will feature strongly, as will the tendency to misdiagnose.

To push patients into neatly labeled boxes, each representing a different condition. Boxes that simplify everyone’s life. The patient considers his medication justified, even if the diagnosis of late-onset autism seems a little iffy. The care provider has only to continue handing out the medication and monitoring the patient. A lengthy and sometimes lifelong relationship that benefits no one, other than the practitioner.

Good doctors, ethical doctors, of whom there are many, whose sole purpose is to ensure the health of their patients, are also compromised as trust in the profession is eroded. Patients no longer view the profession with the dewy-eyed trust enjoyed by doctors fifty years ago. No one is more to blame for this than the quacks and charlatans from within the ranks of medicine itself.

That these quacks were, and are still able, in some instances, to pursue their chosen professions, speaks volumes to the lack of proper, swift, and merciless sanction from governing bodies. Lenient approaches from regulatory bodies within certain states encourage the problem and any potential solutions to eradicating this rot from the medical profession have to be undertaken with the full engagement of these bodies.

It must be eradicated. Medicine cannot afford further dilution of the trust it enjoys from the public. The consequences will be devastating, impacting vaccination rates, terminal care, and the inevitable escalating costs of trying to save those who have ventured away from traditional medicine to seek salvation in the hands of the natural healers and fraudsters that permeate the internet.

If we continue to dispense so easily, to medicate without sound reason, then we are in effect digging our own graves. You cannot magic away the problems of two generations of poorly parented adults with a pill. You see doctor, your patients aren’t ill, they are just ill-prepared.

The post Drugs are Rapidly Becoming Healthcare’s Greatest Burden appeared first on Medika Life.

A key study of psychedelic-assisted psychotherapy for depressed cancer patients actually included no patients with major depression. Other details of the study have been grossly misrepresented in ways that should influence our assessment of the study’s importance.

Most guests had left what we knew would be John Weakland’s last birthday celebration. John was dying from ALS (Amyotrophic lateral sclerosis, Lou Gehrig’s disease).

His lifework as an originator of family and grief problem-focused therapy had already been honored at a special conference in New Orleans. Weeks before his death, John would complete an article about the future directions of family therapy.

At least on that night, complications from that horrible disease did not seem to dull his spirit or his intellect, although his speech was noticeably slurred.

For what would be our last night together, John shared his cache of Cuban cigars and Bas Armagnac with me. We did not say much, mostly just enjoying the clear cloudless night until we fell asleep on the swath of grassy land that he and his wife, artist Anna Wu, owned in Los Altos. She discretely monitored us from inside their house.

John did not ask permission to smoke the cigars from the physicians who had been at the party.

Possession of the cigars was illegal. I recall the cigars having been smuggled into the US and presented to John as a gift in New Orleans. Fortunately, John knew more about how to savor an expensive cigar than I did, else he might have died instantly with a first deep draw.

Although both of us had experience with psychedelics, we did not think to ingest psilocybin that night. If we had wanted to trip, we would not have asked one of the psychiatrists to bestow a diagnosis of adjustment disorder on us to make it legal.

Why can’t two consenting adults legally ingest a substance that evidence suggests is safer than cigar smoke or Armagnac, particularly when it is the last visit together? Or at any time?

If the campaign for psilocybin-assisted psychotherapy succeeds, it will allow psychiatrists to market an expensive package deal of a psychiatric diagnosis, a couple of capsules of psilocybin delivered in an elaborate ritual, with six months of spiritually-oriented support and therapy thrown in.

Research concerning the role of psychedelics in mental health treatment and its superb publicity campaign depends on millions of dollars raised by venture capitalists. In a podcast series hosted by American entrepreneur, investor, author, and podcaster Tim Ferriss, a stream of investor guests expresses a vision of the treatment being provided private spa treatment, as well as psychedelics being used with underperforming athletes and a route to better sex.

At New York University, the ritual involves administering the psychedelic out of a chalice while new age music is played in a candlelit room, intended to create an aura of mysticism.

Before dismissing my skeptical perspective, let’s take a look at one of the key earlier studies cited as the rationale of the recent clinical trial of psilocybin as an antidepressant. The study from NYU is presented as a trial with dramatic results that were obtained when treating depression in terminal cancer patients. None of the patients in that study met the criteria for major depression.

Orchestrating an unprecedented publicity campaign

The article one of two clinical trials of psilocybin with cancer patients that were published with ten commentaries. The other study was from the group at Johns Hopkins that produced the recent randomized trial of psilocybin for major depression in JAMA Psychiatry discussed in my last article. Powerful Placebo in a Psilocybin for Depression Study

Leading the series of commentaries on the study of psilocybin with cancer patients, David Nutt, Editor of Journal of Psychopharmacology remarked:

The honours list of the commentators reads like a ‘who’s who’ of American and European psychiatry and should reassure any waverers that this use of psilocybin is well within the accepted scope of modern psychiatry.

The Heffter Research Institute funded both studies and managed publicity for the special issue. The institute’s website boasted of altmetrics (big data) revealing that the media mentions of the special issue had received over a billion views. The theme of the publicity was a mishmash of claims about mystical experiences, wild speculation about specific areas of the brain that psilocybin affected, and the distinctive religion-without-religion spirituality musings of popular writer Sam Harris.

As part of the publicity campaign, the senior authors of the NYU and Hopkins studies lavishly praised their own work in a long article in Medscape:Psilocybin May Be a Psychiatry Game Changer

The new findings have “the potential to transform the care of cancer patients with psychological and existential distress, but beyond that, it potentially provides a completely new model in psychiatry of a medication that works rapidly as both an antidepressant and anxiolytic and has sustained benefit for months,” Stephen Ross, MD, director of Substance Abuse Services, Department of Psychiatry, New York University (NYU), Langone Medical Center, told Medscape Medical News.

And

Professor Roland Griffiths, of the departments of psychiatry and neuroscience who led the study at Johns Hopkins University school of medicine, said he did not expect the findings, which he described as remarkable. “I am bred as a skeptic. I was skeptical at the outset that this drug could produce long-lasting changes,” he said. These were people “facing the deepest existential questions that humans can encounter — what is the nature of life and death, the meaning of life.”

Delving into the details of the NYU study

The title of the article makes three claims:

(1) that anxiety and depression were being treated (2) that rapid and sustained symptom relief was achieved; and (3) that the cancer was life-threatening.

[How many titles of peer-reviewed articles in clinical oncology or psycho-oncology journals highlight that cancer is life-threatening?]

The 29 patients in the study consisted of 26 patients with adjustment disorder and three with a generalized anxiety disorder.

This study included a clinically mixed sample of ten patients with stage I or II cancer and 18 with stage III or IV cancer with a small representation of a broad range of cancer sites. Staging is not a good predictor of individual life expectancy, particularly in a mixed sample. Most patients still maintained some full or part-time employment or student status. Two died in the course of the study and follow-up period.

Most cancers could be characterized as “life-threatening” except for some skin cancers. The term is not particularly informative or precise in the context of a scientific paper, but the term does serve to dramatize the findings.

The trial is described as a double-blind, placebo-controlled, crossover trial with single-dose psilocybin or niacin (Vitamin B3), with both pills administered in the context of psychotherapy. Patients were randomized to get first either the psychedelic or the placebo pill. Patients then received the other pill in a crossover at seven weeks.

Before receiving the psychedelic or placebo pill in the first round, they were coached to expect a mystical experience.

Patients received 3 sessions of 6 hours total duration in which rapport was established, along with expectations for the drug experience ahead.

The therapist/facilitator/monitor was also present in the five-hour or so session in which the drug or placebo was given and then for 3 sessions of post-integration work. The sequence was repeated for the second administration of a capsule of whatever had not been given the first time. Next were 20 weeks of support and integration of the experience with the therapist who has accompanied the patient through the trial.

The authors claimed the psilocybin achieved ‘rapid and sustained relief of symptoms, but this must be understood in the context of 8 months of supportive psychotherapeutic treatment.

Critical commentary on the study

As a clinical trial. The study is described as “double-blinded,” indicating an intent to keep both the patients and the research team in the dark as to whether the patients had received psilocybin versus vitamin B3. Any mystery would only last until a half hour or so after the patient got the pill. At that point, a marked shift in the patient’s mood and perception alerted the patients and their facilitators to the patient had been given the psychedelic.

The study was no longer blinded a half-hour after the pill was administered and patients had no doubt to what condition they had been assigned.

The study is described as a randomized controlled trial (RCT). That should give confidence that results observed in the follow-up period were not simply due to the passage of time. But here is the catch. In a crossover design, patients get both drug and placebo, just at different times. Those patients who did not get the psilocybin the first time got it at seven weeks. From that point until the last follow-up 26 weeks later, all patients had ingested both psilocybin and the placebo. So, everybody had exposure to the drug and there was, therefore, no control for the passage of time. In that sense, the study was no longer an RCT in the crucial follow-up period in which the ‘sustained relief of symptoms’ is observed.

The study was no longer a randomized trial at long term follow up and the sustained relief of symptoms did not control for passage of time.

As a study of the treatment of patients with psychiatric diagnoses. Ninety percent of patients had a diagnosis of adjustment disorder, which meant that a psychiatric diagnosis had been ruled out for which an evidence-based treatment would have been indicated. Any depressive or anxious symptoms were subthreshold.

Clinicians, particularly non-psychiatrist physicians in cancer care, often prescribe an antidepressant to patients with subthreshold symptoms, but there is no evidence that an antidepressant would improve patient outcomes beyond placebo effects.

Adjustment disorders are administrative diagnoses usually made for documentation and billing purposes. Patients receive this diagnosis to justify clinicians taking some action administratively, but patients with such a diagnosis are a mixed group in terms of the source of any symptoms and the presumed mechanism by which the symptoms were produced.

Psychopharmacologists would not expect the patients with adjustment disorder to have any particular biological abnormality in common. So, the presumed action of a drug effective in treating major depression might not be observable in this population because of the lack of the biological abnormality that an antidepressant is theorized to address.

Conventional antidepressants are not happy pills. They do not make persons below a minimal threshold of depression happier than a placebo.

As a study of cancer patients. Responses to the diagnosis and treatment of cancer are quite varied, but cancer does not typically pose the mental health issues that the authors claimed in the peer-reviewed article and their statements to the media.

My team studied a waiting room sample of over 400 consecutive breast cancer patients at a comprehensive cancer center. We found a third scored in the distressed range on a screening instrument, virtually the same as in a primary care waiting room sample that we had also studied. There were few cases of PTSD, all patients with a history of being treated for major depression.

Most distress among cancer patients resolves in three to six months, typically without the patients obtaining formal mental health treatment. As in other studies, we found that approximately 10–14 percent of patients remained distressed at 6 months, despite receiving a variety of formal interventions. The same proportion of unresolved distress probably holds in other medical populations.

Persistent distress can have diverse causes, including current circumstances beyond cancer, conditions created by the treatment of cancer including being devasted financially, and pre-existing psychopathology.

There are crude, psychometrically unsound checklists for assessing the unmet needs associated with distress in cancer care. The items which are endorsed most vary across populations, but typically the most common are practical matters. A need for formal mental health treatment does not get a strong endorsement.

As a study of end-of-life-treatment. The peer-reviewed paper is vague about the nature of therapy and support provided except for noting it draws on a “number of manualized existentially oriented psychotherapies [that] have been developed to address…existential/spiritual issues.”

Dignity therapy is a particular brand of manualized existential therapy for the end of life. Unanticipated and fascinating results were found in a large RCT.

The multisite trial involved over 400 patients. The study compared this manualized psychotherapy delivered by psychiatrists and psychologists to a simple supportive discussion with someone who was not formally trained as a psychotherapist, such as a pastoral counselor, and to remaining in routine cancer care without additional intervention.

No differences were found among the three groups across two dozen outcome measures, including various measures of depressed mood, hopelessness, and despair, as well as psychological, existential, and spiritual distress.

One reason is a floor effect dictated by the low level of mental health symptoms with which patients entered the study. Their symptoms could not fall any lower. That finding alone should shake up some myths about mental health care at the end of life.

The condition treated by psychiatrists in terminally ill medical patients. All but two had an administrative diagnosis with subclinical symptoms. Outside a small group of psychiatrists and psychologists, I do not think there would be much agreement about the validity of a “cancer-related demoralization syndrome.” Or that is necessarily a clinical problem when patients give up at the end of life and desire a hastened death without seeking further hope, meaning, or purpose in prolonged life. At least not a problem that mental health professionals would be the most equipped to address.

A lot of prescriptive moral judgments are being made in this study about how people should live and die. These psychiatrists have a wealth of ideas about the good death which they apparently promote with great passion in the 8 months of support and drug-assisted psychotherapy. As Stanford David Spiegel indicates in the title to his commentary, the NYU research group believes that they are guiding cancer patients on the last trip.

Outside the trial. a lot of cancer patients face death with their own form of spirituality that has served them well over a lifetime. It is perhaps for good reason that so few Christians enrolled in the study.

Many Christians would rather slowly walk with Jesus on their last trip, not fly with these NYU psychiatrists.

That only a couple of Christians enrolled in the study probably avoided some clashes in theology and basic values.

On the other hand, there are people who very much want an experience with psilocybin that this research group advertises. They may have seen NYU’s normal volunteer study with psilocybin. In what sounds like a Trip Advisor review, the paper reports:

Thirty-three percent of the volunteers rated the psilocybin experience as being the single most spiritually significant experience of his or her life, with an additional 38% rating it to be among the top five most spiritually significant experiences.

Some may even think “Too bad I don’t have cancer.”

They would not have to meet the criteria for major depression. They would only need to impress a psychiatrist with subsyndromal symptoms. That could be easily done by a motivated person.

The nondepressed research participant would get to trip. The NYU researchers would get data points for claims about psilocybin as an antidepressant.

But how perverse is it, that psilocybin needs to be accessed through an RCT of a mental health treatment because it is needlessly kept as criminalized heroin?

For more details of the psychotherapy provided in this trial including patient testimonials see the NYU Alumni News.

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