Many people do not inspect what is reported before forming an opinion or accepting someone else’s opinion. The actual results are certainly worth a look.

But I think we need to consider whether the authors even were asking the right clinical question.

By narrowly construing the trial as a test of the efficacy of MDMA for PTSD, the authors may have missed some limitations. The trial is NOT primarily being a drug trial, but more properly, a trial of a drug always being delivered in conjunction with a poorly specified and unproven psychotherapy.

I have some relevant background and expertise for forming an opinion about this.

I was involved in various stages of writing and reviewing grant proposals, applications for use of human subjects, and justifications for the burden that studies place on medical patients. I was a co-principal investigator on a center grant with the responsibility of developing and implementing psychosocial interventions combined with drugs. I served on the committee monitoring the progress of a major clinical multisite trial of treatment of depression to prevent heart attacks for safety and data quality. I was an external scientific advisor conducting process evaluations that might reveal what happened in trials for anomalous results.

I have never encountered anything at all like the psychotherapy manual for the Nature Medicine trial of MDMA for PTSD.

If you like, you can wade through the actual manual here, but it is very vague and demands of your time to get to crucial details. Or you can see how promoters describe the treatment in promotional material on their websites, including graphic videos.

I am a clinical health psychologist concerned with delivering the best treatment within the limits of scarce funding. That makes me a mental health services researcher. I am deeply concerned with the lack of assurance that the same psychotherapy was delivered across settings in the trial reported in Nature Medicine.

I could imagine making a bit of a fuss if I were on a committee to evaluate ahead of time whether a major clinical trial of MDMA, a drug that was illegal and otherwise unpatentable could depend on the validity of this treatment and whether it was faithfully delivered.

Basically, investors are asking for a monopoly because they will ensure the safety and efficacy of MDMA by embedding it in a package with their psychotherapy. They claim to be so convinced by a lack of evidence that MDMA is safe or effective outside of such a package. So much so that they will not bother to gather new evidence against the null hypothesis of MDMA being unsafe and ineffective for PTSD.

In the loose, informal atmosphere that occasionally develops in closed meetings, I could imagine my younger self reading juicy sections from the manual, and insisting on playing promotional videos to the committee from the 15 sites that were available to prospective participants during recruitment.

With some degree of mock seriousness, I might have asked whether different music might have elicited a different response from patients, whether the flowers and fake artifacts were necessary.

What if a patient did not welcome what was intended to be the soothing touch of a same or different gender person while under the influence of a disorienting drug and while possibly being stimulated to sexual arousal?

I could expect blowback and protests if I raised the last point. I would come prepared with documentation that sex with a patient had occurred in at least one MAPS trial and that the unlicensed counselor had pleaded, of course, that the sex was consensual.

This claim is outrageous without substantiation. I invite you to find it here. Psychedelic therapy has a sexual abuse problem

I doubt anyone involved in reviewing the data from the trial for the US Food and Drug Administration has ever seen such psychotherapy being proposed to accompany all marketing of a drug. I would love to hear the discussion the review will generate.

Claims that findings are groundbreaking, breakthrough, or otherwise extraordinary deserve more scrutiny and maybe even skeptics thinking longer and harder about what was going on in a study.

Many on social media assume that claims that have made it into a world-class medical journal no longer need to be vetted. They believe that they can take what is said about the psychotherapy in an article in an impressive journal with their critical tools to appraise the study being left in their toolbox.

I am not one of those people. I am hoping to convince some readers that they do not want to be that kind of person either. That is generally my goal in teaching and writing about clinical trials, but I think that the Nature Medicine article is a particularly good teachable moment. The authors and their backers are screaming so loudly and incessantly that there has never before been such a study.

I am getting some pushback to my skepticism about the trial, only some of which will be disclosed here. There has been an effort to stop the publication of my critiques and remove what I have published so far. If what I have written were patently stupid, I think that would be discovered soon or later and what I have published could be left published to embarrass me.

The threshold should be high for making an article disappear, rather than simply flagging with a statement of concern or retracting it.

I first probed a fawning New York Times article about the trial with improbable claims, obviously written with the collaboration of the Nature Medicine authors. I complained that the journalist should have protected readers by getting her own experts and by providing an independent critical appraisal.

Is the New York Times a Shill for Promoters of Psychedelics?
Evidence that the newspaper is not sufficiently detached from promoters to provide an open-minded but skeptical…medium.com

Next, I limited myself to a single sentence in the abstract of the Nature Medicine article. I wondered aloud why so few “experts” were speaking out about a reporting of this study that was so wrong in so many ways.

The MDMA-Assisted Therapy for PTSD Study: What You’ll Get Wrong
Seldom have so many experts had such strong opinions about an open-access drug trial they did not read carefully…medium.com

In the last installment, I focused on only the list of authors, the contributions that justified their getting authorship, and the authors’ affiliations. I concluded that there was good reason to treat the study not as strictly as a pharmacological trial but as a trial of psychotherapy in combination with either a drug or an inert pill-placebo. I proposed:

This reframing involves a very different set of criteria that could expose a different set of inadequacies in the trial of MDMA as a treatment for PTSD — such as the lack of standardization of the therapy across settings and therapists.

Surprises in the Authorship of a Paper About MDMA to Treat PTSD
Some of the 39 authors practice alternative medicine and unvalidated psychotherapies, with little research experience

I am pleased that my intuitions have generally been confirmed that there is something wrong going on with the way the study is being sold. Yet, I wince at some of the things I have written and mistakes that may have been made. Even if I have been wrong in some respects, I could be on to something. We could reach a consensus that the study is flawed, at least enough to temper the authors’ claim made in the abstract and echoed all over the world:

“We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.”

The authors and their sponsors are pushing for expedited review and approval by the US Food and Drug Administration. This was hastily done with intravenous infusion of ketamine, which — as I covered here — did not go so well.

One reader,Julian Willet, MD is unconvinced enough by what I have been writing to post a comment:

Nature Medicine is a well-respected journal and generally decently trusted (though naturally, some papers can get through the cracks). Perhaps that occurred, but I cannot say. I skimmed the paper and the results are significant/impactful, which would make it an attractive paper to publish even if there could be potential controversy.

I asked the opinion of an expert statistician who has consulted on trials of psychedelics and he replied:

*I have read the results section a few times since published (and compared) to protocol. I would say that generally it looks sound and I would guess they have a professional statistician in the team or use a consultant. That’s from what I can deduce from the paper.

His comment left me self-doubting and defensive. I went back to the Acknowledgment section of the article. I counted the number of therapists listed. I replied to him, “What if there are 40 therapists?”

Suffice to say, that reply changed his mind and got him doubting too.

Only as I sat down to write this article, did I realize the implications of what I had written to him.

The Nature Medicine article portrayed the clinical trial as evaluating whether MDMA was superior to an inert pill-placebo under tightly controlled conditions. It would be reassuring to know if the results did not vary across the clinics and providers, but we probably should not expect any surprises.

It is simple enough to standardize the providing of a pill and not expect much variation across sites and providers. Not so with psychotherapy that is so incompletely specified. I expect lots of variation in how the psychotherapy is implemented with which patient, with which therapist, in which setting.

The trial is initially blinded so that neither the clinician nor the patient knows whether the patient is assigned to get the MDMA or an inert substance in an identical capsule. The trial quickly becomes unblinded in the first half-hour of the first eight-hour session. There are three such sessions. I would be especially concerned with the improvisation that would occur once the patient and therapist knew whether the patient was getting the MDMA.

I do not have to prove my skepticism is correct. The burden is on the authors of the Nature Medicine article to prove me wrong. They are facing an evaluation by the FDA with a lot at stake.

Stay tuned and we will probe the Results section, aided by the lens I have developed in this article.

The post Before Looking at the Results of the Paper on MDMA to Treat PTSD… appeared first on Medika Life.

This author has built a reputation on his disdain for evidence-based psychotherapies. His books and workshops promote questionable psychotherapies with dubious mechanisms of mind-body interactions, backed up by dramatic anecdotes, not evidence.

Who could that be?

This revelation only encourages me to examine the trial more closely as an evaluation of psychotherapy combined with medication — not as primarily as a drug trial, as most everyone else has been doing.

This reframing involves a very different set of criteria that could expose a different set of inadequacies in the trial of MDMA as a treatment for PTSD — such as the lack of standardization of the therapy across settings and therapists.

Nature Medicine is among the most prestigious medical journals in the world. It seldom publishes clinical trials and never before has published a trial of a medication combined with psychotherapy.

I have already been discussing my concerns about this clinical trial in two Medium articles.

Is the New York Times a Shill for Promoters of Psychedelics? Evidence that the newspaper is not sufficiently detached from promoters to provide an open-minded but skeptical.

The MDMA-Assisted Therapy for PTSD Study: What You’ll Get Wrong. Seldom have so many experts had such strong opinions about an open-access drug trial they did not read carefully

The Nature Medicine article is available open access, meaning you can view it for free.

Mitchell, Jennifer M., et al. “MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.” Nature Medicine (2021): 1–9

Clicking on the link takes you to the article on the website, where you can also download a free PDF. However, if you just read the article on the website, the authors are listed like this:

Click on the […] at the website and it expands to the full list of 39 authors.

That number of authors in itself is mindboggling, especially when you consider that 39 is the number of patients assigned to pill placebo who completed the trial. That ratio of authors to patients in a clinical trial is extraordinary.

Check out the list of authors’ affiliations and their specific contributor statements available in the article that justified awarding authorship. You will find some real surprises.

I will touch on some of these details before ending with a bombshell revelation that changed my thinking about this study, raised my already high level of skepticism about it, and pointed me in some new directions in probing the study.

The 39 authors list 25 different affiliations, of which seven are academic medical settings with research capacity. Authors’ academic degrees are not listed in the article, but a Google search reveals few MDs and fewer psychiatrists. Only a few of the MDs list university medical affiliations.

Four authors list the same academic setting as their affiliation. One is the Ph.D. neuroscientist who is the first author. The other authors in that setting are the Ph.D. regulatory affairs coordinator and an internist and an assistant professor MD Ph.D. who is in residence at a nearby Veterans Administration Hospital.

Beyond the other six academic medical settings that are each listed by one author, there are some interesting affiliations.

The largest number of authors (12) are with the MAPS Public Benefit Corporation, San Jose, California. The for-profit corporation will manage sales for prescription MDMA when it is approved by the Food and Drug and Administration. For now, the corporation provides training for therapists as well as:

A team of wonderful night attendants who stay with study participants at the clinic during the required overnight stay following MDMA sessions. The night attendants continue the care and support of participants by delivering or preparing dinner and breakfast, setting up their sleeping arrangements, and remaining available throughout the night should participants need anything at all. During this time, the therapy team and study physician remain on call should there be any problems or concerns.

Most affiliations are for only one or two authors and seem to be private practice settings awaiting approval of psychedelics by the FDA. Their names are suggestive of particular kinds of mystical spa experiences: Zen Therapeutic Solutions, Fluence (defined as a mysterious, magical, or hypnotic power), Nautilus Sanctuary, Wholeness Center, and the San Francisco Insight and Integration Center.

Some of these settings currently — or will in the future — offer spa experiences for people without requiring a diagnosis of a psychiatric disorder. At Aguazul-Bluewater, Inc, one of the authors of the Nature Medicine article offers Rolfing Structural Integration sessions.

In the relaxed biographic sketches provided at their affiliations, a number of authors express the intention to use prescription MDMA not as a formal mental health treatment, but for wellness treatments administered in spa settings specializing in alternative medicine.

Some of the authors of the Nature Medicine articleespouse the use of psychedelics as a transformative experience conceived as an integration of mysticism and neuroscience that is decidedly outside the range of testable and disprovable scientific explanation.

Many of the authors are clinical psychologists who are not quantitative research scientists, but who instead dabble in impressionistic qualitative or mixed-method research related to psychedelics.

I did not see or endorsements of conventional, evidence-based therapies in any of the authors’ personal statements. I found abundant references to the view of personal change as a mystical or spiritual experience somehow involving neuroscience and the brain, but not really spelled out in conventional scientific terms.

It is safe to say that these clinical psychologists do not confine the psychotherapy they offer for PTSD to the manualized treatments with the strongest scientific support, exposure, and cognitive reprocessing therapy. That would be just too stifling and downright boring, especially given the exciting transformative experience that psychotherapy is supposed to provide.

What does it mean to be listed as an author on an article in a highly selective, prestigious medical journal like Nature Medicine?

It is generally understood that authorship on scientific papers requires an intellectual contribution to the conduct of research. In addition, an author must take responsibility for the final version of the paper that will appear in the journal.

I am “only” a clinical psychologist, and I do not have an M.D. Critics might say I am hypocritically pretending to be more scientific than these authors in calling for a more rigorous, i.e., medical approach to this treatment.

The Nature Medicine article presents the case that MDMA is an amazingly effective treatment for PTSD, yet also that it is potentially so dangerous and subject to abuse that it must remain a prescription-only drug delivered under the supervision of a physician.

MDMA has been around for a while and cannot be patented. The Nature Medicine clinical trial tests a packaged delivery system in which the drug augments or facilitates psychotherapy that is said to dramatically reduce the suffering and burden of PTSD.

No one is claiming that taking MDMA by itself is effective in treating PTSD. There is ample evidence to the contrary. So, what is the nature of the psychotherapy that is presumed to allow MDMA to achieve its therapeutic effect?

The psychotherapy offered in this trial is not presumed to be effective in treating PTSD by itself, without MDMA. There is no prior evidence that the particular psychotherapy administered as part of this trial as effective for any clinical problem in any situation.

Although it has been given little attention in the enormous press coverage that has been given to the trial reported in the Nature Medicine paper, a lot depends on the credibility of the psychotherapy provided in the trial. At stake are hundreds of millions of dollars already invested in what is expected to be the multibillion-dollar business of marketing prescription psychedelics plus psychotherapy in a package ensuring their safety and effectiveness as mental health treatment and pleasurable spa experiences.

If MDMA is not patentable, why not patent the package of the drug plus less expensive psychotherapy with greater evidence of efficacy as a mental health treatment, like a modified version of exposure therapy?

Enter the mastermind behind the psychotherapy being offered in this trial

The intellectual responsibility for this parrticular psychotherapy as it is described in the Nature Medicine article largely depends on the nineteenth author, psychiatrist Bessel van der Kolk.

According to the author-contribution statement, Bessel can de Kolk (KvdK) has unrivaled contributions to the article.

BvdK was among the four authors having full access to all of the data in the study and taking responsibility for the integrity of the data and the accuracy of the data analysis. Other contributions attributed to him include the basic design of the study. He was among the authors who collected the data and carried out sponsor oversight of data collection. He was part of the group that carried out statistical analysis and interpretation of data.

He was among the four authors who drafted the original paper. He was a member of the larger group critically revising the paper for important intellectual content.

The two contributions not listed for BvdK are obtaining funding and carrying out supervision and training.

Outside of this trial, BvdK has an enormous following among credentialed and non-credentialed therapists and counselors, as well as a substantial proportion of laypersons who believe their lives have been impacted in a profound way by adversity and trauma. He has sold millions of copies of popular books worldwide, his workshops draw large crowds, and his videos get huge traffic on YouTube.

Yet, many research-oriented mental health professionals consider BvdK a popularizer, not a research-oriented clinician-scientist. Many of us experience enormous frustration with his talks and writing. He promises too much from unproven psychotherapies. Lasting change does not necessarily come with such theatrics as he suggests.

BvdK denigrates scientific evidence and well-established evidence-based therapies. At the same time, he presents unproven somatic therapies and discredited therapies such as tapping and emotional freedom techniques in vivid anecdotes in which miraculous results never fail to be achieved in dramatic, sudden moments of therapist intervention.

BvdK’s best-selling books, like The Body Has its Reasons, present discredited theories like Polyvagal Theory and Mirror Neuron Theory in simplistic terms. Rebuttal and refutation by experts would require long technical explanations that would bore lay audiences to tears and put them to sleep.

Not everyone would agree with me, and certainly not even all evidence-based clinician-researchers. Yet, I think I could muster a considerable consensus that BvdK’s depictions are not to be trusted of the research status of psychotherapies and the scientific status of their presumed basic mechanisms of change.

Such skepticism is just a useful starting point. We might have to revise our opinion with a closer look at the Nature Medicine article, its supplementary materials, and the enormous publicity its authors have so skillfully orchestrated.

Regardless, there are big questions:

How can a drug which is ineffective when simply taken by itself be combined with a psychotherapy without evidence of effectiveness as a standalone treatment to yield results in the treatment of PTSD that have never before been seen?

And

What if the FDA approval of the marketing of the previously illegal street drug Ecstasy as a treatment for PTSD is restricted excuslively to the drug being delivered with a psychotherapy that was developed under the supervision of Bessel van der Kolk?

That would be very strange, but there is a lot of startup funding betting on that possibility. The Franchising of specialty clinics has already begun.

We will have to see how FDA grapples with whether to tie the marketing of a drug to a specific psychotherapy — or is open to continued experimentation with other packages, breaking the monoply of MAPS.

The post Surprises in the Authorship of a Paper About MDMA to Treat PTSD 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.

Newspapers are a key venue for the promoters to make their case to convert laypersons into consumers in what is projected to be a multibillion-dollar industry.

Should newspapers take on this function to signal that their brand is more avante garde than their stodgy competitors? Or is it newspapers’ job to filter the information they are given and take a critical stance in order to protect their readers?

Arecent article is one of a number in the New York Times covering what is claimed to a breakthrough in the acceptance and use of previously illegal drugs.

Click on this link to the article, preferably on a desktop computer to get the full effect.

A Psychedelic Drug Passes a Big Test for PTSD Treatment. A new study shows that MDMA, known as Ecstasy or Molly, can bring relief when paired with talk therapy to those with…www.nytimes.com

You will see the opening of the article displayed as a bold split-screen ribbon that takes over your entire screen display. One blackened side with white font announces the psychedelic drug MDMA has passed a “big test” as a treatment for PTSD.

The other side is a slick photo that has been shot at an upward angle that might be used for the trailer of a Netflix movie being released next week. A caption indicates that the buff traditional male was a patient in the PTSD clinical trial, not a paid actor.

He is quoted as describing the effects of the drug: “Literally I’m a different person.”

Many readers will relax and be entertained by the article. The article is from the Health section of the NY Times. It might fit better in the Leisure or Entertainment sections.

Some readers might be seeking something other than entertainment and might feel cheated.

Once upon a time, I recommended the NY Times as a trustworthy, authoritative go-to place for intelligent laypersons without the skills, time, or resources to evaluate scientific and medical claims for themselves that might impinge on their well-being or wallet. I stopped when I repeatedly saw prominent journalists publishing fawning reports of the products being offered by positive psychology TED talkers and other wellness wannabe advice gurus.

The NY Times journalists were acting like publicists and were not appropriately critical interpreters of what the gurus were trying to sell us.

Let’s analyze this article and see if we should similarly be skeptical about the promotion of psychedelic drugs in the NY Times, but let’s keep the task simple.

We will give a lot of attention to four large, high-quality staged photos.

These photos represent four of the seven named sources who are quoted. I will comment on how the seven are quoted. I will briefly bring in my other reactions.

I am encouraging readers to be skeptical about what is conveyed in the article if they are making any decisions about their health and wellbeing or for what readers should tell others, as on social media.

Scroll below the banner introducing the and you find it the article is about a peer-reviewed report in one of the most prestigious scientific journals, Nature. However, no link is provided to the paper because it is not yet published. We will have to rely on what the journalist tells us about what is in the paper, assisted by the sources she brings into the article.

Some readers might cry foul at this point. They believe that newspaper articles should provide a link to important papers being discussed so that motivated, sophisticated readers can check what is being said in the newspaper.

Savvy readers might even note that scientific journals often protect their own reputation and the lay public from misleading statements in newspapers by placing an embargo on newspaper accounts until the scientific article is published.

Let’s proceed anyway, and decide whether it is a good idea to rely on the NYT article by itself.

The NYT article introduces its Source #1, a neuroscientist at Johns Hopkins University. He gushes that he is “excited as he gets” about a clinical trial and that this trial is like no other.

The journalist assures the readers that Source #1 is credible because he was not an author of the forthcoming Nature report of the trial.

It does not take much of a Google search to find that Johns Hopkins University is the recipient of millions of dollars from foundations like the one that funded the study. You can also search and find an article where I marveled at the capability of Johns Hopkins University to mount a publicity campaign for papers reporting research on psychedelics.

After some more praise of the research, the NYT journalist brings in the first author of the study as Source #2. Describes as a neuroscientist, she informs us of her delight that now is the first time in 50 years that people are willing to consider psychedelics as medical treatments.

This statement is followed by a large photo of Source #2 that is attributed to the NYT, again dominating an entire desktop display of the article. She is dressed in black and wears a floral kerchief that matches a jungle-like backdrop of lots of probably artificial flowers. The photo is striking, but ambiguous in its message. Certainly, the NYT and the author are opting out of portraying the author as a whitecoat investigator of medications.

Next, readers are introduced to Source #3 who is described as an emeritus professor and the former chair of psychiatry at a prestigious medical school. He complains that:

“All new treatments in medicine have always had a temporary halo effect by being new and by promising more than they can deliver.”

That is the signature statement that this particular expert offers all the time in social media. He is known to be critical of overdiagnosis and overmedication of mental health problems. We cannot be sure how this quote came about. There is no indication that the journalist provided him with a copy of the embargoed article by or invited him to make further comment, as would be customary.

The NYT article has at least provided its obligatory dissenting voice before returning to comments of Source #1the first author of the study. She explains that the study was not an evaluation of a drug but a treatment package in which the drug is combined with psychotherapy. She theorizes that the combination allows “the brain to process painful memories and heal itself.”

This explanation is elaborated and amplified by Source #4, the senior (last) author of the paper. He hints the therapy is intensive and demanding and indicates that the patient must be motivated to work on their traumatic experiences to benefit.

The therapy starts before the patient is given the medication or the placebo to prepare the patient for the experience if they are provided the medication, rather than the placebo, Patients are told to expect from the medication, they will quickly know which condition they have been assigned.

Source #4 acknowledges that participants and clinicians should be blinded to the condition the patient is assigned throughout the trial and the final assessment of outcome. This is so the results can be considered unbiased and valid in the Food and Drug Administration approval process. Source #4 dismisses objections that patients quickly becoming unblinded in this study, by simply saying that this is not a problem.

Newspaper accounts routinely quote senior authors about the purpose and results of the clinical trial that they have overseen. Experienced journalists expect senior authors to be boastful and self-congratulatory and may protect readers by challenging the senior author directly or introducing a dissenting expert. However, Source #4 is also the founder of the funding source for the trial and he has raised over $100 million in two years to promote acceptance of the use of psychedelics as medical treatments and in spa treatments.

Normally, representatives of funding sources are not included as authors on papers reporting clinical trials. Instead, the articles acknowledge who funded the trial, but declare that the funding source had no say in the analysis and interpretation of data.

This is not a typical clinical trial and the NYT including commentary from a funding source is not normal.

It is not reassuring that the funding source is a nonprofit corporation, any more than it is reassuring that other sources who are cited are described as not involved in the conduct of the study when their institutions also receive substantial money from similar foundations.

Source #5 is identified as the patient in the study who was introduced in the first banner display that opened the NYT article. He describes the vivid nightmares that dominated his life before the study and how nothing he tried could free him from them. His life was in ruins.

Then, Source #5 described the treatment sessions he received in the trial:

During his first of three sessions in early 2019, lying on a couch with eyeshades, and in a lucid dreamlike state, Mr. Ostrom encountered a spinning, oily black ball. Like an onion, the ball had many layers, each one a memory. At the center, Mr. Ostrom relived the moment in Iraq, he said, that “I became the person I needed to be to survive that combat deployment.” Over the next two sessions, Mr. Ostrom engaged with “the bully,” as he calls his PTSD alter ego, and asked permission for Scott to return.

Source #5 describes how he is now gainfully employed and owns a house, that he shares with a girlfriend and a service dog named Tim.

Readers do not have a basis for disputing Source #5’s personal account of his lived experience of suffering and miraculous cure. Many readers will find it an inspiring story, maybe even suitable for re-telling in a Netflix film.

But skeptics can point out that such vivid, retrospective subjective experiences are not retrieved from their storage as accurate accounts of what happened. Memories are shaped by retelling and suggestions from the later environment. Source #5’s subjective experiences are not generalizable facts, in the sense that we can expect to hear from other persons who suffer from PTSD. Unless we cast aside all skepticism, we cannot accept his accounts as validating the theoretical accounts that proponents of psychedelic treatment want us to believe. After all, the therapists in the study prepared patients to expect certain experiences and coached their interpretations of their experience while under the influence of the drug.

This account is immediately followed by a full-screen photo of the earlier Source #4, the enterprising senior author and creator of the foundation that raised millions for this ambitious initiative.

Let’s put that aside and focus on what the photo conveys.

I see what could be a rented attic apartment. It must be a cheap place, because the wall is stained, perhaps by a serious leak in the roof. There is an air conditioner that is crammed into the window and an inexpensive ventilation fan. The room is quite messy and could use a good cleaning. The man is sitting cross-legged on the floor and vaguely smiling. He is either entertained by what is watching on a vintage TV or oblivious because of his altered state of consciousness.

I do not know what to make of this, except that is a sharp contrast to the portrayal of the first author in her junglelike background and this man as the head of a flourishing nonprofit foundation.

Some seemingly factual information about the history of MDMA follows, interrupted by a cockamamie theoretical orientation of how MDMA-assisted therapy works that cites a mouse study as evidence:

Its primary therapeutic effect may come from its seeming ability to reopen what neuroscientists refer to as a “critical period,” the window during childhood when the brain has the superior ability to make new memories and store them.

Maybe, but who can know? My skepticism is getting the best of me. Anyway, we may be reaching a saturation point in not being able to learn anything new from further exploration of the photos and sources selected for the article.

I should leave readers on their own to form judgments on their own about Source #6, except that I will point out that he is a junior qualitative researcher at Hopkins, of course not an author of the study. I don’t know how he has the expertise to declare that

The findings ‘make a clear case for medical approval,” something that “represents a sea change that could revolutionize health care.’”

I can’t help commenting on Source #7, a patient who says the MDMA-assisted therapy allowed him:

To revisit his traumatic memory through the eyes of his 4-year-old self, unclouded by stigmas, adult interpretations, or heavy emotion.

“This allowed me to accept myself and recognize who I am,” he said.

The final of the four photos depicts Source #7 in a magical forest of tall trees and no underbrush, looking skyward. Perhaps he has found his Own Private Idaho.

“My Own Private Idaho” is an imaginary place where one is locked in the arms of love — that is, both protected and free. It is the promise of America, chronically out of joint with reality, especially for its most vulnerable inhabitants.

The NY Times invested a lot in producing this article so slickly. I am sure the promoters of psychedelics were pleased with what their collaboration and granting of access to patients accomplished. Maybe readers were entertained, but what did they learn?

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