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?

The post Is the New York Times a Shill for Promoters of Psychedelics? appeared first on Medika Life.