This research paper is a very confusing read, even for someone who is quite familiar with this kind of research. Yet what is said in the paper is crucial to the case being made by Jean Twenge (and Jon Haidt) that government intervention is urgently needed to curb the harms of social media to the mental health of teens. I’ll use the abstract of the paper to discuss how to find flaws in a research study that is intended to influence public health policy.

Parents and school teachers and administrators cannot be expected to interpret original research studies on their own. But they might learn from discussions like this one to be more skeptical of experts who claim their advice is based on social science, but who make emotional appeals and rely on anecdotes to rouse their readership into action.

The ratio of emotional story-telling to actual scientific evidence is very high in stories in the popular press expressing alarm about the damaging effects of teen girls’ use of social media on their mental health.

There is an excess of hype and drama about this topic, even in op-eds in the New York Times. When in doubt, be skeptical of social scientists who try too hard to convince you that they are correct and that other experts have just not noticed something that is obvious to them.

In a widely discussed article, Jean Twenge says that she has been studying generational trends in mental health for over 25 years and that she never before found such a dramatic change in mental health as she saw around 2012.

Have Smartphones Destroyed a Generation? More comfortable online than out partying, post-Millennials are safer, physically, than adolescents have ever been.

Around 2012, I noticed abrupt shifts in teen behaviors and emotional states. The gentle slopes of the line graphs became steep mountains and sheer cliffs, and many of the distinctive characteristics of the Millennial generation began to disappear. In all my analyses of generational data — some reaching back to the 1930s — I had never seen anything like it.

Twenge has advice for parents and teachers:

If you were going to give advice for a happy adolescence based on this survey, it would be straightforward: Put down the phone, turn off the laptop, and do something — anything — that does not involve a screen.

Twenge commands special authority because her views are said to be derived from the best available evidence.

However, most of the key research that Twenge and her fellow advocate Jonathan Haidt cite was not conducted by either of them. I suspect that many of the authors of these studies they cite would disagree with Twenge and Haidt’s interpretation of their work, some vigorously so. That situation makes one centerpiece study led that was led by Twenge particularly important.

The key research article by Twenge and her colleagues is here.

Increases in Depressive Symptoms, Suicide-Related Outcomes, and Suicide Rates Among U.S…In two nationally representative surveys of U.S. adolescents in grades 8 through 12 ( N = 506,820) and national..

The article is unfortunately paywalled, but here is its abstract. We can do a lot with it.

In two nationally representative surveys of U.S. adolescents in grades 8 through 12 (N = 506,820) and national statistics on suicide deaths for those ages 13 to 18, adolescents’ depressive symptoms, suicide-related outcomes, and suicide rates increased between 2010 and 2015, especially among females. Adolescents who spent more time on new media (including social media and electronic devices such as smartphones) were more likely to report mental health issues, and adolescents who spent more time on nonscreen activities (in-person social interaction, sports/exercise, homework, print media, and attending religious services) were less likely. Since 2010, iGen adolescents have spent more time on new media screen activities and less time on nonscreen activities, which may account for the increases in depression and suicide. In contrast, cyclical economic factors such as unemployment and the Dow Jones Index were not linked to depressive symptoms or suicide rates when matched by year.

The editors at a top psychology journal, Clinical Psychological Science, and the reviewers the editors picked were obviously impressed enough to recommend the article and its abstract be published in the form that we now see.

I noticed lots of things that made me suspicious because I have higher standards for talking about risks to health than most psychologists do.

• I received excellent training in my Ph.D. studies as a research-oriented clinical psychologist. I received my doctorate in 1975 but then began working in situations where medical scientists and public health officials demanded stricter standards than what was required of psychologists trying to get published in a respectable psychology journal. Lives depended on what a different kind of expert decided about risks from the often limited and flawed data that was available to them.

The COVID pandemic and the quick decisions that had to be made about what advice could be given concerning vaccination, social distancing and lockdowns put this kind of expertise on display. The world-class experts giving briefings on the best of cable news were good at policing each other to avoid exaggerating what was known and to admit they did not know. “We don’t know yet” was often the best answer, as frustrating as it was.

For a start, I expect more information from an abstract than this one provided. The authors did not follow standard advice on what to include in an abstract. I’ll have a future story documenting how abstracts attached to paywalled articles like the one we are discussing here can actually kill people, aside from spreading misconceptions.

Rather than doing their own research to collect new data, these authors relied on existing survey data sets collected for other purposes. This leaves lots of questions about they did this that the authors do not address in a transparent way.

How did the authors integrate this data from different sources in one study? Relying on someone else’s data is attractive and may at first seem expedient, but effectively and validly doing requires a lot of difficult decision-making.

Inevitably, the original researchers did not ask the right survey questions for new research. What questions in the surveys best fit the new issues researchers wanted to address? How could the new researchers verify that their selection from already collected data was most valid and relevant to their issues?

Twenge and her co-authors imply in the abstract that they had been able somehow to integrate the survey questions with information from the national statistics on deaths by suicide. I knew that was bunk. Ethics committees overseeing the protection of human subjects insist the data be anonymized so that identification and matching of people across data sets becomes virtually impossible.

Then, there is the problem of the small number of suicides in this relatively low-risk group. Let’s stop here and apply some numbers I revealed last time.

Any potential risk factors the authors can find in these pre-existing survey questions must pass the test of predicting relatively infrequent events with some percision. The abstract suggests the authors may have succeeded (“which may account for the increases in depression and suicide), but that would be statistically improbable, given the basic rate of death by suicide and any conceivable fluctuation in the study period of this article.

For 2017, we have about 420 suicides to explain among 20.5 million girls. I wish the authors luck in using whatever fancy statistics they can muster to predict which girls will die by suicide with the risk factors they can pull from other people’s data. Chances are no one died by suicide or only a chance handful from participants in the survey data they acquired. Neither Twenge and her co-authors or readers can tell.

Not being able to identify which of the teens completing the survey died by suicide means the authors will be left making speculative statements beyond what their data allow.

The authors used the term “iGen adolescents” in the abstract to describe the teens they studied. That fits with Jean Twente’s best-selling books, but I was skeptical about such a sweeping term being able to capture much of the similarities and differences in an increasingly diverse and divided America in the association of use of social media and mental health.

Was any similarity of teens falling in this age range more important than the vast range of differences? Consider one white teen having alcoholics or Trump supporters for parents versus another teen having teetotaler Hindu parents who insisted that their teen study hard enough to go to medical school and become a physician? White teens with two Ivy League faculty as parents versus a Black teen raised by a single grandmother who dropped out of high school and does not have internet? Versus a Black teen raised by a single grandmother who dropped out of high school, but the great of the story is the teen’s mother was an innocent victim of random gun violence and the grandmother insists the teen fulfill the mother’s dream and go to college, no excuses accepted?

I could generate thousands of these kinds of contrasts, and some would be quite absurd.

The final conclusion where I seem to be headed is that a generational label like iGen or Generation Z cannot capture much of variations among teens — or across an individual teen’s transition into adulthood and afterward.

“iGen” [Don’t you like the cool choice of labels so that you automatically think of having “iPhones” as what 25 million American teen girls have in common?] might serve to highlight some things teens that might be missed that teens have in common. Surely it misses a lot of things teens don’t have in common, whether they are from radically different backgrounds or with nearly identical demographics but just different in the place of social media in their lives.

The authors end their abstract with straight-faced reassurance that they controlled for “cyclical economic factors such as unemployment and the Dow Jones Index,” matched by year. I can just imagine some badass experts at conferences I have attended who would lie in wait for a speaker to say such a silly thing.

Academics who think their research saves lives can be real a*holes when dealing with other academics whose research they think will never save any lives.

Imagine the response of experts accustomed to identifying health risks from correlations found in survey or surveillance data. Unprepared for what they would hear, some would have spilled coffee on their fancy suits and chocked on the stale Danish from the free conference breakfast as they scrambled to correct the speaker, not allowing anyone to discuss what else the presenter had to say.

I can imagine the string of cliched criticism that could be unleashed.

“Of course, you know that correlation does not equal causality.”

“You can’t do magic with statical controls of correlations when all you have is somebody else’s survey data they collected for some other purposes.”

“What a dumb choice! Are you a psychologist who does not understand regression analysis or do you have books to sell at the conference? Will your next slide tell us where to find your Tedtalk?

Maybe the badass expert would be in an uncharacteristically charitable mood and simply explain:

“I appreciate your effort to find support for a hypothesis that excites you.You should realize that you are relying on statistical controls to settle some issues of causality that are not readily solved. If you were to rely on such controls, you are first making the assumption that you have isolated all the variables that could possibly explain away your findings. I don’t think these crude economic indicators begin to do that. Secondly, you are assuming that these variables are measured without error. I don’t think an economist would say these two variables perfectly measure year to year differences in the economy affecting either teen’s use of social media or dying by suicide.”

One final cynical a*hole comment before we move on —

“If we had used your approach to statistical analysis, we would have concluded at the early days of mystery in the HIV/AIDS epidemic that someone using poppers to enhance orgasm during casual sex or simply having too many Judy Garland LPs in their vinyl collection was a modifiable risk factor.”

Frightened and humiliated, the psychologist trying to finish their talk would miss a very serious and useful message that was being disguised here.

Not knowing what you are doing with bad data and a computer program can lead to all kinds of compelling, but spurious correlations to get worked up about, some more plausible for a while than the modifiable risk factor you are listening for in very noisy data.

So, just what did Twenge and colleagues do with “two nationally representative surveys of U.S. adolescents in grades 8 through 12 (N = 506,820) and national statistics on suicide deaths for those ages 13 to 18, adolescents’ depressive symptoms, suicide-related outcomes, and suicide rates increased between 2010 and 2015?”

That is a true mystery that is never clarified in this abstract. I was stumped at first. I gave the authors the benefit of a doubt and thought maybe they did some kind of prospective analysis, looking ahead and predicting later things that happened to individuals from their earlier responses on surveys.

I had to get a copy of the paywalled article. The overall design of the study was still difficult to decipher from the methods section, where it should have been laid out in detail and given a name, like case-control or cohort study.

I eventually figured out that the authors did not have two “nationally representative surveys of U.S. adolescents.” They had over two dozen cross-sectional retrospective studies (a one-time survey asking about the past year) with nonoverlapping samples and important differences in the questions that were asked. No questions at all about social media in the survey for some years (!).

This dog’s breakfast of a design for this study will be the topic of my next article about this study, as we dig deeper into what can reasonably be claimed from this study and what cannot — if we stick to principles of best science, not just good story-telling.

The post A Stunningly Bad Study Claims Social Media Devastates Teen Girls’ Mental Health appeared first on Medika Life.

I chose to discuss Why We Get Sick, a lecture Maté delivered in London because it puts Maté’s ideas on full display.

The complete video of the lecture was uploaded in August 2019 by How To Academy Mindset. The video is part of a series that includes Jordan Peterson and Bessel van der Kolk. On Google, the YouTube video is re-titled Dr. Gabor Maté on The Connection Between Stress and Disease.

Struggling to get through this video, my mind wandered to thoughts of how lucky I would have been to be in London, maybe at the same theatre, when a true Canadian gift to the world, Leonard Cohen performed the concert captured in the Live in London 2-CD set.

Like Maté, Cohen is a member of the Order of Canada, the highest honor the Crown gives to a civilian. Both must somehow exemplify the order’s Latin motto, desiderantes meliorem patriam, meaning “they desire a better country.

”Live in London (Leonard Cohen album) – WikipediaLive in London is a (double) live album

After a few minutes, I could not stand watching Gabor Maté piling bonkers claims on bonkers claims anymore. It was just too painful to endure the stream of nonsense he was spouting, but I felt it was my duty.

I had taken the challenge of exploring and explaining the hidden-trauma/polyvagal theory/psychedelic psychotherapy nexus of nonsense. . I needed to provide a report of an investigation in progress.

Taking a break, I sought relief in listening to The Future, my favorite song in Cohen’s 2-CD set.

My wife is grateful that I have noise-suppressing headphones that keep my noise out of her ears. She finds Leonard Cohen’s music depressing. She is not a music snob, having played a variety of instruments in rock and country-western bands. She is just more susceptible to the mood contagion from music and language than I am.

I can’t explain to her why I find Cohen’s apocalyptic, dystopic vision in The Future an antidote for Maté, who has a similar vision. I guess Cohen is entertaining and does not tempt me to argue with his “Truth” delivered in well-crafted songs with brilliant lyrics.

Maté offends me by preaching a “Truth” with a call to action.

Maté urges us to abandon what has evolved over time to be evidence-based solutions to health and social problems. We should get involved in long-term, perhaps interminable therapy to exorcise the demons of trauma hidden in our subconscious.

There is no evidence that this prescription would improve our health or extend our life, but Maté claims we would be living more authentically.

The large, well-dressed crowd packing the London theatre enthusiastically cheered as if Gabor Maté were a rock star when the emcee announced:

I am honored and thrilled to introduce you tonight to the renowned physician Dr. Gabor Maté, one of the world’s leading experts in trauma, child development, addiction, and the relationship between stress and disease, please give him a huge welcome.

I am not embarrassed to admit I did not know that Dr. Maté was an expert of such eminence. I looked up his name in the usual places where such eminence should be documented, like Google Scholar. I could find insufficient evidence that he deserves such accolades.

A lot of people are convinced otherwise. They listen intently and find validation in the wild things that he says. I thought it was worthwhile to probe a bit of stuff he said in this lecture.

Maté comes to the podium, looking distinguished, but a bit haggard and world-weary. At first, his eyes are nearly closed. He squints and discloses that he has 55 minutes to lecture. He announces the topic:

We’re looking at two questions, basically one is what is disease, number one, and number two, how do we understand the human beings’ relationship to illness, which really comes through the heart of what is humanity really now.

Whoa, drag me into shallow waters before I go too deep. I do not think you will lend me enough of your attention to answer these questions, nor do I feel up to it.

I admit I was tempted to pounce on this next statement:

Western medicine in which I was trained sees illness or the whole person is somehow a random victim of either genetics or external invaders such as bacteria or virus or toxins or possibly as even a culpable instigator of their own pathology by certain so-called lifestyle choices like eating too much drinking too much or smoking

I developed acute genre confusion. I could not decide whether Maté was making a falsifiable scientific claim, trying to practice philosophy with only a degree in medicine, or reciting bad poetry.

I regained my confidence in my ability to discuss Maté when he said soon thereafter:

Let me just give you three medical facts here and you’ll see immediately how inadequate and insufficient the Western medical perspective is in explaining these facts…

The first fact there is a study that was done in the United States last year that shows that the more episodes of racism an American black woman experiences, the greater the risk for asthma.

Let me give another fact. In the 1930s and 40s the gender ratio of multiple sclerosis — which is an inflammatory degenerative disease of the nervous system — was 1:1. In other words for every man, there was a woman diagnosed. You know what the ratio now is? it’s three and a half women to every man. That immediately tells us it can’t be genetic because the genes don’t change in a population over seven decades or even ten decades or longer.

Number two, it can’t be diet because that doesn’t change for a population. It didn’t change more for women than for men. Nor can it be the climate. There is something going on and whatever it is it can’t just be biological now.

What’s interesting is that when you look at how you treat asthma. If you give to open up the airways and to suppress inflammation that happens in the asthmatic airway you give inhalers or medications by mouth, which are copies of adrenalin and cortisol.

Adrenaline and cortisol are stress hormones of the body. I’ll talk about them later. They’re secreted by the adrenal gland in response to a threat so there’s a drone and cortisol. So, we’re treating asthma with stress hormones. How do we treat multiple sclerosis?

Where this is headed is Maté will explain that everything we don’t understand about health and disease, everything that is inadequate in Western medicine is a matter of ignoring the role of stress and hidden trauma in causing illness and death. Shortly into the lecture, we will un into an impenetrable fog of pseudoscience and nonsequiturs. I will get off the train before the inevitable wreck ahead.

I found the article to which Maté was referring to his comment about asthma in black women.

Coogan PF, Yu J, O’Connor GT, Brown TA, Cozier YC, Palmer JR, Rosenberg L. Experiences of racism and the incidence of adult-onset asthma in the Black Women’s Health Study. Chest. 2014 Mar 1;145(3):480–5.

Experiences of Racism and the Incidence of Adult-Onset Asthma in the Black Women’s Health StudyChronic stress resulting from experiences of racism may increase the incidence of adult-onset asthma through effects on…www.sciencedirect.com

The authors hypothesized

Chronic stress resulting from experiences of racism may increase the incidence of adult-onset asthma through effects on the immune system and the airways.

We conducted prospective analyses of the relation of experiences of racism with asthma incidence in the Black Women’s Health Study, a prospective cohort of black women in the United States followed since 1995 with mailed biennial questionnaires.

The authors used a large data set that had been collected without their specific hypothesis in mind. They had to improvise in reducing and analyzing the data.

An everyday racism score was created based on five questions asked in 1997 and 2009 about the frequency in daily life of experiences of racism (eg, poor service in stores), and a lifetime racism score was based on questions about racism on the job, in housing, and by police. We used Cox regression models to derive multivariable incidence rate ratios (IRRs) and 95% CIs for categories of each racism score in relation to incident asthma.

*The IRRs were 1.45 (95% CI, 1.19–1.78) for the highest compared with the lowest quartile of the 1997 everyday racism score (P for trend <.0001) and 1.44 (95% CI, 1.18–1.75) for the highest compared with the lowest category of 1997 lifetime racism. Among women who reported the same levels of racism in 1997 and 2009, the IRRs for the highest categories of everyday and lifetime racism were 2.12 (95% CI, 1.55–2.91) and 1.66 (95% CI, 1.20–2.30), respectively.\

*Given the high prevalence of experiences of racism and asthma in black women in the United States, a positive association between racism and asthma is of public health importance.

There is no surprise in these results. I do not think that anyone having the expertise to interpret these results would find cause to lose their faith in Western medicine.

The authors discarded the middle half of their sample, based on subjects’ scores on everyday racism. That is not a terrible decision, but the strategy inevitably exaggerates the size of the effect that will be reported. I prefer analyses that do not involve throwing away half the data.

If we are looking for determining effect sizes of noteworthy public health significance, I think a reasonable rule of thumb is IRR = 2.5. If we are going to ramp up and demand intervention, the consensus is IRR = 4.0. We can quibble about these somewhat arbitrary cutoffs, but I think experts would still agree that the effect size found in this study is not impressive.

These are correlational data, so we have to be careful about making causal interpretations. We have to acknowledge that we have a crappy self-report measure constructed after the authors obtained this data set. We have to contend with an incomplete specification of variables that need to be statistically controlled and crude measurement. These are standard critiques of such studies.

I would say at least as it is measured in this study “everyday racism” is not causal, but a risk marker related to other risk factors that might be suitable for intervention. I would say that modifiable risk factors were exposure to dust mites, asbestos, cigarette smoke, and poor air quality in cramped, inadequately ventilated living spaces. I would add poor access to quality medical care, specifically inadequately managed respiratory infections and lack of insurance.

I have some experience with this population. I collaborated with Dr. Jen Culane on the Philadelphia Preterm Birth Prevention Project and wasthe Principal Investigator in my own NIMH study of socially disadvantaged inner-city postpartum women in Philadelphia, mostly black.

As the authors of this study, I am convinced without ever seeing their results, that both racism and high rates of incidence (onset) of asthma are serious problems. Subtle and blatant racist acts against black women are highly prevalent and objective, not subjective. We do not have to go rooting in the subconscious of black women to find evidence of this racism.

However, I am not convinced that these particular findings add to what we already know.

Figuring out what to do about increasing rates of new cases of asthma among black women involves problem-solving that applies evidence accumulated using the diagnostic categories supplied by medicine.

The diagnostic categories have undergone considerable evolution over time, revision of what signs and symptoms, what lab test values to include or exclude, based on how they worked in predicting associations among variables and improving health outcomes. Biomedical research is involved but includes microbiology, immunology, and also epidemiology, including social determinants of health. The goal is to bridge these fields, to establish connections that make a difference in health outcomes.

To call this “Western Medicine’ is an act of cultural imperialism. If the rest of the world had survived to now without the influence of the West or Capitalism or whatever, it would be because similar methods had evolved and had produced similar knowledge.

Casually attaching such labels to phenomena his audiences do not understand scores points with them. It allows Maté to dismiss the knowledge and tools we need to prevent new cases of asthma among these women and reduce the toll of asthma among those women who have already developed this chronic, recurring condition.

Maté paints a cartoonish caricature of medicine locked in silos. He confuses the maps that specialist researchers and clinicians use with the territory they cover. There is so much complexity in methods and findings in immunology. While those who study immune function should be able to communicate with those who are experts on the sources of environmental exposures like mites or black mold, but they cannot reasonably be expected to be experts in those areas.

Overspecialization in research and clinical practice is an important issue, especially for the management of difficult-to-diagnosis, multiple comorbidities with multiple medications. Management must collaborative care between professionals and especially with active patient involvement.

There is no cause for lighting anyone’s hair on fire and putting it out with hammers or other cynical, nihilistic high drama of the kind that Maté acts out in front of audiences who come for the spectacle.

I have less to say about Mate’s claims about the changing gender ratio in multiple sclerosis. For a start, studies in different populations do not consistently support a dramatic trend.

Here is one relevant Canadian study in a top-quality journal.

Orton SM, Herrera BM, Yee IM, Valdar W, Ramagopalan SV, Sadovnick AD, Ebers GC, Canadian Collaborative Study Group. Sex ratio of multiple sclerosis in Canada: a longitudinal study. The Lancet Neurology. 2006 Nov 1;5(11):932–6.

Sex ratio of multiple sclerosis in Canada: a longitudinal studyIncidence of multiple sclerosis is thought to be increasing, but this notion has been difficult to substantiate. In a…www.sciencedirect.com

The article summarized the existing literature

Incidence of multiple sclerosis is thought to be increasing, but this notion has been difficult to substantiate. In a longitudinal population-based dataset of patients with multiple sclerosis obtained over more than three decades, we did not show a difference in time to diagnosis by sex. We reasoned that if a sex-specific change in incidence was occurring, the female to male sex ratio would serve as a surrogate of incidence change.

The study found:

The female to male sex ratio by year of birth has been increasing for at least 50 years and now exceeds 3·2:1 in Canada. Year of birth was a significant predictor for sex ratio (p<0·0001, χ2=124·4; rank correlation r=0·84).

The authors’ interpretation:

The substantial increase in the female to male sex ratio in Canada seems to result from a disproportional increase in incidence of multiple sclerosis in women. This rapid change must have environmental origins even if it is associated with a gene–environment interaction, and implies that a large proportion of multiple sclerosis cases may be preventable in situ. Although the reasons why incidence of the disease is increasing are unknown, there are major implications for health-care provision because lifetime costs of multiple sclerosis exceed £1 million per case in the UK.

This is solid, normal science, representing one step on the path to finding a solution, not at all revolutionary or cause for the fuss that Maté is making.

I’ll pass on commenting on Maté’s claims that we treat asthma or multiple sclerosis with stress hormones. Similarly, for his leap that these “facts” justify a deep dive into the subterranean world of subconscious hidden trauma accumulated in early life.

I have collaborated in the successful writing of major grant applications for these diseases. I am sure the grateful principal investigators would answer any questions I forwarded them, but I think they would think I was smoking medical cannabis if I asked them to comment on choice direct quotes from Maté’s talk.

Leonard Cohen engaged in banter with his audience expressing thanks for the ‘geographical and economic inconvenience’ they had suffered to come to hear his concert in London. Of course, he did not have time set aside for questions and answers at the end. Maybe he did an encore.

Members of Maté’s audience competed at the end of his lecture to get his opinion on a variety of health and social issues.

I guess they thought they had enjoyed a scientific lecture from a rock star celebrity, not a rock concert. I cannot fathom why and I will have to do some more investigation but I will have to prepare if this means I have to watch any more Maté lectures.

Perhaps I can find a lecture that is mercifully short. I will keep some Leonard Cohen music handy, like an epi-pen that I can use if I find myself experiencing an adverse reaction.

Postscript

I was expecting to upload this article last night, but an intense storm rushed through my village, uprooting trees, and cutting off power and internet. I refuse to think that was some divine sign that I should post it.

Sitting in the dark, I reflected on these presumably intelligent English people sitting through Maté’s lecture without leaving, and then some of them asking questions with no challenge to the outrageous things he had said.

The next time they went to a GP or medical specialist, would they chastise her if she did not start by asking them about their hidden trauma? If their parents had cancer, would they rush them into trauma-informed treatment or would they seek the best oncologist available and maybe even get a second opinion.

I think not. The audience knew they had not been to a Leonard Cohen concert or a lecture that should change their patterns of health care.

The audience knew they had been to church and had heard an eminent preacher from Canada, Gabor Maté’s who did his best to whip up an old-time sermon with terrifying hellfire and damnation. Some of the audience talked about his religion with him but they knew they did not have to do anything different in their lives. They were familiar with this genre. They would continue to seek the best health care available, even outside the National Health Service if they had to.

You don’t go to sermons like this and then go home and do anything differently. No intelligent person does that.

My worry is that many people who are respectful of the authority reflected in membership in the Order of Canada, might take Gabor Maté’s words literally and seriously.

I worry about my Canadian neighbors who are not so savvy or cynical. I worry about Americans who are already heeding what Prince Charles and Prince Harry say. Their lives are put at risk by the serious nonsense that Gabor Maté is spreading about cancer and other illnesses and his contempt for medicine and science more generally.

The post Gabor Maté’s Bizarre Ideas on Connections Between Stress and Disease appeared first on Medika Life.

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?

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

Some excellent, large data sets were either being put to purposes which they weren’t well suited or authors were drawing conclusions that really weren’t the results of analyzing the data.

Why can’t they just report their results accurately and transparently and not be afraid of doing so?

Journals are a big part of the problem. They seduce researchers with temptations that they cannot resist.

A while ago the JAMA family of papers spent millions of dollars revamping their publishing platform. The publisher announced that editors were going to make decisions about papers based on altmetrics — how much traffic similar papers have attracted to the journal website, and how much time readers spent there, and therefore how much the journal could charge for advertising.

That means that some papers that are solid science and have important messages for mental health care will be given lower priority. The papers are not in hot, trending topic areas and would not attract broader audiences.

Despite being obviously weak in their methods or data, other papers will be accepted because they are trendy in their conclusions. Some papers will be rejected because they persuasively present inconvenient findings.

In the case of this issue of JAMA Psychiatry, an obvious decision was made by the editors to emphasize racial and ethnic health disparities in a special section Psychiatry and COVID.

A call went out for papers. I doubt that some of the authors even had that intention of examining health disparities or racism in mind when they gathered their data and made plans to analyze it.

I am picking one article to dissect because I have a great deal of respect for one of the authors. I’ve followed his work closely for decades because he does very good work. I think he knew what he and his co-authors were doing in putting a message on their results that weren’t there. He was having harmless fun and not trying to corrupt science.

Naively or on purpose, Greg Simon allowed his co-authors to say silly things in the section discussing implications, where such speculations seem natural.

Maybe I am giving too much credit to Greg but what I liked was that this paper was so transparent in how he manipulated the reviewers and the readers. Right away, he revealed what he was up to in an incredibly transparent abstract. Like a magician spoiling the trick by explaining what he was doing, he was communicating to the smart, attentive members of the audience and allowing them to feel smart. Too bad that most people do not read carefully.

The article could be paywalled by now, but you can access the abstract here and see the context of the statements that I am going to pick out.

The authors state as their research question:

*Could implementation of suicide prediction models reinforce and worsen racial/ethnic disparities in care?”

Translation: How white people’s science hurts black and indigenous people and perpetuates systemic racism.

The huge retrospective study consists of administrative data of 13,980,570 visits by 1,433,543 patients. The data came from seven health systems providing integrated physical and mental health services.

The authors used sophisticated statistics to construct a model predicting which patients would die by suicide within 90 days of when observation of a particular patient started.

The authors conclude

These suicide prediction models may provide fewer benefits and more potential harms to American Indian/Alaskan Native or Black patients…Improving predictive performance in disadvantaged populations should be prioritized to improve, rather than exacerbate, health disparities.

Unraveling this conclusion

In epidemiological/mental health services studies, it is not how big your data set is that matters, but how many events you are available for particular groups.

From the clearly written and transparent abstract, you can tell right off that the data set is not very good to be used to predict black and Native American suicides because there were so few Blacks and Native Americans in the sample.

Hiding in plain sight in the abstract, the authors openly admitted that they only had n=65 black who died by suicide within 90 days of when tracking starred. They only had n= 21 Native Americans who died by suicide within 90 days of when tracking starred.

These are horribly small numbers, even useless, to be used in making generalizable scientific statements. But the situation is even worse. The sample was split between building and validating the model. In the validating sample, there were only 30 black patients and 15 Native Americans.

The authors claim that their predictive model worked well for whites. That would be expected without even seeing the predictive model, because it was built to a predominately white sample.

But who should care about this predictive model?

Recall this was an administrative data set constructed from information collected for other purposes. The diagnosis and service utilization data in the final predictive equation are so crude that the model would not be clinically useful in real-world settings. Maybe it delights epidemiologists for looking so good in terms of statistical significance, but clinicians should ignore it. I am sure that they will.

Every suicide is a tragedy, but because it is such an infrequent event, a base rate “won’t die by suicide” is likely to be more accurate than a predictive model based on group data. Aficionados will recognize that is a classic Paul Meehl observation.

Here comes the pablum.

Pablum is boring tasting baby food. Authors put pablum in papers because they need a filler.

Readers expect certain things to be said about a trending topic, even if things were not among the findings of the paper. Alert reviewers play gatekeeper and keep pablum out of the discussion section if they are not actual findings. In this paper, the authors make the unsubstantiated claim:

Relative benefits and harms of suicide prevention interventions vary by race/ethnicity. Additional attention from a mental health care professional may increase access to beneficial services and likely presents limited harm but could cause stigmatization or discrimination and damage patient-practitioner therapeutic alliances, particularly for patients from marginalized communities already less likely to trust or engage with traditional mental health care.

This may be true or not in other findings that were not cited. Why are the authors bringing this up near the end of a paper that was doomed from the start not to advance our understanding of suicides by ethnic and minority persons?

Of course, a journalist from MedPage Today fell for the trick and gave the authors some extra publicity. One of the authors of the study is quoted in the MedPage Today article:

“We must not ignore unintended consequences of suicide prediction models,” she said via email. “Identifying patients at high risk of suicide could initiate a cascade of more intrusive interventions, including involuntary psychiatric hospitalization and ‘wellness checks’ that put a patient in contact with law enforcement. We have to recognize, due to structural racism, that the risk of these harms is greater for BIPOC [Black, Indigenous, and people of color] populations.”

A touch of moral panic attracts more readers to MedPage Today and the JAMA Psychiatry article, keeping MedPage Today, JAMA Psychiatry, and the authors’ institution happy.

But science suffers from the confirmation of a hypothesis that was not tested, especially when the paper is cited for this conclusion that did not arise in the data.

What important message about racism and health disparities is missing in this paper?

Unwarranted talk about systemic racism distracts from looking for real, modifiable racial disparities.

Mental health services researchers like these authors require large data sets, which come from settings that are organized enough to provide them. This particular study relied on integrated care settings in which patients could easily access both primary medical and mental health treatment. These settings depend on an alignment of incentives, insurance benefits that make integrated care possible.

There were not many black or Native American suicides for which data were available in the settings. That is a serious health disparity. Such patients don’t get to such settings.

Black or Native Americans don’t have the right insurance or live in close proximity to such quality care. It is a long way from most Native American reservations to the doorsteps of a well-resourced integrative care setting. Those who reside on a reservation mostly won’t have the proper insurance nor the transportation to get there.

That was strongly suggested by taking a peek at what data the authors collected or even where they collected it. Nothing fancy had to be done, but then again, they probably would not get their paper in the prestigious JAMA Psychiatry,

You might think from this article that there is harm and even danger for Native Americans to be treated in one of the settings that were studied.

I have a close native American relative by marriage whose 90+ years old (It has to be a guess because birth certificates of many Native Americans are not preserved from back then.) grandmother was a reservation orphan from another tribe who was sent to a Navajo reservation because that nation was able to keep polio victims in the 50s. I wish she could get all the treatment of post-polio syndrome that she deserves in the reservation. She wants to keep working for the US National Parks Service, as she has for decades, and accessible integrated care would help.

Algorithms that poorly predict individual suicides of any race or ethnic background be damned. If we care about social disparities in health, we must concentrate on getting more blacks and Native Americans into treatment in integrated care settings.

The post Suicidology Is Corrupted by Researchers Who Say Things That Aren’t in Their Data appeared first on Medika Life.

Herein you will get a mini-training on how to “Just say No!” to advice experts who come armed with pseudoscience and positive psychology.

Even if we have been fortunate enough to personally avoid the virus, none of us have been perfect in preserving the routines that we had in place to stay healthy before the pandemic and the lockdowns.

Things like eating a healthy diet, exercising regularly, drinking moderately — if at all — and maintaining the social relationships that are important to us.

Keeping ourselves together, individually and collectively, is getting even harder as the pandemic wears on and the lockdowns get longer and stricter.

Only we can decide for ourselves if we are harmlessly indulging ourselves with a bit of eating and drinking or if we have gone too far and need to consider moderation or a plan for strengthening healthy behaviors.

Maybe we are dissatisfied with changes in how we are now looking or feeling. If so, we can take advantage of the disruption of routines of the pandemic to make changes we otherwise would not attempt in normal times.

Sure, we are not alone in all this thinking and deciding. We welcome, sometimes, but not always, friends and family members telling us what they think.

But what about complete stranger advice gurus who claim to know more about us than we do, without even having met us?

Freelance writers, some quite talented, have ample time on their hands and can craft stories to undermine our acceptance of ourselves as being less than perfect and our nobody’s-business-but-our-own sense of autonomy in making our decisions about how we live.

Underemployed writers may simply want to garner clicks on links to their articles to convince media to publish more of their stuff. Advice about how to live better always gets lots of clicks, especially of the cliched variety “Science says everything you think you know is wrong.”

Writers may even be participating in Amazon affiliate programs so they get a kickback for every book sold as a result of readers clicking on links embedded in their articles.

Maybe the writers have plans for their own self-help books. Sales will be boosted with lavish endorsements from the established self-help experts whom the writers have praised in their articles.

Judging from Amazon reviews, there really seems to be a mutual admiration society of advice gurus and self-help experts just loving each other’s work. All self-help merchandise have ratings way above average, and most of it, stupendously so.

Maybe our 2021 new year’s resolution can be to kick the self-help habit by which we buy books and tapes to which we never pay further attention. These products are undoubtedly filled with extravagant claims based on pseudoscience, anyway.

‘We may long ago have grown amused and indifferent to the sidewalk evangelists and prophets who insist we are doomed to burn in hell if we don’t worship their God in their way.

Yet, even educated people, especially educated people, remain susceptible to advice gurus talking about the science of hormones and brains, seemingly spouting knowledge that sounds familiar, but that is beyond their comprehension or ability to contradict.

Here is an article to which we can talk back in ways that prepare us not to be threatened by such articles the inevitable next time they pop up in our newsfeeds.

Your brain on cortisol: Why overstressed gray matter is leading us astray in lockdown

Why a stressful year has led us to drink, eat and shop. It’s our brains on cortisol. When it comes to vices during the pandemic, simply put, it’s been difficult to say “no.”

The title already conveys the presumption that readers are fallen sinners as a result of being led astray by their brains.

Just what does ‘gray matter leading us astray’ mean? Is it like our brain is in the car up ahead and we are driving in a car behind? If so, doesn’t it take a brain to follow our brain?

We had thought that cortisol” and “gray matter” in the title of the article “cortisol” and “gray matter” signaled that science was ahead, but already it seems we are getting lost in metaphysical speculation.

*This is getting deep, shove me into shallow waters.

The serious case against us starts in the first sentence of the article:

*When it comes to vices during the pandemic, simply put, it’s been difficult to say “no.”

Readers are accused of regularly drinking too much and “eating half a birthday cake,” which was okay back in March but is unforgivable now.

Next, it is suggested that readers have been lonely and so are chain-smoking a pack a day. The supreme devil of bad habits has taken ahold of our souls.

But nine months on, when experience has demonstrated that chain-smoking a pack of cigarettes doesn’t compensate for human interaction, why do bad habits continue to compel us?

We — despite many of us being nonsmokers — may be getting defensive, or we may reject this depiction of us as off the wall.

But then, the author summons expert witness “Dr. Robert Lustig, a professor emeritus of pediatric endocrinology at the University of California, San Francisco, and author of “Metabolical” to testify.

Lustig presumes he knows the readers well and accuses us of “illogical pleasure-seeking” caused by the “prolonged traumatic, or ‘chronic toxic,’ stress that prevented us from keeping our desires in check.

The good journalist translates this:

*In scientific terms: When brains are flooded with the stress hormone cortisol on a long-term basis, it inhibits the function of the prefrontal cortex, leading to excessive activation of the “reward center” of the brain — triggering the excessive baking, drinking, smoking and shopping that filled the idle hours of 2020.

So, brains can flood like basements? Now excessive baking and shopping are being added to the bad things with our idle hands. The good professor emeritus of pediatric endocrinology further flails us with his expertise:

Dopamine is the reward neurotransmitter. It is held in check by the prefrontal cortex. When that inhibition is released, the reward center looks for hedonic stimuli,” Lustig said. “Those can be chemical — cocaine, heroin, nicotine, alcohol, sugar — or behavioral — shopping, gambling, internet gaming, social media, pornography.”

So, now the truth is out: We can fess up. According to Lustig, we have been snorting cocaine, shooting heroin, gambling, and masturbating while viewing porno. Good thing that social distancing has reduced the possibility of anyone shaking our hands.

Now that we are whipped, humiliated, and bleeding, the good professor emeritus of pediatric endocrinology delivers his signature sermon on sugar addiction:

Take the beloved carbohydrate sugar. Early in the pandemic, a baking frenzy swept the country, offering both a relatively accessible quarantine hobby and a constant supply of carbs. Like hand sanitizer and toilet paper, flour and yeast went from lowly supermarket staples to hot-ticket items quickly nabbed from store shelves.

The preparation of baked goods in quarantine was clearly driven by more than just the joy of cooking, Lustig said.

Ha! We thought we had other good reasons for learning to bake. Some of us were being altruistic, like baking for our locked-down neighbors who have no fresh biscotti now that the bakery has closed for good.

Or maybe we were perfecting our sourdough. What the bakery offered was never that great. We can find meaning and purpose in learning to make a better sourdough in the long, otherwise empty afternoons of lockdown.

But no way.

This expert Lustig knows this is just our addiction talking, making excuses for us. We are really feeding our addiction and hooking our neighbors on sugar as well.

The good emeritus professor goes on in that vein, but then almost catches himself by acknowledging that:

The jump from sifting flour to full-blown addiction might sound extreme, but it raises the question of why exactly people turn to certain things for comfort even when they know the feeling is fleeting.

The author of the article dismisses Lusting from the stand.

She calls another expert witness for the prosecution, positive psychologist Laurie Santos, a professor of psychology at Yale University and host of “The Happiness Lab” podcast.

That’s the million-dollar question…We know neuroscientifically that there’s a disconnect between the kinds of things that we want and the kinds of things that we like. Wanting is a motivational process. Liking is how you’re going to feel when you get it.”

The flip side is that we don’t have ‘wanting’ for the things that are going to work. Things like taking time to experience social connection, doing nice things for others, taking time to experience gratitude. We just don’t have mechanisms to seek that stuff out. We don’t realize that that’s what’s missing,” Santos said.

Yup, damn us, we have deprivation and suffering all around us and we don’t want things that work and we do not realize what is missing. We are all unenlightened selfish assholes.

The author presents circumstantial evidence that we ordered too much booze online but ignores exculpatory evidence, such as we stopped ordering booze when the bars and restaurants temporarily reopened.

And consumers spent their pittance from the stimulus package to buy cigarettes and smoke at home. Reminds me of the old ‘welfare queens in Cadillacs’ myths of the Reagan era.

Then there were the atrocities of Cyber Monday:

Nov. 30, the first Monday after Thanksgiving, became the biggest online shopping day in U.S. history, with a grand total of $10.7 billion in purchases — a number as indicative of the collective brain’s search for gratification as any other. And one category that surged notably was self-care.

Buying new material possessions just simply doesn’t make us as happy as we think. In fact, we’d be better off spending money on other people.”

Sure, Dr. Santos, practice what you preach and give the money away from your self-help merchandising to less fortunate people.

Weirdly, the author next dismisses Dr. Santos as an expert witness and brings in some kind of sorcerous to condemn the greed and selfishness in her testimony.

Self-care is the ultimate form of expressing self-love,” said Colleen McCann, the author of “Crystal Rx” and founder of a fashion-meets-mysticism brand, Style Rituals. McCann’s services include energetic closet cleanings and self-affirming crystal and Tarot readings, after which clients receive a highly curated “me-time” kit and a mood board. Even as a high-end, niche offering, Style Rituals has been gaining business even though its services have moved fully online, McCann said.

I think I will leave McCann to her self-affirming crystals and consider the prosecution to have rested their case.

*What sayest thou to this, poor sinner? Let me say it over again. There are but few to be saved, but very few. Let me add, but few professors– but few eminent professors. What sayest thou now, sinner? -John Bunyan 1686

Testifying in defense of hapless readers who are muddling through a pandemic for the first time

To paraphrase Eleanor Roosevelt, we’re doing the best we can. It’s just that in the pandemic we are not on our best days. Most of us, even those who are doing relatively well, have taken a few knocks on our chins. We made mistakes.

II keep my comments brief, narrowly addressing the competence of the expert witnesses who seem to claim to know more about our motives than we do.

If we use Google <Robert Lustig>, page upon page of search results consist of praise for his work on sugar addiction. We should not be swayed by the first results of Google searches of such celebrity figures, because they are often manipulated to control what we see, keeping out anything critical.

Nonetheless, in the world of pop psychology, Lustig is widely seen as having “proven” the reality of fructose (fruit sugar commonly added to sweeten soft drinks) as being more addictive than cocaine. However, if we look up his name on Google Scholar, we find that he is not held in high regard by peers, who consider having made much too much of some laboratory studies of rodents. He has drawn premature conclusions about the relevance to humans. Worse, Lusting makes wild claims in his popular books, exploiting the ignorance of lay readers.

Lustig presents a comicbook caricature of how hormones and the nervous system interact. If he said such things in a talk at UC, San Francisco Medical Center where he was faculty, he would be laughed out of the room. I am confident that he would risk being seen as foolish.

Some astute readers have expressed great disappointment with Lustig for making too much of some early observations of rodents and then deliberately fooling lay readers,

NPR to Robert Lustig: You Hurt, Not Help, Your Cause. We’ve written before about the grossly exaggerated accusations against sugars made by Robert Lustig in his…

From flawed studies purportedly linking sugar consumption to Type II diabetes, to outrageous declarations that obesity is “bigger than the bubonic plague,” Lustig has a penchant for baselessly inciting fear in consumers’ minds.

Hormones have multiple functions in a complex system that we only understand in parts. We know enough to say that actions of hormones get reactions from other hormones and the nervous in complex feedback loops.

It is plain silly to say that cortisol is THE stress hormone. Cortisol is not an established biomarker for psychological stress. We cannot say meaningfully say that an individual is too high or too low in cortisol. When we take multiple measurements of cortisol in the laboratory, we usually find that cortisol is only weakly related to differences in human behavior.

I want particularly to take issue with Lustig’s loose notions of toxic stress and of COVID-19 being traumatic. Lustig is guilty of the jingle-jangle fallacy in his lazy use of these terms.

Jingle-jangle fallacies refer to the erroneous assumptions that two different things are the same because they bear the same name (jingle fallacy) or that two identical or almost identical things are different because they are labeled differently (jangle fallacy).

Aspirin, licorice, and even water can make you sick or die in large quantities, but we do label them as toxic. Cholecalciferol (Vitamin D3) is effective as a rat poison.

By analogy, human experiences can be stressful, but the burden is on someone like Lustig to specify what he means by “toxic” and to which specific experiences he is referring.

Overall, the past year living under the threat of COVID has often been stressful but is presumptuous to claim that it has been chronic or toxic for most people most of the time.

Lustig claims the right to loosely apply his notions of toxic and chronic stress to our experience and then he claims he sees precise effects on our neurochemistry. He then condemns what he thinks we have been doing is very bad.

I will be briefer in my comments about Laurie Santos, but many of the same things I have said about Lustig. With great entitlement and presumption, she applies some cartoonish conceptions of how people function is related to observations of their brain functioning. I am irked that she treats her readers as so much more stupid than her Yale colleagues and believes readers can be told noble lies and fairy tales.

Here is a cogent critique of her kind of brain talk:

People these days love to talk about brains. In everyday conversation and mainstream media reports, the organ and its processes are casually invoked (“my synapses are firing”) where once more ordinary language might have sufficed (“I’m thinking”). For good or for bad, there seems to be an increasingly pervasive belief that pretty much everything important about being human can be best explained — and, if need be, fixed — by referring to the mysterious squishy matter inside our skulls.

Maybe we can pick up this conversation about stress and brains and hormones again. My readers can contribute by making comments on this article or even by using the valuable Medium function by which they can turn comments into your own articles. If readers don’t like what I write, they can take to social media and attack me or even try to cybermob out of social media as some positive psychologists have tried.

But for now, we have to live with COVID. Those of us who are lucky to survive will hopefully be able to tell those who did not face COVID how they coped. Live so you can truthfully tell others great stories. If you like, do creative outrageous things in your coping.

We live reminded by COVID of the threat of unplanned death. That gives an excuse for what we do, both good and bad. We hopefully will never have such opportunities again.

I don’t think we need the presumption or permission of advice experts.

If you think you need permission to eat half a cake, you can say Coyne said I could in a Medium article.

*John Bunyan, 1676. THE Strait Gate OR, Great Difficulty of Going to Heaven: Plainly proving, by the Scriptures, that not only the rude and profane, but many great professors, will come short of that kingdom: with directions how and why everyone should strive to enter in. 

The post Your Brain on Cortisol During COVID-19, Your Brain on #Neurononsense appeared first on Medika Life.

I have been following Dr. Nadine Burke-Harris’s meteoric rise for some time. I had hoped that as California’s Surgeon General, Dr. Burke-Harris would dampen her signature pop psychology message that brought her this international attention.

I wish that the California Surgeon General would not talk so much about toxic stress and about implementing trauma-informed care as a major public health strategy, at least not now, in the midst of a COVID-19 winter. From the point of view of scientific evidence, her approach is making even less sense than it did before the pandemic.

Dr. Burke-Harris could be an effective advocate for curbing the pandemic with an evidence-based public health strategy. She could summon her incredible powers of persuasion and capitalize on the trust that a diverse community has in her. Dr. Burke-Harris could counter the skepticism of many people, especially minorities, about the safety of vaccination and concerns that the medical establishment is using them as guinea pigs. She does a magnificent job of that sometimes, before abruptly shifting back to the topic for which she has the greatest passion.

I do not think many academics savor the prospect of publicly taking issue with Dr. Burke-Harris’s approach or be seen as questioning what she strongly claims is the evidence for it. Yet, when media outlets summon academic and government, public health experts, to comment on the latest COVID-19 news, viewers do not see anything like her public health strategy being advocated. There is an obvious gap between what prominent American and international experts versus Dr. Burke consider an effective public health strategy and what is considered evidence. No one seems willing to talk about the gap.

I am an author of hundreds of peer-reviewed papers, some of them critically relevant to Dr. Burke-Harris’s claims. I do not imagine having an opportunity to discuss or debate Dr. Burke-Harris’s policies with her in public. If I somehow found myself in that situation, I am confident that she would have the audience on her side.

I anticipate that members of the audience would be captivated by her incredible personal story and her emotional appeals and her empty claims for trauma-informed care being grounded in science. I doubt many would listen to any evidence that contradicted her views, no matter how compelling I or other academics believed the evidence was.

When evidence faces off against the power of celebrity status and charisma, the evidence is left lying face down in the street. That becomes particularly important to take into account during a pandemic in which people are dying from misinformation.

In California, the week of December 14, 2020, was horrible beyond what anyone could have imagined a year ago.

The availability of beds in ICUs (Intensive Care Units) at hospitals dropped below 15% in more sections of the state, automatically activating a strict lockdown of surrounding communities.

The release of the vaccine by federal health officials for distribution was announced, but that arrival would not be soon enough to avert an impending disaster in California.

At a press conference, Governor Gavin Newsom announced that the state was experiencing the worst yet surge in cases and death. To cope with the rising numbers of death in Southern California, the governor ordered the distribution of 5,000 body bags and put 60 refrigerated trucks on standby to be ready as makeshift morgues.

The California surgeon general takes to the media to manage the crisis

Dr. Nadine Burke-Harris was already widely sought for expert commentary in media appearances before the presence of the virus was discovered in California. She is a media darling and raises the ratings and numbers of viewers tuning in when it is announced that she will be appearing on a news program.

Her media appearances during the pandemic inevitably involve someone changing the topic at hand into a discussion of trauma-informed care. This is often done by the interviewers directing her into her signature pitch.

The week of December 14, Dr. Burke-Harris’s media appearances included an interview completed by Zoom for a local San Francisco news program.

ABC7 talks to California surgeon general Nadine Burke-Harris about COVID-19’s impact on children

The interview was proceeding with the surgeon general giving a hopeful message about how ordinary people could help control the spread of COVID-19.

”We absolutely can stop the tide, and the way that we do that is through the actions of all of us,” the surgeon general said. “We’re asking Californians to stay home and practice the guidelines that we know help to reduce the transmission of COVID-19 by washing hands, wearing a mask, watching our distance, and maintaining that six feet of social distance from others when we do have to go out for essential reasons.”

While Dr. Burke-Harris was still carrying on in this vein, a subtitle Stress and COVID appeared at the bottom of the screen. Then, the interviewer shifted to familiar ground. The TV station website says:

Yet Burke-Harris warns that some of the lasting impacts of the pandemic on children, from physical and mental traumas to toxic stressors, may not be palpable until years from now.

Other public health experts caution about COVID long term and being vigilant about educating and medically screening persons who had only mild symptoms during their acute bout with the disease. Dr. Burke-Harris’s approach is distinctly different:

She says it is critical and timely that California is releasing a roadmap to address some of these challenges head-ons, and working to minimize potentially negative long-term impacts of COVID-19 on families.

”Manifestations are some of the things that we kind of commonly, might intuitively recognize,” Burke-Harris says, “increased risk for things like depression, or increased risk of substance use or substance dependence. But also some things that many people previously didn’t associate with childhood adversity, things like increased risk for heart disease and stroke, even Alzheimer’s.”

The surgeon general adds that the science shows critical factors in mitigating these traumas include positive family environments and early detection of problems.

On another program, the interviewer eagerly pushed the surgeon general into discussing what parents could do for themselves to protect children from long terms of effects of the virus

Interviewer1: Let’s talk about the pandemic and the stress that it is causing so many people, different levels of stress. and how that is affecting people here in California.

Dr. Burke: That’s right. what we are seeing is increased rates of things like intimate partner violence or increased rates of mental health concerns like depression and anxiety, as well as some increased rates of substance use as well. so that — in fact, my office just put out a report about the impact of stress on health and what we can do to help mitigate the effects of toxic stress.

Interviewer2: What are you recommending?

Dr. Burke: Some of the things we are recommending are things like getting regular exercise. nutrition. Certainly, seeking mental health care if that’s necessary. right now, it is certainly a good recommendation for anyone who feels like they need that. in addition, things like mindfulness, meditation. now is a really good time to go online and access that free yoga class. really practice some of these self-care practices.

Interviewer1: We were talking about some part of your work regarding children and how stress affects them and how we can manifest in different ways in those kids. how it can be a lifetime problem. what about the kids during all of this?

Dr Burke: That’s right. the thing, the key that is the most important for children right now — we know that while stress can affect both our mental and our physical health, safe, stable, nurturing relationships and environments are healing for children. in order for us to do that, I go back to what we were just talking about. reducing our own stress levels. for us as parents and caregivers, we have to put our own oxygen masks on so we can be available to help our kids.

I greatly admire Dr. Sanja Gupta and Dr. Anthony Fauci. I consider them some of the finest heroes of the pandemic, fighting medical misinformation with evidence and reason. I confess to getting choked up and just a bit teary-eyed when I watched them on Saturday morning of this horrible week.

At one point, Dr. Anthony Fauci spoke about having flown up to the North Pole to test vaccinate Santa Claus.

Dr. Sanja Gupta breathed a sigh of relief on behalf of parents and children all over the world: They were now reassured that it was safe for Santa Claus to drop off presents and for the children to open them joyously, for the moment, at least, feeling a bit safer from the pandemic. Ok, a few white lies and a bit of silliness, but I think it is less harmful than making up stuff about trauma-informed care.

In all the many hundreds of hours, that Drs. Fauci and Gupta have spent telling adults and children what they can do to cope with the virus and mitigate its effect on family life, why hasn’t reducing toxic stress come up?

Dr. Burke-Harris is indefatigable in spreading her message. I was surprised at what she was able to get past the editor at STAT+ News, which claims to provide exclusive analysis of biotech, Pharma, and the life sciences. There seemed to be some blatantly harmful pseudoscience, starting with the alarmist title:

Children will pay long-term stress-related costs of Covid-19 unless we follow the science

We should also be concerned about how toxic stress brought on by the pandemic or made worse by it, will affect children’s developing brains and bodies and their future health.

And

Decades of studies tell us that the kind of trauma and stress many children are experiencing during the Covid-19 emergency has the potential to embed itself in children’s DNA, dramatically affecting their brains and other critical body systems and, as a result, their health across a lifetime.

And

We must act now to use the science of early childhood development to address the Covid-19-related stress in children’s and caregivers’ lives. If we don’t, the pandemic will in the short term put millions more children than before at risk for hunger, homelessness, abuse, and neglect. Over the long term, it will lead to more children with developmental delays, asthma, diabetes, mental illness, heart disease, cancer, Alzheimer’s disease, and other poor health outcomes.

I have a question for Dr. Burke-Harris.

Your fine educational record includes a master’s degree in public health at Harvard T.H. Chan School of Public Health. What are the odds ratios associated with childhood adversity with any of the physical diseases you list here?

Should we be alarming already stressed-out parents with worries that their emotional state puts their children’s physical health at risk? Is there any remote chance of parents reducing that risk with any action, even taking up yoga or meditation? Should parents feel guilty if they don’t?

The post Record Numbers of Californians Die From COVID-19, Surgeon General Promotes Yoga and Screening for Adverse Childhood Experiences appeared first on Medika Life.

The study obtained consent for exposure to a pathogen with a 12-week delay in curative treatment. Details that are withheld are relevant to human subject concerns in current COVID-19 vaccination research.

The article published in Annals of Internal Medicine sparked a brief, but intense expression of outrage on social media from infectious disease experts, clinical trialists, and ethicists.

Little sign of this controversy is preserved in the biomedical literature. What was said by experts on social media about the ethics of studying infectious diseases in this unusual study should be available in a systematic search of the literature. Especially with the urgency of determining the efficacy and safety of vaccines for COVID-19 with healthy research participants.

Sensitive to the controversy this article had elicited, the official Twitter account of the journal tweeted

Apparently, there were few on Twitter who took advantage of this offer who succeeded in getting a letter published.

What was said by experts on social media about the ethics of studying infectious diseases in this unusual study should be available in a systematic search of the literature. Especially with the urgency of determining the efficacy and safety of vaccines for COVID-19 with healthy research participants.

Our published letter to the editor has largely gone unnoticed because of an exceptionally stubborn journal paywall, combined with delays and glitches in the indexing of letters to the editor. I could not find this letter in recent searches of the journal website or through Google Scholar.

My best friend and colleague University of Pennsylvania Professor of Medical Ethics & Health Jon Merz, MBA, JD, Ph.D., had made polite, persistent, but ultimately futile attempts to get the details of what was told to the two students and what assurances were given in securing their informed consent.

Jon wrote emails to the first author, senior author, and Research Evaluation Board of the Leiden University Medical Centre, Leiden, The Netherlands.

After some exchange of niceties, the response seemed to be an emphatic “Echt, niet!”

The article’s senior author noticed that Jon was an ethicist and presumed that Jon might want to publish on this issue. She reserved the right to protect her team to be the first to publish what was done to ensure informed consent. The team was collaborating with ethicists at Leiden University and she suggested that they would be publishing details.

The senior author also noted that her research staff had not given serious consideration to self-experimentation involving deliberately infecting themselves.

She ended further correspondence with:

Given the ethical debate around controlled human infection studies, we believe that it is important to take the utmost care in informed consent procedures, guidance of our volunteers and the public opinion.

Subsequent publications from this group have not revealed what was told to these students, not even in advisement about how to manage risks to normal volunteers in COVID-19 vaccine research.

Actually, a strong case can be made for cohort-specific informed consent, which involves disclosing specific risks to prospective subjects with particular personal characteristics.

The Head of the REB replied that she preferred that Jon obtain information and consent forms from the senior author of the study. She did not respond to further inquiries.

Our letter

The journal did not require us to sign over the copyright of the letter, so here it is in its entirety:

We read with interest the short report by Roestenberg and colleagues about the experimental infection of 2 graduate students with male cercariae of Schistosoma mansoni.1 The overarching hypothesis of this study is quite provocative. Results would be potentially clinically relevant, except data from only 2 of the originally proposed 17 subjects proposed in the trial registration were reported.2 Information in the trial registration indicates that recruitment is no longer occurring.

No reason is given for writing up the paper with such a small subsample of what was proposed. One is left wondering whether recruitment failed because of the risks and burdens of a study requiring exposure to a pathogen and a 12-week delay in curative treatment. No information is provided about recruitment strategies, target subject population, or information disclosed in the consent form. Was an incentive offered and was it consistent with the risks and burdens of the study? We requested the consent form from the senior author and the IRB, but our request was refused.

Despite recruiting only two subjects, there were six authors and a larger coHSI clinical trials team of 20. We wonder why no members of the team experimented on themselves. The Nuremberg Code provides some guidance for dangerous experiments that hold out no prospect of therapeutic benefit: “5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury could occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.”3 While death or long-term injury from this experiment was unlikely, the principle behind this provision of the Code has a persuasive rationale.

If an experiment is too dangerous or imposes too high a risk and burden, only those who are most informed and free of undue pressures and coercion should be experimental subjects — namely, the investigators. No researcher (or IRB member) should ask others to do anything that they themselves would not do. If recruitment failure was due to the inability to find enough unaligned people willing to undertake such an experiment, we find it ironic and telling that none of the investigators would step into the breach for the good of their science.

We hope the investigators will be open and transparent about their recruitment and consent methods, as others may face similar barriers in trying to replicate and extend their important work.

The authors’ reply

We thank the authors for their interest in our research and sharing their ethical deliberations. Recruitment for this trial has been completed as proposed (n=17) and final trial visits for the last group of volunteers are currently taking place as planned. We aim to provide a full report of the trial results as soon as possible and anticipate final data collection in April 2019. Volunteers were financially compensated for their time and travel expenses according to accepted Dutch standards for medical research with healthy volunteers.

We have performed a thorough review of our informed consent procedures, volunteer expectations, risk assessments and motivation. The results of this study will also be made publicly available. Given the importance of the clinical findings of the first participants in this study to the medical community, we have been specifically requested to publish the clinical details of these initial cases as soon as possible and not await the end of the trial. We apologize for any concerns we might have caused with regards to failed recruitment or early termination and will keep you updated on trial publications.

Note that this reply seems to promise that the results of the larger study will be published. It did not say whether these publications would include the details of the protection of human subjects, including this study’s procedure for ensuring informed consent.

It is very odd to publish results obtained from the first two research participants when a larger study is in progress. This article could be seen as premature and inappropriate because any effects may prove false positives with the accumulation of more data. The authors want to attract attention to their preliminary results, but risk the likelihood of promising results getting more attention than the not-so-promising, but more valid results they will have later.

Responsible researchers do not publish preliminary results from an ongoing study without a very good reason. That is Best Research Practices 101.

Particularly since this group is taking the extraordinary step of publishing results obtained from the first two of a planned larger study, the medical and scientific community have the right to know how consent was obtained and if there were any participants who declined participation once they were fully informed.

If the results of this study are so important that they must be shared at this preliminary stage — after collecting data from only two subjects — then so are the procedures by which the results were produced, including informed consent.

There are unaddressed ethical concerns about this study. What were prospective participants told about possible adverse events, including the risk of death? How much were participants compensated in recognition of this risk? Are there special issues in these participants being students at the research team’s university and their perhaps feeling pressured to give consent?

Our suggestion that the investigators consider doing this research experimentally expose themselves — not someone else — to the pathogen has strong precedent.

A systematic review identified 465 documented instances of medical self-experimentation, including by researchers who went on to receive the Nobel Prize.

Walter Reed’s Yellow Fever Commission in Cuba in 1900 allowed mosquitoes suspected of carrying the deadly disease to bite Commission members, but Reed excused himself from having to do so. One member of the commission developed yellow fever and suffered lifelong chronic ill health. Another member died from the disease.

A classic paper in the New England Journal of Medicinethat is regularly assigned reading in medical ethics classes discussesAuto-Experimentation — An Unappreciated Tradition in Medical Science.

The paper notes

Obermeier, in his efforts to find a cure for cholera that then was epidemic in Berlin, allegedly injected blood from a patient with cholera into himself, and died.

Swiss chemist Albert Hofmann accidentally poisoned himself with LSD and then began purposely auto-experimenting with lower dosages to discover its psychedelic effects.

The NEJM article poses an important ethical question for the Leiden research team:

Investigators cannot serve as subjects in all scientific experiments. But the widespread practice of auto-experimentation raises a fundamental question about the philosophy of research: Is it ethical to subject another person to an experiment if the researcher did not do the experiment on himself first?

What are Katayama syndrome and schistosomiasis?

According to Lancet Infectious Disease, Katayama syndrome

Is an early clinical manifestation of schistosomiasis that occurs several weeks post-infection with Schistosoma spp (trematode) worms…Katayama syndrome appears between 14–84 days after non-immune individuals are exposed to first schistosome infection or heavy reinfection. Disease onset appears to be related to migrating schistosomula and egg deposition with individuals typically presenting with nocturnal fever, cough, myalgia, headache, and abdominal tenderness.

According to the World Health Organization (WHO), schistosomiasis:

Is an acute and chronic parasitic disease caused by blood flukes (trematode worms) of the genus Schistosoma. Estimates show that at least 229 million people required preventive treatment in 2018. Preventive treatment, which should be repeated over a number of years, will reduce and prevent morbidity….

Transmission occurs when people suffering from schistosomiasis contaminate freshwater sources with their excreta containing parasite eggs, which hatch in water…

Chronic schistosomiasis may affect people’s ability to work and in some cases can result in death. The number of deaths due to schistosomiasis is difficult to estimate because of hidden pathologies such as liver and kidney failure, bladder cancer and ectopic pregnancies due to female genital schistosomiasis.

Are psychology graduate and medical students members of vulnerable populations?

Regulations vary by country, but in the U.S., federal rules require that institutions overseeing research conducted with human subjects take special precautions to ensure that consent is obtained is fully informed, voluntary, and without coercion. The concern is heightened when individuals are in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.

U.S. regulations especially cite children, economically deprived persons, and prisoners as vulnerable populations. Students and employees of an institution are not explicitly mentioned.

Yet, researchers can expect that in the review of applications to experiment with students, consideration will be given to how consent is obtained without coercion and how students and employees can decline participation or withdraw from research without fear of reprisals.

Special issues with Leiden University psychology graduate students

The Dutch academic environment is highly competitive. Career advancement is dependent on the demonstration of research productivity, as quantified by the number of authorships on peer-reviewed publications.

Dutch Ph.D. theses consist of a collection of peer-reviewed publications with interspersed commentary. Co-authorships on research conducted by graduate students figure heavily in the hiring, promotion, and tenure of junior and senior faculty.

The publications listed on the curriculum vitae of many department and laboratory heads in the Netherlands consist mostly and sometimes almost entirely of authors stemming from Ph.D. student research.

Dutch psychology students face particular challenges in being able to recruit patients for Ph.D. research from medical hospitals and clinics staffed and controlled by other disciplines. Most of us who have done research in those setting find that authorships can be expected for anyone willing to authorize access to medical patients. These academic administrators are responsible for securing publications for their own colleagues, staff, and Ph.D. students and can be expected to look after them.

I have had to acquire a new data set at another Dutch medical center for a completed manuscript reporting results based on secondary psychometric analyses of self-report measures.

The head of the clinic had given permission for use to some data from a study completed long ago in the clinic, before her time. But she did not respond to repeated emails offering authorship for a minimal of effort sufficient to comply with journal guidelines for determining authorships.

We asked at the last minute before the manuscript was uploaded for her to provide permission to name her in an acknowledgment. The clinic head insisted that she be able to recruit her two new postdocs to read and make comments on the paper. The three of them should then become authors or else the manuscript could not be submitted. We got a new data set elsewhere to reanalyze. As customary, we again offered an opportunity to the source to become an author, but we received a note thanking us but declining.

Decision-making about authorships in Dutch medical settings often involves some compromise between international ethical standards for awarding authorships and the need to maintain collegial relationships with those in control.

In recent years, Leiden University has had a number of scandals about research integrity, gift authorships, and denial of credit for student and early career persons’ contribution to research in the Schools of Education and Psychology.

This past year, the Netherlands Board on Research Integrity (LOWI) concluded that a former professor of psychology at Leiden University was guilty of breaching several rules of scientific integrity. This conclusion was based on the findings of the Academic Integrity Committee (CWI) of Leiden University:

The CWI identified four violations of scientific integrity: (1) blood sample testing without the legally required permission of the Medical Ethics Review Committee, (2) irregularities with publications, (3) repeatedly selectively omitting research results without reporting or explaining this, and (4) submitting grant applications with incorrect (incomplete and manipulated) research data.

Transparency in research ethics during the pandemic

Achieving control over the world COVID-19 pandemic depends on unprecedented international cooperation and the sharing of data obtained from diverse settings and the ethics and informed consent with which these data were obtained.

These were always Best Research Practices and now, more than ever is the time to enforce them.

Academic institutions are expected to share data as well as basic details of their methodology to allow their research to be replicated. Especially in the midst of a pandemic, researchers should be forthcoming and disclose fully the details of how they informed health volunteers about the risks of unprotected exposures to pathogens in their research and how truly voluntary consent was obtained.

We did not anticipate that pandemic would soon be upon us when our letter was published in Annals of Internal Medicine. But we saw no reason why these authors from LUMC should not answer a reasonable question about how they protected human subjects.

Dear Professor Meta Roestenberg of Leiden University Medical Centre,

Could you please inform the scientific community about how you persuaded two students to put their health at risk in your study by getting exposed to pathogens?

Kind regards

Jim

References

1. 1.Langenberg MCC, Hoogerwerf MA, Janse JJ, van Lieshout L, Corstjens PLAM, et al. Katayama Syndrome without Schistosoma mansoni eggs. Ann Intern Med 2019; Jan. 8. doi:10.7326/L18–0438.
2. 2. Roestenberg M. Single-sex controlled human Schistosomiasis infection: safety and dose-finding. https://clinicaltrials.gov/ct2/show/NCT02755324 (accessed January 20, 2019).
3. 3. Nuremberg Code. United States v. Karl Brandt et al, 6 Fed Rules Decisions 305 (1949).

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