A patient who chooses to live reacts to one who chose to die

I blogged a couple of days ago about Anne Örtegren, a patient long suffering with myalgic encephalomyelitis/chronic fatigue syndrome who chose to end her life after much deliberation. Her poignant last blog written before she died attracted a lot of attention outside and in the community of sufferers.

Here is a brief but insightful response from Wilhelmina Jenkins, who chooses to live and try to inspire others in that choice.

A bit of background about Wilhelmina. She became ill with ME/CFS in 1983 while working on her PhD in physics at Howard University. She described to me the experience of feeling her brain had shut down so that she couldn’t even comprehend the chapter she already written. She became totally disabled in 1987. She was not formally diagnosed until 1988  and became a part of support groups and advocacy efforts since then. Her daughter became ill with this disease in 1991 as a high school student.

ME/CFS is a devastating disease. There’s no question that it burns to ashes the life that you thought you had and leaves you with sickness and pain and a quality of life lower than any other major disease. Many people, after a long struggle, decide that they can’t go on any longer. I understand that. I have felt that way many times. But if you can stay, please stay. We need you. We need every voice in the fight for health equity for those living with this disease. We need your witness. We need your stories. And we need to know that you stand with us in the struggle. I do not care if we agree or disagree about anything – I still want you here. You are unique. You are valuable. Reach out if you are in doubt about going on. There will be a hand there for you to grasp, because even when things are darkest, you are a part of a community and you are loved. And when you choose to stay, if no one else has ever said it, I will – you are my hero.

Follow Wilhelmina Jenkins on Facebook.

Readers may also be interested in  The illusion you will be able bodied forever and the limits of empathy.

 

Unethical: Why Bristol University SMILE trial should not have been conducted with chronically ill children

If it should have been conducted at all, the first clinical trial of Lightning Process should not have been conducted with chronically ill children. Safety and efficacy had neither been established with adults, nor healthy children.

Phil Parker, developer of the trademarked, commercial Lightning Process package claims that is not a psychological treatment, but a physical one. He further claims its scientific basis is an amalgamation of neurolinguistic programming, osteopathy, and life coaching.

not psychologicalThere is no plausible scientific mechanism by which Lightning Process would work. A small minority of vulnerable adult and child patients with chronic fatigue syndrome are drawn to the false claims of the health benefits lightning process, which the UK Advertising Standards Authority now forbids posting on the web. This is a truth-in-advertising-problem, not justification for launching a clinical trial. 

Researching the Lightning Process is no more ethically and scientifically justified than researching Prince Charles’s claims that (organic) coffee enemas can slow progression of cancer. Yet, the logic is the same that has been used to justify the SMILE trial.

Protecting-children-520x350Pediatrician Esther Crawley should undergo remedial ethics training and I recommend an excellent source below.

No parents should consent to their children participating in clinical trials of Bristol University, until a transparent independent inquiry reports how and why the SMILE trial was approved.

A belated praise to the parents who stood up against Professor Esther Crawley and all her nastiness. She should apologize to you.

Required reading for Professor Crawley and relevant administrative staff of Bristol University

Ethical Conduct of Clinical Research Involving Children. Edited by Marilyn J. Field and Richard E. Behrman. 448 pp., illustrated. Washington, D.C., National Academies Press, 2004. $57. ISBN 0-309-09207-8

Although the price is listed as US$57. A free downloadable PDF is available here 

No excuse, Professor Crawley, overcoming your being ethically challenged can start with some free reading.

An excellent summary is here Institute of Medicine (US) Committee on Clinical Research Involving Children; Field MJ, Behrman RE, editors. Ethical Conduct of Clinical Research Involving Children. Washington (DC): National Academies Press (US); 2004. Summary.

Ethical Conduct of Clinical Research Involving Children.

REGULATORY CONTEXT  

INTERPRETING RESEARCH RISK AND OTHER REGULATORY CONCEPTS 

UNDERSTANDING AND AGREEING TO CHILDREN’S PARTICIPATION IN RESEARCH  

REGULATORY COMPLIANCE, QUALITY IMPROVEMENT, AND ACCCREDITATION  

ROLES AND RESPONSIBILITIES IN PROTECTING CHILDREN INVOLVED IN RESEARCH  

Some key excerpts

The special ethical and regulatory protections for children may preclude potentially important clinical studies that would be approved for adult participation. This prospect can put pressure on those involved in developing or reviewing studies that include infants, children, or adolescents. A strong system of protections for adult and child participants in research will provide support and guidance for all involved to help them fulfill their legal and ethical responsibilities in such situations.

And

Notwithstanding the expected benefits of policies to increase the amount of research involving infants, children, and adolescents, some caution is appropriate. Unlike most adults, children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf. Their vulnerability demands special consideration from researchers and policymakers and additional protections beyond those provided to mentally competent adult participants in research.

And

As discussed later in this chapter, instances of unethical research practices involving children have prompted public criticism and concern that has contributed to the development of current federal regulations to protect both child and adult participants in research. Since the 1960s, policymakers, researchers, research institutions, and research sponsors have taken a number of steps to strengthen ethical standards and policies for human research and to create formal programs, including institutional review boards (IRBs), to approve and monitor research. Clinical studies funded, conducted, or regulated by the government are now subject to a (mostly) common set of provisions for the protection of human participants in research, including special protections for children. One result is that some potentially important clinical studies that would be approved for adult participation cannot be approved for participation by children.

a9062388703d9f42237ea708b2e088f1--protective-boyfriend-quotes-protective-quotesParents’  “intimate and profound duty to protect and promote their child safety and well-being in research”

…The committee recognizes the important role of parents. They have a most intimate and profound duty and desire to protect and promote their child’s safety and well-being in research, as in all realms of life. Chapter 5, in particular, has discussed how investigators, IRBs, and others can effectively and compassionately support parents in fulfilling their responsibilities and, thereby, help them to feel that they have done the right thing for their child, whatever their choices about the child’s participation in research. Once parents have agreed to their child’s participation in research, they—and older children and adolescents—may sometimes have crucial responsibilities for following the research protocol (e.g., administering medicines or bringing the child in for research appointments). Investigators need to make sure that parents and older children and adolescents understand any such responsibilities before they agree to research participation and that they have appropriate support in adhering to the protocol during the course of the research

Selected Recommendations

Recommendation 4.1: In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

In Section 406 of 45 CFR 46, federal regulations permit research that involves a minor increase over minimal risk without the prospect of direct benefit if the research involves children with a disorder or condition, is likely to yield vital knowledge about that disorder or condition, and entails research experiences that are reasonably similar to those that such children encounter in certain other situations. Consistent with the interpretation of minimal risk, the interpretation of this level of research risk should not allow a higher threshold of risk for children who are exposed to more risk in other aspects of their lives (Recommendation 4.2). Also, consistent with the language of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which defined this standard in 1977, the risk allowed under this category can be only slightly above minimal risk.

Recommendation 4.3: In determining whether proposed research involving a minor increase over minimal risk and no direct benefit can be approved, the term condition should be interpreted as referring to a specific (or a set of specific) physical, psychological, neurodevelopmental, or social characteristic(s) that an established body of scientific evidence or clinical knowledge has shown to negatively affect children’s health and well-being or to increase their risk of developing a health problem in the future.

Recommendation 4.1 In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

Parents should have been warned about unprofessional providers in Esther Crawley’s SMILE trial

The providers of Lightning Process in the SMILE trial were not credentialed health professionals and are not bound by ethical codes.

giphyEsther Crawley’s overdue publication of results from the SMILE trial  deserves close scrutiny for lots of reasons. But especially for what is said about the supervision and qualifications of Lightning Process practitioners who delivered the treatment.

Readers can easily gloss over a seemingly straightforward description of these practitioners in the paper. Yet, a little probing and checking of sources should cause some alarm among the parents who agreed to their children participating in the trial.

The details are alarming enough to cause worry about participating in any clinical trial involving Esther Crawley. She does not look after the safety and rights of children in her care.

This trial was approved by a number of committees at Bristol University. Assured by those well-publicized approvals, parents undoubtedly assumed that their children were protected from risks and needless exposure to quack treatments or providers not bound by enforceable ethical codes. The children did not have these protections, which should give pause to anyone contemplating allowing their children to participate in a trial regulated by Bristol University.

What was said in the published paper

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP. Following the diploma, LP practitioners undertake a further course to learn the tools and delivery required for the LP after which they must pass both a practical and written examination. Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge. They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

Let’s isolate and probe some of these statements.

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy.

advanced practitionerComment: This is does not represent anything approaching a degree from an accredited university or training institute. Phil Parker has been sanctioned by the UK Advertising Standards Authority for false claims about treating and even curing complex medical conditions. Yet the SMILE trial presented the Lighting Process as a treatment to the parents and children.

It would be fascinating to debrief the parents to discover what they assumed in consenting to their children’s participating in the trial. Did they think the children were being treated? Were they informed that the ASA forbade billing Lightning Process as a treatment? That the treatment providers were not chartered or qualified medical or mental health providers?

Neurolinguistic Programming has been widely discredited as quackery and is no longer is discussed in the scientific or clinical literatures.

Life Coaching is so vague a term as to be meaningless. There is no regulation or consistent specification of what is done or forbidden to be done in life coaching.

Clinical Hypnotherapy is not a restricted, independently recognized, nor chartered class of provider. Anyone can call themselves a clinical hypnotherapist. Phil Parker’s institute issues meaningless certificates that be hung on providers’ walls to confuse consumers.

This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP.

 Comment: Sounds impressive, huh? The ‘written and practical examinations’ involve showing adeptness in delivering a quack treatment that involves making false claims and offering pseudoscientific explanations to patients- messages defined by those who sell the training products.  Ability to meet these criteria involves taking trademarked training courses in quackery. Any deficiencies in knowledge or practice that examiners perceive are remedied by taking more courses. Essentially, this is a pyramid scheme from which Phil Parker benefits financially.

Reassured that providers are accredited by “British Institute of Hypnotherapy and NLP?” Go visit the website and you can readily see that it is an extension of Phil Parker’s marketing effort, not something independent or otherwise chartered or regulated. The site offers courses in referrals to people who have completed courses.

At the website a rotating variety of pseudoscientific explanations are provided with claims of dramatic effects of hypnosis that are at odds with the evidence. Visitors are led to believe that hypnotherapy is effective for reducing blood pressure and stopping smoking:

Hypnotherapy can help you kick the habit of smoking into touch for good.

Compare that to what is said by the Cochrane Collaboration:

Does hypnotherapy help people who are trying to stop smoking?

We have not shown that hypnotherapy has a greater effect on six-month quit rates than other interventions or no treatment. There is not enough evidence to show whether hypnotherapy could be as effective as counselling treatment. The effects of hypnotherapy on smoking cessation claimed by uncontrolled studies were not confirmed by analysis of randomized controlled trials.

The site also falsely claims that hypnotherapy can reduce blood pressure. The site is basically an advertisement for exaggerated claims about hypnosis backed by pseudoscientific explanations of how it works.

Hypnotherapists now understood neurology and physiology of using hypnosis and have the evidence of neurosciences support this understanding.

not psychologicalNonsense. This British Institute of Hypnotherapy and NLP is set up and run by a guy who claims neuroscience, osteopathy and neurolingustic programming explain the effects of the Lightning  Process, which are claimed to be physiological, not psychological. Who believes these additional claims about hypnosis are valid?

Consumer beware.

Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge.

But the supervision is in use of a commercial product with a pseudoscientific explanation. So, apparently practitioners are supervised in their willingness and ability to adhere to the scripts they have received as part of products they have purchased. The “continuous professional development” is taking a steady stream of Phil Parker’s training courses. Because his materials are trademarked, no one who is not authorized by Parker to sell his merchandise.

They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

There is a financial conflict of interest in Phil Parker offering courses and training and what the ASA has said cannot be described as treatment and then setting up a professional conduct committee is tied directly to his products.

What should parents be able to expect in bringing their children to a recognized, regulated healthcare site, like the NHS? The treatment providers should be professionals licensed by a governmental or independent body separate from any marketing of training. If not fully licensed or regulated professionals, they should be supervised by professionals, such as medical or mental health clinicians.

The class of providers should also be licensed or chartered so that sanctions with legal consequences can be applied for misconduct or unethical behavior. Providers working with children should be held to some ethical standards in terms of the safety and rights of both children and their parents.

None of these features are present in the treatment provided in the SMILE trial.

Christine Fenton, a retired Deputy Head of two high schools in the UK notes she was responsible for child protection in those roles. She expressed this concern about the basic conflict of Lightning Process and tenets of childhood protection:

LP participants are directed to not talk to others about it – keep secrets – to report positively regardless of their internal view is appalling to me. Child Protection has a key tenet ‘secrets are not ok’ – if an adult tells a youngster to keep a secret it is a form of control & creates an environment in which abuse can occur more easily.

Teachers, like other professionals coming in contact with children are required to take courses about child protective services and the duty to report abuse. They are held legally responsible for violation of the associated rules. However, legally, providers of the lightning process are only ordinary citizens, not professionals and are not held responsible in this manner.

In obtaining approval for the conduct of the SMILE trial from Bristol University, Pediatrician Esther Crawley claimed that sessions of the writing process were taped and that she had responsibility for reviewing the tapes. It strains credibility to claim that she actually listened to all the tapes from the study.

But what does it mean for a physician to supervise a quack treatment provided by quack providers who are not being allowed to call what they do treatment? How does Crawley react when physically ill, impaired children are instructed to deny their fatigue and pain to authority figures such as teachers and parents?

Truly mind-boggling to consider.

How advice gurus sell more products when corporations discover mindfulness training doesn’t work

competative advantage

Corporations purchasing expensive mindfulness training packages for corporate leadership and rank and file employees inevitably discover they do not obtain the benefits that are claimed for mindfulness. How can this become a strategic opportunity for advice gurus to sell more products?

value of happinessIn a recent article in Harvard Review of Business (HBR) article, Daniel Goleman and Matt Lippincott deftly explain that if corporations still believe in the promises of mindfulness, they should purchase their product, training in emotional intelligence. They claim the support of unpublished research, but, as we will see, the published research casts doubts on their product being backed by much evidence.

book cover_24582677-2ecc-4456-a2c1-c2eadfcb8d5b.jpgNo matter. We have a fascinating example of associations with Harvard, research, and University of Pennsylvania being used to brand an advice product as effective and backed by science.  It is a strategy that Amy Cuddy used to present herself as an advice guru before the launch of power posing. Elizabeth Dunn and Michael Norton use the HRB to launch their campaign for the science of smarter spending, how money can buy you happiness, if you follow their advice.

The click link “What really makes mindfulness works” suggests an article from Harvard Review of Business explainswhat really makes mindfulness training work. Actrually, the article actually pitches products for when corporations find mindfulness does not  live up to expectations.

Without Emotional Intelligence, Mindfulness Doesn’t Work

The first two paragraphs skillfully criticize mindfulness as a fad, but argue for a “complicated relationship” between mindfulness and improved executive performance, setting the reader up for a pitch for their product, which provides a more effective route.

Mindfulness has become the corporate fad du jour, a practice widely touted as a fast-track to better leadership. But we suspect that not all the benefits laid at its feet actually belong there. Our research and analysis has revealed a complicated relationship between mindfulness and executive performance—one that is important for leaders to understand as they seek to develop in their careers.

 Mindfulness is a method of shifting your attention inward to observe your thoughts, feelings, and actions without interpretation or judgment. A mindfulness practice often begins simply by focusing on your breath, noticing when your mind wanders, and then bringing it back to your breath. As you strengthen your ability to concentrate, you can then shift to simply noting your inner experience without getting lost in it at any point in your day. The benefits attributed to this kind of practice range from stronger relationships with others to higher levels of leadership performance.

The next paragraph introduces Sean, “a senior leader at a Fortune 100 corporation” who will tell you that mindfulness played a critical role in transforming his career.

To allay readers’ suspicions that Sean may be a fiction contrived by the authors to make a point, they next claim he is one of  “42 senior leaders from organizations throughout the world who practice mindfulness and whom one of us (Matt Lippincott) studied at the University of Pennsylvania.”

This “research” is described in HBR as producing a promoter’s dream list of benefits to practicing mindfulness. Unfortunately, no link is provided to an actual report of methods and results.

I Googled Matt Lippincott. A link to ResearchGate came up

Lippincott has no published research listed, but there was a link to an unpublished dissertation.

This qualitative research study examined detailed reports by senior organizational leaders linking mindfulness to improved leadership effectiveness. Extensive research supports the existence of a relationship between mindfulness and cognitive, physiological, and psychological benefits that may also have a positive impact on leadership effectiveness. Currently, however, little is known about the processes potentially enabling mindfulness to directly influence leadership effectiveness, and as a result this study was designed to explore this gap in the literature. Data was collected through in-depth interviews with forty-two organizational leaders in North and South America and Europe, many with a history of leadership roles at multiple global organizations. Participants credited mindfulness for contributing to enduring improvements to leadership capabilities, and data analysis revealed new findings clarifying the perceived relationship between mindfulness and tangible results for organizational leaders. Specifically, the results indicate that mindfulness is perceived to contribute to the development of behaviors and changes to awareness associated with improved leadership effectiveness. A potential relationship between mindfulness and the development of emotional intelligence competencies linked to increased leadership performance was revealed as well. The contribution of this study to current literature is also discussed, as are recommendations for future research.

So a dissertation with a weak methodology that allows invoking “research” and “University of Pennsylvania” for credibility.

Back to the wrap up of the HBR article, we get the buy-our-product punch line:

We believe that by focusing on mindfulness-as-corporate-fad, leaders run the risk of missing other opportunities to develop their critical emotional skills. Instead, executives would be better served by deliberately assessing and improving their full range of emotional intelligence capabilities. Some of that work may well involve mindfulness training and practice, but it can also include formal EQ assessment and coaching. Other tools and approaches include role-playing, modeling other leaders you admire, and rehearsing in your mind how you might handle emotional situations differently. By understanding that the mechanism behind mindfulness is the improvement of broader emotional intelligence competencies, leaders can more intentionally work on all of the areas that will have the strongest impact on their leadership.

The two authors

Daniel Goleman is Co-Director of the Consortium for Research on Emotional Intelligence in Organizations at Rutgers University, co-author of Primal Leadership: Leading with Emotional Intelligence, and author of The Brain and Emotional Intelligence: New Insights, Leadership: Selected Writings, and A Force For Good: The Dalai Lama’s Vision for Our World. His latest book is Altered Traits: Science Reveals How Meditation Changes Your Mind, Brain, and Body.

Matthew Lippincott is a business owner, researcher, and author involved in the creation of new leadership development solutions. He holds a doctoral degree from the University of Pennsylvania, and has previously held leadership positions at two of the world’s largest software companies.

We get a sense of former Psychology Today editor Daniel Goleman trying to create a brand of advice that unites the Dalai Lama, the good, and corporate competitiveness. Lippincott has delivered a Penn Wharton dissertation uniting mindfulness and emotional intelligence. He got work on this basis.

Hmm, did the link emerge from the data, or is this dissertation simply an informercial aimed at getting a job marketing the combo of mindfulness and emotional intelligence?

The scientific status of emotional intelligence

According to Wikipedia:

Emotional intelligence (EI) is the capability of individuals to recognize their own and other people’s emotions, discern between different feelings and label them appropriately, use emotional information to guide thinking and behavior, and manage and/or adjust emotions to adapt to environments or achieve one’s goal(s).[1]

Although the term first appeared in a 1964 paper by Michael Beldoch, it gained popularity in the 1995 book by that title, written by the author, psychologist, and science journalist Daniel Goleman. Since this time, Goleman’s 1995 analysis of EI has been criticized within the scientific community,[2] despite prolific reports of its usefulness in the popular press.

The Wikipedia offers three stinging critiques backed by links to references.

Emotional intelligence cannot be recognized as form of intelligence

Goleman’s early work has been criticized for assuming from the beginning that EI is a type of intelligence or cognitive ability. Eysenck (2000)[57] writes that Goleman’s description of EI contains unsubstantiated assumptions about intelligence in general, and that it even runs contrary to what researchers have come to expect when studying types of intelligence:

“[Goleman] exemplifies more clearly than most the fundamental absurdity of the tendency to class almost any type of behavior as an ‘intelligence’… If these five ‘abilities’ define ’emotional intelligence’, we would expect some evidence that they are highly correlated; Goleman admits that they might be quite uncorrelated, and in any case if we cannot measure them, how do we know they are related? So the whole theory is built on quicksand: there is no sound scientific basis.”

Emotional Intelligence confuses skills with moral qualities.

Adam Grant warned of the common but mistaken perception of EI as a desirable moral quality rather than a skill, Grant asserting that a well-developed EI is not only an instrumental tool for accomplishing goals, but has a dark side as a weapon for manipulating others by robbing them of their capacity to reason.

Emotional Intelligence has little predictive value.           

Landy (2005)[61] claimed that the few incremental validity studies conducted on EI have shown that it adds little or nothing to the explanation or prediction of some common outcomes (most notably academic and work success).

Some further links I also discovered

Steve Topak’s Don’t Believe the Hype Around ‘Emotional Intelligence’ 

What if I said that emotional intelligence is the ability to recognize, understand and control emotions – not just our own but the emotions of others, as well? What if I said it can be used to manipulate behavior? That sounds a bit different, doesn’t it? Not such a no-brainer anymore, is it?

And

This is not some sort of rhetoric slight of hand nor is that definition controversial. It’s common doctrine. But if authors, consultants and executive coaches were to say that Adolf Hitler was as adept at emotional intelligence as Martin Luther King Jr. – as Adam Grant explains in The Atlantic – they would not sell many books or book a lot of gigs.

Excerpts from a nice comprehensive review

Kilduff M, Chiaburu DS, Menges JI. Strategic use of emotional intelligence in organizational settings: Exploring the dark side. Research in organizational behavior. 2010 Dec 31;30:129-52.

Just as the cognitively smart person may be able to understand options and draw conclusions quickly and competently, so the emotionally intelligent person may be able to assess and control emotions to facilitate the accomplishment of various goals, including the one of getting ahead. We suggest that high-EI people (relative to those low on EI) are likely to benefit from several strategic behaviors in organizations including: focusing emotion detection on important others, disguising and expressing emotions for personal gain, using misattribution to stir and shape emotions, and controlling the flow of emotion-laden communication.

And

We have shown that the strategic disguise of one’s own emotions and the manipulation of others’ emotions for strategic ends are behaviors evident not only on Shakespeare’s stage but also in the offices and corridors where power and influence are traded.

Take away messages.

Don’t expect top quality science from Harvard Business Review, but sliced and diced stuff to sell products a research-based.

Be skeptical of researchers who promote their studies in HBR. They are often publishing an infomercial that to be effective must make extravagant claims that require stronger and more unambiguous findings than research  can possibly produce.

eBook_Mindfulness_345x550I will soon be offering e-books providing skeptical lookseBook_PositivePsychology_345x550 at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills so they dan decide for themselves. I also be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

Sign up at my website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites. Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

Rising early career female academics and second-to-last authorship

Anyone wanna talk gender now?

Are female early career academics getting less credit for work done on behalf of (usually male) faculty who get unearned senior authorships?

My posting of a link to a PLOS One article on gender differences in academic productivity at the wonderful Reviewer 2 Must Be Stopped Facebook page drew some interesting comments. I encourage more commenting at the Facebook pages and at this blog as well.

vicious cycle journal.pone.0183301.g007

My post

Always good when data enter into discussions of whether there are gender differences in productivity and impact and, if so, why? Here are some big data….

I have noticed in the Netherlands a tendency for early career women to be next-to-last author with senior (usually male) faculty last. Knowing the circumstances of this authorship order, I think this is due to rising women taking over responsibility for more day to day supervision of PhD students, but the head of the lab keeping last authorship. Some in the NL accord more prestige or credit to next to last author, but it does necessarily get appreciated elsewhere. Does anyone else notice such practices in the NL or elsewhere?

A comment from a female Australian vision scientist

Yes, been there with next-to-last authorship. I had to fight for last authorship on a PhD student paper for which I did ALL the supervision work.

A comment from a female academic in engineering

I feel there is a huge flaw with assigning such importance to the last authorship position aspect, as I am aware that it is different between disciplines even within a country (in this case Sweden, which happens to be highly relevant). Similarly to what Kyle and others have brought up, in my field the fight is for the first positions and second positions (to escape the oblivion of “et al.,”) while the last position is reserved for the person who probably has most cred already but did the absolute least (this is debatable, because some regard getting money for the project as a full justification for being included as an author even if you do f*-all on the actual paper, while others don’t – at any rate, such aspects should have been defined explicitly in the assumption of who is “productive”, and I sure couldn’t see that in the Methods section). When I was up for tenure it was my first authorships that were counted.

And at the same time I am aware that the medical sciences (where my father does research) regards the last few authorship positions very highly. Even within engineering I am skeptical that we all reason the same regarding author position, since some disciplines (e.g. bioengineering/pharma) may collaborate with medical researchers who adhere to their ideal order…

So in the end, it bothers me VERY much that someone would want to “make science” out of making an incorrect blanket assumption about authorship order when it may vary across disciplines. Especially when I as a young female researcher have used the last position of a paper to send a message to a higher-up coauthor that “we all know you didn’t help at all.” That in particular really bothers me that it could be interpreted as being the most productive/meaningful scientist in the bunch. Anyone wanna talk gender now?

A PhD comic suggested by one commentator

phd comics authorship

The open access article to which I posted a link is interesting in itself and worth a look.

van den Besselaar P, Sandström U. Vicious circles of gender bias, lower positions, and lower performance: Gender differences in scholarly productivity and impact. PLOS One. 2017 Aug 25;12(8):e0183301.

An excerpt from the abstract:

“As the analysis shows, in order to have impact quantity does make a difference for male and female researchers alike—but women are vastly underrepresented in the group of most productive researchers. We discuss and test several possible explanations of this finding, using a data on personal characteristics from several Swedish universities. Gender differences in age, authorship position, and academic rank do explain quite a part of the productivity differences.”

Some key quotes from the article itself:

Several possible explanations of the gender differences in productivity have been suggested. (i) Female researchers are on average substantially younger than male researchers (see Fig 1), and the high productive researchers are to be found in the more senior (higher age) groups [5; 6]. If this would be the only factor, one would expect that the observed productivity differences would further decline (in line with the Xie & Schauman study [9]) and disappear over time. But also other structural and/or behavioral factors may underlie gender productivity differences, hampering female academic careers [7; 15] and leading to a waste of talent. (ii) Women are rather strongly overrepresented in the lower academic positions, and in positions with a temporary contract (Fig 2), positions which are generally characterized by a higher teaching load, less access to funding, less career perspectives, and less opportunities for research [16; 17; 18; 19]. Indeed, there is a positive relation between job level and productivity. This situation is less prone to gradual change, as it may be the effect of gender bias and of a sustained existence of the glass ceiling in academic institutions [15]

iii) Women may have less access to research funding, whereas winning prestigious research grants is characterized by gender biased in favor of men, and above that very influential for the grant winners’ career [15; 14]. (iv) Female researchers have a lower status within teams and collaboration networks, and get less opportunities to become an independent researcher. This is reflected in different author positions on papers. Women more often get the less prestigious positions: the last author (= team leader) is more often a male researcher, whereas female researchers more often occupy ‘in between’ author positions. This may result in a slower career of female researchers compared to the career of male researchers [8; 13]. More directly, Van den Besselaar & Sandström showed that men progress faster through the various academic ranks [22]. (v) Productivity relates to the organizational environment where a researcher works [23], and if female researchers have more problems in being hired in top environments [24], this is expected to affect productivity differences between men and women.

In fact, gender differences may be the effect of a combination of these five factors….

From the integrated results and discussion:

What about the gender differences? In Biology, Life & Medical sciences and in Science and Engineering, women in the higher productivity classes outperform the male researchers, as they have on average a higher number of CSS3 papers: the dotted curves (representing female researchers) for these fields are above the straight curves (representing male researchers). Also in Psychology & Education we see such trend, although in the highest productivity class the scores are equal. In Agriculture and Food Sciences, and in the Social Sciences, the pattern is opposite. As already said, in the Humanities and in Computer Science & Mathematics the pattern is somewhat fuzzy, but in the latter field there are no female researchers in the highest productivity class to compare with male counterparts.

From the Conclusion:

The first question we aim to answer is whether the positive relation between productivity and impact differs between male and female researchers. We showed that this is not the case, and the relation between productivity and the number of high impact papers is about the same for men and women within the distinguished productivity classes. On average, female researchers have a at least similar impact as equally productive male researchers. In fact, we found cases where the ratio between top cited papers and productivity is considerable higher for women than for men. More specifically, the disciplinary demography seems to produce this effect: the lower the share of women in a discipline, the higher their impact compared to male researchers within the same productivity class. This may refer to gendered selection and/or to gendered self-selection.

Secondly, we found that the higher productivity classes are numerically dominated by male researchers. This leads to a lower overall productivity for female researchers, which is also in our sample about 70% of male productivity. This ratio seems to be stable over time. We should however be careful with averages in Lotka distributed data, although nonparametric tests (Mann-Whitney) show that women are outperformed by male researchers is we do not take other factors into consideration.

Thirdly, we investigated whether other variables influence productivity, and therefore explain part of the gendered productivity differences. We indeed found that a variety of factors have an effect on performance, and controlling for those reduced the effect of gender on performance considerable. So, a good part of the productivity differences are due to the fact that men are older and in higher positions, and that those in higher positions are more productive. Female researchers also occupy less last author positions than men do, and this factor also has a negative effect on female productivity. That women more often are in the middle author positions than men, reflects that women have on average lower positions, and that they are less often (conceived as) leader of a team or a collaboration network. This finding reflects that male researchers show a faster career than their female counterparts.

 

 

A dog ate the “fishy business” data for article in Science : What can be done?

dog ate my dataActually, not a dog, but it is an equally lame story: A thief allegedly made off with the only copy of the data from study critics claim never happened. What can be done?

Authors of what could became known as the fishy business study   of effects of microplastics on fish claimed they could not share the data behind their controversial conclusions because the laptop storing the study data had been stolen. They claimed no backup was available. This was not just some psychological study of embodied cognition that no one can replicate about which no one should care. This study helped spark removal of microbeads from toiletries and cosmetics.

Fishy business

Two Swedish fish researchers, with the aid of five colleagues elsewhere in the world, have alleged fraud in a study on the effects of microplastics on larval fish published in Science by two scientists at Uppsala University (UU) in June 2016. The study supposedly took place at the Ar Research Station in Gotland, but the whistleblowers say it never happened, based on eyewitness testimony and other evidence. A preliminary investigation by UU dismissed the claims in August 2016; a second investigation, by an expert panel at Sweden’s Central Ethical Review Board, is still ongoing. An expert hired by that panel filed a more damning report last February that raised the possibility of fraud. Now, both sides are awaiting the expert panel’s final verdict, which may influence an ongoing debate about how Swedish institutions investigate research misconduct.

swedish-fish-assorted-5lb-7Skepticism about the findings and the authors not producing their data led to the study being retracted.*

The incident is causing re-evaluation of Science’s data sharing policies and should give pause elsewhere.

Science has an editorial policy promoting data availability and research transparency.

“Before publication, large data sets must be deposited in an approved database and an accession number…included in the published paper.”

And

“After publication, all data [and code] necessary to understand, assess, and extend the conclusions of the manuscript must be available to any reader of Science.”

But some loopholes:

Small data sets are exempt.

Scientists cannot be trusted to reliably share them upon request.

There are no consistently enforced penalties for investigators not sharing  data.

The Science editorial asked “Does failure to provide raw data post-publication lead to the automatic retraction of the paper?”

Ah, yes, ask PLOS One please note.

The Science editorial proposes

The solution to avoid data disappearing is simple: Journals must mandate and enforce data archival on a recognized, online repository at the time of submission. Only editors and reviewers would have access during peer review; the data would be made generally accessible upon publication.

And provides this rationale:

Publishing verifiable research is a tenet of scientific progress and, ultimately, journals are responsible for guaranteeing compliance with their open-data policy. At a minimum, this responsibility involves a cursory check of the underlying data and ensuring that all data are available for reviewers to assess (4). Science publishes many papers describing major breakthroughs, but these extraordinary claims must be supported by extraordinary evidence. This includes, first and foremost, a complete and understandable data set that is open to reviewers and, ultimately, becomes open to scientists and the public.

Laudable principles, indeed. But this incident occurs at a time just when there is a general retreat on journals enforcing  data sharing policies. There is a call for universities and funding agencies to step into the breach and insist on data being available.

But we know how what happens when the skeptical or merely curious request data. Refusal and even retaliation against those who request data are increasingly being reported. Journals don’t support those who request data. Professional organizations don’t support them. When pushed, universities side with authors who do not want to share their data.

When you request data, you may find no one supports you and you may even lose friends.

I asked for the PACE trial that the investigators had promised would be available as a condition for publishing in PLOS One. I thought the journal would facilitate my obtaining the data. Instead, PLOS slapped a ban on my discussing this in my PLOS Blog Mind the Brain. But PLOS would not publicly acknowledge the restriction nor even spell out the specific conditions-

Was the ban on my writing about the request for the data? About data sharing, more generally? Could I blog about chronic fatigue syndrome/ if I did not mention the PACE trial? Misunderstanding of what I could and could not write about led to comments abruptly being closed on my blog in December 2015 and my being denied access.

Eighteen months after my request, I still have not received the data, but PLOS One finally attached a highly visible Expression of Concern to the PACE paper published in the journal.

I thought it might be time for me to start blogging about PACE and any other topic I might have avoided because of concern about Mind the Brain. I agitated a bit, got others doing so on Twitter. The PLOS Twitter account replied a decision would be forthcoming. My access to Mind the Brain was abruptly cut, with a misleading announcement from PLOS that the parting of our ways was by mutual agreement. It decidedly was not. It was by unilateral fiat.

You can still read my posts at the PLOS blog website. But don’t give them the traffic they crave. You won’t be able to leave comments. Instead go to same blog posts here   at CoyneoftheRealm.com  I welcome your comments there.

*Editorial Retraction

Jeremy Berg

After an investigation, the Central Ethical Review Board in Sweden has recommended the retraction of the Report “Environmentally relevant concentrations of microplastic particles influence larval fish ecology,” by Oona M. Lönnstedt and Peter Eklöv, published in Science on 3 June 2016 (1). Science ran an Editorial Expression of Concern regarding the Report on 1 December 2016 (2). The Review Board’s report, dated 21 April 2017, cited the following reasons for their recommendation: (i) lack of ethical approval for the experiments; (ii) absence of original data for the experiments reported in the paper; (iii) widespread lack of clarity concerning how the experiments were conducted. Although the authors have told Science that they disagree with elements of the Board’s report, and although Uppsala University has not yet concluded its own investigation, the weight of evidence is that the paper should now be retracted. In light of the Board’s recommendation and a 28 April 2017 request from the authors to retract the paper, Science is retracting the paper in full.

Journal of Health Psychology Editor responds to misrepresentations by Cochrane author in Mental Elf blog

A Cochrane review author made a number of false claims in his Mental Elf blog post about why his manuscript about PACEgate was rejected by the Journal of Health Psychology.

Andre Tomlin, Editor of Mental Elf should accept responsibility for unfounded attack on integrity of editorial process at JHP.

Brurberg’s misrepresentations defending PACE suggest he is unfit to be a Cochrane reviewer and that he is a source of bias in Cochrane Reviews of graded exercise therapy for chronic fatigue syndrome

This incident lends weight to calls for release of data for independent reanalysis of Cochrane patient level meta analysis conducted by authors including Brurberg and the Principal Investigator of  the PACE trial.

Pacegate altBrurberg’s statements and the responses of David Marks, editor of Journal of Health Psychology

In his post at Mental Elf, Kjetil G. Brurberg claimed:

I was invited by the Journal of Health Psychology to comment on their ongoing PACE debate. Realizing that some people might view my role in a Cochrane review based on individual patient data as a potential conflict of interest (COI), I consulted the editor on these issues before accepting the invitation. Shortly thereafter, the editor confirmed that he did not see my potential COI a big problem.

david marksDavid Marks replies:

What I actually said was: ‘Almost everybody can be accused of ‘bias’ in one way or another. Any potential conflicts can be declared at the end of the article.” In his original submission, Brurberg declared his COIs as follows: “Kjetil G. Brurberg has co-authored a Cochrane Review about exercise for CFS/ME in which the PACE-trial is included. Brurberg is also a member of the steering committee for an Cochrane individual patient data review that is now submitted.”

Contrary to Brurberg’s statement, it is important to note that his declaration of a conflict of interest was not the reason for the rejection of his paper.  The paper was rejected because of several faults and flaws.  The reviewer’s report listed 14 issues with the paper and ended with the recommendation that “this commentary cannot be accepted without a response to cover the issues raised above.”

The rejection letter sent to the authors was in standard format and COI did not enter the equation. The rejection letter was as follows:

“01-Mar-2017

Dear Dr. Brurberg:

I write you in regards to manuscript # JHP-17-0133 entitled “A PACE-gate or an editorial without perspectives?” which you submitted to the Journal of Health Psychology.

In view of the criticisms of the reviewer found at the bottom of this letter, your manuscript has been denied publication in the Journal of Health Psychology. However I trust the reviewers’ comments will be helpful in the further development of your research for publication.

Thank you for considering the Journal of Health Psychology for the publication of your research.

With best wishes,

David F Marks PhD
Editor
Journal of Health Psychology

editorjhp@gmail.com

David Marks further states:

Brurberg is not telling the truth when he states: “The same COI, however, suddenly became a major issue when I submitted the commentary and my opinions were made known.”

brubergBrurberg also stated in the Mental_Elf  blog:

“all authors who have been supportive to the PACE-trials have been collectively refused.”

David Marks replies.

This statement is manifestly false. The paper by the PACE authors themselves (White, Chalder, Sharpe et al.) and the  paper supportive of PACE paper by Petrie and Weinman were both accepted for publication.  Three papers favorable to PACE were rejected following peer review, in two cases following appeal, because they were of poor  quality. In one case, that of Brurberg et al., the authors misrepresented the Conflict of Interest of the reviewers they had recommended. The attempt by Brurbergb  to deny the reviewers’ COI is futile. Their COI was unambiguously demonstrated and the evidence for it was provided to Brurberg.

Yet, in the thread of comments to his post at Mentsal Elf, Kjetil G. Brurberg compounded his misrepresentations.

The claim that I have nominated reviewers with known conflicts of interest is simply not true…

When asked to nominate reviewers to my own work, I find it important to suggest people who holds the needed distance to me and my work. As the distance increases, it becomes increasingly impossible to have a full overview of peoples’ social life during the last decade. I did not know that one of the suggested reviewers had been sitting next to one of the PACE-authors at a conference dinner, but I would not consider this as a serious conflict of interest.

 Editor Marks replies:

Brurberg fails to mention that the same person (prof x) who sat next to an author of the PACE trial paper at a dinner had also been supervised by another author of the PACE trial paper for 5 years!

When the reviewer recommended by Brurberg was asked to review Brurberg’s manuscript, he declined, stating,

“I might have a personal axe to grind, and having been supervised by Michael Sharpe (who may or may not have anything to do with this manuscript) between 5 and 10 years ago I would probably be regarded as irrevocably conflicted…”

Another reviewer nominated  by Brurberg, Professor Hans Knoop,  another nominated reviewer , wrote the laudatory editorial that accompanied  the original report of the PACE  trial in The Lancet.

The JHP Editor continued:

To bolster his crumbling position, Brurberg states:

“It should not be regarded as dishonest for authors or reviewers to have an opinion on disputed matters as the PACE trial.”

The JHP editor replies:

Nobody, and certainly not this editor, has ever stated that having an opinion is dishonest. What is dishonest is to falsely represent recommended reviewers as having no COI when their conflicts are manifestly strong and long-lasting.

Bruberg states in the blog post itself:

Despite being aware of my “conflicts of interest”, Journal of Health Psychology invited me to write a commentary on Geraghty’s editorial on the PACE trial. You did not declare however that JHP has intellectual conflicts of interests regarding the PACE trial, by only accepting reviewers representing the critics of the PACE trial, and rejecting papers from authors not sharing your views on the PACE trial.

If I had known, I would not have accepted the invitation.”

The Editor replies:

 I think I have already addressed this.

Last ditch attempt to block publication of special issue of Journal of Health Psychology foiled

foiled againPublication of the special issue of Journal of Health Psychology will go forward as planned on Monday July 31.

But there was a last ditch attempt to block publication of the special issue by a powerful but unknown PACE trial advocate. It was finally foiled on Saturday morning, July 29. A weaselly coward suggested papers weren’t properly peer reviewed and that the special issue should therefore not be published.

That of course was nonsense.  It is also an ironic complaint, because the PACE investigator team had demanded that their response to the commentary by Keith Geraghty be published without having to undergo peer review. And the same PACE investigators rejected in their revision of their reply almost all of my detailed review.

journal of health psychologySome threats were made to Sage Publications, the publisher of Journal of Health Psychology, which expressed a reluctance to go forward as planned. As often happens with these kind of pressures, we weren’t told the identity of the complainant. It was clear that whoever s/he was,  this person was powerful in being able to grind to a halt of making the special issue available,  complete with the introductory editorial that was not previously available.

I announced to my colleagues that I would take responsibility for unilaterally breaking the embargo on the press release and post a blog about it. If necessary, I would explain that I did it without permission, because I was making an announcement, not a request.

I prepared the blog on July 28, but waited till 7 AM on July 29 before going live, in hope that Sage would relent. No decision was announced by  that hour, and so I posted the blog.

sage publicationsThe strategy was that we would get visible in social media and be prepared to create an embarrassment for Sage Publications if the publisher did not let us go forward. Actually, all of the papers were available Early Release except Editor David Marks’ great accompanying introductory editorial. We were prepared to move that editorial to a public repository, and if necessary the other articles from the special issue, as well. A few hours later, Sage agreed to go forward and publish the special issue on Monday morning.

Stay tuned for a historic issue of the journal, complete with Editor David Marks’ previously unavailable introduction.

Global expert on distant and faith healing chaired PACE Data Monitoring and Ethics Committee

mild distance-healing1Paul Dieppe, the initial Chair of Data Monitoring and Ethics Committee for the PACE trial is also renowned as a “leading global voice in the understanding and advancement of energy/ spiritual healing.”

Most of my medical colleagues think I’ve gone completely barmy –  Paul Dieppe

Renowned as a leading global voice in the understanding and advancement of energy/ spiritual healing

Paul Dieppe, the Chair of Data Monitoring and Ethics Committee of the PACE trial of cognitive behavior therapy and graded exercise therapy for chronic fatigue syndrome has had a distinguished career, up to a point. He has emeritus status at the University of Exeter Medical School and is described on the website:

Paul qualified as a doctor in London in 1970. He specialised in rheumatology and became ARC professor of rheumatology in Bristol in 1987, and Dean of the Bristol Faculty of Medicine between 1994 and 1997. He then switched to health services research and was the Director of the MRC Health Services Research Collaboration between 1997 and 2007. After that he spent a short time at the University of Oxford before moving to the Peninsula Medical School to work in clinical education research.

With the formation of the University of Exeter Medical School, he took on the role of Professor of Health and Wellbeing.

Yet a more recent (2016) website gives a different picture of him:

exeter professor discovers

And gives a chance for  Dieppe to describe himself:

Paul, now renowned as a leading global voice in the understanding and advancement of energy/ spiritual healing, said: “My goal is to work towards the greater understanding that we can bridge the gap between biomedical thinking and the world of unexplained phenomena around areas such as healing, which if we placed greater value upon, could play a crucial role in the wellbeing of society.”

A further advertisement for the conference at which Dieppe spoke stated that there would be live demonstrations of healing on stage and describes his talk as:

The incredible power of remote healing across distance:  Paul Dieppe, emeritus professor of health and wellbeing, renowned for being at the global forefront of research into Healing.

faith healer in NHSA press release for “the largest meta-analysis of ever undertaken into the effects of non-contact healing”  states:

In fact, there are many healing practices where healer(s) and the one needing healing never come in contact with one another.  Indeed, they may never even meet, let alone know each other.

Paul Dieppe is identified as a Trustee of the group that produced a meta-analysis and he comments on the findings:

“This is a rigorous, high quality scientific report, and it clearly shows that healing intention can have beneficial effects on living systems, both human and non-human. Now we need to explore questions such as who does it work for and in what circumstances, as well as the how and why questions.”

A 2015 interview shows him rejecting scientific methodology as old fashioned materialism. Instead as he favors  anecdotes  and embraces energy/spiritual healing.

Have you come across many instances of actual healing?

Masses of cases. It’s anecdotal stuff, but it’s extremely impressive and extremely convincing. I’ve experienced it myself. A lot of this stuff happens completely under the radar, people just getting on with it in their back room, not part of any particular body or group, just doing their own thing. I went to see one such person, a little old lady in her front-room, and she said the best way to understand healing is to experience it yourself, and asked if I had anything I wanted working on. I told her I had a bad knee, so she said, OK let’s give it a go. And for what it’s worth, it’s been better since then. That was a couple of years ago.

Do you have a sense of what happens in the brain, does it involves specific neural or nervous networks? What systems does it involve?

Life gets difficult when you talk like that. You’ve slipped into the assumption that our materialist knowledge is the appropriate framework for that. We assume our current materialist science can explain everything, so the default position is ‘how can I explain this physiologically within my own materialist framework?’ I’m not convinced that’s the right way to do it.

No, I don’t have a materialist worldview, but if there is a spiritual dimension (which I think there is) I’m curious as to how it interacts with the body. William James, for example, explored how spiritual experiences interacted with ‘the subliminal self’. I wonder if healing is connected to things like trance states, altered states of consciousness, and so on.

OK, well how might it happen in those terms? Certainly there’s a lot of evidence for our ability to alter things through the Autonomic Nervous System via hypnosis. That can give us clues to a lot of this stuff. Hypnosis certainly affects the ANS, it certainly affects the immune system…probably everything. The mind / body split is of course silly. Everything is connected, everything works together. Although it’s easiest to talk in terms of what we can observe physiologically…I think we can control pretty much all of it probably.

OK, so at the moment we’re at or near the peak of a biomedical conception of health and illness. You, by contrast, espouse what you describe as ‘a bio-psycho-socio-spiritual theory of the transcendence of suffering’. How does that go down in academic medical circles?

Most of my medical colleagues think I’ve gone completely barmy, and this is all absolute nonsense. The dominant model in which we work and teach rejects anything to do with spirituality. If you mention words like spirituality or love, you’re rejected. It’s not acceptable behaviour, you’re regarded as someone who should be quietly taken off to the funny farm. So it’s quite lonely. It doesn’t bother me, I’m at the end of my career, I don’t need a new job or a reference, I don’t need to toe the line. It’s irrelevant to me. But I can feel the group discomfort sometimes around this area. I think the medical profession is a bit out of kilter with the rest of society, which is probably more accepting of the link between spirituality and health.

The interview links to a video featuring Dieppe on a trip to Lourdes, a destination for millions seeking miraculous cures.

The Role of the Data Monitoring and Ethics Committee in a Clinical Trial

As chair of the PACE DMECT, Paul Dieppe was in a unique and powerful position, able to monitor incoming data that was unblinded with respect to the group to which participants were assigned.

A recent Medical Research Council document states

6.2 DATA MONITORING COMMITTEE

The role of the Data Monitoring Committee (DMC) is to monitor the data emerging from the trial, in particular as they relate to the safety of participants, and to advise the Trial Steering Committee on whether there are any reasons for the trial not to continue. It is the only body involved in the trial that has access to the unblinded (unmasked) comparative data during the trial.

At the time of the fateful shifting of scoring of subjective outcomes and downgrading of the status of objective outcomes, Dieppe more than anyone else was in a position to know how switching would effect results of the analyses of the data already collected. He supposedly reviewed analyses in closed meetings, excluding Principal Investigator Peter White, but he was also meeting White formally and informally.

distasnce healingDieppe knew exactly what was going on in the most recent data, in terms of emerging  patterns of group differences. He would also have attended the meetings in which changes to the protocol were discussed and approved. Did he remain quiet? Refuse to meet with White in private? Maybe Dieppe relied on the unspoken interconnected consciousness of the two men.

We have a mystery akin to that about what when on before the US elections between Trump and his advisers, on one hand,  and the Russians.

The significance of a science-skeptic heading the PACE DMET

 Even before Dieppe’s colleagues would have described him, as he puts it, going completely barmy, he was a believer in the extreme, almost mystical power of the placebo. Perhaps that made him an ideal choice to head the DMET for a trial that created such an imbalance in nonspecific effects between the active treatments and the comparison group. And then boosted the imbalance as part of treatment and even in a newsletter (!).

But seriously, what we make of someone having such disdain for scientific methodology having the responsibility for ensuring its rigor in a major clinical trial?

 

 

 

 

McMindful: Make money as a mindfulness trainer, no background or weekend retreat required.

McMindful: Make money as a mindfulness trainer, no background or weekend retreat required.

With an interview with

hustleCan a clinical psychologist ethically offer a product with improbable, unsubstantiated claims to be applied to patients by persons who have not been vetted for competence or fitness to treat patients?

A web-based training package promises to turn anyone quickly into a mindfulness trainer, regardless of background or previous training.

Promoters of the package claim it is backed by more science than its competitors.

There are no legal restraints in most jurisdictions on someone calling themselves a mindfulness trainer, coach, or therapist. No training requirements or background check.

There no enforceable ethical codes applicable to such persons once they hang out their shingles.

Many treatment settings are replacing therapists with mindfulness trainers.

Many persons with serious mental health problems seek mindfulness training, but this training does not prepare trainers to recognize and refer such persons.

I didn’t act quickly enough to a series of frantic emails from Seph Fontane Pennock Positive Psychology Program, and so I missed out on a deep discount for an exciting offer to become his next success story.

If I had been quicker. I could have received a 40% discount on a $750 downloadable training package that promised to turn anyone into a money-making mindfulness trainer, without them having to acquire any background or participate in a weekend retreat. It did not matter if a purchaser did not have any clinical background, because the program would release “the real trainer, teacher and coach in yourself that you’ll be proud of.”

My final invitation to become mindfulness trainer came in a breathless gushy, seemingly personalized email that began:  “Hey Jim, I’m blown away by all the emails about the success our members have started to see..”

It continued with testimonials from purchasers who were impressed that they could customize the materials to appear to be their own, including by putting their company logo on them.

The wannabe trainer doesn’t even need to study the package before slapping on a relabeling and selling to clients and industry.

The website makes it clear that it is superior to other training because it is better rooted in science. But just what does “rooted in science” mean? Is that as vague and meaningless as saying that performance of your automobile is rooted in physics? I think claims about the efficacy of interventions needed to be rooted in randomized trials or program evaluation and there is no evidence that this package has been put to these kind of tests.

The package is billed has instantly turning purchasers into mindfulness trainers.

You can simply take this, go out and teach mindfulness …

No longer will you have to go from A to B, from B to C, etc. Instead, you can go straight from A to Z. Mindfulness X is the ultimate shortcut.

It is claimed that professionals will be able to “instantly and successfully teach mindfulness.”

Who is the mastermind behind Mindfulness X?

Dr. Hugo Alberts (Ph.D.) describes himself as a “professor, entrepreneur and coach” who has touched the lives of thousands. With Mindfulness X, he had become a sought after trainer, but decided to stop live presentations in order to touch even more lives with this downloadable product.

I did some fact checking. Hugo (H.J.E.M.)Alberts, Ph.D. is an Assistant Professor in the Clinical Psychological Science Department at Maastricht University. Web of Sciences lists 19 publications for him, including a couple of low quality, underpowered studies of mindfulness.

Most importantly, I find no evidence of any peer-reviewed evaluation of Mindfulness X. The key issue is that Alberts is claiming extraordinary efficacy for this program. If his claims are true, it is more effective than any psychotherapy. Extraordinary claims require….

Elsewhere I have provided continually updated evaluations of mindfulness-based training and therapies. There is still a lack of evidence of any advantage of mindfulness over other active treatments. Claims about mechanism depend on low quality studies that do not rule out anything beyond nonspecific –placebo- effects. There may be no specific mechanism beyond that.

Mindfulness training is mostly a benign treatment, often delivered to persons who are lacking moderate to severe psychological problems. But it can have adverse effects on persons suffering simple or complex PTSD, ruminative chronic depression, or psychosis.

An increasing proportion of the treatment or coaching of persons with serious psychological problems is being done by persons lacking in any protected title or any independent certification of qualifications.

Such providers are not bound by enforceable ethics codes.

My advice to Dr Albert: you are quite junior. If you are serious about your scientific career, concentrate on producing quality research, not so much on making money in ways that threaten perceptions of your integrity. I assume you are a clinical psychologist. You have a responsibility to stick to evidence-based claims and to avoid the harm of turning loose on the community ill-trained or untrained promoters of mindfulness, particularly with vulnerable clients.