Carly Maryhew’s Open letter to TEDxBristol regarding Esther Crawley’s “Disrupting Your View of ME” presentation

Carly Maryhew’s recent open letter to TEDxBristol concerning the failure of Esther Crawley’s recent talk to adhere  to TEDx’s explicit content guidelines is a gem, well worth a read by a general audience.

CaptureAt one level, her letter is a contribution to the ongoing debate about just how infrequently TEDx talks live up to the claim of “Only good science.” We need to amplify and broaden this conversation because the noble concept of a TEDx talks desperately needs rescuing from what TEDx talks have become.

At another level, the letter is a searing indictment of Esther Crawley’s”Disrupting Your View of ME” talk with blow-by-blow pitting of what Crawley said versus the explicit TEDx guidelines.  That Carly Maryhew was a practicing lawyer before she became ill with myalgic encephalomyelitis/chronic fatigue syndrome is apparent.

I had to ask Carly, though, where did the great flashes of activist citizen scientist apparent in the letter come from? After all, this would be an excellent conference presentation about pseudoscience and politics being passed to consumers as science. Carly’s reply something that I commonly hear from the new wave of patient actors/citizen scientist:

“It’s out of necessity to analyze scientific research and related content, mostly from interacting with other patients.”

As Carly’s open letter documents, it’s that very achievement of the patient community that the Esther Crawley is attempted to deny and smear with character assassination and artistic license.

More than that, she argues that one unblinded trial with switched, subjective outcomes does not make a quack treatment evidence-based.

We should look forward to receiving the courtesy of a response from TEDxBristol and gently nudge them if one is not forthcoming. Dissatisfied viewers of the Crawley talk keep posting critical comments at the TEDxBristol, but commentary keeps getting hidden from view from all but those who posted. I recommend anyone who had their comments hidden, submit them as comments moderation at this blog site.

Comments have also been disabled at the official video of Esther Crawley’s talk.

Carly Maryhew’s Open Letter 

15 December 2017

To whom it may concern at TEDxBristol:

As an ME patient, it was with great interest that I watched Professor Esther Crawley’s TEDxBristol talk “Disrupting Your View of ME” on 2 November 2017. Unfortunately, the contents of that talk did not seem to comply with the standards of TEDx, as described in the TEDx Content Guidelines.[1] While that might be sufficient to result in the video merely being displayed with a warning regarding the contents, there are other portions of Professor Crawley’s presentation which are highly offensive for reasons which may not be readily apparent, discussed below. Accordingly, I request that the entire video not be posted by TEDxBristol, either on its own site or on YouTube.

“Guideline 4: Only Good Science”

The most obvious concern is that in much of Professor Crawley’s TEDx talk she is referring to her recently published trial, Specialist Medical Intervention and Lightning Evaluation,[2] abbreviated as SMILE. The “Lightning” in the name of the trial refers to the Lightning Process (LP),[3] a specific form of neuro-linguistic processing (NLP)[4] which was developed and commercialized by Phil Parker.

“Claims made using scientific language should:

  • Be testable experimentally.
  • Be based on theories that are also considered credible by experts in the field.

Claims made using scientific language should not:

  • Be so obscure or mysterious as to be untestable
  • Be based on experiments that can not be reproduced by others
  • Be considered ridiculous by credible scientists in the field.”

Contrary to TEDx guidelines, her claims of success based on the SMILE trial are not testable experimentally due to a failure of her paper to describe the process used by the Lightning Process. This information is also not commonly available online, except via patient accounts, due to Phil Parker requiring that customers not discuss it.[5] LP and the NLP methodology which it is based on are both widely considered debunked pseudoscience by the mainstream medical community.[6]

“Claims made using scientific language should:

  • Be backed up by experiments that have generated enough data to convince other experts of its legitimacy.
  • Show clear respect for the scientific method and scientific thinking generally.

Claims made using scientific language should not:

  • Be based on data that do not convincingly corroborate the experimenter’s theoretical claims.”

There has been no evidence to establish the legitimacy of LP or NLP for any disorder, and Phil Parker has been specifically forbidden to promote LP as a cure for ME/CFS.[7] Other studies conducted into NLP have shown it to be ineffective for other disorders.[8] Indeed, despite Professor Crawley’s claims of success, the methodological flaws in her work mean that her own study has failed to demonstrate effectiveness, due to relying solely on subjective outcomes combined with a lack of blinding or adequate control group.

Such subjective outcome measurements are especially problematic when the treatment itself demands that the customers proclaim it is effective to make it work, as happens in the case of LP,[9] and may be compounded when the subjects are children who may be especially vulnerable to such pressures. As a demonstration of the pressures placed upon children by LP to be accountable for curing themselves, children have been known to attempt suicide when LP fails to work.[10]

“Claims made using scientific language should:

  • Not fly in the face of the broad existing body of scientific knowledge.”

It should be obvious that it flies in the face of reason (and a large body of biomedical research) to claim that any disease or other condition can be successfully treated by teaching children to say “STOP” and make a ritualistic movement.[11] Various patient accounts indicate that they are told symptoms will go away if they stop “doing” their illness, by suppressing negative thoughts to enable them to “grow new neural pathways.”[12]

Professor Crawley’s Accusations

Although I could not find a TEDx guideline regarding making untrue statements on the stage, presumably that is because it is a problem which is so obvious that it shouldn’t need a guideline. Yet it did happen during Professor Crawley’s TEDxBristol talk, much the same as it happened in other recent talks she has given to medical personnel in various venues.[13] At approximately 9:05-9:40 during her TEDxBristol talk, a slide is displayed with a threat written in the style of a stereotypical ransom note. Professor Crawley says “This is an email that I got a few years ago. It was used on the front cover of the Sunday Times, to discuss the research environment for chronic fatigue syndrome. I still laugh at the idea that someone was going to cut my balls off (laughter from audience). Does make you wonder.”

However, this note was not emailed (at least not as a threat) to her. It was an artistic compilation made by an employee of the Sunday Times to sensationalize unsubstantiated threats which another controversial researcher claimed he had received via phone calls.[14] In that article, there is no claim that she received such a threat, though she did claim to receive an email calling her an evil bastard.[15] A recent correspondence from Bristol University, in response to a Freedom of Information Act request from the ME children’s charity Tymes Trust, indicated that they had “received no official reports of harassment of University staff by a third party” from 2010-2017.[16]

It is possible that threats were received by Professor Crawley, albeit not reported, and any such harassment and threats would be universally condemned by the ME/CFS community. But any such harassment categorically did not consist of the letter which Professor Crawley displayed during her TEDx talk, and it is grossly inappropriate for it to have been used in that context, especially with joking that someone meant to cut off her balls, when she knew very well that such threats had never been addressed to her. I cannot claim to know what would motivate someone to misrepresent such a vile threat, but these accusations typically surface when a controversial researcher is facing criticism from patients, doctors, researchers, and other academics due to making absurd claims based on research using shockingly poor methodology,[17] such as was used in the SMILE trial to generate positive results for a therapy which is indisputable pseudoscience.[18]

Similarly, opponents of their work are frequently compared to climate denialists, animal rights activists, and anti-vaxxers,[19] in an attempt to discredit us. The claims which Professor Crawley made in her TEDx talk regarding “a few people and a few organizations” trying to stop their research into ME/CFS is only partly accurate. Patients and patient organizations are indeed trying to stop them from performing unethical and shoddy research which diverts valuable funds from serious researchers who use rigorous methodology to test clear hypotheses. But these are a large majority of ME/CFS patients and nearly every patient organisation,[20] joined by ME/CFS experts, biomedical ME/CFS researchers, and academics based in universities around the world.[21] Our opposition to their research practices and influence does not take the form of threats or harassment, but rather consists of parliamentary questions, Freedom of Information Act requests, petitions, blogs, social media commentary, letters published in scientific journals, and published scientific articles.[22]

Accordingly, I hope that you can understand why patients and their supporters find Professor Crawley’s talk to be so upsetting. Not only is she promoting blatant pseudoscience and making false accusations against the patients who oppose her work, she goes so far as to brazenly suggest that she should be our voice. As at ME/CFS patient, my response is that we must be allowed to speak for ourselves, and that those of us who are too ill to speak should be spoken for by our caregivers and other loved ones.[23] All Professor Crawley needs to do is to stop attempting to silence us.

Additionally, I believe that children with ME/CFS can speak for themselves and be heard when they want to, and even they recognise the SMILE trial’s LP nonsense for what it is. In the words of 10 year old patient Shannon Tiday: “They say ‘raise your hand out and say stop?’ Don’t you think I tried that? What is wrong with these people? Well people’s people, you can’t stop them. And that’s not our fault, so don’t think it’s our fault!”[24]

I would very much appreciate TEDxBristol’s assistance in this by denying Professor Crawley a platform for dangerous pseudoscience and baseless accusations against the ME/CFS patient community.

Thank you,

-Carly Maryhew

A full set of references for the bracketed numbers are available here 

 

 

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.