Appeal to NICE concerning the Guideline Committee for ME/CFS

please signJohn Peters informs me: “Anyone can sign. The letter is going off with a couple of dozen signatures, but the petition is open to all.”

The petition is here. Please sign.

For many years, patients, charities and scientists have listed the deep flaws in studies promoting CBT and GET for ME/CFS, but NICE has accepted the research uncritically and a major part of its advice on the illness follows this approach. In the past a majority of the members of the Guideline Committee have had a conflict of interest.

In the USA, this research has been rejected by the Centers for Disease Control, the Food and Drug Administration, and the Agency for Healthcare Research and Quality. They and the National Institute of Health and the Institute of Medicine/National Academy do not consider CBT and GET to be effective.

There may be 250,000 patients with ME/CFS in the UK: NICE guidelines not only affect the way they are treated by the medical profession, but may be used by insurance companies and benefit agencies. These agencies may place inappropriate expectations on patients to undergo such therapies, despite a lack of evidence that they are safe, and in the case of GET, a strong response from patients that they can cause severe harm.

We call on NICE to ensure:

1. The process of deciding who determines the membership of the Guideline Committee is open and involves stakeholders.

2. Whoever appoints the members of the Guideline Committee does not have any involvement in research into CBT-GET or is currently using these interventions to try to treat ME/CFS or is a colleague of anyone associated with the CBT-GET model.

3. The selection of members of the Guideline Committee is also an open process and involves stakeholders.

4. No one who has previously been a member of an ME/CFS Guideline Committee is eligible to sit on this new committee.

5. No one with a conflict of interest is allowed to be a member of the Guideline Committee, and that conflict of interest includes any financial interest or researcher allegiance or close working association with someone linked to the CBT-GET model.

6. Stakeholders should have a right of appeal with cause against members selected.

Full letter sent to Sir Andrew Dillon: https://www.s4me.info/threads/grahams-finalised-letter-to-nice-january-2018.1885/

More information here: https://www.youtube.com/watch?v=7Y6XFipQigE&feature=youtu.be

On the previous NICE Guideline Committee: https://www.coyneoftherealm.com/blo…based-on-political-considerations-an-exchange

And: https://meagenda.wordpress.com/2008/12/19/a-nice-dilemma-by-margaret-williams-part-two/

Read the letter

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.

CDC – Don’t just discreetly change recommendations for treating chronic fatigue syndrome, publicize the changes!

 

Original Title: BLDG21_0023.jpgNo one is going to notice important changes to Center for Disease Control recommendations for treating chronic fatigue syndrome unless explanations are often and disseminated.

Unless you stumbled on it by accident, you had to be a routine watcher of the CDC website to have noticed a discrete last summer in the agency’s recommendations for treating chronic fatigue syndrome/myalgic encephalomyelitis.

CDC Removes Reference to Disputed ME/CFS Therapies From Website

Last summer: David Tuller University of California, Berkeley lecturer in public health and journalism and activists noted

The CDC website now advises patients to develop an individual management strategy with a health care provider and warns them not to overexert themselves. (However, a separate page about ME/CFS in the CDC’s features section still includes advice about “graded exercise.”)

And

In an email sent in response to questions about the changes, the CDC did not specifically mention graded exercise therapy and cognitive behavior therapy, or concerns about the PACE trial, but said that it rewrote the website section to avoid “confusion” associated with its previous recommendations and to eliminate medical jargon.

“We continue to believe that exercise can be useful for some ME/CFS patients, and also are trying to emphasize that people need to be careful not to overdo it and push themselves so far that it harms their health,” the emailed statement reads. “We also state that talking to a therapist to help find strategies to cope with their illness may be helpful. We know from our past discussions with patients and their loved ones that there has been confusion about what we recommend related to exercise and therapy. We hope that the updated website provides more clarity.”

At the time, the CDC made in promised to Tuller and the patient community that has not been kept:

The CDC also promised to disseminate information about the website changes once the agency has updated the companion pages for health professionals.

Now, a new article by Tuller and science and health journalist Julie Rehmeyer asks

Why did it take the CDC so long to reverse course on debunked treatments for chronic fatigue syndrome?

I highly recommend this article and agree:

While the CDC deserves credit for having removed information based on bad science, that alone is not enough. The agency must also undo the damage it has caused.

I agree well as with Tuller and Rehmeyer’s three recommendations to the CDC:

Acknowledge more publicly that the CDC got things wrong.

And

CDC must actively disseminate the news that it no longer recommends these two ineffective and possibly harmful therapies and that no legitimate evidence supports their use.

And

Reach out directly to health care and medical organizations, such as Kaiser Permanente and the Mayo Clinic, to urge them to stop recommending the treatments and ensure that the information they provide is truly up to date. That outreach should include the UK’s National Institute for Health and Care Excellence.

 

 

 

 

Bristol University should start cleaning up its clinical trial registries by publishing two psychosocial intervention studies

A story in the feisty Bristol Cable revealed Bristol University ignores its responsibilities to publish results of clinical trials. A follow up story announced the university’s pledge to remedy the situation.

The investigation of hidden data involved drug and medical device trials and excluded psychotherapy or psychosocial intervention trials. But here are two trials for which publication is overdue.

One of the trials evaluates a quack treatment, which the Advertising Standards Authority (ASA) advises cannot make claims about health benefits. Its promoter was paid handsomely for the treatment provided in the trial. He capitalized heavily on the trial to advertise his treatment as being evaluated in a clinical trial. Was the trial simply a lucrative infomercial for his discredited product?

box score

There is some evidence that these trials did not go as planned, but that is all the more reason to publish results so that we can understand what went wrong.

lack of transparency

The situation is sufficiently problematic for me to recommend:

Patients should not enroll in psychotherapy trials associated with Bristol University until results of these trials are published.

Patients should be advised that the burden and inconvenience of participating in research is not warranted if the results remain unpublished. You are not obligated to participate in research. Don’t let anyone tell you differently.

A headline in the investigative journalism platform Bristol Cable read:

Medical research in Bristol violates international transparency …

A joint investigation by TranspariMED and the Bristol Cable shows that the University of Bristol has not posted summary results for a single clinical trial onto registries. On the main European trial registry, the university is listed as the sponsor of 14 drug trials involving over 1,600 healthy volunteers and patients. Three trials that ended in 2009, 2011 and early 2016 have still not posted results there. Most of the remaining 11 trials also seem to have been completed, but are still listed as ‘ongoing’, suggesting that the university is not keeping its medical research records up to date.

On Clinicaltrials.gov, the main American registry, the university has registered 16 research projects; it has posted summary results for none of them.

A follow up headline read

Bristol University pledges clinical trial registry cleanup

A spokesperson for the university responded that Bristol had recently started adding results to the European registry. He also explained that until last year, “anyone could set up an account naming the University as the umbrella organisation” on Clinicaltrials.gov. The university has now assumed central control over those registry entries and is working to clean up its data, the spokesperson said.

The founders of the Bristol Cable told The Guardian: ‘We’re holding people to account for their actions’

The investigation was part of a larger international effort to uncover and correct a scandal: results of many drug trials are never published. Or published reports switch outcomes to make the manufacturers’ drugs appear more effective than they actually were in the trials.

Psychotherapy trials are excluded from these investigations. Yet, publishing results of psychotherapy trials consistent with the originally planned outcomes is undoubtedly less common because of lack regulatory oversight of psychotherapy trials. The confirmation bias in published of psychotherapy trials could even be stronger than with drug trials.

But we really cannot get a precise estimate of how many results of psychotherapy trials are being kept out of view. Many psychotherapy researchers do not even register their trials – or register only after they have already peeked at some of their results and can revise what were the originally intended outcomes being investigated.

This situation is unacceptable because it allows the promotion of ineffective and even harmful treatments.

Moreover, investigators have a moral and ethical responsibility to patients who consent to participate in clinical trials. In a trial comparing an intervention the investigators expect to be effective to a control group, half of the patients will not be randomized to the intervention. In many trials, this means the patients will be assigned to the no-treatment control group and get nothing. But these patients will be burdened with extra visits to complete the outcome assessments needed to evaluate the active treatment given to the patients in the other group.

Presumably, if the patients assigned to the control group are not simply confused or misinformed, they voluntarily continue to show up because they believe they are contributing to science and to knowledge that will help others in their predicament, if not themselves.

 

The first trial

The trial registration is ISRCTN72645894 DOI 10.1186/ISRCTN72645894

Early intervention in fatigue: a feasibility study

Study hypothesis

The overall aim of this study is to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to investigate the effectiveness and cost effectiveness of early intervention for chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) compared with standard medical care in primary care.

Intervention

Early intervention for fatigue. The intervention is based on the principles of cognitive, behavioural and graded exercise and is delivered by a trained therapist in an individual face-to-face session with telephone follow-up sessions. Follow up length: 6 month(s); Study entry: single randomisation only

Primary outcome measure: Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months

Secondary outcome measures: Not provided at time of registration

Note that the primary outcomes are not patient clinical outcomes, i.e., whether patients benefited from being assigned to active treatment versus control. The study was explicitly described as a feasibility and acceptability study.

Psychotherapy studies are commonly described in the literature as pilot and feasibility studies, mainly to escape the criticism that the study was small and underpowered.  But, if so, effect sizes for patient outcomes should be presented because they are likely to be exaggerated and not generalizable to what would occur in a larger, better controlled study or in routine practice.

I wonder if the consent forms provided to patients indicated that the investigators were not interested in whether they benefited from treatment.

What results of a freedom of information act request revealed

Feasibility: We aimed to recruit 100 participants to this study, but were only able to recruit 44.  In addition, 9 (32%) who should have received EI did not have all the sessions offered.

Acceptability: Although 12 of the participants told us that some of EI was useful, 11 of these participants also found some parts unacceptable. Four participants were still experiencing fatigue after completing EI and two felt they wanted more help at the end. Four of those we talked to did not find EI acceptable and withdrew. Reasons included: not liking the treatment model, or the way it was delivered.

Fatigue, pain, mood and work status were no different between the two groups at the end of the study however the study was not large enough to show an effect.

Our results show that this type of study is not feasible and EI was not acceptable to a lot of participants

It is a disservice to the patients who participated in the trial that there is no published acknowledgement that the study did not reach its accrual goal because patients did not wish to participate.  Patients who consented to treatment did not generally find it helpful.  Publication of this study could serve as a warning that most primary care patients suspected of having chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) are not interested in treatment based on the principles of cognitive, behavioural and graded exercise. The minority who consented to participate did not find the experience helpful.

The second trial: SMILE

 The trial registration is http://www.isrctn.com/ISRCTN81456207

The study protocol:

Crawley E, Mills N, Hollingworth W, Deans Z, Sterne JA, Donovan JL, Beasant L, Montgomery A. Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Trials. 2013 Dec 26;14(1):444.

An overlapping pilot study

This protocol is also cited for a pilot for which no full report was published, only a summary. The results of this pilot study resulted in the outcomes being switched for the main study.

Crawley E, Mills N, Beasant L, Johnson D, Collin SM, Deans Z, White K, Montgomery A. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials. 2013 Dec 5;14(1):415.

Was this really a separate pilot study or an abortive failed start to the study described in the protocol? We can’t tell.

Among the  sparse details from the pilot study:

Recruitment rates were lower than anticipated, meaning that recruitment continued for longer than planned. This was mainly due to an underestimate of the number of eligible patients at the start of the study (nearly half were not eligible). However, a recruitment rate of 35.9% does not preclude a full study.

And

In addition to the difficulty measuring change in school attendance for those transitioning from GCSEs to A levels, it may be a poor outcome measure for those who do not consider school attendance their primary goal. We suggest that a full study uses other primary outcomes, such as the SF-36 or the Chalder Fatigue Scale and uses school attendance as a secondary outcome.

So, at a time when other evaluations of interventions for ME/CFS were undergoing coordinated switching of outrcomes because of null findings from the FINE trial with the original scoring, the SMILE trial seems to have switched outcomes as well.

The treatment being evaluated in the main study is described as:

The Phil Parker Lightning Process® (LP) is a trademarked intervention that is used for a variety of conditions including CFS/ME. It has been developed from osteopathy, life coaching and neuro-linguistic programming. The intervention includes three group sessions on consecutive days where young people are taught skills that they can try out for themselves including looking at their sitting and standing posture. Families currently pay approximately £620 to attend the LP course.

Even though over 250 children and young people a year use the LP as an intervention for their CFS/ME, there are currently no reported studies investigating the effectiveness or possible side effects (for example serious adverse events) of the LP.

This is an exceedingly weak rationale for inflicting a quack treatment on unsuspecting children. Ethically, there must be a scientific rationale for exposing children to an unproven treatment that might be ineffective or even harmful.

The Advertising Standards Authority (ASA) guidance has ruled that LP cannot be advertised as a treatment:

To date, neither the ASA nor CAP [Committee of Advertising Practice] has seen robust evidence for the health benefits of LP. Advertisers should take care not to make implied claims about the health benefits of the three-day course and must not refer to conditions for which medical supervision should be sought.

Yet, the information sheet for the trial is describing it as a treatment to patients.

The materials patients must read as part of participating in the trial reek of pseudoscientific misinformation.

LP trains individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations.

* Learn about the detailed science and research behind the Lightning Process and how it can help you resolve your issues.

* Start your training in recognising when you’re using your body, nervous system and specific language patterns in a damaging way

 What if you could learn to reset your body’s health systems back to normal by using the well researched connection that exists between the brain and body?

The Lightning Process does this by teaching you how to spot when the PER is happening and how you can calm this response down, allowing your body to re-balance itself.

 The Lightning Process will teach you how to use Neuroplasticity to break out of any destructive unconscious patterns that are keeping you stuck, and learn to use new, life and health enhancing ones instead.

 The Lightning Process is a training programme which has had huge success with people who want to improve their health and wellbeing.

The intervention imposes strange demands on patients that encourage dishonesty, including in completing the outcome evaluations:

  1. Responsibility of patients:

Believe that Lightning Process will heal you. Tell everyone that you have been healed. Perform magic rituals like standing in circles drawn on paper with positive Keywords stated on them. Learn to render short rhyme when you feel symptoms, no matter where you are, as many times as required for the symptoms to disappear. Speak only in positive terms and think only positive thoughts. If symptoms or negative thoughts come, you must stretch forth your arms with palms facing outward and shout “Stop!” You are solely responsible for ME. You can choose to have ME. But you are free to choose a life without ME if you wish. If the method does not work, it is you who are doing something wrong.

Bristol University at first rejected a freedom of information act requests for how much developers of the treatment were paid but on appeal revealed mean cost of a course for trial participants was £567. This means £14,000 wasted on a junk intervention in the pilot study and much more was paid for the full trial.

Special thanks to John Peters for his assistance and his excellent detective work and use of the Freedom of Information Act.

See his blog posts here:

THE SMILE TRIAL (part 1): Why the trial should never have been allowed in the first place.

THE SMILE TRIAL (part 2): A trial so flawed as to be worthless.

THE SMILE TRIAL (part 3): The only one to benefit is Parker. 

And also my post

http://blogs.plos.org/mindthebrain/2016/09/23/before-you-enroll-your-child-in-the-magenta-chronic-fatigue-syndrome-study-issues-to-be-considered/

Parker start your journey

 

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.

Conflict of interest in manuscript peer-review: Expert opinions

Discussion of a recent court case concerning a peer reviewer who failed to disclose a conflict of interest has broader application.

The Committee on Publication Ethics (COPE) has defined the need for authors to declare any potential conflicts of interest in review of the manuscript.

 Recently, Retraction Watch discussed a court case in which one issue was the failure of a reviewer to declare a conflict of interest. Retraction Watch interviewed that peer reviewer and obtained some expert opinions.

bruberg

Kjell Gundro Brurberg, the author accused of misconduct by the Editor of Journal of Health Psychlogy when he nominated reviewers with obvious conflicts of interest.

These opinions are directly relevant to a decision by the Editor of Journal of Health Psychology to reject an appeal of a previous negative decision about manuscript submitted to be part of the Special Issue on PACEgate. The author, Kjell Gundro Brurberg was given an unusual opportunity to nominate additional reviewers, but with the provision that the author ensure reviewers not have a conflict of interest. Nomination of three reviewers with blatant conflicts of interest led to the withdrawal of the opportunity for reconsideration and charges by the editor of authorial misconduct.

The issue of author conflict of interest is also relevant to the controversial Cochrane Review, which Brurberg  co-authored  with others associated with the PACE trial.

Committee on Publication Ethics: Basic Principles

The Retraction Watch article started with a link to the basic principles for reviewers of the Committee on Publication Ethics (COPE), which are clearly spelled out at COPE’s website.

cope basic principles

The legal case in whicn reviewer conflict of interest comes up.

Retraction Watch then summarized a case [A fascinating read, in itself]

Bryan Hardin testified that he was a peer reviewer on a 2016 paper in Critical Reviews in Toxicology, which found that asbestos does not increase the risk of cancer. In the deposition, Hardin—who works at the consulting firm Veritox—also said that he has testified in asbestos litigation on behalf of automakers, such as Ford, General Motors, and Chrysler, but said he had not disclosed these relationships to the journal.

Last year, the first author of the 2016 review withdrew a paper from another journal (by the same publisher) which concluded asbestos roofing products are safe, following several criticisms — including not disclosing the approving editor’s ties to the asbestos industry. In this latest case, the journal told us it believes the review process for the paper was up to snuff, but two outside experts we consulted said they believed Hardin’s relationships — and failure to disclose them — should give the journal pause.

After obtaining a transcript of the case, Retraction Watch interviewed the author and inquired whether he had disclosed a conflict of interest

“No. If — if that’s a new expectation, I’m not aware that as a peer reviewer you’re supposed to disclose that sort of thing, but I — I don’t recall that I did.”

The author further said:

“I have been a peer reviewer on more than one asbestos-related paper” and “I have been retained by ‘several’ companies involved in asbestos litigation.”

Expert opinon

In the article Retraction Watch raised the issue of whether the author’s  ties to the asbestos industry be considered a conflict of interest. An opinion was obtained from Elizabeth Wager, a member of the board of directors of The Center For Scientific Integrity, our parent non-profit organization:

“I’d definitely regard giving expert testimony as a conflict of interest that should be declared by a potential reviewer (or an author). This is also in line with the views of many journals, such as PLOS which specifically notes that “acting as an expert witness” constitutes a non-financial competing interest. In other words, it doesn’t matter whether or not you were paid for such services, just testifying suggests a strong allegiance or interest which editors deserve to know about.”

A further opinion was obtained by Retraction Watch from Trudo Lemmens, a professor of Law & Bioethics at the University of Toronto in Canada who was not involved in this case.

“In my opinion, a peer reviewer who has as an expert been working for a particular industry on a specific issue should at least disclose to the journal his ties to the industry whose interests can be affected by the publication of a paper on that topic.  And journal editors should exclude such peer reviewers from reviewing a paper on that or a related topic, or at least ensure that there are several other more independent reviews of the paper. If for one reason or another they think it is important to get a review by an expert with such a conflict of interest, they should assess that review much more critically. They should then also provide an opportunity to the authors to respond to the peer-review before making a publication decision.”

Lemmens added:

But the more cautious approach would be to exclude reviewers with such a clear COI.

Retraction Watch continued  the discussion with a further quote from Wager:

It’s up to the editor to decide whether a conflict of interest is so great as to disqualify the reviewer, but, whatever the editor decides, s/he obviously needs to be made aware of it by the invited reviewer…If a reviewer’s failure to disclose a relevant interest comes to light after publication the journal should look at the review comments again.

In the thread of comments on the Retraction Watch article

Commentor Richard David Feinman noted:

The problem assumes greater importance when it comes to competing theories in medicine and especially, my own area, medical nutrition. A editor is supposed to recognize a controversial subject and appoint reviewers from both sides of the controversy. Failure to do so constitutes de facto (or intentional) bias. The perfunctory, often inappropriate — take what you can get when you get people to work for you for nothing — guarantees that the party line will be heard and there will be little input from minority opinions.

And, if you do object, you are — if you are lucky — told to submit a letter to the editor. If they take it — no guarantee of publication — the original author has the last word and it is, in any case, like an objection in a court of law: even if sustained, the damage has been done.

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.

Before the PACE-gate opened…

I co-wrote this with a sufferer of myalgic encephalomyelitis whom I have come to accept as a comrade in arms, but any excesses, missteps, or typos are entirely my own.

Did you notice previous to the release of the Special Issue of Journal of Health Psychology,  there were two  banal articles on ME in UK  press?

One about a person who paints to cope with ME 

woman who paints

 

….and another who sends letters to strangers as a therapy for ME.  

letter writer

Is it me or is this a deliberate method of undermining the shocking truth about the real ME sufferers and their abuse by the NHS?

And then  the special issue of Journal of Health Psychology got PACE-gate on the newsstands.

No, not Journal of Health Psychology on the newsstands.

Our feisty little journal is not yet ready for that.

But we saw that Boy George was fading from public view, reduced to sweeping streets for his community service. Our community needed his services. So we gave him a gig as our publicist. He was so grateful for the chance to get back in the limelight, he did not even charge us.

I highly recommend George’s services, but now with his renewed fame, I am afraid he might become pricey.

cfs

Update (August 3, 2017 12:16 PM). Apparently my references to Boy George created some puzzlement, and so I’m appending the following statement: 

As I’ve recounted elsewhere, the Journal of Health Psychology editorial board experienced fierce resistance to our putting together the special issue. There were a number of threats made, and three members of the editorial board who are more loyal to the PACE investigators then to the Journal, resigned, after quite a fuss.

We had a lot of nasty emails going back and forth, particularly between myself and George Davey Smith. Somebody, I assume George passed the emails to the media the UK, and we got a lot of attention, not so much for the Special Issue, but for the nastiness of our exchange. Yet, in the end it ended up attracting tremendous attention to the special issue. A quantification of this attention, altmetrics, showed that within a couple of days, Keith Geraghty’s target article was among the top 5% of articles being tracked.

The Daily Mail found some old photographs of George Davey Smith and myself. The loose link between all of this and Boy George, is  that I was poking fun at George Davey Smith’s ending up promoting us in the media, when he thought he was damaging the launch. I hope this clarifies things.