No, seats on the US Institute of Medicine advisory commitees are not for sale, despite what the Dutch Parliament was told

How the Executive Director of the Health and Medicine Division of the IoM responded to Professor Pim van Gool, the President of the Dutch Health Council disparaging the reputation of the IoM in testimony to the Dutch Parliament.

A likely reason for this unprofessional behavior is that van Gool was motivated to discredit the IoM’s stance on myalgic encephalomyelitis/chronic fatigue syndrome (MEcfs) because a recent document fron the IoM undermines the status quo concerning the illness in the Netherlands..

The incident speaks to the trustworthiness and commitment of the Dutch Health Council to best evidence in evaluating policies concerning MEcfs. Patients and their carers and advocates would do well to be vigilant for the next move from the Dutch Health Council.

The excerpt below is a translation of a transcript from a June 15, 2016 hearing before the Dutch Parliament. The President and Vice President of the Health Council of the Netherlands were appearing before Parliament to inform members about the installation of advisory committees concerning MEcfs.

Special thanks to Lou Corsius who provided the videotape, complete with English subtitles,  as well as the official response from the Institute of Medicine, which was a direct response to an inquiry from Lou.

The misrepresentation of the Institute of Medicine that occurred has immediate current relevance because of the likelihood that  Parliamentiary meetings will soon be held to reevaluate the official Dutch position on this illness.

Who’s who in the excerpt from the transcript

Pim van Gool: President of the Dutch Health Council

Henk Van Gerven: MP, Chairman of this meeting

Hans Severens: Vice President of the Dutch Health Council

Transcript [downloaded and edited from the subtitles provided by Lou Coursius

Starting at 6 minutes 54 seconds

Van Gool:  We received the request to advise in April 2015. At that time we had already been starting up because we knew this request would be submitted. We took explicitly notice of the IOM [Institute of Medicine] report in the US, dated February 2015.

Van Gerven: Can you explain IOM? Not everybody knows what that is.

Van Gool: Institute of Medicine. That is… we want to say that is a bit like the American Health Council. It is not exactly comparable. They  show a bit less scrutiny towards the interests of participants there. Amongst other things one can buy a chair to participate in the advisory process. That is an interesting business model but that is not the model we apply (Van Gool and Severens chuckle). Immediately in May & June one of our most experienced and respected scientific secretaries, dr De Neeling, has contacted 9 scientific associations, the general practitioners, the specialists in internal medicine, in physical rehabilitation, the neurologists, the association for behavioural therapy, the paediatricians, physicians in occupational medicine, etcetera, to actually ….as a hall stand (as a frame) we took that American report, more than 300 pages, very broad exploration, with also a very interesting new position that has been taken,  including a proposition to use another terminology for these issues (he does not use the word illness). We asked them to reflect on this IOM report as a start, actually.

Why did Pim van Gool misrepresent the Institute of Medicine?

 He and his fellow health council members were quite unhinged by the shift in the official American position concerning MEcfs in a report released by the IoM in February 2015. van Gool alludes to the report in the transcript excerpt suggests there is a mobilization of effort to undermine it.

Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness

The full IoM report  is freely available here

A 4-page official briefing on the IoM report is available here.

The primary message of the committee’s report is that ME/CFS is a serious, chronic, complex, systemic disease that often can profoundly affect the lives of can profoundly affect the lives of patients.

IOM diagnostic.PNGImportantly, the IOM report provided new diagnostic criteria that made post-exertional malaise (PEM) a requirement for a diagnosis. It is a defining symptom:  no PEM means no diagnosis of MEcfs is warranted.

PEM

Dutch treatment studies employed looser criteria that did not require PEM. The IOM diagnostic criteria have subsequently been used by the US Agency for Healthcare Quality Research (AHQR) to reject the relevance of any research, notably Dutch research, that did not include PEM in the entry criteria. Furthermore, patients who are characterized by PEM are likely to be harmed by cognitive behavioral therapy and graded exercise therapy, which are considered frontline treatment in current Dutch guidelines. The US Center for Disease Control would subsequently removed CBT and GET from the list of recommended treatments.

To preserve their status quo, the Dutch Health Council must discredit the IOM report.

Lou Corsius alerted the IOM to Pim van Gool and obtained this response:

The official response from the Institute of Medicine

Director IOM: Official statements President Dutch Health Council incorrect

Van: Behney, Clyde <CBehney@nas.edu>

Verzonden: zondag 19 juni 2016 22:40

Aan: Lou Corsius

CC: Frakes, Chelsea

Onderwerp: RE: Questions about scrutiny IOM, claims posed by president of Health Council of the Netherlands

Dear Mr. Corsius,

Thank you for bringing this matter to our attention.  The National Academies of Sciences, Engineering, and Medicine (the Academies) stand behind the Institute of Medicine (IOM) report, which was prepared by experts in the subject matter and was subjected to our rigorous peer review process before it was released, as we do for each of our studies.

I can assure you that the only way one can become a member of the National Academy of Medicine (NAM, formerly IOM) is by being elected by the members of the National Academy of Medicine based on distinguished professional achievement in a field related to medicine and health. One must first be nominated by two members of the NAM who are required to document how a nominee meets the criteria for membership and then be subsequently elected by the full membership of the NAM.

One cannot buy a membership in the NAM, nor can one buy a role as a member of one of the committees that conduct studies and produce our reports. Additionally, all members, including the chairs, of our study committees undergo a very strict review for conflicts of interest prior to their appointment, and we also notify the public about the proposed members for each of our committees twenty days before the first committee meeting so that the public can identify any potential conflicts of interest before the committee begins its work.

Thank you again for making us aware of the statements.

Very best regards,

Clyde

Clyde J. Behney

Executive Director

Health and Medicine Division

National Academies of Sciences,

Engineering, and Medicine

 

 

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Probing the claim a black, working-class man would have to call 80 psychotherapists to get an appointment.

Study of returned calls from psychotherapists for requests for first appointments got lots of attention in social media but were claims accurate?

hands from da VinciA recent paper  reporting results of calls to psychotherapists for a first appointment got lots of attention in social media after a story in The Atlantic  made provocative statements about  its results.

Some of the claims in the Atlantic article resonated with readers assumptions about how difficult it is to get an appointment

Even for those with insurance, getting mental healthcare means fighting and through phone tag, payment confusion, and even outright discrimination

A lot of the attention to the Atlantic article was due to prominent display of the claim:

black man would

Sure, it is plausible that a black working-class man would have a harder time getting an appointment, but it really take 80 to get a first appointment?

The Atlantic article zeroed in the interaction between gender, class, and race that was presented as more complex in the actual report of the study

Among working-class callers, the study showed equal rates of appointment offers between white and black callers; if perceived race were causing class misidentification by therapists, then one would instead expect to see lower appointment offers for black working-class callers. If anything, the true race differences within the middle class may be slightly smaller than observed, and the class differences among blacks may be slightly larger than observed. Ultimately, the sizeable and statistically significant effects support the conclusion that there is a true disadvantage to black middle-class help seekers and all working-class help seekers, relative to middle-class whites.

So maybe class mattered more than race.

The apparent strength of findings might reflect methodological weaknesses of the study and the author’s stereotypes as much as the prejudices of the therapists who were called. The Atlantic article noted:

Heather Kugelmass, a doctoral student in sociology at Princeton University, selected 320 therapists from the directory of Empire Blue Cross Blue Shield’s HMO plan in New York City. She then had voice actors call them and leave voicemail messages saying they were depressed and anxious. They asked for a weekday evening appointment. She distinguished between different income groups by altering the vocabulary and grammar in the scripts, and she used studies on African-American vernacular and Black-accented English to craft the African-American callers’ scripts. The lower-income white callers spoke in a heavy, New York City accent. All of the callers mentioned they  had the insurance that the therapists purportedly accepted.

The Atlantic article acknowledged:

And it’s hard to purposefully make a person sound poor or black. In the working-class white script, for example, the actor said “hiya doc,” instead of “hello,” and mentioned “on the website I seen your name.” The working-class black script included flourishes that bordered on cartoonish, like “a’ight?” and “my numba.”

The Atlantic article drew some strong reactions, like from a psychologist from Australia, where there are different expectations of psychotherapists:

facebook shocked.

But a Minnesota psychiatrist offered a more sympathetic view of the therapists, noting that insurance companies and managed care share some of the responsibility for the difficulties those in need have in getting a first psychotherapy appointment.

only ways to keep doors open

Finally, the Atlantic article provided some relevant statistics

Between 30 and 50 percent of psychologists run their own practices, which allows them to largely control their own schedules, client rosters, and insurance networks. About 30 percent appear to accept no insurance at all, according to the American Psychological Association, a trade group for psychologists.

And

More than half of all counties in the U.S. have no practicing psychiatrists, psychologists, or social workers. In any given year, about one in five Americans has a mental illness, according to the National Alliance on Mental Illness, but nearly 60 percent of those people don’t get services.

And some good quotes, like:

“If it’s a market where you pretty much have to pay for yourself, the rich are always going to win,” Stanford University psychiatry professor Keith Humphreys told KQED recently

The original study reintroduced the concept of the YAVIS patient desired by therapists, something  I have discussed with respect to psychosocial care of cancer patients. The article said

Research suggests that psychotherapists (hereafter also called “therapists”) favor help seekers with the “YAVIS” attributes: young, attractive, verbal, intelligent, and successful (Tryon 1986). Consistent with the YAVIS hypothesis, Teasdale and Hill (2006) found that therapists prefer “psychologically minded” clients and those who share similar values and attitudes. These effects were independent of the demographic characteristics (including race) of the help seekers, but the results were survey based, so social desirability pressures may have influenced the results. In another study, black patients were rated by psychiatrists as “less psychologically minded” as well as “less articulate, competent, [and] introspective” than otherwise equivalent white patients (Geller 1988:124).

The Atlantic article

Not White, Not Rich, and Seeking Therapy

The original study

Kugelmass H. “Sorry, I’m Not Accepting New Patients” An Audit Study of Access to Mental Health Care. Journal of Health and Social Behavior. 2016 Jun;57(2):168-83.

Abstract

Through a phone-based field experiment, I investigated the effect of mental help seekers’ race, class, and gender on the accessibility of psychotherapists. Three hundred and twenty psychotherapists each received voicemail messages from one black middle-class and one white middle-class help seeker, or from one black working-class and one white working-class help seeker, requesting an appointment. The results revealed an otherwise invisible form of discrimination. Middle-class help seekers had appointment offer rates almost three times higher than their working-class counterparts. Race differences emerged only among middle-class help-seekers, with blacks considerably less likely than whites to be offered an appointment. Average appointment offer rates were equivalent across gender, but women were favored over men for appointment offers in their preferred time range.

eBook_Mindfulness_345x550Preorders are being accepted for e-books providing skeptical looks at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills. 

I will also be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

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

 

At least 3 reasons you don’t have to read Understanding Psychosis and Schizophrenia 2

Has the British Psychological Society lost its audience for misrepresentatingn of serious mental disorder?

understanding psychosisThe excellent post by Sameer Jauhar and Paul Morrison about the second edition of Understanding Psychosis and Schizophrenia is getting few comments. Perhaps this is because much of the second edition repeats the heavily criticized first edition, while further eliminating citation of research that would prove embarrassing to what is said.

 

#UnderstandingPsychosis?

An earlier post by Keith Laws, Alex Langsford, and Samei Huda about first edition was probably among the most accessed Mental Elf blog post ever.

Understanding Psychosis and Schizophrenia (2014) National Elf Service

I took the first edition seriously enough to respond with some heavily accessed posts my own, including one with a slideshow.

“Understanding Psychosis and Schizophrenia” and mental health service users 

Barney Carroll on domesticating psychosis [with slide show providing a detailed, evidence-based critique]

But I’m not to be lured  into a discussion again that goes nowhere with BPS authors who react like vampires to garlic whenever evidence is brought up that contradicts their cherished fixed beliefs.

Thankfully, Sameer Jauhar and Paul Morrison zero in on some key points that show the aversion to debating evidence persists. Here are three, but you can find more in their post.

Unwarranted claims that cognitive behavior therapy has effects equivalent to medication for psychosis.

The [BPS] authors state: Experiencing multiple childhood traumas appears to give approximately the same risk of developing psychosis as smoking does for developing lung cancer.

They cite a study where items on a screening questionnaire correlated with recall of adverse events, with an odds ratio of 11 (Bentall et al., 2012).

They state half of people who experience psychosis will experience problems only once, and recover completely, quoting a review which cites 9 studies.

On average, people gain around as much benefit from CBT as they do from taking psychiatric medication.

The authors cite various meta-analyses, but the effect sizes given are not comparable to those for psychotropic medication, especially when considering effects of blinding, even taking into account criticisms regarding included studies (Jauhar et al., 2014), see below.

The discussion thread on the earlier edition of UPS by Keith Laws and colleague drew heavily on Jauhar et al’ excellent meta analysis to demolish claims about the effectiveness  of CBT. That the authors don’t now cite it at all is telling. I don’t believe in the repression of traumatic memories, but I do believe in authors selectively citing only evidence that fits with their biases.

 Exaggerated claims that trauma is strongly linked to psychosis

The [BPS] authors state:

Experiencing multiple childhood traumas appears to give approximately the same risk of developing psychosis as smoking does for developing lung cancer.

They cite a study where items on a screening questionnaire correlated with recall of adverse events, with an odds ratio of 11 (Bentall et al., 2012).

They state half of people who experience psychosis will experience problems only once, and recover completely, quoting a review which cites 9 studies.

And

It is mathematically impossible to explain how the factors they give could contribute to the prevalence they mention; the odds ratio for childhood trauma is between 2-4 in most meta-analyses (Morgan and Gayer‐Anderson, 2016) (with methodological limitations). The odds ratio for smoking and lung cancer varies depending on smoking status and cell type, anywhere up to around 100 (Pesch et al., 2012) and evidence they put for a similar association is based on items from a screening questionnaire that measures phenomena that are not related to what people conventionally call psychosis. Even then, the odds ratio of 11 does not sit well with odds given for current smokers and lung cancer.

Put simply, not everyone who experiences psychosis (however defined) has these risk factors, and not everyone who has these risk factors develops psychosis.

Exaggerated recovery rates for schizophrenia and other psychosis

The review stating 50% of people have recovery at follow-up is not a systematic review. A more recent systematic review suggested that only 13% of people with a diagnosis of schizophrenia met the criteria for recovery (Jääskeläinen et al., 2013). Long-term follow-up of people presenting with first episode psychosis show significant heterogeneity in symptomatic and functional outcome: a multi-centre UK first-episode study showing, in geographically defined populations, that 50% were in symptomatic remission at 10 years (a number of whom were taking antipsychotics), though only 15% fulfilled criteria for functional recovery (Revier et al., 2015).

Preorders are being accepted for e-books providing skeptical lookseBook_PositivePsychology_345x550 at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills. Right now there is a special offer for free access to a Mindfulness Master Class. But hurry, it won’t last.

I will also be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

HappinessCounter, a new digital app that encourages you to smile in your daily life

There is so much wrong with this app from the University of Tokyo and Sony, I don.t know where to start. So, I won’t.

“When she makes a smile, she can use the refridgerator, when she doesn’t smile, she can’t.

HappinessCounter: Smile-Encouraging Appliance to Increase Positive Mood from rkmtlab on Vimeo.

 

HappinessCounter is a new digital appliance that encourages you to smile in your daily life.

As William James stated, and confirmed by several psychological studies, making smiles positively affects on our mental status — we become happier when we laugh. Inspired by this theory, we propose a new digital appliance that naturally facilitates making smiles in our daily life. This system is mainly designed for people living in alone who have difficulty to realize when they are in low spirits and/or to make themselves smile. Our HappinessCounter combines visual smile face recognition, user feedback, and network communication. We installed this system in a home with a single householder, and the system had positive effects on improving the user’s mental status.

Preorders are being accepted for e-books providing skeptical lookseBook_PositivePsychology_345x550 at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills. Right now there is a special offer for free access to a Mindfulness Master Course. But hurry, it won’t last.

I will also be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

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

Mindfulness: A web-based masterclass

eBook_Mindfulness_345x550

 

Like many of my loyal followers, I expected my e-book CoyneoftheRealm Takes a Skeptical Look at Mindfulness to be available by now. Though I’m disappointed that it is not, I’m pleased with the progress that has been made and how I have redefined the structure of the e-book.

My progress

Signs of the direction I am now taking with the e-book can be seen in recent blog posts at Mind the Brain and Quick Thoughts, but also in popular talks like the one I gave at this summer’s European Health Psychology Conference in Padova, Italy.

Coyne of the Realm Takes a Skeptical Look at Mindfulness  traces the claims being made about the practice of mindfulness back into the scientific literature in an inimitable style, wittingly challenging conclusions of bad research, but ultimately leaving readers with strategies for judging mindfulness for themselves.

The revised structure now involves discussion of some key papers in detail and provides readers with additional papers they can analyze themselves, with or without the tips I provide.

Feedback I have received suggests this format is a much improved way of providing tools for deciding for one’s self what, and how to think about mindfulness.  The outpouring of new mindfulness papers with even more outrageous claims about changing lives by changing brains continues. If you believe the social media, mindfulness is getting quicker and more powerful. Now you will be prepared for the pitch being made by promoters and be able to take apart what is being claimed and with what evidence.

Sample Chapters

Some basics of evaluating evidence

5. What are the best forms of evidence?

6. Observational studies: correlation does not equal causality

7. Evaluating comparisons of treatments

8. Evaluating reviews

9. Who says so? Importance of promoter bias and conflict of interest

Better than what? Evaluating comparisons between mindfulness and its alternatives

10. Typical clinical trials evaluating mindfulness: Some good, mostly bad

11. Head to head plus: Unusually informative mindfulness trials

12. Some clinical trials for you to evaluate (with hints)

To express my appreciation to those who preorder the book early, I would like to offer a special invitation as well as a free gift. By year’s end, my 100 minute video Master Class on mindfulness will be available for purchase. Although it will sell for $100.00, anyone who has purchased the CoyneoftheRealm Takes a Skeptical Look at Mindfulness book by November 10 will be receiving an email containing a code for a free Mindfulness Master Class video.

In addition, if you preorder the e-book CoyneoftheRealm Takes a Skeptical Look at Mindfulness before November 10, you will  have an opportunity to submit questions to a pool from which those will be drawn to be addresse in a Q&A session at the end of the video.

So,  preorder the mindfulness e-book or the full set of three Coyne of the Realm Takes a Skeptical Look at… and then submit your nominations for questions to be asked in the Q&A session to james@coyneoftherealm.com.

 

Screening for Distress and Depression vs Optimizing Support and Compassion in Medical Care

My upcoming talks at the Dutch International Congress on Insurance Medicine 2017

screening bookOn Thursday November 9, 2017  I am  pleased to be presenting two talks at the Dutch Society for Insurance Medicine (NVVG) and the Dutch Association of Medical Officers in Private Insurances (GAV) 9th Annual Congress, international day in English on Thursday 9th November 2017.

The Congress is intended for medical officers, insurance and occupational health physicians and others interested in this particular field. Approximately 350 medical doctors in insurance medicine and social benefits are expected to attend. The congress is described as highly appreciated by the participants, and many outstanding and inspiring speakers have contributed over the past years.

I am very pleased to be having another opportunity to present my updated views on screening for depression and distress, as well as whether screening is the optimal way to provide support and compassion in busy routine medical care. Those who are familiar with my work are aware of my skepticism that routine screening improves patient outcomes.

Congress venue:

Van der Valk Hotel Almere

Veluwezoom 45

1327 AK Almere

The Netherlands

Thursday, November 9, 201

9:15- 10:00 Plenary Speaker

The optimal way of providing psychosocial care and care for depression to medical patients

Summary

Provision f routine psychosocial care to medically ill patients can be negatively impacted by assuming that basic supportive care needs are primarily mental health issues. Management of depression poses distinct challenges. Care for chronic and acute medical conditions can create competing demands and  disrupt existing care  for depression. Much co-occurring depression apparent during medical care is among patients represents recurrences with recent or past depression care. Much depression care initiated during medical treatment is with inadequate diagnosis, monitoring, and follow up. Optimization of care depends on recognizing depression is largely a chronic, episodic condition with variable course and incomplete remission. The management of depression care can become out of sync with the course of patients’ depression.

14:40- 15:15 Round 1: Parallel sessions

Screening for distress and procedures versus routine compassion in cancer care

Summary

Screening for distress among cancer is increasingly mandated internationally without regard to the character of existing health systems and psychosocial care. A lack of robust evidence that screening for distress actually improves patient outcomes is being ignored. The invented concept of “distress” does not map well onto distinct sources of patient discomfort and unmet needs. Depending on the health system, introduction of routine screening can tax existing supportive care and uncover needs that  supportive services cannot address. Access to affordable, accessible care consistent with patient preferences is more challenging that detecting ambiguous “distress” among cancer patients. In moderate to high functioning health systems, exisiting provision of supportive and compassionate care can be disrupted by introduction of screening with a greater emphasis on billable procedures and risk of unnecessary treatment.

Readings

Here are a couple of relevant past blog post that you can expect will be updated in my talks:

Where’s the evidence that screening for distress benefits cancer patients? 

Distress- the 6th vital sign for cancer patients?

Psychosocial care focuses too much on young, attractive patients successfully coping with cancer. https://www.coyneoftherealm.com/blogs/mind-the-brain/psychosocial-care-focuses-too-much-on-young-attractive-patients-successfully-coping-with-cancer

And a key review paper with an outstanding group of co-authors:

Thombs BD, Coyne JC, Cuijpers P, De Jonge P, Gilbody S, Ioannidis JP, Johnson BT, Patten SB, Turner EH, Ziegelstein RC. Rethinking recommendations for screening for depression in primary care. Canadian Medical Association Journal. 2012 Mar 6;184(4):413-8.

 

 

 

 

 

 

 

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