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.

 

A sudden reversal of fortune for the biopsychosocial model of illness

Actually, I think this has been coming for a long time, but it just might have happened this morning in the UK online newspaper, The Independent. The public conversation has shifted about the biopsychosocial model of myalgic encephalomyelitis (ME; formerly known as chronic fatigue syndrome) in ways that will not be readily reversed.

Time for unrest: why patients with ME are demanding justice.

A new film sheds light on a condition that is largely ignored. Nathalie Wright reports on the struggles patients based to be taken seriously by doctors.

The Independent article is a long read. I will only ask you to read the first three paragraphs. Unless I am mistaken, you probably read the rest. I encourage you to even count the short three sentence opening as one of those three paragraphs.

“I feel seen for the first time!” exalts one viewer. “I feel vindicated. I finally understand what’s wrong with me, I think I’ve had this all my life,” says another. A doctor admits, “I feel so ashamed.”

I have a brief anecdote about two sobbing, ashamed doctors that I encountered in Amsterdam, but I’ll leave that to the end. Now I only want to pick out a couple of paragraphs that I hope you will not miss if you take on this long read.

The patients’ dilemma

For patients, communicating the seriousness of their illness is often impossible. “I had this experience of trying to describe my symptoms in words to my doctors for 18 months as I was getting worse,” explains Brea. “I would talk about a burning in my brain or my spine or the fact that I would lose the ability to speak or sometimes I would collapse on the floor and I couldn’t lift my head.” When she later requested her medical records almost all of these serious symptoms were translated into “headache pain”.

The biopsychosocial model

Psychosomatic explanations of the disease were being further developed by a small, but influential, group of psychiatrists in the UK. They developed a theory of ME based on the biopsychosocial model of illness, a framework for illness that has also been adopted by the Department for Work and Pensions (DWP), first fully embraced by New Labour. The biopsychosocial model states that illnesses are part biological, part mental, part social. This idea seems common sense, but in practice it is often the psychological elements that are emphasised. Thus, the “biopsychosocial” model of ME is that a patient may have originally had a virus but after that, symptoms are not primarily the result of an ongoing disease process at all. Instead, patients simply have “dysfunctional” or “false” illness beliefs and thus adopt the “sick role”. Spending too much time in bed is the reason they have physical abnormalities, as they become deconditioned due to “exercise avoidance”, and it is assumed that symptoms are reversible by the patient’s own efforts.

My intrusive thought I probably should not share: I wonder if Sir Simon Wessely – if he read this far this morning – is feeling small.

The inseparable politics of the biopsychosocial model

The biopsychosocial model, and the assumption that if people who become disabled from conditions like ME adopted the correct attitudes and behaviours they could recover, seems to appeal to politicians looking to cut the costs of disability payments. “Benefits can often make [ME] patients worse” claimed psychiatrist Simon Wessely, one of the originators of the biopsychosocial model of ME, in 1993 in a meeting with a minister for the disabled. If giving disability benefits to patients, such as those with ME, may foster a culture of dependency, then cutting these benefits can be presented as a positive intervention. According to a document promoting the biopsychosocial framework circulated by Lord Freud, the former minister for welfare reform, it is important for those with health problems like ME to “recognise that the sick role is temporary, in the expectation of recovery” and that giving disability benefits to such patients, may foster a culture of dependency.

The dangerous militancy of patients has been “grossly exaggerated”

Throughout it all, patients were depicted as dangerous militants in the media for criticising the trial, even though they turned out to be vindicated. The tribunal which ordered the release of the trial’s data ruled that “assessment of activist behaviour was, in our view, grossly exaggerated”. The most severely ill (about a quarter of patients are bed or housebound) continued to receive no care at all, with 80 per cent of requests for home visits turned down by the NHS. Added to this, a dearth of social care and difficulty getting benefits meant many patients were left completely desperate and often without any support at all, with even family members often disbelieving their illness. The waste of human potential caused by ME was recently reckoned to cost the UK economy £3.3bn a year in a report by The Optimum Health Clinic Foundation.

Your conflict of interest is showing and should be disclosed

As critics are increasingly pointing out, the problems with PACE went beyond bad science. A 2006 report by the parliamentary Group on Scientific Research into Myalgic Encephalomyelitis had already pointed out that there is a “vested interest private medical insurance companies have in ensuring CFS/ME remains classified as a psychosocial illness”. The report also mentioned cases where advisers to the DWP had also had consultancy roles in such companies. These links were investigated further by the Centre for Welfare Reform who stated in 2016 that: “Emphasising the importance of psychosocial factors and classing ME as a mental health problem could bring immediate financial benefits to insurance companies when policies limit payouts for mental health problems.”

The Americans have moved on

Across the pond in the US, science is moving on. In 2013 the US government asked the Institute of Medicine to convene an expert committee to examine the evidence base for ME. Two years later, their report Redefining an Illness was published. The report stated ME is “an acquired, chronic multi-systemic disease biological in nature” symptoms of which include “immune, neurological and cognitive impairment”. After reviewing thousands of medical papers, the report “stresses that this is a medical – not a psychiatric or psychological – illness”.

Two sobbing, ashamed physicians

I spoke at a showing of Unrest at Amsterdam Medical Centre in October. You can find a copy of a video here.

After the showing, I was leaving to meet friends for dinner. I stopped when I encountered two stylish women still sitting in their seats in the emptying auditorium, sobbing as if one of them had just received a diagnosis of cancer. I said “Excuse me, can I help?” One woman started to talk, but the other had to finish for her.

“My sister and I are both physicians. We just learned tonight how much harm we had been doing to our patients. We were only trying to do what was best for them, but we refused to listen to them. We feel very badly.”

I said:

“I believe that you thought you would doing what was best. Now you feel differently. I’ll bet a lot of your colleagues aren’t there yet. Maybe you and your sister can feel a bit better about yourselves if you help your colleagues get there.”

I turned and walked anyway without seeing their responses.

 

Coyne of the Realm’s open letter to the National Health and Research Medical Centre (NHMRC) of Australia

I received the  message below from Australia. I attempted a timely response to the National Health and Research Medical Centre (NHMRC) concerning their convening of an Advisory Committee to provide advice on research, funding and treatment of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). [Please don’t let this establish an expectation that I can respond to such requests in the future, but this time I did.]

If you have any time to write to the NHMRC at me_cfs@nhmrc.gov.au before Thursday  I’d appreciate it enormously. As you know, professionals hold much more sway with government than us patients.

kangaroo_600_600My assessment of the situation in Australia:

To put it bluntly:  Detection and diagnosis, as well as research and public policy concerning Myalgic Encephalomyelitis (ME) in Australia are a disaster. There is a high likelihood of the situation becoming worse.

The letter to NHMRC

To whom it may concern:

I understand that an Advisory Committee is being established to provide advice on research, funding and treatment of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). I am told that it will convene on December 7 and that you are open to input from the international scientific community. I hope these comments reach you in time or that you otherwise will consider them.

By way of introduction, I am a Professor Emeritus of Psychology in Psychiatry at the Perelman School of Medicine of the University Of Pennsylvania. I have had a visiting professorship in the School of Psychology at Australian National University. I regularly come to Australia. In the past, I have given keynote addresses at the Australian Behavioural and Cognitive Therapy Association in Sydney, presentations at the World Congress of Behavioral and Cognitive Therapies meeting in Melbourne, a keynote at the Australian Skeptics National Convention in Brisbane and numerous talks and workshops on critical thinking and science writing throughout Australia. I particularly enjoy presenting to Australian audiences, because I feel so free to speak directly with a candor that does not always go over well elsewhere. I write here in that spirit and with that candor.

I have no financial conflicts of interest to declare with respect to myalgic encephalomyelitis a.k.a. chronic fatigue syndrome in terms of receiving any financial support from anyone for my opinions.

To put it bluntly:  detection and diagnosis, as well as research and public policy concerning ME in Australia are a disaster and there is a high likelihood of the situation becoming worse.

Epidemiologic data suggest that Australian GPs employ loose criteria for detection and diagnosis, seemingly considering a serious medical condition as simply being a highly prevalent “chronic fatigue”. The risk is that substantial numbers of patients may be denied treatment for treatable medical and physical conditions, whether already diagnosed or not yet diagnosed. Accurate diagnosis of these conditions may be delayed. Much of the treatment research similarly employs loose criteria. The combined failure of some Australian treatment studies to exclude minor common mental problems, the reliance on subjective self-report outcomes and the unblinded designs would lead to even homeopathy appearing effective. Generalizations are being made from patients who do not have the cardinal symptom of postexertional malaise (PEM) to patients who do not participate in the trials, but who have PEM and are at risk risk of harm from receiving these treatments.  In the United States, with stricter diagnostic criteria have now been adopted, Australian treatment studies are not admissible evidence. I’m not at all suggesting blindly following the Americans, but I think their extensive documentation empirical evidence for this position should be considered in the own right. RACP Chronic Fatigue Syndrome Clinical Practice Guidelines have rightly been criticized by patient groups as leading to misdiagnosis, unrealistic expectations for psychological approaches to ME, and and for ignoring accumulating evidence of biological parameters to properly and strictly diagnosed ME.

A planned RCT of online continuing education for health professionals funded by the Mason foundation would likely ensure the bad guidelines potentially leading to ineffective treatment and harm to some patients are going to be more consistently applied.

Australia is convening an advisory committee concerning research, funding, and treatment at a time when the Americans have already begun such a reevaluation, the Dutch are about to, and the British have announced a reconsideration of NICE guidelines. It is important to achieve a balance of viewpoints in the makeup of that advisory committee in terms of general practitioners, consumer/patients/advocates, and researchers. The risk is that glaring problems in the status quo will be perpetuated and emerging research in re-evaluations will be ignored.

To understand how some of these issues can be dealt with, I recommend a summary of a meeting held at the UK House of Lords in September 2017 between Professor Mark Baker, Director of Guidelines, NICE, and, Mr P Boorman, Communications, NICE and patient representatives for a summary of some of the issues involved in assembling committees reevaluating guidelines on myalgic encephalomyelitis.

I’ve examined a recently updated list of the membership of the advisory committee. It’s laudable that there are representatives of advocacy groups are members. However, there should be some concern about such groups that stand out from other advocacy groups in supporting treatments the other groups consider potentially ineffective or harmful. Similarly, it is laudable that Professor Andrew Lloyd is among the members. However, he has passionately and emphatically spoken out in favor of cognitive behaviour therapy and graded exercise therapy, which, for good reason, are no longer recommended by the American Agency for Healthcare Quality Research or Center for Disease Control. I’m particularly concerned by statements attributed to Professor Lloyd in a recent letter from Professor Rodney Phillips, Dean of NSW Medicine. They are almost verbatim from what I get when I submit statements from a member of the Dutch Health Council to Google translator. Perhaps they are drawing on the same talking points. I would hope that the presence of Professor Lloyd would be balanced with the presence of academics from MCRI, the ANU and Melbourne University who hold decidedly different points of view.

I am a member of the Cochrane Collaboration. I shared in one of their Bill Silverman Prize awards for my alerting the collaboration to conflict of interest as a risk of bias. In raising issues about balancing competing interests on the advisory committee, I’m not suggesting financial conflicts of interest, but that clear, strongly held beliefs that might be resistant to contrary evidence.

Finally, my own non-financial declaration of interests: I requested data that the PACE trial investigators had promised would be available as a condition for publishing in PLOS One, the megajournal where I am an Academic Editor. I had thought there would be a timely response to a straightforward request. Two years later, the investigators continue to refuse produce the data, and the Journal has taken the extraordinary step of placing an Expression of Concern on their article, which many interpret as the first step before a retraction.

Similarly, I have raised issues and dueling blogs with David Tovey, a senior administrator at the Cochrane concerning financial conflict of interest and switched outcomes in Cochrane reviews of graded exercise therapy. I was very surprised and disappointed when Dr. Tovey refused my request for individual participant level (IPL) for independent-re-review of a systematic review and meta-analysis in which the PACE investigators were directly involved. These experiences leave me with seriously concerns about the validity of the PACE trial and the Cochrane reviews that depended on studies with similarly coordinated switching of outcomes. So, do take these intellectual and scientific commitments of mine into account, but also consider the need for balance in the membership in the advisory committee for similar intellectual and scientific commitments.

Thank you for your consideration and do not hesitate to contact me if I can be of further assistance.

Sincerely,

James C Coyne, PhD

 

No, seats on the US Institute of Medicine advisory committees 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

 

 

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.

 

 

 

 

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.

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.