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.

 

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

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

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

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

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

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

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

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

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

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

Carly Maryhew’s Open Letter 

15 December 2017

To whom it may concern at TEDxBristol:

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

“Guideline 4: Only Good Science”

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

“Claims made using scientific language should:

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

Claims made using scientific language should not:

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

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

“Claims made using scientific language should:

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

Claims made using scientific language should not:

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

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

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

“Claims made using scientific language should:

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

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

Professor Crawley’s Accusations

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

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

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

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

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

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

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

Thank you,

-Carly Maryhew

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

 

 

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

 

 

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