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 

 

 

Why patients should not enroll in a clinical trial of video gaming treatment for chronic fatigue syndrome

xboxIf I were a patient with with chronic fatigue syndrome/myalgic Encephalomyelitis (CFS/ME), I would not consent to be in a clinical trial of active video gaming for adults. I would consider withdrawing my consent if I had already provided it.

Either decision would be within my rights. I would be acting for myself, but also out of concern for the patient community.

But then again, saying no would mean I would miss dancin’ up with storm with Kinect Dance Central or being all I can be in the endless competition of  Sports Rivals.

  • Enrollment has begun for a clinical trial evaluating a treatment for chronic fatigue syndrome, but important details that should have been set remained ill-defined.
  • The trial is scientifically unsound, likely to contribute misinformation to the existing scientific literature, and has unresolved safety concerns. Recruitment began without patients having had an adequate say.
  • Participation in a clinical trial is not a responsibility that patients must accept. It’s a choice, a gift from them. Consenting to being in a clinical trial often involves patients assuming considerable burden with the hope that their participation will benefit others. Under the Declaration of Helsinki, patients can only be enrolled in clinical trials with their fully informed consent based on full consideration of risks and benefits.
  • Patients need to understand their basic rights and insist on active participation in the planning and design of clinical trials, as well as the analysis, interpretation and dissemination of results. Patients need to be prepared to refuse to consent to a clinical trial or to leave one when these conditions are not met.

An interview with the trial’s principal investigator is here. It raised serious concerns.

Thanks to Sasha Nimmo [I recommend following@sashanimmo on Twitter] for blogging about the opening of enrollment for this trial, interviewing the principal investigator, and providing some invaluable links.

The trial as summarized in the published registration:

Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME) is characterised by profound and debilitating exhaustion, resulting in chronic physical inactivity. The detrimental effects of physical inactivity, potentially related to inflammatory pathways (allostatic load) and the body’s ability to cope with stress, further compound the health risk of the disease. The aetiology of CFS/ME is unclear, and recent research has focussed unsuccessfully on individual inflammatory and immune biomarkers. Cumulative biomarkers such as the allostatic load index have stronger predictive power; enhancing our understanding of factors related to CFS/ME. To improve the health of people with CFS/ME and fill these knowledge gaps, this project will conduct a novel intervention using active video gaming to explore the relationships between allostatic load and physical activity in people with CFS/ME.
Aims
1. To investigate if active video gaming is an effective management strategy to increase the physical activity levels of adults with CFS/ME
2. To investigate the relationship between allostatic load and physical activity in people with CFS/ME
3. To determine the feasibility and acceptability of active video gaming as a management strategy to increase physical activity levels in adults with CFS/ME

The registration does not specify the video game patients to which patients will be randomized. However, in the interview with Sasha Nimmo, the investigator described it as:

A dance-based game called Kinect Dance Central and a sports game called Sports Rivals. These were chosen for pragmatic reasons, they are off-the-shelf easily available games, and after informal consultation with some adults of varying ages and genders with CFS, a preference to sporting and dance-type games was indicated.

Kinect-Demokinect sports rivalsHmm, I would love to see a record of the deliberations out of which this choice of games emerged, how many patients were involved and with what say.

It boggles my mind to imagine patients who actually suffers from ME dancing up a storm with Kinect Direct Center or becoming the “champion they were meant to be in an ever-evolving sports competition”  of Sports Rivals.

Why trial registration is important.

 Trial registrations commits investigators in advance of recruiting for a trial to particular details of the trial, including entry and exclusion criteria, procedures, sample size, primary and secondary outcomes, and key data analyses.

An adequate registration requires all these elements to be clearly specified. When they are not, or when the investigators subsequently ignore the registration, there is heightened risk of selective reporting, bias, and the dumping of misleading information into the scientific literature. Poorly defined trial registrations or their simply ignored by investigators contribute to an untrustworthy literature that communicates an exaggerations of the effectiveness of interventions that would be obtained in clinical practice.

When investigators do not adhere to a well-defined trial registration, they put patients, providers, and policymakers at risk of bad decisions based on poor quality data. Patients may be harmed by what they thought had been established scientifically as a safe, effective treatment.

Scientific Concerns.

The investigators have an inadequate idea of who will participate and how they will be described for clinical and scientific purposes.

 The trial registration does not provide scientifically and clinically useful inclusion criteria. What the principal investigator said in an interview worried me:

 The inclusion criteria for the study stipulate participants will need to have been diagnosed with CFS by a medical specialist and they will be requested to report which criteria were used for their diagnosis. Diagnostic uncertainty is an issue that has surrounded CFS research for some time, and unfortunately there still does not seem to be any consensus agreement. The inclusion criteria were designed to take a pragmatic approach which would provide the opportunity for sub-group analyses at the end of the study to determine whether diagnostic criteria were related to intervention outcomes.

This leaves basic entry criteria undefined. This being left open gives investigators an opportunity to exaggerate the effectiveness of their intervention at the end by making decisions about lumping and splitting of patients after they have already seen their outcome data and picking what works best.

 This looseness in describing entry criteria occurs against the backdrop of considerable confusion in Australia and misdiagnosis of persons suspected of having chronic fatigue syndrome/ myalgic encephalomyelitis. As many as two in five patients who are diagnosed by clinicians do not actually meeting the Fukuda chronic fatigue syndrome definition (CFS) or the International Consensus Criteria for Myalgic Encephalomyelitis (ICC ME).

 A recent article in the journal Clinical Epidemiology  reported:

A total of 535 patients diagnosed with CFS/ME by a primary care physician were identified. Of these, 30.28% met Fukuda criteria. A further 31.96% met both Fukuda criteria and International Consensus Criteria. There were 14.58% reporting chronic fatigue but did not meet criteria for CFS/ME and 23.18% were considered noncases due to exclusionary conditions. Within those meeting CFS/ME criteria, the most common events prior to illness included cold or flu, gastrointestinal illness, and periods of undue stress. Of the 60 symptoms surveyed, fatigue, cognitive, and short-term memory symptoms, headaches, muscle and joint pain, unrefreshed sleep, sensory disturbances, muscle weakness, and intolerance to extremes of temperature were the most commonly occurring symptoms (reported by more than two-thirds of patients). Significant differences in symptom occurrence between Fukuda- and International Consensus Criteria-defined cases were also identified.

Such a mixed bag of patients with unvalidated diagnoses will pose serious problems for any generalizing beyond the immediate sample. A sample collected elsewhere would very likely have a different case mix. Conclusions from this study would not hold.

Any generalizations about the whole sample would represent inaccurate portrayals of the patients within particular subgroups that are defined by specific diagnostic criteria.

No power analysis  [What is that?] is given for the particular recruitment goal of 30 patients stated in the trial registration. A sample of 30 means that 15 patients would be randomized to immediate receipt of the intervention and 15 would be placed on a waiting list. This would be a grossly underpowered trial, which some would argue in itself poses serious scientific and ethical problems.

The investigators’ post-hoc sorting of patients into subgroups would mean much smaller groups than the already small total sample of 30 would be examined, producing statistically meaningless results.

This trial would be a waste of resources and the invalidity of the results would mean that the efforts of patients who had consented to participate were squandered.

Data will be analyzed for a 12 month follow-up, but the study is randomized only for six months.

The principal investigator said in the interview:

The pilot study is designed so that there is a 6 months comparison of the intervention to control and after that time the waitlisted control group will then participate in the intervention for the final six months.

The principal investigator described the clinical trial as only a pilot study, but it is not described that way in the trial registration. Instead, it is clearly aiming to introduce an estimate of the efficacy of the intervention into the literature.

The primary outcome will be assessed at 12 months. However, there is no control group at that point, and so interpretation will be made without the benefit of a comparison. The difficulty that this poses is that any change from 6 to 12 months will be attributed to the intervention, whereas some or all of it of it might be due to changes that would occur in the absence of intervention or by patients remaining in routine care.

Safety concerns.

 The principal investigator seems unaware of the dangers posed to patients by overexertion.

 The principal investigator stated:

 Unfortunately, the issues surrounding the PACE trial have clouded some people’s thoughts regarding the benefit of physical activity for people with chronic conditions such as people with CFS. This is potentially detrimental given the indisputable research surrounding the health benefits of physical activity.

“Indisputable?” I worry what the investigator means by issues surrounding the PACE trial being ‘clouding some people’s thoughts’. If the investigator rejects the serious criticisms that have been leveled against the PACE trial and its investigators, I don’t think they should expect much patient participation.

The investigator group does not grasp the understandable concerns that patients share with researchers like myself and many others about the results of the PACE trial being fatally flawed.

 Moreover, the statements concerning “indisputable research concerning the health benefits of physical activity” is a general statement that is misleading when applied to chronic fatigue syndrome/ myalgic Encephalomyelitis.

The investigator may not be sufficiently medically informed about the condition to anticipate and respond to likely serious adverse events.

The trial registration had conveyed a bias against construing CFS/ME as a physical health condition, rather than a mental health condition. Maybe that bias is now coming home to roost.

The aetiology of CFS/ME is unclear, and recent research has focussed unsuccessfully on individual inflammatory and immune biomarkers.

“Unsuccessfully?” How about the ineffectiveness and harm of treating CFS/ME as a mental disorder with cognitive behavioral therapy and graded exercise therapy?

If I were a patient with ME, I would worry about being harmed by the exercise required for participation in the trial and for the trial team being ill-prepared to respond appropriately. Given the statements that were made in the interview by the principal investigator, I’ve wonder if the consenting process for patients involves accurate portrayal of the potential risks of participating.

 Will the data be shared after the study is completed?

The principal investigator’s answer  evaded revealing whether the data would be shared, with whom, and under what conditions.

Patient should not consent to participation in a trial where data are not publicly shared. The data should be available for reanalysis, checks on the interpretations made by the investigators, and integration with other data in a transparent fashion.

Notoriously, investigators in the PACE trial of cognitive behavior therapy and graded exercise for chronic fatigue syndrome continue to refuse to share their data – even when they published in PLOS One, a journal where making the data available was required. They have attacked the character of anyone seeking access to the data, particularly patients. They have even barred a professional from obtaining access to the data on the grounds she has visited patient websites.

The PACE investigators even argue that the possibility of damage to their interpretations of the trial and their reputations is sufficient to require a noncritical attitude toward them as a condition for receipt of the data. But they readily share their data with colleagues who accept and promote their distorted interpretations.

 The failure to specify that data will be made publicly available without restrictions would alone be sufficient for me to refuse participation in the trial.

An already misleading literature concerning treatment of adults with ME/CFS.

 The scientific literature concerning treatment of chronic fatigue syndrome is dominated by investigators who consistently misrepresent their findings; refuse to share their data; and have financial conflicts of interests that are served by inflated estimates of the efficacy of psychological interventions for ME/CFS.

The financial interests of  investigators have also intruded upon a systematic summary of the effectiveness of intervention, providing misinformation in a recent Cochrane review, so that the review is neither objective nor trustworthy.

 Patient involvement should be from the start of the planning of a trial.

 The “stakeholder advisory group” for this trial has not even met yet, despite recruitment already having begun. The diverse advisory group seems heavy on researcher and professional involvement, and weak on patient representation. Only two patient representatives are indicated.

The principal investigator stated in the interview:

Part of the project involves forming a Stakeholder Advisory Group which will include rheumatologists, exercise physiologists and the research team, but more importantly several people from the general public who are managing CFS and at least two representatives from the SA ME/CFS Society and Bridges and Pathways; all of whom will help finalise the finer points of the intervention before it commences. The Stakeholder Advisory Group is soon to convene to finalise details. I acknowledge that perhaps some members of the ME and CFS community may not agree with all components of the study design, and I welcome any discussions with them in order to improve the proposed project.

Peter Mitchell, Secretary, responded on behalf of the Management Committee of ME/CFS Australia (SA) Inc:

We have no input into the design of the trial.

We are cognizant of the many faults in the PACE trial which claims, incorrectly, to demonstrate the value of GET [graded exercise therapy] for people with ME/CFS.  We are also aware of the survey indicating the harm experienced by patients who have attempted GET.

Our organisation is therefore unequivocally opposed to the practice of GET for patients with ME/CFS, and we would not lend our support to any study that had that intention.

The Bridges and Pathways ME/CFS Multidisciplinary Clinical and Research Centre responded to the question Did you raise any objections about this study?”:

We did not know about it until it was on the [South Australian] ME/CFS Society’s website.

To the question: “What is Bridges and Pathways position on graded exercise therapy?”:

B&P uses a biomedical model of ME/CFS and have a recognition that many people have mitochondrial (energy making) faults or immune system faults that can be increased with physical exercise and stress. These pathways can now be measured and identified using laboratory tests. We do not include graded exercise therapy as one of our recommended treatments.

What patients should require before consenting to participate in research…

An editorial in The BMJ has taken a bold stand about greater patient involvement in all phases of research:

Working with other journals, research funders, and ethics committees, we hope that at some time in the future only research in which patients have been fully involved will be considered acceptable.

In their instructions to authors, The BMJ now includes a section Reporting patients’ involvement in research which states:

As part of its patient partnership strategy, The BMJ is encouraging active patient involvement in setting the research agenda.

We appreciate that not all authors of research papers will have done this, and we will still consider your paper if you did not involve patients at an early stage. We do, however, request that all authors provide a statement in the methods section under the subheading Patient involvement.

This should provide a brief response to the following questions:

How was the development of the research question and outcome measures informed by patients’ priorities, experience, and preferences?

How did you involve patients in the design of this study?

Were patients involved in the recruitment to and conduct of the study?

How will the results be disseminated to study participants?

For randomised controlled trials, was the burden of the intervention assessed by patients themselves?

Patient advisers should also be thanked in the contributorship statement/acknowledgements.

If patients were not involved please state this.

If this information is not in the submitted manuscript we will ask you to provide it during the peer review process.

Please also note also note that The BMJ now sends randomised controlled trials and other relevant studies for peer review by patients.

Will the Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis patients of Australia rise up and inspire the parents of child and teen CFS/ME patients of the UK?

Australian patients face a clear challenge and a clear choice whether to participate in this clinical trial. Maybe they can act in a way that inspires the parents of CFS/ME children in the UK to similarly demand involvement before consenting to their children to participate in a clinical trial. Principal Investigator Esther Crawley has given no indication that she will share her data from a new trial of an Internet-based CBT program for adolescents with CFS.

Esther Crawley has a bad history with the patient community. Through the NHS, she inflicted a quack Lightning Process treatment on children and adolescents with CFS/ME in the SMILE trial. Yet, three years after completing the trial, she still has not published the results. But her friend Phil Parker has profited handsomely. Although the UK’s Advertising Standards Authority (ASA) has forbidden him from advertising the Lightning Process as a medical treatment, Parker has received payment for training and providing treatment in a clinical trial. Parker even implied on his promotional website that his treatment was being used in the Northern Ireland NHS – that is, until I alerted a member of the Northern Irish National Assembly Health Committee and the NHS insignia was removed.

If Esther Crawley won’t commit to publishing the data from her new trial and sharing it in a timely matter, why should parents consent for their children to enroll? Parents should demand greater say in all phases of the trial as a condition for consenting for their children or for keeping their children in the trial. Taking their children out of the trial is their right.