The SMILE Trial Lightning Process for Children with CFS: Results too good to be true?

The SMILE trial holds many anomalies and leaves us with more questions than answers.

keith'ds pouting girl

A guest post by Dr. Keith Geraghty

Honorary Research Fellow at the University of Manchester, Centre for Primary Care, Division of Population Health and Health Services Research

censored
ASA ruling left some awkward moments in Phil Parker’s videos promoting his Lightning Process.

The Advertising Standards Authority previously ruled that the Lightning Process (LP) should not be advertised as a treatment for CFS/ME. So how then, did LP end up getting tested as a treatment in a clinical trial involving adolescents with CFS/ME? Publication of the trial sparked controversy after it was claimed that LP, in addition to specialist medical care, out-performed specialist medical care alone. This blog attempts to shed light on just how a quack alternative online teaching programme, ended up in a costly clinical trial and discusses how the SMILE trial exemplifies all that is wrong with contemporary psycho-behavioural trials; that are clearly vulnerable to bias and spin.

The SMILE trial compared LP plus specialist medical care (SMC) to SMC alone (commonly a mix of cognitive behavioural therapy and graded exercise therapy). LP is a trademarked training programme created by Phil Parker from osteopathy, life coaching and neuro-linguistic programming. It costs over £600 and after assessment and telephone briefings, clients attend group sessions over three days. While there is much secrecy about what exactly these sessions involve, a cursory search online shows us that past clients were told to ‘block out all negative thoughts’ and to consider themselves well, not sick. A person with an illness is said to be ‘doing illness’ (LP spells doing as duing, to signify LP means more than just doing). LP appears to attempt to get a participant to ‘stop doing’ by blocking negative thoughts and making positive affirmations.

Leading psychologists have raised concerns. Professor James Coyne called LP “quackery” and said neuro-linguistic programming “…has been thoroughly debunked for its pseudoscience”. In an expert reaction to the SMILE trial for the Science Media Centre, Professor Dorothy Bishop of Oxford University stated: “the intervention that was assessed is commercial and associated with a number of warning signs. The Lightning Process appears based on neuro-linguistic programming, which, despite its scientific-sounding name, has long been recognised as pseudoscience“.

The first and most obvious question is why did the SMILE trial take place? Trial lead Professor Esther Crawley, who runs an NHS paediatric CFS/ME clinic, says she undertook the trial after many of her patients and their parents asked about LP. Patients with CFS/ME often report a lack of support from doctors and health care providers and some turn to the internet seeking help; some are drawn to try alternative approaches, such as LP. But is that justification enough for spending over £160,000 on testing LP on children? I think not. Should we test every quack approach peddled online: herbs, crystals, spiritual healing – particularly when funding in CFS/ME research is so limited currently? There must also be a compelling scientific plausibility to justify a trial. Simply wanting to see if something helps, does not merit adequate justification.

The SMILE trial has a fundamental design flaw. The trial compared specialist medical care alone (SMC) against SMC plus LP (SMC&LP). To the novice observer this may appear acceptable, but clinical trials are used to test item x against item y. For example, imagine trying to see which drug works better, drug A or drug B, you would not give drug A to one group and both drugs A and B to another group – yet this is exactly what happened in SMILE. In seeking to test LP, Prof. Crawley gave LP&SMC together – rendering any findings from this trial arm as pretty meaningless. The proper controls were missing. In addition, a trial of this magnitude would normally have a third arm, a do-nothing or usual care group, or another talk therapy control – yet such controls were missing.

Next we turn to the trial’s primary outcome measures. These were subjective self-reports of changes in physical function (using SF-36). Secondary outcomes were quality of life, anxiety and school attendance. These outcomes were assessed at 6 months with a follow-up at 12 months. It is reported that SMC+LP outperformed SMC alone on these measures at 6 and maintained at 12 months. However, there is no way to determine whether any claimed improvements came from LP alone, given LP was mixed with SMC. We could assume that LP+SMC meant more support, positive expectations and increased contact time. Here we see how farcical SMILE is as a trial. We have one group getting two treatments (possible double help) and one group getting one treatment (possible half help).

Of particular concern is how few of the available patients enrolled in and completed the trial: 637 children aged 12-18 attended screening or appointment at a specialist CFS/ME clinic; fewer than half (310) were deemed eligible; just 136 consented to receiving trial information and then only 100 were randomised (less than 1/3 of the eligible group). 49 had SMC and 51 had SMC+LP. Overall 207 patients either declined to participate or were not sufficiently interested to return the consent form. Were patients self-selecting? Were those less likely to respond to nonspecific factors choosing not to participate, and were we left with a group interested in LP – give Prof. Crawley said many patients asked about LP?

As the trial progressed, patients dropped out: of the 51 participants allocated to SMC+LP, only 39 received full SMC+LP. At 6-month assessment just 38 of the 48 allocated to SMC and 46 of the 51 in SMC+LP are fully recorded. At 12 months there are further losses to follow-up in both cohorts: 14% in LP and 24% in SMC.  The reasons for participant loss are not fully clear, though the paper reports 5 adverse events (3 in the SMC+LP arm). It is worth noting that physical function at 6 months deteriorated in 9 participants (roughly 10% overall), 8 in the SMC arm, with 5 participants having a fall of ≤10 on the SF-36 physical function subscale (deemed not clinically important). Again questions are raised as to whether some degree of self-selection took place? The fact 3 of the participants assigned to SMC alone appear to have received LP reflects possible contamination of research cohorts that are meant to be kept apart.

 Seven problems stand out in SMILE:

  1. The use of the SF-36 physical function test was questionable. This self-report instrument is not designed or adequately validated for use in children.
  2. Many of the participants appear to have had symptoms of anxiety and depression at the start of the trial. SMILE defined anxiety and depression as a score of ≥12 out of 22 on the self-report HADS. Usually a score of 8 or above is considered positive for mild anxiety and depression, and of above 12 for moderate anxiety and depression[1]. The average mean HADS score at trial entry was 9.6 (meaning using standard cut-offs, most participants met a criteria for anxiety and depression). On the Spence Anxiety Scale (SCAS) the average entry score was 35, with above 33 indicative of anxiety in this age group. Such mild to moderate elevations in depression and anxiety symptoms are very responsive to nonspecific support.
  3. There is an anomaly in the data on improvement: in the physical function test, the average base level of the children at entry into the trial was 54.5 (n=99), considered severely physically impaired. Only 52.5% of participants had been able to attend at least 3 days of school in the week prior to their entry into the study. Yet those assigned to SMC+LP were well enough to attend 3 consecutive days of sessions lasting 4 hours. The reports of severe physical disablement do not match the capabilities of those who participated in the course. Were the children’s self-reported poor physical abilities exaggerated to justify enrolment in the trial? Were the children’s elevated depression and anxiety symptoms responsive to the nonspecific elements in extra time of being assigned to LP plus standard care?
  4. If the subjective self-report is accepted as a recovery criterion, in LP, just 12 hours of talk therapy, added to SMC would cure the majority of children with CFS. Such an effect would be astonishing, if true. In randomized controlled trials in adults with CFS/ME, such dramatic restoration of physical function (a wholesale return to near normal) is universally not seen. The SMILE Trial is clearly unbelievable.
  5. SMILE’s reliance on the broad NICE criteria means there is a clear risk patients were included in the trial who would not have met stricter definitions of the illness. There is a growing concern that loose entry criteria in clinical trials in ME/CFS allow enrolments of many participants who do not in fact have ME/CFS. A detailed study of CFS prevalence found many children are wrongly diagnosed with CFS, when they may just be suffering from general fatigue and/or mental health complaints (Jones et al., 2004). SMILE uses NICE guidelines to diagnose CFS: fatigue must be present for at least 3 months with one or more of four other symptoms, which can be as general as sleep disturbance[2]. In contrast, Jones et al. showed that using the Centre for Disease Control criteria of at least four specific symptoms alongside detailed clinical examination, many children believed to have CFS are diagnosed with other exclusionary disorders, often general fatigue, mental health complaints, drug and alcohol abuse or eating disorders (that are often not readily disclosed to parents or doctors)[3].
  6. LP involves attempting to coerce clients into thinking that they have control over their symptoms and to block out symptoms. This alone would distort any response by a participant in a follow-on questionnaire about symptoms.
  7. LP was delivered by people from the Lightning Process Company. Phil Parker and his employees held a clear financial interest in a positive outcome in SMILE. Such an obvious conflict of interest is hard to disentangle and totally nullifies any outcomes from this trial.

Final Thoughts

The SMILE trial holds many anomalies and leaves us with more questions than answers.

It is not clear whether the children enrolled in the trial, diagnosed with CFS using NICE criteria, might of been deemed non-CFS using more stringent clinical screening (e.g. CDC or IOM Criteria).

There is no way of determining whether any effect following SMC+LP was anything more than the result of non-specific factors, psychological tricks and persuasion.

The fact LP+SMC appears to have cured the majority of participants with as little as 12 hours talk therapy is a big flashing red light that this trial is clearly fundamentally flawed.

There is a very real danger of promoting LP as a treatment for CFS/ME: The UK ME Association conducted a survey of members (4,217 members) and found that 20% of those who tried LP reported feeling worse (7.9% slightly worse,12.9% much worse). SMILE cannot be, and should not be, used to justify LP as a treatment for CFS/ME.

The Lightning Process has no scientific credibility and this trial highlights a fundamental flaw in contemporary clinical trials: they are susceptible to suggestion, bias and spin. The SMILE trial appears to draw paediatric CFS/ME clinical care for children into a swamp of pseudoscience and mysticism. This is a clear step backward. There is little to smile about after reviewing the SMILE trial.

Dr. Geraghty is currently an Honorary Research Fellow within the Centre for Primary Care, Division of Population Health and Health Services Research at the University of Manchester. He previously worked as a research associate at Cardiff University and Imperial College London. He left a career in clinical medicine after becoming ill with ME/CFS. The main themes of his work are doctor-patient relationships, medically unexplained symptoms, quality and safety in health care delivery, physician well-being and evidence-based medicine. He has a special interest in medically unexplained symptoms (MUS), and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. 

Although only recently published, his recent ‘PACE-Gate’: When clinical trial evidence meets open data access is already ranked #2 out of 1,350 papers in altmetics in Journal of Health Psychology.

A recent Times article cited Dr Geraghty on reasons why NICE need to update their recommendations for ME/CFS

Special thanks to John Peters and David Marks for their feedback.

References:
Coyne, J. (2017) Mind the Brain Blog, https://www.coyneoftherealm.com/blogs/mind-the-brain/embargo-broken-bristol-university-professor-to-discuss-trial-of-quack-chronic-fatigue-syndrome-treatment
Dorothy Bishop andExpert Commentary to the SMC (2017) http://www.sciencemediacentre.org/expert-reaction-to-controversial-treatment-for-cfsme/

1. Crawley, E., et al., Chronic disabling fatigue at age 13 and association with family adversity. Pediatrics, 2012. 130(1): p. e71-e79.
2. Crawley, E.M., et al., Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Archives of Disease in Childhood, 2017.
3. Jones, J.F., et al., Chronic fatigue syndrome and other fatiguing illnesses in adolescents: a population-based study. Journal of Adolescent Health, 2004. 35(1): p. 34-40.

Science Media Centre concedes negative reaction from scientific community to coverage of Esther Crawley’s SMILE trial.

“It was the criticism from within the scientific community that we had not anticipated.”

mind the brain logo

Editorial from the

science media centre logo

eat-crow-humble-pieSEPTEMBER 28, 2017

Inconvenient truths

http://www.sciencemediacentre.org/inconvenient-truths/

 

“It was the criticism from within the scientific community that we had not anticipated.”

“This time the SMC also came under fire from our friends in science…Quack buster extraordinaire David Colquhoun tweeted, ‘More reasons to be concerned about @SMC_London?’

Other friends wrote to us expressing concern about the unintended consequences of SMC briefings – with one saying that policy makers were furious at having to deal with the fallout from our climate briefing and others worried that the briefing on the CFS/ME trial would allow the only private company offering the treatment to profit by over-egging preliminary findings.

Eat more crowThose of us who are accustomed to the Science Media Centre UK (SMC) highly slanted coverage of select topics  can detect a familiar defensive, yet self-congratulatory tone to an editorial put out by the SMC in reaction to its broad coverage of Esther Crawley’s SMILE trial of the quack treatment, Phil Parker’s Lightning Process. Once again, critics, both patients and professionals, of ineffectual treatments being offered for chronic fatigue syndrome/myalgic encephalomyelitis  are lumped with climate change deniers. Ho-hum, this comparison is getting so clichéd.

Perhaps even better, the SMC editorial’s concessions of poor coverage of the SMILE trial drew sharp amplifications from commentators that SMC had botched the job.

b1f9cdb8747b66edb7587c798153d4bfHere are some comments below, with emphases added. But let’s not be lulled by SMC into assuming that these intelligent, highly articulate comments, not necessarily from the professional community. I wouldn’t be surprised if hiding behind the pseudonyms are some of the excellent citizen scientists that the patient community has had to grow in the face of vilification and stigmatization led by SMC.

I actually think I recognize a spokesperson from the patient community writing under the pseudonym ‘Scary vocal critic.’

Scary vocal critic says:

September 29, 2017 at 5:59 am

The way that this blog glosses over important details in order to promote a simplistic narrative is just another illustration of why so many are concerned by Fiona Fox’s work, and the impact [of] the Science Media Centre.

Let’ s look in a bit more detail at the SMILE trial, from Esther Crawley at Bristol University. This trial was intended to assess the efficacy of Phil Parker’s Lightning Process©. Phil Parker has a history of outlandish medical claims about his ability to heal others, selling training in “the use of divination medicine cards and tarot as a way of making predictions” and providing a biography which claimed: “Phil Parker is already known to many as an inspirational teacher, therapist, healer and author. His personal healing journey began when, whilst working with his patients as an osteopath. He discovered that their bodies would suddenly tell him important bits of information about them and their past, which to his surprise turned out to be factually correct! He further developed this ability to step into other people’s bodies over the years to assist them in their healing with amazing results. After working as a healer for 20 years, Phil Parker has developed a powerful and magical program to help you unlock your natural healing abilities. If you feel drawn to these courses then you are probably ready to join.” https://web.archive.org/web/20070615014926/http://www.healinghawk.com/prospectushealing.htm

While much of the teaching materials for the Lightning Process are not available for public scrutiny (LP being copyrighted and controlled by Phil Parker), it sells itself as being founded on neurolinguistic programming and osteopathy, which are themselves forms of quackery. Those who have been on the course have described a combination of strange rituals, intensive positive affirmations, and pseudoscientific neuro-babble; all adding up to promote the view that an individual’s ill-health can be controlled if only they are sufficiently committed to the Lightning Programme. Bristol University appears to have embraced the neurobabble, and in their press release about the SMILE results they describe LP thus: “It is a three-day training programme run by registered practitioners and designed to teach individuals a new set of techniques for improving life and health, through consciously switching on health promoting neurological pathways.”

https://www.bristol.ac.uk/news/2017/september/lightning-process.html

Unsurprisingly, many patients have complained about paying for LP and receiving manipulative quackery. This can have unpredictable consequences. This article reports a child attempting to kill themselves after going on the Lightning Process:  Before conducting a trial, the researchers involved had a responsibility to examine the course and training materials and remove all pseudo-science, yet this was not done. Instead, those patient groups raising concerns about the trial were smeared, and presented as being opposed to science.

The SMILE trial was always an unethical use of research funding, but if it had followed its original protocol, it would have been less likely to generate misleading results and headlines. The Skeptics Dictionary’s page on the Lightning Process features a contribution which explains that: “the Lightning Process RCT being carried out by Esther Crawley changed its primary outcome measure from school attendance to scores on a self-report questionnaire. Given that LP involves making claims to patients about their own ability to control symptoms in exactly the sort of way likely to lead to response bias, it seems very likely that this trial will now find LP to be ‘effective’. One of the problems with EBM is that it is often difficult to reliably measure the outcomes that are important to patients and account for the biases that occur in non-blinded trials, allowing for exaggerated claims of efficacy to be made to patients.”

The SMILE trial was a nonblinded, A vs A+B design, testing a ‘treatment’ which included positive affirmations, and then used subjective self-report questionnaires as a primary outcome. This is not a sensible way of conducting a trial, as anyone who has looked at how junk-science can be used to promote quackery will be aware.

You can see the original protocol for the SMILE trial here (although this protocol refers to merely a feasibility study, this is the same research, with the same ethical review code, the feasibility study having seemingly been converted to a full trial a year into the research):

The protocol that: “The primary outcome measure for the interventions will be school attendance/home tuition at 6 months.” It is worth noting that the new SMILE paper reported that there was no significant difference between groups for what was the trial’s primary outcome. There was a significant difference at 12 months, but by this point data on school attendance was missing for one third of the participants of the LP arm. The SMC failed to inform journalists of this outcome switching, instead presenting Prof Crawley as a critic converted by a rigorous examination of the evidence, despite her having told the ethics review board in 2010 that “she has worked before with the Bath [LP] practitioner who is good”. https://meagenda.wordpress.com/2011/01/06/letter-issued-by-nres-following-scrutiny-of-complaints-in-relation-to-smile-lighting-process-pilot-study/

Also, while the original protocol, and a later analysis plan, refer to verifying self-reported school attendance with school records, I could see no mention of this in the final paper, so it may be that even this more objective outcome measure has been rendered less useful and more prone to problems with response bias.

Back to Fiona Fox’s blog: “If you had only read the headlines for the CFS/ME story you may conclude that the treatment tested at Bristol might be worth a try if you are blighted by the illness, when in truth the author said repeatedly that the findings would first have to be replicated in a bigger trial.”

How terrible of sloppy headline writers to misrepresent research findings. This is from the abstract of Esther Crawley’s paper: “Conclusion The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.” http://adc.bmj.com/content/early/2017/09/20/archdischild-2017-313375

Fox complains of “vocal critics of research” in the CFS and climate change fields. There has been a prolong campaign from the SMC to smear those patients and academics who have been pointing out the problems with poor quality UK research into CFS, attempting to lump them with climate change deniers, anti-vaccinationists and animal rights extremists. The SMC used this campaign as an example of when they had “engineered the coverage” by “seizing the agenda”:

http://www.sciencemediacentre.org/wp-content/uploads/2013/03/Review-of-the-first-three-years-of-the-mental-health-research-function-at-the-Science-Media-Centre.pdf

Despite dramatic claims of a fearsome group of dangerous extremists (“It’s safer to insult the Prophet Mohammed than to contradict the armed wing of the ME brigade”), a Freedom of Information request helped us gain some valuable information about exactly what behaviour most concerned victimised researchers such as Esther Crawley:

“Minutes from a 2013 meeting held at the Science Media Centre, an organisation that played an important role in promoting misleading claims about the PACE trial to the UK media, show these CFS researchers deciding that “harassment is most damaging in the form of vexatious FOIs [Freedom of Information requests]”.[13,16, 27-31] The other two examples of harassment provided were “complaints” and “House of Lords debates”.[13] It is questionable whether such acts should be considered forms of harassment.

http://www.centreforwelfarereform.org/news/major-breaktn-pace-trial/00296.html

[A full copy of the minutes is included at the above address.]

Since then, a seriously ill patient managed to win a legal battle against researchers attempting to release key trial data, picking apart the prejudices that were promoted and left the Judge to state that “assessment of activist behaviour was, in our view, grossly exaggerated and the only actual evidence was that an individual at a seminar had heckled Professor Chalder.” http://www.informationtribunal.gov.uk/DBFiles/Decision/i1854/Queen%20Mary%20University%20of%20London%20EA-2015-0269%20(12-8-16).PDF

So why would there be an attempt to present request for information, complaints, and mere debate, as forms of harassment? Rather embarrassingly for Fiona and the SMC, it has since become clear. Following the release of (still only some of) the data from the £5 million PACE trial it is now increasingly recognised within the academic community that patients were right to be concerned about the quality of these researchers’ work, and the way in which people had been misled about the trial’s rsults. The New York Times reported on calls for the retraction of a key PACE paper (Robin Murray, the journal’s editor and a close friend of Simon Wessely’s, does not seem keen to discuss and debate the problems with this work): https://www.nytimes.com/2017/03/18/opinion/sunday/getting-it-wrong-on-chronic-fatigue-syndrome.html The Journal of Health Psychology has published as special issue devoted to the PACE trial debacle: http://journals.sagepub.com/doi/full/10.1177/1359105317722370 The CDC has dropped promotion of CBT and GET: https://www.statnews.com/2017/09/25/chronic-fatigue-syndrome-cdc/ And NICE has decided to a full review of its guidelines for CFS is necessary, citing concerns about research such as PACE as one of the key reasons for this: https://www.nice.org.uk/guidance/cg53/resources/surveillance-report-2017-chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-diagnosis-and-management-2007-nice-guideline-cg53-4602203537/chapter/how-we-made-the-decision https://www.thetimes.co.uk/edition/news/mutiny-by-me-sufferers-forces-a-climbdown-on-exercise-treatment-npj0spq0w

The SMC’s response to this has not been impressive.

Fox writes: “Both briefings fitted the usual mould: top quality scientists explaining their work to smart science journalists and making technical and complex studies accessible to readers.”

I’d be interested to know how it was Fox decided that Crawley was a top quality scientist. Also, it is worrying that the culture of UK science journalism seems to assume that making technical and complex studies (like SMILE?!) accessible for readers is their highest goal. It is not a surprise that it is foreign journalists who have produced more careful and accurate coverage of the PACE trial scandal.

Unlike the SMC and some CFS researchers, I do not consider complaints or debate to be a form of harassment, and would be quite happy to respond to anyone who disagrees with the concerns I have laid out here. I have had to simplify things, but believe that I have not done so in a way which favours my case. It seems that there are few people willing to try to publicly defend the PACE trial anymore, and I have never seen anyone from the SMC attempt to respond to anything other than a straw-man representation of their critics. Lets see what response these inconvenient truths receive.

Reply

Michael Emmans-Dean says:

October 2, 2017 at 8:22 am

The only point I would add to this excellent post is to ask why on earth the SMC decided to feature such a small, poorly-designed trial as SMILE. The most likely explanation is that it was intended as a smokescreen for an inconvenient truth. NICE’s retrieval of their CFS guideline from the long grass (the “static list”) is a far bigger story and it was announced in the same week that SMILE was published.

Reply

Fiona Roberts says:

September 29, 2017 at 9:03 am

Hear hear!

Embargo broken: Bristol University Professor to discuss trial of quack chronic fatigue syndrome treatment.

An alternative press briefing to compare and contrast with what is being provided by the Science Media Centre for a press conference on Wednesday September 20, 2017.

mind the brain logo

This blog post provides an alternative press briefing to compare and contrast with what was provided by the Science Media Centre for a press conference on Wednesday September 20, 2017.

The press release attached at the bottom of the post announces the publication of results of highly controversial trial that many would argue should never have occurred. The trial exposed children to an untested treatment with a quack explanation delivered by unqualified persons. Lots of money was earned from the trial by the promoters of the quack treatment beyond the boost in credibility for their quack treatment.

Note to journalists and the media: for further information email jcoynester@Gmail.com

This trial involved quackery delivered by unqualified practitioners who are otherwise untrained and insensitive to any harm to patients.

The UK Advertising Standards Authority had previously ruled that Lightning Process could not be advertised as a treatment. [ 1 ]

The Lightning is billed as mixing elements from osteopathy, life coaching and neuro-linguistic programming. That is far from having a mechanism of action based in science or evidence. [2] Neuro-linguistic programming (NLP) has been thoroughly debunked for its pseudoscientific references to brain science and ceased to be discussed in the scientific literature. [3]

Many experts would consider the trial unethical. It involved exposing children and adolescents to an unproven treatment with no prior evidence of effectiveness or safety nor any scientific basis for the mechanism by which it is claimed to work.

 As an American who has decades served on of experience with Committees for the Protection of Human Subjects and Data Safety and Monitoring Boards, I don’t understand how this trial was approved to recruit human subjects, and particularly children and adolescents.

I don’t understand why a physician who cared about her patients would seek approval to conduct such a trial.

Participation in the trial violated patients’ trust that medical settings and personnel will protect them from such risks.

Participation in the trial is time-consuming and involves loss of opportunity to obtain less risky treatment or simply not endure the inconvenience and burden of a treatment for which there is no scientific basis to expect would work.

Esther Crawley has said “If the Lightning Process is dangerous, as they say, we need to find out. They should want to find it out, not prevent research.”  I would like to see her try out that rationale in some of the patient safety and human subjects committee meetings I have attended. The response would not likely be very polite.

Patients and their parents should have been informed of an undisclosed conflict of interest.

phil parker NHSThis trial served as basis for advertising Lightning Process on the Web as being offered in NHS clinics and as being evaluated in a randomized controlled trial. [4]

Promoters of the Lightning Process received substantial payments from this trial. Although a promoter of the treatment was listed on the application for the project, she was not among the paper’s authors, so there will probably be no conflict of interest declared.

The providers were not qualified medical personnel, but were working for an organization that would financially benefit from positive findings.

It is expected that children who received the treatment as part of the trial would continue to receive it from providers who were trained and certified by promoters of the Lightning Process,

By analogy, think of a pharmaceutical trial in which the influence of drug company and that it would profit from positive results was not indicated in patient consent forms. There would be a public outcry and likely legal action.

astonishingWhy might the SMILE create the illusion that Lightning Process is effective for chronic fatigue syndrome?

There were multiple weaknesses in the trial design that would likely generate a false impression that the Lightning Process works. Under similar conditions, homeopathy and sham acupuncture appear effective [5]. Experts know to reject such results because (1) more rigorous designs are required to evaluate efficacy of treatment in order to rule out placebo effects; and (b) there must be a scientific basis for the mechanism of change claimed for how the treatment works. 

Indoctrination of parents and patients with pseudoscientific information. Advertisements for the Lightning Process on the Internet, including YouTube videos, and created a demand for this treatment among patients but it’s cost (£620) is prohibitive for many.

Selection Bias. Participation in the trial involved a 50% probability the treatment would be received for free. (Promoters of the Lightning Process received £567 for each patient who received the treatment in the trial). Parents who believed in the power of the the Lightning Process would be motived to enroll in the trial in order to obtain the treatment free for their children.

The trial was unblinded. Patients and treatment providers knew to which group patients were assigned. Not only with patients getting the Lightning Process be exposed to the providers’ positive expectations and encouragement, those assigned to the control group could register the disappointment when completing outcome measures.

The self-report subjective outcomes of this trial are susceptible to nonspecific factors (placebo effects). These include positive expectations, increased contact and support, and a rationale for what was being done, even if scientifically unsound. These nonspecific factors were concentrated in the group receiving the Lightning Process intervention. This serves to stack the deck in any evaluation of the Lightning Process and inflate differences with the patients who didn’t get into this group.

There were no objective measures of outcome. The one measure with a semblance of objectivity, school attendance, was eliminated in a pilot study. Objective measures would have provided a check on the likely exaggerated effects obtained with subjective seif-report measures.

The providers were not qualified medical, but were working for an organization that would financially benefit from positive findings. The providers were highly motivated to obtain positive results.

During treatment, the  Lightning Process further indoctrinates child and adolescent patients with pseudoscience [ 6 ] and involves coercion to fake that they are getting well [7 ]. Such coercion can interfere with the patients getting appropriate help when they need it, their establishing appropriate expectations with parental and school authorities, and even their responding honestly to outcome assessments.

 It’s not just patients and patient family members activists who object to the trial. As professionals have gotten more informed, there’s been increasing international concern about the ethics and safety of this trial.

The Science Media Centre has consistently portrayed critics of Esther Crawley’s work as being a disturbed minority of patients and patients’ family members. Smearing and vilification of patients and parents who object to the trial is unprecedented.

Particularly with the international controversy over the PACE trial of cognitive behavior therapy  and graded exercise therapy for chronic fatigue syndrome, the patients have been joined by non-patient scientists and clinicians in their concerns.

Really, if you were a fully informed parent of a child who was being pressured to participate in the trial with false claims of the potential benefits, wouldn’t you object?

embargoed news briefing

Notes

[1] “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.”

[2] The respected Skeptics Dictionary offers a scathing critique of Phil Parker’s Lightning Process. The critique specifically cites concerns that Crawley’s SMILE trial switched outcomes to increase the likelihood of obtaining evidence of effectiveness.

[3] The entry for Neuro-linguistic programming (NLP) inWikipedia states:

There is no scientific evidence supporting the claims made by NLP advocates and it has been discredited as a pseudoscience by experts.[1][12] Scientific reviews state that NLP is based on outdated metaphors of how the brain works that are inconsistent with current neurological theory and contain numerous factual errors.[13][14

[4] NHS and LP    Phil Parker’s webpage announces the collaboration with Bristol University and provides a link to the officialSMILE  trial website.

{5] A provocative New England Journal of Medicine article, Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma study showed that sham acupuncture as effective as an established medical treatment – an albuterol inhaler – for asthma when judged with subjective measures, but there was a large superiority for the established medical treatment obtained with objective measures.

[6] Instructional materials that patient are required to read during treatment include:

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.

[7] 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.

skeptical-cat-is-fraught-with-skepticism-300x225Special thanks to the Skeptical Cat who provided me with an advance copy of the press release from Science Media Centre.

 

 

 

 

 

 

 

Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered

[October 3 8:23 AM Update: I have now inserted Article 21 of the Declaration of Helsinki below, which is particularly relevant to discussions of the ethical problems of Dr. Esther Crawley’s previous SMILE trial.]

Petitions are calling for shutting down the MAGENTA trial. Those who organized the effort and signed the petition are commendably brave, given past vilification of any effort by patients and their allies to have a say about such trials.

Below I identify a number of issues that parents should consider in deciding whether to enroll their children in the MAGENTA trial or to withdraw them if they have already been enrolled. I take a strong stand, but I believe I have adequately justified and documented my points. I welcome discussion to the contrary.

This is a long read but to summarize the key points:

  • The MAGENTA trial does not promise any health benefits for the children participating in the trial. The information sheet for the trial was recently modified to suggest they might benefit. However, earlier versions clearly stated that no benefit was anticipated.
  • There is inadequate disclosure of likely harms to children participating in the trial.
  • An estimate of a health benefit can be evaluated from the existing literature concerning the effectiveness of the graded exercise therapy intervention with adults. Obtaining funding for the MAGENTA trial depended on a misrepresentation of the strength of evidence that it works in adult populations.  I am talking about the PACE trial.
  • Beyond any direct benefit to their children, parents might be motivated by the hope of contributing to science and the availability of effective treatments. However, these possible benefits depend on publication of results of a trial after undergoing peer review. The Principal Investigator for the MAGENTA trial, Dr. Esther Crawley, has a history of obtaining parents’ consent for participation of their children in the SMILE trial, but then not publishing the results in a timely fashion. Years later, we are still waiting.
  • Dr. Esther Crawley exposed children to unnecessary risk without likely benefit in her conduct of the SMILE trial. This clinical trial involved inflicting a quack treatment on children. Parents were not adequately informed of the nature of the treatment and the absence of evidence for any mechanism by which the intervention could conceivably be effective. This reflects on the due diligence that Dr. Crawley can be expected to exercise in the MAGENTA trial.
  • The consent form for the MAGENTA trial involves parents granting permission for the investigator to use children and parents’ comments concerning effects of the treatment for its promotion. Insufficient restrictions are placed on how the comments can be used. There is the clear precedent of comments made in the context of the SMILE trial being used to promote the quack Lightning Process treatment in the absence of evidence that treatment was actually effective in the trial. There is no guarantee that any comments collected from children and parents in the MAGENTA trial would not similarly be misused.
  • Dr. Esther Crawley participated in a smear campaign against parents having legitimate concerns about the SMILE trial. Parents making legitimate use of tools provided by the government such as Freedom of Information Act requests, appeals of decisions of ethical review boards and complaints to the General Medical Council were vilified and shamed.
  • Dr. Esther Crawley has provided direct, self-incriminating quotes in the newsletter of the Science Media Centre about how she was coached and directed by their staff to slam the patient community.  She played a key role in a concerted and orchestrated attack on the credibility of not only parents of participants in the MAGENTA trial, but of all patients having chronic fatigue syndrome/ myalgic encephalomyelitis , as well as their advocates and allies.

I am not a parent of a child eligible for recruitment to the MAGENTA trial. I am not even a citizen or resident of the UK. Nonetheless, I have considered the issues and lay out some of my considerations below. On this basis, I signed the global support version  of the UK petition to suspend all trials of graded exercise therapy in children and adults with ME/CFS. I encourage readers who are similarly in my situation outside the UK to join me in signing the global support petition.

If I were a parent of an eligible child or a resident of the UK, I would not enroll my child in MAGENTA. I would immediately withdraw my child if he or she were currently participating in the trial. I would request all the child’s data be given back or evidence that it had been destroyed.

I recommend my PLOS Mind the Brain post, What patients should require before consenting to participate in research…  as either a prelude or epilogue to the following blog post.

What you will find here is a discussion of matters that parents should consider before enrolling their children in the MAGENTA trial of graded exercise for chronic fatigue syndrome. The previous blog post [http://blogs.plos.org/mindthebrain/2015/12/09/what-patients-should-require-before-consenting-to-participate-in-research/ ]  is rich in links to an ongoing initiative from The BMJ to promote broader involvement of patients (and implicitly, parents of patients) in the design, implementation, and interpretation of clinical trials. The views put forth by The BMJ are quite progressive, even if there is a gap between their expression of views and their actual implementation. Overall, that blog post presents a good set of standards for patients (and parents) making informed decisions concerning enrollment in clinical trials.

Simon McGrathLate-breaking update: See also

Simon McGrath: PACE trial shows why medicine needs patients to scrutinise studies about their health

Basic considerations.

Patients are under no obligation to participate in clinical trials. It should be recognized that any participation typically involves burden and possibly risk over what is involved in receiving medical care outside of a clinical trial.

It is a deprivation of their human rights and a violation of the Declaration of Helsinki to coerce patients to participate in medical research without freely given, fully informed consent.

Patients cannot be denied any medical treatment or attention to which they would otherwise be entitled if they fail to enroll in a clinical trial.

Issues are compounded when consent from parents is sought for participation of vulnerable children and adolescents for whom they have legal responsibility. Although assent to participate in clinical trials is sought from children and adolescents, it remains for their parents to consent to their participation.

Parents can at any time withdraw their consent for their children and adolescents participating in trials and have their data removed, without requiring the approval of any authorities of their reason for doing so.

Declaration of Helsinki

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

It includes:

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

[October 3 8:23 AM Update]: I have now inserted Article 21 of the Declaration of Helsinki which really nails the ethical problems of the SMILE trial:

21. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

There is clearly in adequate scientific justification for testing the quack Lightning Process Treatment.

What Is the Magenta Trial?

The published MAGENTA study protocol states

This study aims to investigate the acceptability and feasibility of carrying out a multicentre randomised controlled trial investigating the effectiveness of graded exercise therapy compared with activity management for children/teenagers who are mildly or moderately affected with CFS/ME.

Methods and analysis 100 paediatric patients (8–17 years) with CFS/ME will be recruited from 3 specialist UK National Health Service (NHS) CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either graded exercise therapy or activity management. Feasibility analysis will include the number of young people eligible, approached and consented to the trial; attrition rate and treatment adherence; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the interventions. All adverse events will be monitored to assess the safety of the trial.

The first of two treatments being compared is:

Arm 1: activity management

This arm will be delivered by CFS/ME specialists. As activity management is currently being delivered in all three services, clinicians will not require further training; however, they will receive guidance on the mandatory, prohibited and flexible components (see online supplementary appendix 1). Clinicians therefore have flexibility in delivering the intervention within their National Health Service (NHS) setting. Activity management aims to convert a ‘boom–bust’ pattern of activity (lots 1 day and little the next) to a baseline with the same daily amount before increasing the daily amount by 10–20% each week. For children and adolescents with CFS/ME, these are mostly cognitive activities: school, schoolwork, reading, socialising and screen time (phone, laptop, TV, games). Those allocated to this arm will receive advice about the total amount of daily activity, including physical activity, but will not receive specific advice about their use of exercise, increasing exercise or timed physical exercise.

So, the first arm of the trial is a comparison condition consisting of standard care delivered without further training of providers. The treatment is flexibly delivered, expected to vary between settings, and thus largely uncontrolled. The treatment represents a methodologically weak condition that does not adequately control for attention and positive expectations. Control conditions should be equivalent to the intervention being evaluated in these dimensions.

The second arm of the study:

Arm 2: graded exercise therapy (GET)

This arm will be delivered by referral to a GET-trained CFS/ME specialist who will receive guidance on the mandatory, prohibited and flexible components (see online supplementary appendix 1). They will be encouraged to deliver GET as they would in their NHS setting.20 Those allocated to this arm will be offered advice that is focused on exercise with detailed assessment of current physical activity, advice about exercise and a programme including timed daily exercise. The intervention will encourage children and adolescents to find a baseline level of exercise which will be increased slowly (by 10–20% a week, as per NICE guidance5 and the Pacing, graded Activity and Cognitive behaviour therapy – a randomised Evaluation (PACE)12 ,21). This will be the median amount of daily exercise done during the week. Children and adolescents will also be taught to use a heart rate monitor to avoid overexertion. Participants will be advised to stay within the target heart rate zones of 50–70% of their maximum heart rate.5 ,7

The outcome of the trial will be evaluated in terms of

Quantitative analysis

The percentage recruited of those eligible will be calculated …Retention will be estimated as the percentage of recruited children and adolescents reaching the primary 6-month follow-up point, who provide key outcome measures (the Chalder Fatigue Scale and the 36-Item Short-Form Physical Functioning Scale (SF-36 PFS)) at that assessment point.

actigraphObjective data will be collected in the form of physical activity measured by Accelerometers. These are

Small, matchbox-sized devices that measure physical activity. They have been shown to provide reliable indicators of physical activity among children and adults.

However, actual evaluation of the outcome of the trial will focus on recruitment and retention and subjective, self-report measures of fatigue and physical functioning. These subjective measures have been shown to be less valid than objective measures. Scores are  vulnerable  to participants knowing what condition they are assigned to (called ‘being unblinded’) and their perception of which intervention the investigators prefer.

It is notable that in the PACE trial of CBT and GET for chronic fatigue syndrome in adults, the investigators manipulated participants’ self-reports with praise in newsletters sent out during the trial . The investigators also switched their scoring of the self-report measures and produced results that they later conceded to have been exaggerated by their changing in scoring of the self-report measures [http://www.wolfson.qmul.ac.uk/current-projects/pace-trial#news ].

Irish ME/CFS Association Officer & Tom Kindlon
Tom Kindlon, Irish ME/CFS Association Officer

See an excellent commentary by Tom Kindlon at PubMed Commons [What’s that? ]

The validity of using subjective outcome measures as primary outcomes is questionable in such a trial

The bottom line is that the investigators have a poorly designed study with inadequate control condition. They have chosen subjective self-reports that are prone to invalidity and manipulation over objective measures like actual changes in activity or practical real-world measures like school attendance. Not very good science here. But they are asking parents to sign their children up.

What is promised to parents consenting to have the children enrolled in the trial?

The published protocol to which the investigators supposedly committed themselves stated

What are the possible benefits and risks of participating?
Participants will not benefit directly from taking part in the study although it may prove enjoyable contributing to the research. There are no risks of participating in the study.

Version 7 of the information sheet provided to parents, states

Your child may benefit from the treatment they receive, but we cannot guarantee this. Some children with CFS/ME like to know that they are helping other children in the future. Your child may also learn about research.

Survey assessments conducted by the patient community strongly contradict the suggestion that there is no risk of harm with GET.

alemAlem Matthees, the patient activist who obtained release of the PACE data and participated in reanalysis has commented:

“Given that post-exertional symptomatology is a hallmark of ME/CFS, it is premature to do trials of graded exercise on children when safety has not first been properly established in adults. The assertion that graded exercise is safe in adults is generally based on trials where harms are poorly reported or where the evidence of objectively measured increases in total activity levels is lacking. Adult patients commonly report that their health was substantially worsened after trying to increase their activity levels, sometimes severely and permanently, therefore this serious issue cannot be ignored when recruiting children for research.”

See also

Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111.

This thorough systematic review reports inadequacy in harm reporting in clinical trials, but:

Exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse  reactions  to exercise have been  recorded in  a number of  patient surveys. Fifty-one percent of  survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT.

The unpublished results of Dr. Esther Crawley’s SMILE trial

 A Bristol University website indicates that recruitment of the SMILE trial was completed in 2013. The published protocol for the SMILE trial

[Note the ® in the title below, indicating a test of trademarked commercial product. The significance of that is worthy of a whole other blog post. ]

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):1.

States

The data monitoring group will receive notice of serious adverse events (SAEs) for the sample as whole. If the incidence of SAEs of a similar type is greater than would be expected in this population, it will be possible for the data monitoring group to receive data according to trial arm to determine any evidence of excess in either arm.

Primary outcome data at six months will be examined once data are available from 50 patients, to ensure that neither arm is having a detrimental effect on the majority of patients. An independent statistician with no other involvement in the study will investigate whether more than 20 participants in the study sample as a whole have experienced a reduction of ≥ 30 points on the SF-36 at six months. In this case, the data will then be summarised separately by trial arm, and sent to the data monitoring group for review. This process will ensure that the trial team will not have access to the outcome data separated by treatment arm.

A Bristol University website indicates that recruitment of the SMILE trial was completed in 2013. The trial was thus completed a number of years ago, but these valuable data have never been published.

The only publication from the trial so far uses selective quotes from child participants that cannot be independently evaluated. Readers are not told how representative these quotes, the outcomes for the children being quoted or the overall outcomes of the trial.

Parslow R, Patel A, Beasant L, Haywood K, Johnson D, Crawley E. What matters to children with CFS/ME? A conceptual model as the first stage in developing a PROM. Archives of Disease in Childhood. 2015 Dec 1;100(12):1141-7.

The “evaluation” of the quack Lightning Treatment in the SMILE trial and quotes from patients have also been used to promote Parker’s products as being used in NHS clinics.

How can I say the Lightning Process is quackery?

 Dr. Crawley describes the Lightning Process in the Research Ethics Application Form for the SMILE study as   ombining the principles of neurolinguistic programming, osteopathy, and clinical hypnotherapy.

That is an amazing array of three different frameworks from different disciplines. You would be hard pressed to find an example other than the Lightning Process that claimed to integrate them. Yet, any mechanisms for explaining therapeutic interventions cannot be a creative stir fry of whatever is on hand being thrown together. For a treatment to be considered science-based, there has to be a solid basis of evidence that these presumably complex processes fit together as assumed and work as assumed. I challenge Dr. Crawley or anyone else to produce a shred of credible, peer-reviewed evidence for the basic mechanism of the Lightning Process.

The entry for Neuro-linguistic programming (NLP) in Wikipedia states

There is no scientific evidence supporting the claims made by NLP advocates and it has been discredited as a pseudoscience by experts.[1][12] Scientific reviews state that NLP is based on outdated metaphors of how the brain works that are inconsistent with current neurological theory and contain numerous factual errors.[13][14

The respected Skeptics Dictionary offers a scathing critique of Phil Parker’s Lightning Process. The critique specifically cites concerns that Crawley’s SMILE trial switched outcomes to increase the likelihood of obtaining evidence of effectiveness.

 The Hampshire (UK) County Council Trading Standards Office filed a formal complaint against Phil Parker for claims made on the Lightning Process website concerning effects on CFS/ME:

The “CFS/ME” page of the website included the statements “Our survey found that 81.3 %* of clients report that they no longer have the issues they came with by day three of the LP course” and “The Lightning Process is working with the NHS on a feasibility study, please click here for further details, and for other research information click here”.

parker nhs advert
Seeming endorsements on Parker’s website. Two of them –Northern Ireland and NHS Suffolk subsequently complained that use of their insignias was unauthorized and they were quickly removed.

The “working with the NHS” refers to the collaboration with Dr. Easter Crawley.

The UK Advertising Standards Authority upheld this complaint, as well as about Parker’s claims about effectiveness with other conditions, including  multiple sclerosis, irritable bowel syndrome and fibromyalgia

 Another complaint in 2013 about claims on Phil Parker’s website was similarly upheld:

 The claims must not appear again in their current form. We welcomed the decision to remove the claims. We told Phil Parker Group not to make claims on websites within their control that were directly connected with the supply of their goods and services if those claims could not be supported with robust evidence. We also told them not to refer to conditions for which advice should be sought from suitably qualified health professionals.

 As we will see, these upheld charges of quackery occurred when parents of children participating in the SMILE trial were being vilified in the BMJ and elsewhere. Dr. Crawley was prominently featured in this vilification and was quoted in a celebration of its success by the Science Media Centre, which had orchestrated the vilification.

Captured cfs praker ad

The Research Ethics Committee approval of the SMILE trial and the aftermath

 I was not very aware of the CFS/ME literature, and certainly not all its controversies when the South West Research Ethics Committee (REC) reviewed the application for the SMILE trial and ultimately approved it on September 8, 2010.

I would have had strong opinions about it. I only first started blogging a little afterwards.  But I was very concerned about any patients being exposed to alternative and unproven medical treatments in other contexts that were not evidence-based – even more so to treatments for which promoters claimed implausible mechanisms by which they worked. I would not have felt it appropriate to inflict the Lightning Process on unsuspecting children. It is insufficient justification to put them a clinical trial simply because a particular treatment has not been evaluated.

 Prince Charles once advocated organic coffee enemas to treat advanced cancer. His endorsement generated a lot of curiosity from cancer patients. But that would not justify a randomized trial of coffee enemas. By analogy, I don’t think Dr. Esther Crawley had sufficient justification to conduct her trial, especially without warnings that that there was no scientific basis to expect the Lightning Process to work or that it would not hurt the children.

 I am concerned about clinical trials that have little likelihood of producing evidence that a treatment is effective, but that seemed designed to get these treatments into routine clinical care. it is now appreciated that some clinical trials have little scientific value but serve as experimercials or means of placing products in clinical settings. Pharmaceutical companies notoriously do this.

As it turned out, the SMILE trial succeeded admirably as a promotion for the Lightning Process, earning Phil Parker unknown but substantial fees through its use in the SMILE trial, but also in successful marketing throughout the NHS afterwards.

In short, I would been concerned about the judgment of Dr. Esther Crawley in organizing the SMILE trial. I would been quite curious about conflicts of interest and whether patients were adequately informed of how Phil Parker was benefiting.

The ethics review of the SMILE trial gave short shrift to these important concerns.

When the patient community and its advocate, Dr. Charles Shepherd, became aware of the SMILE trial’s approval, there were protests leading to re-evaluations all the way up to the National Patient Safety Agency. Examining an Extract of Minutes from South West 2 REC meeting held on 2 December 2010, I see many objections to the approval being raised and I am unsatisfied by the way in which they were discounted.

Patient, parent, and advocate protests escalated. If some acted inappropriate, this did not undermine the righteousness of others legitimate protest. By analogy, I feel strongly about police violence aimed against African-Americans and racist policies that disproportionately target African-Americans for police scrutiny and stoppng. I’m upset when agitators and provocateurs become violent at protests, but that does not delegitimize my concerns about the way black people are treated in America.

Dr. Esther Crawley undoubtedly experienced considerable stress and unfair treatment, but I don’t understand why she was not responsive to patient concerns nor  why she failed to honor her responsibility to protect child patients from exposure to unproven and likely harmful treatments.

Dr. Crawley is extensively quoted in a British Medical Journal opinion piece authored by a freelance journalist,  Nigel Hawkes:

Hawkes N. Dangers of research into chronic fatigue syndrome. BMJ. 2011 Jun 22;342:d3780.

If I had been on the scene, Dr. Crawley might well have been describing me in terms of how I would react, including my exercising of appropriate, legally-provided means of protest and complaint:

Critics of the method opposed the trial, first, Dr Crawley says, by claiming it was a terrible treatment and then by calling for two ethical reviews. Dr Shepherd backed the ethical challenge, which included the claim that it was unethical to carry out the trial in children, made by the ME Association and the Young ME Sufferers Trust. After re-opening its ethical review and reconsidering the evidence in the light of the challenge, the regional ethical committee of the NHS reiterated its support for the trial.

There was arguably some smearing of Dr. Shepherd, even in some distancing of him from the action of others:

This point of view, if not the actions it inspires, is defended by Charles Shepherd, medical adviser to and trustee of the ME Association. “The anger and frustration patients have that funding has been almost totally focused on the psychiatric side is very justifiable,” he says. “But the way a very tiny element goes about protesting about it is not acceptable.

This article escalated with unfair comparisons to animal rights activists, with condemnation of appropriate use of channels of complaint – reporting physicians to the General Medical Council.

The personalised nature of the campaign has much in common with that of animal rights activists, who subjected many scientists to abuse and intimidation in the 1990s. The attitude at the time was that the less said about the threats the better. Giving them publicity would only encourage more. Scientists for the most part kept silent and journalists desisted from writing about the subject, partly because they feared anything they wrote would make the situation worse. Some journalists have also been discouraged from writing about CFS/ME, such is the unpleasant atmosphere it engenders.

While the campaigners have stopped short of the violent activities of the animal rights groups, they have another weapon in their armoury—reporting doctors to the GMC. Willie Hamilton, an academic general practitioner and professor of primary care diagnostics at Peninsula Medical School in Exeter, served on the panel assembled by the National Institute for Health and Clinical Excellence (NICE) to formulate treatment advice for CFS/ME.

Simon Wessely and the Principal Investigator of the PACE trial, Peter White, were given free rein to dramatize their predicament posed by the protest. Much later, in the 2016 Lower Tribunal Hearing, testimony would be given by PACE

Co-Investigator Trudie Chalder would much later (2016) cast doubt on whether the harassment was as severe or violent as it was portrayed. Before that, the financial conflicts of interest of Peter White that were denied in the article would be exposed.

In response to her testimony, the UK Information Officer stated:

Professor Chalder’s evidence when she accepts that unpleasant things have been said to and about PACE researchers only, but that no threats have been made either to researchers or participants.

But in 2012, a pamphlet celebrating the success of The Science Media Centre started by Wessely would be rich in indiscreet quotes from Esther Crawley. The article in BMJ was revealed to be part of a much larger orchestrated campaign to smear, discredit and silence patients, parents, advocates and their allies.

Dr. Esther Crawley’s participation in a campaign organized by the Science Media Center to discredit patients, parents, advocates and supporters.

 The SMC would later organize a letter writing campaign to Parliament in support of Peter White and his refusal to release the PACE data to Alem Mattheees who had made a requestunder the Freedom of Information Act. The letter writing campaign was an effort to get scientific data excluded from the provisions of the freedom of information act. The effort failed and the data were subsequently released.

But here is how Esther Crawley described her assistance:

The SMC organised a meeting so we could discuss what to do to protect researchers. Those who had been subject to abuse met with press officers, representatives from the GMC and, importantly, police who had dealt with the  animal rights campaign. This transformed my view of  what had been going on. I had thought those attacking us were “activists”; the police explained they were “extremists”.

And

We were told that we needed to make better use of the law and consider using the press in our favour – as had researchers harried by animal rights extremists. “Let the public know what you are trying to do and what is happening to you,” we were told. “Let the public decide.”

And

I took part in quite a few interviews that day, and have done since. I was also inundated with letters, emails and phone calls from patients with CFS/ME all over the world asking me to continue and not “give up”. The malicious, they pointed out, are in a minority. The abuse has stopped completely. I never read the activists’ blogs, but friends who did told me that they claimed to be “confused” and “upset” – possibly because their role had been switched from victim to abuser. “We never thought we were doing any harm…”

 The patient community and its allies are still burdened by the damage of this effort and are rebuilding its credibility only slowly. Only now are they beginning to get an audience as suffering human beings with significant, legitimate unmet needs. Only now are they escaping the stigmatization that occurred at this time with Esther Crawley playing a key role.

Where does this leave us?

stop posterParents are being asked to enroll in a clinical trial without clear benefit to the children but with the possibility of considerable risk from the graded exercise. They are being asked by Esther Crawley, a physician, who has previously inflicted a quack treatment on their children with CFS/ME in the guise of a clinical trial, for which he is never published the resulting data. She has played an effective role in damaging the legitimacy and capacity of patients and parents to complain.

Given this history and these factors, why would a parent possibly want to enroll their children in the MAGENTA trial? Somebody please tell me.

Special thanks to all the patient citizen-scientists who contributed to this blog post. Any inaccuracies or excesses are entirely my own, but these persons gave me substantial help. Some are named in the blog, but others prefer anonymity.

 All opinions expressed are solely those of James C Coyne. The blog post in no way conveys any official position of Mind the Brain, PLOS blogs or the larger PLOS community. I appreciate the free expression of  personal opinion that I am allowed.

 

 

 

 

 

 

Hans Eysenck’s contribution to cognitive behavioral therapy for physical health problems: fraudulent data

  • The centenary of the birth of Hans Eysenck is being marked by honoring his role in bringing clinical psychology to the UK and pioneering cognitive behavior therapy (CBT).
  • There is largely silence about his publishing fraudulent data, editorial misconduct, and substantial undeclared conflicts of interest.
  • The articles in which Eysenck used fraudulent data are no longer cited much, but the influence of his claims which depended on these data remains profound.
  • Eysenck used fraudulent data to argue that CBT could prevent cancer and cardiovascular disease and extend the lives of persons with advanced cancer.
  • He similarly used fraudulent data to advance the claim that psychoanalysis is, unlike smoking, carcinogenic and has other adverse effects on health.
  • Ironically, Eysenck incorporated into his explanations for how CBT works elements of the psychoanalytic thinking that he seemingly detested.

If there is sufficient interest, a follow-up blog post will discuss:

  • Because of Eysenck’s influence, CBT in the UK exaggerates the role of early childhood adversity and much less to functional behavioral analysis than the American behavior therapy and cognitive behavior therapy.
  • Both CBT in the UK and some quack therapy approaches make assumptions about mechanism tied to Eysenck’s use of fraudulent data.
  • Consistent with Eysenck’s influence, CBT for physical problems in the UK largely focuses on self-report questionnaire assessments of mechanism of change and of outcome, rather than functional behavioral and objective physical health outcome variables.

8th-chocolate-happy-birthday-cake-for-HansHappy Birthday, Hans Eysenck

March 12, 2016 was the centenary of the birth of psychologist Hans Eysenck. The British Psychological Society’s  The Psychologist marked the occasion with release of a free app by which BPS members can access a collection of articles about Hans Eysenck from the archives.  Nonmembers can access the articles here.

The introduction to the collection, Philip Corr’s The centenary of a maverick states

Eysenck’s contributions were many, varied and significant, including: the professional development of clinical psychology; the slaying of the psychoanalytical dragon; pioneering behaviour therapy and, thus, helping to usher in the era of cognitive behavioural therapy…

Corr also wrote in the March 30 2016 Times Higher Education:

in defence corr

hans ensenck portraitThe articles collected in The Psychologist were written over many years. Together they present an unflattering picture of a controversial man who was shunned by his colleagues, blocked from getting awards, and who would humiliate those with whom he disagreed rather than acknowledge any contradictory evidence. Particularly revealing are Roderick Buchanan’s   Looking back: The controversial Hans Eysenck and a review of Buchanan’s book by Eysenck’s son Michael, Playing with fire: The controversial career of Hans J. Eysenck.

However, the collection stops short of acknowledging what was revealed in the early 90s in The BMJ: Eysenck knowingly published fraudulent data to back outrageous claims that CBT prevented cancer and extended the lives of patients with terminal cancer, whereas psychoanalysis was carcinogenic. He published his claims in journals he had founded, liberally self-plagiarizing and duplicate publishing with undeclared conflicts of interest. Eysenck received salary supplements and cash awards from German tobacco companies and from lawyers for the American tobacco companies for these activities.

slide 2 r smith should editors slide1 R Smith EysenckThe BMJ gave psychiatrists Anthony Pelosi and Louis Appleby a forum in the early nineties for criticizing Eysenck, even though the articles they attacked had been published elsewhere. The BMJ Editor Richard Smith followed up,  citing Eysenck as an example in raising the question whether editors should publish research articles in their own journal. Pelosi filed formal charges against Eysenck with the British Psychological Society. But, according to Buchanan’s book:

The BPS investigatory committee deemed it “inappropriate” to set up an investigatory panel to look into the material Pelosi had sent them, and henceforth considered the matter closed. Pelosi disagreed, of course, but was left with little recourse.

In an editorial in The Times Simon Wessely acknowledged Pelosi and Appleby’s criticism of Eysenck, but said “It would take more than a couple of psychiatrists to ruffle Eysenck.”

Simon on EysenckWessely suggested that the matter be dropped: the controversy was distracting everyone from the real progress being made in psychological approaches to cancer, like showing a fighting spirit extends the lives of cancer patients.  There was apparently no further mention in the UK press. Read more here.

Eysenck’s articles involving fraudulent data are seldom cited in the contemporary literature, but the claims the data were used to back remain quite influential. For instance, Eysenck claimed psychological factors presented more risk for cancer than many well-established biological factors. Including Eysenck’s data probably allowed one of the most cited meta-analyses of psychological factors in cancer to pass the threshold of hazard ratios strong enough for publication in the prestigious journal, Nature Clinical Practice: Oncology. Without the inclusion of Eysenck’s data, hazard ratios from methodologically weak studies cluster slightly higher than 1.0, suggesting little association that cannot be explained by confounds. A later blog post will document the broader influence of the Eysenck fraud on psychoneuroimmunology.

Eysenck’s claims concerning effects of CBT on physical health conditions now similarly go uncited.  However, the idiosyncratic definition he gave to CBT and his claims about the presumed mechanism by which it improved physical health pervade both CBT as defined in the UK and a number of quack treatments in the UK and elsewhere.

It is important to establish the connection between fraudulent data, distinctive features of CBT in the UK, and presumed mechanisms of action in order to open for re-examination the forms that CBT for physical health problems take in the UK and the way in which claims of efficacy are evaluated.

Fraudulent Data

Eysenck repeated tables and text in a number of places, but I will mainly draw on data as he presented them in the journal he founded, Behaviour Research and Therapy [1,   2], which correspond with what he presents elsewhere.

Eysenck’s Croatian collaborator Grossarth-Maticek conducted the therapy and collected the predictor and outcome data. A personality inventory  was used to classify participants receiving therapy into four types , a cancer-prone type (Type 1), a coronary heart disease (CHD)-prone type (Type 2), and 2 healthy types (Type 3 and Type 4). The typology was derived from quadrants in a 2×2 dichotomization of high versus low and rationality versus anti-emotionality, quite different from the dimensions and item content of the Eysenck Personality Questionnaire. Indeed, Roderick Buchanan noted in his biography that “Eysenck had struggled to banish typological concepts in favour of continuous dimensions for most of his career.” Grossarth-Maticekis questionnaire and typology has been sharply criticized later by Eysenck son Michael, among many others.

Eysenck and Grossarth-Maticek reported results of individually delivered “creative novation behaviour therapy”:

… Effects of prophylactic behaviour therapy on the cancer-prone and the CHD-prone probands respectively after 13 yr. It will be clear that treatment by means of creative novation behaviour therapy has had a highly significant prophylactic effect, preventing deaths from cancer in probands of Type 1, and death from coronary heart disease in probands of Type 2.

table 3 prophylactic effectsFor creative novation behaviour therapy delivered in a group format:

It will be seen that both cancer and CHD mortality are very significantly higher in the control group, as is death from other causes. Incidence rates are also very significantly higher in the control group for cancer, but with a difference below our selected P = 0.01 level of significance for CHD. Most telling is the difference regarding those ‘still living’-79.9% in the therapy group, 23.9% in the control group. The results of the group therapy study support those of the individual therapy group in demonstrating the value of behaviour therapy in preventing death from cancer and CHD, and in lowering the incidence from cancer and possibly from CHD.

table 4 group therapyStrong effects were reported even when the treatment was delivered as a discussion of a brief pamphlet. The companion paper  described this bibliotherapy and provided the pamphlet as an appendix,  which is reproduced here.

This statement is given to the proband, who also receives an introductory 1-hr treatment in which the meaning of the statement is explained, application considered, and likely advantages discussed. After the patient has been given time to consider the statement, and apply it to his/her own problems, the therapist spends a further 3-5 hr with the patient, suggesting specific applications of the principles in the statement to the needs of the patient, and his/her particular circumstances.

Six hundred probands received the bibliotherapy and a control group of 500 matched for personality type, smoking, age and sex received no treatment. Another 100 matched patients received a placebo condition in which they met with interviewers to discuss a pamphlet with “psychoanalytic explanation and suggestions.”

I encourage readers to take a look at the pamphlet, which is less than a page long. It ends with:

The most important aims of autonomous self-activation: your aim should always be to produce conditions would make it possible for you to lead a happy and contented life.

The results were:

There are no statistically significant differences between the control group and the placebo group, which may therefore be combined and considered a single control group. Compared with this control group, the treatment group fared significantly better. In the control group, 128 died of cancer, 176 of CHD; in the treatment group only 27 died of cancer, and 47 of CHD. For ‘death from other causes’, the figures are 192 and 115. Clearly the bibliographic method had a very strong prophylactic effect.

table 5 group and biblioEysenck and Grossarth-Maticek reported numerous other studies, including one in which 24 matched pairs of patients with inoperable cancer were assigned to either creative novation behaviour therapy or a control group. The patients receiving the behaviour therapy lived five years versus the three years of those in the control group, a difference which was highly significant.

Keep in mind that in these studies that all of the creative novation behaviour therapy sessions were solely provided by Grossarth-Maticek.

But let’s jump to a final in a series of tables constructed to make the argument that psychoanalysis was harmful to physical health.

We are here dealing with three groups. Group I is constituted of patients who terminated their  psychoanalytical treatment after 2 yr or less, and were then treated with behaviour therapy.

Group 2 is a control group matched with the members of group I on age, sex, smoking and personality type. Group 3 is a control group which discontinued psychoanalysis, like Group I, but did not receive behaviour therapy. Members of Group I and 2 do not differ significantly in mortality, but Group 3 has significantly greater mortality than either. Looking again at the percentage of patients still living, we find for Group 1 92, 95 and 95%, for Group 2 96, 89 and 95%, for Group 3 the figures are: 72, 63 and 61%. Clearly behaviour therapy can reverse the negative impact psychoanalysis has on survival.

table 15 psychoanalysisIn a number of places, this is explained in identical words:

Theoretically, this conclusion is not unreasonable. We have shown that stress is a powerful factor in causing cancer and CRD, and it is widely agreed, even among psychoanalysts, that their treatment imposes a considerable strain on patients. The hope is often expressed that finally the treatment will resolve these strains, but there is no evidence to suggest that this is true (Rachman & Wilson, 1980; Eysenk & Martin, 1987). Indeed, there is good evidence that even in cases of mental disorder psychoanalysis often does considerable harm (Mays & Franks, 1985). A theoretical model to account for these negative outcomes of psychoanalysis and psychotherapy generally has been presented elsewhere (Eysenck, 1985); it would apply equally well in the psychosomatic as in the purely psychiatric field.

dog breakfastCBT for physical health problems: a dog’s breakfast approach

Grossarth-Maticek had already formulated his approach and delivered all psychotherapy before Eysenck began co-authored papers and promoting him. In a 1982 article without Eysenck as an author, Grossarth-Maticek is quite explicit about the psychoanalytic theory behind his approach:

A central proposition of our research program is that cancer patients are either preoccupied with traumatic events of early childhood or with excessive expectations of the parents during their whole life. They are characterized by intensive internal inhibitions toward expressing feelings and desires. Therefore, we speak of a chronic blockade of expression of feelings and desires. We assume that parents of cancer patients did not respond adequately to the child’s cries for help and these children were obliged very early to do non-conforming daily task. Cancer patients have never learned to express persistent cries for help…

The specific family dynamics in the special educational pattern which block hysterical reactions determine the behavior, which in turn is characterized by excessive persistence of performance of the daily task, disregard of symptoms and lack of aggressiveness in behavior. Through the currents of negative life events (i.e., death of closely connected persons) expressions of loneliness and reactive depression can appear intensively and chronically.

If this is not clear enough:

In our approach we try not to deny the psycho analytic propositions but to integrate the psychoanalytic research program with social psychological and sociological factors, hereby assuming that they have interactive effects on carcinogenesis.

Strangely, Grossarth-Maticek suggests in this article, that the psychoanalytic factors interact with “organic risk factors such as cigarette smoking in the case of lung cancer.” Grossarth-Maticek and Eysenck would soon be receiving tens of thousands of dollars in support from the German tobacco companies and lawyers from the American tobacco companies to promote the idea that personality caused smoking and lung cancer, but any connection between smoking and lung cancer was spurious. Product liability suits against tobacco companies should therefore be dismissed.

In the articles co-authored by Grossarth-Maticek and Eysenck, these roots of what Eysenck repackaged as creative novation behaviour therapy are only hinted at, but are noticeable to the observant reader in references to the role of dependency and autonomy. Fraudulent data are mustered to show the powerful positive effects of this behaviour therapy versus the toxicity of psychoanalysis.

On page 8 of this article, ten  explicitly labeled behavioural techniques are identified as occurring across individual, group, and bibliotherapy:

  • Training for reduction of the planned behaviors initiation of autonomous behavior.
  • Training for cognitive alteration under conditions of relaxation
  • Training for alternative reactions.
  • Training for the integration of cognition, emotionality and intuition.
  • Training to achieve stable expression of feelings.
  • Training for potentiating social behavioral control
  • Training to suppress stress-creating ideas
  • Training to achieve a behavior-directing hierarchic value structure
  • Training in the suppression of stress-creating thought.
  • Abolition of dependence reactions.

This approach has only superficial resemblance to American behavioral therapy and CBT. The emphasis on expression of emotional feelings and abolition of dependent reactions is incomprehensible when it is detached from its psychoanalytic roots. The paper refers to behavioral analysis, but interviews about the past, including childhood experiences are emphasized, rather than applied behavioral analysis. The hierarchies of behavior do not correspond to operant approaches, but to a value structure of autonomy versus dependence.

There is also considerable reference to the use of hypnosis to achieve these goals.

In short, neither the goals nor the methods have much relationship to learning theory at the time that Eysenck was writing nor to contemporary developments in operant conditioning. His approach is a tortured extension of classical conditioning. Outside of the fraudulent data that Grossarth-Maticek developed and that he published with Eysenck, there is little basis for assuming that psychological factors were related to physical health in the way the treatment approach postulated.

It should be kept in mind that Eysenck was not a psychotherapist. He actually detested psychotherapy and generated considerable controversy earlier by arguing that any apparent effects of psychotherapy were due to natural remission. It should also be noted that Eysenck was claiming creation novation behaviour therapy modified personality traits, even when delivered in a brief pamphlet, in ways that could not be anticipated by his other writings about personality. Finally, the particular personality characteristics that Eysenck was talking about modifying were very different than what he assessed with the Eysenck Personality Inventory.

Only “controversial” and “too good to be true” or fraud?

 Before Eysenck began collaborating with Grossarth-Maticek, there was widespread doubts about the validity of Grossarth-Maticek’s work.  In 1973, Grossarth-Maticek’s work had been submitted to the University of Heidelberg as a Habilitation, a second doctoral degree required for a full professorship. It was rejected. One member of the committee, Manfred Amelung, declared the results “too good to be true.” He retained a copy and would later put his knowledge of its details into a devastating critique. According to Buchanan’s biography, Eysenck demanded of Grossarth-Maticek “you must let me check your data, for if you deceive me I will never forgive you.”

Eysenck gained access to the data set, sometimes directing reanalyses by Grossarth-Maticek and his statistician. Other analyses were done by Eysenck’s statisticians in London. Eysenck’s biographer Buchanan noted “there were ample opportunities to select, tease out, or redirect attention – given a data set that was apparently sprawling chaotic but rich and ambitious….From the mid-1980s, Eysenck did virtually all of the writing for publication in English and presumably exerted a strong editorial control.” Buchanan also notes that tobacco companies became skeptical of the strength of findings that were reported, but also their inconsistency. They refused to continue to support Eysenck unless an independent team was set up to check analyses and the conclusions that Eysenck was drawing from them.

Eysenck single-authored a target article for Psychological Inquiry that reproduced many of the tables that we have been discussing. More than a dozen commentators included the members of the independent team, but also others who did not have access to the data, but who examined the tables with forensic attention. The commentary started off with Manfred Manfred Amelung who made use of what he had learned from Grossarth-Maticek’s doctoral work.

Many of the commentators suggested that the intervention studies presented conclusions that were “too good to be true,” not only in terms of the efficacy claim for the intervention, but for the negative outcomes claimed for the control group. But other commentators pointed to gross inconsistencies across different reports in terms of methods and results, clear evidence of manipulation of data, including some patients being counted a number of times, other patients dying twice, Eysenck and Grossarth-Maticek’s improbable ability to obtain matching of intervention patients and controls, and too perfect predictions. In the end, even Grossarth-Maticek’s Heidelberg statistician expressed concerns that there had been tampering with the data.

Both Grossarth-Maticek and Eysenck got opportunities to respond and were defensive and dismissive of the overwhelming evidence of exaggeration of the results and even fraud.

The exchanges in Psychological Inquiry occurred over two issues. Taken together, the critical commentaries are devastating, but the criticisms became diffuse because commentators focused on different problems. It took a more succinct, pithy critique by Anthony Pelosi and Louis Appleby in The BMJ to bring the crisis of credibility to a head.

Anthony Pelosi and Louis Appleby in The BMJ

 In the first round of their two-part attack, Pelosi and Appleby centered on Eysenck and Grossarth-Maticek’s  two articles in Behaviour Research and Therapy, but referenced the critiques in Psychological Inquiry. The incredible effectiveness of these two psychiatrists depended largely on their pointing  out what was hiding in plain sight in the two Behaviour Research and Therapy articles. For instance:

After 13 years, 16 of 50 untreated type 1 subjects had died of a carcinoma. Not one of the 50 cancer prone subjects receiving the psychotherapy died of cancer. The therapy was a genuine panacea, giving equivalent results for type 2 subjects and heart disease. The all cause mortality was over 60% in untreated and 15% in treated subjects. The death rate in the untreated subjects was truly alarming as they began the trial healthy and most were between 40 and 60 years of age.

I encourage readers to compare the Pelosi and Appleby paper to the tables I presented here and see what they missed.

Pelosi and Appleby calculated the effort required by Grossarth-Maticek if he had – as Eysenck insisted- single-handedly carried out all of the treatment.

It is striking that all the individual and group therapy was given by Professor Grossarth-Maticek. The trials were undertaken between 1972 and 1974 and involved 96 subjects (or perhaps 192 subjects, see below) in at least 20 hours of individual work, and at least 10 groups (245 subjects with 20-25 in each) for six to 15 sessions each. Add to this Grossarth-Maticek’s explanatory introduction to bibliotherapy for 600 people, and it can be seen that the amount of time spent by this single senior academic on his experimental psychotherapies is huge and certainly unprecedented.

They summarized inconsistencies and contradictions reported in the Psychological Inquiry, but then added their own observation that a matching of 192 pairs of intervention and control patients had only produced a sample of 192! They suggested that in the two Behaviour Research and Therapy articles there were at least  “10 elaborate misprints or misstatements in the description of the methods” that the editor or reviewers should have caught.

At no point, does the word “fraud” or “fraudulent” appear in Pelosi and Appleby’s first article. Rather, they suggest that  “Eysenck and Grossarth-Maticek… are:

making claims which, if correct, would make creative novation therapy a vital part of public health policy throughout the world.”

They conclude with

For these reasons there should be a total reexamination and proper analysis of the original data from this research in an attempt to answer the questions listed above. The authors give their address as the Institute of Psychiatry in London, which must be concerned about protecting its reputation. Therefore the institute should, in our view, assist in this clarification of the meaning of the various studies. There should also be some stern questions asked of the editors of the various journals involved, especially those concerned among the editorial staff of Behaviour Research and Therapy who, in our opinion, have done a disservice to their scientific disciplines, and indeed to Professors Eysenck and Grossarth-Maticek, in allowing this ill considered presentation of research on such a serious topic.

Eysenck’s reply and Pelosi and Appleby’s response

 Readers can consult Eysenck’s reply  for themselves, but it strikes me as evasive and dismissive. Specific criticisms are not directly answered, but Eysenck points to consistency between his results and those of David Spiegel, who had claimed to get even stronger effects in his small study of supportive expressive therapy for women with metastatic breast cancer. Rather than demolishing the credibility of his work with Grossarth-Maticek, Eysenck argues that Pelosi and Appleby only point to the need for funding of a replication. Eysenck closes with:

Their critical review, however incorrect, full of errors and misunderstandings, and lacking in objectivity, may have been useful in drawing attention to a large body of work, of both scientific and social relevance, that has been overlooked for too long.

Pelosi and Appleby took Eysenck’s reply as an opportunity to get even more specific in the criticisms:

We are accused of being vague in mentioning many errors, inappropriate analyses, and missing details in the publications on this research programme. We value this opportunity to be more specific, to clarify just a few of the questions raised by ourselves and others, which Eysenck has failed to answer, and to outline additional findings from these authors’ investigations.

After a detailed reply, they wrap up with references to the criticisms that Eysenck received in Psychological Inquiry, in an ironic note, turning Eysenck’s attacks on proponents of the link between smoking and lung cancer on to Eysenck himself:

Our concern has been to clarify the methods and analyses of a body of research which, if accurate, would profoundly influence public health policies on cancer and heart disease. Other critics have been more challenging in what they have alleged, and in our opinion the controversy which now surrounds one of academic psychology’s most influential figures constitutes a crisis for the subject itself. The seriousness of the detailed allegations by van der Ploeg, although refuted by Eysenck and Grossarth-Maticek, should in themselves prompt these authors to reexamine their own findings after appropriate further training in the methodology of medical research. Perhaps the most skilfully worded criticism on this subject was made not about Eysenck but by him in a debate on the relation between smoking and cancer. In disputing the findings of Doll and Hill’s epidemiological studies on this association he comments: “What we have found are serious methodological weaknesses in the design of the studies quoted in favour of these theories, statistical errors, and unsubstantiated extrapolations from dubious data to unconfirmed conclusions.” Eysenck owes it to himself and to his discipline to reconsider critically his own work on this subject.

In the over 20 years since this exchange, Pelosi and Appleby and their ally editor Richard Smith of The BMJ failed to get an appropriate response from the British Psychological Society, King’s College London or the Institute of Psychiatry, the journal Behaviour Research and Therapy, or the Committee on Publication Ethics (COPE). This situation demonstrates the inability of British academia to correct bad and even fraudulent science. It stands as a cautionary note to those of us now attempting to correct what we perceive as bad science. Efforts are likely to be futile. On the other hand, the editorship of Behaviour Research and Therapy has passed to an American, Michelle Craske, a professor at UCLA. Perhaps she can be persuaded to make a long overdue correction to the scientific record and remove a serious blemish on the credibility of that Journal.

If there is sufficient interest, I will survey the profound influence of the fraudulent work of Eysenck and Grossarth-Maticek in a future blog post.

  • Because of their influence, CBT in the UK gives an exaggerated emphasis to early childhood adversity and much less to functional behavioural analysis than the American behavior therapy and CBT.
  • Consistent with Eysenck’s influence, CBT for physical problems in the UK largely focuses on self-report questionnaire assessments of mechanism of change and of outcome, rather than functional behavioral and objective physical health outcome variables.

Influences can also be seen in:

Contemporary CBT for physical conditions as practiced in UK, including CBT for irritable bowel syndrome (IBS), fibromyalgia, and other “all in the head” conditions that are deemed Medically Unexplained Symptoms (MUS) in the UK, as in PRINCE trial of Trudie Chalder and Simon Wessely.

The “psychosomatic” approach as seen in neurologist Suzanne O’Sullivan’s  recent editorial in The Lancet and her “It’s All in Your Head”, which won the 2016 Wellcome Book Award and her.

Quack treatments, such as Phil Parker’s Lightning Process, which the UK’s Advertising Standards Authority (ASA) ruled against advertising its effectiveness in treatment of chronic fatigue syndrome/ myalgic Encephalopathy,  multiple sclerosis, and irritable bowel syndrome/digestive issues. The Lightning Process is nonetheless implemented in the UK NHS under the direction of University of Bristol Professor Esther Crawley 

Quack cancer treatments such as Simonton visualization method.

More mainstream, but unproven psychological treatments for cancer including David Spiegel’s supportive expressive therapy. Neither Spiegel –nor anyone else– has ever been able to replicate the finding praised by Eysenck, but repeats his claims in a recent non-peer reviewed article in the UK-based Psycho-Oncology and with a closely related article in BPS’ British Journal of Health Psychology.

More mainstream, but unproven psychological approaches to cancer that claim to improve immune functioning by reducing stress.

Some Scottish readers will understand this message concerning Eysenck’s fraud: The ice cream man cometh.

My usual disclaimer: All views that I express are my own and do not necessarily reflect those of PLOS or other institutional affiliations.