By David Tuller, DrPH
A Final Round in Norway
Lightning Process supporters got some bad news recently when a Norwegian national research ethics panel rejected a proposed study because it was poorly designed and fraught with conflicts of interest, as I wrote about here. But that wasnâ€™t the end of the drama.
Although the ethics panel’s decision was meant to be final and not subject to appeal, the study team appealed anyway, sending a long letter to the ethics panel defending the trialâ€™s methodology and disputing the charges of conflicts of interest. The ethics panel agreed to take up the issue one more time. After another review, the panel reinforced its initial action by firmly rejecting the proposed study a second time. The ethics panel has made clear that it is not categorically against research into the Lightning Processâ€”just this inadequate effort.
The decision triggered predictable complaints from the usual quarters about ME patients. I often find itâ€™s best for me not to respond to everything stupid someone says or writesâ€”especially when others already have. Last week, the Norwegian publication Khrono, which covers higher education and has followed the issue of the proposed LP trial, published a scathing comment from Sigmund Olafsen, a scientist who has a family member with ME.
Under the headline “Worthless and unethical ME research,” here’s what Dr Olafsen wrote about the now-halted trial:
“The project appears to be a banal psychological experiment. Ask some people to fill out a questionnaire, spend three days telling them that it is their own responsibility if they do not feel better almost immediately after the three days, and ask them to fill out the questionnaire again a few weeks later.”
Nina Steinkopf has covered the back-and-forth on this issue at her invaluable blog, MELivet.
Who is ‘Voices of Recovery’?
Iâ€™ve checked out the website of a group called Voices of Recovery, which carries the headline â€œLive a Life You Love.â€ This group has become an official stakeholder in the ongoing process of the UK’s National Institute for Health and Care Excellence (NICE) to create new clinical guidelines for ME/CFS. In November, NICE released a draft version that explicitly recommended against the LP, and invited comments from stakeholders. The agency is scheduled to release a final version next month.
According to the Voices of Recovery website, the organization was “founded in 2020 to represent the voices of those that have fully recovered from chronic illness, particularly Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME) and fibromyalgiaâ€¦We know these diagnoses are not a life sentence! We have over 50 members who have all fully recovered to prove otherwise.â€
The site includes three such recovery storiesâ€”all from people who attribute their success to the Lightning Process. (The group called Recovery Norway, a supporter of the now-halted Norwegian trial, comes to mind.) But who is behind Voices of Recovery? Thatâ€™s a mystery. The domain is registered to an entity called Artemis Coaching in Suffolk, England. I canâ€™t find anything about an Artemis Coaching in Suffolk, England. (There seems to be an executive coach in the US who uses that name for her consulting firm.)
It’s not clear why Voices of Recovery has become a stakeholder at this point in the NICE process–it is too late to submit any comments for consideration. Presumably the group hopes that the NICE committee reverse its current advice against the LP. I am not aware of new data that would persuade the committee to revisit its scientific assessment of this matter.
New Crawley-Parker Paper on LP and CBT
One of the arguments that LP proponents have made in its favor is that it is like CBT in some ways. This debating point arose during the debates in Norway over that now-defunct proposed trial. Professor Michael Sharpe, one of the three lead PACE investigators, has said the LP “has similarities to cognitive behaviour therapy.”
In some peopleâ€™s minds, I guess, comparing the LP to CBT is meant as a sign of respect and validation for the formerâ€”the presumption being that CBT itself enjoys a positive reputation. Viewed from a sideways perspective, it looks more like the reverse–that these experts are essentially affirming that their version of CBT is a muddle of nonsense like the LP, with both interventions based on unproven mechanisms of action.
In any event, it has seemed for a while that the CBT and LP camps were merging into a mutual admiration and support society. That process seems to have reached a new level with a recent paper published in the journal Fatigue: Biomedicine, Health & Behavior. The paper is called “CBT repackaged or a novel treatment? The Lightning Process compared with UK specialist medical care for paediatric Chronic Fatigue Syndrome.”
It is co-authored by, among others, Dr Phil Parker, the spiritual healer, osteopath and now psychologist who created the Lightning Process, and Professor Esther Crawley, Bristol University’s methodologically and ethically challenged pediatrician. Professor Crawley was the lead investigator of a seriously flawed 2017 pediatric trial of the LP. It is not surprising that she and Dr Parker are now proposing further pediatric trials involving both CBT and the LP.
Fatigue is sponsored by the International Association of CFS/ME and has published a number of important papersâ€”including the first formally peer-reviewed refutation of the PACE claims of recovery after the release of unpublished raw data from the trial.* [*Clarification–the PACE trial results were busted in an earlier peer-reviewed paper, in journal correspondence, and perhaps in other venues I’m not aware of. In the previous sentence, I have added a phrase to clarify that I was referring to the first paper to refute the recovery claims by analyzing the unpublished raw data.] (Last fall, Fatigue published a paper on which I was a co-author.) It is not clear why Fatigue decided to publish this bilge.
The new CBT-LP paper does not seem to have undergone a rigorous peer review. It refers, for example, to the â€œimpressiveâ€ findings from Professor Crawley’s 2017 trial, which was published in Archives of Disease in Childhood, a BMJ journal. But the new paper fails to mention the trialâ€™s methodological violations of core scientific principles. These missteps resulted in a 3,000-word correction and a 1,000-word editorâ€™s note. (I instigated these developments by sending a formal letter of complaint to the journal.)
Moreover, the Fatigue paper appears to accept the LPâ€™s physiological explanations at face valueâ€”not surprising, I guess, since Dr Parker is a co-author. Here’s a typical sentence: “LP maintains entirely neurophysiological and biological explanations, conceptualising CFS/ME maintenance as sustained arousal of the autonomic system (or heightened physical stress response), described as the â€˜Physical Emergency Response.'” The reference for this claim about the “entirely neurophysiological and biological explanations” of the LP is a previous paper also co-authored by Dr Parker. This earlier paper, â€œUnderstanding the Lightning Process approach to CFS/ME; a review of the disease process and the approach,â€œ was published in the Journal of Experiential Psychotherapy, which is sponsored by the Romanian Society of Experiential Psychotherapy. (It’s hard for me to remember the last time I saw key information in an academic paper being supported with a reference to this Romanian publication.)
Journals and peer reviewers have no obligation to rubber-stamp the unwarranted assertions of authors or allow them to cite themselves without challenge. Fatigue messed up here.