By David Tuller, DrPH
On Wednesday, I sent the following to Dr Fiona Godlee, editorial director of BMJ. The topic, once again, was the ethically and methodologically challenged Lightning Process study, which was published two years ago in Archives of Disease in Childhood, a BMJ journal. My letter was prompted by the recent appearance of a review paper that cited this Archives report and called the Lightning Process “effective.”
As you know, I have been pressing Archives of Disease in Childhood, a BMJ journal, to address problems with a 2017 paper called “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.” More than a year ago, I reported on Virology Blog and informed Archives of Disease in Childhood that the investigators, a team from Bristol University, recruited 56% of the participants before trial registration, swapped primary and secondary outcomes based on early results, and then failed to disclose these details in the published paper.
Last June, Archives of Disease in Childhood added an editorâ€™s note to the published record. This editorâ€™s note essentially confirmed the methodological and ethical lapses I had documented; it also indicated that the study investigators had provided â€œclarificationsâ€ and that the matter was under “editorial consideration.â€ It is likely that few people have seen the editorâ€™s note, since it is not visible from the paper.
I have continued to highlight this issue publicly because I am seeking to protect childrenâ€™s health and well-being. I am particularly concerned that the Lightning Process trial’s reported findings could negatively impact pediatric health policy as well as the medical care provided to this vulnerable population. Given the study’s violations of core scientific principles, the findings cannot be taken at face value. The paper should not have been published in the first place.
A recent publication illustrates and validates some of the worries about the Lightning Process paper. In late April, Current Opinion in Pediatrics published a major review called “Child and adolescent chronic fatigue syndrome/myalgic encephalomyelitis: where are we now?” Going forward, it is possible this review could influence policy-makers and medical providers. The review could, for example, influence some of those engaged in the ongoing effort by the National Institute for Health and Care Excellence to develop new clinical guidelines for the illness it now calls ME/CFS.
It is therefore troubling that this review in Current Opinion in Pediatrics touts the Lightning Process as having been shown to be â€œeffective.â€ The review does not note that the investigators recruited more than half their participants before trial registration, swapped outcome measures based on the early results, and omitted key information from the published paper. The review also fails to mention the editorâ€™s note, any reading of which should have raised questions about the reported findings. In other words, despite the Lightning Process studyâ€™s recognized deficiencies, the just-published review in Current Opinion in Pediatrics cites the findings uncriticallyâ€“with unknown and possibly deleterious effects on childrenâ€™s health.
It bears reiterating–and re-reiterating–that the Lightning Process is a pseudo-scientific intervention combining life-coaching, neuro-linguistic programming, positive affirmations and osteopathy. Participants are taught that they can overcome illness by controlling and changing their thought patterns. Lightning Process practitioners have declaredâ€“without citing legitimate evidenceâ€“that they can successfully treat multiple sclerosis, eating disorders and other serious conditions. Government regulators have admonished some practitioners for making misleading claims.
Phil Parker, the founder of the Lightning Process, previously taught a course on how to heal people with â€œdivination medicine cards and tarot.â€ The archived website for this course explains that â€œdivination is useful in creating a strong connection with healing/spirit guides.â€ The course also featured lessons in â€œthe use of auras for diagnosis of a clientâ€™s problemsâ€ and in how to â€œprepare a space appropriately so that any energy polluting the room will not interfere with the work you are doing.â€
Since 2017, Archives of Disease in Childhood has provided this spiritual healer with bragging rights that his commercial self-help program can be considered evidence-based. The review in Current Opinion in Pediatrics serves to perpetuate and amplify the unhelpful belief that the Lightning Process trial was robust and worthy of serious consideration.
Fiona, in the interests of preventing sick children from being subjected to questionable interventions, I am pleading with you to ensure that Archives of Disease in Childhood promptly concludes its period of â€œeditorial considerationâ€ and does what it needs to do about the Lightning Process study. The appearance of the new review–whose authors, I assume, did not notice the obscurely located editor’s note–has rendered the situation more urgent. When it comes to safeguarding the integrity of the medical literature, further delay in taking corrective action is unwarranted. It is also unacceptable. The Lightning Process study does not deserve BMJ’s seal of approval.
I am cc-ing several people on this e-mail: Terry Segal, the senior author of the review in Current Opinion in Pediatrics; Professor Alan Montgomery, the senior author of the Lightning Process paper; three members of Parliament who have expressed concern about the poor quality of studies in the ME/CFS domain, along with a parliamentary aide; four physicians involved with the NICE process for developing the new ME/CFS clinical guidelines; Sue Paterson, the director of legal services at Bristol University; Tom Whipple, a science reporter who has covered the illness; Professor Chris Ponting, current vice chair of the CFS/ME Research Collaborative.
Thank you for your attention to this matter.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley