Trial By Error: A Plea to Fiona Godlee on a Familiar Topic

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.”

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Dear Fiona—

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 editor’s note to the published record. This editor’s note essentially confirmed the methodological and ethical lapses I had documented; it also indicated that the study investigators had provided “clarifications” and that the matter was under “editorial consideration.” It is likely that few people have seen the editor’s note, since it is not visible from the paper.

I have continued to highlight this issue publicly because I am seeking to protect children’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 “effective.” 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 editor’s note, any reading of which should have raised questions about the reported findings. In other words, despite the Lightning Process study’s recognized deficiencies, the just-published review in Current Opinion in Pediatrics cites the findings uncritically–with unknown and possibly deleterious effects on children’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 declared–without citing legitimate evidence–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 “divination medicine cards and tarot.” The archived website for this course explains that “divination is useful in creating a strong connection with healing/spirit guides.” The course also featured lessons in “the use of auras for diagnosis of a client’s problems” and in how to “prepare a space appropriately so that any energy polluting the room will not interfere with the work you are doing.”

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 “editorial consideration” 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.

Best–David

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley

Comments on this entry are closed.

  • Alicia Butcher Ehrhardt 16 May 2019, 1:16 am

    I sure hope you’re not getting tired of all the bs – please keep doing this.

  • Peter Trewhitt 16 May 2019, 2:40 am

    This study should never have been undertaken let alone published.

    My understanding is that the Lightening Process instructs participants to speak and act as though their symptoms do not exist, in effect to lie about their condition. Despite such as Prof Sharpe as reported by Reuters claiming such an assertion is vexatious, I repeat the assertion that pressurising vulnerable children to lie about a medical condition is tantamount to child abuse. In ME the core symptom is post exertional malaise, that is exertion exacerbates symptoms, so instructing children to ignore their symptoms puts them at risk of worsening their condition, even potentionally turning a recoverable condition into a lifelong disability. Also if children lie about their condition subsequently how can their self reporting be relied upon to guide doctors or others to treat/manage that condition effectively or safely.

    This also introduces an internal logical contradiction into a methodology that relies on subjective self reported measures. If the Lightening Process successfully achieves its aim to get participants to deny the existence of their symptoms, then any self reported outcome measures are surely invalid. The study did have a potentially objective measure, namely school attendance, which in their protocol was to be assessed from school records, bizarrely the final study only includes self reported measures of school attendance. The authors have not responded to questions about why their one potentetially objective measure was switched to a subjective alternative.

  • Couch Turnip 16 May 2019, 3:13 am

    Come on Fiona, DO THE NEEDFUL.

  • Lady Shambles 16 May 2019, 4:29 am

    “What are we doing here, that is the question. And we are blessed in this, that we happen to know the answer. Yes, in the immense confusion one thing alone is clear. We are waiting for God(lee) to come (clean)– ”

    (Apologies to Samuel Beckett)

  • Wendy Boutilier 16 May 2019, 7:35 am

    Psychics and fortune tellers have used Tarot cards for hundreds of years. Perhaps these prophets of pseudoscience will reference them in their next study. It might make as much sense as the Lightning Process.

  • Richard Vallee 16 May 2019, 10:04 am

    Destroying the reputation of several medical journals in reckless pursuit of an ideological pipe dream, with careless disregard for consequences on patients, even knowingly harming children using obvious pseudoscience as “evidence”. Not the kind of thing one would expect in 2019. 1919, perhaps. 1819, more likely.

    Who will take seriously the likes of BMJ, Lancet and Cochrane once this scam is revealed? Reckless disregard for human lives is not exactly the kind of behavior that inspires confidence, especially when it is so ham-fisted and the mistakes are as obvious as the noon Sun. Truly bizarre.

  • Dr Ellen Goudsmit 16 May 2019, 11:01 am

    Excellent. Can’t recall if the bmj and associated journals still claim to publish rigorous research and best evidence. If so, they are failing.

  • Peter Trewhitt 17 May 2019, 6:11 am

    Just noticed in my comment above I mis attributed a fault from this research group’s School Absence study to the Lighting Process study. My apologies for this mistake.

    The switching of an objective measure of school absence to subjective self reporting without any explanation even when raised by others was part of the School Absence study. The Lightening Process study from the start failed to include any objective measures, despite, as far as we can tell given the secrecy arround what this actually involves, the participants being instructed to ‘lie’ about the symptoms rendering any subjective measures logically as well as scientifically totally unreliable.

    This also raises the issue of secrecy arround what the Lightening Process involves. It is a commercially market package about which all involved are instructed to maintain secrecy. As others have pointed out, it is hardly compatible objective replicable scientific methodology, when what was actually done during the experiment is kept secret.

  • Ryan Carr 20 May 2019, 1:16 am

    The Lightning Process – Gaslight (Part 2)