My Latest Letter on The Lightning Process Study; and an Update

Update: May 23, 2019

I received a response today from Dr Terry Segal, the senior author of the review in Current Opinion in Pediatrics that claimed the Lightning Process had been shown to be “effective.” Dr Segal was not responding to the e-mail I sent her directly last week but to one I sent yesterday to Professor Philip Pizzo, the editor of Current Opinion in Pediatrics, alerting him to the issue. I had cc-d Dr Segal, along with many others.

Below is Dr Segal’s brief message to me, followed by my somewhat longer response. Dr Segal cc-d Professor Pizzo and another colleague from the journal but left off the others.

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Dear Dr Tuller

Thank you very much for your appraisal of our review.
We will consider your comments and the concerns you have raised.

With best wishes

Terry Segal

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Dear Dr Segal–

Thank you for responding to the letter I sent yesterday to the editor of Current Opinion in Pediatrics, Professor Pizzo–that letter was a follow-up to the one I sent you last week. As you know, I have expressed concern that your recent review in the journal—”Child and adolescent chronic fatigue syndrome/myalgic encephalomyelitis: where are we now?”–highlighted the Lightning Process as having been shown to be “effective.”

To recap: The Lightning Process is a pseudo-scientific potpourri of neuro-linguistic programming, life-coaching and osteopathy that was created by Tarot expert Phil Parker, who is also a specialist in reading auras to diagnose people’s ailments. The paper you referenced to support the claim of effectiveness, published two years ago in Archives of Disease in Childhood, violates core methodological and ethical principles and should not have been published to begin with.

It is unfortunate that Archives of Disease in Childhood, a BMJ journal, has put you and your co-authors in the unenviable position of having to revise a just-published review. But BMJ’s failure to act in accordance with its own editorial policies has left the onus on others to take responsibility for protecting children’s health and well-being. In this case, that means protecting children from being subjected to a questionable and unproven intervention like the Lightning Process–especially children already suffering from a debilitating and stigmatizing illness.

More than a year ago, I informed Archives of Disease in Childhood that the Bristol University investigators of the Lightning Process study had recruited 56 out of 100 participants before trial registration, swapped primary and secondary outcomes based on the early results, and failed to disclose these details in the published paper. An obscurely located “editor’s note” posted by Archives of Disease in Childhood last June acknowledged the criticisms, explained that the investigators had provided “clarifications,” and declared the matter to be under “editorial consideration.” That period of editorial consideration has now lasted almost a year. The journal has refused to set a deadline for concluding its deliberations.

Therefore, while I appreciate your willingness to “consider” my concerns, I do need to ask: How long do you expect this period of consideration to last? I suggest that, unlike Archives of Disease in Childhood, you and your co-authors impose on yourselves a short-term deadline for resolving the matter. In reality, it takes half an hour, if that, to scrutinize the relevant trial documentation and ascertain that the paper did not meet the criteria purportedly required for publication in major medical journals like Archives of Disease in Childhood.

In any event, to prevent unnecessary delays, I have included links below to: the protocol for the feasibility trial, the protocol for the full trial, the trial registration and the feasibility trial paper. Thanks again for your attention to this issue. I look forward to the publication of an updated version of the review in Current Opinion in Pediatrics in the near future.

http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/smprotv6final.pdf
http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/protocol1.pdf
https://www.ncbi.nlm.nih.gov/pubmed/24304689
http://www.isrctn.com/ISRCTN81456207

I am cc-ing the people I cc-d on my initial e-mail to Professor Pizzo. I am adding in Professor Ronald Davis, a geneticist and Stanford colleague of Professor Pizzo, who is involved in ME/CFS research and is aware of the Lightning Process study.

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

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By David Tuller, DrPH

Those responsible for publishing the dung heap known as the Lightning Process study have failed in their editorial obligations. They continue to disseminate findings that have been tarted up for publication and have taken no further action to correct the medical literature in the eleven months since posting an obscurely located “editor’s note.”

So now things are getting a bit “meta”–I am contacting the editor of Current Opinion in Pediatrics, the journal in which the Lightning Process study was recently cited and the intervention praised as “effective.” I sent the following letter earlier today to that editor– Professor Philip Pizzo, a pediatrician and infectious diseases expert at Stanford University. I guess in medical terms, this might be considered a form of secondary prevention?

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Dear Professor Pizzo—

Current Opinion in Pediatrics recently published a review called “Child and adolescent chronic fatigue syndrome/myalgic encephalomyelitis: where are we now?” This review cited an intervention called the Lightning Process–well-known in the UK but not in the US–as having been shown to be “effective” in treating children with the illness, when combined with medical care.

The Lightning Process is a commercial, pseudo-scientific grab-bag of neuro-linguistic programming, life-coaching, osteopathy and positive affirmations. Participants are taught that they can overcome illness by controlling and changing their thought patterns. In the UK, 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 practitioners for making misleading claims.

The basis of the new review’s claim that the Lightning Process has been shown to be “effective” is a 2017 paper published in Archives of Disease in Childhood, a BMJ journal, called “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.” Yet in conducting the Lightning Process trial and writing it up the for publication, investigators from the University of Bristol engaged in serious methodological and ethical missteps that cast doubt on the validity and reliability of the reported findings.

I cc-d you on a letter I sent last week to Dr Terry Segal, the senior author of the review, outlining my concerns and urging her to take immediate steps to address the issue. I have not yet heard back from her. I am appealing to you directly now because of the potential harm to children that could arise from disseminating to pediatricians the uncontested and misguided message that the Lightning Process has been shown to be “effective.”

By way of introduction, I am a senior fellow in public health and journalism at UC Berkeley’s Center for Global Public Health, which is part of the School of Public Health. I have been a journalist for decades and more recently received a public health doctorate from Berkeley. For the last few years, I have examined and critiqued some of the research in the ME/CFS field.

I have chronicled my findings in more than 150 posts and articles on the site Virology Blog, hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. I have also written about the issue for The New York Times, the health policy journal Health Affairs, and elsewhere. My investigation of ME/CFS research has been mentioned in Science, Nature, The Wall Street Journal, The Guardian, and Slate, among other publications.

In December of 2017, I documented on Virology Blog that the investigators of the Lightning Process study recruited more than half the participants before trial registration, swapped primary and secondary outcomes based on the early results, and then failed to mention these details in the published paper. The following month, I alerted Archives of Disease in Childhood to these issues in an open letter signed by more than 20 experts from Columbia, Berkeley, Harvard, Stanford, University College London, Queen Mary University of London, and elsewhere.

Last June, Archives posted an editor’s note about the study, which essentially confirmed the concerns I had raised. The note also informed readers that the investigators had provided the journal with “clarifications” and that the matter was now under “editorial consideration.” It is unclear why this period of “editorial consideration” has now lasted almost a year, since it takes no more than ten minutes to verify the details from the relevant trial documentation. It is likely Dr Segal and her co-authors did not notice this editor’s note, since it is not linked directly to the paper itself and has been placed on a separate page in the editorial equivalent of Siberia. I have been vigorously urging BMJ to resolve the matter, so far to no avail.

Phil Parker, the founder of the Lightning Process, has been known in the UK as a spiritual healer. He previously taught a course on how to treat people with “divination medicine cards and tarot,” according to an archived website. The website 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.”

For two past two years, Archives of Disease in Childhood has provided this aura specialist with bragging rights that his expensive self-help program can be considered evidence-based. The new review in Current Opinion in Pediatrics serves to perpetuate and amplify this claim.

Under the circumstances, it goes without saying that the Lightning Process study does not deserve the BMJ seal of approval and cannot be appropriately cited as an authoritative source for any claims of effectiveness. It is especially important to highlight this point now because the UK’s National Institute for Health and Care Excellence (NICE) is currently developing new guidance for the illness. The flawed presentation of the issue in Current Opinion in Pediatrics could influence the opinions of those involved with the NICE process.

I am therefore urging you, as editor of Current Opinion in Pediatrics, to examine this matter and request that the authors promptly update their review. If they still choose to highlight the Lightning Process, they should fully describe the methodological and ethical problems with the trial and the paper, as documented at length on Virology Blog and acknowledged more briefly in the editor’s note posted by Archives of Disease in Childhood.

For more than a year, I have been trying to convince the appropriate people in the UK to address the problems with the Lightning Process study, with little success. To try to expedite the process, I have cc-d several others on my recent letters about the review in Current Opinion in Pediatrics. I am cc-ing this letter to: Dr Terry Segal, the senior author of the review; Dr Fiona Godlee, BMJ’s editorial director; Professor Alan Montgomery, the senior author of the Lightning Process paper; four physicians involved in the process of developing the NICE guidance for ME/CFS; two members of Parliament who have expressed alarm about the poor quality of much ME/CFS research, along with a parliamentary aide; and Sue Paterson, director of legal services at Bristol University.

Thank you for your quick 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