My Follow-Up Follow-Up with Dr Segal about LP Study Citation

By David Tuller, DrPH

Fans of Bristol University’s team of pediatric ME/CFS researchers could be forgiven if they hoped a recent citation of one of the group’s most high-profile studies would help bolster its wobbling reputation. Yet the suggestion that the Lightning Process is an “effective” treatment for kids–highlighted in the abstract of a pediatric review of “CFS/ME”–has focused renewed attention on the illegitimacy of both the claim and the study on which it is based.

Archives of Disease in Childhood published the study online in September, 2017. In December, 2017, I documented on Virology Blog that the investigators violated multiple ethical and methodological principles in the trial itself and the subsequent paper. Specifically, among other concerns, they recruited more than half the participants before trial registration, swapped primary and secondary outcomes based on the early results, and then failed to disclose these irregularities in the published report. This cannot be considered proper science. The study should never have been published. It should now be retracted and the situation should be reviewed as a possible case of research misconduct. The reported findings, such as they are, should not be used as the basis for clinical guidelines or public policy.

On May 17th, I wrote to Dr Terry Segal, the senior author of the new pediatric review, which was published in April by Current Opinion in Pediatrics. Dr Segal did not respond, so on May 22nd I wrote to the journal’s editor. Dr Segal sent me a brief response to that letter on May 23rd, noting that she and her colleagues would “consider” my concerns. I wrote back the same day and suggested she impose a deadline on herself and her colleagues. A week later–last Thursday, May 30th–I decided to give her a nudge and wrote again, reminding her of my suggestion.

Below is that nudge, to which I have not yet received a response. (I already posted this letter on Facebook several days ago.) Underneath, I have posted Dr Segal’s earlier note to me, followed by my previous response to her.

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[May 30, 2018]

Dear Dr Segal–

As you know, I have raised questions about the fact that your recent review of pediatric CFS/ME in Current Opinion in Pediatrics called the Lightning Process an “effective” treatment for children. Given that this claim was highlighted in the abstract, your review has granted enormous credibility to an intervention created by a self-styled Tarot specialist who has also taught spiritual healers the art of using auras as a diagnostic tool.

Last week, you indicated that you and your colleagues would “consider” my concerns about the Bristol University study on which this claim of effectiveness is based. You did not provide a deadline for this period of consideration, so I wrote back asking that you impose one on yourself and your co-authors.

Since I have not heard back, I need to ask again: When do you and your co-authors intend to finish your process of consideration and resolve this matter? Further delay is unacceptable, given the serious public health issues involved and the potential that your review will not only influence the opinions of pediatricians but also those involved in developing new ME/CFS guidelines under the auspices of the National Institute for Health and Care Excellence.

Dr Segal, this is not really a complicated issue. As I documented well over a year ago, the Bristol University investigators, led by Professor Esther Crawley, violated multiple methodological and ethical principles of scientific research in conducting and writing up their trial. Archives of Disease in Childhood, which published the study, posted an obscurely located editor’s note almost a year ago affirming the concerns and noting that the matter was under “editorial consideration.” The journal’s inability or unwillingness to conclude this process of “editorial consideration” clearly suggests that Archives does not want to acknowledge that retraction of the paper is the only viable way in this instance to preserve the integrity of the medical literature.

So I need to ask you again: When do you intend to finish “considering” my concerns? Do you plan to take almost a year, as Archives has now done, despite my many appeals about the issue to Dr Fiona Godlee, editorial director of BMJ? As I noted in my last message, it takes about half an hour, if that, to review the relevant trial documentation and ascertain the troubling facts. I assume you have had the time to do this in the past week. Sooner or later, you will either need to remove the claim that the Lightning Process is “effective”–or introduce the many caveats about why the study on which this claim is based is invalid and cannot provide reliable data. There is no other resolution possible.

Thank you for your attention to this matter. Because of the urgency of this issue, I am again cc-ing multiple people, including: Dr Fiona Godlee, editorial director of BMJ; Sue Paterson, director of legal services at Bristol University; several doctors involved with the development of the new NICE guidance; Professor Philip Pizzo, the editor of Current Opinion in Pediatrics; and two members of Parliament who have expressed alarm at the poor quality of research in the ME/CFS domain, along with a parliamentary aide.

I look forward to your response and a quick resolution of this distressing 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

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[May 23, 2018]

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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[May 23, 2018]

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