Trial By Error: Waiting for Godlee

By David Tuller, DrPH

This morning I sent another letter to Fiona Godlee, editor-in-chief at The BMJ and editorial director at BMJ. Hopefully she will take action soon on the two pediatric papers whose publication has demonstrated that something is seriously amiss at the journals under her stewardship, at least when it comes to this domain of research. The ongoing refusal of the journal editors and Dr. Godlee herself to take responsibility for this mess and clean up their mistakes is rather shocking. The immediate prompt for my new letter was a recently published article by Phil Parker, founder of the Lightning Process, touting the Archives study as evidence that his training program has healing properties.

As it turns out, the editor of Archives of Disease in Childhood last month slapped a notice on the Lightning Process study, dated June 19th. It is of course a completely inadequate statement that leaves the paper as is, at least for now. It is included only in the “responses” section of the online page for the paper, as far as I could tell. That means no one reading the current version of the paper online would likely have any idea that it is under investigation for serious methodological violations, and that these violations raise concerns that its findings are invalid and unreliable.

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Dear Dr. Godlee—

In my letter to you last week, I raised questions about two pediatric studies published in BMJ journals. The first, a 2011 BMJ Open study of school absence, did not appear to have undergone a required ethical review; the investigators exempted it on the false grounds that it was “service evaluation” and not “research.” The second, a 2017 study in Archives of Disease in Childhood of a pseudo-scientific program called the Lightning Process, breached BMJ policy on prospective trial registration and biased its findings by swapping outcome measures half-way through. In both cases, the editors have failed to respond adequately and with an appropriate sense of urgency.

As it turns out, the Archives editor quietly appended an opaque and inadequate notice last month to the Lightning Process study acknowledging that the journal had received expressions of concern about the study’s methodological anomalies. The statement claims that the journal has reviewed its oversight processes and has received “clarifications” from the authors that are “under editorial consideration.” But the statement falls short in multiple respects.

It fails to mention that the journal was alerted to the issues in a letter from 21 experts more than four months earlier. It does not clearly state that the concerns raised are warranted. It does not explain why the inquiry has taken so long when the facts are very clear. It also does not include a deadline by which the journal will conclude its “editorial consideration” of the “clarifications” and take action on the documented issues with trial registration, outcome-swapping, and lack of disclosure of salient information. So for now this paper remains in the literature as is.

In my letter last week, I expressed particular concern that Lightning Process practitioners would be able to cite the Archives study as proof that their woo-woo intervention works. I wanted to let you know that, sure enough, Lightning Process founder Phil Parker has now done just that. In a new journal article called “Understanding the Lightning Process Approach to CFS/ME: a Review of the Disease Process and the Approach,“ he and colleagues present the Archives study as the highlight of a purported “developing evidence base for…efficacy.” (The Parker article appeared in a Romanian “experiential psychology” journal, so we can probably agree that its reach is likely to be limited. But even journals of questionable merit and provenance can provide enough of a veneer of academic credibility to help disseminate and popularize dubious information.)

The Lightning Process is a goulash of osteopathy, positive affirmations, and neuro-linguistic programming. Participants are told they can improve their health by changing their thought patterns. Parker, the founder, previously taught something called the “European College of Holistic Medicine Healing Course.” According to an archived website, this training included “the use of auras for diagnosis of a client’s problems” and “divination medicine cards and tarot,” since “divination is useful in creating a strong connection with healing/spirit guides.” Participants in the course, according to the website, could also expect to learn how to “prepare a space appropriately so that any energy polluting the room will not interfere with the work.”

As I have pointed out multiple times, the Lightning Process study featured multiple methodological lapses. More than half of the 100 participants were recruited before trial registration. Given BMJ policy, Archives should have rejected it on those grounds alone. Beyond that, the investigators swapped primary and secondary outcomes based on those initial results, a recipe for generating biased findings. Then they failed to disclose these details in the Archives paper—a troubling omission of salient information.

BMJ has taken almost six months to investigate a matter that could have been cleared up in a few minutes. Now it has posted a notice about the matter but still left all the questions unresolved. Had editors acted with the appropriate dispatch once alerted to the problems, Parker could not have leveraged BMJ’s prestige in promoting the Lightning Process in his recent journal article.

How much longer will it take for you to address this issue? How many more articles invoking Archives of Disease in Childhood will Phil Parker publish between now and then? How many desperate parents with sick kids will be seeking out the Lightning Process, based on the positive reports from the Archives paper?

In this case, as I have already noted, BMJ editors appear to be prioritizing reputational concerns over professional and moral obligations. The situation has enabled Lightning Process proponents to perpetuate questionable claims by citing BMJ research, so it is imperative that you pursue appropriate remedies sooner rather than later. In the interests of transparency, I am cc-ing representatives of the Health Research Authority, the CFS/ME Research Collaborative, and others already aware of my concerns that BMJ has provided bragging rights to Lightning Process practitioners.

Thank you for your prompt attention to this matter.

Best–David

Comments on this entry are closed.

  • Laura Whittington 11 July 2018, 9:53 am

    Surely there is something seriously wrong if it is possible for some researchers to break the rules. BMJ risks their professional reputation by giving credibility to a paper which deals with a “treatment” that doesn’t even stand up to evaluation by trading standards. Fair treatment for all is essential here therefore BMJ should remove the paper or conclude their investigation immediately.

  • Maggie Wallace 11 July 2018, 11:24 am

    Dear Dr Tuller, you might be interested in an article published in The Guardian today:
    We need more investigations into research misconduct
    https://www.theguardian.com/education/2018/jul/11/we-need-more-investigations-into-research-misconduct?CMP=share_btn_tw

    “But how common is “research misconduct” – fabrication of data, dodgy uses of statistics or even outright research fraud – in the UK?”

    I think that you might be able to help with that question!

  • Su Wilmot 11 July 2018, 11:40 am

    Please keep working on our behalf.

  • saimir velias 11 July 2018, 2:05 pm

    thanks a lot for this post very interesting
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  • Karen Everatt 11 July 2018, 2:27 pm

    Unbelievable that this was ever published, totally unprofessional and to be honest really quite shameful.
    This needs to be corrected immediately!

  • Jennifer Charlesworth 12 July 2018, 1:57 am

    Thank you David. Just to let you know we live in South Africa and about 15 years ago a dear elderly ex nurse friend said I must get my daughter over to England for this amazing Lightening Process which could cure my daughter of ME. As a desperate mother I considered it and my very intelligent daughter googled it and told me that it would be a complete waste of money as they simply blamed the patient if they did not get better – much like the PACE trial. This was at the time that a well known UK TV personality called Esther Rantzen was claiming that LP had cured her daughter of ME!! We are fortunate that LP is not available in South Africa!

  • Kathy Collett 12 July 2018, 8:00 am

    Thank you David for your continued efforts in campaiging for a retraction of the detrimental PACE Trial. You are a hero to many. I can’t wait for the day that PACE is removed as a recommended treatment and it is finally rejected.

  • Lene Christiansen 18 July 2018, 2:30 pm

    Science doesn’t lie. People do. Pace trials should have been retracted long ago. So many people have suffered because of the Pace trials.