Trial By Error: Professor Edwards’ Letter to BMJ’s Dr Godlee About the LP Study

By David Tuller, DrPH

On May 15th, I sent a letter to Dr Fiona Godlee, BMJ’s editorial director, alerting her that a new review in Current Opinion in Pediatrics had highlighted the Lightning Process as an “effective” treatment, based on a flawed study in one of her journals–Archives of Disease in Childhood. The subject line: “a plea about addressing the flawed Lightning Process trial”

I cc-d many people, including Professor Jonathan Edwards, who is currently serving as an advisor to the committee developing new guidelines for ME/CFS under the auspices of the National Institute for Health and Care Excellence. A couple of days later, Professor Edwards followed up with his own letter to Dr Godlee, which was also cc-d to the same group of people. I am posting Professor Edwards’ letter below, with his permission.


Dear Fiona,

I thought I should comment on the email from David Tuller, copied below. I think David is right to raise this as a matter of serious concern and urgency and I think that those of us who may be in a position to influence things have a duty of care to do what we can. I see this as a safeguarding issue, not so different from that faced recently by senior clergy.

Up until now I have limited public statements about issues relating to ME/CFS almost entirely to responses to invitations to give my view on research quality, either from journals or administrative bodies. I have done that because people ask me as a disinterested observer and I want to make sure that is justified.

A number of colleagues and patients asked me to contribute to the NICE ME/CFS guideline committee and, my having indicated that I would be prepared to do so, the committee chair, Peter Barry, asked me to act as an expert witness on the difficulties associated with clinical trials. I have submitted a testimonial indicating my views and will present this to the committee later in the year.

The content of the testimonial is confidential but I discuss ethical issues relating to trials that involve cognitive manipulation, which include SMILE. I allude to SMILE briefly but did not seriously think the Lightning Process would be raised in the context of NICE guidelines. I submitted the testimony before being aware of the review of treatment in minors by Gregorowski, Simpson and Segal that David refers to, which makes an unqualified statement, in the specific context of the current NICE guidelines review, that the Lightning Process has been shown to be effective when added to medical care.

In many ways I would prefer to continue in a passive advisory position. However, it has struck me that having accepted a role that, like your own, has an implicit commitment to medical governance, and with it a responsibility to flag up potential ethical problems, I may need to be more proactive. I appreciate that in the present context you may not have a direct responsibility for editorial decisions at sister journals but I think we have a duty to do what we can to ensure problems are flagged up publicly if we are aware of them.

There are several problems with the SMILE trial and although I agree with David I tend to focus on some different ones. My understanding is that there was disquiet because the Lightning Process had not been shown to be effective in adults prior to a paediatric trial. This seems a valid and serious concern. Perhaps the most worrying aspect is that we are told that Lightning Process subjects are told to ‘keep secret’ information about treatment and progress. ‘Keeping secrets’ is a central red flag in safeguarding of children. There are, in my view, more general ethical issues about trials of unproven treatments that involve cognitive manipulation, particularly in minors, that apply to SMILE, but it is the two above features that worry me most specifically.

In terms of demonstration of efficacy I regard the SMILE trial, along with essentially all trials of therapist-delivered treatment in ME/CFS, as valueless because it was unblinded and used outcomes, which, in the context, were bound to be subject to major expectation bias via role-playing. Further problems with lack of prospective definition of outcome measures and prospective registration David has alluded to and would, I assume, make the trial fall short on journal policy requirements. We have no idea which part of the ‘Process’ has efficacy, if any. All this ought to be obvious to a trained physician, although I have been surprised how many (all with some form of professional interest) claim not to recognise it.

I think we are faced with a major issue of potential harm to minors if the problems with the SMILE trial are not publicly acknowledged. Adverse effects from cognitive and, in particular, exercise based, interventions are a serious concern in the patient community. The key reason why there is a review of NICE guidelines, as I understand it, is that there is a lack of confidence that previous advice has been well grounded in evidence on safety and efficacy. The variation in recommendations for ME/CFS by government health care systems in other countries does not inspire confidence and I suspect other European countries often look to the UK for a lead. I have also recently refereed a manuscript, which an editor has recommended for publication, that casts doubt on the adequacy of surveillance for harms in this area by clinical service units.

I have come to the view that the SMILE trial publication should either be retracted or the journal should ensure that readers are made immediately aware that serious ethical and methodological problems have been raised with the study. I think it is up to those of us directly or indirectly involved in governance to flag this sort of problem up and make sure it is dealt with. I hope you would agree.

Kind regards

Jo Edwards
Professor Emeritus
Department of Medicine
University College London

13 thoughts on “Trial By Error: Professor Edwards’ Letter to BMJ’s Dr Godlee About the LP Study”

  1. Peter Trewhitt

    Hear, hear.

    I particularly second the child safeguarding issues in relation to this study and indeed the use of the Lightning Process with children. Surely it can never be acceptable to instruct children to undertake a process that not only demands they keep secrets from their parents and physicians, but further instructs them to deny to their symptoms to themselves, to their parents and to their physicians.

  2. Steve Hawkins

    Excellent letter. I’m particularly impressed with the way the professor sees the problem from another angle, but one that is possibly even more significant than those pointed out by Dr Tuller.

  3. Susan Taylor-Brown, PHD, MPH

    Together, these 2 letters present reasoned and cogent arguments for retraction of this article. As this process continues to unfold, this experience can be used with other countries to refute policies relying on this study. Well done

  4. Couch Turnip

    Well said. I believe there was also an ethical problem in the researchers being able to telephone the kids at home to try to secure a response over the phone to their questionnaires when the kids didn’t return the questionnaires in the post. I can’t understand how that got through ethical review, I’d feel harassed in that situation. It appears to me that harvesting research results was the priority for this team of researchers, no matter what this meant for the children taking part.

  5. Christine Fenton

    As a past Deputy Head in the UK with a responsibility for Safeguarding Policy, Implementation, staff training & enabling students to understand what is ‘not ok’ in relation to behaviour from adults & others, a key mantra was ‘if an adult/other asks you to keep a secret it’s not ok’ – ‘secrets are not ok’.

    In addition we worked to enable our students to value their own thoughts and experiences & to take responsibility for their own behaviours by talking about them & enabling them to understand themselves.

    The Lightning Process & SMILE trial stand against every safeguarding principle & such behaviour from a staff member towards a student would have led to disciplinary measures & a requirement for additional training.

    The behaviours evidenced in this trial are, in my view & experience, abhorrent & I named them as abusive when the trial was first published.

    Coercive/controlling/blaming behaviours to anyone, child or adult are recognised as part of an abuse cycle.

    Thank you for emphasising this so clearly.

  6. Lady Shambles

    Christine Fenton: excellent observations. Very powerful. Ironic that a paediatrician is unable to grasp their ‘complexity’!

  7. Richard Vallee

    Besides advising participants to keep quiet about the “treatment”, as Edwards says an obvious ethical red flag that is more appropriate for cults than medicine, it should be highlighted that the LP itself is a secret. The medical literature does not explain what it consists of.

    It should go without saying that a clinical trial for a drug whose composition was kept a secret would never be approved. There is no reason why this should be any different here. A medical treatment cannot be a “just trust me” black box. It has to be explained in detail, not only its passive “ingredients” but especially the hypothesized active effect it is having on the either root cause or a mechanism of the illness.

    This secrecy is wholly unacceptable and either the entirety of the so-called process needs to be detailed or any literature based on it should be promptly retracted until it is so. Ideally, both should be done, as it would highlight the ethical lapses that allowed this licensed child abuse to occur.

  8. Pingback: Trial By Error: Professor Edwards’ Letter to BMJ’s Dr Godlee About the LP Study - Virology Hub

  9. Tina Rodwell

    As a mother with a child who has to navigate the idea that the SMILE trial was a good solid research that proves their methods are right and to keep pushing through, I am so grateful that the important points are coming though.

    To tell a child to keep quiet and to blame the mother with non compliance has gone on for far too long and we have no idea how many children have been taken into care because of this sort of approach.

    We need to keep this in the journals and public eye and to let the secret Family Courts know.

  10. Thank you, Professor Edwards, for speaking up, and for being so clear in your expression of the problems you see.

  11. Thank you Professor Edwards for speaking out against these disgraceful treatments.

    It’s time for other academics to join you and Dr Tuller in condemning what has long been a social injustice and harmful exercise purporting to help those who are suffering, especially children.

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