Trial by Error: A Letter to Bristol about my Recent FOI Request; Update Added

By David Tuller, DrPH

UPDATE: Within an hour or two of writing to Bristol, I received a response from the university’s director of legal services. Here’s what she wrote:

Dear Dr Tuller

Thank you for your email. The Information Rights team is making good progress on clearing the back log, your FOI request is currently being processed and I hope it will not be too long before you receive a response.

Kind regards
Sue Paterson

END OF UPDATE

**********

This morning, I sent the following e-mail to Sue Paterson, director of legal services at the University of Bristol.

**********

Dear Ms Paterson—

I recently filed a freedom of information request involving the trial of the Lightning Process as a treatment for pediatric CFS/ME, which was conducted by investigators from the University of Bristol (UoB) and published in Archives of Disease in Childhood (ADC) in 2017. The title of the study: “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.”

In an automatic response, the FOI office informed me that it was short-staffed and therefore experiencing major delays. Since the request was related to my efforts to safeguard children from recommendations based on questionable science, such delays are not optimal. To expedite matters, I thought I would try to bypass the FOI request process and ask these questions directly of you.

The situation has been rendered more urgent because a recent review of pediatric CFS/ME has cited the Lightning Process as an “effective” treatment, based solely on the UoB study. It is therefore critical to address the issues before this review has had much chance to influence public health policy. The National Institute for Health and Care Excellence, for example, is currently developing new guidelines for the illness, which it calls ME/CFS, and the Lightning Process is likely to be raised during the deliberations,

To recap: In December, 2017, I documented in a Virology Blog post that the Lightning Process investigators had recruited more than half the participants before trial registration, swapped outcome measures based on the early results, and then failed to disclose these salient details in the published paper. In January 2018, based on these revelations, twenty-one experts signed a letter to ADC expressing concerns about the conduct and reporting of the trial. In response, ADC promised to review the matter. In June 2018, ADC posted an editor’s note that acknowledged the problems and referred to “clarifications” provided by the investigators.

Given this set of circumstances, I asked the following questions in my recent FOI request to UoB:

1. Did the investigators notify UoB that ADC had raised concerns about the conduct and reporting of their trial? If so, on what date did the investigators notify the university?

2. Have the investigators provided UoB with the formal responses they gave ADC—“clarifications,” per the editor’s note–to the concerns raised about the conduct and reporting of their trial? If so, can you provide a copy of the formal responses or “clarifications” that were given to ADC?

3. Given the nature of the concerns raised by ADC, did UoB set up a review or investigation into the conduct and reporting of the trial? If so, can you provide a copy of the results of this review or investigation?

Thank you. I hope you can provide answers to these questions rather than having me wait through what appears to be a possibly open-ended delay in the normal FOI response function.

In the spirit of transparency, I am cc-ing four physicians and two patient representatives involved in the process of developing the new NICE guidelines; Professor Alan Montgomery, senior author of the Lightning Process study; Dr Fiona Godlee, editorial director of BMJ; Darren Jones, a member of Parliament from the Bristol area, who has expressed concern about the quality of ME/CFS research; Tom Whipple, a science reporter at The Times; and Professor Vincent Racaniello, a Columbia University microbiologist and host of Virology Blog.

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

{ 8 comments… add one }
  • AB 12 June 2019, 12:06 pm

    Thank you Dr Tuller

    Pertinent questions as always

  • Wendy Boutilier 12 June 2019, 12:07 pm

    By understanding a child’s view, we can nurture positive changes: correct distorted ideas, encourage helpful coping, build good interpersonal skills, and foster management of intense emotions. We can support families as they help their children heal and thrive. The Lightning Process doesn’t address anything positive – certainly none of the above.

  • Nancy Blake 12 June 2019, 2:07 pm

    Thank you, again, David! it is easy to underestimate the seriousness of this matter. The physical and psychological harm already being done to children by the Lightning Paocess could become not just UK-wide but beyond that as other nations take their cue from NICE Guidelines if the …trademarked…Lightning Process…is included. And doesn’t the holder of the trademark stand to profit? If so, Phil Parker could become a very wealthy man.

  • Alicia Butcher Ehrhardt 12 June 2019, 10:34 pm

    Thank you. The damage done to children is unconscionable and could be life-long.

    It makes me angry to think about their sanctimonious insistence on following rules when the truth is they would have done nothing without your notification, and are STILL doing nothing, and are happily continuing to do nothing.

    Please keep it up.

  • Couch Turnip 13 June 2019, 3:53 am

    Surely the ADC journal and the University of Bristol can’t indefinitely carry on this nonsensical stance of saying/doing nothing while researchers, like Dr Segal, are free to cite the Lightning Process paper in their work? This is exactly what ‘Expressions of Concern’ are for – to alert the public while an investigation takes place. A year is way too long for nothing to have happened. And doesn’t Bristol University realize it might be damaging its own reputation while it remains silent about what is going on from their end? I’d have thought they’d want the public to know what measures they’re taking/have taken so that they come out of this smelling of roses. These days transparency is what matters, not the detail necessarily but the public having the reassurance that procedures are being correctly followed so that they are protected from harm.

  • jimells 13 June 2019, 10:23 am

    “I hope it will not be too long”

    A real definite maybe for sure. Isn’t there a time limit imposed by law? What about following the law just this one time, Ms Paterson?

    I guess following the law is too much to expect from, you know, the legal department…

Leave a Comment