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



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.


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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