Flawed Chronic Fatigue Research Isn’t Being Retracted from One of The World’s Leading Medical Journals

Dec 24, 2019 | Chronic Fatigue Syndrome, Popular Posts

Flawed Chronic Fatigue Research Isn’t Being Retracted from One of The World’s Leading Medical Journals

While acknowledging that the BMJ (formerly the British Medical Journal), along with its sister publications, is an admirable medical journal, Tuller, senior fellow in public health and journalism at UC Berkeley’s Center for Global Public Health, part of the School of Public Health, takes issue with the publication and its continued endorsement of the Lightning Process study (LP). The LP’s objective is to “Investigate the effectiveness and cost-effectiveness of the Lightning Process (LP) in addition to specialist medical care (SMC) compared with SMC alone, for children with chronic fatigue syndrome (CFS)/myalgic encephalitis (ME).” Archives of Disease in Childhood, a well-regarded BMJ journal, published the results in September 2017.

According to Tuller’s December 13 article in STAT News, LP is a hodge-podge of “of neuro-linguistic programming, life coaching, osteopathy, positive affirmations, and other elements. It aims to train people to improve their health by altering their thought processes and refusing to allow their symptoms to control them.”

Also known as ME/CFS, the disease is a disabling disease marked by immunological, neurological, and other physiological dysfunctions. There are no currently identified diagnostic tests or approved drug treatments for it. The symptoms include [fatigue], a prolonged relapse following minimal amounts of exertion, cognitive impairments, and sleep disorders, among others, according to U.S. agencies.

Dr. Fiona Godlee, the Cambridge University-educated physician who has led the BMJ since 2005, is both editorial director of BMJ, which publishes dozens of titles, and editor-in-chief of The BMJ, one of the world’s leading medical journals. BMJ and Godlee have handled this seriously problematic paper without enforcing BMJ’s expressed requirements of research. BMJ has been a leading voice for the effort to tighten prospective registration requirements and Godlee called the prospective registration policy “the single most valuable tool we have to ensure unbiased reporting of research studies.” And yet, the editor stated, “BMJ policy requires prospective registration of randomised trials but we do not consider a failure to enforce that policy grounds for retraction.”

Beyond questions about the Lightning Process as a treatment modality, the study itself violated core principles of scientific inquiry. The investigators recruited more than half of the participants before trial registration, swapped primary and secondary outcomes after gathering data from the early recruits, and then failed to disclose these critical details in the paper. The mid-trial switch made it easier for the investigators to assert that the Lightning Process was effective.

Despite many requests (by Tuller and over 60 scientists, academics, and other experts from major research universities, as well as patient advocates) to have the BMJ retract the paper, the BMJ doubled-down, and reissued it with editorial. In an email to Tuller, Godee wrote, “In my view, readers and guideline bodies are now equipped to reach their own conclusions on the quality of the evidence in support of this therapy.” 

Of note, Dr. Esther Crawley of the University of Bristol, the LP trial’s lead investigator, has a close relationship with BMJ. Crawley, a pediatrician, has published many papers about this illness in BMJ journals and is an associate editor at BMJ Paediatrics Open.

Source: STAT News

2 Comments

  1. Richard Vallee

    You did your research well. Appreciated.

    One particularly absurd detail I would add: responding to the outcome swapping, which consisted of dropping the planned primary objective measure of school attendance record, Godlee noted in response that she was given assurances by Crawley that the change was not meant to improve the published outcome. Which it did, turning a null result into a tiny false positive.

    Notable that having been a member of the research team on the PACE trial, Crawley has a pattern of being party to mid-trial outcome changes, including dropping all objective measures after it is evident they will show no improvements, to turn null results into barely significant “improvements”. This is a pattern known to Godlee and does not appear to bother the BMJ editorial board, even in open label non-controlled trials.

    Should also be noted that LP promoters claim it can be used to treat and cure other diseases as well, including multiple sclerosis, and that its creator used to diagnose people with Tarot cards and “heal” them with his hands.

    That the BMJ gives credibility to this quackery is inexcusable. And yet the editorial board stands by it and the reality of “optional” requirements. Which raises the question of how common it is to make requirements optional and to excuse blatant violations to “zero tolerance policies” like pre-registration, especially in an open trial that consists mainly of convincing participants to loudly declare themselves as not sick, then rated using questionnaires of little applicability to ME/CFS asking participants about whether they “think” they are sick, with the underlying assumption that they never were in the first place.

    LP participants have to swear an oath of secrecy and never talk about the “treatment”, which in children raises so many ethical red flags one could set up a profitable red-flag business.

  2. Barbara McMullen

    It’s a pity the BMJ will not retract the research. I think I makes them a less valuable journal as a result.

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