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.