Notwithstanding documented procedural and ethics problems, BMJ has inexplicably continued its refusal to retract a deeply flawed article claiming that the so-called “Lightning Study” may be an effective treatment for children with ME/CFS. Even after posting a 3000 word “clarification,” the editors (as I explained here) accepted the “assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase.”
My friend and coauthor David Tuller has now posted an article on STAT News fully detailing this fiasco. Here is the gist:
The Lightning Process trial was not blinded and relied on self-reported outcomes — a design with enormous potential for bias, since participants’ knowledge of what treatment they received can influence their subjective responses to questions about their health. Nevertheless, based on their findings, the investigators declared that the Lightning Process, in combination with medical care, was an “effective” treatment for pediatric CFS/ME. Archives of Disease in Childhood, a well-regarded BMJ journal, published the results in September 2017.
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.
Under the circumstances, continuing to grant the Lightning Process study the BMJ seal of approval can only be described as a form of “gross negligence” on the editorial side. In response to the correction, I appealed to Godlee in an open letter of concern in August 2019, signed by 55 scientists, academics, and other experts from Harvard, Columbia, Stanford, University College London, UC Berkeley, Queen Mary University of London, and elsewhere.
BMJ’s inability to detect problems in these cases, despite supposedly rigorous oversight systems, suggests that its peer-review and editorial processes might need a significant overhaul. Beyond that, the failure to take appropriate steps in the face of disqualifying flaws, like those in the Lightning Process study, suggests that BMJ is prioritizing concerns about reputational damage or other interests over the health and well-being of children, at least in this arena of science.
You can read the entire article here.
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