Trial By Error: My Letter to LP Study’s Senior Author
7 JANUARY 2019
By David Tuller, DrPH
Alan Montgomery is a professor of medical statistics and clinical trials at the University of Nottingham’s School of Medicine. He is also the senior author of the Lightning Process study published in 2017 in Archives of Disease in Childhood, a BMJ journal. Professor Montgomery formerly worked at University of Bristol, along with Professor Esther Crawley and the other co-authors of the Lightning Process study.
As I documented more than a year ago, the Lightning Process study is a methodological and ethical mess that violates core scientific principles. Despite the potential public policy impact of the reported findings, Archives of Disease in Childhood has so far failed to fully resolve the issues. Given the journal’s inability or unwillingness to take the prompt action necessary to protect this vulnerable patient group from bad research, I decided to reach out to Professor Montgomery directly. Considering his credentials, it is perplexing that he agreed to be senior author of the paper, since it improperly identified the study as prospective and failed to mention major outcome-swapping half-way through.
I e-mailed the following letter to Professor Montgomery on Sunday evening (California time), with the subject heading “Retrospective Registration and Outcome-Swapping in Lightning Process Trial.” I cc’d Dr Nick Brown, editor-in-chief of Archives of Disease in Childhood, and Dr Fiona Godlee, editorial director of BMJ. In addition, I cc’d three members of Parliament who have expressed dismay about the poor quality of research in this field and are seeking a parliamentary debate on the issue: Carol Monaghan MP, Darren Jones MP and Nicky Morgan MP. Finally, I cc’d Adom Lowe, Sally Burch and Dr Charles Shepherd, three members of the committee that is developing the ME/CFS guidance for the National Institute for Health and Care Excellence.
Dear Professor Montgomery:
I am a journalist and public health researcher at the University of California, Berkeley