Evidence in the pub/college bar
Tom Jefferson is the first author of the only Cochrane review based solely on unpublished on regulatory data. The review of Neuraminidase inhibitors for preventing and treating influenza was a seen as a major methodological development in the field of evidence-based medicine. The review challenged opinion across the regulatory, industrial and policy arenas, and has since been added as a landmark within the James Lind Library. It was the most accessed review in the Cochrane Library in 2014. The review was published in April 2014 both on the Cochrane Library and the BMJ and was the culmination of a 4-year campaign to obtain a complete set of previously unseen 107 clinical study reports. The emphasis on clinical study reports to the exclusion of publications was an attempt to address the problems of reporting bias which distorts much of literature on neuraminidase inhibitors.
Despite its notoriety, the review and its findings have not led to any detectable change in government policy to everyday use or stockpiling of the drugs but has spawned a series of indirect replies suggesting that independently reviewed complete evidence is not what high level decision makers want. They seem to prefer industry-sponsored reviews and observational studies to justify their decisions.
Tom will briefly list the responses in chronological order prompting discussion on the complex interplay between governments, public health bodies, industry and its key opinion leaders and journal editors.
As a Cochrane author and senior author of the RIAT declaration, Tom fits the definition of a research parasite recently proposed by Drs Longo and Drazen in the New England Journal of Medicine: “people who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited”.
Longo DL, Drazen JM. Data Sharing. N Engl J Med 2016; 374:276-277;