England’s chief medical officer asks for review of drug evaluation in wake of statins controversyBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3300 (Published 16 June 2015) Cite this as: BMJ 2015;350:h3300
The Academy of Medical Sciences, the independent body that represents UK medical science, will carry out a review of the way evidence on drugs is evaluated, after the chief medical officer for England expressed concern that recent controversies had damaged the public’s faith in the way research was carried out and presented.
Sally Davies cited recent debates over the use of drugs such as statins and the antiviral treatment oseltamivir (Tamiflu), both of which have been covered extensively in The BMJ and in the mainstream media.
Davies sent a letter in February to the president of the academy, John Tooke, that said, “There seems to be a view that doctors over-medicate, so it is difficult to trust them, and that clinical scientists are all beset by conflicts of interest from industry funding and are therefore untrustworthy too.” She said that such a situation would not be in the interests of patients or the public’s health.
“I have, therefore, reluctantly come to the conclusion that we do need an authoritative independent report looking at how society should judge the safety and efficacy of drugs as an intervention.”
A copy of her letter was obtained by BBC Radio 4’s File on 4 programme as part of an investigation into concerns about the thrombolytic drug alteplase. The academy has agreed to carry out a review that will start this week and finish by the end of the year. A spokesperson for the Department of Health for England said that the chief medical officer had suggested the review but that it would not report back directly to her.
The academy has initiated a working group project that will look into how randomised controlled trials and observational data are used to make decisions about the safety and effectiveness of drugs and medical interventions. The project will use statins as the main (but not the only) case study, alongside other topics such as treating flu, Ebola virus disease, and rare cancers.
The working group will be chaired by Michael Rutter, former vice president of the Academy of Medical Sciences and professor of developmental psychopathology at King’s College London.
The first stage of the evaluating evidence project will involve small meetings on 17 June to discuss the project’s scope and to identify key questions that the project will aim to answer. These meetings will involve academy fellows and representatives of research funders, the medical royal colleges, regulators, learned societies, and academic institutions. There will then be input and evidence from other organisations and individuals as the project progresses.
Cite this as: BMJ 2015;350:h3300
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thebmj.com News: Researchers say they will send unpublished alteplase data to UK drug regulator on request (BMJ 2015;350:h119, doi:10.1136/bmj.h119); UK drug agency announces review of use of alteplase after stroke (BMJ 2014;349:g5355, doi:10.1136/bmj.g5355)