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Research and evaluation

England’s top doctor orders review into how medicines are evaluated

The chief medical officer requests report ‘reluctantly’ as public confidence wavers over drug research and prescribing decisions.

The chief medical officer (CMO) for England, Dame Sally Davies, pictured, has ordered an independent review into the efficacy and safety of medicines following concerns about a growing perception that doctors and scientists are “untrustworthy”

Source: Infection Control Symposium / Wikimedia Commons

Dame Sally Davies has asked the Academy of Medical Sciences to examine how society should judge the safety and efficacy of drugs as an intervention

The chief medical officer for England, Dame Sally Davies, has ordered an independent review into the efficacy and safety of medicines to address a growing perception that doctors and scientists are “untrustworthy”.

The review, which begins on 17 June 2015, will look at how sources of evidence — including clinical trials and observational data — are used to make decisions about the safety and efficacy of medicines and medical interventions. Its main focus will be the use of statins but it may look at infectious diseases, such as Ebola, and rare cancers.

The review will be carried out by the Academy of Medical Sciences (AMS) — whose fellows have already voiced concerns over the appropriate use of statins — and is expected to report back in 2015.

In a letter to the AMS, Dame Sally cites recent contention over the prescribing of statins to people at low risk of developing heart disease and doubts about the efficacy of the anti-viral oseltamivir (Tamiflu) as having damaged public confidence in drug research.

In the letter, sent to the AMS president, Sir John Tooke, in February 2015, she 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.

“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.”

The AMS confirmed that it is leading the review, prompted by its own concerns as well as those expressed in the letter from Davies.

Academy fellows and academics, regulators, representatives from the medical royal colleges and others will meet to decide the review’s terms of reference and its timetable.

It will be chaired by the former AMS vice-president, Michael Rutter, who is professor of developmental psychopathology at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London.

The AMS says it will be inviting other people and organisations to present evidence to the “Evaluating evidence” project once it is under way.

In a statement, the UK medicines safety watchdog the Medicines and Healthcare products Regulatory Authority said it would support the academy review and was clarifying its exact role in the process.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068759

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  • My sister died last October about 6 weeks after being given Clozipine whilst detained under the Mental health Act

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