MPs call for full results of all past clinical trials to be made publicBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g13 (Published 03 January 2014) Cite this as: BMJ 2014;348:g13
All rapid responses
On the 27th January 2014, the chief medical and pharmaceutical officers of the Department of Health, Sally Davies and Keith Ridge, wrote a ‘For Action’ alert and a letter to NHS England Area Directors, Clinical Commissioning Groups, General Practitioners, Screening and Immunisation Leads, Directors of Public Health, Local Authority Chief Executives, and Community Pharmacies endorsing use of the antiviral drugs oseltamivir and zanamivir for patients with symptoms of influenza.(1,2)
This advice and now-outdated NICE advice (3) take no account of the authoritative Cochrane review which shows the lack of good evidence of benefit with these drugs or of prescribing information about the serious harms they may cause.(4-7) Indeed, the Department of Health advice takes no account of its own report detailing the uncertain benefits of these drugs and the huge amounts of health funds spent in the past and wasted when stockpiled supplies were destroyed.(8)
The Department of Health advice authorises GPs to prescribe the drugs ‘at NHS expense’ not just for the at risk groups described in the NICE document3 but also for ‘certain individuals’ not in the at risk groups.(2) The authorisation is more in line with support of the pharmaceutical industry than the evidence-based care of patients and cost-effective use of valuable NHS funds. This is disgraceful.
The BMJ has published extensively in support of the international AllTrials initiative for open access to data on drug trials.(9) The problems arising from incomplete presentation and even concealment of data are evident in the publicly-documented struggle of researchers to gain access to research data on these very drugs now being promoted by the Department of Health advice.(7) In the Cochrane review of oseltamivir data, Jefferson et al note “We identified that a large number of studies, including data from 60% of the people who have been involved in randomised, placebo-controlled phase III treatment trials of oseltamivir, have never been published. This includes the biggest treatment trial ever undertaken on oseltamivir that on its own included just over 1,400 people of all ages... and ”these data remain unavailable for scrutiny by the scientific community." (5)
We urge the Department of Health to 1) withdraw the alert and letter, 2) insist that the pharmaceutical industry puts all the evidence in the public domain, and 3) review the evidence and publish it to correctly inform prescribers, pharmacists and the public about these drugs.
Patricia McGettigan, Clinical Pharmacologist;
Allyson Pollock, Professor. Global Health, Policy and Innovation Unit, Queen Mary, University of London, UK;
Andrew Herxheimer, Emeritus Fellow. The Cochrane Collaboration, London, UK.
2.270114 Influenza season - Use of antiviral medicines.pdf
4.Jefferson T, Jones MA, Doshi P, Del Mar CB, Heneghan CJ, Hama R, Thompson MJ. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD008965. DOI: 10.1002/14651858.CD008965.pub3.
Competing interests: No competing interests