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• W4246201051 abstract "Previously1Doshi P Heneghan C Jefferson T Oseltamivir for influenza.Lancet. 2015; 386: 1134-1135Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar we called on Joanna Dobson and colleagues2Dobson J Whitley RJ Pocock S Monto AS Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials.Lancet. 2015; 385: 1729-1737Summary Full Text Full Text PDF PubMed Scopus (392) Google Scholar to make public the protocol for their meta-analysis of randomised controlled trials of oseltamivir. This document could easily be uploaded to a repository such as Dryad, and linked to their research paper. We are alarmed that they neither did this nor explained their reasons for not doing so.3Monto AS Dobson J Pocock S Whitley RJ Oseltamivir for influenza—Authors' reply.Lancet. 2015; 386: 1135-1136Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar We are taking this opportunity to reiterate our request. For their work to be taken seriously, there is an imperative to furnish the scientific community with a protocol that pre-dates their analysis. Numerous decisions, from selection of dose for examination, to prespecified and exploratory analysis conducted, definitions of outcomes examined, and statistical methods chosen, cannot be understood and critically assessed without access to the protocol. The Lancet REWARD initiative underscores how important such documents are to sound science.4Chan A-W Song F Vickers A et al.Increasing value and reducing waste: addressing inaccessible research.Lancet. 2014; 383: 257-266Summary Full Text Full Text PDF PubMed Scopus (520) Google Scholar, 5Ioannidis JPA Greenland S Hlatky MA et al.Increasing value and reducing waste in research design, conduct, and analysis.Lancet. 2014; 383: 166-175Summary Full Text Full Text PDF PubMed Scopus (907) Google Scholar Furthermore, the Roche-funded Multi-party Group for Advice on Science (MUGAS), which funded Dobson and colleagues' analysis, held a one day meeting in June 2013 “to develop a statistical analysis plan on Oseltamivir data, both from randomized controlled trials and from observational trials.” The MUGAS press release stated: “This plan will serve as a basis for the post-meeting in depth statistical analysis, eventually to be carried out by MUGAS and MUGAS invited partners”. We call on the authors to release all of these pre-trial documents, and we call on The Lancet to join us in this demand and consider the ramifications of the documents continuing to remain secret. In addition, the conflict of interest disclosure statements for Dobson and colleagues' original article2Dobson J Whitley RJ Pocock S Monto AS Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials.Lancet. 2015; 385: 1729-1737Summary Full Text Full Text PDF PubMed Scopus (392) Google Scholar and letter3Monto AS Dobson J Pocock S Whitley RJ Oseltamivir for influenza—Authors' reply.Lancet. 2015; 386: 1135-1136Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar are incomplete and need to be corrected. Dobson and Stuart Pocock declare “no competing interests”, but Dobson's salary was supported by Roche during the analysis and Pocock told a journalist that he received research funds from Gilead and Genentech.6Lenzer J Why aren't the US Centers for Disease Control and Food and Drug Administration speaking with one voice on flu?.BMJ. 2015; 350: h658Crossref PubMed Scopus (13) Google Scholar Also, Richard Whitley does not inform readers that Gilead Sciences is the patent holder for oseltamivir so readers can evaluate the implications. According to ProPublica and OpenPaymentsData.CMS.gov, Arnold Monto and Whitley also both received money in recent years from companies not listed in The Lancet articles. Finally, despite the fact that all authors are financially linked to the manufacturer or patent holder of oseltamivir, the linked editorial by Heath Kelly and Benjamin Cowling7Kelly H Cowling BJ Influenza: the rational use of oseltamivir.Lancet. 2015; 385: 1700-1702Summary Full Text Full Text PDF PubMed Scopus (22) Google Scholar inaccurately describes Dobson and colleagues as an “independent research group”. The above inaccuracies all need to be addressed, and we call on The Lancet to help ensure that the record is corrected. See appendix for declaration of interests Download .pdf (.14 MB) Help with pdf files Supplementary appendix Oseltamivir for influenza – Authors' replyIn September, we replied to separate letters from Mark Jones and colleagues1 and Peter Doshi and colleagues,2 groups associated with the Cochrane reviews of oseltamivir.3 Their letters were mainly concerned with the substance of findings in our individual patient data meta-analysis of adult treatment studies of oseltamivir.4 Doshi and colleagues noted that the overall results were not strikingly different from “already public data”. This is not surprising, as we were all analysing the same randomised controlled trials, with the addition of one that was made available to us. Full-Text PDF" @default.
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