Published Online: December 19, 2012. doi:10.1001/jamainternmed.2013.3838
Author Contributions: Dr Doshi had full access to the request logfile used in the study and takes responsibility for the accuracy of the data analysis. Study concept and design: Doshi and Jefferson. Acquisition of data: Doshi. Analysis and interpretation of data: Doshi and Jefferson. Drafting of the manuscript: Doshi and Jefferson. Critical revision of the manuscript for important intellectual content: Doshi and Jefferson. Statistical analysis: Doshi.
Conflict of Interest Disclosure: Dr Doshi received [euro]1500 from the European Respiratory Society in support of his travel to the society's September 2012 annual congress, where he gave an invited talk on oseltamivir. Dr Jefferson receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, none of which are on clinical study reports. In 2011-2012, Dr Jefferson acted as an expert witness in a litigation case related to an antiviral (oseltamivir phosphate; Tamiflu [Roche]). Dr Jefferson is on a legal retainer for expert advice on litigation for influenza vaccines in health care workers. Drs Doshi and Jefferson also personally know some European regulators who share an interest in this topic.
Funding/Support: Both authors are co-recipients of a UK National Institute for Health Research grant to carry out a Cochrane review of neuraminidase inhibitors (http://www.hta.ac.uk/2352). Dr Doshi is funded by an institutional training grant from the Agency for Healthcare Research and Quality (#T32HS019488).
Additional Contributions: David Mackay, BVetMed, MSc, PhD, MRCVS, of the European Medicines Agency, closely reviewed the manuscript for accuracy and provided many clarifications about the EMA's policy. Dr Mackay received no compensation for his assistance.