Re: New expert group agrees plan to analyse full data on oseltamivir
Editor, we write to clarify some of the content of the News piece.
Zosia Kmietowicz discussed the Roche-funded "MUGAS" group as well as our Cochrane group, both analyzing the effects of oseltamivir, and stated that "Both groups of researchers will have access to patient level datasets and to the same clinical study reports, as well as observational studies, for their analyses".
This suggests that the MUGAS group and our group will have access to identical information, but we do not think this will be the case.
Our group is currently receiving redacted clinical study reports from Roche under no contract, whereas the MUGAS group will presumably receive unredacted clinical study reports under contract ("Data Analysis Agreement").
Also: while partially redacted individual participant level data appear in the appendices of clinical study reports, they are extremely difficult to use in any robust way because they are printouts of line listings, not in more readily analyzable electronic format.
Robust and comprehensive analyses based on the participant level data we are receiving would entail data re-entry with a huge resource bill and high risk of inputting mistakes. Furthermore given that the electronic datasets would appear to already exist (as they are the basis of the dataset printouts on PDF/paper), we cannot see any legitimate reason Roche would agree to sharing the patient level data in paper (PDF) form, but not analyzeable electronic dataset (e.g. SAS XPORT format).
Our Cochrane review is not concerned with data availability for observational studies because our focus is on randomized controlled trials, of which for oseltamivir there are many. (This inclusion criteria remains unchanged since the review's first version published in 1999.) Indeed it was on the basis of Roche-sponsored randomized trials that Roche stated its drug significantly reduced the risk of hospitalizations and lower respiratory tract complications. We remain interested in evaluating the veracity of Roche's statements.
Tom Jefferson, Researcher, Cochrane Collaboration, Rome, Italy
Peter Doshi, Post doctoral fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Competing interests:
Dr Jefferson receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. Dr Jefferson is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 products
Drs Jefferson and Doshi 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). In 1997-99 Dr Jefferson acted as consultant for Roche, in 2001-2 for GSK and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral which did not get approval from FDA). 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.
Dr. Doshi received €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.
Rapid Response:
Re: New expert group agrees plan to analyse full data on oseltamivir
Editor, we write to clarify some of the content of the News piece.
Zosia Kmietowicz discussed the Roche-funded "MUGAS" group as well as our Cochrane group, both analyzing the effects of oseltamivir, and stated that "Both groups of researchers will have access to patient level datasets and to the same clinical study reports, as well as observational studies, for their analyses".
This suggests that the MUGAS group and our group will have access to identical information, but we do not think this will be the case.
Our group is currently receiving redacted clinical study reports from Roche under no contract, whereas the MUGAS group will presumably receive unredacted clinical study reports under contract ("Data Analysis Agreement").
Also: while partially redacted individual participant level data appear in the appendices of clinical study reports, they are extremely difficult to use in any robust way because they are printouts of line listings, not in more readily analyzable electronic format.
Robust and comprehensive analyses based on the participant level data we are receiving would entail data re-entry with a huge resource bill and high risk of inputting mistakes. Furthermore given that the electronic datasets would appear to already exist (as they are the basis of the dataset printouts on PDF/paper), we cannot see any legitimate reason Roche would agree to sharing the patient level data in paper (PDF) form, but not analyzeable electronic dataset (e.g. SAS XPORT format).
Our Cochrane review is not concerned with data availability for observational studies because our focus is on randomized controlled trials, of which for oseltamivir there are many. (This inclusion criteria remains unchanged since the review's first version published in 1999.) Indeed it was on the basis of Roche-sponsored randomized trials that Roche stated its drug significantly reduced the risk of hospitalizations and lower respiratory tract complications. We remain interested in evaluating the veracity of Roche's statements.
Tom Jefferson, Researcher, Cochrane Collaboration, Rome, Italy
Peter Doshi, Post doctoral fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Competing interests: Dr Jefferson receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. Dr Jefferson is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 products Drs Jefferson and Doshi 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). In 1997-99 Dr Jefferson acted as consultant for Roche, in 2001-2 for GSK and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral which did not get approval from FDA). 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. Dr. Doshi received €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.