• Save
Chris Del Mar, Australasian Cochrane Symposium
Upcoming SlideShare
Loading in...5
×
 

Chris Del Mar, Australasian Cochrane Symposium

on

  • 711 views

Neuraminidase Inhibitors for influenza: avoiding published data. A new era?

Neuraminidase Inhibitors for influenza: avoiding published data. A new era?
Presented by Professor Chris Del Mar, Bond University, at the Australasian Cochrane Symposium, Melbourne, 1 July 2011

Statistics

Views

Total Views
711
Views on SlideShare
639
Embed Views
72

Actions

Likes
0
Downloads
0
Comments
0

1 Embed 72

http://acc.cochrane.org 72

Accessibility

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Chris Del Mar, Australasian Cochrane Symposium Chris Del Mar, Australasian Cochrane Symposium Presentation Transcript

  • Neuraminidase inhibitors
    Jefferson T
    Doshi P
    Jones M
    Heneghan C
    Hama R
    Thompson M
    Del Mar C cdelmar@bond.edu.au
  • unusual features
    Cochrane review as BMJ paper
    ...and as an update BMJ paper
    associated media release
    Channel 4 TV UK
    multiple print media
    adversarial relationship with Pharma
    ongoing
  • Neuraminidase inhibitors for preventing and treating influenza in healthy adults
    Background
    Cochrane response to pandemic flu
    NIs currently recommended for influenza
    prevention - seasonal
    treating - pandemic
    governments stockpiling
    H5N1 – 2007
    H1N1 – 2009
  • What is already known
    neuraminidase inhibitors for influenza...
    global public health drugs
    reduce symptoms, shorten durationof illness~1 day if used <48 hours of onset symptoms
    debate about
    toxicity
    effects on complications
  • history of the review
    1999 – 1st review
    2003 – update
    2005 – update
    2009 – update – current
    2011 – update – forthcoming
    Hayashi ‘s criticism
    • complications;
    • reliance on Kaiser 2003
    • no ‘raw’ data;
    • authors Roche;
    • some unpublished
  • questions
    do NIs...
    ...prevent influenza?
    ...ameliorate influenza?
    ...prevent transmission of influenza?
    ...cause adverse events’
  • Fig 1 Flow of studies identified from 2009 update of randomised controlled trials
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • Fig 2 Flow of studies identified from search for evidence from post-marketing studies (excluding adverse event reporting system)
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • results – 1studies found
  • results: findings
    prophylaxis
  • Fig 4 Effect of neuraminidase inhibitors for prophylaxisagainst lab-confirmed influenza
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • Fig 5 Effect of neuraminidase inhibitors compared with placebo on alleviation of influenza symptoms (intention to treat analysis)
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • Fig 3 Effect of neuraminidase inhibitors compared with placebo on prophylaxis against influenza-like illness
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • Fig 6 Effect of oseltamivir compared with placebo on complicationsbased on Kaiser and 3 other studies: Unpublished studies excluded
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • Fig 7 Effect of oseltamivir compared with placebo on nausea(intention to treat analysis)
    Jefferson, T. et al. BMJ 2009;339:b5106
    Copyright ©2009 BMJ Publishing Group Ltd.
  • NIs: adverse events
    US FDA
    AERS – 1 (FoIA)
    AERS – 2 (historical)
    Japanese PMDA
    submissions from Chugai Pharmaceuticals Co Ltd
    ...there is only poor quality, possibly under-reported, pharmaco-vigilance evidence regarding rarer adverse events...
    Jefferson, T. et al. BMJ 2009;339:b5106
  • What this study adds
    Neuraminidase inhibitors
    reduce the symptoms of influenza modestly
    reduce the chance of people exposed to influenza developinglab-confirmed influenza
    ...but not ILI
    Evidencefor or against their benefit for preventing complications ofinfluenza is insufficient
    Evidence for or against serious adverseevents is lacking, although oseltamivir causes nausea
    Jefferson, T. et al. BMJ 2009;339:b5106
  • future...
  • future...
    Responsiveness to global concerns
    effort
    partnerships
    pharmaceutical industry
    BMJ
    Channel 4
  • future...
    New approach
    combine childhood and adult reviews
    pharma approaches
    regulatory bodies (FDA; Japanese; EMA)
    funding from NIHR (UK)
    cut-off date 12 Apr 2011
  • future...
    Focus on Cochrane processes
    earlier errors
    outcomes
    should we move away from SRs of published RCTs?
    Workshop: Cochrane Reviews of unpublished data
    Cochrane Colloquium Madrid October 2011
  • Thank you