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PRESS STATEMENT

 

Successful launch of new initiative to address unsolved scientific issues

Scientific experts agree on analysis plan for oseltamivir data

 

The precise effectiveness of antiviral drugs for influenza has been the subject of scientific debate for many years. On 18 June 2013, a multidisciplinary group of scientific experts in the field have developed an analysis plan for oseltamivir data during the first Multiparty Group for Advice on Science (MUGAS) meeting. The initiative was taken by four leading academics (Prof. Ab Osterhaus, Prof. Arnold Monto, Prof. Menno de Jong and Prof. Rich Whitley), who, together with scientific experts from various disciplines, have analysed and discussed a data overview provided by Roche, with complimentary research data provided by Prof. Terho Heikinnen, Prof. Nelson Lee, Prof. Allison McGeer, Prof. Jonathan Van-Tam and Prof. Frederick Hayden.

The MUGAS initiative builds on the social concern that specific unsolved scientific issues hamper proper and effective public health guidance. The concept of the MUGAS collaboration has therefore been designed to stimulate in-depth discussion based on the collective scientific data with one clear objective: to bring benefit to society by enhancing public health security.

In this new concept, Roche delegates had been invited to attend the MUGAS meeting as informants, i.e. to present their research and study data and to provide additional information when necessary. In line with the aim of MUGAS to provide an independent data analysis, informants did not attend the actual analysis planning sessions, nor did they participate in any discussions.

In conclusion after a day of intense work and debate, the MUGAS meeting attendants agreed that independent analyses of the existing oseltamivir individual patient database in combination with secondary analysis of the data is required to resolve issues regarding efficacy and safety of oseltamivir. The MUGAS participants developed a framework of an analysis plan – that also will include observational studies as available as well as data from ongoing projects. This will be carried out in the months to come. To that end, the MUGAS meeting assigned work packages to different academic expert groups and institutions. Their combined efforts intend to provide the answers to whether current guidelines on the use of oseltamivir for different target groups need amendment.

The outcome of the analyses will be offered for publication in scientific peer reviewed literature.

To emphasize their determination to bring benefit to society by enhancing public health security, the MUGAS participants unanimously decided to give the MUGAS initiative official legal status. The collaboration will hence be transformed into an international foundation, led by a scientifically renowned Board of Directors. More information will soon be available on www.mugas.net.

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For more information, please contact:

(Europe)
Prof. Ab Osterhaus
Mob: +31 653 268 606
e-mail: a.osterhaus@erasmusmc.nl

(USA)
Prof. Arnold Monto
Mob: +1 (734) 355 8569
e-mail: asmonto@umich.edu

Notes to Editor:

MUGAS participants are:

1. Review Board Members

Review Board Members are stakeholders who have been invited by the four initiating partners to share their expertise and insights. The Review Board is the sole decision-making body of the MUGAS meeting.

Arnold Monto (University of Michigan) – MUGAS initiator
Menno de Jong (AMC Amsterdam) – MUGAS initiator
Ab Osterhaus (Erasmus MC Rotterdam) – MUGAS initiator
Rich Whitley (University of Alabama) – MUGAS initiator
Jonathan Nguyen-Van-Tam (University of Nottingham)
Puja Myles (University of Nottingham)
Fred Hayden (University of Virginia)
Benjamin Cowling (University of Hong Kong)                                 
Abdullah Brooks (John Hopkins University)
Regine Lehnert (Federal Institute for Drugs and Medical Devices, Germany)
Stephen Senn (CCMS-Luxemburg)
Nelson Lee (Chinese University of Hong Kong )
Erhard van der Vries (Erasmus MC Rotterdam)
Allison McGeer (Mount Sinai Hospital, Toronto, Canada)
Tim Uyeki (CDC)

2. Mugas observers

While Review Board Members attend the MUGAS meeting in a private capacity, MUGAS Observers are representatives of relevant stakeholder organizations. They have no decision-making powers.

Andrew Pavia (IDSA)

3. Mugas Informants

Roche delegates had been invited to attend the MUGAS meetings as informants. They had no decision-making powers and did not participate in the analysis sessions.

Don McLean (F. Hoffmann-La Roche)
James Smith (F. Hoffmann-La Roche)
Barry Clinch (F. Hoffmann-La Roche)
Paul Mahoney (F. Hoffmann-La Roche)