European governments should sue the drug firm Roche
8 views
Skip to first unread message
"Peter C. Gøtzsche"
Nov 12, 2012, 5:11:45 AM11/12/12
to an...@cochrane.de, philipp...@gmail.com, da...@davidhammerstein.org, kat...@haiweb.org, laura...@hotmail.com, trudo....@utoronto.ca, bengo...@gmail.com, fergal...@ombudsman.europa.eu
Dear all,
see this BMJ press release that is just about to go to over 3,000 journalists around the world.
bw
Peter
BMJ Press Release
For immediate release, Monday 12 November 2012
Please click on links for full text of papers and contact the authors directly for comment.
Please credit the BMJ - this reassures your audience it is from a reputable, peer reviewed source.
Roche responds to BMJ‘s letter, but fails to address question of missing Tamiflu data
Meanwhile, senior researcher calls for Roche boycott until company releases data
A leading researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the company’s products until it publishes missing data on Tamiflu.
Peter Gøtzsche, leader of the Nordic Cochrane Centre in Copenhagen, was responding to an open letter to Roche from BMJ Editor-in-chief, Dr Fiona Godlee.
The letter is part of the BMJ’s open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.
Last week, Roche issued a “reactive statement” in response to Dr Godlee’s letter, saying it “does not accept or agree with the content of the letter regarding our transparency.”
The company said it had provided the Cochrane group with 3200 pages of information “enabling their questions to be answered” and that a further request for information was denied because the researchers “declined to sign a confidentiality agreement.”
However, the Cochrane researchers say they were never offered a confidentiality agreement at the time of the further request, and say they have “found misleading statements in each of the document’s four paragraphs.” The Cochrane researchers issued a letter to Roche last week - now posted on bmj.com/tamiflu - asking Roche to publicly correct the record.
Roche also says it “has made full clinical data…available to national health authorities,” but the Cochrane researchers say the European Medicines Agency has confirmed to them that it does not have some modules of the studies.
Gøtzsche comments came the same week as Dr Godlee and other campaigners met with health minster Lord Howe to discuss missing data, EU clinical trials regulations, and the role of regulators. Afterwards, MP Sarah Wollaston, who last month raised the issue in parliament, said she hoped to have a full day’s event to discuss further what could be done.
In his response, Gøtzsche said that he questioned “why European governments had not sued Roche to get the money they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects.”
He concludes: “European governments should sue Roche, which might have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish missing Tamiflu data.”
The Cochrane researchers conclude: “We remain interested in conducting the most rigorous, independent assessment of Tamiflu that is possible, and remain interested in obtaining the full study reports promised in December 2009 and complete de-identified electronic patient level reports.”
Contacts:
Professor Peter Gøtzsche, Director, Nordic Cochrane Centre, Copenhagen, Denmark
Tel: +45 35 45 71 12; Mobile: +45 53 64 20 66
Email: p...@cochrane.dk
Peter Doshi, Postdoctoral Fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Tel (mobile): +1 617 407 3019
Email: p...@jhu.edu
Tom Jefferson, Coordinator, Cochrane Acute Respiratory Infections Group, Rome, Italy
Tel (mobile): +39 329 202 5051
Email: jeffer...@gmail.com
Fiona Godlee, Editor-in-Chief, BMJ, London, UK
Tel (via BMJ Group Press Office): +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Read all the correspondence here: bmj.com/tamiflu
Emma Dickinson
BMJ Group PR Manager
BMJ Group
BMA House Tavistock Square
London WC1H 9JR, UK
Tel: +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Web: http://group.bmj.com
Twitter: @BMJ_Group
The BMJ Group Press Office is staffed Mon-Fri, 9am-5pm
For out of hours urgent media enquiries only please call +44 (0)7825 118 107
see this BMJ press release that is just about to go to over 3,000 journalists around the world.
bw
Peter
BMJ Press Release
For immediate release, Monday 12 November 2012
Please click on links for full text of papers and contact the authors directly for comment.
Please credit the BMJ - this reassures your audience it is from a reputable, peer reviewed source.
Roche responds to BMJ‘s letter, but fails to address question of missing Tamiflu data
Meanwhile, senior researcher calls for Roche boycott until company releases data
A leading researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the company’s products until it publishes missing data on Tamiflu.
Peter Gøtzsche, leader of the Nordic Cochrane Centre in Copenhagen, was responding to an open letter to Roche from BMJ Editor-in-chief, Dr Fiona Godlee.
The letter is part of the BMJ’s open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.
Last week, Roche issued a “reactive statement” in response to Dr Godlee’s letter, saying it “does not accept or agree with the content of the letter regarding our transparency.”
The company said it had provided the Cochrane group with 3200 pages of information “enabling their questions to be answered” and that a further request for information was denied because the researchers “declined to sign a confidentiality agreement.”
However, the Cochrane researchers say they were never offered a confidentiality agreement at the time of the further request, and say they have “found misleading statements in each of the document’s four paragraphs.” The Cochrane researchers issued a letter to Roche last week - now posted on bmj.com/tamiflu - asking Roche to publicly correct the record.
Roche also says it “has made full clinical data…available to national health authorities,” but the Cochrane researchers say the European Medicines Agency has confirmed to them that it does not have some modules of the studies.
Gøtzsche comments came the same week as Dr Godlee and other campaigners met with health minster Lord Howe to discuss missing data, EU clinical trials regulations, and the role of regulators. Afterwards, MP Sarah Wollaston, who last month raised the issue in parliament, said she hoped to have a full day’s event to discuss further what could be done.
In his response, Gøtzsche said that he questioned “why European governments had not sued Roche to get the money they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects.”
He concludes: “European governments should sue Roche, which might have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish missing Tamiflu data.”
The Cochrane researchers conclude: “We remain interested in conducting the most rigorous, independent assessment of Tamiflu that is possible, and remain interested in obtaining the full study reports promised in December 2009 and complete de-identified electronic patient level reports.”
Contacts:
Professor Peter Gøtzsche, Director, Nordic Cochrane Centre, Copenhagen, Denmark
Tel: +45 35 45 71 12; Mobile: +45 53 64 20 66
Email: p...@cochrane.dk
Peter Doshi, Postdoctoral Fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Tel (mobile): +1 617 407 3019
Email: p...@jhu.edu
Tom Jefferson, Coordinator, Cochrane Acute Respiratory Infections Group, Rome, Italy
Tel (mobile): +39 329 202 5051
Email: jeffer...@gmail.com
Fiona Godlee, Editor-in-Chief, BMJ, London, UK
Tel (via BMJ Group Press Office): +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Read all the correspondence here: bmj.com/tamiflu
Emma Dickinson
BMJ Group PR Manager
BMJ Group
BMA House Tavistock Square
London WC1H 9JR, UK
Tel: +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Web: http://group.bmj.com
Twitter: @BMJ_Group
The BMJ Group Press Office is staffed Mon-Fri, 9am-5pm
For out of hours urgent media enquiries only please call +44 (0)7825 118 107
Peter C. Gøtzsche, Professor, Director, MD, DrMedSci, MSc
Nordic Cochrane Centre, Rigshospitalet, Dept. 7811
e-mail: p...@cochrane.dk, Tel: +45 35 45 71 12, Fax: +45 35 45 70 07
____________________________
NEW BOOK:
Mammography screening: truth, lies and
controversy.
London: Radcliffe Publishing; 2012.
See
www.cochrane.dk
Featured, for example, in
The
Guardian
JAMA (16 May 2012) and BMJ (17 May 2012)
__________________________
Visiting address: Tagensvej 22, 1st floor
Trisha Greenhalgh
Nov 12, 2012, 5:19:41 AM11/12/12
to pathtodata...@googlegroups.com
Well done Peter
Prof Trisha Greenhalgh
Global Health, Policy and Innovation Unit
Centre for Primary Care and Public Health
Blizard Institute
Barts and The London School of Medicine and Dentistry
Yvonne Carter Building
58 Turner Street
London E1 2AB
t : 020 7882 7325 (PA) or 7326 (dir line)
f : 020 7882 2552
e: p.gree...@qmul.ac.uk
Twitter @trishgreenhalgh
From: "Peter C. G©ªtzsche" <p...@cochrane.dk>
Reply-To: <pathtodata...@googlegroups.com>
Date: Mon, 12 Nov 2012 11:11:45 +0100
To: <an...@cochrane.de>, <philipp...@gmail.com>, <da...@davidhammerstein.org>, <kat...@haiweb.org>, <laura...@hotmail.com>, <trudo....@utoronto.ca>, Ben Goldacre <bengo...@gmail.com>
Cc: <fergal...@ombudsman.europa.eu>
Subject: European governments should sue the drug firm Roche
Reply-To: <pathtodata...@googlegroups.com>
Date: Mon, 12 Nov 2012 11:11:45 +0100
To: <an...@cochrane.de>, <philipp...@gmail.com>, <da...@davidhammerstein.org>, <kat...@haiweb.org>, <laura...@hotmail.com>, <trudo....@utoronto.ca>, Ben Goldacre <bengo...@gmail.com>
Cc: <fergal...@ombudsman.europa.eu>
Subject: European governments should sue the drug firm Roche
Dear all,
see this BMJ press release that is just about to go to over 3,000 journalists around the world.
bw
Peter
BMJ Press Release
For immediate release, Monday 12 November 2012
Please click on links for full text of papers and contact the authors directly for comment.
Please credit the BMJ - this reassures your audience it is from a reputable, peer reviewed source.
Roche responds to BMJ‘s letter, but fails to address question of missing Tamiflu data
Meanwhile, senior researcher calls for Roche boycott until company releases data
A leading researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the company’s products until it publishes missing data on Tamiflu.
see this BMJ press release that is just about to go to over 3,000 journalists around the world.
bw
Peter
BMJ Press Release
For immediate release, Monday 12 November 2012
Please click on links for full text of papers and contact the authors directly for comment.
Please credit the BMJ - this reassures your audience it is from a reputable, peer reviewed source.
Roche responds to BMJ‘s letter, but fails to address question of missing Tamiflu data
Meanwhile, senior researcher calls for Roche boycott until company releases data
A leading researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the company’s products until it publishes missing data on Tamiflu.
Peter G©ªtzsche, leader of the Nordic Cochrane Centre in
Copenhagen, was responding to an open letter to Roche from BMJ
Editor-in-chief, Dr Fiona Godlee.
The letter is part of the BMJ’s open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.
Last week, Roche issued a “reactive statement” in responseto Dr Godlee’s letter, saying it “does not accept or agree with the
content of the letter regarding our transparency.”
The company said it had provided the Cochrane group with 3200 pages of information “enabling their questions to be answered” and that a further request for information was denied because the researchers “declined to sign a confidentiality agreement.”
However, the Cochrane researchers say they were never offered a confidentiality agreement at the time of the further request, and say they have “found misleading statements in each of the document’s four paragraphs.” The Cochrane researchers issued a letter to Roche last week - now posted on bmj.com/tamiflu
- asking Roche to publicly
correct the record.
Roche also says it “has made full clinical data…available to national health authorities,” but the Cochrane researchers say the European Medicines Agency has confirmed to them that it does not have some modules of the studies.
G©ªtzsche comments came the same week as Dr Godlee and other campaigners
met with health minster Lord Howe to discuss missing data, EU clinical
trials regulations, and the role of regulators. Afterwards, MP Sarah
Wollaston, who last month raised the issue in parliament, said she hoped
to have a full day’s event to discuss further what could be done.
In his response, G©ªtzsche said that he questioned “why European governments had not sued Roche to get the money they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects.”
In his response, G©ªtzsche said that he questioned “why European governments had not sued Roche to get the money they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them if it is really true that they show these effects.”
He concludes: “European governments should sue Roche, which might have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish missing Tamiflu data.”
The Cochrane researchers conclude: “We remain interested in conducting the most rigorous, independent assessment of Tamiflu that is possible, and remain interested in obtaining the full study reports promised in December 2009 and complete de-identified electronic patient level reports.”
Contacts:
Professor Peter G©ªtzsche, Director, Nordic Cochrane Centre, Copenhagen, Denmark
Professor Peter G©ªtzsche, Director, Nordic Cochrane Centre, Copenhagen, Denmark
Peter Doshi, Postdoctoral Fellow, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Tel (mobile): +1 617 407 3019
Email: p...@jhu.edu
Tom Jefferson, Coordinator, Cochrane Acute Respiratory Infections Group, Rome, Italy
Tel (mobile): +39 329 202 5051
Email: jeffer...@gmail.com
Fiona Godlee, Editor-in-Chief, BMJ, London, UK
Tel (via BMJ Group Press Office): +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Read all the correspondence here: bmj.com/tamiflu
Emma Dickinson
BMJ Group PR Manager
BMJ Group
BMA House Tavistock Square
London WC1H 9JR, UK
Tel: +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Web: http://group.bmj.com
Twitter: @BMJ_Group
The BMJ Group Press Office is staffed Mon-Fri, 9am-5pm
For out of hours urgent media enquiries only please call +44 (0)7825 118 107
Peter C. G©ªtzsche, Professor, Director, MD, DrMedSci, MSc
Iona Heath
Nov 13, 2012, 12:15:35 PM11/13/12
to pathtodata...@googlegroups.com
Hooray!
Iona Heath
President, Royal College of General Practitioners
President, Royal College of General Practitioners
Fiona Godlee, Editor-in-Chief, BMJ, London, UK
Tel (via BMJ Group Press Office): +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Read all the correspondence here: bmj.com/tamiflu
Emma Dickinson
BMJ Group PR Manager
BMJ Group
BMA House Tavistock Square
London WC1H 9JR, UK
Tel: +44 (0)20 7383 6529
Email: edick...@bmjgroup.com
Web: http://group.bmj.com
Twitter: @BMJ_Group
The BMJ Group Press Office is staffed Mon-Fri, 9am-5pm
For out of hours urgent media enquiries only please call +44 (0)7825 118 107
Peter C. Gøtzsche, Professor, Director, MD, DrMedSci, MSc
Nordic Cochrane Centre, Rigshospitalet, Dept. 7811
e-mail: p...@cochrane.dk, Tel: +45 35 45 71 12, Fax: +45 35 45 70 07
____________________________
NEW BOOK:
Mammography screening: truth, lies and controversy.
London: Radcliffe Publishing; 2012.
Reply all
Reply to author
Forward
0 new messages