獨立研究：特敏福藥效誇大 無助防疫 可致患者精神錯亂
版主: 版主021
Re: 獨立研究：特敏福藥效誇大 無助防疫 可致患者精神錯亂
小孩子小時候得流感有用過
和沒使用時比較
感覺症狀消失有快一點
退燒時間也快一點點....
和沒使用時比較
感覺症狀消失有快一點
退燒時間也快一點點....
荒漠狂沙走萬里 孤寂天涯一人行
繁華落盡一場空 曲終人散皆是夢
繁華落盡一場空 曲終人散皆是夢
-
李誠民
- 註冊會員
- 文章: 1467
- 註冊時間: 週三 6月 23, 2010 10:18 am
Re: 獨立研究：特敏福藥效誇大 無助防疫 可致患者精神錯亂
""這個我們已經討論過囉......
viewtopic.php?f=8&t=93620""-----未公開!!!
這期BMJ有兩篇研究文章(Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2545 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2545 ;; Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2547 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2547 )
有關Newraminidase inhibitors—0seltamivir(Timeflu ,Roche co.)與zanamir( Relenza GSK Co.);;兩篇分析(Analysis)文章(--Multisystem failure: the story of anti-influenza drugs
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2263 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2263;;
Oseltamivir: the real world data
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2371 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2371)
;;三篇編輯(Editorial, The missing data that cost $20bn
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2695 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2695 ;; Neuraminidase inhibitors for influenza
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2548 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2548 ;; The Tamiflu trials
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2630 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2630 )
)文章; 等於對Newraminidase Inhibitors 做了總結報告::以下摘錄Analysis文章::
Multisystem failure: the story of anti-influenza drugs
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2263 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2263
Last year (2013年,適逢Jeffson—Cochrance study追蹤Newraminidase inhibitors 六周年)—1. Roche released full clinical study reports for what we believe are close to all of the oseltamivir(Tamiflu) studies it.2. GlaxoSmithKline also released the reports for studies of zanamivir( Relenza ), and we have now published our analysis of them the Cochrane team, with the help of the BMJ’s open data campaign, finally got access to full clinical study reports on neuraminidase inhibitors. Tom Jefferson and Peter Doshi explain what the new systematic review found and how a series of failures meant that decisions about these drugs were made without the full evidence
Story of neuraminidase inhibitors
• Mid-late 1990s: Around 40 Roche sponsored randomised clinical trials of oseltamivir and 25 Glaxo-Wellcome sponsored randomised trials of zanamivir are completed
• July 1999: FDA approves zanamivir for treatment of influenza
• October 1999: FDA approves oseltamivir for treatment of influenza
• November 2000: FDA approves oseltamivir for prophylaxis of influenza
• June 2002: EMA approves oseltamivir for prophylaxis and treatment
• November 2000: FDA tells Roche that its promotional material claiming a 45% reduction in secondary infections is “false or misleading”
• 2003: Kaiser and colleagues’ pooled analysis of 10 randomised clinical trials conducted before licensing in 1999 is published in Archives of Internal Medicine and concludes that oseltamivir reduces the risk of lower respiratory tract infections resulting in antibiotic use (55%; 4.6% v 10.3% for placebo) and hospital admissions (59% 1.7% v 0.7%) in adults aged 13 to 97 years5
• 2004-5: Governments around the world begin stockpiling oseltamivir spurred by fears of avian influenza H5N1
• 2005: UK and US pandemic contingency plans highlight the importance of antivirals in reducing the impact of a pandemic: Both state treatment will reduce hospital admissions by about 50% and decrease mortality, based on the Kaiser analysis2 3
• January 2006: Cochrane review concludes that oseltamivir reduces complications such as pneumonia. The Kaiser 2003 paper drove the result in meta-analysis
• March 2006: FDA approves zanamivir for prophylaxis of influenza
• 2009: Novel A/H1N1 influenza virus discovered to be spreading in North America. In June 2009 WHO declares A/H1N1 influenza a “pandemic”21
• 2009: Australian and UK governments commission rapid update of Cochrane reviews related to influenza
• 2009: Tip from a reader alerts the Cochrane team that only two of the 10 trials in the Kaiser analysis were published
• 2009: We request data from the authors of the Kaiser pooled analysis and the oseltamivir “pivotal” studies.22 23 The authors respond that they do not have the data and refer us to Roche
• December 2009: Unable to (and unwilling to sign a confidentiality agreement with a secrecy clause necessary to) obtain the 10 trials’ raw data, we conclude that we no longer are sure whether oseltamivir reduces complications of influenza.24 A joint investigation by BMJ and Channel 4 News shows that one of the published trials had been ghostwritten and that the largest treatment trial of oseltamivir conducted (M76001) was presented as a conference abstract carrying the name of a professor who did not recollect being involved; it was never published in full15
• December 2009: Roche promises to release full clinical study reports to legitimate investigators “within the coming days.”25 At the end of the month it releases 3195 pages of study report but none are complete
• 2010-2012: Cochrane team repeatedly requests the full clinical study reports
• 2011: A freedom of information request to the European Medicines Agency provides the Cochrane team with over 20 000 pages from 16 Roche oseltamivir clinical study reports. EMA has no data on zanamivir (the drug was approved at the national regulatory agency level). All but one oseltamivir report was incomplete
• 2012: We publish the interim version of our Cochrane review based on EMA’s incomplete clinical study reports and regulatory comments from the FDA. Our conclusions that there is no evidence the drugs reduce hospital admission and the evidence for or against a possible effect on complications is insufficient are dismissed by the CDC, WHO, and European Centre for Disease Prevention
• February 2012: WHO refuses to answer our questions on the review process that led to the inclusion of oseltamivir on the essential medicines list (www.bmj.com/tamiflu/who)
• February 2012: CDC refuses to answer our requests for clarification on what data its continued promotion of oseltamivir is based on (www.bmj.com/tamiflu/cdc)
• October 2012: BMJ begins publishing Cochrane correspondence with Roche, EMA, CDC, and WHO at bmj.com/tamiflu as part of its Open Data campaign
• 2013: GSK suddenly decides that a contract on data use is no longer necessary to access the zanamivir studies and send the full reports for the 30 trials we requested
• 2013: Roche subsequently releases 77 full clinical study reports of Roche oseltamivir trials
• 2013: Roche begins funding the Multiparty Group for Advice on Science (MUGAS) to reanalyse the oseltamivir dataset
• April 2014: We publish our updated review based solely on full clinical study reports and regulatory documents
Oseltamivir: the real world data
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2371 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2371
這是討論各種研究計畫的設計與實驗結果的關係!.....
To coincide with the publication of an updated systematic review by the Cochrane group the BMJ invited Nick Freemantle and colleagues to consider the current status of observational studies of oseltamivir and their influence on policy and practice..
……………
Influenza is a predictable threat that occurs every year, and people with comorbidities face potentially serious consequences as a result. Requiring or facilitating adequately designed research would be in the public interest, and public funding mechanisms have failed in their duty of care towards patients.
其實Influenza是每年都要流行的,疫苗或抗流感病毒藥物,都是極花錢的,並且製造的大藥廠隱藏了許多不利(harmful , side-effects等)研究報告, 未出刊!!!.........
這是醫師的應具備知識,也是公共議題---讓國人對每年的流感畏懼,也能節省部必要的政府防疫巨額支出!!........
台灣疾管局需要健保費支援,否則財政就倒閉了(?)---防疫經費是政府編列經費支應, 怎可用健保費用(保險費!)支應.……….
viewtopic.php?f=8&t=93620""-----未公開!!!
這期BMJ有兩篇研究文章(Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2545 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2545 ;; Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2547 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2547 )
有關Newraminidase inhibitors—0seltamivir(Timeflu ,Roche co.)與zanamir( Relenza GSK Co.);;兩篇分析(Analysis)文章(--Multisystem failure: the story of anti-influenza drugs
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2263 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2263;;
Oseltamivir: the real world data
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2371 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2371)
;;三篇編輯(Editorial, The missing data that cost $20bn
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2695 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2695 ;; Neuraminidase inhibitors for influenza
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2548 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2548 ;; The Tamiflu trials
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2630 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2630 )
)文章; 等於對Newraminidase Inhibitors 做了總結報告::以下摘錄Analysis文章::
Multisystem failure: the story of anti-influenza drugs
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2263 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2263
Last year (2013年,適逢Jeffson—Cochrance study追蹤Newraminidase inhibitors 六周年)—1. Roche released full clinical study reports for what we believe are close to all of the oseltamivir(Tamiflu) studies it.2. GlaxoSmithKline also released the reports for studies of zanamivir( Relenza ), and we have now published our analysis of them the Cochrane team, with the help of the BMJ’s open data campaign, finally got access to full clinical study reports on neuraminidase inhibitors. Tom Jefferson and Peter Doshi explain what the new systematic review found and how a series of failures meant that decisions about these drugs were made without the full evidence
Story of neuraminidase inhibitors
• Mid-late 1990s: Around 40 Roche sponsored randomised clinical trials of oseltamivir and 25 Glaxo-Wellcome sponsored randomised trials of zanamivir are completed
• July 1999: FDA approves zanamivir for treatment of influenza
• October 1999: FDA approves oseltamivir for treatment of influenza
• November 2000: FDA approves oseltamivir for prophylaxis of influenza
• June 2002: EMA approves oseltamivir for prophylaxis and treatment
• November 2000: FDA tells Roche that its promotional material claiming a 45% reduction in secondary infections is “false or misleading”
• 2003: Kaiser and colleagues’ pooled analysis of 10 randomised clinical trials conducted before licensing in 1999 is published in Archives of Internal Medicine and concludes that oseltamivir reduces the risk of lower respiratory tract infections resulting in antibiotic use (55%; 4.6% v 10.3% for placebo) and hospital admissions (59% 1.7% v 0.7%) in adults aged 13 to 97 years5
• 2004-5: Governments around the world begin stockpiling oseltamivir spurred by fears of avian influenza H5N1
• 2005: UK and US pandemic contingency plans highlight the importance of antivirals in reducing the impact of a pandemic: Both state treatment will reduce hospital admissions by about 50% and decrease mortality, based on the Kaiser analysis2 3
• January 2006: Cochrane review concludes that oseltamivir reduces complications such as pneumonia. The Kaiser 2003 paper drove the result in meta-analysis
• March 2006: FDA approves zanamivir for prophylaxis of influenza
• 2009: Novel A/H1N1 influenza virus discovered to be spreading in North America. In June 2009 WHO declares A/H1N1 influenza a “pandemic”21
• 2009: Australian and UK governments commission rapid update of Cochrane reviews related to influenza
• 2009: Tip from a reader alerts the Cochrane team that only two of the 10 trials in the Kaiser analysis were published
• 2009: We request data from the authors of the Kaiser pooled analysis and the oseltamivir “pivotal” studies.22 23 The authors respond that they do not have the data and refer us to Roche
• December 2009: Unable to (and unwilling to sign a confidentiality agreement with a secrecy clause necessary to) obtain the 10 trials’ raw data, we conclude that we no longer are sure whether oseltamivir reduces complications of influenza.24 A joint investigation by BMJ and Channel 4 News shows that one of the published trials had been ghostwritten and that the largest treatment trial of oseltamivir conducted (M76001) was presented as a conference abstract carrying the name of a professor who did not recollect being involved; it was never published in full15
• December 2009: Roche promises to release full clinical study reports to legitimate investigators “within the coming days.”25 At the end of the month it releases 3195 pages of study report but none are complete
• 2010-2012: Cochrane team repeatedly requests the full clinical study reports
• 2011: A freedom of information request to the European Medicines Agency provides the Cochrane team with over 20 000 pages from 16 Roche oseltamivir clinical study reports. EMA has no data on zanamivir (the drug was approved at the national regulatory agency level). All but one oseltamivir report was incomplete
• 2012: We publish the interim version of our Cochrane review based on EMA’s incomplete clinical study reports and regulatory comments from the FDA. Our conclusions that there is no evidence the drugs reduce hospital admission and the evidence for or against a possible effect on complications is insufficient are dismissed by the CDC, WHO, and European Centre for Disease Prevention
• February 2012: WHO refuses to answer our questions on the review process that led to the inclusion of oseltamivir on the essential medicines list (www.bmj.com/tamiflu/who)
• February 2012: CDC refuses to answer our requests for clarification on what data its continued promotion of oseltamivir is based on (www.bmj.com/tamiflu/cdc)
• October 2012: BMJ begins publishing Cochrane correspondence with Roche, EMA, CDC, and WHO at bmj.com/tamiflu as part of its Open Data campaign
• 2013: GSK suddenly decides that a contract on data use is no longer necessary to access the zanamivir studies and send the full reports for the 30 trials we requested
• 2013: Roche subsequently releases 77 full clinical study reports of Roche oseltamivir trials
• 2013: Roche begins funding the Multiparty Group for Advice on Science (MUGAS) to reanalyse the oseltamivir dataset
• April 2014: We publish our updated review based solely on full clinical study reports and regulatory documents
Oseltamivir: the real world data
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2371 (Published 10 April 2014)
Cite this as: BMJ 2014;348:g2371
這是討論各種研究計畫的設計與實驗結果的關係!.....
To coincide with the publication of an updated systematic review by the Cochrane group the BMJ invited Nick Freemantle and colleagues to consider the current status of observational studies of oseltamivir and their influence on policy and practice..
……………
Influenza is a predictable threat that occurs every year, and people with comorbidities face potentially serious consequences as a result. Requiring or facilitating adequately designed research would be in the public interest, and public funding mechanisms have failed in their duty of care towards patients.
其實Influenza是每年都要流行的,疫苗或抗流感病毒藥物,都是極花錢的,並且製造的大藥廠隱藏了許多不利(harmful , side-effects等)研究報告, 未出刊!!!.........
這是醫師的應具備知識,也是公共議題---讓國人對每年的流感畏懼,也能節省部必要的政府防疫巨額支出!!........
台灣疾管局需要健保費支援,否則財政就倒閉了(?)---防疫經費是政府編列經費支應, 怎可用健保費用(保險費!)支應.……….
