請先參考99-8-17本網站個人呈衛生署文--降血糖藥-梵蒂雅
由於衛生署連分類與用藥都似乎誤解本人意思,故再未答覆,以生誤解,因今天諾美婷事件,個人在此說名糖尿病為甚麼沒有第二線或最後一線用藥,當然與糖尿病分類有關,特說明如下:(也會呈衛生署參考)
糖尿病分類目前是胰島素依賴型(以前的第一型糖尿病)與非胰島素依賴型(第二型糖尿病),胰島素依賴型顧名思義就是血糖升高是身體胰島素缺乏所造成的,非胰島素依賴型指的是血糖升高釋胰島素作用變差了,也就是胰島素抗拒,早期臨床表現是高胰島素血症,飯前血糖升高與胰島素抗拒,所以才會從胰島素發明後,因胰島素對心血管會造成傷害,故又回頭使用與開發口服降糖藥:;,等糖尿病進入後期,普遍胰島分泌胰島素衰竭,成為胰島素缺乏,那就只有用胰島素控制了,所以沒報載第二線或貴署最後一線用藥.
其實在開發所謂胰島素增敏藥物時--梵蒂雅前,就知道胰島素會有刺激Catecholamin的作用--血管收縮與體液滯留問題
蒂帆雅就在1999年上市了,主要藥廠(Glaxo 美國公司)所作研究追蹤根據糖化血色素(HgbA1c)降低1%,當然也隱匿了雖然血糖控治好了,但心血管疾病發生風險上昇了(即可能美國FDA有幫助隱匿之嫌),2008年底對於到底嚴格控制血糖能否降低心血管疾病(?)有了大型研究計畫結果出爐(美國衛生研究院五年計畫,作了三年就停止了,因為結果已顯示致死性新肌梗塞增加了),當然糖化血色素(HgbA1c)是否是好的糖尿病控制指標的文章也在這些年紛紛出現,至少糖尿病控制指標--HgbA1c從6-6.5%放寬到7甚至7.5%
今年八月新英格蘭雜誌(NEJM:Revisiting Rosiglitazone Story--Lessons learned 2010:363.803-6)作者(Dr. Rosen C.J.)就是當初2007年七月美國FDA 專家會議主持人,文中提到自2007年專家會議後,到今年七月專家會議有十篇新的實驗計畫都顯示梵蒂雅會增加心肌梗塞風險(30-80%),文章作者結論為退出市場吧!
有關新藥上市後才來做藥物副作用的研究是否適當,成為討論的焦點,因為這是醫學倫理極嚴重與嚴肅的課題,梵蒂雅 諾美婷 與降血脂藥,藥廠當然不樂於見到,影響新藥上市至少十年;我們在SARS與H1N1流行期間,克流感(美國藥廠)都是相同問題,隱匿或刮大其效用
衛生署請小心,醫生是當醫生前需認同醫師誓言,與受道赫爾辛基與伊斯坦堡宣言所制約的,公衛專家或藥廠並沒這約束--當然如果是醫師還是要小心的
台灣健保許多制度的改變都可能違反了醫師誓言規範,尤其是不尊重(侵犯)醫師專業
P.S.:1.Rosiglitazone:a cautionary tale;Godlee F.:BMJ 2010341:c4896
2.Licensing drugs for diabetes;Lehman R.:BMJ2010;341:c4805
3. 我的前輩告訴我說:現代醫師不可沒有政治關與經濟關
4.有用過梵蒂雅的前輩們,還是先看一下病歷記載,台灣病人是習慣告醫師的--容易,美國是告藥廠與國家--賠償金額極大;;前輩們!同意嗎?ˋ
從諾美婷下市,談梵蒂雅
Re: 從諾美婷下市,談梵蒂雅
李誠民 寫:請先參考99-8-17本網站個人呈衛生署文--降血糖藥-梵蒂雅
由於衛生署連分類與用藥都似乎誤解本人意思,故再未答覆,以生誤解,因今天諾美婷事件,個人在此說名糖尿病為甚麼沒有第二線或最後一線用藥,當然與糖尿病分類有關,特說明如下:(也會呈衛生署參考)
糖尿病分類目前是胰島素依賴型(以前的第一型糖尿病)與非胰島素依賴型(第二型糖尿病),胰島素依賴型顧名思義就是血糖升高是身體胰島素缺乏所造成的,非胰島素依賴型指的是血糖升高釋胰島素作用變差了,也就是胰島素抗拒,早期臨床表現是高胰島素血症,飯前血糖升高與胰島素抗拒,所以才會從胰島素發明後,因胰島素對心血管會造成傷害,故又回頭使用與開發口服降糖藥:;,等糖尿病進入後期,普遍胰島分泌胰島素衰竭,成為胰島素缺乏,那就只有用胰島素控制了,所以沒報載第二線或貴署最後一線用藥.
其實在開發所謂胰島素增敏藥物時--梵蒂雅前,就知道胰島素會有刺激Catecholamin的作用--血管收縮與體液滯留問題
蒂帆雅就在1999年上市了,主要藥廠(Glaxo 美國公司)所作研究追蹤根據糖化血色素(HgbA1c)降低1%,當然也隱匿了雖然血糖控治好了,但心血管疾病發生風險上昇了(即可能美國FDA有幫助隱匿之嫌),2008年底對於到底嚴格控制血糖能否降低心血管疾病(?)有了大型研究計畫結果出爐(美國衛生研究院五年計畫,作了三年就停止了,因為結果已顯示致死性新肌梗塞增加了),當然糖化血色素(HgbA1c)是否是好的糖尿病控制指標的文章也在這些年紛紛出現,至少糖尿病控制指標--HgbA1c從6-6.5%放寬到7甚至7.5%
今年八月新英格蘭雜誌(NEJM:Revisiting Rosiglitazone Story--Lessons learned 2010:363.803-6)作者(Dr. Rosen C.J.)就是當初2007年七月美國FDA 專家會議主持人,文中提到自2007年專家會議後,到今年七月專家會議有十篇新的實驗計畫都顯示梵蒂雅會增加心肌梗塞風險(30-80%),文章作者結論為退出市場吧!
有關新藥上市後才來做藥物副作用的研究是否適當,成為討論的焦點,因為這是醫學倫理極嚴重與嚴肅的課題,梵蒂雅 諾美婷 與降血脂藥,藥廠當然不樂於見到,影響新藥上市至少十年;我們在SARS與H1N1流行期間,克流感(美國藥廠)都是相同問題,隱匿或刮大其效用
衛生署請小心,醫生是當醫生前需認同醫師誓言,與受道赫爾辛基與伊斯坦堡宣言所制約的,公衛專家或藥廠並沒這約束--當然如果是醫師還是要小心的
台灣健保許多制度的改變都可能違反了醫師誓言規範,尤其是不尊重(侵犯)醫師專業
P.S.:1.Rosiglitazone:a cautionary tale;Godlee F.:BMJ 2010341:c4896
2.Licensing drugs for diabetes;Lehman R.:BMJ2010;341:c4805
3. 我的前輩告訴我說:現代醫師不可沒有政治關與經濟關
4.有用過梵蒂雅的前輩們,還是先看一下病歷記載,台灣病人是習慣告醫師的--容易,美國是告藥廠與國家--賠償金額極大;;前輩們!同意嗎?ˋ
avandia對心血管的影響和血糖的的控制到底好還壞?如果不好，我相信actos也應該一樣，不可能兩個一樣的藥對心血管的影響不一樣，而且Nissan先生的研究贊助者與ACTOS藥廠有關，讓人有不同的聯想
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MK
- 院長級
- 文章: 21964
- 註冊時間: 週三 9月 26, 2007 1:47 pm
- 來自: HPLP部
Re: 從諾美婷下市,談梵蒂雅
http://jama.ama-assn.org/cgi/content/abstract/304/4/411cchic 寫: avandia對心血管的影響和血糖的的控制到底好還壞?如果不好，我相信actos也應該一樣，不可能兩個一樣的藥對心血管的影響不一樣
http://jama.ama-assn.org/cgi/content/ab ... 2010.920v2
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李誠民
- 註冊會員
- 文章: 1467
- 註冊時間: 週三 6月 23, 2010 10:18 am
Re: 從諾美婷下市,談梵蒂雅
謝謝您的指教!我從沒使用過這兩種藥;Avandia是GSK在美生產,Actos為GSK與日本武田共同在日本生產,當初上市兩藥互有攻訐,某藥在心血管與心臟功能副作用優於某藥,雖然我不是專家,但覺得是有問題的,GSK在美 在日分別上市,關住至今,您如果有疑問可上網,網上文章一大堆
如有錯誤,請不吝指正!
如有錯誤,請不吝指正!
-
李誠民
- 註冊會員
- 文章: 1467
- 註冊時間: 週三 6月 23, 2010 10:18 am
Re: 從諾美婷下市,談梵蒂雅
摘錄自BMJ 2010:341:c4848 文 不知能否解答您的指正:
.....
Where next for diabetes drugs?
While the focus has been firmly on rosiglitazone, what about pioglitazone? Its manufacturer Takeda had benefited from the controversy of rosiglitazone. But like rosiglitazone, pioglitazone is associated with an increased risk of oedema, heart failure, and bone fracture.23
As Professor Van Belle said, he doesn’t want to be sitting at an FDA advisory meeting in three years’ time discussing pioglitazone. Professor Gale is also concerned. In a letter to the UK regulator in 2008 seen by the BMJ, he wrote that...... “there is an urgent need to determine the safety of pioglitazone”....
...“Pioglitazone may or may not prove to be safer than rosiglitazone. There is an urgent need for more and better data addressing this issue. On present evidence, its safety cannot and should not be assumed,” he wrote. Takeda say that they continuously monitor the safety and efficacy of their compounds. ....
Meanwhile other anti-diabetic drugs using a similar pathway are in development: the chequered history of the glitazones not having deterred manufacturers. According to reports, Dr Reddy’s Laboratories and Nordic Bioscience’s partial PPAR-gamma agonist balaglitazone met its primary endpoint in its first phase III trial in patients with type 2 diabetes (reduction in glycated haemoglobin). It was claimed to be “non-inferior” to pioglitazone. The companies are currently in discussions with regulators and hope to eventually file the drug in the European Union and the United States.24 And both Roche and Metabolex have drugs in phase two trials.25
Will regulators, industry, and the clinical community do a better job for patients next time?
....1997
Troglitazone withdrawn from UK market after six weeks because of hepatotoxicity.....
1999
April: American Diabetes Association declares that the drug’s properties are not shared by any others, offering new options to healthcare professionals
May: Rosiglitazone approved as monotherapy by FDA with label precautions for use in patients with heart failure
September: European Association for the study of Diabetes heard that rosiglitazone would be useful as a first line therapy
October: Rosiglitazone turned down by EMA by 14 of 25 votes
....2000
March: Troglitazone withdrawn in United States....
July: Rosiglitazone given market authorisation in Europe with restrictions and with warnings on heart failure. GlaxoSmithKline (GSK, then SmithKline Beecham) is asked to conduct two post-marketing trials: one study to look at effect on cardiovascular structure; the other to assess cardiovascular safety—the RECORD trial.
October: Pioglitazone approved in Europe
2001
February: FDA approve new warnings on potential for heart failure
2004
With an increasing number of people taking rosiglitazone, World Health Organization picks up safety signals and alerts GSK
June: GSK ordered to publish summaries of results of all its clinical trials on its website once a product has been launched in a settlement in New York
....2005
September: Internal GSK meta-analysis finds 29% non-significant increased risk of ischaemic cardiovascular events.....
2006
February: FDA approves Avandaryl (rosiglitazone maleate and glimepiride)
April: FDA approves new warnings on risks of cardiovascular events
....May: Internal GSK meta-analysis finds 31% increase in ischaemic events.....
June: EMA approves Avaglim (rosiglitazone maleate and glimepiride)
....2007
May: New England Journal of Medicine publishes meta-analysis reporting 43% increased risk of myocardial infarction ...
June: NEJM publishes interim analysis of the RECORD trial
....July: FDA advisory committee finds increased cardiac ischaemic risk but votes to keep drug on market....
October: European Medicines Evaluation Agency asserts positive benefit-risk profile, recommends new warnings for patients with ischaemic heart disease
....November: FDA approves new boxed warnings that drug may increase myocardial ischaemic events, including myocardial infarction, though evidence “inconclusive”...
December: UK Medicine and Healthcare products Regulatory Agency warns drug might be associated with small increased risk of cardiac ischaemia
2008
Updated internal GSK analysis finds no risk of myocardial infarction or other major cardiovascular events
2009
March: International Journal of Cardiology meta-analysis finds no risk of myocardial infarction
June: RECORD trial published in the Lancet. EMA add a statement to their scientific information document saying there was no difference in the number of adjudicated primary endpoints between the arms of the study.
....2010
February: US Senate finance committee releases report that includes internal FDA safety report calling for drug to be withdrawn...
February: GSK responds with 30 page document
June: David Graham’s study leaked to the Pharmalot blog. It is published in JAMA regardless. At the same time, another JAMA journal, Archives of Internal Medicine, publishes an updated meta-analysis by Steve Nissen
13-14 July: FDA advisory committee meeting held. FDA drug approver gives damning verdict on the RECORD trial. Majority of committee vote either to withdraw the drug or restrict it severely
....15 July MHRA meet. Commission on Human Medicines vote to withdraw rosiglitazone.....
....TIDE trial suspended by the FDA...
19-22 July: EMA meet to discuss rosiglitazone
26 July: the MHRA send out “dear doctor” letter advising doctors to consider alternative treatments where appropriate
September: EMA will finalise its review
x:EMA:European Medicines Agency
x:MHRA:Medicines and Healthcare prodoct Regulatory Agency (UK)
Rosglitazone 是Glaxo第二大暢銷藥,每年約有三十億美元銷售額
BMJ2010;341:c5333:inciders criticise FDA's decision not to withdraw rosiglitazone:
......
David Graham, associate director for science and medicine at the FDA’s Office of Surveillance and Epidemiology, was critical of the FDA’s response. “The FDA decision was disappointing, was not in the best interests of patient safety and public health, was not evidence based, and was inherently self contradictory
.....
Where next for diabetes drugs?
While the focus has been firmly on rosiglitazone, what about pioglitazone? Its manufacturer Takeda had benefited from the controversy of rosiglitazone. But like rosiglitazone, pioglitazone is associated with an increased risk of oedema, heart failure, and bone fracture.23
As Professor Van Belle said, he doesn’t want to be sitting at an FDA advisory meeting in three years’ time discussing pioglitazone. Professor Gale is also concerned. In a letter to the UK regulator in 2008 seen by the BMJ, he wrote that...... “there is an urgent need to determine the safety of pioglitazone”....
...“Pioglitazone may or may not prove to be safer than rosiglitazone. There is an urgent need for more and better data addressing this issue. On present evidence, its safety cannot and should not be assumed,” he wrote. Takeda say that they continuously monitor the safety and efficacy of their compounds. ....
Meanwhile other anti-diabetic drugs using a similar pathway are in development: the chequered history of the glitazones not having deterred manufacturers. According to reports, Dr Reddy’s Laboratories and Nordic Bioscience’s partial PPAR-gamma agonist balaglitazone met its primary endpoint in its first phase III trial in patients with type 2 diabetes (reduction in glycated haemoglobin). It was claimed to be “non-inferior” to pioglitazone. The companies are currently in discussions with regulators and hope to eventually file the drug in the European Union and the United States.24 And both Roche and Metabolex have drugs in phase two trials.25
Will regulators, industry, and the clinical community do a better job for patients next time?
....1997
Troglitazone withdrawn from UK market after six weeks because of hepatotoxicity.....
1999
April: American Diabetes Association declares that the drug’s properties are not shared by any others, offering new options to healthcare professionals
May: Rosiglitazone approved as monotherapy by FDA with label precautions for use in patients with heart failure
September: European Association for the study of Diabetes heard that rosiglitazone would be useful as a first line therapy
October: Rosiglitazone turned down by EMA by 14 of 25 votes
....2000
March: Troglitazone withdrawn in United States....
July: Rosiglitazone given market authorisation in Europe with restrictions and with warnings on heart failure. GlaxoSmithKline (GSK, then SmithKline Beecham) is asked to conduct two post-marketing trials: one study to look at effect on cardiovascular structure; the other to assess cardiovascular safety—the RECORD trial.
October: Pioglitazone approved in Europe
2001
February: FDA approve new warnings on potential for heart failure
2004
With an increasing number of people taking rosiglitazone, World Health Organization picks up safety signals and alerts GSK
June: GSK ordered to publish summaries of results of all its clinical trials on its website once a product has been launched in a settlement in New York
....2005
September: Internal GSK meta-analysis finds 29% non-significant increased risk of ischaemic cardiovascular events.....
2006
February: FDA approves Avandaryl (rosiglitazone maleate and glimepiride)
April: FDA approves new warnings on risks of cardiovascular events
....May: Internal GSK meta-analysis finds 31% increase in ischaemic events.....
June: EMA approves Avaglim (rosiglitazone maleate and glimepiride)
....2007
May: New England Journal of Medicine publishes meta-analysis reporting 43% increased risk of myocardial infarction ...
June: NEJM publishes interim analysis of the RECORD trial
....July: FDA advisory committee finds increased cardiac ischaemic risk but votes to keep drug on market....
October: European Medicines Evaluation Agency asserts positive benefit-risk profile, recommends new warnings for patients with ischaemic heart disease
....November: FDA approves new boxed warnings that drug may increase myocardial ischaemic events, including myocardial infarction, though evidence “inconclusive”...
December: UK Medicine and Healthcare products Regulatory Agency warns drug might be associated with small increased risk of cardiac ischaemia
2008
Updated internal GSK analysis finds no risk of myocardial infarction or other major cardiovascular events
2009
March: International Journal of Cardiology meta-analysis finds no risk of myocardial infarction
June: RECORD trial published in the Lancet. EMA add a statement to their scientific information document saying there was no difference in the number of adjudicated primary endpoints between the arms of the study.
....2010
February: US Senate finance committee releases report that includes internal FDA safety report calling for drug to be withdrawn...
February: GSK responds with 30 page document
June: David Graham’s study leaked to the Pharmalot blog. It is published in JAMA regardless. At the same time, another JAMA journal, Archives of Internal Medicine, publishes an updated meta-analysis by Steve Nissen
13-14 July: FDA advisory committee meeting held. FDA drug approver gives damning verdict on the RECORD trial. Majority of committee vote either to withdraw the drug or restrict it severely
....15 July MHRA meet. Commission on Human Medicines vote to withdraw rosiglitazone.....
....TIDE trial suspended by the FDA...
19-22 July: EMA meet to discuss rosiglitazone
26 July: the MHRA send out “dear doctor” letter advising doctors to consider alternative treatments where appropriate
September: EMA will finalise its review
x:EMA:European Medicines Agency
x:MHRA:Medicines and Healthcare prodoct Regulatory Agency (UK)
Rosglitazone 是Glaxo第二大暢銷藥,每年約有三十億美元銷售額
BMJ2010;341:c5333:inciders criticise FDA's decision not to withdraw rosiglitazone:
......
David Graham, associate director for science and medicine at the FDA’s Office of Surveillance and Epidemiology, was critical of the FDA’s response. “The FDA decision was disappointing, was not in the best interests of patient safety and public health, was not evidence based, and was inherently self contradictory
-
李誠民
- 註冊會員
- 文章: 1467
- 註冊時間: 週三 6月 23, 2010 10:18 am
Re: 從諾美婷下市,談梵蒂雅
很抱歉!Actos(pioglitazone)是Lilly co.與武田共同生產的PPARG(TZD)降血糖藥,;控制血糖目的就是減少血管損害,減少心血管疾病與腦中風發生,就如同1970年代控制血壓的 Framgminham study 一樣,所以開發了 ACEI Ca. blockade B1 inhibitor...;
所以Rsoiglitazone會增加30-80%急性心肌梗塞風險,降血糖的目的就不知為何了?
況且ACCORD study顯示嚴格控制血糖,低血糖的機率增加了,致死性心血管疾病風險也增加了,HgbA1c指標值也放寬了--7-7.5%
p.s.:目前也有許多文章探討HgbA1c是否是血糖控制良好的指標?
請指正!
所以Rsoiglitazone會增加30-80%急性心肌梗塞風險,降血糖的目的就不知為何了?
況且ACCORD study顯示嚴格控制血糖,低血糖的機率增加了,致死性心血管疾病風險也增加了,HgbA1c指標值也放寬了--7-7.5%
p.s.:目前也有許多文章探討HgbA1c是否是血糖控制良好的指標?
請指正!
-
李誠民
- 註冊會員
- 文章: 1467
- 註冊時間: 週三 6月 23, 2010 10:18 am
Re: 從諾美婷下市,談梵蒂雅
2010/10/25 回覆 李先生：您好！所傳郵件，業已收悉。 1.經本署再評估含rosiglitazone成分藥品之風險與臨床效益後，有關avandia的再評估結果已於99年10月14日以署授食字第0991412652號公告並回覆台端在案。 2.美國FDA評估結果與本署相似，相關資料及文獻台端可至網站(http://www.fda.gov/Safety/MedWatch/default.htm)自行下載參閱。感謝您的來信，祝您健康、快樂！行政院衛生署 敬復
以下為個人在 本網站讀者對Avendia&actos提出質疑,個人也已經說明我不是這領域專家,但正好有閱讀到BMJ2010;341:c4848文章,文章重點式既然Rosiglitazone(Avendia)如此多,英國已下架,Pioglitazone(Actos) 同屬(TZD PPARG)藥物,更應急迫設計臨床藥物研究,避免Avendia的覆策,故個人才就教於衛生署,回復如上,有答覆個人的問題嗎?
如有興趣的人也可上衛生署提供網址看看有答案嗎? (至少我還較用功的節錄文章)
這是個人在醫聲論壇網站讀者的問題:; avandia對心血管的影響和血糖的的控制到底好還壞?如果不好，我相信actos也應該一樣，不可能兩個一樣的藥對心血管的影響不一樣，而且Nissan先生的研究贊助者與ACTOS藥廠有關，讓人有不同的聯想 謝謝您的指教!我從沒使用過這兩種藥;Avandia是GSK在美生產,Actos為GSK與日本武田共同在日本生產,當初上市兩藥互有攻訐,某藥在心血管與心臟功能副作用優於某藥,雖然我不是專家,但覺得是有問題的,GSK在美 在日分別上市,關住至今,您如果有疑問可上網,網上文章一大堆如有錯誤,請不吝指正! 李誠民 文章主題 : Re: 從諾美婷下市,談梵蒂雅發表於 : 週二 10月 19, 2010 9:07 pm 5 Intern 註冊時間: 週三 6月 23, 2010 10:18 am 文章: 27 摘錄自BMJ 2010:341:c4848 文 不知能否解答您的指正: ..... ............
李誠民 文章主題 : Re: 從諾美婷下市,談梵蒂雅發表於 : 週二 10月 19, 2010 9:35 pm 6 Intern 註冊時間: 週三 6月 23, 2010 10:18 am 文章: 27 很抱歉!Actos(pioglitazone)是Lilly co.與武田共同生產的PPARG(TZD)降血糖藥,;控制血糖目的就是減少血管損害,減少心血管疾病與腦中風發生,就如同1970年代控制血壓的 Framgminham study 一樣,所以開發了 ACEI Ca. blockade B1 inhibitor...; 所以Rsoiglitazone會增加30-80%急性心肌梗塞風險,降血糖的目的就不知為何了? 況且ACCORD study顯示嚴格控制血糖,低血糖的機率增加了,致死性心血管疾病風險也增加了,HgbA1c指標值也放寬了--7-7.5% p.s.:目前也有許多文章探討HgbA1c是否是血糖控制良好的指標? 請指正!
再次就教衛生署如下:
1.Avendia自1999黏上市以來就爭議不斷,直至2005年仍宣稱非重要的增加缺血性事件的發生(non-significant increased risk of ischemic cardiovascular events 29%),至2007年六月新英格蘭雜誌(NEMJ)刊出RECORD 藥物試用報告,直指Avendia有增加心血管疾病風險後,迫使美國FDA不得不在七月召開專家會議,如果建議下架與不表示意見與棄權的專家加總起來,Avendia是應下架的,
2010年美國參院財政委員會報告(包括FDA內部安全報告)此藥應退出市場,也才有今年七月美國第二次的專家會議,如果不是關係藥廠與美國龐大利益,有必要嗎?
當然接著是Actos,另外還有兩種同類要進入藥物試驗第二期(二種),一種進入第三期,Avendia下市,不但關係著美國內龐大訴訟賠償問題,更關係美國藥廠巨大利益,我們拭目以待吧!
美國FDA近十年來,已有許多隱瞞或配合藥廠的不實藥物研究記錄,中華民國衛生署不需警惕嗎?!
2. 糖尿病分類目前還是第一型與第二型嗎?是否應為非胰島素依賴型與胰島素依賴型?
3.自99-7-20初次因蘋果日報A20版刊載貴署發佈之新聞:梵蒂雅暫不下架...個人因引述報載梵蒂雅經貴署列為第二線糖尿病藥,貴署指正是本人誤解,梵蒂雅是最後一線糖尿病藥,請問貴署糖尿病藥有第一 第二 或最後線藥之分嗎?
反倒是醫生網站的基層醫師發問,按健保局規定部分糖尿病患者因其他口服降糖藥反應不佳,使用梵蒂雅卻遭刪除給付,合理嗎?貴屬聲稱要健全基層醫療,貴署與健保局如此作為,能讓有心從事基層的醫師有作唯嗎?糖尿病不試典型慢性病嗎?為什麼醫學中心一個門診會有一 兩百患者?
以下為個人在 本網站讀者對Avendia&actos提出質疑,個人也已經說明我不是這領域專家,但正好有閱讀到BMJ2010;341:c4848文章,文章重點式既然Rosiglitazone(Avendia)如此多,英國已下架,Pioglitazone(Actos) 同屬(TZD PPARG)藥物,更應急迫設計臨床藥物研究,避免Avendia的覆策,故個人才就教於衛生署,回復如上,有答覆個人的問題嗎?
如有興趣的人也可上衛生署提供網址看看有答案嗎? (至少我還較用功的節錄文章)
這是個人在醫聲論壇網站讀者的問題:; avandia對心血管的影響和血糖的的控制到底好還壞?如果不好，我相信actos也應該一樣，不可能兩個一樣的藥對心血管的影響不一樣，而且Nissan先生的研究贊助者與ACTOS藥廠有關，讓人有不同的聯想 謝謝您的指教!我從沒使用過這兩種藥;Avandia是GSK在美生產,Actos為GSK與日本武田共同在日本生產,當初上市兩藥互有攻訐,某藥在心血管與心臟功能副作用優於某藥,雖然我不是專家,但覺得是有問題的,GSK在美 在日分別上市,關住至今,您如果有疑問可上網,網上文章一大堆如有錯誤,請不吝指正! 李誠民 文章主題 : Re: 從諾美婷下市,談梵蒂雅發表於 : 週二 10月 19, 2010 9:07 pm 5 Intern 註冊時間: 週三 6月 23, 2010 10:18 am 文章: 27 摘錄自BMJ 2010:341:c4848 文 不知能否解答您的指正: ..... ............
李誠民 文章主題 : Re: 從諾美婷下市,談梵蒂雅發表於 : 週二 10月 19, 2010 9:35 pm 6 Intern 註冊時間: 週三 6月 23, 2010 10:18 am 文章: 27 很抱歉!Actos(pioglitazone)是Lilly co.與武田共同生產的PPARG(TZD)降血糖藥,;控制血糖目的就是減少血管損害,減少心血管疾病與腦中風發生,就如同1970年代控制血壓的 Framgminham study 一樣,所以開發了 ACEI Ca. blockade B1 inhibitor...; 所以Rsoiglitazone會增加30-80%急性心肌梗塞風險,降血糖的目的就不知為何了? 況且ACCORD study顯示嚴格控制血糖,低血糖的機率增加了,致死性心血管疾病風險也增加了,HgbA1c指標值也放寬了--7-7.5% p.s.:目前也有許多文章探討HgbA1c是否是血糖控制良好的指標? 請指正!
再次就教衛生署如下:
1.Avendia自1999黏上市以來就爭議不斷,直至2005年仍宣稱非重要的增加缺血性事件的發生(non-significant increased risk of ischemic cardiovascular events 29%),至2007年六月新英格蘭雜誌(NEMJ)刊出RECORD 藥物試用報告,直指Avendia有增加心血管疾病風險後,迫使美國FDA不得不在七月召開專家會議,如果建議下架與不表示意見與棄權的專家加總起來,Avendia是應下架的,
2010年美國參院財政委員會報告(包括FDA內部安全報告)此藥應退出市場,也才有今年七月美國第二次的專家會議,如果不是關係藥廠與美國龐大利益,有必要嗎?
當然接著是Actos,另外還有兩種同類要進入藥物試驗第二期(二種),一種進入第三期,Avendia下市,不但關係著美國內龐大訴訟賠償問題,更關係美國藥廠巨大利益,我們拭目以待吧!
美國FDA近十年來,已有許多隱瞞或配合藥廠的不實藥物研究記錄,中華民國衛生署不需警惕嗎?!
2. 糖尿病分類目前還是第一型與第二型嗎?是否應為非胰島素依賴型與胰島素依賴型?
3.自99-7-20初次因蘋果日報A20版刊載貴署發佈之新聞:梵蒂雅暫不下架...個人因引述報載梵蒂雅經貴署列為第二線糖尿病藥,貴署指正是本人誤解,梵蒂雅是最後一線糖尿病藥,請問貴署糖尿病藥有第一 第二 或最後線藥之分嗎?
反倒是醫生網站的基層醫師發問,按健保局規定部分糖尿病患者因其他口服降糖藥反應不佳,使用梵蒂雅卻遭刪除給付,合理嗎?貴屬聲稱要健全基層醫療,貴署與健保局如此作為,能讓有心從事基層的醫師有作唯嗎?糖尿病不試典型慢性病嗎?為什麼醫學中心一個門診會有一 兩百患者?
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李誠民
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Re: 從諾美婷下市,談梵蒂雅
今日(99-11-1)蘋果日報A13版刊登--服糖尿病藥 先簽同意書一文,不知世界上有哪個醫療先進國家服用上市處方藥需簽同意書的?.就教各前輩!!
我在99-7-20接獲衛生署答覆文,因為衛生署指正梵蒂雅為糖尿病最後一線藥(並非第二線藥物),我就猜想衛生署的答覆是官樣文章,;我們知道抗生素有第一 第二 第三線用藥之分,主要有抗藥性的考慮,糖尿病有第一 第二(蘋果日報轉載衛生署文)或最後一線(衛生署指正覆文)之分嗎?我個人是覺得遭污辱的,僅回文而已,但衛生署非常不禮貌的未有所回覆
最近一次針對梵蒂雅再次請衛生署釋疑,衛生署回函提到對梵蒂雅會有更嚴格管控,--要求廠商需一個月內提出風險管控計畫書,不知衛生署會如此無知,---"應包括讓患者在風險評估表上簽同意書",;已上市處方藥物有哪國有如此作的?只有臨床新藥進入第三期(人體實驗) 才有吧?
我曾經在衛生署詢問文中提到,Dr.Rosen C.J.(2007-7-11 FDA專家會議主持人) 今年八月登載於NEJM(Revisiting th3 Rosiglitazone Story--Lessons Leared:2010;363:803-806),他針對今年七月美國FDA專家會議後結論提出他看法--"....theFDA must consider only two choices：either stroger warnings plus the use of informed consent and a registry for compassionate use of rosiglitazone or remoal of the drug from the marked."
我想Dr. Rosen 或FDA 不會沒知識到;上市藥物需使用者簽同意書才能使用,如果如此是世界已上市藥物創舉,同時也承認Glaxo藥廠對rosiglitazone 是post-market 才作負作用藥物的臨床實驗室極其不當的,;Dr. Rosen 只是含蓄的提出決論,他對FDA的建議就是rosiglitazone只有退出市場一途,各位前輩可指證個人的英文能力嗎?(或誤解原意)
台灣代理商本來就沒能力提出風險管控計畫,台灣衛生署會作出如此無知決定,一定是台灣Glaxo藥商請示原廠的結果,中華民國衛生署不要傻了,基層醫師不見得比台灣專家知識差,只是您衛生署的作為,讓基層醫師冷默不關心而以.
我在99-7-20接獲衛生署答覆文,因為衛生署指正梵蒂雅為糖尿病最後一線藥(並非第二線藥物),我就猜想衛生署的答覆是官樣文章,;我們知道抗生素有第一 第二 第三線用藥之分,主要有抗藥性的考慮,糖尿病有第一 第二(蘋果日報轉載衛生署文)或最後一線(衛生署指正覆文)之分嗎?我個人是覺得遭污辱的,僅回文而已,但衛生署非常不禮貌的未有所回覆
最近一次針對梵蒂雅再次請衛生署釋疑,衛生署回函提到對梵蒂雅會有更嚴格管控,--要求廠商需一個月內提出風險管控計畫書,不知衛生署會如此無知,---"應包括讓患者在風險評估表上簽同意書",;已上市處方藥物有哪國有如此作的?只有臨床新藥進入第三期(人體實驗) 才有吧?
我曾經在衛生署詢問文中提到,Dr.Rosen C.J.(2007-7-11 FDA專家會議主持人) 今年八月登載於NEJM(Revisiting th3 Rosiglitazone Story--Lessons Leared:2010;363:803-806),他針對今年七月美國FDA專家會議後結論提出他看法--"....theFDA must consider only two choices：either stroger warnings plus the use of informed consent and a registry for compassionate use of rosiglitazone or remoal of the drug from the marked."
我想Dr. Rosen 或FDA 不會沒知識到;上市藥物需使用者簽同意書才能使用,如果如此是世界已上市藥物創舉,同時也承認Glaxo藥廠對rosiglitazone 是post-market 才作負作用藥物的臨床實驗室極其不當的,;Dr. Rosen 只是含蓄的提出決論,他對FDA的建議就是rosiglitazone只有退出市場一途,各位前輩可指證個人的英文能力嗎?(或誤解原意)
台灣代理商本來就沒能力提出風險管控計畫,台灣衛生署會作出如此無知決定,一定是台灣Glaxo藥商請示原廠的結果,中華民國衛生署不要傻了,基層醫師不見得比台灣專家知識差,只是您衛生署的作為,讓基層醫師冷默不關心而以.