Did FDA Know Of Avandia Dangers In 2002?
Advocacy Group: Diabetes Drug's Problems Were Revealed Long Before Recent Study
(CBS/AP) The consumer advocacy organization Public Citizen claims that the Food and Drug Administration knew about problems associated with the diabetes drug Avandia for nearly five years.
Avandia is linked to a greater risk of heart attack and possibly death, reported a new scientific analysis published online Monday. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death, according to the review published by the New England Journal.
Public Citizen sent a letter to the FDA complaining that an internal FDA memo from 2002 indicates that FDA scientists recommended labels for Avandia and Actos, another common diabetes drug, be changed to include a warning that there had been reports of heart failure for patients using the drugs. The group claims that despite the memo, the labels have not been changed.
“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen in a news release. “As a result, millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.”
The group has called on the FDA to either ban the drugs or include black-box warnings on their labels.
Meanwhile, across the country, people who are taking Avandia are trying to figure out what to do. The American Diabetes Association has fielded 70 calls from patients since Monday's report in the New England Journal of Medicine that Avandia is linked to a significantly higher risk of heart attack and possibly death.
Pat Russo is one of them. She has been taking Avandia for three years, but on Tuesday phoned her doctor when she read news reports that it might raise the risk of heart attack.
“We're taking a wait-and-see approach,” said the 60-year-old business manager from Pennsylvania.
For now, Russo's doctor has advised her to stay on the medicine. And she has a checkup scheduled in a few weeks.
Avandia’s maker, British-based GlaxoSmithKline PLC, contends the drug is safe and that more rigorous studies did not confirm a higher heart attack risk. Most experts say the actual risk to any single patient does appear to be small but that more studies are needed.
The suggestion of a greater heart risk is especially troubling, though, because two-thirds of diabetics die of heart problems.
More than 6 million people worldwide have taken Avandia since it came on the market in 1999 to treat Type 2, the most common form of diabetes and the one linked with obesity.
About 1 million Americans are currently taking Avandia, which sells between $90 and $170 for a one-month supply. Its U.S. sales topped $2.2 billion last year.
The Gonda Diabetes Center at the University of California, Los Angeles has answered at least 10 calls and individual doctors have received scores of e-mails from patients.
Dr. Andrew Drexler, the center's medical director, routinely prescribes Avandia to his patients and has seen their blood sugar levels stabilize. But Drexler said he will be more cautious about prescribing the drug in light of the potential heart risks raised in the New England Journal analysis co-authored by Cleveland cardiologist Dr. Steven Nissen.
“There's definitely concern and confusion,” Drexler said. “We need more information.”
On Monday, the American Diabetes Association and two influential heart groups jointly released a statement advising diabetics to talk to their doctors before stopping any medication. The Food and Drug Administration issued a safety alert about the potential risks but did not ask for a recall because of ongoing studies that suggest a contradictory effect.
That has left some patients like Russo in limbo. High blood sugar in diabetics can lead to heart disease, kidney failure, stroke, blindness and amputation. Diet and exercise are recommended to control blood sugar, but medication is often needed too. Russo also worries that if she quits Avandia, she'll experience blurry vision and fatigue that will hamper her lifestyle.
On the other hand, she doesn't want to stay on a drug that could be unsafe.
“You set yourself up for a death sentence,” she said.
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Did FDA Know Of Avandia Dangers In 2002?
FDA 早在2002年就知道文迪雅安全隐患？
Advocacy Group: Diabetes Drug's Problems Were Revealed Long Before Recent Study
支持者;在这个研究的很早以前，糖尿病药物的问题就出现了。
(CBS/AP) The consumer advocacy organization Public Citizen claims that the Food and Drug Administration knew about problems associated with the diabetes drug Avandia for nearly five years.消费者拥护的美国某公众消费组织
宣称，食品药品管理局知道糖尿病药物文迪雅的相关问题已经有五年了。
Avandia is linked to a greater risk of heart attack and possibly death, reported a new scientific analysis published online Monday. 在星期一的一个新的科学分析中报道: 文迪雅可以增加心脏病发作和死亡的危险。
Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death, according to the review published by the New England Journal.根据新英格兰杂志发表的综述，综合比较几十个研究结果发现文迪雅可以使心脏病的发病率增加43%，使心血管死亡率增加64%。
Public Citizen sent a letter to the FDA complaining that an internal FDA memo from 2002 indicates that FDA scientists recommended labels for Avandia and Actos, another common diabetes drug, be changed to include a warning that there had been reports of heart failure for patients using the drugs. The group claims that despite the memo, the labels have not been changed. 美国公众消费组织在给食品药品管理局的信中控诉，在食品药品管理局2002年的备忘录中，食品药品管理局的科学家建议文迪雅和另一种常见的糖尿病药物高能活胰素的标签应该改变标签，在标签的应该加上有报告表明患者应用此类药物可以导致心衰的警告。这个团体认为虽然有这个备忘录，但是这个标签没有改变。
“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen in a news release.
Sidney Wolfe医师，美国某公众消费组织的卫生研究小组主任在一个新闻发布会上说，对于药品风险评估部门已经提出已经5年的建议，食品药品管理局没有按照这个建议执行，并且对于从事上市后药物安全观察专家的结论没有给与足够的重视和采取相应的措施。
“As a result, millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.” 结果，成百上千万人，因为处方药的使用危险被低估，而没有使用可以替代的、有同样作用或者是更为有效安全处方药物。
The group has called on the FDA to either ban the drugs or include black-box warnings on their labels. 这个团体呼吁食品药品管理局禁止这种药物的使用或者在药物的标签上加一个黑框警告。
Meanwhile, across the country, people who are taking Avandia are trying to figure out what to do. 同时，通过国家，服用文迪雅药物的患者需要设法讨回自己的合法权益。
The American Diabetes Association has fielded 70 calls from patients since Monday's report in the New England Journal of Medicine that Avandia is linked to a significantly higher risk of heart attack and possibly death.自从星期一新英格兰医学杂志的报告报道了文迪雅与严重增加心脏病发作的风险并且可能导致死亡相关，美国糖尿病协会已经接到了70个使用文迪雅的患者的投诉电话。
Pat Russo is one of them. She has been taking Avandia for three years, but on Tuesday phoned her doctor when she read news reports that it might raise the risk of heart attack. Pat Russo是这些患者中的一个，她服用文迪雅已经3年了，当星期二她看到文迪雅可以增加心脏病发作的风险的报告后，她打电话给他的医生。
“We're taking a wait-and-see approach,” said the 60-year-old business manager from Pennsylvania. 宾夕法尼亚州60岁的商业经理说，我们现在采用一种观望的态度。
For now, Russo's doctor has advised her to stay on the medicine. And she has a checkup scheduled in a few weeks. 从现在开始，Russo的医生建议她停止使用这个药物，在几周内给她进行一次预约检查。
Avandia’s maker, British-based GlaxoSmithKline PLC, contends the drug is safe and that more rigorous studies did not confirm a higher heart attack risk. Most experts say the actual risk to any single patient does appear to be small but that more studies are needed. 文迪雅的制造者，英国葛兰素史克公司辩解说，这个药物是安全的，需要进行更有力的研究证明该药有增加心脏病发作的风险。大多数专家认为这个实际的风险对于单独的患者是小的，但是需要更多的研究证实。
The suggestion of a greater heart risk is especially troubling, though, because two-thirds of diabetics die of heart problems. 这个增加心脏病危险的提议非常麻烦，因为有三分之二的糖尿病患者死于心脏问题。
More than 6 million people worldwide have taken Avandia since it came on the market in 1999 to treat Type 2, the most common form of diabetes and the one linked with obesity. Ⅱ型糖尿病是最常见的一种糖尿病，与肥胖相关，自从文迪雅1999年上市治疗Ⅱ型糖尿病，已经有600百万以上的患者服用。
About 1 million Americans are currently taking Avandia, which sells between $90 and $170 for a one-month supply. Its U.S. sales topped $2.2 billion last year. 目前有100万美国人服用文迪雅，使用文迪雅一个月的花费在90-170美元之间，去年文迪雅在美国的销量突破了22亿美元。
The Gonda Diabetes Center at the University of California, Los Angeles has answered at least 10 calls and individual doctors have received scores of e-mails from patients. 洛杉矶的加利福尼亚大学的Gonda糖尿病中心回复了至少十个电话，个别的医生已经收到了几十封患者的电子邮件。
Dr. Andrew Drexler, the center's medical director, routinely prescribes Avandia to his patients and has seen their blood sugar levels stabilize. Andrew Drexler博士，这个医学中心的主任，按照常规给患者开文迪雅，发现患者血糖稳定。
But Drexler said he will be more cautious about prescribing the drug in light of the potential heart risks raised in the New England Journal analysis co-authored by Cleveland cardiologist Dr. Steven Nissen.但是Drexler说，鉴于克利夫兰心脏病学家Steven Nissen，新英格兰医学杂志报告的作者，认为文迪雅有增加心脏病发作的危险，他会在给患者开文迪雅的时候更加小心。
“There's definitely concern and confusion,” Drexler said. “We need more information.” Drexler说，目前有明确的忧虑和混乱，我们需要更多关于文迪雅的信息。
On Monday, the American Diabetes Association and two influential heart groups jointly released a statement advising diabetics to talk to their doctors before stopping any medication. 在星期一，美国糖尿病协会和两个有影响的心脏病组织联合发表声明，建议糖尿病患者在停止任何治疗之前都应该事先同时他们的医生。
The Food and Drug Administration issued a safety alert about the potential risks but did not ask for a recall because of ongoing studies that suggest a contradictory effect.因为持续的研究支持一个相反的观点，食品药品管理局关于文迪雅增加心脏病发作的潜在危险发表了一个安全警告。
That has left some patients like Russo in limbo. High blood sugar in diabetics can lead to heart disease, kidney failure, stroke, blindness and amputation. Diet and exercise are recommended to control blood sugar, but medication is often needed too. Russo also worries that if she quits Avandia, she'll experience blurry vision and fatigue that will hamper her lifestyle. 这使象Russo这样的患者处于两难的境界。高血糖可以导致心脏疾病、肾功能衰竭、中风、失明和截肢术。对于高血糖患者，推荐饮食和锻炼，但是同时治疗也是需要的。Russo同时也担心如果停止使用文迪雅，她会视力模糊和疲劳，这也会妨碍它的健康。
On the other hand, she doesn't want to stay on a drug that could be unsafe.
另一方面，她不想继续使用一个不安全的药物。
“You set yourself up for a death sentence,” she said.
他说，你对你自己进行了死亡宣判。
FDA 早在2002年就知道文迪雅安全隐患？
2007年5月22日，CBC新闻发表关于文迪雅安全隐患安全隐患的新闻，对于文迪雅安全隐患，支持者认为在这个研究的很早以前，糖尿病药物的问题就出现了。
消费者拥护的美国某公众消费组织宣称，食品药品管理局知道糖尿病药物文迪雅的相关问题已经有五年了。在星期一的一个新的科学分析中报道: 文迪雅可以增加心脏病发作和死亡的危险。根据新英格兰杂志发表的综述，综合比较几十个研究结果发现文迪雅可以使心脏病的发病率增加43%，使心血管死亡率增加64%。美国公众消费组织在给食品药品管理局的信中控诉，在食品药品管理局2002年的备忘录中，食品药品管理局的科学家建议文迪雅和另一种常见的糖尿病药物高能活胰素的标签应该改变标签，在标签的应该加上有报告表明患者应用此类药物可以导致心衰的警告。这个团体认为虽然有这个备忘录，但是这个标签没有改变。
Sidney Wolfe医师，美国某公众消费组织的卫生研究小组主任在一个新闻发布会上说，对于药品风险评估部门已经提出已经5年的建议，食品药品管理局没有按照这个建议执行，并且对于从事上市后药物安全观察专家的结论没有给与足够的重视和采取相应的措施。结果，成百上千万人，因为处方药的使用危险被低估，而没有使用可以替代的、有同样作用或者是更为有效安全处方药物。这个团体呼吁食品药品管理局禁止这种药物的使用或者在药物的标签上加一个黑框警告。
同时，通过国家，服用文迪雅药物的患者需要设法讨回自己的合法权益。自从星期一新英格兰医学杂志的报告报道了文迪雅与严重增加心脏病发作的风险并且可能导致死亡相关，美国糖尿病协会已经接到了70个使用文迪雅的患者的投诉电话。
Pat Russo是这些患者中的一个，她服用文迪雅已经3年了，当星期二她看到文迪雅可以增加心脏病发作的风险的报告后，她打电话给他的医生。宾夕法尼亚州60岁的商业经理说，我们现在采用一种观望的态度。从现在开始，Russo的医生建议她停止使用这个药物，在几周内给她进行一次预约检查。
文迪雅的制造者，英国葛兰素史克公司辩解说，这个药物是安全的，需要进行更有力的研究证明该药有增加心脏病发作的风险。大多数专家认为这个实际的风险对于单独的患者是小的，但是需要更多的研究证实。
这个增加心脏病危险的提议非常麻烦，因为有三分之二的糖尿病患者死于心脏问题。Ⅱ型糖尿病是最常见的一种糖尿病，与肥胖相关，自从文迪雅1999年上市治疗Ⅱ型糖尿病，已经有600百万以上的患者服用。目前有100万美国人服用文迪雅，使用文迪雅一个月的花费在90-170美元之间，去年文迪雅在美国的销量突破了22亿美元。洛杉矶的加利福尼亚大学的Gonda糖尿病中心回复了至少十个电话，个别的医生已经收到了几十封患者的电子邮件。Andrew Drexler博士，这个医学中心的主任，按照常规给患者开文迪雅，发现患者血糖稳定。
但是Drexler说，鉴于克利夫兰心脏病学家Steven Nissen，新英格兰医学杂志报告的作者，认为文迪雅有增加心脏病发作的危险，他会在给患者开文迪雅的时候更加小心，目前有明确的忧虑和混乱，我们需要更多关于文迪雅的信息。在星期一，美国糖尿病协会和两个有影响的心脏病组织联合发表声明，建议糖尿病患者在停止任何治疗之前都应该事先同时他们的医生。
因为持续的研究支持一个相反的观点，食品药品管理局关于文迪雅增加心脏病发作的潜在危险发表了一个安全警告。这使象Russo这样的患者处于两难的境界。高血糖可以导致心脏疾病、肾功能衰竭、中风、失明和截肢术。对于高血糖患者，推荐饮食和锻炼，但是同时治疗也是需要的。Russo同时也担心如果停止使用文迪雅，她会视力模糊和疲劳，这也会妨碍它的健康。另一方面，她不想继续使用一个不安全的药物。他说，你对你自己进行了死亡宣判。
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日前，《新英格兰医学杂志》网站刊出研究报告称，治疗Ⅱ型糖尿病的药物罗格列酮具有潜在的安全性问题。这项对42项临床研究进行的荟萃分析显示：在使用罗格列酮治疗Ⅱ型糖尿病的15500名患者中，心肌梗塞及因心血管原因死亡的风险增高。
记者昨天从国家食品药监局获悉，葛兰素史克（天津）有限公司2000年9月获准在中国生产马来酸罗格列酮片（商品名：文迪雅），现有4mg和8mg两个规格。目前，国家药品不良反应病例报告数据库中有关罗格列酮的不良反应主要有水肿（局部或全身）、皮疹、腹泻、低血糖、头晕头痛等，尚未发现此次研究相近不良事件的报告。
国家食品药监局相关人士表示，已经注意到此事件，并正在密切关注美国食品药品监督管理局（FDA）和欧洲药品评价局（EMEA）的调查结果和该药品在我国临床使用的安全性问题，并将及时做出综合性评价。
中国患者为什么会没有？？？？？？？？？
