跨国制药企业罗氏药业近日被英国媒体曝出因隐瞒1.5万例致死和6.5万例不良反应报告而被欧洲药品监管部门紧急调查。国家食品药品监督管理局前日对此表示，正密切关注此事，从我国药品不良反应监测情况来看，该事件涉及药品尚未发现异常现象。

Multinational pharmaceutical enterprise roche pharmaceutical have recently been the British media to expose conceal for 15000 cases of deaths and 65000 cases of adverse reactions report by the European drug regulators and emergency survey。The state food and drug administration had expressed，Is pay close attention to this matter，From our adverse drug reaction monitoring the situation，The incident involving drugs have not yet found abnormal phenomenon。

　　据欧洲药品监管部门披露，共计8万份被隐瞒的死亡或不良反应报告是英国药品和健康产品管理局在对罗氏药业总部进行关于药物安全警戒系统的例行检查时发现的，这些报告最早可以追溯到1997年。

According to the European drug regulators disclosure，A total of 80000 was the death of adverse reactions or hide report is British drugs and health products in administration of roche pharmaceutical headquarters on drug safety alert system for routine check of discovery，These can be traced back to the earliest report in 1997。

　　据了解，此次事件共涉及8种药品，主要治疗乳腺癌、肠癌、肝炎、皮肤和眼睛等疾病。其中，乳腺癌药物赫赛汀、恶性淋巴瘤药物美罗华、丙肝药物派罗欣、直肠癌药物安维汀、肺癌药物特罗凯等5种药品在华有售。这些药品进入中国市场短则几年，长则十几年。

According to understand，The incident involving 8 of drugs，The main treatment for breast cancer、Bowel cancer、hepatitis、The skin and eyes and other diseases。Among them，The breast cancer drug herceptin、Malignant lymphoma mabthera drugs、Hepatitis c pegasys drugs、AnWeiTing rectal cancer drugs、Lung cancer drugs, carleton ruthling five kinds of drugs are available in China。These drugs to enter the Chinese market is short for a few years，Long is more than ten years。

　　国家食品药品监督管理局表示，高度关注罗氏药业瞒报事件，要求罗氏药业说明该事件有关情况，并将密切跟踪罗氏药业对相关病例的评价工作，同时部署加强罗氏药业相关药品不良反应监测工作，深入分析有关监测数据。从目前情况来看，该事件涉及药品在我国不良反应监测中尚未发现异常现象。

The state food and drug administration said，High attention roche pharmaceutical botched blood-collection drive，Requirements that the event about roche pharmaceutical，And will closely track of related cases roche pharmaceutical evaluation，At the same time strengthening the deployment of roche's pharmaceutical related adverse drug reaction monitoring work，In-depth analysis of the monitoring data。From the current situation，The incident involving drug adverse reaction monitoring in our country has not been found abnormal phenomenon。

　　事发后，罗氏药业于前天发表声明，称媒体报道中提及的1.5万例未经安全性评估的不良反应事件仅限于美国一个患者支持项目。罗氏药业基于目前的评估，未发现对罗氏药业产品的安全性产生影响。

After the incident，Roche pharmaceutical in the day before yesterday issued a statement，Media reports said the 15000 cases mentioned without safety assessment of adverse event is limited to the United States, a patient support programs。Roche pharmaceutical based on current evaluation，Did not find the safety of products to roche pharmaceutical impact。

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　　京华时报：首先请您解释一下药品不良反应。

Jinghua times：First will you please explain the adverse drug reaction。

　　孙忠实(卫生部全国合理用药监测系统专家)：药品不良反应是指合格药品在正常用法用量情况下出现的与用药目的无关的有害反应。

Sun faithful(The rational drug use monitoring system of health experts)：The adverse drug reaction is to point to qualified in normal usage and dosage drug occurring and unrelated to the drug harmful response。

　　京华时报：得出药品不良反应的结论之前，会有因果关系评估吗？也就是说，是不是确定了这1.5万人死亡是由这个药品导致的之后才算药品不良反应案例？

Jinghua times：Draw adverse drug reaction before the conclusion，There will be causality assessment？That is，This is determined by the 15000 death is caused to be after drug adverse drug reaction case？

　　孙忠实：不是的。肯定、可疑、可能、不定，这四种情况都算作药品不良反应。去年国家药品不良反应监测中心一共收到852799份不良反应/事件报告，但不一定都是肯定的因果关系。

Sun faithful：no。sure、suspicious、may、uncertain，The four kinds of conditions as adverse drug reaction。Last year the national adverse drug reaction monitoring center received a total 852799 adverse reactions/incident report，But all is not sure causality。

　　京华时报：罗氏药业这个事情出来后，有些患者出现恐慌，您怎么看？

Jinghua times：Roche pharmaceutical this thing comes out，Some patients experienced panic，What do you see？

　　孙忠实：恐慌是没有必要的。对于罗氏药业的这几款药品是否还可以继续使用的问题，英国药品和健康产品管理局认为，虽然罗氏药业的问题报告系统不完善，不过患者还是应该继续服用，因为目前调查还没有发现这些药品对患者存在安全风险的证据。

Sun faithful：Panic is not necessary。For this a few of the roche pharmaceutical drugs is still can continue to use，British drugs and health products that administration，Although roche pharmaceutical problem report system is not perfect，But patients should continue to take，Because the current survey also found no these drugs to patients being security risk evidence。

　　京华时报：这个因果关系评估由谁来做？

Jinghua times：The causal relationship between the assessment by the who will do？

　　孙忠实：一般在国外，包括美国食品药品监督管理局(FDA)、欧盟药品管理委员会、英国药品安全管理委员会，根据这三个机构来判断一些国际用药是否安全。但最终要经过我们国家食品药品监督管理局的监测、评估，最后把关。

Sun faithful：General in the foreign，Including the U.S. food and drug administration(FDA)、The European Union drug management committee、British drug safety management committee，According to the three agencies to determine whether some international drug safety。But ultimately have to pass through our state food and drug administration monitoring、assessment，The last checks。

　　京华时报：为什么？

Jinghua times：why？

　　孙忠实：因为国外的数据不能直接拿来用，国人的体质特征跟国外有差异性，因此应该经过针对国人的专门的监测。

Sun faithful：Because of foreign data cannot be directly and make use of them，The physical features of people with abroad have difference，So for the people should pass special monitoring。

　　京华时报：目前没有发现异常是否代表罗氏药业在中国市场销售的这些药品是安全的？

Jinghua times：There is no abnormal represented in the Chinese market sales roche pharmaceutical of these drugs are safe？

　　孙忠实：由于国内的药品不良反应监测落后于欧美，目前虽未查到相关药品的不良反应数据，但隐患依然存在。所以国家有关部门应高度关注，并密切跟踪罗氏药业对相关病例的评价，加强罗氏药业相关药品不良反应监测，还将进一步深入分析有关监测数据。

Sun faithful：Because domestic adverse drug reaction monitoring backward in Europe and the United States，At present although did not check relevant drug adverse reaction of data，But there are still hidden trouble。So relevant state department should concern，And closely tracking roche to related cases of the evaluation of the pharmaceutical industry，Strengthen roche pharmaceutical related adverse drug reaction monitoring，Will also further analysis of the monitoring data。

　　京华时报：这5种药品在华使用情况怎样？

Jinghua times：These 5 kinds of drug use in China？

　　孙忠实：目前，中国已是罗氏药业在全球范围内药品领域第二大市场和诊断领域最大市场。罗氏药业2011年年报显示，去年该公司药品部门总销售额达31.71亿瑞士法郎(约合206.9亿元人民币)，其中中国市场的销售额达8.91亿瑞士法郎(约合58.14亿元人民币)，同比增长35%。该公司生产的乳腺癌药品赫赛汀和恶性淋巴瘤药品美罗华这两种药基本上已经成为主打药品，其中赫赛汀作为最畅销的产品，贡献了销售额的36%。

Sun faithful：At present，China is already the roche pharmaceutical in global drug field second largest market and diagnostics biggest market。Roche pharmaceutical annual report 2011 shows，Last year, the company pharmaceutical department of total sales of 3.171 billion Swiss francs($20.69 billion yuan RMB)，With China market sales to 891 million Swiss francs($5.814 billion yuan RMB)，Year-on-year growth of 35%。This company produces the breast cancer drug herceptin and malignant lymphoma drug mabthera this two kinds of medicine have basically has become a main drugs，One herceptin as the most popular products，Contributed 36% of sales。

　　京华时报：对于目前的事态，您有什么建议？

Jinghua times：For the present state of affairs，What do you suggest？

　　孙忠实：需要知道官方信息，包括这1.5万份死亡报告，到底是否跟用药有因果关系，安全评估结果怎样？需要根据国人的实际情况分析并公布我们国家的罗氏药业药品不良反应数据，让患者第一时间了解这些信息。(张然)

Sun faithful：Need to know the official information，Including the death of 15000 report，Whether to use causality，Safety assessment results？According to the actual situation of people need analysis and published the our country roche pharmaceutical adverse drug reaction data，Let patients know the first time this information。(ZhangRan)