罗氏事件大量数据与细节仍未公开 国家药监局约谈 Roche events of large quantities of data and details remain publicly questioning the administration's country

　　药品不良反应监测谁是主角 Adverse drug reaction monitoring who is leading role

　　65000份不良反应病例、15161份死亡病例，这些原本应该及时上报监管部门的药品不良反应报告，却在全球知名药企罗氏公司被封存了15年。

65000 cases of adverse reactions、Of 15161 deaths，These should timely report the regulators adverse drug reaction reports，But in the world famous medicine enterprises roche is sealed up for 15 years。

　　这些药品不良反应报告所涉及的8种药品中，有6种在中国销售，其中美罗华在中国销售已经超过12年。

These adverse drug reaction report involves the 8 kinds of drugs，Six in China sales，One in China sales have mabthera over 12 years。

　　最新的消息显示，国家食品药品监督管理局已经约谈罗氏(中国)公司安全官,责成罗氏(中国)公司报告该事件的评价结果；并向世界卫生组织和英国、美国药监机构了解有关情况,希望及时通报该事件的调查结果。同时加强对罗氏公司在中国销售的相关品种的不良反应监测。

The latest news show，The food and drug administration has already questioning roche(China)The company safety officer,Instruct the roche(China)The results of the evaluation of the incident report；And to the world health organization and the UK、The United States about the drug watchdogs,Hope this incident promptly inform the survey results。At the same time, strengthen roche to sell in China related kind of adverse reaction monitoring。

　　国家食品药品监管局通报的消息显示,从目前情况看,该事件涉及的药品在我国不良反应监测中尚未发现异常报告。

The state food and drug supervision bureau reported that news,From what we see,The incident involving drug adverse reaction monitoring in our country has not been found abnormality report。

　　这是罗氏被查出隐瞒不良反应报告后国家食品药品监督管理局第二次“未发现异常”的表态。但是，罗氏在中国销售的药品数量、使用人群、不良反应报告情况，至今没有任何信息。

This is roche was found to conceal adverse reaction after report the state food and drug administration for the second time“No abnormalities are found”said。but，Roche sold in China, the number of drugs、Use the crowd、Report adverse reactions，So far no any information。

　　漏报还是瞒报 Omission or withhold the

　　如果不是英国药品和健康产品管理局对罗氏公司的例行检查，隐瞒了15年的药品不良反应报告不知道还将藏多久。

If not British drugs and health products administration to roche's routine check，Hide 15 years of adverse drug reaction reports don't know how long will also be hid。

　　根据欧洲药品委员会6月21日的表态，英国监管机构发现罗氏在一个药品赞助项目中，未能有效评估80000份不良反应报告。这一项目起始于1997年，罗氏在收集到不良反应报告之后并未上交到药品监管部门。

According to the European medicines committee on 21 June announcement，British regulators found roche in a drug sponsor projects，Failing to assess 80000 a bad reaction reports。The project started in 1997，Roche in the collection to adverse reaction after the report did not hand in to the drug regulators。

　　这个药品赞助项目是一个美国的患者援助项目。最早的不良反应报告出现在1997年，都是美国患者打电话到罗氏美国公司。

This drug sponsor project is an American patients aid projects。The earliest adverse reaction report appeared in 1997，Are American patients make a phone call to the company roche。

　　根据英国《每日邮报》的报道，这些美国患者的电话都被记录在案，却没能走出罗氏公司的文件库。

According to the British《Daily mail》reports，These American patients of the calls were recorded，But could not out of roche's document storehouse。

　　此次事件共涉及8种药物，包括转移性结直肠癌药物安维汀、乳腺癌药物赫赛汀等。这些药物主要用于治疗乳腺癌、肠癌、B型肝炎以及皮肤和眼部疾病。

The incident involving a total 8 drugs，Including metastatic colorectal cancer drug AnWeiTing、The breast cancer drug herceptin, etc。The main drugs for breast cancer、Bowel cancer、Hepatitis B and skin and eye disease。

　　那么，为什么罗氏公司会将这些不良反应病例封存起来而不上报监管部门？这些不良反应病例跟所涉及的药品之间究竟有什么关系？

so，Why roche will these adverse reaction to seal it up and not reported cases supervision department？These adverse reaction with involves the drug cases between what relation？

　　这是至今仍令人困惑的问题。

This is still the tough question。

　　7月11日，罗氏公司在其网站发布《关于罗氏在美国患者援助项目中不良事件漏报情况说明》，但并未解释上述问题。

July 11,，Roche's plan to release on its website《In the United States about roche patients in the aid program adverse events omission case》，But did not explain the above problems。

　　这份说明将未上报的不良事件定义为“漏报”，而不是瞒报。认为没有发现罗氏产品的安全性问题。

The instructions will be not reported adverse events defined as“omission”，Not conceal。Think not found roche the safety of products。

　　按照这份说明，罗氏公司已向卫生监督管理机构提供了未经评估潜在不良事件的初步分析，并正在进行最终的数据确认。但这些数据的最终确认可能还要再等5个月，预计将于今年12月前完成与这些项目有关的所有工作。

According to the instructions，Roche has to the health supervision and administration institution without evaluating potential provides a preliminary analysis of adverse events，Final data and are confirmed。But these data may be the final confirmation wait five months，Is expected in December of this year to complete the project before with all the work。

　　“看到罗氏的这个说明，我也很困惑。”一家外资制药公司的高管告诉记者，跨国制药公司都有一套很完整的药物不良反应监测体系，欧美国家对药物不良反应的上报工作有着非常严格的制度，如果出了问题，事后将要承担巨额罚款。

“See this explanation of the roche，I am also very confused。”A foreign pharmaceutical company executives told reporters，Multinational pharmaceutical companies have a very complete adverse drug reaction monitoring system，European and American countries for adverse drug reactions reported the work has a very strict rules，If a problem，After the event will bear a hefty fine。

　　按照罗氏公司的说明，此次未能上报的不良反应病例都来自该公司的一个美国患者援助项目，这就更让人疑惑：难道对公益项目的监测就会放松？

According to roche's instructions，The failed to report the adverse reactions from the company of the cases are a American patients aid projects，That's even more puzzling：Don't to public welfare project monitoring will relax？

　　这位高管告诉记者，在欧美国家，不论是患者援助这样的公益项目，还是企业正常渠道的销售药品，其不良反应的追踪监测都用同样的标准。所以很难理解罗氏公司特意提到患者援助项目的真正意思。

The executives told reporters，In the European and American countries，Whether patients with such public welfare project aid，Or enterprise normal channel sales drugs，The adverse reaction of the monitor with the same standard。So it is difficult to understand roche have mentioned patients the true meaning of the aid projects。

　　不过，即使是这个美国患者援助项目，罗氏公司也没有公布更多的细节，比如这个项目开展了多少年，有多少患者参与了该项目，通过这个项目罗氏公司提供了多少药品。

but，Even the American patients aid projects，Roche also did not announce more details，Such as the project carried out how many years，How many patients involved in the project，Through this project provides many roche drug。