日前，英国媒体曝出瑞士制药巨头罗氏药业因隐瞒1.5万例致死和6.5万例不良反应报告被英国监管部门紧急调查，涉及8种药品。

a，The British media to expose the Swiss pharmaceutical giant roche pharmaceutical for 15000 cases of deaths and hide 65000 cases of adverse reactions report by the British regulators emergency survey，Involving 8 kinds of drugs。

　　罗氏10日发表声明称，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。

Roche 10, issued a statement that said，Media reported 15000 cases of the mentioned without safety assessment of adverse event is limited to the United States, a patient support programs。

　　国家食品药品监管局表示高度关注罗氏公司瞒报事件，要求罗氏公司说明该事件有关情况，并将密切跟踪罗氏公司对相关病例的评价工作。从目前情况看，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 supervision bureau said high attention roche's botched blood-collection drive，Requirements that the event roche about it，And will closely track of related cases roche of evaluation。From what we see，The incident involving drug adverse reaction monitoring in our country has not been found abnormal phenomenon。

　　英国监管部门紧急调查 British regulators emergency survey

　　近日，英国监管机构的一项调查揭开了跨国制药企业罗氏的尘封档案，总部设在瑞士的罗氏制药被瞬间推至风口浪尖。英国《每日邮报》撰文称，英国药品和健康产品管理局正在紧急调查罗氏制药涉嫌隐瞒严重不良反应一事，所涉及的死亡病例高达15161人。

recently，British regulators an investigation opened a multinational pharmaceutical enterprise roche's dusty archives，Headquartered in Switzerland's roche pharmaceuticals is instant pushed to outlet wave。British《Daily mail》Writing about says，British drugs and health products administration is urgent inquiry's roche's allegedly hiding serious adverse reactions，The death of the cases involved as high as 15161。

　　根据欧洲药品委员会的表态，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8万份不良反应报告。据英国媒体报道，罗氏涉嫌被隐瞒的报 告最早可以追溯到1997年，其中不仅有1.5万份致死病例，还有6.5万份药物导致的副作用报告。罗氏在收集了这些报告之后并没有上交到药品安全部门， 而是将它们“雪藏”了起来。

According to the European medicines committee statement，British regulators found roche in a drug sponsor projects，Failing to assess 80000 a bad reaction reports。According to the British media reported，Roche suspected of hidden against can be traced back to the earliest newspaper in 1997，Which is not only 15000 cases of death，And 65000 of the side effects of the drugs cause report。Roche in collected after the report did not hand in to the drug safety department， But will they“able”up。

　　北京大学公共卫生学院教授周子君指出，按照惯例，一旦出现药品不良反应，药品企业和医生都有责任和义务在第一时间向所在国的药品监督部门报告，而罗氏公司没有尽到这个义务。

Beijing university school of public health professor ZhouZiJun said，According to the usual practice，Once appear adverse drug reaction，Pharmaceutical enterprise and doctor has the responsibility and obligation to the country in the first time the drug department report，Roche's not doing this and obligations。

　　在正常的情况下应该是在药品上市之后，还有一个药品不良反应的监测，在临床应用的时候如果发现病人服用某种药物后死亡，医生认为他是不良反应的话，医生是有责任和义务报告给所在国的药品监督部门的。

In normal circumstances should be listed in the drug after，And a adverse drug reaction monitoring，In the clinical application of time if found patients taking a certain drug after death，The doctor think he is bad reaction words，A doctor is a responsibility and obligation to report of the country in which the drug supervision department。

　　罗氏声明“漏报” Roche statement“omission”

　　10日晚，罗氏发布声明称，此事件为“漏报”。而据欧洲药监局披露，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。

In the evening of 10，Roche in a statement，The events of“omission”。And according to European 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 headquarters on drug safety alert system for routine check of discovery。These can be traced back to the earliest report in 1997。

　　罗氏公司在回应记者采访时表示，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该患者支持项目。该事件系该美国患者支持项目中的不良事件未及时报告，出现漏报事件。

Roche in response to a reporter to interview said，Media reported 15000 cases of the mentioned without safety assessment of adverse event is limited to the United States with the support programs。The event is the American patients in the project support adverse events not timely report，Appear omission events。

　　罗氏(中国)上海有限公司相关负责人表示：“在中国我们是严格遵守中国药监部门对不良事件的报告程序。这件事情发生在欧洲和美国，我们在中国是 符合不良事件的报告程序的，包括严重不良事件的反馈程序，这些都是严格遵守药监局的规定的。罗氏公司基于目前的评估，未发现对罗氏产品的安全性产生影响， 同时也将积极配合政府部门进行相应的问询和调查。”

roche(China)Shanghai Co., LTD, officials say：“In China, we are strictly abide by the China the drug agency to adverse events reporting procedures。The incident happened in Europe and the United States，We in China is accord with adverse events reporting procedures，Including serious adverse events feedback procedures，These are strictly abide by the provisions of the administration's。Roche based on current evaluation，Did not find the safety of products of roche's impact， At the same time also will actively cooperate with the government department for the corresponding information and survey。”

　　那么，所谓“不良事件的报告程序”，究竟是什么样的程序？卫生法学专家、北京大学教授孙东东表示，按照我国的法律规定，医务人员如果在医疗活动 当中发现药品不良事件，可以向卫生行政部门，或者是药监部门报告，他首先应该向卫生行政部门报告。厂家发现有不良反应，如果认为是质量问题，应该召回。如 果是研发当中存在的问题，发现以后要及时调整，同时也要向药监部门报告，比如要调整批号，调整质量标准。

so，The so-called“Adverse events reporting procedures”，What exactly is what kind of program？Health law experts、Beijing university professor SunDongDong said，According to China's laws，Medical personnel if in medical treatment activity in that drug adverse events，Can to public health administrative department，Or is the drug agency report，First he should be to the administrative department of public health reports。Manufacturers found to have adverse reactions，If you think that is the quality problem，Should recall。Such as fruit is research and development of the existing problems，To adjust in time after that，At the same time also to the drug agency report，For example to adjust the batch number，Adjusting quality standards。

　　5种问题药在华销售多年 5 kinds of problems in China for many years drug sales

　　据了解，此次事件共涉及到8种药物，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、肺癌药物特罗凯等药在中国有售。尤其是赫赛汀和美罗华，在中国有着超过10年的销售历史，同时也是最畅销的抗癌药物。

According to understand，The incident involving 8 kinds of drugs were，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 medicine、Hepatitis c pegasys drugs、AnWeiTing rectal cancer drugs、Lung cancer drugs, medicine tarceva in China are available。Especially herceptin and mabthera，In China has a more than 10 years of sales history，At the same time is also the most popular of anti-cancer drugs。

　　此外还有特罗凯，在中国也销售了5年的时间，这些药物在我国有没有出现过副作用致死的案例？它们的副作用到底有多大？周子君表示，目前来看判定患者是因为这些药物的副作用而死亡的难度很大。

In addition to special tarceva，In China also sold 5 years，These drugs in our country have seen death case of side effects？How much their side effects？ZhouZiJun said，So far because the judge patients side effects of drugs and death is the difficulty。

　　周子君表示：“这些药品主要是治疗癌症晚期的药物，癌症晚期的病人很多都是维持治疗，所以癌症晚期的病人很多是死亡的。因此很难说是药物本身引起病人死亡的。”

ZhouZiJun said：“These drugs is mainly to treat cancer drug of late，Cancer is terminal patient many are maintenance treatment，So many of the cancer is terminal patient is dead。So it is difficult to judge whether the drugs' cause the patient died。”

　　病患家属心情复杂 Families mood complicated

　　5种在华销售的涉案药物，有4种针对不同类型的癌症。其中仅美罗华一种药物，去年的全球销售额就达到了60亿瑞士法郎。这些药品进入中国短则几年，长则十几年，挽救了癌症患者的生命，也让此刻的他们心情复杂。

5 in China the disappearance drug sales，There are four according to different types of cancer。Only one drug of mabthera，Last year's global sales reached 6 billion Swiss francs。These drugs into China is short for a few years，Long is more than ten years，Save a cancer patient life，Also let at the moment of their mood complicated。

　　一位癌症患者家属说：“我爸2007年得的肺癌，吃罗氏特罗凯已经很多年了，这两天看到罗氏的新闻，心情挺复杂，最重要的是担心这个药物有问 题。另一方面我也害怕，因为这个事情让特罗凯在中国下架了，就怕到时买不到这个药了。这几年我爸吃这药的效果还不错，肺癌晚期5年多，现在还活着。当然这 个药的副作用也特别大，药价也非常贵，一粒就要660元钱。”

A cancer patient family members said：“My dad of lung cancer in 2007，Eat roche's tarceva has for many years，This two days see roche's news，Mood quite complicated，The most important is worried about the drug have asked questions。On the other hand, I also afraid，Because the things make in China's tarceva off the shelves，Afraid that can't buy this medicine。This years my dad take this medicine effect is good，Lung cancer late more than five years，Now living。This, of course, the side effects of a medicine especially large，Drug prices is also very expensive，A grain of will 660 yuan。”

　　马上就访 'll visit

　　医院：用药后未发生死亡 hospital：After death has not occurred

　　记者查阅资料获悉，在中国，罗氏公司“阿瓦斯汀”药物的不良反应在2009年就出现过，虽然超出了说明书的使用范围，但是这种抗癌药在我国被广泛地应用在眼科中。

Reporters access to information learned，In China，roche“Statins, gas”Drug adverse reactions in 2009 appeared，Although the scope of application of the beyond，But the cancer drug in our country is widely used in the eye。

　　2010年，上海被曝出有十几名眼科患者出现了使用“阿瓦斯汀”的不良反应，最严重者甚至失明。但是这一事件并未阻止“阿瓦斯汀”在中国的使用。由于该药物在临床上对眼科疾病效果还不错，所以医生在征求患者同意后，仍然会继续使用。

2010 years，Shanghai is to expose a dozen ophthalmic patients appeared to use“Statins, gas”Adverse reaction of，The most serious and even blindness。But the incident did not stop“Statins, gas”The use of in China。Because the drugs in clinical effect is good for eye diseases，So the doctor was seeking to patients，Will still continue to use。

　　那么现在，罗氏公司的几种药物是否还可以继续使用？英国药品和健康产品管理局给出了答案：虽然罗氏的问题报告系统不完善，不过患者还是应该继续服用药物，因为目前调查还没有发现对患者存在安全风险的证据。

So now，Roche's several drugs are still can continue to use？British drugs and health products administration point to an answer：Although roche problem report system is not perfect，But patients should continue to take drugs，Because the current survey also found no risk to patients being security of the evidence。

　　中山大学附属肿瘤医院消化道肿瘤主治医师夏奕表示，“阿瓦斯汀”是胃肠癌的常用药，长期使用会发生高血压、蛋白尿等不良反应。但是出血、穿孔则是小概率事件，死亡这种极端事件在他们医院没有发生过。

Affiliated hospital of sun yat-sen university gastrointestinal cancer tumors of physicians XiaYi said，“Statins, gas”Gastric cancer is the common medicine，Use for a long time can happen high blood pressure、Adverse reactions such as proteinuria。But bleeding、Perforation is small probability events，This extreme events in their death hospital didn't happen。

　　对于罗氏抗癌药的使用结果，夏医生表示，罗氏药都挺好用的，但是很贵，一般人用不起。如“阿瓦斯汀”一支五千多元，一般一次要用2、3支，两星期用一次，一年要十几万元花费。

Roche cancer drug for the use of the results，Summer doctors say，Roche medicine is quite good use，But it is expensive，Ordinary people use can't afford it。if“Statins, gas”A five thousand multivariate，A secondary general in 2、3 a，Two weeks with a，Will a year spent ten yuan。

　　专家建议 Experts suggest

　　专家：救济比赔偿更合理 experts：Relief more reasonable than compensation

　　据了解，我国现行的《药品不良反应管理办法》中，并没有任何条例规定企业应该向受害者作出赔偿，因此目前国内尚缺乏药品不良反应相关赔偿机制。

According to understand，China's current《The adverse drug reaction management approach》in，And without any regulations to compensate victims should the enterprise，So the current domestic lack of adverse drug reaction related compensation mechanism。

　　对于药品不良反应的解决办法，很早就引起相关部门的重视和关注。有专家认为，对药品不良反应建立救济机制比赔偿机制更为合理。

For adverse drug reaction solution，Very early to attract the attention of the appropriate departments and attention。Some experts think the，The adverse drug reaction to establish the remedy mechanism is more reasonable than compensation mechanism。

　　记者了解到，对于这类事件，国外的处理方法基本是对制药公司处以大额的罚款，同时制药公司也会对不良反应的患者做出大额赔偿。

The reporter understands，To this kind of events，Foreign processing method for pharmaceutical companies is a basic large fine，At the same time, companies to adverse reaction of the patients to make big compensation。

　　我国2004年出版的《药品不良反应管理办法》中，并没有任何条例规定“药企应对不良反应的受害者做出赔偿”。这意味着，中国目前没有任何规定可以要求药企对不良反应的受害者做出赔偿。

Our country published in 2004《The adverse drug reaction management approach》in，And without any regulations“Medicine enterprises deal with the victims of the adverse reactions to make compensation”。This means that，China currently has no regulation may require drug adverse reaction of the victims of the vulnerable to make compensation。

　　国家食品药品监督管理局药品评价中心专家孙忠实曾公开向媒体表示，我们目前并没有制定“药品不良反应”相关赔偿标准，“以往国内一旦出现药品不 良反应事件，大多数情况都是医院、药企、患者在相关部门的协调下，自行决定一个赔偿金额，私下处理了之。这就反映出中国在医药管理方面存在的弊端”。

The state food and drug administration drug evaluation center experts faithful to the media has publicly he said，We now and not make“Adverse drug reaction”Related compensation standard，“Previous domestic once appear drug is not good reaction events，Most of the time it is is the hospital、Medicine enterprises、Patients in the relevant departments under the coordination，Decide a compensation，Deal with the privately。This reflects the Chinese medicine management in the disadvantages of”。