权威消息人士爆料：“眼药门”医院医师倒药--

权威消息人士爆料：“眼药门”医院医师倒药
2010年09月15日08:40
权威爆料：“眼科门”医院医师倒药
昨日 （9月14日），《每日经济新闻》记者从权威消息人士处获悉，上海市第一人民医院造成61名患者因注射“阿伐斯汀”（Avastin）引发不良反应的“眼科门”事件真相已有眉目。据透露，注射后引起不良反应的药物，是由该院一位副主任医师从一名中国香港籍医师手中购得。这名香港医师拥有内地医师执照，在上海一家知名医院任职。
据悉，该起医疗事件引起上海市委市政府高度重视，已两次召开相关部门的调查协调会，称此次事件为 “近年来上海比较严重的院内感染事件”。目前，上海市公安局已经介入调查。同时据记者了解，卫生部也已派专家组介入调查。
医院医师参与购药
《每日经济新闻》记者昨日获悉，此次病患注射的“阿伐斯汀”是由上海市第一人民医院眼科某位副主任医师和一位院内患者共同到上海另外一家医院购买来的药物。
据上述权威消息人士透露，上海另外一家医院聘用了一位中国香港籍的职业医师。由于罗氏的“Avastin”在香港是正式上市，因此这次的注射药物也是由该医师从香港带回。
该消息人士表示，“就是说，上海市一医院没有药，所以就去另外一个医院‘倒药’，就是一群职业医师在‘倒药’。”
上海市第一人民医院提供的《玻璃腔体内Avastin注射流程表》清楚地显示，患者在看专家门诊时便可领取预约牌，随后凭预约牌签署同意书、做视力检查，然后下楼在眼科门诊1楼119室付费，再乘电梯至2楼手术室注射。
《每日经济新闻》记者获悉，从2007年开始，上海市第一人民医院便开始为患者注射“阿伐斯汀”治疗黄斑变性。该院眼科主任孙晓东教授曾表示，2007年他从美国回来之后，最早是为一个律师注射了“阿伐斯汀”，由于药物效果很好，使用的人也就越来越多了。
除了对药源的调查，对罗氏制药公司的调查也正在进行。记者了解到，上海市卫生局正通过注射药物的批号查询该药物是否为罗氏生产，并了解同一批药物在香港的使用情况。上海罗氏制药公司新闻发言人曹涌表示，罗氏制药将密切配合卫生部门的相关调查。
“阿伐斯汀”注射灰色链条
上海市第一人民医院为患者注射“阿伐斯汀”治疗黄斑变性，至今已是第四年。“阿伐斯汀”注射已经形成一个灰色链条。“阿伐斯汀”，这种在中国内地没有批准上市的药物，却在内地的临床中使用多年。一条严重违法的地下倒药暗道，在此次“眼科门”后得以暴露。
多家医院的眼科医生指出，尽管“阿伐斯汀”在全球批准的所有适应症中都不包括眼部治疗，但多国的临床实践均发现，此药物对黄斑变性有一定疗效。香港食物及卫生局局长周一岳曾介绍道：“虽然安维汀（即阿伐斯汀）的注册用途并非治疗湿性老年黄斑变性，但在注册适应症外使用该药物用于治疗湿性老年黄斑病变，在国际间颇为普遍。”
有业内人士指出，目前对于黄斑变性并没有针对性的治疗药物。从目前已有的治疗手段来看，激光治疗的危险性较高，光动力疗法（PDT），在上海市第一人民医院的一次治疗的报价为16500元。从用于玻璃体内的注射药物来看，目前，同样由罗氏公司生产的Lucentis已通过了美国药监局批准用于治疗黄斑变性，然而一只注射剂的价格也是相当昂贵，接近2000美元。
一位患者向记者计算了他一次注射的费用开销：与“阿伐斯汀”注射相关的可乐必妥滴眼液、其他的片剂针剂以及注射前的验光、眼底检查费用总计480元，均有相关发票；注射时缴付的药品注射费用为200元，没有发票或者收据。据了解，每名患者所付的药品费用，大致在150元到200元不等。这样算来，一次注射的费用总计不到700元。相较该病其他的治疗方法，的确便宜。
而从院方来看，同样也是有利可图。一支“阿伐斯汀”注射液可供40人注射，那么注射剂费用总计在6000~8000元，而其他检查费用总计可达2万元。
香港金宝大药房的工作人员在接受《每日经济新闻》记者电话咨询时表示，一支100g/4ml的“阿伐斯汀”在店内的零售价为4400元港币，不需要处方单即可购买。记者另外在网上查询到的同剂量“阿伐斯汀”销售甚至低至一支人民币2000元。
（责任编辑：杨文彦
Drug used on eyes has not received approval
By Wang Hongyi (China Daily)http://www.chinadaily.com.cn/china/2010-09/15/content_11303651.htm
Updated: 2010-09-15 08:23
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SHANGHAI - Though 10 of the 61 patients who suffered adverse reactions from receiving Avastin injections have recovered, the source and use of the controversial drug is still unknown.
Last week, 116 patients received Avastin injections to treat macular degeneration at the Shanghai No 1 People's Hospital. Sixty-one of the patients experienced negative symptoms like pain, red eyes and unclear vision, and returned to hospital for further treatment.
The hospital said on Monday that most of the patients who suffered adverse reactions had improved, and 10 had recovered and been released from hospital. But it would not give more information.
Avastin, the trade name of bevacizumab, is marketed by Swiss pharmaceutical giant Roche. It first received approval from the US Food and Drug Administration in 2004 to treat metastatic colorectal cancer.
This February, Avastin received approval from China's State Food and Drug Administration to enter the Chinese mainland for the treatment of colorectal cancer, but it has not yet been sold in the market.
"So far, the drug cannot be obtained though formal channels on the Chinese mainland," Cao Yong, a spokesman of Shanghai Roche Pharmaceutical Company, was quoted by the National Business Daily as saying.
"And Avastin is only approved for use for the treatment of metastatic colorectal cancer," he said.
According to a regulation on imported drugs released by the State Food and Drug Administration, all imported drugs should have an imported drug certificate issued by the Ministry of Health. This certificate states the drug's name, producing country and manufacturer.
"The use of imported drugs must comply with the requirements of health authorities," said Tang Jianli, a lawyer from Shanghai Haida Law Office, who is experienced in medical disputes.
"It's illegal for hospitals to use drugs without complying with regulations from the State Food and Drug Administration," Tang said.
An insider in Beijing said it is very common for hospitals to use Avastin to treat macular degeneration, though it is not officially approved.
"Many doctors recommend this drug as effective treatment, and it is cheaper than other officially-approved drugs," the insider said.
A woman from Beijing who declined to be named told China Daily that her mother has received this kind of treatment on her eyes for a few months.
"In March this year, I took my 84-year-old mother to the Beijing People's Hospital for macular degeneration. The doctor recommended Avastin to treat my mother's eyes," she said on Tuesday.
"When I went to pay for the medical expenses, medical staff asked me to pay the fees separately. So I paid the operation fee normally and paid the drug fee to another man," she said. "But the man didn't wear a white coat like doctors usually wear. I think he might not be a doctor."
"What's more, he refused to give me any receipt after I paid the fees. I expressed my doubt and confusion, but the man just said 'you can choose not to use this drug'," she said. "To cure my mother's eyes. I had to accept it."
The woman said she paid about 1,000 yuan ($148) for operation fees, and 450 yuan for each shot of the drug.
"So far, my mother has been injected three times with such drugs. But some patients I met in the hospital have been treated with this drug since 2007. It's hard to believe and understand what is going on," the woman said.
The Ministry of Health is investigating the incident with the State Food and Drug Administration.