2008年1月31日 星期四

PIC/S and Taiwan

Wikipedia article "Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme".

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.

The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of "The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products". The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC.

As a consequence the Pharmaceutical Inspection Co-operation Scheme was formed on 2 November 1995. The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries.


PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995.

See also

External links




為促進本土製藥業與國際市場接軌,衛生署強制要求國內多家藥廠今明兩年投入大規模建廠投資計畫,以符合歐盟「國際標準查廠規範(PIC/S)」的生產標準,總投資金額估計將達100億元,為近年來最大規模的藥廠改造工程。

製藥界指出,依照PIC/S規範,「高致敏性」藥品容易造成交叉汙染,必須設立獨立廠房,「高致敏性」藥品包括:荷爾蒙、抗生素、頭孢子菌素及抗癌用藥。

據了解,「高致敏性」藥品在國內市場占有率至少四成,連同進口商在內,估計一年銷售額約400億元以上。

衛生署去年下半年與製藥業達成協議,並公布「國際標準查廠規」,要求國內168家藥廠若要生產高致敏性藥品,需在民國98年底前,讓廠房達到PIC/S標準。

友華生技董事長蔡正強日前宣布,將投資8億元在雲林虎尾新建全新藥廠,除符合美國食品藥物管理局(FDA)規格外,也以PIC/S為最新的生產規格。

永信藥品董事長李芳全也指出,為符合PIC/S規範,永信已投資4億元興建新針劑廠,預計今年中完工;現有的其他生產線也將投資近1億元,進行設備改造以符合規範。

其餘的中化、生達、杏輝及台灣東洋等上市櫃公司,也自去年下半年至今年起,各自投資1億元至5億元興建新廠,或進行生產線改造。製藥業者預估,有計劃進行生產線改造的藥廠,至少有20家。

台灣區製藥公會理事長黃柏熊表示,衛生署要求各藥廠進行設備改造,各藥廠若無法在明年底前完成,後續可能面臨衛生署不再核發藥證,業界應高度關注。

製藥業者分析,各公司進行生產改造的目的,除在衛生署規定下,爭取國內市場生存空間,各廠近兩年積極拓展海外市場,符合PIC/S規範,也有助廠商進軍歐洲市場,而包括紐澳、加拿大、東南亞等國家,也都落實相同的規定。

&青春不開溜&

新品照片


青春不開溜

作者 : 江清泉策劃

定價:新台幣350元

ISBN: 978-986-01-2268-8

出版日期:2007年12月

出版:臺大出版中心


本書介紹  
 

  這是一本慢活人生書。讓您認識自己身體隨著年紀漸長而來的變化,懂得如何照顧自己、陪伴自己,找到最適合自己節奏的生活方式。
  這是一本青春人生書。這群臺大醫師作者們,以其專業知識,乃至現身說法,教您如何在年歲增長同時,增加智慧,更增添美麗與瀟灑。
  這是一本幸福人生書。生老病死是人生必經過程,不同的是,現代醫學的進步讓我們可以活得更久、更健康、也可以更有尊嚴,閱讀本書,保證幸福指數double!
  這本書由54位臺大醫師共同執筆,全書共分11單元,包括:老化與抗老化概論,身體組成的變化,髮膚五官,循環系統,消化系統,生殖泌尿系統,代謝內分泌系統,造血免疫系統,肌肉骨骼系統,神經認知系統,飲食&習慣等共42篇文章。篇篇精采,值得您咀嚼再三。


目次:

單元1 概論
  老化與抗老化 呂奕樞&嚴崇仁
  中老年的預防保健 林坤霈&陳人壽
  個人化老年照顧 陳晶瑩&呂碧鴻
  老人急症 顏瑞昇&陳石池

單元2 身體組成
  訂作自己──瘦身不嫌晚 林俞佳&黃國晉

單元3髮膚五官
  眼科常見的老化疾病 謝易庭&胡芳蓉
  認識老花眼 陳慕師
  老年人之聽力障礙與助聽器 劉殿楨
  惱人的耳鳴 李仲毅
  銀髮族眩暈教戰守策 楊怡和
  中老年口腔預防保健 林俊彬
  口腔內的義齒治療 王若松
  老年皮膚保健 廖怡華&紀秀華
  談頭髮的老化問題 蔡呈芳
  染髮會影響健康嗎? 蔡呈芳
  紅顏不老──淺談容貌養生與保養式整形
  林靜芸

單元4 循環系統
  人老心不老──心臟血管循環系統的保健
  陳明豐
  中老年人的心律不整 林俊立

單元5 消化系統
  老年人常見的腸胃問題 吳明賢
  談便秘與痔瘡:中老年常見疾病 梁金銅
  腸阻塞 陳炯年
  肝臟與相關肝炎 黃冠棠

單元6 生殖泌尿系統
  銀髮族的性生活 劉詩彬
  晚春心事──談更年期陰道萎縮 何積泓&
  楊友仕
  中老年男性排尿障礙──簡介攝護腺肥大
  症及其治療新知 闕士傑
  婦女尿失禁 林鶴雄

單元7 代謝內分泌系統
  荷爾蒙在年老時的變化 張天鈞
  老化與糖尿病 曾慶孝

單元8 造血免疫系統
  銀髮族常見的血液病變 陳建源&田蕙芬
  流行性感冒及疫苗 吳宗儒&黃立民
  中老年常見腫瘤 洪瑞隆&陳若白&謝銘鈞&
  魏凌鴻&王駿瑋&賴明坤

單元9 肌肉骨骼系統
  骨骼肌肉系統的老化 胡名孝&江清泉
  膝部退化性關節炎Q&A 江清泉
  手指麻到醒?──腕隧道症候群 張志豪
  老化與運動 賴金鑫
  罹患流行性感冒不宜劇烈運動 江清泉

單元10 神經系統認知
  老化的認知情緒變化以及相關疾病 黃宗正
  老化≠記憶退化──如何預防記憶退化 邱
  銘章
  老化與睡眠 李佩玲&余忠仁
  老年憂鬱症 黃宗正

單元11 飲食&習慣
  快活神仙之無窮後患 余忠仁
  健康食品新寵兒──輔酶Q10 鄭金寶

Tainted Drugs Linked to Maker of Abortion Pill 紐約時報

Tainted Drugs Linked to Maker of Abortion Pill

Ariana Lindquist for The New York Times

A patient in Shanghai who was paralyzed by a tainted drug.


Published: January 31, 2008 紐約時報

BEIJING — A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

Skip to next paragraph
Du Bin for The New York Times

Liu Kechen, 29, who also became paralyzed after injections with the contaminated drugs in a Beijing hospital, receives help from his wife, Ma Jingrong, in stretching his legs.

Ariana Lindquist for The New York Times

Feng Weiying, in Shanghai, said the legs of her son, Zhang Qingdong, 7, were paralyzed after he received injections from tainted batches of cancer drugs.

Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour’s drive away.

The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.

When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, a leading consumer advocate and frequent F.D.A. critic, said American regulators ought to be concerned because of accusations that serious health risks had been covered up there. “Every one of these plants should be immediately inspected,” he said.

The director of the Chinese F.D.A.’s drug safety control unit in Shanghai, Zhou Qun, said her agency had inspected the factory that produced mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou said, “but these two plants are in two different places and have different quality-assurance people.”

The investigation of the contaminated cancer drugs comes as China is trying to restore confidence in its tattered regulatory system. In the last two years, scores of people around the world have died after ingesting contaminated drugs and drug ingredients produced in China. Last year, China executed its top drug safety official for accepting bribes to approve drugs.

Shanghai Hualian is a division of one of China’s largest pharmaceutical companies, the Shanghai Pharmaceutical Group, which owns dozens of factories. Neither Shanghai Hualian nor its parent company would comment on the tainted medicine.

Last week, The New York Times asked the F.D.A. whether the Shanghai Pharmaceutical Group exported to the United States any drugs or pharmaceutical ingredients other than the abortion pill. But after repeated requests, the agency declined to provide that information; it did not cite a reason.

On at least two occasions in 2002, Shanghai Hualian had shipments of drugs stopped at the United States border, F.D.A. records show. One shipment was an unapproved antibiotic and the other a diuretic that had “false or misleading labeling.” Records also show that another unit of Shanghai Pharmaceutical Group has filed papers declaring its intention to sell at least five active pharmaceutical ingredients to manufacturers for sale in the United States.

One major pharmaceutical company, Pfizer, declined to buy drug ingredients from Shanghai Pharmaceutical Group because of quality-related issues, said Christopher Loder, a Pfizer spokesman. In 2006, Pfizer agreed to evaluate Shanghai Pharmaceutical Group’s “capabilities” as an ingredient supplier, but so far the company “has not met the standards required by Pfizer,” Mr. Loder said in a statement.

Because of opposition from the anti-abortion movement, the F.D.A. has never publicly identified the maker of the abortion pill for the American market. The pill was first manufactured in France, and since its approval by the F.D.A. in 2000 it has been distributed in the United States by Danco Laboratories. Danco, which does not list a street address on its Web site, did not return two telephone calls seeking comment.

Problems with the cancer drugs first surfaced last summer after leukemia patients received injections of one cancer drug, methotrexate. Afterward, patients experienced leg pain and, in some cases, paralysis. At the People’s Liberation Army No. 307 Hospital in Beijing, a 26-year-old patient, Miao Yuguang, was unable to stand up five days after being injected in the spine with the drug. “We were already unlucky to have this illness,” her father, Miao Futian, said of the leukemia. “Then we ran into this fake drug.”

The authorities recalled two batches of the drug, but issued only mild warnings because the cause of the problem was unclear. Officials with Shanghai Pharmaceutical Group stood by their products, saying that drug regulators investigating the plant had found no problems. But when another cancer drug made in the same factory — cytarabin hydrochloride — also began causing adverse reactions, investigators suspected contamination.

In September, health and drug officials announced that they had found that the two drugs were contaminated with vincristine sulfate, a third cancer drug, during production. After issuing a nationwide alert, the government announced a wider recall, and Shanghai’s drug agency sealed manufacturing units at the plant.

“Many people thought there was a problem with the hospitals,” said Zheng Qiang, director of the Center for Pharmaceutical Information and Engineering Research at Peking University. “It wasn’t until later that they discovered the problem was with the medicine.”

Chinese media attention on the case has surged, after a terse statement by China’s drug agency in December, accusing Hualian company officials of a systematic cover-up of violations at the facility that made the drugs.

Family members at the No. 307 hospital have counted 53 victims in Beijing, and say they were told that there were least 193 victims nationwide. It is unclear how many were paralyzed, because the authorities have not released an official figure. Relatives have joined to share information and advocate for the victims. Based on interviews with several families in Beijing and Shanghai, it appears that about half of those injected still cannot walk.

Wu Jianhua said his daughter, Wu Xi, 15, collapsed on her way to school after an injection in August. “We thought she was tired,” Mr. Wu said. Doctors now say she may never walk without a cane, he said.

Last week, on a window near the gate of the closed plant was a notice from the Shanghai Food and Drug Administration, dated Sept. 8, accusing the plant of “producing substandard medicine that poses major risks of causing serious harm to human health.” It identified a company official, Gu Yaoming, as the “person responsible” for the plant.

Records show Mr. Gu also met with the United States F.D.A. inspectors last May as part of the routine inspection of the plant that makes RU-486.

Reached by telephone, Mr. Gu declined to describe his role at the two plants. “I cannot answer your questions,” he said.

A spokeswoman for China’s Food and Drug Administration, Yan Jiangying, said that Shanghai Hualian had been stripped of its license to produce antitumor drugs, but that this action did not affect RU-486.

Hualian is the latest in a string of tainted medicine cases that have undermined confidence in the safety of drugs here. In 2006, at least 18 Chinese died after an intravenous drug used to treat liver disease, Armillarisin A, was laced with diethylene glycol, a toxic chemical used in some antifreeze. Also in 2006, at least 14 Chinese died after taking a Chinese antibiotic, Xinfu, which was not properly sterilized during production. And more than a hundred people died in Panama after taking cold medicine containing a mislabeled and toxic chemical from China.

In each of these cases, the manufacturer failed to follow good manufacturing practices to ensure the final product was safe.

Describing the cover-up at the factory, Ms. Zhou, the regulator who led the investigation, said workers did not tell investigators that vincristine sulfate — a drug too toxic for use in spinal injections — had been stored in a refrigerator with materials for other drugs.

“At the time, we didn’t think they had lied to us,” Ms. Zhou said. The deception sent investigators on a two-month hunt for other possible causes of the adverse reactions. “If they had been open about the vincristine sulfate in the beginning, maybe fewer people would have been harmed,” she added.

While regulators have accused factory employees of a systematic cover-up of violations in production, they have not said whether superiors at Shanghai Pharmaceutical were aware of it. “We’ll have to wait until the police investigation is finished” to make more details public, said Ms. Yan, the drug agency spokeswoman.

Mr. Zheng at Peking University said that producing multiple drugs in a single workshop was risky, but that some Chinese companies saw it as a way to save money. “It was an accident,” he said of the Hualian case. “But it was bound to happen.”

Jake Hooker reported from Beijing and Shanghai, and Walt Bogdanich from New York. Andrew Lehren contributed reporting from New York.

2008年1月28日 星期一

疾病的世界地圖

看商品放大圖〉
疾病的世界地圖
  • 作 者: 濱田篤郎
  • 譯 者: 曾維貞
  • 出版社: 時報文化
  • 出版日: 2005 年


各種疾病的發現與傳播,和旅行密不可分:舉凡探險、殖民、戰爭、貿易,疾病如影隨形。
亞歷山大帝國因為幼發拉底河畔一 隻小小的蚊子而瓦解;羅馬帝國後期水利工程延宕,瘧疾滋生,帝國從此一蹶不振;玄奘往天竺取經,走過沙漠、高山的嚴酷環境,幾度死裡逃生;西班牙人把天花 帶到美洲新大陸,毀掉了整個印加帝國,但是梅毒也從美洲傳入歐洲,廣為流傳,危害數百年;拿破崙遠征俄國,軍中爆發斑疹傷寒、痢疾等急性傳染病,四十五萬 大軍最後只剩四萬。疾病有如一隻看不見的手,左右了人類歷史的軌跡。


抗生素的發明,一度讓人類以為將使許多傳染病絕跡,但是,隨著抗藥性菌種的出現,肺炎等「舊瘟疫」死灰復燃,愛滋、SARS等「新瘟疫」蠢蠢欲動,便捷迅速的旅行,更為疾病傳播橫添變數。

《疾病的世界地圖》回顧三千年的疾病旅行史,也從二十世紀「旅遊醫學」的角度,提供各種旅行醫療知識,永保現代旅行者安康。


濱田篤郎 Hamada Atsuo

1955 年生於日本東京。東京慈惠會醫科大學畢業,留美後進入該大學擔任熱帶醫學研究室講師。現任海外就業健康管理中心研修交流部長,負責診療海外的日本人;並兼 任東京慈惠會醫科大學、慶應義塾大學等大學講師,日本旅遊醫學全國性組織「出國者健康關懷會」理事。合著有《國外旅行健康必攜》(協和企劃)、《預防職場 傳染病》(中央勞動災害防止協會)等書。

25)濱田篤郎、奥沢英一他.発展途上国に長期滞在する日本人の腸管寄生虫感染状況の変化 
感染症学雑誌 2003;77:138-145
4)福島慎二、濱田篤郎:旅行医学のすすめ~医療機関受診の問題を中心にして.保健の科学 47(10):728-732 2005.
24)Suzuki T., Osada Y., kumagai T., Hamada A., Okuzawa E., Kanazawa T., Early detection of Schistosoma mansoni infection by touchdown PCR in a mouse model. Parasitol. Int. 2006 (in press)

3)Arai, Y.T., Kimura, M., Sakaue, Y., Hamada, A., Yamada, K., Nakayama,
M., Takasaki, T., Kurane, I.: Antibody responses induced by immunization
with a Japanese rabies vaccine determined by neutralization test and
enzyme-linked immunosorbent assay. Vaccine 20:2448-2453, 2002

日本人海外渡航者の疾病罹患状況
濱田篤郎 - Biomedical Perspectives, 1999



曾維貞

高雄市人。輔仁大學日文系畢業,日本京都大學文學碩士。現職編輯,譯著有夢野久作小說集《死後之戀》。Email: souitei@pchome.com.tw


目录
序言 《魂断威尼斯》的真相
笫1章 旅行者与疾病
第2章 由旅行者传入的疾病
笫3章 古典旅游医学时代
第4章 古典旅游医学的兴盛与终结
第5章 现代旅游医学的诞生
第6章 现代旅游医学的医疗指标
第7章 旅游医学与传染病的现况
第8章 古典旅游医学的遗产
第9章 引日本为鉴
结语太空旅行时代,近在眼前


书摘
两次世界大战和古典旅游医学的终结

  经过全盛期的古典旅游医学,在两次世界大战期间发出最后的光芒。两次世界大战的战场不仅限于欧洲,更包含广大热带地区的殖民地,因此,这两次世界大战也是各国在古典旅游医学发展成熟度上彼此较劲的战争。

  1914年第一次世界大战爆发以前,军队中已没有大规模痢疾和伤寒的流行。斑疹伤寒也证实是由虱子传播,士兵的衣服必须经过消毒来驱除虱子。

  不过,第一次世界大战爆发后,德军战况每况愈下,而疏于驱除虱子,最后导致东战线上发生大规模斑疹伤寒的流行。此次流行波及俄国境内,加上当时俄国因革命而动荡不堪,患者人数多达2000万人以上。

   虽然疟疾已有奎宁这种治疗药可医治,但在殖民非洲、亚洲等地的部队仍发生了大流行,特别是在东非的英军,感染疟疾丧生者达10万以上。奎宁的供给足以左 右殖民地战争的胜负。德国因为经济被封锁,无法取得奎宁的原料金鸡纳,加速研发新药的脚步。第一次世界大战时,为防止传染病人侵,各国军队皆以近代化方法 严加戒备,但因方法不够周全,各地仍不时爆发流行。

  两次世界大战之间的20年,微生物学上不断有新的发现。1930年,持续研发疟疾新药的德 国终于成功开发疟涤平(Atebrin)(译注:疟疾的预防与治疗用药奎纳克林[quinaeiine quinacrine]的英国商标);这是第一种不需要金鸡纳的抗疟疾治 疗药。此后,德国仍不断研发新药,在第二次世界大战爆发之前,又成功开发了磷酸氯奎宁(chloroqlzine chloroquine )。1928年,英国的弗莱明爵士 (Sir Alexander Fleming)则发现了青霉素(pellidllin pinicillins ),也就是盘尼西林,来治疗大范围的细菌性传染病。不过,1941年战争爆发后,青霉素才开始批量 生产。而黄热病等病毒性传染病的病原体也相继被发现,各种疫苗陆续成功开发出来。

  在那个时代,各国的当务之急是将军事医学领域里的新知识运用在军队里,严加防范传染病,为下一次世界大战做准备。日本政府、军方与医学界也随着军国主义的高涨,全面加强军事医学。

  由于传染病的病原体己被发现,各国用来确保士兵健康的疫苗和治疗法首度发挥了效用,但生化武器也就在这样的时代背景下逐渐形成。在第二次世界大战前夕,日本和欧美各国在军事医学的发展上已有失控的现象。

   1939年在欧洲战线揭开序幕的第二次世界大战,是全面对抗传染病的一场战争。战线不限于欧洲,后来更扩及非洲和中东、近东,但士兵不畏传染病,奋勇作 战。当日本加入战局时,原本全面武装的同盟国已开始松懈。原来,日军自开战以来即猛攻爪哇,更积极夺取原来由荷兰管理的金鸡纳农园,以断绝同盟国的奎宁来 源。此举严重影响在非洲战线作战的同盟国军队,许多士兵因此暴露于感染疟疾的危险之中。同盟国后来顺利取得奎宁的代替新药疟涤平,在非洲打胜。

   日本参战后引发的东南亚和南太平洋一带的战局,是日本和欧美各国在古典旅游医学水准上较量的最后一战。双方阵营皆运用了过去所累积的知识和技术,全力迎 战。欧美在军队调度上以经验丰富取胜,尤其是疟疾的防疫政策略胜一筹。战争期间,美日双方的军队都服用奎宁和疟涤平来预防疟疾,但是美军因为有建设巴拿马 运河的经验,不忘对士兵施以充分的卫生教育,彻底落实驱蚊的工作。不仅如此,他们预测到兵力会因为疟疾而减弱,早已事先编制预备军。最后,日本的补给线遭 断绝,药剂不足,各地日军在遭受美军攻击以前,就被疟疾瓦解。如此一来,这场战争已分出胜负。

  第二次世界大战结束后,军事医学和热带医学在败战国日本的国内,都被视为往事尘封起来。军事医学留有军国主义的残影,热带医学仍带有帝国主义的气息;在当时的背景下,这样的医学是不被允许的。以这两种医学为基础的古典旅游医学更被视为禁忌,受到压抑。

   另一方面,古典旅游医学的发展在欧美各国内也被迫中止。第二次世界大战后,许多殖民地国家在民族主义的声浪中纷纷独立,群起指责战前的殖民主义或帝国主 义风潮。在这样的国际社会背景下,热带医学不得不转型,只负责解决热带地区居民的健康问题。随着和平时代的来临,公然研究军事医学的风潮也已消褪。而冷战 开始,古典旅游医学更变成一种军事机密,埋没在大家注意不到的角落。

  古典旅游医学于战后随即消失,相较之下,现代旅游医学在欧美正是方兴未艾。
  P61-P64 (sic /pp.61-4)

Sentinel Event Glossary of Terms

這些字彙是我2-3月前所找的 我認為很值得往後參考

The Joint Commission Annual Report Shows Further Improvement in Health Care Quality in Nation's Hospitals

http://www.jointcommission.org/AboutUs/joint_commission_facts.htm

我們要評定領導者,除了考慮其不犯error of commission(因有所作為而犯錯,即做了不該做的,例如把共同因當特殊因處理等之),更要強調機會成本,即他不要犯太多 error of omission(因無為而犯錯,即有些事該做而卻未做),使得良機(新產品、新市場等之)喪失。

Error of Commission
An error which occurs as a result of an action taken. Examples include when a drug is administered at the wrong time, in the wrong dosage, or using the wrong route; surgeries performed on the wrong side of the body; and transfusion errors involving blood cross-matched for another patient.

提供藥品服務(給病人用藥)的時間錯誤 或錯劑量 或路徑錯誤

開刀錯身體另一邊 輸錯交叉配血型之錯

能動失效

Active Failure
An error which is precipitated by the commission of errors and violations. These are difficult to anticipate and have an immediate adverse impact on safety by breaching, bypassing, or disabling existing defenses.

違反 回避 或使既有的防衛, 防御(物)而造成立即的安全問題作用

Error of Omission
An error which occurs as a result of an action not taken, for example, when a delay in performing an indicated cesarean section results in a fetal death, when a nurse omits a dose of a medication that should be administered, or when a patient suicide is associated with a lapse in carrying out frequent patient checks in a psychiatric unit. Errors of omission may or may not lead to adverse outcomes. 顯示應剖腹生產可是因遲疑而造成胎死腹中

護士在該給病人服藥時卻忘掉了ㄅ或是在精神病院中因疏忽未能經常查訪病人而病人自殺

Sentinel Event Glossary of Terms




Accreditation Watch
An attribute of an organization's Joint Commission accreditation status. A health care organization is placed on Accreditation Watch when a reviewable sentinel event has occurred and has come to the Joint Commission's attention, and a thorough and credible root cause analysis of the sentinel event and action plan have not been completed within a specified time frame.

Action Plan
The product of the root cause analysis which identifies the strategies that an organization intends to implement to reduce the risk of similar events occurring in the future. The plan should address responsibility for implementation, oversight, pilot testing as appropriate, time lines, and strategies for measuring the effectiveness of the actions.

Active Failure
An error which is precipitated by the commission of errors and violations. These are difficult to anticipate and have an immediate adverse impact on safety by breaching, bypassing, or disabling existing defenses.

Adverse Drug Event (adverse drug error)
Any incident in which the use of a medication (drug or biologic) at any dose, a medical device, or a special nutritional product (for example, dietary supplement, infant formula, medical food) may have resulted in an adverse outcome in a patient.

Adverse Drug Reaction (ADR)
An undesirable response associated with use of a drug that either compromises therapeutic efficacy, enhances toxicity, or both.

Adverse Event
An untoward, undesirable, and usually unanticipated event, such as death of a patient, an employee, or a visitor in a health care organization. Incidents such as patient falls or improper administration of medications are also considered adverse events even if there is no permanent effect on the patient.

Aggregate Data
Data collected and reported by organizations as a sum or total over a given time period, for example, monthly or quarterly.

Barrier Analysis
The study of the safeguards that can prevent or mitigate (or could have prevented or mitigated) an unwanted event or occurrence. It offers a structured way to visualize the events related to system failure or the creation of a problem.

Benchmarking
Continuous measurement of a process, product, or service compared to those of the toughest competitor, to those considered industry leaders, or to similar activities in the organization in order to find and implement ways to improve it. This is one of the foundations of both total quality management and continuous quality improvement. Internal benchmarking occurs when similar processes within the same organization are compared. Competitive benchmarking occurs when an organization's processes are compared with best practices within the industry. Functional benchmarking refers to benchmarking a similar function or process, such as scheduling, in another industry.

Causation
The act by which an effect is produced. In epidemiology, the doctrine of causation is used to relate certain factors (predisposing, enabling, precipitating, or reinforcing factors) to disease occurrence. The doctrine of causation is also important in the fields of negligence and criminal law. Synonym: causality.

Change Analysis
A study of the differences between the expected and actual performance of a process. Change analysis involves determining the root cause of an event by examining the effects of change and identifying causes.

Circadian Rhythm
The rhythmic repetition of certain phenomena in living organisms at about the same time each day. Without cues provided by light, the human circadian cycle lasts 25.9 hours.

Clinical Pathway
A treatment regime, agreed upon by consensus, that includes all the elements of care, regardless of the effect on patient outcomes. It is a broader look at care and may include tests and x-rays that do not affect patient recovery. Synonym: clinical path.

Common-Cause Variation
See variation.

Complication
A detrimental patient condition that arises during the process of providing health care, regardless of the setting in which the care is provided. For instance, perforation, hemorrhage, bacteremia, and adverse reactions to medication (particularly in the elderly) are four complications of colonoscopy and its associated anesthesia and sedation. A complication may prolong an inpatient's length of stay or lead to other undesirable outcomes.

Coupled System
A system which links two or more activities so that one process is dependent on another for completion. A system can be loosely or tightly coupled.

Error of Commission
An error which occurs as a result of an action taken. Examples include when a drug is administered at the wrong time, in the wrong dosage, or using the wrong route; surgeries performed on the wrong side of the body; and transfusion errors involving blood cross-matched for another patient.

Error of Omission
An error which occurs as a result of an action not taken, for example, when a delay in performing an indicated cesarean section results in a fetal death, when a nurse omits a dose of a medication that should be administered, or when a patient suicide is associated with a lapse in carrying out frequent patient checks in a psychiatric unit. Errors of omission may or may not lead to adverse outcomes.

Fault Tree Analysis
A systematic way of prospectively examining a design for possible ways in which failure can occur. The analysis considers the possible direct proximate causes that could lead to the event and seeks their origins. Once this is accomplished, ways to avoid these origins and causes must be identified.

Flow Chart
A pictorial summary that shows with symbols and words the steps, sequence, and relationship of the various operations involved in the performance of a function or a process. Synonym: flow diagram.

FMECA (failure mode, effect, and criticality analysis)
A systematic way of examining a design prospectively for possible ways in which failure can occur. It assumes that no matter how knowledgeable or careful people are, errors will occur in some situations and may even be likely to occur.

Iatrogenic 1
Resulting from the professional activities of physicians, or, more broadly, from the activities of health professionals. Originally applied to disorders induced in the patient by autosuggestion based on a physician's examination, manner, or discussion, the term is currently applied to any undesirable condition in a patient occurring as the result of treatment by a physician (or other health professional), especially to infections acquired by the patient during the course of treatment. 2. Pertaining to an illness or injury resulting from a procedure, therapy, or other element of care.

Immediate Cause
See proximate cause.

Incident Report
The documentation for any unusual problem, incident, or other situation that is likely to lead to undesirable effects or that varies from established policies and procedures or practices. Synonym: occurrence report.

Indicator 1
A measure used to determine, over time, performance of functions, processes, and outcomes. 2. A statistical value that provides an indication of the condition or direction over time of performance of a defined process or achievement of a defined outcome.

Latent Failure
An error which is precipitated by a consequence of management and organizational processes and poses the greatest danger to complex systems. Latent failures cannot be foreseen but, if detected, they can be corrected before they contribute to mishaps.

Local Trigger
An intrinsic defect or atypical condition that can create failures.

Malpractice
Improper or unethical conduct or unreasonable lack of skill by a holder of a professional or official position; often applied to physicians, dentists, lawyers, and public officers to denote negligent or unskillful performance of duties when professional skills are obligatory. Malpractice is a cause of action for which damages are allowed.

Negligence
Failure to use such care as a reasonably prudent and careful person would use under similar circumstances.

Observation Method
An active method of error surveillance in which a trained observer watches the care delivery process.

Occurrence Screening
A system for concurrent or retrospective identification of adverse patient occurrences (APOs) through medical chart-based review according to objective screening criteria. Examples of criteria include admission for adverse results of outpatient management, readmission for complications, incomplete management of problems on previous hospitalization, or unplanned removal, injury, or repair of an organ or structure during surgery. Criteria are used organizationwide or adapted for departmental or topic-specific screening. Occurrence screening identifies about 80% to 85% of APOs. It will miss APOs that are not identifiable from the medical record.

Outcome
The result of the performance (or nonperformance) of a function(s) or process(es).

Pareto Chart
A special form of vertical bar graph that displays information in such a way that priorities for process improvement can be established. It shows the relative importance of all the data and is used to direct efforts to the largest improvement opportunity by highlighting the "vital few" in contrast to the "many others."

Plan-Do-Study-Act (PDSA) Cycle
A four-part method for discovering and correcting assignable causes to improve the quality of processes. Synonyms: Deming cycle; Shewhart cycle.

Process
A goal-directed, interrelated series of actions, events, mechanisms, or steps.

Proximate Cause
An act or omission that naturally and directly produces a consequence. It is the superficial or obvious cause for an occurrence. Treating only the "symptoms," or the proximate special cause, may lead to some short-term improvements, but will not prevent the variation from recurring.

Retrospective Review
1. A method of determining medical necessity or appropriate billing practice for services that have already been rendered. 2. In behavioral health, evaluative activities conducted when an individual being served is no longer in active treatment.

Risk Containment
Immediate actions taken to safeguard patients from a repetition of an unwanted occurrence. Actions may involve removing and sequestering drug stocks from pharmacy shelves and checking or replacing oxygen supplies or specific medical devices.

Risk Management
Clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury to patients, staff, and visitors and the risk of loss to the organization itself.

Risk Points
Specific points in a process that are susceptible to error or system breakdown. They generally result from a flaw in the initial process design, a high degree of dependence on communication, non-standardized processes, and failure or absence of backup.

Root Cause
The most fundamental reason for the failure or inefficiency of a process.

Root Cause Analysis
A process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.

Sentinel Event
An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response.

Special-Cause Variation
See variation.

Surveillance
Ongoing monitoring using methods distinguished by their practicability, uniformity, and rapidity, rather than by complete accuracy. The purpose of surveillance is to detect changes in trend or distribution to initiate investigative or control measures. Active surveillance is systematic and involves review of each case within a defined time frame. Passive surveillance is not systematic. Cases may be reported through written incident reports, verbal accounts, electronic transmission, or telephone hotlines, for example.

Underlying Cause
The systems or process cause that allow for the proximate cause of an event to occur. Underlying causes may involve special-cause variation, common-cause variation, or both.

Variation
The differences in results obtained in measuring the same phenomenon more than once. The sources of variation in a process over time can be grouped into two major classes: common causes and special causes. Excessive variation frequently leads to waste and loss, such as the occurrence of undesirable patient health outcomes and increased cost of health services. Common-cause variation, also called endogenous cause variation or systemic cause variation, in a process is due to the process itself and is produced by interactions of variables of that process is inherent in all processes, not a disturbance in the process. It can be removed only by making basic changes in the process. Special-cause variation, also called exogenous-cause variation or extrasystemic cause variation, in performance results from assignable causes. Special-cause variation is intermittent, unpredictable, and unstable. It is not inherently present in a system; rather, it arises from causes that are not part of the system as designed.

2008年1月26日 星期六

德國的專業照護( 劉威良)

自由時報2008/01/27

德國的專業照護

■ 劉威良

閱讀「精神病患不是罪犯」一文,心有戚戚焉。我曾在台灣的精神醫療界工作數年,目前在德國也從事相關的行業。

德 國沒有長期關病人的機構,除非是疑有精神問題的罪犯。處理一般精神病患的事務是由多重管道的社會網絡來支援病人。因此,家人不是唯一要扛責任的人,也無需 背決定病人去處的責任,出院的病人有專業照顧者的家庭訪視與照顧,其實不會如一般人想像的可怕,他們會陪伴患者,協助他們重拾一般正常生活的功能。所以, 他們可能與家人住,也可能自己住,或與病友一起住在一般的公寓內。他們不必一大群人居住在一個社區,自然也不會有鄰居抗議的問題,德國的病患就和一般人一 樣住在自己可以料理自己生活起居的地方。

如果是被法院判定為失去行為能力者,在德國必須有法律上的監護人,這人可以是家屬或朋友,家屬也可 以放棄讓專業人士來當。此監護人若非病患的熟識之人,通常是由法院來指派,如果病患無能力支付監護費用,則由國家負擔。監護權的範圍也必須規範清楚監護的 事項,如決定住處、醫療與處理財務及其他事務。監護與否與監護內容都需與患者協商取得同意。另外,監護人並非永久的,法院必需派法官一年來審視探訪病患一 次,由法官一年決定一次這個監護工作是否仍有必要,並取得病患對監督人選的同意。如果法官覺得不需要監護,病患就可馬上成為有行為能力的人。在德國如果不 是精神病患,醫療院所人員如有要限制肢體( 如有攻擊或自傷之虞)需做肢體約束者,也必須取得法官同意,如有緊急需要也要事後補法官的同意書。

所以德國的法官是人權的把關者,並不只是判有罪沒罪的終結者。(作者為旅居德國精神病患專業照護者)

2008年1月25日 星期五

Which? 與 一杯咖啡的熱量




小心:一杯咖啡等于一頓飯!
咖啡
全脂牛奶、巧克力等都使咖啡熱量大增

您早上上班的路上匆匆忙忙的買的那杯咖啡中,可能含有你每天所需攝入熱量的五分之一。

這是英國消費者雜志《Which》測試發現的最新結果。

在《Which?》抽樣檢測的咖啡當中,有一些一杯就包含400卡路里。

專家說,造成咖啡熱量等于一頓飯的"罪魁禍首"是全脂牛奶、奶油和巧克力。相反,一些脫脂卡布奇諾每杯只含有不到30卡路里。

一杯黑咖啡當中几乎不含任何熱量。 想減肥?請遠離咖啡屋中的點心台!

該雜志對三家著名連鎖店調查后發現,咖啡屋中出售的一些點心還不如漢堡包健康。

比如說,一商店內出售的奶酪泡菜三明治提供的熱量為500卡路里。

《Which?》雜志的一名發言人說,一些咖啡屋中出售的三明治卡路里、脂肪和鹽的含量甚至超過巨無霸漢堡包。

在英國,專家建議,女人每天卡路里攝入量為2000,男人2500。

《Which?》發言人說,希望咖啡屋能在店內清除地標出所售產品的熱量指標。




先從今天BBC的一則翻譯新聞說起

"

《泰晤士報》引述英國情報部門的監督機構通信截聽委員會的報告指出,在過去一年,英國的特務組織和其他司法部門等共發出了45萬次申請,要求截查境內人士的電子郵件、電話和郵件等。

通信截聽委員會負責人托馬斯指出,從2005年到2006年間,有關的截查發生了4000起錯誤,這一數字是高得不能接受的。

另一方面,英國首相布萊爾承認,申領身份證人士的指紋可能被當局檢查,以確定是否涉及該國近100萬起未被偵破的罪案。

人權組織形容這兩起事件是蔑視人們隱私的做法。

不過內政部表示,由於以往沒有公布過有關截查通信的數字,所以不能說通信截聽委員會的報告表明,當局收集信息數據的數字大量增加。

《獨立報》報道,英國各大銀行將公布破紀錄的業績,在去年非法收取47億英鎊款項,感謝顧客們的反抗,現在是銀行清還款項的時候。

《獨立報》頭版標題呼籲銀行客戶取回屬於自己的金錢。

英國一個消費者權益互聯網站利用各大銀行將在未來兩星期公布業績的時候,呼籲人們進行大規模的投訴,要求銀行償還非法收取的透支罰款。

消費者權益組織《Which》估計,僅是去年,銀行業收取的未經授權透支罰款就達到47億英鎊。 "

我的目的要介紹約略相對於台灣消費者文教基金會刊物的Which?

Wikipedia中只有英文的介紹

讀者或許可以觀摩其網站

Which? is a subscription-only magazine and website run by Which? Ltd (formerly known as the Consumers' Association, which is still the official name of the charity). Based in the United Kingdom, it engages in advocacy campaigns on various consumer protection issues and aims to promote informed consumer choice in the purchase of goods and services, by testing products, highlighting inferior products or services, and raising awareness of consumer rights. It maintains its independence by not accepting advertising or freebies; everything bought for testing is paid for at full price. Which? is funded entirely by its subscribers and has no shareholders.

Which? carries out systematic testing of consumer products and financial services, the results of which are published in reports in the magazine. The Which? 'Best Buy' label is well-known and respected by industry and consumers. Tests are carried out on consumer items like electrical goods, cars, and computers, as well as health and financial services, and supermarkets. Testing highlights issues such as reliability and value-for-money.

The magazine also raises awareness of trading it believes goes against the interests of consumers. It offers advice on consumers' legal rights and reports on legal cases where it has fought for members' rights. In the May, 2003 issue, for example, the back page featured a couple who won compensation from their credit card firm after purchasing a poor holiday. Another case featured was a life assurance company which had not maintained customer records properly and was forced to pay compensation. Which? also communicates regularly with the OFT and recently brought a 'supercomplaint' against private dentists in the UK. However, Which? has been criticised for its use of junk mail prize draws, similar to Reader's Digest, to gain additional subscribers. It is moving away from this area[citation needed].

Which? Ltd produces several other specialist publications apart from the main Which? magazine. These include Holiday Which?, Computing Which? and Gardening Which. It also publishes several books including the annual Good Food Guide and Giving and Inheriting.

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自來水開始加氟 1945

commie

The noun commie has one meaning:

Meaning #1: a socialist who advocates communism
Synonym: communist

1945年美國自來水開始加氟 許多人說這是共產黨人的陰謀

Jan. 25, 1945: Fluoridation — Better Teeth, or Commie Plot?

By Tony Long Email 01.25.08 | 12:00 AM


1945: Grand Rapids, Michigan, becomes the first U.S. city to fluoridate its drinking water supply.

Fluoridation, implemented as a means of reducing tooth decay, involves adding one part per million of fluoride to the water supply. (The optimum level, according to the Centers for Disease Control, falls between 0.7 and 1.2 ppm.) Fluorine, of which fluoride is a compound, is one of Earth's most abundant elements, found in almost everything. In mammals, the highest natural concentration of fluoride is found in bones and teeth.

日本齒科教育

幾年前我經常看NHK的午間教育節目。發現對於小孩,經常有如何正確刷牙的節目……洪信佳牙醫師談他20多年前留學日本、準備在那兒執業,我就與他他所知道的「日本兒童牙齒健康教育」。他說從一歲多長牙起,父母都要到公所了解,各級學校都有多項健康檢查……所以說,類似牙齒等是終生教育。(他們的牙醫和相關的護士、造齒模工人等教育發達,不像我們一直從缺;對於牙醫診所的各種環保之要求,也很周全;我們從缺…..


讀"扭曲的醫療生態" ( 李秉穎) *附New Warning About Botox

2008/01/25晨在苗栗市讀此投書
我們多少可以從中知道(經濟)"生態"(消長)
我比較不滿意的是文中對於"醫療品質"界定含糊
關於"熱門的美容科" 其實並非真的"沒事"
且看文末所附紐約時報之文

Group Seeks New Warning About Botox




自由廣場
扭曲的醫療生態

■ 李秉穎

報載 台灣醫師因為醫療糾紛被定罪的比率高於其他各國,其實醫師被不當定罪只是台灣社會不公平對待醫界的其中一點,更多的是辱罵、威脅,甚至人身傷害。筆者與一 群關心台灣醫界的同好,曾在民國九十三年對相關事件做過一次問卷調查。發現將近一半執業醫師都遇過醫療糾紛,有過糾紛的事件包括要求賠償(七十五%)、被 辱罵(三十一%)、法律訴訟(二十三%)、人身傷害(六%)。試想,有哪一個「正常」行業會有這麼高比率被罵、被打、被告?那些要求提高醫師被定罪比率的 個人或團體,認為這是社會公義嗎?

醫界被不公平對待的結果是,少糾紛的皮膚科變成年輕醫師的最熱門科系,攸關民眾生命保障的重症科別,則乏 人問津。前述調查中,醫學生家長有高達四十四%的比率,希望自己的子女將來任職皮膚科。也發現許多醫師對於目前執業科別並不滿意,其中有三分之二都是因為 醫療糾紛太多而覺得不如歸去。大約四分之一的醫師考慮過要轉科,而轉科的第一志願則又是皮膚科(三十%)。優秀人才紛紛轉向少糾紛科別,對醫療品質當有負 面影響。

該次調查有個問題,假設有一種外科急症,不開刀的死亡率為九十%,開刀的死亡率為四十%。依照一般的想法,當然應該開刀。執業醫師 在假設自己生病的情形下,要求馬上開刀與完全由醫師決定的比率大約各佔一半。但如果是面對民眾生病,則只有二十四%會積極勸說開刀,其他都是讓家屬決定。 其間的差距來自於醫療糾紛太多所產生的防衛性心態,雖然開刀讓病人的存活率提升,但只要遇上開刀死亡,就很可能會引起醫療糾紛。

不當的醫療糾紛與醫療仲裁不但是一種社會不公,也讓重症醫療逐漸失去優秀人才、讓醫師採取保守性醫療,這對於整體醫療品質有著深遠的負面影響。我們希望台灣能夠理性面對各種醫療事件,並在必要時做出公平的仲裁,這才是醫療品質的保障。

(作者為台大醫學院小兒科副教授)

2008/1/27補

 外電報導,美國傳出16起注射肉毒桿菌死亡的案例。對此,衛生署指出,美國致死的案例,主要是因為醫師施打的劑量及位置不對,因而引發嚴重的副作用所致,衛生署呼籲國內的醫師要小心使用。(張德厚報導)

  衛生署藥政處處長廖繼洲表示,肉毒桿菌素是一種神經肌肉阻斷劑,國內核准用來治療肌肉痙攣、斜視、痙攣性斜頸症等疾病,在美容方面,所核准的則 是使用於除皺眉紋。此次美國致死案例,主要是治療斜頸症時,醫師施打的劑量或位置不對,而產生嚴重副作用所致。廖繼洲:『他可能劑量打得太多,或是打到比 接近喉嚨的地方,因此喉嚨麻痺,吞嚥困難,產生吸入性的肺炎而致死。』

  生產肉毒桿菌的藥廠方面也強調,產生副作用而死亡的患者,本身就有心肺、神經以及肌肉方面的疾病,要不就是上了年紀,目前尚無證據証明肉毒桿菌素跟致死直接相關。

  衛生署進一步指出,國內自開放肉毒桿菌素上市後,共接獲十四例不良反應通報病例,包括胸悶、腹痛、便秘等,並沒有接獲肌肉麻痺、吞嚥困難等副作 用,也沒有亡案例。國內醫師的醫療水準都很高,相信不會出現施打劑量或位置不對的狀況,衛生署會密切注意此事發展,並呼籲醫師要小心使用肉毒桿菌。




Group Seeks New Warning About Botox


Published: January 25, 2008

WASHINGTON — Botox and a similar injected drug have been associated with 16 deaths, four of them in children, and scores of serious injuries that occurred after the drug spread to vital organs, a health advocacy group says.

The drug, a neurotoxin that is used to relax muscles, should come with a far stronger warning label and patients should be given a letter detailing its risks, the group, Public Citizen, said in a petition filed Thursday with the Food and Drug Administration.

Julie Zawisza, a spokeswoman for the agency, said she could not comment while the petition was under review.

Executives at Allergan, the maker of Botox, issued a statement saying that adverse reactions were rare. And because many patients who get the drug are seriously ill, the company said, it is not proved that Botox caused the reactions. Solstice Neurosciences, the maker of a similar drug, Myobloc, did not return a message for comment.

Perhaps best known as a wrinkle remover, Botox is also approved to treat cervical dystonia, a painful knotting of neck muscles. Doctors inject it into multiple spots on the neck, relieving sometimes disabling pain for weeks or months.

But the injection sites sometimes come perilously close to the esophagus, causing partial paralysis that can lead patients to have difficulty swallowing and suffer aspiration pneumonia, caused by breathing in food or liquids, Public Citizen said.

Of the 16 people who died, only one is known to have been undergoing a cosmetic treatment for wrinkles. Most of the others suffered muscle problems or their condition was unknown.

The deaths might have been prevented had patients been adequately warned of the possible dangers, said Dr. Sidney M. Wolfe, director of Public Citizen’s health research group. The labels for Botox and Myobloc mention the issue but not prominently enough, Dr. Wolfe said.

“Nobody should die from the medical use of Botox,” Dr. Wolfe said. “The fact that they are shows that patients don’t have a clue about these problems.”

Health authorities in Europe have done a far better job of highlighting the drugs’ dangers, Dr. Wolfe said. The authorities in Britain and Germany have required drug manufacturers to send letters to doctors warning of the dangers.

On Aug. 9, the Danish Medicines Agency published an analysis of adverse events associated with the products. The analysis found 600 problems associated with the drugs, the petition stated. Half of the serious problems associated with the drugs occurred after the toxin spread, the petition said.

The drugs’ labels in Europe have a prominent section titled “special warnings and precautions for use” that warns of the dangers of the spread of the toxin. The Danish authorities also warned that muscle weakness associated with Botox may be long-lasting, especially among children, the elderly and those suffering serious neurological problems.

Patients in Europe also receive a leaflet warning them to seek medical help if they have trouble breathing, experience dry mouth or have trouble swallowing.

The drugs’ manufacturers and others have reported to the F.D.A. 658 cases of problems associated with Botox and Myobloc, Public Citizen said.





2008年1月22日 星期二

膽固醇試驗沒告訴你的(英文)

Well

What That Cholesterol Trial Didn’t Show


Published: January 22, 2008

The cholesterol drug Vytorin became known for its commercials showing people who look oddly similar to foods like tacos and banana cream pie. But now Vytorin is getting attention that is anything but funny.

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Nola Lopez

Well

Do you take cholesterol medication? Do the latest findings concern you? Join the discussion.

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The medicine combines Zocor, a cholesterol-lowering statin, with Zetia, a drug that limits cholesterol’s absorption into the body, and the hope was that the combination would make it more effective than either drug standing alone. But last week Vytorin’s makers, Merck and Schering-Plough, announced that in a small study it had done no better than Zocor alone in slowing the growth of arterial plaque, which can lead to heart attacks. There’s nothing particularly alarming about the findings (unless you’re a shareholder, perhaps).

But the news set off a panic among patients using cholesterol drugs. One doctor said he assigned a nurse full time to take the calls “and convince patients not to stop their medicine.” Another patient argued with his doctor, claiming the study showed that the drug doubled heart attack risk. (It didn’t; the study wasn’t designed to measure heart attacks.)

“I think this study is being interpreted wrong,” said Dr. Paul D. Thompson, director of cardiology at Hartford Hospital, who personally uses Zetia and (like most of the doctors quoted in this article) has consulted with makers of cholesterol drugs.

He pointed out that Vytorin users did experience a larger drop in cholesterol than the Zocor users. The disappointment was that the decline didn’t translate into a bigger benefit in arterial health. “It didn’t show harm,” Dr. Thompson said. “There were no more cardiac events, no more side effects. There was just no change.”

The fallout from the study was not limited to Vytorin. It has led to a whole new set of questions for scientists about cholesterol drugs. Is lowering LDL, the “bad” cholesterol, all that counts? Or must a drug also raise HDL, the “good” cholesterol, and fight inflammation?

Adding to the confusion, the Vytorin makers dragged their feet on releasing the results, issued the findings in a press release rather than a medical journal and made a lot of people mad.

“Failed trials are important,” said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “The reason the medical community is upset about the delay in reporting this is that we learn as much from a study that fails as we do from a study that succeeds. People are not happy that we didn’t learn about this sooner.”

Dr. Nissen, who says he donates his drug-consulting fees to charity and doesn’t take a tax deduction, added that the study raised interesting scientific questions about the differences in cholesterol drugs.

The most popular — the statins, including Lipitor and Zocor — reduce the amount of cholesterol produced by the liver. In some studies, statins have lowered heart attack risk by 30 percent or more in high-risk patients. Statins also raise HDL levels and have an anti-inflammatory effect. The problem is that statins, particularly at high doses, can have a number of side effects, including muscle pain.

Zetia has a smaller anti-LDL effect than statins, and little effect on HDL or inflammation. On the plus side, because it works primarily in the digestive tract, it potentially has fewer side effects.

Vytorin, by combining Zocor and Zetia, produces a bigger drop in cholesterol than either drug could do alone, and without a marked increase in side effects. The problem is that there are no long-term studies showing that using the drug translates into fewer heart attacks or strokes.

The latest study was a step in that direction. It didn’t set out to measure heart attacks or strokes, but it did look at whether Vytorin slowed plaque buildup on artery walls more than a statin alone.

It didn’t. While it’s been reported that the Vytorin users had more plaque than the Zocor users, that’s not a scientifically correct reading of the data: the difference between the two groups was not statistically significant.

Most important, perhaps, nothing about the trial undermines the settled wisdom about cholesterol and heart disease. The science still shows that lower cholesterol is better, however you achieve it.

“Every way in which we have lowered LDL in the past” has been shown to reduce heart attacks and strokes, said Peter Libby, chief of cardiovascular medicine at Brigham and Women’s Hospital in Boston, who has consulted with drug companies. “All of these different routes to lowering bad cholesterol are correlated with a clinical benefit.”

To be sure, not everyone agrees that drugs are the best way to achieve lower cholesterol. But the Vytorin disappointment doesn’t “mean the whole concept is wrong,” said Dr. Daniel J. Rader, director of the preventive cardiology and lipid clinic at the University of Pennsylvania School of Medicine, who has also consulted with drug companies. “I firmly believe lowering cholesterol is the most validated, most important way we can reduce our risk of heart disease and stroke. Get your LDL down, and the lower the better.”

In fact, the real lesson of the Vytorin confusion may be exactly what its makers have promoted.

“It actually does get back to what the Vytorin commercials show,” said Dr. Nieca Goldberg, medical director of the women’s heart program at New York University, who does not consult for cholesterol drug companies. “Cholesterol comes from what you eat and your family history. I always put in a plug for modifying your diet and exercise. It may not bring about as big of a reduction as medication does, but it helps.”

Cancer Data? 說明癌症研究等資訊公開的重要性

紐約時報這篇Essay說明癌症研究等資訊公開的重要性

Cancer Data? Sorry, Can’t Have It


Published: January 22, 2008

Not long ago, I asked a respected cancer researcher if he could send me raw data from a trial he had recently published. He refused. Sharing data would make the study team members “uncomfortable,” he said, as I might use this to “cast doubt” on their results.

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Royal Art Lodge

I’d heard this before: as a statistician who designs and analyzes cancer studies, I regularly ask other researchers to provide additional information or raw data. Sometimes I want to use the data to test out a new idea or method of statistical analysis. And knowing exactly what happened in past studies can help me design better research for the future. Occasionally, however, there are statistical analyses I could run that might make an immediate and important impact on the lives of cancer patients.

A few years back, a study was published showing that a certain drug could prevent one type of cancer. The problem was that the drug didn’t work very well and had some side effects, so almost no one used it. At the same time, a colleague showed that a protein found in the blood could predict which patients were at high risk for cancer. We put two and two together and realized that we could use the protein test to work out which patients would benefit from the drug.

To make things even easier for us, it turned out that the researchers who had conducted the trial had actually measured this protein in all their patients. So we wrote to them and asked whether they would share their data. They refused on the grounds that they might consider a similar analysis at some point in the future. But years have passed, no such analyses have been forthcoming and few patients are benefiting from what could be a very effective drug.

Given the enormous physical, emotional and financial toll of cancer, one might expect researchers to promote the free and open exchange of information. The patients who volunteer for cancer trials often suffer through painful procedures and harsh experimental treatments in the hope of hastening a cure. The data they provide ought to belong to all of us. Yet cancer researchers typically treat it as their personal property.

I’m sometimes told that sharing data would violate patient privacy — though changing names to codes is easy enough. Other requests are killed by red tape. When a colleague and I wanted to analyze the data from a completed breast cancer trial, merely getting permission to speak to the study’s organizing committee required a one-hour phone call with the scientist in charge of the agenda. Only after another one-hour call with the committee itself were we allowed to submit a formal proposal — to which we received no response.

Most refusals are more blunt. “I am not prepared to release the data at this point,” one researcher wrote me, even though he was a government employee and his trial, which had been published several years earlier, was federally financed.

Dr John Kirwan, a rheumatologist from the University of Bristol in England, has studied researchers’ attitudes on sharing data from clinical trials. He found that three-quarters of researchers he surveyed, as well as a major industry group, opposed making original trial data available. It is worth restating this finding: most scientists doing research on how best to help those in pain, or at risk of death, want to keep their data a secret.

Dr. Kirwan went on to ask his subjects why. Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn’t this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole). This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations. Scientists don’t want to be scooped by their own data, or have someone else challenge their conclusions with a new analysis.

Yet this is exactly what cancer patients need. They want new results to be published as quickly as possible and to encourage a robust debate on the merits of key research findings.

An acquaintance of mine was recently diagnosed with breast cancer, and it gives me some comfort to know that there are drugs she can take that will improve her chance of cure. We know that these drugs are of benefit because more than 20 years ago, a group of Oxford statisticians persuaded researchers around the world to pool data from their breast-cancer trials.

With the rise of the Internet, sharing data has become a simple matter. Geneticists, for example, publish their raw data on a central Web site. The data from medical trials are given freely by patients. They should insist that these belong to science as a whole.

Andrew Vickers is a biostatistician at Memorial Sloan-Kettering Cancer Center in New York.

Tuna Sushi 水銀含量過高 度美國

High Mercury Levels in Tuna Sushi

High Mercury Levels Are Found in Tuna Sushi

Tony Cenicola/The New York Times

Tuna sushi is a popular item in New York but may be risky.


Published: January 23, 2008

Recent laboratory tests found so much mercury in tuna sushi from 20 Manhattan stores and restaurants that at most of them, a regular diet of six pieces a week would exceed the levels considered acceptable by the Environmental Protection Agency.





鎘污染

生活工場含鎘保鮮盒 全面下架

〔記者林相美、楊雅民/台北報導〕消基會月初公布生活工場販售的韓製「LIBERO兩格1.2L微波保鮮盒」含有超量重金屬鎘。台北市衛生局隨即抽驗,同樣發現該款保鮮盒的上蓋黃色部分有超量的鎘,衛生局要求業者限期回收、銷毀,若未及時改善,依法可處三至十五萬元罰款。

生 活工場表示,被台北市衛生局檢出盒蓋鎘含量超過標準值的「LIBERO」微波保鮮盒(見圖,記者林相美攝),是該公司元月三日被消基會檢出不合格全面下架 之後,元月四日衛生局要求該公司配合提供的檢驗樣本,並非未下架的漏網之魚。「LIBERO」微波保鮮盒系列元月三日早已全面下架,並將商品重新送檢,檢 驗報告出爐後,已把所有商品退回韓國。

衛生局藥物食品管理處處長姜郁美解釋,食品容器的鎘、鉛含量不得超過100ppm。不過, LIBERO兩格1.2L微波保鮮盒上蓋黃色部分的鎘含量達162ppm;上蓋白色部份及底盒則皆未檢出鎘、鉛。姜郁美研判,可能是製造過程中加入色素或 塑化劑等材料,帶進些許礦物質,才會導致餐盒有鎘。


wsj

污染與中國工人的全球化代價
2008年01月17日10:21



剛過去的聖誕及新年假期﹐有數百萬美國孩子收到了從中國進口的玩具禮物。這些玩具使用的同樣是在中國生產的含電池。

電池本身使用時並無危險﹐而且價格便宜﹐與用其他電池相比﹐每件玩具平均可以為美國家長節省1.5美元。

但是﹐含電池的生產過程卻有可能發生危害。

王鳳平這些年一直在電池廠上班﹐這些工廠在為美泰(Mattel Inc.)、玩具反鬥城(Toys 'R' Us)和沃爾瑪(Wal-Mart Stores)等美國公司生產含電池。車間里到處都是紅色的含粉塵﹐王鳳平和她的幾百名同事平常就在這樣的環境里工作。

今年45歲的王鳳平現在經常虛弱地走不動路。她的腎有衰竭症狀﹐醫生認為污染可能是罪魁禍首。她以前工作過的香港金山電池國際公司(GP Batteries International Ltd.)設在惠州的超霸電池廠已有約400名工人被查出體內量超標。這種金屬像水銀和鉛一樣屬於對人體有毒的成份﹐有可能導致腎衰竭、肺癌和骨質病變。

這幾個月來﹐美國人發現他們對廉價中國產品的依賴也有讓人不放心的一面。玩具含鉛﹐寵物食品有毒﹐中國產品的安全性突然間成了困擾美國人的事。

而在中國﹐那些為美國人生產消費品的工人早就遭受了生產全球化帶來的傷害。這個全球化製造體系將削減成本奉為第一要務﹐安全問題偏居次位。在發達國家尋找廉價商品的過程中﹐那些有污染環節的行業被逐步轉移到工人缺乏勞動保護、監管不嚴的國家。

鎳-電池行業的演變就是這一趨勢的一個縮影。這種1899年就研製出的電池最早在西方國家大量生產﹐現在的產地主要在中國。中國工人及生產廠週邊的土壤和水質正在遭受著帶來的污染。

現在﹐一些監管機構和企業開始採取行動了。歐盟今年已禁止銷售幾乎所有類別的電池。孩之寶(Hasbro Inc.)等一些企業也開始放棄使用這種電池。

不過﹐在市面銷售的全部電池中﹐仍有3%是含電池﹐在美國銷售的電動玩具、電動工具、無繩電話等產品中﹐含電池仍被普遍使用。除價格便宜之外﹐含電池還有放電迅速的特點。

如今﹐美國自己的電池產業已幾近消亡。這一點在紐約冷泉市的一片長滿植物的土地上可以看得非常明顯。Marathon電池廠曾在這裡為美國軍方生產了30多年的鎳-電池。但1979年﹐這家工廠停產關閉﹐此後美國政府出資1.3億美元清除該廠及周邊地區的污染﹐當地居民也以遭受污染傷害為由提出集體訴訟﹐並在1998年獲賠數百萬美元。

隨著美國和其他西方國家對電池的管制不斷加強﹐鎳-電池的生產開始逐步轉向欠發達國家﹐最後﹐大部分生產廠均在中國安了家。加拿大安大略電池企業Pure Energy Visions主管研發的副總裁約瑟夫•丹尼爾•埃維德(Josef Daniel-Ivad)說﹐幾乎所有電池廠都搬到中國去了﹐因為沒人願意再跟廢料打交道。

現在﹐美國只有兩家公司在生產電池﹐而且它們生產的是用於飛機發動機等高端設備的電池。根據美國法律﹐這兩家公司要遵守嚴格的勞動安全和環境保護法規。

中國政府遵照世界衛生組織(WHO)相關規定對涉及的行業制定了勞動保護政策。當然﹐部分企業是安全的。

不過﹐有了法規以後能否得到落實是另一回事。中國有幾十處地方的污染程度與美國上述“廢棄物污染地”相差無幾。據中國國家環保總局披露的數據﹐中國超過10%的耕地受到等重金屬的污染﹐這些金屬污染物正在進入中國人的食物供應鏈。

過去兩年來﹐至少有十多項研究顯示﹐中國境內種植的水果和蔬菜存在含量超標的情況。據廣東省生態環境與土壤研究所(Guangdong Institute of Ecology)去年發表的研究報告顯示﹐該省佛山市種植的大白菜含量很高。在中國﹐雖然污染並非全部來自電池﹐但電池的確是很主要的一個污染源。

污染的危險往往也會波及到工廠里的工人。去年﹐日本松下公司(Panasonic Corp.)位於無錫的電池廠至少有20名工人被查出體內含量升高﹐有兩人被診斷為中毒。2005年﹐河南新鄉環宇電源股份公司(Huanyu Power Source Co.)有1,000名員工被發現體內的元素超標。松下和環宇均表示﹐它們已對在污染環境下工作的工人採取了防護措施﹐為他們提供了超過中國法律要求的醫療福利和補償。

不過﹐上面這些情況未必都是企業或政府部門主動管理的結果。以松下那家電池廠為例﹐污染的情況是一些工人看到電視節目介紹中毒的知識後自己去檢查後才發現的。

惠州超霸電池廠工人針對污染發起的抗議活動之所以能堅持下來﹐是因為身為該廠工程師的王鳳平向公眾揭露了這件事。

大學畢業的王鳳平出生在一個相對富裕的家庭﹐1995年﹐她進入當時成立不久的惠州超霸電池公司工作﹐擔任機械工程師。當時﹐這家屬於香港上市公司金山工業(集團)有限公司(Gold Peak Industries (Holdings) Ltd.)旗下新加坡上市子公司的工廠在當地享有盛譽﹐該公司後來成為中國最大的鎳-電池生產商。

王鳳平任職的機械部在一幢粉色斜頂的大樓里﹐週圍有圍牆環繞。樓里的生產車間有大約1,500名穿著清一色藍工裝的女工每天12小時組裝用於玩具和其他產品的鎳-電池。隨著公司的不斷發展﹐目前超霸已擁有幾十家美國客戶﹐包括勁量電池(Energizer Battery Co.)、寶潔(Proctor & Gamble)旗下的金霸王(Duracell)、Spectrum Brands Inc.旗下的Ray-O-Vac、孩之寶、美泰、沃爾瑪和玩具反鬥城等。

多年來﹐工廠的工人們老說自己病痛不斷──比如惡心、脫發和乏力等等。但超霸電池公司的管理層聲稱公司不知道的危險程度。該公司首席運營長Henry Leung說﹕“我們知道它有危害﹐但我們以為如果處理方式得當的話就會沒事。這個東西對中國來說是新鮮事物。”

在工廠里﹐王鳳平大多數時間都是在辦公室里畫機械設計圖。但她起訴工廠的訴狀稱﹐2002至2004年間﹐她曾長時間在生產車間工作﹐吸入了大量粉塵。

2003年﹐一些患病的工人自己掏錢在一家職業病醫院進行了檢查﹐得知自己體內的超標。這個消息在工廠內引起了恐慌﹐工人們要求公司承擔檢測費用。最終有數百名工人罷工。

超霸電池公司表示﹐2004年年中﹐當地建起可進行大規模檢測的設施之後﹐公司立刻開始出錢讓員工進行檢測。初步檢查發現﹐有177名工人體內的含量超出了國家規定的上限﹐並有兩人被確診為中毒。幾十名工人立即接受了住院治療。

對人體的影響方式不一﹐因此超霸電池公司的許多超標工人並未發病﹐但這並不表示他們今後不會發病。

大約有900名工人辭掉了工作﹐超霸電池公司給受到影響的工人發放了一次性離職補償﹐最低500美元。該公司說平均補償金額為2100美元。許多工人表示﹐這筆錢連他們的醫藥費都不夠。

超霸稱其為受影響的工人支付了逾100萬美元的補償金和醫藥費﹐已經超出了法律要求的限度。超霸的Henry Leung說﹐公司想關心工人﹐但一些工人故意裝病騙錢。他說﹐那些工人想被診斷為中毒﹐這樣人們就會不斷地給他們賠償金。

就在這件事在工廠內鬧得沸沸揚揚時﹐王鳳平還是個局外人。在這家工廠工作的九年時間中﹐她很少接觸普通工人﹐而她540美元的週薪幾乎是普通工人掙的三倍。其他工人在食堂吃飯﹐而王鳳平則坐在鋪著桌布、擺著精美餐具的經理餐廳里用餐。

但在2004年10月﹐當超霸公司首次掏錢開展全公司範圍的檢測時﹐王鳳平的檢測結果顯示﹐其體內的含量超出了中國政府規定的上限。然而﹐中國職業病法律規定﹐只有連續兩次檢測結果均為超標者才能列為觀察對象。第二次檢測顯示王女士的水平正常﹐因而沒有資格獲得補助。

《華爾街日報》請了倫敦、瑞典和美國的三位職業病醫生審查王女士的病歷﹐他們說她第一次檢測的結果清楚地顯示出腎臟受損的跡象﹐而那可能是中毒的標志。

得州大學公共衛生學院(University of Texas School of Public Health)的職業病和環境科學專家阿爾奇•卡爾森(Arch Carson)博士說﹕“毫無疑問﹐2004年﹐她有無庸置疑的腎臟受損跡象﹐而對於一個工作中會接觸到的人來說﹐這是不容忽視的。”

超霸公司表示﹐它依靠廣州市職業病醫院的專家來確定工人是否需要接受觀察。

未呈現任何症狀的王鳳平繼續打羽毛球和慢跑鍛煉。但到了2006年初﹐她開始覺得極度虛弱﹐還經常頭痛。她的皮膚開始迅速老化﹐眼睛也凹陷下去了。2006年11月﹐王鳳平在當地一家醫院被確診為慢性腎衰竭﹐醫生說這可能會縮短她的壽命。

2006年12月25日﹐王鳳平將自己的診斷結果告知超霸公司管理層。她要求公司送她去廣州的職業病醫院﹐那裡有治療中毒的設施。

隨之而來的是一場僵局。公司聲稱﹐願意為王鳳平提供幫助﹐但她拒絕遵照當地的法律程序辦。根據當地法律﹐王鳳平應先去本地醫院問診﹐以便為廣州的重點職業病醫院提供參考。超霸公司說﹐王鳳平要求他們直接送她去廣州的醫院﹐這違反了規定。

2007年5月﹐王鳳平提起訴訟﹐要求超霸公司給付賠償金和醫藥費共40萬美元。為了給自己的案子提供佐證﹐王鳳平借使用公司電腦的機會下載了一些文件﹐文件顯示她部門內的其他工人也接觸了。超霸公司稱﹐沒有證據表明王鳳平的病與有關﹐而廣州職業病醫院的醫生說﹐她的腎衰竭沒有達到職業病的標准。

去年夏天﹐王鳳平的健康狀況惡化。南京一家醫院的病歷顯示﹐她有發燒和呼吸感染的情況。根據她的病歷﹐醫生們為她治療了慢性腎衰竭﹐並將“長期接觸含物質”列為可能的病因。

包括王鳳平在內的工人們試圖引起人們對這一事件的注意之時﹐一場公關大戰爆發了。2005年﹐超霸公司以誹謗罪起訴代表這些工人的勞工權利組織。這件案子正由香港法院審理。

據知情人士稱﹐去年8月﹐王鳳平和幾名同事准備接受《華爾街日報》一位記者採訪時﹐被警察截住﹐並被扣留在惠州警察局近13個小時。當時在惠州警察局的一名人士說﹐工人們被告知﹐如果他們再向媒體放話﹐將被控以叛國罪。惠州市政府聲稱警方沒有扣留電池廠的工人。

惠州警局的事件發生後﹐王鳳平不再接聽手機。但她開始寫博客﹐為中毒的受害者提供建議。她最近的一篇中文博客文章寫道﹐基本上﹐職業病是可以避免的﹐但這樣做代價高昂。金錢是老闆的命根子。而對他們來說﹐工人的性命一文不值。

在揭露其電池問題的文章出現以後﹐超霸電池公司停止了在自己的工廠中生產這種電池﹐現已將生產環節外包給中國的獨立工廠。

在美國﹐在孩之寶停止使用鎳電池五年後﹐美泰公司和玩具反鬥城尚未採取同樣的措施﹐但均表示正在開發替代品。沃爾瑪不再從金山電池公司採購電池﹐但拒絕表態是否會繼續在產品中使用電池。

美泰公司說﹐電池的一些性能優於替代品﹐比如長期不用時能更好地保持電力。

JANE SPENCER / JULIET YE

王鳳平的博客



pancreas

pancreas : n. (名詞 noun) 【解】胰腺

n.

A long, irregularly shaped gland in vertebrates, lying behind the stomach, that secretes pancreatic juice into the duodenum 十二指腸 and insulin, glucagon高(增)血糖素, and somatostatin( 抑制劑?) into the bloodstream.

[Greek pankreas : pan-, pan- + kreas, flesh.]


pancreas

A gland in the abdomen with two functions: the endocrine pancreas (the islets of Langerhans) secretes the hormones insulin and glucagon; the exocrine pancreas secretes the pancreatic juice. Known by the butcher as sweetbread or gut sweetbread, as distinct from chest sweetbread which is thymus.

すいぞう 膵臓

【解】the pancreas.
膵臓炎 pancreatitis.

南里 征典さん(なんり・せいてん=作家、本名南里勝典=な んり・かつのり)が18 日、膵臓(すいぞう)がんで死去、68歳。通夜は20 日午後6時30分、葬儀は21日 午前11時30分から静岡県伊東市吉田10