邱仁宗

• 1:中国社会科学院哲学研究所

摘要(Abstract)：

本文试图对我国(大陆)21世纪初开始并流行至今的"干细胞治疗"热提供一个比较全面的概览,并对这种具有中国特色的社会现象做出初步的解释,同时讨论了干细胞临床转化中的临床伦理、研究伦理和管理问题,最后扼要总结了我们从中应该吸取的几点教训。

关键词(KeyWords)： 干细胞;临床转化;临床试验;伦理问题;医学专业精神;医学重商主义;临床对照试验;安慰剂

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 邱仁宗

DOI: 10.19524/j.cnki.10-1009/g3.2013.01.002

参考文献(References)：

• ②Dominique　McMahon.Stem　cell　translation　in　China:Current　clinical　activity　and　emerging issues(中国的干细胞移植:目前的临床活动和出现的问题),在中国医学科学院/北京协和医学院生命伦理学研究中心组织的国际生命伦理学研讨会上的发言,2012年12月1日。
• ④胡祥.http://www.1000plan.org/wiki/index.php?doc-view-318,http://www.biogo.net/news/show-21917.html;北科生物.http://money.163.com/09/0910/14/5IRT8AAD00253B0H.html。
• ②北科生物.http://www.beike.cc.
• ①北科生物2009。
• ②参见网站:www.beike.com.
• ②www.cdma.gov.cn.
• ①见马克思引用邓宁格在“工会与罢工”中的话:“一有适当的利润,资本就会非常胆壮起来。只要有10%的利润,它就会到处被人使用;有20%,就会活泼起来;有50%,就会引起积极的冒险;有100%,就会使人不顾一切法律;有300%,就会使人不怕犯罪,甚至不怕绞首的危险。”资本论第一卷.北京:人民出版社,1958:839。
• ①翟晓梅.生命伦理学导论.北京:清华大学出版社,2005:57-80。
• ②参见:http://beikebiotech.com/.
• [1]Amariglio N et al.Donor—derived brain tumor following neural stem cell transplan-tation in an ataxia telangiectasia patient,PLOS Medicine,2009,6(2).http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000029[2009-2-17].
• [2]白剑峰等.吉林硅谷医院仍在进行胚胎干细胞诊疗———“唯一获批”医院忽悠患者?http://health.people.com.cn/GB/17970157.html[2012-5-24].
• [3]Baker M.Tumours spark stem—cell review,Russian treatment linked to cancerous growths.http://www.nature.com/news/2009/090217/full/457941a.html[2009-2-17].
• [4]Balazovic T.Stemming the flow.China Daily,2009-12-24(7).
• [5]Barclay E.Stem—cell experts raise concerns about medical tourism.The Lancet,2009,373:883-883.
• [6]BIONET.Media release:Tighter controls needed on"stem cell tourism"say Euro-pean and Chinese experts.http://www.bionet—china.org/pdfs/BIONET_medica[2009-9-4].
• [7]Beike Biotech homepage.http://beikebiotech.com/[2012-11-10].
• [8]北科生物.http://money.163.com/09/0910/14/5IRT8AAD00253B0H.html.[2009-9-10].
• [9]Chen H.Stem cell governance in China:From bench to bedside.New Genetics and Society,2009,28:267-282.
• [10]陈永杰等.2007中国十大疑似科技骗局.http://bkb.ynet.com/article.jsp?oid=27130453[2008-01-7].
• [11]Cyranosk D.Stem—cell therapy faces more scrutiny in China—But regulations re-main unclear for companies that supply treatments.Nature,2009,459:146-147.
• [12]Cyranosk D.China’s stem—cell rules go unheeded:Health ministry’s attempt at regulation has had little effect.Nature,2010,484:50.
• [13]Dobkin BH et al.Cellular transplants in China:Observational study from the lar-gest human experiment in chronic spinal cord injury.Neurorehabilitation and Neural Repair,2006,20(1):5-13.
• [14]Dyer C.Doctor who sent patients for stem cell injections is accused of exploitation.British Medical Journal.www.bmj.com/content/340/bmj.c197?tab=full[2010-01-13].
• [15]Feng S.Stemming the flow of cells.Global Times,http://www.globaltimes.cn/NEWS/tabid/99/ID/711725/Stemming—the—flow—of—cells.aspx[2012-5-28].
• [16]Stem—Cell Refugees Yanks are flocking to China for therapy.Global Business.ht-tp://www.businessweek.com/magazine/content/07_07/b4021061.htm[2007-2-12]
• [17]华璐.干细胞移植中国之旅:“领跑”背后的监管难题.http://wenzhai.cnxianzai.com/tansuo/2010/0225/187269.html[2010-2-10].
• [18]黄祺.干细胞真相调查:病床上的“赌博”.新民周刊.http://news.xinmin.cn/do-mestic/zonghe/2007/09/19/895568.html[2007-9-20].
• [19]International Society for Stem Cell Research2008Guidelines for the Clinical Trans-lation of Stem Cells.http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinical-Trans.pdf[2010-3-08].
• [20]Kiatpongsan S,Sipp D.Monitoring and regulatingoffshore stem cell clinics.Sci-ence,2009,323:1564-1565.
• [21]Lee S.Professors critique stem cell medical tourism.http://www.thecrimson.com/article/2012/11/29/stem—cell—medical—tourism.[2012-11-29].
• [22]Liao L et al.Stem cell research in China.Philosophical Transactions of the Royal Society,2007.362(1482):1107-1112.
• [23]Lindvall O,Hyun I.Medical innovation versus stem cell tourism.Science,2009,324:1664-1665.
• [24]MacReady N.The murky ethics of stem—cell tourism.The Lancet Oncology,2009,10:317-318.
• [25]McMahon D.et al.A Regulations are needed for stem cell tourism:Insights from China.The American Journal of Bioethics.2010a.http://www.informaworld.com/smpp/title～content=t713606739.[2010-5-10].
• [26]McMahon D.et al.Lost in translation:China’s struggle to develop appropriate stem cell regulations.Scripted,2010b.7(2):274-285.
• [27]McMahon D.et al.Cultivating stem cell innovation in China,Regenerative Medi-cine.2010c,5(1):35-44.
• [28]Murdoch CE,Scott CT.Stem cell tourism and the power of hope.American Jour-nal of Bioethics,2010,10(5):16-23.
• [29]Novella S.Selling stem cell hype.Skeptical Inquirer,2011,35(5).
• [30]Popper K.The Logic of Scientific Discovery.London:Routledge.1959:82-86.
• [31]秦珍子.内地干细胞医疗混乱有机构直接将干细胞注射到血管.http://news.if-eng.com/society/2/detail_2012_04/25/14125819_1.shtml[2012-4-25].
• [32]Qiu J.To walk again.New Scientists,2007,10(11):57-59.
• [33]Qiu J.Injection of hope through China’s stem—cell therapies,2008a,7:122-123.
• [34]Qiu J,Zhu Jianhong.Citizen of the World.The Lancet,2008b,7:202.
• [35]Qiu J.China clamps down on controversial therapies.The Lancet,2009a,373:1534-1535.
• [36]Qiu J.Controversial Chinese stem—cell company gets top billing.http://blogs.nature.com/cgi—bin/mt/mt—tb.cgi/8389[2009-1-02].
• [37]Qiu J.China spinal cord injury network:Changes from within.2009c,8:606-607.
• [38]Qiu J.Trading on hope.Nature Biotechnology.2009d,27(9):790-792.
• [39]Qiu J.Stem cells in China:Wild East or scientific feast?http://www.economist.com/node/15268869.[2010-1-14].
• [40]邱仁宗,翟晓梅.关于干细胞研究及其临床应用伦理管治的回顾与展望.中国医学伦理学,2009,(5):3-9.
• [41]Qiu RZ,Zhai XM.Stem cell research and its clinical application in China:Interac-tions between science,ethics and society,in Bioethics and the Global Politics of Stem Cell Science:Medical Applications in a Pluralistic World.edited by Alastair Campbell and Benjamin Capps,Imperial College Press,UK and World Scientific Publishing Co.2010:395-420.
• [42]王晓萃等.浅谈神经干细胞在临床应用中的伦理问题.医学与哲学,2005,11:40-41.
• [43]Watts J.Controversy in China.Lancet,2005,365(9454):109-110.
• [44]Zarzeczny A,Caulfield T.Stem cell tourism and doctors'duties to minors:A view from Canada.American Journal of Bioethics,2010,10(5):3-15.
• [45]中国科技部和卫生部.人胚胎干细胞研究的伦理指导原则.http://www.most.gov.cn.[2003-12-24].
• [46]中国细胞生物学学会干细胞生物学分会和国家干细胞与再生医学产业技术创新战略联盟就卫生部《关于开展干细胞临床研究和应用自查自纠工作的通知》的声明和意见.http://www.bioon.com/organization/society/515886.shtml[2012-1-16].
• [47]中国卫生部.医疗技术临床应用管理办法.http://baike.baidu.com/view/2592852.htm[2009-12-27].
• [48]中国卫生部.关于开展干细胞临床研究和应用自查自纠工作的通知.http://www.bioon.com/industry/SFDA/515574.shtml[2012-1-11].
• [49]中国卫生部医学伦理专家委员会.细胞的临床试验和临床应用的伦理准则(内部文件).2010.
• [50]中华医学会糖尿病学分会.关于干细胞治疗糖尿病的立场声明和关于干细胞治疗糖尿病外周血管病变的立场声明.http://cdschina.org/news_show.jsp?id=598.html[2010-11-25].
• [51]朱虹等.记者调查称干细胞治疗项目多数未经审批.http://scitech.people.com.cn/GB/17819107.html[2012-5-7].