Traveling Across Borders—The Pitfalls of Clinical Trial Regulation and Stem Cell Exceptionalism
Traveling Across Borders—The Pitfalls of Clinical Trial Regulation and Stem Cell Exceptionalism
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跨境旅行——临床试验监管和干细胞例外论的陷阱
DOI：
10.1080/15265161003754064
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发表时间：
2010
期刊：
影响因子：
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通讯作者：
Dana Wilson‐Kovacs
中科院分区：
文献类型：
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作者：
C. Hauskeller;Dana Wilson‐Kovacs
缺乏关于风险的证据，即使是非危及生命的疾病，如失明，也使得医生不可能代表儿童患者进行干预。这是Zarzeczny和考尔菲尔德的第二类病例的主要关切来源;鉴于这些病例的未知风险，收集有关未经证实的干细胞治疗效果的相关信息至关重要。医生应该采取行动，减少属于第二类的病例的范围，如果可能的话，使其成为一个空集合。虽然我们建议的项目只是朝着这个更大目标迈出的一小步，但我们提出的积极的数据编目将对减少“灰色地带”案件作出重要贡献。考虑到加拿大人口相对较少，因此可能参与干细胞旅行的患者数量有限，国际努力将受到欢迎，可能由CMA，美国医学会（AMA）和英国医学会（BMA）之间的合作伙伴关系协调，甚至可能是世界医学协会（WMA）。重要的是，尽快努力填补围绕未经证实的干细胞治疗的信息空白，并为医生提供履行医疗保健提供者角色所需的工具。在脆弱的患者的生命中，有太多的风险。
An absence of evidence regarding risk, even for nonlife-threatening illnesses such as blindness, makes it impossible for a physician to intervene on behalf of the child patient. This is the main source of concern in Zarzeczny and Caulfield’s second category of cases; given the unknown risks in these cases, the gathering of relevant information regarding the effects of unproven stem cell treatments is of the utmost importance. Physicians ought to take action to reduce the range of cases that fall under the second category, and, if possible, render it an empty set. While the project we recommend would only be a small step toward that larger goal, active cataloging of data which we have proposed will be an important contribution towards reducing the “gray area” cases. Given the relatively small population of Canada, and thus the limited pool of patients who might participate in stem cell travel, an international effort would be welcomed—coordinated perhaps by a partnership between the CMA, the American Medical Association (AMA), and the British Medical Association (BMA), or possibly even the World Medical Association (WMA). It is important that efforts get underway soon to fill the informational void that surrounds unproven stem cell treatments and to give physicians the tools they need to fulfill the role of health care provider. There is simply too much at stake in the lives of vulnerable patients.■