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A Striking Look into the Invisible World of Phase 1 Clinical Trials: A Book Review of Jill Fisher's Adverse Events 对第一阶段临床试验的无形世界的惊人观察:吉尔·费舍尔不良事件的书评
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-24 DOI: 10.1080/14636778.2020.1868989
R. Richards
It is her analysis of how the latter process is instrumental in not only providing the Phase 1 industry with ready access to a pool of dedicated volunteers but also serves to generate data that presents pharmaceutical products in the best and safest way, that demonstrates how social inequalities are exploited for systematic profiteering by the pharmaceutical sector. This quote succinctly encapsulates the argument laid out in Jill A. Fisher's "Adverse Events": the Phase 1 clinical trial industry in the US not only relies upon but also exploits the social inequalities of the society in which it operates. [Extracted from the article] Copyright of New Genetics & Society is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
她分析了后一个过程如何发挥作用,不仅为第一阶段的制药行业提供了现成的志愿者资源,还有助于生成以最佳和最安全的方式呈现制药产品的数据,这表明了制药行业是如何利用社会不平等进行系统性暴利的。这句话简洁地概括了Jill A. Fisher在《不良事件》中提出的观点:美国的第一阶段临床试验行业不仅依赖而且利用了它所处社会的社会不平等。【摘自文章】《新遗传与社会》的版权是Routledge的财产,未经版权所有者的明确书面许可,其内容不得复制或通过电子邮件发送到多个网站或发布到listserv。但是,用户可以打印、下载或通过电子邮件发送文章供个人使用。这篇摘要可以删节。对副本的准确性不作任何保证。用户应参考资料的原始出版版本以获取完整摘要。(版权适用于所有摘要。)
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引用次数: 0
The social shaping of a diagnosis in Next Generation Sequencing 下一代测序中诊断的社会塑造
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-20 DOI: 10.1080/14636778.2020.1853514
J. Kuiper, P. Borry, D. Vears, I. van Hoyweghen
Although Next Generation Sequencing (NGS) has increased our ability to test and diagnose, its results are often not clear-cut and require a complex interpretation and negotiation process by both healthcare professionals and patients involved. In this paper, we explore how diagnoses identified through NGS are socially shaped under influence of the broader social context. Using an analytical framework stemming from the sociology of health and illness and science and technology studies, with a focus on the construction of diagnosis and the role of uncertainty in medicine, we analyze the existing corpus of literature on NGS diagnostic practices. We show how in this early implementation phase of NGS, in which standardization efforts are not yet solidified, the boundary struggles around diagnoses obtained through NGS are particularly visible. We discuss the different steps in the diagnosis shaping process and what it subsequently entails to give and a receive a diagnosis using NGS.
虽然下一代测序(NGS)提高了我们的检测和诊断能力,但其结果往往不明确,需要医疗保健专业人员和相关患者进行复杂的解释和协商过程。在本文中,我们探讨了在更广泛的社会背景的影响下,通过NGS确定的诊断是如何被社会塑造的。使用源自健康与疾病社会学和科学技术研究的分析框架,重点关注诊断的构建和不确定性在医学中的作用,我们分析了关于NGS诊断实践的现有文献语库。我们展示了在NGS的早期实施阶段,标准化工作尚未固化,围绕通过NGS获得的诊断的边界斗争是如何特别明显的。我们讨论了诊断形成过程中的不同步骤,以及随后使用NGS给出和接受诊断所需要的内容。
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引用次数: 4
Governing expectations of forensic innovations in society: the case of FDP in Germany 管理社会对法医创新的期望:以德国自由民主党为例
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-20 DOI: 10.1080/14636778.2020.1868987
Nina Amelung, H. Machado
This article is about the governance of expectations of forensic DNA phenotyping (FDP) innovations in Germany used for the prediction of human externally visible traits such as eye, hair, and skin color, as well as biological age and biogeographic ancestry. In 2019, FDP technologies were regulated under the label “extended DNA analysis”. We focus on the expectations of members of the forensic genetics’ community in Germany, in anticipation and response to those of regulators who advocated for such technologies. Confronted with regulators’ expectations of omnipotent technologies and the optimistic promise that they will enhance public security, forensic geneticists responded with attempts to adjust such expectations, specifying limits and risks, along with a particular logic sorting matters of concern. We reflect on how forensic geneticists’ govern expectations through forms of distributed anticipatory governance, delimiting their obligations, and distributing accountability across the criminal justice system.
这篇文章是关于德国法医DNA表型(FDP)创新的管理期望,用于预测人类外部可见特征,如眼睛、头发和皮肤颜色,以及生物年龄和生物地理血统。2019年,FDP技术在“扩展DNA分析”标签下受到监管。我们关注的是德国法医遗传学社区成员的期望,以及对那些倡导此类技术的监管机构的期望和回应。面对监管机构对全能技术的期望,以及它们将增强公共安全的乐观承诺,法医遗传学家试图调整这种期望,明确限制和风险,同时用一种特殊的逻辑对关注的问题进行分类。我们反思法医遗传学家如何通过分布式预期治理的形式来管理期望,界定他们的义务,并在整个刑事司法系统中分配责任。
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引用次数: 4
Accessing targeted therapies for cancer: self and collective advocacy alongside and beyond mainstream cancer charities. 获取癌症靶向疗法:在主流癌症慈善机构之外的自我和集体宣传。
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-17 eCollection Date: 2021-01-01 DOI: 10.1080/14636778.2020.1868986
Anne Kerr, Choon Key Chekar, Julia Swallow, Emily Ross, Sarah Cunningham-Burley

As precision oncology has evolved, patients and their families have become more involved in efforts to access these treatments via fundraising and campaigning that take place outside of the larger cancer charities. In this paper, we explore the solidarities, networks, and emotional work of the UK-based access advocates, drawing on the stories of nine advocates, which included interviews and content analyses of their social media posts and coverage of their case in news, commentary, and fundraising websites. We consider the emotional and knowledge work of building networks that spanned consumerist and activist agendas, forged individual and collective goals, and orientations toward the public, private, and third sectors as part of securing support and access. Through these various practices, the actors we have studied cultivated personal advantage and solidarities with other patients and advocates, and in so doing engaged in self and collective advocacy alongside and beyond mainstream cancer charities.

随着精准肿瘤学的发展,患者及其家属通过在大型癌症慈善机构之外开展筹款和宣传活动,更多地参与到获得这些治疗的努力中来。在本文中,我们以九位倡导者的故事为基础,对他们的社交媒体帖子以及新闻、评论和筹款网站对其案例的报道进行了访谈和内容分析,探讨了英国获得治疗倡导者的团结、网络和情感工作。我们考虑了建立网络的情感和知识工作,这些网络跨越了消费主义和激进主义议程,形成了个人和集体目标,并面向公共、私营和第三部门,作为确保支持和获取的一部分。通过这些不同的实践,我们所研究的参与者培养了个人优势以及与其他患者和倡导者的团结,并以此参与到主流癌症慈善机构之外的自我和集体倡导活动中。
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引用次数: 0
Assessing public opinions on the likelihood and permissibility of gene editing through construal level theory 通过解释水平理论评估公众对基因编辑的可能性和可容许性的意见
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-11 DOI: 10.1080/14636778.2020.1868985
Derek So, R. Sladek, Y. Joly
Anticipatory policy for gene editing requires assessing public opinion about this new technology. Although previous surveys have examined respondents’ views on the moral acceptability of various hypothetical uses of CRISPR, they have not considered whether these scenarios are perceived as plausible. Research in construal level theory indicates that participants make different moral judgments about scenarios seen as likely or near and those seen as unlikely or distant. Therefore, we surveyed a representative sample of 400 Americans and Canadians about both the likelihood and the permissibility of 23 commonly discussed uses of gene editing. Respondents with more knowledge of gene editing generally thought these applications would be more likely within the next 20 years. There was a strong positive relationship between the perceived likelihood and permissibility of most CRISPR applications. Our results suggest that ongoing public engagement efforts for gene editing could be improved by taking its perceived time-frames into account.
基因编辑的预期政策需要评估公众对这项新技术的看法。尽管之前的调查已经检查了受访者对各种假设的CRISPR用途的道德可接受性的看法,但他们没有考虑这些场景是否被认为是合理的。解释水平理论的研究表明,参与者对可能或接近的情景和不太可能或遥远的情景做出不同的道德判断。因此,我们调查了400名美国人和加拿大人的代表性样本,调查了23种常被讨论的基因编辑用途的可能性和可接受性。对基因编辑有更多了解的受访者普遍认为,这些应用在未来20年内更有可能实现。大多数CRISPR应用的感知可能性和许可度之间存在强烈的正相关关系。我们的研究结果表明,考虑到基因编辑的感知时间框架,可以改善正在进行的公众参与工作。
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引用次数: 4
Past-futures in experimental care: breast cancer and HIV medicine 实验护理的过去和未来:乳腺癌和艾滋病医学
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-06 DOI: 10.1080/14636778.2020.1861542
S. Day, William Viney, Jane Bruton, H. Ward
Cambrosio et al. (2018. “Extending Experimentation: Oncology’s Fading Boundary Between Research and Care.” New Genetics and Society 37 (3): 207–226) argue that “experimental care” in contemporary oncology involves the rapid merging of patient research and care, and invite further study into developments across other health conditions. We present a 2018–2019 study of experimental breast cancer care in an urban clinical setting in the light of two other studies in the same hospital group: in the same cancer service (2013–14) and, prompted by these earlier findings, an interview study in HIV services (2014–15). We found that patients and staff anticipated better outcomes by treating sub-types of breast cancer but they also hoped for a better one-size-fits-all approach, akin to the antiretroviral treatments introduced for HIV and explored in our interview study. We conclude that the promise of targeted treatment for sub-types of disease – variously described as experimental care, personalised, precision, stratified and sub-group medicine – is accompanied by hopes for a single, standard, effective approach.
Cambrosio et al.(2018)。“扩展实验:肿瘤学研究与护理之间逐渐消失的界限”《新遗传学与社会》37(3):207-226)认为,当代肿瘤学的“实验性护理”涉及病人研究和护理的快速融合,并邀请进一步研究其他健康状况的发展。根据同一医院组的另外两项研究:同一癌症服务(2013-14),以及基于这些早期发现的艾滋病毒服务访谈研究(2014-15),我们提出了2018-2019年在城市临床环境中实验性乳腺癌护理的研究。我们发现,患者和工作人员期望通过治疗乳腺癌亚型获得更好的结果,但他们也希望有一种更好的一刀切的方法,类似于我们在访谈研究中探索的针对艾滋病毒的抗逆转录病毒治疗。我们得出的结论是,针对亚型疾病的靶向治疗的前景——被不同地描述为实验性护理、个性化、精确、分层和亚组医学——伴随着对单一、标准、有效方法的希望。
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引用次数: 6
Local mutations: on the tentative beginnings of molecular oncology in Britain 1980–2000 局部突变:1980-2000年英国分子肿瘤学的初步研究
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-02 DOI: 10.1080/14636778.2021.1880887
S. Sturdy
Popular and scientific accounts of the molecularisation of cancer typically attribute it to advances in laboratory science, particularly molecular geneticists. However, historical research has indicated that clinical expertise input was often vital for advancing such work. The present paper reinforces that view. Looking in detail at British research into the molecular genetics of familial cancers during the 1980s and 1990s, it shows that that research, too, depended on crucial input from family cancer clinics. Moreover, the development of clinical services for familial cancers was in turn shaped by the demands of contributing to molecular genetic research. The paper concludes that accounts of the molecularisation of cancer that suppose a one-way transfer of knowledge and practice from laboratory to clinic misrepresent the complex interactions that were involved in molecularising familial cancers, and that were informed by the particular local and national circumstances in which they took shape.
大众和科学对癌症分子化的解释通常将其归因于实验室科学的进步,尤其是分子遗传学家。然而,历史研究表明,临床专业知识的投入往往是至关重要的推进这一工作。本文强化了这一观点。仔细观察上世纪80年代和90年代英国对家族性癌症分子遗传学的研究,结果表明,这些研究同样依赖于家族癌症诊所的关键投入。此外,家族性癌症临床服务的发展反过来又受到分子遗传学研究需求的影响。这篇论文的结论是,假设知识和实践从实验室到临床的单向转移,对癌症分子化的描述歪曲了家族性癌症分子化过程中涉及的复杂相互作用,这种相互作用是由特定的地方和国家环境形成的。
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引用次数: 0
Organizing the precision clinic: arranging expertise, knowledge and technologies in cancer precision medicine clinical trials 组织精准临床:安排癌症精准医学临床试验的专家、知识和技术
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-02 DOI: 10.1080/14636778.2021.1882839
Stefano Crabu
The aim of this article, which draws on qualitative research focussed on working practices around a genomic-informed clinical trial, is to contribute to the ongoing debate on how care professionals and biomedical investigators mobilize collective expertise in and across organizational settings to shape so-called precise knowledge in cancer medicine. In so doing, the paper discusses three interrelated issues concerning the day-to-day practices of those doing what they are supposed to do to produce knowledge capable of enacting a precision oncology regimen: (i) situatedness and reshuffling of the professional jurisdiction (work always takes place in a texture of practices influencing how the work is understood and carried out); (ii) organizing technologies (mobilization of different kinds of medical technologies to produce knowledge when carrying out work practices as a vehicle for epistemic negotiation); and (iii) articulation work (the centrality of cooperative work to enact trial work).
这篇文章的目的,是利用围绕基因组信息临床试验的工作实践的定性研究,为正在进行的关于护理专业人员和生物医学研究人员如何在组织环境中和跨组织环境中调动集体专业知识来形成所谓的癌症医学精确知识的辩论做出贡献。在此过程中,本文讨论了三个相互关联的问题,这些问题涉及那些从事他们应该做的工作以产生能够制定精确肿瘤学方案的知识的人的日常实践:(i)专业管辖权的情境性和重组(工作总是在影响工作如何理解和开展的实践结构中进行);(二)组织技术(在开展工作实践时调动不同种类的医疗技术以产生知识,作为知识谈判的工具);(三)衔接工作(以协同工作为中心制定试点工作)。
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引用次数: 4
Organizing precision oncology: introduction to the special issue 组织精密肿瘤学:特刊导论
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2021-01-02 DOI: 10.1080/14636778.2021.1883501
P. Bourret, P. Castel, H. Bergeron, A. Cambrosio
This Special Issue (SI) on “Organizing precision oncology” features a number of articles initially presented at an International Workshop on “Organizational and epistemic innovation in precision cancer medicine” that took place in November 2018 in Paris. The Workshop was convened to mark the conclusion of a project supported by the French National Cancer Institute (INCa), entitled “Targets and trials: A sociological investigation of personalized cancer medicine in action (PERSONA).” The papers included in the SI have been revised and updated to reflect developments in the two years since the workshop was held. As hinted by the title of the Workshop, they investigate the implementation of precision oncology by focusing on the nexus between organizing and experimenting. The SI thus includes contributions that interface Science & Technology Studies (STS) and Organization Studies to analyze how clinicians and researchers deploy genomic platforms (Cambrosio et al. 2018) and the socio-technical and organizational arrangements that act as a condition of possibility for the performance of this new kind of clinical medicine. According to the 2020 Annual Report of the Personalized Medicine Coalition (PMC; http://www.personalizedmedicinecoalition.org) – an “international, multistakeholder, non-profit organization” for promoting the eponymous domain – the number of individualized medicines on the US market grew by 116% during the previous four years, and more than 75,000 genetic tests are available. In oncology, 61% of clinical trials now incorporate biomarkers compared to just 18% in 2000. In 2020, the FDA approved 27 precision oncology drugs, including 10 new molecular entities (NMEs) and 17 new indications of previously approved drugs, a 35% increase compared to the previous year (Staff Reporter 2021). These data point to a shift from the traditional focus on a tumor’s tissue of origin to the genetic basis of the disease, as highlighted, for instance, by the New Genetics and Society, 2021 Vol. 40, No. 1, 1–6, https://doi.org/10.1080/14636778.2021.1883501
本期关于“组织精准肿瘤学”的特刊(SI)刊载了2018年11月在巴黎举行的“精准癌症医学的组织和认知创新”国际研讨会上首次发表的一些文章。研讨会的召开是为了纪念法国国家癌症研究所(INCa)支持的一个项目的结束,该项目名为“目标和试验:个体化癌症药物的社会学调查”(PERSONA)。自研讨会举办以来,已修订和更新了SI中包含的文件,以反映两年来的发展情况。正如研讨会的标题所暗示的那样,他们通过关注组织和实验之间的联系来研究精确肿瘤学的实施。因此,SI包括将科学与技术研究(STS)和组织研究相结合的贡献,以分析临床医生和研究人员如何部署基因组平台(Cambrosio et al. 2018),以及作为这种新型临床医学表现可能性条件的社会技术和组织安排。根据个性化医疗联盟(PMC;http://www.personalizedmedicinecoalition.org)——一个促进同名领域的“国际、多方利益相关者、非营利组织”——在过去的四年里,美国市场上的个体化药物数量增长了116%,有超过75000种基因测试可用。在肿瘤学领域,61%的临床试验纳入了生物标志物,而2000年这一比例仅为18%。2020年,FDA批准了27种精准肿瘤药物,其中包括10种新分子实体(NMEs)和17种先前批准药物的新适应症,与上一年相比增加了35% (Staff Reporter 2021)。这些数据表明,传统上对肿瘤起源组织的关注转向了疾病的遗传基础,如《新遗传学与社会》(New Genetics and Society) 2021年第40卷第1 - 6期(https://doi.org/10.1080/14636778.2021.1883501)所强调的那样
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引用次数: 5
Beyond full jurisdiction: pathology and inter-professional relations in precision medicine 超越完全管辖权:病理和专业间的关系在精密医学
IF 1.8 4区 医学 Q2 Social Sciences Pub Date : 2020-12-23 DOI: 10.1080/14636778.2020.1861543
H. Bergeron, P. Castel, Audrey Vézian
The rise of precision medicine represents a challenge for pathology, which must now more closely link research and diagnostic and collaborate on new bases with other specialties. Our paper is based on the study of four French cancer centers invested in developing precision medicine. Molecular biology is particularly threatening for pathologists in settings where medical oncologists and biologists believe that the discipline is capable of presiding over if not altogether replacing morphology as the principal basis for diagnosis. However, we will show that the organizational arrangements for circulating tumor specimens and producing diagnoses, as well as the place occupied by pathologists in these arrangements, have varied from place to place and over time. These configurations are the result of preexisting arrangements and local negotiations among professionals, where the aim is rather to include and coordinate specialties within the production line rather than exclude them from the jurisdictional remit.
精准医学的兴起对病理学提出了挑战,病理学现在必须更紧密地将研究和诊断联系起来,并在新的基础上与其他专业合作。我们的论文是基于四个法国癌症中心的研究,这些中心投资于开发精准医疗。分子生物学对病理学家的威胁尤其大,因为医学肿瘤学家和生物学家认为,即使不能完全取代形态学作为诊断的主要依据,这门学科也有能力主导病理学。然而,我们将展示循环肿瘤标本和产生诊断的组织安排,以及病理学家在这些安排中所占据的位置,随着时间和地点的不同而变化。这些配置是现有安排和专业人员在当地谈判的结果,其目的是在生产线内包括和协调专业人员,而不是将其排除在管辖范围之外。
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引用次数: 5
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New Genetics and Society
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