Doctoral Dissertation Research: New Therapies and the Multiplication of Disease Diagnoses

Gil EyalMoran Levy哥伦比亚大学在1950至1990年间，癌症研究经历了一次根本性的转变。20世纪50年代的药物筛选计划在不同类型的患者样本中测试了单一化合物对多种癌症的影响。然而，在第一次化疗试验之后的几十年里，研究人员转向了对狭义癌症亚类(例如绝经后女性转移性乳腺癌)的研究，以测试涉及手术、放射治疗和药物组合的复杂疗法。这些研究设计之间的转变，实际上是彼此的镜像，提出了令人困惑的问题：癌症研究是如何改变其结构和方向的？癌症是如何以及何时不再是一个有意义的临床单位的？多种癌症诊断是如何出现并取代它的？这个项目考察了癌症研究的结构，以解释癌症诊断的倍增。研究人员假设，通过临床试验改进抗癌药物的努力是创造新诊断的一种机制。统计学专业知识的引入迫使癌症科学家将患者样本均质化，以便他们能够比较尽可能相似的治疗组和对照组。这迫使研究人员缩小试验的招募标准，并改变诊断方案。这项研究考察了临床试验中用来预测患者对治疗反应的预后变量是否在随后的试验中变成了改进的招募标准，并最终转化为新的诊断。越来越多的诊断规范限制了患者池，并减缓了符合纳入标准的患者的招募。因此，研究人员还假设，诊断规范增加了可以招募患者的机构之间的合作，加强了对标准化和复杂统计工具的需求，允许研究人员进行多中心试验和处理小患者样本，并加强了肿瘤学的专业化。研究人员进行全面的档案研究并分析来自所有参与癌症研究的主要机构的材料：美国国家癌症研究所、食品和药物管理局、联邦医疗保险、来自美国各地的合作研究小组、美国国家医学图书馆和玛丽·拉斯克论文集。该项目为诊断社会学以及标准化和循证医学社会学做出了重要贡献。诊断社会学询问新的诊断是如何产生的。研究人员提出了一种新的机制来驱动诊断的创建。也就是说，医疗药物不仅通过药品营销和以前非医疗疾病的医学化创造机会和激励来开发新的诊断，而且药物的功能是提取数据，从而将患者群体和现有诊断分开。循证医学社会学质疑临床试验是如何成为生物医学的“黄金标准”的。该项目表明，临床试验的内生效应通过碎片化诊断、临床试验、重组癌症研究以及加强标准化和统计专业知识的需要，加强了试验的黄金地位。这项研究还对理解科学程序(同质化)如何与排斥和不同人口群体的医学知识生产中的差异相互作用作出了重要贡献。

SES-1602895Gil EyalMoran LevyColumbia UniversityBetween 1950 and 1990 cancer research underwent a radical transformation. Drug screening programs in the 1950s tested single compounds on multiple cancers in heterogeneous patient samples. Yet in the decades that followed the first chemotherapy trials, researchers turned to studies of narrow subcategories of cancer (e.g. metastatic breast cancer in postmenopausal women) to test complex therapies involving surgery, radiotherapy and drug combinations. The shift between these research designs, that are practically mirror images of one another, poses puzzling questions: How has cancer research shifted its structure and orientation? How and when did 'cancer' stop being a meaningful clinical unit? How did multiple cancer diagnoses emerge and come to replace it?This project examines the structuring of cancer research to explain the multiplication of cancer diagnoses. The researchers hypothesize that the effort to improve anticancer drugs through clinical trials was a mechanism for creating new diagnoses. The introduction of statistical expertise pressured cancer scientists to homogenize patient samples so that they could compare treatment and control groups that were as similar as possible. This compelled researchers to narrow down trials' recruitment criteria and to transform diagnostic schemes. The study examines whether prognostic variables used in clinical trials to predict patients' responses to treatment turned into refined recruitment criteria in subsequent trials and were eventually translated into new diagnoses. The increasing specification of diagnosis limited patient pools and slowed down the recruitment of patients that met inclusion criteria. The researchers thus also hypothesize that diagnosis specification increased the collaboration between institutions that could recruit patients, reinforced the need for standardization and sophisticated statistical tools, allowing researchers to conduct multicenter trials and to work with small patient samples, and reinforced specialization in oncology. The researchers conduct comprehensive archival research and analyze materials from all major institutions involved in cancer research: The National Cancer Institute, The Food and Drug Administration, Medicare, Cooperative Research Groups from across the U.S, The U.S. National Library of Medicine and The Mary Lasker Paper Collection.This project offers an important contribution both to sociology of diagnosis and to sociology of standardization and evidence-based-medicine. Sociology of diagnosis asks how are new diagnoses created. The researchers suggest a novel mechanism that drives the creation of diagnoses. That is, medical drugs create opportunities and incentives to develop new diagnoses not only through pharmaceutical marketing and through medicalization of previously non-medical conditions, but also that drugs function to extract data that serve to split up patient populations and existing diagnoses. Sociology of evidence-based-medicine asks how clinical trials became the 'gold standard' of biomedicine. This project suggests that the endogenous effects of clinical trials acted to reinforce trials' golden status by fragmenting diagnosis clinical trials restructured cancer research and reinforced the need for standardization and statistical expertise. This study also offers a critical contribution to the understanding of how scientific procedures (homogenization) interact with exclusion and with disparities in the production of medical knowledge about different population groups.