Alberto Cambrosio
Chair and Professor, Department of Social
Studies of Medicine
Professor, Department of Sociology
McGill University
Thursday, November 13, 2008
STS BROWNBAG
"A Conversation with Alberto Cambrosio"
12:00pm – 1:30pm in 2435 Social Science Building
LECTURE
"A Collective Turn in Biomedicine: New Configurations of Practice and New Forms of Objectivity in the Era of Genomics"
4:00pm – 5:00pm in 8417 Social Science Building
(Reception at 3:30pm)
Abstract:
The evolution of Western medicine since World War II may be described as a realignment of biology and medicine that has resulted in the emergence of new practices based on the direct interaction of biology and medicine. The post-war realignment of biology and medicine has in turn been accompanied by the emergence of a new type of objectivity — regulatory objectivity — that is based on the systematic recourse to the collective production of evidence. The term ‘collective’ refers to the kind of evidence that is produced, for instance, by inter-laboratory studies, multi-center clinical trials and research consortia that develop collective devices such as mouse models of disease, genetic maps or clinical and laboratory guidelines. Indeed, collaborative forms of work such as extended networks, expert groups and consortia increasingly structure biomedical activities. The collaboration often extends beyond the border of nations and accelerates the globalization or international standardization of biomedical activities that increasingly distinguish Western biomedicine from other types of medical practices. This ‘collective turn’ is especially visible in two domains, namely genomics — where the production of knowledge relies not only on very large scale collaborative projects such as the Human Genome Project but also on a motley of cooperative groups specializing in a given pathology or specific genes — and, more traditionally, clinical trials, in particular in the field of oncology, where new protocols and therapies emerge from large scale, multi-center clinical trials performed by long-established cooperative groups such as ECOG, in the US, and EORTC in Europe. In this paper we will focus in particular on a new kind of large collaborative clinical trial that emerges at the intersection of these two domains. Its goal is to validate, for clinical purposes, the use of a new type of molecular tool — called ‘genomic signatures’ or ‘gene expression profiles’ — that should allow clinicians to predict both the risk of cancer recurrence and response to therapy. Two ongoing, large-scale genomic signature validation trials focus on breast cancer: the first, to be carried out in Europe, plans to enroll 6,000 patients in 11 participating countries, while the second, will be conducted in North America and plans to enroll 10,000 patients in 900 participating centers. Both trials rely on breast cancer signatures commercialized by biotech companies. They raise issues that fall under the general heading of ‘regulatory objectivity’ and that range from seemingly narrow technical questions — such as how and how fast tumor specimens should be taken from patients and kept until analysis — to questions concerning therapeutic protocols, the complex modalities of informed consent to be obtained from patients, as well as to ‘broader’ questions concerning the redefinition of national and international collaborative links between clinicians and researchers from different disciplines and between public research organization and biotechnology start-ups.
ALBERTO CAMBROSIO BIOGRAPHICAL SKETCH
Please see: http://www.mcgill.ca/ssom/facultyinfo/cambrosio/
Professor, Department of Sociology
McGill University
Thursday, November 13, 2008
STS BROWNBAG
"A Conversation with Alberto Cambrosio"
12:00pm – 1:30pm in 2435 Social Science Building
LECTURE
"A Collective Turn in Biomedicine: New Configurations of Practice and New Forms of Objectivity in the Era of Genomics"
4:00pm – 5:00pm in 8417 Social Science Building
(Reception at 3:30pm)
Abstract:
The evolution of Western medicine since World War II may be described as a realignment of biology and medicine that has resulted in the emergence of new practices based on the direct interaction of biology and medicine. The post-war realignment of biology and medicine has in turn been accompanied by the emergence of a new type of objectivity — regulatory objectivity — that is based on the systematic recourse to the collective production of evidence. The term ‘collective’ refers to the kind of evidence that is produced, for instance, by inter-laboratory studies, multi-center clinical trials and research consortia that develop collective devices such as mouse models of disease, genetic maps or clinical and laboratory guidelines. Indeed, collaborative forms of work such as extended networks, expert groups and consortia increasingly structure biomedical activities. The collaboration often extends beyond the border of nations and accelerates the globalization or international standardization of biomedical activities that increasingly distinguish Western biomedicine from other types of medical practices. This ‘collective turn’ is especially visible in two domains, namely genomics — where the production of knowledge relies not only on very large scale collaborative projects such as the Human Genome Project but also on a motley of cooperative groups specializing in a given pathology or specific genes — and, more traditionally, clinical trials, in particular in the field of oncology, where new protocols and therapies emerge from large scale, multi-center clinical trials performed by long-established cooperative groups such as ECOG, in the US, and EORTC in Europe. In this paper we will focus in particular on a new kind of large collaborative clinical trial that emerges at the intersection of these two domains. Its goal is to validate, for clinical purposes, the use of a new type of molecular tool — called ‘genomic signatures’ or ‘gene expression profiles’ — that should allow clinicians to predict both the risk of cancer recurrence and response to therapy. Two ongoing, large-scale genomic signature validation trials focus on breast cancer: the first, to be carried out in Europe, plans to enroll 6,000 patients in 11 participating countries, while the second, will be conducted in North America and plans to enroll 10,000 patients in 900 participating centers. Both trials rely on breast cancer signatures commercialized by biotech companies. They raise issues that fall under the general heading of ‘regulatory objectivity’ and that range from seemingly narrow technical questions — such as how and how fast tumor specimens should be taken from patients and kept until analysis — to questions concerning therapeutic protocols, the complex modalities of informed consent to be obtained from patients, as well as to ‘broader’ questions concerning the redefinition of national and international collaborative links between clinicians and researchers from different disciplines and between public research organization and biotechnology start-ups.
ALBERTO CAMBROSIO BIOGRAPHICAL SKETCH
Please see: http://www.mcgill.ca/ssom/facultyinfo/cambrosio/