When Experiments Travel: Clinical Trials and the Global Search for Human Subjects

by Adriana Petryna

Overview

The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets.


Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.

Product Details

ISBN-13:	9780691126579
Publisher:	Princeton University Press
Publication date:	05/17/2009
Edition description:	New Edition
Pages:	272
Product dimensions:	6.10(w) x 9.20(h) x 0.80(d)

About the Author

Adriana Petryna is associate professor of anthropology at the University of Pennsylvania. She is the author of the award-winning Life Exposed: Biological Citizens after Chernobyl (Princeton) and the coeditor of Global Pharmaceuticals: Ethics, Markets, Practices.

Table of Contents

Abbreviations ix





INTRODUCTION: EXPERIMENTAL FIELDS 1

The Search for Human Subjects 1

Anthropology and the Global Clinical Trial 5





CHAPTER ONE: ETHICAL VARIABILITY 10

Why Are Clinical Trials Globalizing? 10

Treatment Saturation 19

Experimentality 26

Ethics as "Workable Document" 33

Floater Sites and Hidden Harms 41

The Aftermath of Clinical Trials 44





CHAPTER TWO: ARTS OF DRUG DEVELOPMENT 47

Study Mills 47

Drug-Development Services 53

From Vulnerable to Professional Subjects 61

The Pharmaceutical Boom and Everyday Research 68

Engineering Out Harm 77

The Scientific Plateau and the New Safety Paradigm 85





CHAPTER THREE: THE GLOBAL CLINICAL TRIAL 89

How Many Clinical Trials Are Being Carried Out Worldwide? 89

The Polish Market and the "Nonexistent" Patient 98

Clinical Research Frontiers 106

Collaborations in Global Science 109

Akademia Kliniczna 116

The Work of Slack 119

Patient-Consumers 124

"Our society was not competitive" 127

Pivotal Countries 130

Insurance and Legal Protection 132





CHAPTER FOUR: PHARMACEUTICALS AND THE RIGHT TO HEALTH 139

Reclaiming Patients and the Evidence Base of Drugs 139

"Pharmaceuticals are the new gold" 142

Health Technology Assessment in Brazil 146

The Judicialization of Health 150

Alternative Treatment Guidelines 153

The Clinical Research Unit 156

When a Country Is a Pharmacy 160

A Public Health Experiment 165

What Happens When Clinical Trials End 167

The Values Patients Bring 173

Information Asymmetry and Agency 179





CONCLUSION: THE FUTURE OF GLOBAL MEDICINE 186

Scientific Evidence and Value 186

Drugs as Public Goods 190

Global Health Markets 192

Innovation 195

Acknowledgments 201

Notes 205

References 225

Index 249

What People are Saying About This

Veena Das

This is a very important book, notable for its novel subject, innovative approach, and seriousness. A singular contribution to the anthropology of science and medicine.
— Veena Das, Johns Hopkins University

Arthur Kleinman

This superb book provides the best overview of the pharmaceutical industry's rush to move clinical trials to developing countries, and the intensely troubling moral, political, economic, and cultural issues this effort raises. Petryna's argument is balanced and compelling, and her case studies are riveting.
— Arthur Kleinman, M.D., Harvard University

Paul Rabinow

This thoughtful and reflective book offers us a sobering account of the spread of clinical research in a world without borders and often without norms. Based on careful comparative anthropological research, it both casts light on a gray zone where research, medicine, and capitalism merge, and provides a first-rate example of how an anthropology for the twenty-first century can contribute to our understanding and to the public good.
— Paul Rabinow, author of "Marking Time"

From the Publisher

"This thoughtful and reflective book offers us a sobering account of the spread of clinical research in a world without borders and often without norms. Based on careful comparative anthropological research, it both casts light on a gray zone where research, medicine, and capitalism merge, and provides a first-rate example of how an anthropology for the twenty-first century can contribute to our understanding and to the public good."—Paul Rabinow, author of Marking Time

"This superb book provides the best overview of the pharmaceutical industry's rush to move clinical trials to developing countries, and the intensely troubling moral, political, economic, and cultural issues this effort raises. Petryna's argument is balanced and compelling, and her case studies are riveting."—Arthur Kleinman, M.D., Harvard University

"This is a very important book, notable for its novel subject, innovative approach, and seriousness. A singular contribution to the anthropology of science and medicine."—Veena Das, Johns Hopkins University

Editorial Reviews

Honorable Mention for the 2014 Diana Forsythe Prize, Committee on the Anthropology of Science, Technology, and Computing of the General Anthropology Division, and the Society for the Anthropology of Work

From the Publisher

[S]cholars of the social organization of medicine would appreciate this book for the window it provides into treatment. . . . The book is also an important information source for economic sociologists interested in how a new industry is recontextualized into distant political and professional regimes. Finally, it should be appreciated for the insight it offers into the production of a form of evidence onto which a remarkable amount of importance is placed in contemporary medicine.

Qualitative Sociology - Daniel Menchik

When Experiments Travel is a provocative look inside the outsourcing of clinical trials. The issues that it raises are complex and profound. Hopefully, it will spawn further empirical work and influence the terms of the ongoing debate surrounding the ethics and regulation of international research.

IRB Ethics and Human Research - Alex John London

In When Experiments Travel, Adriana Petryna has written a timely book. It provides an important anthropological perspective on the issues surrounding clinical trials and how to make medical research more transparent and accessible to the general public.

Health Affairs - Dinesh Sharma

She succeeds in presenting a balanced set of viewpoints on a variety of concerns about recruiting practices, informed consent, drug safety, the blurring of lines between clinical practice and research, and issues of distributive justice such as drug pricing and access.

Choice - K.H. Jacobsen

Obama administration officials wondering what to expect from this brewing storm should consult Adriana Petryna's new book When Experiments Travel, which deals with the global clinical trials industry, especially in low-income and middle-income countries.

The Lancet - Helen Epstein

[S]cholars of the social organization of medicine would appreciate this book for the window it provides into treatment. . . . The book is also an important information source for economic sociologists interested in how a new industry is recontextualized into distant political and professional regimes. Finally, it should be appreciated for the insight it offers into the production of a form of evidence onto which a remarkable amount of importance is placed in contemporary medicine.
— Daniel Menchik

Qualitative Sociology

When Experiments Travel is a provocative look inside the outsourcing of clinical trials. The issues that it raises are complex and profound. Hopefully, it will spawn further empirical work and influence the terms of the ongoing debate surrounding the ethics and regulation of international research.
— Alex John London

IRB Ethics and Human Research

In When Experiments Travel, Adriana Petryna has written a timely book. It provides an important anthropological perspective on the issues surrounding clinical trials and how to make medical research more transparent and accessible to the general public.
— Dinesh Sharma

Health Affairs

She succeeds in presenting a balanced set of viewpoints on a variety of concerns about recruiting practices, informed consent, drug safety, the blurring of lines between clinical practice and research, and issues of distributive justice such as drug pricing and access.
— K.H. Jacobsen

Choice

Obama administration officials wondering what to expect from this brewing storm should consult Adriana Petryna's new book When Experiments Travel, which deals with the global clinical trials industry, especially in low-income and middle-income countries.
— Helen Epstein

The Lancet