When Experiments Travel (ebook)

Argumento de When Experiments Travel (ebook)

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.

"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

"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 Affairs0Abbreviations 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