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Medical Research for Hire

The Political Economy of Pharmaceutical Clinical Trials

Jill A. Fisher

Publication Year: 2009

Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care.

Published by: Rutgers University Press

Table of Contents

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pp. vii-

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Acknowledgments

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pp. ix-x

This book is the product of years of dialogue with colleagues, mentors, and friends about the politics of medicine and human subjects research. I have been fortunate to be embedded in networks of talented and generous scholars who have helped make this work better in many different ways. Several...

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Chapter 1: Clinical Trials: Coming Soon to a Physician Near You

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pp. 1-18

A woman and her son wait for the doctor to see them. The doctor, however, is no longer a clinician. Instead, the white male neurologist has transitioned from treating patients to conducting clinical trials for the pharmaceutical industry. To do so, he has converted his private practice into a research...

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Chapter 2: Governing Human Subjects Research

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pp. 19-32

At root and by definition, the clinical trials industry would not be possible without the participation of human subjects. Although it is a highly regulated industry, the research terrain has changed signifi cantly since the United States enacted laws in the 1970s to protect human subjects. To date, there has...

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Chapter 3: Pursuing Contract Research

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pp. 33-65

On my first visit to a large practice, I interviewed Richard,1 a white male physician in his mid-forties who was actively involved in pharmaceutical contract research and had conducted roughly 250 studies since the early 1990s. That day, there were nearly forty studies operating out of his private...

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Chapter 4: Coordinating Clinical Trials

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pp. 66-96

Ruth,1 a charismatic white woman in her early fifties, welcomed me into her office in the clinical research facilities of a large, successful obstetrics and gynecology private practice. Having worked at the investigative site for more than eight years and at another site for several years prior to that, Ruth had...

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Chapter 5: Monitoring the Clinical Trials Industry

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pp. 97-125

One Wednesday evening, I drove to an airport hotel for an interview with Evelyn, 1 a clinical research associate, or “monitor,” at a large contract research organization (CRO). Her company was based in another region of the country, and this was the last evening she was in town before returning home from a...

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Chapter 6: Recruiting Human Subjects

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pp. 126-157

Early in 2005, I received a message on my answering machine. The call was from a company specializing in clinical trials on healthy human subjects and was part of a general recruitment campaign for their facility in the southwestern United States. The woman calling reminded me that I could earn money...

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Chapter 7: Mobilizing Informed Consent

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pp. 158-179

During my fieldwork, I had the opportunity to sit in on an informed consent visit for a study to test the safety of an experimental treatment for Alzheimer’s disease. The prospective human subject was a seventy-five-year-old Latina woman, who was accompanied by her middle-aged son. They had found out...

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Chapter 8: Cultivating Pharmaceutical “Compliance”

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pp. 180-207

Although the majority of my informants seemed to be people who really enjoyed their jobs in the clinical trials industry or who had positive experiences participating in drug studies, I occasionally interviewed someone who was dissatisfied with contract research. One such informant was...

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Chapter 9: Changing Markets in Pharmaceutical Research

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pp. 208-215

The broader context of health care in the United States shapes the organization of pharmaceutical clinical trials. Physician-investigators who conduct studies for pharmaceutical companies and patient-subjects who participate in them do so largely in response to limitations in the structure of health...

Appendix: On Methods

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pp. 217-220

Notes

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pp. 221-244

Index

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pp. 245-257

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About the Author

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pp. 259-

Jill A. Fisher holds a Ph.D. in science and technology studies and is an assistant professor in the Center for Biomedical Ethics and Society at Vanderbilt ...


E-ISBN-13: 9780813545936
E-ISBN-10: 0813545935
Print-ISBN-13: 9780813544090
Print-ISBN-10: 0813544092

Page Count: 272
Illustrations: 1 illustration
Publication Year: 2009

Series Title: Critical Issues in Health and Medicine
Series Editor Byline: Rima D. Apple, Janet Golden

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Subject Headings

  • Drugs -- Testing -- Moral and ethical aspects -- United States.
  • Clinical trials -- Moral and ethical aspects -- United States.
  • Clinical trials -- Economic aspects -- United States.
  • Drugs -- Testing -- Economic aspects -- United States.
  • Contracting out -- United States.
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