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Clinical trials (studies on drugs or medical devices in order to obtain government approval) have branched out from the domestic population to the international population. In the book When experiments travel: Clinical trials and the global search for human subjects, Dr. Adriana Petryna examines the reasons for and the ethical issues associated with this evolution of the testing of modern medicine.
Petryna is an associate professor of anthropology at the University of Pennsylvania. She is also the author of another book, Life exposed: Biological citizens after Chernobyl (2002), and she is the co-editor of the book Global pharmaceuticals: Ethics, markets, practices (2006).
When experiments travel: Clinical trials and the global search for human subjects consists of four chapters: Ethical Variability; Arts of Drug Development; The Global Clinical Trial; and Pharmaceuticals and the Right to Health. There is also a list of abbreviations, an introduction, titled "Experimental Fields", acknowledgements, notes, references, and an index. The footnotes are quite lengthy -- from pages 205 to 223. The footnotes contain both references and comments from the author. The book also includes a guide to 34 acronyms and abbreviations used in the book.
The author writes that "not much has been said about the practical and technical concerns that surround current strategies of clinical research and how they affect collective and public health processes downstream" (p, 6). The author states that her goal "is to foster less partisan and more comprehensive understandings of the human dimension of scientific innovation" (p. 7), and writes that her "book is not 'antiscience' " (p. 6).
On page 7, the author writes, "As health risk becomes a resource for capital, ethical variability becomes a core value and a presumed modus operandi in globalized clinical research". She also writes that the challenge of the anthropological nature of her study is "to engage the transparent and public ways in which private-sector research undergoes global restructuring today" (p. 14). The author writes that she is , "particularly concerned with how scientific integrity is maintained and ensured in new clinical trials frontiers, as well as with conveying the ethical reflections of the diverse actors involved" (p. 17). The term "actors" refers to physicians and scientists involved in clinical trials.
The author writes that the book "examines the organizational cultures of industry-sponsored clinical research, probing scientific, ethical, and regulatory practices" (p. 5). The author then asks the following questions: "Are clinical trials exploitative or are they social goods or some combination of both? How are research protocols designed and data produced? How do the results of clinical trials strengthen or undermine the delivery of affordable and effective interventions? Who is ultimately responsible for the experimental subject's immediate and long-term well-being?" (p. 11).
The book focuses mostly on clinical trials conducted in Eastern Europe, where a majority of outsourced clinical trials take place. The author particularly writes about a trip she took to Poland in 2005 to study the clinical trials industry. The author also looks at clinical trials conducted in Latin America, particularly in Brazil.
The author summarizes the laws and regulations that govern clinical trials research, including the International Conference on Harmonisations' (ICH) "Good Clinical Practices" (GCPs). The author also discusses the organizations involved in clinical trials, such as the Contract Research Organizations (CROs).
Many of the quotes in the book are from anonymous sources, such "a middle-aged business manager" named "Evan" from "Across-the-Globe Research (AGR)". However, no such organization exists. The author writes in the Acknowledgments that "Except in cases where individuals chose to be identified, I have maintained their anonymity to the extent possible by using pseudonyms and creating composite characters and entities that do not refer to any specific businesses" (p. 201). The author also writes in the footnotes in regards to Chapter 1, "I have aggregated the experiences of the researchers and businesspeople I spoke to in two companies", which she has named AR/CH and Tem/po. It is understandable that the sources would be anonymous, considering that some of these anonymous quotes could be considered to be potentially damaging.
The author calls for an "international trial registry" in order to "protect patient-citizens in an era of global experimentality" through, in part, gauging the "relevance of international ethical guidelines" (p. 13).
The book is an interesting and provocative read of the clinical trials industry from an anthropological viewpoint.
© 2010 Stephanie Sarkis
Dr. Stephanie Sarkis is the author of three books: 10 Simple Solutions to Adult ADD: How to Overcome Chronic Distraction & Accomplish Your Goals (2006); Making the Grade with ADD: A Student's Guide to Succeeding in College with Attention Deficit Disorder (2008); and ADD and Your Money: A Guide to Personal Finance for Adults with Attention Deficit Disorder (2009). Dr. Sarkis is an Adjunct Assistant Professor at Florida Atlantic University in Boca Raton, Florida. She is also a National Certified Counselor (NCC) and Licensed Mental Health Counselor (LMHC) based in Boca Raton, Florida. She provides counseling and coaching to children and adults with ADHD/ADD. Her website is www.stephaniesarkis.com.