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Biotechnology Science, Engineering, And Ethical Challenges For The Twenty-First Century Frederick B. Rudolph and Larry V. McIntire, Editors JOSEPH HENRY PRESS Washington, D.C. 1996
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JOSEPH HENRY PRESS · 2101 Constitution Avenue, N.W. · Washington, D.C. 20418
The Joseph Henry Press, an imprint of the National Academy Press, was created with the goal of making books on science, technology, and health more widely available to profes- sionals and the public. Joseph Henry was one of the founders of the National Academy of Sciences and a leader of early American science.
Library of Congress Cataloging-in-Publication Data
Biotechnology: science, engineering, and ethical challenges for the 21st century / Frederick B. Rudolph and Larry V. McIntire, editors. p. cm. Includes bibliographical references and index. ISBN 0-309-05282-3 1. Biotechnology. 2. Biotechnology—Social aspects. I. Rudolph, Frederick B. II. McIntire, Larry V. TP248.2.B574 1996 660'.6—dc20 95-44203 CIP
Copyright 1996 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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Dedication DEDICATED TO THE MEMORY OF José E. Trías
who was vice president and general counsel of the Howard Hughes Medical Institute from 1992 through May 1994. His remarks at the DeLange Conference, included in this book, exemplified his wisdom about the law, science, and life.
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Preface … [H]umanity is always mistrustful of any radical change, especially so in any field that touches their feelings and instincts. All large biological discoveries are bound to affect human feelings and instincts, and so they will always by a great proportion of mankind be greeted as impious, immoral and indecent.
Julian Huxley, Professor of Biology, Rice University, 1924
[Biotechnology is defined as] techniques that use living organisms to make or modify products, improve plants or animals, and develop micro-organisms for specific purposes.
Definition in use by the National Research Council, 1994
Genetically engineered food, gene therapy, DNA fingerprinting: these are the "sound bite" phrases that define the extent of many people's knowledge of biotechnology as the twenty-first century approaches. Yet biotechnology promises to alter people's lives as radically in the next century as did electricity, telecommunications, and the automobile in the twentieth century.
During the past two decades rapid advances in biotechnology have sparked both great interest and intense debate among scientists and non-scientists alike. This volume is intended to increase awareness and stimulate discussion of both the great opportunities and the difficult challenges that advances in biotechnology present for science and for society.
Biotechnology is first and foremost a set of scientific discoveries and
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techniques that make it possible to manipulate the basic building blocks of life: DNA molecules and genes. This technology holds the promise of curing disease, repairing environmental damage, and improving the quality and quantity of agricultural production.
Biotechnology is also an industry that had $6 billion in annual sales in 1993 and is growing rapidly, attracting millions of dollars in investment capital and employing thousands of people.
Many people perceive biotechnology as a threat: not only a threat to accepted ways of being, doing, and working, but also an affront to basic moral values. Tinkering with the genetic makeup of living things (especially human beings) is, in the eyes of many, simply wrong. End of discussion.
Except that it isn't the end of the discussion. Biotechnology will not go away if people shut their eyes to it. It is a reality that will significantly affect how individuals live, work, and make decisions about family, health care, and the future.
Nowhere are the opportunities and challenges of biotechnology thrown into sharper relief than in health care. Therapeutic proteins such as insulin, Factor VIII, and human growth hormone are now being manufactured by recombinant DNA technology. Gene therapy experiments have been approved for the treatment of patients with enzyme deficiencies, inherited high blood cholesterol, arthritis, cancer, and other diseases.
Skin, cartilage, blood vessels, and other body tissues are being "grown" in the laboratory. If such tissue engineering can be made to work on a large scale, it may eventually be unnecessary to obtain tissues and organs from human donors for transplantation.
Scientists have succeeded in identifying genes associated with cystic fibrosis, Huntington's disease, breast and colon cancer, and other disorders, making it possible to identify people at high risk for these conditions years before they develop any symptoms. This capability raises enormous questions: Who has access to an individual's genetic information? How might prospective parents react when told that the fetus the woman is carrying has the gene for a devastating illness? Are all the discoveries and techniques of biotechnology necessarily beneficial to society?
Such disturbing questions lead some people to lash out at scientists: "Why can't they leave well enough alone? There are some things we are better off not knowing." Despite the many benefits that science has brought to modern life, and despite (or perhaps because of) the fact that the pace of scientific discovery has never been more rapid, public confidence in science is at a low ebb.
In addition to questions about the societal impact of biotechnology, there are many unresolved issues related to the means by which the products of biotechnology move from the laboratory to the commercial marketplace.
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Although at first glance these issues appear to be purely pragmatic, a closer look reveals them to be quite complex because they involve questions of values, organizational culture, and public policy.
How much freedom should scientists have to pursue basic, curiosity-driven research? When a private company supports research, how much control should it have over the dissemination of the results of that research? What is the best way to ensure that worthwhile new technologies are developed commercially? Who will make decisions abut the safety, efficacy, and cost-effectiveness of new technologies?
Scientists, constrained by funding limitations and pressures to collaborate with industry and to conduct more research that is targeted to specific objectives, worry about maintaining the integrity and vitality of the research enterprise. Biotechnology company executives face a different set of constraints: The commercial development of a biotechnology product involves significant investment risk. Many difficulties are inherent in the manufacture on a large scale of products based on living organisms. Even if these difficulties can be overcome, a stringent, costly regulatory process (intended to safeguard public health) means that many products that undergo testing may ultimately fail to be approved for marketing.
In one way or another, all of these issues touch on what is arguably the central burning issue of U.S. public policy in the 1990s; the proper role and responsibilities of government. Scientists, the biotechnology industry, and the public all have different and often conflicting expectations of government. Can government simultaneously promote scientific research and innovation (as scientists want), encourage the growth of an industry that benefits the economy (as the biotechnology industry wants), and protect public health and individual privacy (as the public wants)?
This thorny set of complex and interrelated concerns formed the backdrop to a conference organized by Rice University's Institute of Biosciences and Bioengineering in the spring of 1994. This book is a product of the discussions that book place at that conference, which brought a distinguished group of scientists, physicians, ethicists, engineers, attorneys, entrepreneurs, and policymakers together to discuss the scientific, engineering, and ethical challenges presented by biotechnology.
The three-day conference was designed to interweave discussions of scientific and ethical issues because the organizers felt that these two sets of issues are too often rigidly separated. The variety of perspectives represented by the conference speakers reflects the convergence of disciplines that is a hallmark of the biotechnological revolution.
This crossdisciplinary bent is also reflected in the book, which includes, for example, a chapter by Daniel E. Koshland, Jr., distinguished former editor-in-chief of Science magazine, on the ethical issues raised by
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biotechnology. A chapter on the investigation of scientific misconduct is contributed by lawyer Barbara Mishkin. Michael Shuler, professor of chemical engineering at Cornell University, provides an engineer's perspective on the development of biopharmaceuticals.
The book is organized into five sections. Part 1 focuses on basic research in biotechnology, including an overview of recombinant DNA technology, which launched the biotechnological revolution in the 1970s. These chapters orient the reader by outlining the history of biotechnology, describing the current state of the art, and hinting at the challenges that these advances present for society.
Part 2 spotlights current and promising future applications of biotechnology in health care and environmental restoration, delineating both the enormous potential of the technology to treat disease and improve the quality of human lives and the scientific challenges involved in making that potential a reality.
The challenges of technology transfer are considered in Part 3, with chapters examining the nature of relationships between universities, where many scientific discoveries are made, and industry, where they are applied; the government's role in fostering cooperation between academia and industry; the need to balance the conflicting yet legitimate interests of all parties in university-industry collaborations; and the complex relationship between intellectual property rights and technology transfer.
In Part 4 contributors with a wide range of viewpoints explore the difficult and complex issues of ethics, behavior, and values both within science and in society as a whole. Focusing first on the professional values held and expressed by individual scientists, the discussion shifts to an analysis of how scientific misconduct is defined and investigated. An eminent scientist and an ethicist trade viewpoints on the social impact of biotechnology. The section concludes with a critique of the scientific culture and an examination of how certain assumptions (including the notions that science is objective and that technological advance is synonymous with progress) have served to exclude women's health issues from scientific research.
The three chapters in the final section of the book examine the role of government in the development of biotechnology internationally as well as here in the United States. A comparison of American, European, and Japanese approaches to the regulation of drugs is followed by an exposition of the Clinton administration's position on scientific research and the commercialization of biotechnology. The concluding chapter focuses on the federal regulatory process, with an analysis of how the U.S. Environmental Protection Agency develops and refines environmental regulations.
As Julian Huxley, Rice University's first professor of biology, noted in
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1924, humanity is always mistrustful of radical change in fields such as biology that touch people's feelings and instincts. Biotechnology presents society with both tremendous opportunities and enormous challenges. It is up to all of us—scientists, health care professionals, attorneys, engineers, and concerned lay people—to respond to these opportunities and challenges. We hope that this volume will both contribute to and encourage broad participation in an important dialogue that will shape the direction of biotechnology in the twenty-first century.
Larry V. McIntire Frederick B. Rudolph Institute of Biosciences and Bioengineering Rice University
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Acknowledgments The Institute of Biosciences and Bioengineering at Rice University gratefully acknowledges the generous support of Mr. and Mrs. C. M. Hudspeth of Houston, without which this book would not have been possible. In 1991 the Hudspeths created an endowment fund to establish a series of conferences known as the DeLange Conferences, in memory of Mrs. Hudspeth's parents, Albert and Demaris DeLange. The Second DeLange Conference, Biotechnology: Science, Engineering, and Ethical Challenges for the Twenty-first Century, on which this book is based, was held at Rice University, Houston, from February 28 to March 2, 1994.
The Institute also acknowledges the important contributions made to both the conference and this book by Diana Welch, Judith Dickson, Eleanor Mayfield, Janelle Scott, Patricia Gibbons, and the following members of the DeLange Conference Planning Committee: David Hellums, Kathleen S. Matthews, Phillip Bedient, George Schroepfer, Baruch Brody, and Norman Hackerman.
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Contents BASIC RESEARCH: THE FOUNDATION OF BIOTECHNOLOGY
1
1. Overview of Terminology and Advances in Biotechnology
Kathleen S. Matthews
3
2. Advances in Cell and Molecular Biology
Anna Marie Skalka
15
3. Structural Biology as It Applies to Biotechnology
Alexander Wlodawer
28
4. The Future of Biotechnology
C. Thomas Caskey
43
BIOTECHNOLOGY APPLICATIONS TODAY AND TOMORROW
61
5. Effect of the New Biologies on Health Care
Eric Tomlinson
63
6. Gene Therapy: Beyond Genetic Diseases
Savio L. C. Woo
72
7. Tissue Engineering: The Union of Biology and Engineering
Robert M. Nerem
88
8. Development of Biopharmaceuticals: An Engineering Perspective
Michael Shuler
100
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9. Bioremediation: A Promising Technology
Gene F. Parkin
113
FROM LABORATORY TO MARKETPLACE: THE CHALLENGES OF TECHNOLOGY TRANSFER
129
10 Interactions Between Universities and Industry
Jerome Schultz
131
11. National Science Foundation's Perspective on University-Industry Interaction
Neal Lane
147
12. Conflict of Interest in Basic Biomedical Research
José E. Trías
152
13. Patents: Help or Hindrance to Technology Transfer?
Rebecca Eisenberg
161
ETHICS, BEHAVIOR, AND VALUES IN SCIENCE AND SOCIETY
173
14. Ensuring the Ethical Conduct of Research: Who Is Responsible?
Judith P. Swazey
175
15. Misconduct: Regulating and Investigating Scientific Research
Barbara Mishkin
183
16. Ethical Decision Making in a Pluralistic Society
Daniel E. Koshland, Jr.
191
17. Ethical Issues Surrounding the New Technology as Applied to Health Care
Mark A. Rothstein
199
18. Biotechnology Applications and Women's Health Issues
Ruth Ellen Bulger
208
THE ROLE OF GOVERNMENT IN THE DEVELOPMENT OF BIOTECHNOLOGY
223
19. Comparison of U.S., European, and Japanese Policies Affecting Pharmaceutical and Biotechnology Development
Louis Lasagna
225
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20. Expanding the Horizons of Biotechnology in the Twenty-first Century
M. R. C. Greenwood and Rachel E. Levinson
233
21. The Making of Environmental Policy Decisions
Suzanne Giannini Spohn
246
Biographies of the Contributors
261
Index
269
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