National Academies Press: OpenBook

Biotechnology: An Industry Comes of Age (1986)

Chapter: Front Matter

Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Page viii Cite
Suggested Citation:"Front Matter." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1986. Biotechnology: An Industry Comes of Age. Washington, DC: The National Academies Press. doi: 10.17226/18677.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

1 J n Qlson for the Academy Industry Program National Academy of Sciences National Academy of Engineering Institute of Medicine LIBRARY National Research Council 2101 Constitution Avenue N.W. Washington D.C.. 20418 NATIONAL ACADEMY PRESS Washington, B.C. 1986

J V National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 tf& ., y This book is based on a symposium sponsored by the Academy Industry Program, a joint project of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. It has been reviewed according to procedures approved by a Report Review Committee consisting of members of the two Academies and the Institute of Medicine. The National Academy of Sciences (NAS) is a private, self-perpetuating society of dis- tinguished scholars in scientific and engineering research, dedicated to the furtherance of science and technology and their use for the general welfare. Under the authority of its congressional charter of 1863, the Academy has a working mandate that calls upon it to advise the federal government on scientific and technical matters. The Academy carries out this mandate primarily through the National Research Council, which it jointly administers with the National Academy of Engineering and the Institute of Medicine. The National Academy of Engineering (NAE) was established in 1964, under the charter of the NAS, as a parallel organization of distinguished engineers, autonomous in its administration and in the selection of members, sharing with the NAS its responsibilities for advising the federal government. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government, and its own initiative in identifying issues of medical care, research, and education. Library of Congress Cataloging-in-Publication Data Main entry under title: Biotechnology: an industry comes of age. Includes index. Written and supplemented by additional research materials by science writer Steve Olson from transcripts of a conference held in Washington, D.C., Feb. 27-28, 1985, and sponsored by the Academy Industry Program of the National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 1. Biotechnology—Congresses. 2. Genetic engineering —Congresses. I. Olson, Steve, 1956- . II. Academy Industry Program (National Research Council (U.S.)) III. National Academy of Engineering. IV. Institute of Medicine (U.S.) TP248.14.B56 1986 660'.6 85-28442 ISBN 0-309-03631-3 Copyright © 1986 by the National Academy of Sciences No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purposes of official use by the United States government. Printed in the United States of America

Preface ON FEBRUARY 24-27, 1975, in a converted chapel on the grounds of the Asilomar Conference Center in Pacific Grove, California, some 140 scientists, several lawyers, and a dozen or so journal- ists gathered to discuss a profound new development in molecular biology. A few years earlier, researchers had discovered how to isolate and recombine specific segments of DNA, making it possible for the first time to directly manipulate the molecule that gives rise to life. But the new techniques also seemed to pose potential risks—risks that the scientists found impossible to quantify but impossible to ignore. The Asilomar conference, which was sponsored by the National Academy of Sciences, marked an attempt to anticipate and minimize those risks before the research got under way. Just two years later, in March 1977, the National Academy of Sciences sponsored another meeting on the techniques of genetic engineering, this one in the auditorium of the academy's headquarters in Washington, B.C. In this open forum setting, scientists and individ- uals from across the country gathered to freely discuss the benefits and risks of the new techniques. But coming as it did at the height of public concern over recombinant DNA research, the forum generated strong emotions. Participants from an overflow audience repeatedly rose to call for drastic restrictions or a halt to the research. Amidst chants of "We will not be cloned," the proceedings frequently came close to breaking down completely. iii

iv PREFACE There were no such pyrotechnics at the most recent academy confer- ence on genetic engineering, held on February 27-28,1985, to mark the tenth anniversary of the Asilomar conference. Sponsored by the Acad- emy Industry Program of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine, the conference offered a timely demonstration of how the passage of just a few years has affected genetic engineering. For one thing, the conferees were drawn from a much broader range of backgrounds than they were at Asilomar. In addition to scientists, lawyers, and journalists, the roughly 300 attendees included corporate chairmen and vice presi- dents, economists, university administrators, government regulators, a U.S. senator, and Capitol Hill staffers. The topics under discussion had similarly diversified, ranging from patent law to human gene therapy, from analyses of ecological balances to analyses of international competition. But perhaps the most telling difference between this conference and the previous two involves the perceived level of risks associated with recombinant DNA research. As experience with the new techniques has accumulated, researchers have realized that the risks discussed at Asilomar and at the Academy Forum were either far overestimated or nonexistent. As a result, the guidelines that govern research with recombinant DNA have been relaxed several times, and almost all the experiments now conducted are exempt from the guidelines. That is not to say that concerns do not still exist. Participants at the 1985 conference devoted considerable time to discussing the risks associated with human gene therapy or the release of genetically engineered organisms into the environment. In fact, the single most discussed topic at the conference was how the government should regulate, yet not inhibit, useful and safe commercial products now emerging from genetic engineering. But the concerns have matured. No longer is genetic engineering in its infancy, without a base of scientific information and personal experience on which to build. It has entered what might be character- ized as a vigorous childhood, generating its first products and display- ing flashes of the virtuosity to come. The emergence of an ambitious and expanding commercial industry from the seedbed of genetic engineering research has been an impor- tant aspect of that growth. Today companies are using the new techniques to develop products that could have dramatic effects on medicine, agriculture, energy production, and many other fields, and in the long run the potential impact of the new industry is virtually unlimited. The industry's remarkable growth is reflected in the main

PREFACE V title of this book and of the conference on which it is based, biotechnol- ogy. Ten years ago that word, like the industry itself, scarcely existed. Today both are firmly established and are making themselves ever more visible. This book, which was prepared by science writer Steve Olson, is based on the proceedings of the conference supplemented by additional research materials. Individual chapters and the entire book were reviewed by conference participants and by reviewers selected by the National Research Council. On behalf of the Academy Industry Program, we wish to thank each of the speakers who addressed the symposium and to express our special appreciation to Alexander Rich, Sedgwick Professor of Biophys- ics at the Massachusetts Institute of Technology, and Richard J. Mahoney, president and chief executive officer of the Monsanto Com- pany, for cochairing the symposium and for their contributions to the design of its program. For the massive task of organizing the confer- ence, we would like to thank Nancy Gardner Hargrave, staff officer with the National Research Council. Finally, we would like to thank those individuals who contributed their expertise by reviewing and commenting on the symposium's program at various stages: Douglas M. Costle, James D. Ebert, Barbara Filner, Alvin G. Lazen, Robert B. Nicholas, Howard Schneiderman, and Maxine F. Singer. As genetic engineering enters its second full decade, it is poised to once again capture the public's attention. A number of products of biotechnology are approaching the marketplace—the first installments of genetic engineering's long-heralded promise. Difficult but manage- able questions remain to be resolved, questions not only of safety but of regulation, policy, and ethics. Indeed, it is a time of great promise in biotechnology, an apt reminder of the situation that faced the conferees at Asilomar ten years ago. Frank Press President, National Academy of Sciences Robert M. White President, National Academy of Engineering Frederick C. Robbins Former President, Institute of Medicine

Acknowledgments THE ACADEMY INDUSTRY PROGRAM was established in 1983 as a mechanism for bringing the intellectual and financial resources of U.S. industry to the work of the National Research Council and for ensuring the strength of institutional ties to the industrial, scientific, and technological communities. Participating companies, numbering over 60, contribute a total of $1 million each year to support studies, seminars, symposia, and other programs on problems of national consequence for which science and technology are central. The program also provides opportunities for corporate leaders to meet with policymakers from the federal government, universities, and other sectors to discuss national issues. This publication and its dissemination have been made possible by the National Research Council Fund, a pool of private, discretionary, nonfederal funds that is used to support a program of Academy- initiated studies of national issues in which science and technology figure significantly. The NRG Fund consists of contributions from a consortium of private foundations including the Carnegie Corporation of New York, the Charles E. Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T. MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foun- dation, and the Alfred P. Sloan Foundation; the Academy Industry Program, which seeks annual contributions from companies that are concerned with the health of U.S. science and technology and with public policy issues with technological content; and the National Academy of Sciences and the National Academy of Engineering en- dowments. VI

Contents i Genetic Engineering and Biotechnology: An Overview Page 1 2 The Molecular and Microbial Products of Biotechnology Page 14 3 Biotechnology in Agriculture Page 30 4 Human Gene Therapy Page 43 5 The Release of Genetically Engineered Organisms into the Environment Page 54 Ml

VIII CONTENTS Color Plates Follow Page 56 6 Governmental Regulation of Biotechnology Page 64 The New Biotechnology Firms Page 84 8 Patents and Trade Secrets in Biotechnology Page 91 9 University-Industry Relations Page 98 10 Biotechnology in Japan: A Challenge to U.S. Leadership? Page 107 Index Page 117 Four recent and important developments in the regulation of biotechnology should be noted: 1. The White House has approved a federal committee (the Biotechnology Science Coordinating Committee) to coordinate the government's handling of biotechnology issues. 2. Genetically engineered plants, seeds, and tissue cultures can now be patented as a result of a recent decision by an appeals board of the U.S. Patent and Trademark Office. 3. Guidelines on human gene therapy research have been approved by the Recombinant DNA Advisory Committee of the National Institutes of Health. 4. The federal government has approved the first two field tests of genetically engi- neered organisms: (1) to study the effects of the outdoor environment on plants that have been modified to resist disease, and (2) to observe plants sprayed with bacteria altered to prevent frost formation. 12186

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