SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE

Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993

NATIONAL RESEARCH COUNCIL

NATIONAL ACADEMY PRESS
Washington, D.C.
1994



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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 NATIONAL RESEARCH COUNCIL NATIONAL ACADEMY PRESS Washington, D.C. 1994

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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W. Washington, D.C. 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Robert M. White is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce Alberts and Dr. Robert M. White are chairman and vice chairman, respectively, of the National Research Council. This study was sponsored by the National Research Council Basic Science Fund. Copyright 1994 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 COMMITTEE ON SHARING LABORATORY RESOURCES IN BIOLOGICAL RESEARCH HAROLD VARMUS (Chair*), University of California, San Francisco, California JANET ROSSANT, (Chair†), Mount Sinai Hospital, Toronto, Ontario, Canada MELVIN BALK, Charles River Laboratory, Wilmington, Massachusetts JOHN BARTON, Stanford Law School, Stanford, California JAN WITKOWSKI, Cold Spring Harbor Laboratory, Cold Spring Harbor, New York RICHARD WOYCHIK, Oak Ridge National Laboratory, Oak Ridge, Tennessee National Research Council Staff: ERIC FISCHER, Director NORMAN GROSSBLATT, Editor PAULETTE ADAMS, Administrative Assistant * resigned November 1993 † appointed November 1993

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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 BOARD ON BIOLOGY MICHAEL T. CLEGG (Chair), University of California, Riverside, California JOHN C. AVISE, University of Georgia, Athens, Georgia ANANDA M. CHAKRABARTY, University of Illinois Medical Center, Chicago, Illinois GERALD D. FISCHBACH, Harvard Medical School, Cambridge, Massachusetts RICHARD E. LENSKI, Michigan State University, East Lansing, Michigan BARBARA J. MAZUR, E. I. du Pont de Nemours & Co., Wilmington, Delaware DANIEL E. MORSE, University of California, Santa Barbara, California MARY LOU PARDUE, Massachusetts Institute of Technology, Cambridge, Massachusetts DANIEL SIMBERLOFF, Florida State University, Tallahassee, Florida MICHAEL E. SOULÉ*, University of California, Santa Cruz, California SHIRLEY M. TILGHMAN, Princeton University, Princeton, New Jersey HAROLD VARMUS†, University of California, San Francisco, California GEERAT J. VERMEIJ, University of California, Davis, California * term ended June 1994 † resigned October 1993

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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 COMMISSION ON LIFE SCIENCES THOMAS D. POLLARD (Chair), Johns Hopkins University School of Medicine, Baltimore, Maryland BRUCE N. AMES, University of California, Berkeley, California JOHN C. BAILAR, III, McGill University, Montreal, Quebec, Canada J. MICHAEL BISHOP, University of California Medical Center, San Francisco, California JOHN E. BURRIS, Marine Biological Laboratory, Woods Hole, Massachusetts MICHAEL T. CLEGG, University of California, Riverside, California GLENN A. CROSBY, Washington State University, Pullman, Washington LEROY E. HOOD, University of Washington, Seattle, Washington MARIAN E. KOSHLAND, University of California, Berkeley, California RICHARD E. LENSKI, Michigan State University, East Lansing, Michigan EMIL A. PFITZER, Hoffmann La Roche Inc., Nutley, New Jersey MALCOLM C. PIKE, USC School of Medicine, Los Angeles, California HENRY C. PITOT, III, University of Wisconsin, Madison, Wisconsin PAUL G. RISSER, Miami University, Oxford, Ohio JONATHAN M. SAMET, The Johns Hopkins University, Baltimore, Maryland HAROLD M. SCHMECK, JR., Armonk, New York CARLA J. SHATZ, University of California, Berkeley, California SUSAN S. TAYLOR, University of California, San Diego, California P. ROY VAGELOS, Merck & Co., Inc., Whitehouse Station, New Jersey JOHN L. VANDEBERG, Southwest Foundation for Biomedical Research, San Antonio, Texas TORSTEN WIESEL*, Rockefeller University, New York, New York National Research Council Staff PAUL GILMAN, Executive Director SOLVEIG PADILLA, Administrative Assistant * term ended June 1994

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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 Preface The remarkable success of molecular biology as a scientific enterprise over the last two decades is unqualified, but it has been accompanied by a complex phenomenon: the commercialization of its products. In some instances, such as the production of medically important materials by the biotechnology industry, we can point to commercialization as a vindication of public investment in science–a source of jobs, better health, and a competitive economy. But in other cases, the impulse to commercialize what science has produced raises troubling questions about conflicts of interests, the motivations of scientists, and even the legality of their actions. These questions have the potential to disrupt the existing relationships between government, academic centers, individual scientists, and the private sector– relationships that have subsidized the vigorous growth of biomedical science since the end of World War II. Many of the problems inherent in those relationships have surfaced recently and simultaneously in response to some developments in molecular genetics. Investigators can now alter at will the genetic constitution of the laboratory mouse. The abilities to add tailored genes to the mouse genome as “transgenes” and to alter normal genes by “targeted mutations” have transformed the study of what can be considered the best animal model of human development and disease. Because the methods are not trivial, the animals are expensive to maintain, and each new strain has unique properties that are time-consuming to characterize, investigators understandably place great value on the lines they have generated. Under these circumstances, the incentives to share the mice with an industrial partner can be strong: simplified distribution to academic colleagues who also want the mice, financial rewards for the investigators and their sponsoring institutions, and the promise of useful products derived from further work with the mice in the private sector. But there are disadvantages as well: excessive charges and restrictive licensing might actually impede further study of the mice, and the perception of profiteering from the immediate products of federally sponsored research might undermine public confidence in the scientific community and raise ethical and legal issues.

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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 Those concerns received public airing in the middle of 1992 when a private biotechnology firm began to sell mice that carried an important targeted mutation under terms that many in the scientific community considered to be excessively expensive and inappropriately restrictive. In September 1992, the issues were openly discussed in an impromptu afternoon session attended by about 300 people at the Cold Spring Harbor Meeting on Mouse Molecular Genetics. As the moderator of that heated session, I was impressed by the complexity of the issues, the depth of feeling about them, and their potential effects on traditional norms and values in science. I therefore proposed to the Board of Biology, which I then chaired, that a workshop be held early in 1993 to consider genetically altered laboratory mice as a model with which to evaluate the elements that influence the sharing of scientific reagents. The workshop was held at the National Academy of Sciences on March 23 and 24, 1993, and this short report summarizes the views expressed by representatives of the community, academic institutions, the government, and several kinds of companies. Although the forum was intended to provoke the voicing of opinions and not to lead to specific recommendations, the events of the 2 days had an important role in clarifying the central questions, providing factual information, and setting the course of action that has occurred since the meeting. I believe that further dissemination of the proceedings through this summary can extend the value of the workshop in the context of this and future debates over mice and other laboratory tools. I thank the members of the organizing committee for help in planning the workshop and inviting the speakers. Eric Fischer and Paulette Adams of the Board on Biology and Al Lazen of the Commission on Life Sciences deserve special thanks for arrangements and for preparation of this summary of the proceedings. In this instance, as in many others, the National Research Council and the Commission on Life Sciences (parent bodies of the Board on Biology) demonstrated their admirable capacity to provide neutral auspices for reasoned debate of controversial issues. Their financial and administrative support is warmly appreciated. Harold Varmus