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OCR for page R1
USE OF BURY ANIMAL
IN BIOMEDICAL AND
BEHAVIORAL ARCH
Committee on the
Use of Laboratory Animab in
Biomedical add Behavioral Research
Commission on Life Sciences
National Research Council
Institute of Medicine
NATIONAL ACADEMY PRESS
Washington, D.C. 1988
OCR for page R2
NOTICE: The project that is the subject of this report was approved bar 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, "d 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 tom the authors according to
procedurce approved by a Report Review Committee connoting of members of the
National Academy of Sciences, the National Academy of Engineering, Ad the Institute
of Medicine.
The National Academy of Sciences is a private, nonprofit, sell-perpetuating society
of distinguished scholars engaged in scientific and engineering resee - , dedicated to the
furtherance of science Ad technology Ad to their "e for the general welfare. Upon
the authority of the charter granted to it by the Congress ~ 1863, the Academy has
a mandate that requires it to advise the federa`1 government on scientific and technical
matters. Dr Fran Prces ~ president of the National Academy of Sciences.
The National Academy of Engineering was cetabli~hed in 1964, under tEc charter
of the National Academy of Sciences, as a parallel organization of ontst~n cling engineers.
It is autonomous in its administration and in the selection of its members, shanug with
the National Academy of Sciences the responsibility for advising the federal government.
The National Academy of Engineering also sponsors engineering program aimed at
meeting national needs, encourages education "d research, and recognizes the superior
achievements of engmeere. Dr. Robert M. White ~ president of the National Academy
of E:ngineer~g.
The Institute of Medicine was established in 1970 by the National Academy of
Sciences to secure the services of emment members of appropriate professions ~ 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 "d upon its own initiative, to identify
issues of medical care, regears, and education. Dr. Samuel O. Thier is president of the
Institute of Medicine.
The National Research Council was established 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 "d of addling the federal government. Functioning in
accord~cc 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 ~ administered jointly by both
Academies and the Institute of Medicine. Dr. Prank Pro" and Dr. Robert M. White are
chairman and vices airman, respectively, of the National Research Council.
This project was undertaken with both public and priorate sector support. The
following agencies of the federal government provided major funding for the study: the
Departments of the Air Force, Army, and Nary; the National Institutes of Health;
and the National Science Foundation. The following private org~isation~ also provided
support: Abbott Laboratories, American Cyanamid Co., America Hoechet Corp., Berlex
Laboratories Inc., Bristol-Myers Co., Burroughs Wellcome Co., Ciba-Geigy Corp., E.
I. DuPont de Nemours ~ Co., Marion Laboratories Inc., Pfiscr Inc., A. H. Robins
Co., Rorer Group Inc., Sandos Pharmaceuticals Corp., Schering-Plough Corp.1 Searle
Research and Development, Shell Development Co., Sterling Dmg Inc., Syntex Corp.,
and the Upiobn Co.
This worn is related to Department of the Navy Grant No. N00014-85-G-0247
issued by the Officc of Natural Research. The United States Go~rerr~ment has a royalty-free
liceD.se throughout the world in all copyrightable material contained herein.
Library of Congress Catalog Card Number 88-62248
ISBN 0 309 03839 1 _
Printed in the IJnited States of America
First Printing, September 1988
Second Panting, January 1989
Third Printing, April 1989
Fourth P'iniiIIg, September 1989
Fifth Pnoting, July 1990
Sloth Printing, November 199()
Seventh Priming, December 1991
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COMMITTEE ON THE USE OF [ABO}~ATORY AN~A[S I'{
BIOMEDICAL AND BEHAVIORAL RESEARCH
NORMAN HACKERMAN ~ Chairman), Rice University
KURT BENIRSCHKE, University of California, Son Diego Medical
Center
MICHAEL E. DEBAKEY, Baylor College of Medicine
W. JEAN DODDS, New York State Department of Health, Albany,
New York
EDWARD L. GINZTON, Varian Associates, Inc., Palo Alto,
California
CARL W. GOTTSCHALK, The University of North Carolina,
Chapel Hid
ARTHUR C. GUYTON, University of Mississippi School of Medicine
WILLIAM HUBBARD, The Upjohn Company, Hickory Corners,
Michigan
~ OHN KAPLAN, Stanford University School of Law
HAROLD J. MOROWITZ, Yale University
CARL PFAPPMANN, The Rockefeller University
DOMINICK P. PURPURA, Albert Einstein College of Medicine
CHRISTINE STEVENS,* Animal Welfare Institute, Washington, D.C.
LEWIS THOMAS, Memorial SIoan-Ketter~g Cancer Center, New
York City
JAMES MCKENDREE WALL, The Christian Century, Chicago,
Nixon
Staff
JOHN E. BURRIS, Study Director
JUNE S . EWING, Staff Officer
STEVE OLSON, Editor
MARGARET FULTON, Senior Secretary
F RANCES WALTON, A dmin~trativc Secretary
*Did not sign the report.
....
111
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COMMISSION ON LIFE SCIENCES
JOHN E. DOWLING (Chairman), Harvard University
PERRY L. ADKISSON, The Texas A&M University System, College
Station
FRANCISCO 3. AYALA, University of California, Irvine
]. MICHAEL BISHOP, University of California Medical Center, San
Francisco
NINA V . F EDOROFF, Carnegie Institution of Washington,
Baltimore, Maryland
TIMOTHY H. GOLDSMITH, Yale University
RICHARD W. HANSON, Case Western Reserve University School of
Medicine
RALPH W. F . HARDY, Boyce Thompson Institute for Plant
Research, Ithaca, New York
DONALD F. HORNIG, Harvard School of Public Health
ERNEST G. JAWORSKI, Monsanto Company, St. Louis, Missouri
SIMON A. KEVIN, Cornell University
F RANKLIN M. LOEW, Tufts University
ROBERT W. MANN, Massachusetts Institute of Technology
HAROLI) A. MOONEY, Stanford University
JOSEPH E. RALL, National Institutes of Health, Bethesda,
Maryland
RICHARD D. REMINGTON, University of Iowa
RICHARD B. SETLOW, Brookhaven National Laboratory, Upton,
New York
J OSEPH E . VARNER, Washington University
NRC Governing Board Liaison Member
RALPH LANDAU, ~istowei, incorporate], New York City
Staff
ALVIN G . LAZEN, Executive Director
1V
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Contents
PREFACE
EXECUTIVE SUMMARY
·e
V11
1 INTRODUCTION 12
Historical Background, 12
Present Situation, 15
2 PATTERNS OF ANIMAL USE...............................
Numbers of Animals Used, 19
Use of Animals in Research by the Federal Government, 22
Use of Animate in Education, 23
Use of Animals in Testing, 23
New Technologies and Future Laboratory Use of Animab, 25
Summary, 26
3 BENEFITS DERIVED FROM THE USE OF ANIMALS .... 27
Polio, 28
Acquired Immune Deficiency Syndrome, 28
Transplantation, 29
Cardiovascular-Renal Systems, 31
Nervous System, 32
Other Benefits for Humans, 36
Benefits for Animals, 36
Summary, 37
18
v
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V1
CON=NTS
4 ALTERNATIVE METHODS IN BIOMEDICAL AND
BEHAVIORAL RESEARCH 38
Relationships Among Life Forms, 39
Animal Models, 40
Alternatives to Mammab, 41
Alternative Methods in Testing, 44
Summary, 46
5 REGULATORY ISSUES
Approaches to Regulation, 47
Federal Regulations, 49
Government Policy Statements, 53
State Regulations, 56
Approaches to Regulation, 57
Effects of Regulations, 59
Enforcement and Enactment of Regulations and Laws, 62
6 USE OF POUND ANIMAI`S
Supply of Pound Animals, 64
Regulations, 65
Scientific Considerations, 65
Benefits, 65
Cost Considerations, 66
Concerns for the Animals, 66
7 CONCLUSIONS AND RECOMMENDATIONS
Recommendations, 69
REFERENCES
INDIVIDUAL STATEMENTS BY MEMBERS OF
THE COMMITTEE...........................
Arthur C. Guyton, 81
Christine Stevens, 84
APPENDIXES
A. 1896 Report of the National Academy of Sciences.....
B. Curricula Vitae of Committee Members...............
C. Invited Speakers at Committee Meetings
INDEX ........
.47
64
68
. 75
.81
.89
...93
96
- . 98
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Preface
One of the most difficult issues to confront biological scientists,
as well as the society withm which they work, ~ that of the use of
laboratory animals in biomedical and behavioral research. What is
the ethical relationship of investigators to the animate they use? How
may we balance society's desire for the beneficial outcomes of research
with the need to protect animate that generally must be used to yield
those outcomes? Are there truly effective alternative methods to the
use of animals or are these available methods mamly complementary?
Are regulations concerning appropriate care of animals too lenient
or too strict? The questions "e neither easy to mower nor are they
new. In 1896, the National Academy of Sciences issued a statement
in which it Termed the need to use animal ~ medical research
in a letter to United States Senator Jacob H. Ginger (Appendix
A). The question arose because of concerns about the treatment of
animals in research, and the issues did not differ greatly from those
being raised today.
Yet the debate and activity have intensified recently. Research
laboratories have been raided to "liberates animals. The National
Institutes of Health has issued sanctions against several institutions
for lack of full adherence to animal care regulations. Researchers,
who have often failed to present persuasively the case for animal
use in research to the public and to politicians, now are becorn~ng
increasingly anxious about the limitations placed on their research.
..
V11
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V111
PREFACE
Books have appeared presenting the argument that the ~rights" of
animals must be considered equal to those of humans.
In September 1985, the National Research Council, through its
Commission on Life Sciences and with the collaboration of the In-
stitute of Medicine, appointed a committee to examine concerns
about animal use and treatment, benefits derived by humans and
animals from research with animals, and current regulatory and self-
regulatory guidelines for animal care and use. Care was taken to
ensure that the committee membership included scientists from
wicle range of disciplines, as well as nonscientists involved in animal
welfare, law, and ethics. The diverse backgrounds and interests of
the committee provided an opportunity for a wide range of views on
the issues to be presented. However, it also meant that on several of
these issues it was not possible for the committee to reach unanim-
ity, for example, on the uses of pound animate and coverage of rats,
mice, birds, and farm animals used ire biomedical research under the
Animal Welfare Act. The committee was asked to focus on the use of
laboratory animals in research; other uses in testing and education
were to be addressed less intensively. This report is the result of the
comm~ttee's efforts.
The committee met 10 times to collect information, interview
knowledgeable persons, and discuss the issues. One meeting was
a public forum in which the committee heard a spectrum of views
from animal welfare groups, scientists, and anyone else who wished
to share their information or opinions. More than- 200 persons at-
tended and over 50 individuals representing 40 organizations made
oral presentations. In addition, written statements were received
from individuals and organizations who did not attend the public
meeting. In the course of its work, the committee also invited to
other of its meetings about 20 persons who could add to its informa-
tion on government regulatory and research goad, the philosophies
underlying opinions on the appropriateness of animal use, the status
of the development of alternative methods to the use of animals, and
the experience of other countries in the use of animals ant} the regu-
lation thereof. The committee benefited from the wisdom of all these
contributors ~d acknowledges its gratitude for their willingness to
assist in this study.
The committee had hoped to draw on the results of a new survey
of laboratory animal use by the Institute of Laboratory Animal
Resources of the National Research Council. Cor~tractual difficulties
OCR for page R9
PREFACE
1X
postponed this survey; thus, discussions of the numbers of animals
used are based on other data.
The comrn~ttee organized itself to address its charge by forming
three subcommittees societal issues, on regulatory issues, and
on scientific msues. The draft reports of these three sections were
discussed by the entire comrn~ttee as it formed its conclusions and
recommendations and cleveloped this final report.
No committee dealing with an issue so emotionally charged as
this, as diverse In background, and displaying such a vast difference
of opinion about its topic could be expected to come easily to a
consensus. The issues profoundly affect the performance of scientific
research, but they are not themselves scientific. Individual opinion,
life experience, and worI3view play a large part in determining how
any individual approaches the topic. The committee members strove
to put aside their personal interests and to address the overarch-
ing principal issues in a dispassionate manner. The consensus, as
expresser} in the conclusions and recommendations of this report, is
evidence that the committee was reasonably successful. After discus-
sion on some issues, conclusions were reached that, following further
debate, were changed. All had their say, but nevertheless some mem-
bers wanted to make individual statements. Included at the end of
this report are two such statements. These may be useful to help the
reader appreciate the depth of feeling and range of individual opin-
ions that exist on this matter among interested people. They also
indicate that on some of the issues surrounding the use of laboratory
animals, the differences of opinion are too great for a consensus to
be reached at this time.
Some fee] that the timing of this assignment was inopportune.
The scientific community has had little time to work with and adjust
to the new regulations that govern animal research, which makes it
difficult to assess the impact of the regulatory framework. However,
most feel that there is no ideal moment to assess the use of laboratory
animals, for, as history has demonstrated, this issue has been under
active consideration for well over a century. For example, in the
intervening years since the National Academy of Sciences issued its
statement in 1896 on the use of laboratory animals, the level of
public interest has varied, but the issues and concerns have never
disappeared.
We do not expect that this report will end debate about the use
of animals in biomedical and behavioral research. That discussion
in its modern form has been ongoing for more than a century and
OCR for page R10
x
PREFACE
is almost continuously at a critical point. We believe, however, that
the report provides a carefully reasoned statement on the msues. It
also provides a point of departure for further discussion on how to
use anneals appropriately, while recognizing and being sensitive to
the concerns of Al segments of our society.
The committee thanks those who have contributed to its work.
We are grateful to all who shared their views with us at our public
meeting and to those who accepted our invitation to provide infor-
mation at other committee meetings. A list of this latter group is
included as Appendix C. We appreciate the information on the leg-
islative and regulatory framework affecting animal research that was
provided by Marcia D. Brody, who served as a consultant.
We wish especially to recognize the efforts of the stab of the
Commission on Life Sciences who were instrumental in organizing
this effort ant} In working with the committee throughout the effort.
John Burrm was a positive influence ant} a strong ant] steady guide
through the National Research Council report process. June Ewing
provided valuable assistance in many areas, and Alvin Lazen brought
wisdom and insight. Steve Olson edited the report. The information
provided by Wayne Grogan and Dorothy Greenhouse of the NRC's
Institute of Laboratory Animal Resources was of great value to us.
Barbara FiIner of the Institute of Medicine staff also provided useful
insights. Mary Frances Walton's cheerful assistance made our work
go more easily and our attendance at meetings more enjoyable. Mar-
garet Fulton prepared this manuscript, patiently making the changes
required with each revision. We thank them Ad.
Norman Hackerman, Chairman
Committee on the Use of I,aboratory Animals in
Biomedical and Behavioral Research
