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Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

ASSESSING GENETIC RISKS

IMPLICATIONS FOR HEALTH AND SOCIAL POLICY

Lori B. Andrews, Jane E. Fullarton, Neil A. Holtzman, and Arno G. Motulsky, Editors

Committee on Assessing Genetic Risks

Division of Health Sciences Policy

Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C.
1994

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

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 competencies 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 Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the 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. Dr. Kenneth I. Shine is president of the Institute of Medicine.

This project was funded by the National Center for Human Genome Research of the National Institutes of Health (Contract No. NO1-HG-0-001) and by the Health Effects Research Program of the Department of Energy (Contract No. DE-FG05-91ER61115; DOE’s support does not constitute an endorsement of the views expressed in the report). The Lucille P. Markey Charitable Trust provided supplemental funding of the study. Additional support for this project was provided by independent Institute of Medicine funds.

Library of Congress Cataloging-in-Publication Data

Assessing genetic risks : implications for health and social policy / Lori B. Andrews . . . [et al.] editors.

p. cm.

Includes bibliographical references and index.

ISBN 0-309-04798-6

1. Medical genetics—Social aspects. 2. Human chromosome abnormalities—Diagnosis—Social aspects. 3. Medical policy—United States. I. Andrews, Lori B., 1952- .

[DNLM: 1. Hereditary Diseases—genetics. 2. Hereditary Diseases—epidemiology. 3. Risk Factors. 4. Health Policy—United States. QZ 50 A846 1994]

RB155.A76 1994

616’.042—dc20

DNLM/DLC

for Library of Congress 93-47973

CIP

Copyright 1994 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

First Printing, April 1994

Second Printing, February 1996

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staalichemuseen in Berlin.

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

COMMITTEE ON ASSESSING GENETIC RISKS

ARNO G. MOTULSKY (Chair),*+ Professor of Medicine and Genetics,

Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, Washington

LORI B. ANDREWS, Fellow,

American Bar Foundation, Chicago, Illinois

BARBARA BOWLES BIESECKER, Genetic Counselor,

University of Michigan Medical Center, Department of Internal Medicine, Ann Arbor, Michigan

JAMES F. CHILDRESS, Chairman,

Department of Religious Studies,

Edwin B. Kyle Professor of Religious Studies,

University of Virginia, Charlottesville, Virginia

BARTON CHILDS,* Emeritus Professor of Pediatrics,

The Johns Hopkins University School of Medicine, Baltimore, Maryland

FRANCIS S. COLLINS,* Associate Investigator,

Howard Hughes Medical Institute, and

Professor,

University of Michigan Medical Center, Ann Arbor, Michigan

P. MICHAEL CONNEALLY, Distinguished Professor of Medical and Molecular Genetics and Neurology,

Indiana University School of Medicine, Indianapolis, Indiana

HELEN R. DONIS-KELLER, Director,

Division of Human Molecular Genetics,

Professor of Surgery and Genetics,

Department of Surgery, Washington University School of Medicine, St. Louis, Missouri

NORMAN C. FOST, Professor of Pediatrics,

University of Wisconsin School of Medicine, Department of Pediatrics, Madison, Wisconsin

NEIL A. HOLTZMAN, Professor of Pediatrics, Health Policy, and Management and Epidemiology,

The Johns Hopkins University Hospital, Baltimore, Maryland

MICHAEL M. KABACK, Professor of Pediatrics and Reproductive Medicine,

University of California-San Diego, San Diego, California

MARY-CLAIRE KING, Professor of Genetics and Epidemiology,

Department of Molecular and Cell Biology, School of Public Health, University of California at Berkeley, Berkeley, California

PATRICIA A. KING,* Professor of Law,

Georgetown University Law Center, Washington, D.C.

ALEXANDER LEAF,* Jackson Professor of Clinical Medicine, Emeritus,

Harvard University Medical School and

Distinguished Physician,

Veterans Affairs Medical Center, Brockton/West Roxbury, Massachusetts

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

PETER LIBASSI, Dean,

Barney School of Business and Public Administration, University of Hartford, West Hartford, Connecticut;

formerly Senior Vice President,

Travelers, Hartford, Connecticut

ROBERT F. MURRAY, Jr.,* Professor of Pediatrics, Medicine, Oncology, and Genetics,

Howard University College of Medicine, Washington, D.C.

GERALD D. ROSENTHAL,*§ Resident Consultant,

Egyptian Junior Medical Doctors Association, c/o Pathfinder International, Watertown, Massachusetts

MARK A. ROTHSTEIN, Law Foundation Professor of Law, and Director,

Health Law and Policy Institute, University of Houston Law Center, Houston, Texas

CLAUDIA T. WEICKER,

Hartford, Connecticut

NANCY SABIN WEXLER, Professor of Clinical Neuropsychology,

Departments of Neurology and Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York;

President,

Hereditary Disease Foundation, Santa Monica, California

Liaison Panel to the Committee on Assessing Genetic Risks

FRANK FUJIMURA, Scientific Director of Molecular Biology,

Nichols Institute Reference Laboratories, San Juan Capistrano, California

PHILIP R. REILLY, Executive Director,

Shriver Center for Mental Retardation, Waltham, Massachusetts

Staff

JANE EVALYN FULLARTON, Study Director

C. ELAINE LAWSON, Research Associate

RUTH ELLEN BULGER, Director,

Division of Health Sciences Policy

MARY JANE BALL, Project Assistant

NANCY DIENER, Financial Assistant

PHILOMENA MAMMEN, Administrative Assistant

*  

Member, Institute of Medicine

+  

Member, National Academy of Sciences

  

Resigned from the committee April 1993.

§  

Resigned after first meeting of the committee.

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

Preface

The last decade has seen remarkable growth in the understanding of genetics as applied to medicine. In addition, the technology for the detection of genetic diseases has developed rapidly, and testing for genetic diseases with DNA techniques has become increasingly possible. The last few years have also seen the initiation of the Human Genome Project, the aim of which is mapping and ultimately sequencing all human genes—giving special attention to genes that cause or may predispose to disease. As part of this ambitious project, and for the first time in the history of science, a special effort is being made as part of a large research project to explore its broader social implications. Three to five percent of the funding available for the Human Genome Project has been set aside to study the many social, ethical, and legal implications that will result from better understanding of human heredity and its impact on disease. Since assessment of genetic risks by genetic testing is expanding rapidly, the Institute of Medicine (IOM) of the National Academy of Sciences undertook this study to assess the current status and future implications of such testing. This study deals with some of the scientific aspects of genetic risk assessment as well as the many societal problems that have already arisen and are likely to be posed by future developments. The study was supported jointly by the National Center for Human Genome Research at the National Institutes of Health and by the Department of Energy, Health Effects Program of the Life Science Research Office. Supplemental funding was provided by the Markey Charitable Trust, a private foundation, and these funds were matched by the Institute of Medicine.

A multidisciplinary Committee on Assessing Genetic Risks was constituted and held a series of workshops and meetings (including a public meeting) on the

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

many phases of genetic testing and its impact on patients, providers, and laboratories. Based on the information gleaned from the many expert participants in these workshops, the public, the appropriate scientific and policy literature, and extensive discussions at committee meetings, the report was written. As part of its process, the committee had the benefit of a Liaison Panel whose members had industrial relationships. This panel worked with the committee during the information gathering activities; once recommendations and report writing began, the liaison members no longer participated.

The rapidly changing nature of the science and practice of genetic testing has led the committee to approach its recommendations by providing general principles that we hope will be useful today and for the next few years. We tried, whenever possible, to avoid technical complexities without sacrificing scientific accuracy to make our conclusions available to as large an audience as possible.

Our committee hopes that this report will be widely read, not only by various health professionals interested in genetics and medicine, but by a broad audience who makes and influences public policy, such as federal and state legislators, other officials and their staff, members of genetic support groups, and the public. Health professionals, an interested public, and policy makers will need to be well informed to move forward with thoughtful and judicious decision making in this area. These recommendations must be based on solid facts and, at the same time, recognize and respect the multifaceted aspects of our pluralistic society. These recommendations are the result of carefully considered judgment, based on a careful review of the state of the art of genetic testing today and our vision of the future. Since currently no single voice has the authority to make policy recommendations in the field of genetic risk assessment and testing, it is hoped the findings of this broadly based multidisciplinary IOM committee will serve as a set of recommendations on which future decisions can be based.

We addressed the need for better professional training of health professionals and of human and medical geneticists. Many genetic tests will be ordered and interpreted by primary care health practitioners, and not only by geneticists or genetic counselors. A good understanding of genetics will therefore be required for all health care professionals. A movement of genetic testing from academic institutions to commercial laboratories is taking place already and will increase as larger volumes of genetic tests are being ordered. The regulation of laboratories sufficiently expert to carry out genetic testing as well as quality control of testing takes on great importance and we have developed a series of recommendations on these important matters.

Various health care providers and medical geneticists already have considerable experience with newborn screening, with prenatal diagnosis, with carrier testing in high-risk populations, and with testing for a variety of genetic diseases. However, the development of genetic tests for diseases that manifest in middle and late life is just beginning to be explored. It is in this area that much new ground needs to be covered. While interpretation of tests for single gene disorders

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

of late onset, including familial cancer, is not easy, the complexities of testing and interpretations for the gene constellations that predispose to many common diseases such as coronary heart disease, diabetes mellitus, hypertension, and others raise new problems. These dilemmas will become particularly thorny if testing for the yet undiscovered genes predisposing to common psychiatric diseases such as schizophrenia and manic depressive disorders becomes a reality.

Testing of DNA from various body tissues for the early mutational events that predispose to a variety of common cancers is on the horizon. This area of genetic testing promises to revolutionize early cancer detection and poses many problems of health monitoring.

Many issues raised by genetic testing do not have a single or unambiguous solution, and different well-informed and well-meaning observers may disagree with each other. Public health oriented policy makers, many physicians, and a significant proportion of the public might consider the reduction of genetic disease as a principal goal of work in this area. Our committee stressed the importance of autonomous decision making by individuals and by the family even if the development of a genetic disease might be the outcome. We believe that in a society such as ours, autonomy far outweighs any public health considerations. In practice, most informed couples do, in fact, select various courses of actions that lead to a lower frequency of genetic disease.

There is a strong and continuing tradition of nondirective genetic counseling in medical genetics, and we were emphatic in stressing nondirectiveness. However, impressed by medical advances that can lead to prevention and treatment of some genetic diseases, many of us feel that there is an obligation under such circumstances to provide appropriate medical advice with guidance to select a specific preventive or therapeutic course of action after a full discussion of all consequences (including possible insurance repercussions and employment discrimination). At the same time, all committee members strongly uphold the principle of nondirective counseling for reproductive decisions.

Arno G. Motulsky, M.D., Sc.D.

Chair

ADDITIONAL VIEWS OF THE CHAIRMAN*

Our report may strike some observers as emphasizing the problematic aspects of genetic testing. All members of the Committee on Assessing Genetic Risks are excited about the great promise and potential of genetic testing for the prevention and treatment of genetic diseases. Since the positive aspects of genetic testing are clear, this perspective required less explication. Our report, therefore, covers in

*  

The opinions expressed are my own and do not represent the consensus of a majority of the committee.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

some detail the difficulties raised by genetic testing and screening, and suggests some solutions and guidelines.

Our emphasis on genetic education may be considered somewhat utopian when an increasing proportion of the population is illiterate and dropout rates in high schools are rising. Nevertheless, we feel that an understanding of genetics will be most important in the future, not only for an appreciation of the role of genetics in health and disease, but also for making decisions on issues such as the use of foods developed with DNA technologies. Even though we may not be able to educate everyone, much more intensive coverage of genetics in the schools at all levels, as well as responsible reporting in the media, is something to which all of us strongly subscribe.

The recommendations regarding newborn screening represent somewhat ideal scenarios that may require some modification in practice. For example, even though full genetic education and counseling would be ideal prior to newborn screening, such a practice may not be currently realistic. For every single affected infant, there will be many thousands of unaffected children. Pretest education and counseling in such a situation cannot, by necessity, be as comprehensive as in scenarios where the pretest probability for a child to be affected is high. However, once a child is found to be affected, equally intensive counseling and appropriate follow-up are indicated in both situations.

The majority of our committee was persuaded that voluntary participation in neonatal screening was the best way to ensure that children would be screened and parental autonomy maintained. Everyone agreed that testing should always be offered for phenylketonuria (PKU) and hypothyroidism since early treatment is highly successful. Some committee members feel that mandatory screening for these two conditions would be a simpler solution.

The common, medically innocuous sickle cell trait will frequently be detected in African-American children as a side product of newborn testing for sickle cell anemia. Once this knowledge-with its significant reproductive implications for the parents-is available, such information is difficult to withhold and in my opinion should be given to the mother with appropriate genetic counseling.

There is agreement that information regarding carrier status of a medically innocuous genetic trait should not be used to discriminate against a child being considered for adoption. However, once a disease has been diagnosed or if there is a high risk of a medically significant condition, I believe strongly that prospective adoptive parents should be provided this information.

Arno G. Motulsky, M.D., Sc.D.

Chair

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

Acknowledgments

In addition to the work of the committee and staff, the successful completion of a study such as this requires assistance from many people. The committee wishes to express its sincere gratitude to those who participated in and prepared papers for the workshops and public forum (see Appendix A and Volume 2). The committee also wishes to thank those who prepared background papers: David A. Micklos, Director of the DNA Learning Center at the Cold Spring Harbor Laboratory, for his paper on issues in public education (Volume 2); Ann C. M. Smith for her background paper on professional personnel issues prepared in collaboration with Jane Fullarton and C. Elaine Lawson of the committee staff; and Kathi E. Hanna who contributed background papers on genetic testing and genetic counseling, as well as material on personnel issues.

We owe special recognition and thanks to Jane Fullarton, study director, who helped to organize the committee, guided us through the study process, organized the workshops that were essential to the committee's deliberations, edited Volume 2 of the committee report, and assumed substantial responsibility for the preparation of this report. C. Elaine Lawson, research associate, also contributed to this report by collecting and cataloging references, by drafting charts and tables throughout the report, by preparing the data base on public education in genetics, and especially by developing the public education chapter. We also thank Linda Clark and Mary Jane Ball, project assistants, who helped with meeting planning and logistics and prepared briefing books, and especially Mary Jane Ball for her work on the papers in Volume 2. Thanks to Nancy Diener, financial assistant for her help throughout the project. For their editorial assistance, the committee thanks Michael Edington and Betsy Turvene, Institute of Medicine (IOM) editors,

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

and Florence Poillon and Paul Phelps for their consultant editing on the report. Many thanks to Ruth Ellen Bulger, director of the Division of Health Sciences Policy, IOM, who provided policy advice and guidance throughout the course of this study.

This study took place during a period of transition at the Institute of Medicine. Samuel Thier was president of the IOM at the initiation of the study. Stuart Bondurant served as acting president during the transition to the presidency of Kenneth Shine, who assumed his full responsibilities in July 1992. The committee appreciates the leadership provided by them during the course of the study, as well as the oversight provided by Enriqueta Bond, IOM executive officer.

Finally, support for this study was provided jointly by the National Center for Human Genome Research of the National Institutes of Health (NIH) and the Health Effects Research Program of the Department of Energy (DOE). Our special thanks go to Eric Juengst, NIH project officer, and Daniel Drell, DOE project officer, for their support during the study and for their approval of the change in study scope that made the current state-of-the-art assessment of genetic testing possible. We also wish to thank Robert Glaser and Nancy Weber of the Markey Charitable Trust for their supplemental funding of the study, and the Institute of Medicine for matching the Markey Trust funding.

Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
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Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
×

This report includes a number of recommendations that the committee hopes will achieve the goal of acquiring and using genetic information in health care in a manner that respects the autonomy of individuals.

Genetic testing may raise complex or novel questions about the right to access information, and these questions may have legal ramifications. This report should not be interpreted as creating a set of legal guidelines. Relevant laws and regulations will vary from state to state. Clinicians or other persons who have questions about the appropriate management of genetic information may on occasion wish to consider seeking legal counsel.

Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1994. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: The National Academies Press. doi: 10.17226/2057.
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ASSESSING GENETIC RISKS

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Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening.

Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered:

  • Quality control in genetic testing.
  • Appropriate roles for public agencies, private health practitioners, and laboratories.
  • Value-neutral education and counseling for persons considering testing.
  • Use of test results in insurance, employment, and other settings.
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