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Ending Neglect

The Elimination of Tuberculosis in the United States

Lawrence Geiter, Editor

Committee on the Elimination of Tuberculosis in the United States

Division of Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE



    NATIONAL ACADEMY PRESS
    Washington, D.C.


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Page i Ending Neglect The Elimination of Tuberculosis in the United States Lawrence Geiter, Editor Committee on the Elimination of Tuberculosis in the United States Division of Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Page ii NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 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 project has been funded entirely with federal funds from the Centers for Disease Control and Prevention, under Contract No. 200-98-0012. The views presented are those of the Institute of Medicine Committee on the Elimination of Tuberculosis in the United States and are not necessarily those of the funding organization. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on the Elimination of Tuberculosis in the United States. Ending neglect : the elimination of tuberculosis in the United States / Lawrence Geiter, editor; Committee on the Elimination of Tuberculosis in the United States, Division of Health Promotion and Disease Prevention, Institute of Medicine. p. ; cm. Includes bibliographical references and index. ISBN 0-309-07028-7 1. Tuberculosis—United States. I. Geiter, Lawrence. II. Title. [DNLM: 1. Tuberculosis, Pulmonary—prevention & control—United States WF 300 I59e 2000] RC313.A2 I55 2000 614.5′42′0973—dc21 00-056115 The full text of this report is available on line at http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at http://www.iom.edu. Copyright 2000 by the National Academy of Sciences . All rights reserved. Printed in the United States of America 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 Staatliche Museen in Berlin. Cover: Modigliani. Self-portrait, 1919. Oil on canvas. Museu de Arte Contemporanea da Universidade de Sao Paulo. Collection M and Madame Francisco-Matarazzo Sabrinho.

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Page iii “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE Shaping the Future for Health

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Page iv THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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 M. 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. William A. Wulf 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 M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Page v COMMITTEE ON THE ELIMINATION OF TUBERCULOSIS IN THE UNITED STATES MORTON SWARTZ (Chair), Chief, Jackson Firm of Medical Service and Infectious Disease Unit, Massachusetts General Hospital, Boston RONALD BAYER, Professor, Joseph L. Mailman School of Public Health, Columbia University C. PATRICK CHAULK, Senior Associate for Health, Annie E. Casey Foundation, Baltimore, Md. GEORGE COMSTOCK,* Professor of Epidemiology, Johns Hopkins University * Resigned in June 1999 for personal reasons unrelated to committee activities. FRAN DU MELLE, Deputy Managing Director, American Lung Association, Washington, D.C. SUE C. ETKIND, Director, Division of Tuberculosis Prevention and Control, Massachusetts Department of Public Health, Jamaica Plain DAVID FLEMING, Assistant Administrator and State Epidemiologist, Oregon Health Division, Portland AUDREY R. GOTSCH, Professor and Interim Dean, School of Public Health, University of Medicine and Dentistry of New Jersey PHILIP C. HOPEWELL, Associate Dean, San Francisco General Hospital, Division of Pulmonary and Critical Care Medicine, University of California at San Francisco DONALD R. HOPKINS, Associate Executive Director, The Carter Presidential Center, Chicago JOHN A. SBARBARO, Medical Director, University Physician's, Inc., School of Medicine, University of Colorado Health Sciences Center PETER M. SMALL, Assistant Professor of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford Medical Center, Stanford University MARY E. WILSON, Chief of Infectious Diseases and Director, Travel Resource Center, Division of Infectious Diseases, Mount Auburn Hospital, Cambridge, Mass. LESTER N. WRIGHT, Associate Commissioner and Chief Medical Officer, New York Department of Correctional Services, Albany

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Page vi Board on Health Promotion and Disease Prevention Liaison ROBERT FULLILOVE, Associate Dean for Community and Minority Affairs, Joseph L. Mailman School of Public Health, Columbia University Board on Global Health Liaison BARRY BLOOM, Dean, Harvard School of Public Health Study Staff LAWRENCE GEITER, Study Director DONNA ALMARIO, Research Assistant ELIZABETH EPSTEIN, Project Assistant PATRICIA SPAULDING, Project Assistant KATHLEEN STRATTON, Acting Director (through November 1999), Division of Health Promotion and Disease Prevention ROSE MARIE MARTINEZ, Director (from December 1999), Division of Health Promotion and Disease Prevention DONNA D. DUNCAN, Division Assistant

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Page vii Preface In 1905, in his book The Life of Reason, the poet and philosopher George Santayana wrote “Those who do not remember the past are condemned to repeat it.” This statement is particularly apropos now as we attempt to develop a plan for the future elimination of tuberculosis in the United States, ever mindful of the lessons that can be gleaned from the historical record. The incidence of tuberculosis in this country and in Europe began to decline in the late 19th and early 20th centuries with improving social and economic conditions. By the 1930s, the possibility of eliminating this leading infectious cause of death globally began to be pondered by public health experts. The introduction in the early 1950s of the first effective antimicrobial drugs for treatment of tuberculosis was followed in the 1960s by the closing of many tuberculosis hospitals and sanatoriums. The elimination of this dread disease seemed feasible at that time provided public interest and government expenditures commensurate with the task could be marshaled and sustained. This was not to be the case; rather, the declining incidence of tuberculosis in the United States induced complacency and neglect for this disease. Indeed, after several years of decreasing federal support, in 1972 categorical federal funding for tuberculosis control was eliminated entirely. It was not reinstated for 9 years, and then only at a very reduced level. In addition, the scientific community and funding agencies largely disregarded tuberculosis, deeming it of insufficient importance to warrant a high research priority. As a consequence of this lack of funding and research interest, scientific publications in this field decreased by almost 50 percent between 1968 and 1980. The price of

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Page viii this neglect has been the resurgence of tuberculosis in the United States in the late 1980s and early 1990s, with major costs in suffering, death, and economic losses. Reversal of the ensuing increased case rates, many involving patients whose infecting microorganisms were multidrug resistant, was accomplished only with great difficulty and required energetic tuberculosis control measures and markedly increased public expenditures. We are now at a critical juncture. On the one hand, control of tuberculosis in the United States has been regained and we are at an all-time low in the number of new cases (18,361 in 1998). On the other hand, we are particularly vulnerable again to the complacency and neglect that comes with declining numbers of cases. Now is the time to commit to the abolition of the recurrent cycles of neglect followed by resurgence that have been the history of tuberculosis in the latter half of the past century. In 1989, almost simultaneous with an unexpected upsurge in the incidence of tuberculosis in the United States, the Centers for Disease Control and Prevention (CDC) and the Advisory Council for the Elimination of Tuberculosis (ACET) developed a strategic national plan to reduce the incidence of tuberculosis to 3.5 cases per 100,000 persons by the year 2000, and by 2010, to less than 1 case per 1 million population. However, in place of the steady (about 7 percent per year) decline of cases prior to 1985, between 1985 and 1992 cases of tuberculosis increased from 22,210 to 26,673 per year. Since the latter date, the incidence of tuberculosis in the United States has resumed its former rate of decline (again about 7 percent annually) to 18,361 cases in 1998, or 6.8 cases per 100,000 population. At this rate of decline it would take 60 more years to reach the stated 1989 CDC/ACET goal for 2010 (1 case per 1 million population) unless changes were made in the methods used for the control of tuberculosis. This Institute of Medicine report, Ending Neglect: The Elimination of Tuberculosis in the United States, undertaken under sponsorship from the CDC, reviews the lessons learned from the neglect of tuberculosis between the late 1960s and the early 1990s and reaffirms committing to the goal of eliminating tuberculosis in the United States, defined as a case rate of less than 1 case per 1 million population per year. Clearly, to meet this goal aggressive and decisive actions beyond what is now in effect will be required. The report details the following recommendations in full, but a few are listed here: Maintaining control of tuberculosis while adjusting control measures to declining incidence of disease and changing systems of health care management. This will be integral to interrupting transmission of tuberculosis and, most important, to preventing the emergence of multidrug-resistant tuberculosis. Among measures to ensure this, all

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Page ix states should mandate completion of therapy for all patients with active tuberculosis. In addition, to advance toward elimination of tuberculosis in areas of the country with already low rates of tuberculosis, activities toward elimination should be regionalized through both federal and multistate initiatives to improve access to and more efficient utilization of clinical, epidemiological, case management, and laboratory services. Federal categorical funding for tuberculosis control should be retained, providing dedicated resources for this purpose while allowing maximum flexibility and efficiency in its implementation. Accelerating the rate of decline of tuberculosis (aimed at elimination) by increasing efforts at targeted tuberculin testing and treatment of latent infection. This would involve development of more effective methodologies to identify persons with recently acquired tuberculosis infection and increased efforts to evaluate and treat latent infection in persons at high risk of subsequent progression to active disease. Tuberculin skin testing should be required in the medical evaluation of immigrants applying for visas from countries with high rates of tuberculosis. Those found to be tuberculin positive should be required to undergo an evaluation for tuberculosis, and, when appropriate, complete an approved course of treatment for latent infection before receiving their permanent residency card. Similar tuberculin testing should be required of all inmates of correctional institutions and, when indicated, completion of an appropriate course of treatment. Programs of targeted tuberculin skin testing and treatment of latent infection should be intensified for other high-incidence populations such as homeless individuals, undocumented immigrants, and intravenous drug abusers, as indicated by local epidemiological considerations. Developing new tools necessary for the ultimate elimination of tuberculosis, including new diagnostic tests for latent infection, new treatments and an effective vaccine. Increasing involvement of the United States in global tuberculosis control, recognizing the fact that tuberculosis is not constrained by national boundaries and that increasing proportions of new cases in this country are developing in individuals born in countries with high incidences of tuberculosis. Mobilizing and sustaining public support and commitment for elimination of tuberculosis and regularly measuring progress toward that goal. This committee comprised 13 individuals with expertise in tuberculosis (clinical aspects, epidemiology, mycobacteriological research, prevention and control, and health education), ethics, public health policy and infectious disease eradication, state correctional health services, interna

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Page x tional health and general infectious disease. In response to public comment on committee composition that noted an absence of experts on public health tuberculosis laboratories, a special report on this subject was commissioned and is included in this report (Appendix D). The committee met five times, and these included public sessions at four of the meetings. In particular, the final public session was held to provide for full and open discussion on issues raised regarding tuberculin testing (and prophylactic therapy when appropriate) of immigrants to the United States from countries with high incidence rates of tuberculosis. This discussion benefited from the involvement of experts in ethics, immigration law, and public policy as well as representatives from the Immigration and Naturalization Service, CDC, and the Department of State. In addition, committee members conducted site visits to a variety of sites (state and local health departments, CDC, public hospitals, homeless facilities, and facilities for nonadherent infectious patients placed under legal orders to complete therapy), selected to represent a full range of the problems and issues in current tuberculosis control. These sites included ones in Atlanta, San Diego, Seattle/King County and Tacoma/Pierce County in Washington, Boston, Washington, D.C., and Augusta and Portland in Maine (Appendix C). The report is organized in the following fashion. Chapter 1 covers the fundamentals of tuberculosis, including its transmission, pathogenesis, diagnosis, treatment, and control. Chapter 2 reviews the history of tuberculosis in the United States, analyzes the implications of disease elimination, and discusses the ethical issues in moving toward elimination. Chapter 3 considers many of the challenges of tuberculosis programs to prevent a resurgence of tuberculosis in this country as the number of cases declines: maintaining high skill levels and quality of care, needs for performance standards, developing necessary information systems for evaluating case management and disease control, and the increasing use of managed care and the potential for regionalization of control and diagnostic efforts. Chapter 4 makes the case for accelerating the rate of decline of tuberculosis through use of targeted tuberculin skin testing programs and treatment of latent infection; improving methodologies for contact tracing, examination and treatment; changing the medical examination of visa applicants from high-incidence countries to include tuberculin testing and treatment, where appropriate, in those that are tuberculin positive. This change from established procedure evoked the most discussion and greatest attention from the committee. The approaches discussed in this chapter should speed up the current rate of decline of tuberculosis and advance the eventual elimination of this disease in the United States. Chapter 5 describes the current status of tuberculosis research and pinpoints the research needs, both short term (newer methodologies for the

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Page xi diagnosis and treatment of latent tuberculosis) and longer term (vaccine development), that need to be fulfilled to make the elimination of tuberculosis a reality. Chapter 6 identifies the need for an enhanced role of the United States in global tuberculosis control, both from the point of view of self-interest and humanitarian considerations. Chapter 7 covers the important role of public advocacy efforts to develop and sustain the political commitment needed to make elimination of tuberculosis a reality. The committee would like to thank the numerous experts from various governmental agencies, academic institutions, professional organizations, and groups working with immigrants, migrant workers, and the homeless who made presentations at its meetings, thus ensuring consideration of a broad set of views in the development of its recommendations (Appendix B). The committee is particularly grateful to Lawrence Geiter, Ph.D., the IOM study director, for his untiring efforts in working our discussions and contributions into a coherent, thorough, and well-reasoned report within a year of our first meeting, with the assistance of his staff, Donna Almario, Elizabeth Epstein, and Patricia Spaulding. We wish to thank Robert Fullilove, Ed.D., liaison to the IOM Board on Health Promotion and Disease Prevention, who attended and participated in our meetings and discussions, and George Comstock, Dr.P.H., who was originally a committee member until forced to withdraw because of an illness in his family. We also wish to thank Kenneth I. Shine, M.D., president of IOM; Kathleen Stratton, acting director of the Division of Health Promotion and Disease Prevention; and Rose Martinez, director of the Division of Health Promotion and Disease Prevention, for their support and insights. Morton N. Swartz, M.D., Chair

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Page xiii Acknowledgments The committee wishes to express its appreciation to the many individuals who contributed to the completion of this project. We especially want to thank our consultant, Robert C. Good, Ph.D., whose paper appears as Appendix D , and the many workshop presenters who provided the committee with a wealth of information (see Appendix B). This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their participation in the review of this report: Mary Ellen Avery, Harvard Medical School Mark Barnes, Proskauer Rose LLP, New York City Jerrold Ellner, New Jersey Medical School, University of Medicine and Dentistry of New Jersey Lee B. Reichman, New Jersey Medical School National Tuberculosis Center, Newark Barbara G. Rosenkrantz, Harvard University

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Page xiv Sarah Royce, Tuberculosis Control Branch, California Department of Health Services, Berkeley Steven Schroeder, The Robert Wood Johnson Foundation, Princeton, New Jersey Zena Stein, Gertude H. Sergievsky Center, Columbia University While the individuals listed above have provided constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Page xv Contents Please refer to the page image for an unflawed representation of this content. EXECUTIVE SUMMARY 1 1   FUNDAMENTALS OF TUBERCULOSIS AND TUBERCULOSIS CONTROL 13 Historical Epidemiology, 13 Transmission and Pathogenesis of Tuberculosis, 15 Diagnosis and Treatment, 16 Principles of Tuberculosis Control, 19 2   THE CURRENT SITUATION AND HOW WE GOT HERE 23 The History of Tuberculosis, 23 Current Status of Tuberculosis, 27 The Current Legal System, 39 The Reality of Elimination, 44 The Ethics of Tuberculosis Elimination, 46 3   TUBERCULOSIS ELIMINATION AND THE CHANGING ROLE OF TUBERCULOSIS CONTROL PROGRAMS 51 Recommendations, 51 Background, 53 Changes in Tuberculosis Control Program Strategies, 54 Crosscutting Strategies, 59 Conclusion, 82

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Page xvi 4   ADVANCING TOWARD ELIMINATION 86 Recommendations, 86 Background and Introduction, 87 Treatment of Latent Tuberculosis Infection, 88 Current Screening for Immigrants to the United States, 89 The Need for Expanded Screening, 91 Mandatory Screening and Treatment of Latent Infection in Prisons and Other Congregate Settings, 97 Expanding Contact Investigations and Improving Outbreak Management, 101 5   DEVELOPING THE TOOLS FOR TUBERCULOSIS ELIMINATION 122 Recommendations, 123 Background and Introduction, 123 Current Status and Needs, 124 Dynamics of Tuberculosis Research, 131 Current Activities, 132 Research Priorities, 143 6   THE U.S. ROLE IN GLOBAL TUBERCULOSIS CONTROL 149 Recommendations, 149 Global Context of Tuberculosis, 150 Global Tuberculosis Control Efforts, 152 7   MOBILIZING FOR ELIMINATION 159 Recommendations, 159 APPENDIXES A   Statement of Task 171 B   Public Session Agendas 173 C   Site Visit Summaries 182 D   Role of Public Health Laboratories in the Control of Tuberculosis 205 E   Estimating the Number of Tuberculosis Cases That Can Be Prevented by a Program of Screening and Preventive Therapy of Newly Arrived Immigrants to the United States from Countries with a High Rate of Tuberculosis and the Costs of the Program 234 F   Approval Dates for Existing and Prospects for Development of New Antituberculosis Drugs and Vaccines 244 G   Committee Biographies 250 INDEX 257

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Page xvii Ending Neglect

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