The Continuing Challenge of Tuberculosis
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The Continuing Challenge of Tuberculosis September 1993 OTA-H-574 NTIS order #PB94-107570 GPO stock #052-003-01341-0 Recommended Citation: U.S. Congress, Office of Technology Assessment, The Continuing Challenge of Tuberculosis, OTA-H-574 (Washington, DC: U.S. Government Printing Office, September 1993). For sale by the U.S Government Printing Office Superintedent of Documents, Mail Stop: SSOP. Washington DC 20402-93l28 ISBN 0-16 -041966-2 Foreword fter having declined for 30 years, the overall incidence of tuberculosis in the United States has been on the rise since the mid- 1980s. In some communities, the problem is extremely serious, compounding other social ills, including AIDS, hopelessness, drug abuse, and poverty. AParticularly disturbing is the emergence of multidrug-resistant tuberculosis (MDR-TB). MDR-TB has been directly linked to inappropriate and incomplete treatment, which in turn has been linked, in part, to a lack of resources to ensure the proper delivery of tuberculosis services. At at a time when the Nation is focused on health care reform, the threat of TB reminds us of the importance of maintaining a strong public health infra- structure. The Federal Government has a long history of providing resources and leadership to State and local health authorities in the control of TB. However, only in the past few years has the government begun to restore fund- ing to TB programs that were cut during the 1970s and early 1980s. OTA’s report synthesizes current understanding of TB in the United States, including the extent of the disease, the state of research of new preven- tive, diagnostic, and therapeutic technologies to aid in its control, and the deliv- ery of effective TB services. The report also provides an overview of Federal involvement in these activities. It was initiated in response to requests from three committees of Congress: the House Committee on Energy and Commerce’s Subcommittee on Health and the Environment, the House Committee on Government Operations’ Subcommittee on Human Resources and Intergovernmental Relations, and the Senate Committee on Labor and Human Resources. OTA was assisted in the study by a group of public health leaders from academia, industry, government, and public interest groups who met in a work- shop convened by OTA in March 1993. A large number of other experts provid- ed detailed reviews of multiple drafts. OTA gratefully acknowledges the contribution of these individuals. As with all OTA reports, the final responsibility for the content of these assess- ments rests with OTA. Roger C. Herdman, Director . Ill workshop Participants Alan Bloch Margaret Hamburg Peter Selwyn Medical Officer Commissioner of Health Associate Director Surveillance and Epidemiology New York City Department of AIDS Program Branch Health Yale-New Haven Hospital Centers for Disease Control and New York, NY New Haven, CT Prevention U.S. Department of Health and Jeffrey Levi Virginia Shubert Human Services Director Director of Advocacy and Atlanta, GA Government Affairs Public policy AIDS Action Council Housing Works, Inc. Barry Bloom Washington, DC New York, NY Professor Department of Microbiology and Joan Otten Jane Sisk Immunology Director Professor Albert Einstein College of Office of Tuberculosis Control School of Public Health Medicine Jackson Memorial Hospital Columbia University Yeshiva University Miami, FL New York, NY Bronx, NY Lee Reichman Jeffrey Starke Wafaa E1-Sadr President Assistant Professor Director American Lung Association Department of Pediatrics Division of Infectious Diseases New York, NY Baylor College of Medicine Houston, TX Harlem Hospital Center Gisela Schecter New York, NY Tuberculosis Controller Larry Gostin Tuberculosis Control Division Executive Director Department of Public Health American Society of Law, City and County of San Francisco Medicine and Ethics San Francisco, CA Boston, MA OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the participants in OTA’S workshop on Policy Issues in the Control of Tuberculosis, March 23, 1993. The workshop participants do not, however, nec- essarily approve, disapprove, or endorse this report, OTA assumes full responsibility for the report and the accuracy of its contents. iv —.— Preject Staff Clyde J. Behney PROJECT STAFF Assistant Director, OTA Health, Life Sciences, and the MICHAEL E. GLUCK Environment Project Director ADMINISTRATIVE STAFF JULIA T. OSTROWSKY Principal Contractor Beckie Erickson Office Administrator Sharon Y. Hamilton l Daniel B. Carson Research Analyst PC Specialist Carolyn Martin Arna M. Lane Word Processing Specialist Research Analyst Eric L. Gille Secretary Contractors Sue Etkind PUBLISHING STAFF Massachusetts Department of Public Health Mary Lou Higgs Boston, MA Manager, Publishing Services Lynn Powers Denise Felix Production Editor Editorial Consultant Alexandria, VA Dorinda Edmondson Typographer Christine Onrubia Graphic Designer 1 From August 1992 to May 1993 contents 1 Summary and Policy Options 1 Scope of the OTA Report 2 Tuberculosis, Health Care Reform, and Public Health Investments 2 What Is TB? 2 What Is the Risk of TB Infection? 3 Trends in the Incidence of Active TB 3 The Changing Demographics of TB 4 Multidrug-Resistant Tuberculosis 6 Three Strategies for TB Prevention 6 Diagnosis of Active TB 8 Treatment of Active TB 9 Delivering TB Treatment 10 Federal Involvement in TB Control 12 Policy Options for Congress 16 2 Etiology and Transmission of Tuberculosis 27 Ii Transmission and Infectivity 28 Factors Influencing the Probability of Acquiring Tuberculous Infection 28 Factors Influencing the Development of Active TB After Infection 30 Development of Tuberculosis and Its Clinical Manifestations 30 Immune Responses to Tuberculous Infection and Disease 31 Clinical Course in HIV-Seropositive Individuals 32 Clinical Course in Children 32 3 The Changing Epidemiology of Tuberculosis 33 Overall Trends in TB Incidence 33 Demographic Changes in TB 34 Geographic Distribution 35 Race, Ethnicity, Age, and Sex 37 High-Risk Populations 40 vii HIV and AIDS: Epidemiologic Association With TB 42 The Prevalence of TB Among Individuals With MDs 43 Multidrug-Resistant Tuberculosis 44 Recent Outbreaks of MDR-TB in Institutional Settings 46 Factors Underlying the TB Resurgence in the United States 47 4 Strategies to Prevent Tuberculous Infection and Active Disease 49 Infection Control 50 Infection Control Measures 52 Tuberculin Skin Testing and Preventive Treatment 55 Identifying Individuals with Tuberculous Infection 59 Isoniazid Preventive Treatment 61 BCG Vaccination 62 The Nature and Rationale for BCG Vaccines 63 Efficacy and Safety of BCG Vaccination 64 Impact of BCG Vaccination on the Incidence of TB 65 BCG Vaccination Policy in the United States 66 Issues Concerning Future Use of Vaccination Against TB 67 5 Diagnosis and Treatment of Active TB 69 Diagnosis of TB and Resistance to Anti-TB Drugs 70 Treatment of Active TB 72 Rationale for Antimicrobial Treatment of TB 74 Current Treatment Regimens 75 Treatment of TB in Individuals with AIDS 76 Treatment of Multidrug-Resistant TB 76 New Approaches to Treatment 78 The Cost of Drugs for Tuberculosis Treatment 79 6 Delivery of Treatment for Tuberculosis 81 Magnitude of the Problem 82 Factors Involved in Treatment Outcome 84 Provision of TB Control Semices 84 Medical Care Practices 86 Patient Behavior 87 Available Strategies for Improving Treatment Delivery 88 . Vlll 7 Federal Involvement in Tuberculosis Control and Research 91 Public Health Activities 92 The Centers for Disease Control and Prevention 92 Occupational Health and Safety Administration 97 U.S. Departments of Justice and State 98 U.S. Department of Veterans Affairs 98 Indian Health Service 99 Federal Bureau of Prisons 99 U.S. Agency for International Development 99 Health Resources and Services Administration 100 Research and Development 100 National Institutes of Health 100 Regulation of Technologies 102 Health Services Research 102 Housing 103 Reimbursement for TB Services 103 Disability Programs Administered by the Social Security Administration 103 The Role of Federal Health Insurance Programs 103 A Acknowledgments 107 B Abbreviations and Glossary 112 REFERENCES 119 INDEX 141 ix Summary and Policy Options 1 uberculosis (TB) is a contagious disease that has killed millions of people worldwide over the centuries. The lack of a reliable cure prior to this century and TB’s perceived randomness made it a common theme in literatureT and a metaphor for larger social and political ills (84,299). Today, TB continues to be a public health threat in the United States. After decreasing in the country as a whole for many decades, rates of TB disease are again on the rise. In some communities, particularly among economically disadvantaged groups, TB rates have consistently remained high. Recent trends in the incidence of TB have been linked, in part, to decreases in public health investment over the last two decades (45,46,176). Other factors associated with the resurgence of TB include the human immunodeficiency virus (HIV) epidemic, foreign birth, substance abuse, poverty, and hopelessness. An important complication is the emergence of TB strains resistant to the most commonly used anti-TB drugs. Unchecked, these recent trends in TB represent a serious threat to communities already saddled with poor health, poverty, and other social problems. Furthermore, this disease could become a additional major burden to the Nation’s health care system. Unlike the TB of past