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The New Profile of Drug-Resistant Tuberculosis in Russia A Global and Local Perspective SUMMARY OF A JOINT WORKSHOP by the Institute of Medicine and the Russian Academy of Medical Science Steve Olson, Rebecca English, and Anne Claiborne, Rapporteurs Forum on Drug Discovery, Development, and Translation Board on Health Sciences Policy and RUSSIAN ACADEMY OF MEDICAL SCIENCES

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. This study was supported by Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and 223001003T), the U.S. State Department (S-LMAQM- 08-GR-071), the American Diabetes Association, the American Society for Micro- biology, Amgen Inc., the Association of American Medical Colleges, Bristol-Myers Squibb, the Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, the Critical Path Institute, the Doris Duke Charitable Foundation, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals Corporation, and Pfizer, Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-16297-5 International Standard Book Number-10: 0-309-16297-1 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap. edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2011 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2011. The New Profile of Drug- Resistant Tuberculosis in Russia: A Global and Local Perspective: Summary of a Joint Workshop. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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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 Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences 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 Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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PLANNING COMMITTEE FOR THE WORKSHOP ON THE NEW PROFILE OF DRUG-RESISTANT TUBERCULOSIS IN RUSSIA: A GLOBAL AND LOCAL PERSPECTIVE1 GAIL H. CASSELL (Chair), Eli Lilly and Company (retired) DONALD M. BERWICK,2 Centers for Medicare and Medicaid Services BARRY R. BLOOM, Harvard School of Public Health ENRIQUETA C. BOND, QE Philanthropic Advisors RICHARD E. CHAISSON, Johns Hopkins University PAUL FARMER, Partners In Health, Harvard Medical School ANTHONY FAUCI, National Institute of Allergy and Infectious Diseases GARY FILERMAN, Atlas Research GERALD H. FRIEDLAND, Yale University School of Medicine ELAINE K. GALLIN,3 QE Philanthropic Advisors STEPHEN C. GROFT, Office of Rare Disease Research, National Institutes of Health VICTORIA McGOVERN, Burroughs Wellcome Fund NANCY SUNG, Burroughs Wellcome Fund ROY WIDDUS, Global Forum for Health Research 1 Instituteof Medicine planning committees are solely responsible for organizing the work- shop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. 2 Donald Berwick was with the Institute for Healthcare Improvement during planning for the workshop. 3 Elaine Gallin was with the Doris Duke Charitable Foundation until December 2010. v

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FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1 Gail H. Cassell (Co-Chair), Eli Lilly and Company (retired), Indiana Jeffrey M. Drazen (Co-Chair), New England Journal of Medicine, Massachusetts Barbara Alving, National Center for Research Resources, Maryland Leslie Z. Benet, University of California-San Francisco Ann Bonham, Association of American Medical Colleges, Washington, DC Linda Brady, National Institute of Mental Health, Maryland Robert M. Califf, Duke University Medical Center, North Carolina Scott Campbell, Foundation for the National Institutes of Health, Maryland C. Thomas Caskey, University of Texas-Houston Health Science Center Peter B. Corr, Celtic Therapeutics, LLLP, New York James H. Doroshow, National Cancer Institute, Maryland Gary L. Filerman, Atlas Research, Washington, DC Garret A. FitzGerald, University of Pennsylvania School of Medicine Elaine K. Gallin,2 QE Philanthropic Advisors, Maryland Steven K. Galson, Amgen Inc., California Harry B. Greenberg, Stanford University School of Medicine, California Stephen Groft, Office of Rare Disease Research, Maryland Annalisa Jenkins, Bristol-Myers Squibb, New Jersey Michael Katz, March of Dimes Foundation, New York Jack D. Keene, Duke University Medical Center, North Carolina Ronald L. Krall, University of Pennsylvania Center for Bioethics Freda Lewis-Hall, Pfizer, Inc., New York William D. Matthew, National Institute of Neurological Disorders and Stroke, Maryland Mark B. McClellan, Brookings Institution, Washington, DC Carol Mimura, University of California-Berkeley John Orloff, Novartis Pharmaceuticals Corporation, New Jersey Amy P. Patterson, National Institutes of Health, Maryland Janet Shoemaker, American Society for Microbiology, Washington, DC Ellen V. Sigal, Friends of Cancer Research, Virginia Nancy S. Sung, Burroughs Wellcome Fund, North Carolina Jorge A. Tavel, National Institute of Allergy and Infectious Diseases, Maryland 1 Instituteof Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. 2 Elaine Gallin was with the Doris Duke Charitable Foundation until December 2010. vii

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Janet Tobias, Ikana Media, New York Joanne Waldstreicher, Johnson & Johnson, New Jersey Janet Woodcock, U.S. Food and Drug Administration, Maryland Raymond L. Woosley, The Critical Path Institute, Arizona IOM Staff Anne B. Claiborne, Director Andrew Pope, Director, Board on Health Sciences Policy Rebecca A. English, Associate Program Officer Yeonwoo Lebovitz, Program Associate (until November 2010) Genea S. Vincent, Senior Program Assistant (until November 2010) Elizabeth F. C. Tyson, Research Associate (as of January 2011) Robin A. Guyse, Senior Program Assistant (as of January 2011) Rona Briere, Consulting Editor viii

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Reviewers 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 National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its 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 process. We wish to thank the following individuals for their review of this report: Elaine K. Gallin, QE Philanthropic Advisors Ann Ginsberg, TB Alliance Maria Giovanni, National Institute of Allergy and Infectious Diseases, National Institutes of Health Alexander Golubkov, Partners In Health Sergey Popov, I.M. Sechenov Moscow Medical Academy Irina Vasilyeva, Central Tuberculosis Research Institute, Russian Academy of Medical Sciences Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by ix

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x REVIEWERS Dr. Melvin Worth. Appointed by the Institute of Medicine, he was respon- sible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution.

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Contents ACRONYMS xvii 1 INTRODUCTION 1 The Problem of Drug Resistance, 2 The Burden of Drug-Resistant TB, 2 Workshop Objectives, 4 A Realistic Assessment of the Challenges of Drug-Resistant TB, 6 Organization of the Report, 7 2 A GLOBAL PERSPECTIVE ON DRUG-RESISTANT TUBERCULOSIS 9 Difficulties in Estimating the Burden of MDR TB, 10 MDR and XDR TB in South Africa, 14 MDR and XDR TB in China, 14 Historical Perspective on MDR TB Control Efforts, 19 Remaining Challenges, 22 3 DRUG-RESISTANT TUBERCULOSIS IN THE RUSSIAN FEDERATION 29 A Historical Perspective, 30 Epidemiology of TB in the Russian Federation, 31 National MDR TB Surveillance System, 34 xi

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xii CONTENTS 4 TRANSMISSION AND INFECTION CONTROL OF DRUG-RESISTANT TB 37 Transmission of Drug-Resistant TB in China, 38 Transmission-Based Genetic Analysis in South Africa, 39 Reducing Nosocomial Drug-Resistant TB Transmission, 42 5 DIAGNOSIS OF DRUG-RESISTANT TB 49 Rapid Diagnostic Methods, 50 Biochip Technology for TB Diagnosis, 54 Need for Improved Laboratory Capacity, 55 6 TREATMENT OF DRUG-RESISTANT TB 63 PETTS: Making the Case for Drug Resistance Testing and Tailored Treatment Regimens, 64 Treatment of Drug-Resistant TB in the Russian Federation, 67 Drug-Resistant TB and Coinfection with HIV, 68 Innovative Research in MDR TB Treatment, 71 7 TB AND DRUG-RESISTANT TB IN VULNERABLE POPULATIONS 75 Drug-Resistant TB in Children: The Hidden Epidemic, 76 MDR TB Treatment for People with Drug and Alcohol Dependencies, 80 TB in the Prison System of the Russian Federation, 84 8 THE SECOND-LINE DRUG SUPPLY CHAIN 87 A New Paradigm for the Drug Supply for Drug-Resistant TB, 88 MDR TB Treatment and the Drug Supply Chain in the Russian Federation, 90 9 THE DEVELOPMENT OF NEW TB DIAGNOSTICS AND DRUGS 95 The Global Challenge, 96 The Role of Regulatory Science, 97 The Need for Collaboration, 99 10 CONVERGENCE OF SCIENCE AND POLICY TO CREATE A CALL FOR ACTION 101 Key Challenges, 101 Infection Control, 103 Diagnostics, 103 Treatment, 103

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xiii CONTENTS High-Quality Care for All, 104 Linkages from Science to Clinical Care, 106 REFERENCES 109 A AGENDA 113 B SUMMARY OF A MEETING OF THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, HELD MAY 24–25, 2010, MOSCOW, RUSSIAN FEDERATION 121 C PARTICIPANT BIOGRAPHIES 123

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Tables, Figures, and Boxes TABLES MDR TB Data from the Russian Federation, 2007−2009, 35 3-1 7-1 Varying MDR TB Rates Revealed by Surveys of Anti-TB Drug Resistance in South American Children, 2001−2009, 77 FIGURES 3-1 TB incidence by gender and age rises to a peak between ages 25 and 34, 32 3-2 TB incidence and mortality rose in the 1990s and have declined slightly since, 33 3-3 The number of MDR TB patients has continued to grow in the Russian Federation during the 21st century, 36 6-1 The number of new cases of TB-HIV coinfection in the Russian Federation has grown dramatically since 1999, 70 6-2 The number of new HIV cases in Russia declined at the beginning of the decade and began to increase in 2004, 70 The 2004−2005 cohort had worse outcomes than the 2000−2002 7-1 cohort, largely because of alcoholism and drug addiction, 81 xv

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xvi TABLES, FIGURES, AND BOXES 7-2 Default percentages among MDR TB patients dropped substantially after initiation of the DOTS-Plus program through a Global Fund grant, 83 7-3 TB mortality in Tomsk Oblast has fallen at a greater rate than in the Siberian Federal District or the Russian Federation, 84 7-4 The number of active TB patients in Russia’s penal institutions has declined over the past decade, 85 7-5 The number of patients infected with HIV and coinfected with HIV and M.tb. in Russia’s penal institutions has risen since 2004, 86 BOXES 1-1 The Nature of the Threat, 3 2-1 A Social Medicine Perspective, 11 2-2 Drug-Resistant TB in China: Surveillance Results, 16 2-3 The New York City TB Epidemic, 20 4-1 Control of Nosocomial TB Infection in a TB Dispensary in Vladimir Oblast, Russian Federation, 44 5-1 Some Diagnostic Methods Currently in Use for TB, 51 5-2 New Methods for Species Identification of Nontuberculosis Mycobacteria, 52 5-3 Diagnostics and Laboratory Infrastructure in South Africa, 56

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Acronyms AIDS acquired immune deficiency syndrome ART antiretroviral therapy BCG Bacillus Calmette-Guérin vaccine CD4 Cluster of Differentiation 4 CDC Centers for Disease Control and Prevention CTRI Central Tuberculosis Research Institute DNA deoxyribonucleic acid DOTS Directly Observed Treatment Short course FDA Food and Drug Administration FIND Foundation for Innovative New Diagnostics GDF Global Drug Facility GLC Green Light Committee GLI Global Laboratory Initiative GMP Good Manufacturing Practices HIV human immunodeficiency virus IL-7 interleukin-7 IOM Institute of Medicine ISTC International Science and Technology Center xvii

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xviii ACRONYMS ISTC International Standards for Tuberculosis Care LPA line probe assay M.tb. Mycobacterium tuberculosis MDR TB multidrug-resistant tuberculosis MRSA methicillin-resistant Staphylococcus aureus NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NTM nontuberculosis mycobacteria PCR polymerase chain reaction PETTS Preserving Effective Tuberculosis Treatment Study PEPFAR U.S. President’s Emergency Plan for AIDS Relief PPD purified protein derivative RAMS Russian Academy of Medical Sciences TB tuberculosis TDR TB totally drug-resistant tuberculosis USAID U.S. Agency for International Development UV ultraviolet WHO World Health Organization XDR TB extensively drug-resistant tuberculosis