The New Profile of A Global and Local Perspective SUMMARY OF A JOINT WORKSHOP |
Steve Olson, Rebecca English, and Anne Claiborne, Rapporteurs
Forum on Drug Discovery, Development, and Translation
Board on Health Sciences Policy
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
and
RUSSIAN ACADEMY OF MEDICAL SCIENCES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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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.
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-LMAQM08-GR-071), the American Diabetes Association, the American Society for Microbiology, 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.
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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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INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
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 Institute of Medicine planning committees are solely responsible for organizing the workshop, 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.
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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 Institute of 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.
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
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
Dr. Melvin Worth. Appointed by the Institute of Medicine, he was responsible 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.
Contents
The Problem of Drug Resistance
The Burden of Drug-Resistant TB
A Realistic Assessment of the Challenges of Drug-Resistant TB
2 A GLOBAL PERSPECTIVE ON DRUG-RESISTANT TUBERCULOSIS
Difficulties in Estimating the Burden of MDR TB
MDR and XDR TB in South Africa
Historical Perspective on MDR TB Control Efforts
3 DRUG-RESISTANT TUBERCULOSIS IN THE RUSSIAN FEDERATION
4 TRANSMISSION AND INFECTION CONTROL OF DRUG-RESISTANT TB
Transmission of Drug-Resistant TB in China
Transmission-Based Genetic Analysis in South Africa
Reducing Nosocomial Drug-Resistant TB Transmission
5 DIAGNOSIS OF DRUG-RESISTANT TB
Biochip Technology for TB Diagnosis
Need for Improved Laboratory Capacity
6 TREATMENT OF DRUG-RESISTANT TB
PETTS: Making the Case for Drug Resistance Testing and Tailored Treatment Regimens
Treatment of Drug-Resistant TB in the Russian Federation
Drug-Resistant TB and Coinfection with HIV
Innovative Research in MDR TB Treatment
7 TB AND DRUG-RESISTANT TB IN VULNERABLE POPULATIONS
Drug-Resistant TB in Children: The Hidden Epidemic
MDR TB Treatment for People with Drug and Alcohol Dependencies
TB in the Prison System of the Russian Federation
8 THE SECOND-LINE DRUG SUPPLY CHAIN
A New Paradigm for the Drug Supply for Drug-Resistant TB
MDR TB Treatment and the Drug Supply Chain in the Russian Federation
9 THE DEVELOPMENT OF NEW TB DIAGNOSTICS AND DRUGS
The Role of Regulatory Science
10 CONVERGENCE OF SCIENCE AND POLICY TO CREATE A CALL FOR ACTION
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BOXES
2-1 A Social Medicine Perspective
2-2 Drug-Resistant TB in China: Surveillance Results
2-3 The New York City TB Epidemic
4-1 Control of Nosocomial TB Infection in a TB Dispensary in Vladimir Oblast, Russian Federation
5-1 Some Diagnostic Methods Currently in Use for TB
5-2 New Methods for Species Identification of Nontuberculosis Mycobacteria
5-3 Diagnostics and Laboratory Infrastructure in South Africa
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 |
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 |