The Global Crisis of Drug-Resistant Challenges and Opportunities SUMMARY OF A JOINT WORKSHOP by the Institute of Medicine and |
Steve Olson, Rebecca A. English, and Anne B. Claiborne, Rapporteurs
Forum on Drug Discovery, Development, and Translation
Board on Health Sciences Policy
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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NOTICE: The workshop that is the subject of this workshop summary 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 activity was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (HHSN26300023 [Under Base #HHSN263201200074I] and Contract No. N01-OD-4-2139 TO #276; HHSF22301026T [Under Base #HHSF223200810020I]), AbbVie Inc., American Diabetes Association, American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, AstraZeneca, Bristol-Myers Squibb, Burroughs Wellcome Fund, CDC Foundation, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co. Foundation, Eli Lilly and Company, FasterCures, Fondation Mérieux, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, March of Dimes Foundation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., and Sanofi. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.
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International Standard Book Number-10: 0-309-28596-8
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Suggested citation: IOM (Institute of Medicine). 2014. The Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS: Challenges and Opportunities: Summary of a Joint Workshop. Washington, DC: The National Academies Press.
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Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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. 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., 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. Harvey V. Fineberg 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. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.
PLANNING COMMITTEE FOR THE WORKSHOP ON THE GLOBAL CRISIS OF DRUG-RESISTANT TUBERCULOSIS AND THE LEADERSHIP OF THE BRICS COUNTRIES: CHALLENGES AND OPPORTUNITIES1
U.S. Planning Committee
GAIL H. CASSELL (Chair), Harvard Medical School (Visiting)
BARRY R. BLOOM, Harvard School of Public Health
ENRIQUETA C. BOND, QE Philanthropic Advisors
RICHARD E. CHAISSON, Johns Hopkins University
PAUL E. FARMER, Partners In Health, Harvard Medical School
ANTHONY S. FAUCI, National Institute of Allergy and Infectious Diseases
GARY L. FILERMAN, Atlas Health Foundation
GERALD H. FRIEDLAND, Yale University School of Medicine
ELAINE K. GALLIN, QE Philanthropic Advisors
NANCY SUNG, Burroughs Wellcome Fund2
IOM Staff
ANNE B. CLAIBORNE, Forum Director
RITA S. GUENTHER, Program Officer
REBECCA A. ENGLISH, Associate Program Officer
ELIZABETH F. C. TYSON, Research Associate
ANDREW M. POPE, Director, Board on Health Sciences Policy
ROBIN GUYSE, Senior Program Assistant
RONA BRIERE, Consulting Editor
China Liaison Committee Appointed by the Institute of Microbiology, Chinese Academy of Sciences
GUOPING ZHAO (Co-Chair), Institute for Biological Sciences, Chinese Academy of Sciences
LIXIN ZHANG (Co-Chair), Institute of Microbiology, Chinese Academy of Sciences
__________________
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 Nancy Sung was with the Burroughs Wellcome Fund during the planning of the workshop.
Secretaries-in-General
BABAK JAVID, Tsinghua University
YANLIN ZHAO, Chinese Center for Disease Control and Prevention
Members
LIJUN BI, Institute of Biophysics, Chinese Academy of Sciences
JILONG CHEN, Institute of Microbiology, Chinese Academy of Sciences
XIAOXING CHENG, Division of Research, Institute of Tuberculosis, Beijing 309 Hospital
MIN FANG, Institute of Microbiology, Chinese Academy of Sciences
GEORGE FU GAO, Institute of Microbiology, Chinese Academy of Sciences
QIAN GAO, Shanghai Medical College, Fudan University
BAOXUE GE, Clinical and Translational Research Center, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
HUI GUO, Institute of Microbiology, Chinese Academy of Sciences
QI JIN, Institute of Pathogen Biology, Peking Union Medical College, Chinese Academy of Medical Sciences
MINYONG LI, School of Pharmacy, Shandong University
CUIHUA LIU, Institute of Microbiology, Chinese Academy of Sciences
GANG LIU, School of Medicine, Tsinghua University
MIAOMIAO LIU, Institute of Microbiology, Chinese Academy of Sciences
XUETING LIU, Institute of Microbiology, Chinese Academy of Sciences
KAIXIA MI, Institute of Microbiology, Chinese Academy of Sciences
YUEMAO SHEN, Institute of Medicine, Shandong University
SHUYI SI, Institute of Medicinal Biotechnology, Peking Union Medical College, and Chinese Academy of Medical Sciences
FUHANG SONG, Institute of Microbiology, Chinese Academy of Sciences
KANGLIN WAN, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
BEINAN WANG, Institute of Microbiology, Chinese Academy of Sciences
HONGHAI WANG, Institute of Genetics, Fudan University
XUEQIONG WU, Institute of Tuberculosis, Beijing 309 Hospital
JIANPING XIE, School of Life Sciences, Southwest University
WANLI XING, School of Life Sciences, Tsinghua University
LAN XU, International Affairs Office, Institute of Microbiology, Chinese Academy of Sciences
FUPING ZHANG, Institute of Microbiology, Chinese Academy of Sciences
WENHONG, ZHANG, Institute of Infectious Diseases, Huashan Hospital, Fudan University
ZONGDE ZHANG, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing Chest Hospital
XUYU ZHOU, Institute of Microbiology, Chinese Academy of Sciences
Institute of Microbiology, Chinese Academy of Sciences, Staff
ABIODUN ADEBAYO, Postdoctoral Researcher
CAIXIA CHEN, Postdoctoral Researcher
HUANQIN DAI, Associate Professor
SHAOFENG LI, Lab Secretary
FUHANG SONG, Associate Professor
LAN XU, Deputy Director, International Affairs Office
Workshop Implementation Staff:
Students of Professor Lixin Zhang’s Lab, Institute of Microbiology, Chinese Academy of Sciences
Abiodun Adebayo, Elizabeth Ashforth, Chaoxian Bai, Caixia Chen, Jinsong Chen, Xiangyin Chen, Huanqin Dai, Hui Guo, Jianying Han, Wei He, Wenni He, Pei Huang, Xiaopeng Jia, Shaofeng Li, Mei Liu, Miaomiao Liu, Ye Liu, Hanyi Lv, Biao Ren, Fuhang Song, Mengyi Su, Yaojun Tong, Hongfei Wang, Jian Wang, Luoqiang Wang, Qi Wang, Qian Wang, Quanxin Wang, Feng Xie, Na Yang, Jingyu Zhang, Li Zhang, Yuhan Zhang, Ying Zhuo
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FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1
JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA
STEVEN K. GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA
RUSS BIAGIO ALTMAN, Stanford University, CA
MARGARET ANDERSON, FasterCures, Washington, DC
HUGH AUCHINCLOSS, National Institute of Allergy and Infectious Diseases, Bethesda, MD
CHRISTOPHER P. AUSTIN, National Center for Advancing Translational Sciences, Bethesda, MD
ANN C. BONHAM, Association of American Medical Colleges, Washington, DC
LINDA BRADY, National Institute of Mental Health, Bethesda, MD
GAIL H. CASSELL, Harvard Medical School (Visiting), Carmel, IN
PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY
ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN
JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD
GARY L. FILERMAN, Atlas Health Foundation, McLean, VA
MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD
HARRY B. GREENBERG, Stanford University School of Medicine, CA
PETER HONIG, AstraZeneca, Wilmington, PA
KATHY L. HUDSON, National Institutes of Health, Bethesda, MD
LYNN D. HUDSON, Critical Path Institute, Tucson, AZ
S. CLAIBORNE JOHNSTON, University of California, San Francisco
MICHAEL KATZ, March of Dimes Foundation, White Plains, NY
PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD
JACK D. KEENE, Duke University Medical Center, Durham, NC
RUSTY KELLEY, Burroughs Wellcome Fund, Research Triangle Park, NC
RONALD L. KRALL, University of Pennsylvania Center for Bioethics, Steamboat Springs, CO
FREDA C. LEWIS-HALL, Pfizer Inc., New York, NY
CAROL MIMURA, University of California, Berkeley
BERNARD H. MUNOS, InnoThink Center for Research in Biomedical Innovation, Indianapolis, IN
ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY
JOHN J. ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ
__________________
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.
ROBERT E. RATNER, American Diabetes Association, Alexandria, VA
MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ
JAMES S. SHANNON, GlaxoSmithKline, Brentford, Middlesex, UK
JANET SHOEMAKER, American Society for Microbiology, Washington, DC
ELLEN V. SIGAL, Friends of Cancer Research, Washington, DC
LANA R. SKIRBOLL, Sanofi, Washington, DC
BRIAN L. STROM, University of Pennsylvania Perelman School of Medicine, Philadelphia
JANET TOBIAS, Ikana Media and Mount Sinai School of Medicine, New York, NY
JOANNE WALDSTREICHER, Johnson & Johnson, New Brunswick, NJ
JANET WOODCOCK, Food and Drug Administration, Rockville, MD
IOM Staff
ANNE B. CLAIBORNE, Forum Director
REBECCA A. ENGLISH, Associate Program Officer
ELIZABETH F. C. TYSON, Research Associate
ANDREW M. POPE, Director, Board on Health Sciences Policy
ROBIN GUYSE, Senior Program Assistant
Reviewers
This workshop summary 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 workshop summary as sound as possible and to ensure that the workshop summary 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 workshop summary:
William Bishai, KwaZulu-Natal Research Institute for Tuberculosis and HIV, Nelson R. Mandela School of Medicine
Jarbas Barbosa da Silva, Jr., Ministry of Health, Federative Republic of Brazil
Martie van der Walt, South African Medical Research Council
Peter K. Yablonskii, National Association of Phthisiatricians and Saint-Petersburg Research Institute for Phthisiopulmonology, Russian Federation
Wenhong Zhang, Shanghai Huashan Hospital, Fudan University
Yaping Zhang, Chinese Academy of Sciences
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop
summary before its release. The review of this workshop summary was overseen by Melvin Worth. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.
The Diagnosis and Treatment of MDR TB in Hospitals
MDR and XDR TB Chemotherapy in China
Drug-Resistant TB and HIV in China
5 EXPERIENCES WITH MDR TB IN OTHER COUNTRIES
MDR TB in the Russian Federation
Community-Based Care in South Africa
Direct Collaboration in Cambodia and Ethiopia
6 DRUG-RESISTANT TUBERCULOSIS IN PEDIATRIC POPULATIONS
Children as Sentinels for Transmission and Policy Response
Pediatric Drug-Resistant TB in China
Drug-Resistant TB Meningitis in Children
Pediatric MDR and XDR TB in the Russian Federation and Other Countries of the Former Soviet Union
7 GLOBAL PERSPECTIVES ON TRANSMISSION AND INFECTION CONTROL
Infection Control Challenges for Health Care Workers in China
Infection Control Challenges for Health Care Workers in South Africa
Institutional Infection Control in Russia
Stopping Transmission in Institutional and Community Settings
8 RAPID DIAGNOSTIC TECHNOLOGIES: STATUS AND LIMITATIONS
Gaps in Drug Susceptibility Testing in South Africa
The Genetic Diversity of Drug-Resistant TB
9 ADDRESSING DIAGNOSIS AND TREATMENT ACROSS THE SPECTRUM OF DRUG RESISTANCE
The Spectrum of MDR and XDR TB
The Need for a Paradigm Shift in the Treatment of the Spectrum of Drug-Resistant TB
Totally Drug-Resistant TB in India: Lessons and Opportunities from a Clinical Perspective
TB Terminology and Advocacy Needs
10 DEVELOPING AND STRENGTHENING THE DRUG SUPPLY CHAIN FOR DRUG-RESISTANT TB
Overcoming Barriers in the Global Supply Chain
A Systems Perspective on the Global Supply Chain
Information in the Global Supply Chain
11 EMBRACING A NEW VISION FOR RESEARCH
Creating a Synergy of Discovery and Delivery of Care
New Tools to Facilitate TB Research
TBResist: A Global Consortium for Whole-Genome Sequencing of Drug-Resistant TB
12 WHAT WILL BE REQUIRED TO ACHIEVE ZERO DEATHS FROM TB?
Why Has Controlling TB Been So Difficult?
How Can Progress Be Radically Improved?
The Role of the BRICS Countries
13 CREATING AN EVIDENCE-BASED BLUEPRINT FOR ACTION
Addressing Drug-Resistant TB in Children
Adopting Genomic Tools to Map the Epidemic of Drug-Resistant TB and Address Diagnostic Challenges
Blocking Transmission of Drug-Resistant TB
Reforming Drug Distribution and Assuring Drug Quality
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Tables, Figures, and Boxes
TABLES
4-1 Projected Future TB Laboratory Network in China
9-1 Drugs Used to Treat MDR TB
FIGURES
4-1 The majority of MDR TB patients who completed treatment did so at China CDC facilities
5-2 Many factors have compromised MDR TB treatment for a typical patient in KwaZulu-Natal province
AFB | acid-fast bacilli |
AIDS | acquired immune deficiency syndrome |
AMFm | Affordable Medicines Facility for Malaria |
API | active pharmaceutical ingredient |
ART | antiretroviral treatment |
BLF | bronchoalveolar lavage fluid |
BMGF | Bill & Melinda Gates Foundation |
BMI | body mass index |
BRICS | Brazil, Russia, India, China, and South Africa |
CAMELIA | Cambodian Early versus Late Introduction of Antiretrovirals |
China CDC | Chinese Center for Disease Control and Prevention |
CIPRA | Comprehensive International Program for Research on AIDS |
DNA | deoxyribonucleic acid |
DOT | directly observed treatment |
DOTS | Directly Observed Treatment-Short course |
DR TB | drug-resistant tuberculosis |
DST | drug susceptibility testing |
EMR | electronic medical record |
FLD | first-line anti-tuberculosis drug |
GDF | Global Drug Facility |
GHC | Global Health Committee |
GLC | Green Light Committee |
H3 Africa | Human Heredity and Health in Africa |
HBC | high tuberculosis burden country |
HIV | human immunodeficiency virus |
IMCAS | Institute of Microbiology, Chinese Academy of Sciences |
IOM | Institute of Medicine |
IUATLD | International Union Against Tuberculosis and Lung Disease (“The Union”) |
K-RITH | KwaZulu-Natal Research Institute for Tuberculosis and HIV |
LAMP | loop-mediated isothermal amplification |
LED | light-emitting diode |
LPA | line probe assay |
MDR TB | multidrug-resistant tuberculosis |
MHC | major histocompatibility complex |
M.tb. | Mycobacterium tuberculosis |
NGO | nongovernmental organization |
NIAID | National Institute of Allergy and Infectious Diseases |
NIH | National Institutes of Health |
NTM | nontuberculous mycobacteria |
PAS | para-aminosalicylic acid |
PATRIC | Pathosystems Resource Integration Center |
PCR | polymerase chain reaction |
PEPFAR | U.S. President’s Emergency Plan for AIDS Relief |
PMDRT | programmatic treatment and management of MDR and XDR TB patients |
PQR | Price and Quality Reporting |
QFT | QuantiFERON-TB test |
RIF | rifampicin |
RNA | ribonucleic acid |
RNTCP | Revised National TB Control Program |
rRNA | ribosomal ribonucleic acid |
SAT | simultaneous amplification test |
SLD | second-line anti-tuberculosis drug |
TB | tuberculosis |
TBM | tuberculous meningitis |
TDR TB | totally drug-resistant tuberculosis |
THINK | Tuberculosis and HIV Investigative Network of KwaZulu-Natal |
TST | tuberculin skin test |
UNICEF | United Nations Children’s Fund |
U.S. CDC | U.S. Centers for Disease Control and Prevention |
UV | ultraviolet |
UVGI | ultraviolet germicidal irradiation |
VNTR | variable-number tandem-repeat |
WHO | World Health Organization |
XDR TB | extensively drug-resistant tuberculosis |
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