On 11-12 January 2007, Médecins Sans Frontières, supported by Weill Cornell Medical College, convened a symposium entitled No Time to Wait in New York aimed at stimulating efforts to accelerate the development of effective new treatments for tuberculosis (TB). The symposium brought together more than 100 experts from around the world, including drug developers, clinical researchers, health professionals, policy makers, donors, and activists.
Conference participants agreed that current approaches are inadequate to respond to the urgency of the global TB epidemic.
- TB is a global health emergency. Every year TB kills around 2 million people and 9 million develop the disease)
- Almost half a million new cases of multi-drug resistance (MDR) TB are seen every year, and cases of extensively drug-resistant (XDR) TB are increasingly being detected
- TB is the leading killer of people with HIV/AIDS and the inadequacy of tools to diagnose and treat TB are a major threat to the health and lives of HIV/TB co-infected individuals
- We have inadequate and outdated tools for rapid diagnosis, inadequate and outdated drugs to cure many adults and children with TB today, and an inadequate pipeline to ensure our ability to cure the majority of TB cases in the future
- We lack the basic biological understanding of this complex disease to anticipate the most efficient routes to prevent and treat TB
- Clinical trials for drugs and combinations that could be done today are being held back because of a lack of funding and capacity as well as regulatory barriers
- Meaningful gains in TB control will only be made when the treatment of TB, including drug-resistant TB, can be dramatically shortened and simplified Participants call upon governments, intergovernmental agencies, researchers, drug and diagnostic developers, nongovernmental organizations, and funders to take action in five key areas.
1. Accelerate drug discovery
- The public and not-for-profit sector needs to be guaranteed access to professional pharmaceutical services, which mostly exist in the private sector, to develop diagnostics and drugs. Mechanisms must be established to ensure public access to compound libraries and to build appropriate libraries with potential to exhibit anti-TB properties, particularly novel and natural products
2. Expand clinical trial capacity and accelerate clinical development
- Worldwide, only $20 million is spent annually for clinical trials for TB drug compared to around $300 million for HIV drugs in the US alone.* Funding bodies should support the creation of a TB clinical trial platform and the massive expansion of clinical trial capacity, particularly in developing countries
- There is an immediate priority to shorten the time of clinical drug development. Criteria for compassionate use must be established by the WHO and regulatory authorities for important candidate drugs
- In particular, trials for (M)DR-TB drugs must be prioritized because of the explosive spread of drug resistance and the potential of these trials to show efficacy rapidly
- Drug trials should seek to integrate studies of potential new diagnostics
3. Support new approaches to R&D
- The lack of TB drug development is a result of the failure of current profit-driven drug research and development model. The TB community must engage in the World Health Organization’s Intergovernmental Working Group on Innovation, Intellectual Property and Public Health to establish a global R&D framework to help design new ways of setting R&D priorities and financing.
- With respect to TB drug development, participants of the New York symposium support current discussion at the WHO for a treaty on essential health R&D that addresses the question of who pays for essential medical R&D and de-links incentives from drug prices, instead rewarding the impact of inventions according to health care outcomes.
4. Commit to global TB R&D leadership
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Strong political leadership is required to improve collaboration among scientists, drug developers, care providers, and affected individuals, in both developed and developing countries, and develop a global priority research agenda for TB
5. Increase funding for TB R&D activities
- There is a critical funding gap for TB R&D. Around $900 million needs to be invested annually in the development of new tools for TB, but only $206 million was invested in 2005, and the funding gap is expected to widen over time.* A dramatic funding increase is needed to support drug research and development activities. This is above all a matter of political prioritization.
*Feuer C. Tuberculosis research and development: a critical analysis. Treatment Action Group, New York, October 2006
List of participants:
Mary Alexander, Partners in Health US
Joanne Alston, Head of Central Research Department DFID UK
Lawrence Altman, Medical Correspondant NY Times US
Koen Andries, Distinguished Research Fellow Tibotec NV Belgium
David Banta, France
Jaime Bayona, Director Partners in Health-Peru/Socios En Salud Sucursal Peru
Ketty Belizaire, Clinical Operations Manager Global Alliance for TB Drug Development US
Emily Bell, Project Officer of TB Monitoring Project Open Society Institute US
William R Bishai, Professor of Medicine Johns Hopkins School of Medicine US
John S. Blanchard, Professor, Department of Biochemistry Albert Einstein College of Medicine US
Francois Bompart, Vice President Director Sanofi Aventis France
Nellie Bristol, The Lancet US
Ruslana Bryk, Assistant Research Professor of Microbiology and Immunology Weill Cornell Medical College US
Bill Burman, Medical Director- ID Clinic Denver Public Health US
Ken Castro, Assistant Surgeon General, U.S. Public Health Service Director, Division of Tuberculosis Elimination Centers for Disease Control and Prevention US
Richard E Chaisson, Director Center for Tuberculosis Research Johns Hopkins University US
Stewart Cole Director, Institut Pasteur France
Margareth DalColmo, Outpatient Clinic Coordinator Brazilian Society of Respiratory Diseases Brazil
Karel De Beule, Compound Development Team Leader Tibotec Belgium
Mary Ann De Groote, Assistant Professor Colorado State University
Hakim Djaballah, Director MSKCC High
Ken Duncan, Bill and Melinda Gates Foundation US
Priya Eddy, Project Leader Research Global Alliance for TB Drug Development
Sabine Ehrt, Associate Professor Weill Cornell Medical College US
Leon Einck, President Sequella, Inc. US
Wafaa El-Sadr, Director International Center for AIDS Care and Treatment Programs(ICAP), Center for Infectious Disease Epidemiologic Research (CIDER) US
Carlton Evans, Clinical Senior Lecturer Imperial College London Hammersmith Hospital Campus UK
Dan Fitzgerald, Assistant Professor of Medicine Weill Cornell Medical College US
Scott G. Franzblau, Director, Institute for Tuberculosis Research University of Illinois at Chicago
Maria Freire, CEO and President Global Alliance for TB Drug Development
Gerry Friedland, Professor of Medicine and Epidemiology, Director, AIDS Program Yale New-Haven Hospital and Yale University US
Caroline Gallant, UAEM Coordinating Committee Ph.D. Candidate McGill University Canada
Charles Gardner, Associate Director for Health Equity Rockefeller Foundation US
Laurie Garrett Sr., Fellow for Global Health Council on Foreign Relations US
Larry Geiter, Senior Director, Epidemiology & Field Studies Aeras Global TB Vaccine Foundation US
Ann Ginsberg Head of Clinical Development Global Alliance for TB Drug Development
Françoise Girard, Director Open Society Institute US
Michael Glickman, Associate Member Memorial Sloan-Kettering Cancer Center US
Ben Gold, Weill Cornell Medical College US
Ciara Goldstein, EU Policy Officer Global Alliance for TB Drug Development Belgium
Federico Gomez de las Heras, Director GlaxoSmithKline Spain
Renata Guerra, Post-Doc. Fellow Hospital Universitario Clemintino Fraga Filho/Johns Hopkins University School of Medicine US
Anne Gurnett, R & D Team Global Alliance for TB Drug Development
Christy Hanson, TB Research Advisor USAID
Mark Harrington, Executive Director Treatment Action Group (TAG) US
Myriam Haxaire - Theeuwes Sr., Director Project Management Tibotec Buba Belgium
Paul Herrling, Head of Corporate Research Novartis International AG SWITZERLAND
Al Hinman, Director of Communications Global Alliance for TB Drug Development US
Timothy A. Holtz, Epidemiologist-MDR TB Team Centers for Disease Control and Prevention US
Bob Huff, Editorial Director Treatment Action Group (TAG) US
Heather Ignatius, Global Alliance for TB Drug Development
Amina Jindani, International Coordinator St George's, University of London UK
Amy Kapczynski, Yale Law School US
Brian Kelly, Director of Technology Transfer Cornell Research Foundation US
Alan P. Kozikowski, Professor University of Illinois at Chicago US
Anuradha Kulasekaran, Senior- Manager Clinical Research Lupin Limited(Research Park) India
Hannu Laang, Scientific Officer EU-DG research Belgium
Michelle Larsen, Translational Research Specialist Howard Hughes Medical Institute/AECOM US
Martino Laurenzi, Clinical Research Scientist Global Alliance for TB Drug Development US
Didier Leboulleux, Medical Manager Sanofi Aventis France
Vaira Leimane, Director WHO Collaborating Centre for research and training on MDR-TB Latvia
Christian Lienhardt, Director International Union Against TB and Lung Disease France
Gang Lin, Instructor in Microbiology and Immunology Weill Cornell Medical College US
James Love, Director Consumer Project on Technology US
Joanna Lowell, Bio Ventures for Global Health US
Daniel Lowenstein Sr., Account Manager Global Health Strategies US
Zhenkun Ma, Head of Research Global Alliance for TB Drug Development US
Dermot Maher, WHO Switzerland
Apoorva Mandavilli, Senior News Editor Nature Medicine US
Francine Matthys, Institute of Tropical Medicine (ITM) Belgium
David McNeeley, Director, Global Clinical Development Tibotec, Inc US
Donald McNeil Jr., Health & Medicine Reporter NY Times US
Khisi Mdluli, Project Leader Research Global Alliance for TB Drug Development
Howard Milstein, Chairman New York Private Bank & Trust US
Denis A. Mitchison, St George's, University of London UK
Carole D. Mitnick, Instructor Harvard Medical School US
Sonal Munsiff, Director NYC Bureau of TB Control US
Alwyn Mwinga, Associate Director for Science CDC Zambia Zambia
Carl Nathan R.A. Rees Pritchett, Professor of Microbiology Weill Cornell Medical College US
Thomas Nyirenda, South - South Networking Manager EDCTP South Africa
Philip Onyebujoh, TB/HIV research coordinator TDR/WHO Switzerland
Bernard Pecoul, Chief Executive Officer DNDi Switzerland
Mark Perkins, Chief Scientific Officer Foundation for Innovative Diagnostics Switzerland
Mario Raviglione, Director WHO Stop TB Switzerland
Kyu Rhee, Assistant Professor of Microbiology and Immunology Weill Cornell Medical College US
Leonard Sacks, Medical Officer FDA US
Ezio Santos Filho, Independent Consultant on TB/HIV Social Mobilization TB/HIV Community Advisory Committee (CAC) Brazil
Neil W. Schluger, Chair, Tuberculosis Trials Consortium Columbia University US
Dirk Schnappinger, Assistant Professor Weill Cornell Medical College US
Kammerle Schneider Research Associate, Global Health Council on Foreign Relations US
Nina Schwalbe, Policy Director Global Alliance for TB Drug Development US
Sarita Shah, Assistant Professor Albert Einstein College of Medicine US
Christine Sizemore, Section Chief NIH/NIAID US
Luiz Pedro Sorio de Carvalho, Weill Cornell Medical College US
Mel Spigelman, Director Research and Development Global Alliance for TB Drug Development US
Javid Syed, TB/HIV Director Treatment Action Group (TAG) US
Joelle Tanguy, Managing Director The Global Business Coalition on HIV, TB and Malaria US
Thelma E. Tupasi, President Tropical Disease Foundation, Inc. Philippines
Christo van Niekerk, Clinical Research Scientist Global Alliance for TB Drug Development 0059 South Africa
Omar Vandal, Graduate Student Weill Cornell Medical College US
Wim Vandevelde, Director European AIDS Treatment Group (EATG) Belgium
William A. Wells, News Director The Rockefeller University Press US
Katherine Woo, Sr. Director Global Alliance for TB Drug Development US
Karen Wright, Senior Advisor Global Alliance for TB Drug Development US
Gavin Yamey, Senior Editor Public Library of Science(PLOS –) US
Kathleen Young, Executive Director Alliance for Prudent Use of Antibiotics (APUA) US
Ying Zhang, Professor Johns Hopkins University US
Martina Casenghi, Médecins Sans Frontières -Holland
Rachel Cohen, Médecins Sans Frontières -Lesotho
Heather Culbert, Medical Advisor, Manson Unit Médecins Sans Frontières-Holland Nicolas de Torrente, MSF-USA Executive Director Médecins Sans Frontières-USA
Olivier Falhun, Press Officer Médecins Sans Frontières -France
Jessica Fanzo, MSF-USA Medical Intern Médecins Sans Frontières -USA
Karin Fischer, Liddle Medical Coordinator Somalia Médecins Sans Frontières-Holland Kenya
Nathan Ford, Médecins Sans Frontières-UK
Myriam Henkens, International Medical Coordinator Médecins Sans Frontières-Belgium
Unni Karunakara, Director of Medical Unit Médecins Sans Frontières-Holland Switzerland
Buddhima Lokuge, Access Campaign Officer Médecins Sans Frontières-USA
Sharonann Lynch, Médecins Sans Frontières-Lesotho
David Olson, Medical Advisor Médecins Sans Frontières-USA
Roger Perischino, Director of Programs Médecins Sans Frontières-USA
Kevin Phelan, Special Projects Officer Médecins Sans Frontières-USA
Sheila Sheetle, Senior Communication Officer Campaign for Access to Essential Medicines-Médecins Sans Frontière-Switzerland
Ellen t' Hoen, Campaign for Access to Essential Medicines-Médecins Sans Frontières- France
Jennifer Tierney, Director of Marketing Médecins Sans Frontières-USA
Kris Torgeson, MSF-USA Communications Director Médecins Sans Frontières-USA
Mzia Turashvili, Medical Coordinator MSF - OCBA, Malawi
Martine Usdin, Campaign for Access to Essential Medicines-Médecins Sans Frontières-France
Clio Van Cauter, Press Officer Médecins Sans Frontières-Belgium
Francis Varaine, TB Coordinator Médecins Sans Frontières-France
Tido von Schoen-Angerer, Director MSF Campaign for Access to Essential Medicines Médecins Sans Frontières-Switzerland
Maryline Bonnet, Médecins Sans Frontière-Switzerland
Catherine Cornu-Quinn, FNP Médecins Sans Frontières-USA
Sally Najera, Public Health Nurse BPHC/MSF - USA
Philippe Guerin, Médecins Sans Frontières-Epicentre France