E-DRUG: TB Experts Outline Proposals to Speed Up Drug Development
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New York, January 12, 2007
Proposals to accelerate the development of tuberculosis (TB) drugs were outlined today at the conclusion of a two-day symposium titled 'No Time to Wait' convened in New York this week by the international medical humanitarian organization Doctors Without Borders/Medecins Sans Frontieres (MSF) with the support of Howard P. Milstein and Weill Cornell Medical College's Abby and Howard P. Milstein Program in Chemical Biology. The symposium brought together more than 100 TB specialists, drug developers and regulators, policy makers, donors and activists to outline practical proposals to fill the gaps in TB drug research and development (R&D).
'We are failing people with TB,' said Dr. Tido von Schoen-Angerer, Director
of MSF's Campaign for Access to Essential Medicines. 'Diagnosing and
treating TB is one of the greatest challenges facing health care providers
around the world. Things are going from bad to worse with multi-drug
resistant TB and even extensively drug resistant (XDR) TB, particularly in
settings with high HIV prevalence. The urgency for new tools could not be
greater, there is no time to wait.'
TB kills nearly two million people per year, primarily because of
inadequate diagnostic and treatment tools. While roughly one drug for HIV
has been developed each year since the start of the epidemic 25 years ago,
the latest novel TB drug in today's standard therapy was developed in the
1960s. Basic science is not being translated into new TB drugs needed to
improve treatment, according to an MSF analysis of the TB drug pipeline.
There are not enough promising drugs in the pipeline and serious funding
gaps prevent the development of candidate drug compounds through to
clinical trials.
Resistance to TB drugs is growing at a rapid pace, with 450,000 new cases
of drug-resistant TB detected each year. The recent detection of hundreds
of cases of XDR-TB, which is extremely difficult and sometimes impossible
to treat, adds further urgency to the situation. TB remains the main killer
of people with HIV, in large part because existing TB drugs and tests are
poorly adapted for use in people with HIV and AIDS.
'In TB research, there needs to be a convergence of innovation, incentive,
and access,' said Dr. Carl Nathan, Rees Pritchett Professor of Microbiology
and Chairman of Microbiology and Immunology at Weill Cornell Medical
College. 'We need to see openness, leadership and collaboration among all
TB actors.'
Experts attending the symposium emphasized several actions that urgently
need to be taken to improve the situation:
1. Drastically increase funding of TB R&D
2. Accelerate drug discovery
3. Expand clinical trial capacity and speed up clinical development
4. Commit to global TB R&D leadership
5. Support new approaches to R&D, such as a global R&D framework
(Conference statement attached)
'We need increased clinical trial capacity, fast-tracked clinical trials,
and criteria for compassionate use of important candidate drugs,' said Dr.
von Schoen-Angerer. 'To make any real difference, we need to see a dramatic
increase in funding and political will.'
The symposium emphasized a need to build a global TB R&D movement, as was
critical to the advancements in HIV drug development. Strong political
leadership is required to improve collaboration between scientists, drug
developers, care providers, and affected individuals. Symposium
participants agreed on the need for a massive increase in funding by
governments for TB R&D, as current TB drug discovery initiatives are
insufficient. Participants voiced support for an effort launched by
governments at the World Health Assembly in May 2006 to examine alternative
ways to prioritize and finance health-needs-driven R&D.
NO TIME TO WAIT
Overcoming the gaps in TB drug development
Conference Statement
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 Casenghi M, von Schoen-Angerer T. Development of New Drugs
for TB Chemotherapy. Analysis of the current drug pipeline. MSF 2006
- 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
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
Sheila Shettle
Senior Communications Officer
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva, Switzerland
+ 41.22.849.8403
+ 41.79.293.0270 (m.)
www.accessmed-msf.org
Sheila.SHETTLE@geneva.msf.org