[Ip-health] TB Experts Outline Proposals to Speed Up Drug Development

[Sheila.SHETTLE@geneva.msf.org]

Tuberculosis Experts Outline Proposals to Speed Up Drug Development=0D
=0D
New York, January 12, 2007 =E2=80=93 Proposals to accelerate the developmen=
t of=0D
tuberculosis (TB) drugs were outlined today at the conclusion of a two-day=
=0D
symposium titled =E2=80=9CNo Time to Wait,=E2=80=9D convened in New York th=
is week by the=0D
international medical humanitarian organization Doctors Without=0D
Borders/M=C3=A9decins Sans Fronti=C3=A8res (MSF) with the support of Howard=
 P.=0D
Milstein and Weill Cornell Medical College=E2=80=99s Abby and Howard P. Mil=
stein=0D
Program in Chemical Biology. The symposium brought together more than 100=
=0D
TB specialists, drug developers and regulators, policy makers, donors and=
=0D
activists to outline practical proposals to fill the gaps in TB drug=0D
research and development (R&D).=0D
=0D
=E2=80=9CWe are failing people with TB,=E2=80=9D said Dr. Tido von Schoen-A=
ngerer, Director=0D
of MSF=E2=80=99s Campaign for Access to Essential Medicines.  =E2=80=9CDiag=
nosing and=0D
treating TB is one of the greatest challenges facing health care providers=
=0D
around the world. Things are going from bad to worse with multi-drug=0D
resistant TB and even extensively drug resistant (XDR) TB, particularly in=
=0D
settings with high HIV prevalence. The urgency for new tools could not be=
=0D
greater =E2=80=93 there is no time to wait.=E2=80=9D=0D
=0D
TB kills nearly two million people per year, primarily because of=0D
inadequate diagnostic and treatment tools. While roughly one drug for HIV=
=0D
has been developed each year since the start of the epidemic 25 years ago,=
=0D
the latest novel TB drug in today=E2=80=99s standard therapy was developed =
in the=0D
1960s.  Basic science is not being translated into new TB drugs needed to=
=0D
improve treatment, according to an MSF analysis of the TB drug pipeline.=0D
There are not enough promising drugs in the pipeline and serious funding=0D
gaps prevent the development of candidate drug compounds through to=0D
clinical trials.=0D
=0D
Resistance to TB drugs is growing at a rapid pace, with 450,000 new cases=
=0D
of drug-resistant TB detected each year. The recent detection of hundreds=
=0D
of cases of XDR-TB, which is extremely difficult and sometimes impossible=
=0D
to treat, adds further urgency to the situation. TB remains the main killer=
=0D
of people with HIV, in large part because existing TB drugs and tests are=
=0D
poorly adapted for use in people with HIV/AIDS.=0D
=0D
=E2=80=9CIn TB research, there needs to be a convergence of innovation, inc=
entive,=0D
and access,=E2=80=9D said Dr. Carl Nathan, Rees Pritchett Professor of Micr=
obiology=0D
and Chairman of Microbiology and Immunology at Weill Cornell Medical=0D
College.  =E2=80=9CWe need to see openness, leadership and collaboration am=
ong all=0D
TB actors.=E2=80=9D=0D
=0D
Experts attending the symposium emphasized several actions that urgently=0D
need to be taken to improve the situation:=0D
=0D
1.    Drastically increase funding of TB R&D=0D
2.    Accelerate drug discovery=0D
3.    Expand clinical trial capacity and speed up clinical development=0D
4.    Commit to global TB R&D leadership=0D
5.    Support new approaches to R&D, such as a global R&D framework=0D
=0D
   (Conference statement attached)=0D
=0D
=E2=80=9CWe need increased clinical trial capacity, fast-tracked clinical t=
rials,=0D
and criteria for compassionate use of important candidate drugs,=E2=80=9D s=
aid Dr.=0D
von Schoen-Angerer. =E2=80=9CTo make any real difference, we need to see a =
dramatic=0D
increase in funding and political will.=E2=80=9D=0D
=0D
The symposium emphasized a need to build a global TB R&D movement, as was=
=0D
critical to the advancements in HIV drug development. Strong political=0D
leadership is required to improve collaboration between scientists, drug=0D
developers, care providers, and affected individuals. Symposium=0D
participants agreed on the need for a massive increase in funding by=0D
governments for TB R&D, as current TB drug discovery initiatives are=0D
insufficient. Participants voiced support for an effort launched by=0D
governments at the World Health Assembly in May 2006 to examine alternative=
=0D
ways to prioritize and finance health-needs-driven R&D.=0D
=0D
=0D
                              NO TIME TO WAIT=0D
                Overcoming the gaps in TB drug development=0D
=0D
                           Conference Statement=0D
=0D
=0D
On 11-12 January 2007, M=C3=A9decins Sans Fronti=C3=A8res, supported by Wei=
ll Cornell=0D
Medical College, convened a symposium entitled No Time to Wait in New York=
=0D
aimed at stimulating efforts to accelerate the development of effective new=
=0D
treatments for tuberculosis (TB). The symposium brought together more than=
=0D
100 experts from around the world, including drug developers, clinical=0D
researchers, health professionals, policy makers, donors, and activists.=0D
=0D
Conference participants agreed that current approaches are inadequate to=0D
respond to the urgency of the global TB epidemic.=0D
=0D
=C2=A7 TB is a global health emergency. Every year TB kills around 2 millio=
n=0D
people and 9 million develop the disease=0D
=C2=A7   Almost half a million new cases of multi-drug resistance (MDR) TB =
are=0D
seen every year, and cases of extensively drug-resistant (XDR) TB are=0D
increasingly being detected=0D
=C2=A7   TB is the leading killer of people with HIV/AIDS and the inadequac=
y of=0D
tools to diagnose and treat TB are a major threat to the health and lives=
=0D
of HIV/TB co-infected individuals=0D
=C2=A7   We have inadequate and outdated tools for rapid diagnosis, inadequ=
ate=0D
and outdated drugs to cure many adults and children with TB today, and an=
=0D
inadequate pipeline to ensure our ability to cure the majority of TB cases=
=0D
in the future Casenghi M, von Schoen-Angerer T. Development of New Drugs=0D
for TB Chemotherapy. Analysis of the current drug pipeline. MSF 2006=0D
=C2=A7   We lack the basic biological understanding of this complex disease=
 to=0D
anticipate the most efficient routes to prevent and treat TB=0D
=C2=A7   Clinical trials for drugs and combinations that could be done toda=
y are=0D
being held back because of a lack of funding and capacity as well as=0D
regulatory barriers=0D
=C2=A7   Meaningful gains in TB control will only be made when the treatmen=
t of=0D
TB, including drug-resistant TB, can be dramatically shortened and=0D
simplified=0D
=0D
Participants call upon governments, intergovernmental agencies,=0D
researchers, drug and diagnostic developers, nongovernmental organizations,=
=0D
and funders to take action in five key areas.=0D
=0D
1. Accelerate drug discovery=0D
=C2=A7 The public and not-for-profit sector needs to be guaranteed access t=
o=0D
professional pharmaceutical services, which mostly exist in the private=0D
sector, to develop diagnostics and drugs. Mechanisms must be established to=
=0D
ensure public access to compound libraries and to build appropriate=0D
libraries with potential to exhibit anti-TB properties, particularly novel=
=0D
and natural products=0D
=0D
2. Expand clinical trial capacity and accelerate clinical development=0D
=C2=A7 Worldwide, only $20 million is spent annually for clinical trials fo=
r TB=0D
drug compared to around $300 million for HIV drugs in the US alone.*=0D
Funding bodies should support the creation of a TB clinical trial platform=
=0D
and the massive expansion of clinical trial capacity, particularly in=0D
developing countries=0D
=C2=A7 There is an immediate priority to shorten the time of clinical drug=
=0D
development. Criteria for compassionate use must be established by the WHO=
=0D
and regulatory authorities for important candidate drugs=0D
=C2=A7 In particular, trials for (M)DR-TB drugs must be prioritized because=
 of=0D
the explosive spread of drug resistance and the potential of these trials=
=0D
to show efficacy rapidly=0D
=C2=A7 Drug trials should seek to integrate studies of potential new diagno=
stics=0D
=0D
3. Support new approaches to R&D=0D
=C2=A7 The lack of TB drug development is a result of the failure of curren=
t=0D
profit-driven drug research and development model. The TB community must=0D
engage in the World Health Organization=E2=80=99s Intergovernmental Working=
 Group=0D
on Innovation, Intellectual Property and Public Health to establish a=0D
global R&D framework to help design new ways of setting R&D priorities and=
=0D
financing.=0D
=C2=A7 With respect to TB drug development, participants of the New York=0D
symposium support current discussion at the WHO for a treaty on essential=
=0D
health R&D that addresses the question of who pays for essential medical=0D
R&D and de-links incentives from drug prices, instead rewarding the impact=
=0D
of inventions according to health care outcomes.=0D
=0D
4. Commit to global TB R&D leadership=0D
=C2=A7 Strong political leadership is required to improve collaboration amo=
ng=0D
scientists, drug developers, care providers, and affected individuals, in=
=0D
both developed and developing countries, and develop a global priority=0D
research agenda for TB=0D
=0D
5. Increase funding for TB R&D activities=0D
=C2=A7 There is a critical funding gap for TB R&D. Around $900 million need=
s to=0D
be invested annually in the development of new tools for TB, but only $206=
=0D
million was invested in 2005, and the funding gap is expected to widen over=
=0D
time.* A dramatic funding increase is needed to support drug research and=
=0D
development activities. This is above all a matter of political=0D
prioritization.=0D
=0D
=0D
*Feuer C. Tuberculosis research and development: a critical analysis.=0D
Treatment Action Group, New York, October 2006=0D
=0D
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+++++++++++++++++++++=0D
Sheila Shettle=0D
Senior Communications Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Campaign for Access to Essential Medicines=0D
Rue de Lausanne 78=0D
1211 Geneva, Switzerland=0D
+ 41.22.849.8403=0D
+ 41.79.293.0270 (m.)=0D
www.accessmed-msf.org=0D
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