E-DRUG: MSF and DNDi in Lancet: Global framework on essential health R&D
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dear E-druggers,
Please find below an article published in this week's Lancet by Pierre
Chirac, Medecins Sans Frontieres, and Els Torreele, Drugs for Neglected
Diseases Initiative, highlighting the number of drugs targeting neglected
diseases, in the run-up to the World Health Assembly and discussions on a
global framework on essential health R&D.
James Arkinstall,
MSF
Tel +33.1.40.21.28.27
James.ARKINSTALL@paris.msf.org
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Reprinted from The Lancet 2006; 367:1560-1561 with permission from
Elsevier
Full article including table and references is freely accessible on
www.lancet.com
Global framework on essential health R&D
Pierre Chirac, Medecins Sans Frontieres, and Els Torreele, Drugs for
Neglected Diseases Initiative
One of the critical issues to be discussed at the next World Health
Assembly (Geneva, May 22-26) will be a resolution about a global framework
on essential health research and development. Over past years, the crisis
in research and development in the worldwide pharmaceutical industry, and
in particular the absence of research and development for new medicines
targeting diseases that mainly affect people in developing countries
(neglected diseases), has become a global concern.
This worrying situation is clearly shown by the number of drugs targeting
neglected tropical diseases. From 1975 to 1999, only 13 drugs from 1393
new chemical entities (NCE) marketed were indicated for a neglected
disease. The 13 drugs included four for malaria and nine for the most
neglected diseases. Three more drugs could be added if tuberculosis is
included in the analysis.
We have updated these figures to 2004. From 2000 to 2004, an additional
163 NCEs have been marketed in the world, adding up to a total of 1556
NCEs for the 30 years from 1975 to 2004. During these 5 years, four NCEs
targeting neglected diseases have been commercialised. Artemotil is a
derivative from artemisinine discovered in the Chinese traditional
medicine Artemisia annua. Artemotil is available as injection for severe
malaria. Artesunate is another derivative from artemisinine. Artesunate
should be used only in combination (artemisinin-based combination therapy)
to treat malaria. Different co-blisters containing artesunate with a
partner drug (existing antimalarials such as sulfadoxine/pyrimethamine,
amodiaquine, mefloquine) are available on the market. Furthermore, several
co-formulations containing artesunate and the partner drug in the same
tablet are being developed. Lumefantrine is marketed as a co-formulation
with artemether, also a derivative from artemisinine. Miltefosine is the
first oral dug against leishmaniasis. The combination of chlorproguanil
with dapsone (Lapdap) has also been launched during the past years. It is
not a NCE, but there has been research on this drug.
In total, over the past 30 years, the number of drugs targeting neglected
diseases is ten if we consider the most neglected diseases, 18 if we add
malaria, and 21 if we add tuberculosis. These totals still represent only
around 1% of all NCEs (1556) launched during this period - a situation
that is essentially unchanged from 5 years ago.
The emergence of product-development partnerships for neglected diseases
has been encouraging: with sufficient funding the current pipelines for
neglected diseases could potentially deliver eight to nine drugs within
the next 5 years. Although such a step forward would be good, it is not
enough to change the overall situation. Product-development partnerships
in drug research and development for neglected diseases still mainly
depend on philanthropic funding, which reached US$212 million by April,
2005, or 78.5% of the total funding of these initiatives, much of it from
the Bill & Melinda Gates Foundation. Public funding was calculated at a
low 16%, although the British Government in March, 2006, announced
substantial additional funding worth £17 million (or about $30 million).
With promising drug compounds moving into more expensive clinical trials,
there remains a funding gap of several hundred million dollars for
existing initiatives alone.
There is definitely a proactive role for WHO to play here, because only a
long-term commitment by governments to fund and otherwise support research
and development in neglected diseases in the public interest would
substantially change the situation of neglected diseases and neglected
patients.
The report of the WHO's Commission on Intellectual Property Rights,
Innovation, and Public Health, released April 3, 2005, is urging WHO to
"develop a Global Plan of Action to secure enhanced and sustainable
funding for developing and making accessible products to address diseases
that disproportionately affect developing countries". The World Health
Assembly's discussion in May on a global framework on research and
development in essential health will be a timely opportunity for
governments to take action to ensure needs-driven research and development
addressing rich and poor patients' needs. Member states should warmly
welcome the resolution on research and development and start building a
new framework on research and development for essential health.
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