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Health: Neglected diseases

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Safer, Faster, Cheaper Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases

Source: Working Group on Clinical Trials and Regulatory Pathways | November 2011

This report provides policy recommendations to help deliver safer and cheaper medical products to people suffering from neglected diseases in developing countries, where they are needed the most.

Although more drugs and vaccines are reaching late-stage clinical development, says the report, they are held back by a lack of funding to support clinical trials, as well as clinical research and regulatory capacity in settings where neglected diseases are endemic. This undermines safety and the validity of clinical data.

The report recommends a two-pronged approach to improving the quality and regulation of clinical trials in the developing world: establishing regional regulatory pathways for the oversight of clinical trials, and building quality and cost-efficiency into trial design and implementation. It also recommends practical steps that can be taken by donors, drug and vaccine developers, and regulatory authorities to begin implementing the changes.

Chagas disease

Source: The Lancet | April 2010

This article from The Lancet provides useful background information on Chagas disease including its transmission, epidemiology, pathogenisis, diagnosis and treatment. The disease affects eight million people in Latin America and poses a growing health problem in non-endemic areas due to increased trade and travel.

Using climate to predict infectious disease epidemics

Source: WHO | 2005

This report from the WHO assesses the potential for creating early warning systems for vector-borne disease. It reviews the current state of research for several diseases such as dengue fever, leishmaniasis, malaria and West Nile virus.

The report includes an algorithmic framework for developing early warning systems, outlining data requirements and the different components of the system. It also contains two useful tables: one on the sensitivity of different infectious diseases to climate; and one summarising the existing research, identifying in which region the disease is most common, data availability and proposed actions.

A key problem in developing early warning systems, as highlighted by this report, is that non-climatic risk factors such as population immunity and food security strongly affect the potential for a disease outbreak. Equally challenging is the poor disease surveillance in many developing countries — the authors call on these countries to strengthen these systems, to help in the fight against climate change.

The report concludes that it will be important for researchers not to design these systems in isolation — health policymakers should be included at all stages of the design.

Climate change 2001: Impacts, adaptation and vulnerability

Source: Intergovernmental Panel on Climate Change | 2003

The third IPCC assessment report, Climate Change 2001, includes this section on the links between climate change and health. It offers a detailed look at how variations in climate, such as temperature or rainfall, could affect vector-borne disease. In particular, it evaluates computer models that predict climate impact on dengue fever and malaria. The assessment also looks at specific diseases such as leishmaniasis or schistosomiasis, explaining how the disease is spread and how changes in the environment might alter that spread.

The authors take a holistic look at the various factors involved. For example, in assessing schistosomiasis, they also consider the irrigation systems that will likely be needed to cope with expected water shortages resulting from climate change. The schistosomiasis parasite uses water snails as an intermediate host, so irrigation systems will need to be designed in such a way that they do not cause snail populations to multiply.

An update to the research on climate and vector-borne disease is also included in the fourth IPCC assessment report[796kB] although not in as much detail.

Drug development for neglected diseases: a deficient market and a public-health policy failure

Source: The Lancet | June 2002

The so-called 10/90 gap in health research — which refers to the fact that only about 10 per cent of funding is targeted to diseases which account for 90 per cent of the global disease burden — is a well recognised phenomenon which is being targeted by a number of initiatives. This article, by members of the Drugs for Neglected Diseases Working Group at Médicines Sans Frontières, analysed the outcomes of pharmaceutical research and development over the past 25 years and reviewed current public and private initiatives aimed at addressing the lack of research into controlling important infectious diseases in developing countries.

The authors found that of nearly 1400 new drugs marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis (all of which had been developed with public-sector involvement). There is a 13-fold greater chance of a drug being brought to market for central nervous system disorders or cancer than for a neglected disease.

The authors conclude that there is no indication that drug development for "non profitable" infectious diseases will significantly improve in the near future and that new strategies are required to stimulate such development. They argue that a sustainable solution will require the establishment of an international pharmaceutical policy for all neglected diseases. Private sector research obligations should be explored further, and public sector not-for-profit research capacity promoted, particularly for the most neglected diseases.

(Free registration with The Lancet is required to view this article.)