The world has now realized the economic impact of tuberculosis, which is the most dreaded killer disease causing more than two million deaths each year. There is now a fresh awakening amongst high burden countries to fight against the same with new research initiatives. Dr Bernard Fourie, director, Global Alliance for TB Drug Development, was in India as part of the Tuberculosis Research and Development Coalition initiative. The Coalition, under which a few Indian research institutes and leading TB drug manufacturers have already joined hands, would aim at developing a research network to develop new drugs, vaccines and improvement of existing anti-TB therapy with new combinations. And the ultimate objective of this coalition of R&D stakeholders for High Burden Countries is to develop strategies to manage tuberculosis by using all the capabilities of drug research and also medical science, says Dr Fourie in an interview with C H Unnikrishnan of pharmabiz.com. Excerpts :

Anti-tuberculosis drug research had been ignored in the advanced world, as it was not an attractively rewarding effort for the industry since the prevalence of the disease was only in few poor countries. Why is there an immediate awakening now?

It is true that there were no serious efforts in the world to develop newer drugs of TB. And yet no new TB drug has been developed over the last 30 years. At present, the issue is so intense that this killer disease causes more than two million deaths each year, or about 5,500 deaths every day - thus remaining the largest killer of youth and adults in the world today. The disease is rapidly spreading among HIV-infected populations, with one-third of HIV patient deaths attributable to TB. One-third of the world''''s population is currently infected with TB and each year eight million people develop this disease in its active form.

What does Global Alliance stand for and how did it come into existence?

The Global Alliance for TB Drug Development will be responsible for the research and development in endemic countries. The Tuberculosis Research and Development Coalition is part of this Alliance. The Cape Town office of Global Alliance for TB Drug Development was recently launched at the MRC. This office will shoulder the responsibility for research and development in endemic countries. And the other two offices, situated in New York are for the international governance and the Brussels office will look after advocacy and fund-raising.

It is a multi-million dollar project, with total funding expected to exceed US$150 million. The Gates and Rockefeller foundations have already announced commitments totaling US$40 million. It is following a landmark meeting convened by the Rockefeller Foundation and hosted by the MRC last year, the Global Alliance for TB Drug Development was formed by all major role-players in the world, including academia, the public sector, non-governmental organizations, foundations and industry.

What exactly is the new initiative focused on?

The objective of the Global Alliance is straightforward. In order to manage this fast spreading disease effectively, the treatment for TB needs to be shorter, must be equally effective against susceptible and drug resistant tuberculosis, and also must be accessible to the populations who need it most. This treatment should also be on the market in less than ten years.

Since each TB patient can infect hundreds of others, the best way to prevent TB is to treat and cure people who have it and spread it. The creation of the Global Alliance, the most important development in TB control since the World Health Organization declared the disease a global emergency in 1993, brings us much closer to a new treatment. Hence the Global Alliance was formed to bridge the gap between the public and private sector, and to form active research partnerships between the economically and technologically advanced countries and their counterparts in the predominantly high-burden, resource-poor regions.

By employing a ''''virtual research and development'''' operating model, which outsources projects to public or private partners, the Alliance seeks to leverage the resources of both the public and private sectors in the hope of making the effort for TB drug development equal to the need for new and improved drugs. Furthermore, the Alliance''''s lean working model allows the organisation freedom to constantly survey possible leads in TB drug discovery. The Alliance can selectively intervene when it is able to help move a drug candidate towards development and ultimately to regulatory approval.

What is the objective of Tuberculosis Research and Development Coalition, and how is it going to be operated?

Since it is necessary to ensure equity between the North and the South in their access to research funding, manufacturing opportunities and to develop research capacity as a by-product of the global effort, the Tuberculosis Research and Development Coalition of stakeholders in high-burden countries has been formed. The Coalition will focus on those regions in the world most affected by TB, namely Africa, Asia and Latin America.

Apart from new research for anti-TB drugs, the Coalition would also see the initiative as advancing science in general. Any research process, which also generates byproducts or breakthroughs on new terrains like new techniques in existing therapy, new diagnostic methods, vaccine research etc. So that it adds additional momentum to modern science to manage the disease.

Overall, it is going to be a groundbreaking ess all the research capacity in the high-burden regions. For this purpose, forging new networks between scientists is of the utmost importance. And I am very excited about the future of traditional medicines and will also be investigating our involvement in existing networks, particularly where clinical trials are concerned. We don't want to duplicate an existing infrastructure.

How do you look at the intensity of tuberculosis in India and the contributions from the scientific institutions and the industry towards achieving the Coalition's goal?

Since India is one of the high burden countries as far as tuberculosis is concerned and also a country where much of the advanced projects are already been in place both by the industry and research institutions, the Coalition expects India as major stakeholder in the Coalition and it can provide a very significant contribution to the goal of the Coalition.

How do you look at the intensity of tuberculosis in India and the contributions from the scientific institutions and the industry towards achieving the Coalition's goal?

Since India is one of the high burden countries as far as tuberculosis is concerned and also a country where much of the advanced projects are already been in place both by the industry and research institutions, the Coalition expects India as major stakeholder in the Coalition and it can provide a very significant contribution to the goal of the Coalition. The country already has the world's largest pool of manufacturers of anti-tuberculosis agents. This capability and the research skills of the industry can be potentially explored by the initiative.

India is the country with the largest number of TB cases (23 per cent of the world's cases). It is estimated that there are almost 14 million prevalent cases, 2 million new cases per year and 500,000 deaths annually (1 death per minute). Still, the treatment completion is very low and treatment strategies are not yet standardized. Here, as per the available data, the drug resistant TB is common.

This initiative can ignite public-private collaboration to improve treatment and promote research. The research projects on new agents and avenues can be boosted in all the areas like herbal products, biotechnology and the combination chemistry. With this initiative, the private sector companies can play a very important role in catalyzing public sector research.