Conference aims to spur interest in creating better diagnostic tests.
Madhukar Pai, an epidemiologist and tuberculosis (TB) researcher based at McGill University in Montreal, Canada, is co-chairman of the Stop TB Partnership's New Diagnostics Working Group and a consultant to the Bill & Melinda Gates Foundation, headquartered in Seattle, Washington.
He has helped to organize the first ever conference to get the Indian pharmaceutical industry interested in TB innovation: 'TB Diagnostics in India: From Importation and Imitation to Innovation', to be held on 25 and 26 August in Bangalore, India. Nature caught up with him to find out how he thinks emerging economies, such as India, can help to combat the TB epidemic with improved diagnostics.
Is there a good test for TB?
No, there is an urgent need for a simple, cheap and rapid test for TB, like we have for malaria and HIV. Despite all the efforts made by the World Health Organization's (WHO's) Stop TB Partnership and national programmes, TB continues to be a huge problem, with more than 9.4 million cases and 1.3 million deaths a year.
The United Nations' Millennium Development Goal of eliminating the disease by 2050 looks impossible at the current rate of decline. Diagnosis is a key challenge. We are barely detecting 60% of cases, so undiagnosed TB continues to fuel transmission. Misdiagnosis is another concern — there are dozens of inaccurate blood tests for active TB. Earlier this month, the WHO published a policy recommendation against the use of such tests, based partly on my work.
What tests are available?
The WHO currently endorses three diagnostic approaches. These are: visual detection, such as by smear microscopy; growing bacteria in cultures; and molecular DNA tests. Smear microscopy is the main technology used in developing countries, but it misses a large number of cases and does not pick up multi-drug-resistant strains. Culture and molecular tests are more accurate, but their cost and need for sophisticated laboratories is an issue in developing countries.
What's in the pipeline?
Several teams are working on a variety of technologies, from tests for antigens and antibodies, to hand-held molecular tests and non-invasive breath tests.
This kind of development depends on basic research into TB. The Bill & Melinda Gates Foundation is investing a lot of money into this field, as are other groups, such as the Foundation for Innovative New Diagnostics in Geneva, Switzerland, the US National Institutes of Health in Bethesda, Maryland, academics and industry. The hope is that we will have a cheap, accurate and rapid test in about five years.
But one area of concern is the funding gap. An analysis by the Treatment Action Group, a think tank based in New York, estimated that in 2009, just US$41 million was spent on research and development for TB diagnostics — way off the Global Plan to Stop TB's estimate that $740 million will be required each year to the end of 2015.
What part can India play?
There is a lot of buzz about the potential of Brazil, Russia, India, China and South Africa in the development of affordable health-care technologies. This is especially exciting for diseases of poverty, such as TB, that may not be of great interest to rich countries or to industry, which do not see a market to justify investments.
Although these countries have a large TB burden, they also have the technical resources to invest in solutions and are capable of addressing the funding gap by infusing more resources into research and development for diseases such as TB. There is also potential for philanthropic initiatives from high-net-worth individuals and companies in these growing economies.
India is a key player in the emerging power structure. It has a large scientific resource and its success in the information-technology area has inspired entrepreneurship in several areas, including biotechnology.
What are the main challenges?
The Indian industry has done well with generic products but the transition to innovation is not an easy one. In fact, I think easy success with generics has actually made it harder for Indian industry to innovate. Real innovation will require changes such as progressive policies by the government to increase funding and partnership opportunities between government, donors, researchers and the private industry.
What do you hope the Bangalore conference will achieve?
We hope that the meeting will result in partnerships among Indian groups who can work together to solve a big public-health problem for India, but also come up with viable business models that are sustainable for industry.
We have 70 companies participating, plus venture capitalists, donors, funding agencies, government officials and academics. Getting this many groups together has not been easy – many companies are just not interested in TB. Even if a handful of companies and stakeholders make a serious effort at developing innovative products for TB, I would consider that a big success!
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Zorlu, G. India takes the lead on tuberculosis innovation. Nature (2011). https://doi.org/10.1038/news.2011.489