Archive for September 2011
JATB is proud to feature Dr Madhukar Pai this week. He summarizes some of the lessons from the recently held conference entitled “TB diagnostics in India – From importation and imitation to innovation” at Bangalore.
No country has more cases of tuberculosis (TB) than India. Research from India played a critical role in the development of the global strategy to stop TB. Yet, Indian industry and academics have not developed any new tools (diagnostics, drugs or vaccines) for TB. Why has India failed to innovate in TB R&D? To understand this better, we recently organized a conference at St. John´s Research Institute (SJRI)in Bangalore, India. For the first time, this meeting brought togetherover 200 representatives from industry, government, donors, academia, civil society and the media to discuss what it takes to innovate in TB diagnostics in India and to move from importation and imitation to innovation.The goal was to stimulate industry interest and investments in TB innovations.
Why focus on India? India has already made a big contribution in the area of generic drugs and vaccines, and successes in areas such as information technology and mobile telephony have greatly inspired a burgeoning biotechnology industry. With a strong, growing economy, and a large talent pool, there is great potential for India to contribute to what is called as the “More (value) for less (cost) for more (people) or MLM innovation,” especially in the area of healthcare technologies and delivery innovations.
It is often said that industry interest in TB is low, in part because the disease mostly affects the poor in developing countries. While this is true, should 9.4 million TB cases/year not translate into a large global market for companies? What exactly is the size and nature of the TB diagnostics market in India and elsewhere? A preliminary analysis by McKinsey and Company suggested that the TB diagnostics market in India might be in the ballpark of about $100 million, although there was uncertainty surrounding the estimates from the private sector which does not report TB. The Indian TB control program (RNTCP) screens over 7.5 million people with suspected active TB every year, and a similar number is likely to seek care in the private sector. Thus, 15 million persons with suspected TB should translate into a fairly sizeable Indian market. In addition, diagnostics will be needed to diagnose extrapulmonary TB, MDR-TB, childhood TB, and latent TB infection. If a good, point-of-care test were to be developed, it might open the option of intensive and active case finding. Furthermore, if a new test were to be developed on a platform that can be used for other diseases, then this opens new markets beyond TB. Lastly, there is a large potential market outside of India. Clearly, we need a more detailed TB market size analysis to engage both industry and funders.
The TB community has done a poor job of articulating its needs. ‘What products should we develop, and if we did develop products who purchases them?’ is a key question that industry representatives asked. A presentation by a senior RNTCP official provided some clues: What the RNTCP needs most is a new point-of-care test for active TB that is simple, easy, cheap and can be performed with minimal training at primary healthcare level; in addition, the program needs an indigenous, economical, simple, automated (battery operated) or manual molecular test to detect drug resistance that can be done in a peripheral lab with minimal training. This wish list is a great place to start, but will need to be converted into clearly defined target product profiles (TPPs) that test developers and funders can aim for.
Other concerns raised by the industry included: lack of access to Indian sample repositories for test development and validation, and limited funding andR&D facilities for TB;poor regulatory mechanisms to evaluate new tests and assure quality; unclear prequalification process for TB tests by the World Health Organization; lack of venture capital funding for R&D and lack of celebrity/philanthropic support from within India; lack of awareness about funding opportunities, weak or non-existent collaboration between RNTCP and industry, between industry and clinicians, industry and academia. In addition, there are the usual barriers to innovation in India.
Companies, especially those not working in TB, want “mentorship” or technical advice on TB, and it is not clear who they can approach for issues specific to TB. When and how should companies engage with agencies such as WHO (globally) and RNTCP (within India) for advice, possible endorsement or evaluation? What is the procedure for companies to access the government market for TB tests? How will the RNTCP decide on which tests to scale-up, and how much is the RNTCP willing to spend?
As more TB products get developed, it is not clear which agency or organization can conduct head-to-head validation studies to identify the best products for scale-up. More importantly, which agency or organization should take on an “honest broker” role to bring together key stakeholders that make up the complete value chain for TB innovations in India?
Increased industry involvement and investment in TB R&D is an important goal. While the Bangalore conference was clearly a first step to begin a dialogue among the various stakeholders,it became clear that a lot more work is needed to address the needs articulated by the industry.Innovations in TB will also require the support of civil society, media, and patient groups which can bring attention to the need for new TB tools, advocating for scale-up of new products that are already available, and advocacy for increased investment in TB R&D.
Dr Madhukar Pai is a professor and TB researcher based at McGill University, Montreal, Canada. He serves as co-chair of the Stop TB Partnership’s New Diagnostics Working Group (NDWG), and as a consultant to the Bill & Melinda Gates Foundation (BMGF). The views expressed in this article are the author’s ownanddo notnecessarilyreflect those of NDWG or BMGF.
Initially posted on Speaking of Medicine
The views expressed here are entirely of the author.
Society of Social Networking for Education, Health & Agriculture (SNEHA), is an NGO working in selected districts of Uttar Pradesh, Bihar, Maharashtra, W.B., Jharkhand and Rajasthan in India on various health issues including TB. SNEHA is one of the partner organizations under project Axshya of International Union against Tuberculosis and Lung Disease.
A conducted in Maharajganj, one of the project areas revealed the need for a Helpline No. on TB, so that even general people could access authentic information on TB, services and facilities under RNTCP. SNEHA has proposed to initiate this in collaboration with District TB Centers in Maharajganj, Deoria and Gonda districts in first phase.
The District TB Officer, Maharajganj nominated Dr. D.D.Upadhya, Dy DTO- Maharajganj to coordinate the Helpline No. This helpline is officially operational from September 1, 2011 in Maharajganj and Dr. Upadhya is currently responding to the queries on the helpline.
Anyone from district can get information related to general information on TB, stigma and discrimination, myths and misconceptions on TB, services and facilities available under RNTCP in the district by giving the call from 10.00 AM to 4.00 PM. Those who cannot afford the cost of the call, can make a missed call and will give a call back.
Within a short time 38 beneficiaries have taken benefit of this helpline no. Out of 38 queries, 27 were related to general information such as symptoms of TB, the ways in which it spreads, ways to protect oneself against TB etc – a sure indication that there is an urgent need for information on TB among the general public.
For more information/suggestions, pls. feel free to contact:
Society of Social Networking for Education, Health & Agriculture (SNEHA),
Registered office: Harawara, PO- Amaliya, Shahabganj, Chakia, Dist- Chandauli- 232118 ( U.P.)
Helpline No 091-5181-3060.
Contact No- +91-9415831598, E-mail: email@example.com
Communicating on health is a constant challenge. There are doctors, scientists, researchers, academicians and grassroots workers constantly working behind the scenes, trying to make the world a healthier place to live in. And there are the communicators who are getting news out on what all these people are doing. And yet, there are gaps.
Scientists tend to communicate with other scientists, academicians with others like them and so on. Where is the convergence? Who communicates with the lay people, the general readers, and those who actually benefit from all the research and advancements? Who acts as that vital information bridge that enables hope for those suffering from illnesses that need the benefits of research? It’s the health communicators or the health journalists. And they have the toughest job, because they are most often not technically or academically qualified to communicate on health. They have to learn on the job. They constantly grapple with terminology that is difficult to understand; they struggle to access reliable data and most often, also struggle with inadequate knowledge on the topics that they are expected to or want to write about.
But health communicators are important stakeholders who need to be constantly engaged with in order to be able to mainstream health communication in an accurate and credible manner. But this is easier said than done. What health journalists generally get is press releases and/or complex information which they are then expected to convert into information that will make sense to the general reader. The result is often incomplete, inadequate or even inaccurate communication – a situation that is worse than getting no information at all.
The situation therefore merits greater exposure to developments around health issues and deeper interaction with experts who can demystify the complexities associated with the science of diseases. This interaction and exposure can and does translate in easy-to-understand information and awareness among those affected/infected/afflicted with disease. This can happen only when health communicators/journalists become an integral part of the health sector and and are not considered mere appendages, albeit necessary ones to the issue.