Here is a real story that played out in India. 25 year old Mohan from Chhattisgarh state had been ill with cough, fever, and weight loss for a number of weeks. He had all the classic symptoms of TB when he went to a private doctor in his town for help. The doctor advised him to undergo a TB serology (antibody detection) test which cost him 200 rupees at a local private laboratory. Because the rapid serological test was negative for TB, he was sent home with a prescription for some vitamins, iron and a cough syrup. Weeks later, after his condition had worsened further, a sputum microscopy test at another health centre revealed that he had 3+ AFB smear-positive, extensive disease in both lungs. Although TB therapy was initiated, Mohan died shortly after.
Mohan’s story is not unique at all in India, and raises several concerns that will challenge the Government of India which is currently in the process of preparing the blueprint for the next phase of the Revised National TB Control Programme (RNTCP), Phase 3 which will run from 2012-2017. Why was Mohan diagnosed with TB after such a long delay? Why did he need to visit several healthcare providers and why did he not seek care in the public sector DOTS programme? Why was an inaccurate serological test used when much better alternatives were available? Why are inaccurate TB diagnostics tests on the market in India and why is the regulatory system ineffective? Who should be held accountable for Mohan’s death? How many people in Mohan’s family and community were infected with TB during his prolonged and ultimately fatal illness?
By expanding DOTS to cover 100% of the country, India has done well to achieve international targets. The RNTCP has already met the 70/85 targets for case detection and cure. Yet, in 2009, over 2 million TB cases and 280,000 TB deaths kept India at the top of the list of countries with the highest TB burden. It is obvious that TB is not under control in India. One important reason for this is delayed diagnosis and mismanagement of TB. As illustrated by Mohan’s story, diagnostic delays are all too common and by the time a patient is diagnosed with TB, he/she has already visited multiple doctors, and infected several others, perpetuating the cycle of TB transmission.
For a variety of reasons, patients in India are more likely to seek out private doctors who are still the first point of care for the vast majority of TB cases, yet less than 2% of the doctors are referring patients to the free government run DOTS system. Despite its size and importance, the Indian private sector is largely unregulated. Irrational practices are widespread, including dumping of useless diagnostics (e.g. antibody TB tests) from rich countries into India because of weak regulation, doctors receiving kickbacks for tests ordered, and over-reliance on bad tests and under-use of good diagnostics. The serological blood test done on Mohan for TB is known to be inaccurate and inconsistent, and discouraged by the World Health Organization (WHO), yet despite the evidence and lack of any supporting policies, 1.5 million TB serological tests are done in India every year. The market size for this undependable test? At least 15 million US $ per year. Poor TB treatment practices are equally widespread. A recent study from Mumbai showed 106 doctors prescribing 63 different drug combinations for TB. Such irrational practices may explain the emergence of 100,000 drug-resistant TB cases each year in India.
To improve the landscape of TB diagnosis, India must adopt new tools that are accurate, validated and WHO-endorsed, and replace bad tests with ones that can potentially reduce the spread of TB in the community. This will require improvements in regulation of the private sector in general and an intense review of regulation of diagnostics to prevent abuse of suboptimal diagnostics. In addition, ambitious goals must be set. India has already taken the lead in this area, with its impending launch of RNTCP 3, by envisioning an ambitious plan for 2012-2017, that aims to provide universal access to quality diagnosis and treatment for the entire population.
Universal access in India cannot be achieved without scaling up improved diagnostics, and without engaging the dominant private sector in India on a large scale. Small-scale public-private mix (PPM) projects are just not adequate. The need of the hour is socially-oriented yet economically viable, innovative business models that combine public and private financing. Healthcare delivery innovations in Asia are receiving much attention these days, and India can build on successful examples in other sectors to improve TB care by engaging the private and NGO sectors, with the government serving the role of a payer, regulator, and enforcer of quality standards.
That the RNTCP alone cannot make universal access a reality is a given. It demands that a role be played by all the stakeholders in what is essentially a national problem. Private Indian players must work with the Government of India to develop low-cost generic or novel TB diagnostics (“frugal engineering”) that can make a big difference, both nationally and internationally. Indian generic anti-viral drugs dramatically changed the global landscape of access to HIV treatment. Indian-made hepatitis B vaccines helped to dramatically cut down the cost of this vaccine which was simply unaffordable for the country. Similar efforts are currently underway to develop low-cost flu diagnostics, vaccines and drugs. TB deserves the same dedicated focus from various stakeholders, not just in India, but also in other BRICS countries which have the economic and technological capacity to drive such innovations. An upcoming meeting in Bangalore, in August 2011, will attempt to engage Indian industry in TB diagnostic innovations.
The time has come for all Indian healthcare providers, industry, civil society, donors, activists, journalists, politicians, philanthropists and patient groups to rally behind RNTCP 3 and make it a success story. Indian corporate donors, high-net-worth individuals, and philanthropic foundations must step up to support the cause of TB control. The motive is as business driven as it is altruistic because TB affects everyone in India, both rich and poor, and takes its toll on young and working adults in India, resulting in enormous economic losses. Having made good progress in improving TB control in India, it is now time to get ambitious and innovative. Anything less will not save the thousands still dying of TB every day.
Dr Madhukar Pai, author of this article, 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).
Note: The views expressed in this article are the author’s own and do not necessarily reflect those of NDWG or BMGF. Initially published as a guest blog on Science Speaks in April 2011.