Tuberculosis: The Good, The Bad, and The Unfinished

Tuberculosis has been with humans since time immemorial. We have been trying to get rid of tuberculosis since centuries. Have we done enough? Of course not, as tuberculosis is still a leading cause of death.

What can be done to eliminate tuberculosis? This may be the wrong question to ask. We must ask ourselves, what have we done till date and what more can be done to prevent huge loss to mankind from tuberculosis? This article gives an account of what has been done so far (the good); where we went wrong (the bad); and what must be done (the unfinished) to decrease the burden of tuberculosis in India.

Let’s start with the progress made thus far, or the “good”. India has come a long way from starting a National Tuberculosis Program in 1962 (mainly for hospitalizing treatment) to rolling out Revised National Tuberculosis Program in 1993 and state run Revised National Tuberculosis Control Program in 1997, to achieve universal access to tuberculosis control services, leading to its nationwide coverage by 2006.  The national programs imbibed the World Health Organization’s Direct Observed Therapy Shortcourse Strategy in 1994 and its improvised version in 1998. Programmatic Management of Drug Resistant Tuberculosis was started in 2007 to tackle the issues related to resistant form of tuberculosis; achieving a nationwide coverage by 2013 and rolling out Bedaquiline drug under revised program through conditional access in 2016.

Central Tuberculosis Division collaborated with National Information Center in 2012 to develop Nikshaya, a web based solution to monitor tuberculosis patients. The revised tuberculosis program launched Standards of Tuberculosis Care in India in 2014, in accordance with World Health Organization. Cartridge based nucleic acid amplification test like GeneXpert has already been launched at Anti-Retroviral Therapy sites in 2014. India has come up with indigenous TrueNat test for the drug sensitivity testing at near point of care facility. India is moving forward to roll out Universal Drug Sensitivity Test for every newly diagnosed tuberculosis case from now onwards. Tuberculosis case notification was made mandatory by May 2012 but it is only very recently that the Union Health Ministry has made it a criminal offense punishable with a jail term of six months to two years for clinical establishments, pharmacies, chemists and drugists to not notify tuberculosis cases and also an incentive of 1000 INR for anyone who notifies a potential tuberculosis case. National Tuberculosis Institute, Bangalore launched first nationwide anti tuberculosis drug resistance survey of India in 2014 and the results have come out as a shocker in terms of number of drug resistant cases in the country.

The week of March 12, 2018 will be remembered as a stepping stone to India’s fight against tuberculosis. Tuberculosis was declared a public health emergency by World Health Organization in 1993. Our Prime Minister emphasized the fact that even after twenty five years of such a declaration, we are unable to decrease the disease burden. This calls for a change in action plan. India is gearing up to tackle the problem in mission mode by introducing an ambitious target of tuberculosis elimination by 2025, five years ahead of the global target. In this regard, the launch of National Strategic Plan 2017-2025 is applauded. It has got political and financial commitment form Government of India. India became signatory of Global Tuberculosis Caucus in 2017. The mission mode continues with the establishment of India Tuberculosis Research Consortium, an Indian Council of Medical Research initiative to bring together all major national and international stakeholders to develop new tools for tuberculosis elimination, drawing parallelism with Open Source Drug Discovery platform.

Apart from these government efforts, India has enormous sector of national and international nongovernmental organizations doing brilliant work in this sector. Initiative for Promoting Affordable and Quality Tuberculosis Tests, an initiative of non-profit stakeholder and supported by Clinton Health Access Initiative and over 100 private sector labs/hospitals with a pan India presence provides World Health Organization approved tests at lower costs. The Clinton Initiative is also leading the “Zero TB Cities” project in Chennai along with TB Reach. The project will try to create an “island of elimination”. 99DOTS, funded by Gates Foundation, is a low-cost and accessible patient medication package in secondary envelopes adding dosage instruction, and a series of hidden numbers behind the pills to help track the compliance of the medication. Other interesting examples of treatment compliances are the Freedom TB initiative by ZMQ Technologies and eCompliance initiative (with Microsoft) of Operation ASHA.

The Private Provider Interface Agency model by PATH, the World Health Organization, and the Bill & Melinda Gates Foundation strengthens the capacity of private practitioners serving people in slum areas to ensure early, accurate diagnosis of the disease (including drug-resistant forms), effective case management, and successful treatment. The model operates as a part of Mumbai Mission for Tuberculosis Control and has led to improving situation in Maharashtra. Government of India, The Union and World Vision India together launched project Axshya in three hundred districts, across twenty one states, through eight sub-recipient partners. The focus is to facilitate universal access to tuberculosis care especially for the vulnerable and marginalized communities. A standardized patient study in Quality of Tuberculosis (QUTUB) project, by McGill University, World Bank, and ACCESS Health International, has given newer insights on the care seeking behavior of the patients and care delivery modes of the providers.

This was the “good” of the story; let’s move on to the “bad” of the story. India still misses out on the one million tuberculosis suspects who are never diagnosed of tuberculosis. They are not screened on the radar of national tuberculosis control program. They might be going to private players, getting symptomatic relief, however remaining a carrier all this while and incurring high out of pocket expenditure on treatment. India accounts for a very large private sector healthcare infrastructure. We have not been able to tap this potential for overcoming tuberculosis burden. Why we ask to bring the patients to public sector, why can’t we equip the private players to treat them in the standard way? This is a fatal flaw in India’s strategy against tuberculosis. Let the patient choose where to go. An approach like this would require many strings of the national program to be pulled, but its time!

The problem of drugs and its supply chain management is also common in this sector. Out of stock drugs at the tuberculosis centers forces discontinuation of the medication and leads to risk of degraded quality of the drugs being supplied. We must learn from the AIDS/HIV story on how national AIDS control program of the country was able to monitor the drug shortage. The accurate diagnostics at the point of care facility is also a major problem leading to both wrongly diagnosed and under diagnosed pool of tuberculosis suspects which invariable leads to spread of infection.

India’s tuberculosis control pioneers P.V. Benjamin and Frimodt-Moller introduced the mass BCG vaccination in the hope that it would protect against infection by the bacilli. However, it primarily protects only the zero to five age group of population. As was evident in the last Global Forum on Tuberculosis Vaccines at Delhi in February 2018; there is a dire need to find the new tuberculosis vaccine for a better tomorrow. Resources need to be channelled in this direction to see fruitful results. Similarly, there is a need to find newer drugs for shorter treatment regimen to decrease the medication burden on tuberculosis patients.

Let’s come to the “unfinished” part of the story. We need to get back to design board to redesign the strategy to control the dreaded disease. It needs a patient centric approach instead of a provider centric approach. It has been known that over the fifteen years’ time period even though over a billion dollar has been spent of new mechanisms for tackling tuberculosis in India, only a negligible improvement has been seen on the economic loss due to tuberculosis. There is a need for complete assessment of the impact of the disease, not simply to inform policymakers of the burden of disease but also to provide the basis for targeted interventions to control tuberculosis. An extensive involvement of Information and Communication Technology is the need of the hour.

From case detection, diagnosis confirmation, treatment initiation to treatment compliance; all these aspects demand concrete attention in silos and a whole umbrella approach for strengthening the continuum of tuberculosis care. An Information Education Advocacy and Communication component to target the sites where the prevalence of the disease is more; to prompt the masses to call and let a single call provide them with all tangible benefits from the dreaded disease. A Command and Control Center component acting as a hub to receive the calls and schedule appointment of the beneficiaries with the doctor must be another feature. The triage of leading questions will help in identifying the disease case. This provision is needed as it will reduce the load on the diagnostic facilities and help the Center to tag the suspecting patient and not lose him or her from the care radar. Provision of integrated case management software in the command and control center with modules for integrating mapped care facilities to register and track movement of registered beneficiaries; provision of directory service; documentation for each unique ID post conformation; and linking of financial benefits to the tuberculosis patients must be a key feature.

A strong clinical component to be manned by tertiary care center and district level centers with provision of sputum microscopy, nucleic acid based testing like TrueNat and GeneXpert; diagnosis of tuberculosis (also Drug Sensitive or Drug Resistant Tuberculosis); integration of private care providers (registered medical practitioners, private labs, chemists) into the tuberculosis care cascade to improve the clinical outcome for the patients. The approach must have a capacity building, performance monitoring and quality improvement component for training modules for the existing workforce in the tuberculosis care cascade; to lay out the standard operating procedures and manuals for the staff and defining of key performance indicators of the programs, process diagrams and role and responsibilities of the staff involved in tuberculosis care cascade, in accordance with the guidelines from revised national tuberculosis program.

We need to ask ourselves, are we willing to do this? After the political and financial commitment, we need to get to the ground, start rolling, and END Tuberculosis!