Combating TB, the right way

Last month, when a more resistant type of tuberculosis was reported from India, it threatened to take a little of the sheen away from the country's healthcare community that was in self-congratulatory mode for successfully controlling polio. Soon enough, Government authorities got involved — rapping the hospital that reported the highly resistant TB for creating a scare, and wrapping the incident in semantic knots.

The strains of TB reported by Hinduja Hospital, Mumbai — weren't Totally Drug-resistant TB (TDR-TB), just Extensively Drug-resistant (XDR-TB), Government authorities clarified. For health administrators, the difference between T or X forms of medicine-resistant TB means a change in treatment — more medicines, follow-ups for a longer time, and more funds. But health-workers see the debate on T-TB or X-TB as a mere quibble over words. Either way, there still remains much ground to be covered. And that, unfortunately, is the reality.

With approximately two million annual TB cases, and nearly 750 deaths per day — India accounts for one-fifth of the global numbers, ranking near the top among the 22 high-burden countries. The Government estimates Multi-drug Resistant TB (MDR) at approximately three per cent of the annual estimate (or 6000 cases), and 12 per cent of the previously treated three lakh people (approximately 36,000). India's TB prevalence stands at 3.1 million cases in the community.

Statistics are but cold numbers, but they represent human lives — and so the renewed call for a massive ramp-up of the RNTCP (Revised National TB Control Programme), a scale-up in reporting and management of the illness, diagnostic and human infrastructure, and sheer better visibility.

There is a move to make TB a nationally notifiable illness to make sure there is better reporting of the illness. Private doctors would then be mandated to report to the Government the TB-affected people they treat. This would help bring private doctors into the RNTCP, by standardising diagnostic and treatment practices. A significant move, as 50 per cent of patients treated are reportedly by private practitioners.

The Government also needs to take a page out of its own polio and HIV/AIDS campaigns — where its visibility, reinforced human and some other infrastructure, and sourcing of medicines resulted in better access and awareness.

TB needs high-profile endorsements and campaigns to educate people on things as simple as taking care of a persistent cough and refraining from spitting in public!

RESISTANCE CONCERNS

To the Government's credit, its earlier DOTS (Directly Observed Treatment — Short course) programme to combat TB was effective, giving screening and treatment the initial kick-off it required. But complications set in with resistance to the medicines — or when TB-affected people don't get cured by the first-line of TB medicines given to them. Resistance to medicines occurs due to several reasons, including the absence of standardised TB treatment by private doctors.

Private treatment could result in deviations from standard methods of treating the illness — starting from identifying it right, followed by the laboratory tests that doctors use to decide on medication, and then treating it with the right medicines. Next comes another critical aspect — making sure the person takes the four medicines, through six months. In the Government programme, a designated person, like a neighbour or a paan-wallah , makes sure that the patient takes the medicine, besides keeping them motivated to be regular, points out Dr Sarabjit S. Chadha, with the International Union Against Tuberculosis and Lung Disease.

When the first round of TB medicines doesn't work, the individual is moved to the next generation of medicines — more expensive (approximately 300 times more than first-line medicines), more toxic, given for a longer duration (24 months), and worse, with poor outcomes, he adds. For MDR TB, the regime involves six medicines, and for XDR-TB, it is nine medicines, he explains.

BANNED TESTS

The role of diagnostics and treatment cannot be emphasised enough. The Centre, in line with WHO recommendations, had sent an advisory approximately four months ago, to discontinue serological (or blood-based) tests to diagnose TB, as its results aren't accurate. But serological tests continue to be used in labs across the country, for economic reasons, say several studies done by TB experts. It doesn't have the stigma and low-margins of a sputum-smear microscopy — the basic TB test. And it is as expensive as a liquid culture test.

Serological tests continue to be recommended by private practitioners, due to sheer ignorance — as the Government hasn't trained or informed them — and for economic reasons worked out in collusion with private laboratories, says another scientist. In fact, the medicine regulator has been consulted, and serological tests for diagnosing TB have been recommended for a local ban. Whether serological tests are used for reasons economic or otherwise, the Government needs to act quickly, as an inaccurate diagnosis is the difference between life and death for one affected with TB.

Approximately 90 per cent of the serological test kits are imported from Asian countries. And the few Indian manufacturers in the fray stand by their product, saying that it is best suited for the price-sensitive Indian market. In this scenario, the question arises: Why hasn't a point-of-care kit been developed by Indian scientific laboratories and institutions? — A single kit that gives a positive or negative answer like a pregnancy test, asks Dr Chadha.

NEW MEDICINES

New medicines present a similar problem. TB Alliance's Chief Executive Dr Mel Spigelman notes that DR-TB is a global problem, and XDR-TB is confirmed in nearly 70 countries. And the TB strain recently reported from India is one of many extremely deadly and difficult-to-treat forms of XDR-TB. Confirming XDR-TB requires advanced medicine-sensitivity testing, a capability absent in many of the developing counties — where TB is most prevalent. And so, a vast majority of XDR-TB cases go unreported and the known ones only scratch the surface of the problem.

Citing WHO estimates, he says, there are approximately 100,000 cases of MDR-TB in India. On an average, approximately 3-5 per cent of these are estimated to be XDR-TB — implying approximately 3,000-5,000 XDR-TB cases in India. Historically, though, there has been less investment in TB medicines, because a majority of the affected were poor, and therefore, there was little market incentive for the industry to invest in this area. Today, there are some donors and governments investing in TB medicine research, but that must increase in magnitude to stop the disease from spreading and growing worse, he says.

“The primary challenge facing the development of new medicines — and many new medicines are needed — is attracting the resources necessary to complete the science,” he adds. There are approximately 11 new clinical stage TB medicine candidates, and the Alliance is testing multiple new medicines in combination to help new regimens reach patients more quickly. However, without sufficient long-term support, the promise of the global pipeline of new TB medicines won't be realised.

Development of new medicines takes its time, but simple measures like rational use of medicines, better enforcement by Government and adherence by patients — can make a marked difference in combating TB in the country. This, and a little help from celebrities like Oscar-winning musician A. R. Rahman, who was the first global brand ambassador for the Stop TB Partnership .