Friday, August 16, 2013

INDIA'S TB CONTROL - WHAT WENT WRONG?


Nowadays we find TB in news everywhere like shortage of drugs, increasing muti-drug and extensive drug resistance (MDR, XDR), making the treatment expensive and cumbersome. Total drug resistance (TDR) is now a death warrant, our popular serological tests for the diagnosis is declared as worse than useless, and a government order for mandatory case notification. In India, private practitioners are legally authorized to treat TB, but without quality check mechanisms often bypassing the prescribed treatment protocol leading to MDR, XDR and TDR. 

Among the developing nations, India pioneering TB control. A national TB control project was launched in 1962. BCG was used a main intervention with the expectancy of protecting against TB. Free TB treatment was included with public-private partnership (PPP). A fatal flaw in the TB control arouse when directly observed treatment short course (DOTS) because popular and PPP was neglected. In 2012, when India celebrated the golden jubilee year of TB control, the World Health Organization (WHO) named India the worst performer among the developing nations. 

India’s TB control pioneers introduced the mass BCG vaccinations in that hope that it would protect against infection by TB bacilli. In 1979, preliminary results of the 15 year long BCG trail showed no protection against TB bacilli infection. But this much debated results were ignored by then TB control leaders. In 1999, the final results confirmed that TB control project had lost the tool of primary prevention. BCG failed to protect against infection by TB bacilli, but protects against infection progressing to the childhood TB. In 2000, Indian Academy of Pediatrics called for major redesign of TB control, with alternative tactics to prevent and treat infection before it caused disease. DOTS saves life from mortality, but failed to control TB. 

TB bacilli spread through air we breathe making everyone at risk of infection. After infection, majority of us remain well, but the bacilli is alive, latent or dormant causing 10 % to develop TB disease sometime in adult life (In India, 15% are infected by 15 years of age; 40-60% by 40 years). Bacilli escapes easily to environment through spitting and coughing when the disease pathology is in lungs (pulmonary TB) making the lung TB a critical link in chain of transmission. This makes young children susceptible to infection causing a serious life threatening disease called childhood TB. Childhood TB is non infectious; so treating it with the universal neonatal BCG vaccination has no role in TB control. 

One way to control TB is by treating everyone with lung TB very early to break the transmission chain. But this is in theory only; a person with lung TB is infective for many weeks and by the time his sputum is tested positive he would have already infected children in contact. So, even if we attempt to treat all the infected we can bring down the infection rate. But, the target is to treat only 70% with DOTS!! And WHO estimates that only half of the lung TB gets DOTS. So, we have a target like this it’s not going to help India in controlling the TB. Moreover without PPP, it’s highly impractical to treat all the patients with protocol.

Our TB control pioneers designed for free treatment in public and private sectors. They designed a district TB treatment model under PPP. Interesting thing is, TB control is a Central government project whereas health care is State subject, so what happened? Private sector grown exponentially and the TB control project failed to address is huge gap. 

There are major factors predisposing the disease like HIV, poverty, nutritional deficiencies and the increasing Diabetes. In 1990, project review confirmed India’s failure to control TB. When WHO declared TB as global emergency in 1993, Revised National TB Control Programme (RNTCP) using DOTS was launched, but it took 13 years it national wide as government saw no TB emergency in India. So, all those fortunate who received DOTS the cure rate was high and the death rate declined. For those who had extra pulmonary TB, sputum test will not be of help in diagnosis and RNTCP is not interested in them as they do not spread TB bacilli. So, the project illustrates an incomplete health and incomplete public health.

In Epidemiology, “Control” is defined term – the disease burden should be reduced to a pre-stated level within a stipulated time period and prove it to be due to intervention and because of “secular trend”. TB should decline without specific interventions as the socio-economic status increases – that is “secular trend”. But what’s the situation is RNTCP has not set control targets in terms of time frame as well as disease burden. So, it’s not measuring secular trend then how can we say it’s a “control” in RNTCP?

The lesson from the other countries teaches us that to detect and treat infected children so that the latent bacilli are killed and children removed from the infected pool so, they will not develop pulmonary TB as an adult which is a feasible move in India. But this requires a redesigned TB control strategy. So for an effective control both interventions, DOTS, and treatment of latent infection must fit together tightly. 

Economically India loses $23.7 billion on an account of uncontrolled TB; to address this we have RNTCP with a budget of only $200 million. TB control is a human right entitlement and investment in socio-economic development. Poverty leads to TB and TB worsens poverty and poverty alleviation require TB control.

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