TB needs better treatment and drugs

TB needs better treatment and drugs

Despite an enabling environment and political will, India has the highest burden of TB.

As yet another World TB Day has just passed, let us pause and examine some facts.  Tuberculosis (TB) is preventable, completely curable and can be eradicated. India has one of the world’s most successful TB control programmes (RNTCP) in the world.  RNTCP has covered the entire country and had an annual budget of Rs 710 crore in 2012.

And yet, despite an enabling environment and political will, it is a fact that India has the highest burden of TB in the world and accounts for around one fifth of the global incidence. In 2009 out of 9.4 million new TB cases globally, 2 million are estimated to have occurred in India and around 280,000 people succumbed to TB.

Why does this situation exist? Why are we not able to bring the situation under control, like we have, say with polio? Control of TB is governed by three factors – prevention, diagnosis and treatment. In other words, we need effective vaccines, reliable tests to diagnose the infection and new and  more efficient drugs. According to experts, all three are outdated and often ineffective. The BCG vaccine, the only vaccine available for TB, recently celebrated its 90th anniversary; the sputum smear microscopy test, which is still the most widely used diagnostic tool is over 125 years old, and the most commonly used TB drug, rifampicin is more than 50 years old.

Widely misused

The TB sector is riddled by the rampant use of improper diagnostic tests, which lead to wrong diagnosis (false positive or false negative) and mistreatment, or lack of treatment as the case maybe. An example of this is serological (antibody) tests, which give highly inaccurate results.

Despite the issue of alerts against the tests by the WHO and subsequently a ban by the Government of India in June 2012, they are still being widely misused by the private sector for diagnosis of TB. Experts estimate that there are an estimated 1.5 million serological tests performed in India every year. The cost of testing at Rs 500 to Rs 1,500 per test, combined with the cost of unwanted TB drugs used to treat thousands of patients with false-positive results, rivals the entire Indian TB control programme annual budget.

Given the above scenario, it is evident that there is a need for advances in all three areas. But given that we already have a huge problem on hand, there is an urgent and desperate need for newer, improved diagnostic tools and drugs. And yet, industry does not seem to be responding to the problem with the urgency that it needs to. It is also a sad fact that the much needed funds for research and development in TB diagnostics and drugs are not forthcoming as TB is perceived as a poor man’s disease and therefore takes the back burner.  

There is some good news however. After decades, a promising new diagnostic tool, the Xpert has been developed, which promises accurate diagnosis.  According to the Cochrane review on Xpert MTB/RIF by Steingart and colleagues, published in January 2013, “Xpert used as an initial diagnostic test for TB detection and rifampicin resistance detection in patients suspected of having TB, MDR-TB, or HIV-associated TB is sensitive and specific. Xpert may also be valuable as an add-on test following microscopy for patients who have previously been found to be smear-negative.” 

So what prevents from this test being widely used?  The cost according to experts can be the one factor hampering wide usage of this test. There are also concerns that since the Xpert can diagnose drug resistant (DR) TB as well, India might just not be able to cope with having to treat all the new cases of MDR TB that are likely to emerge.

A back of the envelope calculation reveals it would involve tripling of the current annual budget if we have to tackle the problem of TB effectively. But considering the scale of the problem, such concerns are irrelevant. We must find solutions to the problem because a failure to do so also means failing so many people who are entitled to health.  It also has to be tackled at several levels.  The government has to come forward and commit itself to action.  Industry has to respond with much more investment in R&D for TB. 

For sure, industry must be aware of bottomlines, profitability and feasibility. But what about the people who suffer from undiagnosed or misdiagnosed TB? What about those who don’t have access to newer drugs?  What about the lost productivity to the nation because of a young productive population falling victim to an avoidable disease? 

There are giant pharma industries in the world that have made indeterminate amounts of money, developing and rolling out drugs for hypertension, diabetes and cancer. Can these companies not set aside minuscule amounts of their profits for the R&D of TB? Or is that the altruistic view of a hopeless idealist?