OVERVIEW – INDIA

TB kills nearly an Indian per minute. Despite having effective medicines to cure it since half a century!

Tuberculosis is a neglected medical field since it belongs to realms of poor. Global Health R&D is heavily tilted in favor of the diseases of the rich and there is a stark lack of research in TB:

·      The two main tools used in India today to diagnose tuberculosis are quite ancient; sputum test is 127 years old while chest X-ray, 114.

·      For prevention, newborns are given a shot of BCG vaccine – 88 years aged & fruitless.

·      5 effective anti-TB drugs, being used to treat the sick, materialized over 43 years ago.

However, using the same tools wisely, West was able to rein in TB way back in 1970s.

Then, global R&D on TB was switched off, ignoring Asia and Africa, still visibly simmering.

Hence, no new tests, vaccines or drugs since! And sadly, none, it appears, in the offing.

Era of first national TB program (1962-92): TB-control in free India has been terribly mismanaged; it is a disease of the voiceless poor. Govt. took 30 agonizing years to acknowledge – that its first national TB program launched in 1962 was a dreadful failure. Under that scheme, patients were fed cheap and less effective drugs (e.g. Thiacetazone) that took over a year to heal.

Revised National TB Control Program (DOTS): Then, around 1998, with massive international funding, the govt. embarked upon a new program, which is a paradigm shift – with 5 radical changes:

1.   Best drugs (SEHR&Z) are now used, that cure speedily – within mere 6 – 8 months.

2.   ‘Given just thrice a week, TB medicines are equally effective’ claim several studies. So now, patient takes just three doses a week (3/7), and not everyday as before. Visiting the dispensary thrice a week is so convenient; thus, ‘supervision’ becomes feasible. Besides, since overall less drugging is involved, the 3/7 regime costs half as much.

3.   Patient is closely watched – till cured. His home address is carefully recorded and verified; he remains traceable. No hospitalization; he stays at home but is required to visit a nearby clinic and swallow drugs right in front of a worker, who even goes to his house with the dose if he fails to show up!

4.   Chest X-ray stands omitted – in infectious cases.

5.   Diagnosis and follow up is by sputum smear test alone.

6.   TB specialist has been removed from the scene. ‘Trained’ MBBS doctors now run the program.

However, the new program has sparked off new controversies:

1.        Omission of Chest X-ray: The real focus of relentless human research has perpetually been on lucrative ailments; medicine is inundated with breathtaking tools to detect illnesses of the rich and mighty like obesity, hypertension and heart disease. But for TB, Indian clinicians are desperately handicapped, constrained to rely upon the same two ancient tools – sputum smear test and chest X-ray.

No doubt, sputum test is cheap and confirmatory of the presence of TB. Sighting of causative TB germs in sputum slide of a symptomatic person is a definitive proof of diagnosis while no pattern of shadows in chest X-ray is typical (and hence diagnostic) of TB. While doctors misread & disagree over interpretation of X-ray shadows, there are no such controversies in sputum test.

So, government deleted X-ray (in infectious cases) from the menu of DOTS – a sputum-based venture. Once a patient’s sputum comes positive, he is treated for 6-8 months without an X-ray. Blindly!

This is wrong, illegal & unethical. It violates basic human rights. First, man refuses to do any R&D! Then he brazenly drops one of the mere two tools at his disposal! It is like deliberately piercing one of the two eyes, claiming that one is enough. Despite some limitations, X-ray is indispensable and complimentary to sputum test. No qualified doctor, in case he himself develops infectious TB, would submit thus to blind TB treatment without first undergoing a chest X-ray.

Further, ‘spotting an X-ray shadow’ instantly electrifies the doctor to clinch the presence or absence of TB. Without an X-ray, the treating physician is virtually blindfolded. He fails to distinguish extensive from minimal lung damage in a given case. And, once patient’s sputum dries up, his follow up becomes speculative. Besides, deliberate refusal to obtain and preserve for future reference visual records of an event so vital (at times fatal) amounts to a medico-legal crime. Even otherwise, by itself, the sputum test detects only 48% of the sick; it does not detect pediatric, extra-pulmonary or smear negative TB.

Fate of such a mammoth program has been left precariously hanging from a feeble thread – at the mercy of a solitary test and its sole performer. Are govt. labs, technicians and their reporting 100% reliable?

Therefore, X-rays must be done at diagnosis (as in China) and then every 2 months of treatment. Read More !

2.        Program suffers from a unique lack of professionalism; the entire clinical operation appears somewhat non-technical. In the absence of any criteria for the selection of its key person (the district TB officer), non-experts are practically running the show. Leaving TB-expert unused means national waste. Worse, experts do not get to supervise, not even remotely, the clinical decisions of the vast army of field doctors some of whom, despite a solitary training on paper, have little motivation or aptitude for TB. TB-expert must be made to closely oversee each field doctor – like a big brother. > Read More !

3.        All key DOTS players in the field remain saddled with enormous non-TB work. They end up working part time for TB – a gloomy prospect in combating what the WHO deems ‘a global emergency’.

4.        Even though validated by certain trials, this new thrice weekly (3/7) concept is still in its infancy; it has yet to pass the ultimate test – the test of time. Till then, caution ought to be exercised. Several nations aboard WHO-operated DOTS bandwagon and even some which are supplied anti-TB drugs by Global Drug Facility, have chosen to stick to the traditional time tested daily regime. Read More !

5.        Total number of doses having been drastically slashed, each dose assumes magnified significance. Now, a patient just can’t afford to miss even a single dose, making ‘supervision’ indispensable. In other words, non-enforcement of impeccable supervision over thrice-weekly regime can prove catastrophic.

6.        The patient takes his doses on, say, Monday, Wednesday and Friday. Suppose, he duly takes his Friday dose, but somehow misses the Monday dose, and then is able to take it only on the next appointed day i.e. Wednesday. A miss thus occurs. This single ‘trivial looking’ miss is able to cause a prolonged 5-day gap – hardly compatible with cure. Therefore, this 2-day risky gap in design, kept to accommodate a weekend, must be eliminated forthwith and we must adopt five-doses-per-week regime.

7.        Since case detection relies primarily on sputum smear microscopy, the design favors the sputum positives and discriminates against the rest who, no doubt, are not spreading infection to others, but personally face equal risk. Besides, diagnosis of childhood and extra-pulmonary TB is a highly complex process. DOTS pipeline, with its hastily trained plain MBBS doctors, unsupervised by experts, poses a risky option for kids as also for HIV +ve, pregnant, diabetic or MDR probables. Read More !

8.        An American TB patient is diagnosed as per a superior protocol. State of the art ‘Sputum Culture and Sensitivity Test for AFB’ (no doubt, unaffordable, unrealistic and impossible in India) is the cornerstone. Specialists’ opinion is available at the click of a mouse. What to talk of chest X-ray, every test that WHO guidelines prohibit Indian doctors from conducting on innocent citizens can be and are often done there – if needed PCR, Eliza, Ultrasound, CT scan, MRI, Bactec, DNA finger printing. Daily dose or five doses per week is preferred at least during the initial intensive phase and supervision is executed to near perfection. Patients and health workers receive plentiful incentives. Read More !

9.        The Indian design is hardly futuristic; it has not been appropriately adapted to the booming economy and fast growing capacity of India. One is compelled to construe that a colossal program worth millions of dollars involving landmark deviation from past, deciding the fate of ailing millions was conceived, funded and clinched between 1992 and 1997 by a handful of government officials unilaterally, without an exhaustive nation-wide debate befitting a change of such magnitude and without garnering a semblance of consensus amongst the Indian medical fraternity. Is this democracy?Read More !

10.      Failure of the government for a decade (1997 – 2007) to stitch up an optimal merger with nation’s colossal private sector, which caters to over half the caseload of TB, is a predictable outcome of its autocratic functioning. Having failed to enroll qualified private practitioners, it is recklessly inducting quacks, giving tacit approval to quackery in India. Read More !

11.      While RNTCP consultants routinely waste lakhs on 5-star conferences, all that a patient gets is medicines for six months worth about Rs. 300 (Rupees three hundred only). For diagnosis, consumables spent in sputum test cost peanuts. He receives no incentives – nor does the health worker. Read More !

12.      To silence criticism, the government is projecting superior results obtained in a group of easy-to-cure patients (Cat I) as cure rates of the program per se, as if those were obtainable in all segments of patients, a dishonest practice. Hasn’t govt.’s health data often proved false and misleading in the past? Read More !