OTHER CONTROVERSIES OF RNTCP NEEDING RESOLUTION:
Apart from the controversies involving the drastic changes as discussed above, some other controversial features of lesser magnitude that need to be revisited and resolved are:
1. If someone is given drugs (he is already resistant to) plus one new drug, we encourage the germ to become resistant to the newly added drug. Hence we never add a single drug to a failing regime – precisely what is being practiced under this new program. Failure in Category I means transfer on to Category II, which is nothing but addition of simply one more drug.
2. Few trials have been done in the arena of extra-pulmonary TB; the guidelines of RNTCP are thus arbitrary and unscientific. Surgeons, who end up dealing with bulk of extra-pulmonary TB cases, are often skeptic of thrice-weekly regime in the first place. To them, category III regime appears too little and duration of 6 months too short, especially in gland, brain and intestinal TB etc. Orthopedic surgeons, unconvinced with DOTS, often prefer to treat bone TB for a year. Worse, some of them fear that the brief, inadequate exposure to category III medicines, rather than curing, might be fostering drug resistance instead. Till R&D resolves the issues, must we not give the benefit of doubt to the patient – by erring, if at all, on the higher (and safer) side – by giving cat I in extra-pulmonary cases as well and prolonging the Continuation Phase?
3. Follow up of extra-pulmonary TB patients is done by periodic sputum testing, with no utility at all. This must be corrected and made more scientific.
4. Dosage of an allopathic medicine is proportional to patient’s weight. Lower dose often fails to cure, fosters resistance; the risk escalates further in case of an intermittent regime.
· However, the same ready-made cocktail of drugs in fixed dosage is uniformly fed to wide range of patients – whether the weight is 35 or 50 or 59 kilograms. No doubt, average weight of a poor sick Indian could be 35 to 50 Kg; originally, the strips had probably been finalized accordingly. But as taller, heftier, more affluent and diabetic individuals enter the speedily expanding program; the dose becomes more and more deficient.
· A 50 to 59 kg patient deserves extra doses.
· Under DOTS, a patient who weighs over 60 kg indeed gets 150 mg of Rifampicin extra – a miserly provision. What about extra dose of other medicines?
· Patients weighing over 50 kg are thus starkly vulnerable to treatment failure and development of resistance.
· Further, in Indian field conditions, who bothers to record weight anyway?
· A study* (17) found only 15% cards had a single weight entry; weighing machine was often missing from clinics.
5. Intensive phase in Cat II lasts for 3 months. But curiously, injection SM is terminated after 2 months (after mere 24 shots) arbitrarily without a sputum test – yet another sadistic cost-cutting measure. SM must be given for all 3 months since this category includes the toughest cases. In a case, where sputum refuses to turn negative even after 3 months and IP is further extended, SM should be continued in to 4th month as well.
6. When a Cat I patient remains sputum positive at 2 months, IP with 4 drugs (EHRZ) is continued for the 3rd month. Thereafter, irrespective of sputum status, he is given 2 drugs (CP). If he continues to remain sputum positive even after 5 months, he is declared ‘failure’. Under RNTCP, since no culture is done to ascertain whether the AFB detected in his sputum tests is dead or alive, IP with all 4 drugs ought to be continued for 5 months till the patient is declared a failure.
7. In order to detect ‘failure’ early and to be able to take remedial action promptly, all Cat II sputum positive patients ought to be screened, wherever possible, by sputum culture & sensitivity testing as well as chest X-rays.
8. Some of the pioneer trials (validating intermittence) consisted of, along with oral drugs, an injection as well. Unable to prick himself, the patient had to regularly approach the worker – enhancing levels of interaction, supervision and compliance – thus bringing out superior results than if purely oral regimes had been employed as in patients in Cat I and Cat III of DOTS.
9. Some trials date back to 1960s when initial drug resistance levels might have been lower than today since drugs have since been long misused. Besides, same 3 regimes are uniformly applied all over India, disregarding local resistance patterns, which are unclear since routine sputum culture and sensitivity is neither feasible nor done; different studies have thrown up confusing, widely variable figures. Four drugs are recommended where initial resistance to Isonex is considerably high as is probably the case in India. So, no Indian should be treated with 3 drugs – precisely what is being done in category III.
10. It is possible that in some unspecified regions in India, the initial drug resistance to the drug, Isoniazide (H), may be considerably high. At such places, doesn’t the continuation phase (CP) with HR become practically mono-therapy that may foster resistance to Rifamycin (R)? Notably, the Chinese treatment regime differs during the CP when 3 drugs are given (instead of 2 as in India). Chinese Regime for new sputum smear positive cases is 2 H3R3Z3E3 / 4 H3R3E3.
11. Many patients though recorded as fresh cases, have had some prior exposure to anti-TB medicines, which are easily available with quacks, chemists and pharmacists. Self-medication too is not uncommon. All this affects the outcome negatively, especially in patients allotted the soft category, namely Cat III.
12. In non-DOTS, in view of high initial resistance levels prevailing in India, only 1 category namely schedule I (2SHE / 10HE) should be retained; the other -schedule II (12HE) – ought to be done away with.
13. Most of the Indian trials validating the principles of DOTS had been conducted mainly at NTI Bangalore and TRC Chennai – mainly in ‘institutional setting’. Large-scale operational trials in actual field conditions were not duly conducted prior to embarking on the pilot projects.