- Tuberculosis is a major public health problem in India, with India accounting for 25% of global TB cases. The thrice-weekly dosing protocol used in India's TB program is ineffective and promotes high relapse and drug resistance rates. A review of over 50,000 patient records from a government hospital found that over 6,500 patients had been registered for TB treatment more than once, indicating relapse. The author filed a public interest litigation in the Supreme Court of India arguing for a switch to daily drug dosing, which was implemented nationwide in 2017 and will benefit millions of patients.
1. TB: A HUGE PROBLEM
• Kills 2 Indians in 3 minutes.
• Maximum cases in the world.
• 25% of global burden.
• In 2 days, India generates more cases than entire
USA in a year.
• Drug resistance is rising.
Many countries controlled TB.
INDIA FAILED.
2. TB IS A DISEASE OF POOR PEOPLE
• Poor diet, Low immunity.
• 90% Global R&D in science is for the rich.
Little research in TB:
• Sputum test (1882) – 135 years old.
• BCG vaccine (1921) – 96 years old.
• 5 Primary TB Drugs (1944 - 66): NO NEW drug
since 50 years.
• Man is busy with angioplasty, CT Scan, MRI,
BEAUTY CREAMS, hair for bald, VIAGRA.
3. Mission of my life: TB Eradication
• Movie: https://www.youtube.com/watch?v=W1mzieNJe4c. 1999
• Book: http://tbfreeworld.org/get-book-a-death-every-minute-by-dr-raman-kakar/ (Hindi,
English, Tamil) 2000.
• Book: The Test of Time (265-page critique of India’s Revised TB Program) 2005.
• Petition in Delhi High Court 2007 (WP )
• Website www.tbfreeworld.org (2009)
• Quit private-practice to join Government’s TB Program (2010); a watchdog of national policy.
• Radio programs.
https://www.facebook.com/RadioManavRachna1078fm/posts/444796842290079
• Edited and published 7 Hindi Books for patients, families, health-workers (on my website).
• Letter Published in BMJ: https://www.bmj.com/content/348/bmj.g2514/rr/763999
• Oration of my research in world conference in South Africa: http://tbfreeworld.org/world-
conference-dr-raman-kakars-lecture-oral-presentation-of-abstract-re-recorded-unofficially/
• Published research:
http://www.davidpublisher.org/index.php/Home/Article/index?id=25164.html
• Petition in Supreme Court. https://indianexpress.com/article/india/india-news-india/doctors-
tenacity-nudges-government-to-overhaul-tb-programme-tuberculosis-4388704/
• Editorial in a journal: http://tbfreeworld.org/wp-content/uploads/2017/05/Editorial-in-
Journal.pdf
4. 1ST NATIONAL TB PROGRAM
• 1962 - 1992. FAILED.
• Ancient STH regimen, healed in over a year.
As per Govt. POLICY, Indians deprived of
modern powerful drugs (RIF,ETH,PZD).
India 30 years behind the World.
5. RNTCP (DOTS) 1997
• SEHRZ (newer drugs included).
• But adopted Low-cost “THRICE WEEKLY DOSE PROTOCOL”:
(Patient takes doses on Monday, Wednesday, Friday only).
• Everyone surprised but Govt. of India, backed by WHO,
invested Billions.
• Sputum based (Sp+ report confirms TB).
• Decentralized – dose at patient’s door step.
• 19 column registers – Name, Address, Phone No. Onus
shifted.
• Patient-wise Boxes.
• Directly Observed (60% compliance failure).
6. DAILY DOSE HAD PASSED TEST OF TIME
• Since discovery, 5 DRUGS given in DAILY dose
worked wonders - MIRACLE.
• Thrice weekly experiment: Most doctors
NOT CONVINCED.
• 20 High TB Burden Countries rejected it,
continue DAILY dose.
• India, China exceptions.
7. District Govt. Hosp. - TB OPD
IDEAL TB HUB to find Truth of DOTS (2010-2018) 9 YEARS
Aim: TO FIND A PATIENT WHO DID NOT GET
LONG-LASTING RECOVERY WITH A SINGLE
COURSE OF THRICE-WEEKLY DOTS, LATER … RE-
REGISTERED ….for a 2nd innings
Govt. allocated 2 Unique ID’s… Tracked …… VERIFIABLE Report
8. 2 METHODS of Data Collection
1. RETROSPECTIVE RECORD REVIEW of Hand-written
Registers:
• Motivated workers (USP).
• Duration : 18 years (from 1st April 2000 to till date)
• Original writer (local worker) joined in…. CREDIBLE Results
2. CLINICAL AUDIT ongoing in TB OPD
• 1 Recurrence case per day (Average), Observer Controlled.
• Half come in from Delhi Institutes
9. RESULTS
No. of Registered Patients whose
LONG-TERM OUTCOME
(Fate) could be Scrutinized
Roughly over
50,000
Patients found REGISTERED TWICE
or Thrice or 4/5/6/7 times etc.
6,541
Multi-drug-resistant cases Roughly 560
DEATHS 1,987
DEFAULT 2,630 (quit
recording in 2015)
10. DOTS ERA: Out of 15 million registered
2 million took 2 or more cycles of therapy.
Streptomycin Inj. Given to Retreatment case :
INDIA 24 ( 3 Per Week x 8 Weeks)
NEPAL 60 ( 1 Per Day x 2 Months)
11. Is THRICE-WEEKLY as good as DAILY ?
• COCHRANE Review:
INSUFFICIENT EVIDENCE
• Review in THORAX - Favors Daily Dose
• Systematic Review in BMJ – Lack of research
on DOTS programs, in general.
• India-specific Review by GS Azhar
• 10% RELAPSE in INDIA
12. CONCLUSION
• Under India’s Routine Program Conditions,
Thrice-weekly Regimen is INEFFECTIVE.
• RE-REGISTRATION IS HIGH; promotes drug-
resistance on an INDUSTRIAL SCALE, a global
threat!
Hence, we should switch over to Daily Dose
13. PIL FILED IN SUPREME COURT
WP(C) No. 604 of 2016
• Registrar pointed out 32 DEFFECTS in 504 page petition: I Rectified.
• SC FUNCTIONS LIKE INDIAN ARMY : Meticulous, Dependable,
Lightening speed.
• I argued myself; no Advocates; I spent NO MONEY, except
stationery.
• Order (23.1.17): Implement Daily Regimen soon.
• November 2017: Daily dose implemented across India, benefiting
millions.