Indian Healthcare's New Mistake/Folly

A flawed last-ditch attempt to 'eliminate' TB?

A few weeks back the good folks in the email community of the Medico-Friend Circle began discussing the Indian Ministry of Health’s new BCG vaccination ‘program’. Intriguingly, this time BCG was being given not to infants as it’s usually done, but to adults. Though this ‘program’ — which in reality is a research study or trial — began in early 2024, many public health experts in the country have been in the dark about its details, and about the rationale behind the study. Sitting thousands of kilometers away in the US, I was able to parse the internet for some clues as to how this began, and wrote a Twitter thread based on the materials I gleaned. What follows is a reproduction of that thread, and the link to a Google Drive folder in which I uploaded those materials, including importantly a Ministry-authored document detailing the logistics of this study.

Image courtesy UNICEF

TB & BCG: Old Serum in New Vials

The Union govt & ICMR are conducting a massive research study/trial - 'Adult BCG Vaccination under programmatic implementation' - in which a section of Ind's adult population will get the BCG vaccine, & another section will be the 'control'.

This study/trial began in January this year and has been picking momentum in recent weeks in many states, even though there is no strong evidence that such "revaccination" of adults with BCG will have substantially positive public health effects.

Many experts have been expressing caution and/or consternation at what prima facie looks like an ill-conceived research trial, misleadingly being called a public health 'programme', with little to no field-wide consultation and deliberation.

Vaccination in general provides massive public benefits, and even BCG vaccination provides some protection in infants and children. However, its usefulness in adolescents & adults is minimal at best, & being a live vaccine, it needs to be approached with much caution.

Merck, a major manufacturer of BCG, itself has this to say: "the efficacy of BCG against TB remains controversial. Prospective efficacy trials have shown that the protective benefit of BCG against clinical TB was variable, ranging from 0–80%."

A more recent study published in the Lancet Global Health concluded that the "overall effectiveness of BCG vaccination against all tuberculosis was [a very low] 18%."

In short, it appears that the Union govt & ICMR, realizing that the Indian state will be unable to make true its grand pronouncements of "eliminating" TB by 2025, have put all their final eggs in the BCG basket, despite that basket being riddled with gaping holes.

This is the main document from the Ministry of Health, that lays out the (weak) rationale for this study and explains the study design and other logistical aspects. We need an intense scrutiny of this from PH experts. https://drive.google.com/file/d/1wSpIFtBZ-tpJEXC7kstEfL9nsWogscmQ/view

A quick glance shows that the study's success is going to be determined by using an unconventional primary outcome measure: instead of going back to the vaccinated individuals, govt's going to rely on entries in a digital portal & evaluate formally notified TB cases

There is a lot to be said about the scientific & epidemiological rationale of this, besides the disturbing fact that such a major study will be depending upon the vagaries of the contemporary Indian state's notoriously variable, unreliable & tamper-prone digital infrastructure

For those interested in understanding what rationale the govt and its health/medical bureaucracy are providing for conducting this study, the above document devotes a mere two pages (Chapter 2) to it.

Slightly more detailed analyses can be found in some of the articles of the Feb-March 2023 issue of the Indian Journal of Medical Research, published by ICMR: https://www.ncbi.nlm.nih.gov/pmc/issues/439886/

It seems that these IJMR articles provide the core medical-scientific underpinning to this study. Again, these deserve intense scrutiny from experts, esp this one which seems to be relied on most heavily:

Even if one were to accept the conclusions of these articles at face value, none of their arguments warrants, or even suggests, a full-fledged massive BCG vaccination program spanning 23 states and thousands of people (what we are currently seeing).

This report, from March 2024, rightly indicates that the adult TB vaccination 'programme' is actually a study/trial, and hence the participants are to be 'volunteers'. (The 'hunt on' part of it, of course, is a sad reflection on the way health studies r conducted in our country.)

Volunteering for such a study means that folks are told that this is a study (and not a free govt vaccination programme), that they are provided all the relevant information, & that they THEN voluntarily agree to be administered BCG.

However, as this @Nivarana4India comic shows, govt authorities are saying one thing on paper, even as on the ground things are completely different.

To go back to the above ToI report, here's a baffling quote from it: "A total of 20% of state’s population would be selected as volunteers". That is, the govt and its agents will use all their resources & power to 'select' you but you must convince yourself that you 'volunteered'

At this point let me introduce historian Niels Brimnes and his deeply detailed study of TB control programs in 20th century India: "Languished Hopes: Tuberculosis, the State, and International Assistance in Twentieth-century India."

This is a great book but like some great books, it is not as well-known, and there don't seem to be a lot of copies of it around. Brimnes, after studying this history of the Indian state's TB programs over the decades, had this to say:

Moving beyond the contention that India failed to control TB because it was a poor developing country, the analysis presented here identifies a number of more specific misguided priorities. The modern historian can only be surprised by the prolonged faith in the BCG vaccine. The fact that it took more than 20 years from when BCG was applied on a mass scale until a major trial was conducted in a 'third world' setting is certainly one of the darker chapters in the history of post-war international health. Too much confidence in abstract social planning in post-colonial India did little to help control tuberculosis. There was a clear gap between the nicely drafted and scientifically based plans of the National TB Institute (NTI) and the realities on the ground. One interesting fault-line ran between WHO and UNICEF. First, the two UN organisations disagreed on how to employ BCG. Despite conflicting scientific evidence of the value of BCG, the vaccine was unequivocally promoted by the Scandinavians in ITC and by UNICEF, while WHO only reluctantly followed suit. As ITC prepared to withdraw from India, the tension emerged again: WHO wanted to integrate BCG in a broader control scheme, while UNICEF opted for pure mass vaccination. In both cases, the vertical approach of UNICEF prevailed over WHO's more horizontal perspective.

Since there seems to be little public awareness about this development, here are some resources for people interested in exploring this development further: https://drive.google.com/drive/folders/11YtWQNqhHqQojEiweY7rSLQB9dOoWuJg?usp=drive_link

Finally, in any discussion of TB and state/bureaucratic efforts to ‘control’ it, it is always imp to remember that these efforts have never taken seriously the issues of inequality, marginalization, & political solutions. Many public health experts, for decades if not longer, have been insisting that ‘technological solutions’ (like drugs and vaccines) will always have a limited impact on tuberculosis if the general social conditions continue to remain unequal and dire. Today, yet again, that basic TB fact, explained in more detail in this 2016 article, needs reiteration.