Stephen Lewis — TB in India: Rhetoric vs. Reality

Statement by AIDS-Free World Co-Director Stephen Lewis upon returning from an October fact-finding trip to Mumbai and Delhi to assess tuberculosis in India.

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Toronto, October 27, 2017—I recently completed an extensive tuberculosis fact-finding tour to India. My AIDS-Free World colleague Georgia White and I spent three days in Mumbai and four days in Delhi. They were, as might be imagined, days of dawn-to-dusk activity and of great intensity. We visited hospitals and clinics and dedicated TB centres; we visited private-sector facilities and dispensaries; we met with city government officials and senior bureaucrats with the Ministry of Health; we met with doctors and lawyers involved in recent dramatic court cases. We met with the World Health Organization (WHO), USAID, the Clinton Health Access Initiative (CHAI), Gates, and Médecins Sans Frontières (MSF) [in both Mumbai and Delhi]. Above all, we met with TB patients and survivors. I don’t pretend that we more than scratched the surface, but I feel pretty confident about what we gleaned.

The visit was greatly assisted, in its organization, by the US Centers for Disease Control and Prevention (CDC). Senior staff of the CDC, from both Atlanta and India, accompanied us and included various of their own projects in the visits we made. However, the opinions expressed in this statement are mine alone … the CDC escapes implication in any way.

Allow me at the outset to make what I think is a relevant point: I’m not new to these exploratory field trips. For five and a half years, from 2001 through 2006, as the UN’s Special Envoy on HIV and AIDS in Africa, I travelled through some 16 high-prevalence countries doing very much what I’ve done in India. You learn, in the process, what it is that induces trust and what induces skepticism. You learn to measure words, slogans, statistics, and claims of success very carefully. You learn that critics of palpable integrity and NGOs with grassroots knowledge tend to be much more reliable than governments. Thus, for example, the Treatment Action Campaign in South Africa had a much closer affection for truth than did the Government of South Africa.

In my opinion, the same proves true of India.

Some of the things I want to say in this statement are not easily said. I recognize that there are many, in India and outside, who feel that India has dramatically turned the corner on TB. In the minds of the India protagonists, the evidence abounds: the government is calling for the elimination of TB by 2025; there is a new National Strategic Plan, with ambitious ideas endorsed by the government, that runs from 2017 to 2025; the financial resources through that period are to be doubled; GeneXpert, the excellent diagnostic tool, is being rolled out across the country; the two new drugs, bedaquiline and delamanid, are also scheduled for broader rollout; first- and second-line drug susceptibility testing (DST) are in use or on the agenda; patients with TB are tested for HIV, and patients with HIV are tested for TB; the government is moving from intermittent therapy to fixed-dose combinations on a daily basis; the private sector is to be engaged; above all, the Prime Minister has added his voice to the crescendo of endorsement.

I want, with all my heart, to believe that this picture of achievement is real. But I am seized by incredulity. There are too many factors that give me pause. Let me lay them out.

First, the health sector in India has been starved for resources for 20 years. This pulverizing under-investment compromises every effort to come to grips with tuberculosis. The health systems are so fragile, so overburdened, that it’s simply not going to be possible to subdue TB in the way the government pretends. Last year, health received 1.15% of GDP; by 2025 it will rise to a pathetic 2.5%… that’s still nowhere near enough to turn the tide. It will require an investment of 6% to 7% annually to achieve what has been promised.

Not enough attention is paid to that simple economic reality. It’s as though endlessly repeating the mantra of good intentions is enough. It’s not. You can’t embrace success when the foundations of the public health system are perilously frayed by neglect … 1% a year for 20 years is a gross rebuke to the health of the nation.

If we were to put this in the context of the Sustainable Development Goals, it would quickly be recognized that the goal of eliminating TB by 2025 is aspirational mythology. During our trip, we barely heard reference to latent TB, although a third of the population has it, and it could, with hallucinatory implications, lead to active TB. The social determinants of health lie in tatters: homelessness, overcrowding, poor nutrition, food insecurity, and excruciating poverty, taken together, constitute a death knell for public health.

Second, and talking of good intentions, we noticed something most unsettling during the trip. Time and time again, various officials and administrators associated with the health system reeled off the elements of government policy—2025 as a target date, lots of money, GeneXpert rollout, DSTs for second-line drugs, etc., etc.—without once suggesting that there might be an obstacle, a challenge, a difficulty. It was almost a parody of practiced public relations. One senior health official even used the phrase, “Everything is perfect.”

But two things were invariably missing: a sense of urgency and any reference to the people living with tuberculosis.

Now for some, that may not matter. For me, it’s absolutely telltale. India faces a tuberculosis crisis of monumental proportions. As is well known, India accounts for 27% of the new cases—some 2.8 million—and 29% of the deaths—some 900,000—worldwide. It’s a plague that haunts the nation. It defies credulity that people can speak dispassionately, entirely without emotion about grievous matters of morbidity and mortality. It was as if everything was taken for granted: the design was in place and the implementation is therefore preordained. I’ve seen that pattern before with HIV; it’s absolutely fatal when the urgency is absent.

Equally stunning was the short shrift paid to survivors or people living with TB. The obsession with statistical data, of every kind, left tuberculosis without a human face. Patients become numbers.

I had that feeling indelibly etched in my mind when watching hospitalized children, with or without TB. We visited the vast, teeming public paediatric hospital in Delhi, where toddlers were lying three and four to a bed. Dr. Singh, the lead doctor, was explaining to us that there was no way to isolate children with TB, nor was there focused paediatric care for children in specialized MDR-TB settings. And, in a fashion reminiscent of the earliest treatment for children with HIV, they’re breaking pills for adults into small fragments, hoping for successful treatment of childhood TB. The need for new drugs for children could not be more compelling, and there is, in fact, a new formulation, developed by TB Alliance, that should now be destined for every hospital in India.

Third, the way things seem to work is embodied in the case of a girl of 18 who had to go to court to receive bedaquiline. Shreya’s story is a history of misdiagnosis, of resistance to first-line drugs, of rejection by state practitioners, and, throughout adolescence, years of agony living with MDR and XDR-TB as she attempted to survive. The story of her medical saga speaks volumes.

What happened to Shreya should strike a cautionary note in all those who think that the government should now be trusted. The case is not as complicated as it’s made to seem. Simply put, Shreya, in order to survive, needed bedaquiline. The national TB program, for reasons that the High Court found implausible, refused to supply the drug. It took the intervention of the Lawyers Collective, led by Anand Grover, to file a lawsuit and win the case. According to Grover, with whom we spent a good deal of time, the pivotal element in the case was the filing in court of a submission from Dr. Jennifer Furin of Harvard Medical School. With consummate academic and scientific credentials, she argued the case for bedaquiline, irrefutably countering the position put forth by the government. Because of our trip to India, I read the brief from Jennifer Furin … it should be mandatory reading for everyone concerned with the fate of tuberculosis in India.

Dr. Furin, in restrained, analytic medical prose, shows that bedaquiline (which, after all, was given conditional approval by WHO in 2012), was entirely appropriate and necessary for Shreya. There were data at hand, based on treating MDR in some 6,000 patients globally, indicating that it was clearly the right treatment for Shreya, who by then had XDR-TB. Depending on the jurisdiction, success rates ranged from 71% to 100%!

The court was clearly impressed by Dr. Furin, as referenced by Anand Grover, and was clearly unimpressed by the counter-arguments of the government. As a result, Shreya went on bedaquiline, and the government was ordered to rollout the drug to some 70 sites from a current total of six. This latter is particularly instructive and sobering. For those who heap plaudits on the government for the promise of widely distributing bedaquiline, it must be pointed out that it wasn’t the government’s choice. It was a judicial order (in fact, the court went even further: it also directed the government to provide Shreya with delamanid, which was made available by MSF). Some will say that the National Strategic Plan itself speaks of expanding bedaquiline to 140 sites, but the difference between a planning document and a court order is patently clear.

Permit me a footnote. Shreya is a remarkable young woman. As is now known, she and her father actually read about bedaquiline in a newspaper article and decided to demand it. Their extraordinary determination to take on the obdurate Government of India, and to prevail, is a stunning tale of courage and tenacity. Shreya was at death’s door, obstructed by a handful of medical oligarchs who used every imaginable ploy to deny treatment, and she never gave up.

But there’s more to the story. The doctor who treated Shreya and kept her alive is Dr. Zarir Udwadia. It is legitimate to say that he has done more in the fight against TB than the entire legions of the government apparatus. It was Dr. Udwadia’s famous Clinical Infectious Diseases article in 2012, arguing that India was facing totally drug-resistant TB, that spawned the government’s recognition that MDR-TB was an emergency. It was partial and begrudging, but the country was shocked by Udwadia’s revelations, and it was necessary that there at least be acknowledgement of a crisis. Dr. Udwadia’s entire practice is focused on MDR and XDR-TB. Whereas drug-susceptible TB is addressed to some extent across the country, drug-resistant TB is out of control. It is the greatest single challenge in the TB world in India, and it has escalated wantonly, thanks to a government mired in inertia and indifference.

Behind the scenes, in government circles, Dr. Udwadia was reviled. But he rejected both intimidation and silence. His determined advocacy reached a recent zenith when he emerged as Shreya’s doctor. Where the government physicians had refused treatment with bedaquiline, Dr. Udwadia stepped in. It’s gratifying to report that Shreya converted just last month: there is no current sign of TB. It is, however, incomparably sad to report that her lungs are so compromised that survival will be a constant struggle. It should never have come to that for Shreya: she stands as a medical billboard for the failures of the Indian health system in addressing tuberculosis.

Should I have put that in the past tense? Have things really turned around? Allow me a highly subjective comment. When I raised Udwadia’s name in conversation with very senior officials of the Ministry of Health, in two different hospital settings, the reaction ranged from derisive smirks to dismissive contempt. I’m not elevating Dr. Udwadia to sainthood, but he deserves far better. It’s absolutely an indication of how smugly cavalier some government officials can be. And it does not augur well for the seriousness with which tuberculosis must be taken. It’s rather like being told—as I was—triumphantly, that India was now rolling out daily treatment regimens, but of course there was no admission that the critical change in direction came from the courts not the government.

The issues to be faced are truly daunting. MDR-TB is an implacable foe, but as of Tuesday, October 10, 2017, according to what we were told by WHO, 728 people in all of India were receiving bedaquiline. Yet those afflicted with MDR-TB, in 2015, were estimated to number 130,000 (the numbers may change marginally when WHO’s latest figures are published on October 30). MDR-TB is the Dante’s Inferno of India. Clinics are overwhelmed. Granted, not absolutely everyone with MDR-TB requires bedaquiline, but for those who do, there is still no sense of emergency that matches the exigency. Everything moves at a tortoise’s pace.

Fourth, complicating all of it is the private sector. Despite the costs associated with private medicine, anywhere between 60% and 80% of India’s population turns first to the private sector for health care. This may sound surprising, but there’s a certain logic to it. The public health care system has been so battered by neglect that an entire massive alternative apparatus has emerged.

The government exercises negligible regulatory control and, so far as we were able to ascertain, doesn’t really understand how the private sector works. This is especially true when it comes to tuberculosis and poses a major problem for the government: How do you deal with a galloping infectious disease in two separate compartments that want little to do with each other?

The fact is that you hardly deal with it at all. It will be a herculean task to integrate TB control in the private sector with the public sector. Admittedly, there are admirable efforts underway. The Global Fund, PATH, FIND, and CHAI are about to launch—assuming Global Fund approval—a major initiative to inform and galvanize the private sector. PATH is the genesis of the initiative, called the Public Private Interface Model, and it has a strong rationale: persuade the private sector to notify the public sector of all TB cases and encourage the private sector to do so by guaranteeing free diagnostic and treatment services in every instance.

However, it’s really a microscopic drop in the ocean of need. There was one particularly telling moment when we visited a nursing home where the PATH model had been introduced.  The very impressive head of PATH told us, with great animation, of the vast new integrated working relationship with the private sector. Then we asked the attending private-sector doctor for his views; there poured forth a veritable storm of complaints: too many patients, no drugs, costs (including transportation and doctor’s fees) impossible for patients to afford, poor follow-up, minimal counselling, endless waits, family disruption, rampant stigma, extreme illness, ignorance amongst the clinicians … it was a litany of vociferous despair.

Much of what we heard of the private sector, especially in the slums of Mumbai and the vast rural hinterland, mirrored that description. Almost everyone we visited characterized the private sector the most difficult dimension to deal with. But apart from good intentions, and as we’ve noted, the occasional intervention, there’s very little to give confidence that the gap will be bridged. I must emphasize: this is no small matter. If the private sector is not successfully reformed, TB, and especially MDR-TB, will remain a nemesis forever.

It was interesting that the most encouraging note I heard about the private sector came from Dr. Soumya Swaminathan, who has just been appointed Deputy-Director General of the WHO. She said that in Chennai there has been established a TB centre of excellence exclusively for, and staffed by, the private sector. Apparently, there’s a vigorous campaign afoot to demonstrate that the private sector can be mobilized to respond to tuberculosis. Dr. Swaminathan wasn’t sanguine by any means … she, too, considers the private sector the Achilles heel of public policy, but she held out a glimmer of hope for the centre of excellence as a potential model in other parts of the country.

Finally, in this cursory overview of mine, there’s yet another truly critical aspect of the tuberculosis scourge … an aspect in search of a model. In almost every meeting—particularly with MSF and with Dr. Daksha Shah, the Municipal TB Officer for Mumbai—whenever treatment was discussed, there was a plea for counsellors. 

Rather like people living with HIV, the need for a counsellor through the anxious, dispiriting, often agonizing TB regimens, is crucial to holding body, soul, spirits and adherence together.

The patients and survivors with whom we met were beset with difficulty. Collectively, they had stories of misdiagnosis; interrupted treatment because of excruciating side effects; family disruption; astronomic costs; stigma, discrimination, and rejection; interrupted education; inability to find or hold a job … generally life as a bewildering miasma of pain and confusion. This was particularly true of three young people we met, currently being treated—with apparent success—with bedaquiline and delamanid, courtesy of MSF. They couldn’t have been more than in their early 20s; each of them had gone through the turbulence of traditional treatment, and each of them deeply relied on counselling. But counsellors are in short supply.

For example, in Mumbai we learned that there were 44 counsellors in total, jointly financed by the CDC and SHARE India, but there was urgent need for another 11. There was no guarantee that they could be found or funded. At MSF in Mumbai, we heard a remarkably eloquent affirmation of the role of counsellors, placing them in the highest category of need and priority. It was clear that when dealing with MDR-TB, a one-on-one relationship is invaluable, and any counsellor should have no more than a handful of ‘clients.’ Juxtapose that with what we heard from hospitals where counsellors could have up to 200. It’s just preposterous. But it also posits inevitable skepticism behind the so-called determination to eliminate tuberculosis.

That’s the conundrum that I readily admit suffuses this overall statement. There is no question that the new rhetoric around TB portends progress. It’s encouraging to see signs of movement in the high political domain. It’s equally encouraging to see signs of progress on the ground, accentuated by the number of external agencies and organizations who offer help. However, the entire history, past and present, of the way tuberculosis—MDR and XDR above all—is treated in India gives me significant pause. My colleague and I left India feeling that it was far too early to shower accolades on the government. Nothing in the last several years gives cause for confidence that the reality will match the rhetoric.

I realize that there are many in the TB universe who feel that this is the time for currying favour, for telling the Indian government what a good job it’s doing, for choking back criticism and lavishing praise. With greatest respect, I disagree. This is the time to pounce on every stitch of evidence that suggests delinquency; this is the time to give the government no opportunity whatsoever to renege on its own pronouncements. This is the time to name and shame. In fact, what better time with the imminent conference on TB in Moscow and the High-Level UN meeting on TB in New York next year? The government of India will want to be seen in a virtuous light.

There are huge numbers of lives at stake. Shreya showed how perilous a life can be. Until those lives are no longer viewed as expendable, it’s impossible to be confident about the future.

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Stephen Lewis co-directs AIDS-Free World, an international advocacy organization that works to tackle the root . He is the former UN Special Envoy for HIV/AIDS in Africa and former Canadian Ambassador to the United Nations. 

(Photo: © AIDS-Free World)