Indians don’t deserve to be dying of a disease that has been treatable since 1948

Public health policies in India are guided by recommendations made by the World Health Organisation and other international agencies such as the Bill and Melinda Gates Foundation. But do these policies always work?

A paper published recently in the June issue of the Health and Human Rights Journal spoke of WHO's “double standards” for recommending unsound medical treatment advice for low-income countries citing cost considerations.

Scroll.in spoke to one of the authors, Dr Salmaan Keshavjee, associate professor of social medicine and global health at Harvard Medical School, who spoke about the importance of India tailor-making tuberculosis policies for the country based on sound evidence. Between the years 2007 and 2010, Keshavjee served as chair of the WHO’s Green Light Committee Initiative, helping countries fight multi-drug tuberculosis.

What is the kind of evidence that the WHO has ignored while recommending treatment protocols for the poor countries?
TB has been treatable since 1948. The idea that you have to treat people quickly, so as to not spread the disease was known well in 1950s and '60s. And we knew that despite using multiple drugs for our treatment, drug resistance would emerge. This is the phenomenon seen with the use of any drug.From the very early days we knew that drug resistance would emerge during treatment.

As much as stopping the TB epidemic was a driver of science, the policy response for poorer countries has been marked by a willingness to ignore science. For example, in the 1950s, even even when it was known we need to give two or three drugs to avert getting drug resistance, the WHO advocated for giving isoniazid monotherapy to patients, leading to newer cases of preventable drug resistance.

In the early 2000s, the WHO recommended something called Category II, which added a drug to the already failed Category I regimen (first line treatment for TB). If you do that, it leads to what we call amplification of resistance. You may have been resistant to one or two drugs but then you become resistant to three or four drugs.

We also do not follow a lot of protocols followed by the Western countries. Like, say, active case finding (where health workers go looking for TB cases) or treating patients with latent TB (when the person is exposed to the infection, but does not have the disease).
Before we had medicines, we knew we needed to look for contacts and the idea of active case finding. Especially in the '50s and '60s. In the 1960s, there was a very large clinical trial conducted by the United States’ Center for Disease Control by George Comstock. This formed the basis for treatment of what people at the time called “latent TB.” We now know that 10% of people with so-called latent TB end up getting the active disease and that people who are treated with chemoprophylaxis had a lower risk of getting TB and dying of TB. This risk reduction went up to 20 years after treatment. So, without a shadow of doubt, we knew that giving chemoprophylaxis was really, really important.

But in 1974, the WHO recommended that chemoprophylaxis should not be done in low-resource countries, because of concerns over cost and capacity. Even though this was what constituted good epidemic control at the time. But the bottom line is that there were a double standard in advice emanating from the WHO to people living in poor countries.

I think the Indian programme followed the advice they received by the WHO. So, only children and people with HIV with latent TB are given the prophylactic treatment. But really, you should be providing post-exposure prophylaxis to the entire household of a TB patient. Only treating kids and not the adults does not make sense because kids get the disease from the adults.

Beyond that, if you look at studies done, rates of TB among people from the household where the patient lives are around 1,500 to 4,000 per 100,000 population – more than 10 to 20 times the population rate. They are a high risk group. You want to intervene and reduce the rates of TB. It’s a critical part of stopping the epidemic. It’s scientifically proven.

I think not treating latent TB is one of (the) biggest problems in the current global strategy. Also, not advocating active case finding. if you don't find other active patients, and you didn’t stop the latent cases from becoming active. Places that are overcrowded, places where people have poor nutrition. The minute someone turns on (gets active TB), you get more transmission. That’s why no matter how much you spend on drugs and passively finding cases, one cannot stop the epidemic.

WHO also does not support the supplementary nutrition programme, saying that there is not enough evidence to show that the outcomes for the disease is better. They do however support patient counselling for nutrition. Some states in India have a programme for supplementary nutrition.
TB is not just a biological disease. It is a biosocial condition. You really do have to intervene on social aspects. If people say we have to have a trial to show that starving people need food, we may need the same thing to show, I suppose, that parachutes work.

You do something that is morally and logically sensible. Because we know that it helps people. It’s hard to take a lot of pills on an empty stomach. It makes people feel sick.

Remember, even before we had antibiotics, treatment for TB involved sending people them to sanatoriums where they received good food and rest. It was an important part of treating people in the pre-antibiotic era. Now we are asking 'should we give food to people who are clearly starving, clearly poor and have a consumptive disease?' From my personal perspective it does not make sense.

When it comes to diagnostics, India still used smear microscopy (looking for the bacteria under a microscope in the sputum sample) in most parts of the country. WHO is now pushed for GeneXpert that detects rifampicin (first line TB drug) resistance in less than two hours.
Focusing on the use of smear microscopy as the be all and end all of TB diagnostics was bad advice (from WHO). Because smear microscopy does not pick drug resistance. It does not pick up TB in children. It does not pick up TB of people living with HIV. It does not pick up extrapulmonary TB. At the best times, it only has the sensitivity (when you see the bug) 60-70% of the time. The only reason it was advocated is because it was cheap and easy to operate.

However, GeneXpert is a more sensitive test. So if people are coughing up to 10,000 bacteria, you will be able to see it through smear microscopy. GeneXpert can pick up if you have below up to 50 bacteria. Compared to smear microscopy, GeneXpert is a huge huge step forward. Not only does it pick smaller amounts of bacteria, it also tells you if the bacteria has rifampicin resistance. Thus it’s an important test and tests GeneXpert should be a key part of diagnosing people thought to be infected with TB.

But GeneXpert does not detect the resistance in other TB drugs such as isoniazid.

In which case if you give short course chemotherapy (first line TB treatment), it will lead to amplification of resistance. Isoniazid mono resistance across a number different places in the world ranges from 8% to 28%. That’s a reasonably large number. So the question is should we be checking for isoniazid mono resistance or not? In an ideal world, yes. But given where we work, where until recently we were using only smear microscopy, using GeneXpert is light years ahead. So there are gaps, yes, but it is much better than what was advocated before.

The question is why aren’t there new technologies? There are a couple of answers.

First answer is generally people with TB are poor, and generally not seen as a big market. But WHO’s endorsement of GeneXpert and the way they brought down the the price, by paying the manufacturer a certain amount of money, in a way made the entry into the market more difficult for other competitors. I am not blaming WHO, I am saying this happened. It kind of in a way temporarily brought down the innovation around TB diagnostics. We have not seen that kind of endorsement for the HIV community or really for any other disease. But this is what we saw in the case of TB. It may have been necessary given the reliance on smear microscopy, but it did dampen the entry of new innovators.

Overall, what we are seeing in TB is that we have had a situation where there had been differential TB policies for rich and poor countries and we have very centralised control of TB in the WHO. The struggle against this disease has not been the same as for other diseases, most notably HIV.

WHO advice was a minimalistic approach. It was not an optimal approach for countries with high burden of TB. It was probably a good starting point. But it was not a sound way to contain the epidemic. The policies were driven by the selective Primary Health Care movement and the feeling that there was not enough money to do too much in poor countries.

Therefore, the idea was to keep it very simple and very easy. Any complexity was left out. Drug resistance is a complexity. Disease that is not in the lungs – extrapulmonary disease – is a complexity. Disease in children or HIV patients is a complexity. They were left out.

You ask if that was bad? It depends on how you look at it. It saved the lives of people with regular TB. It was systematic and it was easy to implement. It was bad in the sense that if you didn’t have that kind of TB (that this strategy focused on) or you were child, or you have HIV, or extrapulmonary you didn’t get the care you deserved. That’s why it was bad. Many millions of people people were saved and many millions of people likely died.

Why was it pursued when the WHO team knew that it was not the policy in Europe, in America, in Canada, and Britain, Australia and New Zealand. I think, it is because of the pressures to have low cost simple intervention that poor countries could implement and the lack of will on the part of international donors to invest in building health systems.

Why did they think double standard was ok for poorer countries? I do not have any answers for that question. It’s complex, and I think it is linked to colonialism, neo-colonialism, neoliberalism, and other social phenomena. Regardless of the cause, this unsound advice was a violation of human rights and ended up being policy for more than two decades. Now we are seeing some movement towards comprehensive approach. But for two decades many people lost their lives unnecessarily to the disease. It is a difficult thing to really understand.

The WHO charter set out to achieve attain the highest standard. People in poor countries are not different species. They deserve the same care as rich countries. Creating a double standard of care for the poor has always been a mistake.

What kind of changes should India make to policies related to TB?
Looking for the future, we have to ask ourselves what should happen. And the fact that the BRICS countries (Brazil, Russia, India, China, South Africa) have some of the highest TB rates offers an opportunity for these countries to invest in research development on their own. It offers an opportunity for them to synchronise their TB treatment policies with tried and tested scientific approaches used by richer countries. They should do this because these approaches they give good outcomes, they give better outcomes and they have better epidemic control policies. Also because those policies tend to be more protective of human rights and of life. I think we should be moving in that direction.

It gives the BRICS countries an opportunity to go beyond what the WHO is saying and base their policies on science. This offers a lot of opportunity for the BRICS countries to demonstrate leadership in policy setting, in research and development in creating new TB drugs and diagnostics, in creating a pooled procurement for existing drugs so that they can be purchased for lower the prices

Perhaps some poorer countries don’t have capacity. I understand that. But when you start to think of it, we have to build capacity in these countries.

A lot of countries who say they cannot do active case finding have sophisticated subway systems, they have nuclear missiles, large militaries and a lot of things that require significant organisation and a lot of planning. One has to concede that active case finding and treating people with latent TB, is simple compared to some of these complex tasks. For exampl, India has sent a probe to Mars, India has one of the strongest militaries in the world. Are you telling me that it’s impossible to do this in India? I would find that very difficult to believe.

I think the reason why India should adopt a comprehensive approach to TB control that includes active case finding, treatment of latent TB, treatment of all kinds of TB, and have patient supports is because Indians deserve better. They don’t deserve to be dying of a disease that is treatable since the late 1940s.