The head of ICMR speaks about the health challenges facing the country, and the importance of data-driven policy making.

BY AKSHAI JAIN

Dr. Soumya Swaminathan is a slight woman with a shock of wavy white hair and a manner as easy with a smile as it is with interrogation. At the helm of all medical research in the country, she’s also the head of the Indian Council of Medical Research (ICMR) and the Department of Health Research in the Ministry of Health and Family Welfare.

Detailed and critical research is, she believes, key to formulating healthcare policy and evaluating the benefits of current programmes. It can do for healthcare what her father M.S. Swaminathan’s crops did for Indian agriculture.

In the midst of answering phone calls, signing files, and meeting officials, she outlines some of the many questions that we need to be asking.

Healthcare and public health in India seem to be at a crossroads, and in some ways our situation is unique. We have a high burden of both communicable diseases (like malaria) and non-communicable diseases (like diabetes, cancer, cardiovascular diseases). The burden of non-communicable diseases is increasing rapidly in both urban and rural areas. Government health spending however seems to have plateaued, but the amount people spend on private healthcare has increased. Where are we headed? Going forward how do you see the role of the government versus the private sector?

 I think this is an important question. I feel that the government has to take the primary responsibility for providing healthcare, especially primary healthcare. There is no doubt that the private sector will play a big role. Their involvement might increase, and we might see more public-private partnerships—of which varied models are being tried out. But the responsibility for oversight and governance will continue to lie with the government. Even if we enter into public-private partnerships for running government health facilities or laboratories we will have to be in charge of the supervision and quality control. We will need to ensure that what is needed is being provided and the quality and the cost of the services is as per what had been decided.

Primary healthcare is envisaged to be a large component of preventive and promotive healthcare—which needs to be strengthened. Even the prime minister is talking about wellness. We have to start addressing lifestyle issues, improve screening for common ailments, blood pressure, diabetes, cancer and so on. The role of providing preventive and promotive healthcare (like running large immunisation campaigns or screening programmes) is again primarily that of the government. The government’s immunisation programme currently provides ten vaccines (the private sector provides many more, but those are only available to those who can afford them). The number of vaccines does need to be increased, but we have to compare the benefits of different approaches and do detailed cost-benefit analysis on issues like this.

To address behavioural and lifestyle challenges we’ll have to start large awareness campaigns. In some of these cases, like alcohol and tobacco-related health issues, policy interventions would need to be made by the government. This could be in the form of a ‘sin tax’ which some countries have used to fund treatment of alcohol and tobacco-related diseases.

Non-communicable diseases are increasingly rapidly in urban and in rural India. In a survey of 86 villages in Maharashtra’s Gadchiroli district, Dr Abhay and Rani Bang found that stroke, a lifestyle disease, is the most frequent cause of death in the area. Fourteen per cent of deaths in these villages occur due to stroke. Places like this seem to going through an “epidemiological” transition. As you’ve already mentioned this is an area where preventive and promotive healthcare is important (these issues needs a “bio-social” as opposed to a “bio-medical” approach). How are these interventions, approaches going to be designed?

 According to WHO’s Global Burden of Disease studies the top risk factors in India (that lead to disease) are high blood pressure, high blood sugar and indoor and outdoor air pollution, in that order. Indoor air pollution is chronic in rural areas where women still used solid fuels to cook indoors.

Hypertension and blood sugar require behavioural changes and lifestyle modifications. Planning these interventions will require a lot of research in the area of social delivery—we need to look at people’s practices, their risk behaviours, why they’re doing certain things. These will help us design the most effective strategies for bringing about behavioural change. They will help us address questions like— at what age, what level are community programmes more effective? Are peer groups better than a doctor?

We have to do many more studies. Right now, out of the total healthcare expenditure only a very small proportion is going to public health research and within public health research a tiny proportion goes to health economics—looking at socio-behavioural patterns, cost effectiveness, etc. We need to expand the capacity to do the kind of research that will inform policy. I think ICMR’s priorities now are really going to be in the area of implementation research—we have a lot of tools that are being developed in medical colleges and research institutes across the country that have not found their way into practice or policy. We need to bridge that gap between knowledge and action.

Could you give some examples of the kind of tools that you’re talking about?

I’m talking about a test for, let’s say, blood sugar, or one of the infectious diseases—kala azar or dengue. How do we get this into the healthcare programme? There is a company in India that has developed a TB diagnostic test that is supposedly as good as international WHO-approved tests. Our job at ICMR is to help with the validation of indigenous products like these, and to work with the entrepreneurs to improve them. We’d like to give the health ministry a range of products that are made in India, and are a fraction of the cost of imported ones—which is what will convince them to buy these things. I’m trying to position ICMR as a knowledge partner that works with businesses.

We need to do the studies that bridge the policy-action gap. So before I ask industry to collaborate on pneumococcal vaccines, I first need to know the exact burden of pneumococcal pneumonia among children in India. I also need to know whether introducing a vaccine will bring down deaths.

We have good surveillance systems for a few diseases. For rotavirus-induced diarrhoea we have data from different parts of the country for the last 4-5 years. So within a year we will be able to gauge the impact of the recently introduced indigenous rotavirus vaccine.

Another example is the human papillomavirus (HPV) vaccine for cervical cancer in women. This vaccine has got a lot of bad press recently because of the Supreme Court case on the HPV vaccine trial, so a lot of time has been lost. We have data on the prevalence of HPV in women of different age groups. Data from the vaccine trials would have helped us compare its benefits with those from a screening program for cervical cancer. At what cost does a vaccine like this become beneficial? With this information in hand we can spur industry, telling them the price point at which the vaccine would work.

These are some of the areas we’re working on. We’re trying to also do something similar with TB and nutrition. We’ve collaborated with Tata Trusts to introduce nutritional supplements for TB patients in Odisha in an effort to reduce drug resistance in patients. We’re trying it in a couple of districts before we take the results to the health ministry.

Implementation research of this nature needs resources—that is why the government needs to put in more resources into health research. This research will help us understand and predict outcomes. It will shorten the process of introducing new effective treatments. We have a lot of ideas, but are not able to fund everything.

You’ve talked about implementation research being one of your priorities. Given that the funds are very tight, what are some of the other priorities for ICMR in the next few years?

I can answer that in a couple of ways—one is that we’re actually trying to prepare a strategy document for ICMR where we develop a framework that will make it easier for us to prioritise.

Other than that we have developed a few different priority areas: evidence to policy is one of our key priorities; setting up data systems and data repositories is another. We have vast amounts of data, we do survey after survey. But is this data being utilised optimally to drive interventions, in the formulation of policy? Are we making it available to the people who need to use it?

Leveraging traditional knowledge or medicine is another area—I think there’s a lot of untapped potential there. We need to create systems to validate ayurvedic treatments using clinical trials; discover new medicines from herbs and bring them into the mainstream drug development process.

The last area is building capacity for health and biomedical research. Given how few researchers we have right now, this will be an investment in our future. We need to build capacity in science and technology in general, but obviously for ICMR the focus will be on medical research.

In terms of health budget we need the full budget to be able to deliver all the programmes. In the TB programme, for example, we’ve been able to get only half of what was envisaged in the 2012-17 five-year plan. So it has not been able to deliver what it had originally proposed to do. The same has happened in the case of other programmes.

The allocation for health research is less than 1 per cent of the healthcare budget. So we’re not able to work fast or efficiently.

You’re the medical editorial policy director at the journal Nature. What is your opinion of India’s current medical research output?

I think we have a long way to go because medical research is given low priority. If you look all of science and technology, our overall research output is very low if you benchmark it against China or other western countries. But if you look at medical research, that is an even tinier percentage of overall research being carried out.

A recent paper by Dr. Samiran Nundy and his colleagues showed that research output from most medical colleges in India was zero. Five institutions (AIIMS, PGMIR Chandigarh being among them) in the country accounted for 80-90 per cent of the output even though we have nearly 400 medical colleges. Most of these colleges do not produce even a single paper. We need to start with medical students, inculcating a spirit of scientific enquiry in them, giving them exposure to research methods. Faculty members of our medical colleges need to start doing research apart from teaching.

Funds are of course tight, but we also need to build the capacity to use existing resources allocated for research optimally. If we focus on this in the next ten years we’ll be able to improve quality.

You’ve mentioned that we have a lot of data. But how reliable and systematic is this data?

 You’re right. We have to judge the quality of this data—but we also have a lot of data that is well collected, standardised. We have ICMR surveys, National Family Health Survey (NHFS) data, other multi-centric studies, and 40 years of data on nutrition from the National Nutrition Monitoring Bureau (NNMB).

The bedrock of health is nutrition. India’s figures are abysmal: nutrition data from across 28 states and Delhi, shows that 38.7 per cent of children under 5 in India are stunted (a measure of chronic under-nutrition), 19.8 per cent are wasted (acute under-nutrition). India’s average annual rate of decline for under-five stunting, between 2006-2014 has been 2.3 per cent per year, much better than the 1.2 per cent the country saw during 1992 and 2006. However, India still lags behind neighbours and even some sub-Saharan countries. Nepal has an average annual decline rate of 3.3 per cent per year, and Bangladesh matches that of India.

Despite this, 40 years after being established, the NNMB has been shut down by the Union Health Ministry. This bureau, under ICMR, had been critical in informing the government’s poverty alleviation interventions with periodic assessments of nutrient deficiency among tribal communities, pregnant women, adolescents and the elderly in India. How are we going to keep track of the nutritional intakes of vulnerable populations?

This is something we’re discussing. We’re trying to see if we can mobilise resources outside government. We’re also talking to the Registrar-General of India to see what kind of (replacement) surveys might be useful, since we don’t want to repeat what other surveys might be doing. It is important that we convince the government to reinstitute some sort of nutritional survey because otherwise we’re not going to have any data to benchmark our initiatives against—we won’t know which areas need more attention, whether we’re making progress.

We’re soon going to have a meeting where we’re calling all stakeholders, national and international, to try to come up with a single national survey that collects data for all parameters. We will also try to come up with a model to identify research questions based on this data.

You’d also mentioned a national system for collecting data on non-communicable diseases…

That will be part of this single survey.

Who is going to be administering this survey?

That is again something that needs to be discussed. What we need to try and do is to harmonise all existing surveys, which are currently not comparable because some of them use different definitions. We need to create one survey platform.

There is a wide agriculture-nutrition disconnect in India. The crops that are grown most commonly and receive the maximum support from the government are not the most nutritious. Economics rather than nutritional requirements dictates what crops are grown. Are genetically modified, fortified, crops like Golden rice a solution to this? What else can be done to bridge this?

That is just one way of intervening—the interventions can be at many levels. Currently people are eating a cereal-rich diet low in vitamins and micronutrients. GM rice can of course provide some of these, as can zinc-fortified milk. GM crops are just one way of doing this, bio-fortification (breeding crops to increase their nutritional value) is equally effective.

The bottom line though is that people need to get a balanced diet. What most people get in the public distribution system (PDS) is what they can afford to eat. They can’t afford fruits and vegetables. NMMB surveys show that the intake of fruit and vegetable in the Indian diet is less than 5 per cent of recommended dietary amounts.

So you have to improve the basket of things available in the PDS. Crops like millets are not available now because farmers are not growing them. They don’t grow them since there’s no assured market, and so millets are expensive. If the government assures a minimum support price for them farmers might start growing them. We also need to figure out how to include locally available foods—like the leaves of the drumstick plant and other wild leaves—in our diet. In parallel, the fortification of rice, wheat, oil and milk should also be explored.

People also need to be educated on health. Even those who can afford to eat well don’t know what a healthy diet is, they eat too much carbohydrate, oil, salt and sugar.

We’ve talked a bit about data; and about the lack of detailed epidemiological studies in India. Apart from rotavirus and HPV are there any other diseases for which we’ve got adequate data?

We have studies like the INDIAB or India Diabetes study, a national prevalence survey for diabetes, hypertension and pre-diabetes. It is the largest survey in the world and has covered all the states and union territories. So far we’ve got data for 17 states, the remaining are in progress. This study allows us to compare prevalence rates between rural and urban areas, highly urbanised states and more backward states, etc. We will be able to benchmark progress of the national program against non-communicable diseases (over the next 5-7 years) against this data.

Is all this data in the public domain?

The first stage of the INDIAB Study is done. We had a dissemination meeting in April 2016, and the data is in the public domain. But I do find that a lot of our data is not publicly available. For example there was a large study supported by ICMR that looked at bone health—bone mineral density, vitamin D levels—in about 2,000 adults from across the country. It was an extremely well conducted study, but the data from it was not made available. We’re now analysing it, but this is something that should have been done long ago. We need to be more responsible with data.

ICMR is also trying to come up with a data sharing policy. That again is an area where you need a policy; you want to be open and transparent, and at the same time there might be intellectual property issues or concerns like protecting investigators, etc. that you have to keep in mind. International agencies now make it mandatory for researchers (using public money) to put their data in the public domain.

Mental health is a largely ignored area in India. Is this something that ICMR is going to be addressing and how?

I got interested recently when I attended a high level meeting in Washington. Mental health accounts for a large proportion of disability around the world. Depression, anxiety, suicide rate are increasing in young adults—these are critical areas that need to be addressed. We’re planning to have a consultation on identifying priority areas where implementation research is needed to be able to implement interventions at the community level.

We obviously don’t have enough psychiatrists in the country, so we need to think of different approaches. Who else can help at the community level? A handful of NGOs working in this area have been able to use community workers to identify mental health issues and be part of the follow-up care. They’ve experimented with different models to deal with a range of disorders—from schizophrenia to depression. A huge amount of work is needed in this area.

You’ve been quoted in a recent news report saying that “In the last three years, drug testing and registration has suffered due to strict norms”. You’ve also mentioned that under the new rules that the government is coming out with—fresh clinical trials related to drug policies, strategies to administer drugs for particular diseases and combination of drug therapies will be cleared by local ethics committees and wouldn’t need to go through the Drug Controller- General of India (DCGI). Isn’t there a great risk of misuse here?

I wasn’t talking about a blanket relaxation of regulations. What I meant was that we need to make them a little more rational. You can’t club all clinical trials together in one box. A trial of a new drug molecule is very different from that of a treatment protocol that combines two drugs that have already been individually approved for use. The risks here are very different.

The idea here is to free capacity for people to do high level clinical trials in institutes that have good ethics committees, evaluate trial protocols, and make sure that all norms are being followed. The Drug Controller-General of India (DCGI) needs to be free to focus on regulatory trials—of new drugs, etc.

Our current set of rules has led to a situation where delays often make research irrelevant. In global trials for example, Indian investigators can often not take part because by the time they get permission to go ahead with the trails, other countries have very often already finished enrolling. At the end of the day it’s Indian patients who suffer.

Take the case of a new drug, bedaquiline, for TB. By the time permission was granted for a trial in India other countries had already recruited patients so we ended up recruiting only five patients, two from Delhi and three from Chennai. That’s all the experience—five patients—that we have in India for this important new drug. When the drug company in question comes to us for registration our first question is—how do we know this drug works since you didn’t recruit enough Indian patients in your trial?

There are many other cases where clinical trials are unnecessary. The dosage of antibiotics does not depend on ethnicity: an American needs the same dose as an Indian. So why do we need to do these repeat trials?

These are old rules, some of them kneejerk reactions, that we need to rationalise. We have to differentiate between different types of clinical trials, and not subject everyone to the same scrutiny.

Some critics believe rates for under-nutrition in India are highly exaggerated. They blame this on the application of a uniform WHO-specified height to decide whether or not a child of a given age and gender is stunted. And similarly, a uniform WHO-specified weight to decide whether or not the child is underweight, regardless of race, socio-cultural background, geographical location or time or vegetarian versus meat diet. Any failure to meet the standard is attributed to malnutrition and the child classified as malnourished.

Arvind Panagariya, one of these critics, maintains that this leads to glaring statistical inconsistencies in comparisons between India and Africa. India’s infant mortality rates are much lower yet rates of under-nutrition and stunting are much higher. Comparing Kerala with Senegal, the former has a life expectancy of 74 years while the latter is 62, yet we are told Kerala has a higher proportion of stunted and under-weight children than Senegal. Do you agree?

WHO standards are fine; they included communities from all over the world including India. The criteria was birth circumstance, i.e. children who were not limited by birth or the environment. In India you can see the difference between children born into different environments (food, water). That shows the differences are not genetic. I don’t believe in this theory that we are genetically small and that we should change our standards.

So there are other reasons for the anomalies that are pointed out. Do we know what they are?

We are getting closer—there is lots of work going on. One of the interesting new things we’re doing is looking at the microbiomes of people living in slums (the human microbiome is the aggregate of microorganisms that resides on and in skin, saliva and mucus and in the gastrointestinal tracts). We’ve found very early differences in the enteric (intestinal) passage colonisation by pathogens and bacteria. What we’re realising is that just giving extra nutrition is not going to work, neither is just replacing dirty water with clean water. You have to take care of sanitation, drinking water and nutrition starting from pregnancy and early childhood.

Once enteric dysfunction gets established in these children (a disease called enteropathy) they don’t seem to be able to absorb nutrients, which is I think one of the reasons why our iron and folic acid programmes don’t work. Contrary to belief the problem is not worms—the government is deworming children twice a year, but many randomised controlled trials have shown deworming doesn’t really have an impact.

It’s critical that we do impact evaluations of our programmes. We’ve spent a lot of time and money on them, but if after 15 years of running the iron and folic acid programme our rates of anaemia are unchanged, what exactly is happening? Ironically, the government is now starting the National Iron Plus initiative, moving into younger age groups—children under two. In India we’re not doing enough impact evaluations and follow up studies.

There is very little drug R&D in India. Why do you think this is the case?

Some companies are now investing in drugs. Sun Pharma recently signed a MoU with the International Centre for Genetic Engineering and Biotechnology (ICGEB), Delhi, to develop a new dengue drug.

You’re also working with them on a malaria eradication project in Madhya Pradesh. What are the desired outcomes of that? Is it to develop new drugs?

The malaria project is to demonstrate that a particular strategy could work to eliminate malaria from an entire district. India is committed to eliminating malaria by 2027, so this project is an effort to implement focused interventions in one place to see what works and what changes need to be made in our malaria eradication programme. Our MoU with Sun Pharma is a fairly broad one that also includes drug development, but there’s nothing specific on the cards right now.

Are there other diseases where you’re looking for partnerships?

Depending on our interest, we’re open to partnerships with the private sector. There has to be private support for research, too. You asked why there’s little private R&D in India—that’s something you’ve got to ask the industry. Maybe they’re just happy selling generics.

You’ve done a lot of work on TB, especially paediatric TB. India has reduced TB rates only slowly.  The multi-country Sentinel Project on drug-resistant TB, which you’ve been involved with, has found that in India drug-resistant TB prevalence in adults and children is about the same. Unfortunately the tests used on adults are inaccurate for children and people with HIV. There’s a lot to be done on the TB front. How is ICMR handling the TB epidemic?

First we need a national prevalence survey to give an estimate of the true burden. We need to move quickly on research priorities like diagnostics, shortening treatments by using a combination of newer drugs and coming up with a universal treatment regimen. Currently we first have to test drug sensitivity and then determine treatment. We need to work towards a combination of drugs that will work regardless. Then there are adjunct therapies that can be used to stimulate immunity to improve treatment outcomes. We also need to tackle conditions like TB meningitis in children.

You’ve also talked about eradicating measles…

It is one of the diseases targeted for elimination, so ICMR will support the government like it did for polio, by providing evidence and research, doing environmental surveillance and transmission research. We’re formulating a plan with the Health Ministry.

In a paper you wrote in The Lancet you talk about steps the government is taking to tackle antibiotic resistance—recording of patient details, establishment of a National Programme on Antimicrobial Surveillance in ten laboratories at academic centres, etc. This sounds like a very large and ambitious plan. What is its current status?

It’s ongoing. The surveillance has started in four hospital laboratories, and we’re in the process of extending it to ten.

Genomics is the current buzzword. How relevant is it to India? Are we better off using our limited resources on more urgent needs like primary healthcare?

It’s difficult to prioritise. Genetic studies have a significant role to play in understanding disease causation, pathology and transmission. Within genetics there’s host genetics and microbial genetics. In TB for example, microbial genetics studies are important—they can tell us about why there’s more drug resistance in certain parts of the country, they can tell us about transmission habits, and can help with early detection of drug resistance and so on.

Host genetics studies are relevant in diseases like cancer and non-communicable diseases because they can actually guide treatment, give you a better understanding, and help develop new therapies. So I think given our limited resources we need to focus on ones that are most important for us.

If you were to do an M.S. Swaminathan on Indian healthcare what would that be?

I think our biggest challenging is improving primary healthcare. We should come up with a model that is cost effective, makes sense in our own context and focuses on promotive and preventive healthcare. I think this would go a long way in reducing  the disease burden, otherwise we’re going to have to invest increasingly more in tertiary care.

But we’re spending nearly Rs 5,000 crore on establishing three new AIIMS in Maharashtra, West Bengal and Andhra Pradesh…

There’s a need for that. The government is setting them up to address current requirements. It’s also why the government is setting up the dialysis centres. But we should really be looking at how to prevent chronic disease rather than focusing on how many patients we can provide dialysis to.

We have to do the tertiary care, take care of people who’re sick, but we need to invest much more heavily in preventing the causes of these disabilities, whether it’s diabetes, hypertension, or chronic fatigue.

You’re the second woman director of the ICMR in its 100-year history. Is this evidence of an increasing role of women in Indian science?

I hope it’s a pointer to more equality in the future. Every third director should be a woman. I think that’s likely to happen, too.

(Akshai Jain has worked with Outlook, Mint and Tehelka. He now freelances, and his latest hobby-horse is science journalism)

 

 

 

 

 

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One Comment

Nagpal, 1 year ago

Good…..research analysis is reflective of fair social objective …

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