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Type-II diabetes can be controlled in 6 months, claims Hyderabad hospital

Dr Nageshwar Reddy of Asian Institute of Gastroenterology is treating a patient at a rural camp
A burgeoning population and the advent of a range of new pathogenic and lifestyle diseases has made healthcare in India extremely complex. The medical fraternity has risen to the occasion at every step to meet the challenges in maintaining and improving public health, delivering several new molecules and therapeutic procedures to improve the overall wellbeing of the populace. In a new series, Business Standard brings you five institutions that stand out in the field of medical research in India.  />
The gut, they say, is the brain of our physical body. The large and the small intestines, the bacteria within and the environment created by the enzymes, hormones and acids could make our body either fragile, delicate or invincible. There is also that in-between stage in which we are ailing and have no idea how to get the balance of our body right. Diabetes, pancreatitis, gut cancers and a myriad of other diseases abound, especially nowadays, when we gorge on processed foods and have limited physical activity.  While lifestyle changes should be the go-to for good health, it's a choice few make willingly and for the long term. Add to this, the poor South Asian gene structure and you have a deadly cocktail.

“Nearly a third of the diabetics in India are thin, so we need to understand our population and its response to medication and environment," says Dr K Srinath Reddy, President Public Health Foundation of India.

We begin a series on hospitals that are not only known for clinical excellence but are also driven by the patient loads they have seen. They are now using their experience and cumulative knowledge to look for ways to provide relief to patients.

The principle healer

Dr Nageshwar Reddy and his team have been working for the past twenty years in Hyderabad and have set up a hospital with the most advanced technologies in gastroentrology. Most Indians may not know of the hospital but internationally, it is among the most respected names.

There is a calm to Dr Nageshwar Reddy's demeanour. He comes in quickly and settles into his chair. The next hour is a revelation on the business of a corporate hospital that practices low-cost delivery, works with more than 55 salaried doctors, and believes in cutting-edge basic research that translates into medicine for healing. Dr Reddy's mission was to create a big platform in the field of gastroentrology. “Getting a Nobel is a long shot, but my dream is to get awards like the Lasker, or other the big prizes for medical research.  We have clinical material, we have talent,” he says. There is no greed in the ambition, no burning hunger, just a self assurance that the job has to be done, and will be done.

A people-over-profit approach

The OPD at the Asian Institute of Gastroenterology (AIG) only shuts when the last patient has been examined -- even if it is 1 a.m. early morning. Though the hospital has a month-long waiting period, each patient visiting the hospital is sent home only after complete investigation. There is no question of making a patient endure multiple visits. The hospital, which does the largest number of endoscopic procedures in the world, has priced them at under Rs 1,000 or almost a third the cost elsewhere else.

When a gastroentrologist gets a call from the hospital for a post to be filled, he heads there immediately.  There are more than ten applicants for a single post given the institute's reputation for research.

Apart from clinical excellence, it is the hospital's thrust on research that makes it the preferred choice for patients, many of whom travel thousands of kilometers to get a cure for the incurable at an affordable cost. There is no point offering therapy that is out of reach for the common man,” says Dr Reddy.

Quadria Capital, an investor in the hospital, agrees. “Volumes are so high that my investment is viable even at the lowest costs that the hospital offers,” Says Dr Amit Varma, himself an intensive care specialist and managing partner of the fund.

So, what ailments does AIG treat?

Multi-pronged attack on diabetes

Insulin, which is secreted from the pancreas, controls blood sugar. One becomes diabetic when the insulin level goes up or one develops resistance to insulin. When bariatric surgery evolved, it was found that it is the duodenum that controls insulin usage. 

AIG is working on a procedure in which a duodenal sleeve is inserted to allow ingested food to slide through the stomach without touching the duodenum. The sleeve stays in place with the help of a special valve, an anchoring device which fixes it in the stomach. The sleeve is flexible and made of silicone, and was tested in bile, in stomach acid, and in a combination of both for durability. It took 3-4 years to design the sleeve and a year to perfect the  anchoring device. Once the sleeve is inserted, there is a reduction in the number of anti-inkeratins -- cells that slow down metabolic activity. This reduction causes the body's insulin use to increase and within six months, type-II diabetes is controlled to a large extent. “Forty patients have undergone this treatment. After a year, when we removed the sleeve, the patients continued to remain free of diabetes,” says Dr Reddy. The study aims to observe patients over five years. “The biggest challenge is to improve the food habits of patients during that time. They should switch to a high-fibre, zero-carb, zero-refined food diet,” he says.

First phase clinical trials have been completed in Europe and the US  on DMR (duodenal mucosal resurfacing), the second surgical option. The idea is to burn the mucosa of the duodenum using a special hot water balloon. The surface mucosa gets destroyed and when the new mucous is generated, it does not have anti-inkeratins. The duodenal wall is like that of a new born baby. One hundred and fifty surgeries have been done all over the world, mainly in Europe. A three-year follow up study shows diabetes control. “ We will be starting the procedure in AIG  within two months,” says the doctor. 

In both DMR and sleeve insertion, the stomach wall has been regenerated with cells of the kind we were born with.

Stem cells, the healers.

Whenever there is an injury in the body, stem cells emerge from the bone marrow and regenerate onto the injured part. Often times, though, the stem cells get trapped elsewhere – in lungs and the spleen -- and die.

For patients of chronic pancreatitis, diabetes, it has been found that the bone marrow, the natural healer in our body is unable to send specific stem cells to the pancreas for healing. This genetic deficiency is called bach2G. In the therapy,  the bone marrow cells are taken, modified in a culture and injected directly through the pancreatic artery into the pancreas. AIG has done 10 procedures with excellent response from patients. Diabetes was controlled following which long-term clinical trials have started.

The promise of Theracyte

The third thing AIG is excited about is an immuno-isolated device called Theracyte.  It is a small bag that only allows body serum to enter, without a single cell intruding. Once it is placed, blood vessels grow around it and it gets integrated in the body.  It is made of a special material fibre,  neutral and stable and has a narrow opening through which insulin producing islet cells are inserted. Normally, islets cells are difficult to transplant,  and for donor cells it is even harder since antibodies would attack it, but this immuno-isolated bag is protected from antibodies. The best part is that islets can be lab grown, or taken from anybody -- even from germ free pig farm as an experiment in Minnesota showed --- and transplanted in the patient.

AIG is doing a project in collaboration with  IISc and IIT Hyderabad to developing its own bag under the government-funded Imprint project.  According to Dr Reddy, the bag being worked on will be superior to the existing Theracyte and will be ready in a year and a half.

Funding : The fuel for research

A separate research block being set up at the new facility that the hospital will be moving to by year end, is primarily funded by the Healthcare Foundation of the hospital and financed by individual philanthropists. According to Dr Reddy, plenty of tax exempt CSR money is available, apart from government funding. Many times funds available at  Department of Science and Technology (DST), Department of Biotechnology (DBT), the Indian Centre of Medical research (ICMR) lie unutilised.

AIG has no dearth of grants with funds flowing in from Rockefeller, NIH and Wellcome Trust.

International collaborations

The hospital has tie-ups with hospitals like Johns Hopkins and Mayo clinic for international projects. For instance, one project with Johns Hopkins is on a micro biome. Indian immigrants to the US and those in India are being studied. It was found that immigrant Indians were developing colitis, a colonic inflammation and Johns Hopkins wanted to find out why. So AIG examined the stomach micro-flora of both resident Indians and immigrants. When Indians immigrate, the micro-flora changes completely, while food habits remain the same and that was causing a problem. AIG now has micro-flora expertise in lab. Three papers have been published in Nature, with international collaboration. 

Patents and prospects of commercialisation

Though there is little profit in research, it is critical for building a knowledge base for translational application. The hospital has two patents ready for commercialisation. It has identified new jaundice-causing virus for which a pathological test can be developed.

The hospital has also patented a technique called IPS that converts skin cell to liver cells. Shinya Namayaka, a Japanese scientist had initially developed this technology. He started by taking stem cells, and converting the fibroblasts to islet cells.

AIG believes liver transplant is very difficult because of lack of donors, the high incidence of organ rejection, and lifelong dependence on immuno-suppressants. So the scientist researchers worked successfully on converting skin cells into liver cells. “We put four different substances and created a culture, and within a week the scrapings from the skin cell were converted into liver cells," says the doctor. With one fibroblast from the skin cell, billions of liver cells can be created. The next step includes refining the process and creating a  matrix to give it the shape of a liver. In a  couple of years, an artificial liver will be created in the lab. Since it is made using a patient's own skin immuno=suppressants will become redundant.

AIG's major achievement has been to get a  scientist with knowledge and experience in CRISPR  technology, which is capable of cutting off the defective part of the gene, inserting a modified gene and putting it back. Right now, India does not permit working on the embryo since it is a delicate area loaded with ethical issues. But if it did, as China has, the information available on identifying defective genes would go a long way in eliminating gene related defects.

AIG is working on this technology for liver cancer. During the operation, cancer cells are removed, and lymphocytes which maintain the body's immunity are studied to understand how they have been compromised. The immunity compromising gene is taken out and new strong ones are added to give the body a powerful army to fight cancer. 

Striding into the future

AIG is moving to a new 1,000-bed facility at Gachibowli with an independent building for research, in a few months. It uses the best of biomedical equipment with its devices and offers them at the prototypes stage, while the physician's inputs are responsible for final tweaking.

The hospital has a strong academic pull and every doctor has a research project.  Thrice a week, the outpatient department closes at 4 p.m., which is early by AIG standards. Thursdays are earmarked for research meeting wherein the basic research team joins the doctors to present and discuss progress on difficult cases. Here the opinion of all participants counts, regardless of seniority. It is this approach that increases the gradient in the learning curve for all.

International exposure

This kind of exposure is only possible in government hospitals. International doctors visit the hospital and find that the exposure they get in a week at AIG is quite substantial.

Dr Reddy believes that doctors who only focus on money burn out fast, there has to be a higher purpose and a spirit of giving to keep them motivated.

He says India's huge basic science support programme has plenty of unrealised potential. For instance,  Hyderabad's  CCMB  (Cellular and molecular biology) has churned out many Phds who don't find opportunities in India so they go abroad and begin working there. He believes that like China, India too needs to call its precious diaspora back.

If every private institution takes on the responsibility of doing basic research, it could change the landscape of growth in the country. AIG has more than 500 good papers in prestigious international journals, which in itself is no mean achievement.

Giving back

Dr Reddy has a strong sense of giving back to society. He had invented a gastric stent 15 years ago, called the Nagi stent. He gave the manufacturing rights to a Korean company on the condition that it should be affordably priced. Nagi is the largest selling stent in the world today.

A few years later, an MNC modified and began selling the stent at many times the cost, even while there is a bar on the sale of Nagi in the US.

Of course the hospital got nothing for it. But Dr Reddy has no regrets, as he believes that the stent is helping more patients. He wants his hospital to be an example of low-cost, sustainable, best-in-class treatment -- not just in India, but the world over.

Watch this space for the next article in this series, on Apollo Hospital's human touch