Things are looking up for the estimated 42 million diabetics in India. A check with endocrinologists, following a Mint reader’s query about insulin pumps a couple of weeks ago, showed many developments in the laboratories on the insulin front.
Researchers at the Amrita Centre for Biotechnology in Kollam, Kerala, are conducting animal trials on an insulin pump that will cost just a fraction of the Rs2.5 lakh-plus pump being retailed by Medtronic, and the slightly cheaper Korean model, Dana Diabecare II. With Bangalore’s Biocon as its industrial partner, this Tifac (Technology Information Forecasting & Assessment)-assisted project aims to produce an insulin pump that would retail for below Rs30,000.
Biocon is also at the centre of the inhaled insulin race—this is a powdered form of insulin absorbed by lungs through a hand-held inhaler. Nasulin spray, which it is developing with Bentley Pharmaceuticals, has recently entered Phase 2 trials. Closer to launch in the Indian market is Pfizer India’s Exubera, a variant of inhaled insulin, approved by the US Food and Drug Administration in 2006.
Hot on Pfizer’s trail are competitors Novo Nordisk India and Eli Lilly India, busy conducting clinical trials of this ‘blockbuster technology’. Novo Nordisk’s version, called AERx, is said to be a liquefied formulation.
Meanwhile, globally, the R&D pipeline of almost all the pharma majors is chock-a-block with new diabetes-related products. Among others, expect a miniature insulin-delivery pump called the Nanopump in 2008.
All this frenzied action on newer insulin-delivery mechanisms is necessitated because insulin can’t be taken orally—enzymes in the stomach make it ineffective.
Insulin has to be injected under the skin, a factor that leads to poor compliance and aggravates the condition.
So, are we going to see a trend away from the conventional syringes and pens to newer mechanisms for managing diabetes?
As Dr Harish Kumar, head of endocrinology at the Amrita Institute of Medical Sciences in Kochi, points out: “Insulin-delivery mechanisms have improved manifold over the years. Earlier, it needed to be stored in vials that had to be transferred to a syringe. It was a cumbersome process. Now, you get pens with premixed insulin dose. We are now moving to the next step—insulin pumps. At the moment, it is the best insulin-delivery mechanism in the market.”
The insulin pump
In insulin-pump therapy, or continuous subcutaneous insulin infusion (CSII), the patient is connected to a programmable pump attached to a storage reservoir, from which insulin is infused into the tissue under the skin. The advantage is that this continuous, day-long delivery more closely mimics the natural secretion of insulin from the pancreas rather than one-time injections.
Over the years, with demand dictating the supply chain, insulin pumps have become increasingly sophisticated.
Among the many models available in the market are battery-operated devices as small as a pager, which can be clipped to the belt or clothing. A reservoir inside the pump sends the insulin to the body through a tiny plastic tube, called an infusion set. Some other models also come equipped with a glucometer and a wizard for calculating boluses (fast-acting insulin doses).
Insulin pumps today are prohibitively expensive and, as of now, recommended mostly for patients suffering from Type 1 diabetes (also called juvenile diabetes), a condition in which the pancreas cannot produce insulin). Patients of juvenile diabetes form a minuscule percentage of the diabetic population in the country. That, probably, explains why sales have been low despite the pump having been available in India for the last three-four years.
Dr S.K. Wangnoo, senior endocrinologist at Indraprastha Apollo Hospitals in New Delhi, says pumps are also beneficial for Type 2 patients (in which the pancreas do not produce sufficient insulin or the body is resistant to insulin) who need up to four shots of insulin daily as well as for pregnant women with diabetes. “The ideal candidates for insulin-pump therapy are also patients whose sugar levels fluctuate alarmingly and tend towards hypoglycaemia (dangerously low sugar levels),” he says.
Delhi-based businesswoman Pooja Wadhawan, 28, is one such case. “At night, my sugar level used to drop so low that I would even fall unconscious at times,” she says.
Wadhawan, who was diagnosed with diabetes seven years ago, tried every means before switching to a pump three years ago. She claims it has worked really well for her.
“It gives me a lot of flexibility,” she says, describing how, if she misses a meal, she can easily skip a dose to avoid hypoglycaemia and if she binges on desserts, she can take an extra dose to avoid sugar levels climbing up dangerously.
Milind Shah, managing director, Medtronic India, says that clinical studies have proven that insulin pumps can reduce severe hypoglycaemia by up to 85% and mild-to-moderate hypoglycaemia by nearly 60%, compared to multiple daily injections.
Not all doctors, however, are enthusiastic about pumps (see table of pros and cons). Endocrinologist Dr Sujeet Jha, who practises at the Max Institute of Allied Sciences, New Delhi, refers to the UK-based NICE (National Institute for Clinical Excellence) site (www.nice.org.uk), which provides prescribing guidance to doctors on new technologies, and is fairly cautious about using insulin pumps.
Jha also raises the issue of insulin storage in the pump device: Normally, it is advised that insulin be stored in cool temperatures. “I am not sure what prolonged exposure to temperatures above 35°C will do to insulin,” he says.
Wadhawan, who has been using the pump for three years now, says she has not faced any such problems yet as she works in an air-conditioned office, and if she knows she is going to be outdoors, she stores just enough for a two-day dose rather than a week’s.
Meanwhile, the next big thing is inhaled insulin. Exubera, the first one to be released, is a fast-acting powder form of insulin that is inhaled before each meal. The disadvantage is that a long-acting insulin still needs to be supplied each day by injection.
While pharma companies are hailing it as a potential ‘blockbuster technology’, doctors are not as enthusiastic. They say inhaled insulin should be given to patients only if their blood sugar is not being controlled by other methods. Or, it should be given to a person who has a very strong and lasting fear of injections or because he or she has severe and persistent problems with injection sites.
Another disadvantage is that smokers, or those suffering from lung problems, cannot use it. Also, as Dr Harish Kumar points out, the inhaled-insulin device itself is fairly large: about nine inches. So, you cannot carry it around in your pocket.
He admits that the insulin works very well and that the inhaled-insulin devices of other companies, most of them in various stages of trials, are much smaller—though reports suggest that Novo Nordisk’s product is also as big as a paperback book.
It’s estimated that 246 million people worldwide suffer from diabetes—the number is projected to reach 380 million by 2025.
Not surprisingly, pharma companies are investing huge sums in research to find better ways to manage the condition. Keep watching this space.
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