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Trial by ordeal

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Veenu Sandhu New Delhi

Diabetes research in India hasn’t quite kept pace with the epidemic proportions the disease has assumed. But efforts are on to look for alternatives to the insulin injection.

Last year in March, when 11-year-old Shreya Dutt fell ill, her parents thought it was the routine viral fever. A week later, the fever subsided but the child continued to lose weight alarmingly. She stopped going out to play, was always extremely thirsty and hungry, urinated more frequently and appeared tired all the time. A round of tests confirmed that the viral fever had triggered diabetes. The symptoms had appeared suddenly and had manifested themselves as quickly. Shreya, doctors said, suffered from Type 1 diabetes in which the pancreas fail to produce insulin, the hormone needed to convert sugar into energy.

 

For over a year now, a much thinner Shreya has been getting insulin injections twice a day to help maintain her blood sugar level. Her parents know that she will have to learn to live with this chronic condition. They also realise that with regular medication, exercise and diet modification she can lead as healthy and normal a life as anybody else. There are enough examples in the world to prove that — actor Halle Berry, king of Rock ’n’ Roll Elvis Presley, talk show host Larry King, Olympic athlete Gary Hall, all have suffered from diabetes. Closer home, actor Kamal Hassan, VJ-turned-actor Gaurav Kapoor, Leader of the Opposition in Lok Sabha Sushma Swaraj and former Pakistani cricketer Wasim Akram are diabetic. But every time their daughter is pricked with the needle to inject insulin into her body, the Dutts cringe. “For the last one year, I have been looking for an alternative way, other than the injection, to give the medicine to my daughter,” says Jawahar Dutt, Shreya’s father. “She’s dealing with it fine, but I wish there was a tablet she could pop or a spray she could inhale instead of taking the injection.”

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Diabetes research worldwide has been two-pronged: one, to find new drugs to control diabetes, and two, to find new means of administering insulin (such as insulin sprays, nasal insulin, pancreas transplantation are by creating artificial pancreas). Not only is the research extremely expensive and time consuming, the success rate is very low. “The paradigm is still towards injected insulin,” says Vivek Shenoy, general manager of Bangalore-based Biocon which hopes to soon enter into a partnership with a global pharmaceutical company to start international trials for oral insulin to treat Type 2 diabetes. If successful, this would be the first such insulin to be consumed orally. “We have been testing different insulins for oral consumption since 2004. After we zeroed in on the lead candidate, the trials on it have been on for about five years,” says Shenoy. “This is a new molecule, a modified insulin. If regular insulin would be given in tablet form, it would be broken down by the digestive system and would be totally useless,” he adds. “We have to be sure that the drug works across populations and gene pools.” Having gone through two phases of clinical trials on humans on multiple hundreds of patients, the drug is now ready to be tested globally. Even if all goes well, the oral tablet is still a few years away from the market.

“Some companies are also trying to develop microparticles of insulin that can be inhaled,” says S K Wangnoo, senior endocrinology consultant, Indraprastha Apollo Hospital. One inhaled form of insulin by Pfizer did come to the market under the name of Exubera but was discontinued a year later in 2008. Pfizer had then said that there simply weren’t enough takers for the drug to justify the expense of making it. Wangnoo says there are safety concerns about insulin that is inhaled and absorbed through the lungs. “Now there is research to come up with finer particles of insulin that can be absorbed in the upper respiratory tract instead of reaching the lungs,” he says. “A particular company also came up with oral spray but it didn’t catch much attention because the patient needed 10 to 20 sprays in the mouth and on top of that one insulin injection in the night.”

What is, however, catching on somewhat is insulin through pumps. “It’s a pager-like device that supplies steady stream of the necessary amount of insulin into the abdomen,” says Wangnoo. India, he adds, currently has more than 5,000 insulin pump users. But not everybody can afford an insulin pump. “Each costs about Rs 2.5 lakh to Rs 3 lakh along with a monthly expenditure of Rs 4,000 to Rs 5,000,” says the doctor.

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Diabetes is a huge drain on national income. World Health Organisation predicts that between 2005 and 2015, India will suffer a net loss of national income worth $336.6 billion from diabetes and cardiovascular diseases. A solution does not appear anywhere close in sight. “Research in diabetes is still clinical and mostly in rudimentary stages,” says Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Obesity, Metabolic Diseases and Endocrinology. Though transplantation of pancreas cells, or islet cells, was another option which was being explored, Misra says, “Initially there was great enthusiasm since some studies showed great success, but later studies did not give very encouraging results. This procedure requires great deal of expertise and is available only in a few centres in the world and not in India.”

But there is hope yet. An oral drug is under test. “Twice- or thrice-a-week insulin injection could be launched in a year or so,” says Wangnoo. “Recent trials have shown that once-a-week injection of a drug called Exenatide leads to powerful lowering of blood sugar. Research and drug development in this area is in a very exciting stage; close to 150 drugs are under development,” adds Misra.

An official with a pharmaceutical company says diabetes research is a zero-sum game. “If a drug works, you will hit jackpot. Else, it’s billions of dollars down the drain.” For Shreya Dutt and her parents, for whom diabetes is now a lifelong reality, that’s a risk worth taking.

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First Published: Aug 20 2011 | 12:26 AM IST

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