Moorthy was a senior sales manager with Dunlop in
Calcutta. When he was diagnosed with Diabetes in 1982. Refusing to believe it, He emerged himself in work. A year later when fatigue and excessive thirst - the first indicators became unbearable he went back the doctor, who confirmed that it was indeed diabetes.
The doctor started him on mild anti - diabetic tablets and then prescribed stronger medicine. By last year Moorthy was jabbing 20 units of insulin a day to control his blood sugar level. He had mean while left the Dunlop job which involved much traveling and become a sedentary stockbroker in kochi.
Today Moorthy, has a more active work and schedule and is completely of insulin even the sweet meats he occasionally takes don't raise his blood sugar level above 185mg.
Moorthy's life partnership with the insulin syringe would have remained intact if a young industrialist, P.N.E Balaram had not gifted a herbal tablet. Balaram had been making the tablets in a cornes of his factory in
Thrissur, Kerala. And giving them away to diabetes patients. Simultaneously, he was testing it scientifically.
Now the world famous Mayo Clinic of the US has shown an interest in doing the testing - to find out the herbal preparation really rejuvenates pancreatic cells which produce insulin. A Silent Killer diabetes no cure in modern medicine; allopathy A pill a day keep diabetes away: Balaram spent over a decade to prove the efficacy of his wonder drugs can achieve only 'disease management', which means they help patients to help with it. Living with diabetes is a full time occupation involving meters, tests, strips, hospitals, trips, tablets, insulin shorts diet control - and the constant fear of loosing life and limb.
There a hundred million diabetic in India. A WHO study says by AD 2000 every fourth
diabetic patient will be an Indian. Balaram's herbal tablet has the potential to prove WHO wrong Patients who have taken it vouch for it. Among them are scientists, proffesors and industrialists. All display a new vigour. "It is a miracle", says K.N. Suryanarayan a businessman who took it for a month and lost all unwanted blood sugar.
Balaram 36, says he makes the medicine from common plants in Kerala an that he got the formula from an old palm leaf manuscript written in Sanskrit, it apparently has a cure for several major diseases.
Balaram had watched his father waste away and die of diabetes. He knew the pain and the fear it caused by diabetic neuropathy.
Yet he did not show great interest when an out-of-town Ayurvedic vaid offered him the palm leaf book. They had meet at sri Krishna temple in Guruvayoor, in Thrissur, and soon formed a bonf of affection. One day the vaid brought with him a palm leaf bundle wrapped in cloth.
"I was not at all impressed", Says Balaram who now believes that it was divine force that brought them together. "But before I could say anything the vaid said: 'Don't just dismiss it try out that anti-diabetic formula someone you know'."
For several weeks, the palm leaves lay untouched in Balaram's house in Thrissur. But every time he went to the Guruvayoor temple he felt tinge of conscience.
A few months later he made some Sanskrit scholars translate the manuscript in Malayalam. He collected the ingredients, prepared a formulation, and in 1987 gave the first dose to the diabetic father of a close friend. It was just out of curiosity.
After a week the friend came back for more medicine. His father's blood sugar, which had resisted allopathic oral anti-glucose medicines, had fallen sharply.
It changed the way Balaram looked at the medicine. His business antenna was up. He started a quest that would lead to the setting up of a herbal pharmaceutical company.
Instead of merely mixing and selling a 'wonder cure, he travelled scientific lane, setting up a small lab at his factory in Thrissur and hiring a team of researchers headed by V.S. Parasuraman, a former drugs controller of Kerala.
Over half a decade the team refined the formulation to make it what it is now: a potent drug. Feedback from Balaram's friends and acquaintances who tried it out was exciting. All of them, he says, reported a new feeling of well-being, besides a sharp drop in blood sugar.
He knew the skeptical world of endocrinologists-diabetes specialists-would dismiss it as a quackremedy. He needed scientific validation to convince them.
In 1992 he took the formulation to the Indian Council of Medical Research (ICMR), New Delhi. It asked him to go back home ---to the Amala Research Centre in Thirssur or to the Sree Chitra Institute of Medical Sciences in Thiruvananthapuram.
At Amala the director, Dr Ramadasan Kuttan, had long been researching on a herbal cure for cancer. While working with the M.V. Anderson Hospital in New York he isolated circumine from turmeric and published a paper on its anti-cancer properties in several western medical journals in 1985. His work led to global research on circumine, particularyat the National Cancer Institute in Maryland USA.
Dr. Kuttan, who has published more than 80 international papers, readily agreed to test Balaram's for mulation on animals. Balaram used Dr Kuttan's contacts in the US to obtain the protocol for animal testing, and imported the chemical alloxan-researchers use it to induce diabetes in animals.
The research was hush-hush for fear that the pharmaceutical lobby would throw a spanner in the works. Making a plan based on the imported protocol, Dr Kuttan standardised the chemicals and equipment over a few months. And the trials lasted one and a half years.
He found that the formulation lowered the blood sugar and glycosylated haemoglobin (another indicator of diabetes) and vitalised the liver and the kidney. More startling, the formulation had done reversed the damage that alloxan had done to the rats' pancreatic cells. It was a major breakthrough in diabetes research.
"The drug," says Dr Kuttan, "has shown a remarkable ability to rejuvenate the pancreatic beta cells in laboratory tests on rodents. It is the first drug to show such results."
The next step was human testing. Dr Kuttan prepared a protocol and chose ten willing diabetic patients, one of whom dropped out midway. Balaram's researchers put them through a month-long regimen of exercise and diet. When it was clear that the regimen had made no difference to their blood sugar they were given the herbal medicine.
Dr Kuttan monitored their blood sugar and glycosylated haemoglobin levels, and kidney and liver functions every month, and found these normal at the end of six months. All the nine patients had registered a remarkable improvement. "If these findings are validated in controlled clinical trials among diabetic patients," says Dr Kuttan, "then we are on the threshold of a monumental discovery".
Balaram's rushed the test report to Kerala Health Secretary V. Vijayachandran, who scanned it and passed it on to Prof. R. V. Jayakumar of the Thiruvananthapuram Medical college. An endocrinologist, Jayakumar had started a diabetic clinic at the college and is one of the three principal investigators in a diabetic research project of the ICMR.
"The technical report brought out one thing clearly," says Jayakumar.
"The herbal drug did have anti diabetic properties and had shown a promising ability to repair damage to the pancreatic beta cells which are responsible for producing insulin."
To double-check, Jayakumar recommended double-blind, placebo controlled human trials. The health secretary agreed to fund it. The trials will begin after the ethics committee of the medical college clears the project.
Balaram, meanwhile, got in touch with Mayo Clinic in Minnesota, the world leader in diabetes research. He faxed a report to May's research director Dr Sreekumaran Nair, who belongs to Kerala.
Within weeks Dr. Nair flew into Kochi and went back with a pouchful of samples. A fortnight later Dr Nair telephoned Balaram: Mayo would bear half the cost human trials.
Dr Nair was, however, cautious while talking to THE WEEK: "The preliminary data does show that the drug has repaired the damage to the pancreas, but it needs to be controlled trials. If the results from the proposed study in Thiruvananthapuram are promising I will be happy to perform some additional studies in US."
Infact not everybody is willing to take the results at the face value. "Is this drug just reversing the effect of alloxan damage or is it showing anti diabetic properties?" Wonders Dr R.S Hariharan, endocrinologist who heads the diabetology department at Madras Medical College.
Dr. Hariharan says the improved functioning of the liver and kidney could have been because the drug had merely reversed the damage that alloxan caused. He makes another research point: " Dr Kuttan shouls have tested the drug on diabetic bio-bred (BB) rats."
Researchers the world over have to models to test anti-diabetic formulation on animals. One is to use chemicals like alloxan or streptokinase to induce diabetes in rats. The other is to use BB rats - specially bred rats that are hereditarily diabetic. BB rats better mimic Type II diabetes in humans (non- insulin dependent diabetes). Most researchers, however, use the chemical model first because BB- rats are difficult to come by.
"It doesn't matter whether alloxan has been used to induce diabetes or BB rats are used," says Dr. Prassana and metabolism at M.S. Ramaiah Medical College, Banglore. "It is just the first phase ultimately the acid taste is the human trials." Dr. Kuttan, mean while is planning to test the drug on BB rats.
Dr. Kumar, who has researched several Ayurvedic anti- diabetic drugs, is concerned more about toxicity. " Lab test may show no toxic chemicals," he explains, "but several modern drugs that passed such tests showed their ugly side many years after they were introduced." Balaram's drug, named Cogent db, has cleared toxicity tests, and the state drug controller has issued a licence to start serial production. There is no anxiety to obtain patient because, as Dr Kuttan said, India doesn't register product patients, and it costs $20,000 for a US patient. While Dr. Kuttan is writing a paper on his findings, Balaram has put the technical report of the animal trials on the internet (www.indianmade.com/cybele). He is making the blue print for a Cogent db production plant in Idukki, Kerala. It wasn't the web page or the technical reports that persuaded the Coimbatore Arya Vidya Pharmacy place a huge order for the drug for it's 700 retail outlets across the country. The Director of the pharmacy, M.V Gopalan Kutty, had tested it on himself: he was diabetic. Not that Web page has gone un-noticed. Subas Kannan, chief executive officer of Malaysia's oze marketing Sdn Bhd, saw it for months ago and took some samples to Malaysia. He returned in may to place an order for 100 crore tablets!
Kannan's company markets Australian and Indian herbal products in Malaysia, Singapore and Brunei. Pharmeceutical majors Wockhard and Cipla are in touch with Balaram for distribution rights elsewhere.
Balaram apparently has a couple of herbal surprises up his sleeve. "The palm leaf manuscript has many more formulae," he said. "But it is not easy to decipher them and prepare the drugs."
Animal trials on one of the drugs just been concluded at the super specialty medical institute in south India. The drug has shown "an astounding anti-clogging" property and the research leader says it could be useful against arteriosclerosis.
The young man behind the herbal drug, PNE. Balaram's is not new to herbs: He is a graduate in botany. But it was in electronics that he tried to make a fortune.
Coming from family, Balaram setup Ezhuthassan Electronics in collabration with Toshiba of Japan in 1983 to manufacture Teltronix television VCR and satellite system. He captured a sizeable share in the south, and manufacture a precursor of the DTH (direct-to-home) system enabling TV viewers to receive satellite transmission signals. The projects crashed after the Russian satellite ICRAN came spinning down, and the company is enmeshed in legal tangles. His next venture was the golden valley mineral water, which is sailing well. "I have sold a chunk of my shares in this company to fund research on the herbal drug," he says.
Ever since he started taking the herbal drug seriously he has been spending ten hours a day, meeting doctors, researchers and patents. He has refused to sell the formula of divulge it, saying it is the will of the lord of Guruvayoor. There is a growing body of evidence that herbal anti-diabetic preparation that include neem, pann, amla, haldi and other ingredients could help in controlling the blood sugar. Four years the Indian council of medical research (ICMR) started the 'vijayasar' trials for an anti-diabetic drug. It founded three teams of endocrinologists at the medical colleges in Thiruvananthapuram. Chennai and Cuttack.
After extensive trails the team broke the code of the double blind trail. (One team puts together the drug and identical looking placebos while the other team administers the drugs to two groups of patients. This method, known as the double-blind, ensures that neither team knows which patients have taken what. The marked medicines are coded and the code is broken only when the trials are over.) The preliminary results showed that Vijayasar could help in controlling mild Type II diabetes. There are good allopathic drugs like tolbutamine (Rastinol) which could do the job but Vijayasar is non-toxic as well. However, Vijayasar was found ineffective in sever cases of diabetes.
In January this year doctors at Chennai's Apollo Hospital, Dr. Ambedakar Institute of diabetes and the Kilpauk medical college tested a herbal anti-diabetic drug on patients. Their experiments showed that the continued dosages of the drug was effective in reducing the serum fructosomine levels (which was checked on days 0, 30, 60 and 90) and glycosylated hemoglobin levels. Hyponidd, as the drug is called, is now being made available by its manufactures - Mumbai-based Charak Pharmaceuticals.While there has been a resurgence in research in plant derived formulation. The world over, modern methods have not been resigned to the back burner. Scientists in the west are working on new drugs and treatments methods to combat diabetes. Surgeons and doctors in the Us has been experimenting with a technique called islet cells transplantation. The expensive surgery involves transplanting foetal panecreatic islet cells in diabetic patients. The technique was first tried out in in 1990 and is now conducted at Cornell Medical Centre New York and the University of Miami School of Medicines. "An islet cell transplantation will cost close to $100,000," says Dr. T.Divya, a senior resident at New York Methodist hospital. "It has to be done in conjunction with a renal transplant and the patient will have to be on long term immunosuppressive therapy." Over 200 such transplants have been done but only a few have succeeded.
Aming the newer drugs available for diabetics are Acarbose and Troglitazone. Acarbose helps keep blood sugar levels manageable soon after a meal by prolonging the digestion. But side effects could include indigestion and cramps. Troglitazone, realized in the US yearly last year was hailed as a major step towards making diabetes easily manageable. It was approved by the US Food and drugs administration over 20,000 patients already have already taken it.
It decreases body insulin resistance, so that the existing insulin in the body can more efficiently transport glucose in to the cells.
However, it doesn't start acting until weeks after treatment. Early this year the doctors reported liver toxicity problems associated with the drug. At least one patient died of lever failure.