Diabetes: Record Number of New Treatments in Development
New Hope as Human and Economic Costs Mount
Bin He (left) and Aiying Wang are
Bristol-Myers Squibb researchers
who work on developing innovative
treatments for diabetes.
It seems you can’t pick up a newspaper or magazine today without seeing an article about diabetes. And no wonder -- complications from the disease rank as among the leading causes of death in the U.S. in both men and women.
Diabetes affects more than 30 million Americans, or about 8 percent of the population. Of those, almost 15 million are diagnosed, but more than 6 million, about one third, are unaware they have diabetes. New cases of the disease have risen more than 90 percent over the last 10 years, and since 1987 the number of deaths from the disease has risen by 45 percent, according to the U.S. Centers for Disease Control and Prevention and the American Diabetes Association.
However, there is growing hope. Biopharmaceutical companies are developing nearly 200 new diabetes medicines, a record number. “The diabetes medicines now in the research pipeline are contributing substantially to the incredible progress made in the last five years by biopharmaceutical companies in developing new and more effective diabetes treatments,” says Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies.
What is the Cost of Diabetes?
In 2007, the total cost of diabetes in the U.S. was estimated at $174 billion, which includes medical care for the disease and chronic diabetes-related complications. Or simply put, in the U.S. alone, over one in every eight health care dollars is spent treating patients with diabetes, of which prescription medicines account for only 10 percent.
Indirect costs, resulting from absenteeism, disease-related unemployment disability and loss of productivity, were estimated at $58 billion.
Worldwide, the numbers are staggering: diabetes affects approximately 246 million people, making it one of the most prevalent chronic health conditions.
While those numbers are huge, most alarming, predicts the World Health Organization, the number of people with diabetes may double by 2030. Researchers project the greatest increase to be in the Middle East, sub-Saharan Africa and India.
In the U.S., researchers project that one out of three children who are currently in the first grade of school will develop diabetes when they reach adulthood unless steps are taken to prevent the disease.
What is Diabetes?
Diabetes affects the way the body processes food. The normal process is for the body to break down food sugars to glucose, which is then circulated through the blood. The glucose in the blood then enters cells, which use it as fuel. Insulin, a hormone produced in the pancreas, helps convert sugar and starches into glucose and move it into cells.
In a normally healthy person, the pancreas adjusts the amount of insulin in the blood to accommodate the amount of food being ingested. In people with diabetes, the process breaks down and too much glucose, or sugar, remains in the blood.
When that happens, other body functions are affected. Left untreated over a prolonged period of time, diabetes can result in serious, life-threatening conditions, including kidney failure, heart failure, blindness, and loss of nerve function in the hands and feet. The disease also affects the gums and teeth. The most serious of the complications is heart disease. People with diabetes are two times as likely to have a heart attack or stroke as people without the disease.
“I know firsthand how devastating diabetes can be,” says Cindy Rubin, M.D., group director in Metabolic Disease Global Clinical Research, Bristol-Myers Squibb. “When I was an internist, I treated many patients with diabetes. Many of the patients also had other medical conditions, such as dyslipidemia, cardiovascular disease and kidney and eye damage.”
If patients do not know the signs and symptoms of diabetes -- frequent urination, excessive thirst, extreme hunger, increased fatigue, irritability and blurred vision -- they may not even be aware they have the disease until they develop one of its complications, which all too often include heart disease, stroke, blindness, kidney disease and limb amputations.
What Causes Diabetes?
The exact causes of diabetes are unknown, but genetics and environmental factors -- particularly obesity and lack of exercise -- play large roles.
People can develop diabetes at any age. There are three main kinds: type 1, type 2 and gestational diabetes. Type 1 diabetes, formerly known as juvenile or insulin-dependent diabetes, is generally diagnosed in children or adolescents. In this type, beta cells in the pancreas no longer produce insulin because the body’s immune system has attacked and destroyed them. Treatment includes taking insulin and possibly another injectable medicine, as well as watching diet and getting exercise.
Type 2 diabetes, formerly called adult-onset or non-insulin-dependent diabetes, is the most common form of the disease. It represents about 90 percent of all cases. This form of the disease begins with insulin resistance, in which the body does not use insulin properly. The pancreas tries to compensate by producing more, but then it loses its ability to generate enough when the patient eats a meal. Type 2 diabetes is a progressive disease with multiple physiological defects and significant impact on health care.
Worldwide, type 2 diabetes is reaching epidemic proportions, with the prevalence rate expected to grow from 220 million patients today to over 350 million worldwide by 2025. A patient with type 2 diabetes can expect their life expectancy to be shortened by 15 years.
Obesity and lack of exercise increase the chances of developing type 2 diabetes. Treatment often includes multiple medications used in combination as well as watching diet and getting exercise.
Gestational diabetes develops in some women during the late stages of pregnancy. It is caused by pregnancy hormones or a shortage of insulin in the body. It generally goes away after the baby is born although the patient is predisposed to developing type 2 diabetes later in life.
How is Diabetes Treated?
The first treatment for diabetes was injectable insulin, discovered in 1922. Since then, many other treatments that help the body absorb less glucose, increase the efficiency of insulin and reduce the amount of glucose produced by the body have come to market, but there are no cures.
“Often,” says Rubin, “it’s very challenging to keep patients’ blood glucose under good control and manage associated conditions and complications.”
There is hope, however, for people with diabetes as new treatments are being developed to help them manage the disease and lead productive lives. A recent report by PhRMA reveals that the nation’s pharmaceutical research and biotechnology companies have a record 183 treatments in development to treat diabetes.
Bristol-Myers Squibb is among them. In July, the U.S. Food and Drug Administration approved ONGLYZA™ (saxagliptin) for the treatment of type 2 diabetes in adults. ONGLYZA is being developed and marketed through a collaboration with AstraZeneca. Another investigational product for the treatment of type 2 diabetes discovered by company researchers, dapaglifozin, is in late-stage clinical development, also in collaboration with AstraZeneca. Other investigational compounds are in earlier stages of development.
Says Bristol-Myers Squibb’s Chris Cann, vice president, Disease Area Lead, Metabolics, “Our diabetes research and development efforts reflect the company’s commitment to discovering and developing innovative medicines for serious diseases.”