Magazine article FDA Consumer

Probing the Pancreas

Magazine article FDA Consumer

Probing the Pancreas

Article excerpt

The human pancreas, an elongated, flattened gland behind the stomach, is involved or affected by a number of diseases, including diabetes mellitus, cystic fibrosis, pancreatitis, and pancreatic cancer. These conditions are diagnosed and treated with products regulated by the Food and Drug Administration.

The pancreas is composed of two major types of tissues:

* exocrine tissue (acini), which secretes digestive enzymes via the pancreatic duct into the duodenum (part of the small intestine leading from the stomach)

* endocrine tissue (islets of Langerhans), which produces and secretes the hormones insulin and glucagon directly into the blood.

Endocrine tissue contains alpha, beta and delta cells. Beta cells produce insulin and alpha cells produce glucagon. These hormones regulate blood glucose levels. Delta cells secrete the hormone somatostatin, which inhibits insulin and glucagon secretion.


A deficiency of insulin in the body results in diabetes mellitus, which affects about 13 million individuals in the United States. It is characterized by a high blood glucose (sugar) level and glucose spilling into the urine due to a deficiency of insulin. As more glucose concentrates in the urine, more water is excreted, resulting in extreme thirst, rapid weight loss, drowsiness, fatigue, and possibly dehydration. Because the cells of the diabetic cannot use glucose for fuel, the body uses stored protein and fat for energy, which leads to a buildup of acid (acidosis) in the blood. If this condition is prolonged, the person can fall into a diabetic coma, characterized by deep labored breathing and fruity-odored breath.

There are two types of diabetes. In Type I diabetes, formerly called juvenile-onset diabetes, the pancreas cannot produce insulin. People with Type I diabetes must have daily insulin injections. But they need to avoid taking too much insulin because that can lead to insulin shock, which begins with a mild hunger. This is quickly followed by sweating, shallow breathing, dizziness, palpitations, trembling, and mental confusion. As the blood sugar falls, the body tries to compensate by breaking down fat and protein to make more sugar. Eventually, low blood sugar leads to a decrease in the sugar supply to the brain, resulting in a loss of consciousness. Eating a sugary food can prevent insulin shock until appropriate medical measures can be taken.

Type II diabetes, formerly called adult-onset diabetes, can occur at any age. The pancreas can produce insulin, but the cells do not respond to it.

For many years, treatment was insulin therapy for Type I and oral sulfonylureas and/or insulin therapy for Type II.

Metformin (glucophage) was the first antidiabetic drug approved by FDA (May 1995) for the treatment of Type II diabetes since the oral sulfonylureas were introduced in 1984. Metformin promotes the use of insulin already in the blood. This May 1995 approval was followed by the September 1995 approval of another antidiabetic drug, Acarbose (precose), in September 1995. It slows down the digestion and absorption of complex sugars, which reduces blood sugar levels after meals.

Before 1982, insulin was purified from beef or pork pancreas. This was a problem for those diabetics allergic to animal insulin. Researchers produced a synthetic insulin called humulin. Approved by FDA in 1982, it was the first genetically engineered consumer health product manufactured for diabetics. Synthetic insulins can be produced in unlimited quantities.

Another possible treatment for diabetes includes surgically replacing the pancreas' endocrine tissues (islets of Langerhans) with healthy islet of Langerhans tissue grafts. Since 1988, 45 patients worldwide have undergone successful transplantation.

Cystic Fibrosis

The major problem of cystic fibrosis, the number one genetic killer disease of children in the United States, is that the body overproduces thick, sticky mucus. …

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