By
The Associated Press
TRENTON, N.J. - Amid an explosion of U.S. cases of Type 2 diabetes, pharmaceutical companies are testing drugs on two groups once excluded from experiments for safety reasons: children and the elderly.
Bristol-Myers Squibb, Novartis and Pfizer are among the major drug makers testing new drugs or going back and testing approved ones on youngsters or senior citizens.
The move comes at a time when America's aging population is contributing to an increase in Type 2, or adult onset, diabetes. Doctors say they are also seeing a startling number of children with the disease.
"The vulnerability in these two groups is greater," said Dr. Robert Sherwin, president of the American Diabetes Association and director of the Diabetes Endocrinology Center at Yale University School of Medicine. "That's why this is important."
These two groups of patients represent a huge market for drug companies. If the Food and Drug Administration approves their diabetes pills for youngsters and elderly people, the pharmaceutical companies can market the drugs to these groups.
Another force behind the research trend is prodding from the National Institutes of Health and the FDA to include senior citizens, children and minorities in all drug trials. The FDA in December mandated that children be included in all drug research, and for a couple years it has been offering drug companies an extra six months of patent exclusivity if they do so.
For many years, children, the elderly and women who were or might become pregnant were excluded from clinical trials. Researchers worried that the drugs could harm a fetus, stunt a child's growth or interfere with puberty, or make elderly patients sicker. Senior citizens are more prone to side effects in general, in part because many have heart disease and other chronic illnesses.
Until December, when a diabetes pill for youngsters was approved by the FDA, insulin shots were the only approved treatment for children with Type 2 diabetes. About a dozen pills have been approved for adults, however.
Once drugs win FDA approval, doctors are free to prescribe them for other, unapproved uses. And many doctors are prescribing these diabetes pills to children and elderly people.
But picking the right dosage is a guessing game because of the lack of experimental data.
Diabetes is the nation's No. 7 killer. Uncontrolled diabetes frequently causes heart disease, severe kidney damage, nerve damage, blindness and amputations.
In Type 1, or juvenile, diabetes, the body does not produce any insulin. In Type 2 patients, the body doesn't produce enough or uses insulin inefficiently. Obesity, lack of exercise and aging are risk factors for Type 2 diabetes.
The number of Americans with diagnosed or undiagnosed diabetes jumped from about 12 million in 1994 to about 16 million today; more than 90 percent have Type 2 diabetes. About 800,000 new cases of diabetes are diagnosed each year in this country, up from about 600,000 in 1991.
Type 2 diabetes in children and adolescents is such a new phenomenon that accurate numbers are not yet available. However, at medical conferences in the past few years, diabetes specialists have been reporting that they are now seeing several dozen new cases of adolescents with Type 2 diabetes each year, instead of just one or two.
Two years ago, FDA asked Bristol-Myers Squibb, maker of Glucophage, the top-selling pill for Type 2 diabetes, to test it in children. In December, the drug became the only diabetes pill approved for patients under 18.
Squibb recently announced it is designing studies in children for its Glucovance, just approved last summer.
Novartis is recruiting 270 people ages 70 to 90 for testing with its drug Starlix. Novartis also plans studies on children.
Pfizer, the world's biggest pharmaceutical company, also has tested its diabetes drugs on seniors. The company makes Glucotrol and Diabinese.
