Cholesterol-lowering statin drugs, the most prescribed pills in the world, have become a family affair.
Middle-aged men, many women and the elderly are routinely put on the powerful drugs to lower high cholesterol. Now the nation's leading pediatric group says that certain high-risk children as young as 8 may also be put on statin therapy, just like Mom, Dad and Grandpa.
The new guidelines from the American Academy of Pediatrics have been sharply criticized by many pediatricians and parents. They worry about the long-term health consequences of the drugs and have raised questions about financial ties between the academy and drug companies. There is also concern that the guidelines could lead to more widespread use of the drugs among children. An estimated 13 percent of children have total cholesterol above 200 milligrams per deciliter, the threshold used in adults to determine high cholesterol.
But the doctors who wrote the guidelines say they have been largely misunderstood. They say that far from leading to widespread use of statin drugs by children, the guidelines target the small percentage of children with genetic cholesterol problems or those with several worrisome risk factors, like obesity, high blood pressure and diabetes.
''I don't see this as a major groundswell for the indiscriminate use of lipid-lowering drugs,'' said Dr. Stephen Daniels, a member of the A.A.P.'s nutrition committee and chairman of the department of pediatrics at the University of Colorado Denver School of Medicine. ''That's exactly why we need these guidelines, to say where the limits of that usage should be.''
It's not clear how many children will be affected. About 1 in 500 have genetic cholesterol disorders, and doctors estimate that currently, about 30 percent to 60 percent of those children haven't had a diagnosis. Over all, only about 5 percent of children have levels of LDL, or ''bad'' cholesterol, above 130. Drug therapy would be suggested for children with bad cholesterol of 130 only if they have diabetes. Otherwise, drugs would be recommended for those with bad cholesterol of 160 and a family history of heart disease or two other risk factors, or when bad cholesterol hits 190.
Already five statin drugs -- Bristol-Myers Squibb's Pravachol, Pfizer's Lipitor, Merck's Zocor and Mevacor, and Novartis's Lescol -- have been approved for use in children with genetic cholesterol disorders. But there is little data on long-term use.
''People should realize that these drugs have only been studied in children with a genetic defect that causes very high cholesterol levels,'' said Dr. Dianne Murphy, director of the Food and Drug Administration's office of pediatric therapeutics, who noted that those children were followed for only two years.
Some doctors say the short-term data on statin use in children is reassuring and mirrors long-term safety data in adults. ''The concept is that prevention should start early,'' said Dr. Daniels. ''You already have children who have risk factor levels that would be a concern for an adult.''
But the lack of long-term data has caused concern among many pediatricians, who say children often metabolize drugs differently than adults.
Dr. Darshak Sanghavi, a pediatric cardiologist at the University of Massachusetts Medical School, said statin drugs may affect a child's endocrine system, which regulates growth and development, among other things. ''I, for one, feel unsafe simply saying children are little adults in this case,'' he said.
The medical literature is filled with examples of mistakes made when medical experts extrapolated data from one group to another. For years, doctors assumed that since menopause hormones appeared to protect the hearts of middle-aged women, then older women would benefit even more. But when the issue was studied in the large Women's Health Initiative trial, older women on hormones turned out to have a far higher risk for heart attack and stroke.
