While some doctors applauded the idea, others were incredulous. In particular, these doctors called attention to a lack of evidence that the use of the cholesterol-lowering drugs, called statins, in children would prevent heart attacks later in life.
“What are the data that show this is helpful preventing heart attacks?” asked Dr. Darshak Sanghavi, a pediatric cardiologist and assistant professor at the University of Massachusetts Medical School. “How many heart attacks do we hope to prevent this way? There’s no data regarding that.”
Nor, Dr. Sanghavi added, are there data on the possible side effects of taking statins for 40 or 50 years.
Other doctors said the recommendation would distract from common-sense changes in diet and exercise, which are also part of the new guidelines.
“To be frank, I’m embarrassed for the A.A.P. today,” said Dr. Lawrence Rosen of Hackensack University Medical Center in New Jersey, vice chairman of an academy panel on traditional and alternative medicine. He added: “Treatment with medications in the absence of any clear data? I hope they’re ready for the public backlash.”
Doctors who sat on the academy’s committee on nutrition, which issued the guidelines, agree there are no long-term data on statin use in children. But they say there are adequate safety data to justify the recommendations. One statin, Pravachol, has already been approved by the Food and Drug Administration for use in children as young as 8.
“We extrapolate from the information we have in adults,” said a member of the panel, Dr. Nicolas Stettler, an assistant professor of pediatric epidemiology at the Children’s Hospital of Philadelphia. “We know that in adults, decreasing cholesterol and giving some of those drugs decreases risk of heart disease or death. So there’s really no reason to think that would be any different in children.”
Some recent ultrasound studies of the carotid arteries in high-risk children also show that statin use in children does appear to slow the progression of heart disease, Dr. Stettler said.
To be sure, the statin recommendation does not apply to most children. “Among the vast majority of children, this will not even be an issue,” said Dr. Daphne Hsu, a chief of pediatric cardiology at Children’s Hospital at Montefiore.
But it signals a more aggressive approach to treating cardiovascular disease at a young age using drugs that have been studied primarily in adults.
Under the old guidelines, children considered at high risk for heart disease could be given statins starting at age 10. The new guidelines apply to children as young as 8 with LDL, or “bad,” cholesterol of 190 milligrams per deciliter, or those with LDL of 160 and a family history of heart disease or two other risk factors. Among children with diabetes, drug treatment may begin when bad cholesterol reaches 130.
In addition, the academy recommended that children with a family history of heart disease be screened as early as the age of 2 and no later than the age of 10. And by the age of 12 months, if a doctor is concerned about future weight problems, low-fat milk may be recommended.
Although the real numbers are small, some experts worry that the new guidelines will encourage too much reliance on drug therapy rather than more difficult lifestyle changes.
“It will open the door for pharmaceutical companies to heavily advertise and promote their use in 8-year-olds, when we don’t know yet the long-term effect on using these drugs on prepubertal kids,” said Dr. Alan Greene, a pediatrician in Danville, Calif., and the founder of the popular Web site DrGreene.com.
None of the doctors on the academy’s nutrition panel have disclosed any financial relationship with makers of statin drugs. (The report’s lead author, Dr. Stephen Daniels, told The Associated Press that he had worked as a consultant to Abbott Laboratories and Merck, but not on their cholesterol drugs. He was not available for comment on Monday.)
Some childhood obesity experts said they understood the need for the new guidelines, but added that there needed to be more focus on public health changes to address childhood obesity.
“When you have a kid whose cholesterol looks like an overweight 65-year-old, what do you do?” said Dr. David Ludwig, director of the childhood obesity program at Children’s Hospital in Boston. “The committee had to balance the risks of treating children with powerful drugs, about which there is limited long-term data, with the risks of not treating children with unprecedented cardiovascular disease risk factors.”
Even so, Dr. Ludwig says he has some concerns about what the guidelines say about public health.
“My concern is what this is saying about society when we are so quick to prescribe drugs for these conditions before having systematically attacked the problem from the public health perspective,” he said.
Part of the concern about statin use in children stems from the fact that there is still controversy about how widespread their use should be in adults. Statins, which are the most prescribed drugs in the world, have been shown to lower risk for heart attack and death in middle-aged men with existing heart disease. But there is little evidence they prolong life in healthy men, women or people over 70. And since statins have been around only since the mid-1980s, there is no evidence to show whether giving statins to a child will lower his or her risk for heart attack in middle-age.
Side effects, particularly muscle pain and cognitive problems, also have been a concern in adults, but it is unclear whether children will experience similar problems.
“We’re talking about potentially treating thousands and thousands of children simply to possibly prevent one heart attack,” says Dr. Sanghavi, from the University of Massachusetts. “That kind of risk benefit calculation is entirely absent from the A.A.P.’s policy.”
While most of the attention has focused on the drug therapy guidelines, far more parents may be affected by the recommendation that low-fat milk products are appropriate to give to children after the age of 12 months. Historically, low-fat milk has been discouraged for very young children because fat is essential to brain development. But the academy noted that because children were getting so much fat elsewhere in their diets, low-fat milk may be recommended by pediatricians if they are concerned about future weight problems.
“Obviously all of us want kids to really take care of their health,” said Dr. Marcie Schneider, a member of the nutrition committee who is an adolescent medicine specialist in Greenwich, Conn. “We want them exercising, we want them eating well. You try the least invasive things always first, but at some point if that’s not helping enough, you need to go to the next level.”
