Wednesday, July 9, 2008


Tara Parker-Pope, NY Times This aggressive new recommendation for warding off heart disease in some children has stirred a furious debate among pediatricians since the American Academy of Pediatrics issued it. 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. . .

"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. . .

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. . .

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

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.). . .

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

LA Times The guidelines, produced by a seven-member panel and published in the academy's journal, Pediatrics, did not include any disclosures about the authors' ties to drug makers. One author, Dr. Stephen Daniels, a pediatrician at Cincinnati Children's Hospital, has acknowledged working as a consultant for Merck & Co., which markets statins, and Stettler said he had participated in industry-funded clinical trials of cholesterol drugs. Dr. Jerold F. Lucey, editor of the journal, said that disclosures weren't required for academy-issued guidelines because the panels were already rigorously vetted. The academy issued a statement saying "there is no involvement by any commercial entity in the development of any statement or report emanating from the AAP."

The editors were "naive in expecting people would swallow those recommendations without letting us know if the participants had ties to the companies that make statins," said Dr. Jerome P. Kassirer, a professor at Tufts University School of Medicine and a former editor of the New England Journal of Medicine.


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