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Healthy Skepticism Library item: 13925

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Sharav VH.
AAP Recommends Aggressive Screening + Statins Use for Children
AHRP Infomail 2008 Jul 8


Full text:

The American Academy of Pediatrics (AAP) is poised to issue recommendations for “wider cholesterol screening for children and more aggressive use of cholesterol-lowering drugs starting as early as the age of 8 in hopes of preventing adult heart problems.”

This is a highly controversial recommendation that smacks of pharmaceutical company influence. Indeed this recommendation overturns the AAP position-as reported in 2002, by The Washington Post:
“The American Academy of Pediatrics (AAP) worries that the FDA’s February approval of Merck’s Mevacor (lovastatin) — for children with a disorder that gives them very high blood cholesterol — could fuel more statin use when there is still little long-term safety and efficacy data in children, said John Moore, a pediatric cardiologist at Philadelphia’s M.C. Hahnemann Medical Center and chairman of the AAP’s cardiology section. There’s also no consensus on how best to treat high cholesterol in youngsters, he said.”
See:
http://www.washingtonpost.com/ac2/wp-dyn/A42383-2002May6?language=printer

Neither reporters of the Associated Press or The New York Times questioned what scientific evidence supports the use of statins in children who do not have heart disease. Cholesterol-lowering drugs were first introduced in 1987 (Mevacor), and are currently the most prescribed drugs in the U.S.

So, why has there been no dramatic improvement in U.S. mortality rates?
Why are more Americans becoming obese, diabetic—and dying of heart attacks compared to the rest of the world?

Statins have been proven effective ONLY in patients with a prior history of heart attacks-not in those deemed to be “at risk” because of high cholesterol.
http://ahrp.blogspot.com/2007/01/are-lipid-lowering-statins-guidelines.html

To gain insight one must turn to physicians who are not on the payroll of drug manufacturers. Doctors, such as John Abramson, MD, author of Overdosed America (2004), points out that in clinical trials that included healthy but high-risk people without heart disease, statins were shown to be of no benefit. For example, for women of any age who do not have heart disease or diabetes, and for men older than 69—who do not have heart disease or diabetes-there was no benefit from ingesting statins.

For men aged 30-69 years who are at high risk of developing heart disease statins show a modest benefit: Out of 50 high-risk men taking a statin every day for five years, only one avoids a “cardiac event.” In other words, of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction with no benefit. [1] http://www.thelancet.com/journals/lancet/article/PIIS0140673607605194/fullte
xt

Is it good medicine to expose children to risks of harm in adults are questioned?

What is the overall effect on children’s health of taking a drug?
Warnings and side effects listed on the drugs’ label: Lipitor:
http://www.fda.gov/cder/foi/label/2007/020702s050lbl.pdf

Given the potential risks of harm from statins-including cognitive impairment, liver damage, and muscle pain, weakness, rigidity, shouldn’t we seek alternative ways to reduce the risk of heart disease? Life-style changes, healthy eating, no smoking, and exercise are PROVEN EFFECTIVE against cardiovascular disease-and they pose NO risk of any sort.

Why, then, does the American Academy of Pediatrics recommend a dubious course of treatment with drugs instead?
One clue may be found in list of donors who include McDonald-whose fast-food has contributed mightily to US children’s obesity and cholesterol epidemic-and pharmaceutical companies that market statins, such as, AstraZeneca (Crestor), Sanofi-Aventis (Zocor), Merck (Mevacor, Vytorin).
http://www.aap.org/donate/fcfhonorroll.htm

Neither the AP nor the Times informed readers about AAP’s financial ties to companies with vested interests in the recommendation.

The Times quotes Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. He stated: “We are in an epidemic. The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.”

Times readers are not informed that Dr. Bhtia has extensive pharmaceutical ties as a consultant, speaker, and sits on several company advisory boards-and these may just influence his bald, unsubstantiated statements.
See: http://www.nortonhealthcare.com/pdf/KCH-2045%20Newborn%20Symposium.pdf

Another AAP committee member, Dr. Stephen Daniels, is quoted stating: “the new advice is based on mounting evidence showing that damage leading to heart disease, the nation’s leading killer, begins early in life.” AP reporter, Lindsey Tanner—but not NYT reporter, Tara Parker Pope — informed readers that he has worked as a consultant to Abbott Laboratories and Merck & Co.

The 2008 AAP cholesterol recommendations are a crass example of how financial conflicts of interest can influence treatment recommendations by American professional medical associations.

Reference:

Wright JM and Abramson J. Are lipid-lowering guidelines evidence-based? THE LANCET Vol 369 January 20, 2007 169.
http://www.thelancet.com/journals/lancet/article/PIIS0140673607605194/fullte
xt

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

http://www.nytimes.com/2008/07/07/health/07cholesterol.html
THE NEW YORK TIMES
July 7, 2008
Cholesterol Screening Is Urged for Young By TARA PARKER-POPE

The nation’s pediatricians are recommending wider cholesterol screening for children and more aggressive use of cholesterol-lowering drugs starting as early as the age of 8 in hopes of preventing adult heart problems.

The new guidelines were to be issued by the American Academy of Pediatrics on Monday.

The push to aggressively screen and medicate for high cholesterol in children is certain to create controversy amid a continuing debate about the use of prescription drugs in children as well as the best approaches to ward off heart disease in adults.

But proponents say there is growing evidence that the first signs of heart disease show up in childhood, and with 30 percent of the nation’s children overweight or obese, many doctors fear that a rash of early heart attacks and diabetes is on the horizon as these children grow up.

Previously, the academy had said cholesterol drugs should be considered in children older than 10 if they fail to lose weight after a 6- to 12-month effort. The academy estimated that under the current guidelines, 30 percent to 60 percent of children with high cholesterol were being missed. And for some children, cholesterol-lowering drugs, called statins, may be their best hope of lowering their risk of early heart attack, proponents said.

“We are in an epidemic,” said Dr. Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. “The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.”

Dr. Bhatia said that although there was not “a whole lot” of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.

Surprisingly, the paper published in the medical journal Pediatrics that explains the new guidelines notes that among adolescents, average total cholesterol levels as well as LDL and HDL cholesterol have remained stable, while triglyceride levels have dropped, based on data collected from 1988 to 2000.

It is not clear how many children would be affected by the new guidelines.
The recommendations call for cholesterol screening of children and adolescents, starting as early as the age of 2 and no later than the age of 10, if they come from families with a history of high cholesterol or heart attacks before 55 for men and 65 for women.

Screening is also recommended for children when family history is unknown, or if they have other risk factors, like being at or above the 85th percentile for weight, or have diabetes.

If the child’s cholesterol level is normal, retesting is suggested in three to five years. Although lifestyle changes are still recommended as the first course of action, drug treatment should be considered for children 8 years and older who have bad cholesterol of 190 milligrams per deciliter and who also have a family history of early heart disease or two additional risk factors, the new recommendations say.

The guidelines give no guidance on how long a child should stay on drug treatment.

But they do say the first goal should be to lower bad cholesterol levels to less than 160 milligrams or possibly as low as 110 milligrams in children with a strong family history of heart disease or other risk factors like obesity.

Because statins have been around since only the mid-1980s, there is no evidence to show whether giving statins to a child will lower the risk for heart attack in middle age.

The academy also now recommends giving children low-fat milk after 12 months if a doctor is concerned about future weight problems. Although children need fat for brain development, the group says that because children often consume so much fat, low-fat milk is now appropriate.

http://www.nytimes.com/aponline/health/AP-MED-Children-Cholesterol.html
THE ASSOCIATED PRESS
Cholesterol drugs recommended for some 8 – year – olds By LINDSEY TANNER July 7, 2008

CHICAGO – For the first time, an influential doctors group is recommending that some children as young as 8 be given cholesterol-fighting drugs to ward off future heart problems.

It is the strongest guidance ever given on the issue by the American Academy of Pediatrics, which released its new guidelines Monday. The academy also recommends low-fat milk for 1-year-olds and wider cholesterol testing.

Dr. Stephen Daniels, of the academy’s nutrition committee, says the new advice is based on mounting evidence showing that damage leading to heart disease, the nation’s leading killer, begins early in life.

It also stems from recent research showing that cholesterol-fighting drugs are generally safe for children, Daniels said.

Several of these drugs are approved for use in children and data show that increasing numbers are using them.

“If we are more aggressive about this in childhood, I think we can have an impact on what happens later in life … and avoid some of these heart attacks and strokes in adulthood,” Daniels said. He has worked as a consultant to Abbott Laboratories and Merck & Co., but not on matters involving their cholesterol drugs.

Drug treatment would generally be targeted for kids at least 8 years old who have too much LDL, the “bad” cholesterol, along with other risky conditions, including obesity and high blood pressure.

For overweight children with too little HDL, the “good” cholesterol, the first course of action should be weight loss, more physical activity and nutritional counseling, the academy says.

Pediatricians should routinely check the cholesterol of children with a family history of inherited cholesterol disease or with parents or grandparents who developed heart disease at an early age, the recommendations say. Screening also is advised for kids whose family history isn’t known and those who are overweight, obese or have other heart disease risk factors.

Screening is recommended sometime after age 2 but no later than age 10, at routine checkups.

The academy’s earlier advice said cholesterol drugs should only be considered in children older than 10 after they fail to lose weight. Its previous cholesterol screening recommendations also were less specific and did not include targeted ages for beginning testing.

Because obesity is a risk factor for heart disease and often is accompanied by cholesterol problems, the academy recommendations say low-fat milk is appropriate for 1-year-olds “for whom overweight or obesity is a concern.”

Daniels, a pediatrician in the Denver area, agreed that could include virtually all children. But he said doctors may choose to offer the new milk advice only to 1-year-olds who are already overweight or have a family history of heart problems.

The academy has long recommended against reduced-fat milk for children up to age 2 because saturated fats are needed for brain development.

“But now we have the obesity epidemic and people are thinking maybe this isn’t such a good idea,” said Dr. Frank Greer of the University of Wisconsin, co-author of the guidelines report, which appears in the July edition of Pediatrics, the group’s medical journal.

Very young children are increasingly getting fats from sources other than milk and Greer said the updated advice is based on recent research showing no harm from reduced-fat milk in these youngsters.

With one-third of U.S. children overweight and about 17 percent obese, the new recommendations are important, said Dr. Jennifer Li, a Duke University children’s heart specialist.

“We need to do something to stem the tide of childhood obesity,” Li said.

Li said that 15 years ago most of her patients with cholesterol problems had an inherited form of cholesterol disease not connected to obesity.

“But now they’re really outnumbered” by overweight kids with cholesterol problems and high blood pressure, she said.

Dr. Elena Fuentes-Afflick, a pediatrics professor at the University of California at San Francisco, also praised the new advice but said some parents think their kids will outgrow obesity and cholesterol problems, and might not take it seriously.

“It’s hard for people to really understand” that those problems in childhood can lead to serious health consequences in adulthood, Fuentes-Afflick said.

 

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