Recent guidelines recommending cholesterol tests for children fail to weigh health benefits against potential harms and costs, according to a new commentary authored by three physician-researchers at UCSF.
Moreover, the recommendations are based on expert opinion, rather than solid evidence, the researchers said, which is especially problematic since the guidelines' authors disclosed extensive potential conflicts of interest.
The guidelines were written by a panel assembled by the National Heart, Lung and Blood Institute ( NHLBI) and published in Pediatrics, in November 2011. They also were endorsed by the American Academy of Pediatrics. The guidelines call for universal screening of all 9 to 11-year-old children with a non-fasting lipid panel, and targeted screening of 30 to 40 percent of 2 to 8-year-old and 12 to 16-year old children with two fasting lipid profiles. Previous recommendations called only for children considered at high risk of elevated levels to be screened with a simple non-fasting total cholesterol test.
The call for a dramatic increase in lipid screening has the potential to transform millions of healthy children into patients labeled with so-called dyslipidemia, or bad lipid levels in the blood, according to the commentary by Thomas Newman, MD, MPH, Mark Pletcher, MD, MPH and Stephen Hulley, MD, MPH, of the UCSF Department of Epidemiology and Biostatistics and e-published on July 23 in Pediatrics.
"The panel made no attempt to estimate the magnitude of the health benefits or harms of attaching this diagnosis at this young age," said Newman. "They acknowledged that costs are important, but then went ahead and made their recommendations without estimating what the cost would be. And it could be billions of dollars."
Some of the push to do more screening comes from concern about the obesity epidemic in U.S. children. But this concern should not lead to more laboratory testing, said Newman. "You don't need a blood test to tell who needs to lose weight. And recommending a healthier diet and exercise is something doctors can do for everybody, not just overweight kids," he said
The requirement of two fasting lipid panels in 30 to 40 percent of all 2 to 8-year olds and 12 to 16 -year- olds represents a particular burden to families, he said.
"Because these blood tests must be done while fasting, they can't be done at the time of regularly scheduled 'well child' visits like vaccinations can," said Newman. "This requires getting hungry young children to the doctor's office to be poked with needles on two additional occasions, generally weekday mornings. Families are going to ask their doctors, 'Is this really necessary?' The guidelines provide no strong evidence that it is."
The authors note that the panel chair and all members who drafted the lipid screening recommendations disclosed an "extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments." Some of those relevant relationships include paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs such as Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Roche and Sankyo.
"The panel states that they reviewed and graded the evidence objectively," said Newman. "But a recent Institute of Medicine report recommends that experts with conflicts of interest either be excluded from guideline panels, or, if their expertise is considered essential, should have non-voting, non-leadership, minority roles."
Evidence is needed to estimate health benefits, risks and costs of these proposed interventions, and experts without conflicts of interest are needed to help synthesize it, according to Newman. He said that "these recommendations fall so far short of this ideal that we hope they will trigger a re-examination of the process by which they were produced."
Newman and Hulley have no disclosures. Pletcher has NIH funding to support research on targeting of cholesterol-lowering medications to prevent cardiovascular disease.
- Thomas B. Newman, Mark J. Pletcher, and Stephen B. Hulley. Overly Aggressive New Guidelines for Lipid Screening in Children: Evidence of a Broken Process. Pediatrics, July 23, 2012 DOI: 10.1542/peds.2012-0481
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