According to three UCSF researchers, recent guidelines that recommend children to be tested for cholesterol levels fail to weigh health benefits against potential harms and costs. The researchers highlight the fact that the recommendations, published in Pediatrics, are not based on solid evidence, but on expert opinion, which raises the issue of potential conflict of interest due disclosure of the guidelines’ authors.
The guidelines, which call for all 9 to 11-year-olds with a non-fasting lipid panel to be screened, and targeted screening of 30 to 40% of 2 to 8-year-old and 12 to 16-year olds with two fasting lipid profiles, were written in November 2011 by a panel assembled by the National Heart, Lung and Blood Institute (NHLBI) and endorsed by the American Academy of Pediatrics. Earlier recommendations included screening only children considered at high risk of elevated levels by using a simple non-fasting total cholesterol test.
According to the comment published online in the July 23 issue of Pediatrics, Thomas Newman, MD, MPH, Mark Pletcher, MD, MPH and Stephen Hulley, MD, MPH, of the UCSF Department of Epidemiology and Biostatistics warn that such a drastic increase in lipid screening has the potential to transform millions of healthy children into patients labeled with dyslipidemia, i.e. bad lipid levels in the blood.
“The panel made no attempt to estimate the magnitude of the health benefits or harms of attaching this diagnosis at this young age. 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.”
He acknowledges the fact that part of the argument for increased screening is due to concerns about the obesity epidemic in U.S. children. However, he continues saying that this should not lead to more laboratory testing. He adds: “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.”
Having to screen two fasting lipid panels in 30 to 40% of all 2 to 8-year olds and 12 to 16-year old children puts a particular burden onto families. He explains: “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. 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 of the comment point out that the panel chair and all members involved in drafting the lipid screening recommendations disclosed an “extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments.”
Some of these disclosures consisted of relevant relationships that included paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs, including companies like Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Sankyo and Roche.
“The panel states that they reviewed and graded the evidence objectively. 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.”
He points out that what is needed is evidence to estimate health benefits, risks and costs of these proposed interventions, and experts who have no conflict of interest to help attain this, stating: “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, whilst Pletcher has received NIH funding to support research on targeting of cholesterol-lowering medications to prevent cardiovascular disease.
Written by Petra Rattue