McCrindle et al titled their response to our commentary, “Bringing Evidence to the Debate.” However, they primarily reiterated the rationale already in the guidelines, rather than bringing new evidence to address our concerns.
One concern was that the guideline did not address the cost-efficacy of its recommendations. McCrindle et al cited studies of the cost-efficacy of screening for the rare (1 in 500) genetic condition familial hypercholesterolemia (FH). However, such a narrowly focused screening program was not recommended in the guideline. The $8700 per year gained that they quote is irrelevant because it refers to a program to screen family members of known FH cases,1 not to the population-wide screening program they recommend, which would be far less cost-effective.
McCrindle et al are right in that our commentary contained opinions. So did theirs. It may help to highlight areas where we agree and disagree.
We agree that:
Childhood lipid levels can identify children at increased risk of arteriosclerosis decades later.
Clinical trials have shown that treating the 1 child in 500 who has FH can lead to improvements in intermediate outcomes such as coronary atherosclerosis.
Trials of whether treating the much larger number of children with high lipid levels as recommended by the proposed guidelines reduces future coronary events have not been done and are unlikely ever to be feasible.
Our areas of disagreement relate both to the aggressive nature of the National Heart, Lung, and Blood Institute guidelines and to the process by which they were produced.
We disagree that it is acceptable to make screening recommendations without estimating the health benefits, harms, and costs that might result. Because such estimates are essential for informed decision-making, we disagree that the “guidelines provide clinicians with the necessary evidence … to make their own informed judgment as to the utility and role for these recommendations.”
In the absence of randomized trial evidence of clinical event benefits, we disagree with making a “strong recommendation,” requiring a “compelling rationale for an alternative approach” (quoted from Tables 1–3, Evidence Grading System, Strength of Recommendations).2
Most important, we disagree that it is appropriate for panel members with extensive conflicts of interest to have leading roles in creating practice guidelines.
Conflicts of interest among authors of guidelines were discussed in a recent report3 from the Institute of Medicine (IOM). With the exception of disclosing conflicts, none of the panel's recommendations were followed (Table).
The panel members, however well-meaning, are only human, and it is unreasonable to believe that the large body of research on conflicts of interest that led to the IOM recommendations does not apply to them. A flawed process led to overly aggressive guidelines in which the strength of the evidence was misrepresented and key evidence needed to evaluate the guidelines was lacking. We can and should do better. Let's start by following this key IOM recommendation: scientists with extensive conflicts of interest should not be permitted to have leadership or voting roles on guideline panels.
Conflict of Interest:
Dr Pletcher has received National Institutes of Health funding to support research on targeting of cholesterol-lowering medications for prevention of cardiovascular disease. Drs Hulley and Newman have nothing to declare.
- Kavey R,
- Simons-Morton DG,
- de Jesus J
- 3.↵IOM (Institute of Medicine). Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press; 2009
- Copyright © 2013 by the American Academy of Pediatrics