Primary prevention with over-the-counter statins: A cautionary tale

Abstract

F f c “ t s On January 14, 2005, I voted, reluctantly, against aking a statin (lovastatin) available over the counter OTC) for primary prevention of cardiovascular disase. I was one of the 20 members of a Food and Drug dministration (FDA) advisory committee who did so 4 committee members voted in favor). Why my relucance? I was reluctant because in my book primary prevenion, in both individual patients and populations, is a ood thing, vastly preferable to such things as angiolasty and bypass surgery. And statins, with their subtantial efficacy and relatively low toxicity, appear at rst glance to be “poster drugs” for primary prevention. When they were first introduced, I found myself thinkng that they should probably be put in the drinking ater.) On the basis of that principle alone, therefore, I ould have voted for approval. So why did I vote gainst it? Strom has recently articulated at least 11 “core” linical concerns that led him to conclude the followng: “Although statins are great prescription drugs, hese considerations suggest that they would make poor ver-the-counter drugs.” These concerns were as folows. (1) Unlike the indications for virtually all other TC drugs, the condition being treated is not selfiagnosable. (2) Contrary to the conditions for use of ll other OTC drugs, OTC statin therapy is expected to e long term. (3) Efficacy is dose-related and requires onitoring for titration, which is optional for OTC use. 4) The lower dose proposed for OTC availability, rimarily to increase the margin of safety, could preent more appropriate dosing. (5) OTC users might istakenly conflate more serious disease (eg, angina) ith hypercholesterolemia. (6) People might use the