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Undisclosed Conflicts of Interest
IN RESPONSE:
I acknowledge that I should have disclosed my potential conflicts of interest; I did not do so previously because, after careful thought, I considered that they were either outdated or insufficiently related to the content of my presentation to warrant inclusion. My 3 articles cited by Dr. Musher (1-3) as representing research studies supported by Pfizer were, in fact, all from a single study, the Vascular Basis for the Treatment of Myocardial Ischemia Study, which was funded by a National Institutes of Health Research Project (RO1) grant and by the National Heart, Lung, and Blood Institute. These 3 articles comprise the design manuscript (1), the primary end point manuscript (2), and a small database study (3). Only a small proportion of supplemental funding for that clinical trial was provided by Pfizer, and there had not been funding from Pfizer for that study for more than 2 years before I wrote the Update. Since that clinical trial was completed, my relationship with Pfizer has been minimal.
The year 2004 was indeed extraordinary for the field of cardiology because research published that year dramatically expanded the understanding of the “lipid hypothesis” and clarified the role of inflammation in the clinical and anatomic manifestations of coronary atherosclerosis. Specifically, statin studies that were published in 2004 were unique because they compared an intensive regimen of atorvastatin with a less intense regimen of another statin, thereby enabling an evaluation of comparative efficacy based on magnitude of lipid-lowering or the specific agent used. In contrast, earlier studies of the clinical benefit of individual statins used only placebo controls. The landmark atorvastatin studies that I cited for 2004 provided critical information concerning optimal goals of lipid-lowering (4) and critical data correlating anatomic improvement in coronary atherosclerosis from lipid-lowering with statins to the clinical benefit of lipid-lowering therapy with statins (5). The results from these 2 atorvastatin studies led to revised recommendations of lipid-lowering goals by the National Cholesterol Education Program's Adult Treatment Panel III. A third innovative atorvastatin study expanded the role of lipid-lowering in primary prevention and was terminated prematurely because an interim analysis found a significant benefit in the active treatment group (6). The apparent disproportion of atorvastatin studies in 2004 was attributable to the fact that most of the year's important studies of lipid-lowering strategies used atorvastatin. My focus on these studies was balanced by a presentation of a broad spectrum of cardiology topics: coronary revascularization strategies in stable and unstable coronary syndromes, new pharmacologic therapy and device therapy for heart failure, management strategies for atrial fibrillation, public use of automatic external defibrillators, management strategies for high-risk coronary patients undergoing noncardiac surgery, percutaneous carotid stenting, and percutaneous heart valve implantation.
To provide complete disclosure of any perception of a potential financial conflict of interest, I have now revised my disclosure statement: “Dr. Stone received research grants from Pfizer (not active) and Boston Scientific Corporation (active), served on a now-defunct advisory board for CV Therapeutics, and has served on an advisory board for Pfizer (not active). He has received honoraria from Pfizer for several speaking engagements.”
Article and Author Information
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Potential Financial Conflicts of Interest: Honoraria: P.H. Stone (Pfizer Inc.); Grants received: P.H. Stone (Pfizer Inc. [inactive], Boston Scientific); Advisory boards: P.H. Stone (Pfizer Inc. [inactive], CV Therapeutics [inactive]).
