to the editor: On December 8, 2003, I had the honor of testifying before the U.S. Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee in Washington, D.C. This adventure started with an editorial I wrote for the May 15, 2002, issue of American Family Physician.1 The third U.S. Preventive Services Task Force (USPSTF) found good evidence that the benefit of low-dose (81 mg) daily aspirin therapy in persons at high risk (10-year risk of at least 6 percent) for coronary heart disease (CHD) outweighs any potential harm.2 The USPSTF recommended that we discuss the benefits and harms of aspirin chemoprophylaxis with our at-risk patients, and this recommendation was subsequently endorsed by the American Heart Association (AHA) and the American Diabetes Association (ADA).
Nearly 18 months later I was contacted by the Bayer Health Care Organization, inviting me to participate in the FDA Advisory Committee meeting. When I asked them why they were contacting me, their reply was that they had read the AFP editorial1 and wanted a family physician to testify on the importance of primary prevention of CHD.
Over-the-counter drug labeling supplies information to consumers so they can safely self-medicate, while professional drug labeling provides advice to health care professionals on the safe and effective use of the drug. Currently, the approved professional labeling regarding cardiovascular indications for aspirin use includes suspected acute myocardial infarction (MI), prevention of recurrent MI, and unstable and chronic stable angina. Based on results of recent studies,3,4 Bayer submitted a Citizen’s Petition requesting the FDA’s approval for expanded cardiovascular indications and labeling for the use of a daily aspirin regimen (75 to 325 mg) in persons at high risk for CHD.
The day-long meeting with the FDA Advisory Committee was inspirational and humbling. Data were presented, analyzed, subanalyzed, and debated. I was part of a group who testified during the Open Public Hearing, which was then followed by a heated discussion by the advisory committee. The debate centered on the risk-benefit ratio of aspirin use. Despite studies totaling nearly 55,000 subjects, women and minorities were under-represented, and it was unclear exactly how many were in a low-risk CHD category compared with a moderate-risk category. While there was a 27 percent decrease in nonfatal MIs, the data were less clear with silent and fatal MIs. Although the committee ultimately voted against approval of the request, the reasons given for their votes were enlightening—many who voted “no” took daily aspirin themselves for prophylaxis! The proceedings from this committee can be found online athttp://www.fda.gov/ohrms/dockets/ac/cder03.html#CardiovascularRenal.
So, where does that leave family physicians? We have three major organizations (USPSTF, AHA, and ADA) recommending low-dose aspirin for primary prevention in persons at moderate to high risk for CHD, while the FDA notes that further studies need to be performed. Because these studies will probably not be performed, we are left to what we do best—talk to our patients. For patients who are at increased risk, we can talk to them about modifying their risk factors while discussing the risks and benefits of low-dose aspirin to arrive at a mutual decision. We then need to keep alert for further studies that may help resolve this dilemma.