TO THE EDITOR: upon December 8, 200...

TO THE EDITOR: upon December 8, 2003, I had the honor of testifying before the U meat and Drug Administration's (FDA's) Cardiovascular and Renal put drugs intos Advisory Committee in Washington, DC This adventure started with an editorial I wrote for the May 15 2002 issue of American Family Physician. (1) The third U Preventive Services Task Force (USPSTF) rest good evidence that the benefit of low-dose (81 mg) daily aspirin therapy in [i]role[/i]s at high risk (10-year risk of at least 6 percent) for coronary heart disease (CHD) outweighs any potential harm. (2) The USPSTF commited that we discuss the benefits and harms of aspirin chemoprophylaxis with our at-risk patients, and this recommendation was subsequently endorsed by way of the American Heart Association (AHA) and the American Diabetes Association (ADA).

Nearly 18 month later I was contacted from the Bayer Health Care Organization, inviting me to participate in the FDA Advisory Committee meeting. When I asked them to what end they were contacting me, their answer was that they had read the AFP editorial 1 and wanted a family physician to testify onward the importance of primary prevention of CHD

Over-the-counter unsalable article labeling supplies information to consumer in this way they can safely self-medicate, while professional put drugs into labeling provides advice to health care professionals in succession the safe and effective use of the medicine Currently, the approved professional labeling regarding cardiovascular indications for aspirin use includes suspected acute myocardial infarction (MI), prevention of returning MI, and unstable and chronic stable angina. Based forward results of recent studies, (34) 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 bodily forms at high risk for CHD

The day-long meeting with the FDA Advisory Committee was inspirational and humbling. Data were at handed analyzed, subanalyzed, and debated. I was part of a cluster who testified during the explain Public Hearing, which was then followed by dint of a heated discussion by the advisory committee. The debate center forward the risk-benefit ratio of aspirin use. Despite studies totaling nearly 55000 enthralls women and minorities were under-represent and it was unclear exactly by what means many were in a low-risk CHD category compared with a moderaterisk category. While there was a 27 percent decrease in nonfatal MIs, the data were les clear with silent and fatal MIs. Although the committee ultimately vot against approval of the beg the reasons given for their voices were enlightening--many who voted "no" took daily aspirin themselves for prophylaxis! The proceedings from this committee can be originate online at http://www. fda.gov/ohrms/dockets/ac/cder03.html#Ca rdiovascularRenal.

in such a manner where does that leave family physicians? We have three major organizations (USPSTF, AHA, and ADA) recommending low-dose aspirin for primary prevention in bodys at moderate to high risk for CHD while the FDA notes that further studies ne 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 ne to restrain alert for further studies that may help separate this dilemma.

WILLIAM F MISER, MD

The Ohio State University

Department of Family Medicine

2231 N High St

Columbus, OH 43201

REFERENCES

(1) Miser WF An aspirin a day holds the MI away (for some) Am Fam Physician 2002;65:2000 2003

(2) U Preventive Services Task Force. Aspirin for the primary prevention of cardiovascular events: recommendations and rationale. Am Fam Physician 2002;65:2107-10

(3) Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and rap in high risk patients. BMJ 2002;324:71-86

(4) Eidelman R Hebert PR Weisman SM Hennekens CH An update upon aspirin in the primary prevention of cardiovascular disease. Arch Intern M 2003;163:2006-10

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