Cardiovascular and Renal Drugs Advisory Committee


December 8, 2003


Hilton, The Ballrooms, Gaithersburg, MD



8:30 - 8:45 a.m. Call to Order and Introductions                           Jeffery Borer, M.D.

Chair, Cardiovascular and Renal Drugs

Advisory Committee


                        Conflict of Interest Statement                             Dornette Spell-LeSane, M.H.A., NP-C

                                                                                                Executive Secretary, FDA


8:45 - 9:00 a.m. Welcome and Introductory Comments                 Douglas Throckmorton, M.D.

                                                                        Division of Cardiovascular and Renal Drugs,





The committee will discuss whether aspirin should be recommended for primary prevention of myocardial infarction. Professional labeling for aspirin currently recommends its use for prevention of a second myocardial infarction.


9:00 a.m.          Sponsor Presentation


Introduction                                                                  Erica Peitler, RPh

                                                            Bayer HealthCare LLC

                                                            Morristown, NJ



Aspirin Benefit/Risk in Primary Prevention                      Thomas Pearson, M.D., M.P.H., Ph.D.

University of Rochester

School of Medicine, Rochester, NY


Safety/Efficacy in Moderate Risk                                    Colin Baigent, M.D.

Population                                                                     University of Oxford

                                                                                    Oxford, UK


Aspirin Use in Women                                                   C. Noel Bairey Merz, M.D.

                                                                                    Cedars-Sinai Medical Center

                                                                                    Los Angeles, CA


Cardiovascular and Renal Drugs Advisory Committee


December 8, 2003


Sponsor Presentations Cont.


Aspirin Utilization                                              Randall Stafford, M.D., Ph.D.

                                                                        Stanford School of Medicine

                                                                        Stanford, CA



Aspirin in Clinical Practice                                  Eric Topol, M.D.

The Cleveland Clinic Foundation

Cleveland Ohio


10:00 – 10:30                            Questions


10:30 – 10:45                            Break



10:45 – 11:15                            FDA Presentation       


                        Regulatory History of Aspirin

Michelle M. Jackson, Ph.D.

Interdisciplinary Scientist, Microbiologist

Division of Over-The-Counter

Drug Products, FDA


Statistical Analyses of the                                   Chenxiong (Charles) Le, Ph.D.

Bayer’s Citizens Petition                        Statistician

Division of Biometrics I,

Office of Biostatistics,

Office of Pharmacoepidemiology and Statistical Science, FDA



11:15 – 12:00                            Committee Discussions/Questions to the FDA


12:00 –  1:00                             Lunch


1:00 –    1:30                             Open Public Hearing


1:30 –    2:30                             Committee Discussions


2:30 –    2:45                             Break


2:45 –    4:45                             Committee Questions/Summary


5:00 p.m.                                  Adjournment