8:00 Call to Order and Opening Remarks Allan Gibofsky, M.D., J.D.
Introductions Chair, AAC
Conflict of Interest Statement Jayne E. Peterson, R.Ph., J.D.
Acting Executive Secretary, AAC, FDA
8:15 Welcome Brian E. Harvey, M.D., Ph.D.
Acting Director, Div. of Anti-Inflammatory,
Analgesic, and Ophthalmologic Drug Products (DAAODP), FDA
Introduction and Overview of the Topic Joel Schiffenbauer, M.D.
8:45 Background and Scientific Status John J. Cush, M.D.
9:30 Merck Research Laboratories
Introduction Agustin Melian, M.D.
Director, Clinical Research
Merck Research Laboratories
Design Considerations in Acute Gouty David I. Daikh, M.D., Ph.D.
Arthritis Studies Assistant Professor of Medicine
University of California at San Francisco
San Francisco VA Medical Center
Experience of Etoricoxib and Indomethacin Agustin Melian, M.D.
In Acute Gouty Arthritis
Lessons Learned David I. Daikh, M.D., Ph.D.
1:00 Open Public Hearing
2:00 Committee Discussion and Questions
Special Government Employee (SGE) Consultants (Voting)
Michael H. Weisman, M.D. H. James Williams, M.D.
Professor of Clinical Medicine Professor of Medicine
UCLA Dept. of Internal Medicine
Director, Div. of Rheumatology Div. of Rheumatology
Dept. of Medicine University of Utah
Cedars-Sinai Medical Center 50 North Medicine Drive
8700 Beverly Blvd., B-131 Salt Lake City, Utah 84132
Los Angeles, California 90048
Bruce N. Cronstein, M.D.
Brian F. Mandell, M.D., Ph.D. Professor of Medicine and Pathology
Clinical Professor of Medicine NYU Medical Center
Penn State Hershey School of Medicine Department of Medicine
Cleveland Clinic, Div. of Medicine Division of Rheumatology
Dept. of Rheumatology 550 First Avenue
9500 Euclid Ave., A50 New York, New York 10016
Cleveland, Ohio 44195
Government Employee Participants/Discussants (Voting)
Robert Terkeltaub, M.D. Marc C. Hochberg, M.D., MPH
Chief, VAMC Rheumatology Section Professor of Medicine
Professor of Medicine in Residence, UCSD Head, Division of Rheumatology and
Director, UCSD Rheumatology Training Program Clinical Immunology
Associate Division Director, UCSD Rheumatology School of Medicine
Allergy-Immunology Division University of Maryland
VAMC, 1111-K, 3350 La Jolla 22 South Greene Street
Village Drive Baltimore, Maryland 21201
San Diego, California 02161
H. Ralph Schumacher, M.D.
Professor of Medicine, Division of Rheumatology
University of Pennsylvania, School of Medicine
VA Medical Center
University and Woodland Avenue
Philadelphia, Pennsylvania 19104