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
Staff
Physician
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.
10:30 Break
10:45 Discussion
11:30 Lunch
1:00 Open Public Hearing
2:00 Committee Discussion and
Questions
3:15 Break
5:00 Adjourn
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