Food and Drug Administration        

Center for Drug Evaluation and Research (CDER)


Arthritis Advisory Committee (AAC)


June 3, 2004


ACS Conference Room, Room 1066

5630 Fishers Lane, Rockville, MD




Issue:  Trial Design and Endpoints for Drugs for Acute Gout


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

Food and Drug Administration        

Center for Drug Evaluation and Research (CDER)


Arthritis Advisory Committee 


June 3, 2004


Meeting Participants


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