**FDA Consultants**

**(Voting)**

Steven Abramson, M.D.

Professor and Chairman, Division of Rheumatology

NYU School of Medicine

Hospital for Joint Diseases

301 East 17th Street

New York, New York 10003

Ralph B. D'Agostino, Ph.D.

Professor of Mathematics/Statistics

and Public Health

Boston University

111 Cummington Street

Boston, Massachusetts 02215

Robert H. Dworkin, Ph.D.

Professor of Anesthesiology

Neurology, Oncology and Psychiatry\
University of Rochester\
School of Medicine and Dentistry\
601 Elmwood Avenue, Box 604\
Rochester, New York 14642

Janet Elashoff, Ph.D.

Director, Division of Biostatistics

Cedars-Sinai Medical Center

8700 Beverly Boulevard

Los Angeles, California 90048

John T. Farrar, M.D.

Senior Scholar

University of Pennsylvania

Center for Clinical Epidemiology and Biostatistics

Room 816, Blockley Hall

423 Guardian Drive

Philadelphia, Pennsylvania 19104

**PATIENT REPRESENTATIVE**

Leona M. Malone, L.C.S.W.

8D Lexington Lane East

Palm Beach Gardens, Florida 33418

Thomas Fleming, Ph.D.

Professor and Chairman

Department of Biostatistics

University of Washington

Health Sciences Bldg., Room F-600

1705 Pacific Ave., NE

Seattle, Washington 98195

Charles H. Hennekens, M.D.

Visiting Professor of Medicine &

Epidemiology and Public Health

University of Miami, School of Medicine

2800 South Oceans Blvd., PHA

Boca Raton, Florida 33432

Steven Nissen, M.D.

Medical Director, Cleveland Clinic\
Cardiovascular Coordinating Center\
Department of Cardiovascular Medicine

9500 Euclid Ave.

Cleveland, Ohio 44195

Emil Paganini, M.D., FACP, FRCP

Section Head, Dialysis

Cleveland Clinic Foundation

9500 Euclid Avenue, M82

Cleveland, Ohio 44195

Steven L. Shafer, M.D.

Professor of Anesthesia

Stanford University

VA Palo Alto Health Service Care Center System

531 Miranda Avenue

Palo Alto, California 94304

Alastair J.J. Wood, M.D. **(Meeting Chair)**

Assistant Vice Chancellor

Professor of Medicine,

Professor of Pharmacology

Vanderbilt University Medical Center

23^rd^ Avenue S. at Pierce Avenue

Room 550 RRB

Nashville, Tennessee 37232-6602

**FDA CONSULTANTS**

**(NON-VOTING)**

Byron Cryer, M.D. (**Speaker and Discussant**)

Associate Professor of Medicine

Division of Gastroenterology

University of Texas Southwestern Medical School

4500 S. Lancaster Road (111B1)

Dallas, Texas 75216

Milton Packer, M.D. **(Speaker only)**

Center for Biostatistics and Clinical Sciences

University of Texas Southwestern Medical School

5323 Harry Hines Blvd

Dallas, Texas 75390

**NATIONAL INSTITUTES OF HEALTH PARTICIPANTS**

**(VOTING)**

Richard O. Cannon III, M.D.

Clinical Director, Division of Intramural Research

National Institutes of Health

Building 10-CRC, Room 5-3330

10 Center Drive

Bethesda, Maryland 20892-1454

Michael J. Domanski, M.D.

Head, Clinical Trials Group

National Heart, Lung, and Blood Institute

10 Center Drive

Bethesda, Maryland 20892-1454

Lawrence Friedman, M.D.

National Institutes of Health

31 Center Drive, MSC 2490

Bethesda, Maryland 20892-2490

**GUEST SPEAKERS**

**(NON-VOTING)**

Garret A. FitzGerald, M.D.

Department of Pharmacology

University of Pennsylvania School of Medicine

Room 153, Johnson Pavilion

3620 Hamilton Walk

Philadelphia, Pennsylvania 19104-6084

Ernest Hawk, M.D., M.P.H.

National Institutes of Health

National Cancer Institute

Director, Office of Centers

NCI/OD/NIH

6116 Executive Blvd., Suite 7000

Bethesda, Maryland 20892

Constantine Lyketsos, M.D., M.H.S.

The Johns Hopkins Medical Institutions

The Johns Hopkins Hospital

Department of Psychiatry

600 North Wolfe Street

Baltimore, Maryland 21287

Bernard Levin, M.D.

M.D. Anderson Cancer Center

The University of Texas

1515 Holcombe Blvd

Houston Texas, 77030

**FDA PARTICIPANTS**

**CENTER FOR DRUG EVALUATION AND RESEARCH**

Jonca Bull, M.D.

Director, Office of Drug Evaluation V

Office of New Drugs

David Graham, M.D., M.P.H.

Medical Officer

Office of Pharmaceutical Science,

Office of Pharmacoepidemiology and Statistical Science

Brian Harvey, M.D.

Deputy Director, Office of Drug Evaluation V

Office of New Drugs

Sharon Hertz, M.D.

Deputy Director, Division of Anti-Inflammatory, Analgesic and
Ophthalmologic Drug Products

John Jenkins, M.D., F.C.C.P.

Director, Office of New Drugs

Sandy Kweder, M.D.

Deputy Director, Office of New Drugs

Robert O\'Neil, Ph.D.

Director, Office of Biostatistics

Joel Schiffenbauer, M.D.

Medical Officer

Division of Anti-Inflammatory, Analgesic and

Ophthalmologic Drug Products

Paul Seligman, M.D.

Director, Office of Pharmacoepidemiology and Statistical Science

Robert Temple, M.D.

Director, Office of Drug Evaluation I

Anne Trontell, M.D., M.P.H.

Deputy Director, Office of Drug Safety

Lourdes Villalba, M.D.

Medical Officer

Division of Anti-Inflammatory, Analgesic and

Ophthalmologic Drug Products

James Witter, M.D., Ph.D.

Medical Team Leader

Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug
Products