Food and Drug Administration
Center for Drug Evaluation and Research
Summary Minutes of the
Gastrointestinal Drugs Advisory Committee
8777 Georgia Ave., Silver Spring, MD
March 19, 2002
M. Michael Wolfe, M.D., Chair Joel Richter, M.D.
Nancy L. Geller, Ph.D. Michael Camilleri, M.D.
Maria H. Sjogren, M.D. Byron Cryer, M.D.
Ronald Fogel, M.D. John Thomas LaMont, M.D.
Robert Alan Levine, M.D. David Colin Metz, M.D.
Scott Lippman, M.D. Curt Furberg, M.D.
Nancy A. Roach
Bernard Levin, M.D. John A. Baron, M.D.
Alex Krist, M.D. Anil Rustgi, M.D.
David F. Ransohoff, M.D. Barry Kramer, M.D.
David A. Lieberman, M.D. George S. Goldstein, M.D.
Florence Houn, M.D Victor Raczkowski, M.D.
Mark Avigan, M.D. Rick Pazdur, M.D.
These summary minutes for the March 19, 2002 meeting of the Gastrointestinal Drugs Advisory Committee were approved on March 29, 2002.
I certify that I attended the March 19, 2002 meeting of the Gastrointestinal Drugs Advisory Committee and that these minutes accurately reflect what transpired.
Thomas H. Perez, M.P.H., R.Ph. M. Michael Wolfe, M.D.
Executive Secretary Chair
This report contains public information that has not been reviewed by the agency or the Gastrointestinal Drugs Advisory Committee. The official summary minutes will be prepared, circulated, and certified as usual. Transcripts will be available in about 12 days. External requests should be submitted to the Freedom of Information office.
The Gastrointestinal Drugs Advisory Committee of the Food and Drug Administration, Center for Drug Evaluation and Research met March 19, 2002 at the Holiday Inn, 8777 Georgia Ave., Silver Spring, MD
The committee discussed standards in study designs of clinical trials testing the efficacy and safety of chemopreventive agents that are being developed to gain FDA approval in reducing the risk of sporadic colorectal adenomatous polyps and sporadic colorectal cancer.
The Committee had received a briefing document from the FDA.
There were approximately 100 persons in the audience. The meeting was called to order at 8:00am by the Chair, M. Michael Wolfe, M.D. Thomas H. Perez, Executive Secretary of the Gastrointestinal Drugs Advisory Committee read the Meeting Statement. The Committee members and discussants introduced themselves.
The presentations began at 8:25 a.m. and proceeded as follows.
Epidemiology and Mechanisms of Colorectal Cancer
Anil K. Rustgi, M.D., T.Grier Miller Associate Professor of Medicine and Genetics; University of Pennsylvania
Colorectal Cancer Screening and Surveillance
David A. Lieberman, M.D., Chief, Division of Gastroenterology, Oregon Health Sciences University
Overview of Chemoprevention Trials
Bernard Levin, M.D., Vice President for Chemoprevention, Professor of Medicine, UTMD Anderson Cancer Ctr
Benefit and Risk Analysis for Chemoprevention of Sporadic Colorectal Cancer
Mark Avigan, M.D., C.M., Medical Officer, Division of Gastrointestinal and Coagulation Drug Products
The Open Public Hearing included six participants, and began at approximately 11:00 a.m.
Robert S. Sandler, M.D., consultant for Merk Pharmaceuticals
Priscilla Savary, Colorectal Cancer Network
Gary Gordon, M.D., National Cancer Institute
Ernie Hawk, M.D., National Cancer Institute
Gary Kelloff, M.D., National Cancer Institute
The meeting was reconvened after lunch at approximately 1 p.m.
Introduction to the Questions by Mark Avigan, M.D., and
Charge to the Committee by Victor F.C. Raczkowski, M.D.
A thorough discussion of the questions followed, and the meeting was adjourned at 4:40 p.m.
The Committee discussed the following questions to which no votes were requested or taken. The complete discussion will be made available through the verbatim meeting transcripts. The trascript will be posted on the FDA Webpage.
Questions for Gastrointestinal Drugs Advisory Committee
Chemoprevention of Sporadic Colorectal Cancer (CRC)
March 19, 2002
If adenomatous polyp suppression is not a clinically meaningful benefit, what additional information would be needed to demonstrate that partial or complete suppression of polyps is of clinical benefit in such individuals?