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Review of the Fialuridine (FIAU) Clinical Trials (1995)

Chapter: Appendix C: Agendas from the Three Committee Meetings

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Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
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C Institute of Medicine Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials

First Committee Meeting

Monday and Tuesday, July 25-26, 1994

The Foundry Building (Room 2004)

AGENDA

MONDAY, July 25, 1994

8:30 a.m.

EXECUTIVE SESSION

 

Welcoming remarks, introductions and charge to committee

 

Joseph S. Cassells, M.D.

(IOM Interim Executive Officer)

 

Morton Swartz, M.D.

(Professor of Medicine, Harvard Medical School; Chief, James Jackson Firm; and Emeritus Chief, Infectious Disease Unit, Medical Services, Massachusetts General Hospital)

 

Frederick J. Manning, Ph.D.

(Study Director)

 

Discussion of bias/conflict of interest issues

 

Joseph Cassells

10:15 a.m.

Break

10:30 a.m.

Findings of the FDA Office of Compliance

 

Mary L. Richardson

(Acting Director, Division of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration)

Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×

 

Ross Pierce, M.D.

(Medical Officer, Clinical Investigations Branch, Division of Scientific Investigations, Office of Compliance, (CDER), U.S. Food and Drug Administration)

12:00 Noon

Luncheon Buffet, Meeting Room 2004

1:00 p.m.

Report of the FDA Task Force on Fialuridine: Hepatic and Pancreatic Toxicity

 

Roger L. Williams, M.D.

(Associate Director for Science and Medical Affairs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration)

2:00 p.m.

Role of the Division of Anti-Vital Drug Products

 

David Feigal, M.D.

(Director, Division of Anti-Viral Drug Products, Office of Drug Evaluation, CDER, U.S. Food and Drug Administration)

3:15 p.m.

Break

3:30 p.m.

Review of Studies R91-010 and PPPC

 

Jay H. Hoofnagle, M.D.

(Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health)

5:00 p.m.

Meeting Adjourns for the Day

TUESDAY, July 26, 1994

8:00 a.m.

Review of Studies R89-001 and R90-001

 

Lawrence Corey, M.D.

(Professor, Laboratory Medicine, Microbiology and Medicine, Virology Office, University of Washington, Seattle)

Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×

 

Douglas D. Richman, M.D.

(Professor of Pathology and Medicine, University of California, San Diego)

 

Stephen E. Straus, M.D.

(Chief Laboratory of Clinical Investigation, Medical Virology Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health)

10:00 a.m.

Review of Preclinical Studies

 

John Emmerson, Ph.D.

(Distinguished Lilly Research Scholar, Toxicology Division, Eli Lilly)

11:00 a.m.

Eli Lilly Overview

 

Donald G. Therasse, M.D.

(Director, Anti-Infective Division, Eli Lilly Research Laboratories )

 

Allan J. Weinstein, M.D.

(Vice President, Eli Lilly Research Laboratories)

12:15 p.m.

Lunch, Meeting Room 2004

1:00 p.m.

Report to the Director, NIH, of the Director's Advisory Committee's (DAC) Subcommittee to Review FIAU Studies

 

David R. Challoner, M.D.

(Vice-President for Health Affairs, University of Florida)

 

David M. Kipnis, M.D.

(Distinguished University Professor of Medicine, Washington University School of Medicine)

2:15 p.m.

EXECUTIVE SESSION

 

Barbara Rice, NAS Office of News and Public Information

 

Discussion of Work Plan

3:00 p.m.

Break

3:15 p.m.

Continuation of Work Plan Discussion

Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×

5:00 p.m.

Adjourn

INSTITUTE OF MEDICINE COMMITTEE TO REVIEW THE FIALURIDINE (FIAU/FIAC) CLINICAL TRIALS

Second Committee Meeting

Thursday and Friday, September 8-9, 1994

Cecil and Ida Green Building

Room 116

AGENDA

THURSDAY, Sept. 8, 1994

8:00 a.m.

EXECUTIVE SESSION (study outline; tape; report on patient interviews )

9:30 a.m.

Presentations to the Committee

 

Judith Fallon, M.D.

(Former Chair, Institutional Review Board NIAID)

 

Howard Austin, M.D.

(Chair, Institutional Review Board NIDDK)

10:30 a.m.

David Feigel, M.D.

(Director, Antiviral Drug Division CDER, FDA)

12:00 Noon

Lunch

1:00 p.m.

Continuation of presentations

 

Barbara Savarese, R.N.

(Study Coordinator R-90, R-91, 6-mo. trials)

2:00 p.m.

Robin McKenzie, M.D.

(Medical Officer, NIAID, Associate Investigator, 6 mos. trial)

Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×

3:00 p.m.

Yoon Park, R.N.

(Clinical Nurse, Warren Grant Magnuson Clinical Center, R-90, R-91, 6-mo. studies)

4:00 p.m.

EXECUTIVE SESSION

5:00 p.m.

Meeting Adjourns for the Day

FRIDAY, Sept. 9, 1994

8:00 a.m.

Presentations to the Committee

 

Peter Barton Hutt, LL.D.

(Former General Counsel FDA)

10:00 a.m.

Mary Richardson

(Deputy Director, Division of Scientific Investigations, Office of Compliance, CDER, FDA)

 

Ross Pierce, M.D.

(Division of Scientific Investigations, Office of Compliance CDER)

12:00 p.m.

Lunch

1:00 p.m.

EXECUTIVE SESSION (study plan, writing assignments, info needs)

INSTITUTE OF MEDICINE COMMITTEE TO REVIEW THE FIALURIDINE (FIAU/FIAC) CLINICAL TRIALS

Third Committee Meeting

Wednesday and Thursday, November 16-17, 1994

The Foundry Building

Room 2004

AGENDA

WEDNESDAY, Nov. 16, 1994

8:30 a.m.

Review of Draft Report Sections

Each author in turn; see attached outline

Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×

10:15 a.m.

Break

10:30 a.m.

Resume Review of Draft Sections

12:00 Noon

Luncheon Buffet, Meeting Room 2004

1:00 p.m.

Assemble Recommendations and Conclusions

2:30 p.m.

Break

3:00 p.m.

Revision of Report Sections

On laptops in 2004 or at HSPD Offices

5:00 p.m.

Meeting Adjourns for the Day

THURSDAY, Nov. 17, 1994

8:00 a.m.

Review of Revised and New Sections

10:15 a.m.

Break

10:30 a.m.

Resume Review

12:00 p.m.

Lunch, Meeting Room 2004

1:00 p.m.

Resume Review

3:15 p.m.

Rewrites as necessary

5:00 p.m.

Adjourn

Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×
Page 178
Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×
Page 179
Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×
Page 180
Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×
Page 181
Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×
Page 182
Suggested Citation:"Appendix C: Agendas from the Three Committee Meetings." Institute of Medicine. 1995. Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/4887.
×
Page 183
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In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants.

In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.

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