C Workshop Agenda
Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities 7-8 April 1997
Objectives:
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to review newly available data
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to consider important ancillary issues
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to extract generic lessons from a specific case
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to explore preemptive approaches and mechanisms for introducing new contraceptives in the future
DAY ONE-MONDAY, 7 APRIL 1997 |
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8:30 a.m. |
OPENING STATEMENT, CHARGE TO COMMITTEE, PARTICIPANTS Allan Rosenfield, Chair |
8:45 |
WHAT INTERNATIONAL DATA TELL US NOW: (Committee Rapporteur: Hedia Belhadj) Data and Analysis from WHO/HRP, Family Health International, and Population Council Postmarketing Surveillance Olav Meirik, WHO/HRP Paul Van Look WHO/HRP |
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QUESTIONS AND COMMENTS |
10:00 |
WHAT U.S. DATA TELL US NOW: (Committee Rapporteur: Nancy Buc) Data and Analysis: NICHD and Kaiser-Funded Clinic-Based Studies Andrew Davidson, Columbia University Debra Kalmuss, Columbia University |
10:30 |
Helen Koo, Research Triangle Institute |
11:00 |
Data and Analysis from 1995 National Survey of Family Growth Jacqueline Darroch, Alan Guttmacher Institute |
11:30 |
Data and Analysis from Population Council Studies Irving Sivin, Population Council |
12 noon |
QUESTIONS AND COMMENTS |
12:15 p.m. |
LUNCH |
1:00 |
A RANGE OF PERSPECTIVES: SOME PREPARED REMARKS AND A DIALOGUE (Committee Rapporteur: Rebecca Cook) Cynthia Pearson, National Women's Health Network Julia Scott, National Black Women's Health Project Ellen Moskowitz, Hastings Center Martha Ellen Katz, Department of Social Medicine, Harvard Medical School; Martha Eliot Health Center, Children's Hospital |
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QUESTIONS AND COMMENTS |
2:30 |
IMPLANT REMOVAL AND TRAINING (Committee Rapporteur: Judy Norsigian) |
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Clinical Issues: David Archer, Eastern Virginia Medical/Jones Institute |
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Case Material: United Kingdom: Angela Davey, Hoechst-Marion-Roussel, United Kingdom with Lynne Gaffikin, JHPIEGO Baltimore: Paul Blumenthal, Johns Hopkins Bayview Medical Center Indonesia: Paul Blumenthal, Ruth Simmons, University of Michigan |
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METHOD COST-EFFECTIVENESS: IMPLICATIONS FOR NEW FORMULATIONS (Committee Rapporteur: David Mowery) Felicia Stewart, Kaiser Family Foundation |
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QUESTIONS AND COMMENTS |
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BREAK ad libitum |
3:30 |
BIOCOMPATIBILITY, MEDICAL APPLICATIONS OF SILICONE-BASED MATERIALS: REVIEW OF PERTINENT FINDINGS (Committee Rapporteur: Donald McDonnell) James Anderson, Case Western Reserve Noel Rose, Johns Hopkins |
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VAGINAL HIV/SIV TRANSMISSION Monkey SIV Data: Preston Marx, Aaron Diamond Research Center Human Epidemiologic Data: Ward Cates, Family Health International |
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QUESTIONS AND COMMENTS |
5:30 |
CHAIRMAN'S INSTRUCTIONS, ADJOURNMENT |
DAY TWO-TUESDAY, 8 APRIL 1997 |
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8:30 |
SUMMATION: WHAT HAVE WE HEARD? WHERE DOES IT LEAVE US? |
9:00 |
LOOKING TO THE FUTURE A Federal Standards Defense: What Difference Might It Make? Michael Green, Iowa Law Center |
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The Reproductive Health Technologies Project: Objectives and Plans Marie Bass, Bass and Howes, Inc. |
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WHO Strategic Initiative for Introduction of New Methods: Illumination from Early Experience Ruth Simmons |
9:45 |
OTHER PREPARATORY AND PREVENTIVE APPROACHES Lead Discussants: Ruth Macklin, Albert Einstein College of Medicine Marian Secundy, Howard University Program in Clinical Ethics |
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GENERAL DISCUSSION Tutti |
12:30 p.m. |
ADJOURNMENT |
NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE
WORKSHOP
Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities
7 April 1997—Lecture Room
8 April 1997—Members' Room
2101 Constitution Avenue, N.W.
Washington, DC 20418
PARTICIPANTS
James M. Anderson, MD, PhD
Professor of Pathology, Macromolecular Science, and Biomedical Engineering
Case Western Reserve University
Lisa Angerame
Government Relations Manager American Society for Reproductive Medicine
Washington, D.C.
Felice Apter, PhD
Research Division
Office of Population
U.S. Agency for International Development
David Archer, MD
Director of Clinical Research
The Jones Institute
Eastern Virgina Medical College
Marie Bass
Project Director
Reproductive Health Technologies Project
Washington, D.C.
Paul Blumenthal, MD
Associate Professor
Johns Hopkins University
Bayview Medical Center
Willard Cates, Jr., MD, MPH
Senior Vice President
Biomedical Affairs
Family Health International
Jacqueline E. Darroch, PhD
Senior Vice President
Vice President for Research
The Alan Guttmacher Institute
Angela Davey
Head, Medical Information Services
Hoechst Marion Roussel Ltd.
United Kingdom
Andrew R. Davidson, PhD, MBA
Center for Population and Family Health
Columbia University
Judith M. DeSarno
President and CEO
National Family Planning and Reproductive Health Association
Washington, D.C.
Henry L. Gabelnick, PhD
Director
Contraceptive Research and Development Program
Lynne Gaffikin, PhD
JHPIEGO Corporation
Baltimore, MD
Michael D. Green, JD
College of Law
University of Iowa
Gary Grubb, MD, MPH
Director
Women's Health Care
Wyeth Ayerst Laboratories
Diane Harrison, MD, FACOG
Director, Clinical Affairs
Medical Affairs Department
Wyeth-Ayerst Laboratories
Stephen F. Heartwell, MD
Associate Professor
Department of Obstetrics and Gynecology
University of Texas Southwestern Medical School
(Chair, Norplant Foundation)
Stephen Isaacs, JD
Center for Health and Social Policy
Pelham, New York
Lisa Kaeser
The Alan Guttmacher Institute
Washington, D.C.
Debra Kalmuss, PhD
Center for Population and Family Health
Columbia University
Martha Ellen Katz, MD
Department of Social Medicine
Harvard Medical School
Martha Eliot Health Center
Children's Hospital
Helen P. Koo, PhD
Research Triangle Institute
Johanna K. Kouru
General Counsel
Leiras Oy
Pekka Lahteenmaki, MD
Leiras Oy
Ruth Macklin, PhD
Professor
Department of Epidemiology and Social Medicine
Albert Einstein College of Medicine
Preston A. Marx, PhD
Aaron Diamond AIDS Research Center
AIDS Animal Models Laboratory at LEMSIP
Christine Mauck, MD
Medical Officer
Reproductive and Urologic Drug Products Division
Center for Drug Evaluation and Research
Food and Drug Administration
Olav Meirik, MD, PhD
Special Program of Research, Development, and Research Training in Human Reproduction
World Health Organization
Thomas Merrick
Advisor for Population
Human Development Department
The World Bank
Ellen Moskowitz, JD
Associate for Law
The Hastings Center
Susan F. Newcomer, PhD
Sociologist/Demographer
Demographic and Behavioral Sciences Branch
Center for Population Research
National Institute for Child Health and Human Development
Cynthia Pearson
Executive Director
National Women's Health Network
Marjorie Powell, JD
Assistant General Counsel
Pharmaceutical Research and Manufacturers Association
Noel Rose, MD, PhD
Professor
Department of Immunology and Infectious Disease
School of Hygiene and Public Health
Professor of Medicine
Johns Hopkins University
Julia R. Scott, RN
National Black Women's Health Network
Washington, D.C.
Marian Gray Secundy, EdD
Director, Program in Clinical Ethics
Department of Community Health and Family Practice
Howard University
College of Medicine
James Shelton, MD
Acting Chief
Office of Population
Bureau of Science and Technology
U.S. Agency for International Development
Ruth Simmons, PhD
Health Behavior and Health Education
School of Public Health
University of Michigan
Irving Sivin
Center for Biomedical Research
The Population Council
Jeffrey Spieler
Chief, Research Division
Office of Population
U.S. Agency for International Development
Robert Spirtas, DrPH
Chief
Contraceptive Evaluation Branch
Center for Population Research
National Institute of Child Health and Human Development
Felicia H. Stewart, MD
Director of Reproductive Health Programs
Henry J. Kaiser Family Foundation
Sean B. Tipton
Director of Public Affairs
The Endocrine Society
Paul Van Look, MD, PhD
Special Program of Research, Development, and Research Training in Human Reproduction
World Health Organization
Sandra Waldman, MA, MS
Director
Office of Public Information
The Population Council
Margaret Weber, MD
Senior Director, Clinical Affairs
Medical Affairs Department
Wyeth-Ayerst Laboratories