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Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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UNDERSTANDING THE BENEFITS AND RISKS OF PHARMACEUTICALS

Workshop Summary

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

Leslie Pray, Rapporteur

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

THE NATIONAL ACADEMIES PRESS

500 Fifth Street, N.W. Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This study was supported by contracts between the National Academy of Sciences and the Department of Health and Human Services (Contract Nos. 223-01-2460, HHSP233200600500P, HHSP23320042509X1, HHSP2330060043OP, and N01-OD-4-2139), the Department of Veterans Affairs (Contract No. V101(93)P-2136), Abbott Laboratories, American Diabetes Association, American Society for Microbiology, Amgen, Inc., Association of American Medical Colleges, AstraZeneca Pharmaceuticals, Blue Cross Blue Shield Association, Burroughs Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly and Company, Entelos, Inc., GlaxoSmithKline, Johnson and Johnson, March of Dimes Foundation, Merck and Company, Pfizer, Inc., Schering-Plough Research Institute, and UnitedHealth Group. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-10738-9

International Standard Book Number-10: 0-309-10738-5

Additional copies of this report are available from the

National Academies Press,

500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2007 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

Suggested citation: Institute of Medicine (IOM). 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press.

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

—Goethe

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES


Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION

Gail H. Cassell (Co-Chair),

Eli Lilly and Company (1/1/2005–12/31/2008)

Edward W. Holmes (Co-Chair),

National University of Singapore (1/1/2005–12/31/2008)

Naomi Aronson,

Blue Cross and Blue Shield Association (1/9/2007–12/31/2008)

Leslie Z. Benet,

University of California, San Francisco (1/1/2005–12/31/2008)

Nina Bhardwaj,

New York University School of Medicine (1/1/2005–9/7/2006)

Catherine Bonuccelli,

AstraZeneca Pharmaceuticals (1/9/2007–12/31/2008)

Linda Brady,

National Institute of Mental Health (1/9/2007–12/31/2008)

Robert M. Califf,

Duke University Medical Center (1/1/2005–12/31/2008)

Scott Campbell,

American Diabetes Association (1/1/2005–12/31/2008)

C. Thomas Caskey,

University of Texas-Houston Health Science Center (1/1/2005–12/31/2008)

Francis D. Chesley, Jr.,

Agency for Healthcare Research and Quality (1/9/2007–12/31/2008)

Mark Clanton,

National Cancer Institute (1/1/2005–12/31/2006)

Peter Corr,

Pfizer Inc. [Retired] (1/9/2007–12/31/2007)

Jeffrey M. Drazen,

New England Journal of Medicine (1/1/2005–12/31/2008)

William E. Evans,

St. Jude Children’s Research Hospital (1/1/2005–12/31/2006)

Joseph M. Feczko,

Pfizer Inc. (1/9/2007–12/31/2008)

Wayne Fenton [Deceased],

National Institute of Mental Health (1/1/2005–9/3/2006)

Garret A. FitzGerald,

University of Pennsylvania School of Medicine (1/1/2005–12/31/2008)

Elaine K. Gallin,

The Doris Duke Charitable Foundation (1/1/2005–12/31/2008)

Steven K. Galson,

U.S. Food and Drug Administration (1/9/2007–12/31/2008)

Alan M. Garber,

Stanford University (1/1/2005–12/31/2007)

Mikhail Gishizky,

Entelos, Inc. (1/1/2005–12/31/2008)

Stephen Groft,

National Institutes of Health (1/1/2005–12/31/2008)

Carole A. Heilman,

National Institute of Allergy and Infectious Diseases (1/1/2005–3/13/2006)

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

Dale Hu,

Centers for Disease Control and Prevention (1/1/2005–12/31/2005)

Michael Katz,

March of Dimes Birth Defects Foundation (1/1/2005–12/31/2008)

William F. Keane,

Merck & Co., Inc. (1/1/2005–12/31/2008)

Chaitan Khosla,

Stanford University (1/1/2005–12/31/2006)

Antonia Kolokathis,

Pfizer Inc. (1/1/2005–12/31/2005)

Allan M. Korn,

Blue Cross and Blue Shield Association (1/1/2005–12/31/2008)

David Korn,

Association of American Medical Colleges (1/1/2005–12/31/2006)

Ronald L. Krall,

GlaxoSmithKline (1/9/2007–12/31/2008)

Jeffrey M. Leiden,

Clarus Ventures (1/1/2005–12/31/2007) (at the time of this workshop, Dr. Leiden was representing Abbott Laboratories)

John M. Leonard,

Abbott Laboratories (1/9/2007–12/31/2008)

Nancy Loving,

National Coalition for Women with Heart Disease (1/1/2005–6/7/2006)

John R. Marler,

National Institute of Neurological Disorders and Stroke (1/1/2005–12/31/2008)

Musa Mayer,

AdvancedBC.org (1/1/2005–12/31/2007)

Mark B. McClellan,

AEI-Brookings Joint Center for Regulatory Studies (4/2/2007–12/31/2008)

Garry A. Neil,

Johnson & Johnson (1/1/2005–12/31/2008)

Joshua J. Ofman,

Amgen, Inc. (1/1/2005–12/31/2008)

Susanne Pattee,

Cystic Fibrosis Foundation (1/1/2005–12/31/2007)

Cecil B. Pickett,

Schering-Plough Research Institute (1/1/2005–12/31/2006)

Joanne L. Rhoads,

National Institute of Allergy and Infectious Diseases (1/9/2007–12/31/2008)

Brian Schuster,

U.S. Department of Veterans Affairs (1/1/2005–12/31/2006)

B. A. Schwetz,

U.S. Department of Health and Human Services (1/1/2005–12/31/2008)

Janet Shoemaker,

American Society for Microbiology (1/1/2005–12/31/2008)

Lana Skirboll,

National Institutes of Health (1/9/2007–12/31/2008)

Nancy S. Sung,

Burroughs Wellcome Fund (1/1/2005–12/31/2008)

James R. Swartz,

Stanford University (1/1/2005–12/31/2005)

Reed V. Tuckson,

UnitedHealth Group (1/1/2005–12/31/2008)

Sean Tunis,

Centers for Medicare and Medicaid Services (1/1/2005–12/31/2006)

Janet Woodcock,

U.S. Food and Drug Administration (1/1/2005–12/31/2008)

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

IOM Staff

Robert B. Giffin, Director (July 2006–present)

Alexander K. Ommaya, Director (January 2005–July 2006)

Adrienne Stith Butler, Senior Program Officer (December 2006– May 2007)

Sally Robinson, Program Officer (December 2006–present)

Heather Begg, Program Associate (January 2005–July 2006)

Andrea Knutsen, Senior Program Assistant (October 2005–present)

Jennifer Rainey, Research Assistant (January 2005–July 2006)

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Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We wish to thank the following individuals for their review of this report:

Naomi Aronson, Blue Cross Blue Shield Association

Scott Campbell, American Diabetes Association

Steven Galson, U.S. Food and Drug Administration

Jeffrey Leiden, Clarus Ventures

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Bradford Gray, Editor, Milbank Quarterly and Principal Research Associate, Urban Institute. Appointed by the National Research Council and Institute of Medicine, he was responsible for making certain that an

Suggested Citation:"Front Matter." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the author and the institution.

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All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them.

To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

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