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Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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MULTIPLE SCLEROSIS

CURRENT STATUS AND STRATEGIES FOR THE FUTURE




Janet E. Joy and Richard B. Johnston, Jr., Editors

Committee on Multiple Sclerosis: Current Status and Strategies for the Future

Board on Neuroscience and Behavioral Health

INSTITUTE OF MEDICINE




NATIONAL ACADEMY PRESS
Washington, D.C.

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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    NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418

    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. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance.

    Support for this project was provided by the National Multiple Sclerosis Society. The views presented in this report are those of the Institute of Medicine Committee on Multiple Sclerosis: Current Status and Strategies for the Future and are not necessarily those of the funding agencies.

    Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's home page at www.nap.edu. The full text of this report is available at www.nap.edu.

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

    Library of Congress Cataloging-in-Publication Data

    Multiple sclerosis : current status and strategies for the future / Janet E. Joy and Richard B. Johnston, Jr., editors.

    p. ; cm.

    Includes bibliographical references and index.

    ISBN 0-309-07285-9 (hardcover)

    1. Multiple sclerosis.

    [DNLM: 1. Multiple Sclerosis—therapy. 2. Multiple Sclerosis—physiopathology. 3. Research. WL 360 M956378 2001] I. Joy, Janet E. (Janet Elizabeth), 1953- II. Johnston, Richard B., 1935-

    RC377 .M8455 2001

    616.8′34—dc21

    2001002431

    Copyright 2001 by the National Academy of Sciences. All rights reserved.

    Printed in the United States of America.

    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. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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“Knowing is not enough; we must apply. Willing is not enough; we must do.”

Goethe

Image: jpg
~ enlarge ~

INSTITUTE OF MEDICINE

Shaping the Future for Health

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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    THE NATIONAL ACADEMIES

    National Academy of Sciences
    National Academy of Engineering
    Institute of Medicine
    National Research Council

    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. Bruce M. Alberts 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. William A. Wulf 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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    COMMITTEE ON MULTIPLE SCLEROSIS: CURRENT STATUS AND STRATEGIES FOR THE FUTURE

    RICHARD B. JOHNSTON, JR. (Chair), Professor of Pediatrics, National Jewish Medical and Research Center, University of Colorado School of Medicine

    JACK P. ANTEL, Professor of Neurology and Neurosurgery, Montreal Neurological Hospital and Institute, McGill University, Quebec, Canada

    SAMUEL BRODER, Executive Vice President for Medical Affairs, Celera Genomics, Rockville, Maryland

    JESSE M. CEDARBAUM, Vice President of Clinical Affairs, Regeneron Pharmaceuticals, Tarrytown, New York

    PATRICIA K. COYLE, Professor of Neurology, State University of New York, Stony Brook

    STEPHEN L. HAUSER, Professor of Neurology, University of California, San Francisco School of Medicine

    LISA I. IEZZONI, Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts

    SUZANNE T. ILDSTAD, Director of Institute for Cellular Therapeutics, University of Louisville, Kentucky

    SHARON L. JULIANO, Professor of Anatomy and Cell Biology and Neurosciences Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland

    DONALD L. PRICE, Professor of Pathology, Neurology and Neuroscience, Johns Hopkins University School of Medicine, Baltimore, Maryland

    RAYMOND P. ROOS, Professor of Neurology, University of Chicago, Illinois

    ALAN J. THOMPSON, Professor of Neurology, University College, London, England

    STEPHEN G. WAXMAN, Professor of Neurology, Yale Medical School, New Haven, Connecticut

    HARTMUT WEKERLE, Director, Max-Planck-Institut fur Neurobiologie, Planegg-Martinsreid, Germany

    Study Staff

    JANET E. JOY, Study Director

    JOHN A. ROCKWELL, Research Assistant

    AMELIA B. MATHIS, Project Assistant

    LINDA LEONARD, Administrative Assistant (until 9/2000)

    LORA K. TAYLOR, Administrative Assistant (from 9/2000)

    TERRY C. PELLMAR, Board Director

    CARLOS GABRIEL, Financial Associate

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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    BOARD ON NEUROSCIENCE AND BEHAVIORAL HEALTH

    ANN M. GRAYBIEL (Chair), Massachusetts Institute of Technology, Cambridge

    KENNETH B. WELLS (Vice-Chair), Neuropsychiatric Institute, University of California, Los Angeles

    NANCY E. ADLER, University of California, San Francisco

    RICHARD J. BONNIE, University of Virginia School of Law, Charlottesville

    WILLIAM E. BUNNEY, University of California, Irvine

    RICHARD G. FRANK, Harvard Medical School, Boston, Massachusetts

    JEROME KAGAN, Harvard University, Cambridge, Massachusetts

    HERBERT D. KLEBER, Columbia University and New York State Psychiatric Institute, New York, New York

    BEVERLY B. LONG, World Federation for Mental Health, Atlanta, Georgia

    KATHLEEN R. MERIKANGAS, Yale University, New Haven, Connecticut

    STEVEN M. MIRIN, American Psychiatric Association, Washington, D.C.

    STEVEN M. PAUL, Lilly Research Laboratories, Indianapolis, Indiana

    DAVID REISS, George Washington University Medical Center, Washington, D.C.

    RHONDA J. ROBINSON-BEALE, Blue Cross/Blue Shield of Michigan, Southfield

    STANLEY J. WATSON, University of Michigan, Ann Arbor

    STEPHEN G. WAXMAN, Yale Medical School, New Haven, Connecticut

    NANCY S. WEXLER, Columbia University, New York, New York

    ANNE B. YOUNG, Massachusetts General Hospital, Boston

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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Preface

Multiple sclerosis (MS) is not a new disease. Its effects on the brain were described in the 1830s, and it was identified as a distinct clinical entity in the 1860s. In fact, writings from the Middle Ages appear to describe individuals with this condition. MS is the most common neurological disorder of young adults; there are approximately 350,000 people with MS in the United States and an estimated 2 million patients worldwide.

Research on the disorder has been energetic over recent decades. In 1996, the U.S. National Institutes of Health (NIH) spent almost $83 million on MS research. This sum exceeded the NIH expenditure that year on asthma, tuberculosis, or cervical cancer. MS has not been neglected by researchers in this country or worldwide.

As a result, important progress has been made in defining the pathologic changes of MS, in using new imaging techniques for evaluation, and in developing treatments that can modify its course. Yet, despite concerted effort on the part of many good researchers, the fundamental elements of MS are still not understood, and the path toward consistently preventing its progression or curing it remains obscure. For example, we do not know what causes MS to appear in one person and not another. We do not know what role genes play. We have known for decades that MS has a widely variable clinical expression and unpredictable course, but do the variations reflect different causative agents or different responses to the same basic cause? Most investigators consider MS to be an autoimmune disease, but what incites the autoimmune response—a change in the cells of the nervous system so that they appear foreign or a microbial agent that mimics a cell component? Why is it approximately twice as common in women

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as in men? How can we most effectively relieve the various troubling symptoms of MS such as pain and fatigue? How can we help people with MS adapt to the disease and live their lives to the fullest level possible?

The National Multiple Sclerosis Society was founded in 1946 to address these and other questions about MS. Its mission is simple and forthright: “To end the devastating effects of multiple sclerosis.” Through the efforts of its 650,000 members and staff, it has made extraordinary contributions to understanding MS by a series of highly imaginative programs in research and patient services, including almost $300 million in research grants. The report that you see here is the result of a request from the Society to the Institute of Medicine (IOM) for guidance in developing a strategic plan to direct future investments in MS research.

The multidisciplinary committee convened by the IOM in response to this request was charged to review current knowledge of all aspects of MS from cells to symptoms; to identify techniques, resources, and innovations used outside the field that might be applied to the MS challenge; and to recommend strategies that might push MS research forward most effectively.

To address its charge, the committee, with the support of IOM staff, reviewed the scientific literature related to all aspects of MS and received input from 45 outside consultants: 9 of these wrote state-of-the-art commentaries on symptom management, some told us what they needed most as MS patients, and 17 described the newest science during three workshops. Most of the workshop participants were not primarily involved in MS research or with MS patients but agreed to brainstorm with us about how the best of their disciplines might be applied to MS. We clearly could not have accomplished our work without the help of these consultants, and their listing in the Acknowledgments badly understates our gratitude. Finally, the committee recognizes with the deepest appreciation the support given by the extraordinary staff assigned to us by the IOM—Janet Joy, John Rockwell, Amelia Mathis, and Terry Pellmar. In particular, Janet Joy, study director and neuroscientist by training, with intelligence, humor, and an exceptional intensity of commitment, inspired and guided us to the completion of our task.

Richard B. Johnston, Jr., M.D.
Chair

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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Acknowledgments

People live with multiple sclerosis (MS) for decades, making it a disease of selves as well as cells. The committee's assessment of the current status of progress against MS thus entailed a review from biomedical perspectives, as well as from psychological and social perspectives. This massive undertaking could not have been accomplished without the help of an array of experts as multifaceted as the disease itself. The committee is deeply indebted to these many people for their valuable contributions.

The following people wrote invaluable background papers for the committee: Dedra Buchwald (fatigue), Howard Fields (pain), Robert W. Hamill (bladder and bowel control), David E. Krebs (assistive technology), T. Jock Murray (cognitive impairment), Peggy Neufeld (assistive technology), Trevor Owens (genetic animal models), Robert G. Robinson (depression and brain injury), William Z. Rymer (spasticity and weakness), and Marca Sipski (sexual function).

Another group presented a series of excellent talks on new approaches to MS research at workshops for the committee. This group includes Mindy Aisen, Michael Conneally, Scott E. Fraser, Chien Ho, Ole Isacson, Elliott D. Kieff, Jeffery Kocsis, Henry McFarland, Deborah Miller, Rhona Mirsky, Marc Peschanski, John C. Roder, Jay Siegel, Joy Snider, Lawrence Steinman, Barbara Vickrey, and Michael Weinrich. (Topics are listed individually in Appendix C.)

The following people provided technical comments on draft sections of the report: Robert Burke, Mary Horwitz, Peggy Neufeld, John Roder, and Richard Rudick. Still others served as technical consultants either in meetings with the committee, sharing unpublished reports, or in consultations with Institute of Medi-

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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cine (IOM) staff. This group includes Elaine Collier, Gary Karp, Lorna Layward, Ian McDonald, Sarah Minden, Audrey Penn, and Albert van der Pol.

All of these people gave generously of their time and made a tremendous and much appreciated contribution to the breadth and depth of this report.

Stephen Reingold, Vice President of Scientific Programs, and Nicholas LaRocca, Director of Health Care Delivery and Policy Research, at the National Multiple Sclerosis Society were indispensable to the committee's efforts. They provided the committee with volumes of background material and fielded an endless stream of inquiries from IOM staff. They were unfailingly quick to reply to queries and provided stores of information.

Miriam Davis and Jane Durch provided substantive editing for sections of the report, Amy Fluet wrote material for several of the explanatory boxes in the report, and Florence Poillon edited the uncorrected proofs. Each of them greatly enhanced the readability of the report and we are grateful for their excellent work.

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 National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making the 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 participation in the review of this report:

Fred Barkhof, Diagnostic Radiology, Vrije Universiteit Hospital, Amsterdam, Netherlands

George Ebers, Professor, Department of Clinical Neurology, Oxford University

Jill S. Fischer, Director, Psychology Program (1985-2000), Mellen Center for MS Treatment and Research Cleveland Clinic

Zach W. Hall, Vice Chancellor, Office of Research, University of California, San Francisco

Charles A. Janeway, Jr., Department of Immunobiology, Yale School of Medicine

Alan M. Jette, Dean, Sargent College of Health and Rehabilitation Services, Boston University

Jurg Kesselring, Professor and Head, Department of Rehabilitation Centre, Valens, Switzerland

Samuel K. Ludwin, Professor, Pathology Department, Queens University, Ontario, Canada

Robert H. Miller, Associate Professor, Case Western Reserve University School of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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Mary Beth Moncrief, Manager, Associate National Scientific Program Juvenile Diabetes Foundation International

John Newsom-Davis, Professor, Clinical Neurology, University of Oxford

Michael B.A. Oldstone, Professor, Department of Neuropharmacology, Division of Virology, The Scripps Research Institute

Jerry Wolinsky, Professor, Department of Neurology, University of Texas, Houston Medical Center Health Science Center

Although the individuals listed above have provided constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Joseph B. Martin, Dean, Harvard Medical School and Floyd R. Bloom, Chair, Department of Neuropharmacology, the Scripps Research Institute, who were responsible for making certain that an 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 Committee on Multiple Sclerosis: Current Status and Strategies for the Future and the Institute of Medicine.

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Contents

EXECUTIVE SUMMARY 1
1     INTRODUCTION 17
    The U.S. National Multiple Sclerosis Society, 19
    Recent Advances in MS, 21
    Origin of the Study, 21
    Previous Reviews of MS Research Programs, 22
    The IOM Committee and Its Mandate, 24
    How the Committee Carried Out its Task, 26
    Organization of the Report, 26
    References, 27
2     CLINICAL AND BIOLOGICAL FEATURES 29
    The Clinical Picture: Symptoms, Disease Course, Variation, and Diagnosis, 29
    Underlying Disease Mechanisms, 54
    Animal Models of MS, 90
    References, 104
3     CHARACTERISTICS AND MANAGEMENT OF MAJOR SYMPTOMS 115
    Cognitive Impairment, 115
    Depression, 120
    Spasticity and Weakness, 128
Suggested Citation:"Front Matter." Institute of Medicine. 2001. Multiple Sclerosis: Current Status and Strategies for the Future. Washington, DC: The National Academies Press. doi: 10.17226/10031.
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    Ataxia and Tremor, 138
    Bladder and Bowel Dysfunction, 140
    Visual Disturbances, 148
    Fatigue, 149
    Sexual Dysfunction, 155
    Pain, 158
    References, 166
4     DISEASE MANAGEMENT AND MEASUREMENT 177
    Living with MS, 178
    Measuring Functional Status and Quality of Life, 193
    Assistance, 205
    Information and Communication, 216
    Health Care, 221
    References, 229
5     STRATEGIES FOR FUTURE RESEARCH ON DISEASE MECHANISMS 241
    Technologies and Research Strategies, 267
    References, 272
6     FUTURE STRATEGIES FOR THERAPIES 277
    Strategies for Disease Modification, 278
    Challenges in MS Clinical Trials, 298
    Shared Resources, 312
    References, 318
7     BUILDING AND SUPPORTING THE RESEARCH ENTERPRISE 325
    Research Funding, 325
    Human Resources, 333
    Infrastructure, 339
    Clinical Trials, 340
    Biotechnology and Pharmaceutical Firms, 341
    Health Care Research, 343
    Role of Voluntary Health Organizations, 344
    References, 346
8     RECOMMENDATIONS 347
    Etiology and Pathogenesis, 348
    Tools for Research and Diagnosis, 355
    Therapeutics, 358
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    Health Status and Quality of Life, 361
    Research Enterprise, 363
    References, 367
APPENDIXES
    A     Committee and Staff Biographies, 371
    B     List of Expert Consultants, 377
    C     Workshop Agendas, 379
    D     Kurtzke's Expanded Disability Status Scale, 385
    E     Drugs Used in the Treatment of MS, 387
    F     U.S. Social Security Administration's Criteria for Qualifying as Disabled from MS, 401
    G     Treatments That Have Been Claimed to Be of Benefit in MS, 405
INDEX 413
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List of Tables and Figures

TABLES

2.1     Varieties of MS, 30
2.2     Initial Signs and Symptoms of MS, 32
2.3     Prognostic Relapse Indicators, 34
2.4     Information Provided by Neuroimaging, 38
2.5     Proposed CSF Disease Markers in MS, 44
2.6     Poser Diagnostic Criteria for MS, 46
2.7     MRI Criteria for Definite MS, 46
2.8     Evoked Potentials as a Diagnostic Tool in MS, 47
2.9     Disease-Modifying Therapies for Relapsing MS, 49
2.10     Clinical Pathological Correlations in Common Syndromes of MS, 62
2.11     Selected Diseases That Are Believed to Be Autoimmune Based, 69
2.12     Possible Autoantigens in MS, 71
2.13     CNS Demyelinating Diseases That Resemble MS, 85
2.14     Koch's Postulate on Causations of Disease by a Pathogen, 88
2.15     Agents Isolated or Implicated in the Etiology of MS, 89
2.16     Animal Models of MS, 91
2.17     Comparison Between Multiple Sclerosis and EAE, 92
2.18     Animal Viruses That Induce Demyelination, 96
3.1     Medications Used to Treat Depression, 124
3.2     Depression and Beta-Interferon, 126
3.3     Medications Used to Treat Spasticity, 134
3.4     Indications of Bladder Dysfunction, 141
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3.5     Medications Used to Treat Bladder and Bowel Dysfunction, 144
3.6     Medications Used to Treat Optic Neuritis and Abnormal Eye Movements, 150
3.7     Medications Used to Treat Fatigue, 154
3.8     Neurological Pathways That Control Sexual Response in Men and Women, 157
3.9     Medications Used to Treat Erectile Dysfunction, 159
5.1     Hypothetical Results of a Clinical Trial, 262
6.1     MRI Outcomes for Clinical Trials, 310
7.1     Research Budgets of Selected Health Organizations in 1998, 329

FIGURES

1.1     MS distribution map, 18
1.2     The nerve fiber in multiple sclerosis, 19
2.1     Spectrum of disease course, 31
2.2     Areas of the CNS affected by MS, 32
2.3     MRI scans of the brain, 37
2.4     Oligodendrocyte making myelin, 55
2.5     Pathogenesis, 57
2.6     Axonal transection and degeneration, 59
2.7     Possible mechanisms of demyelination, 61
2.8     The blood-brain barrier, 63
2.9     Interactions between major cell components of the immune system, 68
2.10     Possible mechanism of viral etiology, 70
3.1     Functions controlled by nerves at different levels of the spine, 129
5.1     Demyelination and axonal degeneration in multiple sclerosis, 242
5.2     Possible role of AMPA/kainate receptors on neurons and glia, 244
6.2     Lineage of neural stem cells, 294
7.1     Relationship between NIH disease-specific research funding, 327
7.2a     Summary of publications in general medical journals, 328
7.2b     Summary of publications in neurology journals, 330
7.3     Ph.D and postdoctoral fellowship trends, 335
7.4     Trends in postdoctoral fellowship applications, 337
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Multiple Sclerosis: Current Status and Strategies for the Future Get This Book
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Multiple sclerosis is a chronic and often disabling disease of the nervous system, affecting about 1 million people worldwide. Even though it has been known for over a hundred years, no cause or cure has yet been discovered-but now there is hope. New therapies have been shown to slow the disease progress in some patients, and the pace of discoveries about the cellular machinery of the brain and spinal cord has accelerated.

This book presents a comprehensive overview of multiple sclerosis today, as researchers seek to understand its processes, develop therapies that will slow or halt the disease and perhaps repair damage, offer relief for specific symptoms, and improve the abilities of MS patients to function in their daily lives.

The panel reviews existing knowledge and identifies key research questions, focusing on:

  • Research strategies that have the greatest potential to understand the bio- logical mechanisms of recovery and to translate findings into specific strategies for therapy.
  • How people adapt to MS and the research needed to improve the lives of people with MS.
  • Management of disease symptoms (cognitive impairment, depression, spasticity, vision problems, and others).

The committee also discusses ways to build and financially support the MS research enterprise, including a look at challenges inherent in designing clinical trials. This book will be important to MS researchers, research funders, health care advocates for MS research and treatment, and interested patients and their families.

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