PML: What MS-Treating Clinicians Need to Know

Sponsored by the Postgraduate Institute for Medicine

Release date: December 2006
Expiration date: December 2007
Estimated time to complete activity: 1 hour
This educational program is supported through an educational grant from Biogen IDEC and Elan Pharmaceuticals Inc.

Program Overview

The reporting of progressive multifocal leukoencephalopathy (PML) in association with natalizumab therapy, leading to the temporary withdrawal from the market of this agent, makes education regarding this relatively unusual disease critical. This program will outline the current state of knowledge of PML and discuss the disease itself (both the primary disease and the phenomenon occurring secondary to reversible causes). The clinical manifestations of PML vs. MS, the association of PML with natalizumab and other immune modulators/suppressants, and the fact that there is no current treatment—save immune restoration—will also be covered.

Target Audience

This activity has been designed to meet the educational needs of neurologists and physicians involved in the management of patients with multiple sclerosis.

Learning Objectives

Upon completion of this activity, the participant will be able to:

Faculty

Eugene O. Major, Ph.D.
Program Chair
Senior Investigator, Laboratory of Molecular Medicine and Neuroscience Chief, Division of Intramural Research National Institute of Neurological Disorders and Stroke

Eugene O. Major, PhD, received his degree from the University of Illinois Medical Center in infectious diseases and microbiology and was a part of a team that established a research center on the genetics of viruses that caused cancer. Following academic appointments as associate professor at the University of Illinois Medical School and the Loyola University Medical School and as an associate dean of graduate programs, Dr. Major joined the National Institute of Neurological Disorders and Stroke at the NIH in 1981. He has developed a basic research laboratory in the intramural program focusing on mechanisms of viral pathogenesis in the human nervous system which includes JC Virus induced demyelination, progressive multifocal leukoencephalopathy, and HIV-1 associated encephalopathy. As chief of the laboratory of molecular medicine and neuroscience, Dr. Major's investigations focus on the biology of virus infections in nervous system cells derived from the human developing brain and the molecular regulation which controls viral gene expression. Dr. Major has received the NIH Merit Award for his work on PML as well as NIH recognition for distinguished service in studies on the consequences of HIV-1 infection in the human nervous system. Dr. Major has recently been elected to the Academy of Neurosciences in India; he is a member of the board of directors of People to People, the Ethiopian non-Governmental Organization on AIDS; and he is an elected, active member of the American Neurological Association (ANA). Dr. Major also holds a number of U.S. and international patents on unique cell lines developed from the human central nervous system which can be applied to transplantation therapies for neurodegenerative diseases. Dr. Major's laboratory maintains extensive collaborations with clinical colleagues and participates in clinical trials as a basic science laboratory as a certified CLIA laboratory which also supports FDA regulatory studies.

Dr. Major's work has been published in over 180 papers as well as numerous text and review books. Dr. Major is a founding member of the International Society for Neurovirology and The Journal of NeuroVirology, and he is an adjunct professor at the George Washington University School of Medicine.

Dr. Major is the coordinator for AIDS research in the NINDS Intramural Program and has served as the acting deputy director of the NINDS for two years, as the basic neuroscience program director of the intramural program, and as the co-chair of the White House Office of Science and Technology Policy Intra-Agency Committee on Prion Science.

Igor J. Koralnik, MD
Associate Professor of Neurology
Harvard Medical School

Igor J. Korlanik, MD, is an associate professor of neurology at Harvard Medical School, and director of the HIV/Neurology Center at Beth Israel Deaconess Medical Center.

Dr. Korlanik earned his MD at the University of Geneva Medical School, and he held his internship and residency in internal medicine at Geneva University Hospital. Dr. Koralnik conducted his residency in neurology in the Harvard-Longwood Neurology Training Program at Harvard Medical School and a post-doctoral fellowship in molecular biology of retroviruses at the National Institutes of Health.

With specialties in neuro-infectious diseases and neuroAIDS, Dr. Koralnik is the author of numerous peer-reviewed publications. The focus of Dr. Koralnik’s research program is progressive multifocal leukoencephalopathy and its etiologic agent, the polyomavirus JC.

David B. Clifford, MD
Melba and Forest Seay Professor of Clinical Neuropharmacology in Neurology
Professor of Medicine
Washington University School of Medicine

David M. Clifford, MD, is the Melba and Forest Seay Professor of Clinical Neuropharmacology in Neurology and Professor of Medicine. He received his BA summa cum laude in chemistry and history from Southwestern University and his MD from Washington University School of Medicine. He completed residency programs in medicine and neurology at Barnes Hospital in St. Louis and served as postdoctoral fellow in neurology before becoming appointed as a research instructor in neurology.

Dr. Clifford has assumed positions of leadership in the medical school, including chairing the executive committee of the faculty council, faculty clinical representative to the faculty practice plan and serving on numerous committees.

Board-certified in psychiatry and neurology, Dr. Clifford has served as president of the medical staff of St. Louis ConnectCare, the corporation providing indigent health care in the St. Louis region and as medical director of neurology for Barnes Jewish Hospital.

On a national basis, Dr. Clifford has chaired the neurology section of the AIDS Clinical Trials Group, served on the scientific program committees for the American Academy of Neurology and for the Conference on Retroviruses and Opportunistic Infections, as a counselor for the American Neurological Association, chairs the external advisory committee for the National NeuroAIDS Tissue Consortium and is a member of the American Federation for AIDS Research scientific advisory board. He sits on the editorial boards of The Journal of NeuroVirology and NeuroAIDS and is a frequent ad hoc reviewer for the major neurologic journals. He is listed in "Best Doctors in the U.S."

Dr. Clifford is the principal investigator of the NINDS-supported Neurologic AIDS Research Consortium (NARC), a national group including over 20 medical centers that organizes and supports clinical trials for HIV neurologic complications. In addition, Dr. Clifford has participated in pharmacologic investigations in Parkinson's disease and multiple sclerosis. He is also the principal investigator for the Washington University AIDS clinical trials unit organized to lead translational research relevant to HIV/AIDS.

Intructions for Credit

Physician Continuing Education
Accreditation Statement

This activity has been planned and implemented in accordance with the essential areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Postgraduate Institute for Medicine (PIM) and Healthology. The Postgraduate Institute for Medicine (PIM) is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation
The Postgraduate Institute for Medicine designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

Fee Information
There is no fee for this educational activity.

Disclosure of Conflicts of Interest
The Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity and patient care recommendations. PIM is committed to providing its learners with high-quality CME activities and related materials that promote improvements of quality in healthcare and not a specific proprietary business interest of a commercial interest.

The following faculty reported a real or apparent conflict of interest:

Dr. Eugene O. Major (Program Chair) No financial interest/relationships relating to the topic of this activity.

Dr. Igor J. Koralnik Type of financial relationship: grants/research support for Biogen IDEC and Elan Pharmaceuticals.

Dr. David B. Clifford Type of financial relationship: grants/research support for Pfizer and Neurogesix. Received honorarium from Biogen IDEC, Boehringer Ingelheim, Genzyme Pharmaceuticals and Elan Pharmaceuticals.

The following planners and managers reported a real or apparent conflict of interest:

Thomas Maxwell Mundy, MD (Healthology) No financial interest/relationships relating to the topic of this activity.

Jan Hixon, RN, BSN, MA (PIM) No financial interest/relationships relating to the topic of this activity.

Method of Participation

There are no fees for participating and receiving CME credit for this activity. During the period December 2006 through December 31, 2007, participants must: 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) complete the post-test by recording the best answer to each question in the answer key on the evaluation form; and 4) complete the evaluation form.

A statement of credit will be issued only upon receipt of a completed activity evaluation form and a completed post-test with a score of 70 percent or better. Your statement of credit will be mailed to you within three weeks.

Media

Internet

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Postgraduate Institute for Medicine (PIM), Healthology Inc. and Biogen IDEC and Elan Pharmaceuticals Inc. do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of PIM, Healthology Inc. and Biogen IDEC and Elan Pharmaceuticals Inc. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

Produced by Healthology Inc. © 2006

Sponsored by the Postgraduate Institute for Medicine
Supported through an educational grant from Biogen IDEC and Elan Pharmaceuticals Inc.