1 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION + + + CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICES ADVISORY COMMITTEE + + + NEUROLOGICAL DEVICES PANEL + + + January 27, 2011 9:00 a.m. Hilton Washington DC North 620 Perry Parkway Gaithersburg, Maryland PANEL MEMBERS: THOMAS G. BROTT, M.D. Temporary Non-Voting Chair KAREN E. ANDERSON, M.D. Temporary Non-Voting Member KAREN B. DOMINO, M.D., M.P.H. Temporary Non-Voting Member KEVIN DUFF, Ph.D. Temporary Non-Voting Member JONAS H. ELLENBERG, Ph.D. Temporary Non-Voting Member DAVID C. GOOD, M.D. Temporary Non-Voting Member WAYNE K. GOODMAN, M.D. Temporary Non-Voting Member MAE O. GORDON, Ph.D. Temporary Non-Voting Member SCOTT Y.H. KIM, M.D. Temporary Non-Voting Member WILLIAM M. McDONALD, M.D. Temporary Non-Voting Member JANE S. PAULSEN, Ph.D. Temporary Non-Voting Member GUERRY M. PEAVY, Ph.D. Temporary Non-Voting Member CHRISTOPHER A. ROSS, M.D., Ph.D. Temporary Non-Voting Member GLENN T. STEBBINS, Ph.D. Temporary Non-Voting Member ANDREW WINOKUR, M.D., Ph.D. Temporary Non-Voting Member E. FRANCINE STOKES McELVEEN, J.D., M.S. Consumer Representative DAVID H. MUELLER, M.S. Industry Representative MICHELLE CARRAS Patient Representative OLGA I. CLAUDIO, Ph.D. Designated Federal Officer Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 2 FDA REPRESENTATIVES: MALVINA B. EYDELMAN, M.D. Director, Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices, Office of Device Evaluation GERETTA WOOD Director, Advisory Committee Program SANDY WALSH Press Contact FDA PRESENTERS: MARJORIE SHULMAN Program Operations Staff, Office of Device Evaluation LCDR BRADLEY CUNNINGHAM CDRH/ODE/DONED ANNA GEORGIOPOULOS, M.D. Medical Officer, FDA/CDRH/ODE/DONED PETER G. COMO, Ph.D. Neuropsychologist/Lead Reviewer, FDA/CDRH/ODE/DONED CARA KRULEWITCH, CNM, Ph.D., FACNM Branch Chief, OSB/DEPI/EERB2 ALLISON KOMIYAMA, Ph.D. Neurobiologist, FDA/CDRH/OSEL LAWRENCE PARK, A.M., M.D. Medical Officer, FDA/CDRH/ODE/DONED OPEN PUBLIC HEARING SPEAKERS: KENDRICK MOXON LORETTA WILSON SARAH H. LISANBY, M.D. PAMELA SULLIVAN, M.D. JAN EASTGATE VINCE BOEHM on behalf of LEONARD R. FRANK LAURA J. FOCHTMANN, M.D. BARBARA WINKLER RICHARD WEINER, M.D., Ph.D. ROBERT ROCA, M.D. WILLIAM NARROW, M.D., M.P.H. Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 3 OPEN PUBLIC SPEAKERS: (cont.) JULIE K. HERSH JOHN BREEDING, Ph.D. ANITA HAGIN, RN, B.S.N. AMY LUTZ KENDRICK MOXON on behalf of EVELYN SCOGIN JAN EASTGATE on behalf of DIAN'NA POSTHAUER DOROTHY DUNDAS DANIEL FISHER, M.D., Ph.D. DANIEL FISHER, M.D., Ph.D., on behalf of CAROL JEAN REYNOLDS LAUREN TENNEY, M.Phil., M.A., M.P.A. DAVID BOGER, M.D. MARY ROSEDALE, Ph.D., PMHNP-BC, NEA-BC DONALD JOHNSON KATHERINE KITTY DUKAKIS Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 4 INDEX PAGE CALL TO ORDER - Thomas G. Brott, M.D. 7 PANEL INTRODUCTIONS 7 CONFLICT OF INTEREST STATEMENT - Geretta Wood 9 APPOINTMENT OF TEMPORARY NON-VOTING MEMBERS- 12 Geretta Wood GENERAL ANNOUNCEMENTS - Geretta Wood 12 FDA PRESENTATION Device Classification and Reclassification - 13 Marjorie Shulman ECT History & Regulatory Background - 17 LCDR Bradley Cunningham QUESTIONS TO FDA 22 OPEN PUBLIC HEARING SPEAKERS Kendrick Moxon 25 Loretta Wilson 29 Sarah H. Lisanby, M.D. 32 Pamela Sullivan, M.D. 36 Jan Eastgate 39 Vince Boehm on behalf of Leonard R. Frank 42 Laura J. Fochtmann, M.D. 45 Barbara Winkler 48 Richard Weiner, M.D., Ph.D. 51 Robert Roca, M.D. 55 William Narrow, M.D., M.P.H. 58 Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 5 INDEX PAGE OPEN PUBLIC HEARING SPEAKERS (cont.) Julie K. Hersh 64 John Breeding, Ph.D. 67 Anita Hagin, RN, B.S.N. 69 Amy Lutz 72 Kendrick Moxon on behalf of Evelyn Scogin 75 Jan Eastgate on behalf of Dian'na Posthauer 78 Dorothy Dundas 80 Daniel Fisher, M.D., Ph.D. 83 Daniel Fisher, M.D., Ph.D., on behalf of Carol Jean Reynolds 86 Lauren Tenney, M.Phil., M.A., M.P.A. 89 David Boger, M.D. 92 Mary Rosedale, Ph.D., PMHNP-BC, NEA-BC 95 Donald Johnson 98 QUESTIONS TO OPEN PUBLIC SPEAKERS 100 FDA PRESENTATION FDA Assessment of ECT - Anna Georgiopoulos, M.D. 137 Cognitive and Memory Adverse Events: 150 FDA Systematic Literature Review - Peter G. Como, Ph.D. FDA Safety Meta-Analyses: Cognition and Memory - 162 Cara Krulewitch, CNM, Ph.D., FACNM Neurological Changes and Death - Allison Komiyama, Ph.D. 165 FDA Effectiveness Review - Lawrence Park, A.M., M.D. 172 Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 6 INDEX PAGE OPEN PUBLIC HEARING SPEAKER Katherine Kitty Dukakis 196 QUESTIONS TO FDA 198 ADJOURNMENT 238 Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 7 M E E T I N G (9:00 a.m.) DR. BROTT: I would like to call this meeting of the Neurological Devices Panel to order. I'm Dr. Thomas G. Brott, the Chairperson of this Panel. I'm a neurologist who specializes in stroke and also Director of Research at Mayo Clinic in Florida. At this meeting, the Panel will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy. Before we begin, I would now like to ask our distinguished Panel members and FDA staff seated at this table to introduce themselves. Please state your name, your area of expertise, your position and affiliation, and why don't we start with Dr. Eydelman. DR. EYDELMAN: Good morning, and thank you everybody for making it here today. My name is Malvina Eydelman. I'm Director of the Division of Ophthalmic, Neurological and ENT Devices here at FDA. DR. GOODMAN: Good morning. I'm Wayne Goodman. I'm a psychiatrist, Chair of the Department of Psychiatry at Mount Sinai School of Medicine in New York, and my expertise is in psychopharmacology and use of devices. DR. KIM: Hi, I'm Scott Kim. I'm a psychiatrist and a bioethicist Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 8 from the University of Michigan. DR. DUFF: My name is Kevin Duff. I'm a neuropsychologist in the Department of Neurology at the University of Utah, and I specialize in mild cognitive impairment and early dementia. DR. PAULSEN: Hi, my name is Jane Paulsen. I'm a neuropsychologist and Professor of Neurology and Psychiatry at the University of Iowa. MS. WOOD: I'm Geretta Wood. I'm the Director of the Advisory Committee staff for the Center for Devices and Radiological Health. The Designated Federal Officer, Dr. Olga Claudio, has been delayed in the weather this morning, so I will be filling in for her until her arrival. Thank you very much. DR. GOOD: Good morning. I'm Dr. David Good. I'm a neurologist, Professor and Chair of Neurology at Penn State University in Hershey, Pennsylvania. My major interest is stroke and rehabilitation, neurorehabilitation. DR. ROSS: Hi, I'm Chris Ross from Johns Hopkins. I'm a Professor of Psychiatry, also Professor of Neurology, Neuroscience, and Pharmacology. I do research in a variety of neurodegenerative diseases and also research in schizophrenia and affective disorder, and my clinical practice is mainly in geriatric psychiatry. DR. ELLENBERG: Good morning. I'm Jonas Ellenberg, Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 9 Professor of Biostatistics and Associate Dean in the School of Medicine at the University of Pennsylvania. My interest is in mostly children's neurology, but I go with what's available. MS. CARRAS: Good morning. I'm Michelle Carras. I'm the Patient Representative. I'm a graduate student in public health from Johns Hopkins Bloomberg School of Public Health, and I have bipolar disorder and I have several generations of family members who have mood disorder. MS. STOKES McELVEEN: I'm Francine Stokes McElveen. I'm General Counsel, Coppin State University, a constituent institution of the University of Maryland Systems. MR. MUELLER: Good morning. My name is David Mueller. I'm the official Industry Representative. I have a consulting firm in medical device regulatory affairs and many years of experience in the field. DR. BROTT: Thank you. We may also have some individuals on the telephone. If you can hear me and introduce yourselves, please do so at this time. MS. WOOD: Okay. We will get a list of who is on the telephone and provide that to you later in the meeting. Good morning, everyone. We appreciate you making the effort to be here in the inclement weather, and we welcome you to this meeting of the Neurological Devices Panel. I will now read the Conflict of Interest Statement. Free State Reporting, Inc. 1378 Cape Saint Claire Road Annapolis, MD 21409 (410) 974-0947 10 The Food and Drug Administration is convening today's meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee under the authority of the Federal Advisory Committee Act (FACA) of 1972. With the exception of the Industry Representative, all members and consultants of the Panel are special Government employees or regular Federal employees from other agencies and are subject to Federal conflict of interest laws and regulations. The following information on the status of this Panel's compliance with Federal ethics and conflict of interest laws are covered by, but not limited to, those found at 18 U.S.C.