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Status of the Artificial Heart Program STATUS OF THE ARTIFICIAL HEART PROGRAM HEARINGS BEFORE THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT OF THE COMMITTEE ON SCIENCE AND TECHNOLOGY HOUSE OF REPRESENTATIVES NINETY-NINTH CONGRESS SECOND SESSION FEBRUARY 5, 1986 [No. 941 Printed for the use of the Committee on Science and Technology U.S. GOVERNMENT PRINTING OFFICE 60-2420 WASHINGTON : 1986 For sale by the Superintendent of Documents, Congressional Sales Office U.S. Government Printing Office, Washington, DC 20402 F)7 1- &c COMMITTEE ON SCIENCE AND TECHNOLOGY DON FUQUA, Florida, Chairman ROBERT A. ROE, New Jersey MANUEL LUJAN, JR., New Mexico° GEORGE E. BROWN, JR., California ROBERT S. WALKER, Pennsylvania JAMES H. SCHEUER, New York F. JAMES SENSENBRENNER, JR., MARILYN LLOYD, Tennessee Wisconsin TIMOTHY E. WIRTH, Colorado CLAUDINE SCHNEIDER, Rhode Island DOUG WALGREN, Pennsylvania SHERWOOD L. BOEHLERT, New York DAN GLICKMAN, Kansas TOM LEWIS, Florida ROBERT A. YOUNG, Missouri DON RITTER, Pennsylvania HAROLD L. VOLKMER, Missouri SID W. MORRISON, Washington BILL NELSON, Florida RON PACKARD, California STAN LUNDINE, New York JAN MEYERS, Kansas RALPH M. HALL, Texas ROBERT C. SMITH, New Ilampshire DAVE McCURDY, Oklahoma PAUL B. HENRY, Michigan NORMAN Y. MINETA, California HARRIS W. FAWELL, Illinoik MICHAEL A. ANDREWS, Texas WILLIAM W. COBEY, Jaj., North Carolina BUDDY MACKAY, Florida ** JOE BARTON, Texas TIM VALENTINE, North Carolina D. FRENCH SLAUGHTER, JR., Virginia HARRY M. REID, Nevada DAVID S. MONSON, Utah ROBERT G. TORRICELLI, New Jersey RICK BOUCHER, Virginia TERRY BRUCE, Illinois RICHARD H. STALLINGS, Idaho BART GORDON, Tennessee JAMES A. TRAFICANT, JR., Ohio HAROLD P. HANSON, Executive Director ROBERT C. KVWHAM, General Counsel REGINA A. DAVIS, Chief Clerk Joycz GROSS FREiwALD, Republican Staff Director SUBCOMMIrrEE ON INVESTIGATIONS AND OVERSIGHT HAROLD L. VOLKMER, Missouri, Chairman MICHAEL A. ANDREWS, Texas RON PACKARD, California JAMES A. TRAFICANT, JR., Ohio F. JAMES SENSENBRENNER, JR., HARRY M. REID, Nevada Wisconsin GEORGE E. BROWN, JR., California SID W. MORRISON, Washington CHERYL COODLEY, Staff Director GREG SIMON, Counsel IRENE GLOWINSKI, Congjessional &ience Fellow CAROLYN RAVADAUOH, Republican Technical Consultant 'Ranking Republican Member. "Serving on Committee on the Budget for 99th Congress. (11) CONTENTS WITNESSES February 5, 1986: Page Dr. Jack G. Copeland, professor and chief, University of Arizona, College of M edicine (prepared statem ent) ..................................................................... 6 Dr. Robert K. Jarvik, President, Symbion, Inc., Salt Lake City, UT, ac- companied by Dr. Don Grabarz; and Dr. Sidney M. Wolfe, director, Public Citizen Health Research Group, Washington, DC ................ 31 Mel Schroeder, family member, artificial heart recipient, Ferdinand, IN; Dr. George Annas, J.D., M.P.H., Edward R. Utley, professor of health law, Boston University Schools of Medicine and Public Health, Boston, MA; and Dr. William C. De Vries, artificial heart program, Humana Heart Institute International, Louisville, KY ................................................ 144 Dr. Claude Lenfant, Director, National Heart, Lung and Blood Institute, National Institutes of Health; Charles L. McIntosh, M.D., Ph.D., Chair- man, Circulatory System Devices Advisory Panel, U.S. Food and Drug Administration; and John A. Norris, J.D., M.B.A., Deputy Commission- er of Food and Drugs, Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services, accompa- nied by Dr. Kshitij Mohan, Center for Devices and Radiological Health. 277 APPENDIX 1. Tabulation of Clinical Use of Mechanical Circulatory Support Devices for Bridge to Transport and Permanent Application ............................................ 359 2. Summary of Clinical Use of Mechanical Circulatory Support Devices for Bridge to Transplant and Permanent Applications .......................................... 364 3. Clinical Experience with Thoratec VAD ................................................................. 365 4. New England Journalof Medicine; editorial by Dr. Relman .............................. 367 5. Additional statement, for the record, of Mrs. Barney Clark ............................... 369 6. Edited oral rem arks of Dr. Lenfant ......................................................................... 373 (i11) STATUS OF THE ARTIFICIAL HEART PROGRAM WEDNESDAY, FEBRUARY 5, 1986 HOUSE OF REPRESENTATIVES, COMMITTEE ON SCIENCE AND TECHNOLOGY, SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT, Washington, DC. The subcommittee met, pursuant to call, at 9:30 a.m., in room 2318, Rayburn House Office Building, Hon. Harold L. Volkmer (chairman of the subcommittee) presiding. Mr. VOLKMER. Good morning, he Subcommittee on Oversight and Investigation will come to or Before we begin I would like to inquire if Dr. Jack Copeland is present. Will he acknowledge if he is present? Does not appear to be here. OK. Thank you very much. Heart disease is the leading cause of death in the United States. One approach to the treatment of heart disease is the artificial heart. From its inception- early 1960's the artificial heart rogram was intended not o- 0 sA-ve the lives of the victims of heart disease but to also allow those individuals to live healthy and productive lives in the company of their family and friends. Largely through federally funded research the artificial heart program has advanced from a dream to a reality. It has been used as a permanent device to prolong the lives of Barney Clark, Bill Schroeder, and others. Just recently in Minnesota an artificial heart prolonged the life of Mary Lund thereby enabling her to undergo a human heart transplant this past weekend. Through the courage of people like Barney Clark, William Schroeder, and Mary Lund we now under- stand more fully the potential and the problems associated with the artificial heart. Hopefully our greater understanding will further the develop- ment of an artificial heart that will fulfill the aspirations which give birth to the artificial heart program. There are questions that must be asked about the wisdom and utility of the present artificial heart program. Today we will exam- ine whether the technology of the artificial heart is advanced enough to justify its usage in human beings on either a temporary or permanent- basis. We will hear about recent artificial heart implants within the last several days, under emergency conditions. And we will exam- ine FDA procedures for handling such emergencies. (1) 2 We will examine how use of an artificial heart affects the quality of life for the recipients and their families. We will review the role of the Federal Government in overseeing the development of the artificial heart and in prescribing its use. Throughout this hearing we will be guided by the concern all America faces; the development of effective, affordable, and human means to save the lives of the victims of heart disease. To assist us in the hearing today are two specialists most often associated with the artificial heart program, Dr. Robert Jarvik and Dr. William DeVries. We appreciate their presence and the time they have taken to be with us. Dr. Jack Copeland was to have been here, but his presence was required at the hospital as he just this past Monday implanted yet another artificial heart. My staff was in contact just last evening, and he said he may be able to make it. But we told him if it was necessary for him to attend his patient we would accept his statement which we have received that will be made a part of the record, and if we have any questions of him we will submit them to him in writing. [The prepared opening statement of Mr. Volkmer follows:] 3 fFILEDO NOT CopyREMOVE CCiflTTEE ON SCIENCE AND TECHNOLOGY U.S. HOUSE OF REPRESENTATIVES WASHINGTON, DC HEARING ON APTIFICIAL HEARTS ' .. L3'.' . :- OPt STATFMENT ' " iO) MORNING. THE HEARING WILL COME TO ORDER, HEART DISEASE IS THE LEADING CAUSE OF DEATH IN THF t:;lb :',"'ATES. ONE APPROACH TO THE TREATMENT OF HEART :SEASE-!S THE APT!'ICIAL HEART. i:-R7U ITS I.'!CEPTION IN THE EARLY 1960'S, THE ARTIF'.IAL ,:EART PROGRAM wAS INTENDED NOT O?$LY TO SAVE THE LIVES OF THE Vl.I1!MS CF HEART DISEASE, BUT ALSO TO ALLOW THOSE INDIVIDUALS TO LIVE HEALTHY AND PRODUCTIVE LIvES IN THE COMPANY CF THEIR FAMILIES AND FRIENDS. LARGELY THROUGi- f-EDERALI.Y-FUNDED RESEARCH. THE ARTIFICIAL HEART PROGRA:i. HAS ADVANCED FROM A DREAM TO A REALITY. IT HAS BEEN USED PS A FCQRANEN7 DEVICE TO PROLONG THE LIVES OF BAFNEY CLARK, BILL S'rHROEDEF AND OTHERS. JUST RECENTLY IN MINNESOTA, THE 'ART;FIC AL HEART PRONGED THE LIFE OF ?AARY LUND, THEREBY EcABL:N t HER TO UNDERGO A HUMAN HEART TRANSPLANT TH,. OAST 'WEE 4 -2- THROUGH THE COURAGE OF PEOPLE LIKE BARNEY CLARK, BILL SCHROEDER, AND MARY LUND, WE NOW UNDERSTAND MORE FULLY THE FOTE14TIAL AND THE PROBLEMS ASSOCIATED W'TH rHE ARTI IC!AL HEART. HOPEFULLY OUR GREATER UNDERSTANDING WILL FURTHER THE DEVELOPMlENT OF AN ARTIFICIAL HEART THAT WILL FULFILL THE ASPIRATiONS WHICH GAVE BIRTH TO THE ART;FIC AL HEART PROGRAM. THERE AU QUE-STIONS THAT MUST BE ASKED ABOUT THE WISDOM AND UTILITY OF THE PRESENT ARTIFICIAL HEART PROGRAM. TODAY WE WILL EXAMINE WHETHER THE TECHNOLOGY OF THE ARTIFICIAL HEART IS ADVANCED ENOUGH TO JUSTIFY ITS USAGE IN HUMAN BEINGS ON EITHER A TEMPOPARY OR PERMANENT BASIS. WE WILL HEAR ABOUT RECENT ARTIFICIAL HEART PLANTS WITHIN THE LAST SEVERAL DAYS, UNDER EMERGENCY CONDITIONS, AND WE WILL EXAMINE FDA's PROCEDURES FOR HAND--ING SUCH EMERGENCIES. WE WILL EXAMINE HOW USE OF AN
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