I.V 64/3:106-10 FED-DOCS SUSPENSION OF MEDICAL RESEARCH AT WEST JOINT HEARING BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND AND SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON VETERANS' AFFAIRS ONE HUNDRED SIXTH CONGRESS FIRST SESSION 58-700CC APRIL 21, 1999 Printed for the use of the Committee on Veterans' Affairs Serial No. 106-10 DEPOSITORY MAR 2 3 2000 STANFORD UNIVERSITY U.S. GOVERNMENT PRINTING OFFIC WASHINGTON: 2000 For sale by the U.S. Government Printing Office Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 CONTENTS OPENING STATEMENTS Hon. Terry Everett, Chairman, Subcommittee on Oversight and Investiga- Appelbaum, Paul, M.D., Chair, Department of Psychiatry, University of Mas- Prepared statement of Dr. Appelbaum Kizer, Kenneth, M.D., M.P.H., Under Secretary for Health, Department of Veteran Affairs; accompanied by John Feussner, M.D., Chief Research and Development Officer, Department of Veteran Affairs, and Timothy Gerrity, M.D., Special Assistant to Chief Research and Development Officer, Depart- Prepared statement of Dr. Kizer, with attachments Meslin, Eric M., Ph.D., Executive Director, National Bioethics Advisory Com- Prepared statement of Dr. Meslin Pandol, Stephen, Former Director, Research and Development, West Los An- geles VA Medical Center, Department of Veterans Affairs; accompanied by Dean Norman, Acting Chief of Staff, West Los Angeles VA Medical Center, Department of Veterans Affairs; Kenneth Clark, Chief Network Officer and Former Director, West Los Angeles VA Medical Center, Depart- ment of Veterans Affairs, and Ronald Norby, Clinical Manager and Deputy Network Director, Veterans Integrated Service Network 22 Prepared statement of Dr. Pandol Puglisi, J. Thomas, Director, Division of Human Subject Protections, Office Shamoo, Adil E., M.D., Professor, Department of Biochemical and Molecular Prepared statement of Dr. Shamoo MATERIAL SUBMITTED FOR THE RECORD Letter from President Clinton to National Bioethics Advisory Commission, Transcript produced for CBS News 48 Hours, dated April 15, 1999 68 SUSPENSION OF MEDICAL RESEARCH AT WEST LOS ANGELES AND SEPULVEDA VA MEDICAL FACILITIES AND INFORMED CONSENT AND PATIENT SAFETY IN VA MEDICAL RESEARCH WEDNESDAY, APRIL 21, 1999 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, AND SUBCOMMITTEE ON HEALTH, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 334, Cannon House Office Building, Hon. Terry Everett (chairman of the subcommittee) presiding. Present: Representatives Everett, Buyer, Stearns, Moran, McKeon, Brown, Gutierrez, Snyder, Rodriguez, Shows, and Doyle. OPENING STATEMENT OF HON. TERRY EVERETT, CHAIRMAN, SUBMCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS Mr. EVERETT (presiding). The hearing will come to order. Good morning. This hearing will examine the suspension on March 22, 1999, of all medical research at the VA's West Los Angeles Medical Facility. We will also examine informed consent issues in VA medical research, generally. After learning of the suspension of the research, Chairman Cliff Stearns of the Health Committee, and Ranking Democratic Member Corrine Brown of the Oversight and Investigations Subcommittee, and I were extremely concerned, and decided to have an expedited joint hearing. We wanted a public report on what happened, and what is being done about the situation. Obviously, the VA has failed to protect our veterans at the West Los Angeles Medical Research Facility. We know that much already. The Subcommittee on Oversight and Investigations has been conducting oversight of VA patient safety issues as part of its oversight plan, and I regret to say that this is a major patient safety issue. This is the most serious trouble in VA medical research in many, many years. For the VA, the suspension is unprecedented. VA medical research is too important not to do it right. It has given veterans and all Americans many pioneering advances in medicine. We insist that the VA find out what the problems are, and correct them. We also insist that those who are responsible be identified, and held accountable, something the VA has not been consistent in |