рив KF 27 G663 1992K COMMITTEE ON GOVERNMENT OPERATIONS JOHN CONYERS, JR., Michigan, Chairman CARDISS COLLINS, Illinois STEPHEN L. NEAL, North Carolina ROBERT E. WISE, JR., West Virginia FRANK HORTON, New York CHRISTOPHER SHAYS, Connecticut C. CHRISTOPHER COX, California ILEANA ROS-LEHTINEN, Florida WILLIAM H. ZELIFF, JR., New Hampshire SCOTT L. KLUG, Wisconsin BERNARD SANDERS, Vermont (Independent) Caplan, Arthur, Ph.D., director, center for biomedical ethics, University DeGregorio, Michael W., Phar.D., professor of oncology, University of Texas Health Science Center, San Antonio, TX Evans, Nancy, vice president, Breast Cancer Action, San Francisco, CA Greenwald, Peter, M.D., Director, Division of Cancer Prevention and Control, National Cancer Institute, accompanied by Leslie Ford, M.D., and Susan Nayfield, M.D., Community Oncology and Rehabilitation Healy, Bernadine, M.D., Director, National Institutes of Health, accom- panied by Thomas Puglisi, Ph.D., Office for Protection from Research Payne, Hon. Donald M., a Representative in Congress from the State of New Jersey, and chairman, Human Resources and Intergovern- mental Relations Subcommittee: Opening statement Peck, Carl, M.D., Director, Center for Drug Evaluation and Research, Food and Drug Administration, accompanied by Gregory P. Burke, M.D., Director, and Robert L. Justice, M.D., medical officer, Division of Oncology and Pulmonary Drug Products Piantadosi, Steven, M.D., Ph.D., associate professor of oncology, and di- rector, biostatistics, oncology center, Johns Hopkins University School Rodriguez-Trias, Helen, M.D., president-elect, American Public Health Letters, statements, etc., submitted for the record by: Caplan, Arthur, Ph.D., director, center for biomedical ethics, University DeGregorio, Michael W., Phar.D., professor of oncology, University of Evans, Nancy, vice president, Breast Cancer Action, San Francisco, CA: Informed consent form from the National Surgical Adjuvant Breast Healy, Bernadine, M.D., Director, National Institutes of Health: Press release from the National Coalition for Cancer Research entitled "NCCR policy statement: The Breast Cancer Prevention Trial" Payne, Hon. Donald M., a Representative in Congress from the State of New Jersey, and chairman, Human Resources and Intergovern- Letters, statements, etc., submitted for the record by-Continued Payne, Hon. Donald M., a Representative in Congress from the State Letter dated October 15, 1992, from Dr. Lynn Rosenberg, president, women Letter from Gregory P. Burke, M.D., Director, Division of Oncology Results of the cancer research campaign adjuvant trial Peck, Carl, M.D., Director, Center for Drug Evaluation and Research, Rodriguez-Trias, Helen, M.D., president-elect, American Public Health Thomas, Hon. Craig, a Representative in Congress from the State of Page 133 154 125 117 101 56 47 3 APPENDIXES Appendix 1.-Letters from patients and the National Network to Prevent 173 Appendix 2.-Informed consent form: May 1992 version of model form, proposed changes, Lahay Clinic form 185 Appendix 3.-Articles on the risks of tamoxifen 208 Appendix 4.-FDA criticism of informed consent document 238 247 Appendix 6.-Letter from FDA in response to Chairman Payne's followup questions 270 |