Innovation in Medical Technology: Ethical Issues and Challenges

Index

AbioCor artificial heart, 63–64 Academic-corporate collaborations for introduction of new devices, 67–71 “Accepted and routine practice of medicine,” 30 Advocacy groups, 10–11, 34 Agency for Healthcare Research and Quality (AHRQ), 103, 104, 141n6 AIDS drugs, 50 Alzheimer disease, 86 Amantadine, 50 American College of Obstetricians and Gynecologists, 73 American Infertility Association, 76 American Medical Association, 8; Ethical Guidelines for Clinical Investigation, 40 American Society of Reproductive Medicine, 73, 74, 99 Antiangiogenesis agents, 8 Antihypertensive drugs, 15 Anti-Vivisection Society, 38 Anxiety about new technologies, 21–22 Artificial heart, 63–64 Assisted reproductive technology (ART), 21, 72–83; assessing results of, 74; birth defects and, 74, 79, 80, 82–83; case study of, 77–83; costs of, 72, 76; data collection for, 112; embryo cryopreservation for, 77–78, 81; embryo culture media for, 74, 78–79, 82–83, 97; informed consent for, 79–80, 107, 110; laboratories for, 73, 78; multiple gestation and, 74, 76, 79–80, 81, 99; outcomes in regulated vs. unregulated environments, 99, 139n2 (ch. 7); pace and demand for, 76–77; patient information about, 105; patients’ commitment to process of, 75–76; preimplantation genetic diagnosis for, 73, 75, 80; procedures for, 72–73, 138–39n1 (ch. 5); regulatory control of, 73, 77, 98–99; success rates of, 72, 99 Autonomy of patient, 34, 105, 110, 116 Bailey, Charles P., 60–61 Balloon angioplasty, 18–19, 95–96, 137n14, 139n1 (ch. 7) Beecher, Henry, 40, 137n1 Belmont Report, 31–33, 36, 42, 95, 100, 101, 135n3 Biological determinism, 87 Birth defects and ART, 74, 79, 80, 82–83 Bloodletting, 28 Bone marrow transplantation (BMT), with highdose chemotherapy, for breast cancer, 9–11, 12, 15, 112 Boundaries between research and practice, 32–33 Brain cancer, monoclonal antibody therapy for, 108, 109 Brain imaging. See Functional magnetic resonance imaging Breast cancer: high-dose chemotherapy with bone marrow transplant for, 9–11, 12, 15, 112; postmenopausal hormone replacement therapy and, 13–14, 96 Brighthouse Institute for Thought Sciences, 88 Cardiac catheterization, 60 Cardiopulmonary bypass, 58 Cardiovascular surgery, 57–71; artificial heart, 63–64; cardiopulmonary bypass for, 58; case study of, 66–71; closed-chest, beating-heart, 57, 65, 66–71; coronary artery bypass grafting, 17–18, 68–69; minimally invasive, 58–60, 61; for mitral valve stenosis, 60–61; online sharing of information about, 112; for ventricular septal defects, 65 Index Case reports, publication of, 7, 112 Case studies: assisted reproductive services, 77–83; closed-chest, beating-heart surgery, 66–71; fMRI to evaluate anger reactions, 88–93; o=-label use of drugs, 51–56 Chemotherapy, high-dose, with bone marrow transplant for breast cancer, 9–11, 12, 15, 112 Cheney, Dick, surgery on, 114 Chronic obstructive pulmonary disease (COPD), 48 Cingulotomy, 15–16, 136n8 Clinical research organizations, 34 Common Rule, 42, 44, 99, 139–40n3 Conflicts of interest, 8, 13, 22, 26, 33, 62, 99, 102, 111; academic-corporate collaborations for introduction of new devices, 67–71; disclosure of information to patients and, 105, 107; drug trials sponsored by pharmaceutical companies, 98; o=-label use of drugs, 52–53; physicians’ financial interests and infertility treatments, 78–79 Consequences of innovations, 20–22; disclosure of information about, 105–11 Continuous venovenous hemofiltration (CVVH), 103, 140–41n5 Cooley, Denton, 57, 59 Coronary angioplasty, 18–19, 95–96, 137n14, 139n1 (ch. 7) Coronary artery bypass grafting, 17–18, 68–69, 137n13 Coronary artery disease, 16–20, 136n10 Coronary stents, 19, 21, 95–96, 139n1 (ch. 7) Costs: and access to treatments, 21; vs. benefits of treatments, 21; e=ect on adoption of innovations, 9; of fertility services, 72; of new vs. older antihypertensive agents, 15 Declaration of Helsinki, 38, 121–26 Department of Health and Human Services (DHHS), 34; definition of research, 99; Regulations for the Protection of Human Subjects, 43, 127–29 Dilantin, 50 Disclosure of information to patients, 105–11, 116; about surgical innovations, 62–63; how much detail to provide, 107; how to disclose, 111; persuasive influence of physicians and, 106–7; what to disclose, 110 Dissemination of technology, 6–20; duty to learn and to educate, 111–13, 116 Double-blind trials, 5 Drug E=icacy Study Implementation (DESI), 26 Drug recalls, 55–56, 138n2 Duties to learn and to educate about innovations, 111–13 Emanuel, Ezekiel, 45–46 Embryo cryopreservation, 77–78, 81 Emotional vulnerability of patients, 106 Entremed, 8 Ethics of human research, 21, 23, 34–35, 37–46, 135–36n1; AMA Guidelines, 40; Common...