Index
A
Abbott Laboratories, 190n.1
Abbreviated new drug application (ANDA), 6, 40–41
Abdominal aortic aneurysm repair, 116
Access
to new drugs, 53–67
Adrenal medulla tissue transplantation, 100
Adriamycin, 60
AIDS (acquired immune deficiency syndrome), 5, 55, 83, 144
drug therapies, 145, 172, 174–175, 178
Alcon Laboratories, Inc., 81
Allergan Medical Optics, 81
Allergy treatment, 89
Alzheimer's disease, 190
American Home Products Corporation, 190n.1
American Medical Association, 7, 107–108
Ancillary services, 24
Angioplasty equipment, 77
Animal research, 5, 99, 128, 170–171
Annual update factor, 28
Antibacterials, 160
Antibiotics, 37
Antihistamines, 89
Antihypertensive drugs, 25–26
Antitrust legislation, 2
Appendectomies, 97
Applied research, 188
Arterial switch surgery, 98
Artificial Heart Program (NIH), 74, 75
Assessment of technology, 31, 84, 100, 111, 141, 144–145
Association of Community Cancer Centers (ACCC), 55, 58
Austenal Dental, Inc., 73
Austria, 129
Autologous bone marrow transplantation, 56
Axid, 50n.10
Azidothymidine (AZT), 175
B
Baby boom, 22
Banyu Pharmaceutical Company, Ltd., 164
Baxter Healthcare Corporation, 149
Beckman, Arnold, 91
Beckman Instruments, Inc., 91
medical device industry, 81
pharmaceutical industry, 126–127, 130, 133, 134
Biliary lithotripsy, 79–80, 98
“Bioequivalence,” 17n.4
Biologics Evaluation and Research Center
(FDA), 179–180n.1
Biotechnology, 8
drug regulation, 129, 173, 175, 177
Blood cardioplegia, 98
Blue Cross and Blue Shield Association, 61–62, 105
Medical Advisory Panel, 106
Blue Shield of California, 108, 113, 116, 117, 120n.5
Breast cancer, 56
Breast reconstruction, 116
Bristol-Myers Squibb, 158, 183, 190n.1
C
Calcium channel blockers, 37
California, 29–30
Medicaid coverage, 47–48, 107, 113
Office of Statewide Health Planning and Development, 112
Cancer
chemotherapy innovations, 53–56, 64
chemotherapy reimbursement, 7, 56–65
drugs, 5, 17n.5, 40, 55, 59–62, 64, 83, 172, 174, 175, 178
Capoten, 50n.10
Carcinogenicity bioassay, 171
Cardiac arrhythmias, 4
Cardiac catheterization, 28, 116
Cardiac Pacemaker Registry, 85
Cardiac pacemakers, 76, 85, 91
Cardiac surgery, 28, 96–97, 98, 112, 113, 116
Cardiac transplantation, 99, 112, 113–114, 120n.5, 151
Cardiovascular disease
drug therapies, 37, 40, 174, 175
mortality, 37
Carte Sanitaire, 151
Case management, 13
Catastrophic Care Act (1988), 61, 62
Catheter ablation of abnormal cardiac conduction foci, 116
Cefazolin, 160
“Centers of excellence,” 115
Cephalosporins, 25
Certificate-of-need regulations, 1, 113
Chemonucleolysis, 108
Chemotherapy
reimbursement policies, 7, 56–65, 66
Chest radiographs, 30
Chiron Corporation, 81
Chiron Ophthalmics, Inc., 81
Cholesterol-reducing drugs, 26, 37, 162
Chronic disease drugs, 40
Ciba-Geigy Corporation, 158, 161
Cimetidine, 25
Class action suits, 136
Class III devices, 17n.8, 76, 79, 80–81
Clinical practice, 37, 55, 141
Clinical trials
cancer therapies, 54, 55, 61, 62, 63, 64, 65, 66, 67
pharmaceutical, 7, 40, 128, 136, 158–159, 171–174, 178–179, 180n.2
Phases of, 5, 170–176, 180nn.2, 4, 5, and 7
surgical procedures, 13, 99, 102, 103
Cochlear implants, 11, 28, 109–110
Coding
medical devices, 94–95
surgical procedures, 13, 97, 102, 105, 107–111, 118
Compassionate use, 7, 17n.5, 173, 178–179
Computerized tomography, 24, 29–30, 103, 146, 148–149, 151
Concurrent review, 13
Consumer groups, 130
Contact lenses, 18n.12
Contingency fees, 136
Coopervision G.m.b.H., 81
Coronary artery bypass grafting (CABG), 24, 26, 98, 99, 112–113
reimbursement policy, 108, 111
selective contracting, 14, 115, 116
Coronary artery disease, 26
Cost containment, 1–2, 6–7, 31, 77
and medical device innovation, 10–12, 77–79, 82, 83, 86
private insurers, 57
and surgical procedure innovation, 13–14, 96, 108, 111, 113, 116, 118, 119
Cost-effectiveness, 119
cardiac transplantation, 113–114
of drug formularies, 50n.20
lithotripsy, 149–150
and medical device innovation, 10–12, 91, 142, 146, 152
model of diffusion and, 22, 24–26, 27, 30–31
MRI utilization, 29
pharmaceutical studies, 8, 25–26, 190
public policy and, 144, 145, 190
Costs
of disease, 190
health care, 1, 4, 15–16, 21–22, 25, 26– 27, 50n.20, 77, 85, 151, 181, 186, 187, 190
hospital, 7, 75, 77, 111, 147–148
lithotripsy, 78
medical device innovation, 10, 18n.12, 91–92
pharmaceutical research and development, 6, 37–40, 41, 42–43, 44, 45, 46, 100, 127, 182–183, 187
physicians and, 27
surgery, 14, 79, 81, 97, 98, 99–100, 105, 110–111, 112, 114, 115, 116, 118, 119
of technology, vii, 63, 145–146 See also
Prices, pharmaceutical
Reimbursement
Crippled Children's Services, 113
Crout, Richard, 175
Current Procedural Terminology (CPT), 13, 57, 107–108, 119n.1
Cyclosporine, 96
Cytoxan, 60
D
Demand
for health services, 142
for medical devices, 75
for pharmaceuticals, 139n.8, 157
Denial of payment, 56, 58, 61, 63, 65
Denmark
health care system, 147, 148, 150, 151
pharmaceutical industry, 126–127, 131– 132, 134
Development of technology. See
Research and development
“Device lag,” 10, 83
Devices. See
Medical devices
Devices and Radiological Health Center (FDA), 179–180n.1
Diagnosis-related groups (DRG), 1–2
hospitals and, 13, 27, 28, 56–57, 63, 77, 109, 110, 117, 119n.2
pharmaceutical therapies, 56–57, 179
surgical procedures, 11, 109–110, 117
Diagnostic technologies, 26, 75, 144
Dialysis machines, 151
Diasonics, Inc., 79
Diffusion of technology, 16, 27, 29, 66
control of, 1, 2, 10, 21, 56, 73
and health care costs, 21–22, 24–26, 30–31
medical devices, 10, 70, 71, 72, 73, 85, 91, 141, 144, 146, 149–150
payment policies and, 14, 28, 53, 77, 109, 119, 144, 150–151
surgical procedures, 13, 96, 97, 101–102, 112–113, 114, 119
DiMasi, Joe, 39
Dornier Medical Systems, 9, 79, 149–150
Dow Chemical Company, 183
Doxazosin, 156
Drug Amendments (1962, Food, Drug, and Cosmetic Act), 169
Drug Evaluation and Research Center (FDA), 179–180n.1
Drug Evaluations (American MedicalAssociation), 7, 61
Drug Information (U.S. Pharmacopeia), 7, 61
Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Act, 1984), 6, 40–41, 42, 129–130, 135, 139n.9, 177
Drugs. See
Pharmaceuticals
Duke University, 42
Dutch Organization for Applied Scientific Research, 149
E
Effectiveness evaluation, 21
pharmaceuticals, 174, 175, 179–180n.1, 180n.4
Efficacy evaluation
medical devices, 4, 12, 15, 18n.10
surgical procedures, 99, 101–102
Electrocardiograms, 30
Electronic fetal monitoring, 24
Electron microscopy, 36
Electrophysiologic mapping (EPS), 116
EMI Medical, Inc., 148–149
Endoscopic papillotomies, 103
End-stage renal disease, 25, 26, 98
health care systems, 14, 123, 124, 147– 148, 152
medical device innovation, 15, 141–146, 148–153
patent laws, 14, 15, 17n.2, 123, 129–130, 133, 137, 138n.5, 139n.9
pharmaceutical innovation, 14–15, 37, 123–138, 157–158, 163, 165
European Commission, 124, 128, 129, 134, 135, 137, 152
European Court of Justice, 134, 138n.1, 139n.12
European Economic Community (EEC), 137, 163, 164
medical device policies, 141–146, 149–153
pharmaceutical regulation, 15, 128, 130, 131, 132, 133, 135, 136, 138n.1, 139n.11, 161
European Parliament, 130
European Patent Convention, 129, 138n.5
Evaluation
pharmaceutical, 4, 5, 61, 63, 174, 175, 179–180n.1, 180nn.2 and 4, 185
surgical procedures, 12–13, 99, 101–102, 104–105, 111
Exercise tolerance testing, 26
Experimental therapies, 7, 17n.5, 64, 99, 102
Extracorporeal shock wave lithotripsy (ESWL), 78–80
Extracranial/intracranial arterial bypass surgery, 99
F
“Fast-follower” drugs, 184–185
Federalism, 85
Fee-for-service systems, 1, 26, 30, 108
Fiberoptic endoscopes, 96
Fluorouracil, 60
Food, Drug, and Cosmetic Act (1938), 5, 169
Drug Amendments (1962), 169 510 (k)
provision, 9–10, 11, 18n.10, 93
Medical Device Amendments (1976), 9, 10, 76
Food and Drug Administration (FDA)
cancer drug approval and labeling, 55, 58, 59–61, 64, 65, 66–67, 83, 175
Cardiac Pacemaker Registry, 85
evaluation centers, 179– 180n.1 510(k)
applications, 9–10, 11, 18n.10, 93
generic drug regulations, 6, 139n.9, 170
medical device regulation, 4, 9–10, 11, 12, 18nn.10 and 11, 28, 76, 79–81, 82, 83, 85, 93, 100, 108
pharmaceutical regulation, 4, 5–6, 7, 8, 17n.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92–93, 97, 100, 101, 102, 108, 128, 136, 169–176, 177, 179, 180nn.7 and 8, 188
Food Safety and Applied Nutrition Center
(FDA), 179–180n.1
Formularies, 7–8, 17n.7, 30, 47–48, 50n.20, 61, 102
Fox, Renee, 4
France
health care system, 138nn.3 and 6, 147– 148, 151
medical device industry, 81, 149, 150
pharmaceutical industry, 126, 127, 130, 134, 137–138
pharmaceutical regulation, 128, 132, 133
Fujisawa Pharmaceutical Company, Ltd., 160, 162
G
Gallstone lithotripsy, 79–80, 98
Gastric balloon placement, 99
General Accounting Office (GAO), 10, 18n.11, 76
General Electric Company, 73
Generic drugs, 7, 43, 46, 47, 61, 65
in Europe, 15, 123–124, 131, 133
HMOs and, 30
regulation of, 6, 17n.4, 40–41, 42, 139n.9, 170, 177, 185
Generic substitution laws, 7
Genetic engineering, 145
medical device regulation, 151
pharmaceutical industry, 126, 127, 133, 138, 162, 163, 166, 186–187
pharmaceutical regulation, 128, 130, 132, 134
Gibbon, John H., Jr., 96–97
Glaxo Holdings P.L.C., 161, 190n.1
Good Licensing Practices, 161
Good Manufacturing Practices, 150, 161
Gross National Product price deflator, 43, 50n.14
Group C drugs, 5, 17n.5, 55, 62, 63, 178 See also
Cancer: drugs
H
Hairy cell leukemia, 64
Hatch, Orrin G., 85
Health care, 56
costs, 1, 4, 15–16, 21–22, 25, 26–27, 50n.20, 75, 77, 85, 151, 181, 186, 187, 190
Europe, 14, 123, 124, 147–148, 152
Japan, 163
liability, 94
technology and, 22–24, 53, 82, 142
Health Care Financing Administration (HCFA), 8, 24
Bureau of Eligibility, Reimbursement and Coverage (BERC), 106
Cardiac Pacemaker Registry, 85
Common Procedure Coding System, 119n.1
experimental therapy coverage, 62–63, 67, 179
medical device coverage, 10–11, 12, 80, 81–82, 85
Office of Coverage Policy, 10–11
pharmaceutical coverage, 17n.5, 178
surgical procedures coverage, 105, 106, 109–110, 113, 114, 115
Health care market, 3–4
Health insurance, 4, 22, 26, 138n.7, 148, 178
Health Insurance Association of America, 7, 62
Health maintenance organizations (HMO), 57
cost containment, 1–2, 11–12, 58, 187
drug formularies, 17n.7
selective contracting, 105, 115
technology utilization, 29–30, 31
Health outcomes
surgical, 14, 99, 100, 112–113, 114, 115, 116
technology and, 21, 22, 24–26, 28
Heart valves, 76
Hewlett-Packard Company, 73, 149
High Technology Directive (1987), 130
Hip fracture patients, 116
Hoechst-Roussel Pharmaceuticals, Inc., 158
Hoffman-LaRoche, Inc., 90, 161
Home health care, 12
Honeywell, Inc., 115
Hospital Provisions Act (Netherlands), 151
Hospitals, 144
clinical research, 63, 66, 128, 179
coding practices, 13, 105, 109–110, 118, 119n.2
competition for patients and surgeons, 29, 55, 104, 112–113, 114
cost shifting, 57
costs of technology utilization, 24, 26
liability, 94
payment systems and cost containment, 1, 7, 26, 75, 77, 79, 91, 105, 111, 118, 119
Prospective Payment System and, 11, 14, 27–29, 56, 63, 77, 117, 118, 119
Howmedica, Inc., 73
Humana Hospital Audubon, 104
Human immunodeficiency virus (HIV), 5
Hydroxyzine, 156
Hypertension, 30
I
Imaging devices, 23, 26, 75, 91
Immunostimulants, 162
Immunosuppressive drugs, 96
Inflation, 43, 50n.14, 184, 187
Innovation, 1–2
dynamic model of, 2–5
medical devices, 4, 8–12, 89–95, 97
medical devices, Europe, 15, 141–153
pharmaceutical, Europe, 14–15, 37, 123–138, 157–158, 163, 165
pharmaceutical, public policy and, 5, 47–49, 123–124, 135–138, 181–182, 183, 184, 185, 186, 188, 189, 190
pharmaceutical, regulation and, 169–177, 181–182, 186–187
pharmaceutical, reimbursement and, 63–65, 178–179
surgical procedures, 4, 12–14, 96–119
Inpatient treatment, 57
Institutional Review Boards (IRB), 13, 99, 171, 173, 180n.3
Insurance
Europe, 147
health, 4, 22, 26, 138n.7, 148, 178
Japan, 157
liability, 10
Insurers, 178
and drug labeling, 59, 61, 62, 64, 65–66
and surgical procedures, 14, 105, 106, 115, 120n.4
Interferon, 64–65
Internal Revenue Service, 90
International Classification of Diseases, 109
Intraocular lenses, 18n.12, 73, 80–82, 111, 117
Intrauterine devices, 76
Investigational device exemption (IDE), 81, 82
Investigational drugs, 17n.5, 62–63, 173, 178–179
Investigational New Drug (IND), 37–38, 55, 170, 171–174
treatment IND, 5–6, 55, 62, 178
IOLAB Corporation, 81
Ireland, 129, 133–134, 138nn.3 and 5, 147
Israel, 81
Italy, 130
health care system, 138n.3, 147, 149
pharmaceutical industry and regulation, 130, 133, 134, 137–138, 162
J
National Health Insurance, 157, 159, 161, 163–164
pharmaceutical industry and regulation, 2, 14, 15–16, 126, 127, 129–130, 139n.11, 155–166, 187
Johnson & Johnson Products, Inc., 81, 190n.1
Journal of the American Medical Association, 104
K
Kaiser Permanente, 29–30
Kentucky, 47–48
Kidney stone lithotripsy, 78, 79, 80, 149– 150
Kyowa Chemical Industry Company, Ltd., 157
L
Laparoscopic gynecological surgery, 14
Lasagna Committee. See
National Committee
to Review Current Procedures for
Approval of New Drugs for Cancer and
AIDS
Laser atherectomies, 96
Lawyers, 137
Lederle Laboratories, 158
Liability law
and diffusion of technology, 2, 10, 71, 72, 75–76, 84, 94
Lilly, Eli, & Company, 160, 164, 190n.1
Linear accelerators, 151
Lithotripsy, 9, 28, 73, 78–80, 98, 149–150, 151
Liver transplantation, 98, 112, 151
Louisville, Ky., 104
Lung cancer, 56
M
Magnetic resonance imaging, 26, 29, 146, 149, 151
Managed care plans, 13, 29–30, 48, 57, 58
Marion Laboratories, Inc., 183
Marketing, 185
Massachusetts General Hospital, 112
Mastectomy, 116
Medicaid, 1
pharmaceutical reimbursement, 8, 17n.7, 47–48, 50n.19, 178
surgical procedures coverage, 106–107
Medical care. See
Health care
Medical compendia, 7, 17n.6, 61, 67
Medical Device Amendments (1976, Food,
Drug, and Cosmetic Act), 9, 10, 76
Medical devices
Classes of regulation, 17n.8, 76, 79, 80–81
diffusion of, 10, 70, 71, 72, 73, 85, 91, 102, 141, 144, 146, 149–150
patent protection, 9, 70–71, 89–90, 100– 101
regulation of, 4, 9–10, 11, 12, 17nn.8 and 9, 18n.10 and 11, 28, 76, 79–81, 82, 83, 84, 85–86, 97, 100, 108, 173
and surgical innovation, 96, 108
Medical devices industry, 8–9, 12, 95, 152
regulation and, 9–10, 69–73, 74, 76, 79, 86, 86n.1
research spending, 18n.12, 75, 90, 91–92, 145–146
Medical devices innovation, 4, 8–12, 89–95, 97
public policy and, 69–86, 89, 92, 95, 141– 142, 144–145
Medical oncology, 54
Medical practice. See Clinical practice
Medicare, 77
and demand for technology, 1, 75
medical device reimbursement, 12, 25, 28, 79, 80, 81, 82, 85
pharmaceutical reimbursement, 6, 57, 62– 63, 178
surgical procedure reimbursement, 105, 106, 107, 109, 113, 114, 115, 116–117, 120n.6 See also
Prospective Payment System
Medstone International, 79
Medtronic, Inc., 91
Meiji Seika Pharmaceutical International,
Ltd., 157
Merck & Company, Inc., 158, 161, 164, 182, 183–184, 188, 190, 190n.1
Mergers, 183
Meta-analysis, 101
Methotrexate, 60
Methylmethacrylate, 96
Metropolitan Life Insurance Company, 115
Microprocessors, 93
Modifiable selective reimbursement, 14
Monitoring technologies, 94
Morbid obesity, 99
Mortality and morbidity, 14, 37, 99, 100, 111, 115
Mutamycin, 60
Myocardial infarction, 25
N
National Aeronautics and Space Administration, 74–75
National Cancer Act (1971), 54
National Cancer Institute (NCI), 55, 62, 64, 172, 179
National Center for Health Statistics, 109
National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS (Lasagna Committee), 62, 172, 173
National Health Insurance (Japan), 157, 159, 161, 163–164
National Health Service (United Kingdom), 132, 150, 153n.2
National Hospital Formulary, 61
National Institutes of Health (NIH), 63
and AIDS drugs, 174
Artificial Heart Program, 74, 85
cancer therapy media campaign, 55
research spending, 49, 54, 67, 72, 74, 75, 85, 102, 103, 182–183, 188
Small Business Innovation Research grants, 92
National Science Foundation, 188
Netherlands, 126–127, 130, 131–132, 134, 138n.3, 147–148, 151
New chemical entities (NCE), 37, 126, 129, 186–187, 188, 191n.2
discoveries, Japan, 159, 160, 162, 164– 165
reimbursement policy, 178
New Drug Application (NDA), 170
approval time, 37–38, 42, 172, 173, 174–176
available to generic competition, 139n.9
data requirements, 6, 50n.9, 171
supplemental, 7, 61, 64, 176–177, 179
New York (state), 113
Nixon, Richard M., 54
Non-steroidal anti-inflammatory drugs
(NSAID), 37
Northgate Research Corporation, 79
O
Office of Health Technology Assessment (OHTA), 10–11, 28
Off-label use, 7, 58–62, 64–65, 179, 180n.8
Omnibus Budget Reconciliation Act (1980), 117
Open-heart surgery, 28, 98, 112, 113, 116
Ophthalmology, 80
Opportunity costs, 7, 49n.6, 50n.16
Oral H2 blockers, 103
Oregon, 107
Organ transplants, 28, 96, 107, 114
bone marrow, 56
cardiac, 99, 112, 113–114, 120n.5, 151
Orphan disease drugs, 174
Outcomes. See
Health outcomes
Outpatient services, 11, 12, 27, 57, 77, 116– 117
P
Parallel importing, 132
“Parallel track system,” 6
Parkinsonism, 100
Patent protection, 100–101, 182, 189
effective patent life, 6, 14, 15, 17nn.2 and 3, 41–43, 47, 53, 64–65, 123
Europe, 14, 15, 17n.2, 123, 129–130, 133, 137, 138n.5, 139n.9
Japan, 15, 16, 156, 160, 163, 165
medical devices, 9, 70–71, 89–90, 100– 101
pharmaceuticals, 5, 6, 40, 41–43, 46, 47, 50n.11, 64–65, 66, 139n.9, 163, 165, 177, 185, 186
Patient outcomes. See
Health outcomes
in clinical research, 50n.9, 62, 63
and payment policies, 56, 62, 63, 66, 120n.6, 131, 147
Payers, 4
and health care costs, 27, 119
and medical devices, 94
and pharmaceuticals, 17n.5, 62, 102, 178, 180n.8, 187
for investigational therapies, 62–63, 178– 179
Medicare, 62–63, 77, 81–82, 85, 116–117, 120n.6
physician, 1–2, 18n.13, 30, 105, 110, 118
public policy, 1–2, 5, 6–7, 12, 13–14, 15– 16, 16n.1, 75, 178–179
surgical procedure, 97, 104–117 See also
Coverage; Prospective Payment System; Reimbursement
Peer review, 13, 105, 111, 117
Penicillin, 156
Pepcid, 50n.10
Peptic ulcer disease, 25, 98, 99, 103
level="1"Percutaneous biopsy, 103
Percutaneous catheter ablation, 116
Percutaneous endoscopic techniques, 78
Percutaneous transluminal coronary angioplasty (PTCA), 11, 108, 112
Peter Principle, 26
Pfizer, Inc., 73, 156, 158, 163, 190n.1
Pfizer Laser Systems, 73
Pharmaceutical Affairs Law (Japan), 161
Pharmaceutical Manufacturers Association, 49n.5, 183, 191n.2
Pharmaceutical producer price index (PPPI), 43, 50nn.13 and 14
Pharmaceuticals, 22
AIDS drugs, 144, 145, 172, 174–175, 178
approval time, 17n.3, 37–38, 42, 172, 173, 174–176, 180nn.5 and 6
cancer drugs, 5, 17n.5, 40, 54, 55, 59–62, 64, 83, 172, 174, 175, 178
cardiovascular disease drugs, 37, 40, 174, 175
cholesterol-reducing drugs, 26, 37, 162
clinical trials, 7, 40, 128, 136, 158–159, 171–174, 178–179, 180n.2, 4, 5 and 7
cost-effectiveness analysis, 8, 25–26, 190
diffusion of technology, 102
drug formularies, 7–8, 17n.7, 30, 47–48, 50n.20, 102
drug utilization, 15–16, 30, 125, 138n.3
new drugs, 8, 23, 36, 40, 45, 46–47, 48, 53–67
off-label use, 7, 58–62, 64–65, 179, 180n.8
patent protection, 5, 6, 40, 41–43, 46, 47, 50n.11, 64–65, 66, 89, 100–101, 139n.9, 163, 165, 177, 185, 186
Phases of clinical trials, 5, 170–176, 180nn.2, 4, 5 and 7
polypharmacy, 69
product life cycle, 40–41, 43, 46, 47, 50n.18, 93, 184–185
regulation, Europe, 15, 123, 128–129, 131–132, 133, 135, 136, 137, 138n.1, 139n.11, 161
regulation, FDA, 4, 5–6, 7, 8, 17nn.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92–93, 97, 100, 101, 102, 108, 128, 136, 169– 176, 177, 179, 180nn.5, 6, 7 and 8, 188
regulation, Japan, 156, 158–159, 160–161, 164
research and development, 6, 35–49, 126– 127, 128–129, 135, 138n.4, 181–190
and surgical innovation, 96, 108
used in lithotripsy, 80 See also
Prices, pharmaceutical
Pharmaceuticals industry, 37, 65, 73, 89, 90, 95
and clinical trials, 61, 64, 172, 176
Europe, 15, 126–127, 129, 132, 133–134, 135–136, 137, 138n.1, 139n.10
patent protection and, 129–130, 177, 186
pricing behavior, 8, 43, 177, 187
research and development, 8, 35, 36, 38, 40, 46–47, 49, 127, 181–188, 190
return on investment, 8, 43–46, 47, 49n.6, 50n.16, 53, 64, 65, 123, 129, 177, 183, 185–186, 190
Pharmaceuticals innovation, 4, 5–8, 66, 166, 184, 186, 188, 189, 190
Europe, 14–15, 37, 123–138, 157–158, 163, 165
public policy and, 5, 47–49, 123–124, 135–138, 181–182, 183, 184, 185, 186, 188, 189, 190
regulation and, 169–177, 181–182, 186– 187
reimbursement and, 63–65, 178–179
Phase I trials, 171, 173, 180n.2
Phase II trials, 5, 172, 175–176, 180n.5
Phase III trials, 173–174, 175–176, 180nn.4 and 5
Phase IV studies, 5, 176, 180n.7
Philips Medical Systems International, 149
pH meter, 91
Physician Payment Review Commission
(PPRC), 109
and coding systems, 13, 107–109, 118
and health care costs, 27–28, 119
liability and, 94
payment systems, 1–2, 18n.13, 30, 105, 110, 118
prescription practices, 59, 64–65, 69, 176
reimbursement policies and, 1, 30, 53, 58, 85
and technological innovation, 4, 17n.6, 53, 65–66
Physician's Desk Reference, 59
Platelet activating factor antagonists, 162
Platinol, 60
Pneumonia, 25
“Polyintervention,” 69–70, 73–74, 78, 83–85, 86, 86n.1
Polypharmacy, 69
Portugal, 127, 129, 133, 138n.5, 147
Post-marketing surveillance
medical devices, 10, 76, 83, 101–102
pharmaceuticals, 5, 6, 136, 170, 176–177
Pre-certification, 13
Preclinical testing, 170–171
Preferred provider organizations (PPO), 1–2, 11
Pre-marketing application (PMA), 10, 79, 81, 82
Pre-marketing approval, 2, 15, 16, 136
medical devices, 9–10, 76, 79, 82, 83
Prices, pharmaceutical, 8, 43, 44, 45, 50nn.13, 14, and 16, 139n.8, 186, 187
Europe, 123, 130–133, 134, 135, 136, 137, 138nn.6 and 7
Private foundations, 103
Private sector
European health care systems, 148
insurance industry, 178
public policy and, 78
Professional Review Organizations, 117
Prospective Payment Assessment Commission (ProPAC), 28, 110
Prospective Payment System (PPS)
and clinical research, 63
and diffusion of technology, 1–2, 27, 28, 31, 56–57
Prudential Insurance Company of America, 115
Public Health Service, 10–11
Europe, 14–15, 123–138, 141–153
medical device innovation, 69–86, 89, 92, 95, 141–142, 144–145
payment, 1–2, 5, 6–7, 12, 13–14, 75, 178– 179
pharmaceutical innovation, 5, 47–49, 123–124, 135–138, 181–182, 183, 184, 185, 186, 188, 189, 190
Pulse oximetry, 89–90
Q
Quality-adjusted life years, 25, 31n.1
Quality of life, 25–26, 142–143
Quinolones, 162
R
approval time, 17n.3, 37–38, 42, 172, 173, 174–176, 180nn.5 and 6
Classes of medical devices, 17n.8, 76, 79, 80–81
generic drugs, 6, 17n.4, 40–41, 42, 139n.9, 170, 177, 185
medical devices, 4, 9–10, 11, 12, 17nn.8 and 9, 18nn.10 and 11, 28, 71, 72, 75–76, 78–81, 82, 83, 84, 85, 89, 92–93, 100, 108
medical devices, Europe, 15, 143–144, 150, 152
pharmaceuticals, 4, 5–6, 7, 8, 17nn.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92–93, 97, 100–102, 108, 169–177, 186–187
pharmaceuticals, Europe, 15, 123, 128– 129, 131–132, 136, 137, 138n.1, 139n.11, 161
pharmaceuticals, Japan, 156, 158–159, 160–161, 164
Phases of clinical trials, 5, 170–176, 180nn.2, 4, 5 and 7
“polyintervention,” 69–70, 73–74, 78, 83– 85, 86, 86n.1
surgical procedures, 97, 100, 113 See also
Food and Drug Administration
and diffusion of technology, 26–30, 31, 53
Europe, 131, 144, 145–146, 147, 148, 150–151
HMOs and managed care plans, 13, 29– 30, 57, 58
Medicaid, 8, 17n.7, 47–48, 50n.19, 106– 107, 178
and medical devices, 71, 72, 77, 80, 83, 85, 94–95
Medicare, 6, 11, 12, 25, 27, 28, 31, 56–57, 62–63, 77, 79, 80, 81, 82, 85, 105, 106, 107, 109, 113, 114, 115, 116–117, 120n.6, 178
pharmaceutical, 6–8, 47–48, 56–65, 66, 177, 178–179, 180n.8
surgical procedures, 13, 96, 105, 106, 107, 109, 113, 114, 115, 116–117, 118, 120n.6 See also
Coverage; Payment
Reischauer, Edwin O., 155
Renal transplantation, 98, 107
Renin inhibitors, 162
Research, 16, 23–24, 74, 102, 103, 127, 142
animal studies, 5, 99, 128, 170–171
biomedical, 2–3, 48–49, 72, 75, 82, 138n.2, 182–183, 184, 188
cost-effectiveness, 8, 22, 24–26, 27
university, 13, 14, 54, 55, 92, 103, 149, 173, 184, 188
Research Councils (United Kingdom), 149
Research and development
cancer and AIDS drugs, 40, 54–55, 64, 144, 145
contraceptives, 10
demand for technology and, 3, 4–5
medical devices, 9, 11, 12, 70, 74–75, 85, 89, 90–91, 92, 95
medical devices, Europe, 144, 145, 149– 150, 152
patent protection and, 6, 9, 41–43, 47, 64– 65, 185, 186
payment policies and, 11, 47–48, 64, 187
pharmaceutical, 6, 35–49, 64–65, 66, 181–190
pharmaceutical, costs of, 8, 37–40, 41, 42–43, 44, 45, 46–47, 49, 49nn.4, 5 and 6, 50n.17, 162, 182–183
pharmaceutical, Europe, 15, 123, 127, 131, 133–134, 135–136, 137, 186–187
pharmaceutical, Japan, 159–160, 162, 164, 165, 166, 186–187
pharmaceutical, return on investment, 8, 43–46, 47, 50n.16, 53, 64, 65, 123, 177, 183, 185–186, 190
public policy and, 2, 47–48, 66–67, 85, 181–182, 183–184, 188
Resource-based relative value scale(RBRVS), 1–2, 13, 18n.13, 30, 118– 119
Return on assets (ROA), 185–186, 190n.1
Rhône-Poulenc, Inc., 183
Risk-adjusted economic returns, 185
Rorer Group, Inc., 183
Roussel Uclaf, 158
S
Safety
medical devices, 12, 15, 18n.10, 79, 82, 83, 84, 85, 86
pharmaceuticals, 4, 5, 174, 175, 179–180n.1, 180n.2, 185
Sandoz, Inc., 158
Schering AG, 158
Schering-Plough Corporation, 190n.1
research spending, 74, 75, 103, 127, 135
Selective contracting, 13–14, 113–118, 119, 120n.4
Self-insured employers, 67, 115
Shionogi & Company, Ltd., 164
Shumway, Norman Edward, 99
Sick Funds Council (Netherlands), 151
Siemens Corporation, 149
Small Business Innovation Research program, 92
Smallpox, 190
SmithKline Beecham P.L.C., 81, 183, 190n.1
Social security health care systems, 147–148
Spain
health care system, 138n.3, 147, 148
pharmaceuticals in, 127, 129, 132, 133, 134, 138nn.5 and 6
Squibb Corporation, 183
Stanford University, 99, 112, 113, 120n.5
States, 1, 8, 47–48, 50n.19, 76, 85, 187
“Substantial equivalence,” 17n.9
Supplemental NDA, 7, 61, 64, 176–177, 179
Supratentorial craniotomy, 107
cardiac, 28, 96–97, 98, 112, 113, 116
case loads, 112
cataract, 81
coding, 13, 97, 102, 105, 107–111, 118
selective contracting, 13–14, 113–118, 119, 120n.4
Swan-Ganz catheter monitoring, 108
Sweden, 129, 136, 147, 150, 153n.2
Switzerland, 138n.3
pharmaceutical development, 126, 129, 132, 138, 166, 186–187, 191n.2
T
Tagamet, 50n. 10
Taito Corporation, 157
Tax Equity and Fiscal Responsibility Act (1982), 56
assessment of, 31, 84, 100, 111, 141, 144–145
cost-effectiveness of, 12, 91, 152
dynamic model of innovation, 2–5
and health care costs, 1, 6, 21, 22–24, 114
policy incentives and, 1–2, 16, 53, 75, 77, 141, 142
use of, reimbursement and, 26–30, 56–63 See also
Diffusion of technology;
Research and development
Technomed International, Inc., 79
Texas Heart Institute, 115
Thatcher, Margaret, 127
Tissue plasminogen activator, 110
Total hip joint replacement, 96
Toyo Jozo Company, Ltd., 157
import restrictions, 138n.1, 139nn.11 and 12, 156
parallel importing, 132
Translation of technology, 70, 141
Transparency Directive (1990), 134
Transurethral resection of the prostate (TURP), 109
Treaty of Rome, 124, 131, 132, 134, 138n.1, 139nn.11 and 12
Tufts University, 39
U
Ulcer treatment, 103
Ultrasound, 75
“Unbundling,” 108, 120n.3
Uninsured persons, 22
United Kingdom
health care system, 138n.3, 147, 148
medical device industry, 146, 148–149
medical device regulation, 150, 151
National Health Service, 132, 150, 153n.2
pharmaceutical industry, 126, 127, 132, 134, 138, 138n.2 and 4, 139n.14, 166, 186–187
pharmaceutical regulation, 128, 130, 132– 133, 134, 136
United States, 2, 14, 15–16, 29, 31, 123
generic drug policy, 15, 40–41, 133
and medical device industry, 69–70, 73– 78, 85–86, 152
medical device market, 148, 150, 153
national debt, 189
Occupation Administration (Japan), 155, 156
patent law, 17n.2, 129–130, 165
pharmaceutical industry in, 36–40, 126, 127, 135–136, 157–158, 162, 163, 166, 183, 186–187, 188, 189, 191n.2
and cost containment, 8, 30, 77, 81, 85, 110
medical device regulation, 10, 76, 81, 83
pharmaceutical regulation, 170, 171, 177, 186, 189
U.S. Pharmacopeia, 7, 17n.6, 61
Universities, 13, 14, 54, 55, 92, 103, 149, 173, 184, 188
University of California at San Francisco, 111
“Upcoding,” 108
Upjohn Company, 190n.1
Uruguay Round trade talks, 164, 165
Utilization review, 6–7, 29, 30, 62, 117
V
Vagotomy techniques, 98
VAMP Ltd., 139n.14
Vasotec, 50n.10
Vepesid, 60
Veterinary Medicine Center (FDA), 179– 180n.1
W
Warner Lambert Company, 190n.1
Washington (state), 47–48
Waxman-Hatch Act. See Drug Price
Competition and Patent Term
Restoration Act
West Germany. See Germany
World War II, 15, 139n.10, 155
X
X-ray crystallography, 36
Y
YAG laser, 18n.12
Yarbro, John W., 63
Z
Zantac, 50n.10