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Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
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Index

A

AABB, see American Association of Blood Banks

ABRA, see American Blood Resources Association

Acquired immunodeficiency syndrome, see AIDS

Advisory committees, 10, 213

FDA, 10, 15, 45-46, 213, 231

see also Blood Products Advisory Committee, FDA

Africa, 128, 129

Agency for Health Care Policy and Research, 233

AHF, see Antihemophilic factor

AIDS, 2, 67, 304

death rate, 61-65, 116

incubation period, 67, 68-69, 70, 73, 115-116

as a notifiable disease, 151-152

see also HIV testing;

HIV transmission

Albumin, 31, 32, 304

Aledort, Louis, 75, 147, 248

Alpha Therapeutic

donor deferral policy, 72, 109, 110, 143

heat treatment, 88, 91, 92, 156-157

recalls, 162, 254, 257

American Association of Blood Banks (AABB), 26, 36-37, 54, 71, 104 -105

and directed donation, 74

Inspection and Accreditation (I&A) program, 37

American Blood Commission (ABC), 41

American Blood Resources Association (ABRA), 26, 38, 66, 67

and donor screening and deferral, 72, 107, 142, 143

and surrogate testing, 72, 107

American College of Surgeons, 36

American Medical Association, 36

American Red Cross (ARC), 9, 26, 29, 30, 34, 35, 66, 71, 115, 208

and directed donation, 74

recalls, 180, 252

American Society of Anesthesiologists, 36

Amyl nitrates, see ''Poppers"

Annals of Internal Medicine, 255

Anti-HBc test, see Hepatitis B core antigen test

Antihemophilic factor (AHF), 1, 8, 19, 31, 170-171, 303

children treated, 85, 188-190

FDA licensing, 81-82, 86-97, 91, 92, 151, 177

heat treatment licensing, 73, 91, 92, 95-96, 177, 259

and hepatitis, 5, 73, 78, 85, 155, 157-158

home infusion, 20, 171

immune suppression theory, 69

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

implicated in HIV transmission, 2, 68, 208

and plasma pooling, 1, 19, 31

recalls, 7, 58, 148, 149, 164

reducing use of, 182-185, 200, 202

risk disclosure, 8, 231

substitution with cryoprecipitate, 4, 71, 175, 176, 177, 181-182, 250, 251

surveillance programs, 67

viral inactivation, 4, 5, 57, 76, 81-82, 86-97, 154-158, 177

Anti-inhibitor complex, 32, 303

Armor Pharmaceutical, 87, 92, 96

Assistant Secretary for Health, 3, 11n, 42, 58, 77, 212, 218n

leadership changes and failures, 59, 213, 214

Autologous donation, 53, 106, 108, 177, 303

B

Baxter Healthcare, 30, 88, 92

recalls, 58, 180

Behringwerke, A.G., 86, 87-88, 93

Best practices, 12, 16, 221, 232-234

Biologics, 43-44, 303

Biologics Act, 43, 44, 47-48

Blood and plasma products, 25-34, 303

distribution and shortages, 33-34

regulation and licensing, 30, 47-48, 50

see also terms listed under Plasma derivatives and Whole blood products

Blood banks and centers, 1, 9, 19, 27, 29, 34-35, 78, 208, 221, 303

community, 19, 26, 29, 35, 36, 37-38, 53-54

denial of risk, 9, 211-212

and directed donation, 74-75

donor screening policies, 6, 78, 102, 106, 162, 208, 211

hospital, 26, 29, 35, 36

licensure and registration, 49-51, 52

marginal interventions, 215, 216, 227-228

standard operating procedures, 73, 108, 142

and surrogate testing, 6, 107

Blood Products Advisory Committee (BPAC), FDA, 3, 7, 26, 45-46, 94 , 135, 212, 213, 219

AHF recall meeting and recommendations, 58, 75, 137, 152-153, 210, 213

donor screening policies, 71, 77

and lookback tracing, 159

panel composition and expertise, 15, 46, 121, 126, 213, 229-230

and surrogate testing, 75, 119-121

Blood Safety Director, 11-12, 218-219

Blood shield laws, 2, 48-49, 139, 223-224

Blood transfusion, 1, 9, 19, 20, 21, 27, 51, 131, 208

early AIDS cases, 58, 63, 64, 65, 68-69

Glaser case, 190-191

HIV incidence among recipients, 1, 19, 21, 169

PHS recommendations, 73, 177

Bove, Joseph, 121, 148

Brandt, Edward, 77, 148, 149, 154

Bureau of Biologics, FDA, 44, 51

1982 meeting, 66, 248

and swine flu episode, 140, 153

C

Canterbury v. Spence, 198

Case reporting, 67

chronologies, 61-65

MMWR reports, 58, 59, 68, 248, 250

CCBC, see Council of Community Blood Centers

CDC, see Centers for Disease Control and Prevention

CD4:CD8 ratios, 68, 76, 117-118

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Center for Biologics Evaluation and Research (CBER), FDA, 26, 44-45, 46, 52

Center for Drugs and Biologics (CDB), FDA, 44

Centers for Disease Control and Prevention (CDC), 2, 9, 20, 26, 42 , 161, 208, 220-221

challenges to credibility of, 114, 115-116, 125-126

changes of directors, 59, 213

donor screening and deferral recommendations, 6, 71, 102, 105-117

donor screening research, 77

Emerging Infections Program, 221

initial evidence of blood-borne transmission, 2, 66, 70-71, 101, 208

interagency agreements, 77

interagency support and rivalry, 13, 116-117, 125-126, 212, 225

January 4, 1983 public meeting and outcomes, 3, 58, 70-71, 89, 102 , 105-117, 213, 251

opportunistic disease epidemiology studies, 60, 66

risk group exclusion recommendations, 106

surrogate testing recommendations, 6, 71, 102, 106

surveillance and reporting systems, 13-14, 67, 76, 79, 221, 226, 248, 249

and swine flu episode, 59-60, 126-127, 140, 225

see also MMWR reports

Children,

see also Infants

AHF concentrate treatment of, 85, 188-190

cryoprecipitate treatment of, 71, 176, 251

early cases among, 62, 63, 64, 65, 68, 250

hemophiliac, 68, 250

Chronologies

case reporting, 61-65

critical events, 58-59, 247-259

Clinical Laboratories Improvement Act, 50

Clinical options

chronology of, 176-177, 248-259

risk communication, 8, 16, 72, 170, 175-181, 201-203, 232-233

College of American Pathologists, 36

Communication, see Risk communication

Community blood centers, 19, 26, 29, 35, 36, 37-38, 53-54

Compensation system, 13, 224

Competitiveness, 94-95

Confidential unit exclusion, 130

Conflicts of interest, 16-17, 213, 233-234

Cost-effectiveness analyses, 214-215

Council of Community Blood Centers (CCBC), 27, 37-38, 54

and directed donation, 74

and initial evidence of blood-borne transmission, 71

Creutzfeldt-Jakob disease (CJD), 128, 131

Critical events, 58-59, 247-259

Cryoprecipitate, 27, 29, 107, 305

destruction of units from AIDS patients, 164

infants treated, 71, 176, 189-190, 251

poor plasma, 27, 29

substitution for AHF concentrate, 4, 71, 175, 176, 177, 181-182, 250, 251

Curran, James, 60

Cutter Laboratories, 155, 253.

see also Miles Inc.

Cytomegalovirus (CMV), 1, 32, 120, 305

D

DDAVP (desmopressin acetate)

FDA licensing, 176

National Hemophilia Foundation

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

recommendation, 72, 176, 178

substitution for AHF concentrate, 251

Deaths

from AIDS, 61-65, 116

among hemophiliacs, 258

Delta hepatitis virus (HDV), 84

Directed donations, 74-75, 176, 305

Division of Blood Diseases and Resources (DBDR), 43, 90

Donation of blood, see Autologous donation; Blood banks and centers; Directed donations; Donor screening and deferral; Paid donors; Plasma collection centers; Plasmapheresis; Volunteer donors

Donohue, Dennis, 71, 119, 150-151

Donor screening and deferral, 5-6, 71, 101-103, 122

ABRA policies, 72, 107, 142, 143

blood industry opposition, 124

CDC 1983 meeting and outcomes, 6, 71, 102, 105-117

early practices, 104-105

education and information programs, 72, 73, 108, 142

gay groups influence on policy, 71, 109-112, 122, 124, 228

hepatitis, 103-105, 111, 129

HIV antibody tests, 129

HTLV I and HTLV II, 130, 131

information deficit impacts, 3, 6, 103, 115-116, 210

lack of consensus regarding, 3, 70-71, 102, 103, 105, 123-124

lack of leadership on, 116-117, 125-128

PHS exclusion recommendations, 6, 107-108

pilot and local studies, 76-77

plasma industry policies, 72, 78, 107, 109-110, 151-152, 162

questioning about risk factors, 3, 6, 71, 102, 106, 107, 109-112, 130

regulatory triggers and actions, 215, 216

self-deferral, 77, 101, 110, 130, 215, 216

see also Lookback tracing

E

Elective surgery

autologous donations, 106

delay, 71, 177, 178, 251

ELISA (enzyme-linked immunosorbent assay) test, 78, 128

Emerging Infections Program, CDC, 221

Engleman, Edgar, 115, 118

Epstein, Jay, 159-160

Erythrocytes, see Red blood cells

Ethnic groups, anti-HBc testing, 75, 118, 120

Exported plasma, 31, 33

F

Factor VIII concentrate, see Antihemophilic factor

Fatalities, see Deaths

FDA, see Food and Drug Administration

Federal Food, Drug, and Cosmetic Act, 44, 51

Fibrinogen, 32, 305

Foege, William, 67

Food, Drug, and Cosmetics Act, 44, 48

Food and Drug Act of 1906, 43

Food and Drug Administration (FDA), 7, 9, 14-15, 43-46, 51, 67, 70 , 71, 135-136, 208, 221, 226-231

advisory committees, 10, 15, 45-46, 213, 230-231

blood product licensing and registration, 49-50, 139

Center for Biologics Evaluation and Research (CBER), 26, 44-45, 46 , 52

changes of administrators, 59, 212

DDAVP licensing, 176

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

and donor screening policies, 6, 7, 77, 108-109, 228

heat treatment licensing, 73, 91, 92, 96, 177, 259

HIV tests licensing, 59, 78

and industry self-regulation, 51, 139-140, 162-163

leadership failures, 212

and lookback tracing, 7, 136, 137-138, 158-160, 163-164, 228

March 1983 letters to blood industry, 3, 7, 58, 73, 108, 136-137, 142-146, 164

marginal and partial interventions, 14, 163-166, 227

policy analyses and review, 14, 15, 228, 230-231

recall policy, 3, 7, 52-53, 135, 137, 138-139, 142-158, 164, 208, 211, 228, 229-230

regulatory authority, 1-2, 7, 19-20, 47, 138-141

relationship with blood industry, 7, 14, 14-15, 51, 135, 138-140, 162-163, 227, 230

rivalry with CDC, 125-126, 210

viral inactivation approval and licensing, 4, 12, 91-92, 221-222, 259

see also Blood Products Advisory Committee;

Bureau of Biologics, FDA

Fractionation, see Plasma processing and fractionation

Francis, Donald, 70-71, 106, 116-117

Fresh frozen plasma (FFP), 27, 29, 175, 177, 305

substitution for AHF concentrate, 250

G

Gay activists, 71, 109-112, 122, 124, 228

Gay Related Immunodeficiency Disease (GRID), 66

General Accounting Office, 44

Glaser, Elizabeth, 190-191

Granulocytes, 29

Greater New York Blood Program, 110

Growth hormone, 128

H

Haitian immigrants, 61-64, 66, 69, 248

donor screening and deferral, 106, 122

HBV, see Hepatitis B virus

HDV, see Delta hepatitis virus

Health Care Financing Agency (HCFA), 51

Heat treatment, 59, 81, 86-88, 95, 154-158, 258

FDA licensing, 73, 91, 92, 96, 177, 259

for hepatitis, 5, 73, 78

and inhibitor formation, 87, 88-89, 95, 96, 259

Hemophilia, 1, 19, 38-39, 306,

see also National Hemophilia Foundation

Hemophiliacs, 221

children, 68, 250

confidence in AHF concentrate, 195, 196

early AIDS cases among, 58, 62-65, 67, 68, 89, 102, 197, 249, 250

epidemiological surveillance of, 67, 249

and hepatitis as acceptable risk, 195, 196-197

HIV incidence among, 1, 19, 21, 64, 68, 169, 252, 253, 258

opportunistic diseases, 58, 66-67

and risk communication, 195-200, 201, 202-204

and sexual transmission, 178-179, 255

Hemophilia Treatment Centers, 39, 76, 171, 173-174

Hepatitis, 1, 19, 30, 103-104, 306

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

as acceptable medical risk, 8, 48-49, 82, 93, 172-173

Hepatitis A virus, 83, 84, 85

Hepatitis B core antigen (anti-HBc) test, 76, 118

BPAC recommendations for, 59, 75, 119

CDC recommendations for, 6, 102, 106, 112, 116-117

and ethnic groups, 75, 118, 120

and homosexuals, 118, 120, 121

as NANB virus marker, 114, 129

objections to, 75, 113-114, 120-121

reliability as AIDS marker, 75, 106, 112-113, 114, 118, 119-120, 123

Hepatitis B surface antigen test, 83, 85, 105

Hepatitis B virus (HBV), 41, 43, 83-85, 103, 131, 306-307

and AHF heat treatment, 5, 73, 78

inactivation methods, 4, 76, 78, 79, 81-82, 93-95

similarity to HIV transmission, 2, 68, 72-73, 102, 123, 150, 208, 248, 249

Hepatitis C virus (HCV, NANB virus), 5, 84, 85-86, 93, 129, 131, 307

HIV disease, see AIDS

HIV-1, 4, 306.

see also Human T-cell lymphotropic virus

HIV testing, 78, 101, 128, 129, 131, 256

FDA licensing, 59, 78

positive result, relation to AIDS diagnosis, 257, 258

previously untested units, 165

window period, 78, 129

see also ELISA test;

Western Blot test

HIV transmission

AHF implicated in, 2, 68, 208

by asymptomatic carriers, 62, 73, 116, 137, 208

hepatitis analogy, 2, 68, 72-73, 102, 123, 150, 208, 248, 249

initial evidence of blood-borne, 3, 9, 66-70, 73, 102, 137, 148-149, 250-253

see also Blood transfusion;

Intravenous drug users; Maternal transmission;

Risk groups;

Sexual transmission

HIV-2, 129, 306

HIV-0, 129

Homosexual men, 6, 20, 102, 104, 111

anti-HBc testing, 118, 120, 121

behavioral hypothesis for disease, 66

differentiating higher risk, 75

and donor questioning, 3, 6, 105-106, 109-112, 122

early cases among, 2, 20, 60, 61-65, 66, 67, 248

opportunistic diseases among, 60, 66

see also Gay activists

Hospital blood banks, 26, 29, 35, 36

HTLV, see Human T-cell lymphotropic virus

Human immunodeficiency virus, see HIV-1;

HIV testing;

HIV transmission;

HIV-2

Human T-cell lymphotropic virus (HTLV), 129-130, 158, 159

HTLV III, 65, 77, 256, 257, 258, 307

see also HIV-1

Hygienic Laboratory, NIH, 44

Hyland Therapeutics, 74, 252

I

Immune globulin, 31, 32, 33, 97, 307-308

Imported blood, 29, 33-34

Incentives to industry, 5, 95, 214-215

Incubation period, 67, 68-69, 70, 73, 115-116

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Infants

blood transfusion cases, 58, 68, 102, 250

cryoprecipitate treatment of, 71, 176, 189-190, 251

early cases among, 58, 62, 68-69, 250

Information, see Knowledge base and information deficits

Informed consent, 8, 197-199, 231

Institutional and organizational factors, 8, 9-10, 12, 208-209, 219 , 220

Institutionalized persons, 104

Interstate commerce, 30, 47, 49-50

Intravenous drug users (IVDUs)

donor screening and deferral of, 104-105, 106

early cases, 61-65, 66, 67, 69-70, 102

maternal transmission by, 69

opportunistic infections, 66

Irwin Memorial Blood Bank, 76, 112, 118

IV drug use, see Intravenous drug users

K

Kaposi's sarcoma, 60, 61, 67, 77, 308

Knowledge base and information deficits chronologies, 61-65, 248-259

donor screening and deferral, 3, 6, 103, 115-116, 210

and regulatory actions, 3, 7, 9, 136, 141, 208, 209

and reliance on regulated industries, 10, 139-140, 213

and risk communication, 8, 197, 199, 200, 202, 209

Koplan, Jeffrey, 116

L

Lancet, 256

Large-Linked Database (LLDB), 226

Leadership failures, 9-10, 208-209, 212-214

donor screening and deferral, 116-117, 125-128

Legislation, see names of specific statutes (listed under "Regulation" in this index)

Leukocytes, see White blood cells

Liability, 223-224,

see also Blood shield laws

no-fault compensation system, 13, 224

Licensing and registration

blood banks, 49-51, 52

blood products, 30, 50

interstate commerce, 30, 47, 49-50

Lookback tracing, 128

FDA policy, 7, 136, 137-138, 158-160, 163-164, 228

presidential directive for, 158, 159

Lymphadenopathy-associated virus (LAV), 77, 256, 257, 258, 308

Lymphocytes, 131, 308,

see also CD4:CD8 ratios

M

Malaria, 1, 128

MASAC, see Medical and Scientific Advisory Council

Maternal transmission, 62, 69

Glaser case, 190-191

Media, 199-200, 258

Medical and Scientific Advisory Council (MASAC), NHF, 27, 40, 71-72, 172, 173, 174, 192-194, 251

and cryoprecipitate substitution, 71, 175, 176, 177, 200

DDAVP recommendation, 72, 176

and directed donation, 176

donor screening recommendations, 72, 143

heat-treated product recommendation, 177, 258

1983 meeting, 251

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

recall recommendation, 75, 147, 254, 257

and sexual transmission, 178-179

Medical World News, 115

Miles Inc., 92, 157

MMWR reports

AIDS cases, 58, 59, 68, 248, 250

hemophiliac infection rate, 257

opportunistic infection cases, 2, 60, 66

transmission theories, 69-70, 257

viral inactivation, 59, 258

Morbidity and Mortality Weekly Report, see MMWR reports

Multiple sex partners, 58, 73, 106

N

NANB hepatitis, see Hepatitis C virus

National Blood Exchange, 36

National Blood Foundation, 36

National Blood Policy of 1973, 41

National Blood Resources Program, 43

National Cancer Institute (NCI), 4, 59, 77, 79

National Gay Task Force, 112

National Heart, Lung, and Blood

Institute (NHLBI), 41, 43, 90

AIDS conferences, 77

donor screening research, 77, 118

immunologic change study, 77

National Hemophilia Foundation (NHF), 9, 27, 39-40, 66, 67, 172-173, 208, 210,

see also Medical and Scientific Advisory Council

AIDS Task Force, 173, 176, 252

chronology of actions, 248-259

clinical advisories and bulletins, 72, 74, 173-174, 175-181, 212, 248-259

and cryoprecipitate substitution, 175, 176, 177

DDAVP recommendation, 72, 176, 178

experience and expertise, 192-194

heat-treated product recommendation, 96, 258

initial recommendations, 3, 71-72

and recalls, 74, 253

and sexual transmission, 177, 178-179

and surveillance and reporting system, 76, 248, 249

ties with plasma industry, 8-9, 173, 194, 212, 234

treatment maintenance recommendations, 74, 252, 253, 254, 257

National Institute of Allergy and Infectious Diseases (NIAID), 43

National Institutes of Health (NIH), 2, 9, 20, 26, 42-43, 44, 66, 67, 77, 78, 161, 208, 221

changes of directors, 59, 213

research funding and priorities, 77, 90, 161

see also National Cancer Institute;

National Institute of Allergy and Infectious Diseases

National Marrow Donor Program, 36

National Microbiology Institute, NIH, 44

Neoantigenicity, 87, 95

News media, 199-200, 258

New York Blood Center, 77

NHF, see National Hemophilia Foundation

No-fault compensation system, 13, 224

Non-A, non-B (NANB) hepatitis, see Hepatitis C virus

Nongovernmental organizations, see Blood banks and centers;

National Hemophilia Foundation;

Plasma industry

O

Office of Maternal and Child Health, 172-174

Opportunistic diseases, 308-309,

see also Kaposi's sarcoma;

Pneumocystis carinii pneumonia

among hemophiliacs, 58, 66-67

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

among homosexuals, 60, 66

early cases, 60, 61, 66-67

P

Paid donors, 30, 31, 41, 43, 51, 104

Pasteur Institute, 4, 77

PCP, see Pneumocystis carinii pneumonia

Pediatric cases, see Children;

Infants

Pentamidine, 60

Petricciani, John, 142, 145

Pharmaceutical companies, 31

Pharmaceutical Manufacturers Association (PMA), 75, 147, 149, 153

Physicians

and blood transfusion, 177

case reporting, 67

communication to patients, 8, 9, 180, 195-200, 208

concern over patient AHF reduction, 9, 200

confidence in AHF concentrate, 195, 196

counteracting media attention, 199-200

denial and downplaying of risk, 8, 195-196, 199-200, 202

and hepatitis as acceptable risk, 195, 196-197

and informed consent, 8, 197-199

reduction of AHF use, 178

Plasma collection centers, 9, 30, 31, 108, 208

donor screening, 6, 78, 108-109

in prisons, 30

standard operating procedures, 73, 108, 142

Plasma derivatives, 27, 28, 29-33, 41, 43, 50, 54, 309.

see also Albumin;

Antihemophilic factor (AHF);

Anti-inhibitor complex;

Fibrinogen;

Immune globulin;

Plasma protein fraction

Plasma industry, 1, 9, 19, 26, 28, 30-31, 210

donor screening and deferral policies, 72, 78, 107, 109-110, 151-152, 162

heat treatment licensing, 5, 91, 92

and NHF, 8-9, 173, 194, 212, 234

self-regulation, 51, 139-140, 162-163

viral inactivation research activities, 4, 5, 79, 82, 86-88, 88, 90-91, 93

see also Plasma collection centers;

Plasma processing and fractionation

Plasmapheresis, 29, 30, 309

Plasma processing and fractionation, 5, 31, 91, 92, 309

Plasma protein fraction (PPF), 33, 309

Platelets, 27, 29, 43, 131, 309

Pneumocystis carinii pneumonia (PCP), 60, 61, 66, 67

Political environment

impact on regulatory actions, 7, 20, 57, 125, 140, 141, 145-146

insensitivity to AIDS epidemic, 124-125, 140, 146, 161

see also Gay activists

Pooling of plasma, 1, 19, 31

reduction in pool size, 12, 153-154, 165, 222

"Poppers,"; 66, 69

Practice guidelines, 12, 16, 221-222, 232-234

Presidential Commission on the Human Immunodeficiency Virus, 138, 159

Prison inmates, 62, 69-70

as donors, 30, 104, 122

Product treatment, see Heat treatment;

Viral inactivation

Professional associations, 3, 26-27, 36, 71.

see also American Association of Blood Banks;

American Blood Resources Association;

Council of Community Blood Centers

p24 antigen test, 129, 309

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Public Health Service Act, 42, 44, 48, 51, 52, 138

Public Health Service (PHS), 9, 19, 20, 26, 41-42, 77, 208

Blood Safety Council, 12, 219-223, 232

Committee on Opportunistic Infections in Patients with Hemophilia 1982 meeting, 58, 67, 76-77, 89, 218, 249

initial prevention recommendations, 3, 58, 72-73, 89, 108

leadership failures, 11, 212-214, 218

personnel changes, 59, 212-213

regulatory triggers and actions, 10, 214-217

research activities and funding, 76-77

risk group exclusion recommendations, 6, 107-108

sexual transmission prevention recommendations, 58, 73

transfusion recommendations, 73, 177

see also Assistant Secretary for Health;

Centers for Disease Control and Prevention;

Food and Drug Administration;

National Institutes of Health

Public opinion and concern, 19, 57, 128

impacts on blood donation, 34, 78, 111, 121

Q

Questioning of donors, 3, 6, 71, 102, 106, 107, 109-112, 130

opposition to, 109-112, 122, 228

R

Ratnoff, Oscar, 71

Reagan Administration

insensitivity to AIDS epidemic, 124-125, 140, 146, 161

and regulation issues, 20, 57, 125, 140

Recalls

ARC, 180, 252

automatic, 4, 7, 75, 147, 153, 210

delays in implementation, 7, 137, 154-158, 164, 208

FDA policy, 3, 7, 52-53, 135, 137, 138-139, 142-154, 211, 228, 229

manufacturers, 58, 74, 162, 180, 252, 253, 254, 257

NHF position, 74, 253

phased and staged, 144-145, 227

regulatory triggers and actions, 215, 216

Recipient tracing, see Lookback tracing

Recombinant DNA techniques, 97, 309-310

Red blood cells (RBCs), 25, 27, 29, 131, 310

Red Cross, see American Red Cross

Regional centers, see Hemophilia Treatment Centers

Regulation, 47-49

advisory committees' role, 10, 213

industry self-regulation, 51, 139-140, 162-163

under Reagan Administration, 20, 57, 125, 140

see also Biologics Act;

Blood shield laws;

Clinical Laboratories Improvement Act;

Donor screening and deferral;

Federal Food, Drug, and Cosmetic Act;

Food and Drug Administration;

Licensing and registration;

National Blood Policy of 1973;

Public Health Service Act

Research activities, 4, 59

and industry competitiveness, 94-95

isolation of virus, 4, 57, 59, 71, 77-78, 256

NIH, 77, 90, 161

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

PHS, 76-77

risk group similarities, 58, 61, 62, 67, 249

screening tests, 57, 73, 78, 79, 108

viral inactivation methods, 57, 76, 78, 79, 88, 89, 90-96

Resource limitations, 7, 59, 141 NHF, 172, 192-194

Risk assessment, 209-211

CDC role, 225

chronology of, 248-259

and early information deficit, 3-4, 9, 75, 115-116, 208

Risk communication, 8-9, 15-17, 169-172, 201-204, 211, 231-234

CDC role, 225-226

clinical options, 8, 16, 72, 170, 175-181, 201-203, 232-233

and information deficits, 8, 197, 199, 200, 202, 209

by National Hemophilia Foundation, 8, 72, 172-174, 193-195, 201, 202-203, 208, 212, 232-233

regulatory triggers and actions, 215, 217

sexual transmission, 178-179

Risk groups, 5, 101-102, 104, 215, 216

case reports, 61-65

hepatitis markers present across, 66, 113, 118

PHS exclusion recommendations, 6, 107-108

research on similarities among, 58, 61, 62, 67, 249

sexual contact with members of, 63, 106, 108, 255

see also Blood transfusion;

Haitian immigrants;

Hemophiliacs;

Homosexual men;

Intravenous drug users

S

Science, 256

Secondary transmission, 177, 178-179

Secretary of Health and Human Services, 11, 13, 218, 225

Self-deferral, 101, 110, 130, 215, 216

Serum hepatitis, see Hepatitis B virus

Sexual transmission, 2, 9, 63, 69, 101, 178-179, 255

and hemophiliacs, 178-179, 255

multiple partners, 58, 73, 106

to partners of risk group members, 63, 106, 108, 255

PHS prevention recommendations regarding, 58, 73

Shanbrom, Edward, 86-87, 93

Stanford University Blood Bank, 76-77, 118

State government

blood bank licensing, 50-51

blood shield laws, 2, 48-49, 224

and case reporting, 67

Statutes, see names of specific statutes (listed under ''Regulation" in this index)

Surrogate marker testing, 3, 4, 101, 310

accuracy and reliability, 112-113, 119

BPAC industry task force, 75, 119-121

BPAC meeting and outcomes, 59, 75, 103, 119-122

CDC recommendations, 6, 71, 102, 106

CD4/CD8 ratios, 76, 117-118

opposition to, 72, 113-114, 120-121

see also Hepatitis B core antigen test

Surveillance programs

Blood Safety Council, 12, 220, 221

CDC, 13-14, 67, 76, 79, 221, 226, 248, 249

Swine flu episode, 59-60, 126, 127, 140, 146, 225

T

Thrombocytes, see Platelets

Suggested Citation:"Index." Institute of Medicine. 1995. HIV and the Blood Supply: An Analysis of Crisis Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/4989.
×

Tort system, 12, 223-224

Trade associations, see American Blood Resources Association; Professional associations

Transfusion, see Blood transfusion

Truman v. Thomas, 198

V

Vaccine Adverse Event Reporting

System (VAERS), 226

Vaccines, 256, 311

liability, 223-224

swine flu, 59, 126-127

Viral inactivation, 81, 91

double inactivation methods, 12, 222

FDA approval and licensing, 4, 12, 91-92, 221-222, 259

for hepatitis, 4, 76, 78, 79, 81-82, 93-95

research activities, 57, 76, 78, 79, 88, 89, 90-96

see also Heat treatment

Volunteer donors, 1, 19, 31, 37, 41, 51, 104, 111

W

Western Blot test, 78, 257

White blood cells (WBCs), 25, 27, 311.

see also CD4:CD8 ratios;

Granulocytes;

Lymphocytes

Whole blood products, 20, 25, 27, 29, 53, 104, 164,

see also Cryoprecipitate;

Fresh frozen plasma;

Granulocytes;

Platelets;

Red blood cells

Women, 61, 63, 64, 65, 69

Wyngaarden, James, 77

Z

Zero-risk approaches, 211

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking Get This Book
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During the early years of the AIDS epidemic, thousands of Americans became infected with HIV through the nation's blood supply. Because little reliable information existed at the time AIDS first began showing up in hemophiliacs and in others who had received transfusions, experts disagreed about whether blood and blood products could transmit the disease.

During this period of great uncertainty, decision-making regarding the blood supply became increasingly difficult and fraught with risk. This volume provides a balanced inquiry into the blood safety controversy, which involves private sexual practices, personal tragedy for the victims of HIV/AIDS, and public confidence in America's blood services system.

The book focuses on critical decisions as information about the danger to the blood supply emerged. The committee draws conclusions about what was done—and recommends what should be done to produce better outcomes in the face of future threats to blood safety.

The committee frames its analysis around four critical area:

  • Product treatment—Could effective methods for inactivating HIV in blood have been introduced sooner?
  • Donor screening and referral—including a review of screening to exlude high-risk individuals.
  • Regulations and recall of contaminated blood—analyzing decisions by federal agencies and the private sector.
  • Risk communication—examining whether infections could have been averted by better communication of the risks.
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