Index
A
AABB, see American Association of Blood Banks
ABRA, see American Blood Resources Association
Acquired immunodeficiency syndrome, see AIDS
see also Blood Products Advisory Committee, FDA
Agency for Health Care Policy and Research, 233
AHF, see Antihemophilic factor
incubation period, 67, 68-69, 70, 73, 115-116
as a notifiable disease, 151-152
see also HIV testing;
HIV transmission
Alpha Therapeutic
donor deferral policy, 72, 109, 110, 143
heat treatment, 88, 91, 92, 156-157
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
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
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
immune suppression theory, 69
implicated in HIV transmission, 2, 68, 208
reducing use of, 182-185, 200, 202
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
Behringwerke, A.G., 86, 87-88, 93
Best practices, 12, 16, 221, 232-234
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
and directed donation, 74-75
donor screening policies, 6, 78, 102, 106, 162, 208, 211
licensure and registration, 49-51, 52
marginal interventions, 215, 216, 227-228
standard operating procedures, 73, 108, 142
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
Brandt, Edward, 77, 148, 149, 154
Bureau of Biologics, FDA, 44, 51
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
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
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
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
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
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
substitution for AHF concentrate, 251
Deaths
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
HIV antibody tests, 129
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
ELISA (enzyme-linked immunosorbent assay) test, 78, 128
Emerging Infections Program, CDC, 221
Epstein, Jay, 159-160
Erythrocytes, see Red blood cells
Ethnic groups, anti-HBc testing, 75, 118, 120
F
Factor VIII concentrate, see Antihemophilic factor
Fatalities, see Deaths
FDA, see Food and Drug Administration
Federal Food, Drug, and Cosmetic Act, 44, 51
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
and donor screening policies, 6, 7, 77, 108-109, 228
heat treatment licensing, 73, 91, 92, 96, 177, 259
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
and inhibitor formation, 87, 88-89, 95, 96, 259
Hemophilia, 1, 19, 38-39, 306,
see also National Hemophilia Foundation
Hemophiliacs, 221
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
as acceptable medical risk, 8, 48-49, 82, 93, 172-173
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
see also Human T-cell lymphotropic virus
HIV testing, 78, 101, 128, 129, 131, 256
positive result, relation to AIDS diagnosis, 257, 258
previously untested units, 165
see also ELISA test;
Western Blot test
HIV transmission
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-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
I
Immune globulin, 31, 32, 33, 97, 307-308
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
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
see also CD4:CD8 ratios
M
MASAC, see Medical and Scientific Advisory Council
Glaser case, 190-191
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
and directed donation, 176
donor screening recommendations, 72, 143
heat-treated product recommendation, 177, 258
1983 meeting, 251
recall recommendation, 75, 147, 254, 257
and sexual transmission, 178-179
Medical World News, 115
MMWR reports
AIDS cases, 58, 59, 68, 248, 250
hemophiliac infection rate, 257
opportunistic infection cases, 2, 60, 66
transmission theories, 69-70, 257
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
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 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
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
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
P
Paid donors, 30, 31, 41, 43, 51, 104
PCP, see Pneumocystis carinii pneumonia
Pediatric cases, see Children;
Infants
Pentamidine, 60
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
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
reduction in pool size, 12, 153-154, 165, 222
Practice guidelines, 12, 16, 221-222, 232-234
Presidential Commission on the Human Immunodeficiency Virus, 138, 159
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
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
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
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
and industry competitiveness, 94-95
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
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
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
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
liability, 223-224
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
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
Wyngaarden, James, 77
Z
Zero-risk approaches, 211