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



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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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

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HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 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