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From page 323... ... , 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) Read the entire page →
From page 324... ... 324 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, 8182, 86-97, 154-158, 177 Anti-inhibitor complex, 32, 303 Armor Pharmaceutical, 87, 92, 96 Assistant Secretary for Health, 3, 1 in, 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, 47~8, 50 see also terms listed under Plasma derivatives and Whole blood products Blood banks and centers, 1, 9, 19, 27, 29, 3~35, 78, 208, 221, 303 community, 19, 26, 29, 35, 36, 3738, 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 INDEX 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, 45~6, 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, 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 Read the entire page →
From page 325... ... , 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, 11~117, 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, 126127, 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, 61~5 325 critical events, 58-59, 247-259 Clinical Laboratories Improvement Act. Read the entire page →
From page 326... ... , 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, 15~151 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, 10~105 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, 7 71, 102, 103, 105, 123-124 lack of leadership on, 116-117, 125-128 PHS exclusion recommendations, 6, 107-108 pilot and local studies, 7~77 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 INDEX self-deferral, 77, 101, 110, 130, 215, 216 see also Lookback tracing E Elective surgery autologous donations, 106 delay, 71, 177, 178, 251 ELI SA (enzyme-linked immune sorb ent 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) Read the entire page →
From page 327... ... , 66 General Accounting Office, 44 Glaser, Elizabeth, 19~191 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, 154158, 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, 6265, 67, 68, 89, 102, 197, 249, 250 epidemiological surveillance of, 67, 249 and hepatitis as acceptable risk, 195, 19~197 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 Read the entire page →
From page 328... ... 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 INDEX initial evidence of blood-borne, 3, 9, 66-70, 73, 102, 137, 148-149, 25~253 see also Blood transfusion; Intravenous drug users; Maternal transmission; Risk groups, Sexual transmission HIV-2, 129, 306 HIV-D, 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, 105106, 109-112, 122 early cases among, 2, 20, 60, 6165, 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 1 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 Read the entire page →
From page 329... ... , 226 329 Leadership failures, 9-10, 208-209, 212-214 donor screening and deferral, 116117, 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, ] Read the entire page →
From page 330... ... , 41, 43, 90 AIDS conferences, 77 donor screening research, 77, 118 immunologic change study, 77 National Hemophilia Foundation (NHF) , 9, 27, 39~0, 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, 248259 and cryoprecipitate substitution, 175, 176, 177 DDAVP recommendation, 72, 176, 178 experience and expertise, 192-194 INDEX heat-treated product recommendation, 96, 258 initial recommendations, 3, 71-72 and recalls, 74, 253 and sexual transmission, 177, 178179 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) Read the entire page →
From page 331... ... see also Albumin; Antihemophilic factor (AHF) ; Antiinhibitor complex; Fibrinogen; Immune globulin; Plasma protein fraction 331 Plasma industry, 1, 9, 19, 26, 28, 3~31, 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, 162163 viral inactivation research activities, 4, 5, 79, 82, 86-88, 88, 9~91, 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) Read the entire page →
From page 332... ... , 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, 139140, 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, 9~95 isolation of virus, 4, 57, 59, 71, 7778, 256 NIH, 77, 90, 161 Read the entire page →
From page 333... ... INDEX PHS, 7~77 risk group similarities, 58, 61, 62, 67, 249 screening tests, 57, 73, 78, 79, 108 viral inactivation methods, 57, 76, 78, 79, 88, 89, 9~96 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 Foun dation, 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, 106 107-108 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, 178-179 333 Secretary of Health and Human Services, 11, 13, 218, 225 Self-defe~Tal, 101, 110, 130, 215, 216 Serum hepatitis, see Hepatitis B virus Sexual transmission, 2, 9, 63, 69, lOl, 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, lot, 310 accuracy and reliability, 112-113, 119 BPAC industry task force, 75, 1 l 9 121 BPAC meeting and outcomes, 59, 75, 103, 119-122 CDC recommendations, 6, 71, 102, CD4/CD8 ratios, 76, 117-118 opposition to, 72, 113- 114, 120121 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 Read the entire page →
From page 334... ... , 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, 9~96 INDEX see also Heat treatment Volunteer donors, 1, 19, 31, 37, 41, 51, 104, 111 W Western Blot test, 78, 257 White blood cells (WBCs) Read the entire page →

From page 323...

... , 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)

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From page 324...

... 324 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, 8182, 86-97, 154-158, 177 Anti-inhibitor complex, 32, 303 Armor Pharmaceutical, 87, 92, 96 Assistant Secretary for Health, 3, 1 in, 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, 47~8, 50 see also terms listed under Plasma derivatives and Whole blood products Blood banks and centers, 1, 9, 19, 27, 29, 3~35, 78, 208, 221, 303 community, 19, 26, 29, 35, 36, 3738, 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 INDEX 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, 45~6, 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, 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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From page 325...

... , 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, 11~117, 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, 126127, 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, 61~5 325 critical events, 58-59, 247-259 Clinical Laboratories Improvement Act.

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From page 326...

... , 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, 15~151 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, 10~105 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, 7 71, 102, 103, 105, 123-124 lack of leadership on, 116-117, 125-128 PHS exclusion recommendations, 6, 107-108 pilot and local studies, 7~77 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 INDEX self-deferral, 77, 101, 110, 130, 215, 216 see also Lookback tracing E Elective surgery autologous donations, 106 delay, 71, 177, 178, 251 ELI SA (enzyme-linked immune sorb ent 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)

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From page 327...

... , 66 General Accounting Office, 44 Glaser, Elizabeth, 19~191 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, 154158, 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, 6265, 67, 68, 89, 102, 197, 249, 250 epidemiological surveillance of, 67, 249 and hepatitis as acceptable risk, 195, 19~197 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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From page 328...

... 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 INDEX initial evidence of blood-borne, 3, 9, 66-70, 73, 102, 137, 148-149, 25~253 see also Blood transfusion; Intravenous drug users; Maternal transmission; Risk groups, Sexual transmission HIV-2, 129, 306 HIV-D, 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, 105106, 109-112, 122 early cases among, 2, 20, 60, 6165, 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 1 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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From page 329...

... , 226 329 Leadership failures, 9-10, 208-209, 212-214 donor screening and deferral, 116117, 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, ]

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From page 330...

... , 41, 43, 90 AIDS conferences, 77 donor screening research, 77, 118 immunologic change study, 77 National Hemophilia Foundation (NHF) , 9, 27, 39~0, 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, 248259 and cryoprecipitate substitution, 175, 176, 177 DDAVP recommendation, 72, 176, 178 experience and expertise, 192-194 INDEX heat-treated product recommendation, 96, 258 initial recommendations, 3, 71-72 and recalls, 74, 253 and sexual transmission, 177, 178179 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)

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From page 331...

... see also Albumin; Antihemophilic factor (AHF) ; Antiinhibitor complex; Fibrinogen; Immune globulin; Plasma protein fraction 331 Plasma industry, 1, 9, 19, 26, 28, 3~31, 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, 162163 viral inactivation research activities, 4, 5, 79, 82, 86-88, 88, 9~91, 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)

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From page 332...

... , 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, 139140, 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, 9~95 isolation of virus, 4, 57, 59, 71, 7778, 256 NIH, 77, 90, 161

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From page 333...

... INDEX PHS, 7~77 risk group similarities, 58, 61, 62, 67, 249 screening tests, 57, 73, 78, 79, 108 viral inactivation methods, 57, 76, 78, 79, 88, 89, 9~96 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 Foun dation, 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, 106 107-108 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, 178-179 333 Secretary of Health and Human Services, 11, 13, 218, 225 Self-defe~Tal, 101, 110, 130, 215, 216 Serum hepatitis, see Hepatitis B virus Sexual transmission, 2, 9, 63, 69, lOl, 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, lot, 310 accuracy and reliability, 112-113, 119 BPAC industry task force, 75, 1 l 9 121 BPAC meeting and outcomes, 59, 75, 103, 119-122 CDC recommendations, 6, 71, 102, CD4/CD8 ratios, 76, 117-118 opposition to, 72, 113- 114, 120121 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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From page 334...

... , 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, 9~96 INDEX see also Heat treatment Volunteer donors, 1, 19, 31, 37, 41, 51, 104, 111 W Western Blot test, 78, 257 White blood cells (WBCs)

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Index Pages 323-334

Index
Pages 323-334