HIV AND THE BLOOD SUPPLY -- Copyright -- Preface -- REFERENCE -- Contents -- Executive Summary -- HISTORY -- The Risk of AIDS -- Immediate Responses to Evidence of Blood-Borne AIDS Transmission -- Opportunities to Reformulate Policy -- Research Activities -- FINDINGS -- Product Treatment -- Donor Screening and Deferral Policies -- Regulations and Recall -- Communication to Physicians and Patients -- CONCLUSIONS -- Decisionmaking Under Uncertainty -- Bureaucratic Management of Potential Crises -- RECOMMENDATIONS -- The Public Health Service -- The Centers for Disease Control and Prevention -- The Food and Drug Administration -- Communication to Physicians and Patients -- REFERENCES -- 1 Introduction -- HIV INFECTION VIA BLOOD TRANSFUSION -- THE COMMITTEE'S CHARGE -- ORGANIZATION OF THE REPORT -- REFERENCES -- 2 The U.S. Blood Supply System -- INTRODUCTION -- BLOOD AND BLOOD PRODUCTS -- Whole Blood and Components -- Plasma and Derivatives -- Plasma Collection -- Plasma Processing -- Blood and Blood Components Distribution -- BLOOD COLLECTION ORGANIZATIONS -- Community Blood Banks -- The American Red Cross Service -- Hospital Blood Banks -- PROFESSIONAL ASSOCIATIONS -- American Association of Blood Banks -- AABB Inspection and Accreditation Program -- Council of Community Blood Centers -- American Blood Resources Association -- HEMOPHILIA ORGANIZATIONS -- The Nature of Hemophilia -- Hemophilia Treatment Centers -- National Hemophilia Foundation -- Medical and Scientific Advisory Council -- ROLE OF THE U.S. PUBLIC HEALTH SERVICE -- National Blood Policy of 1973 -- Public Health Service -- Centers for Disease Control and Prevention -- National Institutes of Health -- National Institute of Allergy and Infectious Diseases -- National Heart, Lung, and Blood Institute -- Food and Drug Administration -- Blood Products Advisory Committee.

BLOOD AND BLOOD PRODUCT REGULATION -- Statutory Background -- Biologics Act -- Public Health Service Act -- Blood Shield Laws -- Federal Licensure of Blood Collection Organizations -- Establishment Licensure and Registration -- Product Licensure -- Other Required Licensure -- REGULATORY AUTHORITY OF THE FDA -- Compliance with Regulations -- Recall Policy -- SUMMARY -- REFERENCES -- 3 History of the Controversy -- INTRODUCTION -- THE RISK OF AIDS -- Kaposi's Sarcoma and PCP in Homosexual Men -- Opportunistic Infections Among Heterosexual Intravenous (IV) Drug Users and Haitian Immigrants -- Increased Risk Among Individuals with Hemophilia and a Similarity to Hepatitis B -- Further Evidence of Sexual and Blood-Borne Transmission of AIDS -- Summary -- IMMEDIATE RESPONSES TO EVIDENCE OF BLOOD-BORNE AIDS TRANSMISSION -- The CDC's Public Meeting -- The Blood Bank Community's Statement -- Position of the National Hemophilia Foundation -- Position of the Plasma Fractionation Industry -- Federal Recommendations on the Prevention of AIDS -- Summary and Comment -- RECONSIDERING THE EVIDENCE: FURTHER ATTEMPTS TO FORMULATE POLICIES -- Summary and Comment -- RESEARCH ACTIVITIES -- The Public Health Service Effort -- Isolation of the Virus and Development of a Screening Test -- Summary and Comment -- REFERENCES -- 4 Product Treatment -- INTRODUCTION -- CRITICAL TIME PERIOD: 1970-1983 -- Hepatitis -- Viral Inactivation of AHF Concentrate -- Early Methods -- Studies by U.S. Plasma Fractionation Companies -- Problems of Viral Inactivation Development -- Impact of the First Reported Cases of AIDS in Individuals with Hemophilia -- Federal Research Support for Viral Inactivation -- Specific Viral Inactivation Methods -- Testing for the Effectiveness of the Inactivation Process -- FDA Approval and Licensing of Treated Factor VIII -- ANALYSIS AND CONCLUSIONS -- SUMMARY.

AFTERWARD -- Subsequent Events -- Current Procedures and Challenges -- REFERENCES -- 5 Donor Screening and Deferral -- INTRODUCTION -- Critical Events -- Critical Event 1 -- Critical Event 2 -- Explanatory Hypotheses -- DONOR SCREENING PRACTICES -- Hepatitis -- Donor Pools -- Early Donor Screening Practices -- ANALYSIS AND FINDINGS -- January 4, 1983, CDC Meeting -- Outcomes of the Meeting -- Donor Questioning and Opposition to It -- Surrogate Testing and Opposition to It -- Criticism of the CDC's Data and Motives -- Risk Assessment -- Lack of Leadership -- Conclusions -- December 1983 Blood Products Advisory Committee Meeting -- Interim Local Efforts to Screen Aggressively -- Reliability of Surrogate Tests -- Task Force Report on Surrogate Testing -- Comment on the Blood Products Advisory Committee -- Informing the Public -- AIDS Politics -- CONCLUSIONS -- Hypothesis One -- Hypothesis Two -- Political Factors -- Ideological Factors -- Organizational Factors -- Historical Factors -- AFTERWORD -- Donor Screening 1985-1995 -- HIV -- Hepatitis -- HTLV-I and HTLV-II -- Current Donor Screening Procedures -- Current Infectious Risk Through Blood Transfusion -- REFERENCES -- 6 Regulations and Recall -- INTRODUCTION -- FRAMEWORK OF ANALYSIS -- Critical Events -- Critical Event 1 -- Critical Event 2 -- Critical Event 3 -- Critical Event 4 -- FDA Regulatory Authority and Practice -- Explanatory Hypotheses -- FINDINGS AND CONCLUSIONS -- FDA Letters of March 1983 -- Analysis -- Summary and Conclusions -- Nonautomatic Recalls -- Analysis -- Summary and Conclusions -- Heat-Treated AHF Concentrate and the FDA's Recall Policy -- Analysis -- Summary and Conclusions -- Lookback and Notification of Individuals Transfused with Contaminated Blood Products -- Analysis -- Summary and Conclusions -- INFLUENCE AND RESPONSIBILITIES OF OTHER ORGANIZATIONS.

Governmental Organizations -- Nongovernmental Organizations -- Implications -- THE ADVANTAGES OF MARGINAL THINKING -- Lookback and Notification -- Removal of Untreated AHF Concentrate -- Use of Screened Whole Blood -- Destruction of Potentially Contaminated Cryoprecipitate -- Innovative Techniques for Pooling Plasma -- Testing Previously Untested Blood and Plasma for HIV -- SUMMARY -- REFERENCES -- 7 Risk Communication to Physicians and Patients -- INTRODUCTION -- FRAMEWORK FOR ANALYSIS -- Critical Questions -- Critical Factors -- The Role of the National Hemophilia Foundation -- RISK REDUCTION OPTIONS -- Specific Options -- The Process for Developing NHF Guidelines -- CASE STUDIES -- Case Study One: Conviction and Change -- Case Study Two: Reduction in Use of AHF Concentrate -- Case Study Three: Continue AHF Concentrate Treatment -- Case Study Four: Prescribing Cryoprecipitate for a Newborn and Continuing AHF Concentrate Treatment For a Four-Year-Old -- Case Study Five: A Transfusion Case -- Summary of the Case Studies -- OBSTACLES TO COMMUNICATION -- Institutional Obstacles -- Resources and Expertise of the NHF -- The NHF and the Plasma Fractionation Industry -- Communication Style of the NHF -- Social and Cultural Obstacles -- CONCLUSIONS -- REFERENCES -- 8 Conclusions and Recommendations -- GENERAL CONCLUSIONS -- Decisionmaking Under Uncertainty -- Risk Perception -- Risk Assessment Versus Risk Management -- Consider the Full Range of Possibilities -- Risk Reduction Versus Zero Risk -- Risk Communication -- Bureaucratic Management of Potential Crises -- Coordination and Leadership -- Advisory Mechanisms -- Analytic Capability and Long-Range Vision -- Presumptive Regulatory and Public Health Triggers -- Product Treatment -- Donor Screening -- Recall -- Communication to Patients and Providers -- RECOMMENDATIONS -- The Public Health Service.

Leadership -- Blood Safety Council -- Compensation Policy -- The Centers for Disease Control and Prevention -- Early Warning Systems -- Surveillance -- The Food and Drug Administration -- Risk Reduction -- Decision Processes -- Regulatory Efforts -- Advisory Committees -- Communication to Physicians and Patients -- Clinical Practice -- Credibility -- REFERENCES -- Appendixes -- A Individuals Interviewed by the Committee -- B Individuals Providing Oral and Written Testimony (for a public meeting held September 12, 1994) -- C Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Asse... -- D Key Documents Provided to the Committee -- E Glossary of Acronyms and Terms -- Acronyms -- Terms -- SOURCES -- F Committee and Staff Biographies -- COMMITTEE -- STAFF BIOGRAPHIES -- Index.