HIV and the blood supply : an analysis of crisis decisionmaking / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors.

Format:

Book

Contributor:

Leveton, Lauren B.

Sox, Harold C.

Stoto, Michael A.

Institute of Medicine (U.S.). Committee to Study HIV Transmission Through Blood and Blood Products.

Language:

English

Subjects (All):

AIDS (Disease)--United States.

AIDS (Disease).

Blood banks--Risk management--United States.

Blood banks.

Blood banks--Law and legislation--United States.

Medical policy--United States.

Medical policy.

Physical Description:

xi, 334 p. : ill.

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1995.

Language Note:

English

Summary:

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, decisionmaking 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.

Contents:

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

REFERENCES

1 Introduction

HIV INFECTION VIA BLOOD TRANSFUSION

THE COMMITTEE'S CHARGE

ORGANIZATION OF THE REPORT

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

3 History of the Controversy

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

RESEARCH ACTIVITIES

The Public Health Service Effort

Isolation of the Virus and Development of a Screening Test

4 Product Treatment

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

5 Donor Screening and Deferral

Critical Events

Critical Event 1

Critical Event 2

Explanatory Hypotheses

DONOR SCREENING PRACTICES

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

Hypothesis One

Hypothesis Two

Political Factors

Ideological Factors

Organizational Factors

Historical Factors

AFTERWORD

Donor Screening 1985-1995

HIV

HTLV-I and HTLV-II

Current Donor Screening Procedures

Current Infectious Risk Through Blood Transfusion

6 Regulations and Recall

FRAMEWORK OF ANALYSIS

Critical Event 3

Critical Event 4

FDA Regulatory Authority and Practice

FINDINGS AND CONCLUSIONS

FDA Letters of March 1983

Analysis

Summary and Conclusions

Nonautomatic Recalls

Heat-Treated AHF Concentrate and the FDA's Recall Policy

Lookback and Notification of Individuals Transfused with Contaminated Blood Products

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

7 Risk Communication to Physicians and Patients

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

8 Conclusions and Recommendations

GENERAL CONCLUSIONS

Risk Perception

Risk Assessment Versus Risk Management

Consider the Full Range of Possibilities

Risk Reduction Versus Zero Risk

Risk Communication

Coordination and Leadership

Advisory Mechanisms

Analytic Capability and Long-Range Vision

Presumptive Regulatory and Public Health Triggers

Donor Screening

Recall

Communication to Patients and Providers

The Public Health Service.

Leadership

Blood Safety Council

Compensation Policy

Early Warning Systems

Surveillance

Risk Reduction

Decision Processes

Regulatory Efforts

Advisory Committees

Clinical Practice

Credibility

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.

Notes:

"Committee to Study HIV Transmission through Blood and Blood Proucts, Division of Health Promotion and Disease Prevention, Institute of Medicine."

Includes bibliographical references and index.

ISBN:

9786610193110

9780309176132

0309176131

9781280193118

1280193115

9780309588270

0309588278

9780585001746

058500174X

OCLC:

814271527