Quantitative Health Risk Analysis Methods: Modeling the Human Health Impacts of Antibiotics Used in Food Animals (International Series in Operations Research & Management Science)

367 Pages·2005·2.78 MB·English

by  Jr.

Quantitative Health Risk Analysis Methods
Modeling the Human Health Impacts of
Antibiotics Used in Food Animals
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* A list of the early publications in the series is at the end of the book *
Quantitative Health Risk Analysis Methods
Modeling the Human Health Impacts of
Antibiotics Used in Food Animals
by
Louis Anthony Cox, Jr.
Cox Associates and
University of Colorado
Louis A. Cox
Cox Associates and University of Colorado
Denver, CO, USA
Library of Congress Control Number: 2005049015
ISBN-13: 978-0-387-25909-3
ISBN-10: 0-387-25909-0
ISBN-13: 978-0-387-26118-8 (e-book)
ISBN-10: 0-387-26118-4 (e-book)
Printed on acid-free paper.
©2006 by Springer Science+Business Media, Inc.
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Printed in the United States of America.
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To Cope and Michael –
For making good humor, hard work, and complete commitment to
scientific truth central in a political world
Contents
Preface........................................................................................................xiii
Acknowledgments.....................................................................................xvii
CHAPTER 1
Qualitative and Quantitative Risk Analysis
1. Introduction: A Need for New Methods...................................................1
1.1 Challenges and Goals......................................................................................2
1.2 Overview of Contents......................................................................................4
2. Background and Motivation......................................................................5
2.1 Difficult Tradeoffs...........................................................................................5
2.2 Recent History.................................................................................................7
2.3 The Role of Risk Analysis.............................................................................11
3. Qualitative Risk Analysis........................................................................11
3.1 Some Examples of Qualitative Risk Rating Frameworks.............................11
The Brenner Scheme for Order-Of-Magnitude Risk Rating.........................14
US FDA-CVM’s Guidance Document # 152 and its limitations.................15
3.2 Lessons from Previous Approaches..............................................................18
4. A Mathematical Theory of Qualitative Risk Rating................................23
5. What Should Be Done Instead?...............................................................31
6. Discussion and Conclusions....................................................................32
APPENDIX Proof of Theorem 1................................................................32
CHAPTER 2
Risk Analysis: Goals and Methods
1. Introduction to Health Risk Analysis......................................................37
1.1 Risk Assessment............................................................................................37
Quantitative Definition of Risk.....................................................................39
1.2 Risk Management..........................................................................................42
1.3 Risk Communication.....................................................................................42
2. Purposes and Outputs of Risk Analysis...................................................43
3. Risk Analysis with Uncertain Data..........................................................47
4. Desired Outputs of Risk Analysis............................................................54
5. Introduction to Risk Assessment.............................................................56
5.1 A Rapid Risk Rating Technique (RRRT)......................................................56
viii
6. Risk Management....................................................................................64
6.1 Definition of Risk Management....................................................................64
6.2 Purposes and Outputs of Risk Management..................................................65
6.3 Methods for Risk Management Decision-Making........................................65
6.4 Methods of Risk Management to Avoid........................................................66
6.5 Validating Risk Management Results...........................................................67
7. Communicating Risk Analysis Results....................................................67
7.1 Steps in Risk Communication.......................................................................68
7.2 Purposes of Risk Communication.................................................................68
7.3 Desired Outputs of Risk Communication......................................................69
7.4 Methods for Risk Communication................................................................71
7.5 Participatory Risk-Management Decision Processes....................................72
8. Summary and Conclusions......................................................................74
CHAPTER 3
Hazard Identification
1. Definition of Risk Assessment................................................................77
2. A Bayesian Network Framework............................................................78
3. Introduction to Hazard Identification......................................................83
3.1 Definition of Hazard Identification...............................................................83
3.2 Purposes and Goals of Hazard Identification................................................85
4. Methods of Hazard Identification............................................................87
4.1 Causal Inference From Epidemiological Data...............................................87
4.2 Refuting Non-Causal Explanations...............................................................91
4.3 Seeking Positive Evidence for a Causal Relation..........................................98
5. Case Study: Did Ending Avoparcin Use Reduce Human Resistance?...109
6. A Systems Dynamics Approach to Hazard Identification......................112
6.1 Model Definitions and Equations................................................................113
6.2 Model-Based Analysis of Potential Resistance Hazards.............................116
7. Hazard Identification Methods to Avoid...............................................118
7.1 A Case Study: Presenting Real vs. Hypothesized Hazards.........................124
8. Conclusions...........................................................................................129
CHAPTER 4
Exposure Assessment
1. Introduction to Risk Quantification.......................................................131
2. Introduction to Exposure Assessment....................................................132
2.1 Definition and Purposes of Exposure Assessment......................................132
3. Exposure Assessment Methods: Simulation.........................................134
3.1 Practical Simulation-Based Exposure Modeling.........................................136
3.2 Simulation Based on Conditioning, Not Imitation......................................141
Contents ix
4. Attribution-Based Exposure Modeling..................................................144
4.1 Attribution through Multiple Stages............................................................151
5. Systems Dynamics Models of Exposure...............................................154
5.1 Model Development and Simplifying Assumptions...................................154
5.2 Estimating Model Parameters from Data....................................................156
5.3 Using the Model to Make Predictions.........................................................158
6. Exposure Assessment Methods to Avoid..............................................160
6.1 Prevalence-Based Exposure Metrics...........................................................160
6.2 Holistic Statistical Exposure Modeling.......................................................161
7. Validating and Refining Exposure Models............................................163
8. Qualitative Exposure assessment...........................................................165
9. Summary and Conclusions....................................................................167
CHAPTER 5
Dose-Response Modeling and Risk Characterization
1. Introduction to Dose-Response Modeling.............................................170
1.1 Definitions and Purposes of Dose-Response Modeling..............................171
2. Microbial Dose-Response Modeling.....................................................173
2.1 Empirical Statistical Dose-Response Models..............................................173
2.2 Biologically Motivated Statistical Dose-Response Models........................176
2.3 Multi-Component Dose-Response Models.................................................182
2.4 Epidemiological Exposure-Response Models.............................................182
2.5 Practical Dose Response Models: Summary..............................................183
2.6 Validating Dose-Response Models.............................................................185
2.7 Showing Uncertainty In Dose-Response Models........................................187
3. Health Consequence Modeling..............................................................188
4. Risk Characterization............................................................................192
4.1 Definition and Purposes of Risk Characterization......................................192
4.2 Desired Outputs of Risk Characterization...................................................193
4.3 Methods for Risk Characterization..............................................................195
4.4 Methods of Simplified Risk Characterization to Avoid..............................203
4.5 Rapid Risk Rating Technique (RRRT) Approach.......................................203
4.6 Validation of Risk Characterization Results...............................................209
5. Uncertainty and Sensitivity Analyses...................................................210
5.1 Uncertainty Analysis...................................................................................210
5.2 Sensitivity Analysis.....................................................................................214
6. Discussion and Summary......................................................................220
CHAPTER 6
Human Health Risks from Virginiamycin: A Case Study
1. Introduction...........................................................................................225
1.1 Background on QD, VRE, VREF, and VREFA...........................................226
x
2. Risk Assessment Data and Methods......................................................228
2.1 Estimating Total Number of VREF Cases Per Quarter...............................230
Estimating VREF Cases per Quarter in Australia.......................................230
Estimating VREF Cases per Quarter in the United States..........................233
2.2 Estimated Fraction of VRE Cases that are VREFA.....................................233
Estimating the Australian VREFA Fraction of VRE by Upper Bounding..234
Estimating the U.S. VREFA Fraction..........................................................235
2.3 Fraction of Exogenous (Non-Nosocomial) VREF Cases............................236
2.4 Fraction of VREFA Cases Attributable to Chickens....................................237
2.5 Fraction of VREFA Cases with QD Resistance...........................................238
QD Resistance Fraction Among VREFA Cases in Australia......................238
QD Resistance Fraction Among VREFA Cases in the United States.........239
2.6 QD Effectiveness Fraction...........................................................................239
2.7 Fraction of VREFA Cases Prescribed QD Over Time.................................240
2.8 Time-Varying QD Resistance Fraction.......................................................240
2.9 Health Consequences of Treatment Failures...............................................242
2.10 Summary....................................................................................................243
3. Results...................................................................................................242
3.1 Results for Australia....................................................................................242
3.2 Results for USA...........................................................................................246
4. Discussion of Results and Key Drivers.................................................248
5. Summary and Conclusions....................................................................249
APPENDIX: Estimating Human Health Consequences of
QD Resistance...........................................................................................251
CHAPTER 7
Dynamic Modeling and Uncertainty Analysis
1. Introduction...........................................................................................255
1.1 Motivation: How Does History Constrain Future Risks?...........................256
1.2 A Growing Concern: Managing Potential Future Risks.............................257
1.3 From Qualitative Hazard Identification to Quantitative Risk Assessment.259
2. Deterministic Modeling and Results.....................................................260
2.1 VRE Colonization Dynamics Model...........................................................260
3. Bayesian Monte Carlo (BMC) Uncertainty Analysis............................263
3.1 Selecting Priors for Probabilistic Sensitivity Analysis................................264
3.2 Data on Historical QD Resistance Rates.....................................................265
3.3 Bayesian Monte Carlo (BMC) Estimation of Posterior Distributions.........266
3.4 Stochastic Discrete-Event Simulation (DES) of Time-to-Outbreak............266
4. Results of Uncertain Dynamic Model...................................................267
4.1 Initial Bayesian Analysis and Estimation of Parameters.............................267
4.2 Revised Prescription Rate for QD...............................................................268
Contents xi
4.3 Human Health Risks vs. Key Parameter Values.........................................269
4.4 Estimated Individual and Population Risks.................................................271
5. Discussion.............................................................................................272
6. Summary and Conclusions....................................................................274
CHAPTER 8
Potential Human Health Benefits of Animal Antibiotics
1. Introduction...........................................................................................277
1.1 A Risk Management Dilemma for Virginiamycin......................................278
2. Framework for Assessing Impacts.........................................................280
3. Data For RRRT Risk-Benefit Calculations...........................................283
3.1 Calculation of ∆F.........................................................................................283
–
3.2 Calculation of P ..........................................................................................286
4. Results for Virginiamycin impacts........................................................288
5. Uncertainty and Sensitivity Analyses....................................................289
6. Extensions to Cattle and Swine.............................................................291
7. Comparison to risks in Australia...........................................................291
8. RRRT for Macrolides and Enrofloxacin................................................292
9. Discussion.............................................................................................299
9.1 Comparison to Other Risk Assessment Approaches...................................299
9.2 Comparison of Model Predictions to Experience........................................300
9.3 Other Considerations and Extensions..........................................................301
10. Summary and Conclusions..................................................................304
APPENDIX: The Log-Exponential Risk Model.......................................306
References..................................................................................................309
Index..........................................................................................................343