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Avian Influenza: The Threatening Pandemic


Description: The purpose of this report is to describe the threatening world pandemic caused by avian influenza, also known as bird flu. This report discusses the origins of the disease, the bird-to-human infection risks, the catastrophic health crisis avian flu poses, and the efforts by world governments and international health organizations to mitigate of the impact the threat to humans.

The U.S., Asia and Europe are the focus of this study. Primary attention is paid to the clinical market segment and, separately, to the medical procedures and supplies for the influenza infection control market. An analysis of the technology trends and developing areas of influenza infection science is provided, along with a review of the market for pharmaceutical agents, vaccines and hospital supplies in clinical use. Activity in research-including the factors that influence infection control-are addressed in this review. Also discussed are changes that have stimulated this disease and patterns of information processing in assessing its spread. Several subjects related to the major elements of influenza treatment such as disposable plastic supplies, needles and lancets are discussed only briefly because they are considered entirely different fields or markets.

The goal of this report is to review the potential threat of a human influenza pandemic resulting from the avian flu virus. It defines the responses that are now being undertaken worldwide by governmental authorities to contain the spreading bird flu.

Specifically, this study contains:

- A comprehensive overview of the several categories of anti-influenza technology platforms that are or will be revolutionizing flu related healthcare in hospitals.

- Full descriptions of the public health measures involved in controlling the spread of avian influenza and the prevention of cross infection to humans.

- Analysis of the technological approaches undertaken by various world governments, as well as industry and end-user response to these ideas.

- Regulatory issues and legislation affecting use and marketing of influenza prevention and treatment products.

- Forecasts for each category of infection control.


Contents: 1. Overview 5
1.1 Statement of Report 5
1.2 Scope of Report 5
1.3 Objectives 5
1.4 Methodology 6
1.5 Executive Summary 6

2. The Basics of Human Influenza 9
2.1 Influenza, the Disease 9
2.1.1 Symptoms 9
2.1.2 Transmission 9
2.1.3 Public Health Factors 10
2.1.4 Influenza Diagnosis 10
2.2 Influenza Viruses 11
2.2.1 Types, Subtypes and Strains 11
2.2.1.1 Influenza Type A and its Subtypes 12
2.2.1.2 Highly Pathogenic versus Lowly Pathogenic Avian Influenza A Viruses 13
2.2.1.3 Human Influenza Viruses and Avian Influenza A Viruses 13
2.2.1.3.1 Influenza A H5 13
2.2.1.3.2 Influenza A H7 13
2.2.1.3.3 Influenza A H9 13
2.2.1.4 Influenza Type B 14
2.2.1.5 Influenza Type C 14
2.2.2 How Influenza Viruses Change: Drift and Shift 14
2.2.3 Seasons and Human Influenza 15
2.2.4 Risk Factors and Human Influenza 16
2.2.5 Human Influenza Complications, Comorbidities and Dangers 16
2.2.5.1 Flu complications in children and teenagers 17
2.2.6 Human Influenza Prognosis 17
2.3 Pandemic Influenza 18
2.4 How Influenza Viruses Change 18

3. The Basics of Avian Influenza 19
3.1 Avian Influenza in Birds 19
3.1.1 Avian Influenza Outbreaks in Poultry 20
3.1.2 More Information About Avian Influenza Viruses 21
3.2 Transmission of Influenza A Viruses between Animals and People 21
3.3 Avian Influenza Infection in Humans 22
3.3.1 Instances of Avian Influenza Infection in Humans 22
3.3.2 Symptoms of Avian Influenza in Humans 23
3.3.3 Antiviral Agents for Influenza 23
3.4 Avian Influenza (H5N1) 23
3.4.1 Avian Influenza (H5N1) Outbreaks 23
3.5 All Types of Avian Influenza Worldwide Outside of Asia 25
3.5.1 Canada 25
3.5.2 Netherlands 26
3.5.3 United States 26
3.5.3.1 Delaware 26
3.5.3.2 Texas 26
3.5.3.3 Maryland 26
3.5.3.4 International Response 27
3.5.3.5 Available Options 27

4. Epidemiology of Avian Influenza 28
4.1 Worldwide Avian Influenza 29
4.2 H5N1 Avian Influenza: Timeline 32
4.3 U.S. Avian Influenza 37

5. Influenza Diagnosis and Laboratory Issues 38
5.1 "Classic" Methods for Influenza Diagnosis 38
5.2 Example Lab: Yale New Haven Hospital (YNHH) 40
5.3 Conventional PCR Assay for Sub-typing Influenza Virus 41
5.3.1 Gel Analysis 41
5.4 Real Time TaqMan PCR 43
5.4.1 From PacMan to TaqMan-A Computer Game Revisited 43
5.4.2 The Advantages of Real-Time TaqMan PCR Over Conventional Quantitative PCR 45
5.5 Example Strategy for Avian Influenza 46
5.6 Laboratory Safety Issues for H5N1 Viruses 46
5.6.1 Biosafety Level 3 46
5.6.2 Biosafety Level 3-Ag 51
5.6.3 CDC Criteria for Testing 52
5.6.4 What Samples Are Needed? 52

6. Preparedness 53
6.1 Education 53
6.2 Ethical and Legal Issues 53
6.3 Worldwide 55
6.3.1 Overarching Goals, Objectives and Actions for WHO and National Authorities, by Phase 56
6.3.1.1 Interpandemic Period, Phase 1-Overarching Goal 56
6.3.1.2 Interpandemic Period, Phase 2-Overarching Goal 58
6.3.1.3 Pandemic Alert Period, Phase 3-Overarching Goal 61
6.3.1.4 Pandemic Alert Period, Phase 4-Overarching Goal 64
6.3.1.5 Pandemic Alert Period, Phase 5-Overarching Goal 67
6.3.1.6 Pandemic Period, Phase 6-Overarching Goal 70
6.3.2 Recommendations for Non-Pharmaceutical Public Health Interventions 75
6.4 U.S. 78
6.4.1 U.S. National Plan 78
6.4.2 U.S. Locally 87
6.4.2.1 Community Preparedness Leadership and Networking 87
6.4.2.2 Surveillance 88
6.4.2.3 Public Health and Clinical Laboratories 88
6.4.2.4 Healthcare and Public Health Partners 89
6.4.2.5 Infection Control and Clinical Guidelines 90
6.4.2.6 Vaccine Distribution and Use 90
6.4.2.7 Antiviral Drug Distribution and Use 90
6.4.2.8 Community Disease Control and Prevention 91
6.4.2.9 Public Health Communications 91
6.4.2.10 Workforce Support: Psychosocial Considerations and Information Needs 92
6.4.2.11 State Plans 92
6.5 The Hospital Response 92
6.5.1 Introduction 92
6.5.2 Key Assumptions 93
6.5.3 Arrival 93
6.5.4 Triage 94
6.5.5 Isolation 95
6.5.6 Patient Movement 96
6.5.7 Communication 97
6.5.8 Medical Evaluation 98
6.5.9 Diagnosis 98
6.5.10 Treatment 98
6.5.11 Potential for Surge 99
6.6 Business Preparedness 100
6.7 School Preparedness 102
6.8 Individual Preparedness 105

7. Economics of Avian Influenza 109
7.1 Impact on Governments 109
7.1.1 Worldwide Economic Impact of Avian Flu 109
7.1.2 U.S. Nationally 113
7.2 Impact of a Pandemic 125
7.2.1 Supply Side Effect 125
7.2.2 Demand Side Effect 126

8. Fighting the Flu 128
8.1 The Worldwide Pharmaceutical Industry 128
8.1.1 FDA Approved Vaccines: Tamiflu and Relenza 129
8.1.2 Stockpiling 129
8.1.3 Total Avian Influenza Drug Market Size and Growth 129
8.2 Funding 129
8.3 Antiviral Agents for Influenza: Background Information 129
8.3.1 Introduction 129
8.3.1.1 Antiviral Usage Recommendation-2005-06 129
8.3.2 Neuraminidase Inhibitors (Zanamivir, Oseltamivir) 130
8.3.3 How do the Neuraminidase Inhibitor Drugs Work? 130
8.3.4 How Effective are the Neuraminidase Inhibitor Drugs? 130
8.3.4.1 Treatment 130
8.3.4.2 Chemoprophylaxis 130
8.3.4.3 Side Effects of the Neuraminidase Inhibitor Drugs 130
8.3.4.4 Antiviral Resistance to the Neuraminidase Inhibitor Drugs 131
8.3.5 Adamantane Derivatives (Amantadine, Rimantadine) 131
8.3.5.1 Antiviral Activity: How do the Adamantane Drugs Work? 131
8.3.5.2 How Effective are the Adamantane Drugs? 131
8.3.5.2.1 Treatment 131
8.3.5.2.2 Chemoprophylaxis 131
8.3.5.3 Side Effects of the Adamantane Drugs 132
8.3.5.4 Antiviral Resistance 132
8.3.6 Adamantanes Compared with Neuraminidase Inhibitors 132
8.3.7 Anti-Avian Influenza Drugs, Generics and Patents 133
8.3.7.1 Taiwan 133
8.3.7.2 India 134
8.3.7.3 Other Countries 135
8.3.8 Regulatory Issues 135
8.3.9 New Anti-Avian Influenza Therapy 135
8.3.10 Pharmaceutical Business Perspective 136
8.3.10.1 A Market Dominated by GSK and Roche 136
8.3.10.2 Generic Presence 136
8.3.10.3 Challenging Tamiflu 137
8.4 Other Treatment Requirements 137
8.5 Business Opportunities 138

INDEX OF FIGURES

Figure 2.1: Influenza Subtypes 12
Figure 2.2: Timeline of Emergence of Influenza A Viruses in Humans 15
Figure 2.3: Model of the Emergence of a Pandemic Virus 18
Figure 3.1: Map of H5N1 Instances and Asian Migratory Bird Zones 24
Figure 3.2: Map of H7N3 in British Columbia 25
Figure 4.1: Nations with Confirmed Cases of H5N1 Avian Influenza 29
Figure 4.2: World: Affected Areas with Confirmed Cases of H5N1 Avian Influenza Since 2003 30
Figure 4.3: World: Affected Areas with Confirmed Cases of H5N1 Avian Influenza Since January 2006 30
Figure 4.4: World: Areas Reporting Confirmed Occurrence of H5N1 Avian Influenza in Poultry and Wild Birds Since January 2006 31
Figure 4.5: World: Areas Reporting Confirmed Occurrence of H5N1 Avian Influenza in Poultry and Wild Birds Since 2003 31
Figure 4.6: Waterfowl Flyways of North America 37
Figure 5.1: FDA-approved Kit-based Test 38
Figure 5.2: Immunofluorescence-based Detection 39
Figure 5.3: Uninfected and Infected Tissue Cultures 39
Figure 5.4: TEM of Negatively Stained Influenza Virions (from Cultures) 40
Figure 5.5: PCR Assay Graphic 41
Figure 5.6: PCR assay 42
Figure 5.7: "Amplicon" Generation 42
Figure 5.8: The TaqMan 5-3 Nuclease Assay 43
Figure 5.9: TaqMan Amplification Plot 44
Figure 5.10: TaqMan Fluorescent Reaction Components 45
Figure 5.11: Biosafety Level 3-Ag-Full Tyvek Body Suit 51
Figure 6.1: Signage: Informing Staff 93
Figure 6.2: Signage: Informing Patients 94
Figure 6.3: Respiratory Etiquette Kit 95
Figure 6.4: Isolation 96
Figure 6.5: Communication Scheme 97
Figure 6.6: Surge 99

INDEX OF TABLES

Table 2.1: Probability of Influenza Diagnosis Using Office-Based Testing 11
Table 2.2: Prescribing Guidelines for Treating Influenza 11
Table 2.3: Influenza Virus Types 12
Table 2.4: H5N1 Cases and Deaths, 2003-2005 15
Table 4.1: Phase 3 is the Current WHO Phase of Alert 28
Table 4.2: Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO, 2003-2006 29
Table 4.3: Early (Pre Wave I) Events in Asia, 1996, 1997 and 2003 32
Table 4.4: Wave I 32
Table 4.5: Wave II 33
Table 4.6: Wave III 34
Table 5.1: Methods for Influenza Diagnosis 38
Table 5.2: Summary of Current Clinical Virology Laboratory Tests for Influenza 40
Table 6.1: Interpandemic Period, Phase 1-Planning and Coordination 56
Table 6.2: Interpandemic Period, Phase 1-Prevention and Containment 56
Table 6.3: Interpandemic Period, Phase 1-Health System Response 57
Table 6.4: Interpandemic Period, Phase 1-Communications 58
Table 6.5: Interpandemic Period, Phase 2-Planning and Coordination 58
Table 6.6: Interpandemic Period, Phase 2-Situation Monitoring and Assessment 59
Table 6.7: Interpandemic Period, Phase 2-Prevention and Containment 59
Table 6.8: Interpandemic Period, Phase 2-Health System Response 60
Table 6.9: Interpandemic Period, Phase 2-Communications 61
Table 6.10: Pandemic Alert Period, Phase 3 - Planning and Coordination 61
Table 6.11: Pandemic Alert Period, Phase 3-Situation Monitoring and Assessment 62
Table 6.12: Pandemic Alert Period, Phase 3-Prevention and Containment 62
Table 6.13: Pandemic Alert Period, Phase 3-Health System Response 63
Table 6.14: Pandemic Alert Period, Phase 3-Communications 64
Table 6.15: Pandemic Alert Period, Phase 4-Planning and Coordination 64
Table 6.16: Pandemic Alert Period, Phase 4-Situation Monitoring and Assessment 65
Table 6.17: Pandemic Alert Period, Phase 4-Prevention and Containment 65
Table 6.18: Pandemic Alert Period, Phase 4-Health System Response 66
Table 6.19: Pandemic Alert Period, Phase 4-Communications 67
Table 6.20: Pandemic Alert Period, Phase 5-Planning and Coordination 67
Table 6.21: Pandemic Alert Period, Phase 5-Situation Monitoring and Assessment 68
Table 6.22: Pandemic Alert Period, Phase 5-Prevention and Containment 68
Table 6.23: Pandemic Alert Period, Phase 5-Health System Response 69
Table 6.24: Pandemic Alert Period, Phase 5-Communications 70
Table 6.25: Pandemic Period, Phase 6-Planning and Coordination 70
Table 6.26: Pandemic Period, Phase 6-Situation Monitoring and Assessment 71
Table 6.27: Pandemic Period, Phase 6-Prevention and Containment 72
Table 6.28: Pandemic Period, Phase 6-Health System Response 73
Table 6.29: Pandemic Period, Phase 6-Communications 74
Table 6.30: National Measures (Living or Traveling Within an Affected Country) 75
Table 6.31: International Measures (for Entering or Exiting a Country) 77
Table 6.32: State and Local Planning Checklist-Community Preparedness Leadership and Networking 87
Table 6.33: State and Local Planning Checklist-Surveillance 88
Table 6.34: State and Local Planning Checklist-Public Health and Clinical Laboratories 89
Table 6.35: State and Local Planning Checklist-Healthcare and Public Health Partners 89
Table 6.36: State and Local Planning Checklist-Healthcare and Public Health Partners 90
Table 6.37: State and Local Planning Checklist-Vaccine Distribution and Use 90
Table 6.38: State and Local Planning Checklist-Antiviral Drug Distribution and Use 91
Table 6.39: State and Local Planning Checklist-Community Disease Control and Prevention 91
Table 6.40: State and Local Planning Checklist-Public Health Communications 91
Table 6.41: State and Local Planning Checklist-Workforce Support: Psychosocial Considerations and Information Needs 92
Table 6.42: Arrival 93
Table 6.43: Triage 94
Table 6.44: Isolation 95
Table 6.45: Patient Movement 96
Table 6.46: Communication 97
Table 6.47: Medical Evaluation 98
Table 6.48: Diagnosis 98
Table 6.49: Treatment 98
Table 6.50: Surge 99
Table 6.51: Plan for the Impact of a Pandemic on Your Business 100
Table 6.52: Plan for the Impact of a Pandemic on Your Employees and Customers 101
Table 6.53: Establish Policies to be Implemented During a Pandemic 101
Table 6.54: Allocate Resources to Protect Your Employees and Customers During a Pandemic 101
Table 6.55: Communicate to and Educate Your Employees 102
Table 6.56: Coordinate with External Organizations and Help Your Community 102
Table 6.57: Planning and Coordination: 103
Table 6.58: Continuity of Student Learning and Core Operations 104
Table 6.59: Infection Control Policies and Procedures 104
Table 6.60: Communications Planning 104
Table 6.61: Items to have on Hand for an Extended Stay at Home 107
Table 6.62: Immunizations FAQ 107
Table 6.63: WHO Global Plan for Pandemic Preparedness 110
Table 7.1: Assumptions Underlying Estimates of the Supply-Side Impact of an Avian Flu Pandemic 126
Table 7.2: Assumed Declines in Demand, by Industry, in the Event of an Avian Flu Pandemic 127
Table 8.1: Top 30 Pharmaceutical and Biotech Companies Ranked by Healthcare Revenue ("Big Pharma") 128
Table 8.2: Recommended Daily Dosage of Influenza Antiviral Medications for Treatment and Prophylaxis 133
Table 8.3: Examples of Preparedness Supplies 138




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