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© 2004 Unconventional Concepts, Inc.1
Health and National Security Issues of the USA
International Conference on Bio-terrorismKCDC of the Republic of Korea
August 6, 2004
By Michael HopmeierSpecial Advisor to the US Surgeon
General, WMD and Homeland SecurityUnconventional Concepts, Inc.
3811 N. Fairfax Drive, Suite 720Arlington, VA 22203 USA
703-797-4562
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2© 2004 Unconventional Concepts, Inc.
Outline
• Threats to public health
• Current assets US Medical Preparedness
• Issues in Preparedness
• Public Health in the US Disease Prevention and Preparedness
• Summary Key Points
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3© 2004 Unconventional Concepts, Inc.
“A bioterrorism attack anywhere in the world is inevitable in the 21st
century.”
Anthony Fauci, Director, NIAID
Source: Clinical Infectious Diseases 2001;32:678
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4© 2004 Unconventional Concepts, Inc.
Some Bioterrorism Agents
• Bacteria Anthrax Brucellosis Glanders Plague Tularemia Q-fever
• Viruses Smallpox Venezuelan Equine Encephalitis Viral Hemorrhagic Fevers Nipah Virus
• Toxins Botulinum Staphylococcal Enterotoxin B Ricin T-2 mycotoxins E-coli (0157:H7)
Source: http://etl2.library.musc.edu/bioterrorism/resources/ppt_files/5
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5© 2004 Unconventional Concepts, Inc.
Bioterrorism is not the only threat
• 1996 Mad Cow Disease
• 1997 Bird Flu (Avian)
• 1999 Nipah Virus
• 1999 West Nile Virus
• 2003 Monkey Pox
• SARS 2003
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6© 2004 Unconventional Concepts, Inc.
Emerging and Re-Emerging Threats in the U.S. and Abroad
• Bovine Spongiform Encephalopathy (BSE)
• Cryptosporidiosis• Dengue • Diarrheal Diseases
• Diphtheria• E. Coli• Ebola Virus
• Hantavirus Pulmonary Syndrome (HPS)
• Human Immunodeficiency Virus (HIV)
• Influenza (Avian)• Legionnaires’ Disease• Listeriosis• Lyme Disease• Rift Valley Fever• West Nile Encephalitis• Tuberculosis (Multi-
resistant
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7© 2004 Unconventional Concepts, Inc.
Public Health IS a National Security Issue!
NIE 99-17D, January 2000 “The Global Infectious Disease Threat and Its Implications for the United States “
“This report represents an important initiative on the part of the Intelligence Community to consider the national security dimension of a nontraditional threat. It responds to a growing concern by senior US leaders about the implications--in terms of health, economics, and national security--of the growing global infectious disease threat. The dramatic increase in drug-resistant microbes, combined with the lag in development of new antibiotics, the rise of megacities with severe health care deficiencies, environmental degradation, and the growing ease and frequency of cross-border movements of people and produce have greatly facilitated the spread of infectious diseases. “
People, produce, and animals !
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8© 2004 Unconventional Concepts, Inc.
Causes of Mortality in the US1900-2001
103,000
3,247
42 million
270 Million
InfectiousDisease
Nuclear(Japan)
TerrorismEvents
Soldier Deathsin Battle
Source: Multiple resources
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9© 2004 Unconventional Concepts, Inc.
Leading Cause of Mortality in Adults in US for 2002
3.071,372Diabetes Mellitus6.
4.2101,537Accidents (unintentional injuries)
5.
5.1123,013Chronic Lower Respiratory diseases
4.
6.8163,538Cerebrovascular Disease3.
22.9553,768Malignant neoplasms (Cancer)
2.
29.0700,142Disease of the heart1.
Deaths Per 100,000 Population
NumberCause of DeathRank
Source: http://www.infoplease.com/ipa/a0005110.html
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10© 2004 Unconventional Concepts, Inc.
Leading Causes of Mortality Among Adults aged 15-59 Worldwide, 2002
1,332,000
2,279,0005783,000
1,036,000HIV/AIDS
Ischeamic heartdisease
Tuberculosis
Cerebrovasculardisease
Anthrax**Data from 2001
Source: http://www.who.int/whr/2003/en/Facts_and_Figures-en.pdf
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11© 2004 Unconventional Concepts, Inc.
6 Leading Causes of Mortality throughout the world, 2002
Rank Cause Total Deaths
1 Ischaemic Heart Disease 7,181,000
2 Cerebrovascular Disease 5,509,000
3 Lower Respiratory Disease 3,884,000
4 HIV/AIDS 2,777,000
5Chronic Obstructive Pulmonary Disease
2,748,000
6 Diarrheal Disease 1,798,000
Source: http://www.infoplease.com/ipa/A0779147.html
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• Increasing global travel
• Rapid access to large populations
• Poor global security & awareness
Why Now?
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13© 2004 Unconventional Concepts, Inc.
Why Now?
The world is becoming smaller!
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14© 2004 Unconventional Concepts, Inc.
Sources of Agents for Terrorism Use
• World Directory of Collections of Cultures and Microorganisms 453 worldwide repositories in 67 nations 54 ship/sell anthrax 18 ship/sell plague
• International black-market sales associated with governmental programs
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15© 2004 Unconventional Concepts, Inc.
Current Assets
US Medical Preparedness
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16© 2004 Unconventional Concepts, Inc.
US Medical System
• Roughly 6000 hospitals
• 853,000 physicians and surgeons (2002)
• 2.4 million registered nurses (2002)
• 230,000 pharmacists (2002)
• $22 billion spent on healthcare construction (2002)
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17© 2004 Unconventional Concepts, Inc.
Funding for Medical Preparedness Activities
• HHS: $3.5B for Bioterrorism preparedness activities in 2003 HRSA: $500M to improve surge capacity and
hospital readiness CDC: $900M to improve public health capacity
• AHRQ: $5M for Anti-Bioterrorism Initiative• NIH: $1.7B for bioterrorism research
Grants directed towards Bioterrorism preparedness improve overall preparedness in hospitals and communities
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Cumulative Civilian Biodefense Spending by Agency, FY2001-FY2005
68%
22%
5%
3%
2%-1%
-1%
DHS
DoD
DoA
EPA
NSF
DoS
DHHS
Total Spending for FY2001 - FY2005 = $22,107,800,000
DHHS
DHS
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US Government Civilian Biodefense Funding, FY2001-FY2005
0
500
1000
1500
2000
2500
3000
3500
4000
4500
FY 2001
FY 2002
FY 2003
FY 2004(estimate)
Fy 2005(budget)
In Millions
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20© 2004 Unconventional Concepts, Inc.
U.S. Government Expenditures by Function 1940-1996
13.213
5.481
1.7
0
2
4
6
8
10
12
14
National Defense Nuclear WeaponsInfrastructure
Health
Tri
llio
ns
of
Do
llars
(19
96)
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21© 2004 Unconventional Concepts, Inc.
2/3 of a Push Package
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22© 2004 Unconventional Concepts, Inc.
The Strategic National Stockpile: Push Packs
• Used to supplement and re-supply state and local public health agencies in the event of a national emergency anywhere and anytime in the US with the 12 hour Push Package containing: Antibiotics Chemical antidotes Life support medications IV administration Airway maintenance supplies Medical/surgical Items
Source:http://www.bt.cdc.gov/stockpile/index.asp
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23© 2004 Unconventional Concepts, Inc.
Project Bioshield
• $5.6 Billion over 10 years for private-sector procurement of vaccines
• Long-term authority for Government to buy billions of dollars worth of new drugs from private companies
• Allow FDA to quicken drug-approval process during emergencies
• Includes 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile
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Bioterrorism Agent Vaccine Availability
IND TC83 Viral Encephalidites
Vi polysaccharide conjugate Typhoid
17D yellow fever, live attenuatedHemorrhagic fevers
Vaccinia virus, live unattenuated, licensed varicella immune globulin (VZIG)
Smallpox
Investigational New Drug Q-Fever
Investigational New Drug Tularemia
Investigational pentavalent toxoid botulinum antitoxin (equine)
Botulism
Formaldehyde-killed whole cell,production discontinued in 1999, licensed, does not prevent pneumonic plague
Plague
AVA (BioThrax), inactivatedcell-free preparation, licensed
Anthrax
Available VaccineDisease/Agent
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25© 2004 Unconventional Concepts, Inc.
Research, Development, and Acquisition
Potential BioShield Procurements Under Consideration: Safer Smallpox Vaccine (MVA) rPA anthrax Vaccine Anthrax treatment products
• adjuncts to Antibiotics Botulinum antitoxin
• Equine Recombinant plague vaccine Botulinum vaccine Anti-radiation drugs and chemical antidotes
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26© 2004 Unconventional Concepts, Inc.
Research and Development
Potential Future Candidates for BioShield Procurement: Ebola-Marburg vaccine Rift Valley Fever Vaccine Novel antibiotics/antinfectives Novel antiviral drugs Polyclonal human anthrax and botulinum
antitoxins from transgenic animals 3rd Generation anthrax vaccine
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27© 2004 Unconventional Concepts, Inc.
Anthrax Vaccine Policy Questions
• Critical Questions – interim answers• What size stockpile is enough? 75 million
doses? What will be needed in the event of an attack or
more than one attack? What is the value of vaccine after the attack?
• Antibiotic sparing• Protection for residual contamination
What vaccination policy should be followed?• How much pre-event vaccination is needed?
First responders Dense urban population
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28© 2004 Unconventional Concepts, Inc.
Smallpox Vaccines: Unanswered Questions
• How long can we rely on traditional New York City Bureau of Health (NYCBH) vaccines? Known incidence of adverse events Evidence for higher than expected incidence of
myopericarditis Increasing public resistance to vaccination
• Will demand for safer vaccines require a turnover of the stockpile to newer alternatives when they become available?
• How much are we willing to pay for a national stockpile of safer smallpox vaccines?
• Will the proven value of NYCBH vaccines to control smallpox be a critical factor in the decision?
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29© 2004 Unconventional Concepts, Inc.
Issues in Preparedness
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30© 2004 Unconventional Concepts, Inc.
Decision Making without Data
• Need to make decisions rapidly in the absence of data
• Access to subject matter experts is required• No “textbook” experience to guide response• Understanding of “risk” evolved as outbreak
unfolded• Need coherent, rapid process for addressing
scientific issues in midst of crisis
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31© 2004 Unconventional Concepts, Inc.
Effects Magnification
Don’t need large numbers of casualties to incur massive damage – economic, social, psychological, political Example: Impact of anthrax via mail
• 5 deaths• 18 infected• 30,000 treated with antibiotics• 10,000 treated for 60 days• Many billions of dollars cost + impact
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32© 2004 Unconventional Concepts, Inc.
Key Focus Areas
• Education Professionals Public
• Organization of Existing Assets Personnel Materiel
• Infrastructure Healthcare Labs Information
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33© 2004 Unconventional Concepts, Inc.
Lessons Learned• Detection and Surveillance
Detection:• For small outbreaks, medical professional reporting more
important than non-traditional systems• Value of electronic syndromic surveillance for early
detection of larger outbreaks
Ongoing Surveillance• Need surge capacity to rapidly ramp up citywide
surveillance to triage suspect cases– Hotlines, field activities, data analysis
• Prioritize management of data – Linking Epidemic Information Exchange (epi) with labs
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34© 2004 Unconventional Concepts, Inc.
Biological Agents
• Syndrome Recognition Most bio-terrorist agents initially induce
an influenza-like prodrome, including fever, chills, myalgias, or malaise
Syndromic patterns• Rapidly progressive pneumonia• Fever with rash• Fever with altered mental status• Bloody diarrhea• descending flaccid paralysis• Respiratory Failure
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35© 2004 Unconventional Concepts, Inc.
Public Health Responseto Bioterrorism
• Detection & surveillance
• Rapid laboratory diagnosis
• Epidemiologic investigations
• Implementation of control measures
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36© 2004 Unconventional Concepts, Inc.
Close Cooperation with Clinicians, Healthcare, and First Responder
Communities
• Emergency departments, EMS Responders, primary care clinics
• Infection control units• Physician networks, private offices• Hospitals• Medical examiners, coroners• Poison control• Law enforcement, fire, and other first
responders• Pharmacies
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37© 2004 Unconventional Concepts, Inc.
Clues to Possible Bioterrorism I• Single case caused by an uncommon agent• Large number of ill persons with similar disease,
syndrome, or deaths• Large number of unexplained disease, syndrome,
or death• Unusual illness in a population• Higher morbidity & mortality than expected with a
common disease or syndrome• Multiple disease entities coexisting in the same
patient• Disease with an unusual geographic or seasonal
distribution
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38© 2004 Unconventional Concepts, Inc.
Clues to Possible Bioterrorism II • Multiple atypical presentations of disease agents• Similar genetic type of agent from distinct sources• Unusual, atypical, genetically engineered,
or antiquated strain• Endemic disease with unexplained increased incidence• Simultaneous clusters of similar illness in
non-contiguous areas• Atypical aerosol, food, or water transmission • Ill persons presenting during the same time period• Concurrent animal disease
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39© 2004 Unconventional Concepts, Inc.
Public Health in the US
Preparedness and Disease Prevention
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40© 2004 Unconventional Concepts, Inc.
What are the Preparedness Priorities?
• Terrorism
• Emerging Infections
• Natural Disasters
• Mental Health and Resilience
• Chronic Disease Prevention
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41© 2004 Unconventional Concepts, Inc.
How Can We Solve/Address the Preparedness Priorities?
• Invest more resources in our public health system
• Develop partnerships between law enforcement, public health, and education agencies at all levels of government
• Expand international cooperation
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42© 2004 Unconventional Concepts, Inc.
Why is Disease Prevention a Preparedness Priority?
• 7 out of 10 Americans who die each year are killed by a preventable chronic disease
• Tobacco-related illnesses kill 435,000 people each year
• Obesity-related illness kills 400,000 Americans each year
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43© 2004 Unconventional Concepts, Inc.
How Can We Solve/Address Chronic Health Priorities?
Healthier behavior Eat healthy foods Be physically active Don't smoke Limit alcohol and avoid drug abuse
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44© 2004 Unconventional Concepts, Inc.
How is the Surgeon General's Office/HHS helping?
• Health initiatives such as: Steps to a HealthierUS Healthy Lifestyles & Disease Prevention Small Steps Campaign
• Increased funding for bio-terrorism preparedness
• Better food safety through import inspections • Better public health and hospital planning
and coordination • Increased use of volunteers through the
Medical Reserve Corps
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45© 2004 Unconventional Concepts, Inc.
Summary
Key Points
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46© 2004 Unconventional Concepts, Inc.
What are the Problems?
• Coordination
• Disorganized public health infrastructure
• Lack of plans and programs in place
• Decision making without data
• Insufficient resources
• Incomplete understanding of threats
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47© 2004 Unconventional Concepts, Inc.
Problem Solving Efforts
• Create a stronger public health infrastructure
• Invest in surveillance systems to monitor illnesses in humans and animals
• Billions of dollars spent on preparedness
• Enhancing international cooperation
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48© 2004 Unconventional Concepts, Inc.
Key Points Summary1. Infectious diseases and public health ARE National
Security issues, as well as a worldwide problem2. We need preparedness for all infectious diseases
and public health issues• including chronic health problems
3. Any public health system has to be able to respond to all aspects of a disaster, or even a non-disaster
4. There are always emerging problems• Continuous process
5. Science and Society need to integrate to train the public on health issues
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PREPARING AND PREPARING AND DEFENDING THE PUBLIC IS DEFENDING THE PUBLIC IS
THE FIRST PRIORITYTHE FIRST PRIORITY