© 2004 unconventional concepts, inc. 1 health and national security issues of the usa international...

© 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

[email protected]

mailto:[email protected]

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


“A bioterrorism attack anywhere in the world is inevitable in the 21st

century.”

Anthony Fauci, Director, NIAID

Source: Clinical Infectious Diseases 2001;32:678


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


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


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


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 !


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


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


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


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

• Increasing global travel

• Rapid access to large populations

• Poor global security & awareness

Why Now?


Why Now?

The world is becoming smaller!


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


Current Assets

US Medical Preparedness


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)


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

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

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


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)


2/3 of a Push Package


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


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

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


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


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


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


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?


Issues in Preparedness


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


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


Key Focus Areas

• Education Professionals Public

• Organization of Existing Assets Personnel Materiel

• Infrastructure Healthcare Labs Information


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


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


Public Health Responseto Bioterrorism

• Detection & surveillance

• Rapid laboratory diagnosis

• Epidemiologic investigations

• Implementation of control measures


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


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


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


Public Health in the US

Preparedness and Disease Prevention


What are the Preparedness Priorities?

• Terrorism

• Emerging Infections

• Natural Disasters

• Mental Health and Resilience

• Chronic Disease Prevention


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


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


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


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


Summary

Key Points


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


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


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


PREPARING AND PREPARING AND DEFENDING THE PUBLIC IS DEFENDING THE PUBLIC IS

THE FIRST PRIORITYTHE FIRST PRIORITY

© 2004 unconventional concepts, inc. 1 health and national security issues of the usa international...

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