Health and National Security Issues of the USA International Conference on Bio-terrorism KCDC of the Republic of Korea A

1. Health and National Security Issues of the USAInternational Conference on Bio-terrorismKCDC of the Republic of KoreaAugust 6, 2004 By Michael Hopmeier Special Advisor to the US Surgeon General, WMD and Homeland SecurityUnconventional Concepts, Inc. 3811 N. Fairfax Drive, Suite 720 Arlington, VA 22203 USA 703-797-4562 hopmeier@unconventional-inc.com

2. 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

3. “A bioterrorism attack anywhere in the world is inevitable in the 21st century.”Anthony Fauci, Director, NIAID Source: Clinical Infectious Diseases 2001;32:678

4. 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) Some Bioterrorism Agents Source: http://etl2.library.musc.edu/bioterrorism/resources/ppt_files/5

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

6. 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 Emerging and Re-Emerging Threats in the U.S. and Abroad

7. 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 !

8. 103,000 Infectious Disease 3,247 Nuclear (Japan) 42 million Terrorism Events Soldier Deaths in Battle 270 Million Causes of Mortality in the US1900-2001 Source: Multiple resources

9. Leading Cause of Mortality in Adults in US for 2002 Rank Cause of Death Number Deaths Per 100,000 Population 1. Disease of the heart 700,142 29.0 2. Malignant neoplasms (Cancer) 553,768 22.9 3. Cerebrovascular Disease 163,538 6.8 Chronic Lower Respiratory diseases 4. 123,013 5.1 Accidents (unintentional injuries) 5. 101,537 4.2 6. Diabetes Mellitus 71,372 3.0 Source: http://www.infoplease.com/ipa/a0005110.html

10. Leading Causes of Mortality Among Adults aged 15-59 Worldwide, 2002 *Data from 2001 Source: http://www.who.int/whr/2003/en/Facts_and_Figures-en.pdf

11. 6 Leading Causes of Mortality throughout the world, 2002 Source: http://www.infoplease.com/ipa/A0779147.html

12. Why Now? • Increasing global travel • Rapid access to large populations • Poor global security & awareness

13. Why Now? The world is becoming smaller!

14. 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

15. Current Assets US Medical Preparedness

16. 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)

17. Funding for Medical Preparedness Activities Grants directed towards Bioterrorism preparedness improve overall preparedness in hospitals and communities • 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

18. Cumulative Civilian Biodefense Spending by Agency, FY2001-FY2005 DHS DHHS Total Spending for FY2001 - FY2005 = $22,107,800,000

19. US Government Civilian Biodefense Funding, FY2001-FY2005 In Millions

20. 13.213 14 12 10 8 5.481 Trillions of Dollars (1996) 6 4 1.7 2 0 National Defense Nuclear Weapons Health Infrastructure U.S. Government Expenditures by Function 1940-1996

21. 2/3 of a Push Package

22. 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

23. 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

24. Bioterrorism Agent Vaccine Availability Disease/Agent Available Vaccine Anthrax AVA (BioThrax), inactivated cell-free preparation, licensed Formaldehyde-killed whole cell, production discontinued in 1999, licensed, does not prevent pneumonic plague Plague Botulism Investigational pentavalent toxoid botulinum antitoxin (equine) Tularemia Investigational New Drug Q-Fever  Investigational New Drug Smallpox Vaccinia virus, live unattenuated, licensed varicella immune globulin (VZIG) Hemorrhagic fevers 17D yellow fever, live attenuated  Typhoid Vi polysaccharide conjugate Viral Encephalidites  IND TC83

25. 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

26. 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

27. 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

28. 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?

29. Issues in Preparedness

30. 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

31. 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

32. Key Focus Areas • Education • Professionals • Public • Organization of Existing Assets • Personnel • Materiel • Infrastructure • Healthcare • Labs • Information

33. 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

34. 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

35. Public Health Responseto Bioterrorism • Detection & surveillance • Rapid laboratory diagnosis • Epidemiologic investigations • Implementation of control measures

36. 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

37. 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

38. 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

39. Public Health in the US Preparedness and Disease Prevention

40. What are the Preparedness Priorities? • Terrorism • Emerging Infections • Natural Disasters • Mental Health and Resilience • Chronic Disease Prevention

41. 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

42. 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

43. 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

44. 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

45. Summary Key Points

46. 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

47. 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

48. Key Points Summary • Infectious diseases and public health ARE National Security issues, as well as a worldwide problem • We need preparedness for all infectious diseases and public health issues • including chronic health problems • Any public health system has to be able to respond to all aspects of a disaster, or even a non-disaster • There are always emerging problems • Continuous process • Science and Society need to integrate to train the public on health issues

49. PREPARING AND DEFENDING THE PUBLIC IS THE FIRST PRIORITY