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Health and National Security Issues of the USA International Conference on Bio-terrorism KCDC of the Republic of Korea August 6, 2004 By Michael Hopmeier Special Advisor to the US Surgeon General, WMD and Homeland Security Unconventional Concepts, Inc. 3811 N. Fairfax Drive, Suite 720 Arlington, VA 22203 USA 703-797-4562 [email protected] 1 © 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 2 © 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 © 2004 Unconventional Concepts, Inc. 3 Some Bioterrorism Agents • Bacteria Anthrax Brucellosis Glanders Plague Tularemia Q-fever Source: http://etl2.library.musc.edu/bioterrorism/resources/ppt_files/5 © 2004 Unconventional Concepts, Inc. • Viruses Smallpox Venezuelan Equine Encephalitis Viral Hemorrhagic Fevers Nipah Virus • Toxins Botulinum Staphylococcal Enterotoxin B Ricin T-2 mycotoxins E-coli (0157:H7) 4 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 5 © 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 (Multiresistant 6 © 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 ! © 2004 Unconventional Concepts, Inc. 7 Causes of Mortality in the US 1900-2001 103,000 3,247 42 million Infectious Disease Nuclear (Japan) Terrorism Events Soldier Deaths in Battle 270 Million Source: Multiple resources © 2004 Unconventional Concepts, Inc. 8 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 553,768 22.9 (Cancer) 3. Cerebrovascular Disease 163,538 6.8 4. Chronic Lower Respiratory diseases Accidents (unintentional injuries) Diabetes Mellitus 123,013 5.1 101,537 4.2 71,372 3.0 5. 6. Source: http://www.infoplease.com/ipa/a0005110.html © 2004 Unconventional Concepts, Inc. 9 Leading Causes of Mortality Among Adults aged 15-59 Worldwide, 2002 783,000 1,036,000 5 2,279,000 HIV/AIDS Ischeamic heart disease Tuberculosis Cerebrovascular disease Anthrax* *Data from 2001 1,332,000 Source: http://www.who.int/whr/2003/en/Facts_and_Figures-en.pdf © 2004 Unconventional Concepts, Inc. 10 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 5 Chronic Obstructive Pulmonary Disease 2,748,000 6 Diarrheal Disease 1,798,000 Source: http://www.infoplease.com/ipa/A0779147.html © 2004 Unconventional Concepts, Inc. 11 Why Now? • Increasing global travel • Rapid access to large populations • Poor global security & awareness Why Now? The world is becoming smaller! 13 © 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 14 © 2004 Unconventional Concepts, Inc. Current Assets US Medical Preparedness 15 © 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) 16 © 2004 Unconventional Concepts, Inc. 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 17 © 2004 Unconventional Concepts, Inc. Cumulative Civilian Biodefense Spending by Agency, FY2001-FY2005 DHS 22% 5% DHHS 3% 68% 2% -1% -1% DHS DoD DoA EPA NSF DoS DHHS Total Spending for FY2001 - FY2005 = $22,107,800,000 US Government Civilian Biodefense Funding, FY2001-FY2005 In Millions 4500 4000 FY 2001 3500 3000 FY 2002 2500 2000 FY 2003 1500 1000 500 DH HS tat e fS .o NS F De pt EP A Do A Do D DH S 0 FY 2004 (estimate) Fy 2005 (budget) U.S. Government Expenditures by Function 1940-1996 14 13.213 Trillions of Dollars (1996) 12 10 8 5.481 6 4 1.7 2 0 National Defense © 2004 Unconventional Concepts, Inc. Nuclear Weapons Infrastructure Health 20 2/3 of a Push Package 21 © 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 © 2004 Unconventional Concepts, Inc. 22 Project Bioshield • $5.6 Billion over 10 years for privatesector 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 23 © 2004 Unconventional Concepts, Inc. Bioterrorism Agent Vaccine Availability Disease/Agent Available Vaccine Anthrax AVA (BioThrax), inactivated cell-free preparation, licensed Plague Formaldehyde-killed whole cell, production discontinued in 1999, licensed, does not prevent pneumonic plague Botulism Investigational pentavalent toxoid botulinum antitoxin (equine) Tularemia Investigational New Drug Q-Fever Investigational New Drug Smallpox Hemorrhagic fevers Typhoid Viral Encephalidites Vaccinia virus, live unattenuated, licensed varicella immune globulin (VZIG) 17D yellow fever, live attenuated Vi polysaccharide conjugate IND TC83 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 25 © 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 26 © 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 27 © 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? 28 © 2004 Unconventional Concepts, Inc. Issues in Preparedness 29 © 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 30 © 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 31 © 2004 Unconventional Concepts, Inc. Key Focus Areas • Education Professionals Public • Organization of Existing Assets Personnel Materiel • Infrastructure Healthcare Labs Information 32 © 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 © 2004 Unconventional Concepts, Inc. 33 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 © 2004 Unconventional Concepts, Inc. 34 Public Health Response to Bioterrorism • • • • Detection & surveillance Rapid laboratory diagnosis Epidemiologic investigations Implementation of control measures 35 © 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 36 © 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 37 © 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 38 © 2004 Unconventional Concepts, Inc. Public Health in the US Preparedness and Disease Prevention 39 © 2004 Unconventional Concepts, Inc. What are the Preparedness Priorities? • • • • • Terrorism Emerging Infections Natural Disasters Mental Health and Resilience Chronic Disease Prevention 40 © 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 41 © 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 42 © 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 43 © 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 44 © 2004 Unconventional Concepts, Inc. Summary Key Points 45 © 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 46 © 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 47 © 2004 Unconventional Concepts, Inc. Key Points Summary 1. Infectious diseases and public health ARE National Security issues, as well as a worldwide problem 2. 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 © 2004 Unconventional Concepts, Inc. 48 PREPARING AND DEFENDING THE PUBLIC IS THE FIRST PRIORITY 49 © 2004 Unconventional Concepts, Inc.