The Bioterrorism Band-Aid:

1. The Bioterrorism Band-Aid: Why We Cannot Manage Bioterrorism with a Broken Public Health System

2. Edward P. Richards • Director, Program in Law, Science, and Public Health • Louisiana State University Law Center • richards@lsu.edu • http://biotech.law.lsu.edu • Google: Smallpox Law

3. Thesis • Public Health is Driven by Fear • Bioterrorism Frightens Politicians • Bioterrorism Gets Attention • Bioterrorism Preparedness Does Not Improve Public Health • The Smallpox Vaccination Plan for Health Care Providers Shows why Public Health Infrastructure and Trust Matters • We Have to Fix Public Health and Health Care to be Prepared for All Public Health Disease Threats

4. Why is Bioterrorism so Scary? • Bombs and Armed Attacks • Open and Obvious • Obvious Endpoints • Chemical and Bioterrorism • Includes Nuclear Contamination • Stealth • Unknown reach • Unknown Duration

5. Why Smallpox Bioterrorism? • Stable Aerosol Virus • Relatively Easy to Produce • Infectious at Low Doses • 10 to 12 day incubation period • High mortality rate (30%) • No proven treatment

6. Victims as Vectors • Smallpox Spreads Primarily Through Person to Person Contact • People are Infectious When They Start to Develop Sores • Stay Infectious Until They Recover or Die • Cases must be isolated until cured • Contacts should be Vaccinated and Quarantined for 2 weeks

7. The President's Smallpox Vaccination Campaign • In mid-December, the White House announced a campaign to vaccinate 500,000 health care workers over the next two months • Three months later, approximately 10,000 health care workers have been vaccinated and many hospitals have refused to participate • Why?

8. Smallpox Vaccine is Dangerous • Only dangerous vaccine in use • Live Virus Vaccine (Vaccinia Virus) • Must be Infected to be Immune

9. Complications of Vaccination • Local Lesion • Can be Spread on the Body and to Others • Progressive (Disseminated) Vaccina • Deadly Like Smallpox, but Less Contagious

10. Historic Probability of Injury • 35 Years Ago • 5.6M New and 8.6M Revaccinations a Year • 9 deaths, 12 encephalitis/30-40% permanent • Death or Severe Permanent Injury - 1/1,000,000 • Injuries were to Immunosuppressed Persons

11. How Have Medical Risks Changed? • Immunosuppression Was Rare in 1970 • Immunosuppression is More Common • HIV, Cancer Chemotherapy, Arthritis Drugs, Organ Transplants • Because of HIV privacy policies, many HIV infected persons do not know it • Many Others Do Not Realize Their Medicines Make Them Immunosuppressed

12. How Have Legal Risks Changed? • Society has much less tolerance for risk • Society has lower respect for public health authorities • Tort law was a minor problem in 1970 • Now you must have legal immunity or it is too risky to use smallpox vaccine

13. Homeland Security Act • Section 304 provides governmental immunity to persons and institutions participating in the smallpox vaccination program • You must sue the Public Health Service under the Federal Tort Claims Act • Probably cannot win under discretionary immunity • Even if it is dumb, you cannot sue for things the government does on purpose • Atom bomb cases

14. Problems with Sec. 304 • Poorly Drafted • Probably does not apply to medical staff members • Some other ambiguities • Cuts off compensation • Injured health care providers are limited to worker's compensation • Injured third parties such as family members and patients are out in the cold

15. Concerns of Health Care Providers • Health Departments do not have enough personnel • Hospitals are worried about paying worker's comp costs • Workers are worried about injuries and the limited payments by comp • Everyone is worried about risks to immunosuppressed patients and family members and how to pay for their care

16. Epidemiologic Issues • Many hospitals believe the plan is unsound so it does not justify taking any risks • No provisions for regionalizing care • No provisions for triaging smallpox cases away from hospitals • No provisions for quarantine and isolation

17. Isolation and Quarantine • Do You Let Them Stay at Home and Promise to Not Go Out? • How do They Get Food? • Medical Care? • Take Over A Hotel or Prison? • No Good Respiratory Isolation • If Someone Gets Sick, All Are At Risk • Pest House

18. What if there is a Smallpox Outbreak? • CDC Assumption - Hard to Spread • Limited Transmission • Self-policed Quarantine At Home • Vaccinate Contacts and Trace New Cases • Other Scientists - Easy to Spread • Hard Quarantine for Cases and Contacts • Mass Immunization • Which Way Do You Want to Bet? • Is the CDC Being Politically Expedient?

19. Why Are We Unprepared for Smallpox? • Public Health Believed the Virus Was Safely Locked Away • Stopping vaccinations was controversial • No Work on Better Vaccines • Intelligence Agencies Knew Smallpox Out of the Box in 1992 • Public Health Did Not Know this Until 1999 • 10 Years Could Have Solved the Vaccine Problem

20. Are We Doing Better with AIDS? • Set up by the Bathhouses in the 1970s • Huge Hepatitis B Epidemic • Really got AIDS Started • What have we Learned? • Bathhouses are Open Again • AIDS is on the Increase • We do even know how many are infected

21. Other Emerging Infectious Diseases • Lyme Disease • West Nile • Dengue • Resurgence of Tuberculosis • 5,000 people a year die of food borne illness

22. Why is Fear Necessary for Public Health? • Effective Prevention Depends on Fear • Fear Justifies Personal and Tax Costs • Fear Justifies Personal Risk • Fear Must Cut Across Classes • The Middle and Upper Classes do not Fear AIDS - We do Little to Prevent it • TB Scared Wealth New Yorkers - TB Control Increases

23. Primal Fear of Epidemics • Breaks Down Family and Community Structures • Fear of the Infected • No Backup When Caregivers are Ill • Synchronous Infection Wiped out the Indigenous Peoples in the Americas • Disrupts Society • Scholars argue plague ended the feudal system • Critical to conquest of the Americas

24. Public Health is a Fundamental Government Function • Epidemics Threaten Public Order • Right of Societal Self-Defense • Justifies Draconian Actions Under National and International Law • From Quarantining Philadelphia to Putting Alaskan Sex Offenders on the Internet

25. Epidemics in the US • Colonial Cities Were Wracked by Yellow Fever, Malaria, Cholera, and Typhoid • Periodic Smallpox, Lots of Tuberculosis • Individuals, Cities, and Even States were Quarantined • Life Expectancy in Boston in 1840 was 25

26. Public Health in the Constitution • Original Intent is Clear • Police Power Went to the States • Federal Government Retained Control over Interstate Commerce and National Security

27. State Public Health • Most Public Health is done by state, county, and local government • Sanitation • Communicable Disease Control • Environmental Health • Broad Powers • Seizure of Property • Personal Restrictions • Information Collection

28. Federal Public Health • First Acts of Congress • Public Health Hospitals • Quarantine Stations • National Security Powers • Much Later • FDA, Agriculture Department, HHS, CDC • Interstate Commerce Powers

29. Could the Feds Require Smallpox Vaccination? • Are There Federal Police Powers? • Could the Invasion Clause of the Constitution Support Mass Smallpox Vaccinations as a Protection Against Terrorist Invasion? • Current Method • Threaten State Funding • Political Intimidation • Health Departments are Afraid to Resist

30. Public Health Revolution • Sanitation Movement – Mid 1800s • Clean Drinking Water • Waste Disposal • Disease Control • Vaccinations • TB Control • Epidemiology: Investigation and Intervention

31. Triumph of Public Health • High Point - 1960s • TB is Controlled • Vaccinations for Major Communicable Diseases • Life Expectancy More than Doubled in 100 Years • 1968 - Surgeon General Says Public Health is Solved, on to Chronic Diseases

32. Destruction of Public Health • Medicare, Medicaid, Private Health Insurance Make Medical Care Much More Financially Rewarding • Medical Care is a Much More Expensive and Cannibalizes Public Health Money • Health Departments Fill with Medical Care People • Research is Dominated by Drugs for Chronic Illness • We Even Rationalize Away the Fear of AIDS by Treating it as a Personal Choice

33. The Political Consensus Breaks Down • Without Fear, the Public Will not Pay for Prevention • Politicians want Health Directors who Do not Make Trouble about Public Health • When Budgets are Cut, Public Health is First • Hard to Hire and Retain Trained Staff • Schools of Public Health Lose Their Focus • Privacy Trumps Public Good

34. Parallel Problems in Health Care • Reduced Hospital Beds • Empty hospital beds costs money • Managed care and DRGs have shorted hospital stays, reducing the need for beds • Reduced Emergency Room Capacity • EMTALA has forced many hospitals to close their ERs • Most remaining city ERs are over capacity • If you cannot handle routine traffic, how can you handle a large number of causalities?

35. Why Bioterrorism Money Does Not Help • Post 911 Congress has Appropriated Billions for Terrorism and Bioterrorism • Most is Law Enforcement and Fire Departments, Some Public Health • Equipment • Training • No Personnel • No Long Term Commitments • Mandates Cost More than the Funding

36. Doing the Numbers • Health and Public Health Care are Expensive when They Work Well • They Are Much More Expensive When They Work Poorly • Only the Government Can Capture the Savings • Private Insurers and Employers have too much turn over and too short a time horizon

37. States Cannot Do the Job • State Budgets are too Variable • Local Politicians are too Short-Sighted • Insurance and Health Care Are National Business and Need Federal Regulation • The Feds Already Control a Large Part of the Budget

38. Public Health as National Defense • The White House Recognizes that Public Health is Part of National Defense • National Defense is a Federal Function • Demands Stable Federal Money • Demands National Coordination • Cannot Be Done By Telling the States to Manage Bioterrorism on Short-Term Money

39. End of Presentation