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