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Smallpox, SARS, and Bioterrorism

Smallpox, SARS, and Bioterrorism. Lessons Learned and Future Challenges http://biotech.law.lsu.edu/cphl/Talks.htm. Edward P. Richards. Edward P. Richards Director, Program in Law, Science, and Public Health Harvey A. Peltier Professor of Law Paul M. Hebert Law Center

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Smallpox, SARS, and Bioterrorism

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  1. Smallpox, SARS, and Bioterrorism Lessons Learned and Future Challenges http://biotech.law.lsu.edu/cphl/Talks.htm

  2. Edward P. Richards Edward P. Richards Director, Program in Law, Science, and Public Health Harvey A. Peltier Professor of Law Paul M. Hebert Law Center Louisiana State University Baton Rouge, LA 70803-1000 richards@lsu.edu http://biotech.law.lsu.edu LSU Progam in Law, Science, and Public Health

  3. Topics for Discussion • Smallpox Vaccine Campaign • SARS • Bioterrorism Preparedness • Questions throughout LSU Progam in Law, Science, and Public Health

  4. Why Smallpox Bioterrorism? • Stable aerosol Virus • Easy to Produce • Infectious at low doses • Human to human transmission • 10 to 12 day incubation period • Up to 30% Mortality rate LSU Progam in Law, Science, and Public Health

  5. Global Eradication Program • 1967 - Following USSR proposal (1958) WHO initiated Global Eradication Program • Based on Ring Immunization • Vaccinate All Contacts and their Contacts • Quarantine Contacts for Incubation Period • Involuntary - Ignore Revisionist History • 1977 - Oct. 26, 1977 last known naturally occurring smallpox case recorded in Somalia • 1980 - WHO announced world-wide eradication LSU Progam in Law, Science, and Public Health

  6. LSU Progam in Law, Science, and Public Health

  7. Smallpox in the US • Last Cases in 1947 • Routine vaccinations ended in the early 1970s • About 50% of persons have not been vaccinated • Vaccine effectiveness declines with time LSU Progam in Law, Science, and Public Health

  8. Why did We Stop Immunizing? • Cost Benefit Analysis • Vaccine was Very Cheap • Program Administration was Expensive • Risks of Vaccine Were Seen as Outweighing Benefits • Products Liability was Invented LSU Progam in Law, Science, and Public Health

  9. Problems of a Naïve Population • Disease Equilibrium • Recurring diseases that produce immunity leave most of the population immune • Mostly affect children • Epidemics are deadly but not destabilizing • Naïve Populations • Everybody gets sick about the same time • Destabilizes - look at indigenous tribes LSU Progam in Law, Science, and Public Health

  10. How Fast Does Smallpox Spread? Do you have to mass vaccinate?

  11. Traditional Model • Assumptions • Most people are susceptible • Significant mixing in urban areas • Fairly efficient transmission • Fast regional and then national and international spread • Synchronous infection will shut down society • Must use mass vaccination LSU Progam in Law, Science, and Public Health

  12. New Model (Used by CDC) • Assumptions • Vaccinated people are less susceptible • Limited mixing in urban areas • Inefficient transmission • Slow Spread • No destabilization • Allows contact tracing and ring immunizations LSU Progam in Law, Science, and Public Health

  13. Why Not Vaccinate Everyone? Why roll the dice on which model is right?

  14. Smallpox Vaccine • Live Virus Vaccine (Vaccinia Virus) • Not Cowpox, Might be Extinct Horsepox • Must be Infected to be Immune • Crude Preparation We Have in Stock • Prepared from the skin of infected calves • Filtered, Cleaned (some), and Freeze-dried • New Vaccine is Clean, but still Live LSU Progam in Law, Science, and Public Health

  15. Historic Probability of Injury • Small Risk from Bacterial and Viral Contaminants • Small Risk of Allergic Reaction • 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 LSU Progam in Law, Science, and Public Health

  16. Complications of Vaccination • Local Lesion • Can be Spread on the Body and to Others • Progressive (Disseminated) Vaccina • Deadly Like Smallpox, but Less Contagious LSU Progam in Law, Science, and Public Health

  17. How Have Risks Changed? • Immunosuppressed Persons Cannot Fight the Virus and Develop Progressive Vaccinia • Immunosuppression Was Rare in 1970 • Immunosuppression is More Common • HIV, Cancer Chemotherapy, Arthritis Drugs, Organ Transplants LSU Progam in Law, Science, and Public Health

  18. What Happened Last time - 1947 New York Outbreak • Case from Mexico • 6,300,000 Vaccinated in a Month • 3 Deaths from the Smallpox • 6 Deaths from the Vaccine • Would Have Been Much Higher Without Vaccination LSU Progam in Law, Science, and Public Health

  19. Hypothetical 2003 Outbreak • Smallpox is Spread by Terrorists in NY City • 100 People are Infected • They ride the Subway, Shop in a Mall, Work and Live in Different High Rise Buildings • What are the Choices? • Isolation and Contact Tracing • Ring Immunization • Mass Immunization • What Would the Public Demand? LSU Progam in Law, Science, and Public Health

  20. Mass Immunization • Assume 1,000,000 Vaccinated in Mass Campaign with No Screening • Assume 1.0% Immunosuppressed • 10,000 Immunosuppressed Persons • Probably Low, Could be 2%+ • Potentially 1-2,000+ Deaths and More With Severe Illness LSU Progam in Law, Science, and Public Health

  21. Role of Medical Care • Smallpox • Can Reduce Mortality with Medical Care • Huge Risk of Spreading Infection to Others • Very Sick Patients - Lots of Resources • Mass Casualties Swamp the System • Vaccinia • VIG - more will have to be made • Fewer patients - longer time LSU Progam in Law, Science, and Public Health

  22. What Does Isolation Mean? • Proper Isolation • Negative Pressure Isolation Rooms • Very Few • Hospitals and Motels • No Respiratory Isolation is Possible for more than a few cases • One Case Infects the Rest • House Arrest • Impossible to Enforce • How do they get Food and Medical Care? LSU Progam in Law, Science, and Public Health

  23. Smallpox Vaccination Campaign Fall 2002 - Spring 2003

  24. Why Did White House Wait so Long? • Key year for bioterrorism – 1993 • Credible information that the Soviet Union had tons of smallpox virus it could not account for • CIA did not tell CDC • Still Debating Destruction of the Virus in 1999 • Should have started on a new vaccine • Should have worked out a vaccination program LSU Progam in Law, Science, and Public Health

  25. Vaccinating the Military • Required of Combat Ready Troops • Combat ready personnel are medically screened and discharged if they have conditions that would complicate vaccination • All are young and healthy • Not a good control group LSU Progam in Law, Science, and Public Health

  26. Vaccinating Health Care Workers • All ages • Many have chronic diseases that compromise the immune system or otherwise predispose to complications • Have not been medically screened • ADA makes medical screening legally questionable • Political concerns make it impossible LSU Progam in Law, Science, and Public Health

  27. CDC Plan • Voluntary vaccinations • No screening or medical records review • Self-deferral LSU Progam in Law, Science, and Public Health

  28. Problems in the CDC Plan • Conflicting information on removing vaccinated workers from the workplace • No focus on who should be vaccinated - random volunteers do not produce a coherent emergency team • Assumed patients would walk into the hospital • Ignored Securing ERs to prevent this • No attention paid to hospital and worker concerns LSU Progam in Law, Science, and Public Health

  29. Liability for Primary Vaccine Injuries • Informed Consent • Was the Patient Warned of the Risk? • Is it 1/1,000,000 or is it 1/10 for the Immunosuppressed? • Negligent Screening • Is it reasonable to rely on self-screening when the clinical trials demanded medical testing and records review? LSU Progam in Law, Science, and Public Health

  30. Liability for Secondary Spread • Spread to Family Members • Is a Warning to the Vaccinee Enough? • Should there be Investigation? • Spread to Patients by Health Care Providers • Should Vaccinated Persons be in the Workplace while Healing? • Should Patients be Warned? LSU Progam in Law, Science, and Public Health

  31. Employment Discrimination Issues • What Happens When Health Care Providers and Others Refuse Vaccination? • What if they Cannot be Immunized? • Must they be Removed from Emergency Preparedness Teams? • What about Other Workplace Sanctions? LSU Progam in Law, Science, and Public Health

  32. Costs to Hospitals and Workers • Is a vaccine injury a worker's compensation injury? • Should be, but many comp carriers baulked at assuring they would pay • Who pays for secondary spread injuries? • Who pays for time off work and replacing workers? • Does the worker have to take sick leave? LSU Progam in Law, Science, and Public Health

  33. Homeland Security Act Solution • "For purposes of this section, and subject to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an individual during the effective period of a declaration by the Secretary under paragraph (2)(A)." LSU Progam in Law, Science, and Public Health

  34. What Triggers This? • Secretary of HHS Must Make a Declaration • Must Specify the Covered Actions • Immunity Only Extends to Covered Use of Vaccine • Does Not Apply to Unauthorized Use or Blackmarket • Includes People and Institutions LSU Progam in Law, Science, and Public Health

  35. What is Excluded? • Probably Worker’s Comp • Not a Liability Claim • If Included, then the Injured Worker has no Compensation • Black-market and Direct Inoculation • Only injuries, not costs of lost time and other hospital costs LSU Progam in Law, Science, and Public Health

  36. Effect on Injured Workers, Their Families, and Patients • No compensation beyond comp • Questions about whether comp would pay • Might have to use vacation and sick leave • Smallpox compensation act was eventually passed but not implemented and is too limited LSU Progam in Law, Science, and Public Health

  37. The Real ProblemLack of Information • What is the real risk of complications? • Never clarified the risk to immunosuppressed persons • Why now? • Has something really changed? • Is this just Swine Flu all over again? LSU Progam in Law, Science, and Public Health

  38. The End Result • Less than 35,000 vaccinated out of a target of 500,000 • Many of those were reservists who were vaccinated outside the hospital setting • Smallpox vaccination has been discredited LSU Progam in Law, Science, and Public Health

  39. The Problem • Smallpox is still a real threat • The CDC plans for dealing with an outbreak are completely unrealistic • Should we start vaccinating the population? • Vaccinating health care workers alone is not epidemiologically sound or politically acceptable LSU Progam in Law, Science, and Public Health

  40. Lessons Learned • There is a critical breakdown between national security and public health information • Not surprisingly, the CDC must bow to political pressure from the White House • State health departments do not have the expertise or the political isolation to develop independent approaches LSU Progam in Law, Science, and Public Health

  41. SARS LSU Progam in Law, Science, and Public Health

  42. Spanish Influenza • The prologue to Swine Flu and to SARS • Global pandemic in 1918-1919 • May have killed 60,000,000 worldwide • May have killed 600,000 in the US • We do not know why it was so much more fatal • This is why we overreacted to Swine Flu LSU Progam in Law, Science, and Public Health

  43. Critical Characteristics of SARS • Virus related to the common cold • Spreads by coughing and sneezing • Harder to spread than a cold • Much easier to spread than tuberculosis • Exact odds of transmission are unknown • Looks like other common diseases • About 8% die despite aggressive treatment LSU Progam in Law, Science, and Public Health

  44. Hospitals as Vectors • Hospitals and health care workers are often the major vector for epidemic communicable diseases • Smallpox • Ebola • Now SARS LSU Progam in Law, Science, and Public Health

  45. Why are Hospitals Vectors? • Concentrated susceptible populations • Workers move between patients with few sanitary precautions • Patients move around freely • Hospitals make workers bear the cost of illness so they do not go home LSU Progam in Law, Science, and Public Health

  46. SARS Control • Identify the sick people • Treat the sick people without infecting others • Keep contacts of sick people at home for 10-14 days LSU Progam in Law, Science, and Public Health

  47. Problems for Hospitals • How do you staff when you have to send people home who have been exposed before the patient was identified? • How do you keep people coming to work when they get scared? • Who protects the facility from walk-ins? • Do you sort in the parking lot? LSU Progam in Law, Science, and Public Health

  48. Financial and Legal Issues for Hospitals • Who is going to pay the extra costs of care? • Who is going to pay for replacing furloughed staff? • Who picks up the comp costs? • What about SARS-related lawsuits? LSU Progam in Law, Science, and Public Health

  49. Home Isolation • Who pays people who have to stay home from work? • Who brings them food? • Who takes care of their medical needs? • Who takes care of their psychological needs? • If you ignore these, they will not stay home LSU Progam in Law, Science, and Public Health

  50. How is Toronto different from the US?

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