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Health Care Ethics and Bioterrorism 20 April 2004

Health Care Ethics and Bioterrorism 20 April 2004. Edward P. Richards Director, Program in Law, Science, and Public Health Louisiana State University Law Center http://biotech.law.lsu.edu. Scenario One. 12 year old girl in the ER Fever Unusual rash with some sores Sick, but not serious

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Health Care Ethics and Bioterrorism 20 April 2004

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  1. Health Care Ethics and Bioterrorism20 April 2004 Edward P. Richards Director, Program in Law, Science, and Public Health Louisiana State University Law Center http://biotech.law.lsu.edu

  2. Scenario One • 12 year old girl in the ER • Fever • Unusual rash with some sores • Sick, but not serious • What should you worry about? • What do you do? • Who do you call?

  3. Ethical Issues • You are worried, but you do not know what you are dealing with • What are the issues?

  4. More info • State lab says it is not smallpox • Looks like another pox, probably monkey pox • Contagious, but not as serious as smallpox • Only protection is smallpox vaccine • What do you do now?

  5. What would have happened if it had been smallpox?

  6. Why Smallpox Bioterrorism? • Stable aerosol Virus • Easy to Produce • Infectious at low doses • Human to human transmission • 10 to 12 day incubation period • High mortality rate (30%) • CDC Materials

  7. Herd Immunity – Key to Eradication • Smallpox Spreads to the Non-immune • Immunization Slows the Spread Dramatically • Epidemics Die Out Naturally • Herd Immunity Protects the Unimmunized • You do not need 100% to end an epidemic

  8. Small Pox Vaccine History • 1000 AD - China, deliberate inoculation of smallpox into skin or nares resulting in less severe smallpox infection. Vaccinees could still transmit smallpox • 1796 - Edward Jenner demonstrated that skin inoculation of cowpox virus provided protection against smallpox infection • 1805 - Italy, first use of smallpox vaccine manufactured on calf flank • 1864 - Widespread recognition of utility of calf flank smallpox vaccine • CDC Materials

  9. Small Pox Vaccine History • 1940’s - Development of commercial process for freeze-dried vaccine production (Collier) • 1950 - Pan American Sanitary Organization initiated hemisphere-wide eradication program

  10. Global Eradication Program • 1967 - Following USSR proposal (1958) WHO initiated Global Eradication Program • Based on Ring Immunization • Vaccinate All Contacts and their Contacts • Isolate 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 • CDC Materials

  11. Smallpox Vaccine • Live Virus Vaccine (Vaccinia Virus) • Not Cowpox, Might be Extinct Horsepox • Must be Infected to be Immune • Crude Preparation We Have Now • Prepared from the skin of infected calves • Filtered, Cleaned (some), and Freeze-dried • New Vaccine is Clean, but still Live • Just failed the clinical trials

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

  13. 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

  14. 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?

  15. Eradication Ended Vaccinations • Cost Benefit Analysis • Vaccine was Very Cheap • Program Administration was Expensive • Risks of Vaccine Were Seen as Outweighing Benefits • Stopped in the 1970s • Immunity Declines with Time

  16. Universal Vulnerability • Agriculture and Smallpox • Stays Endemic or Dies Out Forever • Most Communities had Significant Immunity • Isolated Communities • Synchronous Infection • Break Down of Social Order • Now the Whole World is Susceptible

  17. Why have the Have Risks of Vaccination 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

  18. How have Attitudes toward Risk Changed? • How have our attitudes about risk changed? • How has this affected vaccinations? • What has caused this change?

  19. Role of Medical Care • Smallpox • Can Reduce Mortality with Medical Care • Huge Risk of Spreading Infection to Others • Very Sick Patients - Lots of Resources • Cannot Treat Mass Casualties • Vaccinia • VIG - more will have to be made • Less sick patients - longer time

  20. Hypothetical 2004 Outbreak

  21. 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

  22. What are the Choices? • Isolation and Contact Tracing • Ring Immunization • Mass Immunization • What would you do? • What if you guess wrong?

  23. Is Quarantine a Realistic Option? • Proper Isolation • Negative Pressure Isolation Rooms • Very Few • Hospitals and Motels • No Respiratory Isolation is Possible • One Case Infects the Rest

  24. House Arrest • Need to provide income support • Food • Medical Care • Emotional Support • If many people resist, it is impossible to enforce

  25. The Costs of 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

  26. What are the Ethical and Political Issues? • Vaccinate early • Stop the epidemic but with lots of complications • Wait until you are sure • Lots more deaths

  27. Pre-Outbreak Immunizations • Can We Control who Gets the Vaccine? • Introduces a Disease into the Community • Can Spread Person to Person • Black-market Vaccine • Inoculation from Vaccinated Persons

  28. Smallpox as a Threat • What should we do based on what we know now? • What if we knew terrorists had the virus? • What if there has been an outbreak in the mideast? • What if there is an outbreak in NYC? • What there are a few cases, but it is controlled?

  29. Other Agents • Anthrax • Not contagious • Can be treated with antibiotics, but it is better to start within 12 hours of exposure • There is a vaccine • Plague, tularemia • Contagious • Potential agents • Treatable with antibiotics unless bioengineered

  30. Nature’s Own • Flu • SARS • HIV and related agents • Ebola • Avian Flu • West Nile • Who knows what else?

  31. What if there is an outbreak? • Do you keep the ER open? • What if you people are afraid to treat patients? • Do you admit potentially infected patients? • What are the risks? • Who pays for the costs to the hospital? • What if there is not enough vaccine or antibiotics to go around?

  32. The Ethics of Plans • Is it ethical to make plans that cannot be implemented? • Is there a duty to speak up and say we are not ready? • What happens to health care workers and government employees who say the plans will not work?

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