Health Care Ethics and Bioterrorism 20 April 2004

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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

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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?

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Ethical Issues

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

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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?

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What would have happened if it had been smallpox?
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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

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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

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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

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Small Pox Vaccine History

• 1940s - Development of commercial process for
  freeze-dried vaccine production (Collier)
• 1950 - Pan American Sanitary Organization
  initiated hemisphere-wide eradication program

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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

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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

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Complications of Vaccination

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

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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

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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?

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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

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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

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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

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How have Attitudes toward Risk Changed?

• How have our attitudes about risk changed?
• How has this affected vaccinations?
• What has caused this change?

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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

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Hypothetical 2004 Outbreak
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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

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What are the Choices?

• Isolation and Contact Tracing
• Ring Immunization
• Mass Immunization
• What would you do?
• What if you guess wrong?

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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

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House Arrest

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

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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

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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

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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

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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?

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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

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Natures Own

• Flu
• SARS
• HIV and related agents
• Ebola
• Avian Flu
• West Nile
• Who knows what else?

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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?

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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?