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
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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?
Ethical Issues
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You are worried, but you do not know
what you are dealing with
What are the issues?
More info
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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?
What would have happened if
it had been smallpox?
Why Smallpox Bioterrorism?
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Stable aerosol Virus
Easy to Produce
Infectious at low doses
Human to human
transmission
10 to 12 day incubation
period
High mortality rate (30%)
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CDC Materials
Herd Immunity – Key to
Eradication
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Smallpox Spreads to the Non-immune
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Immunization Slows the Spread
Dramatically
Epidemics Die Out Naturally
Herd Immunity Protects the
Unimmunized
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You do not need 100% to end an epidemic
Small Pox Vaccine History
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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
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CDC Materials
Small Pox Vaccine History
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1940’s - Development of commercial
process for freeze-dried vaccine
production (Collier)
1950 - Pan American Sanitary
Organization initiated hemisphere-wide
eradication program
Global Eradication Program
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1967 - Following USSR proposal (1958) WHO
initiated Global Eradication Program
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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
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CDC Materials
Smallpox Vaccine
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Live Virus Vaccine (Vaccinia Virus)
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Crude Preparation We Have Now
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Not Cowpox, Might be Extinct Horsepox
Must be Infected to be Immune
Prepared from the skin of infected calves
Filtered, Cleaned (some), and Freeze-dried
New Vaccine is Clean, but still Live
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Just failed the clinical trials
Complications of Vaccination
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Local Lesion
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Can be Spread
on the Body
and to Others
Progressive
(Disseminated)
Vaccina
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Deadly Like
Smallpox, but
Less Contagious
Historic Probability of Injury
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Small Risk from Bacterial and Viral
Contaminants
Small Risk of Allergic Reaction
35 Years Ago
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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
What Happened Last time 1947 New York Outbreak
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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?
Eradication Ended
Vaccinations
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Cost Benefit Analysis
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Vaccine was Very Cheap
Program Administration was Expensive
Risks of Vaccine Were Seen as
Outweighing Benefits
Stopped in the 1970s
Immunity Declines with Time
Universal Vulnerability
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Agriculture and Smallpox
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Isolated Communities
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Stays Endemic or Dies Out Forever
Most Communities had Significant
Immunity
Synchronous Infection
Break Down of Social Order
Now the Whole World is Susceptible
Why have the Have Risks of
Vaccination Changed?
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Immunosuppressed Persons Cannot
Fight the Virus and Develop Progressive
Vaccinia
Immunosuppression Was Rare in 1970
Immunosuppression is More Common
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HIV, Cancer Chemotherapy, Arthritis Drugs,
Organ Transplants
How have Attitudes toward
Risk Changed?
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How have our attitudes about risk
changed?
How has this affected vaccinations?
What has caused this change?
Role of Medical Care
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Smallpox
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Can Reduce Mortality with Medical Care
Huge Risk of Spreading Infection to Others
Very Sick Patients - Lots of Resources
Cannot Treat Mass Casualties
Vaccinia
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VIG - more will have to be made
Less sick patients - longer time
Hypothetical 2004 Outbreak
Smallpox is Spread by
Terrorists in NY City
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100 People are Infected
They ride the Subway, Shop in a Mall,
Work and Live in Different High Rise
Buildings
What are the Choices?
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Isolation and Contact Tracing
Ring Immunization
Mass Immunization
What would you do?
What if you guess wrong?
Is Quarantine a Realistic
Option?
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Proper Isolation
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Negative Pressure Isolation Rooms
Very Few
Hospitals and Motels
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No Respiratory Isolation is Possible
One Case Infects the Rest
House Arrest
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Need to provide income support
Food
Medical Care
Emotional Support
If many people resist, it is impossible to
enforce
The Costs of Mass
Immunization
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Assume 1,000,000 Vaccinated in Mass
Campaign with No Screening
Assume 1.0% Immunosuppressed
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10,000 Immunosuppressed Persons
Probably Low, Could be 2%+
Potentially 1-2,000+ Deaths and More
With Severe Illness
What are the Ethical and
Political Issues?
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Vaccinate early
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Stop the epidemic but with lots of
complications
Wait until you are sure
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Lots more deaths
Pre-Outbreak Immunizations
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Can We Control who Gets the Vaccine?
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Introduces a Disease into the Community
Can Spread Person to Person
Black-market Vaccine
Inoculation from Vaccinated Persons
Smallpox as a Threat
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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?
Other Agents
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Anthrax
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Not contagious
Can be treated with antibiotics, but it is better to
start within 12 hours of exposure
There is a vaccine
Plague, tularemia
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Contagious
Potential agents
Treatable with antibiotics unless bioengineered
Nature’s Own
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Flu
SARS
HIV and related agents
Ebola
Avian Flu
West Nile
Who knows what else?
What if there is an outbreak?
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Do you keep the ER open?
What if you people are afraid to treat
patients?
Do you admit potentially infected patients?
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What are the risks?
Who pays for the costs to the hospital?
What if there is not enough vaccine or
antibiotics to go around?
The Ethics of Plans
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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?