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
Louisiana State University
Baton Rouge, LA 70803-1000
richards@lsu.edu
http://biotech.law.lsu.edu
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Topics for Discussion
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Smallpox Vaccine Campaign
SARS
Bioterrorism Preparedness
Questions throughout
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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
Up to 30% Mortality rate
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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
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
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Smallpox in the US
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Last Cases in 1947
Routine vaccinations ended in the early
1970s
About 50% of persons have not been
vaccinated
Vaccine effectiveness declines with time
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Why did We Stop Immunizing?
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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
Products Liability was Invented
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Problems of a Naïve
Population
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Disease Equilibrium
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Recurring diseases that produce immunity
leave most of the population immune
Mostly affect children
Epidemics are deadly but not destabilizing
Naïve Populations
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Everybody gets sick about the same time
Destabilizes - look at indigenous tribes
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How Fast Does Smallpox
Spread?
Do you have to mass vaccinate?
Traditional Model
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Assumptions
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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
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New Model (Used by CDC)
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Assumptions
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Vaccinated people are less susceptible
Limited mixing in urban areas
Inefficient transmission
Slow Spread
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No destabilization
Allows contact tracing and ring
immunizations
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Why Not Vaccinate Everyone?
Why roll the dice on which model
is right?
Smallpox Vaccine
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Live Virus Vaccine (Vaccinia Virus)
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Crude Preparation We Have in Stock
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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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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 LSU Progam in Law, Science, and
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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
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How Have Risks 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
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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
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Hypothetical 2003 Outbreak
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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 the Public Demand?
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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
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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
Mass Casualties Swamp the System
Vaccinia
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VIG - more will have to be made
Fewer patients - longer time
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What Does Isolation Mean?
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Proper Isolation
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Hospitals and Motels
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Negative Pressure Isolation Rooms
Very Few
No Respiratory Isolation is Possible for more than
a few cases
One Case Infects the Rest
House Arrest
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Impossible to Enforce
How do they get Food and Medical Care?
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Smallpox Vaccination
Campaign
Fall 2002 - Spring 2003
Why Did White House Wait so
Long?
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Key year for bioterrorism – 1993
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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
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Vaccinating the Military
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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
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Vaccinating Health Care
Workers
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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
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CDC Plan
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Voluntary vaccinations
No screening or medical records review
Self-deferral
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Problems in the CDC Plan
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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
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Liability for Primary Vaccine
Injuries
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Informed Consent
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Was the Patient Warned of the Risk?
Is it 1/1,000,000 or is it 1/10 for the
Immunosuppressed?
Negligent Screening
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Is it reasonable to rely on self-screening
when the clinical trials demanded medical
testing and records review?
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Liability for Secondary Spread
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Spread to Family Members
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Is a Warning to the Vaccinee Enough?
Should there be Investigation?
Spread to Patients by Health Care
Providers
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Should Vaccinated Persons be in the
Workplace while Healing?
Should Patients be Warned?
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Employment Discrimination
Issues
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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?
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Costs to Hospitals and
Workers
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Is a vaccine injury a worker's compensation
injury?
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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?
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Homeland Security Act
Solution
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"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)."
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What Triggers This?
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Secretary of HHS Must Make a
Declaration
Must Specify the Covered Actions
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Immunity Only Extends to Covered Use of
Vaccine
Does Not Apply to Unauthorized Use or
Blackmarket
Includes People and Institutions
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What is Excluded?
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Probably Worker’s Comp
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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
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Effect on Injured Workers,
Their Families, and Patients
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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
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The Real Problem
Lack of Information
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What is the real risk of complications?
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Why now?
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Never clarified the risk to
immunosuppressed persons
Has something really changed?
Is this just Swine Flu all over again?
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The End Result
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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
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The Problem
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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
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Lessons Learned
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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
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SARS
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Spanish Influenza
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The prologue to Swine Flu and to SARS
Global pandemic in 1918-1919
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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
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Critical Characteristics of SARS
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Virus related to the common cold
Spreads by coughing and sneezing
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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
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Hospitals as Vectors
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Hospitals and health care workers are
often the major vector for epidemic
communicable diseases
Smallpox
Ebola
Now SARS
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Why are Hospitals Vectors?
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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
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SARS Control
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Identify the sick people
Treat the sick people without infecting
others
Keep contacts of sick people at home
for 10-14 days
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Problems for Hospitals
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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?
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Financial and Legal Issues for
Hospitals
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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?
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Home Isolation
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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
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How is Toronto different from
the US?
Central Health Authority
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Nearly instant coordination of all docs
and hospitals
Ability to set uniform standards
Ability to coordinate staffing
Ability to control referrals and redirect
patients
Ability to shut down elective care and
clear out hospitals
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Much more extensive social
service and public health system
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People to do the things to make home
isolation work
Immediately set up a comp system
No health insurance issues on payment
Compliant Population
No tort issues
Few objections to isolation
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US Model
Law and Plans are Cheap
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Lots of planning
Plans never really address the
impossibility of carrying them out
Lots of special laws
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Poorly thought out
Never come with staff or money to handle
the problems
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What Would Happen with an
Outbreak?
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Would we limit transportation as was
done in Canada?
Would people really stay home?
How would hospitals cope with a lot of
critically ill patients when they cannot
handle the everyday flow of patients?
None of the plans include putting
everyone else on the street
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Bioterrorism Issues
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Communicable diseases
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The SARS and Smallpox issues
Anthrax
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This is the big worry of the national
security folks
Easier to manage because it is treatable
and not contagious
Hard because it could be a lot of people
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The General Problem
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Wholly inadequate public health system
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Not enough people with the right skills
Not enough people to manage day to day
problems
Completely dysfunctional in many
communities
Lots of Plans, no resources
Excess capacity or surge capacity?
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Lessons
Just say No to Unworkable
Plans
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The first step is honesty
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This is impossible for public health people
Go along or be fired
The ones that are left have learned the
lesson
Private Hospitals Must Take the Lead
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Quit Worrying about the Law
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No judge is going to stop disease
control in a crisis
Do not support detailed, confusing laws
Stick with broad agency authority in a
crisis
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Focus on Permanent
Resources
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Emergency responses must build on day to
day operations if they are to work
If we cannot run an emergency care system,
we cannot respond to mass disasters
We need to talk about the trade off between
elimination of excess capacity and emergency
preparedness
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Demand Better Public Health
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Demand fully qualified public health
professionals
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I do not know if there is a single board-certified
public health doc in the state system
Epidemiologists have dropped 1/3 in 10 years to
about 1200 in the whole country
Provide political protection for public health
professionals
Separate Indigent Care and Environment
from Public Health
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