Smallpox, SARS, and Bioterrorism

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Smallpox, SARS, and Bioterrorism

• Lessons Learned and Future Challenges
• http//biotech.law.lsu.edu/cphl/Talks.htm

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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_at_lsu.edu
• http//biotech.law.lsu.edu

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Topics for Discussion

• Smallpox Vaccine Campaign
• SARS
• Bioterrorism Preparedness
• Questions throughout

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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
• Up to 30 Mortality rate

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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
• 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

• 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?

• Cost Benefit Analysis
• 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

• 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

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How Fast Does Smallpox Spread?

• Do you have to mass vaccinate?

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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

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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

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Why Not Vaccinate Everyone?

• Why roll the dice on which model is right?

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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 in Stock
• 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

• 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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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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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

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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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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?

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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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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

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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?

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Smallpox Vaccination Campaign

• Fall 2002 - Spring 2003

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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

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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

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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

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CDC Plan

• Voluntary vaccinations
• No screening or medical records review
• Self-deferral

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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

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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?

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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?

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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?

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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?

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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)."

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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

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What is Excluded?

• Probably Workers 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

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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

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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?

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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

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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

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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

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SARS
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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

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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

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Hospitals as Vectors

• 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?

• 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

• 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

• 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

• 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

• 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?
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Central Health Authority

• 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

• 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
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Law and Plans are Cheap

• Lots of planning
• Plans never really address the impossibility of
  carrying them out
• Lots of special laws
• Poorly thought out
• Never come with staff or money to handle the
  problems

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What Would Happen with an Outbreak?

• 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

• Communicable diseases
• The SARS and Smallpox issues
• Anthrax
• 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

• Wholly inadequate public health system
• 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
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Just say No to Unworkable Plans

• The first step is honesty
• 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

• 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

• 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

• Demand fully qualified public health
  professionals
• 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