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 [email protected]

http://biotech.law.lsu.edu

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Topics for Discussion

    Smallpox Vaccine Campaign SARS Bioterrorism Preparedness Questions throughout LSU Progam in Law, Science, and Public Health 3

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 LSU Progam in Law, Science, and Public Health 4

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 LSU Progam in Law, Science, and Public Health 5

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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 LSU Progam in Law, Science, and Public Health 7

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 LSU Progam in Law, Science, and Public Health 8

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 LSU Progam in Law, Science, and Public Health 9

How Fast Does Smallpox Spread?

Do you have to mass vaccinate?

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 LSU Progam in Law, Science, and Public Health 11

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 LSU Progam in Law, Science, and Public Health 12

Why Not Vaccinate Everyone?

Why roll the dice on which model is right?

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 LSU Progam in Law, Science, and Public Health 14

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 LSU Progam in Law, Science, and Public Health 15

Complications of Vaccination

  Local Lesion  Can be Spread on the Body and to Others Progressive (Disseminated) Vaccina  Deadly Like Smallpox, but Less Contagious LSU Progam in Law, Science, and Public Health 16

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 LSU Progam in Law, Science, and Public Health 17

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 LSU Progam in Law, Science, and Public Health 18

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 LSU Progam in Law, Science, and Public Health 20

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 LSU Progam in Law, Science, and Public Health 21

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

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 LSU Progam in Law, Science, and Public Health 24

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 LSU Progam in Law, Science, and Public Health 25

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 LSU Progam in Law, Science, and Public Health 26

CDC Plan

   Voluntary vaccinations No screening or medical records review Self-deferral LSU Progam in Law, Science, and Public Health 27

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 LSU Progam in Law, Science, and Public Health 28

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)." LSU Progam in Law, Science, and Public Health 33

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 LSU Progam in Law, Science, and Public Health 34

What is Excluded?

   Probably Worker’s 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 LSU Progam in Law, Science, and Public Health 35

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 LSU Progam in Law, Science, and Public Health 36

The Real Problem Lack 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 LSU Progam in Law, Science, and Public Health 38

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 LSU Progam in Law, Science, and Public Health 39

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 LSU Progam in Law, Science, and Public Health 40

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 LSU Progam in Law, Science, and Public Health 42

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 LSU Progam in Law, Science, and Public Health 43

Hospitals as Vectors

    Hospitals and health care workers are often the major vector for epidemic communicable diseases Smallpox Ebola Now SARS LSU Progam in Law, Science, and Public Health 44

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 LSU Progam in Law, Science, and Public Health 45

SARS Control

   Identify the sick people Treat the sick people without infecting others Keep contacts of sick people at home for 10-14 days LSU Progam in Law, Science, and Public Health 46

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 LSU Progam in Law, Science, and Public Health 49

How is Toronto different from the US?

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 LSU Progam in Law, Science, and Public Health 51

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 LSU Progam in Law, Science, and Public Health 52

US Model

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 LSU Progam in Law, Science, and Public Health 54

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 LSU Progam in Law, Science, and Public Health 55

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 LSU Progam in Law, Science, and Public Health 56

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

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 LSU Progam in Law, Science, and Public Health 59

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 LSU Progam in Law, Science, and Public Health 60

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 LSU Progam in Law, Science, and Public Health 61

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 LSU Progam in Law, Science, and Public Health 62