The Bioterrorism Band-Aid:

Why We Cannot Manage Bioterrorism with a Broken Public Health System

Edward P. Richards Director, Program in Law, Science,

and Public Health Louisiana State University Law

Center richards@lsu.edu http://biotech.law.lsu.edu Google: Smallpox Law

Thesis Public Health is Driven by Fear

Bioterrorism Frightens Politicians Bioterrorism Gets Attention

Bioterrorism Preparedness Does Not Improve Public Health

The Smallpox Vaccination Plan for Health Care Providers Shows why Public Health Infrastructure and Trust Matters

We Have to Fix Public Health and Health Care to be Prepared for All Public Health Disease Threats

Why is Bioterrorism so Scary? Bombs and Armed Attacks

Open and Obvious Obvious Endpoints

Chemical and Bioterrorism Includes Nuclear Contamination Stealth Unknown reach Unknown Duration

Why Smallpox Bioterrorism?

Stable Aerosol Virus Relatively Easy to

Produce Infectious at Low Doses 10 to 12 day incubation

period High mortality rate (30%) No proven treatment

Victims as Vectors

Smallpox Spreads Primarily Through Person to Person Contact People are Infectious When They Start to

Develop Sores Stay Infectious Until They Recover or Die

Cases must be isolated until cured Contacts should be Vaccinated and

Quarantined for 2 weeks

The President's Smallpox Vaccination Campaign In mid-December, the White House

announced a campaign to vaccinate 500,000 health care workers over the next two months

Three months later, approximately 10,000 health care workers have been vaccinated and many hospitals have refused to participate

Why?

Smallpox Vaccine is Dangerous

Only dangerous vaccine in use Live Virus Vaccine (Vaccinia Virus) Must be Infected to be Immune

Complications of Vaccination

Local Lesion Can be Spread

on the Body and to Others

Progressive (Disseminated) Vaccina Deadly Like

Smallpox, but Less Contagious

Historic Probability of Injury

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 Injuries were to

Immunosuppressed Persons

How Have Medical Risks Changed?

Immunosuppression Was Rare in 1970 Immunosuppression is More Common

HIV, Cancer Chemotherapy, Arthritis Drugs, Organ Transplants

Because of HIV privacy policies, many HIV infected persons do not know it

Many Others Do Not Realize Their Medicines Make Them Immunosuppressed

How Have Legal Risks Changed?

Society has much less tolerance for risk

Society has lower respect for public health authorities

Tort law was a minor problem in 1970 Now you must have legal immunity or

it is too risky to use smallpox vaccine

Homeland Security Act Section 304 provides governmental

immunity to persons and institutions participating in the smallpox vaccination program

You must sue the Public Health Service under the Federal Tort Claims Act

Probably cannot win under discretionary immunity Even if it is dumb, you cannot sue for things

the government does on purpose Atom bomb cases

Problems with Sec. 304 Poorly Drafted

Probably does not apply to medical staff members

Some other ambiguities Cuts off compensation

Injured health care providers are limited to worker's compensation

Injured third parties such as family members and patients are out in the cold

Concerns of Health Care Providers

Health Departments do not have enough personnel

Hospitals are worried about paying worker's comp costs

Workers are worried about injuries and the limited payments by comp

Everyone is worried about risks to immunosuppressed patients and family members and how to pay for their care

Epidemiologic Issues Many hospitals believe the plan is

unsound so it does not justify taking any risks

No provisions for regionalizing care No provisions for triaging smallpox

cases away from hospitals No provisions for quarantine and

isolation

Isolation and Quarantine Do You Let Them Stay at Home

and Promise to Not Go Out? How do They Get Food? Medical Care?

Take Over A Hotel or Prison? No Good Respiratory Isolation If Someone Gets Sick, All Are At Risk Pest House

What if there is a Smallpox Outbreak? CDC Assumption - Hard to Spread

Limited Transmission Self-policed Quarantine At Home Vaccinate Contacts and Trace New Cases

Other Scientists - Easy to Spread Hard Quarantine for Cases and Contacts Mass Immunization

Which Way Do You Want to Bet? Is the CDC Being Politically Expedient?

Why Are We Unprepared for Smallpox? Public Health Believed the Virus Was

Safely Locked Away Stopping vaccinations was controversial No Work on Better Vaccines

Intelligence Agencies Knew Smallpox Out of the Box in 1992

Public Health Did Not Know this Until 1999

10 Years Could Have Solved the Vaccine Problem

Are We Doing Better with AIDS?

Set up by the Bathhouses in the 1970s Huge Hepatitis B Epidemic Really got AIDS Started

What have we Learned? Bathhouses are Open Again AIDS is on the Increase We do even know how many are infected

Other Emerging Infectious Diseases

Lyme Disease West Nile Dengue Resurgence of Tuberculosis 5,000 people a year die of food

borne illness

Why is Fear Necessary for Public Health?

Effective Prevention Depends on Fear Fear Justifies Personal and Tax Costs Fear Justifies Personal Risk

Fear Must Cut Across Classes The Middle and Upper Classes do not

Fear AIDS - We do Little to Prevent it TB Scared Wealth New Yorkers - TB

Control Increases

Primal Fear of Epidemics Breaks Down Family and Community

Structures Fear of the Infected No Backup When Caregivers are Ill Synchronous Infection Wiped out the

Indigenous Peoples in the Americas Disrupts Society

Scholars argue plague ended the feudal system

Critical to conquest of the Americas

Public Health is a Fundamental Government Function

Epidemics Threaten Public Order Right of Societal Self-Defense Justifies Draconian Actions Under

National and International Law From Quarantining Philadelphia to

Putting Alaskan Sex Offenders on the Internet

Epidemics in the US

Colonial Cities Were Wracked by Yellow Fever, Malaria, Cholera, and Typhoid

Periodic Smallpox, Lots of Tuberculosis Individuals, Cities, and Even States

were Quarantined Life Expectancy in Boston in 1840 was

25

Public Health in the Constitution

Original Intent is Clear Police Power Went to the States Federal Government Retained

Control over Interstate Commerce and National Security

State Public Health Most Public Health is done by state,

county, and local government Sanitation Communicable Disease Control Environmental Health

Broad Powers Seizure of Property Personal Restrictions Information Collection

Federal Public Health

First Acts of Congress Public Health Hospitals Quarantine Stations National Security Powers

Much Later FDA, Agriculture Department, HHS,

CDC Interstate Commerce Powers

Could the Feds Require Smallpox Vaccination?

Are There Federal Police Powers? Could the Invasion Clause of the

Constitution Support Mass Smallpox Vaccinations as a Protection Against Terrorist Invasion?

Current Method Threaten State Funding Political Intimidation Health Departments are Afraid to Resist

Public Health Revolution Sanitation Movement – Mid 1800s

Clean Drinking Water Waste Disposal

Disease Control Vaccinations TB Control Epidemiology: Investigation and

Intervention

Triumph of Public Health

High Point - 1960s TB is Controlled Vaccinations for Major Communicable

Diseases Life Expectancy More than Doubled in

100 Years 1968 - Surgeon General Says Public

Health is Solved, on to Chronic Diseases

Destruction of Public Health Medicare, Medicaid, Private Health

Insurance Make Medical Care Much More Financially Rewarding Medical Care is a Much More Expensive and

Cannibalizes Public Health Money Health Departments Fill with Medical Care

People Research is Dominated by Drugs for

Chronic Illness We Even Rationalize Away the Fear of

AIDS by Treating it as a Personal Choice

The Political Consensus Breaks Down

Without Fear, the Public Will not Pay for Prevention Politicians want Health Directors who Do not

Make Trouble about Public Health When Budgets are Cut, Public Health is First Hard to Hire and Retain Trained Staff

Schools of Public Health Lose Their Focus Privacy Trumps Public Good

Parallel Problems in Health Care Reduced Hospital Beds

Empty hospital beds costs money Managed care and DRGs have shorted hospital

stays, reducing the need for beds Reduced Emergency Room Capacity

EMTALA has forced many hospitals to close their ERs

Most remaining city ERs are over capacity If you cannot handle routine traffic, how

can you handle a large number of causalities?

Why Bioterrorism Money Does Not Help Post 911 Congress has Appropriated

Billions for Terrorism and Bioterrorism Most is Law Enforcement and Fire

Departments, Some Public Health Equipment Training

No Personnel No Long Term Commitments Mandates Cost More than the Funding

Doing the Numbers Health and Public Health Care are

Expensive when They Work Well They Are Much More Expensive When

They Work Poorly Only the Government Can Capture the

Savings Private Insurers and Employers have too

much turn over and too short a time horizon

States Cannot Do the Job

State Budgets are too Variable Local Politicians are too Short-

Sighted Insurance and Health Care Are

National Business and Need Federal Regulation

The Feds Already Control a Large Part of the Budget

Public Health as National Defense

The White House Recognizes that Public Health is Part of National Defense

National Defense is a Federal Function Demands Stable Federal Money Demands National Coordination Cannot Be Done By Telling the States to

Manage Bioterrorism on Short-Term Money

End of Presentation