Health Care Ethics and Bioterrorism20 April 2004

Edward P. RichardsDirector, Program in Law, Science, and

Public HealthLouisiana State University Law Center

http://biotech.law.lsu.edu

Scenario One

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

You are worried, but you do not know what you are dealing with

What are the issues?

More info

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?

Stable aerosol Virus Easy to Produce Infectious at low doses Human to human

transmission 10 to 12 day incubation

period High mortality rate (30%)

CDC Materials

Herd Immunity – Key to Eradication

Smallpox Spreads to the Non-immune Immunization Slows the Spread

Dramatically Epidemics Die Out Naturally

Herd Immunity Protects the Unimmunized You do not need 100% to end an

epidemic

Small Pox Vaccine History 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

CDC Materials

Small Pox Vaccine History 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 1967 - Following USSR proposal (1958)

WHO initiated Global Eradication Program 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

CDC Materials

Smallpox Vaccine

Live Virus Vaccine (Vaccinia Virus) Not Cowpox, Might be Extinct Horsepox Must be Infected to be Immune

Crude Preparation We Have Now Prepared from the skin of infected calves Filtered, Cleaned (some), and Freeze-dried

New Vaccine is Clean, but still Live Just failed the clinical trials

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

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

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?

Eradication Ended Vaccinations

Cost Benefit Analysis 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 Agriculture and Smallpox

Stays Endemic or Dies Out Forever Most Communities had Significant

Immunity Isolated Communities

Synchronous Infection Break Down of Social Order

Now the Whole World is Susceptible

Why have the Have Risks of Vaccination 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

How have Attitudes toward Risk Changed?

How have our attitudes about risk changed?

How has this affected vaccinations?

What has caused this change?

Role of Medical Care Smallpox

Can Reduce Mortality with Medical Care Huge Risk of Spreading Infection to

Others Very Sick Patients - Lots of Resources Cannot Treat Mass Casualties

Vaccinia VIG - more will have to be made Less sick patients - longer time

Hypothetical 2004 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 you do? What if you guess wrong?

Is Quarantine a Realistic Option?

Proper Isolation Negative Pressure Isolation Rooms Very Few

Hospitals and Motels No Respiratory Isolation is Possible One Case Infects the Rest

House Arrest

Need to provide income support Food Medical Care Emotional Support If many people resist, it is

impossible to enforce

The Costs of 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

What are the Ethical and Political Issues?

Vaccinate early Stop the epidemic but with lots of

complications Wait until you are sure

Lots more deaths

Pre-Outbreak Immunizations

Can We Control who Gets the Vaccine? Introduces a Disease into the

Community Can Spread Person to Person

Black-market Vaccine Inoculation from Vaccinated

Persons

Smallpox as a Threat 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 Anthrax

Not contagious Can be treated with antibiotics, but it is better

to start within 12 hours of exposure There is a vaccine

Plague, tularemia Contagious Potential agents Treatable with antibiotics unless

bioengineered

Nature’s Own

Flu SARS HIV and related agents Ebola Avian Flu West Nile Who knows what else?

What if there is an outbreak? Do you keep the ER open? What if you people are afraid to treat

patients? Do you admit potentially infected

patients? 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

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?