1. Preparing for Smallpox Edward P. Richards, JD. MPH Director, Program in Law, Science, and Public Health Harvey A. Peltier Professor of Law Louisiana State University Law Center richards@lsu.edu http://biotech.law.lsu.edu

2. What is the Real Risk? Casualties or a Break Down in Social Order?

3. Why TOPOFF is Deceiving The two most important variables - the public and the media - are not involved No one is at risk –No one gets sick, has to get vaccinated, or even risks political embarrassment Everyone shows up at work! Medical care capacity is not challanged

4. Lessons and Limits from SARS Excellent compliance with home quarantine No panic and overwhelming of hospitals Depended on: –Comprehensive public medical care system –Most cases were health care workers –No vaccinations or prophylaxis –Government provided compensation and daily support –Complete trust in the Health Officer and system

5. Key Issues in the US Uncertain Information Inappropriate Expertise Unreliable Plans Potential Catastrophic Breakout

6. Uncertain Information There is no good data on smallpox transmission in a naïve population There is no good risk data on mass immunizations in a naïve population with significant immunosuppression Community reaction to anthrax, which posed little risk, is not reassuring for smallpox

7. Inappropriate Expertise Public health directors are chosen for administrative and political skills Most public health physicians are experts in personal medical care, not disease control Many departments have lost their most skilled professionals Very limited trust of health officials

8. Unreliable Plans States and local government produced plans to get federal funding Plans must show community preparedness Plans assume that all personnel will show up for work and obey all orders Employees who question whether plans are workable are fired

9. Potential Catastrophic Breakout Epidemics in naïve populations can spread geometrically Underestimating current cases or transmission rates leads to dramatic errors in estimates of future cases If public cooperation with control efforts breaks down, it will be very difficult to reestablish order

10. Command and Control Issues How do you evaluate the reliability of technical experts you have to depend on? How do you deal with questionable experts and strategies? How do you deal with unworkable or incomplete plans?

11. Examples of Ignored Issues Every police officer, health care worker, and EMS worker has to be vaccinated within hours of an outbreak Plans say no mandatory vaccinations Compensation for time off work, medical and other costs is critical Individual eligibility for vaccination should be known before an outbreak What about illegals and others outside the system?

12. Public Participation and Information The general public and the media need to know well before an outbreak what each individual can expect and will be expected to do What they are told must be what you are going to do, including the strategy for managing a breakout This forces a discussion of compensation, health care access, and mandatory or mass vaccination

13. Strategic Issues How do you anticipate breakout? How do you decide when to start mass immunization? Will you shoot the soccer mom and kids to enforce quarantine? Is the CDC's mass immunization plan workable, or should we use a variant of the 1947 model? How do our plans change if there is smallpox outside the US?

14. Wrap-Up Smallpox bioterrorism is possible because of hubris Current plans assume there will be no breakdown in public services and a compliant public There is no fallback if these assumptions are wrong A fallback plan and decision criteria must be in place before an outbreak