1. Ethical Issues in Pandemic Flu
Kathy Kinlaw
Emory University
Center for Ethics

2. Keeping allocation/prioritization in broader context
What can be done to increase vaccine production (vs. allocate scarce resource)?
Shorten time between recognition of new viral strains and intervention
Balance vaccines and antivirals utilization
How do we make sure vaccine gets to high risk groups once determined? Plan for public engagement, including involvement of state and local officials, that will improve “uptake” of vaccine by priority groups
Education of providers
Larger questions of personal freedom and choice – e.g. quarantine

3. Maximize Preparedness to Minimize Allocation Needs

4. Levels of Allocation
What budget and other resources are available for agencies dealing with influenza? (vs. other societal needs)
What resources are committed to prevention vs. crisis response?
Who receives scarce resources?

5. Underlying Values or Principles (Which May be Competing)
Respect for the rights of the individual (autonomy interests)
Equity - treat people equally (usually adds, a decent minimum level) local control re distribution of vaccine may lead to lack of equity
Utility - greatest good for the greatest number affected
Beneficence - Quality of Life/quality of benefit
Efficiency - maximize beneficent care, eliminate non-beneficial expenditure

6. Criteria for prioritization
Historically, ACIP priority is individuals at high risk
of hospitalization
Refine nature of hospitalization – length of stay, ICU stay, severity of illness
Risk of death
Beneficence-based commitment (promote good and remove harm) – likelihood of medical benefit
Even vaccination of HCP’s based on decreasing transmission to high risk groups
Herd immunity discussion based on impact on high risk groups (esp. elderly); working group called for need for impact data; would not lower priority of vaccination for older patients
Does raise questions of seeing children as means to an end

7. Spectrum of Local/Central Control
Current
Position –
Some guidance
Much local
Authority
Local communities
not satisfied with
current guidance?
Increased
Guidance
? Role of community
input and ethical
transparency
Mandated categories
For vaccination; no local
control
Vaccine Orders and
distribution centralized
Incentives for vaccina-
tion and “penalties”
for failure to be
vaccinated
Equity? Consistency
Would this really help
local communities?
Total Local Control
“Let the Market Work”
No Guidance
Local Autonomy
Respect for individual
choice
Is this really what local
Communities want?
Access issues

8. Pandemic Flu moves us closer to:
Central control -> Collaboration
Mandated practices

9. Public Health Commitment
Long-term objective - Collective action by community to promote health of members
Movement away from free market, individual pursuit to a societal decision
Allocation as short term policy for crisis

10. Other ethical considerations
Procedural Ethics – who decides
Community involvement through process that has integrity
Cultural sensitivity – (e.g. sovereign nations)
Special consideration to those already marginalized in society already; potentially vulnerable populations

11. Equity - Egalitarian Approach
Fair distribution of resources across total population
Regardless of utility, benefit
Either random selection or % of all
Vaccinating significant % of population may not be possible
e.g., Meltzer et al ‘99 study - production, delivery and admin. of vaccine to 60% of U.S. population in short time as infeasible
Despite production of 150 million doses of swine flu vaccine in US was done in 3 mos; Meltzer et all estimate need for 320 million doses of vaccine to provide 2 doses for 60% of the population; producing, delivering and administering that in a 2 to 3 month period has never been done

12. A Look at Utility Maximization
Greatest Good for greatest # affected
Sum of the Benefit to each individual minus Cost to each individual
Overall utility maximization NOT = each individual’s utility maximized; ? of respect to individuals as ends in themselves, not merely means to overall utility
Indeed might violate fundamental rights of individuals or groups (low priority groups)

13. Triage cont.
Based on maximizing utility (greatest good for greatest #)
? Greatest medical utility, eg. Saving lives
OR Greatest military good - return to the fight

14. E.G. Triage and Vaccine Prioritization
Are we vaccinating those most at risk of severe illness or life lost OR
Preventing harm, maintaining “fighting strength” by vaccinating those most likely to spread disease?

15. Efficiency Criteria Cost effective analysis –
Which alternative is most effective use of resources?
Effectiveness/health benefits of these alternatives can be measured in non-monetary units, such as years of life saved or quality adjusted life years (QALY’s)
difficulty of identifying objective measurement of benefit
not concerned with distribution of benefits

16. Objectives for Pandemic Vaccination
Will Primary Goal be:
to prevent overall # of deaths?
to prevent deaths in high risk pts?
To decrease gross attack rates?
To decrease severe morbidity?
To decrease disruptions of essential services?
See Meltzer, Cox, Fukuda 1999

17. Prioritization of Limited Vaccine
Varying Strategies
Those at High Risk for influenza-related complications, including death
determining who is at highest risk as dependent on epidemiology of pandemic
Those in essential community services
Those most likely to disseminate virus
Re epidemiology of virus - if the viral strain proved especially dangerous to 20 to 34 year olds as did the 1918 epidemic, priority of high risk would shift

18. Other ethical considerations
Procedural Ethics – who decides
Community involvement through process that has integrity
Cultural sensitivity – (e.g. sovereign nations)
Special consideration to those already marginalized in society already; potentially vulnerable populations

19. Increasing Prioritization for Decreasing Dissemination ?
Essential Services/Primary disseminators of disease
health care providers
long term care/chronic care workers (nursing homes, assisted living, mental health facilities, rehabilitation, home care)
Other essential services?
Pre-school and school children - high attack rates in early phases of epidemic; accessible
Values:
Decrease dissemination of illness - beneficence and efficiency
And -> utility, max. good by decrease spread
Recent studies indicating possible increase in risk of hospitalization for young children (< 2, maybe 2 – 4)
And with school age, accessible immunization group that would decrease spread to homes, etc.

20. Prioritization cont. High Risk Persons Disseminators
Pts with chronic pulmonary or cardiovascular disorders
Others at high risk for complications from influenza (see ACIP recs) note age groups most at risk with viral stain
Residents of long term care facilities
Others age 65 and >
Disseminators
Family members of high risk persons
Other essential services
fire, police, mass transportation, sanitation morticians
Workers accessible through employers
College students
Others at high risk include: long term care or chronic care facility residents; those with chronic metabolic disease like diabetes, renal dysfunction, immunosuppression, incl. HIV+ patients; those on long term aspirin therapy(at risk for Reye’s syndrome, pregnant women in 2nd or 3rd trimester

21. Timing Combine values of: Urgency/high risk Likelihood of benefit
Decreasing dissemination
Efficiency – access to at risk groups and providers (LTC and chronic care facilities; preschools)
Beneficence and Utility

22. Phasing of Prioritization?
HC Wkrs;
Pts with
Respir and
Cardiovasc
disorders
School &
LTC Wkrs
&Residts
Other
High
Risk
Family
Of High
Risk Pts
Age
65 & >
Groups
Workers
College
Esst’l
Svcs.
Phase 1
Phase 2
Phase 3
Timing may allow vaccination of LTC/chronic workers and residents because of access, prior to/parallel to other high risk patients This is where efficiency as value may impact timing.