Minnesota Pandemic Ethics Project: Minnesota Pandemic Ethics Project: A Look at VaccinesA Look at Vaccines

Confronting the Ethics of Pandemic Influenza Planning: Confronting the Ethics of Pandemic Influenza Planning: The 2008 Summit of the States The 2008 Summit of the States

J. Eline (Ellie) Garrett, JDJ. Eline (Ellie) Garrett, JDMinnesota Center for Health Care EthicsMinnesota Center for Health Care Ethics

on behalf of the on behalf of the Minnesota Pandemic Ethics Project TeamMinnesota Pandemic Ethics Project Team

Minnesota Center for Health Care Ethics Minnesota Center for Health Care Ethics 2006 Pandemic Influenza Ethics 2006 Pandemic Influenza Ethics

Project on VaccinesProject on Vaccines

Vaccine 25 (2007) 6522-6536

2006 Vaccine Project2006 Vaccine Project

Diverse workgroup, ~35 participantsDiverse workgroup, ~35 participants Prioritization based onPrioritization based on

• Risk of mortalityRisk of mortality• Vaccine responseVaccine response• Risk of transmissionRisk of transmission• Key worker roleKey worker role

Exposure risk not prioritizedExposure risk not prioritized

MN Pandemic Ethics ProjectMN Pandemic Ethics Project2007 – present2007 – present

A collaboration between theA collaboration between the

Minnesota Center for Health Care Ethics Minnesota Center for Health Care Ethics and theand the

University of Minnesota Center for BioethicsUniversity of Minnesota Center for Bioethics

funded by thefunded by the

Minnesota Department of HealthMinnesota Department of Health

Team MembersTeam Members

MN Center for MN Center for Health Care EthicsHealth Care Ethics• J. Eline GarrettJ. Eline Garrett• Karen G. GervaisKaren G. Gervais• Ruth MickelsenRuth Mickelsen• Angela Witt PrehnAngela Witt Prehn• Dorothy E. VawterDorothy E. Vawter

U of MN Center for U of MN Center for BioethicsBioethics• Debra A. DeBruinDebra A. DeBruin• Jeffrey KahnJeffrey Kahn• JP Leider JP Leider • Joan LiaschenkoJoan Liaschenko• Mary Faith MarshallMary Faith Marshall• Steven MilesSteven Miles• Elizabeth ParillaElizabeth Parilla• Carol TauerCarol Tauer• Susan WolfSusan Wolf

Scope of ProjectScope of Project

Ethical frameworks for rationing Ethical frameworks for rationing health-related resources during health-related resources during severe pandemicsevere pandemic• VaccinesVaccines• N95sN95s• MasksMasks• Antivirals (treatment and prophylaxis)Antivirals (treatment and prophylaxis)• VentilatorsVentilators

Recommendations, not mandatesRecommendations, not mandates

Pandemic: Assumptions for Pandemic: Assumptions for Severe Pandemic Severe Pandemic

Groups at riskGroups at risk• Very youngVery young• Very oldVery old• Co-morbiditiesCo-morbidities• Healthy 15-40 yr oldsHealthy 15-40 yr olds

2 sources of mortality2 sources of mortality• FluFlu• Disrupted critical infrastructuresDisrupted critical infrastructures

Guidance is context-specificGuidance is context-specific

ProcessProcess Comprehensive review of plans and Comprehensive review of plans and

literatureliterature• AW Prehn, DE Vawter. AW Prehn, DE Vawter. Ethical Guidance for Ethical Guidance for

Rationing Scarce Health-Related Resources in a Rationing Scarce Health-Related Resources in a Severe Influenza Pandemic: Literature and Plan Severe Influenza Pandemic: Literature and Plan Review Review (2008)(2008)

Convened 100+ Minnesotans to develop Convened 100+ Minnesotans to develop preliminary guidance preliminary guidance • Diverse – expert and “lay”Diverse – expert and “lay”

Community engagement (in process)Community engagement (in process)• Web-based public commentWeb-based public comment• Small groups – metro and ruralSmall groups – metro and rural

Ethical Guidance for Rationing Ethical Guidance for Rationing in Severe Pandemicin Severe Pandemic

State State GeneralGeneral AntiviralsAntivirals PPEPPE VaccinesVaccines VentilatorsVentilators

FloridaFlorida ++

New YorkNew York ++

TennesseeTennessee ++ ++ ++ ++

UtahUtah ++

WisconsinWisconsin ++ ++

As of March 2008

MN Ethical Frameworks: OverviewMN Ethical Frameworks: Overview

Statewide, public-private perspective Statewide, public-private perspective Guidance for decision-making Guidance for decision-making

• CommitmentsCommitments• PrinciplesPrinciples• GoalsGoals• StrategiesStrategies

Ethical CommitmentsEthical Commitments

Pursue common goodPursue common good• Be accountable, transparent, Be accountable, transparent,

trustworthytrustworthy• Promote solidarity, mutual responsibilityPromote solidarity, mutual responsibility• Respond fairly, effectively, efficientlyRespond fairly, effectively, efficiently

Principles and GoalsPrinciples and Goals

Protect the population’s healthProtect the population’s health• Reduce mortality and serious morbidityReduce mortality and serious morbidity

Protect public safety and civil orderProtect public safety and civil order• Reduce disruption to critical Reduce disruption to critical

infrastructuresinfrastructures• Promote public understanding and Promote public understanding and

confidence confidence

Principles and Goals Principles and Goals (cont.)(cont.) Treat people fairly, recognizing moral Treat people fairly, recognizing moral

equality of allequality of all• Reduce significant differences in Reduce significant differences in

mortality/morbiditymortality/morbidity• Remove barriers to fair accessRemove barriers to fair access• Honor reciprocity obligations to workersHonor reciprocity obligations to workers• Reduce significant differences in opportunities for Reduce significant differences in opportunities for

normal lifespannormal lifespan• Use fair processUse fair process

Principles (not goals)are co-equal; must Principles (not goals)are co-equal; must be balancedbe balanced

Strategies: GeneralStrategies: General

Do not ration based on: Do not ration based on: • Social value (gender, socio-economic Social value (gender, socio-economic

class, race, citizenship, etc.)class, race, citizenship, etc.)• Quality of lifeQuality of life• Duration of extended lifeDuration of extended life• First-come, first-servedFirst-come, first-served

Ration based on combinations of Ration based on combinations of clinical and non-clinical clinical and non-clinical considerations considerations

Key Worker StatusKey Worker Status

To reduce mortality and disruption of To reduce mortality and disruption of infrastructures infrastructures

Highest priority goes to workers with Highest priority goes to workers with additional characteristics, e.g., high additional characteristics, e.g., high exposure, risk of mortality exposure, risk of mortality

Usually prioritized simultaneously with Usually prioritized simultaneously with groups in general population, based on groups in general population, based on different considerations different considerations

Age-based Rationing?Age-based Rationing?

An alternative to random processesAn alternative to random processes Depends on broad public agreementDepends on broad public agreement

• Children before adults?Children before adults?• Younger adults before older?Younger adults before older?• Elders before others?Elders before others?

MN not alone in considering ageMN not alone in considering age• WHOWHO• US Interagency Working GroupUS Interagency Working Group

• Indiana 2006 recommendationsIndiana 2006 recommendations

A Look at One Framework:A Look at One Framework:VaccinesVaccines

De-Prioritized or Excluded De-Prioritized or Excluded

Natural immunityNatural immunity Medical contraindicationsMedical contraindications Unacceptable vaccine responseUnacceptable vaccine response Imminently and irreversibly dyingImminently and irreversibly dying Satisfactory alternative protectionsSatisfactory alternative protections

Strategies: Strategies: 2 Parallel Tracks with 6 Tiers2 Parallel Tracks with 6 Tiers

Track A: Track A: Key WorkersKey Workers

Track B: Track B: General PublicGeneral Public

Tier 1Tier 1 ++

Tier 2Tier 2 ++ ++

Tier 3Tier 3 ++ ++

Tier 4Tier 4 ++

Tier 5Tier 5 ++

Tier 6Tier 6 ++

Track A – Key WorkersTrack A – Key Workers

Tiers based on combinations of:Tiers based on combinations of:• Risk of occupational exposureRisk of occupational exposure• Risk of morbidity/mortalityRisk of morbidity/mortality• ““Irreplaceability”Irreplaceability”• Vaccine responseVaccine response

Track B – General PopulationTrack B – General Population

Tiers based on combinations ofTiers based on combinations of• Risk of morbidity/mortalityRisk of morbidity/mortality• Vaccine responseVaccine response• Possibly age (children at moderate risk Possibly age (children at moderate risk

prioritized over adults at moderate risk)prioritized over adults at moderate risk)

Moving from 2006 to Moving from 2006 to Current ProjectCurrent Project

Adjust resource-specific frameworks Adjust resource-specific frameworks to work as a package (and to to work as a package (and to coordinate with comprehensive plan)coordinate with comprehensive plan)• Don’t systematically disadvantage (or Don’t systematically disadvantage (or

advantage) any groupadvantage) any group More attention to occupational More attention to occupational

exposure riskexposure risk Possibility of age-based rationing Possibility of age-based rationing

(esp. prioritizing kids)(esp. prioritizing kids)

Fit with Feds?Fit with Feds?

2005 HHS guidance for 2005 HHS guidance for moderatemoderate pandemicpandemic

Proposed federal guidance for severe Proposed federal guidance for severe pandemic:pandemic:• Multiple goals, tracks and tiersMultiple goals, tracks and tiers• Protects infrastructuresProtects infrastructures• Prioritizes children before adults in some Prioritizes children before adults in some

circumstancescircumstances• Attends less to differences in response and Attends less to differences in response and

availability of alternative protectionsavailability of alternative protections• Attends to homeland security and national Attends to homeland security and national

defense goalsdefense goals

Draft ReportsDraft Reports DE Vawter, JE Garrett, AW Prehn, et al. DE Vawter, JE Garrett, AW Prehn, et al. For For

the Good of Us All: Ethically Rationing Health the Good of Us All: Ethically Rationing Health Resources in Minnesota in a Severe Influenza Resources in Minnesota in a Severe Influenza Pandemic: Preliminary Report Pandemic: Preliminary Report (2008)(2008)

DA DeBruin, E Parilla, J Liaschenko, et al. DA DeBruin, E Parilla, J Liaschenko, et al. Implementing Ethical Frameworks for Implementing Ethical Frameworks for Rationing Scarce Health Resources in Rationing Scarce Health Resources in Minnesota During Severe Influenza Pandemic Minnesota During Severe Influenza Pandemic (2008)(2008)

Available (soon) at www.stolaf.edu/mnethx Available (soon) at www.stolaf.edu/mnethx and www.bioethics.umn.edu and www.bioethics.umn.edu

Next StepsNext Steps

Public comment (web-based)Public comment (web-based)• Watch www.stolaf.edu/mnethx or Watch www.stolaf.edu/mnethx or

www.bioethics.umn.edu www.bioethics.umn.edu Public engagement pilotPublic engagement pilot

• Small groupsSmall groups• Metro, ruralMetro, rural

For more informationFor more information

Ellie Garrett Ellie Garrett MN Center for Health Care EthicsMN Center for Health Care Ethics

garrette@stolaf.edu garrette@stolaf.edu

(612) 964-9425(612) 964-9425 Contact info for other team members:Contact info for other team members:

www.stolaf.edu/mnethx or www.stolaf.edu/mnethx or www.bioethics.umn.eduwww.bioethics.umn.edu