Relative change in transplant data

1

1.5

2

2.5

1995

1997

1999

2001

2003

2005

2007

Chan

ge re

lativ

e to

199

5 ba

selin

e

Deaths and Wait List Removals

Deceased Donors

Wait List

7,984

101,043

9,048

What To Do?What To Do?

All efforts so far: nibbling at the edges Dramatic, effective change is needed If there are insufficient volunteers to work

construction atop skyscraper as diplomat in dangerous 3rd world country other undesirable jobs

How do we volunteers? We pay them more

All efforts so far: nibbling at the edges Dramatic, effective change is needed If there are insufficient volunteers to work

construction atop skyscraper as diplomat in dangerous 3rd world country other undesirable jobs

How do we volunteers? We pay them more

Financial Incentives (FI)Financial Incentives (FI)

We should make all reasonable efforts to organ donation

“reasonable” defined by evidence, not by emotions

study FI for deceased donations w pilot studies FI not intrinsically unethical (benefits:harms) pilot studies can measure benefits:harms pilot studies in limited area (1 state or small group)

Change NOTA, based on high benefits/harms

FI highly effective in every sector of economy b/c they expand options in personal lives

We should make all reasonable efforts to organ donation

“reasonable” defined by evidence, not by emotions

study FI for deceased donations w pilot studies FI not intrinsically unethical (benefits:harms) pilot studies can measure benefits:harms pilot studies in limited area (1 state or small group)

Change NOTA, based on high benefits/harms

FI highly effective in every sector of economy b/c they expand options in personal lives

Reasons Not to DonateReasons Not to Donate

Desire to bury body intact (religion, own belief) Avoidance of confronting loss, own mortality Distrust of medical community Belief that allocation is not equitable Misunderstanding of tx effectiveness Lack of understanding of brain death Stresses at time of sudden unexpected death

Desire to bury body intact (religion, own belief) Avoidance of confronting loss, own mortality Distrust of medical community Belief that allocation is not equitable Misunderstanding of tx effectiveness Lack of understanding of brain death Stresses at time of sudden unexpected death

NOTA Allows 1 Reason to DonateNOTA Allows 1 Reason to Donate

The sole permissible incentive: Service to others (altruism)

The sole permissible incentive: Service to others (altruism)

Objections to FI for Deceased DonorsObjections to FI for Deceased Donors

Main objections: FI Will Harm/Benefit, Organ Donation FI will undermine social fabric

dilute desirable spirit of altruism commodify human body parts introduce coercion, voluntariness

Main objections: FI Will Harm/Benefit, Organ Donation FI will undermine social fabric

dilute desirable spirit of altruism commodify human body parts introduce coercion, voluntariness

FI

Will

Harm/Benefit:

Organ

Donation

FI

Will

Harm/Benefit:

Organ

Donation

Donation b/c $$$ anger/insult BUT, ppl familiar w payment for valuable goods We can measure this in pilot study

Donation b/c $$$ anger/insult BUT, ppl familiar w payment for valuable goods We can measure this in pilot study

Impulse to do good not binary (all-or-none) most ppl part altruist, part self-interested FI might add enough motivation to persuade

Motivation variable, law blunt instrument FI: token of societal gratitude (=tax incentives) Level of social cohesion measurable!

Impulse to do good not binary (all-or-none) most ppl part altruist, part self-interested FI might add enough motivation to persuade

Motivation variable, law blunt instrument FI: token of societal gratitude (=tax incentives) Level of social cohesion measurable!

FI

Will

Undermine

Social

Fabric:

Dilute

Desirable

Spirit

of

Altruism

FI

Will

Undermine

Social

Fabric:

Dilute

Desirable

Spirit

of

Altruism

Donors of blood and other tissues paid no compelling ethical distinction from organs

Donation implies property rights in organs “One cannot give away what one does not own any more

than one can sell it” (AMA 1995) Recipients pay for organs—only the donor does not

benefit financially! Type of FI & $ amt regulated, no organ bazaar

Donors of blood and other tissues paid no compelling ethical distinction from organs

Donation implies property rights in organs “One cannot give away what one does not own any more

than one can sell it” (AMA 1995) Recipients pay for organs—only the donor does not

benefit financially! Type of FI & $ amt regulated, no organ bazaar

FI

Will

Undermine

Social

Fabric:

Commodify

Human

Body

Parts

FI

Will

Undermine

Social

Fabric:

Commodify

Human

Body

Parts

Informed consent must be voluntary FI more likely poor to donate, so

burden of donation on poor un =, unfair Circumstances of poor make FI coercive BUT, well-off don’t clean toilets, pick berries

we don’t ban toilets and berries we allow free choice, make conditions safe

What is coercion? In context of free society: Forcing others to do what they would not otherwise

do. So FI not coercive.

Informed consent must be voluntary FI more likely poor to donate, so

burden of donation on poor un =, unfair Circumstances of poor make FI coercive BUT, well-off don’t clean toilets, pick berries

we don’t ban toilets and berries we allow free choice, make conditions safe

What is coercion? In context of free society: Forcing others to do what they would not otherwise

do. So FI not coercive.

FI

Will

Undermine

Social

Fabric:

Coercion

Voluntariness

FI

Will

Undermine

Social

Fabric:

Coercion

Voluntariness

FI not intrinsically unethical FI acceptable when benefits/harms positive

every fear about FI based on assumptions yet, effects of fears about FI measurable no good reason to prohibit pilot study of FI policy/law then based on evidence, not emotion

Pilot studies must be ethically designed sound science, measurable outcomes, set time FI moderate value, lowest level to donation FI only for deceased donors, not living no buying organs: allocation by UNOS algorithms

FI not intrinsically unethical FI acceptable when benefits/harms positive

every fear about FI based on assumptions yet, effects of fears about FI measurable no good reason to prohibit pilot study of FI policy/law then based on evidence, not emotion

Pilot studies must be ethically designed sound science, measurable outcomes, set time FI moderate value, lowest level to donation FI only for deceased donors, not living no buying organs: allocation by UNOS algorithms

InferencesInferences

FI for Pilot Studyfor SC or Region 11

FI for Pilot Studyfor SC or Region 11

Examples, (likely) most to least effective: Deposit of $1,000-5,000 into donor’s estate Estate tax credit $10,000 Funeral expenses up to $5,000

Examples, (likely) most to least effective: Deposit of $1,000-5,000 into donor’s estate Estate tax credit $10,000 Funeral expenses up to $5,000

The case for FI fundamentally a moral one: Which is morally preferable:

prohibit FI because society might degenerate or more poor might choose to donate

offer $1,000-5,000 and save up to 8 lives for every new donor

The case for FI fundamentally a moral one: Which is morally preferable:

prohibit FI because society might degenerate or more poor might choose to donate

offer $1,000-5,000 and save up to 8 lives for every new donor

Relative change in transplant data

1

1.5

2

2.5

1995

1997

1999

2001

2003

2005

2007

Chan

ge re

lativ

e to

199

5 ba

selin

e

Deaths and Wait List Removals

Deceased Donors

Wait List

7,984

101,043

9,048

A Final WordA Final Word

“We have never encountered a single policy more at odds with public welfare than the current [altruism-only] organ procurement policy in the United States . . . If the current policy is maintained, the shortage will continue to grow worse, as will the needless suffering.

“We have never encountered a single policy more at odds with public welfare than the current [altruism-only] organ procurement policy in the United States . . . If the current policy is maintained, the shortage will continue to grow worse, as will the needless suffering.

--Blair and Kaserman, Yale Journal of Regulation, 1991--Blair and Kaserman, Yale Journal of Regulation, 1991

Rapid Organ Recovery Ambulances Update

Last Updated: Thu, 11/19/2009 - 1:57pm

 

Early in 2008, Judicial Watch initiated an investigation of a government sponsored organ procurement program. The program, known as Rapid Organ Recovery Ambulances (RORA), was administered in New York City and received funding from the Health Resources and Services Administration of the Department of Health and Human Services. As highlighted in a June blog series, the program breached ethical and medical standards, discriminately targeted minorities, and raised institutional credibility questions.

As part of its investigation, Judicial Watch sued the Fire Department of New York (FDNY) and reached a favorable settlement after FDNY obfuscated transparency by not disclosing related records. Following its publications on this dubious program, Judicial Watch continued to follow-up to receive the actual program data. Judicial Watch recently received some additional documents that further shed light on the program and demonstrate the power of public exposure.

Many of the program goals for which RORA was funded have yet to be met. As noted in a previous blog entry, the ethical White Paper that was slated to be written by February 2008 has yet to be written as of October 2009. According to HRSA's letter, data from the ambulance and procurement activities have yet to be gathered as “there have been no ambulance or EMS dispatches for rapid organ recovery.” On one hand, readers should be relieved that the program has yet to actually be put into action. On the other hand, however, the US government provided millions of dollars based on a proposal that was not fully carried out. The documents provided do not demonstrate that HRSA stopped funding RORA even after the White Paper was not provided. The documents further do not demonstrate where the money actually went

…

http://www.judicialwatch.org/foiablog/2009/nov/rapid-organ-recovery-ambulances-update.

Rapid Organ Recovery Ambulances Update

Last Updated: Thu, 11/19/2009 - 1:57pm

 

Early in 2008, Judicial Watch initiated an investigation of a government sponsored organ procurement program. The program, known as Rapid Organ Recovery Ambulances (RORA), was administered in New York City and received funding from the Health Resources and Services Administration of the Department of Health and Human Services. As highlighted in a June blog series, the program breached ethical and medical standards, discriminately targeted minorities, and raised institutional credibility questions.

As part of its investigation, Judicial Watch sued the Fire Department of New York (FDNY) and reached a favorable settlement after FDNY obfuscated transparency by not disclosing related records. Following its publications on this dubious program, Judicial Watch continued to follow-up to receive the actual program data. Judicial Watch recently received some additional documents that further shed light on the program and demonstrate the power of public exposure.

Many of the program goals for which RORA was funded have yet to be met. As noted in a previous blog entry, the ethical White Paper that was slated to be written by February 2008 has yet to be written as of October 2009. According to HRSA's letter, data from the ambulance and procurement activities have yet to be gathered as “there have been no ambulance or EMS dispatches for rapid organ recovery.” On one hand, readers should be relieved that the program has yet to actually be put into action. On the other hand, however, the US government provided millions of dollars based on a proposal that was not fully carried out. The documents provided do not demonstrate that HRSA stopped funding RORA even after the White Paper was not provided. The documents further do not demonstrate where the money actually went

…

http://www.judicialwatch.org/foiablog/2009/nov/rapid-organ-recovery-ambulances-update.

Donation-procurement stepsDonation-procurement stepsTake referral callAssess potential donorTalk with family, request donationManage donor in ICU Place organs (UNOS algorithm)Move donor to OR, manage surg teamsPackage, ship organsComplete all paperwork

Take referral callAssess potential donorTalk with family, request donationManage donor in ICU Place organs (UNOS algorithm)Move donor to OR, manage surg teamsPackage, ship organsComplete all paperwork

Basic strategy: division of labor, specialized personnel

Basic strategy: division of labor, specialized personnel

Family Support Counselor (counseling, nursing) emotional support education (brain death, value of tx)

Nurse Clinician (ICU nurse) manage donor in ICU

Organ Recovery Coordinator (OR nurse/tech) manage donor in OR, distribute organs

Clinical Services Liaison (business PR/sales) staff education record review

Aftercare Counselor (counseling) follow-up counseling, support groups, satisfaction surveys

Family Support Counselor (counseling, nursing) emotional support education (brain death, value of tx)

Nurse Clinician (ICU nurse) manage donor in ICU

Organ Recovery Coordinator (OR nurse/tech) manage donor in OR, distribute organs

Clinical Services Liaison (business PR/sales) staff education record review

Aftercare Counselor (counseling) follow-up counseling, support groups, satisfaction surveys

HRSA Transplant Center Growthand Management Collaborative

HRSA Transplant Center Growthand Management Collaborative

Best Practices Evaluation (2003-2007) Institutional Vision And Commitment Dedicated Team Aggressive Clinical Style Patient And Family Centered Care Aggressive Management of Performance

Outcomes

Best Practices Evaluation (2003-2007) Institutional Vision And Commitment Dedicated Team Aggressive Clinical Style Patient And Family Centered Care Aggressive Management of Performance

Outcomes

Donation Rate by Year

Year

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Don

ors

per

mill

ion

of p

opul

atio

n

0

10

20

30

40

50

60

All OPO's

Lifepoint 2 S.D.

Origin of Prohibition of FIOrigin of Prohibition of FI

UAGA 1968: no ban on selling/buying Cyclosporine tested 1979, clin use 1982 Tx rapidly → growth industry Organ entrepreneurs NOTA 1984: no “valuable consideration”

harms of pmnt substantially outweigh benefits Benefits:harms has changed in last 20 yrs

UAGA 1968: no ban on selling/buying Cyclosporine tested 1979, clin use 1982 Tx rapidly → growth industry Organ entrepreneurs NOTA 1984: no “valuable consideration”

harms of pmnt substantially outweigh benefits Benefits:harms has changed in last 20 yrs

Sources of Organs for TxSources of Organs for Tx

Deceased donors (brain death) Living donors Donors after cardiac death Xenografts De novo organs (regenerative technologies)

Deceased donors (brain death) Living donors Donors after cardiac death Xenografts De novo organs (regenerative technologies)

Greatest potential gain with least ethical controversy