Rela%ve change in transplant data Change rela%ve to 1995 baseline Wait List 101,043 9,048 Deaths and Wait List Removals 7,984 Deceased Donors 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 3 rd world country other undesirable jobs How do we volunteers? We pay them more 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 1
Reasons 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 NOTA Allows 1 Reason to Donate The sole permissible incentive: Service to others (altruism) Objections to FI for Deceased Donors Main objections: FI Will Harm/Benefit, FI will undermine social fabric dilute desirable spirit of altruism commodify human body parts introduce coercion, voluntariness Organ Donation 2
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 FI Will Undermine Social Fabric: Dilute Desirable Spirit of Altruism 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: Commodify Human Body Parts 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 3
FI Will Undermine Social Fabric: Coercion Voluntariness 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. Inferences 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 for Pilot Study for 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 4
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 Rela%ve change in transplant data Change rela%ve to 1995 baseline A Final Word Wait List 101,043 We have never encountered a single policy more at 9,048 odds with public welfare than the current [altruismonly] organ procurement policy in the Wait United List Removals Deaths and States... If the current policy is maintained, the shortage will continue to grow worse, as will the needless suffering. 7,984 Deceased Donors --Blair and Kaserman, Yale Journal of Regulation, 1991 5
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 followup 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 steps Take referral call Assess potential donor Talk with family, request donation Manage donor in ICU Place organs (UNOS algorithm) Move donor to OR, manage surg teams Package, ship organs Complete all paperwork 6
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 HRSA Transplant Center Growth and 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 60 Donation Rate by Year Donors per million of population 50 40 30 20 10 All OPO's Lifepoint 2 S.D. 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year 7
Origin 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 Sources of Organs for Tx Deceased donors (brain death) Living donors Donors after Greatest cardiac potential death gain with least ethical controversy Xenografts De novo organs (regenerative technologies) 8