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www.bradford.ac.uk/management Researching Transplantation Ethics in Medical Law Lisa Cherkassky LLB, PGCE(PCE), LLM, PGC(HEP).

Www.bradford.ac.uk/management Researching Transplantation Ethics in Medical Law Lisa Cherkassky LLB, PGCE(PCE), LLM, PGC(HEP)

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www.bradford.ac.uk/management

Researching Transplantation Ethics in Medical Law

Lisa Cherkassky LLB, PGCE(PCE), LLM, PGC(HEP).

Why Medical Law?

...and why transplantation?

• Interest & boredom• PhD?• Transplants = death!• “Law & ethics”• Topical & current• Useful & general knowledge

Overview of Research (1/2)Works published:

• Cherkassky, L. “Rational rejection? The ethical complications of assessing organ transplant candidates in the UK and the USA.” [2010] Journal of Law and Medicine, vol. 18 (1).

• Cherkassky, L. “Does the U.S. do it better? A comparative analysis of liver allocation protocols in the United Kingdom and the United States.” [2011] Cambridge Quarterly of Healthcare Ethics, vol.20(3).

• Cherkassky, L. “Presumed consent in organ donation: is the duty finally upon us?” [2010] European Journal of Health Law, vol. 17(2), 149.

Overview of Research (2/2)

Works under review:

• “Economy or Morality? The Secret World of Liver Transplant Candidate Assessment.” (under review).

• “Assessment of mentally-ill (liver) transplant candidates in the UK.” (under review).

• “Smoke and mirrors: the power of transplant teams in the USA.” (under construction).

Lessons learnt (1/3)

NHS Blood and Transplant (www.nhsbt.nhs.uk)

Patients waiting for organ: 7,977 Transplants between April 2009-March 2010: 3,709

The United Network for Organ Sharing (www.unos.org) administer the Organ Procurement and Transplantation Network (www.transplantliving.org).

Patients waiting for organ: 108,948 Transplants January – June 2010: 14,141

Lessons learnt (2/3)

Transplantation happens in two stages:

1: Patient assessment

2: Organ allocation on waiting list

Lessons learnt (3/3)

Utilitarianism: The greatest good for the greatest number.

Rights-based ethics: Everybody has a equal right to resources.

Duty-based ethics: We have a moral duty to treat those in urgent need.

Virtue-based ethics: Altruism rewarded, immoral and self-inflicted behaviour judged.

1. “Rational rejection? The ethical complications of assessing organ transplant candidates in the UK and the USA.” [2010] Journal of Law and Medicine, vol. 18 (1).

• The “best bet” principle;• The “need” principle;• The “moral worth” principle.

Question: “on what moral grounds do transplant teams justify their controversial decisions?”

Answer: “best bet” undercuts “best interests”.

2. ““Does the U.S. do it better? A comparative analysis of liver allocation protocols in the United Kingdom and the United States.” [2011] Cambridge Quarterly of Healthcare Ethics, vol. 20(3).

• Allocation policies:– UK liver allocation;

– US liver allocation;

• Comparative analysis.

Question: “who better meets the best interests of transplant patients?”

UK: ‘Super Urgent’ v ‘Rotation Sequence’– ‘Super Urgent’ factors: blood group, time of registration.

– ‘Elective’ factors: zone then blood match, quality, pressures.

US: ‘Status 1A’ or ‘MELD’ score– ‘Status 1A’ factors: urgency, blood group, waiting time, donor size.

– ‘MELD’ factors: urgency, blood group, waiting time, donor size.

U.K. v U.S. Liver Allocation

Dr Alexander Gimson, Chair of the U.K. Liver Advisory Group, has advised that a new strategy is being piloted:

“For various reasons the [Sequence] may be a dissatisfactory allocation system. For this reason, we are developing a new universal Liver Transplant Allocation Scheme for the United

Kingdom. We will be testing in a real time simulation model the benefit of allocating organs on the basis of need, utility and finally

on the basis of transplant benefit the number of net life years gained from transplantation”.

2. ““Does the U.S. do it better? A comparative analysis of liver allocation protocols in the United Kingdom and the United States.” [2011] Cambridge Quarterly of Healthcare Ethics, vol. 20(3).

• Allocation policies:– UK liver allocation;

– US liver allocation;

• Comparative analysis.

Question: “who better meets the best interests of transplant patients?”

Answer: “the U.S. via MELD scoring system, but...”

3. “Presumed consent in organ donation: is the duty finally upon us?” [2010] European Journal of Health Law, vol. 17(2), 149.

• Organ Donation (Presumed Consent) Bill of 2009;• Organ Donation Taskforce 2008;• “Procedural” difficulties;• “Ethical” difficulties;• “General” concerns;• Suggested amendments.

Question: “is it feasible to impose the opt-out system into UK law?”

Answer: “yes”.

4. “Economy or Morality? The Secret World of Liver Transplant Candidate Assessment.” (under review).

• Department of Health Standards;• NHS Blood and Transplant Protocols.

Question: “is the candidate assessment process fair and ethical to transplant candidates?”

The Truth About Assessment

Reality:

Starkly different approaches when regulating MDT’s and patient assessment methods.

‘Difficult ethical decisions’

Stage two

Stage one

Transplant Teams

Who are they?– transplant surgeons, – anaesthetists, – hepatologists, – microbiology clinician, – transplant nurses, – dietician, – psychiatric nurse, – social worker,– Insurance case manager (U.S.)

Purpose? Task?

4. “Economy or Morality? The Secret World of Liver Transplant Candidate Assessment.” (under review).

• Department of Health National Standards 2005;• NHSBT “general” protocols 2009;• NHSBT “alcoholic” candidates 2005;• NHSBT “drug user” candidates 2009.

Question: “is the secret world of candidate assessment fair and ethical to transplant candidates?”

The Truth About AssessmentDepartment

of HealthNHSBT General

NHSBT Alcohol

NHSBT Drug

5 year / 50% rule 5 year / 50% rule and quality of life/anti-social

Specialist in substance misuse

Specialist in substance misuse

Psychiatric liaison nurse for difficult patients

Must assess undefined “risk factors”

Substance use in “wider social network”

Physical and psychological assessment

Rejection: past non-compliance or relapse

Rejection: failure to comply with assment/treatmt

Second opinion at another centre

Second opinion at another centre

New: potential contraindications

4. “Economy or Morality? The Secret World of Liver Transplant Candidate Assessment.” (under review).

• Department of Health National Standards 2005;• NHSBT “general” protocols 2009;• NHSBT “alcoholic” candidates 2005;• NHSBT “drug user” candidates 2009.

Question: “is the secret world of candidate assessment fair and ethical to transplant candidates?”

Answer: “not in a million years – no benchmarks or

objective, measurable criteria - total discretion”.

5. “Assessment of mentally-ill (liver) transplant candidates in the UK.” (under review).

• Department of Health National Standards 2005;• NHSBT “general” protocols 2009;

– 5 year / 50% rule.

Question: “are mentally ill transplant candidates assessed fairly, objectively, and provided with adequate safeguards against discriminatory decisions?”

Answer: “not a trace of fairness – no benchmarks, no criteria,

no consistency, no objectivity - total discretion”.

Della Burnside, NHS Blood and Transplant’s Chair of the Transplant Policy Review Committee:

“The decision is pragmatic and depends on the likelihood of a good quality outcome, with compliance to treatment and follow-up that

is necessary to maintain good graft function and a return to health. A person who has an unrecognised episode of depression

which was not treated but leads to an overdose would not be a barrier to transplantation, whereas a person with severe

depression that had not responded to full treatment and left the patient suicidal may contra-indicate transplantation”.

Conclusion

• Department of Health play a minimum role; maximum discretion afforded to NHS Blood and Transplant when developing policies;

• Stage 1 (assessment) is largely unregulated and conducted in private with little consistency, measurable clinical criteria, safeguards or redress against discrimination;

• Stage 2 (allocation) is largely procedural and impartial;• Particular groups of candidates are inevitably discriminated against

because we have a shortage of resources.

What Else?

Piece 1: 7,984 words;

Piece 2: 7,491 words;

Piece 3: 8,918 words;

Piece 4: 7,708 words;

Piece 5: 3,837 words; ...35,938 words 2010 (year 1).

Medical law textbook (9 chapters);

Palgrave MacMillan, publication 2012/2013;- Mental Health Law.