Download Slide 1

Researching Transplantation
Ethics in Medical Law
Lisa Cherkassky
LLB, PGCE(PCE), LLM, PGC(HEP).
www.bradford.ac.uk/management
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:
2: Organ allocation
on waiting list
1: Patient
assessment
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?”
U.K. v U.S. Liver Allocation
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.
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:
Stage one
‘Difficult ethical
decisions’
Stage two
Starkly different approaches when regulating MDT’s and patient
assessment methods.
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 Assessment
Department
of Health
NHSBT
General
NHSBT
Alcohol
NHSBT
Drug
5 year / 50% rule 5 year / 50% rule Specialist in
and quality of
substance
life/anti-social
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 New: potential
at another centre 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.