Dead, or dead enough?

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Dead, or dead enough?

• Jay M. Baruch, MD
• Center for Biomedical Ethics
• Brown Medical School

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'In this world nothing is certain but ...uh
taxes. Benjamin Franklin (2003)
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Case

• A body declared dead by brain death criteria was
  scheduled to be taken to the OR for organ
  procurement. Because he was infected with MRSA,
  the patient was no longer considered a suitable
  donor candidate and procurement was called off.
  The respiratory therapist was unsure what to do
  next. He didnt feel comfortable shutting off the
  ventilator without an order from the ICU
  resident. He was told to shut it off, the patient
  was dead. The respiratory therapist insisted on a
  written order.

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Case

• A patient suffering from terminal heart failure
  receives a heart transplant from a 25-year-old
  woman struck by a car. She was declared brain
  dead. Her father consented to organ donation. The
  patient was placed on a ventilator. The surgeon
  in charge of the transplant also supervised the
  medical team managing the young woman. Her death
  occurred when the ventilator was shut off, thus
  causing her heart to stop. After waiting a few
  minutes, the heart was removed and
  transplantation surgery begun.

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First heart transplant-December 3, 1967

• Dr. Christiaan Barnard
• Fanfare and publicity
• Ethical inquiry
• No standardized brain death criteria
• Was patient dead using cardiac criteria?
• Was death hastened by heparin and regitine?
• Conflict of interest
• Ghoul factor

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Why talk about death?

• Transplantation is both life-saving and death
  ridden.
• Renee Fox
• Something must happen to one person for another
  to be saved
• Complex relationship between organ
  transplantation, death determination and
  definition, and decisions to limit or withdraw
  treatment

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Organ donation and death

• Until 1960s, little controversywe died all at
  once
• What changed?
• Life prolonging (or death prolonging) technology
• Organ donation
• What signs of life important that their loss
  constitutes death?
• Boundary issues
• Life and death, allowing to die and killing,
  medical progress and hubris
• Is there single critical point where social
  behaviors associated with death begins?

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What do we mean by death?

• Dead donor rule (Late 1960s and early 1970s)
• Life-sustaining organs must never be removed
  before donor declared dead
• Donors can not be killed for the purpose of
  obtaining their organs
• Uniform Anatomic Gift Act (1968)
• Patients over 18 years of age can designate
  organs to be donated for transplantation after
  legally declared dead
• Harvard Brain Death Criteria (1968)
• irreversible cessation in cardiopulmonary
  function
• irreversible cessation of all brain function,
  including cortex and brainstem.
• Uniform Determination of Death Act (1981)
• recognized both criteria for declaring death
  described by Harvard Committee
• All states have legislation recognizing both

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Organ donation Ethical concepts at stake

• Respect for individual autonomy and liberty
• Informed consent
• Avoid commodification of patients/bodies
• Treatment of persons as ends unto themselves, not
  means to satisfy ends of others
• Dignity for dying patients and their families
• Beneficence
• Nonmaleficience
• Utilitarian principle of greatest good for the
  greatest number
• Conflicts of interest
• Public trust in medical profession
• (allocation and justice issuesanother session
  entirely!!)

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Brain death

• Well settled and persistently unresolved.
• Capron AM. N Engl J Med 20013441244-1246
• Fails to correlate with any biological or
  philosophical understanding of death.
• Does death of brain equal death of organism?
• Irreversible loss of cerebral cortex vs whole
  brain
• Structural vs. functional integrity

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Harvard Ad Hoc Committee to Examine the
Definition of Brain Death

• Operational criteria confusing-- irreversible
  coma not brain death
• Clinical picture
• Heart beat
• Skin warm and well-perfused
• Breathing
• Functioning vital organs
• Capable of somatic growth
• Capable of reproduction
• Conceptual disarray-- terminally ill, not dead
• 1985 Pelle Lindbergh Flyers star declared brain
  dead
• In same article, terms like critical condition
  and near death.

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Why are brain dead patients dead?

• Receive treatment
• Brain dead patient may receive CPR if heart stops
• Anesthesia
• Ambiguous language
• More than a corpse
• Beating heart cadaver?
• Neomort?
• New nursing rituals

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Non-heart beating cadaveric donation (NHBCD)

• Irreversible cessation of heart, lung, and brain
  function
• Abandoned since early 1970s with adoption of
  brain death criteria
• organs from brain-dead donors had better survival
• Refocus on NHBCD because families of
  near-brain-dead patients frustrated at not being
  able to donate.
• Reduce warm ischemia, organs need to be removed
  quickly
• Timing of death important
• Tension between maximizing organ viability and
  satisfying the dead donor rule

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NHBCD two clinical situations

• Controlled
• Patient or family has refused life-sustaining
  treatment, opted to withdraw life support and
  consented to organ donation after death
• Uncontrolled
• Organ procurement follows sudden and
  unanticipated cardiopulmonary arrest and failed
  resuscitation measures

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Uncontrolled NHBCD Consent

• Femoral cannulation and perfusion as soon as
  possible to reduce warm ischemia time
• Can perfusion precede permission for organ
  procurement?
• What can be done to the body before without
  permission of family?

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Tip-toeing around explicit consent

• Consent for perfusion donation after perfusion
  begun
• Regional Organ Bank of Illinois, after refused
  permission for cannulation in 35 cases, undertook
  preservative infusion without family consent
• Justification?? Non-deforming, non-mutilating--thu
  s not required
• Six of seven families consented to donation
• Ethically problematic performing invasive
  procedures on dying patients without consent
• Consent to practice invasive procedures on
  recently dead
• Disrespectful to persons or bodies
• Ignore families wishes
• Compromises trust in medical profession
• Religious objections

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Ethics of pre-precurement treatment?

• Drugs given before withdrawal of life support to
  improve preservation of organs may shorten life
  of dying donor
• Drugs given for benefit of another
• Doctrine of double effect

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Rule of double effect

• Effects that would be morally wrong if caused
  intentionally are permissible if foreseen but
  unintended
• Roman Catholic theologians in Middle ages
• What do you do when cant avoid all harmful
  actions
• Four conditions
• Goal is good or morally neutral
• Intend good effect
• Cant get good effect through bad effect
• Proportionality

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Controlled NHBCD Pittsburgh Protocol (1993)

• Critical symbolic leap linked planned death of
  one person to procurement of organs for another
• Controlled time and place that death occurred
  (OR)
• 2 minutes of circulatory arrest before death
  certified
• Families must decide to withdraw life support
• Death declared by MD unaffiliated with
  procurement
• Clear separation between medical team treating
  patient and organ recovery team
• Documentation requirements for auditing purposes
• Lay community involved in policy development
• Ethics consultation before procurement

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Speilman B, McCarthy CS. Beyond Pittsburg
protocols for controlled non-heart-beating
cadaver organ recovery. Kennedy Inst Ethics J
1995 5323-333.

• Several centers without policies addressing key
  features such as timing of death after cardiac
  arrest
• Conflicts of interest
• single procurement coordinator acting on behalf
  of donor AND recipient
• procurement organizations collaborated with
  doctors on use of medications for patient
  suffering
• All but three DID NOT allow families to be
  present at time of death
• More than half did not use ethics committees or
  consultants during protocol development.
• April 1997 60 minutes reported organs being
  removed before they were actually dead.
• One month later requested report from IOM

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Institute of Medicine reports-1997 and 2000

• Supported NHBCDs
• Criticized national procurement organizations for
  incomplete and inconsistent protocols
• Need for written, standardized protocols
• No center should undertake NHBCD program until
  policies and procedures that address palliative
  care and withdrawal of LST
• 5-minute observation time after asystole
• Ethics consultation critical to protocol
  development, implementation and review
• Must address donor eligibility and criteria for
  declaring death.
• Recognize relevant conflicts of interest and set
  preventative safeguards

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Is the NCHCD really dead?

• Empirical issues When is asystole reversible?
• How long must one wait? Unclear clinical data
• Pittsburgh protocol 2 minutes
• Institute of Health report 5 minutes
• Conceptual problems Meaning of irreversibility
• Autoresuscitation vs. cardioversion
• Cannot be restarted
• Will not be restarted because decision made not
  to
• Public anxiety about being prematurely declared
  dead

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Youngner S, Arnold R, DeVita M. When is death?
Hastings Center Report 199929 14-21.

• ICU patient A, potential NHBCD refuses CPR
• ICU patient B, not a donor, willing to undergo
  CPR
• Under many NHBOD protocols, five minutes after
  CPR, patient A is dead whereas patient B is not,
  because CPR could possibly restore spontaneous
  circulation.
• Imply patient A wasnt really dead when death
  certified.
• Take ICU patient C, who refuses CPR and organ
  donation. In many ICUs, C would be certified dead
  in less than two minutes of pulselessness and
  asystole on cardiac monitor.
• Using this comparison, if potential NHBCD are to
  treated like other ICU patients, observation time
  to death certification should be much shorter.

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Critical issuescardiopulmonary definition of
death

• Is it functioning of heart and lungs?
• Patients whose lungs are supported with
  ventilators are alive
• Patients on ECMO or with artificial heart are
  considered alive.

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NCHBD and the brain

• Is brain tissue dead at exact moment of
  irreversible cardiac death?
• Is cardiac death significant, or really a proxy
  for loss of brain function, the one that really
  matters? (Bernat et al. HCR 1219825-9)

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Source of public ambivalence and confusion

• Time interval to determine death
• Fears of premature declaration
• Is consensus on time interval to death really
  important?
• Conceptual disarray of brain death
• Cognitive dissonance
• Lack of clarity among medical professionals

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Public ambivalence and confusion (cont)

• Minority and vulnerable communities
• Marginalized by health care profession
• Doubts about definitions of irreversibility
• Competing needs
• Concerns about unfair distribution of organs
• Religious groups
• Suspicion of secular, scientific definitions of
  death
• Orchestrated nature of death controlled NHBD
• Ventilator withdrawal, artificial setting
• Moral nature of decision itself, confusion with
  euthanasia
• Utilitarian benefits vs dignity of dying and
  sanctity of life

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Public ambivalence and confusion (cont)

• Transplantation surgery
• Awe of surgeons on frontiers of science vs
  visceral fear of removing organs and putting them
  in others
• Novels and movies tap into fears of persons
  exploited for morally questionable ends

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Truog RD, Robinson WM. Role of brain death and
the dead-donor rule in the ethics of organ
transplantation. Critical Care Medicine 2003(31)

• Plagued with inconsistencies and contradictions
• Wide range of definitions of death proposed,
  each with its own strengths and weaknesses
  depending on medical and social context. But it
  is clear we will never be able to choose between
  these on the basis of scientific knowledge
  alone.
• Alternative view based not on brain death and
  dead-donor rule, but ethical principles of
  nonmaleficence and respect for persons.
• Individuals who desire to donate their organs and
  who are either neurologically devastated or
  imminently dying should be allowed to donate
  their organs, without being first declared dead.
• The difficult question What is death? replaced
  by equally difficult question, When are patients
  sufficiently close to death or sufficiently
  neurologically impaired that they can choose to
  be an organ donor?

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Practical questions for NHBCD policy

• How is discussion about organ donation initiated
  and when?
• Which patients can be NHCBDs?
• Protect vulnerable persons
• Withdrawal of LST will lead predictably/quickly
  to death.
• Mechanisms if death prolonged
• Informed consent
• Withdrawal of LST separate from organ procurement
• Procedures performed prior to death
• Consent can be withdrawn anytime

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Practical concerns for NHBCD protocols?

• Care of dying patient
• Protocol designate individuals who may withdraw
  care
• Family supportallowances for grieving process
• Comfort measures, including pain management
• Measures that intentionally hasten death
  prohibited
• Femoral cannulation without consent?
• Use of vasodilators or anticoagulants
• When are donors dead?
• Conflicts of interest for professionals and
  institutions eliminated
• Support for medical staff
• Are unethical and illegal practices preventable?

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Ethics in Medical Progress, with Special
Reference to Transplantation (1966)

• this symposium was planned because of the
  growing realization that progress in medicine
  brings in its train ethical problems which are
  the concern not only of practicing doctors but of
  the whole community, and which are unlikely to be
  solved without intensive study of an
  interdisciplinary kind.
• Opening remarks, Michael Woodruff, transplant
  surgeon at University of Edinburgh