From a letter from Not Dead Yet dated January 3, 2012 to John R. Lake, M.D. President, Board of Directors OPTN/UNOS, 700 N. 4th St. Richmond, VA 23218
Dear Dr. Lake:
Thank you for notifying us of UNOS’ response to the request that we and others made that OPTN/UNOS reopen the comment period for the Proposal to Update and Clarify Language in the DCD Model Elements in order to enable the development and submission of comments by organizations representing people with spinal cord injuries, brain injuries and neuromuscular disabilities. We are grateful that the UNOS Board withdrew the proposal for later reissue and solicitation of public comment.
This proposal only came to our attention in early November, but we are interested in providing preliminary comments to the original March 2011 proposal in the hope that they may be of some value if there is enough time to consider them prior to reissuing the proposal.
Section C – Candidate Evaluation
The specific language changes in the proposal regarding Section “C” on “Candidate Evaluation” shown below are most relevant to our concerns:
A potential DCD donor should be evaluated by the primary healthcare team and the local OPO to determine if the candidate meets the following criteria:
A patient with a permanent and irreversible neurological injury (i.e. upper spinal cord injury), or permanent and irreversible disease (i.e. end-stage musculoskeletal or pulmonary disease) that results in necessary life-sustaining medical treatment or ventilated support may be a suitable candidate for DCD.
A patient with end-stage musculoskeletal disease, pulmonary disease or upper spinal cord injury may also be a suitable DCD candidate.
Clearly, the deletion of the sentence, “Before evaluating a patient as a DCD candidate, the hospital’s primary healthcare team and the legal next of kin must have decided to withdraw ventilated support or other life-sustaining treatment and that decision must be documented in the patient’s chart,” eliminates the bright line between the decision to withdraw life-sustaining treatment and the evaluation of a donor candidate. Deleting the word “then” from the second sentence in the same paragraph further highlights the loss of this important protection.
The specifically named targets for this change in the protocol are people with upper spinal cord injuries, and “end-stage” musculoskeletal or pulmonary disease that requires ventilated support or other life-sustaining medical treatment. It should be noted that people with musculoskeletal diseases sometimes require feeding tubes due to swallowing problems, even though they may not require ventilation. It’s unclear if such persons would also qualify as “end-stage.”
In any case, the new protocol raises the concern that the potential for organ donation could become a factor that weighs in favor of a decision to withdraw life-sustaining treatment. This concern is relevant whether the decision maker is the disabled individual, who may be going through difficult changes in his or her health or other circumstances, or a surrogate decision-maker, who may be a caregiver or have other complex personal and conflicted interests in the decision.
Section F – Pronouncement of Death
As we mentioned in our previous letter, another concern about the proposed changes centers on the appropriateness of the sentence added to Section F, “Pronouncement of death can only be made after a sufficient time period has passed, as defined by hospital policy.” Deferring to “hospital policy” to define when death occurs for purposes of organ procurement raises the concern that a person could be considered dead in one hospital and not in another. There is obvious pressure to shorten the waiting time in order to enhance the quality of organs for transplant.
The newly injured are at the greatest risk for being declared dead prematurely. In the experience of people with disabilities, there is tremendous variation among physicians in the accuracy of their predictions about health and disability outcomes, and this variation appears to be not simply based on medical skill, but on personality and values as well. “Hospital policy” in any given institution may be as much a reflection of personality and internal politics as medical science and is, therefore, difficult to justify as a basis for establishing the number of minutes or seconds that are required to determine whether circulatory function has irreversibly ceased as a prerequisite to organ procurement.
A recent study from Canada acknowledged the subjective nature of neurological prognostication and the significance of this issue in connection with organ procurement policies.
The subjective nature of neuroprognostication may lead to variability in the incidence of death associated with the withdrawal of lifesustaining therapy. With the recent advent of programs for organ donation following cardiovascular death, potential variability in mortality and withdrawal of life-sustaining therapy among patients with severe traumatic brain injury would be of major importance from a medicolegal perspective. The ethical debate surrounding organ donation following cardiovascular death having recently reached a public hearing highlights the need to improve our understanding of withdrawal of life-sustaining therapy for this specific population of patients. Turgeon, et al., Mortality associated with withdrawal of life-sustaining therapy for patients with severe traumatic brain injury: a Canadian multicentre cohort study, CMAJ DOI 10.1503/cmaj 101786 (August 29, 2011)
Though the study was conducted in Canada, the concern is applicable to U.S. hospitals as well.
Most importantly, we are concerned about people with significant disabilities who may be prospective organ donors based on surrogate decisions that may or may not reflect the individual’s wishes. The reality that such decisions may be made immediately following a traumatic injury, and may be influenced by a physician’s faulty predictions or “rush to judgment”, only serves to emphasize the importance of strict scientific criteria for determining death for purposes of organ procurement.
Moreover, many states have health care decisions laws that grant virtual carte blanche decision making authority once a diagnosis of “persistent vegetative state” (PVS) has been rendered. The fact that such diagnoses are often made before an appropriate waiting period has elapsed (one year for traumatic brain injury and three months for anoxic brain injury – Childs NL, Mercer WN, Childs JW. Accuracy of diagnosis of persistent vegetative state. Neurology 1993; 43: 1465-1467), and the fact that PVS diagnoses have a high rate of error (Andrews, Murphy, Munday and Littlewood, Misdiagnosis of the vegetative state: retrospective study in a rehabilitation unit, British Medical Journal 1996;313:13-16 (6 July)), have not been factored into the statutory language in terms of added safeguards that the diagnosis is accurate. Nor, as yet, have recent developments involving people who wake up after being administered a specific drug resulted in new safeguards to protect individuals from precipitous and irreversible decisions that end their lives.
OPTN/UNOS should and must take these factors into account in proposing changes to the DCD Model Elements.
Thank you again for your time and attention. We look forward to reviewing the proposal when it is reissued, and will also be glad to assist in ensuring that appropriate disability organizations are informed of the proposal and have an opportunity to submit comments as well.
Diane Coleman, J.D.
Not Dead Yet
497 State Street
Rochester, NY 14608