The following letter was sent by Not Dead Yet:
June 14, 2012
John R. Lake, M.D.
Board of Directors
Organ Procurement and Transplantation Network/United Network on Organ Sharing
700 North 4th Street
Richmond, VA 23218
Dear Dr. Lake:
I am writing as President and CEO of Not Dead Yet, a national disability rights organization. Not Dead Yet’s primary goals are to oppose legalization of assisted suicide from a secular disability rights perspective and to oppose various forms of nonconsensual withholding of life-sustaining treatment from people with disabilities. The purpose of this letter is to provide comments on the Proposal to Update and Clarify Language in the DCD (Donation after Cardiac Death) Model Elements.
Failure to Acknowledge and Outreach to Affected Groups
At the outset, I note that the listing of “Affected Groups” at page 1 and 2 of the public comment notice includes “Donor Family Members” but not Prospective Donors. Since the protocol explicitly contemplates conscious donors who may choose to donate their organs following withdrawal of life-sustaining treatment, this appears to be a significantly affected group. This raises the question, raised in our preliminary comments, about whether OPTN/UNOS has again failed to solicit comments from organizations representing the affected groups who qualify as prospective donors.
Addition of the Term “Disease” Handled in a Misleading Manner
The public comment notice states, “Please comment on what impact the following changes in terminology might have on your institution: … The addition of the term “disease” which is included in the suitable candidate evaluation section.”
According to the public comment notice:
While rare, DCD donation may occur in patients that do not have a neurological injury, but a disease that renders them ventilator dependent (i.e. amyotrophic lateral sclerosis). As such, the term “disease” was included in the language that describes suitable candidate conditions. This change will be more specific in allowing these candidates to grant first person consent for donation and make these Model Elements more consistent with current practice.
The notice refers to “a disease that renders them ventilator dependent (i.e. amyotrophic lateral sclerosis).” The use of “i.e.” rather than “e.g.” suggests that ALS is the only disease that may render someone ventilator dependent. Obviously, this is not the case, as other neuromuscular disabilities, such as muscular dystrophy and spinal muscular atrophy, as well as post-polio syndrome are among the “diseases” that can require the use of a ventilator to sustain life. In fact, I myself have a progressive neuromuscular disease which is likely to make me ventilator dependent in the future. If people with all of the relevant conditions were indicated, rather than the one condition which the public has been conditioned to view as invariably and rapidly terminal (i.e. ALS), OPTN/UNOS might anticipate a broader and more concerned reaction to the proposed revisions.
Furthermore, it must be noted that the previous, and withdrawn, proposal specifically mentioned people with “upper spinal cord injury” as DCD eligible. Among the national organizations that contacted OPTN/UNOS expressing concern about the previous proposal was United Spinal. The new proposal no longer mentions spinal cord injury separately, but subsumes this under the category of “neurological injury.”
It should also be noted that the DCD Model Elements that went into effect in July 2007, when these issues were not on the disability community’s “radar screen”, specifically provided that “A patient . . . who has a non-recoverable and irreversible neurological injury resulting in ventilator dependency but not fulfilling brain death criteria may be a suitable candidate for donation after cardiac death. Other conditions [may] include end stage musculoskeletal disease, pulmonary disease, and high spinal cord injury.” (See Steinbrook, R, Organ Donation After Cardiac Death, N Engl J Med 357;3, p. 212, July 19, 2007.)
It’s difficult to escape the conclusion that the 2012 proposal language has been manipulated to avoid flagging disability groups that represent people who are now classified as potential DCD candidates. At the same time, the language encourages institutions to tap into “currently unrealized donor potential” by notifying them of the eligibility of these same groups.
Failure to Restore the Ethical Safeguard of Separation Between Organ Procurement and Decision to Withdraw Life-Sustaining Treatment
The 2007 NEJM article cited above discussed ethical concerns about DCD as follows:
[S]ome physicians and nurses at the bedside “continue to have concerns about the ethical propriety of the practice” that “are numerous, complex and related to the specific roles they play.” Some feel uncomfortable about participation in medical practices that may be required during the transition from end-of-life care to organ donation. For example, in multidisciplinary ICUs, doctors and nurses who care for both potential organ donors and organ recipients may have conflicting interests. They may be uncomfortable recommending the withdrawal of life-sustaining treatment for one patient and hoping to obtain an organ for another. (Steinbrook, pp. 210-211.)
The public comment notice acknowledges that the previous proposal in 2011 generated comments urging revisions to:
Explicitly endorse in the Proposal the longstanding ethical safeguard that the donor family not be approached about organ donation until the time at which a decision to withdraw life sustaining measures has been agreed to by the patient’s next of kin, as recommended by the Institute of Medicine. The proposed Requirements remove the important stipulation separating patient care from donation solicitations. Whereas previously the hospital’s primary healthcare team and the legal next of kin must have decided to withdraw ventilated support or other life-sustaining treatment before the patient is evaluated as a DCD candidate, under the proposed policy a patient may be evaluated as a DCD candidate prior to a decision by family members and caregivers, which ought to be free from external pressure. Gone is the crucial wall separating patient care from donation solicitations. Such undue influence on difficult decisions at a heart-wrenching time is ethically unacceptable.
In response to this entreaty, the public comment notice states:
- The OPO [Organ Procurement Organization] Committee disagrees with the position that a patient may not be evaluated as a DCD candidate prior to a decision by family members and caregivers to withdraw life sustaining measures.
- The OPO Committee disagrees with the position that a donor family not be approached about organ donation until the time at which a decision to withdraw life sustaining measures have been agreed to.
- The OPO Committee noted that the deleted language “the hospital’s primary healthcare team and the legal next of kin must have decided to withdraw ventilated support or other life-sustaining treatment before the patient is evaluated as a DCD candidate” in the original proposal was included then deleted during the drafting of the original proposed changes.
- That language has never been included in any version of the bylaws.
The implication that the ethical principle of separation between health care treatment decisions and organ procurement has never existed is an effort to rewrite history. In 2000, the Institute of Medicine recommended that “the decision to withdraw life-sustaining treatment should be made independently of and prior to any staff initiated discussion of organ and tissues donation.” Committee on Non-Heart Beating Transplantation Ii, Institute Of Medicine, Non-Heart-Beating Organ Transplantation: Practice and Protocols 16 (National Academy Press 2000).
More recently, Arthur Caplan, a leading bioethicist based at the University of Pennsylvania Medical Center, noted:
From its early days, transplant policy in the United States and in nearly every other nation with a donation system made a clear division between those health professionals with responsibility for the best interests of very sick patients with healthy organs and those responsible for very sick patients who needed healthy organs. . . . Increasingly, those who request organs and tissues are attempting to approach families before their loved ones are dead. Some organ procurement teams are subtly shifting the criteria by which death is pronounced in order to maximize the odds of obtaining a transplantable vital organ. (A Caplan, Going Too Extreme, pp. 30-31, Bioethica Forum / 2010 / Volume 3 / No. 2)
The public comment notice continues its attempt to justify abandonment of the ethical principle of separation by citing a federal regulation that “hospitals are obligated to notify OPOs about ‘individuals whose death is imminent, or who have died’.” (CFR 42, Volume 3, Revised October 1, 2004, Chapter IV, Part 482: Sec.482.45). Thus, the referral to an OPO could occur prior to the family being aware of donation options. The public comment notice also states that “the evaluation of a patient as a potential organ donor can be facilitated without OPO communication with the family” and that this evaluation could occur prior to a decision to withdraw treatment.
This proposed justification raises several questions. If the use of a ventilator would enable an individual to live for an extended period of time, and the decision to withdraw the ventilator has not been made, then how could that individual be identified as someone “whose death is imminent” for purposes of referring the individual to the OPO under the federal regulation? What would an evaluation of a live potential donor consist of that does not require patient or health care proxy consent? Would the true purpose of the evaluation procedure be disclosed or hidden from the patient or family if and when consent is secured?
In short, the justification fails to make sense, much less provide an ethical basis for allowing OPO involvement with individuals for whom a decision to withdraw treatment has not been made. People who would not die but for the removal of life support should not have the presence of OPO personnel or the prospect of organ donation suggested in any way as a potential factor in the decision to withdraw a ventilator or other life sustaining treatment. Any implication that a person’s organs are valued more than their life is unacceptable. The separation between health care decisions and organ procurement must be restored and carefully observed in policy and practice.
Failure to Provide Safeguards for Conscious Individuals
As noted above, the proposed changes affecting people who depend on ventilators “will be more specific in allowing these candidates to grant first person consent for donation and make these Model Elements more consistent with current practice.” The separation between health care decisions and organ procurement is perhaps most essential for individuals who are considering ending their lives through withdrawing a ventilator or other form of life sustaining treatment.
About 15 years ago, a disabled friend wrote a public letter to Jack Kevorkian about her father who had ALS. She opposed Kevorkian’s activities, telling of how she had convinced her father to try living on a ventilator when he progressed to the point of needing one. He went home from a Denver rehabilitation facility using a ventilator and enjoyed two more years with his family. On the day he was discharged, the nurses told the family how much they wished more doctors and families would support this option, saying that he was only the second person in many years to go home on a vent.
People with disabilities know that the decision to refuse life sustaining treatment can be very complex, and many of the factors are psychological, social and even economic in terms of the residential and home care options available.
In contrast, the public comment notice sounds like an insensitive bureaucrat wrote it:
The OPO Committee noted that there have been cases when the OPO is contacted by the hospital when patients have irrecoverable, ventilator dependant, devastating neurologic injuries or illness and the patient is making the decision to withdraw the ventilator or cardiopulmonary assist device. This level of autonomy is consistent with the Federal Patient Self Determination Act of 19901. In these cases, the OPO and hospital have a legal obligation to honor the patients advance directive which may include organ donation. Good end-of-life care would dictate that if the patient has questions or requests information regarding the donation process, then both the OPO and the hospital should cooperate to ensure that the patient receives the information required to make an informed decision.
Back in the 1980’s, several court cases involving young men on ventilators established the right to refuse treatment, using a similarly superficial approach. Men like Larry McAfee and David Rivlin did not want to be stuck in a nursing facility and, in essence, said “give me liberty or give me death.” (Applebome, P, An angry man fights to die, then tests life, New York Times, Feb. 7, 1990, http://www.nytimes.com/1990/02/07/us/an-angry-man-fights-to-die-then-tests-life.html?pagewanted=all&src=pm.) The courts uniformly ignored the demand for freedom from confinement in a nursing facility and the need for home care, and uniformly found a “right to die.” Years later, one of the bioethicists involved in the Rivlin case issued an apology to the disability rights activists who criticized these rulings:
I am now embarrassed to realize how limited was the basis on which I made my decisions about David Rivlin. In hindsight, it has been very well documented that there was no medical need for Rivlin to be effectively incarcerated in a nursing home. If Rivlin had been given access to a reasonable amount of community resources, of the sort that other persons with disabilities were making use of at the time, he could have been moved out of the nursing home and probably could have had his own apartment. He could have been much more able to see friends, get outside a bit, and generally have a much more interesting and stimulating life. The reasons he gave for wanting to die were precisely how boring and meaningless life was for him.
This is the key lesson that disabilities advocates are trying to teach the rest of us. If we look at a case one way, it seems that the problem is the person’s physical disability. If we shift our view, we realize that the problem is not the disability, but rather the refusal of society to make reasonable and not terribly expensive accommodations to it.
There’s every reason to believe in hindsight that David Rivlin died unnecessarily, and that we who claimed to care about his “rights” should have been demanding that services be made available for him rather than that he be allowed to die. As one who argued the wrong thing back then, I apologize for my shortsightedness. Brody, H, A bioethicist offers an apology, Health, Oct 6 2004, http://www.lansingcitypulse.com/lansing/archives/041006/features/health.asp
OPTN/UNOS has made similar mistakes, which should be corrected rather than being again codified into public policy. While the organ procurement community is not solely responsible to develop safeguards to ensure that an individual’s decision to withdraw life sustaining treatment is truly informed and voluntary, that community can certainly call for appropriate safeguards, help ensure that the disability community’s leadership in developing safeguards is respected and followed, and draw a firm line between organ procurement efforts and health care decisions.
Incorrect Language Suggesting That Next of Kin May Overrule Patient or Designated Agent
The public comment notice states:
For the purpose of obtaining authorization for a DCD recovery, “legal next of kin” can include any of the following:
1. the patient who consents to be an organ donor candidate
2. the next of kin as defined by state or local law
3. the designated health care agent
As worded, this could be taken to imply that any of the above could authorize DCD in a specific case. In each specific case, only one of the three can authorize DCD, depending on patient capacity and state surrogacy law. In general, the designated health care agent trumps the next of kin, and the patient trumps both. The language should be clarified to avoid the potential for misunderstanding.
Violations of Civil and Constitutional Rights of People With Disabilities
On May 24, 2012, the National Disability Rights Network (NDRN) issued a groundbreaking report condemning third party decisions to withhold medical treatment including hydration and nutrition from individuals with disabilities without a terminal condition or permanent unconsciousness as a denial of the basic constitutional and civil rights of individuals with disabilities. NDRN is the national association of the federally funded protection and advocacy agencies in all 50 states, charged to protect the civil rights of people with disabilities. (These should not be confused with adult protective services.) The NDRN Report states:
In recent years, new types of assistive and medical technology and procedures have emerged that allow people with disabilities, even those with the most significant disabilities, to live longer lives and improve their quality of life to live outside of institutions in their own homes in the community. The legacy of eugenics however, and the basic discriminatory structures that underlie it, are still powerful factors in medical decision making by some doctors and surrogate decision makers for people with disabilities. These technologies and procedures have not only been used to enhance quality of life, but they have also been used, at times, to reinforce social policies that devalue people with disabilities and keep them separate from community life. In fact, there are times, as this report will describe where physicians recommend and family or other surrogate decision makers decide to not provide a needed transplant, to withhold medical treatment including hydration and nutrition of individuals without a terminal condition, or to sterilize people all on the basis of their disabilities. Applied in these ways, medical decision making and procedures are discriminatory and deny basic constitutional rights to individuals with disabilities including the rights to liberty, privacy, and other statutory and common law rights. Devaluing People with Disabilities: Medical Procedures that Violate Civil Rights, at pp. 10-11. http://www.ndrn.org/images/Documents/Resources/Publications/Reports/Devaluing_People_with_Disabilities.pdf
The NDRN report states that reliance on ethics committees and consultations are insufficient protections of a patient’s legal rights and that hospitals and other providers must “establish and implement due process protections to ensure the civil rights of a person with a disability are protected . . . .” Too many in the health care system have given virtual “carte blanche” powers to surrogates so long as they decide to deny life-sustaining care. This is not acceptable.
The procedures outlined in the DCD proposal, and the existing practices on which they are said to be based, appear to treat people who depend on a ventilator or other form of life support, but are not otherwise terminally ill (e.g. from end stage cancer), as though they are expendable commodities rather than people. These individuals are singled out for discriminatory treatment by those who pursue what would otherwise be a laudable and noble goal. What has already transpired and what is proposed as policy must be revisited and revised to give full weight to the civil and constitutional rights of individuals with the most significant disabilities. And that process cannot take place without the substantial involvement of people who themselves depend on ventilators and other forms of life-sustaining treatment as well as those who advocate on their behalf.
If there are any questions concerning these comments, please don’t hesitate to contact me …
Diane Coleman, J.D.
Not Dead Yet
497 State Street
Rochester, NY 14608