Whether we are renewing our driver's licenses, watching the TV news or just picking up a newspaper, it's impossible to miss the campaign to persuade us to sign an organ donation card. We see story after story about how grieving relatives have been comforted by donating a loved one's organs after a tragic death, and how grateful the people are whose lives have been changed by the "gift of life".
But in the understandable zeal to save or extend as many lives as possible through organ transplantation, are some ethical boundaries being crossed? A case in point is the newer issue of non-heart-beating organ donation (NHBD), which comprises about 2% of all organ donations now but is expected to increase with more widespread use.
While most public information about organ donation emphasizes that organs can be taken only after "all efforts to save your life have been exhausted" and brain death has been determined, in the past decade a little-known innovation has been changing these rules. Now, organ donation can occur in a person who is not brain dead but whose relatives have agreed to withdraw a ventilator (a machine that supports or maintains breathing) and have the person's kidneys, liver or pancreas removed when the heartbeat stops.
When organ transplantation was first attempted, organs were taken from people who had recently died. These organs usually failed, however, because they had deteriorated too much during the dying process.
In 1968, an ad hoc committee at Harvard recommended a new way of determining death -- the loss of function of the entire brain. This is commonly known now as brain death. Before this, only the irreversible loss of heart and breathing function (cardiac death) had been generally used to determine the point of death.
Brain death has been promoted as a method to determine death when a person is on a ventilator but still has a pulse, blood pressure and other signs of life. Brain death holds that the lack of functioning of the entire brain is the truest sign of death and that the rest of the body soon stops functioning even if the ventilator is continued. The immediate clinical benefit of adopting this new method of determining death into law was that vital organs like the heart, liver and kidneys could be removed ("harvested", in transplant terminology) while still functioning, and would therefore be more likely to be transplanted successfully. In brain death organ donation, the ventilator is continued until the organs are removed.1 In all states now, death can be legally determined either by the traditional irreversible cardiac death or by brain death.
While questions about brain death are still being debated in ethical circles, it is now apparent that the number of organs from people declared brain dead will never be enough to treat all patients who need new organs. Thus, in the past decade, doctors and ethicists have turned to a new source of organs -- patients who are not brain dead but who are on ventilators and considered "hopeless". In these patients, the ventilator is withdrawn and organs are quickly taken when cardiac death rather than brain death is pronounced. This is known as non-heart-beating organ donation. At the present time, about half of all organ procurement organizations have been involved in at least one NHBD procedure, even though most people are unaware of this new method of obtaining organs.
One of the first and few public discussions of NHBD in the media occurred in April 1997 when the CBS television program 60 Minutes aired a segment on NHBD, which began with the case of a young woman who was shot in the head and, although not brain dead, was judged to be fatally injured and a perfect candidate for NHBD. However, the medical examiner that conducted a later autopsy said that he believed the gunshot wound was survivable. This led narrator Mike Wallace to question the little-known NHBD policies at some hospitals that would allow taking organs for transplants from persons who could be, in Wallace's words, "not quite dead".
The 60 Minutes segment went on to examine the proposed NHBD policy at a Cleveland hospital that included potentially dangerous drugs such as Heparin (a blood thinner) and Regitine (a drug that dilates blood vessels) to help preserve the donor patient's organs before death. This prompted a local prosecutor to raise the specter of such policies "seeking to hasten the deaths of terminally ill patients to obtain their organs for transplant".2 At the program's end, Wallace predicted that as a result of the broadcast NHBD was unlikely to continue. But he was wrong.
Transplant organizations immediately condemned the 60 Minutes segment as inaccurate and unfair and defended NHBD as an ethical way to obtain organs after death. By December, the Institute of Medicine (IOM), the research arm of the National Academy of Sciences, delivered a report on NHBD. While the report admitted that some hospitals were using questionable methods to get organs for transplants, it called NHBD "ethically acceptable" and called for more research and the setting of national standards for NHBD. This 1997 IOM report3 did not address all issues, such as standards for withdrawal of treatment decisions, but instead made recommendations such as having transplant surgeons wait five minutes after the heart stops before harvesting organs. After this report, the brief flurry of media interest in the topic dissipated.
However, in 2000, the IOM issued a follow-up report4 that found that almost none of the recommendations made about NHBD were now being followed universally. Even more shocking, the 2000 report revealed that the participants in the report could not reach a consensus on even such basic issues as whether conscious people on ventilators should be allowed to donate organs using NHBD. Despite this, the report still encouraged all organ procurement organizations to use NHBD.
Although, as the IOM report showed, there are great variations in NHBD procedures among various hospitals, NHBD is generally divided into "controlled" and "uncontrolled" categories. Controlled NHBD refers to situations where a decision is made to withdraw a ventilator, wait for the heart to stop (cardiac death) and then rapidly remove the person's organs before he or she deteriorates. Uncontrolled NHBD refers to situations where a person suddenly dies and cannot be resuscitated. In uncontrolled NHBD, tubes are then inserted into the donor and cold preservation fluid is instilled to preserve the organs until transplantation. Since such cases occur in an emergency situation, this method of preserving organs also gives time to notify family members and obtain consent for the donation. While legal in a few states, the uncontrolled NHBD procedure is not often done due to cost, technical difficulties and public resistance to starting preservation of organs before family consent is obtained. We will therefore only examine the more common controlled NHBD procedure.
Although controlled NHBD policies vary widely, once the decision to withdraw treatment is reached, medications such as blood thinners and blood vessel dilators are often started to preserve the potential transplant organs. NHBD supporters deny that such medications harm a potential donor, but even an accidental administration of such medications to an average patient would be considered a serious, reportable mistake.
When the ventilator is removed, doctors wait for the patient's heart and breathing to stop, declare cardiac death either immediately or after a waiting period of two to five minutes and then begin to take the organs in an operating room. The legal standard of irreversible cardiac death is considered met because the decision has already been made not to restart the heart by cardiopulmonary resuscitation (CPR) and the heart is not expected to resume beating on its own. Even though brain death is not a requirement in NHBD, some NHBD supporters maintain that the brain death soon follows when the heart and breathing stop, despite animal studies and CPR experience itself, which show that even complete recovery of consciousness is possible after several minutes if resuscitative efforts are successful.
If, as sometimes happens, the potential NHBD patient does not stop breathing as expected and continues to have a heartbeat, doctors usually wait an hour before canceling the transplant. Since the decision to withdraw treatment has already been made, the patient is then returned to the hospital room to eventually die without treatment being resumed.
Reports and articles supporting NHBD dismiss the withdrawal of the ventilator as an ethical problem because the withdrawal decision is supposed to be made before and independently of the NHBD decision. This crucial first step in NHBD may deserve the most scrutiny, however. As the 2000 Institute of Medicine report states, "controlled non-heart-beating organ donation cannot take place unless life-sustaining treatment is stopped".5 Thus, innovations such as the "living will" and other advance directives, as well as "right to die" court cases allowing the withdrawal of even basic treatment from non-dying people, were crucial to the development of NHBD.
The 1997 IOM report describes the potential non-heart-beating donor as follows: "These patients are either competent with intolerable quality of life or incompetent, but not brain dead because of severe, generally neurological, illness or injury with an extremely poor prognosis as to survival or any meaningful functional status". Note that this description includes not only patients on a ventilator who are judged to have little potential for a "meaningful" life but also fully conscious people who find their lives "intolerable". Indeed, one of the first patients considered for NHBD was a conscious, 48-year-old woman with multiple sclerosis who asked to have her ventilator stopped and her organs donated.6 This particular patient unexpectedly continued to breathe after the ventilator was removed and by the time she actually died, her organs were felt to have deteriorated too much for transplantation. Still, the 2000 IOM report acknowledged that such requests still occur and found no agreement among their ethicists and doctors as to whether such conscious terminally ill or disabled people should be granted such requests.
This intersection of the "right to die" and organ donation is condemned by many people, including disability advocate Diane Coleman, who has predicted that "there is going to be growing pressure on disabled people who are dependent on life support to 'pull the plug'. Allowing them to believe that they are being altruistic by doing so through organ donation will only increase the pressure on disabled people to choose to die in the belief that by giving their organs up, their lives can have some meaning. The danger is especially acute for people who are newly disabled, many of whom believe, falsely, that their lives can never be worth living".7
In the case of the incompetent (unconscious or otherwise unable to make medical decisions) patient, there are other serious ethical concerns about NHBD, including what and who determines a "meaningful functional status" for such a vulnerable patient. Although supporters of NHBD insist that withdrawal of ventilators is legally and ethically allowable because such patients are "hopeless", these decisions are routinely being made because of potential quality of life concerns rather than ability to survive. NHBD policies also avoid the question of how quickly the determination of such hopelessness is being made. This can have dire consequences for the NHBD patient.
For example, in a January 2000 Nursing Library journal article8, nurse Myra Popernack describes the case of a 16-year-old car accident victim who, two days after his accident, was evaluated as a potential organ donor. The doctor told the family that their son was not brain dead but would remain in a "vegetative" state and "probably could not survive without continued life support", even though the so-called permanent "vegetative" state is supposed to be determined only after at least three months. The family agreed to withdraw the ventilator and have a non-heart-beating organ donation.
In this case, the young man unexpectedly continued breathing after the ventilator was withdrawn and the transplantation procedure was canceled. He was returned to his room where no treatment was resumed except for pain medication and, of course, he eventually died. Ironically, the family was so upset by all this that they refused to even donate tissues like corneas and bones after their son died. Despite this outcome, the nurse-author was still enthusiastic about NHBD.
This case is not unusual and it should raise concerns about denying such patients even a chance for recovery. For instance, I have been involved in a similar case where a chaplain in a Catholic hospital asked the mother of a teenage accident victim about organ donation shortly after her daughter was injured. The mother was horrified and refused. Her daughter was able to get off the ventilator and breathe on her own a few days later. Although this young girl is still disabled, she has defied the doctor's early prognosis that she would be a "vegetable".
Contrary to many people's perceptions, a ventilator is most often a short-term therapy used to support a patient's breathing during a crisis until he or she can resume breathing without assistance. In the past, traditional ethics have allowed for the withdrawal or withholding of any treatment if that treatment was futile in terms of survival or excessively burdensome to the patient. However, that principle has become so corrupted that even such basic care or treatment such as food, water and crucial medications like insulin or heart medicine are now being withdrawn to make sure a person dies sooner rather than later or does not continue to live with a diminished quality of life.
In cases of severe head injuries, strokes or other critical conditions that can qualify a patient for NHBD, it is virtually impossible at the beginning to accurately predict whether the patient will die or what level of recovery he or she may eventually attain. As a nurse for 34 years, I have personally seen many such patients, who initially needed a ventilator and who were even expected to die, go on to completely recover.
Organ donation can truly be "the gift of life", and innovations such as adult stem cells and the donation of a kidney or part of a liver by a living person generally pose no ethical problems and hold much promise to increasingly meet the needs of people with failing organs. In 2001, the Lancet, a British medical journal, reported on a case in Sweden where doctors were able to successfully transplant lungs one hour after a woman died after a failed resuscitation.9 Unfortunately, the recipient later died from causes unrelated to the transplant, but such a case may mean that, in the future, organs may be retrieved without depending on a withdrawal-of-treatment decision coupled with a rapid declaration of death and organ removal. And, of course, tissues such as corneas, skin and bone can be donated up to several hours after a natural death.
But the laudable goal of saving more lives through transplantation cannot sacrifice ethical principles or occur without vigorous public scrutiny. The quiet implementation of an innovation like NHBD is disturbing, especially when people are urged to sign an organ donor card with little or no awareness of what that action can mean. While most people who sign such cards believe that only a careful determination of brain death will allow their organs to be removed, such cards do not say how death will be actually determined. In one study, organ donation was canceled in about one-third of cases because the criteria for brain death could not be met.10 Thus, NHBD is also seen as a "fall back" position to get those organs anyway, as well as from cases involving withdrawal of treatment decisions.
There is also the danger of NHBD allowing society to slide even further down the slippery slope of the "right to die". The issue of choice already often overrides traditional ethics when life or death issues are involved. Right now, some prominent ethicists are also proposing that the definition of brain death be expanded to include patients with lesser brain damage, so that even more organs can be obtained for transplantation. Doctor Michael DeVita, a doctor supporting NHBD, has even predicted that, "if assisted suicide becomes acceptable, then a discussion about organ donation is probably reasonable".11
Organ donation has become a kind of sacred cow -- in our society today no one is supposed to criticize any aspect of it lest lives be lost. But as in any other issue involving ethical principles, we must be sure that a desired good end does not justify any and every means of accomplishing that end. The practice of NHBD needs public scrutiny and reevaluation.
3 Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement (1997), Institute of Medicine. National Academy Press. Available online at http://books.nap.edu/books/0309064244/html/index.html [Back]
6 Michael A. DeVita and James V. Snyder, "Development of the University of Pittsburgh Medical Center Policy for the Care of Terminally Ill Patients Who May Become Organ Donors after Death Following the Removal of Life Support" in Procuring Organs for Transplant, ed. Robert M. Arnold, et al. (Baltimore: Johns Hopkins University Press, 1995), p. 58. [Back]
8 Myra L. Popernack, "Are We Overlooking a Hidden Source of Organs?", Nursing Library, January, 2000. Available online at http://www.findarticles.com/cf_dls/m3231/1_30/58916375/p1/article.jhtml [Back]
11 Dr. Michael DeVita, PBS News hour online forum: Organ Transplant Controversy, January 2, 1998. Available online at http://www.pbs.org/newshour/forum/january98/organ5.html [Back]